Canada Gazette, Part I, Volume 151, Number 3: Safe Food for Canadians Regulations

January 21, 2017

Statutory authority

Safe Food for Canadians Act

Sponsoring agency

Canadian Food Inspection Agency

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive summary

Background

Evolution of food safety risk

Canada has one of the best food safety systems in the world but this system must continue to strengthen the oversight of foods that are increasingly at risk of contamination. These high-risk foods include fresh fruits and vegetables and prepared foods that do not fall under the current commodity-based regulations (i.e. foods from what is known as the non-federally registered sector [NFRS]).

As consumers demand more convenient, ready-to-eat products (e.g. bagged salads), the risk of exposure to hazards also increases since these products are intended to be consumed without further cooking. Consumers also increasingly expect foods to be available year-round, which increases demand for imported foods (especially fresh fruits and vegetables) that are often sourced from countries with underdeveloped food safety systems (e.g. from some countries in South America).

The volume of fresh fruits and vegetables and NFRS foods being imported into Canada has approximately doubled, from $11.7 billion in 2006 to $22.8 billion in 2015. With respect to fresh fruits and vegetables, a 43% increase in imports of these products from South America has been observed over the past four years.

Over the same period, an increase in food safety issues has been observed from all domestic and foreign sources. From 2011 to present, there have been 84 recalls related to fresh fruits and vegetables as well as 1 573 recalls related to food from the NFRS. Together, these represent more than 70% of all recalls over this period.

The new risks with fresh fruits and vegetables are of particular concern, as a preventive food safety oversight program does not currently exist for this sector in Canada. As a result, identification of a food safety hazard is often only possible after illnesses have been reported, rather than through early detection and intervention prior to the entry of food into the retail market. A 2013 study in the Journal of Food Protection demonstrated that from 2001 to 2009, 27 fresh fruit and vegetable–related outbreaks occurred in Canada and resulted in over 1 500 cases of illness.

The import-related aspect of this risk was illustrated by an incident that resulted in a Canada-wide Salmonella outbreak in 2014. This outbreak was linked to numerous products derived from imported chia seeds and prepared in Canada. It required the recall of 24 products from 9 different manufacturers, with many of these products being from the NFRS. This comprehensive recall was made more complex because of the absence of licensing, preventive control, and traceability requirements for those who imported and prepared these products. The absence of such requirements made it difficult for the CFIA to identify affected food businesses and ensure that the products were removed from the marketplace.

In addition, high-profile food safety incidents have also been associated with food from federally registered establishments and have highlighted other areas where the food safety system could be strengthened. For example, a listeriosis outbreak over the summer and fall of 2008 spanned five provinces and resulted in 57 human illnesses and 23 deaths. The costs (including medical costs, non-medical costs, productivity losses and federal government costs) associated with this outbreak were estimated to be approximately $242 million. The outbreak was eventually linked to ready-to-eat meat products and a subsequent independent report on the outbreak contained several recommendations for the CFIA. These included suggestions for simplifying and modernizing regulations in accordance with preventive food safety practices and for requiring regulated parties to make the CFIA aware of food safety issues in a timely manner.

A 2012 E. coli outbreak associated with meat products resulted in the largest beef recall in Canadian history, involving the recall and disposal of 12 million pounds of meat products. There were 18 confirmed illnesses and significant economic effects (costs estimated at between $16 million and $27 million) associated with this outbreak. The recommendations that were generated following this incident noted that, among other things, the CFIA did not possess the power to compel regulated parties to provide adequate documentation in the event of a significant food safety incident.

These events have highlighted the scale and interconnected nature of current production systems, and have also shown that contamination can occur at any stage along the import, preparation and distribution chains. These events also underscore the value of preventive approaches (e.g. licensing, preventive controls, and traceability) and the central role that industry has in producing safe food by preventing incidents before they occur rather than dealing with contaminated food once it is on the market.

In light of these challenges, supporting public health and instilling confidence in Canada's food system remain key priorities for the CFIA's Food Safety Program. This program aims to mitigate risks to public health associated with diseases and other health hazards related to the food supply system and to manage food safety emergencies and incidents. The Program achieves its objectives by promoting food safety awareness and verifying compliance by industry with science-based regulations. The program also delivers initiatives to ensure that consumers receive food safety and nutrition information, and to mitigate unfair market practices that affect consumers and industry. Collaboration with other governments and stakeholders further enhances the Agency's ability to track, detect and mitigate risks associated with food and the food supply system, including food-borne illness.

Legislative and regulatory context

Five pieces of legislation govern this program: the Canada Agricultural Products Act (CAPA), the Consumer Packaging and Labelling Act (CPLA), the Food and Drugs Act (FDA), the Fish Inspection Act (FIA), and the Meat Inspection Act (MIA).

The regulatory framework underpinning the CFIA's Food Safety Program is composed of 13 different regulations (plus 2 additional regulations: the Food and Drug Regulations [FDR] and the CPLR). These include regulations made under the CAPA, the FIA, and the MIA, which cover nine food commodities (i.e. dairy, fish and seafood, fresh fruits and vegetables, honey, maple products, meat, processed eggs, processed [fruit and vegetable] products, and shell eggs).

For each of these food commodities, the CFIA operates separate food safety, consumer protection, and inspection programs. With respect to foods, there are additional requirements found in the Licensing and Arbitration Regulations (LAR), the Livestock and Poultry Carcass Grading Regulations, the Icewine Regulations, and the Organic Products Regulations, 2009.

When it comes fully into force, the SFCA, which received royal assent on November 22, 2012, will repeal and consolidate the CAPA, the FIA, the MIA and the food-related provisions of the CPLA. Once the SFCA is fully in force, all food in Canada within the mandate of the CFIA would be regulated by two federal legislative regimes — the SFCA and the FDA.

International context

Internationally, the CFIA leads the Government of Canada's implementation of the World Trade Organization's Agreement on the Application of Sanitary and Phytosanitary Measures, and plays a significant role in the three official international standard-setting bodies (ISSBs) to promote science-based international standards. In the case of food, Codex Alimentarius (Codex) standards provide the foundation for robust domestic regulatory systems and contribute to a predictable trade environment, reducing business risks and facilitating market access.

These international approaches to food safety are changing quickly. Codex maintains food standards, guidelines and codes of practice that promote the use of systems-based, preventive approaches to food safety that include Hazard Analysis and Critical Control Point (HACCP) (see footnote 3) principles, Good Manufacturing Practices (GMPs), and Good Agricultural Practices (GAPs). These approaches address safety and quality along the entire food production and distribution continuum by identifying and controlling hazards in order to prevent food safety problems. These systems-based approaches recognize that those who prepare or import food have the primary responsibility for the safety of their products and must implement preventive programs to identify and control hazards.

Other countries have made significant progress adopting the approaches described by Codex as they modernize their own food safety systems. For example, the United States (U.S.) has introduced the Food Safety Modernization Act (FSMA) and associated regulations that grant new and expanded authorities to the U.S. Food and Drug Administration to enhance the safety of the U.S. food supply. Canada and the United States are working together to harmonize regulatory approaches between the two countries where possible, including approaches on food safety. Under the Regulatory Cooperation Council (RCC), the CFIA has been working with its counterparts in the U.S. Department of Agriculture and the U.S. Food and Drug Administration on a number of food safety initiatives, some of which will be furthered by the proposed Regulations.

Issues

Food-borne illness remains a significant public health concern in Canada that causes approximately four million illnesses annually (one in eight Canadians), which results in approximately 238 deaths and 11 600 hospitalizations. A conservative estimate of the annual economic cost to Canadians, the national economy and the health care system is $2.8 billion. (see footnote 4) Recent food safety incidents have demonstrated that changes in consumer preferences and production and distribution systems have produced new food safety challenges. Today, when problems occur, they can affect more products more quickly, and cross into different sectors, into different countries and affect businesses regardless of their size.

Canada's current federal food regulatory framework has varying requirements and approaches for nine specific food commodities, and has not been regularly updated or streamlined since the CFIA's creation in 1997. It has no federal requirements for registration or licensing, preventive controls or traceability for food prepared in or imported into Canada other than for some of these nine specific food commodities. As a result, foods prepared in Canada or imported into Canada are not all subject to the same regulatory requirements, and some food safety requirements do not reflect advances in technology, science and food safety best practices.

For example, all food is subject to the FDA, which contains a broad prohibition against the sale of unsafe food; however, this Act does not require licences or registrations for food businesses. It also does not require all food businesses to put in place preventive controls or preventive control plans that are based on HACCP principles. This means that the large majority of foods prepared in Canada or imported into Canada are not subject to preventive approaches. Examples of foods in this category include spices, snack foods, bakery products, fats and oils, and infant formula. In practice, this means that preparation and import of these foods, which can be as risky as the preparation of foods of federally registered establishments (e.g. meat), are not subject to the same requirements given that the applicable legislation does not include the same requirements or inspection tools.

These differing approaches among food sectors pose a significant challenge to the CFIA's goal of managing risks consistently across different types of establishments and foods. Differing approaches also mean that businesses involved with multiple food commodities need to meet varying requirements in different regulations, which places an additional burden on these stakeholders.

Further hindering the creation of a level playing field for all Canadian food businesses is the requirement that food businesses producing food that incorporates more than one commodity (e.g. a pepperoni pizza) have to comply with multiple sets of applicable requirements (e.g. requirements for grading, labelling, container sizes and weights) in regulations made under the CAPA, the FIA, the MIA and the CPLA. Also, with respect to many exported food products, the CFIA does not have the legislative authority to issue certificates that may be required by foreign countries. This may impede market access for some Canadian businesses.

Canada must also keep pace with international food safety standards, and changes to the food safety systems of Canada's trading partners so that Canadian food exporters can continue to enjoy access to foreign markets. Taken together, these factors are hindering the creation of a level playing field for all Canadian food business establishments, and have highlighted areas where the current food regulatory framework could be modernized.

Objectives

The key objectives of the proposed Regulations are to

• apply internationally recognized standards for food safety to food that is imported into or prepared in Canada for interprovincial trade or for export. This would better prevent food safety incidents and assist in rapidly removing unsafe food from the market when incidents occur;
• support market access for Canadian exporters by keeping pace with food safety modernization efforts in other countries, such as the United States, who are moving to systems-based approaches, and strengthening Canada's reputation for having a world-class food safety system; and
• consolidate 13 food commodity-based regulations plus the food-related provisions of the CPLR to a single set of more outcome-based requirements (i.e. requiring an expected result instead of listing steps to achieve the expected result), where appropriate. This would improve consistency, enable innovation and flexibility, and level the playing field across foods and between importers and domestic preparers of food for export or interprovincial trade.

Description

The proposed Regulations contain 17 parts and would include requirements respecting the following: Trade; Licences; Preventive Control Measures; Traceability; Commodity-specific Requirements; Recognition of Foreign Systems; Ministerial Exemptions; Inspection Legends; Packaging; Labelling; Grades and Grade Names; Seizure and Detention; and Organic Products. Some of these requirements would be phased in to reflect different levels of industry readiness and the concerns of small businesses that are involved in importing food, or preparing food for export or for interprovincial trade.

The SFCA also provides for authority to incorporate by reference in the Regulations documents that are internally or externally generated as of a particular date or that may change over time. The flexibility to change an incorporated document would allow the CFIA to make its regulatory framework more responsive to concerns of industry and consumers by responding more promptly, where necessary, to modern science and innovations, which might otherwise require regulatory change. Before making changes to internally generated, incorporated documents that may change from time to time, the CFIA would consult with stakeholders in a similar way as consultations for regulatory changes and in accordance with the CFIA's Incorporation by Reference (IBR) Policy. (see footnote 5)

Key food safety elements

The proposed Regulations would establish three key food safety elements:

• (1) Licences: Under the proposed Regulations, licences would be required for food importers, for persons (e.g. food businesses) preparing food for export or for interprovincial trade, with some exceptions (as described in the section “Exceptions and Exemptions”), and for persons slaughtering food animals from which meat products for export or interprovincial trade may be derived. Licence applications would require certain information from the applicant regarding their identity (e.g. business name) and business activities, which would inform risk-based oversight. The proposed licence would be valid for a period of two years for a fee of approximately $250, and could be suspended or cancelled in cases of non-compliance. Regulated parties would be able to apply for one or multiple licences.
• (2) Traceability: The proposed Regulations would apply the international standard for traceability established by Codex to persons importing, exporting and interprovincially trading food, as well as to other persons holding a licence issued under the SFCA, and to growers and harvesters of fresh fruits or vegetables that are to be exported or traded interprovincially. Electronic or paper records would be required to be prepared and kept in order to track food forward to the immediate customer (e.g. a retailer or another food business) and backwards to the immediate supplier (i.e. one step forward, one step back along the supply chain). Retailers would not be required to trace forward their sales to consumers.
• The proposed Regulations would require that traceability information be provided, upon the Minister's request, within 24 hours, or some shorter period, if the information is considered necessary to identify or respond to a risk of injury to human health, or some longer period if the information is not considered necessary for a recall that is or may be ordered. The information would need to be provided in French or in English and, where electronic, in a format that could be imported and manipulated by standard commercial software. The information would need to be accessible in Canada.
• (3) Preventive controls and preventive control plan (PCP): The proposed Regulations would require food subject to the Regulations and activities (e.g. importing, preparing meat products for export or interprovincial trade) to meet food safety requirements and that those activities be conducted in a manner that is consistent with internationally recognized agricultural and manufacturing practices (i.e. GAPs, GMPs and HACCP). The proposed Regulations would address the following key preventive control elements:

• sanitation, pest control, and non-food agents;
• conveyances and equipment;
• conditions respecting establishments;
• unloading, loading and storing;
• competency (i.e. for staff);
• hygiene;
• communicable diseases and lesions; and
• investigation and notification, complaints and recall.

In addition to the three key food safety elements, certain commodity-specific requirements for food safety would remain in place where appropriate. For example, the current regulations require imported meat products to be sourced from a country with an inspection system that is approved by the Minister under the MIA. This requirement would be maintained in the proposed Regulations.

With some exceptions, regulated parties would be required to produce and maintain a written PCP demonstrating how the preventive controls and other requirements (e.g. for packaging and labelling) are met. Where appropriate, regulated parties would have the flexibility to apply the preventive controls and other measures on an outcome-based approach that demonstrates that their operations and food products comply with the proposed Regulations.

The steps related to the preparation of a PCP would be based on HACCP principles and would include, where applicable,

1. a description of the biological, chemical, and physical hazards that could contaminate the food, the measures used to prevent or eliminate those hazards, and evidence that the measures are effective;
2. a description of critical control points (steps at which a control can be applied and that is essential to prevent or eliminate the hazard), their related control measures, and evidence that they are effective;
3. a description of the critical limits (i.e. the limit at which a hazard is acceptable without compromising food safety) for each critical control point;
4. the procedures for monitoring the critical control points in relation to their critical limits;
5. a description of the corrective action procedures for each critical control point;
6. a description of the procedures used to verify the implementation that the PCP meets the requirements of the SFCA and the proposed Regulations; and
7. documents that demonstrate that the information has been recorded and that the PCP has been implemented with respect to the foregoing.

Subject to certain exceptions (described in the subsequent section entitled “Exceptions and exemptions”), a written PCP would be required for

• every licence holder who imports food or prepares food to be sent or conveyed from one province to another;
• every person who grows or harvests fresh fruits or vegetables to be exported or to be sent or conveyed from one province to another;
• every licence holders preparing fish products or meat products to be exported; and
• every person, including a licence holder, exporting food who requires or requests an export certificate from the CFIA.

Exceptions and exemptions

Based on an analysis of the food safety risk, an exception and several exemptions are set out in the proposed Regulations.

An exception from the written PCP requirements is proposed for some regulated parties that generate $30,000 or less in annual gross food sales (i.e. micro-sized businesses). This exception would not apply to regulated parties that slaughter food animals from which meat products for export or inter-provincial trade are derived, or that prepare meat products, dairy products, fish, eggs, processed egg products, or processed fruits and vegetables, or if an export certificate is requested.

Exemptions from licensing, preventive controls, and written PCP requirements are also proposed, unless an export certificate is requested, for

• alcoholic beverages;
• food additives; and
• some unprocessed foods that will be further prepared (e.g. grains, oilseeds, pulses and other foods such as green coffee beans and hops). These foods must be labelled with the words “For Further Preparation Only”, and may not be prepackaged food for consumers. These foods are listed in a schedule to the proposed Regulations.

The proposed Regulations would also include certain exemptions similar to those that exist in current federal regulations, such as food for personal use, food carried on any conveyance that is intended for the crew or passengers, or food for analysis, evaluation, research, or a food exhibition provided that the food is part of a shipment that weighs 100 kg or less or, in the case of eggs, is part of a shipment of five or fewer cases. Food that passes only in transit through Canada is also proposed to be exempt, provided the shipment travels in bonds.

Importation of non-compliant food or interprovincial trade of non-compliant food to be subsequently brought into compliance (e.g. through relabelling the food) would be permitted provided that the food is imported by a licence holder, is clearly labelled with “For Further Preparation Only” and is brought into compliance within three months from the day on which it was imported or traded interprovincially, unless a longer time period is granted by the Minister.

Export

Under the SFCA, the Minister may issue export certificates. The proposed Regulations would provide the process by which a regulated party may request an export certificate where one is requested to, for example, fulfill a foreign government requirement. Under the proposed Regulations, exporters would be permitted to meet foreign customer requirements that differ from certain requirements of the Regulations, if those differences are substantiated by documentation (e.g. a contract or a description of a foreign government requirement).

Membership requirements for buyers and sellers of fresh fruits and vegetables

The Licensing and Arbitration Regulations would be repealed, and the proposed Regulations would require that buyers and sellers of fresh fruits and vegetables be members of the Fruit and Vegetable Dispute Resolution Corporation (DRC) to obtain an exemption from the trade of fresh fruit or vegetable provisions in Part 2, Division 2 of the proposed Regulations. The DRC is a non-profit, membership-based organization serving the produce sector that offers dispute resolution services (e.g. mediation and arbitration) to its members. It should be noted that over 80% of fresh fruit and vegetable buyers and sellers are already members of the DRC.

Meat

Proposed changes to existing requirements for meat would increase alignment with requirements for other foods regulated by the CFIA to the extent possible given meat-specific food safety risks. For example, current mandatory inspection requirements for all imported meat products would be removed, and replaced with targeted inspection requirements based on risk. Also, mandatory licensing of meat storage facilities would be removed except for persons who would handle and store imported meat products for inspection.

Exemptions from some existing meat product–specific requirements are proposed for meat products that contain a mixture of ready-to-eat meat and other non-meat ingredients (e.g. frozen pepperoni pizza). The proposed Regulations would treat these meat products more similarly to all other prepared foods.

Recognition of foreign systems

The proposed Regulations would prescribe the standards to be met for the Minister to recognize a foreign system of inspection for meat products and shellfish, and to recognize systems for preparing meat that are used in meat product establishments. The proposed Regulations would also provide for circumstances in which ministerial recognition must be suspended or cancelled. When the SFCA fully comes into force, systems that are recognized under the MIA or FIA would continue to be recognized under the proposed Regulations.

Ministerial exemptions

The authority for the Minister to exempt food from requirements for the purpose of test-marketing a food that is new or of alleviating shortages would be expanded to all foods. Ministerial exemptions could be granted only when they would not result in a risk of injury to human health and, with regards to test-market exemptions, when they would not confuse or mislead the public or disrupt the normal trading patterns of industry or the normal patterns of food pricing.

Inspection legends

Provisions related to inspection legends that exist in current commodity-specific regulations made under the CAPA, the FIA and the MIA would be carried over under the proposed Regulations.

Container sizes and standard weights

Requirements for standard weight and container sizes that currently exist in commodity-specific regulations under the CAPA, the MIA, the FIA and the CPLA would be included in the proposed Regulations.

Labelling and standards of identity

The proposed Regulations would make some changes to requirements relating to labelling and standards of identity provisions (e.g. for processed eggs). Proposed changes would group similar provisions together and reduce duplication and differences where possible.

Labelling provisions would be included in the body of the proposed Regulations whereas standards of identity would be incorporated by reference in the proposed Regulations and maintained by the CFIA (in accordance with CFIA's Incorporation by Reference Policy).

Existing requirements of the CPLA and its regulations apply to prepackaged food sold in Canada, including food sold within a province, and have been included in the proposed Regulations. The intra-provincial application of these requirements would be maintained.

Grade requirements

Grade requirements in existing regulations would be consolidated into two documents (noted below) that would be incorporated by reference in the proposed Regulations:

1. The proposed Beef, Bison, and Veal Carcass Grade Requirements would be maintained by the Canadian Beef Grading Agency (CBGA) according to conditions outlined in a Memorandum of Understanding between the CBGA and the CFIA; and
2. The proposed Canadian Grade Compendium would consolidate all other Canadian grade requirements in a single document organized by commodity and maintained by the CFIA.

Organic products

Under the Organic Products Regulations, 2009, only producers of organic products and anyone labelling and packaging organic products are required to be certified. The proposed Regulations would expand certification to also include other service providers to allow organic integrity to be maintained along the entire supply chain. In addition, the proposed Regulations would include the organic certification of aquaculture products.

Regulatory and non-regulatory options considered

1. Status quo

The SFCA would not come fully into force and the strengthened authorities provided by the Act would not be put in place. Moreover, the opportunity to streamline and consolidate the existing varying requirements would be lost. Maintaining the status quo would not address new risks facing the Canadian food safety system posed by the continued globalization of the food supply, new products and processing methods, lessons learned from recent food safety incidents, and changing consumer preferences. In addition, the Canadian system would not incorporate new food safety approaches that are internationally accepted and being adopted by Canada's trading partners which could result in market access issues for Canadian producers.

2. Regulatory option

The regulatory option was chosen, as it is the most effective way to respond to the challenges and opportunities posed to the food safety system as the food industry, global trade in food, food safety risks and food safety risk mitigation approaches all evolve. While this would place additional costs on certain sectors of Canadian industry, the regulatory option is the best means for protecting Canadians from food safety risks while creating a more level playing field for Canadian food businesses.

Benefits and costs

The cost-benefit analysis assessed the potential incremental impacts of the regulatory proposal's coming into force. The potential impacts (i.e. costs and benefits) represent the incremental differences between the baseline and regulatory scenarios.

The baseline scenario describes the situation under the current regulatory framework and what it would look like in the future if the proposed Regulations do not come into force.

The regulatory scenario describes the future situation if the proposed Regulations do come into force.

Due to the scope of the proposed Regulations, baseline and regulatory descriptions of only the most significant elements of the proposal are presented here. All of the baseline and regulatory descriptions have been documented in a cost-benefit analysis report, which is available by request.

Baseline

Overarching description

Current regulations under the CAPA, FIA, MIA and the food-related provisions of the CPLA would continue to exist and be enforced. Foods that are not covered by the current regulations under the CAPA, FIA and MIA would continue to be covered primarily by the FDA and FDR.

Licensing

In general, the CFIA registers some establishments and maintains requirements for some importers and operators to be licensed.

The current licensing and registration requirements as they exist under the CAPA, FIA and MIA regulations are as follows:

• Dairy Products Regulations — dairy establishments are registered and cheese importers are licensed
• Egg Regulations — egg (shell) establishments are registered
• Processed Egg Regulations — processed egg establishments are registered
• Processed Products Regulations — processed product establishments are registered
• Fresh Fruit and Vegetable Regulations — voluntary registration for certain warehouses. This covers packers of potatoes (grown in and shipped from Nova Scotia, New Brunswick, Prince Edward Island, Quebec and Ontario) and apples (grown in and shipped from Nova Scotia, New Brunswick, Quebec, Ontario and British Columbia)
• Honey Regulations — honey establishments are registered
• Maple Products Regulations — maple establishments are registered
• Meat Inspection Regulations, 1990 — meat establishments are registered and every operator of a registered establishment is licensed
• Fish Inspection Regulations — fish establishments are registered and fish importers are licensed
• Non-federally registered sector — these commodities (i.e. food other than that subject to regulations listed above) are not subject to the current regulations under CAPA, FIA and MIA and therefore have no registration or licensing requirements.

There are no required intraprovincial licences or registrations administered by the CFIA.

Preventive controls and preventive control plans (PCPs)

Some food sectors have implemented food safety plans, based on HACCP principles, to demonstrate how they achieve compliance (for example voluntary Food Safety Enhancement Program [FSEP] and Quality Management Program [QMP]) with regulatory requirements. These are the current industry practices based on regulatory coverage:

• Dairy Products Regulations — voluntary registration for the FSEP. Once recognized, the FSEP requirements detailed in CFIA manuals are mandatory
• Egg Regulations — voluntary registration for the FSEP. Once recognized, the FSEP requirements detailed in CFIA manuals are mandatory
• Processed Egg Regulations — voluntary registration for the FSEP. Once recognized, the FSEP requirements detailed in CFIA manuals are mandatory
• Processed Products Regulations — voluntary registration for the FSEP. Once recognized, the FSEP requirements detailed in CFIA manuals are mandatory
• Fresh Fruit and Vegetable Regulations — some fresh fruit and vegetable primary producers and packers voluntarily use CanadaGAP® (a food safety plan that uses HACCP principles); other primary producers and fresh fruit and vegetable handlers (e.g. packers, fresh-cut operators) may have food safety systems implemented due to customer requirements (e.g. supermarkets)
• Honey Regulations — voluntary registration for the FSEP. Once recognized, the FSEP requirements detailed in CFIA manuals are mandatory
• Maple Products Regulations — voluntary registration for the FSEP. Once recognized, the FSEP requirements detailed in CFIA manuals are mandatory
• Meat Inspection Regulations, 1990 — every operator of an establishment registered under the MIA and Meat Inspection Regulations (i.e. slaughter, processing/boning/cutting/labelling, etc., and storage — dry/cold) is required to carry out control programs in accordance with the FSEP Manual and the Meat Hygiene Manual of Procedures (MHMOP) adequate for their activities. Additionally, no meat product (as per requirements of the MIA and Meat Inspection Regulations, 1990) may be exported unless it meets the export requirements (e.g. it needs to be prepared in a registered establishment in which valid control programs [FSEP, MHMOP] are implemented and maintained)
• Fish Inspection Regulations — all fish processors (interprovincial) are required to have QMP. Some importers voluntarily follow QMP (i.e. they are not required to). As for exporters, most exports come from QMP establishments and those from non-registered establishments use voluntary protocols
• Non-federally registered sector — these commodities (i.e. food other than that subject to the regulations listed above) do not fall under the CAPA, FIA, or MIA regulations and therefore are not subject to mandatory preventive controls or preventive control plans.

Traceability

While many regulated parties in the food sector have implemented voluntary traceability systems, others do not have the necessary practices, including record keeping, to facilitate timely food safety investigations, recalls or withdrawals. The resulting information gaps within the food supply chain may lead to less efficient and inaccurate responses to a food safety incident.

Currently, there are some traceability regulatory requirements for the fish and meat sectors. It should be noted that the CFIA Act provides the Minister with the authority to order a food recall.

Regulatory scenario

Overarching description

The proposed Regulations under the SFCA would come into force and replace the current regulations under the CAPA, FIA, MIA, and the food-related provisions of CPLA. Foods that are not covered by the current CFIA food regulations under the CAPA, FIA and MIA would be covered by the proposed Regulations (as well as the FDA and FDR, as is the case with all food).

Licensing

The definition of “food commodity” in the SFCA is broader than the definition of “agricultural product” under the CAPA, “fish” under the FIA and “meat product” under the MIA. The proposed Regulations would extend licensing requirements to encompass all regulated parties who import food or prepare them for interprovincial trade or for export. This means that some regulated parties that prepare food destined for interprovincial trade or for export that are not currently regulated under the CAPA (e.g. cookies, cake mixes) would be required to have a licence under the SFCA. Also, all importers of food would be required to be licensed. The proposed Regulations would no longer provide for registration of establishments since licence holders would be subject to requirements related to the establishment where the food is being prepared. Additionally, anyone requesting an export certificate would require a licence.

PCP

A PCP is a written document that sets out how food safety and other regulatory requirements would be achieved. Preventive control requirements are a combination of control measures (including a PCP) that, when taken as a whole, provide for a science-based approach to managing risks posed by hazards and contribute to achieving compliance with other regulatory requirements.

Anyone who imports or prepares food commodities destined for interprovincial trade would be required to develop, document, maintain and implement a PCP as well as comply with the preventive controls applicable to their activities. Additionally, anyone who prepares food for export or exports food and who requires or requests an export certificate would be required to have a PCP. Note that fresh fruit and vegetable primary producers (i.e. persons who grow or harvest fresh fruits and vegetables regardless of how they are packaged) would be considered to be preparers of food when it comes to the proposed PCP requirements.

Some regulated parties would not be required to have a written PCP but would still be required to comply with the preventive control requirements. These parties include

• micro-businesses (i.e. less than or equal to $30,000 in annual gross sales) in the non-federally registered fresh fruit and vegetable, honey, and maple sectors; and
• preparers of food, other than fish and meat products, for export only that do not need or request export certification.

Traceability

The international standard for traceability established by Codex calls for tracking of food commodities forward to the immediate customer (e.g. a retailer or another food business) and trace materials / food commodities backwards to the immediate supplier (“one step forward, one step back”).

The proposed Regulations would apply the Codex standard to every stage of the food supply chain, from production to retail (excluding direct sales to consumers). This means that all licence holders and persons exporting or trading interprovincially would have to adhere to the traceability requirements. The requirements would also apply to growers and harvesters of fresh fruit or vegetables for export and interprovincial trade.

Affected stakeholders

Based on the differences between the baseline and regulatory scenarios, the following stakeholders would be affected by the proposed Regulations' coming into force:

• Food industry businesses
  • Preparers of food for interprovincial trade
  • Preparers of food for export
  • Food importers
  • Food exporters
  • Interprovincial traders of food
  • Fresh fruit and vegetable primary producers
  • Organic food industry, including certification bodies and conformity verification bodies
• Canadians (i.e. consumers)
• Government
  • CFIA
  • Health Canada
  • Canada Border Services Agency (CBSA)
  • Public Health Agency of Canada
  • Provincial/territorial governments

Descriptions of the affected stakeholders have been documented in a cost-benefit analysis report, which is available by request.

Identified benefits and costs

This section provides a list and descriptions of some potential benefits and costs that the significant elements of the proposed Regulations may impose on affected stakeholders. These potential impacts represent incremental benefits and costs (i.e. those above and beyond the baseline).

The listing is broken up into categories based on benefits/costs that were monetized or benefits that were described qualitatively by the analysis. It should be noted that all significant costs were monetized by the analysis, so no qualitative costs are documented in the Regulatory Impact Analysis Statement (RIAS).

The descriptions of all of the potential benefits and costs have been documented in a cost-benefit analysis report, which is available by request.

Monetized benefits

Review time of CFIA food safety regulations

In the baseline, there are 13 separate sets of CFIA food regulations that need to be reviewed by the food industry, plus the food-related provisions of the CPLR that may need to be reviewed by the food industry (in addition to the FDR). In comparison, in the regulatory scenario, there would only be a single set of CFIA food regulations to be reviewed. As a result, businesses would only need to review one set of regulations instead of potentially multiple sets (e.g. a meat industry business would no longer need to consult the Meat Inspection Regulations, the Livestock and Poultry Carcass Grading Regulations [if applicable], and the CPLR).

Additionally, the proposed regulatory text would be current, and it is expected that the regulatory review time would be reduced, as some of the current CFIA regulations were drafted decades ago and use regulatory text that is outdated and that differs from regulation to regulation. An example of this is in the Fish Inspection Regulations where, unlike in the Meat Inspection Regulations, the definition of exports also includes interprovincial trade.

No establishment registration applications

Establishments that are currently required to be registered under the CAPA, FIA, and MIA regulations would no longer need to be registered in the regulatory scenario. Therefore, establishment managers would no longer have to take the time to register. Registration requirements vary across the current regulations, but generally, establishments are required to renew their registrations annually.

Note that the analysis included currently licensed fish or cheese importers in this benefit.

Streamlined/integrated export certification process

Currently, export certification processes differ across the various food commodities. One commonality is that export certification applications are submitted to the CFIA via fax or email. With the current system, applicants receive application status updates by contacting the CFIA and receive their export documents from the CFIA.

The proposed licensing requirements would be supported by a new automated electronic system that would streamline the export certification process. Licence holder information (e.g. licence number, name of licence holder, address[es] of establishment[s]) would be integrated into an online export certification application form. This would provide consistency and efficiencies for both exporters and the CFIA. Additionally, this integration would allow applicants to receive status updates online and print issued certificates online.

More efficient and effective food safety recalls and investigations

As a result of the proposed traceability requirements, recalls and investigations would be conducted in a more efficient and effective manner, which would minimize economic losses for affected businesses. Traceability information would be more readily available and precise. These factors would reduce the duration of recalls/ investigations and minimize unnecessarily wasted food through improved targeting of affected products, in comparison with the baseline scenario.

CFIA produce licence no longer required

Under the proposed Regulations, fresh fruit and vegetable dealers would not be required to have a CFIA produce licence. Therefore, dealers would no longer have to take the time to apply for a licence. However, this benefit would be diminished by the fact that the affected stakeholders would have to apply for DRC membership.

Qualitative benefits

Reduced food safety risk

There are approximately four million cases of food-borne illness annually in Canada. This means that one in eight Canadians is affected by food-borne illness every year. Annually, these illnesses result in 11 600 hospitalizations and 238 deaths. A conservative estimate of the annual economic cost this imposes on Canadians, the national economy and the health care system is $2.8 billion.

The proposed Regulations would have stronger food safety rules than the current regulations under the CAPA, the FIA and the MIA to mitigate the risk of food-borne illness by actively promoting the prevention of food safety incidents. Some examples of proposed requirements that would help achieve this are requirements for written preventive control plans in food sectors where none were previously required (e.g. currently the non-federally registered and fresh fruit and vegetable sectors).

While the magnitude of the positive impact that these stronger rules would have on the food safety risk for Canadians is uncertain since there was a lack of sufficient information to conduct a proper risk assessment/analysis, it would be reasonable to assume that these measures would reduce the risk to some degree, for the following reasons:

• preventive controls and PCP requirements would use a HACCP-based approach to food safety that is systematic and preventive (i.e. catch potential food safety issues before they happen)
• traceability requirements would enable a more rapid response to food safety issues, resulting in less unsafe food reaching consumers
• licensing requirements would provide the CFIA with a means of communicating with all regulated parties, which would facilitate an improved emergency response when food safety issues occur.

This reduction in risk would mean that the number of food-borne illnesses across Canada would be reduced when comparing the baseline scenario to the regulatory scenario.

This would in turn reduce the costs to

• Canadians
  • reduced number of premature deaths, cases of illness, chronic conditions (i.e.sequelae)
  • reduced drug treatment costs, caregiver costs, recovery costs
• the national economy
  • reduced productivity loss from worker absenteeism and workers coming in sick and not performing optimally
  • reduced number of food safety recalls that businesses need to address
• the health care system
  • reduced number of physician visits, hospitalizations, emergency room visits, clinic visits
  • reduced drug treatment costs.

Increased international regulatory alignment

Major trading partners, such as the United States, are adopting preventive controls in their regulatory approaches. Therefore, businesses that develop new PCPs (and/or follow the corresponding food safety HACCP-based requirements) due to regulatory implementation would benefit from increased alignment with international food safety requirements.

Also, international regulatory alignment would increase as a result of the move from differing prescriptive-based regulatory approaches for each regulated food commodity in the baseline to a single outcome-based (where appropriate) regulatory approach for regulated food commodities.

The increased international regulatory alignment has the potential to increase trade opportunities for the food industry as it would maintain existing market access opportunities for Canadian businesses and support their expansion. Without the proposed PCP and food safety requirements, Canada would be out of step with its major trading partners that are moving to a preventive control regulatory approach to food safety, and this would put market access at risk.

Outcome-based regulatory approach (where appropriate)

The current regulations under the CAPA, the FIA and the MIA primarily take a prescriptive approach to food safety, which has the potential to limit the way a food business can operate. In comparison, the proposed Regulations would reduce, where appropriate, the current prescriptive food commodity-specific requirements, by moving to a system of requirements that articulates the expected outcomes as they relate to food commodities.

This outcome-based approach would provide businesses with the opportunity for innovation without having to wait for regulatory changes to allow for it, which could lead to reduced compliance costs (e.g. processing costs) over time as businesses find more efficient/effective methods of compliance.

More level playing field for food industry

Currently, some food importers and preparers of food for interprovincial trade or for export have to comply with commodity-specific regulatory requirements while others do not. Also, some of these regulatory requirements, such as establishment registration and food safety plans, vary between different commodities.

With the proposed Regulations, the CFIA would move to a single-food regulatory approach. In general, this would mean that there would be a levelling of the competitive playing field for all regulated parties across commodities. Imports would be held to the same standards and requirements as domestic food.

Enhanced food safety reputation for Canada

The proposed Regulations would implement stronger food safety rules than are currently in place. The strengthened rules would generally apply, with some exceptions, to importers, and preparers of food for export and interprovincial trade and cover all food commodities.

This would enhance Canada's international reputation as a global food safety leader, which has the potential to lead to increased international trade opportunities for Canadian food businesses by helping to maintain their access to existing markets and support the development of new market access opportunities.

Reduced production costs for processed egg businesses

The processed egg standards of identity would require less egg solid in processing than is currently required. This would reduce production costs for a business that prepares processed egg products.

Additionally, this change would assist in improving the industry's international trade competitiveness.

Improved CFIA knowledge of food industry

Currently, the CFIA is knowledgeable about food establishments that are registered under the CAPA, FIA and MIA regulations, but has limited to no knowledge of food establishments not covered by these regulations.

As a result of the proposed licensing requirements, the CFIA would have improved knowledge of the entire food industry. More specifically, the Agency would know who is importing food, preparing food for interprovincial trade or export, or exporters who require export certification. This would provide the CFIA with a means of communicating with all regulated parties, which would facilitate an improved emergency response when food safety issues occur. Additionally, the CFIA would be able to more strategically and efficiently focus its food safety efforts based on risk as a result of this improved knowledge.

Moreover, the CFIA would have improved knowledge of the food industry, as the proposed PCP requirements would allow for a consistent single-food inspection approach. This would facilitate a more comprehensive assessment of Canadian food safety, as inspection findings from different food commodity sectors would be directly comparable.

Monetized costs

Licence applications

In the regulatory scenario, all food importers or preparers of food for interprovincial trade or for export would be required to obtain a licence from the CFIA. Additionally, exporters that need export certification would need a licence. In order to obtain this, a business would have to take the time to apply to the Agency. Licences would be required to be renewed every two years.

It should be noted that the licensing fee was not included in this cost, as fee charges are considered to be transfer payments and should not be regarded as economic costs, as per Treasury Board of Canada Secretariat (TBS) cost-benefit analysis guidance. (see footnote 6)

Development and documentation of PCPs

All food importers or preparers of food for interprovincial trade, and preparers of meat and fish products for export, subject to certain exceptions, would be required to develop and document a PCP in the regulatory scenario. The analysis assumed that this would be done at the establishment level. Costs associated with this would include the time needed to complete the plan and potentially hiring external expertise for assistance. It is also expected that the costs associated with PCP development and documentation would increase with the volume and the complexity of the activities being carried out by a food business.

When an export certificate is requested, the exporter and the preparer of the food for export would be required to have a PCP.

Implementation of preventive controls and PCPs (i.e. food safety requirements)

Once a PCP has been developed and documented, it would have to be implemented. Costs that would be associated with this would include implementing new preventive controls, training and education for employees, equipment changes, verification that preventive controls are working and record keeping. As mentioned above, the magnitude of this cost would increase with the volume and complexity of a food business.

Some stakeholders who are not required to have a written PCP would still be required to have preventive controls (i.e. food safety requirements) in place.

Maintenance of PCPs

Where a PCP is required, it would need to be maintained in order to comply with regulatory requirements, and adapt to new or changing establishment practices. It is assumed by the analysis that this would occur on an annual basis.

Development of traceability systems

In the regulatory scenario, persons importing, exporting and interprovincially trading food, as well as other persons holding a licence issued under the SFCA, would be required to maintain traceability records. Therefore, traceability systems would need to be developed by these businesses. This would include the costs associated with developing traceability procedures and policies, and tools to be used with the system. The magnitude of this cost would be dependent on the current traceability practices of stakeholders and the scale and size of industry operations being considered.

Implementation of traceability systems

Under the proposed Regulations, businesses would be required to have a traceability system in place. In general, these systems would need to be implemented at the establishment level. (see footnote 7) Implementation means that regulated parties would have to prepare and keep records on the food commodities supplied to them and the food supplied by them, as well as the locations to which they move foods, and incorporated or source food commodities, before supplying a food to another person.

CFIA regulatory implementation

For the CFIA, regulatory implementation would transform and modernize the Agency's approach to food safety. However, the CFIA would not require any additional food safety program or inspection funding or resources from current levels, as the proposed Regulations would allow the CFIA to operate more efficiently and redistribute its food safety resources more strategically. That said, there would be some additional CFIA resources required for compliance promotion and industry engagement when the Regulations come into force.

Methodology

This section briefly describes the methodology, data sources and key assumptions used to estimate the monetized (and quantified) benefits and costs. The entire methodology has been documented in a cost-benefit analysis report, which is available by request.

Number of affected food businesses and establishments

The following data sources were used to estimate the number of affected businesses:

• CFIA registered establishment and licence holder lists;
• Statistics Canada's Business Register data taken from the TBS Regulatory Cost Calculator; and
• CBSA importer databases.

The estimated number of affected businesses are presented in the table below.

Estimated number of affected businesses by the year the business would have to review the proposed Regulations

2018	2019	2020	2021	2022	2023	2024	2025	2026	2027	TOTAL
21 025	7 467	36 791	2 339	2 368	2 398	2 429	2 458	2 489	2 520	82 285

The analysis estimated that on average there are approximately 1.25 establishments per business.

Current industry practices

The analysis had to account for current industry practices in order to estimate the impacts of moving from the baseline to the regulatory scenario. For example, if a business or establishment is already implementing preventive controls and a PCP, then no costs or benefits would be realized by the business or establishment when the proposed preventive control and PCP requirements would come into force.

Accounting for current industry practices was based on data and information from the following:

• CFIA data on registered establishments that currently implement a HACCP-based food safety plan;
• CanadaGAP® data;
• Conference Board of Canada reports; and
• U.S. Food and Drug Administration (U.S. FDA) cost-benefit analysis.

Note that the analysis only used U.S. data in cases where no Canadian data was available.

Annual growth and turnover in the number of businesses and establishments

CFIA data for registered establishments and licensed importers from 2013 to 2016 was used to estimate the annual growth and turnover in the number of affected businesses and establishments.

Number of small and micro businesses

Data from the Business Register was used to estimate the number of small businesses impacted by the Regulations (i.e. businesses with less than 100 employees).

Model parameters and assumptions

The basic assumptions and parameters that were used in this cost-benefit analysis include the following:

• The analysis covered a 10-year time period from 2018 to 2027;
• Discount rate = 7%;
• All monetary values are represented using constant year 2012 prices; and
• Wage rate data was from Statistic Canada's Labour Force Survey (2012) and was obtained via the TBS Regulator Cost Calculator
  • Wage rates were increased by 25% to account for overhead costs, consistent with the methodology used by TBS.

Monetized benefits and costs

These were the general methodological models used to monetize the most significant impacts:

Benefits — More efficient and effective food safety recalls and investigations

• The costs of recalls and investigations for affected businesses would be reduced because of the proposed traceability requirements
• The following model was used to monetize this impact: CANRC × RSCOPE × NRC × (1 – TCOMP) = impact
  • CANRC — the cost of a Canadian food recall was estimated using a food industry article (see footnote 8) found in a literature review, which was adjusted to the Canadian context
    • The cost of a recall presented costs for a mid-sized processor ranging from $246K to $33.4M in U.S. dollars. These costs were converted to the Canadian context (e.g. size, distribution, productivity of Canadian businesses), which resulted in a range of $139K to $18.8M in Canadian dollars
    • The CFIA classifies recalls into one of three categories based on risk to public health of the unsafe food. It was assumed that a business involved in a
      • low-risk recall would incur the low end of the cost range (i.e. $139K)
      • high-risk recall would incur the high end of the cost range (i.e. $18.8M)
      • medium-risk recall would incur the mid-point of the cost range (i.e. $9.5M)
  • RSCOPE — percent reduction of the cost of a food recall due to traceability was estimated using a report produced for Agriculture and Agri-Food Canada in 2013
    • The report stated that traceability can reduce the scope of a recall by 50% and in some cases by 95%
    • These percentages needed to be lowered to account for the differences in the traceability information that would be required by the proposed Regulations and those presented in the report
    • The analysis assumed that implementing the proposed traceability requirements would reduce the cost of a recall by 25%. That said, there are currently traceability requirements for preparers in the meat and fish sectors. So it was assumed that the cost would be reduced by 12.5% in these sectors
  • NRC — the number of primary recalls (i.e. number of recall incidents, which may have resulted in one recall or multiple recalls) is based on information from the CFIA recall database
    • The estimated number of primary recalls for the base year (2014) was based on a 4-year average (2010−2013)
      • Class I (high risk) — 77
      • Class II (medium risk) — 85
      • Class III (low risk) — 102
  • TCOMP — the percentage of businesses that currently have traceability systems in place was based on a Conference Board of Canada report
    • The report stated that 66% of preparers of food for export or inter-provincial trade and 56% of food importers, exporters and inter-provincial traders have a traceability system in place
    • The analysis assumed that 66% of affected businesses have a traceability system in place and this was used as a proxy for the percentage of recalls where a traceability system would be in place (i.e. no benefit from the proposed requirements)

Costs — Development and documentation of PCPs

• These costs represent the time needed to complete the initial plan. The estimated average annualized costs for an impacted business to develop and document a PCP are $260
• The standard cost model (SCM) was used to monetize this impact (TIME × FREQUENCY × WAGE × POPULATION = impact)
  • TIME — estimates based on data/information from a USFDA cost-benefit analysis on the proposed Preventive Controls rule
  • FREQUENCY — this would be a one-time cost for establishments
  • WAGE — assumed a manager would perform this task
  • POPULATION — based on estimates of affected stakeholders

Costs — Implementation of preventive controls and PCPs

• These costs would include capital costs, training costs, activity costs and record-keeping costs. The estimated average annualized costs for an impacted business to implement preventive controls and a PCP are $6,370
• The SCM plus additional capital costs were used to monetize this impact
  • TIME — estimates based on data/information from the USFDA cost-benefit analysis on the proposed Preventive Controls rule
  • FREQUENCY — these would be ongoing costs for establishments
  • WAGE — there would be multiple tasks associated with these costs. Depending on the task, it was assumed a manager, supervisor or worker would perform the task
  • POPULATION — based on estimates of affected stakeholders
  • Additional costs — one-time costs (e.g. possible equipment purchases), which were estimated based on data/information from the proposed Preventive Controls rule cost-benefit analysis
• For those businesses that would not be required to have a PCP, there would still be costs associated with preventive control requirements. The estimated average annualized costs for an impacted business (i.e. eligible for the exception) to implement preventive controls are $3,826
  • all preventive control implementation costs would be carried by these businesses
  • the costs for these businesses are included in the “Preventive Controls for businesses exempt from PCPs” costs category in the Estimated Annualized Values of the Significant Impacts table in the “Estimated Results” section of the RIAS

Costs — Maintenance of PCPs

• These costs represent the time required to maintain a PCP. The estimated average annualized costs for an impacted business to maintain a PCP are $464
• The SCM was used to monetize this impact
  • TIME — estimates based on data/information from the USFDA cost-benefit analysis on the proposed Preventive Controls rule
  • FREQUENCY — these would be ongoing costs for establishments starting in the second year the PCP was in place
  • WAGE — assumed a manager would perform this task
  • POPULATION — based on estimates of affected stakeholders

Estimated results

The results for all estimated costs are presented as negative values (e.g. –$1), while results for all estimated benefits are presented as positive values (e.g. $1).

The estimated annualized values of the significant impacts detailed in the Methodological section are presented in the table below.

Estimated annualized values of the significant impacts (in Canadian dollars [CAD], constant year 2012 prices, 2018* present value [PV] base year, 7% discount rate)

Impact Category — Description	Annualized Values
Benefits
Review time of CFIA food safety regulations: Avoided time to review current regulations	$660,627
LICENSING
No establishment registration applications	$151,817
Streamlined / integrated export certification process	$1,170,009
LICENSING TOTAL	$1,321,826
TRACEABILITY
More efficient and effective food safety recalls and investigations	$136,435,001
TRACEABILITY TOTAL	$136,435,001
CFIA fresh fruits and vegetables produce licence no longer required	$3,761
Costs
Review time of CFIA food safety regulations: Proposed Regulations	-$1,139,190
LICENSING
Licence application	-$150,135
LICENSING TOTAL	-$150,135
TRACEABILITY
Development of traceability system	-$15,371
Implementation of traceability system	-$3,638,286
TRACEABILITY TOTAL	-$3,653,656
PREVENTIVE CONTROLS and PCPs**
Development and documentation of PCP	-$3,626,047
Implementation of preventive controls and PCP	-$88,888,284
Preventive controls for businesses exempt from PCPs	-$32,925,281
Maintenance of PCP	-$6,481,033
PREVENTIVE CONTROLS and PCPs TOTAL**	-$131,920,646
CFIA regulatory implementation	-$2,468,809

* The analysis covered a 10-year time period (2018–2027).

