Vol. 146, No. 12 — June 6, 2012
Registration
SOR/2012-105 May 17, 2012
FOOD AND DRUGS ACT
Regulations Amending the Food and Drug Regulations (1638 — Lecithin)
P.C. 2012-640 May 17, 2012
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 (1638 — Lecithin).
REGULATIONS AMENDING THE FOOD AND DRUG
REGULATIONS (1638 — LECITHIN)
AMENDMENTS
1. The portion of item L.3 of Table VIII to section B.16.100 of the Food and Drug Regulations (see footnote 1) in columns II to IV is replaced by the following:
|
Item No. |
Column II |
Column III |
Column IV |
|||
|---|---|---|---|---|---|---|
|
L.3 |
(1) Surfaces that come in contact with food (2) Infant cereal products |
(1) Release agent (2) Release agent |
(1) Good Manufacturing Practice (2) 1.75% as consumed |
|||
2. (1) Subsection B.25.062(1) of the French version of the Regulations is replaced by the following:
B.25.062. (1) Sous réserve du paragraphe (2), est interdite la vente d’un aliment étiqueté ou annoncé comme pouvant être consommé par des bébés, si ledit aliment contient un additif alimentaire.
(2) The portion of paragraph B.25.062(2)(b) of the Regulations before subparagraph (i) is replaced by the following:
- (b) the following foods that are labelled or advertised for consumption by infants and that contain ascorbic acid:
(3) Paragraphs B.25.062(2)(c) and (d) of the Regulations are replaced by the following:
- (c) infant cereal products that contain lecithin;
(d) foods that are labelled or advertised for consumption by infants and that contain citric acid;
COMING INTO FORCE
3. 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 lecithin as a release agent in the production of infant cereal products at a maximum level of use of 1.75% as consumed.
Evaluation of available data supports the safety and effectiveness of this food additive in the above specified use. Therefore, the Regulations are amended to permit the use of the above noted food additive as described.
Lecithin would be added to the gruel process (cooking) of cereals as a release agent. Lecithin would help to release the sheets of cereals from the drum dryers, which, in turn, would reduce or prevent caramelization thus improving colour and flavour of the finished cereal products. These amendments benefit infants by allowing greater availability of infant cereal products while continuing to protect their health and safety. In addition, these amendments benefit industry by improving the colour and flavour of the finished cereal products.
Description and rationale
In order to enable the use of lecithin as described above, amendments are required to Table VIII to section B.16.100 and to paragraph B.25.062(2)(c) of the Regulations. Subsection B.25.062(1) of the French version of the Regulations is amended by replacing the term “et” by the term “ou” in the expression “aliment étiqueté et annoncé.” In addition, amendments are made to paragraphs B.25.062(2)(b) and (d) to correct inconsistencies. 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.
An Interim Marketing Authorization (IMA) has been issued to permit the immediate use of this food additive as proposed in the submission while the regulatory process was undertaken to amend the Regulations. It was published in the government notices section of the Canada Gazette, Part Ⅰ, on
- July 18, 2009, for lecithin as a release agent in the production of infant cereal products at a maximum level of use of 1.75% as consumed.
The IMA expired on July 18, 2011, for lecithin as a release agent in the production of infant cereal products. Health Canada confirms that the results of the pre-market safety assessment that was conducted prior the issuance of the IMA to permit the use of lecithin as a release agent in the production of infant cereal products remain valid.
The Minister has the option to recommend or not to the Governor in Council that the Regulations be amended to permit the use as described above for this food additive. Based on its safety and efficacy assessment and the history of safe use of lecithin in the production of infant cereal products since the issuance of the IMA, the Minister is recommending that amendments be made to enable the use for this food additive.
Consultation
The amendments permit the use of this food additive in infant cereal products for which there are requirements set out in Division 25 of the Regulations.
Health Canada has announced the publication of the IMA for this food additive through postings on its Web site. Health Canada also notified World Trade Organization members about this IMA and the proposed regulatory amendments at the time of publication of the IMA in the Canada Gazette, Part Ⅰ. The IMA was published in the Canada Gazette, Part Ⅰ, in 2009, followed by a 75-day comment period. The Government has received no objections or safety concerns regarding this use since the publication of the IMA.
Implementation, enforcement and service standards
The Canadian Food Inspection Agency (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 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 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