Canada Gazette, Part I, Volume 148, Number 50: titre

December 13, 2014

Regulations Amending the Food and Drug Regulations (Food — Various Subjects)

Statutory authority

Food and Drugs Act

Sponsoring department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

Pursuant to the Jobs, Growth, and Long-term Prosperity Act (Bill C-38), the Department of Health (the Department) has undertaken a number of initiatives to create a more efficient and responsive regulatory framework for foods. These proposed regulatory amendments are designed to implement specific efficiencies enabled by Bill C-38.

Bill C-38 replaced Interim Marketing Authorizations (IMAs) with the more efficient and scientifically responsive Marketing Authorizations (MAs). In light of this change, the repeal of provisions in the Food and Drug Regulations (FDR) that formerly applied to IMAs is being proposed.

To fulfill the intention of Bill C-38 to make regulating substances that occur or are used in food more efficient, the repeal of provisions in the FDR and the regulatory table respecting the maximum residue limits for veterinary drugs is also being proposed. Those provisions are no longer needed, as the maximum residue limits are now more efficiently identified in a Marketing Authorization.

Similarly, it is proposed to repeal the provisions in the FDR and the regulatory table respecting maximum or trace levels of contaminants and other adulterating substances and replace them with a single, more scientifically responsive List of Contaminants and Other Adulterating Substances in Food that would be incorporated by reference in the FDR.

As a continuation of previous work conducted with respect to food additives in implementing Bill C-38, the repeal of provisions in Part E relating to saccharin is being proposed in order to enable the inclusion of saccharin as a food additive in table-top sweeteners in the new Marketing Authorization for Food Additives That May Be Used as Sweeteners.

Background

With the enactment of the Jobs, Growth and Long-term Prosperity Act, the Food and Drugs Act (FDA) was amended to give the Minister of Health (the Minister) the authority to issue MAs to permit the use of specific substances in foods (e.g. food additives and veterinary drug residues in foods) and health representations/claims for foods. The amendments also provided an expanded authority to incorporate by reference public documents into MAs, or directly into the FDR. These amendments were intended to allow the Minister to act rapidly on certain science and safety decisions, and to improve efficiency in the food regulatory system, ultimately making it more responsive to emerging health and safety issues.

Interim Marketing Authorizations (IMAs)

IMAs can no longer be issued because the new authority to issue MAs replaced the authority to issue IMAs in the Food and Drugs Act. As a result, section B.01.056 of the FDR respecting the process for applying for an IMA is no longer relevant. All existing IMAs were grandfathered and kept active until they expired two years after they were issued.

Maximum Residue Limits (MRLs) for Veterinary Drugs in Foods

On May 22, 2013, the Department issued a Marketing Authorization for Maximum Residue Limits for Veterinary Drugs in Foods, which incorporated by reference the List of Maximum Residue Limits for Veterinary Drugs in Foods. This List is based on the existing Table III of veterinary drug maximum residue limits of Part B, Division 15, of the FDR. The Standing Joint Committee for the Scrutiny of Regulations (SJCSR) has written to the Department requesting that it address redundancies and inconsistencies between the list incorporated into the Marketing Authorization for Maximum Residue Limits (MRLs) for Veterinary Drugs in Foods and Table III in Division 15 of the FDR. The Committee has stated that industry may potentially be confused as to which rules apply since the documents contain different MRLs in some cases. Consequently, this proposal would address the redundancies and inconsistencies by removing Table III from the FDR.

Contaminants and other adulterating substances in foods

Maximum levels (MLs) pertaining to certain contaminants in foods are presently prescribed as tolerances in Table I of Division 15 of the FDR. Sections B.01.046 and B.01.047 set out prohibitions and exemptions to the prohibitions with respect to adulterants in foods. MLs pertaining to certain contaminants and other adulterating substances are also found in the guidance document Canadian Standards (Maximum Levels) for Various Chemical Contaminants in Foods. The Minister has established 11 new MLs through guidance documents since the 1970s (rather than amending regulations) since these can be more easily updated as science evolves and food safety issues that require prompt action to avoid toxicity are identified. While this has allowed the efficient establishment of up-to-date MLs, the result is two parallel sets of maximum levels — one within and one without the FDR.