** Note that the benefits associated with preventive controls and PCPs, such as a reduced food safety risk, are included as qualitative benefits in the analysis.

The table below provides a summary of all of the potential benefits and costs associated with the regulatory proposal.

Cost-benefit statement (in millions of CAD, constant year 2012 prices, 2018* PV base year, 7% discount rate)

Costs, Benefits and Distribution	2018	2019	2020	2021	2027	Total (PV)	Annualized Value
A.1 Quantified Impacts ($) — BENEFITS
Food Industry — Small Businesses	$57.7	$59.7	$156.7	$160.0	$162.7	$943.6	$134.4
Food Industry — Medium / Large Businesses***	$1.3	$1.3	$3.4	$3.5	$3.5	$20.6	$2.9
CFIA	$0.0	$0.0	$0.0	$0.0	$0.0	$0.0	$0.0
Total Benefits**	$59.0	$61.1	$160.1	$163.4	$166.3	$964.2	$137.3
A.2 Quantified Impacts ($) — COSTS
Food Industry — Small Businesses	-$42.8	-$106.6	-$97.4	-$198.3	-$167.5	-$948.2	-$135.0
Food Industry — Medium / Large Businesses***	-$0.2	-$0.6	-$1.0	-$0.8	-$0.8	-$5.0	-$0.7
CFIA	-$3.3	-$4.2	-$4.1	-$4.1	$0.0	-$17.3	-$2.5
Total Costs**	-$46.3	-$111.4	-$102.5	-$203.2	-$168.3	-$970.6	-$138.2
NET BENEFITS						-$6.4	-$0.9
B. Quantified Impacts (in non-$) — Positive Impacts
Small Businesses — Number of new preventive control plans (PCPs) developed annually	3 563	2 909	1 257	3 098	540	13 915	1 392
Medium / Large Businesses — Number of new PCPs developed annually***	13	10	10	1	1	39	4
TOTAL — Number of PCPs developed annually	3 576	2 919	1 266	3 099	541	13 955	1 395
NOTES: * The analysis covered a 10-year time period (2018–2027). ** Numbers may not add up due to rounding. *** Medium / large businesses would not be as impacted by the proposed Regulations as small businesses since most medium / large businesses are already in compliance with the proposed requirements.
C. Qualitative Impacts Consumers
Positive Impacts Reduced food safety risk for Canadians, which would reduce occurrences of food-borne illness and thereby reduce costs to Canadians, the national economy and the health care system Increased confidence in the safety of domestic and imported food Increased knowledge of the food industry Increased compliance of imported food labels with Canadian food labelling requirements (e.g. bilingual labels) Increased confidence in organic aquaculture products and potentially increase consumer access to these products
Food Industry
Positive Impacts Level playing field regardless of the food commodity or whether it is domestic or imported food Enhanced reputation for Canada as a global food safety leader, which could lead to increased international trade opportunities as well as help maintain existing and support opportunities for new market access Increased international regulatory alignment with major Canadian trading partners (e.g. United States), which would help maintain existing and support opportunities for new market access Increased federal regulatory alignment with provincial/territorial food safety regulations in some cases, which has the potential to lead to domestic trade opportunities Increased opportunity for innovation (i.e. find more efficient and effective compliance methods) without having to wait for regulatory changes to permit it Regulatory ability to respond more rapidly to changes in industry and international grade standards Reduced communications with the federal government due to inconsistencies, misalignments, and interpretations of requirements from multiple sets of regulations Increased knowledge and self-awareness of their processes and production Food products that are a mixture of ready-to-eat meat and other non-meat ingredients would not be subject to all federal meat-specific requirements Reduce production costs for preparers of processed egg products Ministerial exemption application process would be streamlined, transparent and use a common approach system Market access could potentially improve for food sectors that could not previously be licensed or have access to formal CFIA export certificates Improved financial protection for fresh fruit and vegetable dealers Increased opportunity for organic certification and ability to market products with the Canadian Organic Logo Negative Impacts Currently the non-federally registered sector would have to label non-compliant food products when they are imported or conveyed to another province and would be brought into compliance through further processing Customs brokers that do not use the Integrated Import Declaration system of the Government of Canada's Single Window Initiative would have to adjust the Automated Import Reference System (AIRS) codes used to provide information to the CFIA
Federal Government
Positive Impacts The CFIA would take a consistent approach to food safety inspection and oversight, which would allow the Agency to be more effective and efficient Expanded food safety regulatory coverage to include all food commodities whether domestic or imported, which would improve the Agency's knowledge of the entire food industry and its practices The CFIA would be better able to trace and sanction fraudulent and deceptive practices, which can have food safety consequences, and other issues of regulatory non-compliance The Canadian Border Services Agency (CBSA) could benefit from a more streamlined approach at the border for food importers as a result of consistent admissibility requirements Health Canada and Public Health Agency of Canada (PHAC) would receive more accurate and timely information when specific food issue cases arise Reduced communications and discussions for Health Canada with industry and the CFIA due to inconsistencies, misalignments, and interpretations of regulatory requirements
Negative Impacts The CBSA would have to assist importers at the border that do not use electronic clearance and do not have a licence
Provincial and Territorial Governments
Positive Impacts Increase regulatory alignment with provincial/territorial food safety regulations in some cases Negative Impacts Need to update provincial/territorial regulatory references to CFIA food safety regulations

Sensitivity analysis

A sensitivity analysis is the portion of a cost-benefit analysis that attempts to deal with the uncertainty that is inherent in predicting the future. Sensitivity analysis involves changing key parameters and assumptions and assessing how this affects the costs and benefits of the regulatory proposal.

Given the scope of this cost-benefit analysis, there were many uncertain parameters and assumptions that could be varied for the sensitivity analysis. However, the analysis chose to focus on two key parameters and assumptions that affect basically all of the estimated impacts

• discount rate (3%, 7% and 10%); and
• annual industry growth rates (estimated growth used in the analysis +/- 3 percentage points).

In the case of the food industry growth rate, a higher rate would increase the estimated number of affected businesses, while a lower rate would decrease the number. As for the discount rate, a higher discount rate would place relatively less emphasis on estimated future impacts, while a lower rate would place relatively more emphasis on future impacts.

Note that the medium discount rate and medium food industry growth rates were used to estimate the base results of the cost-benefit analysis (i.e. the results presented in the Cost-Benefit Statement)

Sensitivity analysis — Cost-benefit summary table (CAD, constant year 2012 prices, 2018 PV base year)

Discount Rate	Food Industry Growth Rate	Annualized Benefits	Annualized Costs	Total (NPV)	Annualized Value
Low (3%)	Medium (annual growth rates)	$140,845,432	-$141,612,425	-$6,542,611	-$766,994
Medium (7%)	Medium (annual growth rates)	$137,282,025	-$138,193,247	-$6,400,040	-$911,222
High (10%)	Medium (annual growth rates)	$134,595,781	-$135,611,496	-$6,241,128	-$1,015,715
Low (3%)	Low (annual growth rates -3 percentage points)	$104,683,462	-$102,190,503	$21,265,454	$2,492,960
Medium (7%)	Low (annual growth rates -3 percentage points)	$102,844,957	-$100,527,494	$16,276,897	$2,317,464
High (10%)	Low (annual growth rates -3 percentage points)	$101,409,112	-$99,221,914	$13,439,382	$2,187,198
Low (3%)	High (annual growth rates +3 percentage points)	$188,989,219	-$196,073,050	-$60,426,520	-$7,083,832
Medium (7%)	High (annual growth rates +3 percentage points)	$182,800,561	-$189,866,397	-$49,627,478	-$7,065,836
High (10%)	High (annual growth rates +3 percentage points)	$178,228,444	-$185,278,187	-$43,317,618	-$7,049,743

The results of the sensitivity analysis suggest that the potential impact of the Regulations would be dependent on industry growth as the net impacts are positive in a low-growth scenario and negative in the medium- and high-growth scenarios.

Additionally, the sensitivity analysis examined the impact on the estimated results based on varying an assumption used for the benefit of more efficient and effective food safety recalls and investigations because of traceability (see table below). The assumption is that affected recalls would be evenly distributed among the risk classifications (i.e. low, medium, high). This assumption was made as food can become unsafe at any point along the food chain and the CFIA does not have information to indicate that the impacts on recalls would vary based on the different risk classifications.

For the sensitivity analysis, the assumption was varied where only low-risk recalls or high-risk recalls would be affected (see table below).

Sensitivity analysis — More efficient and effective food safety recalls and investigations (in millions of CAD, constant year 2012 prices, 2018 PV base year, 7% discount rate)

	Distribution of Impact on Recalls by Risk Classification
	Even Distribution	Only Impacts Low-Risk Recalls	Only Impacts High-Risk (and Some Medium-Risk) Recalls
Net Annualized Value	-$0.9	-$135.0	$134.7

This analysis shows how the estimated results are dependent on the assumed distribution. However, it should be noted that it is highly unlikely that all of the affected recalls would be either entirely high- or low-risk. This contributed to the rationale used by the analysis in choosing an even distribution.

Distributional analysis

In addition to the distributional impacts on small business presented in the Cost-Benefit Statement table, the analysis also examined the distribution of costs across the currently registered, fresh fruits and vegetables, and non-federally registered sectors. The annualized costs of the proposed Regulations are estimated to be distributed across these sectors as follows: federally registered sector — 23%, fresh fruits and vegetables sector — 35%, and non-federally registered sector — 42%.

The provincial/territorial distribution of establishments for food manufacturing and fresh fruit and vegetable producers is as follows: Alberta — 7%, British Columbia — 21%, Manitoba — 3%, New Brunswick — 4%, Newfoundland and Labrador — 2%, Nova Scotia — 4%, Ontario — 31%, Prince Edward Island — 3%, Quebec — 22%, Saskatchewan — 3%, and Northwest Territories, Nunavut and Yukon — 0.1%.

Conclusions

By focusing on the significant impacts of the regulatory proposal, the cost-benefit analysis estimated the annualized value of the costs and benefits would be approximately -$138.2 million and $137.3 million, respectively. In addition to the significant impacts that the analysis monetized, there would be numerous qualitative impacts including, but not limited to,

• a reduction in food safety risk for consumers by putting in place requirements that will support the prevention of food safety incidents before they occur;
• increased international and domestic regulatory alignment that will support the maintenance and expansion of market access for Canadian exports;
• an outcome-based regulatory approach (where appropriate) that results in a more level playing field for food industry businesses that provides them with opportunities for growth and innovation;
• a consistent and more effective food safety approach to inspection and oversight by the CFIA;
• the CFIA's food safety regulatory coverage expanded to include all food commodities; and
• an enhanced reputation for Canada as a global food safety leader.

The estimated monetized net benefit (i.e. benefits less costs) of the regulatory proposal would have an annualized value of approximately -$0.9 million. However, this is a conservative estimate, as the principal benefit of a reduced food safety risk for Canadians was not included as a monetized benefit since there was a lack of sufficient information needed to quantify it. Nevertheless, it would be reasonable to assume that the proposed stronger food safety rules would reduce this risk for Canadians to some degree supporting the prevention of food safety incidents before they occur and supporting more efficient and effective responses when food safety incidents do occur. This change in risk would reduce occurrences of food-borne illness, thereby reducing costs to Canadians, the national economy and the health care system. For example, if the proposed Regulations reduced the occurrences of food-borne illness by

• 1%, the estimated annualized net benefit would increase to approximately $27 million;
• 5%, the estimated annualized net benefit would increase to approximately $138 million; and
• 10%, the estimated annualized net benefit would increase to approximately $277 million.

In addition to an expected reduction in the occurrences of food-borne illness, the stronger food safety rules would increase the confidence Canadians have in the safety of domestic and imported food. Also, consumers would have increased knowledge of the food industry as they would have access to a list of all licence holders. Additionally, consumers would start to see an increase in the compliance of imported food labels with Canadian requirements (e.g. bilingual labels). Finally, regulatory organic requirements would be extended to aquaculture, which would increase consumer confidence in organic aquaculture products and potentially increase consumer access to these products through expanded equivalency arrangements for imports.

The significant changes resulting from regulatory implementation would result in significant benefits for affected businesses. The estimated annualized value of these benefits is $137.3 million. The main driver of the benefits is that the proposed traceability requirements would enable food recalls and investigations to be conducted in a more efficient and effective manner, which would minimize economic loss for affected businesses.

While the benefits for affected businesses would be significant with regulatory implementation, businesses would also carry significant costs from the above- mentioned changes. The estimated annualized value of these costs would be approximately -$138.2 million, which represents less than 2% of the $7.3 billion in net revenues realized in the Canadian food manufacturing subsector. (see footnote 9) As with any new additional business cost, there is the potential for the business to attempt to “pass along” the cost to buyers (e.g. consumers). For the food industry that would be impacted by the proposed Regulations, it is a competitive industry where a significant portion of businesses are already compliant with the proposed requirements. Furthermore, because Canada is a small open economy in the global market, imported products coming from the United States (where businesses are already meeting the equivalent requirements such as the preventive controls) further intensify competition in the Canadian market. As a result, it is probable that impacted businesses in Canada would rather absorb the additional costs to at least maintain their current market share. These factors would mitigate the potential impact that the business costs would have on consumer prices while increasing the likelihood that a business would have to absorb the majority of the costs.

The main drivers of the costs are the proposed requirements for affected businesses to have a PCP and follow preventive control requirements. The main benefit for businesses that develop PCPs and follow preventive control requirements would be a reduction in the food safety risk of their product, which would contribute to potential purchasers of their food having increased confidence in its safety. Additionally, these businesses would directly benefit from having increased knowledge of their processes and production and increased alignment with international food safety requirements. This would help to maintain existing market access for Canadian businesses and support the development of new market access opportunities. Also, without the proposed broadened application of preventive control and PCP requirements, Canada would be out of step with our major trading partners who are moving to a preventive control regulatory approach to food safety, which would put market access at risk.

Medium/large businesses would be less affected by the proposed Regulations since most are already in compliance with the proposed requirements. Small businesses would be affected to a greater degree by the proposed Regulations if they are involved in importing food, or preparing food for export or for interprovincial trade.

For the CFIA, regulatory implementation would transform and modernize the Agency's approach to food safety. However, the CFIA would not require any additional food safety funding or resources from current levels as the proposed Regulations would allow the CFIA to operate more efficiently and redistribute its food safety resources more strategically. Therefore, regulatory implementation would essentially be cost neutral for the CFIA with the exception of compliance promotion and industry engagement, which were estimated to be an annualized cost of approximately –$2.5 million. Note that as a result of CFIA compliance promotion and industry engagement the costs of dealing with importers at the border for CBSA would be negligible.

The entire cost-benefit analysis report is available by request.

“One-for-One” Rule

The “One-for-One” Rule applies and the regulatory proposal would be considered an IN under the Rule since there would be an overall increase in administrative burden. The additional burden would be primarily associated with the licensing application requirements and the record-keeping associated with the PCP and traceability requirements. However, businesses would benefit from some reduced burden (i.e. administrative relief), which would be primarily a result of the CFIA no longer requiring the registration of certain establishments and the integration of the proposed licensing system with the export certification process in the CFIA's new automated electronic system.

The following table presents all of the requirements included in the analysis that would impose administrative burden on or provide administrative relief to businesses:

Impact Category	Task Description	Why is it an "Administrative Burden"?	Administrative Burden Imposed or Relief Provided
Overarching	Review time of CFIA food safety regulations	Familiarization with information obligations	Burden imposed
Licensing	Licence applications	Authorizations	Burden imposed
	No establishment registration applications	Authorizations	Relief provided
	Streamlined/integrated export certification process	Authorizations, filling out forms, compiling data	Relief provided
Preventive controls and PCPs	Implementation of preventive controls and PCPs	Collecting and retaining data	Burden imposed
Traceability	Implementation of traceability systems	Collecting and retaining data	Burden imposed
Requirements for fresh fruit and vegetable dealers	CFIA produce licence no longer required (includes DRC membership requirement)	Authorizations	Relief provided

The estimated costs of the administrative burden were based on information gathered from a literature review, cost-benefit analyses from other jurisdictions (e.g. the U.S. Food and Drug Administration), reasonable assumptions and consultation with stakeholders and CFIA subject matter experts.

The following assumptions were used to estimate the administrative burden impacts:

Administrative relief — No establishment registration applications

• Almost all of the estimated benefits associated with no longer requiring establishment registration would provide administrative relief (i.e. the time no longer required to obtain or maintain registration)
• SCM variables used to monetize this relief:
  • TIME — estimated based on number of data fields required in the application forms (varies based on food commodity and the application type [new, amendment, or renewal]). It was assumed that it would take an individual an average of 15 seconds to fill out a data field. Also, it was assumed that it would take a small business an average of 5 minutes and a medium/large business an average of 15 minutes to obtain and make a copy of any document required for submission (number of documents varies based on food commodity). Finally, the analysis accounted for the fact that application packages can be submitted by mail, fax and email. Also, if required, there can be on-site reviews of food safety plans and construction design layouts
  • FREQUENCY — after the initial registration, registration renewal requirements vary by food commodity, but the vast majority require annual renewal (with amendments as required)
  • WAGE — it was assumed a manager would perform this task plus a 25% markup for overhead costs
  • POPULATION — based on annual estimates of affected establishments used in the cost-benefit analysis

Administrative relief — Streamlined/integrated export certification process

• All estimated benefits associated with a streamlined/integrated export certification process were considered to provide administrative relief (i.e. reduced time to submit information to the CFIA)
• SCM variables used to monetize this relief:
  • TIME — it was estimated that an exporter would save 10 minutes of their time per application
  • FREQUENCY — this is an ongoing task based on applications for export certification
  • WAGE — it was assumed a manager would perform this task plus a 25% markup for overhead costs
  • POPULATION — The CFIA estimated that there are 165 000 export certificates issued annually. Since the CFIA does not track the number of applications (i.e. successful and unsuccessful), it was assumed that this represents 95% of the total number of annual applications. The annual growth in the number of applications was based on the estimated growth of the food industry used in the cost-benefit analysis

Administrative relief — CFIA fresh fruits and vegetables produce licence no longer required

• Only the estimated benefits associated with the differences in the time to apply, amend or renew a CFIA produce licence versus DRC membership for fresh fruit and vegetable dealers were considered to provide administrative relief (i.e. reduced application time)
• The SCM plus other costs were used to monetize this impact:
  • TIME — estimated based on number of data fields required in the application forms (varies between CFIA and DRC). It was assumed that it would take an individual an average of 15 seconds to fill out a data field. Also, it was assumed that it would take a small business an average of 5 minutes and a medium/large business an average of 15 minutes to obtain and make a copy of any document required for submission (number of documents varies based on food commodity). Finally, the analysis accounted for the fact that application packages can be submitted by mail, fax and email
  • FREQUENCY — after the initial application, CFIA fresh fruits and vegetables licences require annual renewal whereas DRC membership does not need to be renewed
  • WAGE — it was assumed a manager would perform this task plus a 25% markup for overhead costs
  • POPULATION — based on estimates of affected stakeholders used in the cost-benefit analysis

Administrative burden — Review time of CFIA food safety regulations

• Existing and new businesses would have to take the time to review the proposed Regulations. However, new businesses would not have to take the time to review the current (applicable) CFIA regulations that would be repealed
• The SCM was used to monetize this impact:
  • TIME — estimated based on consultation with CFIA subject matter experts
  • FREQUENCY — this would be a one-time cost for businesses
  • WAGE — assumed a manager would perform this task
  • POPULATION — based on estimates of affected stakeholders

For the TIME variable, the following table provides CFIA estimates of the time required by a food preparing business (based on employee size) to review a regulation.

Review times for a food preparing business to review a regulation

Business Size Number of Employees	Review Time for a Regulation (Hours) for a Food Preparing Business
	Minimum	Maximum	Average
1 to 4	3	40	21.50
5 to 99	3	40	21.50
100 to 500	3	40	21.50
More than 500	3	40	21.50

The underlying assumption that explains why the times are the same for every business regardless of size was that reviewing (i.e. reading and understanding) a regulation does not include time to develop compliance strategies (e.g. preventive controls) and therefore would not vary due to operational complexities.

These estimated average regulatory review times represent the starting point used to estimate the times required for all food businesses based on the type of operations. In order to make the estimations, the following assumptions were made:

1. The time required to review a regulation would vary based on the operations of the business

• Businesses that do not prepare food would take less time to review since their operations are apt to be less complicated and not all of the regulatory provisions would be applicable
• Compared with the review time for businesses that prepare food, the time would be reduced by
  • 75% for importers and exporters
    • the assumption being that these businesses do not prepare food at all — i.e. simple operations
  • 95% for interprovincial traders
    • the assumption being that these businesses only have to comply with minimal requirements
  • 0% for fresh fruit and vegetable (FFV) primary producers
    • the assumption being that these businesses have complicated operations

2. For the proposed Regulations, the CFIA would have interpretive guidance, model systems and plain language examples to help reduce review times

• Additionally, the CFIA would target these documents to specific stakeholder categories (e.g. importer), which would allow stakeholders to only review what would be relevant for them
• These documents would reduce review times by 50%

3. For the proposed Regulations, the CFIA has conducted extensive industry consultations on the proposed Regulations, which would help further reduce review times

• Based on this, it was assumed that
  • all large businesses (more than 500 employees) have been reviewing CFIA regulatory consultation material and are already aware of the majority of the provisions
    • as a result their review time would be reduced by 50%
  • some medium-sized businesses (100 to 500 employees) have been reviewing CFIA regulatory consultation material and are already aware of the majority of the provisions
    • as a result their review time would be reduced by 25%
  • a few small businesses (less than 100 employees) have been reviewing CFIA regulatory consultation material and are already aware of the majority of the provisions
    • as a result their review time would be reduced by 12.5%

Based on these assumptions, the following table contains the estimated average review times for a single regulation in the baseline and regulatory scenarios for all stakeholder categories:

Review Time for a Regulation (Hours)

Business Size Number of Employees	BASELINE Regulations					PROPOSED Regulations
	Preparers for interprovincial trade or export	Importers	Interprovincial traders	Exporters	FFV primary producers	Preparers for interprovincial trade or export	Importers	Interprovincial traders	Exporters	FFV primary producers
1 to 4	21.50	5.38	1.08	5.38	21.50	9.41	2.35	0.47	2.35	9.41
5 to 99	21.50	5.38	1.08	5.38	21.50	9.41	2.35	0.47	2.35	9.41
100 to 500	21.50	5.38	1.08	5.38	21.50	8.06	2.02	0.40	2.02	8.06
More than 500	21.50	5.38	1.08	5.38	21.50	5.38	1.34	0.27	1.34	5.38

It was assumed that the percentage of time required to review the proposed Regulations that would be related to administrative burden requirements would be

• 90% for food retailers
• 90% for interprovincial traders
• 10% for all other impacted stakeholders

For the current regulations, the percentages were assumed to be

• 0% for food retailers
• 0% for interprovincial traders
• 5% for all other impacted stakeholders

Note that for the fish and meat sectors, it was assumed that 10% of the time required to review the current regulations would be related to administrative burden requirements as these regulations have similar requirements as the proposed Regulations (e.g. licensing/registration and record keeping for food safety and traceability). In cases of multi-food businesses that deal with meat and fish, it was assumed that 7.5% of the time would be related to administrative burden.

Administrative burden — Licence applications

• All of the estimated costs associated with licence applications would impose an administrative burden (i.e. the time required to become or maintain a licence)
• The SCM variables used to monetize this burden:
  • TIME — it was assumed that all applications would be submitted electronically via the CFIA website. The time estimated was based on the number of data fields required in the application form (varies based on food commodity and the application type — new, amendment or renewal). It was assumed that it would take an individual an average of 15 seconds to fill out a data field. Also, it was assumed that the form would be “dynamic,” in the sense that some questions (i.e. data fields) would only be presented to the applicant if applicable. For example, questions regarding the types of fish products that an establishment deals with would only be asked to establishments that stated that they deal with fish. Finally, it was assumed that it would take an individual an average of 5 minutes to find the form the first time and 2.5 minutes on subsequent occasions (the underlying assumption being that the CFIA would provide a direct link to the form on its home web page)
  • FREQUENCY — after applying for the initial licence, licences would be required to be renewed every two years (with amendments as required)
  • WAGE — it was assumed that a manager would perform this task plus a 25% mark-up for overhead costs
  • POPULATION — based on estimates of affected businesses used in the cost-benefit analysis

Administrative burden — Implementation of PCPs and food safety requirements

• Only the estimated costs associated with PCP record keeping would impose an administrative burden
• The SCM variables used to monetize this burden:
  • TIME — see the table below for the assumptions used for this variable

PCP implementation — Data on administrative burden time by business size (i.e. number of employees)

Description	Less than 20 employees	20 to 99 employees	100 to 499 employees	Greater than 499 employees
Process Controls
Number of processes per facility	2	2	6	10
Average hours to generate calibration records per process (manager level)	0.335	0.335	0.335	0.335
Number of calibration records per process per year	24	24	24	24
Average hours to document monitoring of process controls per record (working level)	0.05	0.05	0.05	0.05
Monitoring records per process per year	365	365	365	365
Average hours to generate verification instrumentation calibration records per process (manager level)	0.335	0.335	0.335	0.335
Number of calibration records per process per year	24	24	24	24
Allergen Controls — label application review
Frequency of review per hour per line	1.5	1.5	1.5	1.5
Hours of operation per day	8	16	24	24
Days of operation per year	357	357	357	357
Hours per application record keeping (working level)	0.013	0.013	0.013	0.013
Number of production lines per facility	3	7	13	18
Sanitation Controls — monitoring and verification
Total hours per year for monitoring record keeping (supervisor level)	11.125	22.375	133.875	133.875

• FREQUENCY — these would be ongoing annual costs for establishments
• WAGE — depending on the task, it was assumed that a manager, supervisor or worker would perform the task
• POPULATION — based on estimates of affected establishments used in the cost-benefit analysis
• For those businesses that would not be required to have a written PCP (i.e. no record keeping), there would be no administrative burden costs

Administrative burden — Implementation of traceability systems

• The SCM variables used to monetize this burden:
  • TIME — estimated based on data/information from a USFDA cost-benefit analysis on the Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 rule. Reductions to the time estimates were made since the U.S. rule requires the recording of significantly more information
  • in cases where an establishment would have to trace both forward and back, it was assumed that an individual would require approximately 6.5 hours annually for traceability record keeping. In cases where an establishment would only have to trace either forward or back, it was assumed that an individual would require half as much time
• FREQUENCY — this would be an ongoing cost for establishments
• WAGE — assumed an administrative support worker would perform this task
• POPULATION — based on estimates of affected establishments used in the cost-benefit analysis

In the table below, the results for all estimated new administrative burden (i.e. costs) are presented as negative values (e.g. -$1), while the results for all estimated new administrative relief (i.e. benefits) are presented as positive values (e.g. $1).

Estimated annualized values of administrative impacts for the “One-for-One” Rule (CAD, constant year 2012 prices, 2012 PV base year**, 7% discount rate)

Impact Category	Task Description	Annualized Values
Overarching	Review time of CFIA food safety regulations	-$108,150
Licensing	Licence applications	-$100,041
	No establishment registration applications	$99,598
	Streamlined and integrated export certification process	$779,626
PCP	Implementation of PCPs	-$9,658,028
Traceability	Implementation of traceability systems	-$2,424,343
Requirements for fresh fruit and vegetable dealers	CFIA produce licence no longer required (includes DRC membership requirement)	$2,492
Total annualized* administrative impact on all businesses		-$11,408,846
Estimated number of affected businesses		82 285
Average annualized administrative impact per affected business		-$139

* Numbers may not add up due to rounding.

** The analysis covered a 10-year time period (2018–2027).

The estimated total annualized increase in administrative burden to all businesses would be $11,408,846. This would equate to an average annualized administrative cost per affected business of $139.

Since 2010, the CFIA has consulted extensively with businesses and industry associations on potential food safety regulations. In general, businesses have been supportive of the proposed preventive control, PCP, and traceability requirements, which are the requirements that would impose the most administrative burden. However, concerns have been expressed related to the knowledge and capacity of some small businesses in meeting the proposed regulatory requirements given the amount of potential burden.

Based on these concerns and the fact that businesses would carry significant additional administrative costs, the CFIA has designed flexibility into the proposed Regulations (e.g. staggered coming-into-force dates for preventive control, PCP, and traceability requirements) and a comprehensive suite of compliance promotion products for small businesses, to reduce the burden they face, while maintaining proposed food safety standards.

The entire “One-for-One” Rule analysis is available on request.

Small business lens

Since 2010, the CFIA has consulted extensively with small businesses (including a targeted consultation in 2015), associations that represent small businesses and that serve specific ethnic communities, and organizations that represent and assist small businesses on potential food safety regulations. Feedback has been generally supportive of the proposed regulatory framework; however, concerns were expressed related to the knowledge and capacity of some small businesses in meeting the proposed regulatory framework.

Given these concerns and the fact that small businesses who are subject to the proposed Regulations would carry significant additional administrative and compliance costs due to the proposed Regulations, the CFIA worked on the development of the proposed Regulations and the accompanying compliance promotion products to lower some of the costs faced by small businesses while maintaining proposed food safety standards.

The small business lens compares the estimated costs that would be faced by small businesses in an “initial” regulatory option with a “flexible” (i.e. lower cost) regulatory option. This comparison is done in the Regulatory Flexibility Analysis Statement. Estimates of the costs were based on information gathered from a literature review, cost-benefit analyses from other jurisdictions (i.e. U.S. FDA), reasonable assumptions, and consultation with stakeholders and CFIA staff. For the purposes of the small business lens, the proposed Regulations would represent the flexible option.

This flexible option would include (but would not be limited to)

• “Model systems” that would provide examples of processes demonstrated to achieve compliance with the regulatory outcome;
• Plain language guidance documents that would further assist with compliance;
• PCP templates available for small businesses to assist with compliance;
• Staggered coming-into-force dates for certain requirements for food sectors where no registration requirement for establishments currently exists (e.g. non-federally register sector), which would provide additional time to understand the proposed requirements and delay the costs for compliance; and
• An exception from the PCP requirements for businesses with annual gross food sales of $30,000 (see footnote 10) or less for businesses in the non-federally registered, fresh fruits and vegetables, maple or honey sectors. However, exempted businesses would still have to adhere to preventive control requirements.

For the small business lens, the initial option for the design of the proposed Regulations would not have any model systems, plain language guidance, PCP templates or exception from PCP requirements. Additionally, there would be a single coming-into-force date for all regulatory provisions.

In the table below, the results for all estimated costs are presented as negative values (e.g. -$1). Note that the small business lens only analyzes costs (i.e. no benefits are included).

Regulatory Flexibility Analysis Statement (CAD, constant year 2012 prices, 2018 PV base year**, 7% discount rate)

	Initial Option		Flexible Option
Short description	— No model systems provided to businesses — No "plain language" resources provided to businesses — A single coming-into-force date — No micro-business exception from PCP requirements — No PCP templates available for businesses		— Model systems provided to businesses — "Plain language" resources provided to businesses — Staggered coming-into-force dates for certain food sectors — Micro-business exception from PCP requirements — PCP templates available for businesses
Number of small businesses impacted****	83 179		80 923
	Initial Option		Flexible Option
	Annualized Value ($)	Present value	Annualized Value ($)	Present value
Compliance costs
Review time of CFIA food safety regulations***	-$838,753	-$5,891,053	-$313,959	-$2,205,114
Development of traceability system	-$16,525	-$116,063	-$15,011	-$105,432
Development and documentation of PCP	-$8,764,144	-$61,555,678	-$3,606,662	-$25,331,683
Implementation of preventive controls and PCP	-$135,542,504	-$951,993,828	-$73,898,441	-$519,031,725
Preventive controls for businesses exempted from PCPs	$0	$0	-$32,925,281	-$231,253,399
Maintenance of PCP	-$9,650,149	-$67,778,610	-$6,462,298	-$45,388,477
TOTAL compliance costs*	-$154,812,075	-$1,087,335,231	-$117,221,652	-$823,315,831
Administrative costs
Review time of CFIA food safety regulations	-$282,749	-$1,985,909	-$160,256	-$1,125,574
Licence application	-$164,828	-$1,157,682	-$142,951	-$1,004,029
Implementation of traceability system	-$4,225,343	-$29,677,042	-$3,548,142	-$24,920,662
Implementation of PCP	-$29,202,482	-$205,106,015	-$14,407,359	-$101,191,264
TOTAL administrative costs	-$33,875,402	-$237,926,649	-$18,258,709	-$128,241,529
Total costs (all small businesses)	-$188,687,477	-$1,325,261,880	-$135,480,361	-$951,557,360
Total cost per impacted small business	-$2,268	-$15,933	-$1,674	-$11,759
Risk considerations	Having no model systems, plain language tools or PCP templates combined with a single coming-into-force date for all regulatory requirements would make it more difficult for small businesses to comply. This would put food safety at risk.		Model systems, plain language tools and PCP templates combined with staggered coming-into-force dates for regulatory requirements would assist small businesses with compliance. This would reduce food safety risk. Excepted micro-businesses would still have to comply with food safety requirements. Also, the exception would only apply to very small businesses that would typically have less complex food operations (i.e. less risk of food contamination) than small, medium or large businesses.

* Numbers may not add up due to rounding.

** The analysis covered a 10-year time period (2018–2027).

*** The review of the Regulations, which was classified as a benefit by the cost-benefit analysis, was included in this cost-based small business lens analysis, as small businesses would carry significant short-term costs due to this impact, which caused its annualized value to be negative (i.e. a cost) over the 10-year time period.

**** It should be noted that the number of small businesses impacted in the initial option was greater than in the flexible option. This was due to the fact that the initial option has a single coming-into-force date in 2018, whereas the flexible option has staggered coming-into-force dates (i.e. not all small businesses in operation in 2018 would continue to be in operation by the dates in 2019, 2020 and 2021).

The flexible option is recommended for the design of the proposed Regulations by the CFIA. It was estimated that this option would reduce the average annualized cost per affected business from approximately $2,268 (i.e. initial option) to $1,674 (i.e. flexible option). This would result in an estimated average annualized savings of $594 per affected small business. The total savings for all small businesses would have an annualized value of $53.2 million.

It is estimated that approximately 8 606 businesses that do not already have a PCP would be eligible for the exception from the PCP requirements.

For small businesses in the food manufacturing sector, the average net profit/loss was +$18,600 in 2014. So the estimated costs per impacted small business would represent about 9% profits. That said, in this sector 70% of businesses are profitable versus 30% that are non-profitable. The profitable businesses have an average net profit of $64,000, so the impact of the costs on profit would be less (2.6%). The non-profitable businesses have an average net loss of $85,000 so the additional costs would not significantly increase these losses.

The completed Small Business Lens Checklist is included as an appendix to the RIAS. The entire small business lens analysis is available by request.

Consultation

The CFIA undertook significant engagement with stakeholders as it developed the proposed Regulations. This included hosting two major food safety forums since 2013 that were attended by industry, academia, consumer groups, and other stakeholders. The CFIA also released discussion documents in 2013, 2014, and 2015.

Since 2013 the CFIA has participated in over 300 external stakeholder events where the proposed regulatory framework was presented and discussed and has reached thousands of individuals through webinars and face-to-face sessions. Stakeholders, including other federal departments and agencies, provincial and territorial governments, international trading partners, food businesses, industry associations, and consumers, have responded by sending in over 100 detailed submissions in relation to the proposed regulatory framework. Overall, industry is supportive of the proposed direction, which is seen as being consistent with global approaches to food safety and aligned with the U.S. FSMA.

The CFIA's most recent consultations were in response to concerns that were expressed in previous consultations about the ability and capacity of small businesses to meet the proposed requirements. In April 2015, the CFIA launched a targeted consultation with micro and small businesses on options for reducing costs that would be imposed by the Regulations. This engagement occurred through multiple channels including face-to-face sessions, webinars, and an on-line survey. In addition, a version of the draft preliminary regulatory text, as it then read, was released publicly for stakeholder review and comment in April 2015.

Key messages and themes expressed by stakeholders

Stakeholders expressed support for the proposed regulatory approach

• Moving to a single set of regulations that covers all food would significantly improve regulatory consistency and reduce regulatory duplication and complexity;
• Having the same regulatory requirements for domestic food businesses and importers would create a more level playing field that allows for innovation and flexibility;
• Allowing businesses to hold multiple licences that are structured to their needs would allow them to meet the proposed requirements while still maintaining diverse business models;
• Having a consistent approach to the promotion of compliance with the proposed preventive control and PCP requirements would be consistent with U.S. approach to compliance promotion with its own HACCP-based system of preventive controls and PCPs; and
• Outcome-based regulations would allow for innovation and flexibility, but would require additional training for inspectors to ensure that interpretation of the proposed Regulations is consistent.

Support was expressed for the HACCP-basis of the preventive control requirements as long as those requirements align with internationally recognized standards, and as long as those requirements are consistent with the requirements of existing CFIA-recognized HACCP-based systems (e.g. the Food Safety Enhancement Program, the Quality Management Program for fish).

Support was expressed from the domestic and international fresh fruit and vegetable industry for

• Proposed new food safety requirements at the farm level, as they would reflect the industry's work to date in implementing CanadaGAP®; (see footnote 11) and
• A requirement for membership in the DRC to replace the LAR. This would address a Canada–United States RCC commitment to address financial risk mitigation in the trade of fresh fruits and vegetables by eliminating the dual licensing system for fresh fruit and vegetable dealers in Canada.

Consumers were generally supportive of the proposal and felt that licensing and consistent food safety requirements across all sectors are a step in the right direction. Some did express concerns that this could lead to higher prices for food products.

Concerns

A number of concerns were highlighted during the consultations.

1. Many importers currently operate from outside of Canada. A requirement to have a Canadian fixed place of business could result in significant costs associated with setting up an office in Canada.

CFIA response: The proposed Regulations would allow for importers who do not have a fixed place of business in Canada to hold a licence if they have a fixed place of business in a foreign state that has a food safety system that provides at least the same level of protection to that of Canada. Canada has such an arrangement with the U.S. Food and Drug Administration, which was signed in 2016.

2. The proposed regulatory approach could present a significant burden to small businesses that are currently not familiar with the CFIA, or have limited knowledge of HACCP.

Several associations representing small business recommended that the written PCP exception level be raised significantly from $30,000 in annual gross sales, but this represented a minority of stakeholders that provided feedback during the CFIA's 2015 consultation on this subject. In contrast, strong support for the proposed exemption amount was expressed by the majority of industry stakeholders during the consultation. This view is supported by recent FDA research which suggested that food risks/hazards are not dependent on the size of an operation. (see footnote 12) Indeed, some industry stakeholders expressed the view that there should not be an exception at all.

CFIA response: The proposed Regulations would include an exception from the written PCP requirements for businesses in some sectors with annual gross food sales from the previous 12 months of $30,000 or less at the time of applying for the licence. This threshold is consistent with the goods and services tax / harmonized sales tax (GST/HST) account registration requirements for small suppliers under the Excise Tax Act. These businesses would still, however, require a licence for basic oversight and compliance promotion, and would be required to meet other regulatory requirements, including preventive controls. Licensing, traceability, and preventive control requirements would also be phased in so that sectors which have not previously been subject to these requirements would have more time to adapt to them. Additional time will be provided to some businesses with annual gross food sales of $30,000 or less, and no more than four employees. Plain language guidance documents, model systems, and tools would be available to help small businesses meet these requirements.

Training

3. The need for a comprehensive training system to support the implementation of the proposed Regulations was the focus of a number of stakeholder comments during the 2013 and 2014 consultations. These comments, often from industry and academic stakeholders, indicated the need for the CFIA to provide inspector training that will allow inspectors to consistently enforce any new requirements and to stay abreast of new technologies used to prepare food.

CFIA Response: The CFIA is developing a Learning and Training Architecture that includes improved recruitment, standardized training, supported technology information solutions and enhanced proactive science capacity. In addition, under a new private-public partnership, Safe Food Canada — The Learning Partnership, the CFIA is collaborating with key stakeholders from industry, academia, and provincial/territorial governments to explore the development of a national training and certification curriculum for food safety. This initiative has the potential to standardize professional development for regulators and all employees in the food industry.

Regulatory cooperation

The proposed Regulations would allow Canada to keep pace with food regulatory modernization initiatives being pursued by its trading partners, in particular with the United States, which is Canada's largest export market for food. There is good alignment between the approaches in the proposed Regulations and in the FSMA rules. Both frameworks note the importance of broadly applied preventive approaches, and both frameworks recognize the primary role that industry plays in the preparation and import of safe food. Food businesses in both countries will be required to have a licence or registration, have good manufacturing practices, have traceability requirements, perform hazard analysis, establish preventive controls, and conduct monitoring. Both the United States and Canada will help small businesses in meeting the new food safety requirements of new regulations by providing assistance through plain language guidance documents, interactive decision tools, and phased-in application dates. The concurrent nature of work on FSMA and work on the proposed Regulations has allowed the CFIA to use this as an opportunity to align our approaches with those of the United States or to minimize differences where it was possible and appropriate to do so.

Some differences exist, namely in the scope of the application of the rules. The U.S. rules apply to all food producers — including those whose product remains in the same state or is sold locally. The proposed Regulations would generally only apply to businesses that import food or prepare food for export or interprovincial trade, and would not apply to those food producers that trade solely within a province (with the exception of some provisions). The FSMA also does not apply to those products that are regulated by the U.S. Department of Agriculture (meat, poultry, and certain egg products) whereas the proposed Regulations would apply to these products that fall under the CFIA's mandate.

The proposed Regulations and the FSMA's requirements provide generally similar exemptions. The FSMA provides exemptions for specific business types (e.g. restaurants, food retail establishments, certain farms) and exempts certain products (e.g. alcoholic beverages, certain fresh fruits and vegetables that are rarely consumed raw, and raw agricultural products). These exemptions are generally consistent with those in the proposed Regulations (e.g. alcoholic beverages, food additives, grains, oilseeds).

The FSMA rules offer “modified requirements” rather than exemptions for what it describes as “qualified facilities.” Qualified facilities can either be “very small businesses” or facilities that average less than US$500,000 in annual sales and that sell over half of their production to “qualified end-users” (i.e. direct to consumers, restaurants, retail establishments) not more than 275 miles away. In place of a documented PCP, these facilities must attest to the FDA that they have identified hazards and implemented preventive controls, and continue to monitor them and retain appropriate documents.

In defining “very small businesses” the FDA noted that the results of its study of the U.S. food processing sector revealed that even in the smallest category of businesses in the U.S. processed food sector (i.e. those with fewer than 20 employees), nearly all had substantial annual sales that exceed $1 million. (see footnote 13) The FDA noted that its goal in establishing this definition was to exempt only a small percentage of U.S. food from coverage of this rule in order to minimize the risk of food-borne illness. In light of this, the FDA concluded that a “very small business” definition of business with sales under $1 million was appropriate as it would exempt less than 1% of the dollar value of food produced in the United States. (see footnote 14) Thus, the modified requirements would only be available to the very smallest businesses and would account for 0.6% of annual U.S. food sales. (see footnote 15)

The requirements described in the proposed Regulations would also help to sustain a major achievement under the RCC, the Food Safety Systems Recognition Arrangement. This arrangement between the U.S. Food and Drug Administration (FDA), Health Canada, and the CFIA was signed in April 2016 and it recognizes that the U.S. and Canadian food safety control systems provide a similar level of public health protection. By recognizing each other's systems, the U.S. FDA and Canada are expressing that they have confidence that they can leverage each other's science-based regulatory systems. For example, the agreement allows the importing country to consider the exporting country's comparable level of oversight.

The changes introduced in the proposed Regulations are important for maintaining this arrangement as they would keep the Canadian and U.S. approaches comparable.

Rationale

Canada has one of the best food safety systems in the world, but this system must continue to adapt and improve as the food safety environment evolves. Approximately 82 000 businesses of all sizes are deeply integrated into supply chains that prepare and import Canada's food. In these integrated chains, smaller businesses often supply foods used as ingredients by larger businesses and problems can occur at any stage of preparation (e.g. prior to import, during preparation, during distribution). In such a system, when problems do occur they can quickly become widespread geographically and affect multiple sectors. At the same time, consumers are demanding more information in order to make informed decisions about the foods they purchase.

Industry integration is observed in many countries and foreign regulators and international standard-setting bodies (i.e. Codex) are increasingly advocating the use of systems-based, preventive approaches that identify potential hazards to foods and appropriate controls in order to prevent food safety problems before they occur. They are also advocating the adoption of other practices, such as record keeping, to help recall food products from the market quickly in the event of a food safety incident.

The proposed Regulations would address changes to risks and changes in business practices by establishing a modern and robust legislative framework for food that is prepared in Canada or imported into Canada. The proposed Regulations would also provide new authorities to prevent food safety incidents, respond quickly when incidents occur, and maintain market access.

The proposed Regulations would also better align Canada with international approaches by increasing the consistency of the application of these principles and approaches in Canada in a way that focuses on preventing food safety incidents and recognizes the primary role that industry plays in the preparation and import of safe food. For example, Codex guidance on traceability will be applied to a broader range of food businesses. This will address the risk from situations where recall is hindered because a business is unable to provide information regarding where that food originated and where it was sent.

Codex guidance suggesting the broad application of preventive approaches is reflected in the requirement for preventive controls and PCPs (subject to certain exceptions) in the proposed Regulations. These requirements would apply to certain food businesses importing food, or preparing food for export or for interprovincial trade. The choice to broadly apply these approaches also recognizes the integrated nature of Canadian food supply chains that integrate businesses conducting activities representing different levels of risk. The requirements in the proposed Regulations also reflect the lessons learned from previous food safety incidents. Other means of carrying out compliance verification and enforcement, such as increased sampling and testing, are more intrusive and costly and would reduce industry accountability.

While the non-federally registered food sector and the fresh fruit and vegetable sector have not been subject to preventive control requirements in the past, many within these sectors have already adopted preventive controls and traceability measures through voluntary programs. That said, there is still a significant number that have not and the proposed Regulations would have the greatest effect on these businesses — which are often small.

Small business activities are often simple and have few controls to implement. In these cases it is relatively simple for an inspector to verify that the business poses a lower food safety risk and is meeting its preventive control requirements. As a business increases in size (i.e. as revenues increase), its activities often become more complex (i.e. they conduct more sophisticated operations, increase their volume of production, increase their number of employees). This increased complexity makes it difficult to perform effective inspections without written documentation, such as a PCP.

This difference in complexity and its associated risks have led the CFIA to provide an exception to the PCP requirements for certain micro-businesses with gross annual sales of $30,000 or less that sell interprovincially, import or export. This provides an exception for a number of businesses (i.e. ~9 500 out of ~82 000 total food businesses) that does not substantially weaken the effectiveness of the PCP requirement (i.e. increase food safety risks). The $30,000 threshold was also chosen since it is aligned with the GST/HST exemption limit and offers a straightforward means to identify micro-businesses. In addition, to help mitigate the costs of new requirements while continuing to support an acceptable level of system-wide food safety, the CFIA is proposing a number of measures to enhance compliance including “model systems,” plain language guidance documents, PCP templates, and staggered coming-into-force dates for certain requirements in certain sectors that would be included in the proposed Regulations.

The proposed Regulations would also streamline existing regulations to reduce the potential for inadvertent differences and duplications. Modification of commodity-specific requirements for meat products that are a mix of ready-to-eat meat products and other ingredients (e.g. frozen pepperoni pizza) will reduce duplicate requirements. In this situation the meat would already have been subject to food safety requirements for ready-to-eat meat products earlier in the chain of preparation and would not be subject to a second set of regulations for ready-to-eat meat when it is incorporated into the final food product. Streamlining will also address non-food safety requirements (e.g. standards of identity) in a more consistent manner that is flexible enough to accommodate new industry practices.

As other countries modernize their food safety requirements, Canada will need to demonstrate that comparable domestic requirements are in place to maintain market access. This is important given that Canada exported approximately $25.4 billion of food in 2013, a 31% increase from 2009, and exports are significant contributors to the Canadian economy and the Canadian food industry, which is valued at approximately $87.9 billion.

Overall, the proposed Regulations would have several benefits. For consumers, a broader range of foods sold in Canada would be subject to requirements that focus on preventing food safety risks and enable a faster response in the event of a food safety emergency. Beyond a more effective and efficient inspection system, the proposed Regulations are expected to yield cost savings to governments and Canadians through a reduction in food-borne illnesses and costs to the health care system. In addition, implementing the proposed Regulations would be the most cost-effective approach for Government as inspectors would be designated under one act, rather than four (i.e. the CAPA, FIA, MIA and CPLA) and would be trained to a consistent inspection approach enabling deployment to the sectors of highest risk.

Finally, industry would benefit from increased consumer confidence in their products, enhanced market access opportunities through regulatory alignment with major trading partners and less-costly or fewer investigations and recalls. Overall, it is estimated that industry would derive a net benefit from the new streamlined licensing system and more targeted efficient recalls.

Implementation, enforcement and service standards

The CFIA is proposing a phased approach for the coming into force of the proposed Regulations that reflects the different levels of industry readiness and the concerns of small businesses. Table 1 provides an overview of the phased implementation.

