Vol. 145, No. 26 — December 21, 2011
Registration
SOR/2011-280 December 2, 2011
FOOD AND DRUGS ACT
Regulations Amending the Food and Drug Regulations (1614 — Food Additives)
P.C. 2011-1388 December 1, 2011
His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act (see footnote b), hereby makes the annexed Regulations Amending the Food and Drug Regulations (1614 — Food Additives).
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS
(1614 — FOOD ADDITIVES)
AMENDMENTS
1. Paragraph B.14.005(a) of the Food and Drug Regulations (see footnote 1) is replaced by the following:
- (a) a Class II preservative;
- (a.1) in the case of prepared hams, shoulders, butts, picnics and backs, gelatin;
2. (1) Paragraph B.14.031(a) of the English version of the Regulations is replaced by the following:
- (a) a Class I preservative;
(2) Section B.14.031 of the Regulations is amended by adding the following after paragraph (a):
- (a.1) a Class II preservative;
3. Paragraph B.14.032(d) of the Regulations is amended by adding the following after subparagraph (xi):
(xi.1) a Class II preservative,
4. Section B.14.033 of the Regulations is replaced by the following:
B.14.033.[S]. Potted Meat, Meat Paste or Meat Spread shall be fresh or preserved meat that is comminuted and cooked, and may contain meat binder, salt, sweetening agents, spices, other seasonings, a gelling agent, sodium acetate and sodium diacetate and shall have a total protein content of not less than 9%.
5. Section B.14.035 of the Regulations is replaced by the following:
B.14.035.[S]. Meat Loaf, Meat Roll, Meat Lunch or Luncheon Meat shall be fresh or preserved meat that is comminuted, cooked and pressed into shape, and may contain a dried skim milk product obtained from skim milk by the reduction of its calcium content and a corresponding increase in its sodium content, in an amount not exceeding 3% of the finished food, as well as filler, meat binder, salt, sweetening agents, glucono delta lactone, spices, other seasonings, milk, eggs, a gelling agent, sodium acetate, sodium diacetate and partially defatted beef fatty tissue or partially defatted pork fatty tissue, and shall have a total protein content of not less than 11%.
6. (1) The portion of section B.14.037 of the Regulations after paragraph (c) is replaced by the following:
- (d) may contain
- (i) a Class I preservative, and
- (ii) a Class II preservative.
- (i) a Class I preservative, and
(2) Section B.14.037 of the Regulations is renumbered as subsection B.14.037(1) and is amended by adding the following:
(2) For the purpose of subsection (1), scalps and snouts are considered to be head meat.
7. Part Ⅱ of Table XI to section B.16.100 of the Regulations is amended by adding the following before item S.1:
Item No. |
Column I |
Column II |
Column III |
|---|---|---|---|
S.01 |
Sodium Acetate |
(1) Brawn; Headcheese; Meat by-product loaf; Meat loaf; Potted meat; Potted meat by-product; Prepared meat; Prepared meat by-product; Prepared poultry meat; Prepared poultry meat by-product; Preserved meat; Preserved meat by-product; Preserved poultry meat; Preserved poultry meat by-product; Sausage (2) Unstandardized preparations of
|
(1) Good Manufacturing Practice
|
8. Part Ⅱ of Table XI to section B.16.100 of the Regulations is amended by adding the following after item S.2:
Item No. |
Column I |
Column II |
Column III |
|---|---|---|---|
S.21 |
Sodium Diacetate |
(1) Brawn; Headcheese; Meat by-product loaf; Meat loaf; Potted meat; Potted meat by-product; Prepared fish or prepared meat (Division 21); Prepared meat; Prepared meat by-product; Prepared poultry meat; Prepared poultry meat by-product; Preserved fish or preserved meat (Division 21); Preserved meat; Preserved meat by-product; Preserved poultry meat; Preserved poultry meat by-product; Sausage (2) Unstandardized preparations of
|
(1) 0.25% of final product weight
|
9. Section B.21.006 of the Regulations is amended by striking out “and” at the end of paragraph (r), by adding “and” at the end of paragraph (s) and by adding the following after paragraph (s):
- (t) contain a Class II preservative.