In pursuing the opportunity to make additional changes to Division 15, beyond those addressing veterinary drug residues in food, to address contaminants and other adulterants in food, the Department is proposing amendments in order to gain regulatory efficiencies and advance the following policy objectives:

Saccharin sweeteners

Saccharin was de-listed in the 1970s as a food additive in Canada on the basis of a study suggesting a human health concern about the ingestion of saccharin. However, access to saccharin sweeteners sold under certain restrictions was maintained under Part E of the FDR. A more recent submission to the Department requesting that saccharin be reconsidered as a food additive prompted another safety evaluation in which it was concluded that the study in question was not relevant to humans. It was also concluded that the body of scientific evidence supported the safety of saccharin as a food additive when it is used under prescribed conditions. This conclusion is consistent with the positions of both the Joint FAO/WHO Expert Committee on Food Additives (JECFA) of the Food and Agriculture Organization of the United Nations and the World Health Organization and the European Commission's Scientific Committee on Foods. The Department recently enabled the use of saccharin as a food additive in a number of unstandardized foods and is proposing to extend this use to table-top sweeteners. In order to do so, the regulatory restrictions on the sale of saccharin that were introduced to Part E of the FDR at the time that saccharin was de-listed as a food additive must be removed.

Objectives

The objectives of this proposal are the following:

Description

In keeping with the legislative authorities of the Jobs, Growth, and Long-term Prosperity Act, and to achieve efficiency gains, the Department is undertaking the following amendments to the FDR.

Interim Marketing Authorizations (IMAs)

The amendments made to the FDA through Bill C-38 included the Minister's new Marketing Authorization authority, which replaced the Minister's authority to issue IMAs. Existing IMAs were grandfathered; however, with the new MA authorities in force, no new IMAs may be issued. Section B.01.056 of the FDR regarding the process to apply for an IMA is therefore no longer relevant and would be repealed.

Maximum Residue Limits (MRLs) for Veterinary Drugs in Foods

The Minister has issued a Marketing Authorization for Maximum Residue Limits for Veterinary Drugs in Foods that incorporates by reference an ambulatory list replicating Table III currently in Division 15 of the FDR. Therefore, Table III would be repealed.

Residues of veterinary drugs in food are considered adulterants, and foods that contain such residues are subject to paragraph 4(1)(d) of the FDA. The MA exempts a food containing residues of veterinary drugs below set MRLs from paragraphs 4(1)(a) and (d) of the FDA in the same manner that section B.15.003 was used in the FDR. Since the new MA contains the exemption from paragraph 4(1)(d) of the FDA, section B.15.003 is redundant and would be repealed.

Amendments are also proposed to resolve a discrepancy between Part B and Part C of the FDR in relation to the presence in food of drugs listed in subsection B.01.048(2) and paragraph C.01.611(1)(b). Specifically, paragraphs B.01.048(1)(b) and (c) currently prohibit the use of any drug listed in subsection B.01.048(2) in meat, meat by-products, eggs or milk intended for consumption. This provision would be amended to prohibit the use of those drugs in any food; the reference to meat, meat by-products, eggs or milk would be replaced by a reference to “any food.” This amendment would be consistent with Part C (section C.01.610.1), which prohibits the sale of the drugs listed in sub-section B.01.048(2) for administration to animals that produce food or are consumed as food.

Similarly, paragraph C.01.611(1)(a) is being amended to replace the reference to “residues within the limits prescribed by these Regulations” with a reference to the maximum residue limits set out in the list referred to in the Marketing Authorization for Maximum Residue Limits for Veterinary Drugs in Foods, since these limits will no longer be set out in the FDR given the proposed repeal of Table III to Division 15.

Paragraph C.01.611(1)(b) is also being amended to replace the reference to “meat, meat by-products, eggs or milk” with a reference to “food,” in order to reflect the fact that other foods derived from animals can also be set out in the list referred to in the Marketing Authorization for Maximum Residue Limits for Veterinary Drugs in Foods.