Table 1. Overview of phased implementation timelines

	Meat, Fish, Eggs, Processed Egg, Dairy, Processed Products, Honey, Maple products	Fresh Fruits and Vegetables	All Other Foods (see footnote 16)
			>$30K and ≥5 Employees	>$30K and <5 Employees	≤$30K
Licence (see footnote 19)	Immediately		+ 2 years	+ 2 years	+ 2 years
Traceability	Immediately (+1 year for growers and harvesters of fresh fruits and vegetables)		+ 2 years	+ 2 years	+ 2 years
Preventive controls (see footnote 20)	Immediately	+ 1 year	+ 2 years	+ 3 years	+ 3 years
Written PCP (see footnote 21)	Immediately	+ 1 year	+ 2 years	+ 3 years	Not required (see footnote 22)

The CFIA will maintain open and transparent communication with stakeholders to facilitate the transition and implementation period for the proposed Regulations through the CFIA website.

When the SFCA comes fully into force, it will repeal the CAPA, the FIA, the MIA and the food-related provisions of the CPLA. Two federal legislative regimes within the CFIA mandate would apply to food in Canada — the FDA and the SFCA. Food prepared for sale only within provinces will continue to be subject to the requirements of the FDA that generally apply to all food in Canada and to some requirements of the SFCA.

Implementation of the proposed Regulations would be supported by

• new plain language guidance documents that facilitate the understanding of the requirements;
• the outcomes of a review (including consultations) on the CFIA's service standards and user fees;
• continued communication and engagement with stakeholders;
• new compliance promotion tools to assist industry in meeting the regulatory requirements;
• a new Learning and Training Architecture for food inspectors;
• a new science-based approach to risk rating of foods;
• a modernized and integrated approach to inspection;
• modern IM/IT systems and tools;
• a new performance measurement framework that considers a range of systemic indicators and accountabilities; and
• increased emphasis on a government–industry partnership on food safety.

Compliance and enforcement

The CFIA uses a range of tools to verify compliance, including inspections, surveillance, sampling, and testing. When non-compliance is determined, the CFIA takes enforcement action commensurate with the seriousness of the non-compliance. Under the proposed Regulations, the Minister may suspend or cancel a licence. For example, a licence would be suspended immediately, upon notice, where there is a risk of injury to human health. This enforcement tool would be in addition to other compliance and enforcement tools and measures available to inspectors, including food product seizure and detention, an order to remove a product from Canada, and a recall order, and/or penalties such as the issuance of an administrative monetary penalty under the Agriculture and Agri-Food Administrative Monetary Penalties Act.

Performance measurement and evaluation

It is expected that the proposed Regulations would improve the ability of the CFIA and regulated parties to prevent and manage food safety risks, better protect consumers, and maintain and expand market access for Canada. The CFIA is developing a food program performance framework to measure how well its activities, processes, and services contribute to these outcomes.

The CFIA is developing performance indicators to measure the performance of the Regulations, once they come into force. These indicators will allow the CFIA to monitor and assess whether the Regulations are achieving the goal of increasing food safety in Canada. To date, the following indicators have been proposed for this purpose:

1. Increase in the number of CFIA-licensed food manufacturers that have a system in place to promote food safety (target: to be determined) [source: CFIA internal data]; and
2. Increase in the number of CFIA-licensed food importers that have a system in place to promote food safety (target: to be determined) [source: CFIA internal data].

Contact

Richard Arsenault
Executive Director
Domestic Food Safety Systems and Meat Hygiene Directorate
Canadian Food Inspection Agency
1400 Merivale Road, Tower 1
Ottawa, Ontario
K1A 0Y9
Telephone: 613-773-6156
Email: CFIA-Modernisation-ACIA@inspection.gc.ca

Small Business Lens Checklist

1. Name of the sponsoring regulatory organization:

2. Title of the regulatory proposal:

3. Is the checklist submitted with a RIAS for the Canada Gazette, Part I or Part II?

☑ Canada Gazette, Part I ☐ Canada Gazette, Part II

A. Small business regulatory design

I	Communication and transparency	Yes	No	N/A
1.	Are the proposed Regulations or requirements easily understandable in everyday language?	☐	☑	☐
The majority of the provisions of the proposed Regulations are easily understandable in everyday language. Some sections however, are technical in nature. Plain language tools will be developed in everyday, non-technical language and will be targeted to different affected stakeholder groups to explain the regulatory requirements. For example, importers would have guidance tailored to their specific needs, as would businesses who prepare food for inter-provincial trade.
2.	Is there a clear connection between the requirements and the purpose (or intent) of the proposed Regulations?	☑	☐	☐
3.	Will there be an implementation plan that includes communications and compliance promotion activities, that informs small business of a regulatory change and guides them on how to comply with it (e.g. information sessions, sample assessments, toolkits, websites)?	☑	☐	☐
4.	If new forms, reports or processes are introduced, are they consistent in appearance and format with other relevant government forms, reports or processes?	☑	☐	☐
II	Simplification and streamlining	Yes	No	N/A
1.	Will streamlined processes be put in place (e.g. through BizPaL, Canada Border Services Agency single window) to collect information from small businesses where possible?	☑	☐	☐
2.	Have opportunities to align with other obligations imposed on business by federal, provincial, municipal or international or multinational regulatory bodies been assessed?	☑	☐	☐
3.	Has the impact of the proposed Regulations on international or interprovincial trade been assessed?	☑	☐	☐
4.	If the data or information, other than personal information, required to comply with the proposed Regulations is already collected by another department or jurisdiction, will this information be obtained from that department or jurisdiction instead of requesting the same information from small businesses or other stakeholders? (The collection, retention, use, disclosure and disposal of personal information are all subject to the requirements of the Privacy Act. Any questions with respect to compliance with the Privacy Act should be referred to the department's or agency's ATIP office or legal services unit.)	☐	☐	☑
The data or information, other than personal information, required to comply with the proposed Regulations is not already collected by another department or jurisdiction.
5.	Will forms be pre-populated with information or data already available to the department to reduce the time and cost necessary to complete them? (Example: When a business completes an online application for a licence, upon entering an identifier or a name, the system pre-populates the application with the applicant's personal particulars such as contact information, date, etc. when that information is already available to the department.)	☐	☑	☐
The type of information currently collected by the CFIA varies by food program and differs from the information that will be required under the regulatory proposal. However, the information will be pre-populated for renewal or in the case of amendment or application for other licences or permissions granted by the CFIA.
6.	Will electronic reporting and data collection be used, including electronic validation and confirmation of receipt of reports where appropriate?	☑	☐	☐
7.	Will reporting, if required by the proposed Regulations, be aligned with generally used business processes or international standards if possible?	☑	☐	☐
8.	If additional forms are required, can they be streamlined with existing forms that must be completed for other government information requirements?	☐	☐	☑
The forms required under the proposed Regulations cannot be streamlined with existing forms required for other government information requirements, as the information required is not currently being collected.
III	Implementation, compliance and service standards	Yes	No	N/A
1.	Has consideration been given to small businesses in remote areas, with special consideration to those that do not have access to high-speed (broadband) Internet?	☑	☐	☐
2.	If regulatory authorizations (e.g. licences, permits or certifications) are introduced, will service standards addressing timeliness of decision making be developed that are inclusive of complaints about poor service?	☑	☐	☐
3.	Is there a clearly identified contact point or help desk for small businesses and other stakeholders?	☑	☐	☐

B. Regulatory flexibility analysis and reverse onus

IV	Regulatory flexibility analysis	Yes	No	N/A
1.	Does the RIAS identify at least one flexible option that has lower compliance or administrative costs for small businesses in the small business lens section? Examples of flexible options to minimize costs are as follows: Longer time periods to comply with the requirements, longer transition periods or temporary exemptions; Performance-based standards; Partial or complete exemptions from compliance, especially for firms that have good track records (legal advice should be sought when considering such an option); Reduced compliance costs; Reduced fees or other charges or penalties; Use of market incentives; A range of options to comply with requirements, including lower-cost options; Simplified and less frequent reporting obligations and inspections; and Licences granted on a permanent basis or renewed less frequently.	☑	☐	☐
2.	Does the RIAS include, as part of the Regulatory Flexibility Analysis Statement, quantified and monetized compliance and administrative costs for small businesses associated with the initial option assessed, as well as the flexible, lower-cost option?	☑	☐	☐
3.	Does the RIAS include, as part of the Regulatory Flexibility Analysis Statement, a consideration of the risks associated with the flexible option? (Minimizing administrative or compliance costs for small business cannot be at the expense of greater health, security or safety or create environmental risks for Canadians.)	☑	☐	☐
4.	Does the RIAS include a summary of feedback provided by small business during consultations?	☑	☐	☐
V	Reverse onus	Yes	No	N/A
1.	If the recommended option is not the lower-cost option for small business in terms of administrative or compliance costs, is a reasonable justification provided in the RIAS?	☐	☐	☑
The recommended option is the lower-cost option.

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council proposes to make the annexed Safe Food for Canadians Regulations pursuant to

• (a) sections 51 (see footnote a) and 75 of the Safe Food for Canadians Act (see footnote b);
• (b) section 12 of the Canadian Dairy Commission Act (see footnote c);
• (c) subsection 18(1) of the Consumer Packaging and Labelling Act (see footnote d);
• (d) subsection 55(1) (see footnote e) of the Controlled Drugs and Substances Act (see footnote f);
• (e) subsection 462.3(2) (see footnote g) of the Criminal Code (see footnote h);
• (f) subsection 19(1) of the Customs Tariff (see footnote i);
• (g) subsection 5(1) (see footnote j) of the Feeds Act (see footnote k);
• (h) subsection 30(1) (see footnote l) of the Food and Drugs Act (see footnote m);
• (i) subsection 64(1) (see footnote n) of the Health of Animals Act (see footnote o);
• (j) subsection 4(1) (see footnote p) of the Seeds Act (see footnote q);
• (k) section 32 (see footnote r) of the Canada Agricultural Products Act (see footnote s);
• (l) sections 3 (see footnote t) and 12 of the Fish Inspection Act (see footnote u); and
• (m) section 20 (see footnote v) of the Meat Inspection Act (see footnote w).

Interested persons may make representations concerning the proposed Regulations within 90 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Richard Arsenault, Executive Director, Domestic Food Safety Systems & Meat Hygiene Directorate, Canadian Food Inspection Agency, 1400 Merivale Road, Tower 1, Ottawa, Ontario K1A 0Y9 (tel.: 613-773-6156; email: CFIA-Modernisation-ACIA@inspection.gc.ca).

Ottawa, December 15, 2016

Jurica Čapkun
Assistant Clerk of the Privy Council

Safe Food for Canadians Regulations

PART 1

Interpretation

Definitions

1 (1) The following definitions apply in these Regulations.

Act means the Safe Food for Canadians Act. (Loi)

brine pack or packed in brine, in respect of a processed fruit or vegetable product, means that the product is in a package in which a water and salt solution is used as the liquid packaging medium, with or without the addition of sugar. (conservé dans la saumure ou mis en conserve dans la saumure)

carcass means the body of a dead animal. (carcasse)

case, in respect of eggs, means a package that is intended to contain 30 dozen eggs. (caisse)

catch-weight food means food that, because of its nature, cannot normally be portioned to predetermined fixed quantities and is, as a result, usually sold in containers of different quantities. (aliment à poids variable)

close proximity, in respect of an item of information that is shown on a label, means immediately adjacent to the item of information and without any intervening printed, written or graphic matter. (à proximité)

commercial sterility means the condition of a food that has been subjected to a thermal treatment, alone or in combination with other treatments, to render the food free from viable forms of micro-organisms, including spores, that are capable of growing in the food at temperatures at which the food is intended to be normally kept during storing, conveying and selling. (stérilité commerciale)

common name, with reference to a food, means

• (a) the name of the food that is printed in boldface type, but not in italics, in the Standards of Identity Document or in any of sections 252 to 254;
• (b) the name of the food that is printed in boldface type, but not in italics, in a provision of the Food and Drug Regulations; or
• (c) in any other case, the name by which the food is generally known or that identifies its function. (nom usuel)

Compendium means the document entitled Canadian Grade Compendium, prepared by the Agency and published on its website, as amended from time to time. (Recueil)

condemn means to identify a food animal, its carcass, the parts of its carcass or its blood as inedible following a determination by an inspector to that effect. (condamner)

consumer prepackaged, in respect of a food, means packaged in a container in the manner in which the food is ordinarily sold to or used or purchased by an individual — or in which the food may reasonably be expected to be obtained by an individual — without being repackaged, to be used for non-commercial purposes. (de consommation préemballé)

container means an outer receptacle or covering that is used or to be used in connection with a food. It includes a wrapper and a confining band but does not include a conveyance or any container that is an integral part of a conveyance. (contenant)

contaminated, in respect of a food, means that the food, among other things,

• (a) contains a chemical, drug, food additive, heavy metal, industrial pollutant, ingredient, microbe, pest control product, poison, toxin or other substance that is not permitted under, or that is in excess of limits or levels provided under, the Food and Drugs Act;
• (b) contains a micro-organism, chemical substance or extraneous material that is in excess of levels set out in the document entitled Biological, Chemical and Physical Standards for Food, prepared by the Agency and published on its website, as amended from time to time; or
• (c) contains anything that is inedible or has come into contact with anything that might cause the food to become inedible. (contaminé)

cured, in respect of an edible meat product, means that salt and at least 100 p.p.m. of sodium nitrite, potassium nitrite, sodium nitrate or potassium nitrate, or any combination of them, has been added to the meat product. (saumuré)

dairy product means milk or a food that is derived from milk, alone or combined with another food, and that contains no oil and no fat other than that of milk. (produit laitier)

dress means to dress a carcass in accordance with subsection 144(1). (habiller)

drug has the same meaning as in section 2 of the Food and Drugs Act. (drogue)

dye mark means an ink mark that consists of the word “dyed” or “teint” or a deposit of ink that is applied to an egg's shell by the holder of a licence to grade eggs. (marque de teinture)

egg means an egg of a domestic chicken of the species Gallus domesticus or, in respect of a processed egg product, means that egg or an egg of a domestic turkey of the species Meleagris gallopavo. It does not include a balut. (œuf)

egg carton means a package that is capable of being closed and that is intended to contain not more than 30 eggs in separate compartments. (boîte à œufs)

eviscerate means

• (a) in respect of the carcass of a bird, other than an ostrich, rhea or emu, to remove the respiratory, digestive, reproductive and urinary systems, with or without the kidneys, and the other thoracic and abdominal organs; and
• (b) in respect of any other carcass, to remove the respiratory, digestive, reproductive and urinary systems, except the kidneys, and the other thoracic and abdominal organs. (éviscérer)

Fees Notice means the document entitled Canadian Food Inspection Agency Fees Notice, published by the Agency on its website, as amended from time to time. (Avis sur les prix)

fish includes shellfish, crustaceans and other marine animals, and any of their parts, products and by-products. (poisson)

food has the same meaning as in section 2 of the Food and Drugs Act. (aliment)

food additive has the same meaning as in subsec- tion B.01.001(1) of the Food and Drug Regulations. (additif alimentaire)

food animal means a bird or mammal, other than a marine mammal, from which an edible meat product may be derived. (animal pour alimentation humaine)

fresh fruit or vegetable means a fresh plant or fresh edible fungus, or part of such a plant or fungus, that is a food. It does not include a food referred to in subparagraph 9(2)(c)(i). (fruit ou légume frais)

game animal means a wild animal that is a food animal — including an animal that lives in an enclosed territory under conditions of freedom similar to those of wild animals — that is hunted under a licence issued by a province. (gibier)

gelling agent has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations. (agent gélatinisant)

heavy pack, in respect of a processed fruit or vegetable product, means a package in which the minimum amount of water required for proper processing of the product is used as the liquid packaging medium. (conserve épaisse)

hermetically sealed package means a package that is designed to be and is secure against the entry of micro-organisms, including spores. (emballage hermétiquement scellé)

inedible, in respect of a food, means that the food is not fit for use as food. (non comestible)

licence means a licence that is issued under paragraph 20(1)(a) or (b) of the Act. (licence)

maple product means a food that is obtained exclusively by the concentration of maple sap or maple syrup. (produit de l'érable)

maple sap means sap that is obtained exclusively from trees of the genus Acer. (sève d'érable)

meat means the edible part of the carcass of a food animal, that is, the muscle associated with the skeleton, tongue, diaphragm, heart, gizzard or mammalian oesophagus, with or without accompanying and overlying fat, together with those parts of the bones, skin, sinews, nerves, blood vessels and other tissues that normally accompany the muscle and are not normally removed in dressing a carcass. It does not include the muscles associated with the lips, snout, ears or scalp, mechanically separated meat or meat to which an ingredient other than meat has been added. (viande)

meat by-product means the edible blood of a food animal or an edible organ or tissue that is derived from the carcass of a food animal. It does not include meat or mechanically separated meat. (sous-produit de viande)

meat product means the carcass of a food animal, the blood of a food animal or a product or by-product of its carcass, and any other food that contains the blood of a food animal or a product or by-product of its carcass. It does not include

• (a) gelatin, bone meal, collagen casing, hydrolyzed animal protein, monoglycerides, diglycerides or fatty acids; or
• (b) any food that contains a meat product in an insignificant quantity, having regard to the nature of the food and of the meat product. (produit de viande)

mechanically separated meat means an edible meat product that is obtained by removing most of the bone and cartilage from a comminuted meat product from which the bone and cartilage was not previously removed and that does not contain more than 0.027% calcium for every 1% protein or any bones or bone fragments larger than 2 mm. (viande séparée mécaniquement)

metric unit means a unit of measurement set out in Schedule I to the Weights and Measures Act. (unité métrique)

organic product means a food commodity that has been certified as organic either under subsection 342(1) or as described in subparagraph 354(1)(a)(ii). (produit biologique)

ornamental container means a container that, except on the bottom, does not bear any advertising material, other than a trade-mark or common name, and that, because of any design appearing on its surface or because of its shape or texture, is sold as a decorative item in addition to being sold as the container of a food. (contenant décoratif)

poultry carcass means the carcass of a slaughtered turkey, duck, goose, guinea fowl or bird of the species Gallus domesticus. (carcasse de volaille)

prepackaged, in respect of a food, means packaged in a container in the manner in which the food is ordinarily sold to or used or purchased by a person. (préemballé)

President means the President of the Agency. (président)

principal display panel means

• (a) in the case of a consumer prepackaged food whose container is mounted on a display card, the part of the label that is applied
  • (i) to all or part of the principal display surface,
  • (ii) to all or part of the surface of the display card that is displayed or visible under customary conditions of sale or use, or
  • (iii) to all or part of both of those locations;
• (b) in the case of a consumer prepackaged food whose container is an ornamental container, the part of the label that is applied
  • (i) to all or part of the bottom of the container,
  • (ii) to all or part of the principal display surface, or
  • (iii) to all or part of a tag that is attached to the container;
• (c) in the case of a consumer prepackaged food whose container is not described in paragraph (a) or (b), the part of the label that is applied to all or part of the principal display surface;
• (d) in the case of a prepackaged food other than a consumer prepackaged food, the part of the label
  • (i) that is applied or attached to all or part of the surface of the container that is displayed or visible under customary conditions of sale or use, or
  • (ii) if the container does not have such a surface, that is applied to any part of the container, except the bottom, if any; or
• (e) in the case of a food that is not a prepackaged food, the part of the label that is applied or attached to all or part of the surface of the food that is displayed or visible under customary conditions of sale or use. (espace principal)

principal display surface, in respect of the container of a consumer prepackaged food, means

• (a) if the container has a surface that is displayed or visible under customary conditions of sale or use, the total area of that surface, excluding the top, if any;
• (b) if the container has a lid that is the part of the container that is displayed or visible under customary conditions of sale or use, the total area of the top surface of the lid;
• (c) if the container does not have a particular surface that is displayed or visible under customary conditions of sale or use, 40% of the total surface area of the container, excluding the top and bottom, if any, if it is possible for that 40% to be displayed or visible under customary conditions of sale or use;
• (d) if the container is a bag with surfaces of equal dimensions, the total area of one of the surfaces;
• (e) if the container is a bag with surfaces of different dimensions, the total area of one of the largest surfaces;
• (f) despite paragraphs (a) to (e), if the container does not have a surface that is displayed or visible under customary conditions of sale or use on which a label can be applied, the total area of one side of a tag that is attached to the container;
• (g) despite paragraphs (a) to (e), if the food is wine that is exposed for sale, any part of the surface of the container, excluding its top and bottom, that can be seen without having to turn the container; and
• (h) if the container is a wrapper or confining band that is so narrow in relation to the size of the food it contains that it cannot reasonably be considered to have any surface that is displayed or visible under customary conditions of sale or use, the total area of one side of a tag that is attached to the container. (principale surface exposée)

processed egg product means any food for which a standard is set out in Volume 2 of the Standards of Identity Document. (produit d'œufs transformés)

processed fruit or vegetable product means any food

• (a) for which a standard is set out in Volume 4 of the Standards of Identity Document;
• (b) for which a grade is established in Volume 3 of the Compendium;
• (c) that is set out in any of items 2 to 11, column 1, of Table 3 of Schedule 3 or in column 1 of Table 4, 5 or 6 of that Schedule; or
• (d) to which Division 3 of Part 10 applies. (produit de fruits ou de légumes transformés)

ready-to-eat, in respect of a meat product, means that it has been subjected to a treatment or process that is sufficient to inactivate vegetative pathogenic micro-organisms or their toxins and control spores of food-borne pathogenic bacteria so that the meat product does not require further preparing before consumption except washing or thawing or exposing it to sufficient heat to warm it without cooking it. (prêt à manger)

refrigerated, in respect of a food, means that it is exposed to a temperature of 4°C or less, without being frozen. (réfrigéré)

sanitary conditions means conditions or circumstances that do not present a risk of contamination of a food. (conditions hygiéniques)

shellfish means a bivalve mollusc of the class Bivalvia or a carnivorous marine mollusc of the class Gastropoda, or any product that is derived from one of those molluscs. (mollusque)

solid pack, in respect of a processed fruit or vegetable product, means a package in which the fruits or vegetables have been partially or wholly precooked before processing so as to allow the fruits or vegetables to pack closely with the minimum amount of free liquid. (conserve compacte)

Standards of Identity Document means the document entitled Canadian Standards of Identity, prepared by the Agency and published on its website, as amended from time to time. (Document sur les normes d'identité)

tray, in respect of eggs, means a package, other than an egg carton, that is intended to contain not more than 30 eggs in separate compartments. (plateau)

vacuum pack, in respect of a processed fruit or vegetable product, means in a package in which a minimum amount of liquid packaging medium is used and in which a vacuum is created mechanically. (conservé sous vide)

wine means an alcoholic beverage that meets the standard set out in section B.02.100 of the Food and Drug Regulations. (vin)

Foreign state

(2) For the purposes of these Regulations, a reference to “foreign state” includes a reference to a WTO Member as defined in subsection 2(1) of the World Trade Organization Agreement Implementation Act.

Terms used in documents incorporated by reference

(3) For the purpose of the incorporation by reference into these Regulations of any documents prepared by the Agency, terms that are used but not defined in those documents have the same meaning as in these Regulations.

Definition prepare — producing

2 (1) Subject to subsection (2), for the purpose of the definition prepare in section 2 of the Act, producing, including growing and harvesting, is a prescribed activity.

Exception

(2) In Parts 1 to 10, 12 and 13, the activity prescribed under subsection (1) is limited, for any food commodity other than an organic product, to the growing or harvesting of fresh fruits or vegetables.

Documents — official languages

3 For greater certainty, any document that is required under these Regulations to be prepared, kept or maintained must be prepared, kept or maintained in at least one official language.

Clarification — “prepackaged”

4 For greater certainty, a reference to “prepackaged” in respect of a food is, unless otherwise provided, a reference to a consumer prepackaged food and to a prepackaged food other than a consumer prepackaged food.

PART 2

Trade

DIVISION 1

General

Subsection 10(1) of Act

5 (1) For the purpose of subsection 10(1) of the Act, the prescribed food commodity that it is prohibited to send or convey from one province to another — or to import or export — except in accordance with these Regulations is any food commodity.

Subsection 10(2) of Act

(2) For the purpose of subsection 10(2) of the Act, the prescribed food commodity that it is prohibited to import without a licence is a food other than a food referred to in any of paragraphs 9(2)(a) to (c).

Subsection 10(3) of Act

(3) For the purpose of subsection 10(3) of the Act, the prescribed food commodity that it is prohibited to send or convey from one province to another — or to import or export — unless it meets the requirements of these Regulations is any food commodity.

Section 12 of Act

6 For the purpose of section 12 of the Act, the prescribed food commodity that it is prohibited to have in one's possession for the purpose of sending or conveying from one province to another — or for the purpose of exporting — unless it meets the requirements of these Regulations is any food commodity.

Subsection 13(1) of Act

7 (1) For the purpose of subsection 13(1) of the Act, the prescribed food commodity that is to be exported or to be sent or conveyed from one province to another is any food commodity and the prescribed activities that it is prohibited to conduct in respect of that food commodity, except in accordance with these Regulations, are

• (a) manufacturing, preparing, storing, packaging and labelling; and
• (b) if the food commodity is an organic product, in addition to the activities set out in paragraph (a), advertising and conveying.

Subsection 13(2) of Act

(2) For the purpose of subsection 13(2) of the Act, the prescribed food commodities that are to be exported or to be sent or conveyed from one province to another are a food, other than a food referred to in paragraph 9(2)(a) or (b), and a food animal and the prescribed activities that it is prohibited to conduct in respect of those food commodities without a licence are

• (a) in the case of a food,
  • (i) manufacturing, processing, treating, preserving, grading, packaging and labelling, other than
    • (A) the packaging of fresh fruits or vegetables in the field by a person who grows or harvests them if they are to be sent or conveyed from one province to another to be subsequently manufactured, processed, treated, preserved or graded by a licence holder, and
    • (B) the packaging and labelling of a food referred to in subparagraph 9(2)(c)(i) if, when the food is exported or is sent or conveyed from one province to another, it has a label applied or attached to it that bears the expression “For Further Preparation Only” or “pour conditionnement ultérieur seulement” and it is not a consumer prepackaged food, and
  • (ii) if the food is a meat product, in addition to the activities set out in subparagraph (i), storing and handling, in its imported condition, for the purposes of the exercise of an inspector's powers under the Act; and
• (b) in the case of a food animal, slaughtering.

Interprovincial trade, import and export

8 Any food that is sent or conveyed from one province to another or that is imported or exported

• (a) must not be contaminated;
• (b) must be edible;
• (c) must not consist in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance; and
• (d) must have been manufactured, prepared, stored, packaged and labelled under sanitary conditions.

Import

9 (1) Any food that is imported must have been manufactured, prepared, stored, packaged and labelled in a manner and under conditions that provide at least the same level of protection as that provided by sections 44 to 82.

Exception

(2) Subsection (1) does not apply in respect of

• (a) a food additive;
• (b) a beverage that contains more than 0.5% absolute ethyl alcohol by volume; or
• (c) a food that is set out in Schedule 1 that
  • (i) is unprocessed and will be manufactured, processed or treated for use as a grain, oil, pulse, sugar or beverage,
  • (ii) has a label applied or attached to it that bears the expression “For Further Preparation Only” or “pour conditionnement ultérieur seulement”, and
  • (iii) is not a consumer prepackaged food.

• Import — fixed place of business
• 10 (1) A person who imports a food and who does not have, in Canada, a fixed place of business from which they carry on business related to the food must send or convey the food directly to Canada from a foreign state in which they have such a place of business and that has a food safety system that provides at least the same level of protection as that provided by the provisions of the Act and these Regulations.

Exception

(2) Subsection (1) does not apply in respect of the foods referred to in paragraphs 9(2)(a) to (c).

In transit

(3) For the purpose of subsection (1), if the food passes only in transit through the foreign state from which the person carries on business related to the food, the person is not considered to have sent or conveyed the food directly to Canada from that foreign state.

Import information and fee

11 (1) A person who imports a food must pay the applicable fee set out in the Fees Notice and provide the following import information to the Minister:

• (a) the person's name and address and, if applicable, the number of their licence to import;
• (b) the name and address of the person from whom the food is received;
• (c) the name of the foreign state of origin;
• (d) the address of the first destination of the food in Canada;
• (e) a description of the food, including its common name and quantity; and
• (f) any other information that is related to the import of the food, in the form approved by the President.

• Provision of import information
• (2) The import information must be provided before the import or, in the case of a food other than a meat product, at any other time authorized by the Minister if the person who imports the food requests it.

Meat products

(3) For the purpose of subsection (2), the foods set out in paragraphs 24(a) and (b) are not to be considered meat products.

Import — further inspection

12 (1) If an inspection is conducted at the time of the import and an inspector determines that a further inspection is required,

• (a) in the case of a meat product,
  • (i) the meat product must be immediately delivered, by the person who imports it, to an establishment where it will be stored and handled in its imported condition by a licence holder and must be kept in that establishment until the further inspection is completed, and
  • (ii) the person who imports the meat product must provide the address of that establishment to the inspector if it is different from the address of the first destination provided under paragraph 11(1)(d); and
• (b) in the case of a food other than a meat product, the food must be kept, by the person who imports it, at the first destination whose address was provided under paragraph 11(1)(d) until the further inspection is completed.

Meat products

(2) For the purpose of subsection (1), the foods set out in paragraphs 24(a) and (b) are not to be considered meat products.

Exception

(3) Paragraph (1)(b) does not apply if the Minister authorizes, under subsection 11(2), that the import information be provided after the import.

Interprovincial trade and export

13 (1) Any food that is sent or conveyed from one province to another or that is exported must meet the following requirements:

• (a) if the food is manufactured, processed, treated, preserved, graded, packaged or labelled in Canada, that activity must be conducted by a licence holder in accordance with the Act and these Regulations, unless the activity is
  • (i) the packaging of fresh fruits or vegetables in the field by a person who grows or harvests them if they are to be sent or conveyed from one province to another to be subsequently manufactured, processed, treated, preserved or graded by a licence holder, or
  • (ii) the packaging or labelling of a food referred to in subparagraph 9(2)(c)(i) if, when the food is exported or is sent or conveyed from one province to another, it has a label applied or attached to it that bears the expression “For Further Preparation Only” or “pour conditionnement ultérieur seulement” and it is not a consumer prepackaged food;
• (b) if the food, other than a food referred to in paragraph 9(2)(c), has been imported, it must have been imported by a licence holder in accordance with the Act and these Regulations; and
• (c) in the case of a meat product,
  • (i) if any meat product that it contains was manufactured, processed, treated, preserved, graded, packaged or labelled in Canada, that activity was conducted by a licence holder in accordance with the Act and these Regulations,
  • (ii) if any meat product that it contains was imported, that meat product was imported by a licence holder in accordance with the Act and these Regulations, and
  • (iii) if any meat, meat by-product or mechanically separated meat that it contains is derived from food animals that were slaughtered in Canada, the food animals were slaughtered by a licence holder in accordance with the Act and these Regulations.

Exception

(2) Subsection (1) does not apply in respect of the foods referred to in paragraphs 9(2)(a) and (b).

Exemption

(3) A person may export a food in respect of which a requirement of these Regulations has not been met if the food has a label applied or attached to it that bears the word “Export” or “exportation” and if

• (a) in the case where the unmet requirement is not one set out in subsection (1), section 26 or 32, any of sections 84 to 86, section 88, 91 or 97, any of paragraphs 124(1)(a) to (f), subsection 124(2), any of sections 127 to 135, 137 to 143 or 146 to 152, subsection 153(3), any of sections 155 to 157, section 163, 166 or 198, paragraph 246(a) or section 274 and where the foreign state to which the food is to be exported has a different requirement on the same matter, the person prepares and keeps a written document that substantiates that the foreign state's requirement has been met; and
• (b) in the case where the unmet requirement is set out in subsection 17(1) — except as that subsection relates to icewine —, section 18, any of sections 185 to 189, section 192, 194 or 197 — except as that section relates to icewine —, any of sections 232 to 237, section 241 or 243, subsection 245(2), paragraph 246(c) or (d), section 250, any of sections 252 to 255, section 257, 258, 262, 263, 265 or 270, paragraph 273(a), section 275, any of sections 279 to 282, section 292, 300, 301, 309 or 312, any of sections 315 to 322 or section 324 or 325 and where the foreign state to which the food is to be exported does not have a requirement on the same matter, the person prepares and keeps a written document that sets out the specifications on that matter that are stipulated in the contract under which the food is being exported and that substantiates that those specifications have been met.

Export certificates

14 (1) To obtain a certificate or other document referred to in section 48 of the Act in respect of a food commodity, a person must

• (a) hold a licence to export the food commodity, unless it is not intended for commercial use;
• (b) for any activity that they conduct in respect of the food commodity,
  • (i) in the case of a food, comply with the applicable requirements of Part 4, unless the food is not intended for commercial use,
  • (ii) in the case of a food commodity referred to in paragraph (b) of the definition food commodity in section 2 of the Act, other than an animal, for which a competent authority of a foreign state requires a certificate or other document referred to in section 48 of the Act for its import into that foreign state for the purpose of human consumption, comply with the applicable requirements of Part 4 — other than sections 45 and 46 — as if the food commodity were a food, and
  • (iii) in the case of a food commodity referred to in subsection (2), comply with the applicable requirements of Part 4 — other than sections 45 and 46 — as if the food commodity were a food; and
• (c) make an application to the Minister in a form approved by the President and pay the applicable fee set out in the Fees Notice.

Prescribed food commodity

(2) For the purpose of paragraph (c) of the definition food commodity in section 2 of the Act, a prescribed food commodity is any commodity that is derived from an animal or plant, or any of its parts,

• (a) that is not otherwise included in paragraph (a) or (b) of that definition; and
• (b) for which a competent authority of a foreign state requires a certificate or other document referred to in section 48 of the Act for its import into that foreign state for the purpose of human consumption.

Exemption

(3) The food commodity referred to in subsection (2) is exempted from the application of any provision of the Act and these Regulations that is not necessary to give effect to this section. For greater certainty, the exemption does not include section 6 of the Act.

Inspection before export

(4) Before the Minister issues the certificate or other document referred to in section 48 of the Act, the Minister may require that an inspection be conducted before the food commodity is exported.

Inspection — fee and accessibility

(5) If an inspection is required, the applicant must pay the applicable fee set out in the Fees Notice and must make the food commodity readily accessible to an inspector at the time of inspection.

Exemption — non-compliant food

15 (1) A person may send or convey from one province to another or import a food that does not meet the requirements of the Act or these Regulations — other than the requirements set out in Volume 4 of the Standards of Identity Document and the requirements set out in section 186 as that section relates to fresh fruits or vegetables, processed fruit or vegetable products or honey, sections 187 to 190, and section 301 as that section relates to fresh fruits or vegetables or processed fruit or vegetable products — if

• (a) a label that bears the expression “For Further Preparation Only” or “pour conditionnement ultérieur seulement” is applied or attached to the food;
• (b) subject to subsection (3), the food will be manufactured, processed, treated, preserved, graded, packaged or labelled so that it meets the requirements of the Act and these Regulations within
  • (i) three months after the day on which the food is sent or conveyed from one province to another or imported, or
  • (ii) any longer period that is specified by the Minister at the person's request; and
• (c) in the case of import, the food is not a meat product.

• Licence holder
• (2) The activities referred to in paragraph (1)(b) must be conducted by a licence holder.

Prohibition — mixture

(3) It is prohibited for a person to mix a food referred to in subsection (1) that is contaminated with a food that is not contaminated so that it meets the requirements of the Act and these Regulations, unless authorized to do so by the Minister if the Minister is of the opinion that no risk of injury to human health will result.

Exemption — import for export

16 (1) A person may import a food that does not meet the requirements of the Act or these Regulations — other than the requirements set out in Volume 4 of the Standards of Identity Document and the requirements set out in section 186 as that section relates to fresh fruits or vegetables, processed fruit or vegetable products or honey, sections 187 to 190, section 301 as that section relates to fresh fruits or vegetables or processed fruit or vegetable products and Part 14 — if

• (a) a label that bears the expression “Imported for Export” or “importé pour l'exportation” is applied or attached to the food; and
• (b) the food will be manufactured, processed, treated, preserved, graded, packaged or labelled for the purpose of exporting it.

Licence holder

(2) The activities referred to in paragraph (1)(b) must be conducted by a licence holder.

Compliance with standard — interprovincial trade, import and export

17 (1) It is prohibited for a person to send or convey from one province to another or to import or export any food for which a standard is set out in the Standards of Identity Document unless the food meets that standard.

Food likely to be mistaken — interprovincial trade, import and export

(2) It is prohibited for a person to send or convey from one province to another or to import or export any food that is intended for sale and that is likely to be mistaken for a food for which a standard is set out in the Standards of Identity Document unless the food meets that standard.

Food likely to be mistaken — packaging and labelling

(3) It is prohibited for a person to package or label any food that has been imported or sent or conveyed from one province to another, or that is to be exported or to be sent or conveyed from one province to another, in such a manner that it is likely to be mistaken for a food for which a standard is set out in the Standards of Identity Document unless the food meets that standard.

Use of food additives and other substances

18 A food additive or other substance may be used in or on a food that has been imported or that is to be exported or to be sent or conveyed from one province to another and for which a standard is set out in the Standards of Identity Document only if their use is permitted under these Regulations or the Food and Drugs Act and complies with the limits or levels, if any, that are provided under these Regulations and that Act.

Exemption — conveyers

19 (1) Subject to subsection (2), the Act and these Regulations do not apply to a person who conveys a food commodity if their sole concern, in respect of the food commodity, is its conveyance.

Exception

(2) The following provisions, and any provision of the Act and these Regulations that is necessary to give effect to them, apply to the person referred to in subsection (1):

• (a) the provisions of Division 2 of this Part;
• (b) sections 344 to 349; and
• (c) subsection 356(3).

Personal use

20 For the purpose of section 19 of the Act, the importing, exporting or sending or conveying from one province to another of a food is carried out solely for personal use if the food is not intended for commercial use and

• (a) is imported, exported, sent or conveyed by an individual, otherwise than in the course of business, and is part of a shipment of food in a quantity that is not more than the quantity set out in the document entitled Maximum Quantity Limits for Personal Use Exemption, prepared by the Agency and published on its website, as amended from time to time; or
• (b) is imported or exported and is part of the personal effects of an immigrant or emigrant.

Exemption — return to Canada of exported food

21 (1) The import requirements of the Act and these Regulations do not apply in respect of a food that is imported after having been exported from Canada if the food is in its exported condition and if

• (a) in the case of a food other than a meat product, the food is sent back to
  • (i) the person who exported it from Canada, if that person holds a licence to export, or
  • (ii) the person who was last in possession of it before its export, from among the persons who manufactured, processed, treated, preserved, graded, packaged or labelled it; and
• (b) in the case of a meat product, the import is authorized by an inspector and the meat product is immediately delivered to an establishment where it is stored and handled in its imported condition by a licence holder.

Meat products

(2) For the purpose of subsection (1), the foods set out in paragraphs 24(a) and (b) are not to be considered meat products.

Exemption — import, export and interprovincial trade

22 (1) The Act and these Regulations do not apply in respect of a food that is imported, exported or sent or conveyed from one province to another if

• (a) the food is carried on a conveyance for use by the crew or passengers;
• (b) the food is intended and used for analysis, evaluation, research or a Canadian or international food exhibition and is part of a shipment that weighs 100 kg or less or, in the case of eggs, is part of a shipment of five or fewer cases;
• (c) the food is not intended or sold for use as food and a label that indicates its intended use and bears the expression “Not for Use as Human Food” or “ne peut servir à l'alimentation humaine” is applied or attached to it;
• (d) in the case of a food that is imported, the food
  • (i) is imported from the United States into the Akwesasne Reserve for use by an individual who has established permanent residence on that Reserve, or
  • (ii) is part of a bonded shipment that is sent or conveyed from a foreign state to a cruise ship or military ship in Canada for use by the crew or passengers; or
• (e) in the case of a food that is sent or conveyed from one province to another, the food is sent or conveyed from one federal penitentiary to another.

In transit

(2) For the purpose of subparagraph (1)(d)(i), if the food is part of a bonded shipment that passes only in transit through the United States, the food is not considered to have been imported from the United States.

Exemption — bonded shipment

23 The Act and these Regulations do not apply in respect of a food that is part of a bonded shipment that is sent or conveyed from one foreign state to another if

• (a) the food is manufactured or prepared in a foreign state; and
• (b) the food passes only in transit through Canada.

Non-application — meat products

24 Subparagraph 7(2)(a)(ii), subsection 29(2), paragraph 30(1)(e), subsection 32(2), paragraph 43(1)(b) and sections 67, 122, 165, 166 and 283 do not apply in respect of the following foods:

• (a) meat products — other than those that are set out in column 1 of Part A of Table 2 to Volume 7 of the Standards of Identity Document — that are a mixture of a ready-to-eat meat product and a food other than a meat product, if
  • (i) in the case where the ready-to-eat meat product that is contained in the mixture was manufactured, processed, treated, preserved, graded, packaged or labelled in Canada, that activity was conducted by a licence holder in accordance with the Act and these Regulations,
  • (ii) in the case where the ready-to-eat meat product that is contained in the mixture was imported, it was imported by a licence holder in accordance with the Act and these Regulations, and
  • (iii) in the case where the mixture is imported,
    • (A) the foreign state from which it is imported has, at the time that it is manufactured, prepared, stored, packaged or labelled, as the case may be, and at the time of the import, a system of inspection in relation to meat products that is recognized under these Regulations,
    • (B) the establishment where the food animal from which the ready-to-eat meat product that is contained in the mixture is derived was slaughtered, and any establishment where that meat product was manufactured, processed, treated, preserved, handled, tested, graded, coded, stored, packaged or labelled, have, at the time that the activity is conducted and at the time of the import, a system for manufacturing, processing, treating, preserving, handling, testing, grading, coding, slaughtering, storing, packaging or labelling, as the case may be, that is recognized under these Regulations, and
    • (C) the holder of the licence to import provides an inspector with an official document issued by the foreign state, in the form approved by the President, that states that the ready-to-eat meat product that is contained in the mixture meets the requirements of the Act and these Regulations; and
• (b) broth, lard, leaf lard, tallow or other rendered fat, suet, shortening, flavour and extract if
  • (i) in the case where the meat product from which they are derived was manufactured, processed, treated, preserved, graded, packaged or labelled in Canada, that activity was conducted by a licence holder in accordance with the Act and these Regulations,
  • (ii) in the case where the meat product from which they are derived was imported, it was imported by a licence holder in accordance with the Act and these Regulations, and
  • (iii) in the case where they are imported,
    • (A) the foreign state from which they are imported has, at the time that they are manufactured, prepared, stored, packaged or labelled, as the case may be, and at the time of the import, a system of inspection in relation to meat products that is recognized under these Regulations,
    • (B) the establishment where the food animal from which the meat product from which they are derived was slaughtered, and any establishment where the meat product was manufactured, processed, treated, preserved, handled, tested, graded, coded, stored, packaged or labelled, have, at the time that the activity is conducted and at the time of the import, a system for manufacturing, processing, treating, preserving, handling, testing, grading, coding, slaughtering, storing, packaging or labelling, as the case may be, that is recognized under these Regulations, and
    • (C) the holder of the licence to import keeps a document that substantiates that the conditions set out in clauses (A) and (B) are met.

DIVISION 2

Trade of Fresh Fruits and Vegetables

Non-application — definition fresh fruit or vegetable

25 The definition fresh fruit or vegetable in subsection 1(1) does not apply in this Division.

Prohibition

26 (1) It is prohibited for a person to

• (a) sell or negotiate the sale on another person's behalf of any fresh fruit or vegetable that is to be exported or to be sent or conveyed from one province to another;
• (b) purchase or negotiate the purchase on another person's behalf of any fresh fruit or vegetable that is to be imported or to be sent or conveyed from one province to another;
• (c) receive or receive on another person's behalf any fresh fruit or vegetable that has been imported or sent or conveyed from one province to another; or
• (d) send or convey from one province to another or import or export any fresh fruit or vegetable.

Exception — persons

(2) Subsection (1) does not apply to

• (a) a person who is a member in good standing of the Fruit and Vegetable Dispute Resolution Corporation, a corporation incorporated under Part 2 of the Canada Not-for-profit Corporations Act, as described in its by-laws;
• (b) a person who only sells fresh fruits or vegetables directly to consumers if that person paid less than $100,000 for the fresh fruits and vegetables that they sold to consumers within the previous 12 months;
• (c) a person who only purchases, sells or negotiates the purchase or sale on another person's behalf, sends or conveys from one province to another or imports or exports less than one metric ton (2 205 lb) of fresh fruits and vegetables per day;
• (d) a person who only sells fresh fruits or vegetables that they have grown themselves; or
• (e) an organization that is a registered charity as defined in subsection 248(1) of the Income Tax Act or a club, society or association described in paragraph 149(1)(l) of that Act.

Exception — nuts and wild fungi

(3) Subsection (1) does not apply in respect of nuts or wild fungi.

PART 3

Licences

Paragraph 20(1)(a) of Act — import

27 (1) For the purpose of the issuance of a licence to import under paragraph 20(1)(a) of the Act, the prescribed food commodity is a food.

Paragraph 20(1)(a) of Act — export

(2) For the purpose of the issuance of a licence to export under paragraph 20(1)(a) of the Act, the prescribed food commodities are

• (a) a food;
• (b) a food commodity referred to in subparagraph 14(1)(b)(ii); and
• (c) a food commodity referred to in subsection 14(2).

Paragraph 20(1)(b) of Act — imported food commodity

28 (1) For the purpose of the issuance of a licence under paragraph 20(1)(b) of the Act, the prescribed food commodity that has been imported is a food and the prescribed activity in respect of that food commodity is storing and handling, in its imported condition, for the purposes of the exercise of an inspector's powers under the Act.

Paragraph 20(1)(b) of Act — food commodities that are to be sent or conveyed from one province to another

(2) For the purpose of the issuance of a licence under paragraph 20(1)(b) of the Act, the prescribed food commodities that are to be sent or conveyed from one province to another are a food and a food animal and the prescribed activities in respect of those food commodities are

• (a) in the case of a food, manufacturing, processing, treating, preserving, grading, storing, packaging and labelling; and
• (b) in the case of a food animal, slaughtering.

Paragraph 20(1)(b) of Act — food commodities that are to be exported

(3) For the purpose of the issuance of a licence under paragraph 20(1)(b) of the Act, the prescribed food commodities that are to be exported are a food, a food animal, a food commodity referred to in subparagraph 14(1)(b)(ii) and a food commodity referred to in subsection 14(2) and the prescribed activities in respect of those food commodities are

• (a) in the case of a food, a food commodity referred to in subparagraph 14(1)(b)(ii) and a food commodity referred to in subsection 14(2), manufacturing, processing, treating, preserving, grading, storing, packaging and labelling; and
• (b) in the case of a food animal, slaughtering.

Application

29 (1) An application for the issuance, renewal or amendment of a licence must be made to the Minister in a form approved by the President.

Application — meat products

(2) An application for the issuance, renewal or amendment of a licence to slaughter food animals, to manufacture, process, treat, preserve, grade, package or label a meat product or to store and handle a meat product in its imported condition must include at least one proposed work shift for each establishment where the activity is conducted.

Work shift

(3) A work shift must be

• (a) in the case of slaughtering, a work shift during which no inspection station referred to in subsection 56(4) is operated for more than 7.5 hours in one day and 37.5 hours in one work week, excluding meal times; and
• (b) in the case of manufacturing, processing, treating, preserving, grading, packaging or labelling a meat product or storing and handling a meat product in its imported condition, a work shift during which those activities are conducted
  • (i) for not more than 7.5 hours in one day and 37.5 hours in one work week, excluding meal times, or
  • (ii) between 6:00 a.m. and 6:00 p.m.

Conditions for issuance, renewal or amendment

30 (1) The Minister may issue, renew or amend a licence if

• (a) the applicable fee set out in the Fees Notice is paid;
• (b) in the case of an application for the issuance of a licence, the applicant is not in default of payment of any fee related to the Act that is set out in the Fees Notice;
• (c) the applicant, whether or not they are already a licence holder conducting the activity in respect of which the application for the issuance, renewal or amendment of the licence is made,
  • (i) in the case of a licence in respect of a food, complies with the applicable requirements of Part 4, and
  • (ii) in the case of a licence in respect of a food commodity referred to in subparagraph 14(1)(b)(ii) and a food commodity referred to in subsection 14(2), complies with the applicable requirements of Part 4 — other than sections 45 and 46 — as if the food commodity were a food;
• (d) in the case of an application for the issuance, renewal or amendment of a licence to import, the applicant carries on business related to the food in respect of which the application is made from a fixed place of business that is
  • (i) in Canada, or
  • (ii) in a foreign state that has a food safety system that provides at least the same level of protection as that provided by the provisions of the Act and these Regulations;
• (e) in the case of an application for the issuance, renewal or amendment of a licence to slaughter food animals, to manufacture, process, treat, preserve, grade, package or label a meat product or to store and handle a meat product in its imported condition, a work shift has been approved by the President for each establishment where the activity is conducted;
• (f) the information submitted in the application is complete, truthful and not misleading; and
• (g) the Minister is of the opinion, based on the information that was made available to him or her, that no risk of injury to human health will result.

Inspection fee

(2) If an inspection is required to verify that the condition set out in paragraph (1)(c) is met, the applicant must pay the applicable fee set out in the Fees Notice.