10. The portion of section B.21.021 of the Regulations before paragraph (a) is replaced by the following:
B.21.021.[S]. Preserved fish or preserved meat shall be cooked or uncooked fish or meat that is dried, salted, pickled, cured or smoked and may contain a Class I preservative, a Class II preservative, dextrose, glucose, spices, sugar and vinegar, and
11. Section B.22.006 of the Regulations is amended by adding the following after paragraph (a):
- (a.1) a Class II preservative;
12. Paragraph B.22.021(a) of the Regulations is replaced by the following:
- (a) a Class I preservative;
- (a.1) a Class II preservative;
COMING INTO FORCE
13. These Regulations come into force on the day on which they are registered.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Regulations.)
Issue and objectives
The Food and Drug Regulations (“the Regulations”) regulate the sale and use of food additives in Canada, listing the permitted food additives and how they may be used. Health Canada has received submissions from industry requesting that the Regulations be amended to permit the use of sodium acetate as a preservative in standardized and unstandardized preparations of meat, meat by-products, poultry meat, or poultry meat by-products, at a maximum level of use consistent with good manufacturing practice, and to permit the use of sodium diacetate as a preservative in standardized and unstandardized preparations of meat, meat by-products, poultry meat, or poultry meat by-products, prepared and preserved fish products, at a maximum level of use of 0.25% of final product weight.
Sodium acetate is currently listed in Table X to section B.16.100 of the Regulations for use as a pH adjusting agent in unstandardized foods at a maximum level of use consistent with good manufacturing practice. In addition, provision exists in Table XIII for the use of sodium acetate as a starch modifying agent in starch at a maximum level of use consistent with good manufacturing practice. Sodium diacetate is currently listed in Part Ⅲ of Table XI to section B.16.100 of the Regulations for use as a preservative in bread and in unstandardized foods (excluding unstandardized preparations of a meat and meat by-product, unstandardized fish and unstandardized poultry meat and poultry meat by-product), at a maximum level of use of 3 000 ppm.
Evaluation of available data supports the safety and effectiveness of these food additives in the above specified uses. Therefore, the amendments to the Regulations permit the extended use of these food additives as described.
These amendments benefit the consumers by allowing greater availability of food products while continuing to help protect their health and safety. In addition, these amendments benefit industry by providing the meat, poultry meat and fish industry with two additional antimicrobial preservatives to enhance the safety of meat, poultry meat and fish products.
Description and rationale
These amendments enable the extended use of sodium acetate currently listed in the tables to section B.16.100 of the Regulations as a pH-adjusting agent and as a starch-modifying agent and the extended use of sodium diacetate currently listed in Table XI to section B.16.100 of the Regulations as a Class III preservative. These amendments permit the use of sodium acetate as a Class II preservative in standardized and unstandardized preparations of meat, meat by-products, poultry meat, or poultry meat by-products, at a maximum level of use consistent with good manufacturing practice. In addition, the amendments permit the use of sodium diacetate as a Class II preservative in standardized and unstandardized preparations of meat, meat by-products, poultry meat, poultry meat by-products, prepared and preserved fish products, at a maximum level of use of 0.25% of final product weight.
There is no anticipated increase in cost to government from the administration of these amendments to the Regulations. Furthermore, compliance costs incurred by the manufacturers are not considered to be a factor because the use of food additives is optional.
Interim Marketing Authorizations (“IMAs”) have been issued to permit the immediate use of these food additives as proposed in the submissions while the regulatory process was undertaken to amend the Regulations. They were published in the Government notices section of the Canada Gazette, Part Ⅰ, on
- September 20, 2008 — sodium acetate as a preservative in standardized and unstandardized preparations of meat, meat by-products, poultry meat, or poultry meat by-products, at a maximum level of use consistent with good manufacturing practice;
- September 20, 2008 — sodium diacetate as a preservative in standardized and unstandardized preparations of meat, meat by-products, poultry meat, poultry meat by-products, prepared and preserved fish products, at a maximum level of use of 0.25% of final product weight; and
- February 14, 2009 — sodium diacetate as a preservative in standardized prepared and preserved fish products, at a maximum level of use of 0.25% of final product weight.