Contaminants and other adulterating substances in foods

It is proposed to consolidate MLs listed as tolerances in Table I of Division 15 and the rules set out in sections B.01.046 and B.01.047 into a list that would be incorporated by reference in section B.15.001 of Division 15 of the FDR. The list would be maintained on an administrative basis and published on the Department's Web site, similar to what is currently being done for food additives and MRLs for veterinary drugs in foods. Consequently, sections B.01.046 and B.01.047 and Table I of Division 15 would be removed from the FDR.

The publication of the List of Contaminants and Other Adulterating Substances in Foods on the Department's Web site will coincide with the coming into force of the proposed amendments following their publication in the Canada Gazette, Part II. This will ensure continuity in the applicability of the existing rules for contaminants and other adulterating substances. Moving forward, changes to the list will be made administratively using the Minister's authority set out in Bill C-38, following established processes.

Saccharin sweeteners

On April 24, 2014, saccharin was added to the List of Permitted Sweeteners and is permitted for use in a number of foods, but not in table-top sweeteners, the only food category in which it cannot be authorized until it is removed from Part E of the FDR. Regulatory amendments are proposed to amend Part E of the FDR to eliminate the current conditions of sale applicable to saccharin in table-top sweeteners by removing references to “saccharin sweeteners.” Including saccharin in the List of Permitted Sweeteners incorporated by reference in the Marketing Authorization for Food Additives That May Be Used as Sweeteners would permit it to be used in table-top sweeteners. Moving forward, the list would be maintained administratively using the Minister's authority established in Bill C-38.

Miscellaneous amendments

Subparagraph B.02.100(b)(iii) of the FDR contains an error in the English version. Language pertaining to subparagraph B.02.100(b)(iv) [“(iv) yeast foods, in accordance with Table XIV to section B.16.100”] was inadvertently added to the above-mentioned provision and a repeal of the added language is therefore proposed.

Section B.14.004 of the FDR contains an error in the French version. An [N] symbol representing a standard is found in the French version when in fact the provision does not prescribe a standard. The English version is correct; an amendment to the French version to remove the [N] symbol is being proposed.

“One-for-One” Rule

The “One-for-One” Rule does not apply to this proposal as the amendments do not introduce new or incremental administrative burden costs to business.

Small business lens

The proposed amendments to the FDR would not impose annual nationwide costs over $1 million, nor would they have a disproportionate impact on any small businesses. As a result, the small business lens does not apply.

Consultation

This proposal reflects various amendments to the FDR. The following is a brief summary of consultations on these issues.

Interim Marketing Authorizations (IMAs) and Marketing Authorizations (MAs)

The amendments to replace the IMA authorities with MAs and to permit incorporation by reference were introduced with the Jobs, Growth, and Long-Term Prosperity Act and consultations on them were held during the legislative process. Included in the consultations were the next steps the Department would take, including this regulatory proposal, to ensure further efficiencies.

Maximum Residue Limits (MRLs) for veterinary drugs for foods

On February 2, 2013, a Notice of Intent (NOI) was published in the Canada Gazette, Part I, outlining the Minister's new authority to create a Marketing Authorization (MA) for veterinary drug MRLs. The NOI invited stakeholder comments for 60 days, during which time the Department received no comments.

Contaminants and other adulterating substances in food

Consultations have not been held on the proposed amendments to repeal sections B.01.046 and B.01.047 and Table I to Division 15 and to create a List of Contaminants and Other Adulterating Substances in Foods, which would be incorporated by reference in Division 15 of the FDR. The intent is to house existing rules, which have previously undergone consultation, in one list. Therefore, there is no need to proceed with a technical consultation on the rules themselves. This is considered a technical amendment to provide a more efficient regulatory process. Incorporating by reference the List of Contaminants and Other Adulterating Substances in Foods would allow the Department to administratively modify the list based on current science and to respond in a timely manner to emerging issues that can have an impact on the health and safety of consumers. The Department would conduct technical consultations on any proposed future modifications to the list, after it is established, as part of an established administrative procedure.