Refusal of issuance, renewal or amendment

31 The Minister may refuse to issue, renew or amend a licence if

• (a) in the five years before the day on which the application is made, the applicant or any of their directors or officers have
  • (i) had a licence suspended or cancelled, or
  • (ii) been convicted of an offence under the Act or the Food and Drugs Act; or
• (b) in the case of an application for the amendment or renewal of a licence, the applicant is in default of payment of any fee related to the licence that is set out in the Fees Notice.

Establishment

32 (1) A licence holder must conduct the activities that are identified in their licence, other than importing and exporting, in the establishment that is identified in the licence for the activities.

Work shift

(2) Subject to subsection (3), if the activities are conducted in respect of a food animal or meat product, they must be conducted during a work shift approved by the President, unless otherwise authorized by an inspector.

Exception — ante-mortem examination

(3) In the case of the slaughtering of a food animal, the ante-mortem examination may be conducted outside a work shift.

Amendment without application

33 (1) If a licence holder is unable to conduct an activity that is identified in their licence in one of the establishments that are identified in the licence, the Minister may amend the licence, without having received an application for the amendment, to remove the authorization to conduct that activity in that establishment.

Written notice

(2) The Minister must notify the licence holder in writing of the amendment and the date on which it takes effect.

Expiry

34 (1) A licence expires two years after the date of issuance or renewal that is specified in it, unless the licence is cancelled before that date.

Expiry — amendment

(2) If the Minister amends a licence, its expiry date remains unchanged.

Invalidity

35 A licence becomes invalid if the licence holder

• (a) becomes subject to a receivership or bankrupt; or
• (b) surrenders the licence and it is not subject to a cancellation procedure.

Grounds for suspension

36 The Minister may suspend a licence if

• (a) the licence holder does not comply with any provision of the Act, other than section 15, or with any provision of these Regulations, the Food and Drugs Act or the Food and Drug Regulations;
• (b) the licence holder is in default of payment of any fee related to the licence that is set out in the Fees Notice; or
• (c) the Minister is of the opinion that a risk of injury to human health may result if the licence holder continues to conduct an activity that is identified in the licence.

Suspension

37 (1) The Minister must not suspend a licence unless the licence holder

• (a) was provided with an inspection report that sets out the grounds for the suspension and the date by which corrective action must be taken in order to avoid the suspension; and
• (b) failed to take corrective action by that date.

Written notice

(2) The Minister must notify the licence holder in writing of the suspension and the date on which it takes effect.

Risk of injury to human health

38 (1) Despite section 37, if the Minister is of the opinion that a risk of injury to human health may result if the licence holder continues to conduct an activity that is identified in the licence, the Minister may suspend the licence immediately after the licence holder is provided with an inspection report that sets out the grounds for the suspension.

Written notice

(2) The Minister must notify the licence holder in writing that their licence is suspended and that the suspension takes effect immediately.

Duration of suspension

39 A suspension of a licence remains in effect until an inspector determines that corrective action has been taken or until the licence is cancelled.

Grounds for cancellation

40 The Minister may cancel a licence if

• (a) the licence holder fails to take corrective action within 90 days after the day on which the licence was suspended, unless a longer period is granted by the Minister at the request of the licence holder;
• (b) the licence holder continues to conduct an activity that is identified in their licence while the licence is suspended;
• (c) the licence holder or any of their directors or officers have been convicted of an offence under the Act or the Food and Drugs Act;
• (d) the licence holder does not comply with any provision of the Act, other than section 15, or with any provision of these Regulations, the Food and Drugs Act or the Food and Drug Regulations and, since its issuance or renewal, the licence
  • (i) has already been suspended for non-compliance with that provision, or
  • (ii) has already been suspended twice; or
• (e) the licence holder was not in compliance with section 15 of the Act at the time of their application for the issuance, renewal or amendment of the licence or at any time during the period of validity of the licence.

Cancellation

41 (1) The Minister must not cancel a licence unless the licence holder was notified of the grounds for cancellation and was provided with an opportunity to be heard in respect of the cancellation.

Written notice

(2) The Minister must notify the licence holder in writing of the cancellation and the date on which it takes effect.

PART 4

Preventive Control Measures

Interpretation

Definitions

42 The following definitions apply in this Part.

agronomic input means an input that is used in the growing of fresh fruits or vegetables, and includes agricultural chemicals, biological controls, pollinators, commercial fertilizers, compost, compost tea, green manure, manure, mulch, row covers, soil amendments and pulp sludge. (intrant agronomique)

control measure means a measure that can be applied to prevent or eliminate any biological, chemical or physical hazard that presents a risk of contamination of a food. (mesure de contrôle)

critical control point means a step at which a control measure can be applied and is essential to prevent or eliminate any biological, chemical or physical hazard that presents a risk of contamination of a food. (point de contrôle critique)

low-acid food means a food of which any food unit has a pH that is greater than 4.6 and a water activity, as determined by the ratio of the water vapour pressure of the food unit to the vapour pressure of pure water at the same temperature and pressure, that is greater than 0.85. (aliment peu acide)

operator means

• (a) the holder of a licence to manufacture, process, treat, preserve, grade, store, package or label a food, to store and handle a meat product in its imported condition or to slaughter a food animal;
• (b) any person who grows or harvests fresh fruits or vegetables; and
• (c) any person who handles fish in a conveyance. (exploitant)

scheduled process means a thermal treatment that is applied to a food, to achieve commercial sterility in the food, in combination with the critical physical and chemical factors that affect the treatment's ability to achieve commercial sterility. (traitement programmé)

Application — food and food animals

43 (1) Unless otherwise specified, the requirements of this Part apply only in respect of

• (a) foods that are to be exported or to be sent or conveyed from one province to another;
• (b) imported meat products during their storing and handling in their imported condition for the purposes of the exercise of an inspector's powers under the Act; and
• (c) food animals from which meat products that are to be exported or to be sent or conveyed from one province to another may be derived.

Exception

(2) Despite subsection (1), section 84 applies, in the case of the holder of a licence to import, in respect of any imported food.

Application — establishment

(3) The requirements of this Part that apply in respect of an establishment apply only in respect of

• (a) in the case of the holder of a licence referred to in paragraph (a) of the definition operator in section 42, an establishment that is identified in their licence;
• (b) in the case of a person referred to in paragraph (b) of that definition, the establishment where that person grows or harvests fresh fruits or vegetables; and
• (c) in the case of a person referred to in paragraph (c) of that definition, the conveyance where that person handles fish.

Establishment — slaughtering game animals

(4) Despite paragraph (3)(a), for the purposes of section 48, subsection 49(1) and sections 54, 64, 65 and 69, in the case of an establishment where game animals are slaughtered, the establishment is limited to the facility, in the establishment, where the meat products that are derived from the game animal are manufactured, processed, treated, preserved, packaged or labelled.

Non-application — game animals

(5) Sections 53, 56 and 67 do not apply in respect of an establishment where game animals are slaughtered.

Biological, Chemical and Physical Hazards

Identification, analysis, prevention and elimination of hazards

44 (1) An operator must identify and analyze the biological, chemical and physical hazards that present a risk of contamination of a food and must prevent or eliminate those hazards using control measures that are shown by evidence to be effective, including, in the case of a meat product, the control measures that are set out in the document entitled Preventive Control Plan Requirements for Biological Hazards in Meat Products, prepared by the Agency and published on its website, as amended from time to time.

Imported food

(2) The holder of a licence to import must comply with subsection (1) in respect of food that is imported.

Treatments and Processes

Treatments and processes

45 (1) An operator must subject a food to any process or treatment that is necessary to eliminate any biological, chemical or physical hazard that might be present in the food and that presents a risk of contamination of the food, including any treatment that is necessary for the food to meet the standards that are set out in the document entitled Biological, Chemical and Physical Standards for Food, prepared by the Agency and published on its website, as amended from time to time.

Method

(2) To verify that the food meets the standards referred to in subsection (1), the operator must use a method that is shown by evidence to be effective.

Application of scheduled process to low-acid food

46 (1) If a low-acid food is packaged in a hermetically sealed package, an operator must apply the scheduled process referred to in subparagraph (3)(a)(i) and, if batch thermal treatment is applied, must use a temperature-sensitive indicator that visually indicates that the package has been thermally treated.

Exception — refrigerated or frozen food

(2) Subsection (1) does not apply if the low-acid food is kept refrigerated or kept frozen and the statements “Keep Refrigerated” and “garder réfrigéré”, or “Keep Frozen” and “garder congelé”, as the case may be, are shown on the principal display panel.

Documents

(3) The operator must prepare written documents that set out the following information:

• (a) for each low-acid food,
  • (i) a description of the scheduled process that will be applied to it, together with the name of the person who is responsible for developing the process, and
  • (ii) the formulation of the food; and
• (b) for each application of the scheduled process to a low-acid food,
  • (i) the name of the food and its production volume,
  • (ii) the equipment that is used for the thermal treatment, the start and end times and temperature of the treatment and, if applicable, the pressure that is used in the treatment,
  • (iii) a description of any maintenance of, and of any modifications to, the equipment that is used for the thermal treatment,
  • (iv) any deviations from the scheduled process and any corrective action taken,
  • (v) the incubation results, and
  • (vi) a description of any treatment of the cooling water.

Retention period of documents

(4) The documents that set out the information referred to in paragraph (3)(a) must be kept for three years after the day of the most recent application of the scheduled process to the low-acid food, and the documents that set out the information referred to in paragraph (3)(b) must be kept for three years after the day of the application of the scheduled process.

Maintenance and Operation of Establishment

Responsibility of operator

47 An operator must maintain and operate an establishment so that the requirements of sections 48 to 78 are met.

Sanitation, Pest Control and Non-food Agents

Clean and sanitary condition

48 (1) An establishment, and any conveyance or equipment in it that is used in connection with an activity that is regulated under the Act, must be clean and in a sanitary condition.

Cleaning and sanitation

(2) The cleaning and sanitation of the establishment, and of any conveyance or equipment in it that is used in connection with an activity that is regulated under the Act, must be conducted in a manner that does not present a risk of contamination of a food.

Animals — establishment

49 (1) An establishment must be protected against the entry of any animal that presents a risk of contamination of a food.

Animals — facility or conveyance

(2) No animal is to be in a facility or conveyance where a food is manufactured, prepared, stored, packaged or labelled or where food animals are slaughtered, unless the animal is

• (a) a food that is to be manufactured, prepared, stored, packaged or labelled in the facility or conveyance;
• (b) a food animal that is to be slaughtered in the facility or conveyance, whether or not the meat products that may be derived from it are to be exported or to be sent or conveyed from one province to another; or
• (c) an animal that is to be used in the manufacturing or preparing of a food in the facility or conveyance.

Risk of contamination

(3) Any measures that are taken for the purpose of complying with subsections (1) and (2) must not present a risk of contamination of a food.

Sanitizers, agronomic inputs and non-food chemical agents

50 Any sanitizer, agronomic input or non-food chemical agent in an establishment must

• (a) be properly and clearly identified;
• (b) be suitable for its intended use and not present a risk of contamination of a food; and
• (c) be handled and used in a manner that does not present a risk of contamination of a food and that, if applicable, is in accordance with the manufacturer's instructions.

Conveyances and Equipment

Conveyances and equipment — food

51 Any conveyance or equipment that is used in the manufacturing, preparing, storing, packaging or labelling of a food or in the slaughtering of food animals must

• (a) be appropriate for the food and for the activity being conducted and, if applicable, for the food animals that are to be slaughtered;
• (b) be designed, constructed and maintained to prevent contamination of the food;
• (c) be constructed of, and maintained using, materials that are suitable for their intended use and, if the materials present a risk of contamination of the food, that are
  • (i) corrosion-resistant,
  • (ii) durable,
  • (iii) capable of withstanding repeated cleaning and, if applicable, sanitizing, unless the equipment is intended for a single use, and
  • (iv) free of any noxious constituent;
• (d) be equipped with instruments to control, indicate and record any parameters that are necessary to prevent contamination of the food;
• (e) function as intended;
• (f) be accessible and, if necessary, able to be easily disassembled, for cleaning, sanitizing, maintenance and inspection;
• (g) be of sound construction and in good repair;
• (h) be used, maintained and, if necessary, calibrated
  • (i) in accordance with the manufacturer's instructions, and
  • (ii) in a manner that does not present a risk of contamination of the food; and
• (i) only have food contact surfaces that are
  • (i) smooth,
  • (ii) free from pitting, cracks and flakes, and
  • (iii) non-absorbent.

Other conveyances and equipment

52 Any conveyance or equipment in an establishment that is used to handle contaminated materials, waste or any other thing that is inedible must

• (a) be used only for that purpose;
• (b) be identified as being reserved for that purpose; and
• (c) meet the applicable requirements of section 51.

Equipment — slaughtering

53 An establishment where food animals are slaughtered must have equipment for restraining the food animals for examination and inspection.

Conditions Respecting Establishments

Land

54 (1) Any land that forms part of an establishment must not present a risk of contamination of a food or, if it does present such a risk, measures must be taken to eliminate the risk.

Location

(2) An establishment must not be located near any place or thing that presents a risk of contamination of a food unless measures are taken to eliminate the risk.

Interior of facility or conveyance

55 The interior of any facility or conveyance where a food is manufactured, prepared, stored, packaged or labelled or where food animals are slaughtered must be

• (a) of sanitary design to prevent the accumulation of contaminants including dust, dirt, micro-organisms and food particles and to permit effective maintenance, cleaning and, if applicable, sanitizing;
• (b) designed, constructed and maintained in such a manner that
  • (i) the size and layout is adequate to accommodate the activity being conducted and the equipment used in the activity,
  • (ii) the entry of insects, rodents and other vermin is prevented,
  • (iii) any floors, walls, ceilings, windows and doors are smooth, non-absorbent and impervious to moisture, except in areas where food animals are received, handled or held, and
  • (iv) any floors provide or permit good drainage;
• (c) constructed of, and maintained using, materials that are
  • (i) suitable for their intended use and appropriate for the food and for the activity being conducted and, if applicable, for the food animals that are to be slaughtered,
  • (ii) durable,
  • (iii) capable of withstanding repeated cleaning and, if applicable, sanitizing, and
  • (iv) free of any noxious constituent; and
• (d) of sound construction and in good repair.

Slaughtering — separate areas

56 (1) An establishment where food animals are slaughtered must have separate areas for

• (a) keeping, examining and inspecting food animals;
• (b) segregating and isolating food animals under section 131 or paragraph 139(b);
• (c) holding food animals that show a deviation from normal behaviour, physiology or appearance; and
• (d) humanely killing food animals under paragraph 139(c).

Inedible meat products area

(2) The establishment must also have an enclosed inedible products area where inedible meat products are handled.

Movement of food animals

(3) Floors, ramps, gangways and chutes that are used by food animals in the establishment must provide secure footing and must not present a risk of injury to the food animals during movement.

Inspection stations

(4) The establishment must be equipped with

• (a) inspection stations at locations specified by the President for ante-mortem inspections; and
• (b) inspection stations at locations specified by the President for post-mortem inspections or, if it is an establishment where a licence holder is authorized to conduct a post-mortem examination program, stations for post-mortem examinations.

Design, construction and maintenance — movement

57 (1) A facility or conveyance where a food is manufactured, prepared, stored, packaged or labelled or where food animals are slaughtered must be designed, constructed and maintained in such a manner that the movement of persons and things within, into and out of it is controlled.

Movement — no risk of contamination

(2) The movement must not present a risk of contamination of the food.

Incompatible activities

58 Physical or other effective means must be used to separate incompatible activities in order to prevent contamination of a food.

Separation of food

59 Physical or other effective means must be used to separate a food from

• (a) anything that presents a risk of contamination of the food;
• (b) any food that does not meet the requirements of the Act or these Regulations; and
• (c) anything that is manufactured, prepared, stored, packaged or labelled in an establishment and not intended or sold for use as food.

Arrival at establishment of certain food

60 On arrival at an establishment of any food, whether or not it is to be exported or to be sent or conveyed from one province to another, that presents a risk of injury to human health, that is exempted from the application of the import requirements of the Act and these Regulations under section 21 or that does not meet the requirements of the Act or these Regulations, the food must be identified as such and placed in a designated area within the establishment and any other measures that are necessary to prevent contamination of any other food in the establishment must be taken.

Lighting

61 (1) An establishment must be equipped with natural or artificial lighting that is appropriate for the food and for the activity being conducted and, if applicable, for the food animals that are to be slaughtered.

Light fixtures

(2) Light fixtures in the establishment must

• (a) be capable of withstanding repeated cleaning and, if applicable, sanitizing; and
• (b) not present a risk of contamination of the food in the event of breakage.

Ventilation system

62 A facility or conveyance where a food is manufactured, prepared, stored, packaged or labelled or where food animals are slaughtered must be equipped with a ventilation system that

• (a) provides natural or mechanical ventilation with sufficient air exchange to provide clean air and to remove unclean air and odours that might affect the food;
• (b) is accessible and, if necessary, able to be disassembled, for cleaning, maintenance and inspection;
• (c) is capable of withstanding repeated cleaning; and
• (d) functions as intended.

Temperature and humidity

63 (1) The temperature and humidity level in a facility or conveyance where a food is manufactured, prepared, stored, packaged or labelled or where food animals are slaughtered must be maintained at levels that are appropriate for the food and for the activity being conducted and, if applicable, for the food animals that are to be slaughtered.

Heating, cooling or humidity-control system

(2) If the facility or conveyance is equipped with a heating, cooling or humidity-control system, the system must

• (a) if necessary, be equipped with instruments that control, indicate and, if required, record the temperature and humidity levels;
• (b) be accessible and, if necessary, able to be disassembled, for cleaning, maintenance and inspection;
• (c) be capable of withstanding repeated cleaning; and
• (d) function as intended.

Removal and disposal of contaminated materials and waste

64 (1) An establishment must have means for the removal and disposal of contaminated materials and waste and, if necessary, be equipped with a drainage, sewage and plumbing system that functions as intended.

Frequency and manner

(2) Contaminated materials and waste must be removed and disposed of at a frequency that is sufficient to prevent contamination of a food and in a manner that does not present a risk of contamination of a food.

Cleaning stations, lavatories, etc.

65 (1) An establishment must be equipped with hand cleaning and sanitizing stations, lavatories, showers, drinking water stations, break rooms and change rooms, if they are necessary to meet the needs of the establishment, that

• (a) are appropriately equipped and appropriate in number and size for the number of persons using them;
• (b) are located in the establishment so that they are readily accessible to the persons using them; and
• (c) are capable of withstanding repeated cleaning and, if applicable, sanitizing.

Hand cleaning and sanitizing stations

(2) The hand cleaning and sanitizing stations must supply water at a temperature and pressure that permit the effective cleaning of hands.

Lavatories

(3) The lavatories must not provide direct access to any area where a food is manufactured, prepared, stored, packaged or labelled or where food animals are slaughtered.

Area for inspector's use

66 At the request of an inspector, the inspector must be provided with an area that is readily accessible, appropriately equipped and appropriate in size for the exercise of their powers, and the performance of their duties and functions, under the Act.

Office, lockers, etc., for inspector

67 (1) If a meat product or processed egg product is manufactured, prepared, stored, packaged or labelled in an establishment, an inspector must be provided with

• (a) a furnished office that is readily accessible, appropriately equipped and appropriate in size for the exercise of their powers, and the performance of their duties and functions, under the Act;
• (b) lockers and cabinets that are readily accessible and appropriate for the protection and storing of their equipment and documents; and
• (c) access to a lockable storage facility or equipment that is appropriate for the protection, preservation and storing of samples.

Private office, change rooms, etc., for inspector

(2) If food animals are slaughtered in an establishment, the office referred to in paragraph (1)(a) must be private and the inspector must also be provided with access to a lavatory, a shower and a change room in the establishment.

Water — contact with food

68 (1) Any water that might come into contact with a food must, unless the water does not present a risk of contamination of the food, be potable and must

• (a) be protected against contamination; and
• (b) meet the standards set out in the document entitled Guidelines for Canadian Drinking Water Quality – Summary Table, prepared by the Federal-Provincial-Territorial Committee on Drinking Water of the Federal-Provincial-Territorial Committee on Health and the Environment and published by the Department of Health on its website, as amended from time to time.

Steam and ice — contact with food

(2) Any steam or ice that might come into contact with a food must be made from water that meets the requirements of subsection (1), unless the steam or ice does not present a risk of contamination of the food.

Water — cross-connections

(3) Any system that supplies water that meets the requirements of subsection (1) must not be cross-connected with any other system, unless measures are taken to eliminate any risk of contamination of a food as a result of the cross-connection.

Water given to food animals

(4) Any water that is given to food animals that are to be slaughtered in an establishment must not present a risk of injury to the health of those animals and must not present a risk of contamination of the meat products that may be derived from those animals.

Supply of water, steam and ice

69 (1) An establishment must be supplied, as appropriate for the food and for the activity being conducted and, if applicable, for the food animals that are to be slaughtered, with

• (a) water that is adequate in quantity, temperature, pH and pressure to meet the needs of the establishment;
• (b) steam that is adequate in quantity and pressure to meet those needs; and
• (c) ice that is adequate in quantity to meet those needs.

Treatment of water, steam or ice

(2) Any treatment of water, steam or ice must be applied in a manner that does not present a risk of contamination of a food.

Unloading, Loading and Storing

Conveyances

70 Any conveyance that is used to convey a food to or from an establishment and that is unloaded or loaded at the establishment

• (a) must be designed, constructed and maintained to prevent contamination of the food;
• (b) must be constructed of, and maintained using, materials that are suitable for their intended use and, if the materials present a risk of contamination of the food, that are
  • (i) durable,
  • (ii) capable of withstanding repeated cleaning and, if applicable, sanitizing, and
  • (iii) free of any noxious constituent;
• (c) must be capable of maintaining the temperature and humidity at levels that are appropriate for the food and, if necessary, be equipped with instruments that control, indicate and record those levels;
• (d) must be of sound construction and in good repair;
• (e) must not contain or have contained animals, pest control products as defined in subsection 2(1) of the Pest Control Products Act or any other material or substance that presents a risk of contamination of the food; and
• (f) must be clean and in sanitary condition at the time of unloading or loading, as the case may be.

Unloading and loading

71 Any unloading and loading of a food and, if applicable, of food animals that are to be slaughtered, from or onto a conveyance at an establishment, must be conducted in a manner that does not present a risk of contamination of a food.

Storing — food

72 (1) Any storing of a food must be conducted in a manner that does not present a risk of contamination of the food.

Storing — other

(2) Any storing of conveyances, equipment, sanitizers, agronomic inputs, chemical agents, starter products, packaging material, labels or any other thing that is used in the manufacturing, preparing, storing, packaging or labelling of a food must be conducted in a manner that does not present a risk of contamination of the food.

Definition starter products

(3) In subsection (2), starter products means the materials that are used to start the growing of fresh fruits or vegetables and includes seeds, seedlings, plants, cuttings, canes, seed potatoes and nursery stock.

Competency

Competencies and qualifications

73 Any person who is involved in the manufacturing, preparing, storing, packaging or labelling of a food or in the slaughtering of food animals must have the competencies and qualifications that are necessary to carry out their duties.

Hygiene

Clothing, footwear and protective coverings

74 Any person who enters or is in an area where a food is manufactured, prepared, stored, packaged or labelled or where food animals are slaughtered must wear clothing, footwear and protective coverings, including gloves, a hairnet, a beard net and a smock, that are in good condition, clean and in sanitary condition and that are appropriate for the food and for the activity being conducted.

Personal cleanliness

75 Any person who enters or is in an area where a food is manufactured, prepared, stored, packaged or labelled or where food animals are slaughtered must maintain personal cleanliness to prevent contamination of the food, including by cleaning and, if necessary, sanitizing their hands

• (a) immediately on entering the area;
• (b) immediately after using a lavatory;
• (c) immediately before beginning to conduct the activity; and
• (d) at a frequency appropriate for the food and for the activity being conducted.

Spitting, chewing gum and other acts

76 Any person who enters or is in an area where a food is manufactured, prepared, stored, packaged or labelled or where food animals are slaughtered must refrain from spitting, chewing gum, using tobacco products, eating, having unnecessary contact with the food and doing any other act that presents a risk of contamination of the food.

Objects and substances — risk of contamination

77 Any person who enters or is in an area where a food is manufactured, prepared, stored, packaged or labelled or where food animals are slaughtered must refrain from wearing or using any object or substance that presents a risk of contamination of the food.

Reporting of disease, illness, symptoms and lesions

78 Any person who works in an area where a food is manufactured, prepared, stored, packaged or labelled or where food animals are slaughtered and who has a disease or illness, symptoms of a disease or illness or an open or infected lesion must report them to the operator.

Communicable Diseases and Lesions

Risk of contamination

79 An operator must prevent any person who is suffering from, or is a known carrier of, a communicable disease or who has an open or infected lesion from being in an area of an establishment where a food is manufactured, prepared, stored, packaged or labelled or where food animals are slaughtered, if the person's condition presents a risk of contamination of the food.

Investigation and Notification, Complaints and Recall

Investigation

80 (1) An operator who suspects on reasonable grounds that a food presents a risk of injury to human health or does not meet the requirements of the Act or these Regulations must immediately investigate the matter.

Results — risk of injury

(2) The operator must immediately notify the Minister of the results of their investigation and immediately take action to mitigate any risk of injury to human health, unless the results of the investigation establish that the food does not present such a risk.

Complaints procedure

81 (1) An operator must prepare, keep and maintain a written document that sets out a procedure for receiving, investigating and responding to complaints that are received in relation to a food.

Complaints

(2) If a complaint is received, the operator must implement the procedure and prepare a written document that sets out the details of the complaint, the results of the investigation and the actions taken based on those results and keep it for two years after the day on which the actions are completed.

Recall procedure

82 (1) An operator must prepare, keep and maintain a written document that sets out a recall procedure that enables the effective recall of a food, the name of a contact person who is responsible for the procedure and the name of a contact person who is responsible for conducting recalls.

Recall simulation

(2) The operator must conduct a recall simulation based on the recall procedure at least once a year.

Recall

(3) If a food is recalled, the operator must

• (a) immediately notify the Minister and immediately implement the recall procedure; and
• (b) prepare a written document that sets out the details of the recall, including any information that substantiates its effectiveness, and keep the document for two years after the day on which the recall is initiated.

Imported food

83 The holder of a licence to import must comply with sections 80 to 82 in respect of a food that is imported.

Preventive Control Plan

Licence holders

84 (1) A licence holder must prepare, keep and maintain a written preventive control plan that meets the requirements of section 87 for any activity that they conduct in respect of a food or food animal that is identified in their licence.

Exception — food to be exported

(2) Despite subsection (1), a preventive control plan is not required to be prepared, kept or maintained for any activity that the licence holder conducts in respect of a food, other than fish or a meat product, that is to be exported, unless a certificate or other document referred to in section 48 of the Act will be sought in respect of the food.

Exception — sales of $30,000 or less

(3) Despite subsection (1), if a licence holder's gross sales that are derived from food are $30,000 or less for the 12 months before the day on which they most recently made an application for the issuance, renewal or amendment of a licence, a preventive control plan must be prepared, kept and maintained only for any activity that they conduct in respect of

• (a) food animals, meat products, fish, dairy products, eggs, processed egg products and processed fruit or vegetable products that are identified in their licence; and
• (b) any food in respect of which a certificate or other document referred to in section 48 of the Act will be sought.

Exception — game animals

(4) Despite subsection (1), a preventive control plan is not required to be prepared, kept or maintained for the slaughtering of a game animal or for any activity that the licence holder conducts, in respect of meat products that are derived from a game animal, in the establishment where the game animal is slaughtered.

Growers or harvesters of fresh fruits or vegetables

85 Any person who grows or harvests fresh fruits or vegetables must prepare, keep and maintain a written preventive control plan that meets the requirements of section 87 for any activity that they conduct in respect of those fresh fruits or vegetables if the fresh fruits are vegetables are

• (a) to be exported and a certificate or other document referred to in section 48 of the Act will be sought in respect of the fresh fruits are vegetables; or
• (b) to be sent or conveyed from one province to another and the person's gross sales that are derived from food are more than $30,000 for the previous 12 months.

Implementation

86 Any person who is required to prepare, keep and maintain a preventive control plan must implement that plan.

Content of preventive control plan

87 (1) The preventive control plan must include

• (a) a description of the measures that will be taken to ensure that the applicable requirements of sections 127 to 135, 197, 203, 206, 283 and 288, subsection 289(1), section 290, subsections 301(1) and (3), section 305, paragraph 307(a) and sections 310, 312, 314, 315, 318, 319, 321 and 323 are met;
• (b) a description of the measures that will be taken to ensure that the food is packaged and labelled in a manner that does not contravene subsection 6(1) of the Act;
• (c) in relation to the applicable requirements of sections 45 to 79, paragraphs 104(b) and 124(1)(f), sections 125, 126 and 137 to 153, paragraphs 155(b) and (c), section 156, paragraph 157(a), section 183, paragraph 278(b) and section 311,
  • (i) a description of the biological, chemical and physical hazards that are identified under section 44 as presenting a risk of contamination of a food, of the control measures that are used to prevent or eliminate those hazards and of the evidence that shows that the control measures are effective,
  • (ii) a description of the critical control points, of the related control measures and of the evidence that shows that the control measures are effective,
  • (iii) a description of the critical limits for each critical control point,
  • (iv) the procedures for monitoring the critical control points in relation to their critical limits,
  • (v) the corrective action procedures for each critical control point,
  • (vi) the procedures to verify that the implementation of the preventive control plan results in compliance with the Act and these Regulations, and
  • (vii) documents that substantiate that the preventive control plan has been implemented with respect to subparagraphs (i) to (vi); and
• (d) supporting documents that evidence the information recorded under paragraphs (a) and (b) and subparagraphs (c)(i) to (vi).

Additional content — import

(2) The preventive control plan of the holder of a licence to import must also include the elements set out in subparagraphs (1)(c)(i) to (vii) in relation to the requirement of section 9.

Additional content — export

(3) The preventive control plan of the holder of a licence to export must also include the elements set out in subparagraphs (1)(c)(i) to (vii) in relation to the requirement of subsection 13(1).

Additional content — post-mortem examination program

(4) The preventive control plan of a licence holder who is authorized under section 158 to conduct a post-mortem examination program must also include the elements set out in subparagraphs (1)(c)(i) to (vii) and paragraph (1)(d) in relation to that program and must meet the requirements set out in the document entitled Fundamentals of the Post-mortem Examination Program, prepared by the Agency and published on its website, as amended from time to time.

PART 5

Traceability

Documents

88 (1) Any person who sends or conveys a food from one province to another, or imports or exports it, any holder of a licence to slaughter a food animal, to manufacture, process, treat, preserve, grade, store, package or label a food or to store and handle a meat product in its imported condition and any person who grows or harvests fresh fruits or vegetables that are to be exported or to be sent or conveyed from one province to another must, if they provide the food to another person, prepare and keep documents that set out the following information:

• (a) the common name of the food, a lot code to enable the food to be traced and the name and principal place of business of the person by or for whom the food was manufactured, prepared, stored, packaged or labelled;
• (b) unless the food was sold at retail, the date on which the food was provided and the name and address of the person to whom it was provided;
• (c) if applicable, the name and address of the person who provided the food to them and the date on which it was provided;
• (d) the name of any food commodity that was incorporated into the food or from which the food is derived and, if applicable, the name and address of the person who provided the food commodity to them and the date on which it was provided; and
• (e) if applicable, the address of each location where the food and any food commodity referred to in paragraph (d) were moved before the food was provided to another person, the name of an individual who is responsible for each location and the date of each movement.

Documents — retail sale

(2) Any person who sells a food at retail, other than a restaurant or other similar enterprise that sells the food as a meal or snack, must prepare and keep documents that set out the information specified in paragraphs (1)(a) and (c) to (e).

Retention period of documents

(3) The documents referred to in subsections (1) and (2) must be kept for two years after the day on which the food was provided to another person or sold at retail, as the case may be, and must be accessible in Canada.

Production of documents

89 (1) A person must, at the Minister's request, provide the Minister with any document referred to in section 88, or any part of such a document,

• (a) within 24 hours after receipt of the request, or within
  • (i) any shorter period that is specified by the Minister, if the Minister considers that it is necessary in order to identify or respond to a risk of injury to human health associated with a food commodity, or
  • (ii) any longer period that is specified by the Minister, if the Minister considers that the document is not necessary for a recall that is or may be ordered under subsection 19(1) of the Canadian Food Inspection Agency Act; and
• (b) if provided electronically, in a single file and in plain text that can be imported into and manipulated by standard commercial software.

Definition plain text

(2) In paragraph (1)(b), plain text means data whose semantic content is available without the use of cryptographic techniques.

Labelling

90 Subject to sections 204 and 205, a label that bears the information specified in paragraph 88(1)(a) must be applied or attached to, or accompany, a food — other than a food that is to be exported — that is provided to another person by a person referred to in section 88.

PART 6

Commodity-specific Requirements

DIVISION 1

Dairy Products

Preparing

91 Any milk or cream that is used in preparing a dairy product that is to be exported or to be sent or conveyed from one province to another must meet the applicable requirements of the legislation of the province in which the dairy product is prepared.

DIVISION 2

Eggs

Pasteurization

92 (1) A licence holder may pasteurize eggs in the shell only if they are graded Canada A or Grade A.

Import — eggs pasteurized in shell

(2) Eggs that are pasteurized in the shell and that are imported must have been graded Grade A before pasteurization.

Import — Grade C or Grade Nest Run

93 A person who imports eggs that are graded Grade C or Grade Nest Run must deliver them directly to an establishment where eggs are processed and treated by a licence holder.

Import — ungraded eggs

94 A person may import eggs that are not graded in accordance with subsection 301(1) if the person

• (a) before the import, notifies the Minister in writing of the quantity of ungraded eggs that are to be imported, the date of the import and the name of the licence holder and address of the establishment referred to in paragraph (c);
• (b) packages them in a container that is labelled with the expression “Ungraded Eggs” or “œufs non classifiés”; and
• (c) delivers them directly to an establishment where eggs are processed and treated by a licence holder.

Removal — imported ungraded eggs

95 A person who removes imported ungraded eggs from the establishment referred to in paragraph 94(c) must

• (a) process and treat them before removing them; or
• (b) deliver them directly to another establishment where eggs are processed and treated by a licence holder.

Interprovincial trade

96 (1) A person who sends or conveys any of the following eggs from one province to another must deliver them to an establishment where eggs are processed and treated by a licence holder:

• (a) eggs that are graded Canada A or Canada B that bear a dye mark;
• (b) eggs that are graded Canada C;
• (c) eggs that are graded Grade C or Grade Nest Run that are imported; and
• (d) ungraded eggs that are imported in accordance with section 94.

Interprovincial trade — Canada Nest Run

(2) A person who sends or conveys eggs that are graded Canada Nest Run from one province to another must deliver them to an establishment where eggs are either graded or processed and treated by a licence holder.

Interprovincial trade — ungraded eggs

(3) A person may send or convey from one province to another eggs that are not graded in accordance with subsection 301(1), other than eggs that are rejected in accordance with subsection 311(1) and eggs that are imported in accordance with section 94, if the person

• (a) packages them in a container that is labelled with the expression “Ungraded Eggs” or “œufs non classifiés”; and
• (b) delivers them to an establishment where eggs are either graded or processed and treated by a licence holder.

Ink

97 If a licence holder applies ink to an egg's shell, the ink must be fast-drying and indelible and it must not present a risk of injury to human health.

Trays

98 Before sending plastic trays to an egg producer, a licence holder must clean, sanitize and dry them.

DIVISION 3

Processed Egg Products

Processing and treating of eggs

99 (1) A licence holder may process and treat eggs only if they

• (a) are edible;
• (b) do not emit an abnormal odour;
• (c) are not mouldy;
• (d) have not been in an incubator;
• (e) do not have an internal defect, other than a particle of the oviduct or a blood spot neither of which exceeds 3 mm in diameter;
• (f) are not leakers, except if they become leakers while being transferred to the egg-breaking equipment and they are prepared in a manner that prevents the contamination of the processed egg product; and
• (g) are free from dirt and other foreign matter.

Processing and treating of processed egg products

(2) A licence holder may process and treat processed egg products only if they are derived from eggs that meet the requirements of paragraphs (1)(a) to (g).

Temperature

100 (1) Any of the following processed egg products that are to be exported or to be sent or conveyed from one province to another and that are processed or treated in an establishment that is identified in a licence must have been chilled to 4°C or less before being removed from the establishment:

• (a) liquid whole egg;
• (b) liquid yolk;
• (c) liquid egg white or liquid albumen;
• (d) liquid whole egg mix;
• (e) liquid yolk mix; and
• (f) liquid egg product.

Exemption

(2) Despite subsection (1), the Minister may, in writing, authorize a person to remove a processed egg product that has not been chilled to 4°C or less if the Minister is of the opinion that no risk of injury to human health will result.

DIVISION 4

Fish

Prohibition — import of mitten crab or puffer fish

101 (1) It is prohibited for a person to import

• (a) a live, freshwater mitten crab of the genus Eriocheir; or
• (b) a puffer fish of the family Tetraodontidae.

Non-application of personal use exemption

(2) Section 19 of the Act does not apply to an import referred to in subsection (1).

Import of live or raw shellfish

102 (1) The holder of a licence to import may import live or raw shellfish only if the foreign state in which the shellfish is harvested, manufactured, prepared, stored, packaged or labelled, as the case may be, has, at the time the activities are conducted and at the time of the import, a system of inspection in relation to the shellfish that is recognized under these Regulations.

Exception

(2) Subsection (1) does not apply in respect of the import of the adductor muscles of scallops or the meat of geoducks.

Shellfish

103 A licence holder may manufacture, prepare, store, package or label shellfish that is to be exported or to be sent or conveyed from one province to another only if the shellfish is harvested in an area

• (a) that has been classified under the Canadian Shellfish Sanitation Program and that is not subject to an order prohibiting fishing issued under the Management of Contaminated Fisheries Regulations; or
• (b) that is subject to an order prohibiting fishing issued under the Management of Contaminated Fisheries Regulations but the shellfish has been decontaminated in accordance with the decontamination plan submitted in connection with a licence to fish for food purposes issued under those Regulations.

Frozen fish

104 A licence holder must

• (a) protect from dehydration and oxidation all frozen fish that is stored in a conveyance; and
• (b) maintain any storage area of a conveyance where frozen fish is stored at a temperature of -18°C or less.

DIVISION 5

Fresh Fruits or Vegetables

Interpretation

Definitions

105 The following definitions apply in this Division.

apple means a fresh apple for which a grade is prescribed by these Regulations. (pomme)

onion means a fresh onion for which a grade is prescribed by these Regulations. (oignon)

potato means a fresh potato for which a grade is prescribed by these Regulations. (pomme de terre)

Application

Whole fresh fruits or vegetables

106 This Division applies only in respect of fresh fruits or vegetables that are whole.

Fresh fruits or vegetables packaged together

107 The requirements of sections 109 to 117 and 259 as well as the requirements applicable under Division 2 of Part 10 and Part 12 in respect of fresh fruits or vegetables do not apply in respect of consumer prepackaged fresh fruits or vegetables if the container contains more than one type of fresh fruit or vegetable but no other food and if

• (a) the label that is applied or attached to the container bears the expression “Fresh Pack” or “emballage frais” or, in the case of consumer prepackaged fresh vegetables if the container contains more than one type of fresh vegetable but no other food, the expression “Stew-pack” or “légumes mixtes” or the expression “Vegetables for Stew” or “légumes pour ragoût”;
• (b) no one type of fresh fruit or vegetable in the container exceeds 1 kg net weight; and
• (c) the net weight of the fresh fruits or vegetables in the container does not exceed 10 kg.

Fresh fruits or vegetables packaged with other food

108 The requirements of sections 109 to 117 and 259 as well as the requirements applicable under Division 2 of Part 10 and Part 12 in respect of fresh fruits or vegetables do not apply in respect of consumer prepackaged fresh fruits or vegetables if the container contains more than one type of fresh fruit or vegetable together with other food and if

• (a) the label that is applied or attached to the container bears the expression “Gift Pack” or “emballage-cadeau” or the expression “Combo Pack” or “emballage mixte”;
• (b) no one type of fresh fruit or vegetable in the container exceeds 1 kg net weight; and
• (c) the net weight of the fresh fruits or vegetables and other food in the container does not exceed 10 kg.

Import

Potatoes from foreign state

109 (1) Imported potatoes must meet the requirements for the grade Canada No. 1 that are set out in the Compendium.

Presumption — potatoes from United States

(2) Potatoes that are imported from the United States are considered to meet the requirements for the grade Canada No. 1 that are set out in the Compendium if the potatoes have been graded in the United States and meet the applicable requirements set out in the document entitled Grade Standard Requirements for Fresh Fruits or Vegetables Imported from the United States, prepared by the Agency and published on its website, as amended from time to time.

Apples from foreign state other than United States

110 (1) Apples that are imported from a foreign state other than the United States must meet the requirements for the grade Canada Extra Fancy, Canada Fancy or Canada Commercial that are set out in the Compendium.

Apples from United States

(2) Apples that are imported from the United States must meet the requirements for the grade Canada Extra Fancy or Canada Fancy that are set out in the Compendium.

Presumption — apples from United States

(3) Apples that are imported from the United States are considered to meet the requirements for the grade Canada Extra Fancy or Canada Fancy that are set out in the Compendium if the apples have been graded in the United States and meet the applicable requirements that are set out in the document entitled Grade Standard Requirements for Fresh Fruits or Vegetables Imported from the United States, prepared by the Agency and published on its website, as amended from time to time.

Presumption — general

111 Fresh fruits or vegetables, other than potatoes or apples, that are imported from the United States are considered to meet the requirements that are set out in the Compendium if the fruits or vegetables have been graded in the United States and meet the applicable requirements that are set out in the document entitled Grade Standard Requirements for Fresh Fruits or Vegetables Imported from the United States, prepared by the Agency and published on its website, as amended from time to time.

Foreign states — onions, potatoes and apples

112 Onions and potatoes that are imported from a foreign state other than the United States, and apples that are imported from a foreign state other than the United States and New Zealand, must meet and be certified by the Minister as meeting the following requirements:

• (a) the applicable requirements of Parts 10 to 12;
• (b) in the case of onions, the requirements for a grade of onions that are set out in the Compendium;
• (c) in the case of potatoes, the requirements for the grade Canada No. 1 that are set out in the Compendium; and
• (d) in the case of apples, the requirements for the grade Canada Extra Fancy, Canada Fancy or Canada Commercial that are set out in the Compendium.

Onions, potatoes and apples imported from United States

113 (1) Onions, potatoes and apples that are imported from the United States must

• (a) meet the following requirements and be accompanied at the Canadian port of entry by a copy of a serially numbered certificate or evidence, in the form of a facsimile or a copy of an email message, issued by the federal department responsible for agriculture in the United States, that establishes that the following requirements are met:
  • (i) the applicable requirements of Parts 10 to 12,
  • (ii) in the case of onions, the requirements for a grade of onions that are set out in the Compendium,
  • (iii) in the case of potatoes, the requirements for the grade Canada No. 1 that are set out in the Compendium, and
  • (iv) in the case of apples, the requirements for the grade Canada Extra Fancy or Canada Fancy that are set out in the Compendium; or
• (b) meet and be certified by the Minister as meeting the requirements set out in subparagraph (a)(i) and, in accordance with the applicable general tolerances for inspection at the time of shipping or repackaging that are set out in the Compendium, the requirements set out in subparagraph (a)(ii), (iii) or (iv).

Endorsement

(2) The certificate and evidence referred to in paragraph (1)(a) must be endorsed with the expression “Meets Canadian Import Requirements for Grades, Packaging, Labelling and Standard Container Size” or “satisfait aux exigences d'importation du Canada visant la classification, l'emballage, l'étiquetage et la taille des contenants normalisés”.

Apples imported from New Zealand

114 (1) Apples that are imported from New Zealand must

• (a) meet the following requirements and be accompanied at the Canadian port of entry by a copy of a serially numbered certificate or evidence, in the form of a facsimile or a copy of an email message, issued by the ministry responsible for agriculture in New Zealand, that establishes that the following requirements are met:
  • (i) the applicable requirements of Parts 10 to 12, and
  • (ii) the requirements for the grade Canada Extra Fancy, Canada Fancy or Canada Commercial that are set out in the Compendium; or
• (b) meet and be certified by the Minister as meeting the requirements set out in subparagraph(a)(i) and, in accordance with the applicable general tolerances for inspection at the time of shipping or repackaging that are set out in the Compendium, the requirements set out in subparagraph (a)(ii).

Endorsement

(2) The certificate and evidence referred to in paragraph (1)(a) must be endorsed with the expression “Meets Canadian Import Requirements for Grades, Packaging, Labelling and Standard Container Size” or “satisfait aux exigences d'importation du Canada visant la classification, l'emballage, l'étiquetage et la taille de contenants normalisés”.

Non-application

115 Sections 112 to 114 do not apply to onions, potatoes or apples that are part of a shipment that consists of not more than

• (a) 15 containers of onions with an aggregate net weight of not more than 250 kg of onions;
• (b) 15 containers of potatoes with an aggregate net weight of not more than 250 kg of potatoes; and
• (c) 15 containers of apples with an aggregate net weight of not more than 250 kg of apples.

In transit

116 For the purposes of sections 109 to 115, if fresh fruits or vegetables are sent or conveyed to Canada in a bonded shipment from a foreign state other than the United States and pass only in transit through the United States, the fresh fruits or vegetables are considered not to have been imported from the United States.

Application

117 (1) An application for a certificate referred to in section 112 or paragraph 113(1)(b) or 114(1)(b) must be made to the Minister in a form approved by the President and be accompanied by the applicable fee set out in the Fees Notice.

Inspection

(2) The Minister may require an inspection for the purpose of deciding whether to issue the certificate.

Inspection — fee and accessibility

(3) If an inspection is required, the applicant must pay the applicable fee set out in the Fees Notice and must make all the onions, potatoes or apples readily accessible to an inspector at the time of inspection.

DIVISION 6

Meat Products and Food Animals

Interpretation

Definitions

118 The following definitions apply in this Division.

official veterinarian means a veterinarian who is designated as an inspector under subsection 13(3) of the Canadian Food Inspection Agency Act. (médecin vétérinaire officiel)

on-farm food safety program means a program that relates to food animals that is operated on a farm or at a similar place and under which hazards relating to the safety of meat products that may be derived from those food animals are identified, analyzed and controlled. (programme de salubrité des aliments à la ferme)

specified risk material has the same meaning as in section 6.1 of the Health of Animals Regulations. (matériel à risque spécifié)

split means to cut a carcass lengthwise along the median line. (fendre)

Application — food and food animals

119 (1) Unless otherwise specified, the requirements of this Division apply only in respect of

• (a) meat products that are to be exported or to be sent or conveyed from one province to another;
• (b) imported meat products during their storing and handling in their imported condition for the purposes of the exercise of an inspector's powers under the Act; and
• (c) food animals from which meat products that are to be exported or to be sent or conveyed from one province to another may be derived.

Exception

(2) Despite subsection (1), section 165 applies in respect of any imported meat product.

Application — establishment

(3) The requirements of this Division that apply in respect of an establishment apply only in respect of an establishment that is identified in a licence to manufacture, process, treat, preserve, grade, package or label a meat product, to store and handle a meat product in its imported condition or to slaughter a food animal.

Inspection Services

Inspection services during work shift

120 (1) Inspection services are to be provided during work shifts that are approved by the President, having regard to the number of inspection stations and the minimum number of hours of inspection determined under sections 121 and 122.

Other inspection services on request

(2) Inspection services may be provided outside a work shift if a licence holder submits a written request to the President and an inspector is available.

Inspection stations — slaughtering

121 (1) The President must, for the purposes of the exercise of an inspector's powers, and the performance of their duties and functions, under the Act, determine the number of inspection stations that are required annually during each work shift, for each establishment where food animals are slaughtered by a licence holder, having regard to

• (a) the animal species that are slaughtered;
• (b) the method of carcass examination or inspection that is used;
• (c) the speed of the slaughter line; and
• (d) the volume of production.

Additional inspection stations

(2) The President may permit one or more additional inspection stations for a work shift, on an annual or hourly basis, having regard to the factors set out in subsection (1), if the licence holder submits a written request to the President and an inspector is available.

Minimum hours of inspection — other activities

122 The President must, for the purposes of the exercise of an inspector's powers, and the performance of their duties and functions, under the Act, determine the minimum number of hours of inspection that are required per year during each work shift, for each establishment where a meat product is manufactured, processed, treated, preserved, graded, packaged or labelled, or stored and handled in its imported condition, by a licence holder, having regard to

• (a) the nature and complexity of the activities that are conducted by the licence holder in the establishment;
• (b) the size of the establishment, the layout of equipment and the type of equipment and technology that are used;
• (c) the range of meat products and the volume of production;
• (d) work scheduling practices; and
• (e) the inspection records in respect of the establishment and the activities that are conducted by the licence holder in the establishment and, if available, any such inspection records regarding comparable establishments where the same activities are conducted.

Notice

123 (1) A licence holder must notify the President in writing of any change that affects any of the factors set out in subsection 121(1) or section 122 or if an additional inspection station that is permitted under subsection 121(2) on an annual basis is no longer required.

