Vol. 144, No. 6 — March 17, 2010

Registration

SOR/2010-40 February 23, 2010

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1587 — Food Additives)

P.C. 2010-209 February 23, 2010

Her 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 (1587 — Food Additives).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1587 — FOOD ADDITIVES)

AMENDMENTS

1. Paragraph B.08.049(b) of the Food and Drug Regulations (see footnote 1) is amended by striking out “and” at the end of subparagraph (iii), by adding “and” at the end of subparagraph (iv) and by adding the following after subparagraph (iv):

(v) sodium hexametaphosphate, in the case of liquid whey destined for the manufacture of concentrated or dried whey products.

2. Item S.3 of Table XII to section B.16.100 of the Regulations is amended by adding, in columns II and III, the following after subitem (6):

Item No.	Column II Permitted in or Upon	Column III Maximum Level of Use
S.3	(7) Liquid whey destined for the manufacture of concentrated or dried whey products	(7) 800 p.p.m. in the concentrated or dried whey products

3. Subsection B.25.062(2) of the Regulations is amended by striking out “or” at the end of paragraph (e), by adding “or” at the end of paragraph (f) and by adding the following after paragraph (f):

(g) infant formula that contains concentrated or dried whey products manufactured with liquid whey to which sodium hexametaphosphate has been added.

COMING INTO FORCE

4. 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 a submission from industry requesting that the Regulations be amended to permit the use of sodium hexametaphosphate at a maximum level of use of 148 parts per million (p.p.m.) as a sequestering agent in liquid whey during the evaporation process, resulting in a level of 731 p.p.m. in the concentrated or dried whey products following the evaporation process. The evaporated products include whey liquid concentrate, powder and its derivatives; whey liquid or powder protein concentrate; and whey lactose liquid concentrate or powder. These concentrated or dried whey products are used as ingredients in a variety of foods, including infant formula.

Evaluation of available data supports the safety and effectiveness of this food additive in the above specified use. These amendments to the Regulations permit the use of sodium hexametaphosphate in liquid whey as a sequestering agent for the manufacture of concentrated or dried whey products at a maximum level of use not exceeding 800 p.p.m. in the concentrated or dried whey products, and permit these whey products to be used in infant formula. Since there are no safety concerns regarding the use of sodium hexametaphosphate as a sequestering agent in liquid whey, these amendments also permit the resulting evaporated whey products to be used as ingredients in a variety of foods that were not the subject of submissions to Health Canada. These amendments also reduce the regulatory burden to both government and industry.

The new use of sodium hexametaphosphate benefits the consumers by allowing greater availability of quality food products, while continuing to protect their health and safety. In addition, the use of sodium hexametaphosphate benefits industry by facilitating the manufacture of quality food products.

Description and rationale

These amendments to the Regulations enable the use of sodium hexametaphosphate, a food additive currently listed in the Tables to section B.16.100, as a sequestering agent in liquid whey during the evaporation process.

There is no anticipated increase in cost to government from the administration of these amendments to the Regulations. The use of food additives is optional and therefore a manufacturer choosing to use a food additive in its products voluntarily assumes the costs associated with its use and compliance with the Regulations.

The only regulatory options available to address this submission are for the Minister to recommend or not to the Governor in Council that the Regulations be amended to permit the new use for this food additive. Based on its safety and efficacy assessment, Health Canada recommends that the new use of this food additive be enabled.

Consultation

These amendments permit the use of sodium hexametaphosphate in foods for which there are compositional and health and safety standards set out in Divisions 8 and 25 of the Regulations. Consequently, input regarding the use of sodium hexametaphosphate in liquid whey during the evaporation process, and the use of the resulting evaporated products such as whey liquid concentrate, powder and its derivatives into infant formula was sought from the Canadian Food Inspection Agency (the CFIA) and the National Dairy Council. These organizations expressed their support for these amendments.

The proposed Regulations were prepublished in the Canada Gazette, Part I, on July 4, 2009, followed by a comment period which ended on September 13, 2009. No comments were received on the proposed Regulations.

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 concentrates its resources where risk is the greatest. Each CFIA commodity inspection program performs ingredient verifications at which time inspectors compare formulations and lists of ingredients, and perform on-site verification of the manufacture of the product. The frequency of inspection depends on the history of compliance of a particular product, the history of compliance of the manufacturer and the food safety risk.

Contact

John Salminen
Acting 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

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