Saccharin sweeteners

Consultation was undertaken in November 2006 and stakeholders expressed support for the reinstatement of saccharin as a food additive. Some stakeholders requested additional information on the Department's evaluation, in particular the various studies used by the Department's scientists to review the safety of saccharin. The Bureau of Chemical Safety in the Department's Food Directorate provided these stakeholders with an extensive list of studies that had been reviewed during this assessment and the relevant references.

Other stakeholders requested clarification pertaining to the use of saccharin during pregnancy and the labelling requirements associated with the use of this additive. The Department responded to these questions by providing an overview of the animal studies that were conducted to examine possible effects of saccharin on the fetus. These studies provided the scientific evidence to support the conclusion that saccharin can be safely consumed by humans, including pregnant or breastfeeding women.

A Notice of Proposal was posted on the Department's Web site in October 2013 to advise stakeholders of the Department's intention to enable the use of saccharin, calcium saccharin, potassium saccharin and sodium saccharin as sweeteners in various unstandardized foods, with the exception of table-top sweeteners.

In response, three comments were received from domestic and foreign industry associations. All three association responses indicated support for the proposal. A fourth was received from a foreign government.

One of the associations and the foreign government requested that modifications to the listing be made to allow for broader use of these food additives. In response, the Department indicated that the permitted foods to which the sweeteners can be added and the maximum levels of use are determined by the results of the safety evaluation of the requested maximum levels of use and the requested foods set out in the food additive submission. The Department also indicated that it could consider a new food additive submission requesting an extension of use so that these sweeteners could be added to a new food or be used at a different maximum level.

Rationale

These amendments would meet the objective of creating administrative efficiencies, one of the objectives of the Jobs, Growth and Long-term Prosperity Act, and remove redundant provisions in the FDR to prevent possible confusion.

With respect to contaminants and other adulterating substances, proceeding with the incorporation by reference of a List of Contaminants and Other Adulterating Substances in Foods would strengthen regulatory responsiveness and efficiency by enabling the Department to amend its health and safety rules in response to new science and/or emerging issues in a more timely fashion. Similar regulatory structures are already in place for food additives and veterinary drug MRLs and have proven a great success. Furthermore, consolidating rules within a single list will facilitate stakeholder compliance.

The removal of the saccharin provisions in Part E would be a benefit to the food industry as it would allow saccharin to be used in table-top sweeteners in a manner consistent with the use of other permitted sweeteners in table-top sweeteners. This would also allow for consistency in labelling and at points of sale with other table-top sweeteners.

Implementation, enforcement and service standards

The Department is proposing that the amendments come into force on the day in which they are registered.

The regulatory proposal also includes transitional provisions that permit the sale of saccharin sweeteners. These provisions will be in place when the new amendments are registered to continue compliance in accordance with Part E of the former Regulations for one year beginning on the day on which the proposed Regulations come into force. The transitional period will allow existing saccharin sweeteners to become compliant with the new requirements.

These amendments do not alter existing compliance activities under the provisions of the FDA and the FDR, which are enforced by the Canadian Food Inspection Agency.

Contact

Dionne Saul-Hamilton
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Canada
Holland Cross, Tower B, 5th Floor
1600 Scott Street
Address Locator: 3105A
Telephone: 613-960-6851
Fax: 613-941-7104
Email: LRM_MLR_consultations@hc-sc.gc.ca

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council, pursuant to subsections 30(1) (see footnote a) and 30.5(1) (see footnote b) of the Food and Drugs Act (see footnote c), proposes to make the annexed Regulations Amending the Food and Drug Regulations (Food — Various Subjects).

Interested persons may make representations concerning the proposed Regulations within 75 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 Dino Covone, Senior Policy Analyst, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Canada, Holland Cross, Tower B, 5th Floor, 1600 Scott Street, Address Locator: 3105A, Ottawa, Ontario K1A 0K9 (fax: 613-941-7104; email: LRM_MLR_consultations@hc-sc.gc.ca).