Adjustment

(2) If the President becomes aware of a change referred to in subsection (1), the President must reconsider and, as appropriate, adjust the number of inspection stations that are required or the minimum number of hours of inspection that are required.

Edible Meat Products

Identification of edible meat products

124 (1) A licence holder may identify a meat product as edible only if

• (a) the food animal from which the meat product is derived, or a sample from the shipment that the food animal is part of, is subjected to an ante-mortem examination in accordance with section 137;
• (b) the food animal, other than a game animal, from which the meat product is derived, or a sample from the shipment that the food animal is part of, is subjected to an ante-mortem inspection in accordance with section 138;
• (c) the carcass of the food animal from which the meat product is derived is dressed or partially dressed;
• (d) the carcass, its parts and the blood from which the meat product is derived are subjected to a post-mortem inspection in accordance with subsection 148(1) or a post-mortem examination in accordance with section 149;
• (e) the meat product is edible;
• (f) the meat product does not contain any specified risk material;
• (g) the meat product is not a meat product referred to in section 125; and
• (h) the meat product is not contaminated.

Other identifications

(2) The identification of a meat product as edible under any of sections 155 to 157 is considered to be an identification under this section if the requirements of subsection (1) are met.

Inedible meat products

125 A licence holder must not identify any of the following meat products as edible:

• (a) a heart — other than the heart of a domesticated rabbit or of a bird that is not an ostrich, rhea or emu — unless it is opened or inverted and has all blood clots and attached blood vessels removed;
• (b) a liver, unless the gallbladder is removed;
• (c) a gizzard, unless its contents and lining are removed and the gizzard is washed;
• (d) a meat product that contains a urinary bladder, an intestine or any part of a urinary bladder or intestine, unless the bladder, intestine or part is used as a natural casing for the meat product and meets the requirements of section 126; and
• (e) a meat product with an artificial casing, unless the casing is manufactured from a material that is free of any noxious constituent.

Natural casings

126 A urinary bladder, an intestine or any part of a urinary bladder or intestine may be used as a natural casing for an edible meat product if

• (a) the contents and mucous lining of the bladder, intestine or part were removed and the bladder, intestine or part was washed;
• (b) in the case of a bladder, it was inverted and placed in brine for at least 12 hours and was subsequently rinsed with water; and
• (c) the casing is clean.

Humane Treatment

Avoidable suffering or injury

127 A licence holder must handle a food animal in a manner that does not cause it avoidable suffering or avoidable injury and must not subject it to any condition that may cause such suffering or injury.

Hitting

128 (1) A licence holder must not hit a food animal with a whip, prod or, except for the purpose of section 140 and for the application of a tattoo to the food animal, any other object.

Electric prod

(2) A licence holder may apply an electric prod to a food animal if

• (a) the food animal is a pig or a bovine;
• (b) the prod is applied to the lateral portion of the rear leg muscles between the hock joint and the hip joint; and
• (c) the food animal has sufficient space to move forward.

Assessing

129 (1) A licence holder must assess whether a food animal is showing signs of suffering or injury on its arrival at the establishment.

Monitoring

(2) After the food animal's arrival, the licence holder must monitor it on a continuous basis, including assessing the conditions to which the food animal is subjected in the establishment that may cause avoidable suffering, avoidable injury or death.

Corrective action

(3) If a licence holder determines that conditions exist that may cause avoidable suffering, avoidable injury or death to a food animal, the licence holder must immediately take corrective action to remedy the situation.

Alleviation of suffering

(4) If a food animal is showing signs of suffering, a licence holder must immediately

• (a) alleviate its suffering;
• (b) humanely kill it; or
• (c) slaughter it in accordance with these Regulations.

Non-application — game animals

(5) This section does not apply in respect of game animals.

Game animals

130 A licence holder who has direct control over a game animal must

• (a) monitor it on a continuous basis, including assessing the conditions to which the game animal is subjected in the establishment that may cause avoidable suffering, avoidable injury or death;
• (b) immediately take corrective action if such conditions exist; and
• (c) if the game animal is showing signs of suffering, immediately
  • (i) alleviate its suffering,
  • (ii) humanely kill it, or
  • (iii) slaughter it in accordance with these Regulations.

Segregation and isolation

131 A licence holder must

• (a) segregate different species of food animals; and
• (b) isolate a food animal that may cause suffering, injury or death to other food animals because of its nature, temperament, gender, weight, age or any other cause.

Overcrowding

132 A licence holder must provide a food animal with sufficient space to avoid the suffering, injury or death of the animal.

Ventilation

133 A licence holder must provide a food animal with sufficient ventilation to avoid the suffering, injury or death of the animal.

Handling

134 (1) A licence holder who handles, restrains, holds, segregates, renders unconscious, slaughters or humanely kills a food animal must

• (a) be able to do so, by reason of the person's competence and physical condition, without causing avoidable suffering or avoidable injury to the food animal; and
• (b) do so in a manner and under circumstances in which the equipment that is used will not cause avoidable suffering or avoidable injury to the food animal.

Areas of establishment and equipment

(2) A licence holder must use only areas of an establishment and equipment for the handling, restraining, holding, segregating, rendering unconscious, slaughtering or humane killing of a food animal that are designed, constructed and maintained in order not to cause avoidable suffering or avoidable injury to the food animal.

Water and feed

135 (1) A licence holder must provide a food animal — other than a food animal that is confined in a crate — that is unloaded from a conveyance at an establishment with

• (a) water or another source of hydration as soon as it is unloaded; and
• (b) feed, within 24 hours after it is unloaded.

In crate

(2) In the case of a food animal that is confined in a crate, the licence holder must provide the food animal with water or another source of hydration and with feed within 24 hours after it arrives at the establishment.

Removal and Keeping

Removal

136 (1) A licence holder must notify an official veterinarian before a food animal is removed from an establishment.

Keeping

(2) A licence holder must notify an official veterinarian before keeping a food animal in an establishment for more than seven days.

Ante-mortem Examination and Inspection

Ante-mortem examination

137 (1) A licence holder must conduct an ante-mortem examination of a food animal that is to be slaughtered, or of a sample from the shipment that the food animal is part of, within 24 hours before the slaughter and in accordance with the document entitled Ante-Mortem Examination and Presentation Procedures for Food Animals, prepared by the Agency and published on its website, as amended from time to time.

Deviations

(2) If the licence holder, in the course of the ante-mortem examination or at any other time before slaughter, suspects that the food animal shows a deviation from normal behaviour, physiology or appearance, the licence holder must hold it for an inspection by an official veterinarian, unless otherwise authorized by an official veterinarian.

Ante-mortem inspection

138 (1) A licence holder must present for an ante-mortem inspection a food animal, other than a game animal, that is to be slaughtered, or a sample from the shipment that the food animal is part of, within 24 hours before the slaughter and in accordance with the document entitled Ante-Mortem Examination and Presentation Procedures for Food Animals, prepared by the Agency and published on its website, as amended from time to time.

Official veterinarian

(2) The inspection must be conducted by an official veterinarian or by an inspector under the supervision of an official veterinarian.

Deviations

(3) If an inspector who is not an official veterinarian suspects that the food animal shows a deviation from normal behaviour, physiology or appearance, the licence holder must hold it for an inspection by an official veterinarian.

Condemnation

139 A licence holder must take the following measures if an official veterinarian determines, after an inspection, that any meat product that would be derived from a food animal could not be identified as edible under section 124:

• (a) condemn the food animal;
• (b) segregate the food animal;
• (c) humanely kill the food animal; and
• (d) condemn the carcass and any blood collected from the food animal.

Slaughtering and Dressing

Requirement before bleeding

140 Before bleeding a food animal, other than a game animal, a licence holder must use one of the following methods either to render it unconscious in a manner that prevents it from regaining consciousness before death or to slaughter it:

• (a) deliver a blow to the head with a mechanical device in a manner that causes an immediate loss of consciousness;
• (b) apply an electrical current in a manner that causes an immediate loss of consciousness; or
• (c) expose it to a gas or a gas mixture in a manner that causes a rapid loss of consciousness.

Requirement after bleeding starts

141 A licence holder must not cut the carcass of a food animal after bleeding has started if it shows signs of sensibility that may indicate a potential return to consciousness.

Requirement before suspending

142 (1) A licence holder must not suspend a food animal before it is rendered unconscious or slaughtered using a method set out in section 140 or before it is ritually slaughtered or is humanely killed.

Exception — certain birds

(2) Despite subsection (1), a licence holder may suspend a bird, other than an ostrich, rhea or emu, by its legs immediately before it is rendered unconscious or slaughtered using a method set out in section 140 or immediately before it is humanely killed.

Ritual slaughter

143 Despite section 140, a licence holder who ritually slaughters a food animal with the intent of complying with Judaic or Islamic law must

• (a) restrain the food animal;
• (b) administer one continuous cut of not more than one back-and-forth movement of a knife, without it being lifted off the food animal, resulting in the rapid, simultaneous and complete severance of the jugular veins and carotid arteries, in a manner that causes the animal to bleed immediately; and
• (c) rapidly and completely bleed it, to render it unconscious in a manner that prevents it from regaining consciousness before death.

Dressing

144 (1) After a food animal is bled, a licence holder must dress the carcass in the following manner:

• (a) in the case of the carcass of a pig,
  • (i) remove the hair, scurf, toenails and developed mammary glands or remove the skin, head, developed mammary glands and feet at the carpal and tarsal joints, and
  • (ii) eviscerate and split it;
• (b) in the case of the carcass of a bird,
  • (i) remove the feathers and hair or remove the skin,
  • (ii) remove the head, uropygial gland and feet at the tarsal joints, and
  • (iii) eviscerate it;
• (c) in the case of the carcass of a goat,
  • (i) remove the hair, head, toenails and developed mammary glands or remove the skin, head, developed mammary glands and feet at the carpal and tarsal joints, and
  • (ii) eviscerate it; and
• (d) in the case of the carcass of any other food animal,
  • (i) remove the skin, head, developed mammary glands and feet at the carpal and tarsal joints,
  • (ii) eviscerate it, and
  • (iii) split it, except in the case of a sheep, calf or domesticated rabbit.

Partial dressing

(2) Despite subsection (1) and on request of the licence holder, the President must authorize the licence holder to partially dress a carcass if

• (a) the licence holder establishes that there is a market for partially dressed carcasses; and
• (b) the licence holder's procedure for partial dressing is such that the carcass is sufficiently dressed to enable a post-mortem examination or inspection.

• Blood clots, bone splinters and extraneous matter
• 145 A licence holder must remove any blood clot, bone splinter and extraneous matter from the carcass of a food animal and from the parts of its carcass and must identify what was removed as inedible.

Processing of blood

146 A licence holder must process a food animal's blood in the inedible products area described in subsection 56(2) unless the licence holder

• (a) collects it in a manner that prevents contamination;
• (b) protects it against contamination after it is collected; and
• (c) does not defibrinate it by hand.

Identification and correlation

147 (1) A licence holder must identify the blood, if it is collected to be processed as an edible meat product, and the parts of the carcass of a food animal in order to correlate the blood and the parts with the carcass from which they were removed.

Maintenance of identification

(2) The identification must be maintained until the completion of the post-mortem inspection or examination.

Post-mortem Inspection and Examination

Post-mortem inspection

148 (1) A licence holder must, during the course of dressing or partial dressing, present the carcass, its parts and any blood that is collected to be processed as an edible meat product to an official veterinarian or an inspector under the supervision of an official veterinarian for a post-mortem inspection.

Deviations

(2) A licence holder must not, before the post-mortem inspection, remove from the carcass any part that shows a deviation from normal appearance, unless authorized to do so by an official veterinarian.

Non-application — post-mortem examination program

(3) This section does not apply to a licence holder who is authorized to conduct a post-mortem examination program under section 158.

Post-mortem examination

149 A licence holder who is authorized to conduct a post-mortem examination program under section 158 must, during the course of dressing or partial dressing, subject the carcass, its parts and the blood, if it is collected to be processed as an edible meat product, to a post-mortem examination that is to be conducted under the supervision of an official veterinarian.

Inedible Meat Products

Condemnation

150 A licence holder must condemn the carcass, its parts or the blood of a food animal if an official veterinarian or an inspector under the supervision of an official veterinarian determines, after a post-mortem inspection, that any meat product that would be derived from any one of them would be inedible.

Identification

151 A licence holder must identify as inedible

• (a) any carcass, parts of a carcass or blood that is rejected by the licence holder during a post-mortem examination; and
• (b) the carcass of a food animal that dies other than by slaughter in accordance with these Regulations.

Treatment

152 (1) A licence holder may treat as inedible any meat product that

• (a) does not have its movement restricted by an inspector; or
• (b) has its movement restricted by an inspector if the licence holder obtains an inspector's authorization to move the meat product to the inedible products area described in subsection 56(2).

Identification

(2) The licence holder must identify as inedible any meat product that the licence holder treats as inedible.

Inedible products area

153 (1) A licence holder must move a carcass, its parts, the blood of a food animal and any other meat product that is condemned or identified as inedible to the inedible products area described in subsection 56(2).

Labelling and disposal

(2) The licence holder must take one of the following measures in respect of a meat product that is moved to the inedible products area:

• (a) apply or attach a label to it that indicates its intended use and bears the expression “Not for Use as Human Food” or “ne peut servir à l'alimentation humaine”; or
• (b) dispose of it in accordance with subsection 64(2).

Specified risk material

(3) Despite subsection (2), the licence holder must keep a meat product that is a specified risk material, contains a specified risk material or is derived from a specified risk material in a separate area of the inedible products area and must handle and destroy it in accordance with Part I.1 of the Health of Animals Regulations.

Treatment

Contaminated meat product

154 A licence holder must take one of the following measures in respect of a contaminated meat product:

• (a) subject it to a treatment or process that eliminates the contamination; or
• (b) identify it as inedible.

Trichinella spp. — pork

155 A licence holder may identify as edible a meat product that is derived from a pig and that does not require further preparing before consumption other than washing or thawing or exposing it to sufficient heat to warm it without cooking it, only if

• (a) the pork is subjected to a treatment or process that inactivates Trichinella spp. viable larvae;
• (b) the pork is derived from a carcass that tests negative for the detection of Trichinella spp. larvae using a method that is shown by evidence to be effective; or
• (c) the pig originates from a farm that operates an on-farm food safety program under which the risk of Trichinella spp. infection is negligible.

Trichinella spp. — equine

156 A licence holder may identify as edible a meat product that is derived from an equine if its carcass tests negative for the detection of Trichinella spp. larvae using a method that is shown by evidence to be effective.

Bovine cysticercosis

157 A licence holder may identify as edible a meat product that is derived from a bovine whose carcass is affected by or shows evidence of bovine cysticercosis only if the licence holder

• (a) removes the parts of the carcass that are affected and identifies them as inedible; and
• (b) subjects the remaining parts to a treatment or process that inactivates bovine cysticercosis viable larvae.

Post-mortem Examination Program

Application

158 (1) The holder of a licence to slaughter may apply in writing to the President for an authorization to conduct a post-mortem examination program concerning a food animal referred to in the document entitled Fundamentals of the Post-mortem Examination Program, prepared by the Agency and published on its website, as amended from time to time.

Contents

(2) The application must contain

• (a) the licence holder's licence number and the address of the establishment where the program will be conducted; and
• (b) a copy of the licence holder's preventive control plan that meets the requirements of section 87.

Authorization

(3) The President must authorize the licence holder to conduct a post-mortem examination program if

• (a) the preventive control plan that is included in the licence holder's application meets the requirements of section 87; and
• (b) the President is of the opinion, based on the information that was made available to him or her, that the licence holder is able to conduct the program in compliance with these Regulations.

Grounds for suspension

159 The President may suspend a licence holder's authorization to conduct a post-mortem examination program if

• (a) the licence holder does not comply with their post-mortem examination program;
• (b) the licence holder does not comply with any provision of the Act or of these Regulations; or
• (c) the President is of the opinion that a risk of injury to human health may result if the licence holder continues to conduct the program.

Suspension

160 (1) The President must not suspend a licence holder's authorization to conduct a post-mortem examination program unless the licence holder

• (a) was provided with an inspection report that sets out the grounds for the suspension and the date by which corrective action must be taken in order to avoid the suspension; and
• (b) failed to take corrective action by that date.

Written notice

(2) The President must notify the licence holder in writing of the suspension and the date on which it takes effect.

Risk of injury to human health

161 (1) Despite section 160, if the President is of the opinion that a risk of injury to human health may result if the licence holder continues to conduct the program, the President may suspend the authorization immediately after the licence holder is provided with an inspection report that sets out the grounds for the suspension.

Written notice

(2) The President must notify the licence holder in writing that their authorization is suspended and that the suspension takes effect immediately.

Suspension — duration

162 A suspension of an authorization to conduct a post-mortem examination program remains in effect until an inspector determines that corrective action has been taken.

Food Animal Information Document and Document Keeping

Required information

163 (1) Before slaughtering a food animal that is an equine or a bird other than an ostrich, rhea or emu, the holder of a licence to slaughter must obtain documents that contain the following information from the person who owned or had the possession, care or control of the food animal before its arrival at the establishment where it is to be slaughtered:

• (a) the name and contact information of the person who owned it and any person who had the possession, care or control of it immediately before its arrival at the establishment;
• (b) the last location where it was raised or kept before its arrival at the establishment, including the address of the location, its code or the number that identifies it;
• (c) the food animal's identification number or any other information that identifies it;
• (d) the name of the on-farm food safety program under which the food animal was raised or kept, if applicable;
• (e) in the case of a bird,
  • (i) the time at which the bird was placed into a crate,
  • (ii) the time at which the bird was last provided with a source of hydration before being loaded, and
  • (iii) the time at which the bird was last provided with feed before being loaded;
• (f) a description of any physical or chemical hazard that could contaminate any meat product that is derived from the food animal;
• (g) in respect of the last 120 days of the life of a bird that has been used for breeding or egg production or in respect of the entire life of any other bird,
  • (i) the mortality rate for the flock from which the bird originates,
  • (ii) the name of any disease or syndrome that was diagnosed in the flock from which the bird originates and the date on which the flock recovered from the disease or syndrome,
  • (iii) the names of any drugs and vaccines that were administered to the bird, as well as
    • (A) their route of administration,
    • (B) the first and last date of their administration,
    • (C) the dosage that was administered, and
    • (D) the withdrawal period or, in the case of an extra-label drug administration, a copy of the prescription that was issued by a veterinarian and an attestation by a competent person or body with respect to the withdrawal period for that administration, and
  • (iv) the name of any drug that has been administered in the last 14 days that requires a withdrawal period; and
• (h) in respect of the last 180 days of the life of an equine,
  • (i) the name of any disease or syndrome that was diagnosed or a description of any deviation from normal behaviour, physiology or appearance,
  • (ii) the names of any drugs and vaccines that were administered, as well as
    • (A) their Drug Identification Numbers, if any,
    • (B) their route of administration,
    • (C) the last date of their administration,
    • (D) the dosage that was administered, and
    • (E) the withdrawal period or, in the case of an extra-label drug administration, a copy of the prescription that was issued by a veterinarian and an attestation by a competent person or body with respect to the withdrawal period for that administration, and
  • (iii) the use of the equine.

Exception — equines and birds

(2) Despite subsection (1), the licence holder may, after notifying an inspector, slaughter the equine or bird without having first obtained the documents referred to in subsection (1) if the meat product that is derived from it

• (a) will be held by the licence holder until those documents are obtained; or
• (b) will be identified as inedible.

Exception — game animals

(3) Subsection (1) does not apply in respect of game animals.

Retention period of documents

(4) The documents referred to in subsection (1) must be kept for one year beginning on the day on which the food animal arrives at the establishment.

Document keeping

164 (1) The holder of a licence to slaughter must prepare and keep documents that set out the following information:

• (a) for a food animal that is slaughtered, the date and time that it was slaughtered and the findings related to the ante-mortem examination and, if the licence holder is authorized to conduct a post-mortem examination program, to the post-mortem examination, including the reason for any condemnation or rejection;
• (b) for a food animal that is found dead at the time of its arrival at the establishment or that dies in the establishment other than by slaughter in accordance with these Regulations,
  • (i) the date and time that the food animal was found dead or was humanely killed,
  • (ii) its identification number or any other information that identifies it, and
  • (iii) the details of its disposal; and
• (c) the total number of food animals referred to in paragraph (b), per day.

Retention period of documents

(2) The documents referred to in subsection (1) must be kept for one year beginning on the day on which the food animal arrives at the establishment.

Import and Export

Import

165 The holder of a licence to import may import an edible meat product only if

• (a) the foreign state from which it is imported has, at the time that it is manufactured, prepared, stored, packaged or labelled, as the case may be, and at the time of the import, a system of inspection in relation to meat products that is recognized under these Regulations;
• (b) the establishment where the food animal from which the meat product is derived was slaughtered, and any establishment where the meat product was manufactured, processed, treated, preserved, handled, tested, graded, coded, stored, packaged or labelled, have, at the time that the activity is conducted and at the time of the import, a system for manufacturing, processing, treating, preserving, handling, testing, grading, coding, slaughtering, storing, packaging or labelling, as the case may be, that is recognized under these Regulations; and
• (c) the licence holder provides an inspector with an official document issued by the foreign state, in the form approved by the President, that states that the meat product meets the requirements of the Act and these Regulations.

Export

166 (1) A licence holder may export a meat product only if

• (a) the licence holder provides an inspector with a written document that substantiates that the requirements of the foreign state to which it is to be exported are met in respect of that meat product; and
• (b) a certificate or other document is issued under section 48 of the Act in respect of that meat product.

Exception — removal notice

(2) Subsection (1) does not apply in respect of a meat product that is subject to a notice ordering its removal from Canada under subsection 32(1) of the Act.

PART 7

Recognition of Foreign Systems

Meaning of shellfish — limitation

167 In this Part, shellfish does not include the adductor muscles of scallops and the meat of geoducks.

Recognition of inspection system

168 (1) A system of inspection of a foreign state in relation to meat products or shellfish may be recognized in accordance with subsections (2) and (3).

Application

(2) An application for the recognition of the system of inspection must be made to the Minister in writing by the foreign state and must contain the following information:

• (a) in the case of a system of inspection in relation to meat products,
  • (i) an indication of the species of birds or mammals and a description of the meat products to which the system applies, and
  • (ii) the approximate number of establishments where the manufacturing, preparing, storing, packaging or labelling of meat products that are to be exported to Canada would be conducted and an indication of the activities that would be conducted in those establishments;
• (b) in the case of a system of inspection in relation to shellfish, an indication of the species and the growing and harvesting areas to which the system applies;
• (c) the volume of meat products or shellfish to which the system applies that is anticipated to be exported to Canada per year;
• (d) information that relates to each of the items set out in paragraph (3)(a) or (b), as the case may be; and
• (e) the name, title and signature of the authorized representative of the foreign state who makes the application.

Recognition by Minister

(3) The Minister must recognize the system of inspection in respect of which the application is made if the system provides at least the same level of protection as that provided by the provisions of the Act and these Regulations, having regard to

• (a) in the case of a system of inspection in relation to meat products,
  • (i) the applicable legislative framework, controls and procedures,
  • (ii) the organizational structure of the authority that is responsible for the system,
  • (iii) the implementation of the system,
  • (iv) the resources that support the objectives of the system,
  • (v) the humane treatment of the food animals that are presented for slaughter,
  • (vi) the chemical residue monitoring and microbiological monitoring that is carried out in relation to the meat products,
  • (vii) the certification process that relates to the export of the meat products, and
  • (viii) any other relevant information; and
• (b) in the case of a system of inspection in relation to shellfish,
  • (i) the applicable legislative framework, controls and procedures,
  • (ii) the organizational structure of the authority that is responsible for the system,
  • (iii) the implementation of the system,
  • (iv) the resources that support the objectives of the system,
  • (v) the chemical and microbiological monitoring that is carried out in relation to the shellfish, including monitoring for biotoxins,
  • (vi) the monitoring of the waters in the growing and harvesting areas to assess their suitability for their intended purpose, and
  • (vii) any other relevant information.

Recognition of system — meat product establishment

169 (1) Once a foreign state's system of inspection in relation to meat products is recognized, a system of manufacturing, processing, treating, preserving, handling, testing, grading, coding, slaughtering, storing, packaging or labelling that is used in an establishment and that is subject to that system of inspection may be recognized in accordance with subsections (2) and (3).

Application

(2) An application for the recognition of the system of manufacturing, processing, treating, preserving, handling, testing, grading, coding, slaughtering, storing, packaging or labelling must be made to the Minister in writing by the foreign state in which the establishment is located and must contain the following information:

• (a) the name of the person who conducts the applicable activities and the establishment's address;
• (b) the establishment's registration number or another establishment identification number that is provided by the foreign state;
• (c) a statement that identifies the system in respect of which the application is made;
• (d) a declaration by the authorized representative of the foreign state who makes the application that states that the system in respect of which the application is made is subject to the foreign state's recognized system of inspection and complies with the foreign state's requirements that apply to the conduct of those activities in respect of meat products that are to be exported to Canada; and
• (e) the name, title and signature of the authorized representative of the foreign state who makes the application.

Recognition by Minister

(3) The Minister must recognize a system of manufacturing, processing, treating, preserving, handling, testing, grading, coding, slaughtering, storing, packaging or labelling in respect of which an application is made if

• (a) the foreign state's system of inspection in relation to the relevant meat products is recognized under subsection 168(3); and
• (b) the system of manufacturing, processing, treating, preserving, handling, testing, grading, coding, slaughtering, storing, packaging or labelling is subject to that system of inspection and complies with the foreign state's requirements that apply to the conduct of those activities in respect of meat products that are to be exported to Canada.

Suspension of recognition — system of inspection

170 (1) The Minister must suspend the recognition of a foreign state's system of inspection if

• (a) the foreign state fails to notify the Minister, as soon as feasible, of any changes that it has made to the system or to the legislation governing the system; or
• (b) the system no longer provides at least the same level of protection as that provided by the provisions of the Act and these Regulations.

Suspension of recognition — system used in establishment

(2) The Minister must suspend the recognition of a system of manufacturing, processing, treating, preserving, handling, testing, grading, coding, slaughtering, storing, packaging or labelling referred to in section 169 if

• (a) the system no longer complies with the foreign state's requirements that apply to the conduct of those activities;
• (b) the system is no longer subject to the foreign state's system of inspection; or
• (c) the recognition of the foreign state's system of inspection to which the system is subject has been suspended.

Notice

(3) The Minister must notify the foreign state in writing of the suspension under subsection (1) or (2), the grounds for the suspension and the date on which it takes effect.

Effective date

(4) The suspension takes effect on the day on which the notice is issued.

Reinstatement

(5) If the situation that gave rise to a suspension no longer exists, the Minister must notify the foreign state in writing that the recognition is no longer suspended.

Cancellation of recognition — system of inspection

171 (1) The Minister must cancel the recognition of a foreign state's system of inspection if

• (a) no meat products or shellfish to which the system applies have been imported from the foreign state in the previous five years;
• (b) the situation that gave rise to a suspension has not been remedied within 12 months after the day on which the recognition was suspended; or
• (c) the foreign state requests the cancellation.

Cancellation of recognition — system used in establishment

(2) The Minister must cancel the recognition of a system of manufacturing, processing, treating, preserving, handling, testing, grading, coding, slaughtering, storing, packaging or labelling referred to in section 169 if

• (a) the recognition of the system of inspection to which it is subject has been cancelled;
• (b) no meat products that were manufactured, processed, treated, preserved, handled, tested, graded, coded, stored, packaged or labelled using the system have been imported in the previous five years;
• (c) the situation that gave rise to a suspension has not been remedied within 12 months after the day on which the recognition was suspended; or
• (d) the foreign state in which the establishment is located requests the cancellation.

Notice

(3) The Minister must notify the foreign state in writing of the cancellation under subsection (1) or (2), the grounds for the cancellation and the date on which it takes effect.

Effective date

(4) The cancellation takes effect on the day on which the notice is issued.

Systems existing before coming into force of these Regulations

172 (1) The following systems are considered to be recognized under this Part:

• (a) any system of inspection of a foreign state in relation to meat products that was, immediately before the day on which these Regulations come into force, approved for the purposes of the Meat Inspection Act;
• (b) any system of inspection of a foreign state in relation to shellfish if that foreign state was, immediately before the day on which these Regulations come into force, authorized in respect of the import into Canada of those shellfish for the purposes of the Fish Inspection Act; and
• (c) any systems of manufacturing, processing, treating, preserving, handling, testing, grading, coding, slaughtering, storing, packaging and labelling that are used in an establishment in a foreign state in relation to meat products if, immediately before the day on which these Regulations come into force, both the establishment and the system of inspection of the foreign state in relation to those meat products were approved for the purposes of the Meat Inspection Act.

Suspension and cancellation

(2) For greater certainty, the recognition of a system referred to in subsection (1) may be suspended or cancelled in accordance with this Part.

PART 8

Ministerial Exemptions

Application

173 A person may apply, in a form approved by the President, for an exemption from the application of a provision of the Act or these Regulations for the purpose of test-marketing a food or of alleviating a shortage in Canada in the available supply of a food that is manufactured, processed or produced in Canada.

Exemption

174 (1) The Minister may, in writing, make the exemption if

• (a) the applicable fee set out in the Fees Notice is paid;
• (b) the information submitted in the application for the exemption is complete, truthful and not misleading;
• (c) the food in respect of which the application for the exemption is made meets the requirements set out in paragraphs 8(a) to (d);
• (d) the Minister is of the opinion that no risk of injury to human health will result;
• (e) in the case of an application for an exemption for the purpose of test-marketing a food, the exemption will not
  • (i) confuse or mislead the public, or
  • (ii) disrupt the normal trading patterns of the industry or the normal food pricing patterns; and
• (f) in the case of an application for an exemption for the purpose of alleviating a shortage in Canada in the available supply from domestic production of a food, the exemption is necessary to alleviate that shortage.

Conditions

(2) The Minister may, at any time, make the exemption subject to conditions.

Period of validity

(3) The exemption is valid until the expiry date that is specified in the exemption or, if no date is specified, until the end of the period that is two years after the day on which the exemption is made.

Cancellation

175 The Minister may cancel an exemption if

• (a) the Minister is of the opinion that a risk of injury to human health may result if it is not cancelled; or
• (b) the holder of the exemption does not comply with any condition to which the exemption is subject or any provision of the Act or these Regulations other than a provision in respect of which the exemption is made.

PART 9

Inspection Legends

Definition inspection mark — inspection legends

176 For the purpose of the definition inspection mark in section 2 of the Act, the inspection legends set out in Figures 1 and 2 of Schedule 2 are prescribed.

Meat products — Figure 1 of Schedule 2

177 (1) A licence holder or an inspector is authorized to apply the inspection legend set out in Figure 1 of Schedule 2 to, and use it in connection with, a meat product, whether prepackaged or not, if the following conditions are met:

• (a) the meat product was manufactured, processed, treated, preserved, packaged or labelled by the licence holder in accordance with the Act and these Regulations;
• (b) if the meat product or any meat product that it contains was manufactured, processed, treated, preserved, graded, packaged or labelled in Canada, that activity was conducted by a licence holder in accordance with the Act and these Regulations;
• (c) if the meat product or any meat product that it contains was imported, it was imported by a licence holder in accordance with the Act and these Regulations;
• (d) if any meat, meat by-product or mechanically separated meat that the meat product contains is derived from food animals that were slaughtered in Canada, the food animals were slaughtered by a licence holder in accordance with the Act and these Regulations;
• (e) the meat product meets the requirements set out in Volume 7 of the Standards of Identity Document and those set out in paragraphs 8(a) to (d) and in Division 6 of Part 6; and
• (f) the inspection legend is applied or used in an establishment that is identified in the licence holder's licence, unless the meat product is to be exported and the inspection legend is applied to the conveyance or used in connection with the conveyance in which the meat product is exported.

Meat products — Figure 2 of Schedule 2

(2) The licence holder or inspector is authorized to apply and use the inspection legend set out in Figure 2 of Schedule 2 instead of the one set out in Figure 1 of that Schedule if the meat product is a prepackaged meat product and its container

• (a) is a hermetically sealed package that is labelled in a legible and permanent manner so as to make it possible to identify the establishment that is identified in the licence holder's licence;
• (b) is a casing or bag that is closed by a clip, if the licence holder's licence number is legibly engraved on the clip and is visible when the clip is closed; or
• (c) bears the licence holder's licence number on any part of the label except the part, if any, that is applied or attached to the bottom of the container.

Processed egg products

178 A licence holder or an inspector is authorized to apply the inspection legend set out in Figure 1 of Schedule 2 to, and use it in connection with, a prepackaged processed egg product if the following conditions are met:

• (a) the processed egg product was manufactured, processed, treated, preserved, packaged or labelled by the licence holder in accordance with the Act and these Regulations;
• (b) if the processed egg product or any processed egg product that it contains was manufactured, processed, treated, preserved, packaged or labelled in Canada, that activity was conducted by a licence holder in accordance with the Act and these Regulations;
• (c) if the eggs from which the processed egg product is derived were processed, treated, preserved, graded, packaged or labelled in Canada, that activity was conducted by a licence holder in accordance with the Act and these Regulations;
• (d) the processed egg product meets the requirements set out in Volume 2 of the Standards of Identity Document and those set out in paragraphs 8(a) to (d) and in Division 3 of Part 6; and
• (e) the inspection legend is applied or used in an establishment that is identified in the licence holder's licence.

Fish

179 A licence holder or an inspector is authorized to apply the inspection legend set out in Figure 1 or 2 of Schedule 2 to, and use it in connection with, prepackaged fish if the following conditions are met:

• (a) the fish was manufactured, processed, treated or preserved by the licence holder in accordance with the Act and these Regulations;
• (b) if the fish or any fish that it contains was manufactured, processed, treated, preserved, graded, packaged or labelled in Canada, that activity was conducted by a licence holder in accordance with the Act and these Regulations; and
• (c) the fish meets the requirements set out in Volume 3 of the Standards of Identity Document and those set out in paragraphs 8(a) to (d) and in Division 4 of Part 6.

Licence number

180 A licence holder or an inspector who applies or uses the inspection legend set out in Figure 1 of Schedule 2 must replace the numbers “00” with the licence holder's licence number.

Inspection documents

181 (1) Publishers of documents on the subject of the inspection of meat products, processed egg products or fish are authorized to use the inspection legends set out in Figures 1 and 2 of Schedule 2 when publishing those documents.

Advertising documents

(2) Publishers of documents that advertise meat products, processed egg products or fish are authorized to use the inspection legends set out in Figures 1 and 2 of Schedule 2 when publishing those documents.

Stamps

(3) Manufacturers of stamps are authorized to use the inspection legends set out in Figures 1 and 2 of Schedule 2 when manufacturing stamps if the stamps that bear the inspection legend are provided to a person who is authorized under section 177, 178 or 179 to apply and use the inspection legend.

Labels and packages

(4) Printers of labels and manufacturers of packages are authorized to use the inspection legends set out in Figures 1 and 2 of Schedule 2 when printing labels and manufacturing packages if the labels and packages that bear the inspection legend are provided to a person who is authorized under section 177, 178 or 179 to apply and use the inspection legend.

Official export labels

(5) Despite subsection (4), printers of official export labels are authorized to use the inspection legends set out in Figures 1 and 2 of Schedule 2 when printing those labels only if the labels that bear the inspection legend are provided to an inspector.

Advertising and sale

(6) A person who is authorized under any of subsections (1) to (5) to use an inspection legend is authorized to advertise and sell the labels, packages, documents and stamps, as the case may be, that bear the inspection legend.

Advertising and sale of certain foods

182 A person is authorized to advertise, and to use the inspection legends set out in Figures 1 and 2 of Schedule 2 for that purpose, and sell meat products, prepackaged processed egg products or prepackaged fish that have the inspection legend on them, or that have it used in connection with them, if the inspection legend was applied or is used in accordance with these Regulations.

PART 10

Packaging

DIVISION 1

General

Requirements for packages

183 A prepackaged food that is sent or conveyed from one province to another or that is imported or exported must meet the following requirements:

• (a) its package
  • (i) must be suitable for its intended use and appropriate for the food,
  • (ii) must be capable of protecting the food against moisture, loss, damage, contamination and deterioration during normal handling, storing and conveying,
  • (iii) must be clean and in sanitary condition,
  • (iv) must be of sound construction,
  • (v) must be free from odours that might affect the food,
  • (vi) must not impart any undesirable substance to the food,
  • (vii) must not have a design or mark, or be of a colour, that enhances the appearance of the food with respect to its quality or composition, and
  • (viii) must be new, in the case of
    • (A) a liner that is used in connection with a processed egg product,
    • (B) a package of a processed egg product, if the package is made of corrugated fibreboard,
    • (C) an egg carton of eggs that are graded under these Regulations, and
    • (D) a tray of eggs that are graded Canada A or Canada B that is made of molded pulp;
• (b) in the case of a processed egg product, its package must, if it has previously been used and is not constructed of corrosion-resistant material, be lined with a sanitary plastic or equivalent liner;
• (c) in the case of eggs that are graded under these Regulations, its package must, if it is a plastic tray that has previously been used, be sanitized and dry before re-use; and
• (d) in the case of eggs that are graded Canada A or Canada B, its package must not have previously been used to package ungraded eggs or eggs that are graded Canada Nest Run.

DIVISION 2

Standard Container Sizes

Application

184 Unless otherwise specified, the requirements of this Division apply in respect of foods that are sent or conveyed from one province to another, foods that are imported and foods — other than foods that are set out in column 1 of Table 1 of Schedule 3 or foods that are set out in any of items 5 to 10, column 1, of Table 2 of that Schedule — that are exported.

Table 1 of Schedule 3 — weight or volume requirements

185 The container of a consumer prepackaged food that is set out in column 1 of Table 1 of Schedule 3 must be of a size that corresponds to a net quantity by weight or by volume that is set out in column 2 or 3.

Table 2 of Schedule 3 — weight requirements

186 (1) Subject to subsections (3) and (4) and section 189, the container of a consumer prepackaged food that is set out in column 1 of Table 2 of Schedule 3 must be of a size that corresponds to a net quantity by weight that is set out in column 2.

Table 3 of Schedule 3 — weight requirements

(2) Subject to section 189, the container of a prepackaged food that is set out in column 1 of Table 3 of Schedule 3 must be of a size that corresponds to a net quantity by weight that is set out in column 2.

Exception

(3) Subsection (1) does not apply to a consumer prepackaged food that is set out in any of items 2 to 4, column 1, of Table 2 of Schedule 3 if

• (a) in the case of a catch-weight food, a label that bears the net weight for retail sale is applied or attached to the food;
• (b) its container is a hermetically sealed package; or
• (c) it has a net quantity that is greater than 1 kg.

Exception — volume capacity

(4) The container of a consumer prepackaged food that is set out in any of items 5 to 10, column 1, of Table 2 of Schedule 3 may have any volume capacity that is set out in Table 7 of that Schedule, in the case of metric containers, or Table 8 of that Schedule, in the case of imperial containers.

Table 4 of Schedule 3 — volume and dimension requirements

187 Subject to section 189, the container of a prepackaged food that is set out in column 1 of Table 4 of Schedule 3 must be of a size that corresponds to a net quantity by volume that is set out in column 2 or 3 and must have the dimensions that are set out in column 4 or 5 for that net quantity.

Table 5 of Schedule 3 — volume and dimension requirements

188 (1) Subject to section 189, the container of a prepackaged food for which a grade is prescribed by these Regulations and that is set out in column 1 of Table 5 of Schedule 3 must, if the container is a hermetically sealed package, be of a size that corresponds to a net quantity by volume that is set out in column 2 or 3 and, if it is a metal container, it must also have the dimensions that are set out in column 4 or 5 for that net quantity.

Table 6 of Schedule 3 — volume and dimension requirements

(2) Subject to section 189, the container of a prepackaged food for which no grade is prescribed by these Regulations and that is set out in column 1 of Table 6 of Schedule 3 must, if the container is a hermetically sealed package, be of a size that corresponds to a net quantity by volume that is set out in column 2 or 3 and, if it is a metal container, it must also have the dimensions that are set out in column 4 or 5 for that net quantity.

Exception

189 The container of a prepackaged food that is set out in any of items 2 to 11, column 1, of Table 3 of Schedule 3 or in column 1 of Table 4, 5 or 6 of that Schedule may be of a size that is greater than the sizes that are required by sections 186 to 188 if

• (a) the container holds a net quantity of food that is
  • (i) not more than 20 kg, in the case of a food that is packaged by weight, or
  • (ii) not more than 20 L, in the case of a food that is packaged by volume; and
• (b) the declared net quantity of food that is shown on the label is a whole number multiple of
  • (i) 500 g, in the case of a food that is packaged by weight, or
  • (ii) 500 mL, in the case of a food that is packaged by volume.

Certain prepackaged fresh fruits or vegetables

190 (1) The container of prepackaged fresh fruits or vegetables, other than consumer prepackaged fresh fruits or vegetables that are set out in any of items 5 to 10, column 1, of Table 2 of Schedule 3, for which a grade is prescribed by these Regulations must have a capacity that is not greater than

• (a) 200 kg net weight, in the case of apples, pears, peaches and apricots; and
• (b) 50 kg net weight, in the case of any other fresh fruit or vegetable.

Exception

(2) Subsection (1) does not apply in respect of fresh fruits or vegetables that are exported.

DIVISION 3

Standard of Fill for Processed Fruit or Vegetable Products

Application

191 The requirements of this Division apply in respect of foods that are sent or conveyed from one province to another, foods that are imported and foods that are exported.

Frozen processed fruit or vegetable products

192 The package of a frozen processed fruit or vegetable product must be filled with the product to at least 90% of its volume capacity.

Non-frozen processed fruit or vegetable products

193 The package of a processed fruit or vegetable product, other than a frozen processed fruit or vegetable product,

• (a) must be filled with as much of the product as its preparation allows; and
• (b) must not contain more syrup, brine, water or other liquid packaging medium than is necessary for the processing of the product.

Hermetically sealed packages

194 Despite section 193, a processed fruit or vegetable product that is in a hermetically sealed package must meet the requirements for minimum drained weight and average drained weight that are set out in the document entitled Minimum Drained Weights and Average Drained Weights for Processed Fruit or Vegetable Products in a Hermetically Sealed Package, prepared by the Agency and published on its website, as amended from time to time.

PART 11

Labelling

DIVISION 1

General

Interpretation

Definition Canadian unit

195 In this Part, Canadian unit means a unit of measurement that is set out in Schedule II to the Weights and Measures Act.

False, misleading or deceptive labelling

196 (1) For the purposes of subsection 6(1) of the Act, labelling a food in a manner that is false, misleading or deceptive or is likely to create an erroneous impression includes using a label that bears

• (a) any representation in which expressions, words, figures, depictions or symbols are used, arranged or shown in a manner that may reasonably be considered to qualify the declared net quantity of a consumer prepackaged food or as likely to deceive with respect to the net quantity of a consumer prepackaged food; or
• (b) any expression, word, figure, depiction or symbol that implies — or may reasonably be considered to imply — that a consumer prepackaged food contains any matter that it does not in fact contain or does not contain any matter that it does in fact contain.

• False, misleading or deceptive selling, importing and advertising
• (2) For the purposes of subsection 6(1) of the Act, selling, importing or advertising a food in a manner that is false, misleading or deceptive or is likely to create an erroneous impression includes selling, importing or advertising a consumer prepackaged food whose label bears the elements set out in paragraph (1)(a) or (b).

Declaration of net quantity — labelling

(3) For the purposes of subsection 6(1) of the Act, using a label that bears a declaration of net quantity of a consumer prepackaged food does not constitute labelling a food in a manner that is false, misleading or deceptive if

• (a) the declaration meets all of the requirements under the Act; and
• (b) the net quantity of the food is, subject to the prescribed tolerance, not less than its declared net quantity.

• Declaration of net quantity — selling, importing or advertising
• (4) For the purposes of subsection 6(1) of the Act, selling, importing or advertising of a consumer prepackaged food that bears a declaration of net quantity does not constitute selling, importing or advertising a food in a manner that is false, misleading or deceptive if the conditions set out in paragraphs (3)(a) and (b) are met.

Reference to Schedule 4

(5) For the purpose of paragraph (3)(b), the prescribed tolerance for a declared net quantity that is set out in column 1 of the applicable table in Schedule 4 is the tolerance that is set out in column 2 or 3 for that net quantity.

Standard Prescribed for Food

Food meeting standard

197 A food, whether prepackaged or not, that is sent or conveyed from one province to another, or imported or exported, and whose label bears a common name printed in boldface type, but not in italics, in the Standards of Identity Document or in any of sections 252 to 254 must meet any standard that applies in respect of that common name.

Icewine

198 It is prohibited for a person to sell a consumer prepackaged food whose label bears the word “icewine” or the expression “ice wine” or “ice-wine” or “vin de glace” or any similar word or expression, or any abbreviation of, symbol for or phonetic rendering of any of those words or expressions, unless the food meets the standard set out in Volume 8 of the Standards of Identity Document.

DIVISION 2

Basic Requirements

Non-application of Division

Solely for export

199 This Division does not apply in respect of a consumer prepackaged food that is manufactured, prepared, packaged or labelled only for export and that is not sold for consumption in Canada.

Label Required

Sale — prepackaged food

200 It is prohibited for a person to sell a prepackaged food unless a label that meets the requirements of this Division is applied or attached to the prepackaged food in the manner set out in these Regulations.

Requirements relating to prohibition in subsection 10(3) of Act

201 A prepackaged food that is sent or conveyed from one province to another or that is imported must have a label applied or attached to it in the manner set out in these Regulations.

Exception

202 Sections 200 and 201 do not apply in respect of prepackaged foods that are

• (a) confections that are sold individually, commonly known as one-bite confections;
• (b) fresh fruits or vegetables that are packaged in a wrapper, or a confining band, that is less than 13 mm (1/2 inch) in width; or
• (c) fresh fruits or vegetables that are packaged in a protective wrapper, or a protective bag, that is clear and transparent and on which no information is shown other than a price, bar code, number code, environmental statement or product treatment symbol.

Information

Prepackaged Foods

Prepackaged food

203 (1) Unless otherwise provided by this Part, a label that is applied or attached to a prepackaged food must bear the following information:

• (a) the common name of the food, on the principal display panel;
• (b) the name and principal place of business of the person by or for whom the food was manufactured, prepared, stored, packaged or labelled, on any part of the label except the part, if any, that is applied or attached to the bottom of the container of the food; and
• (c) any other information that is required to be shown on the label of the prepackaged food in accordance with the requirements of the Food and Drug Regulations for prepackaged products within the meaning of those Regulations.

Exception — name and principal place of business

(2) The information referred to in paragraph (1)(b) may be shown on the part of the label, if any, that is applied or attached to the bottom of the container if it is also shown on a part of the label that is not applied or attached to the bottom of the container.

Exception — common name

204 (1) The following foods need not be labelled with the common name:

• (a) prepackaged fresh fruits or vegetables that are packaged in such a manner that the fresh fruits or vegetables are visible and identifiable in the container; and
• (b) consumer prepackaged fresh apples or pears that are packaged in such a manner that the name of their variety is shown on any part of the label except the part, if any, that is applied to the bottom of the container.

Definition apple

(2) In paragraph (1)(b), apple means a fresh apple for which a grade is prescribed by these Regulations.

Exception — name and principal place of business

205 Consumer prepackaged fresh fruits or vegetables that are packaged at retail in such a manner that the fresh fruits or vegetables are visible and identifiable in the container need not be labelled with the name and principal place of business referred to in paragraph 203(1)(b).

Consumer Prepackaged Foods

Consumer prepackaged food — declaration of net quantity

206 A label that is applied or attached to a consumer prepackaged food must bear, on its principal display panel, a declaration of net quantity of the food.

Place of manufacture — label or container

207 If the label that is applied or attached to a consumer prepackaged food bears any reference, direct or indirect, to the place of manufacture of the label or container, the reference to that place must be accompanied by an additional statement that indicates that the reference relates only to the place of manufacture of the label or container.

Name of importer

208 (1) If a consumer prepackaged food was wholly manufactured, processed or produced in a foreign state and the name and principal place of business of the person in Canada for whom it was manufactured, processed or produced or the person by whom it was stored, packaged or labelled in Canada is shown on its label, that information must be preceded by the expressions “Imported by” and “importé par” or the expressions “Imported for” and “importé pour”, as the case may be, unless the geographic origin of the consumer prepackaged food is shown on the label in accordance with subsection (3).

Food packaged in Canada

(2) If a food that was wholly manufactured, processed or produced in a foreign state is packaged in Canada other than at retail and the name and principal place of business of the person in Canada for whom the food was manufactured, processed or produced is shown on the label that is applied or attached to the resulting consumer prepackaged food, that information must be preceded by the expressions “Imported by” and “importé par” or the expressions “Imported for” and “importé pour”, as the case may be, unless the geographic origin of the food is shown on the label in accordance with subsection (3).

Geographic origin

(3) The geographic origin of a food must, subject to the requirements of any other federal or provincial law, be shown

• (a) in close proximity to the name and principal place of business of the person by or for whom the food was manufactured, processed or produced; and
• (b) in characters of at least the same height as those in which the information referred to in paragraph (a) is shown.