The IMAs expired on September 20, 2010, for sodium acetate in standardized and unstandardized preparations of meat, meat by-products, poultry meat, poultry meat by-products and for sodium diacetate in standardized and unstandardized preparations of meat, meat by-products, poultry meat, poultry meat by-products, prepared and preserved fish products, and on February 14, 2011, for sodium diacetate in standardized prepared and preserved fish products. Health Canada confirms that the results of the pre-market safety assessment that were conducted prior to the issuance of these IMAs remain valid.
The Minister has the option to recommend or not to the Governor in Council that the Regulations be amended to permit the uses described above of these food additives. Based on its safety and efficacy assessment and the history of safe use of sodium acetate in standardized and unstandardized preparations of meat, meat by-products, poultry meat, or poultry meat by-products and of sodium diacetate in standardized and unstandardized preparations of meat, meat by-products, poultry meat, poultry meat by-products, prepared and preserved fish products since the publication of the IMAs, the Minister is recommending to amend the Regulations to enable the extended uses of these food additives.
Consultation
The amendments permit the extended use of sodium acetate and sodium diacetate in foods for which standards are set out in Division 14 (Meat, its Preparations and Products) and in Division 22 (Poultry, Poultry Meat, Their Preparations and Products), and the extended use of sodium diacetate for which standards are set out in Division 21 (Marine and Fresh Water Animal Products) of the Regulations. Consequently, input regarding the use of these food additives was sought from the Canadian Meat Council, the Further Poultry Processors Association of Canada, the Canadian Poultry and Egg Processors Council, and the Canadian Food Inspection Agency (CFIA). All groups have expressed their support for these amendments to the Regulations.
In addition, Health Canada has announced the publication of the IMAs for these food additives through postings on its Web site. Health Canada also notified World Trade Organization members of these IMAs and the proposed regulatory amendments at the time of publication of the IMAs in the Canada Gazette, Part Ⅰ. The IMAs for sodium acetate in standardized and unstandardized preparations of meat, meat by-products, poultry meat, or poultry meat by-products and for sodium diacetate in standardized and unstandardized preparations of meat, meat by-products, poultry meat, poultry meat by-products, prepared and preserved fish products were published in the Canada Gazette, Part Ⅰ, in 2008 and the IMA for sodium diacetate in standardized prepared and preserved fish products was published in the Canada Gazette, Part Ⅰ, in 2009. These publications were followed by a 75-day comment period. The Government has received no comments regarding the safety of the use of these food additives.
Implementation, enforcement and service standards
The CFIA is responsible for the enforcement of the Food and Drugs Act and the Regulations with respect to foods. The CFIA uses a science-based risk management approach to set its food safety priorities. Using this approach as its foundation, the CFIA plans its inspection and testing programs for foods, taking into account the degree of risk associated with a particular sector and would concentrate its resources where risk is the greatest. Each CFIA commodity inspection program performs ingredient verifications at which time inspectors compare formulation and list of ingredients, and perform on-site verification of the manufacture of the product. The frequency of inspection depends on the compliance history in relation to the manufacturing of a particular type of food product, the compliance history of the manufacturer and the food safety risk.
Contact
Barbara Lee
Director
Bureau of Chemical Safety
Health Canada
251 Sir Frederick Banting Driveway
Tunney’s Pasture
Address Locator: 2203B
Ottawa, Ontario
K1A 0K9
Telephone: 613-957-0973
Fax: 613-954-4674
Email: sche-ann@hc-sc.gc.ca
Footnote a
S.C. 2005, c. 42, s. 2
Footnote b
R.S., c. F-27
Footnote 1
C.R.C., c. 870