Ottawa, December 4, 2014

JURICA ČAPKUN
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (FOOD — VARIOUS SUBJECTS)

AMENDMENTS

1. Subsection B.01.001(1) of the Food and Drug Regulations (see footnote 1) is amended by adding the following in alphabetical order:

“List of Contaminants and Other Adulterating Substances in Foods” means the List of Contaminants and Other Adulterating Substances in Foods, published by the Department of Health on its website, as amended from time to time; (Liste de contaminants et d'autres substances adultérantes dans les aliments)

2. Sections B.01.046 and B.01.047 of the Regulations are repealed.

3. Paragraphs B.01.048(1)(b) and (c) of the Regulations are replaced by the following:

4. Section B.01.056 of the Regulations is repealed.

5. Subparagraph B.02.100(b)(iii) of the English version of the Regulations is replaced by the following:

6. The portion of section B.14.004 of the French version of the Regulations before paragraph (a) is replaced by the following:

B.14.004. La viande, les sous-produits de viande ou leurs préparations sont falsifiés s'ils renferment ou si on leur a ajouté l'une des substances ou catégories de substances nommées ci-dessous :

7. Section B.15.001 of the Regulations is replaced by the following:

B.15.001. (1) A food referred to in column 2 of Part 1 of the List of Contaminants and Other Adulterating Substances in Foods is adulterated if the corresponding substance referred to, by name or class, in column 1 is present in or on the food.

(2) A food referred to in column 2 of Part 2 of the List of Contaminants and Other Adulterating Substances in Foods is adulterated if the corresponding substance referred to, by name or class, in column 1 is present in or on the food in an amount that exceeds the maximum level set out in column 3.

(3) If a substance referred to, by name or class, in column 1 in Part 2 the List of Contaminants and Other Adulterating Substances in Foods is present in or on the corresponding food referred to in column 2, the food is, in respect of the presence of the substance, exempt from the application of paragraph 4(1)(a) of the Act if the amount of the substance does not exceed the maximum level set out in column 3.

(4) Subsections (1) to (3) do not apply to a substance that is present in or on a food as

8. Section B.15.003 of the Regulations is repealed.

9. Tables I and III to Division 15 of Part B of the Regulations are repealed.

10. Paragraphs C.01.611(1)(a) and (b) of the Regulations are replaced by the following:

11. The heading of Part E of the Regulations is replaced by the following:

CYCLAMATE SWEETENERS

12. Section E.01.001 of the Regulations is replaced by the following:

E.01.001. (1) In this Part, “cyclamate sweetener” means any of the following substances sold as a sweetener:

(2) Part B does not apply to any cyclamate sweetener.

13. Section E.01.002 of the Regulations is replaced by the following:

E.01.002. No person shall sell a cyclamate sweetener that is not labelled as required by this Part.

14. Section E.01.003 of the Regulations is replaced by the following:

E.01.003. No person shall, in advertising a cyclamate sweetener to the general public, make any representation other than with respect to the name, price and quantity of the sweetener.

15. Section E.01.004 of the Regulations is replaced by the following:

E.01.004. Every cyclamate sweetener shall be labelled to state that it should be used only on the advice of a physician.

16. Section E.01.005 of the Regulations is replaced by the following:

E.01.005. Every cyclamate sweetener shall be labelled to show

TRANSITIONAL PROVISIONS

17. (1)In this section,

“former Regulations” means the Food and Drug Regulations as they read immediately before the day on which these Regulations come into force. (règlement antérieur)

“saccharin sweetener” means a saccharin sweetener as defined in subsection E.01.001(1) of the former Regulations. (édulcorant à la saccharine)

(2) Despite sections 11 to 16, if, on the day immediately before the day on which these Regulations come into force, a saccharin sweetener was sold in accordance with Part E of the former Regulations, the sale of the sweetener may continue in accordance with Part E of the former Regulations for a period of one year beginning on the day on which these Regulations come into force.

COMING INTO FORCE

18. These Regulations come into force on the day on which they are registered.

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