Flavouring ingredient

209 (1) If a flavouring ingredient is added to a consumer prepackaged food, the label that is applied or attached to the consumer prepackaged food must bear a statement that indicates that the flavouring ingredient is imitation, artificial or simulated if

• (a) the ingredient is not derived from a natural substance such as meat, fish or poultry or fruits, vegetables, edible yeast, herbs, spices, bark, buds, roots, leaves or other plant material; and
• (b) the label bears a pictorial representation that suggests the natural food flavour that corresponds to the added flavouring ingredient.

Statement

(2) The statement must be shown

• (a) on or in close proximity to the pictorial representation, if the representation is shown on the principal display panel;
• (b) on the principal display panel, in close proximity to the common name, if the pictorial representation is shown on a part of the label other than the principal display panel; or
• (c) on or in close proximity to the portion of the pictorial representation shown on the principal display panel, if the representation is shown on the principal display panel and on another part of the label.

Application of Label

Prepackaged food

210 The label of a prepackaged food must be applied or attached in such a manner that the food will be labelled at the time it is sold.

Consumer prepackaged food — container

211 Subject to section 213, the label of a consumer prepackaged food that is offered for sale must be applied or attached to the container in accordance with section 212.

Principal display surface

212 (1) All or part of the label of a consumer prepackaged food must be applied to the principal display surface.

Ornamental container

(2) Despite subsection (1), in the case of a consumer prepackaged food whose container is an ornamental container, the label may be applied to the bottom of the container or attached to the container.

Display card

213 In the case of a consumer prepackaged food whose container is mounted on a display card, the label may be applied to the surface of the display card that is displayed or visible under customary conditions of sale or use.

Advertisement

Net quantity — principal display panel

214 It is prohibited for a person to advertise a consumer prepackaged food unless a label is applied or attached to the food in the manner set out in these Regulations and the label bears on its principal display panel the declaration of net quantity required by this Part.

Representations relating to net quantity

215 It is prohibited for a person, in advertising a consumer prepackaged food, to make any representation with respect to the net quantity of the food except in the manner set out in this Part for the declaration of net quantity.

Type Size — Specific Information

Consumer prepackaged food

216 (1) In the case of the label of a consumer prepackaged food, the following information must be shown in characters of at least the minimum height that is set out in column 3 or 4 of Schedule 5 for the area of a principal display surface that is set out in column 1 or 2:

• (a) the numerical quantity in the declaration of net quantity; and
• (b) the statement referred to in section 209 that indicates that a flavouring ingredient is imitation, artificial or simulated.

Container mounted on display card — specific case

(2) For the purpose of subsection (1), in the case of a container that is mounted on a display card, the heading “Area of Principal Display Surface” in Schedule 5 is to be read as “The Total Area of the Surface of the Display Card that is Displayed or Visible under Customary Conditions of Sale or Use”, if the information is shown on a label that is applied to all or part of that surface.

Consumer prepackaged wine — specific case

(3) Despite paragraph (1)(a), in the case of consumer prepackaged wine, the numerical quantity in the declaration of net quantity may, if the net quantity is 750 mL, the container is no taller than 360 mm and the area of the principal display surface is greater than 258 cm², be shown in characters of a height less than the minimum height that is set out in column 3 of Schedule 5, but must be shown in characters that are at least 3.3 mm in height.

Manner of Showing Declaration of Net Quantity

Legibility

Consumer prepackaged food

217 The declaration of net quantity that is shown on the label of a consumer prepackaged food must

• (a) be in distinct contrast to any other information or pictorial representation on the label; and
• (b) show the numerical quantity in boldface type.

Declaration by Volume, Weight or Numerical Count

General requirements

218 (1) Subject to section 219, the declaration of net quantity of a consumer prepackaged food must be shown by volume, in the case of a food that is a liquid or gas or is viscous, or by weight, in the case of a food that is solid.

Established trade practice

(2) If it is the established trade practice to show the net quantity of a consumer prepackaged food in another manner, subsection (1) does not apply and the declaration must be shown in accordance with that practice.

Oysters

(3) Despite subsections (1) and (2), in the case of oysters that are sold in the shell, other than those in a hermetically sealed package, the declaration of net quantity may be shown by volume, weight or numerical count.

Specific requirements

219 The declaration of net quantity of a consumer prepackaged food must be shown by volume, weight or numerical count in accordance with the document entitled Units of Measurement for the Net Quantity Declaration of Certain Foods, prepared by the Agency and published on its website, as amended from time to time.

Metric Units

Permitted units of measurement

220 The declaration of net quantity of a consumer prepackaged food must be shown in metric units, unless otherwise provided by these Regulations.

Millilitres, litres, grams and kilograms

221 (1) The metric units that are to be shown in a declaration of net quantity of a consumer prepackaged food must be in

• (a) millilitres, if the net volume of the food is less than 1 000 mL;
• (b) litres, if the net volume of the food is 1 000 mL or more;
• (c) grams, if the net weight of the food is less than 1 000 g; and
• (d) kilograms, if the net weight of the food is 1 000 g or more.

Half-litre or half-kilogram

(2) Despite paragraphs (1)(a) and (c), 500 mL may be shown as 0.5 L and 500 g may be shown as 0.5 kg.

Decimal fraction

(3) In the case referred to in paragraph (1)(c), the net weight may be shown as a decimal fraction of a kilogram if the food is packaged from bulk at retail or is a catch-weight food that is sold by a retailer.

Number of digits

222 (1) When the declaration of net quantity of a consumer prepackaged food is shown in metric units, it must be shown in the decimal system to three figures.

Net quantity below 100 g or mL

(2) Despite subsection (1), if the net quantity is below 100 g or 100 mL, it may be shown to two figures.

Zero as final decimal

(3) Despite subsections (1) and (2), any final zero appearing to the right of the decimal point need not be shown.

Quantity less than one

223 If the declaration of net quantity of a consumer prepackaged food is shown in metric units and the quantity is less than one metric unit, the quantity must be shown

• (a) in words; or
• (b) in the decimal system, with a zero preceding the decimal point.

Metric Units and Canadian Units

Grouping

224 If the declaration of net quantity of a consumer prepackaged food is shown in metric units and Canadian units, those units must be grouped together, except that any symbol or pictogram that is shown in accordance with the Canada Consumer Product Safety Act or any regulations made under that Act may be shown between those units.

Canadian units of volume

225 (1) If the declaration of net quantity of a consumer prepackaged food whose volume is less than one gallon includes Canadian units, those units must be in fluid ounces, except that 20 fluid ounces may be shown as one pint, 40 fluid ounces as one quart, 60 fluid ounces as three pints, 80 fluid ounces as two quarts or as one-half gallon and 120 fluid ounces as three quarts.

Oysters

(2) Despite subsection (1), in the case of oysters that are sold in the shell, other than those in a hermetically sealed package, the declaration of net quantity must, if shown by volume, be shown in bushels or pecks.

Net quantity in advertisement

226 If the declaration of net quantity of a consumer prepackaged food or of a serving of the food is shown in metric units and Canadian units, the net quantity of the food or serving in an advertisement may be shown in either a metric unit or a Canadian unit.

Individually Packaged Food Sold as One Unit and Servings

Individually packaged food sold as one unit

227 If a consumer prepackaged food is sold as one unit but consists of two or more individually packaged foods that are labelled with the information required for a consumer prepackaged food, the declaration of net quantity of the consumer prepackaged food being sold as one unit must show

• (a) the number of individually packaged foods in each class of food, as well as the common name of the food in each class; and
• (b) the total net quantity of the individually packaged foods in each class, or the net quantity of each identical individually packaged food in each class.

Prohibition — representation respecting number of servings

228 It is prohibited for a person to apply or attach to any consumer prepackaged food a label that bears any representation with respect to the number of servings contained in the consumer prepackaged food unless the label bears a declaration of net quantity of each serving in accordance with section 229.

Servings

229 (1) The declaration of net quantity of a serving of a consumer prepackaged food must be shown

• (a) in close proximity to the representation with respect to the number of servings contained in the consumer prepackaged food; and
• (b) in characters of the same height as those in which that representation is shown.

Units

(2) The declaration of net quantity of a serving must be shown

• (a) in accordance with the requirements of sections 218, 219 and 221 to 225 respecting the declaration of net quantity of the food; and
• (b) in metric units, unless otherwise provided by these Regulations.

Representation — cups or tablespoons

(3) If the representation with respect to the number of servings is made in terms of cups or tablespoons,

• (a) one cup is equivalent to 250 mL and one tablespoon is equivalent to 15 mL; and
• (b) the declaration of net quantity need not meet the requirements of paragraph (2)(b).

DIVISION 3

Specific Requirements for Certain Foods

Application of Division

Interprovincial trade, import and export

230 The requirements of this Division apply in respect of foods that are sent or conveyed from one province to another, foods that are imported and foods that are exported.

Declaration of Net Quantity

Non-application of certain provisions

231 The requirements relating to the declaration of net quantity that are set out in the following provisions do not apply in respect of a consumer prepackaged food:

• (a) paragraph 234(d);
• (b) paragraph 242(a);
• (c) paragraph 250(1)(j);
• (d) paragraph 258(1)(b);
• (e) paragraph 262(1)(a);
• (f) paragraph 265(1)(a);
• (g) subsection 270(1); and
• (h) paragraph 273(a).

Declaration of net quantity

232 Any declaration of net quantity that is required by this Division must be shown by volume, weight or numerical count in accordance with the document entitled Units of Measurement for the Net Quantity Declaration of Certain Foods, prepared by the Agency and published on its website, as amended from time to time.

Location of Information

Food or container

233 (1) A label that bears the information required by this Division in respect of a food must be applied or attached

• (a) in the case of a prepackaged food, to its container; or
• (b) in the case of food that is not prepackaged, to the food.

Any part of label

(2) The information may be shown on any part of the label, unless otherwise provided by this Division in respect of the food.

Bottom of food or container

(3) Despite subsection (2), the information must not be shown on the part of the label, if any, that is applied or attached to the bottom of the prepackaged food or container unless it is also shown

• (a) on the part of the label, if any, where the information is required to be shown under another provision of this Division in respect of the food; or
• (b) if paragraph (a) does not apply, on any part of the label that is not applied or attached to the bottom of the food or container.

Dairy Products

Prepackaged dairy products

234 The following information must be shown on the principal display panel of a prepackaged dairy product:

• (a) in the case of butter, calorie-reduced butter, light butter or lite butter, dairy spread and whey butter,
  • (i) the word “Cultured” or “de culture”, preceding the common name in English or following the common name in French, if the dairy product has been prepared from cream to which a bacterial culture has been added,
  • (ii) the word “Whipped” or “fouetté”, preceding the common name in English or following the common name in French, if the dairy product has had air or inert gas uniformly incorporated into it as a result of whipping,
  • (iii) the word “Unsalted” or “non salé”, in close proximity to the common name, if the dairy product is unsalted and has not been cultured, and
  • (iv) the word “Salted” or “salé”, in close proximity to the common name, if the dairy product is salted and has been cultured;
• (b) in the case of a combination of skim milk powder and whey powder, the percentage of each powder;
• (c) in the case of partly skimmed milk powder, dairy spread and calorie-reduced butter, the percentage of milk fat; and
• (d) in all cases, a declaration of net quantity that is
  • (i) in metric units or Canadian units, or both, in which case the units must be grouped together, if a standard is set out in Volume 1 of the Standards of Identity Document for the dairy product, or
  • (ii) in metric units, if no standard is set out in Volume 1 of the Standards of Identity Document for the dairy product.

Prepackaged dairy products — not consumer prepackaged

235 The following information must be shown on the principal display panel of a prepackaged dairy product other than a consumer prepackaged dairy product:

• (a) in the case of cheese in its original shape, made from pasteurized milk, the word “Pasteurized” or “pasteurisé”, unless the list of ingredients indicates that the cheese is made from pasteurized milk;
• (b) in the case of buttermilk powder, the percentage of milk fat;
• (c) in the case of skim milk powder that has a whey protein nitrogen content of not less than 6.0 mg/g, the expression “Low Heat” or “Low Temperature” or “basse température” or the abbreviation “Low Temp.” or “basse temp.”; and
• (d) in the case of skim milk powder that has a whey protein nitrogen content of not more than 1.5 mg/g, the expression “High Heat” or “High Temperature” or “haute température” or the abbreviation “High Temp.” or “haute temp.”.

Consumer prepackaged dairy products

236 The following information must be shown on the principal display panel of a consumer prepackaged dairy product:

• (a) in the case of cheese and cheese curd, the percentage of moisture;
• (b) in the case of cheese, cheese curd and evaporated partly skimmed milk or concentrated partly skimmed milk, the percentage of milk fat;
• (c) in the case of a dairy product that consists of or was manufactured or prepared wholly or partly from milk that is the normal lacteal secretion, free from colostrum, obtained from the mammary gland of an animal other than a cow, the source of the milk, unless the source is indicated in the common name; and
• (d) in the case of a dairy product that is sold as one unit but consists of two or more individual packages of butter patties, butter reddies or other related dairy products, the number of individual packages, as well as the net quantity of each individual package, if the total net quantity of the individual packages is more than 20 g.

Consumer prepackaged cheese

237 (1) The following information must be shown on the principal display panel of a consumer prepackaged (naming the variety) cheese:

• (a) the relative firmness of the cheese;
• (b) except in the case of a soft white cheese, the principal ripening characteristic of the cheese;
• (c) in the case of hard cheese that is intended for grating and has a moisture content of 34% or less, the expression “Hard Grating Cheese” or “fromage dur à râper”; and
• (d) in the case of a mixture of grated or shredded cheeses, the varieties of the cheeses, in descending order of their proportion in the cheese.

Exceptions

(2) Subsection (1) does not apply to the following cheeses:

• (a) cheddar cheese;
• (b) cream cheese;
• (c) cream cheese with (naming the added ingredients);
• (d) cream cheese spread;
• (e) cream cheese spread with (naming the added ingredients);
• (f) whey cheese;
• (g) (naming the variety) whey cheese;
• (h) processed (naming the variety) cheese;
• (i) processed (naming the variety) cheese with (naming the added ingredients);
• (j) processed cheese food;
• (k) processed cheese food with (naming the added ingredients);
• (l) processed cheese spread;
• (m) processed cheese spread with (naming the added ingredients);
• (n) cold-pack (naming the variety) cheese;
• (o) cold-pack (naming the variety) cheese with (naming the added ingredients);
• (p) cold-pack cheese food;
• (q) cold-pack cheese food with (naming the added ingredients);
• (r) cottage cheese;
• (s) creamed cottage cheese; and
• (t) any cheese that is listed in the table to section B.08.033 of the Food and Drug Regulations.

Relative firmness

(3) The relative firmness of the cheese must be identified by one of the following expressions:

• (a) “Soft White Cheese” or “fromage à pâte fraîche” or “fromage frais”, if it has a moisture on fat-free basis content of 80% or more;
• (b) “Soft Cheese” or “fromage à pâte molle”, if it has a moisture on fat-free basis content of more than 67% but less than 80%;
• (c) “Semi-soft Cheese” or “fromage à pâte demi-ferme”, if it has a moisture on fat-free basis content of more than 62% but not more than 67%;
• (d) “Firm Cheese” or “fromage à pâte ferme”, if it has a moisture on fat-free basis content of 50% or more but not more than 62%; and
• (e) “Hard Cheese” or “fromage à pâte dure”, if it has a moisture on fat-free basis content of less than 50%.

Principal ripening characteristic

(4) The principal ripening characteristic of the cheese must be identified by one of the following words or expressions:

• (a) “Ripened” or “affiné”, if the ripening process develops within the whole body of the cheese;
• (b) “Surface Ripened” or “affiné en surface”, if the ripening process starts from the surface and moves into the body of the cheese;
• (c) “Blue Veined” or “à pâte persillée”, if veins of mould occur within the body of the cheese; and
• (d) “Unripened” or “non affiné” or “Fresh” or “frais”, if the cheese has not undergone any ripening.

Imported dairy products

238 (1) The label of the following dairy products must bear the expression “Product of ” or “produit de”, followed by the name of the foreign state of origin:

• (a) an imported prepackaged dairy product; and
• (b) a consumer prepackaged cheese that is packaged in Canada from imported bulk cheese for which a standard is set out in Volume 1 of the Standards of Identity Document.

Principal display panel

(2) In the case of the cheese referred to in paragraph (1)(b), the information must be shown on the principal display panel.

Exemption

239 Sections 234, 236 and 238 do not apply to an individual portion of a consumer prepackaged dairy product that is sold

• (a) by automatic vending machine or mobile canteen; or
• (b) by a restaurant or other commercial enterprise when served with meals or snacks.

Prepackaged dairy products to be exported

240 The label of a prepackaged dairy product that is to be exported must bear the expression “Product of Canada” or “produit du Canada”.

Type size

241 The information that is required by sections 238 and 240 must be shown in boldface type in characters that are at least 16 mm (5/8 inch) in height, in the case of a prepackaged dairy product other than a consumer prepackaged dairy product.

Eggs

Graded prepackaged eggs

242 The label of prepackaged eggs that are graded under these Regulations must bear the following information:

• (a) a declaration of net quantity; and
• (b) in the case of eggs that are pasteurized in the shell, the words “Pasteurized” and “pasteurisé”, as well as the expressions “Graded Canada A Before Pasteurization” and “classifié Canada A avant pasteurisation” or the expressions “Graded Grade A Before Pasteurization” and “classifié Catégorie A avant pasteurisation”, as the case may be.

Size of label of graded egg

243 It is prohibited for a person to apply to an egg that is graded Canada A, Canada B, Grade A or Grade B a label that covers an area that is larger than 2.5 cm².

Imported eggs

244 (1) The label of imported prepackaged eggs must bear the expressions “Product of” and “produit de”, followed by the name of the foreign state of origin.

Location and type size

(2) That information must be shown

• (a) in the case of a container other than a tray with an overwrap or an egg carton, in characters that are at least 6 mm in height; and
• (b) in the case of a tray with an overwrap or an egg carton, on the top or side of the tray or egg carton, in characters that are at least 1.5 mm in height.

Eggs to be exported

245 (1) The label of prepackaged eggs that are graded under these Regulations and that are to be exported must bear the expressions “Product of Canada” and “produit du Canada”.

Location and type size

(2) That information must be shown

• (a) in the case of a container other than a tray with an overwrap or an egg carton, immediately below the common name, in characters that are at least 13 mm in height; and
• (b) in the case of a tray with an overwrap or an egg carton, on the top or side of the tray or egg carton, in characters that are at least 1.5 mm in height.

Processed Egg Products

Prepackaged processed egg products

246 The label of a prepackaged processed egg product must bear the following information:

• (a) the inspection legend set out in Figure 1 of Schedule 2, if the prepackaged processed egg product is sent or conveyed from one province to another or exported;
• (b) the official inspection mark of the foreign state of origin, if the prepackaged processed egg product is imported;
• (c) the expression “Product of Turkey Eggs” or “produit d'œufs de dinde” or the expression “Product of Turkey Eggs and Chicken Eggs” or “produit d'œufs de dinde et de poule”, as the case may be, if the processed egg product was manufactured or prepared from eggs of a domestic turkey or from eggs of a domestic turkey and eggs of a domestic chicken; and
• (d) the expression “Pan-dried” or “séché sur plaque” or the expression “Spray-dried” or “séché par pulvérisation”, as the case may be, if the processed egg product is dried egg white or dried albumen.

Imported prepackaged processed egg products

247 The label of an imported prepackaged processed egg product must also bear the expression “Product of” or “produit de”, followed by the name of the foreign state of origin.

Prepackaged dried egg blends

248 The label of the following prepackaged processed egg products must bear the expression “Product of Canada and” or “produit du Canada et”, followed by the name of the foreign state of origin:

• (a) dried whole egg that is a blend of imported and Canadian dried whole egg;
• (b) dried yolk that is a blend of imported and Canadian dried yolk; and
• (c) dried egg white or dried albumen that is a blend of imported and Canadian dried egg white or dried albumen.

Fish

Definitions

249 The following definitions apply in sections 250 to 257.

brine means sea water, with or without the addition of salt, or a solution of salt and fresh water. (saumure)

fillet means a slice of fish flesh of irregular size and shape, whether cut into sections or not, that

• (a) has been removed from the carcass of a fish by cuts that are parallel to the backbone; and
• (b) has had the internal organs, head, fins and all discoloured flesh and bones, other than intramuscular or lateral bones, removed. (filet)

minced refers to particles of skeletal muscle that have been separated from clean, sound fish that has had the head and all internal organs, bones, skin and discoloured flesh removed. (haché)

salted fish means fish of the Gadidae family that has been preserved by salt and that has a salt content of 12% or more by wet weight and a moisture content of not more than 65%. (poisson salé)

whitefish means fish of the species Coregonus clupeaformis, Coregonus nasus or Prosopium cylindraceum. (poisson blanc)

Prepackaged fish

250 (1) The label of prepackaged fish must bear the following information:

• (a) in the case of salmon that is in a hermetically sealed package, the words “Skinless” or “sans peau” and “Boneless” or “sans os”, if the skin and the vertebrae have been removed from the salmon and the salmon consists of sections of flesh that are cut transversely from the fish and are nearly equal in length to the height of the hermetically sealed package;
• (b) in the case of minced salmon or trimmings from the tail and nape sections of a salmon or other small pieces of salmon, the word “Minced” or “saumon haché” or the expression “Salmon Tips” or “bouts de saumon”, as the case may be, if the salmon or trimmings are in a hermetically sealed package;
• (c) in the case of unfrozen lobster meat that has been packaged without the addition of brine, the expression “Dry Pack” or “emballage à sec”;
• (d) in the case of fish sticks, fish fingers and other uniform rectangular portions of breaded fish flesh that were manufactured or prepared from minced fish, a descriptive term declaring that the food is manufactured or prepared from minced fish;
• (e) in the case of bivalve molluscs in the shell that are not in a hermetically sealed package, the date of processing and an expression, code or identifier that indicates the area from which the bivalve molluscs were harvested;
• (f) in the case of tuna that is in a hermetically sealed package, one of the following expressions to describe the colour of the fish flesh:
  • (i) “White Meat Tuna” or “chair de thon blanc” or “White Tuna” or “thon blanc”, if the tuna is of the species Thunnus alalunga or Thunnus germo and has a diffuse luminous reflectance of not less than 33.7% of that of magnesium oxide,
  • (ii) “Light Meat Tuna” or “chair pâle de thon” or “Light Tuna” or “thon pâle”, if the tuna has a diffuse luminous reflectance of not less than 22.6% of that of magnesium oxide, and
  • (iii) “Dark Meat Tuna” or “chair foncée de thon” or “Dark Tuna” or “thon foncé”, if the tuna does not meet the requirements of subparagraph (ii);
• (g) in the case of salted fish, one of the following expressions to describe the processing of the fish:
  • (i) “Split Fish” or “poisson fendu”, if the fish is split and at least two thirds of the anterior of the backbone has been removed,
  • (ii) “Split Fish with Entire Backbone” or “poisson fendu avec colonne vertébrale entière”, if the fish is split and no portion of the backbone has been removed,
  • (iii) “Fillet” or “filet”, in the case of a filet as defined in section 249, and
  • (iv) any other expression that is distinctive from those set out in subparagraphs (i) to (iii) and that describes the processing of the fish;
• (h) in the case of salted fish, one of the following expressions to describe the salt or moisture content of the fish:
  • (i) “Slack Salted Fish” or “poisson faiblement salé”, if, after salting is complete, the fish has a salt content of not more than 25% by dry weight,
  • (ii) “Light Salted Fish” or “poisson légèrement salé”, if, after salting is complete, the fish has a salt content of more than 25% but not more than 33% by dry weight,
  • (iii) “Dried Heavy Salted Fish” or “poisson fortement salé séché”, if, after salting is complete, the fish has a salt content of more than 33% by dry weight and has a moisture content of not more than 54%, and
  • (iv) “Green Heavy Salted Fish” or “poisson fortement salé en vert”, if, after salting is complete, the fish has a salt content of more than 33% by dry weight and has a moisture content of more than 54% but not more than 65%;
• (i) in the case of fish that is in a hermetically sealed package, an indication, as part of the common name, as to whether the fish was manufactured or prepared
  • (i) by mincing, flaking or another special process,
  • (ii) from selected parts of fish, or
  • (iii) for dietetic use; and
• (j) in all cases, a declaration of net quantity.

Mackerel

(2) In the case of mackerel or mackerel fillets that are packaged without the addition of water, brine or a vinegar solution and that are in a hermetically sealed package, the label must bear the drained weight in addition to the declaration of net quantity, if the drained weight is less than 80% of that quantity.

Descriptive terms — minced fish

(3) The descriptive term referred to in paragraph (1)(d) must be shown in close proximity to the common name and in characters that are at least the height that is the greater of

• (a) one-half the height of the characters in which the common name is shown, and
• (b) 1.6 mm.

Prepackaged fish placed in another container

251 If prepackaged fish that is labelled in accordance with this Part is placed in another container and the resulting product is prepackaged fish, other than consumer prepackaged fish, the resulting product need not be labelled with the declaration of net quantity referred to in paragraph 250(1)(j).

Salmon — common name

252 (1) If salmon that is in a hermetically sealed package is of a species that is set out in column 1 of the table to this section, the common name that is required to be shown on the label is any common name that is set out for that species in column 2.

Exception

(2) Despite subsection (1), in the case of minced salmon that is in a hermetically sealed package that contains mixed species, the common name that is required to be shown on the label is Minced Salmon.

TABLE

Item	Column 1 Species	Column 2 Common Name
1	Oncorhynchus gorbuscha	Pink Salmon
2	Oncorhynchus keta	Chum Salmon
		Keta Salmon
3	Oncorhynchus kisutch	Coho Salmon
		Medium Red Coho Salmon
4	Oncorhynchus nerka	Red Salmon
		Red Sockeye Salmon
		Sockeye Salmon
5	Oncorhynchus tschawytscha	Chinook Salmon
		King Salmon
		Spring Salmon
6	Salmo gairdnerii	Deep Sea Trout
		Steelhead Salmon
7	Salmo salar	Atlantic Salmon
		Salmon

Tuna — common name

253 If tuna that is in a hermetically sealed package is of a species that is set out in column 1 of the table to this section, the common name that is required to be shown on the label is Tuna or any common name that is set out for that species in column 2.

TABLE

Item	Column 1 Species	Column 2 Common Name
1	Euthynnus alletteratus	Atlantic Black Skipjack
		Atlantic Little Tunny
2	Euthynnus lineatus	Black Skipjack
		Little Tunny
3	Euthynnus yaito or Euthynnus affinis	Kawakawa
		Little Tuna
4	Katsuwonus pelamis or Euthynnus pelamis	Skipjack
5	Sarda chiliensis or Sarda lineolata	Bonito
		Bonito Tuna
6	Thunnus alalunga or Thunnus germo	Albacore
7	Thunnus albacares or Neothunnus macropterus	Yellowfin Tuna
8	Thunnus atlanticus	Blackfin Tuna
9	Thunnus maccoyii	Southern Bluefin Tuna
10	Thunnus obesus or Parathunnus mebachi	Bigeye Tuna
11	Thunnus thynnus orientalis	Oriental Tuna
12	Thunnus thynnus thynnus or Thunnus thynnus	Atlantic Bluefin Tuna
13	Thunnus tonggol or Neothunnus rarus	Tonggol Tuna

Frozen lobster meat — common name

254 The common name that is required to be shown on the label of prepackaged frozen lobster meat is Frozen Lobster Meat.

Fish in hermetically sealed package

255 In the case of fish that is in a hermetically sealed package, the declaration of net quantity referred to in paragraph 250(1)(j) must be shown on the principal display panel.

Imported prepackaged fish

256 The label of imported prepackaged fish must bear the name of the foreign state of origin.

Prepackaged whitefish

257 The label of prepackaged whitefish, other than imported prepackaged whitefish, must bear the name of the lake and province of origin.

Fresh Fruits or Vegetables

Prepackaged fresh fruits or vegetables

258 (1) The label of prepackaged fresh fruits or vegetables must bear the following information:

• (a) in the case of apples, the name of the variety; and
• (b) in all cases, a declaration of net quantity.

Prepackaged apples placed in another container

(2) If prepackaged fresh apples that are labelled in accordance with this Part are placed in another container and the resulting product is prepackaged fresh apples, other than consumer prepackaged fresh apples, the resulting product need not be labelled with the name of the variety.

Definition apple

(3) In paragraph (1)(a) and subsection (2), apple means a fresh apple for which a grade is prescribed by these Regulations.

Declaration of net quantity

(4) Unless the declaration of net quantity is shown by numerical count, it must be shown in metric units or Canadian units, or both, in which case the units must be grouped together.

Imported prepackaged fresh fruits or vegetables

259 (1) The expression “Product of” or “Produce of” or “produit de”, “Grown in” or “cultivé dans” or “Country of Origin” or “pays d'origine”, followed by the name of the foreign state in which the fresh fruits or vegetables were grown, or other words that clearly indicate that foreign state, must be shown on the principal display panel of imported prepackaged fresh fruits or vegetables in close proximity to the declaration of net quantity or the grade name.

Prepackaged fresh fruits or vegetables placed in another container

(2) If prepackaged fresh fruits or vegetables that are labelled in accordance with this Part are placed in another container and the resulting product is prepackaged fresh fruits or vegetables, other than consumer prepackaged fresh fruits or vegetables, the resulting product need not be labelled with the information referred to in subsection (1) if that information is readily discernible and legible without having to open the container and is not obscured by the container.

Subsequent repackaging

(3) This section applies whether or not the imported prepackaged fresh fruits or vegetables are subsequently repackaged in Canada.

Type size

260 (1) The information that is required by section 259 must be shown in boldface type in characters of at least the minimum height that is set out in column 3 or 4 of Schedule 5 for the area of a principal display surface that is set out in column 1 or 2.

Exception

(2) Subsection (1) does not apply in respect of consumer prepackaged fresh fruits or vegetables that are packaged from bulk at retail or catch-weight foods that are sold by a retailer.

Reusable plastic container

261 Despite subsection 260(1), in the case of prepackaged fresh fruits or vegetables, other than consumer prepackaged fresh fruits or vegetables, whose container is a reusable plastic container, the characters must be at least 1.6 mm in height.

Processed Fruit or Vegetable Products

Prepackaged processed fruit or vegetable products

262 (1) The label of a prepackaged processed fruit or vegetable product must bear the following information:

• (a) a declaration of net quantity, in metric units, on the principal display panel;
• (b) the expression “Solid Pack” or “conserve compacte”, in the case of a solid pack in which there is little or no free liquid;
• (c) the expression “Heavy Pack” or “conserve épaisse”, in the case of a heavy pack that contains the maximum drained weight of the food that processing will permit;
• (d) the expression “In Water” or “dans l'eau”, if the product is packaged in water;
• (e) the expression “Contents ... Per Cent Slack Filled” or “... pour cent du contenant non rempli” or “Contents ... Per Cent Short Weight” or “contient ... pour cent de moins que le poids indiqué”, if the package is slack filled or contains less than the minimum net and drained weights prescribed by these Regulations;
• (f) the expression “With Pectin” or “avec pectine” immediately below the common name, in the case of jam, jelly or marmalade to which pectin has been added;
• (g) the total percentage of sweeteners added, if any, in the case of frozen fruits packaged in sugar, invert sugar, dextrose or glucose in dry form;
• (h) the word “Seville” or “Séville” or “Bitter” or “amère” or the expression “Extra Bitter” or “extra amère”, in the case of orange marmalade made from Seville or other bitter varieties of oranges;
• (i) the word “Whole” or “entiers” or “Cut” or “coupés” or the expression “French Cut” or “coupe française” or “French Style” or “à la française” or “Asparagus Style” or “genre asperges” or “Whole Vertical Pack” or “entiers, emballage vertical”, as the case may be, to describe the style of cut or packaging in the case of green or wax beans that are frozen or in a hermetically sealed package;
• (j) the expression “Tips Removed” or “pointes enlevées” or “Without Tips” or “sans pointes” immediately below the common name, in the case of asparagus cuts or cuttings that are graded Canada Choice and packaged without tips;
• (k) the expression “Cream Style” or “maïs crème”, “Packed in Liquid” or “conservé dans un liquide”, “Brine Pack” or “conservé dans la saumure” or “Packed in Brine” or “mis en conserve dans la saumure” or “Vacuum Pack or “conservé sous vide”, as the case may be, in the case of corn that is in a hermetically sealed package;
• (l) the expression “Vitamin C Added” or “additionné de vitamine C” or the word “Vitaminized” or “vitaminé”, in the case of apple juice, mixed vegetable juice, tomato juice cocktail, prune nectar, apricot nectar, grape juice or grape juice from concentrate, to which ascorbic acid has been added in order to increase the Vitamin C content;
• (m) the expression “A Water Extract of Dried Prunes” or “extrait aqueux de pruneaux secs” immediately following the common name, in the case of prune nectar;
• (n) the word “Clingstone” or “à noyau adhérent”, in the case of peaches that are in a hermetically sealed package and that have stones or pits that adhere to the flesh, or the word “Freestone” or “à noyau non adhérent”, in the case of peaches that are in a hermetically sealed package and whose flesh separates readily from the stones or pits;
• (o) the expression “Keep Refrigerated” or “garder réfrigéré”, in the case of sauerkraut with preservative, or a fruit juice that is in a non-hermetically sealed package;
• (p) the word “Wild” or “de type sauvage” or “Cultivated” or “de type cultivé”, as the case may be, as well as the abbreviation “I.Q.F.” (Individually Quick Frozen) or the word “surgelés” or the expression “Non-free Flowing” or “non individuellement congelés”, in the case of frozen blueberries;
• (q) the word “Sparkling” or “pétillant”, “mousseux” or “gazéifié” or “Carbonated” or “carbonaté”, “mousseux” or “gazéifié”, in the case of apple juice, apple juice from concentrate, grape juice or grape juice from concentrate, to which carbon dioxide under pressure has been added; and
• (r) the word “Pitted” or “dénoyautées”, in the case of frozen sweet cherries that are whole and stemmed and that have had the pits removed, or the word “Unpitted” or “non dénoyautées”, in the case of frozen sweet cherries that are whole and stemmed and that have not had the pits removed.

Definitions

(2) The following definitions apply in paragraph (1)(i).

asparagus style or whole vertical pack, in respect of whole beans, means that the beans are packaged parallel to the sides of a package and are substantially equal in length, whether the beans are frozen or in a hermetically sealed package. (genre asperges ou entiers, emballage vertical)

cut, in respect of beans, means that the pods are cut transversely into pieces that are not more than 50.8 mm (2 inches) in length and not less than 19.05 mm (3/4 inch) in length, except in the case of shorter end pieces that result from cutting, whether the beans are frozen or in a hermetically sealed package. (coupés)

French cut or French style, in respect of beans, means that the pods are sliced lengthwise, whether the beans are frozen or in a hermetically sealed package. (coupe française ou à la française)

whole, in respect of whole beans, means that the beans are not arranged in any definite position in a package, whether the beans are frozen or in a hermetically sealed package. (entiers)

Identification name

263 A food that is set out in column 1 of Schedule 6 that is frozen or in a hermetically sealed package, that is packaged in syrup or fruit juice, or in fruit juice to which sugar has been added, and that has a percentage of soluble solids that is set out in any of paragraphs (a) to (e) of column 2 must be labelled with the identification name that is set out for that percentage in column 3.

Name of foreign state

264 (1) The label of an imported prepackaged processed fruit or vegetable product must bear the name of the foreign state where the processed fruit or vegetable product was packaged.

Type size

(2) The name must be shown in characters that are at least 1.6 mm in height.

Product packaged for Canadian importer

(3) Despite subsection (2), if the product was packaged for a Canadian importer under the importer's private label, the name must be shown in characters that are at least

• (a) 6.4 mm (1/4 inch) in height, if the declaration of net quantity is more than 283.5 g (10 ounces); and
• (b) 3.2 mm (1/8 inch) in height, if the declaration of net quantity is 283.5 g (10 ounces) or less.

Honey

Prepackaged honey

265 (1) The label of prepackaged honey that is graded under these Regulations must bear the following information:

• (a) a declaration of net quantity, in metric units or, in the case of prepackaged honey that is sold as one unit but that consists of two or more individual packages, the number of those packages and the net quantity of each, in metric units; and
• (b) the word “Creamed” or “en crème” or another word that indicates that the contents are granulated, “Liquid” or “liquide”, “Pasteurized” or “pasteurisé” or “Pressed” or “de presse”, as the case may be.

Location

(2) In the case of consumer prepackaged honey, the information must be shown on the principal display panel.

Graded Canadian honey

266 The label of prepackaged honey that is produced in Canada and graded under these Regulations must bear the expression “Product of Canada” or “produit du Canada” or “Canadian Honey” or “miel canadien”.

Imported prepackaged honey

267 (1) The label of imported prepackaged honey must bear the expression “Product of” or “produit de” followed by the name of the foreign state of origin.

Type size

(2) In the case of imported prepackaged honey, other than consumer prepackaged honey, that information must be shown in characters that are at least 9.5 mm in height.

Honey packaged from imported honey

268 The label of consumer prepackaged honey that was packaged from imported honey and graded under these Regulations must bear the expression “Product of” or “produit de” followed by the name of the foreign state of origin.

Blend of Canadian and imported honey

269 (1) The label of prepackaged honey that is a blend of imported honey and Canadian honey and graded under these Regulations must bear the expression “A Blend of Canadian and (naming the foreign state or states of origin) Honey” or “mélange de miel canadien et de miel (indication de l'État étranger ou des États étrangers d'origine)” or “A Blend of (naming the foreign state or states of origin) Honey and Canadian Honey” or “mélange de miel (indication de l'État étranger ou des États étrangers d'origine) et de miel canadien”.

Sources of honey

(2) The states of origin, Canadian or foreign, must be shown in descending order of the proportion of honey from each state.

Maple Products

Net quantity

270 (1) The label of a prepackaged maple product must bear a declaration of net quantity in metric units.

Exception

(2) Subsection (1) does not apply to maple syrup unless it is graded under these Regulations.

Imported maple products

271 The label of the following maple products must bear the name of the foreign state of origin:

• (a) any imported prepackaged maple syrup whose net quantity is 5 L or less; and
• (b) any other imported prepackaged maple product whose net quantity is 5 kg or less.

Meat Products

Inspection legend — non-prepackaged edible meat products

272 (1) An edible meat product that is not prepackaged must bear the following information:

• (a) the inspection legend set out in Figure 1 or 2 of Schedule 2, if the edible meat product is sent or conveyed from one province to another or exported; and
• (b) the official inspection mark of the foreign state of origin, if the edible meat product is imported.

Application of inspection legend

(2) In the case of an edible dressed or partially dressed whole carcass or an edible dressed or partially dressed carcass side, other than such a carcass or carcass side of a domesticated rabbit or a bird that is not an ostrich, rhea or emu, the inspection legend must be applied after the post-mortem inspection or examination and before refrigeration, by

• (a) stamping it directly onto the carcass or carcass side; or
• (b) applying to the carcass or carcass side a label that is shown prominently and that bears the inspection legend, a unique identifier and the date of slaughter of the food animal from which the carcass or carcass side is derived.

Size of inspection legend

(3) If an inspection legend or official inspection mark of a foreign state is applied directly on an edible meat product, the transverse axis passing through the centre of the legend or mark must be at least 25 mm in length.

Prepackaged edible meat products

273 The label of a prepackaged edible meat product must bear the following information on the principal display panel:

• (a) a declaration of net quantity, in metric units, shown in the manner required by sections 221 to 224 and 227, whether the meat product is a consumer prepackaged meat product or not;
• (b) a statement that indicates that the meat product must be kept refrigerated or kept frozen, as the case may be, unless the meat product
  • (i) is packaged in a hermetically sealed package and treated to achieve commercial sterility,
  • (ii) is dried to attain a water activity of 0.85 or less,
  • (iii) has a pH of 4.6 or less,
  • (iv) is packaged in salt or a saturated salt solution, or
  • (v) is fermented and has a pH of 5.3 or less, and a water activity of 0.90 or less, at the end of the fermentation;
• (c) in the case of a poultry carcass that is dressed or partially dressed, the expressions “With Giblets” and “avec abats” or “avec abattis”, if giblets are packaged with the poultry carcass and it has been graded under these Regulations; and
• (d) in the case of a poultry carcass of a chicken or young duck that is dressed or partially dressed, or a portion of such a carcass, the expression “May Contain Kidneys” or “peut contenir les reins”, if the kidneys have not been removed or it may contain kidneys.

Inspection legend — prepackaged edible meat products

274 (1) The label of a prepackaged edible meat product must also bear the following information:

• (a) the inspection legend set out in Figure 1 or 2 of Schedule 2, if the prepackaged edible meat product is sent or conveyed from one province to another or exported; and
• (b) the official inspection mark of the foreign state of origin, if the prepackaged edible meat product is imported.

Principal display panel

(2) In the case of a prepackaged meat product, other than a consumer prepackaged meat product, the inspection legend or the official inspection mark of the foreign state of origin must be shown on the principal display panel.

Tamper-resistant seal

(3) Despite subsection (2), in the case of a prepackaged meat product, other than a consumer prepackaged meat product, the inspection legend or the official inspection mark of the foreign state of origin may be shown on the tamper-resistant seal, if such a seal is used, unless that seal is applied to the bottom of the container.

Edible meat products

275 (1) The label of an edible meat product may bear a word or expression that is set out in column 1 of Schedule 7 only if the edible meat product meets the requirements that are set out in column 2.

Location

(2) If such a word or expression is shown on the label, it must be shown in close proximity to the common name.

Animal species

276 The label of an edible meat product may describe the meat product as, or as being derived from, a carcass or part of a carcass or a cut, organ or tissue of an animal only if the label bears the name of the animal species, as it is commonly known, from which the meat product was derived.

Ready-to-eat product

277 The label of an edible meat product may bear a word or expression that indicates or suggests that it is a ready-to-eat product only if the requirements of section 45 are met in respect of the edible meat product.

Uncooked meat products

278 The following information must be shown on the principal display panel of a prepackaged edible meat product that is not a ready-to-eat product but could be mistaken for one:

• (a) the expression “Must Be Cooked” or “doit être cuit” or “Raw Product” or “produit cru” or the word “Uncooked” or “non cuit”, or any equivalent word or expression, in close proximity to the common name, to indicate that the meat product requires cooking before consumption; and
• (b) comprehensive cooking instructions — such as a combination of internal temperature and cooking time — that, if followed, will result in a ready-to-eat meat product.

Prepackaged poultry carcass

279 In the case of a prepackaged poultry carcass, if the carcass is dressed or partially dressed and has been graded under these Regulations, the common name must be shown on

• (a) the part of the package that lies on or over the anterior centre of the breast of the poultry, if the carcass is individually packaged; or
• (b) on a tag that is attached to the V of the wishbone of the poultry carcass, if it is not individually packaged.

Consumer prepackaged poultry carcass

280 In the case of a consumer prepackaged poultry carcass, if the carcass is dressed or partially dressed and has been graded under these Regulations, the label must bear

• (a) if the poultry carcass has been basted, the words “Basted” and “imprégné”, the words “Pre-basted” and “préimprégné”, the expressions “Deep Basted” and “imprégné en profondeur” or the words “Self-basting” and “auto-imprégné”, as applicable, as well as the expressions “Graded before Basting” and “classifié avant imprégnation”;
• (b) if it is graded Canada Utility, the expressions “May Have Parts Missing” and “des parties peuvent manquer”;
• (c) if its breast bone has been removed, the expressions “Breast Bone Removed” and “bréchet enlevé”;
• (d) if it has been stuffed, the words “Stuffed” and “farci” and the expressions “Graded before Stuffing” and “classifié avant d'être farci”; and
• (e) if it has been seasoned, the words “Seasoned” and “assaisonné” and the expressions “Graded before Seasoning” and “classifié avant assaisonnement”.

Poultry carcass — not individually packaged

281 In the case of a prepackaged poultry carcass, if the carcass is dressed or partially dressed and has been graded under these Regulations, but it is not individually packaged, the following information must be shown on a tag that is attached to the V of the wishbone of the poultry carcass:

• (a) the name and principal place of business of the person by or for whom the poultry carcass was packaged; and
• (b) the expression “May Contain Kidneys” or “peut contenir les reins”, if the poultry carcass is that of a chicken or young duck, or a portion of such a carcass, and it may contain kidneys or the kidneys have not been removed.

Word “ham”

282 The label of an edible meat product may bear the word “Ham” or “jambon” only if the product is derived from the hind leg of a dressed swine carcass above the tarsal joint.

Label of edible meat products — exception

283 (1) An edible meat product whose label does not comply with these Regulations may be sent or conveyed from an establishment that is identified in a licence if

• (a) it is a prepackaged meat product, other than a consumer prepackaged meat product, that is sealed with a tamper-resistant seal or it is in a conveyance that is sealed with a tamper-resistant seal;
• (b) it is sent or conveyed to another establishment where meat products are manufactured, processed, treated, preserved, graded, packaged or labelled by a licence holder; and
• (c) it is accompanied by
  • (i) a written document from the licence holder that states that the meat product is identified as edible under section 124, and
  • (ii) a list of ingredients in accordance with the requirements of the Food and Drug Regulations for prepackaged products within the meaning of those Regulations.

Tamper-resistant seal

(2) The tamper-resistant seal on the prepackaged meat product or conveyance must not be broken until after the meat product arrives at the other establishment.

Imported meat products

284 (1) The label of an imported meat product must bear the expressions “Product of” and “produit de”, followed by the name of the foreign state of origin, in close proximity to the common name.

Type size

(2) The information must, whether the meat product is a consumer prepackaged meat product or not, be shown in characters of the height required by subsections 292(2) and (3).

Subsequent packaging or labelling

(3) This section applies whether or not the imported meat product is subsequently packaged or labelled in Canada without being manufactured or prepared in Canada.

Imported consumer prepackaged poultry carcasses

285 In the case of an imported consumer prepackaged poultry carcass, if the carcass is dressed or partially dressed and has been graded under these Regulations, the information required by subsection 284(1) must be shown in the same colour as the grade name.

DIVISION 4

General Requirements

Information

Compliance with requirements of this Part

286 If a prepackaged food need not be labelled with any item of information referred to in this Part, but is nevertheless labelled with that item of information, the item of information must meet the requirements of this Part.

Use of word “classifié”

287 Whenever a provision of these Regulations requires the word “classifié” to be shown on a label, the word “classé” may be used in its place.

Official Languages

Prepackaged food

288 The information that a label of a prepackaged food, other than a consumer prepackaged food, is required by this Part to bear must, unless otherwise provided by this Part, be shown in at least one official language.

Consumer prepackaged food

289 (1) The information that a label of a consumer prepackaged food is required by this Part to bear must be shown in both official languages in accordance with subsections B.01.012(1) to (10) of the Food and Drug Regulations, except as otherwise provided by those subsections.

Modifications

(2) For the purpose of subsection (1),

• (a) the expression “principal display panel” in subsections B.01.012(8) and (10) of the Food and Drug Regulations has the same meaning as in section 1 of these Regulations;
• (b) a reference to “these Regulations” in subsection B.01.012(2), (3), (7) or (8) of the Food and Drug Regulations is to be read as a reference to “Part 11 of the Safe Food for Canadians Regulations”; and
• (c) a reference to “manufactured, processed, produced or packaged”, “manufactured, processed or packaged” or “manufactured, processed, produced or packaged for resale” in the definitions local food and specialty food in subsection B.01.012(1) of the Food and Drug Regulations and in subsection B.01.012(9) of those Regulations is to be read as a reference to “manufactured, processed, treated, preserved, produced or packaged”.

Legibility and Type Size

General criteria

290 The information that a label is required by these Regulations to bear must be

• (a) clearly and prominently shown; and
• (b) readily discernible and legible to the purchaser under the customary conditions of purchase and use.

Upper or lower case

291 Whenever a word or expression that appears in quotation marks in these Regulations is required to be shown on a label, it may, unless otherwise provided, be shown in upper or lower case, or both, so long as it meets the legibility and character height requirements of these Regulations.

Type size

292 (1) This section applies unless another provision of this Part specifies a character height for a particular item of information.

Consumer prepackaged foods

(2) The information that a label of a consumer prepackaged food is required by this Part to bear must be shown in characters that are at least 1.6 mm (1/16 inch) in height.

Exception

(3) That information, other than the declaration of net quantity, may be shown in characters that are at least 0.8 mm (1/32 inch) in height if

• (a) the information that a label is required by Division 2 to bear is shown on the principal display panel; and
• (b) the area of the principal display surface is 10 cm² (1.55 square inches) or less.

Measurement of type size

293 The height of the characters in words shown on a label is to be determined by measuring

• (a) the height of an upper case letter, if the words are shown in upper case only; and
• (b) the height of the lower case letter “o”, if the words are shown in lower case or in both upper and lower case.

DIVISION 5

Exemptions from this Part

Divisions 2 and 4

294 In Divisions 2 and 4, only sections 200, 201, 203, 210, 211, 289 and 290 apply in respect of a consumer prepackaged food that is

• (a) manufactured, prepared, packaged or labelled for use by commercial or industrial enterprises or institutions without being sold by them as consumer prepackaged foods;
• (b) manufactured, prepared, packaged or labelled only for sale to or by a duty free shop; or
• (c) distributed to one or more persons for no consideration.

Declaration of net quantity

295 The following consumer prepackaged foods need not be labelled with the declaration of net quantity referred to in section 206:

• (a) an individual portion of a food that is prepared by a commissary and sold by automatic vending machine or mobile canteen;
• (b) a catch-weight food that is sold to a retailer; and
• (c) an individual portion of a food that is sold by a restaurant or other commercial enterprise when served with meals or snacks.

• Raspberries or strawberries
• 296 Sections 206, 215 and 228 do not apply in respect of consumer prepackaged raspberries or consumer prepackaged strawberries that are packaged in the field in a container that has a capacity of 1.14 L or less.

Individually measured food

297 (1) A declaration of net quantity of a consumer prepackaged food that is an individually measured food need not meet the legibility and character height requirements of paragraph 216(1)(a), subsections 216(2) and (3), paragraph 217(b) and subsection 292(2).

Food packaged from bulk

(2) The declaration of net quantity of a consumer prepackaged food, other than an individually measured food, that is packaged from bulk at retail, need not, if it is clearly shown on the principal display panel in Canadian units,

• (a) meet the legibility and character height requirements of paragraph 216(1)(a), subsections 216(2) and (3), paragraph 217(b) and subsection 292(2); or
• (b) be shown in metric units.

• Definition individually measured
• (3) In this section, individually measured, with respect to a food, means that the food is measured and packaged in a manner other than in accordance with a predetermined fixed quantity and, as a result, is sold in varying quantities.

Individually packaged food sold as one unit

298 A label of a consumer prepackaged food need not meet the requirements of sections 206, 227 and 228 if

• (a) the consumer prepackaged food is sold as one unit but consists of fewer than seven identical individually packaged foods;
• (b) each of those individually packaged foods is labelled with the information required by this Part; and
• (c) that information is clearly visible at the time of sale.

PART 12

Grades and Grade Names

Interpretation

Definitions

299 The following definitions apply in this Part.

beef carcass has the same meaning as in the Grades Document. (carcasse de bœuf)

bison carcass has the same meaning as in the Grades Document. (carcasse de bison)

colour reading means a reading of the colour reflectance of the muscle of a livestock carcass that is obtained by an accurate light-reflectance measuring instrument. (valeur colorimétrique)

grader means a person who is designated as a grader for the purposes of the Act under subsection 13(3) of the Canadian Food Inspection Agency Act. (classificateur)

grade roller means a tool that is used to apply a roller brand on each side of a livestock carcass. (rouleau à estampiller)

Grades Document means the document entitled Beef, Bison and Veal Carcass Grade Requirements, prepared by the Canadian Beef Grading Agency and published on its website, as amended from time to time. (Document de classification)

grade stamp means a mark that is applied to a livestock carcass and that shows the grade name and the grader's code. (cachet de classification)

grade stamp applicator means a tool that is used to apply a grade stamp or a yield stamp to a livestock carcass. (applicateur de cachet de classification)

grading stand means a platform that is used for grading livestock carcasses. (plate-forme de classification)

identification code means a distinct code that is applied to a food animal before slaughter and grading to ensure its traceability. (code d'identification)

knife-rib means to cut the left side, or the left and right sides, of a beef carcass or bison carcass in the following locations by severing the vertebrae and cutting 15 cm or more beyond the longissimus muscles in order to expose those muscles for evaluation by a grader:

• (a) in the case of a beef carcass, between the 12th and 13th ribs; and
• (b) in the case of a bison carcass, between the 11th and 12th ribs. (incision transversale)

livestock carcass means a beef carcass, bison carcass, ovine carcass or veal carcass. (carcasse de bétail)

lot means a group of food animals or a quantity of livestock carcasses that, for any reason, is considered together for inspection. (lot)

marketing agency means a board or commission that is established under an Act of a province that regulates the marketing of bovine or ovine animals. (office de commercialisation)

meat inspection stamp means

• (a) an inspection legend that is prescribed under section 176 in respect of a meat product; or
• (b) a mark that is authorized under an Act of a province to be applied to or used in connection with a livestock carcass or poultry carcass after inspection. (cachet d'inspection de viande)

musculature means the size and shape of the muscles of a livestock carcass. (musculature)

ovine carcass has the same meaning as in the Compendium. (carcasse d'ovin)

primal cut means

• (a) in the case of a beef carcass or bison carcass, the round, sirloin, short loin, rib or chuck of the carcass side; and
• (b) in the case of an ovine carcass or veal carcass, the leg, loin or foresaddle of the carcass side. (coupe primaire)

producer means a person who sells livestock for slaughter. (producteur)

provincial establishment means an establishment

• (a) that is registered under an Act of a province that regulates the inspection of livestock carcasses or poultry carcasses; or
• (b) where livestock carcasses or poultry carcasses are prepared by a person who is authorized to do so under an Act of a province that regulates the inspection of those carcasses. (établissement provincial)

roller brand means the mark that is applied to a beef carcass and that shows the grade name and the number that is assigned to the establishment where the livestock carcass is graded. (marque d'estampillage)

sub-primal cut means a cut of meat that is greater than 125 cm³ and that is derived from a beef carcass or a primal cut of a beef carcass. (coupe sous-primaire)

trim means to remove all or part of the external fat from a livestock carcass. (parer)

veal carcass has the same meaning as in the Grades Document. (carcasse de veau)

weighmaster means an employee of an establishment that is identified in a licence or of a provincial establishment who is trained by a grader to operate a scale that is approved under section 3 of the Weights and Measures Act. (peseur)

yield class has the same meaning as in the Compendium or the Grades Document, as applicable. (catégorie de rendement)

yield stamp has the same meaning as in the Compendium or the Grades Document, as applicable. (cachet de rendement)

Grade Names

Prescribed grade names

300 For the purpose of the definition grade name in section 2 of the Act, the grade names that are set out in the Compendium and in the Grades Document are prescribed in respect of foods.

Application and Use of Grade Name

Mandatory grading

301 (1) Subject to subsections (7) and 305(1), any egg, fish, fresh fruit or vegetable, processed fruit or vegetable product, honey, maple syrup or beef carcass in respect of which grades are prescribed by these Regulations that is sent or conveyed from one province to another — or imported or exported — must be graded, must meet the requirements that are set out in the Compendium or the Grades Document in respect of the applicable grade of that food and must be labelled, in accordance with the Compendium or the Grades Document, with the applicable grade name that is set out in the Compendium or the Grades Document.

Optional grading

(2) Despite subsection (1), the following foods in respect of which grades are prescribed by these Regulations may be sent or conveyed from one province to another — or imported or exported — without being graded:

• (a) frozen gutted Pacific salmon;
• (b) fresh blueberries, fresh cantaloupes, fresh crabapples, fresh cranberries, fresh field rhubarb and fresh strawberries; and
• (c) if they are in a hermetically sealed package, mixed vegetables (macédoine), stewed tomatoes, tomato puree, tomato pulp, tomato paste, tomato ketchup and tomato chili sauce.

Graded foods

(3) Subject to subsections (7) and 305(1), if a food referred to in subsection (2), or any of the following foods for which grades are prescribed by these Regulations, is graded and sent or conveyed from one province to another — or imported or exported — it must meet the requirements that are set out in the Compendium or the Grades Document in respect of the applicable grade of that food and be labelled, in accordance with the Compendium or the Grades Document, with the applicable grade name that is set out in the Compendium or the Grades Document:

• (a) a dairy product;
• (b) a bison carcass, ovine carcass or veal carcass;
• (c) a poultry carcass that is dressed or partially dressed.

• Application of grade name — conditions
• (4) A grade name may be applied to or used in connection with a food if

• (a) the food meets the requirements of paragraphs 8(a) to (d);
• (b) the food meets the requirements that are set out in the Standards of Identity Document;
• (c) in the case of a dairy product, an egg, fish, a processed fruit or vegetable product, honey or maple syrup, the food has been graded by a licence holder; and
• (d) the food is packaged and labelled in accordance with these Regulations or the Compendium.

Labelling of grade name

(5) In the case of a consumer prepackaged food, the grade name must be shown

• (a) on the principal display panel or in the manner set out in the Compendium; and
• (b) in characters of at least the minimum height that is set out in column 3 or 4 of Schedule 5 for the area of a principal display surface that is set out in column 1 or 2, or in the manner set out in the Compendium.

Official languages

(6) The grade name must be shown in accordance with sections 288 and 289 — as if it were information that is required by Part 11 to be shown on the label of the food — except in the case of consumer prepackaged fish or consumer prepackaged maple syrup, in which case the grade name may be shown in only one official language.

Exceptions

(7) Subsection (1) does not apply to a fresh fruit or vegetable that is exported and subsection (3) does not apply to a dairy product that is exported.

Authorized application or use

302 (1) Subject to subsection (2), a licence holder is authorized, in accordance with this Part, to apply a grade name to or use a grade name in connection with a food that is identified in their licence.

Livestock carcass or poultry carcass

(2) In the case of a livestock carcass or a poultry carcass that is dressed or partially dressed, only a person who is referred to in the Compendium or the Grades Document is authorized, under the circumstances set out in the Compendium or the Grades Document, to apply a grade name in accordance with this Part.

Authorized use — reproduction

303 The following persons are authorized to reproduce a grade name:

• (a) a person who prints labels or manufactures packages, if the labels or packages that bears the grade name are provided to a person who is authorized to apply or use the grade name;
• (b) a person who publishes documents on the subject of a food that is graded;
• (c) a person who publishes documents that advertise a food that is graded; and
• (d) a person who manufactures grade stamp applicators or grade rollers, if the person delivers them directly to a grader.

Authorized use — advertising or sale

304 Any person is authorized to use a grade name in the advertising or sale of a food if the food is labelled with the grade name in accordance with these Regulations.

Imported Foods

Foreign state grade designation

305 (1) If the Compendium indicates that an imported food is to be labelled with a grade designation that is established by the foreign state of origin, the imported food must be labelled with that grade designation rather than with a grade name, and the grade designation must be shown in accordance with subsections 301(5) and (6) as if it were a grade name.

Certain foods graded by licence holder

(2) Despite subsection (1), if an imported processed fruit or vegetable product, an imported dairy product or imported fish is graded by a licence holder, it must be labelled with the applicable grade name that is set out in the Compendium for processed fruit or vegetable products, dairy products or fish that are not imported.

Maple syrup

(3) Maple syrup that is imported and that is graded and packaged in Canada may, if it is graded in an establishment that is identified in a licence, other than an establishment where maple syrup is prepared directly from maple sap, be labelled with the applicable grade name that is set out in the Compendium for maple syrup that is not imported.

No prescribed grade name

306 An imported food in respect of which no grade name is prescribed by these Regulations may be labelled with the grade designation that is established by the foreign state of origin if

• (a) the food meets the requirements for the grade designation that are established by that foreign state;
• (b) the food is labelled in accordance with these Regulations; and
• (c) the name of that foreign state of origin is clearly indicated on the label.

Exceptions and Additional Requirements

Beef Carcasses

Imported beef

307 Despite section 301, a beef carcass, or a carcass side, hind quarter, front quarter, primal cut or sub-primal cut of a beef carcass, that is not prepackaged may be imported if

• (a) it is graded and labelled in accordance with the requirements, in respect of grades of beef carcasses, that are established by the foreign state of origin; or
• (b) it is accompanied by documentation, for presentation to an inspector or grader, that indicates the grade designation that is established by the foreign state of origin.

Non-prepackaged beef

308 Despite section 301, a beef carcass, or a carcass side, hind quarter, front quarter, primal cut or sub-primal cut of a beef carcass, that is not prepackaged and that does not bear a grade name may be sent or conveyed from one province to another if it is accompanied by documentation, for presentation to an inspector or grader, that indicates its grade name.

Ungraded beef

309 (1) Despite section 301, a beef carcass, or a carcass side, hind quarter, front quarter, primal cut or sub-primal cut of a beef carcass, that has not been graded may be sent or conveyed from one province to another or exported in the following circumstances:

• (a) if it is prepackaged, its container is labelled with the expressions “Ungraded Beef” and “bœuf non classifié”; and
• (b) if it is not prepackaged, it is accompanied by documentation, for presentation to an inspector or grader, that indicates that it is ungraded.

• Non-application of paragraph 15(1)(a)
• (2) Paragraph 15(1)(a) does not apply in respect of a beef carcass, or a carcass side, hind quarter, front quarter, primal cut or sub-primal cut of a beef carcass, that meets the requirements set out in subsection (1).

Ungraded beef — imported

(3) Despite section 301, a beef carcass, or a carcass side, hind quarter, front quarter, primal cut or sub-primal cut of a beef carcass, that has not been graded may be imported in the following circumstances:

• (a) if it is prepackaged, its container is labelled with the expressions “Ungraded Beef” and “bœuf non classifié”; and
• (b) if it is not prepackaged, it is accompanied by documentation, for presentation to an inspector or grader, that indicates that it is ungraded.

Fish

Prepackaged fish

310 Prepackaged fish that is sent or conveyed from one province to another — or imported or exported — must be labelled in at least one official language, in close proximity to the grade name, with the applicable class and size designation, if any, that are set out in the Compendium.

Eggs

Ungraded eggs

311 (1) Ungraded eggs that are received at an establishment where eggs are graded by a licence holder must be graded and labelled with the applicable grade name that is set out in the Compendium or, if they do not meet the requirements in respect of any grade that are set out in these Regulations, they must be rejected.

Rejected eggs

(2) Eggs that are rejected must be destroyed or be placed in a container that is labelled with the words “Rejects” and “rejetés”.

Eggs — Canada A

312 Eggs that are graded Canada A must be labelled with the applicable size designation that is set out in the Compendium. The size designation must be shown on the container in both official languages, in close proximity to the grade name.

Fresh Fruits or Vegetables

Imported prepackaged fresh fruits or vegetables

313 Despite section 301, consumer prepackaged fresh fruits or vegetables that are imported and sold in their original container may be labelled with a grade designation that is established by the foreign state of origin if they meet the requirements of the foreign state in respect of that grade designation and those requirements are substantially equivalent to the requirements, if any, that are applicable under these Regulations in respect of the fruits or vegetables.

Fresh fruits or vegetables — size designation

314 Fresh fruits or vegetables that are sent or conveyed from one province to another or imported must be labelled with the applicable size designation, if any, that is set out in the Compendium. The size designation must

• (a) be shown in close proximity to the grade name;
• (b) in the case of prepackaged fresh fruits or vegetables, other than consumer prepackaged fresh fruits or vegetables,
  • (i) if their container is a reusable plastic container, be shown in characters that are at least 1.6 mm in height, or
  • (ii) if their container is not a reusable plastic container, be shown in characters of at least the minimum height that is set out in the Compendium for the grade name;
• (c) in the case of consumer prepackaged fresh fruits or vegetables, be shown in characters of at least the minimum height that is set out in column 3 or 4 of Schedule 5 for the area of a principal display surface that is set out in column 1 or 2; and
• (d) be shown in accordance with sections 288 and 289 as if it were information that is required by Part 11 to be shown on the label of the food.

Processed Fruit or Vegetable Products

Processed fruit or vegetable products

315 (1) A processed fruit or vegetable product that is sent or conveyed from one province to another — or imported or exported — must be labelled with the applicable size designation, if any, that is set out in the Compendium. The size designation must be shown in close proximity to the grade name in characters that are at least 1.6 mm in height.

Ungraded as to size or mixed sizes

(2) Despite subsection (1), green or wax beans, peas, lima beans, asparagus tips or spears, whole white potatoes, whole carrots or cut carrots-whole style — in a hermetically sealed package — that have not been size graded or that are not all of the same size may be labelled, as the case may be, with the expressions

• (a) “Ungraded as to Size” and “non calibré”; or
• (b) “Assorted Sizes” and “grosseurs assorties” or “Mixed Sizes” and “grosseurs mixtes”.

Official languages

(3) The size designation referred to in subsection (1) and the expressions referred to in paragraphs (2)(a) and (b) must be shown in accordance with sections 288 and 289 as if it were information that is required by Part 11 to be shown on the label of the food.

Substandard processed fruit or vegetable products

316 (1) Despite section 301, a processed fruit or vegetable product that does not meet the requirements in respect of any grade that are set out in these Regulations may be sent or conveyed from one province to another — or imported or exported — if it is labelled with the words “Substandard” and “sous-régulier”.

Official languages

(2) The words referred to in subsection (1) must be shown in accordance with sections 288 and 289 as if it were information that is required by Part 11 to be shown on the label of the food.

Non-application of paragraph 15(1)(a)

(3) Paragraph 15(1)(a) does not apply to a processed fruit or vegetable product that is labelled in accordance with subsections (1) and (2).

Honey

Substandard honey

317 (1) Despite section 301, honey that does not meet the requirements in respect of any grade that are set out in these Regulations may be sent or conveyed from one province to another — or imported or exported — if it is labelled with the words “Substandard” and “sous-régulier”.

Official languages

(2) The words referred to in subsection (1) must be shown in accordance with sections 288 and 289 as if it were information that is required by Part 11 to be shown on the label of the food.

Non-application of paragraph 15(1)(a)

(3) Paragraph 15(1)(a) does not apply to honey that is labelled in accordance with subsections (1) and (2).

Honey — colour class

318 (1) Honey that is sent or conveyed from one province to another — or imported or exported — must be labelled with the applicable colour class that is set out in the Compendium. The colour class must be shown on the container, in close proximity to the grade name, either in characters of at least the minimum height that is set out in column 3 or 4 of Schedule 5 for the area of a principal display surface that is set out in column 1 or 2 or in the manner set out in the Compendium.

Official languages

(2) The colour class referred to in subsection (1) must be shown in accordance with sections 288 and 289 as if it were information that is required by Part 11 to be shown on the label of the food.

Maple Syrup

Maple syrup — colour class

319 Maple syrup that is graded Canada Grade A and is sent or conveyed from one province to another or exported, or that is graded Grade A and is imported, must be labelled with the applicable colour class that is set out in the Compendium. The colour class must be shown on the container in both official languages in characters of at least the minimum height that is set out in column 3 or 4 of Schedule 5 for the area of a principal display surface that is set out in column 1 or 2.

Labelling of Grade Name and Packaging of Graded Food

Illustration of grade name

320 A grade name that is applied to a beef carcass, bison carcass, ovine carcass, veal carcass, poultry carcass that is dressed or partially dressed, dairy product or egg must be as illustrated in the Compendium or the Grades Document.

Prepackaged cut of beef

321 A grade name that is applied to a prepackaged primal cut or sub-primal cut of a beef carcass must correspond to the grade of the beef carcass from which it is cut.

Beef — Canada AAA

322 A cut from a beef carcass that is graded Canada AAA and that is exported in a container may be labelled with the expression “Canada Choice” or “Choix Canada” instead of the grade name.

Livestock carcass — removal of marking

323 (1) A grade stamp, roller brand or yield stamp must not be removed from a livestock carcass or a primal cut of a livestock carcass unless the removal is at the direction of and under the supervision of a grader or the livestock carcass or primal cut is being trimmed for further processing.

Removal of marked fat

(2) If fat that is marked with a grade stamp, roller brand or yield stamp is removed from a livestock carcass or a primal cut, the fat must be disposed of under a grader's supervision unless the fat is

• (a) reapplied to the same livestock carcass or primal cut from which it was removed; or
• (b) applied, under a grader's supervision, to another livestock carcass or primal cut that bears the same grade stamp, roller brand or yield stamp.

Beef carcass — rib

(3) If the carcass referred to in paragraph (2)(b) is a beef carcass that is graded Canada A, Canada AA, Canada AAA or Canada Prime, the fat must be applied to the rib of the carcass.

Livestock carcass — additional marks

324 A livestock carcass or primal cut of a livestock carcass that is marked with a grade stamp, roller brand or yield stamp may bear another mark only if

• (a) the mark is shown only once on the livestock carcass or once on each primal cut;
• (b) the mark is shown alone or in combination with a date;
• (c) the size of the mark and, if applicable, the date that accompanies it do not exceed 76 mm in height or width; and
• (d) the mark and the date, if applicable, do not touch the grade stamp, the roller brand or the yield stamp.

Packaging of poultry carcasses in same container

325 Only graded poultry carcasses that are dressed or partially dressed and that have the same common name may be packaged in the same container.

Conditions for Grading of Certain Foods

Grading of Livestock Carcasses

Request for grading

326 A grader may apply a grade name to a livestock carcass in an establishment that is identified in a licence or in a provincial establishment if one of the following persons has requested that the carcass be graded:

• (a) a person who is in authority in the establishment;
• (b) a producer; or
• (c) the person who is in possession of the livestock carcass.

Conditions for grading

327 A grader may apply a grade name to a livestock carcass if

• (a) the carcass bears a meat inspection stamp or, in the case of an imported beef carcass, the official inspection mark of the foreign state of origin;
• (b) the grading takes place
  • (i) in the case of a bison carcass or ovine carcass, in the establishment that is identified in a licence, or the provincial establishment, where the animal was slaughtered,
  • (ii) in the case of a veal carcass, in the establishment that is identified in a licence, or the provincial establishment, where the animal was slaughtered or where the carcass was divided into primal cuts or sub-primal cuts, or
  • (iii) in the case of a beef carcass, in the establishment that is identified in a licence, or the provincial establishment, where the animal was slaughtered or in the establishment that is identified in a licence where the carcass was divided into primal cuts or sub-primal cuts;
• (c) the carcass has been weighed by a weighmaster using a scale that is approved under section 3 of the Weights and Measures Act;
• (d) the carcass is presented for grading
  • (i) at a grading stand where the lighting intensity, measured at the level of the grading stand, is at least 1 000 lx, or
  • (ii) in a cooler where the lighting intensity, measured at the loin level of the carcass, is at least 200 lx;
• (e) at least 10 minutes before grading the carcass has been
  • (i) in the case of a beef carcass or bison carcass, knife-ribbed by an employee of the establishment where the carcass is graded, under the grader's supervision, or
  • (ii) in the case of a veal carcass, cut on the lean of the brisket by an employee of the establishment where the carcass is graded, under the grader's supervision, to enable the grader to determine the colour reading of the veal carcass;
• (f) the establishment where the carcass is graded has adequate equipment and facilities for weighing and grading livestock carcasses; and
• (g) the grading equipment is functioning properly and is accurate.

Adequate facilities

328 (1) If more than 400 livestock carcasses are graded per hour in an establishment that is identified in a licence or in a provincial establishment, more than one grading stand is required for the purpose of paragraph 327(f).

Grading stand — requirements

(2) For the purpose of paragraph 327(f), a grading stand must be easily adjustable for height and must

• (a) if the rate of grading is 150 carcasses per hour or less, be at least 3 m long and 2 m wide;
• (b) if the rate of grading is more than 150 carcasses per hour but not more than 300 carcasses per hour, be at least 4 m long and 2 m wide; and
• (c) if the rate of grading is more than 300 carcasses per hour, be at least 5 m long and 2 m wide.

Weighing before trimming

329 A livestock carcass to which a grade name is to be applied must be weighed before it is trimmed, unless an inspector or grader directs that it be trimmed before it is weighed.

Grading of Poultry Carcasses

Conditions for grading — dressed carcass

330 (1) A grader may apply a grade name to a poultry carcass that has been dressed if

• (a) the carcass is from poultry slaughtered in an establishment that is identified in a licence or in a provincial establishment;
• (b) the carcass has been inspected under the Act or under an Act of a province that regulates the inspection of poultry carcasses;
• (c) in the case of a chilled poultry carcass, the flesh or skin is not dried out;
• (d) the carcass is not discoloured from insufficient bleeding;
• (e) the carcass has no more than one heart, liver, gizzard and neck packed with it or inserted into it;
• (f) in the case of a poultry carcass that weighs more than 900 g, the breast bone is intact; and
• (g) the carcass has not been basted or stuffed.

Conditions for grading — partially dressed carcass

(2) A grader may apply a grade name to a poultry carcass that has been partially dressed if

• (a) the carcass meets the requirements set out in paragraphs (1)(a) to (g);
• (b) the carcass has been eviscerated;
• (c) the epidermis has been removed from the feet and shanks;
• (d) the claws have been removed;
• (e) the head, if present, is wrapped; and
• (f) the beak, if present, is clean.

Grading in an establishment

(3) A grade name may only be applied to a poultry carcass in an establishment that is identified in a licence or in a provincial establishment.

Grading of Eggs

Condition for grading

331 (1) A licence holder may apply a grade name to an egg only if the egg

• (a) is edible;
• (b) does not emit an abnormal odour;
• (c) is not mouldy;
• (d) has not been in an incubator;
• (e) does not have any internal defect; and
• (f) is of a usual colour.

Exception

(2) Despite paragraph (1)(e), a licence holder may apply the grade name Canada C to an egg that has a particle of the oviduct or a blood spot neither of which exceeds 3 mm in diameter.

Grading Certificates

Conditions for issuance

332 (1) A grader — or a licence holder, the operator of a provincial establishment or a marketing agency under the direction of a grader — may issue a grading certificate in respect of a livestock carcass or a lot of livestock carcasses if

• (a) at the time of delivery of the food animal or lot of food animals to an establishment that is identified in a licence or to a provincial establishment for slaughter, the producer has
  • (i) requested the certificate,
  • (ii) identified each animal that is to be slaughtered with an identification code, and
  • (iii) completed and filed with a person who is in authority in the establishment a list that associates each identification code with the producer; and
• (b) after slaughter, the identification code of each slaughtered animal is retained on or transferred to the livestock carcass by a person who is in authority in the establishment.

Certificate — required contents

(2) The grading certificate must be signed by the grader and contain the following information:

• (a) the name and address of the producer;
• (b) the name of any person who is acting on behalf of the producer;
• (c) the name and address of the establishment where the livestock carcasses were graded;
• (d) the certificate number;
• (e) the date of slaughter;
• (f) for each livestock carcass,
  • (i) its identification code,
  • (ii) its warm weight as determined by a weighmaster, and
  • (iii) its grade;
• (g) in the case of a lot of livestock carcasses,
  • (i) the number of livestock carcasses per grade or per yield class, and
  • (ii) the number of livestock carcasses that have been condemned under these Regulations;
• (h) in the case of a grading certificate that is issued in respect of a beef carcass that is graded Canada A, Canada AA, Canada AAA or Canada Prime, the yield of the beef carcass;
• (i) in the case of a grading certificate that is issued in respect of a beef carcass or bison carcass, an indication, if applicable, of its
  • (i) age,
  • (ii) musculature,
  • (iii) meat colour,
  • (iv) marbling, specifically, the amount, size and distribution of intramuscular fat deposits in the longissimus muscles,
  • (v) fat colour or texture,
  • (vi) fat measurement, and
  • (vii) pronounced masculinity;
• (j) in the case of a grading certificate that is issued in respect of a lamb carcass, as defined in the Compendium,
  • (i) the fat measurement,
  • (ii) the score for musculature of each primal cut and the average score for musculature,
  • (iii) in the case of a carcass that is graded Canada AAA, the yield, and
  • (iv) an indication of any musculature demerits, meat colour demerits or fat colour demerits that were assigned to the carcass; and
• (k) in the case of a grading certificate that is issued in respect of a mutton carcass, as defined in the Compendium, the fat measurement.

Recording of information

(3) The information referred to in subsection (2) may be recorded on the grading certificate by the licence holder, the operator or the marketing agency referred to in subsection (1).

PART 13

Seizure and Detention

Detention tag

333 An inspector who seizes and detains a thing under section 25 of the Act must apply or attach a detention tag to it on which the following information is shown:

• (a) the expression “UNDER DETENTION” and the word “RETENU”, in capital letters;
• (b) the detention tag number;
• (c) a description of the thing;
• (d) the reason for the seizure and detention;
• (e) the date of the seizure and detention; and
• (f) the inspector's name and signature.

Prohibition — removal of detention tag

334 It is prohibited for a person to remove a detention tag from a thing that has been seized and detained unless authorized to do so by an inspector.

Notice of detention

335 (1) As soon as feasible after a thing has been seized and detained, an inspector must provide a notice of detention to its owner or to the person having possession, care or control of it at the time of its seizure.

Content of notice of detention

(2) The notice of detention must indicate that the thing was seized and detained under section 25 of the Act and set out the following information:

• (a) the detention tag number;
• (b) a description of the thing;
• (c) the reason for the seizure and detention;
• (d) the date of the seizure and detention;
• (e) the place of the seizure and detention;
• (f) the inspector's name and signature; and
• (g) a telephone number to call for further information about the seizure and detention.

Storage conditions

336 Anything that is seized must be stored by the person to whom the notice of detention is provided, under storage conditions that are appropriate for its preservation and at the person's expense.

Notice of release

337 If a thing is released under section 30 of the Act, an inspector must provide a notice of release to the person to whom the notice of detention was provided.

PART 14

Organic Products

Interpretation

Definitions

338 The following definitions apply in this Part.

aquaculture animal means an animal that is raised in captivity in fresh, brackish or salt water. (animal d'aquaculture)

aquatic plant means a plant that is cultivated or naturally growing in fresh, brackish or salt water. It does not include fresh fruits or vegetables. (plante aquatique)

CAN/CGSB 32.310 means the Canadian General Standards Board standard CAN/CGSB 32.310, entitled Organic Production Systems — General Principles and Management Standards, as amended from time to time. (norme CAN/CGSB 32.310)

CAN/CGSB 32.311 means the Canadian General Standards Board standard CAN/CGSB 32.311, entitled Organic Production Systems — Permitted Substances Lists, as amended from time to time. (norme CAN/CGSB 32.311)

CAN/CGSB 32.312 means the Canadian General Standards Board standard CAN/CGSB 32.312, entitled Organic Aquaculture Standards, as amended from time to time. (norme CAN/CGSB 32.312)

certification body means a person who is accredited as a certification body under section 358 or 360 and who is responsible for the organic certification of food commodities and for the certification of various activities in respect of organic products. (organisme de certification)

conformity verification body means a person who, having complied with the requirements set out in ISO/IEC 17011, has entered into an agreement with the Agency under subsection 14(1) of the Canadian Food Inspection Agency Act to assess, recommend for accreditation and monitor certification bodies. (organisme de vérification de la conformité)

ISO/IEC 17011 means the International Organization for Standardization standard ISO/IEC 17011, entitled Conformity assessment — General requirements for accreditation bodies accrediting conformity assessment bodies, as amended from time to time. (norme ISO/CEI 17011)

ISO/IEC 17065 means the International Organization for Standardization standard ISO/IEC 17065, entitled Conformity assessment — Requirements for bodies certifying products, processes and services, as amended from time to time. (norme ISO/CEI 17065)

various activities means manufacturing, processing, treating, handling, slaughtering, producing, storing, packaging, labelling and conveying. (diverses activités)

Prescribed food commodities

339 (1) For the purpose of paragraph (c) of the definition food commodity in section 2 of the Act, the following are prescribed food commodities:

• (a) feed as defined in section 2 of the Feeds Act; and
• (b) seed as defined in section 2 of the Seeds Act.

Feed

(2) For the purpose of paragraph (1)(a), a reference to “livestock” in the definition feed in section 2 of the Feeds Act is to be read as a reference to “livestock or aquaculture animals”.

Exemption

(3) A food commodity that is not otherwise included in paragraph (a) or (b) of the definition food commodity in section 2 of the Act is exempted from the application of any provision of the Act and of these Regulations that is not necessary to give effect to this Part. For greater certainty, the exemption does not include section 6 of the Act.

Various Activities

Conduct of activities

340 The various activities may only be conducted in respect of an organic product by a person who holds a certification that is granted under section 342 or 345 in respect of the activities and must be conducted in accordance with

• (a) in the case of a food commodity other than a seaweed, aquatic plant or aquaculture animal, CAN/CGSB 32.310; and
• (b) in the case of a seaweed, aquatic plant or aquaculture animal, CAN/CGSB 32.312.

Certification

Organic Certification of Food Commodities

Application

341 (1) A person who wishes to obtain the organic certification of a food commodity must apply to a certification body.

Content

(2) The application must contain

• (a) the name of the food commodity;
• (b) a statement that sets out the activities, among the various activities, that are conducted by the applicant in respect of the food commodity;
• (c) a statement that sets out the substances and materials that are used by the applicant to conduct the activities and that describes the manner in which those substances and materials are used;
• (d) a document that sets out in detail the methods that are used by the applicant to conduct the activities and the control mechanisms that are in place to ensure that those methods meet the requirements that are set out
  • (i) in the case of a food commodity other than a seaweed, aquatic plant or aquaculture animal, in CAN/CGSB 32.310, and
  • (ii) in the case of a seaweed, aquatic plant or aquaculture animal, in CAN/CGSB 32.312;
• (e) a statement that sets out the activities, among the various activities, that are conducted by a third party on behalf of the applicant in respect of the food commodity, the name of the third party and a copy of the certificate referred to in subsection 345(2) that they hold for the activity that they conduct; and
• (f) in the case of a multi-ingredient food commodity, a statement that sets out its composition and the percentage of its contents that are organic products.

Time of initial application

(3) In the case of an initial application for the organic certification of a food commodity, the application must be filed within 12 months before the day on which the food commodity is expected to be sold or, in the case of the following food commodities, at least 15 months before that day:

• (a) maple products;
• (b) field crops or crops that are grown in greenhouses with an in-ground permanent soil system;
• (c) uncultivated seaweeds and aquatic plants; and
• (d) aquaculture products with a production cycle of more than 12 months.

Certification

342 (1) A certification body must certify a food commodity as organic if it determines, after on-site verification, that

• (a) the substances and materials that are used by the applicant to conduct the activities, among the various activities, in respect of the food commodity are set out and are used in the manner described
  • (i) in the case of a food commodity other than a seaweed, aquatic plant or aquaculture animal, in CAN/CGSB 32.310 or CAN/CGSB 32.311, and
  • (ii) in the case of a seaweed, aquatic plant or aquaculture animal, in CAN/CGSB 32.312;
• (b) the methods that are used by the applicant to conduct the activities, among the various activities, in respect of the food commodity and the control mechanisms that are in place meet the requirements, and comply with the general principles respecting organic production, that are set out
  • (i) in the case of a food commodity other than a seaweed, aquatic plant or aquaculture animal, in CAN/CGSB 32.310, and
  • (ii) in the case of a seaweed, aquatic plant or aquaculture animal, in CAN/CGSB 32.312;
• (c) if a third party conducts an activity, among the various activities, on behalf of the applicant in respect of the food commodity, the third party holds a certification for that activity; and
• (d) in the case of a multi-ingredient food commodity, at least 70% of its contents are organic products and its composition meets the requirements that are set out in CAN/CGSB 32.310.

Certificate

(2) The certification body must provide the applicant with a certificate that confirms the organic certification of the food commodity and that indicates whether CAN/CGSB 32.310 or CAN/CGSB 32.312 is applicable, the period of validity referred to in subsection (3) and, in the case of a multi-ingredient food commodity, the percentage of its contents that are organic products.

Period of validity

(3) The organic certification of a food commodity is valid for 12 months beginning on the day on which it is granted under subsection (1).

Determination of percentage of organic products

343 The percentage of the contents of a multi-ingredient food commodity that are organic products must be determined in accordance with CAN/CGSB 32.310.

Certification of Various Activities in Respect of Organic Products

Application

344 (1) A person who wishes to conduct an activity, among the various activities, in respect of an organic product and who does not hold a certification that is granted under section 342 must apply to a certification body for certification of the activity.

Content

(2) The application must contain

• (a) an indication of the type of organic product;
• (b) an indication of the activity, among the various activities, that is to be conducted in respect of the organic product;
• (c) a statement that names the substances and materials that are to be used to conduct the activity in respect of the organic product and that describes the manner in which those substances and materials are to be used; and
• (d) a document that sets out in detail the methods that are to be used to conduct the activity in respect of the organic product and the control mechanisms that are to be in place to ensure that those methods meet the requirements that are set out
  • (i) in the case of a food commodity other than a seaweed, aquatic plant or aquaculture animal, in CAN/CGSB 32.310, and
  • (ii) in the case of a seaweed, aquatic plant or aquaculture animal, in CAN/CGSB 32.312.

Certification

345 (1) A certification body must certify the activity for which the application is being made in respect of an organic product if it determines, after an on-site verification, that

• (a) the substances and materials that are to be used to conduct the activity are set out and are to be used in the manner described
  • (i) in the case of a food commodity other than a seaweed, aquatic plant or aquaculture animal, in CAN/CGSB 32.310 or CAN/CGSB 32.311, and
  • (ii) in the case of a seaweed, aquatic plant or aquaculture animal, in CAN/CGSB 32.312; and
• (b) the methods that are to be used to conduct the activity and the control mechanisms that are to be in place meet the requirements, and comply with the general principles respecting organic production, that are set out
  • (i) in the case of a food commodity other than a seaweed, aquatic plant or aquaculture animal, in CAN/CGSB 32.310, and
  • (ii) in the case of a seaweed, aquatic plant or aquaculture animal, in CAN/CGSB 32.312.

Certificate

(2) The certification body must provide the applicant with a certificate that confirms the certification of the activity in respect of the organic product and that indicates the type of organic product to which it applies and the period of validity referred to in subsection (3).

Period of validity

(3) The certification of the activity in respect of an organic product is valid for 12 months beginning on the day on which it is granted under subsection (1).

Suspension and Cancellation

Suspension

346 (1) Subject to subsection (2), the certification body must suspend a certification that is granted under section 342 or 345 if

• (a) the holder of the certification does not comply with any provision of the Act or this Part;
• (b) the substances or materials that are used by the holder of the certification are other than those that are set out
  • (i) in the case of a food commodity other than a seaweed, aquatic plant or aquaculture animal, in CAN/CGSB 32.310 or CAN/CGSB 32.311, and
  • (ii) in the case of a seaweed, aquatic plant or aquaculture animal, in CAN/CGSB 32.312;
• (c) the food commodity comes into contact with a substance or material other than one that is set out
  • (i) in the case of a food commodity other than a seaweed, aquatic plant or aquaculture animal, in CAN/CGSB 32.310 or CAN/CGSB 32.311, and
  • (ii) in the case of a seaweed, aquatic plant or aquaculture animal, in CAN/CGSB 32.312;
• (d) the substances or materials that are used by the holder of the certification are set out, but are not used in the manner described,
  • (i) in the case of a food commodity other than a seaweed, aquatic plant or aquaculture animal, in CAN/CGSB 32.310 or CAN/CGSB 32.311, and
  • (ii) in the case of a seaweed, aquatic plant or aquaculture animal, in CAN/CGSB 32.312;
• (e) the manufacturing, processing, treating, handling, slaughtering, producing, storing, packaging, labelling or conveying methods that are used by the holder of the certification do not meet the requirements, or do not comply with the general principles respecting organic production, that are set out
  • (i) in the case of a food commodity other than a seaweed, aquatic plant or aquaculture animal, in CAN/CGSB 32.310, and
  • (ii) in the case of a seaweed, aquatic plant or aquaculture animal, in CAN/CGSB 32.312; or
• (f) in the case of a multi-ingredient food commodity, less than 70% of its contents are organic products.

Necessary steps

(2) The certification body must not suspend a certification unless the holder of the certification

• (a) was provided with a report that sets out the grounds for the suspension and the date by which corrective action must be taken in order to avoid the suspension; and
• (b) failed to take corrective action by that date or any later date that is granted by the certification body at the request of the holder.

Request for extension of time

(3) The request referred to in paragraph (2)(b) may only be made once.

Written notice

(4) The certification body must notify the holder of the certification in writing of the suspension and the date on which it takes effect.

Duration of suspension

(5) A suspension of a certification remains in effect until the certification body determines that corrective action has been taken or until the certification is cancelled.

Cancellation

347 (1) The certification body must cancel a certification if

• (a) the holder of the certification fails to take corrective action within 30 days after the day on which the certification was suspended;
• (b) the holder of the certification was not in compliance with section 15 of the Act at the time of the application made under section 341 or 344 or at any time during the period of validity of the certification; or
• (c) while the certification is suspended,
  • (i) in the case of a certification that was granted under section 342, the holder of the certification
    • (A) sends or conveys from one province to another a food commodity that is labelled with an expression that is referred to in subsection 350(1) or (2),
    • (B) sends or conveys from one province to another a food commodity that has on it the product legend that is set out in Schedule 8 or a food commodity in connection with which that product legend is used,
    • (C) applies or attaches to a food commodity a label that bears an expression that is referred to in subsection 350(1) or (2) or uses such an expression in the advertisement of a food commodity, or
    • (D) applies the product legend that is set out in Schedule 8 to, or uses it in connection with, a food commodity, and
  • (ii) in the case of a certification that was granted under section 345, the holder of the certification continues to conduct an activity that is identified in their certification.

Necessary steps

(2) The certification body must not cancel a certification unless the holder of the certification was notified in writing of the grounds for the cancellation and was provided with an opportunity to be heard in respect of the cancellation.

Written notice

(3) The certification body must notify the holder of the certification in writing of the cancellation and the date on which it takes effect.

General

Documents

348 The holder of a certification must prepare, keep and maintain the documents that are set out in the following standards, in accordance with those standards:

• (a) in the case of a food commodity other than a seaweed, aquatic plant or aquaculture animal, CAN/CGSB 32.310; and
• (b) in the case of a seaweed, aquatic plant or aquaculture animal, CAN/CGSB 32.312.

Changes affecting certification

349 The holder of a certification must immediately notify the certification body of any change that could affect the certification and of any complaint that they receive in relation to the organic integrity of the organic product referred to in the certification.

Labelling and Advertising

Expressions

350 (1) The expressions “organic” or “biologique” or “organique”, “organically grown” or “cultivé biologiquement”, “organically raised” or “élevé biologiquement” and “organically produced” or “produit biologiquement” and any similar expressions, including abbreviations of, symbols for and phonetic renderings of those expressions, may only be shown on the label or used in the advertisement of a food commodity that is to be sent or conveyed from one province to another if

• (a) the food commodity is an organic product; and
• (b) in the case of a multi-ingredient food commodity, at least 95% of its contents are organic products.

“Organic ingredients” expression

(2) Despite subsection (1), if a multi-ingredient food commodity is an organic product but less than 95% of its contents are organic products, it may be labelled with or advertised using the expression “organic ingredients” or “d'ingrédients biologiques” if that expression is

• (a) immediately preceded by the percentage of its contents that are organic products, rounded down to the nearest whole number; and
• (b) in characters of the same height and prominence as the words, numbers, signs or symbols that indicate the applicable percentage.

Multi-ingredient food commodities

(3) Despite subsection (1), the list of ingredients that is shown on the label of a multi-ingredient food commodity that is not an organic product may indicate which of the ingredients, if any, are organic products.

Additional information

351 If an expression that is referred to in subsection 350(1) or (2) is shown on the label of a food commodity that is to be sent or conveyed from one province to another, the label must also bear the following information:

• (a) the name of the certification body that certified the food commodity as organic;
• (b) in the case of a multi-ingredient food commodity, the organic contents that are identified as organic in its list of ingredients; and
• (c) in the case of an imported food commodity on whose label the product legend that is set out in Schedule 8 is applied, the expression “Product of” or “produit de” immediately preceding the name of the foreign state of origin or the word “Imported” or “importé” in close proximity to that product legend.

Expressions and information in both official languages

352 (1) Subject to subsection (2), the expressions that are referred to in subsections 350(1) and (2) and paragraph 351(c) and the information that is referred to in paragraph 351(b) must be shown on the label of a food commodity in both official languages.

Exception

(2) Those expressions and that information may be shown on the label of a food commodity in only one official language if the food commodity is any of the following:

• (a) a feed as defined in section 2 of the Feeds Act;
• (b) a seed as defined in section 2 of the Seeds Act; or
• (c) a food, if subsection B.01.012(3), (7) or (11) of the Food and Drug Regulations allows the required information to be shown in only one official language.

Feed

(3) For the purpose of paragraph (2)(a), a reference to “livestock” in the definition feed in section 2 of the Feeds Act is to be read as a reference to “livestock or aquaculture animals”.

Interprovincial Trade and Import

Interprovincial trade

353 A food commodity that is sent or conveyed from one province to another and that is labelled with or advertised using an expression that is referred to in subsection 350(1) must

• (a) be an organic product;
• (b) in the case of a multi-ingredient food commodity, have at least 95% of its contents be organic products; and
• (c) meet the requirements of subsections 350(2) and (3) and sections 351 and 352.

Import

354 (1) A food commodity that is imported and that is labelled with or advertised using an expression that is referred to in subsection 350(1) must

• (a) be
  • (i) certified as organic under subsection 342(1),
  • (ii) imported from a foreign state with which the Agency has entered into an agreement or arrangement regarding the import and export of organic products and be certified as organic, in accordance with the agreement or the arrangement, by a certification body that is accredited by that foreign state, or
  • (iii) imported from a foreign state with which the Agency has not entered into such an agreement or arrangement, but be certified as organic by a certification body that is accredited by a foreign state that is referred to in subparagraph (ii) with the certification being in accordance with the agreement or arrangement referred to in that subparagraph;
• (b) in the case of a multi-ingredient food commodity, have at least 95% of its contents be organic products; and
• (c) meet the requirements of subsections 350(2) and (3) and sections 351 and 352.

Demonstration

(2) The person who imports the food commodity must be able to demonstrate that the food commodity meets one of the requirements set out in paragraph (1)(a) by providing, on the request of the Minister or an inspector, a certificate that confirms the organic certification of the food commodity.

Retention period of certificate

(3) The certificate referred to in subsection (2) must be kept for five years after the day on which the food commodity is imported.

Product Legend

Definition inspection mark — product legend

355 For the purpose of the definition inspection mark in section 2 of the Act, the product legend that is set out in Schedule 8 is prescribed.

Application

356 (1) A person is authorized to apply the product legend that is set out in Schedule 8 to, and use it in connection with, a food commodity if

• (a) the food commodity is an organic product; and
• (b) in the case of a multi-ingredient food commodity, at least 95% of its contents are organic products.

Advertisement and sale

(2) A person is authorized to advertise and sell a food commodity that has on it the product legend that is set out in Schedule 8 or a food commodity in connection with which that product legend is used if

• (a) the food commodity is an organic product; and
• (b) in the case of a multi-ingredient food commodity, at least 95% of its contents are organic products.

Application or use — item other than food commodity

(3) A person is authorized, for advertisement or information purposes, to apply the product legend that is set out in Schedule 8 to, and use it in connection with, any item to which the Act applies, other than a food commodity.

Conformity Verification Bodies and Certification Bodies

Application for accreditation

357 A person who wishes to be accredited as a certification body must apply for the accreditation, in writing, to a conformity verification body and must undergo an assessment, in accordance with ISO/IEC 17011, to verify

• (a) their compliance with ISO/IEC 17065;
• (b) the knowledge, with respect to organic certification, of the person, of their employees and, as applicable, of their subcontractors; and
• (c) the validity of their certification methodology and the validity of the results of that methodology.

Accreditation

358 (1) On the recommendation of a conformity verification body, accompanied by supporting documents, the President must accredit the applicant, provide them with an accreditation number and notify them of the period of validity referred to in subsection (2).

Period of validity

(2) The accreditation of a certification body is valid for five years beginning on the day on which the President accredits the applicant.

Refusal

359 If the conformity verification body refuses to recommend the applicant's accreditation, it must send them a notice by registered mail that states the reasons for the decision and notifies the applicant of their right to make a request, within 30 days after the day on which they receive the notice, to the President for a review of the decision. The conformity verification body must also send a copy of the notice to the President.

Review

360 The President must, on request, review the decision referred to in section 359 and, if the President decides to confirm it, must provide a copy of his or her decision with reasons to the applicant. If the President does not confirm the decision, the President must accredit the applicant, provide them with an accreditation number and notify them of the period of validity referred to in subsection 358(2).

Suspension

361 (1) Subject to subsection (2), on the recommendation of a conformity verification body, the President must suspend the accreditation of a certification body if it does not comply with any provision of the Act, this Part or ISO/IEC 17065.

Necessary steps

(2) The President must not suspend an accreditation unless the certification body

• (a) was provided with a report that sets out the grounds for the suspension and the date by which corrective action must be taken in order to avoid the suspension; and
• (b) failed to take corrective action by that date or any later date that is granted by the conformity verification body at the request of the certification body.

Request for extension of time

(3) The request referred to in paragraph (2)(b) may only be made once.

Written notice

(4) The President must notify the certification body in writing of the suspension and the date on which it takes effect.

Provision of lists

(5) The certification body must provide the President, within 15 days after the day on which the suspension takes effect, with a list of the holders of the certifications that it has granted and a list of pending applications for certification.

Duration of suspension

(6) A suspension of an accreditation remains in effect until the conformity verification body determines that corrective action has been taken or until the accreditation is cancelled.

Cancellation

362 (1) On the recommendation of a conformity verification body, the President must cancel an accreditation if the certification body

• (a) fails to take corrective action within 30 days after the day on which the accreditation was suspended;
• (b) was not in compliance with section 15 of the Act at the time of the application made under section 357 or at any time during the period of validity of the accreditation; or
• (c) continues, while their accreditation is suspended, to accept applications for certification, to make determinations under subsection 342(1) or 345(1), to suspend certifications under subsection 346(1) or to cancel certifications under subsection 347(1).

Necessary steps

(2) The President must not cancel a certification unless the certification body was notified in writing of the grounds for the cancellation and was provided with an opportunity to be heard in respect of the cancellation.

Written notice

(3) The President must notify the certification body in writing of the cancellation and the date on which it takes effect.

PART 15

Temporary Non-application to Certain Food Commodities and Persons

Certain foods — 24-month delay

363 (1) Subsections 5(2) and 7(2), section 9, paragraphs 13(1)(a) and (b), subsections 15(2) and 16(2) and sections 42 to 84 and 86 to 90 do not apply, for the 24-month period that begins on the day on which these Regulations come into force, in respect of foods other than dairy products, eggs, processed egg products, fish, fresh fruits or vegetables, processed fruit or vegetable products, honey, maple products and meat products.

Certain foods — additional delay

(2) Sections 9, 42 to 84, 86 and 87 do not apply in respect of foods other than dairy products, eggs, processed egg products, fish, fresh fruits or vegetables, processed fruit or vegetable products, honey, maple products and meat products for 12 months after the last day of the period referred to in subsection (1) to any person who did not have more than four employees at any one time during the last 12 months of the period referred to in that subsection.

Certain foods — additional delay

(3) Sections 9 and 42 to 83 do not apply in respect of foods other than dairy products, eggs, processed egg products, fish, fresh fruits or vegetables, processed fruit or vegetable products, honey, maple products and meat products for 12 months after the last day of the period referred to in subsection (1) to any person whose gross sales derived from food were $30,000 or less for the last 12 months of the period referred to in that subsection.

• Fresh fruits or vegetables — 12-month delay
• 364 Sections 9 and 42 to 87 do not apply in respect of fresh fruits or vegetables for the 12-month period that begins on the day on which these Regulations come into force, and sections 88 to 90 do not apply in respect of fresh fruits or vegetables for the same period, to any person who grows or harvests them, unless the person is the holder of a licence to conduct an activity in respect of those fresh fruits or vegetables.

Aquatic plants and aquaculture animals — 24-month delay

365 (1) Part 14 does not apply in respect of aquatic plants and aquaculture animals for the 24-month period that begins on the day on which these Regulations come into force.

Exception

(2) However, during that period, an application referred to in section 341 or 344 may be made in respect of any aquatic plant or aquaculture animal and a certification in respect of the aquatic plant or aquaculture animal may be granted under section 342 or 345. If such a certification is granted, Part 14 applies in respect of any aquatic plant or aquaculture animal referred to in the certification.

PART 16

Transitional Provisions

Food commodity considered to meet applicable requirements

366 Any food commodity that, immediately before the day on which these Regulations come into force, meets the applicable requirements under the Canada Agricultural Products Act, the Fish Inspection Act or the Meat Inspection Act is considered, on that day, to meet the applicable requirements of these Regulations.

Certificates, authorizations, exemptions, certifications and accreditations

367 (1) Each certificate, authorization, exemption, certification or accreditation that is set out in column 1 of the table to this section and that has not expired before the day on which these Regulations come into force is considered to have been issued or obtained under the provision of the Act or these Regulations that is set out in column 2.

Period of validity

(2) Unless it is suspended or cancelled under these Regulations, the certificate, authorization, exemption, certification or accreditation remains valid until the end of the period for which it was issued or obtained.

Suspensions

(3) A certificate, authorization, exemption, certification or accreditation that was suspended before the day on which these Regulations come into force and that continues to be suspended on that day is considered to be suspended under these Regulations.

Applications

(4) An application for any certificate, authorization, exemption, certification or accreditation that is set out in column 1 of the table to this section that was made before the day on which these Regulations come into force and in respect of which no decision has been made is considered to be an application under these Regulations for the certificate, authorization, exemption, certification or accreditation referred to in the provision of the Act or these Regulations that is set out in column 2.

TABLE

Item	Column 1 Existing Certificates, Authorizations, Exemptions, Certifications and Accreditations	Column 2 Provisions of the Act or These Regulations
1	Certificate issued under section 24 of the Egg Regulations in respect of eggs for export	Section 48 of the Act
2	Authorization obtained under subsection 29.1(5) of the Meat Inspection Regulations, 1990	Subsection 158(3) of these Regulations
3	Exemption obtained under section 2.2 of the Fresh Fruit and Vegetable Regulations	Section 174 of these Regulations
4	Authorization obtained under subsection 2.3(2) of the Fresh Fruit and Vegetable Regulations	Section 174 of these Regulations
5	Authorization issued under subsection 9.1(5) of the Processed Products Regulations	Section 174 of these Regulations
6	Exemption obtained under section 59.2 of the Processed Products Regulations	Section 174 of these Regulations
7	Exemption obtained under section 63 of the Processed Products Regulations	Section 174 of these Regulations
8	Authorization obtained under subsection 29(4) of the Honey Regulations	Section 174 of these Regulations
9	Authorization obtained under subsection 36(3) of the Consumer Packaging and Labelling Regulations	Section 174 of these Regulations
10	Certification issued under section 13 of the Organic Products Regulations, 2009	Section 342 of these Regulations
11	Certification issued under section 15 of the Organic Products Regulations, 2009	Section 345 of these Regulations
12	Accreditation issued under section 6 or 8 of the Organic Products Regulations, 2009	Section 358 or 360 of these Regulations

PART 17

Consequential Amendments, Repeals and Coming into Force

Consequential Amendments

Canadian Dairy Commission Act

EEC Aged Cheddar Cheese Export Regulations

368 The definition aged cheddar cheese in section 2 of the EEC Aged Cheddar Cheese Export Regulations (see footnote 23) is replaced by the following:

aged cheddar cheese means Canadian-produced cheddar cheese that is graded Canada 1 under the Safe Food for Canadians Regulations and aged for a period of not less than nine months; (fromage cheddar fort)

Consumer Packaging and Labelling Act

Consumer Packaging and Labelling Regulations

369 The definition wine in subsection 2(1) of the Consumer Packaging and Labelling Regulations (see footnote 24) is repealed.

370 Section 4 of the Regulations and the heading before it are replaced by the following:

Exemptions from Sections 4, 5, 6 and 10 of the Act

4 Prepackaged products that are subject to regulations respecting packaging, labelling and marking under the Feeds Act, Fertilizers Act, Pest Control Products Act or Seeds Act are exempt from sections 4, 5, 6 and 10 of the Act.

371 (1) Paragraph 5(1)(a) of the Regulations is repealed.

(2) Paragraph 5(2)(a) of the Regulations is repealed.

(3) Paragraph 5(3)(a) of the Regulations is repealed.

372 The definition specialty product in subsection 6(1) of the Regulations is replaced by the following:

specialty product means a prepackaged product that is an imported product

• (a) that is not widely used by the population as a whole in Canada; and
• (b) for which there is no readily available substitute that is manufactured, processed, produced or packaged in Canada and that is generally accepted as being a comparable substitute; (produit spécial)

373 Subsection 14(5) of the Regulations is repealed.

374 Section 18 of the Regulations and the heading before it are repealed.

375 (1) The definition individually measured commodity in subsection 19(1) of the Regulations is repealed.

(2) Subsections 19(2) to (4) of the Regulations are replaced by the following:

(2) Prepackaged products that are packaged from bulk on a retail premises, other than wallpaper or floor covering, are exempt from paragraph 4(1)(b) of the Act and from section 14 of these Regulations, if the net quantity of the product is clearly shown on the principal display panel of its label in terms of a Canadian unit.

376 Section 22 of the Regulations is replaced by the following:

22 The declaration of net quantity of a prepackaged product that is packed for dispensing in aerosol form shall show the net quantity of the product by weight.

377 Subsection 28(2) of the Regulations is replaced by the following:

(2) Despite subsection (1), if a prepackaged product referred to in that subsection consists of less than seven identical products that are packaged separately and those products are labelled to show all of the information required by the Act and these Regulations and that information is clearly visible at the time of sale, no information is required to be shown on the prepackaged product being sold as one unit and the prepackaged product is exempt from sections 4 and 10 of the Act.

378 The heading before section 32 and sections 32 to 34 of the Regulations are repealed.

379 Subsections 36(1) and (2) of the Regulations are replaced by the following:

36 (1) Subject to subsection (3), a prepackaged product consisting of facial tissue, that is manufactured before January 1, 1997, may only be sold in a container whose size corresponds to a net quantity of product

• (a) of a numerical count of less than 50;
• (b) of a numerical count of 50, 60, 100, 120, 150 or 200; or
• (c) of a numerical count of more than 200, if the container is of a size that corresponds to a net quantity of product that is a multiple of 100 units.

(2) Subject to subsection (3), the net quantity of a prepackaged product referred to in subsection (1) shall be shown in terms of numerical count.

380 Section 40 of the Regulations is replaced by the following:

40 When an inspection is made of a prepackaged product consisting of liquid, the net quantity of the prepackaged product shall be determined on the basis that the liquid is at a temperature of 20°C (68°F).

Controlled Drugs and Substances Act

Industrial Hemp Regulations

381 The Industrial Hemp Regulations (see footnote 25) are amended by replacing “under section 14 of the Canada Agricultural Products Act” with “under section 2.1 of the Seeds Act” in the following provisions:

• (a) paragraph 8(1)(k);
• (b) paragraph 13(2)(e); and
• (c) paragraph 31(b).

Criminal Code

Regulations Excluding Certain Indictable Offences from the Definition of “Designated Offence”

382 (1) Paragraph 1(b) of the Regulations Excluding Certain Indictable Offences from the Definition of “Designated Offence” (see footnote 26) is repealed.

(2) Paragraph 1(k) of the Regulations is repealed.

(3) Section 1 of the Regulations is amended by striking out “and” at the end of paragraph (m) and by adding the following after paragraph (m):

• (m.1) Safe Food for Canadians Act; and

Customs Tariff

Determination of Country of Origin for the Purposes of Marking Goods (NAFTA Countries) Regulations

383 The note below the heading of Schedule III to the Determination of Country of Origin for the Purposes of Marking Goods (NAFTA Countries) Regulations (see footnote 27) is replaced by the following:

Note: In accordance with Schedule I to these Regulations, only some goods are required to be marked so as to indicate the country of origin. For the packaging and labelling of food products, the requirements of the Safe Food for Canadians Act continue to apply.

Feeds Act

Feeds Regulations, 1983

384 Subparagraph 19(1)(d.2)(ii) of the Feeds Regulations, 1983 (see footnote 28) is replaced by the following:

• (ii) a food animal, as defined in subsection 1(1) of the Safe Food for Canadians Regulations, that was raised or slaughtered to become an edible meat product;

Food and Drugs Act

Food and Drug Regulations

385 (1) The definition principal display panel in subsection B.01.001(1) of the Food and Drug Regulations (see footnote 29) is replaced by the following:

principal display panel means, despite the meaning assigned to that term in section A.01.010,

• (a) in the case of a label that is applied to a consumer prepackaged food within the meaning of subsection 1(1) of the Safe Food for Canadians Regulations, the principal display panel as described in paragraphs (a) to (c) of the definition of that term in that subsection;
• (b) in the case of a label that is applied to a prepackaged product other than a consumer prepackaged food that is subject to the Safe Food for Canadians Regulations, the part of the label that is applied to all or part of the side or surface of the container that is displayed or visible under normal or customary conditions of sale or use and, if the container does not have such a side or surface, the part of the label that is applied to any part of the container, except the bottom, if any; and
• (c) in the case of a label that is applied to a food that is not a prepackaged product, the part of the label that is applied to all or part of the side or surface of the food that is displayed or visible under normal or customary conditions of sale or use; (espace principal)

(2) Paragraph (a) of the definition common name in subsection B.01.001(1) of the Regulations is replaced by the following:

• (a) the name of the food printed in boldface type, but not in italics, in a provision of these Regulations,

386 Subsection B.01.402(8) of the Regulations is repealed.

387 Paragraphs B.01.502(2)(b) and (c) of the Regulations are replaced by the following:

• (b) a representation provided for by paragraph 262(1)(g) or section 263 of the Safe Food for Canadians Regulations;
• (c) a representation provided for by Table 2 to Volume 7 of the document entitled Canadian Standards of Identity, prepared by the Canadian Food Inspection Agency and published on its website, as amended from time to time;

388 Subsection B.01.513(2) of the Regulations is replaced by the following:

(2) Subsection (1) does not apply to the statement or claim “light” or “léger” when used with respect to rum.

389 Subsection B.14.018(1) of the Regulations is amended by replacing “by a grading authority established under the Canada Agricultural Products Act” with “under the Safe Food for Canadians Act”.

390 Paragraph B.27.002(2)(a) of the Regulations is replaced by the following:

• (a) the low-acid food is kept under refrigeration and the statement “Keep Refrigerated” and “Garder réfrigéré” is carried on the principal display panel of the label of its container, as well as on the label of its shipping container; or

391 The Regulations are amended by replacing “section 14 of the Consumer Packaging and Labelling Regulations” with “paragraph 216(1)(a) and subsections 216(2) and (3) of the Safe Food for Canadians Regulations” in the following provisions:

• (a) paragraphs B.01.014(a) and (b);
• (b) paragraph B.01.015(1)(a);
• (c) paragraph B.01.016(a);
• (d) paragraph B.01.017(1)(a);
• (e) paragraph B.01.019(a);
• (f) paragraph B.01.020(1)(a);
• (g) paragraphs B.01.022(a) and (b);
• (h) paragraph B.01.023(a); and
• (i) subparagraph B.01.035(5)(a)(i).
  

Health of Animals Act

Health of Animals Regulations

392 (1) The definition registered processed egg station in section 2 of the Health of Animals Regulations (see footnote 30) is repealed.

(2) Paragraph (c) of the definition country of origin in section 2 of the Regulations is replaced by the following:

• (c) with respect to an animal product or animal by-product — other than non-fertilized ova, semen and meat as defined in subsection 1(1) of the Safe Food for Canadians Regulations — that has undergone processing that would prevent the introduction of any reportable disease, any disease referred to in Schedule VII and any serious epizootic disease to which the species from which the product or by-product was derived is susceptible and that can be transmitted by the product or by-product, the country in which the product or by-product underwent that processing; (pays d'origine)

(3) Section 2 of the Regulations is amended by adding the following in alphabetical order:

processed egg product establishment means an establishment where eggs or processed egg products are processed, treated or preserved by the holder of a licence that is issued under paragraph 20(1)(b) of the Safe Food for Canadians Act; (établissement de produits d'œufs transformés)

393 Paragraph 5(3)(a) of the Regulations is replaced by the following:

• (a) removed to and destroyed at an establishment where food animals are slaughtered by the holder of a licence that is issued under paragraph 20(1)(b) of the Safe Food for Canadians Act; or

394 Subsection 34(3) of the Regulations is amended by replacing “registered processed egg station” with “processed egg product establishment”.

395 Subsection 175.1(2) of the Regulations is replaced by the following:

(2) Subsection (1) does not apply to an ovine that is transported directly for slaughter either to an establishment where food animals are slaughtered by the holder of a licence that is issued under paragraph 20(1)(b) of the Safe Food for Canadians Act or to an establishment that is registered under an Act of a province that provides for the inspection of ovine carcasses.

Seeds Act

Seeds Regulations

396 (1) The definitions Act and officially recognized laboratory in subsection 2(2) of the Seeds Regulations (see footnote 31) are replaced by the following:

Act means the Seeds Act. (Loi)

officially recognized laboratory means a seed testing laboratory that is designated by the Minister as an accredited laboratory under section 2.1 of the Act. (laboratoire reconnu officiellement)

(2) Subsections 2(3) and (4) of the Regulations are repealed.

397 Paragraph 13.2(1)(b) of the Regulations is replaced by the following:

• (b) the grader or sampler does not comply with a provision of the Act or these Regulations.

Repeals

Canada Agricultural Products Act

398 The following Regulations are repealed:

• (a) the Egg Regulations (see footnote 32);
• (b) the Fresh Fruit and Vegetable Regulations (see footnote 33);
• (c) the Honey Regulations (see footnote 34);
• (d) the Maple Products Regulations (see footnote 35);
• (e) the Processed Egg Regulations (see footnote 36);
• (f) the Processed Products Regulations (see footnote 37);
• (g) the Dairy Products Regulations (see footnote 38);
• (h) the Licensing and Arbitration Regulations (see footnote 39);
• (i) the Livestock and Poultry Carcass Grading Regulations (see footnote 40);
• (j) the Organic Products Regulations, 2009 (see footnote 41); and
• (k) the Icewine Regulations (see footnote 42).
  

Fish Inspection Act

399 The Fish Inspection Regulations (see footnote 43) are repealed.

Meat Inspection Act

400 The Meat Inspection Regulations, 1990 (see footnote 44) are repealed.

Coming into Force

Registration

401 These Regulations come into force on the day on which they are registered.

SCHEDULE 1

(The definition fresh fruit or vegetable in subsection 1(1) and paragraph 9(2)(c))

Exclusions — Foods Used as Grain, Oil, Pulse, Sugar or Beverage

• 1 amaranth
• 2 barley
• 3 buckwheat
• 4 camelina
• 5 canola
• 6 chickpeas
• 7 cocoa beans
• 8 coffee beans
• 9 dry beans
• 10 dry faba beans
• 11 dry peas
• 12 flaxseed
• 13 hemp
• 14 hops
• 15 lentils
• 16 maize (corn)
• 17 millet
• 18 mustard seeds
• 19 oats
• 20 quinoa
• 21 rapeseed
• 22 rice
• 23 rye
• 24 safflower seeds
• 25 sorghum
• 26 soybeans
• 27 sugar beets
• 28 sugar cane
• 29 sunflower seeds
• 30 tea leaves
• 31 triticale
• 32 wheat
• 33 wild rice

SCHEDULE 2

(Sections 176 to 180, subsections 181(1) to (5), section 182 and paragraphs 246(a), 272(1)(a) and 274(1)(a))

Inspection Legends

Figure 1

Figure 2

SCHEDULE 3

(The definition processed fruit or vegetable product in subsection 1(1), sections 184 to 189 and subsection 190(1))

TABLE 1
Consumer Prepackaged Food (Net Quantity by Weight or Volume)

Item	Column 1 Consumer Prepackaged Food	Column 2 Net Quantity by Weight	Column 3 Net Quantity by Volume
1	Peanut butter	250 g	—
		375 g	—
		500 g	—
		750 g	—
		1 kg	—
		1.5 kg	—
		2 kg	—
2	Wine	—	50mL
		—	100mL
		—	200mL
		—	250mL
		—	375mL
		—	500mL
		—	750mL
		—	1L
		—	1.5L
		—	2L
		—	3L
		—	4L
3	Glucose syrup and refined sugar syrup	—	125mL
		—	250mL
		—	375mL
		—	500mL
		—	750mL
		—	1L
		—	1.5L
		—	2L
		—	More than 2L, in increments of 1L

TABLE 2
Consumer Prepackaged Food (Net Quantity by Weight)

Item	Column 1 Consumer Prepackaged Food	Column 2 Net Quantity by Weight
1	Honey that is graded under these Regulations	150 g or less
		250 g
		375 g
		500 g
		750 g
		1 kg
		1.5 kg
		2 kg
		3 kg
		5 kg
2	Sliced bacon	100 g or less, in increments of 1 g
		250 g
		375 g
		500 g
		1 kg
3	Sliced ready-to-eat meat products and potted meat products	100 g or less, in increments of 1 g
		125 g
		150 g
		175 g
		200 g
		250 g
		300 g
		375 g
		400 g
		500 g
		600 g
		700 g
		900 g
		1 kg
4	Sausages and sausage meat	100 g or less, in increments of 1 g
		125 g
		175 g
		225 g
		250 g
		300 g
		375 g
		450 g
		500 g
		600 g
		675 g
		750 g
		900 g
		1 kg
5	Fresh carrots for which a grade is prescribed by these Regulations	1.36 kg (3 lb) or less
		2.27 kg (5 lb)
		4.54 kg (10 lb)
		11.3 kg (25 lb)
		22.7 kg (50 lb)
6	Fresh potatoes for which a grade is prescribed by these Regulations	1.36 kg (3 lb) or less
		2.27 kg (5 lb)
		4.54 kg (10 lb)
		9.07 kg (20 lb)
		22.7 kg (50 lb)
		34 kg (75 lb)
		45.4 kg (100 lb)
7	Fresh beets for which a grade is prescribed by these Regulations	1.36 kg (3 lb) or less
		2.27 kg (5 lb)
		4.54 kg (10 lb)
		11.3 kg (25 lb)
		22.7 kg (50 lb)
8	Fresh onions for which a grade is prescribed by these Regulations	1.36 kg (3 lb) or less
		2.27 kg (5 lb)
		4.54 kg (10 lb)
		11.3 kg (25 lb)
		22.7 kg (50 lb)
9	Fresh parsnips for which a grade is prescribed by these Regulations	1.36 kg (3 lb) or less
		4.54 kg (10 lb)
		9.07 kg (20 lb)
		11.3 kg (25 lb)
		22.7 kg (50 lb)
10	Fresh rutabagas for which a grade is prescribed by these Regulations	1.36 kg (3 lb) or less
		2.27 kg (5 lb)
		4.54 kg (10 lb)
		11.3 kg (25 lb)
		22.7 kg (50 lb)

TABLE 3
Prepackaged Food (Net Quantity by Weight)

Item	Column 1 Prepackaged Food	Column 2 Net Quantity by Weight
1	Honey that is graded under these Regulations, other than consumer prepackaged honey that is graded under these Regulations	7 kg
		15 kg
		30 kg
		More than 30 kg, in increments of 1 kg
2	Frozen fruits for which a grade is prescribed by these Regulations, with added sugar, syrup, fruit juice or fruit juice from concentrate	225 g
		425 g
		1 kg
		1.25 kg
		1.5 kg
		1.75 kg
		2 kg
3	Frozen fruits for which a grade is prescribed by these Regulations, dry pack or pie pack, unsweetened, no sugar added	300 g
		600 g
		1 kg
		1.25 kg
		1.5 kg
		1.75 kg
		2 kg
4	Frozen peas, frozen whole kernel corn and frozen lima beans, for which a grade is prescribed by these Regulations	350 g or less
		500 g
		750 g
		1 kg
		1.25 kg
		1.5 kg
		1.75 kg
		2 kg
5	Frozen spinach for which a grade is prescribed by these Regulations	300 g or less
		500 g
		750 g
		1 kg
		1.25 kg
		1.5 kg
		1.75 kg
		2 kg
6	Frozen mixed vegetables or macédoine, frozen peas and carrots and frozen whole, diced or sliced carrots, for which a grade is prescribed by these Regulations	300 g or less
		500 g
		750 g
		1 kg
		1.25 kg
		1.5 kg
		1.75 kg
		2 kg
7	Frozen special blends or combination mixed vegetables, if the blends or mixed vegetables contain one or more vegetables that are graded under these Regulations	300 g or less
		500 g
		750 g
		1 kg
		1.25 kg
		1.5 kg
		1.75 kg
		2 kg
8	Other frozen vegetables — including asparagus, broccoli, Brussels sprouts, cauliflower and green and wax beans — for which a grade is prescribed by these Regulations	300 g or less
		500 g
		750 g
		1 kg
		1.25 kg
		1.5 kg
		1.75 kg
		2 kg
9	Frozen cooked squash, and frozen diced uncooked squash, for which a grade is prescribed by these Regulations	400 g or less
		750 g
		1 kg
		1.25 kg
		1.5 kg
		1.75 kg
		2 kg
10	Frozen french-fried potatoes for which a grade is prescribed by these Regulations	225 g or less, in increments of 25 g
		250 g
		500 g
		1 kg
		1.25 kg
		1.5 kg
		1.75 kg
		2 kg
		More than 2 kg but not more than 20 kg
11	Glace fruits, glace pineapple, cut oranges, lemon and citron peel, cut mixed peel and cut mixed fruit	100 g
		225 g
		450 g

TABLE 4
Prepackaged Food (Net Quantity by Volume and Container Dimensions)

Item	Column 1	Column 2	Column 3	Column 4	Column 5
	Prepackaged Food	Net Quantity by Volume		Container Dimensions1
		Millilitres/Litres	Fluid Ounces	Millimetres	Inches2
1	Frozen concentrated apple juice or frozen apple juice concentrate for which a grade is prescribed by these Regulations	177 mL	6.25	54 × 98	202 × 314
		355 mL	12.5	68 × 123	211 × 414
		909 mL	32	103 × 142	401 × 510
		1.36 L	48	107 × 177	404 × 700
1 The dimensions correspond to the diameter and height of the container. 2 Dimensions are expressed in the manner that is used in the industry, e.g. "211" means 2 11/16 inches.

TABLE 5
Food for which a Grade is Prescribed by these Regulations if the Container is a Hermetically Sealed Package (Net Quantity by Volume and Metal Container Dimensions)

Item	Column 1	Column 2	Column 3	Column 4	Column 5
	Prepackaged Food	Net Quantity by Volume		Metal Container Dimensions1
		Millilitres/Litres	Fluid Ounces	Millimetres	Inches2
1	Fruits packaged with or without water, fruit juice and fruit juice from concentrate, syrup or any combination, heavy pack or solid pack	142 mL	5	68 x 56	211 x 203.5
		284 mL	10	68 x 101	211 x 400
		398 mL	14	76 x 112 or 87 x 90	300 x 407 or 307 x 309
		540 mL	19	87 x 115	307 x 409
		796 mL	28	103 x 119	401 x 411
		1.36 L	48	107 x 177	404 x 700
		2.84 L	100	157 x 177	603 x 700
2	Vegetables, other than vegetables for which specific provision is made in this Table	284 mL	10	68 × 101	211 × 400
		398 mL	14	76 × 112 or 87 × 90	300 × 407 or 307 × 309
		540 mL	19	87 × 115	307 × 409
		796 mL	28	103 × 119	401 × 411
		1.36 L	48	107 × 177	404 × 700
		2.84 L	100	157 × 177	603 × 700
3	Fruit and vegetable juices, but not including concentrated apple juice or apple juice concentrate, carbonated juices or juices that are packaged with nitrogen	200 mL or less	7 or less	Any dimensions	Any dimensions
		250 mL	8.8	Any dimensions	Any dimensions
		284 mL	10	62 × 118 or 68 × 101	207.5 × 410.5 or 211 × 400
		398 mL	14	76 × 112	300 × 407
		500 mL	17.6	Any dimensions	Any dimensions
		540 mL	19	87 × 115	307 × 409
		750 mL	26.4	Any dimensions	Any dimensions
		796 mL	28	103 × 119	401 × 411
		1 L	35.2	Any dimensions	Any dimensions
		1.36 L	48	107 × 177	404 × 700
		1.5 L	52.8	Any dimensions	Any dimensions
		1.82 L	64	Any dimensions	Any dimensions
		2 L	70.4	Any dimensions	Any dimensions
4	Asparagus	341 mL	12	68 x 115	211 x 409
		540 mL	19	87 x 115	307 x 409
		796 mL	28	103 x 119	401 x 411
		1.36 L	48	107 x 177	404 x 700
		2.84 L	100	157 x 177	603 x 700
5	Corn, vacuum pack	199 mL	7	68 × 82	211 × 304
		341 mL	12	87 × 85	307 × 306
		540 mL	19	87 × 115	307 × 409
		2.13 L	75	157 × 152	603 × 600
6	Mushrooms in brine	128 mL	4.5	68 × 50	211 × 200
		284 mL	10	68 × 101	211 × 400
		398 mL	14	76 × 112	300 × 407
		540 mL	19	87 × 115	307 × 409
		796 mL	28	103 × 119	401 × 411
		1.36 L	48	107 × 177	404 × 700
		2.84 L	100	157 × 177	603 × 700
7	Tomato paste	156 mL	5.5	54 × 88	202 × 308
		369 mL	13	76 × 101	300 × 400
		796 mL	28	103 × 119	401 × 411
		1.36 L	48	107 × 177	404 × 700
		2.84 L	100	157 × 177	603 × 700
		3.58 L	126	157 × 222	603 × 812
8	Tomato pulp, tomato puree and concentrated tomato juice or tomato juice concentrate	341 mL	12	68 × 115	211 × 409
		540 mL	19	87 × 115	307 × 409
		796 mL	28	103 × 119	401 × 411
		1.36 L	48	107 × 177	404 × 700
		2.84 L	100	157 × 177	603 × 700
		3.58 L	126	157 × 222	603 × 812
9	Maraschino, creme de menthe and cocktail cherries	125 mL	—	Any dimensions	Any dimensions
		250 mL	—	Any dimensions	Any dimensions
		375 mL	—	Any dimensions	Any dimensions
		2 L	—	Any dimensions	Any dimensions
		4 L	—	Any dimensions	Any dimensions
10	Sweet potatoes, cut	277 mL	8	68 x 82	211 x 304
		540 mL	19	87 x 115	307 x 409
		796 mL	28	103 x 119	401 x 411
		1.36 L	48	107 x 177	404 x 700
		2.84 L	100	157 x 177	603 x 700
11	Sweet potatoes, whole	597 mL	21	107 x 87	404 x 307
12	Tomato catsup, catsup, tomato ketchup or ketchup	375 mL	—	Any dimensions	Any dimensions
		540 mL	19	87 × 115	307 × 409
		575 mL	—	Any dimensions	Any dimensions
		750 mL	—	Any dimensions	Any dimensions
		1 L	—	Any dimensions	Any dimensions
		1.25 L	—	Any dimensions	Any dimensions
		1.5 L	—	Any dimensions	Any dimensions
1 The dimensions correspond to the diameter and height of the metal container. 2 Dimensions are expressed in the manner that is used in the industry, e.g. "211" means 2 11/16 inches.

TABLE 6
Food for which No Grade is Prescribed by these Regulations if the Container is a Hermetically Sealed Package (Net Quantity by Volume and Metal Container Dimensions)

Item	Column 1	Column 2	Column 3	Column 4	Column 5
	Prepackaged Food	Net Quantity by Volume		Metal Container Dimensions1
		Millilitres/Litres	Fluid Ounces	Millimetres	Inches2
1	Beans with pork or beans and pork, beans or vegetarian beans	128 mL	4.5	68 × 50	211 × 200
		227 mL	8	68 × 82	211 × 304
		284 mL	10	68 × 101	211 × 400
		398 mL	14	76 × 112 or 103 × 69	300 × 407 or 401 × 212
		540 mL	19	87 × 115 or 103 × 85	307 × 409 or 401 × 306
		796 mL	28	103 × 119	401 × 411
		1.36 L	48	107 × 177	404 × 700
		2.84 L	100	157 × 177	603 × 700
2	Infant and junior foods that are processed fruit or vegetable products	128 mL	4.5	54 × 72	202 × 213.5
		213 mL	7.5	68 × 76	211 × 300
3	Vegetable soups, condensed	284 mL	10	68 × 98 or 68 × 101	211 × 314 or 211 × 400
		398 mL	14	76 × 112	300 × 407
		540 mL	19	87 × 115	307 × 409
		796 mL	28	103 × 119	401 × 411
		1.36 L	48	107 × 177	404 × 700
		2.84 L	100	157 × 177	603 × 700
4	Vegetable soups, ready-to-serve	227 mL	8	68 × 82	211 × 304
		284 mL	10	68 × 98 or 68 × 101	211 × 314 or 211 × 400
		398 mL	14	76 × 112	300 × 407
		540 mL	19	87 × 115	307 × 409
		796 mL	28	103 × 119	401 × 411
		1.36 L	48	107 × 177	404 × 700
		2.84 L	100	157 × 177	603 × 700
5	Spaghetti in tomato sauce	128 mL	4.5	68 × 50	211 × 200
		227 mL	8	68 × 82	211 × 304
		284 mL	10	68 × 101	211 × 400
		398 mL	14	76 × 112	300 × 407
		540 mL	19	87 × 115	307 × 409
		796 mL	28	103 × 119	401 × 411
		1.36 L	48	107 × 177	404 × 700
		2.84 L	100	157 × 177	603 × 700
6	Pineapple, sliced, crushed, tidbits or chunks	142 mL	5	68 × 56	211 × 203.5
		227 mL	8	87 × 52	307 × 201.25
		284 mL	10	68 × 101	211 × 400
		398 mL	14	76 × 112 or 87 × 90	300 × 407 or 307 × 309
		540 mL	19	87 × 115	307 × 409
		796 mL	28	103 × 119	401 × 411
		1.36 L	48	107 × 177	404 × 700
		2.84 L	100	157 × 177	603 × 700
7	Grapefruits, oranges and grapefruit and orange sections	142 mL	5	68 × 56	211 × 203.5
		284 mL	10	68 × 101	211 × 400
		398 mL	14	76 × 112 or 87 × 90	300 × 407 or 307 × 309
		540 mL	19	87 × 115	307 × 409
		796 mL	28	103 × 119	401 × 411
		1.36 L	48	107 × 177	404 × 700
		2.84 L	100	157 × 177	603 × 700
8	Fruit juices, including citrus and pineapple juices, but not including lemon, lime, grape, cherry, black currant or raspberry juices, the juices of other berries, carbonated juices or juices that are packaged with nitrogen	200 mL or less	7 or less	Any dimensions	Any dimensions
		250 mL	8.8	Any dimensions	Any dimensions
		284 mL	10	62 × 118 or 68 × 101	207.5 × 410.5 or 211 × 400
		398 mL	14	76 × 112	300 × 407
		500 mL	17.6	Any dimensions	Any dimensions
		540 mL	19	87 × 115	307 × 409
		750 mL	26.4	Any dimensions	Any dimensions
		796 mL	28	103 × 119	401 × 411
		1 L	35.2	Any dimensions	Any dimensions
		1.36 L	48	107 × 177	404 × 700
		1.5 L	52.8	Any dimensions	Any dimensions
		1.82 L	64	Any dimensions	Any dimensions
		2 L	70.4	Any dimensions	Any dimensions
9	Bean sprouts and vegetables for chop suey	284 mL	10	68 × 101	211 × 400
		398 mL	14	76 × 112	300 × 407
		540 mL	19	87 × 115	307 × 409
		796 mL	28	103 × 119	401 × 411
		1.36 L	48	107 × 177	404 × 700
		2.84 L	100	157 × 177	603 × 700
10	Mushrooms, including creamed, stems and pieces in brine	128 mL	4.5	68 × 50 or 54 × 72	211 × 200 or 202 × 213.5
		284 mL	10	68 × 101	211 × 400
		398 mL	14	76 × 112	300 × 407
		540 mL	19	87 × 115	307 × 409
		796 mL	28	103 × 119	401 × 411
		1.36 L	48	107 × 177	404 × 700
		2.84 L	100	157 × 177	603 × 700
11	Pie fruits, pie fillers and pie fillings	284 mL	10	68 × 101	211 × 400
		398 mL	14	76 × 112 or 87 × 90	300 × 407 or 307 × 309
		540 mL	19	87 × 115	307 × 409
		796 mL	28	103 × 119	401 × 411
		1.36 L	48	107 × 177	404 × 700
		2.84 L	100	157 × 177	603 × 700
12	Jams, jellies, marmalades and preserves (conserves), but not including cranberry jelly, jellied cranberries or cranberry sauce	250 mL or less	—	Any dimensions	Any dimensions
		375 mL	—	Any dimensions	Any dimensions
		500 mL	—	Any dimensions	Any dimensions
		750 mL	—	Any dimensions	Any dimensions
		1 L	—	Any dimensions	Any dimensions
		1.5 L	—	Any dimensions	Any dimensions
		2 L	—	Any dimensions	Any dimensions
		3 L	—	Any dimensions	Any dimensions
		4 L	—	Any dimensions	Any dimensions
13	Mandarin oranges	142 mL	5	68 × 56	211 × 203.5
		284 mL	10	75 × 82	215 × 304
		2.42 L	85	157 × 155	603 × 602
14	Grape juice, concentrated grape juice or grape juice concentrate and grape juice from concentrate, but not including carbonated juices or juices that are packaged with nitrogen	200 mL or less	7 or less	Any dimensions	Any dimensions
		250 mL	8.8	Any dimensions	Any dimensions
		284 mL	10	62 × 118	207.5 × 410.5
		341 mL	12	Any dimensions	Any dimensions
		500 mL	17.6	Any dimensions	Any dimensions
		682 mL	24	Any dimensions	Any dimensions
		750 mL	26.4	Any dimensions	Any dimensions
		1 L	35.2	Any dimensions	Any dimensions
		1.14 L	40	Any dimensions	Any dimensions
		1.36 L	48	107 × 177	404 × 700
		1.5 L	52.8	Any dimensions	Any dimensions
		1.82 L	64	Any dimensions	Any dimensions
		2 L	70.4	Any dimensions	Any dimensions
15	Pickles, relishes and chutneys	125 mL or less	—	Any dimensions	Any dimensions
		250 mL	—	Any dimensions	Any dimensions
		375 mL	—	Any dimensions	Any dimensions
		500 mL	—	Any dimensions	Any dimensions
		750 mL	—	Any dimensions	Any dimensions
		1 L	—	Any dimensions	Any dimensions
		1.25 L	—	Any dimensions	Any dimensions
		1.5 L	—	Any dimensions	Any dimensions
		2 L	—	Any dimensions	Any dimensions
		2.84 L	100	Any dimensions	Any dimensions
		4 L	—	Any dimensions	Any dimensions
16	Green olives, but not including ripe olives, black olives or California ripe olives	125 mL or less	—	Any dimensions	Any dimensions
		225 mL	—	Any dimensions	Any dimensions
		250 mL	—	Any dimensions	Any dimensions
		375 mL	—	Any dimensions	Any dimensions
		398 mL	—	Any dimensions	Any dimensions
		500 mL	—	Any dimensions	Any dimensions
		625 mL	—	Any dimensions	Any dimensions
		750 mL	—	Any dimensions	Any dimensions
		1 L	—	Any dimensions	Any dimensions
		1.25 L	—	Any dimensions	Any dimensions
		1.5 L	—	Any dimensions	Any dimensions
		2 L	—	Any dimensions	Any dimensions
17	Sauerkraut with preservative	284 mL	10	68 × 101	211 × 400
		398 mL	14	76 × 112 or 87 × 90	300 × 407 or 307 × 309
		540 mL	19	87 × 115	307 × 409
		796 mL	28	103 × 119	401 × 411
		909 mL	32	Any dimensions	Any dimensions
		1.36 L	48	107 × 177	404 × 700
		2.84 L	100	157 × 177	603 × 700
18	Horseradish sauce, prepared horseradish and creamed horseradish	125 mL or less	—	Any dimensions	Any dimensions
		250 mL	—	Any dimensions	Any dimensions
		500 mL	—	Any dimensions	Any dimensions
		2 L	—	Any dimensions	Any dimensions
		4 L	—	Any dimensions	Any dimensions
1 The dimensions correspond to the diameter and height of the metal container. 2 Dimensions are expressed in the manner that is used in the industry, e.g. "211" means 2 11/16 inches.

TABLE 7
Fresh Vegetables — Volume Capacity of Metric Containers

Item	Volume Capacity of Metric Containers
1	500 mL
2	1 L
3	2 L
4	4 L
5	6 L
6	13 L
7	18 L
8	36 L

TABLE 8
Fresh Vegetables — Volume Capacity of Imperial Containers

Item	Volume Capacity of Imperial Containers
1	1 pint (551 mL)
2	1 quart (1.1 L)
3	2 quarts (2.27 L)
4	4 quarts (4.55 L)
5	6 quarts (6.82 L)
6	11 quarts (12.5 L)
7	16 quarts (18.2 L)
8	32 quarts (36.4 L)

SCHEDULE 4

(Subsection 196(5))

TABLE 1
Tolerances for Net Quantities Declared in Metric Units of Mass for Consumer Prepackaged Catch-Weight Food

Item	Column 1 Declared Net Quantity	Column 2 Tolerance (%)	Column 3 Tolerance (g)
1	≤ 60 g	10	—
2	> 60 g but ≤ 600 g	—	6
3	> 600 g but ≤ 1 kg	1	—
4	> 1 kg but ≤ 1.5 kg	—	10
5	> 1.5 kg but ≤ 3 kg	0.66	—
6	> 3 kg but ≤ 4 kg	—	20
7	> 4 kg but ≤ 10 kg	0.5	—
8	> 10 kg but ≤ 15 kg	—	50
9	> 15 kg but ≤ 250 kg	0.33	—
10	> 250 kg but ≤ 500 kg	—	750
11	> 500 kg	0.15	—

TABLE 2
Tolerances for Net Quantities Declared in Canadian Units of Mass or Weight for Consumer Prepackaged Catch-Weight Food

Item	Column 1 Declared Net Quantity	Column 2 Tolerance (%)	Column 3 Tolerance (ounces)
1	≤ 2 ounces	10	—
2	> 2 ounces but ≤ 20 ounces	—	0.2
3	> 1.25 lb but ≤ 2.2 lb	1	—
4	> 2.2 lb but ≤ 3.3 lb	—	0.35
5	> 3.3 lb but ≤ 6.6 lb	0.66	—
6	> 6.6 lb but ≤ 8.8 lb	—	0.71
7	> 8.8 lb but ≤ 22 lb	0.5	—
8	> 22 lb but ≤ 33 lb	—	1.76
9	> 33 lb but ≤ 550 lb	0.33	—
10	> 550 lb but ≤ 1 100 lb	—	26.4
11	> 1 100 lb	0.15	—

TABLE 3
Tolerances for Net Quantities Declared in Metric Units of Mass or Volume for Consumer Prepackaged Food Other than Catch-Weight Food

Item	Column 1 Declared Net Quantity	Column 2 Tolerance (%)	Column 3 Tolerance (g or mL)
1	≤ 50 g or mL	9	—
2	> 50 g or mL but ≤ 100 g or mL	—	4.5
3	> 100 g or mL but ≤ 200 g or mL	4.5	—
4	> 200 g or mL but ≤ 300 g or mL	—	9
5	> 300 g or mL but ≤ 500 g or mL	3	—
6	> 500 g or mL but ≤ 1 kg or L	—	15
7	> 1 kg or L but ≤ 10 kg or L	1.5	—
8	> 10 kg or L but ≤ 15 kg or L	—	150
9	> 15 kg or L	1	—

TABLE 4
Tolerances for Net Quantities Declared in Canadian Units of Mass or Weight for Consumer Prepackaged Food Other than Catch-Weight Food

Item	Column 1 Declared Net Quantity	Column 2 Tolerance (%)	Column 3 Tolerance (ounces)
1	≤ 1.75 ounces	9	—
2	> 1.75 ounces but ≤ 3.5 ounces	—	0.16
3	> 3.5 ounces but ≤ 7 ounces	4.5	—
4	> 7 ounces but ≤ 10.6 ounces	—	0.32
5	> 10.6 ounces but ≤ 17.6 ounces	3	—
6	> 1.1 lb but ≤ 2.2 lb	—	0.53
7	> 2.2 lb but ≤ 22 lb	1.5	—
8	> 22 lb but ≤ 33 lb	—	5.28
9	> 33 lb	1	—

TABLE 5
Tolerances for Net Quantities Declared in Canadian Units of Volume for Consumer Prepackaged Food Other than Catch-Weight Food

Item	Column 1 Declared Net Quantity	Column 2 Tolerance (%)	Column 3 Tolerance (fluid ounces)
1	≤ 1.75 fluid ounces	9	—
2	> 1.75 fluid ounces but ≤ 3.5 fluid ounces	—	0.16
3	> 3.5 fluid ounces but ≤ 7 fluid ounces	4.5	—
4	> 7 fluid ounces but ≤ 10.6 fluid ounces	—	0.32
5	> 10.6 fluid ounces but ≤ 17.6 fluid ounces	3	—
6	> 17.6 fluid ounces but ≤ 35.2 fluid ounces	—	0.53
7	> 35.2 fluid ounces but ≤ 2.2 gallons	1.5	—
8	> 2.2 gallons but ≤ 3.3 gallons	—	5.28
9	> 3.3 gallons	1	—

TABLE 6
Tolerances for Net Quantities of Consumer Prepackaged Food Declared by Numerical Count

Item	Column 1 Declared Net Quantity (Numerical Count)	Column 2 Tolerance
1	< 50	0
2	≥ 50 but ≤ 100	1
3	> 100, with an individual weight of ≤ 14 g or ≤ 0.5 ounce	0.75% of the declared net quantity, rounded up to the next whole number
4	> 100, with an individual weight of > 14 g or > 0.5 ounce	0.5% of the declared net quantity, rounded up to the next whole number

SCHEDULE 5

(Section 216, subsection 260(1), paragraphs 301(5)(b) and 314(c), subsection 318(1) and section 319)

Minimum Type Size — Principal Display Surface

Item	Column 1 Area of Principal Display Surface (cm2)	Column 2 Area of Principal Display Surface (inches2)	Column 3 Minimum Character Height (mm)	Column 4 Minimum Character Height (inch)
1	≤ 32	≤ 5	1.6	1/16
2	> 32 but ≤ 258	> 5 but ≤ 40	3.2	1/8
3	> 258 but ≤ 645	> 40 but ≤ 100	6.4	1/4
4	> 645 but ≤ 2 580	> 100 but ≤ 400	9.5	3/8
5	> 2 580	> 400	12.7	1/2

SCHEDULE 6

(Section 263)

Identification Names for Food Packaged in Syrup or Fruit Juice

Item	Column 1 Food	Column 2 Percentage of Soluble Solids	Column 3 Identification Names
1	(1) Apricots (2) Blackberries (3) Boysenberries (4) Cherries (sour, pitted) (5) Crabapples (6) Currants (7) Gooseberries (8) Lawtonberries (9) Loganberries (10) Raspberries (red and purple) (11) Rhubarb (12) Strawberries (13) Thimbleberries (14) Apples (15) Blueberries (16) Cherries (sweet) (17) Plums and prune plums (18) Grapefruits	(a) ≥ 25% but ≤ 35%	(a) Extra Heavy Syrup or Extra Heavy Fruit Juice Syrup
		(b) ≥ 19% but < 25%	(b) Heavy Syrup or Heavy Fruit Juice Syrup
		(c) ≥ 15% but < 19%	(c) Light Syrup or Light Fruit Juice Syrup
		(d) ≥ 11% but < 15%	(d) Slightly Sweetened Water or Slightly Sweetened Fruit Juice
		(e) ≥ 5% but < 11%	(e) Packaged in (naming the Fruit) Juice or Packaged in Mixed Fruit Juice
2	(1) Cantaloupes and melons (2) Fruit cocktail (3) Fruit salad and tropical fruit salad (4) Fruits for salad (5) Peaches (6) Pears (7) Pineapples (8) Mandarin oranges (9) Sweet potatoes	(a) ≥ 23% but ≤ 35%	(a) Extra Heavy Syrup or Extra Heavy Fruit Juice Syrup
		(b) ≥ 18% but < 23%	(b) Heavy Syrup or Heavy Fruit Juice Syrup
		(c) ≥ 14% but < 18%	(c) Light Syrup or Light Fruit Juice Syrup
		(d) ≥ 10% but < 14%	(d) Slightly Sweetened Water or Slightly Sweetened Fruit Juice
		(e) ≥ 5% but < 10%	(e) Packaged in (naming the Fruit) Juice or Packaged in Mixed Fruit Juice
3	(1) Maraschino cherries	(a) ≥ 40%	(a) Extra Heavy Syrup or Extra Heavy Fruit Juice Syrup

SCHEDULE 7

(Subsection 275(1))

Word or Expression on Label of Edible Meat Product

Item	Column 1 Word or Expression	Column 2 Requirements
1	"Baked" "Oven Roasted"	Subjected to dry heat without direct contact with a flame for a time sufficient to produce the characteristics of a baked or roasted meat product, such as a brown crust on the surface, rendering of surface fat or caramelization of sugar. The meat product must be ready-to-eat.
2	"Barbecued"	Cooked with seasoning. The meat product must be ready-to-eat.
3	"Basted" "Deep Basted" "Pre-basted" "Self-basting"	Injected with meat broth that contains at least 15% solid matter, no more than 3% of which is composed of the following ingredients or any combination of them: (a) edible fats or oils of vegetable origin; and (b) butter.
4	"Breaded"	Coated with a combination of batter and bread or cracker crumbs.
5	"Cooked" "Fully Cooked"	Subjected to heat for a time sufficient to produce the characteristics of a cooked meat product in respect of friability, colour, texture and flavour. The meat product must be ready-to-eat.
6	"Corned"	Cured.
7	"Dried" "Dry" "Semi-dry"	Dehydrated. The meat product must be ready-to-eat.
8	"Freeze-dried"	Dehydrated by freeze-drying.
9	"Jellied"	Has a gelling agent added in an amount exceeding 0.25% of the meat product.
10	"Rolled"	Boned, rolled and tied.
11	"Semi-boneless"	At least 45% deboned.
12	"Shankless"	In the case of a foreleg, has the forelimb removed at the elbow joint; in the case of a hind leg, has the hind limb removed at the knee joint.
13	"Smoked"	Smoked in accordance with the Food and Drug Regulations.
14	"Stuffed" "Stuffed with"	Stuffed with an edible meat product that has been cooked or dehydrated or to which has been added any substance, other than any meat, meat by-product or mechanically separated meat, or stuffed with one or more of the following ingredients: bread, grains, fruits, nuts, vegetables or similar ingredients. The edible meat product may contain seasoning and animal or vegetable fat.
15	"With Giblets"	Contains a liver, heart or gizzard or any combination of them from a food animal of the same species.
16	"With Natural Juices"	Packaged in a package that contains the juices that result from the cooking of the edible meat product.

SCHEDULE 8

(Clauses 347(1)(c)(i)(B) and (D), paragraph 351(c) and sections 355 and 356)

Product Legend

The product legend is to appear in black with a white background (as illustrated), in black with a transparent background or in colour. If it appears in colour, the background is white or transparent, the outer and inner borders as well as the hills are green (Pantone no. 368), the maple leaf is red (Pantone no. 186) and the lettering is black.

[3-1-o]