Vol. 146, No. 13 — June 20, 2012

Registration

SOR/2012-112 June 1, 2012

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1608 — Disodium Ethylenediaminetetraacetate)

P.C. 2012-742 May 31, 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 (1608 — Disodium Ethylenediaminetetraacetate).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1608 — DISODIUM ETHYLENEDIAMINETETRAACETATE)

AMENDMENT

1. Item D.1 of Table XII to section B.16.100 of the Food and Drug Regulations (see footnote 1) is amended by adding the following in columns II and III after subitem (6):

Item No.	Column II Permitted in or Upon		Column III Maximum Level of Use
D.1	(7)	Edible coating for sausages	(7)	80 p.p.m. in the edible coating, calculated on the basis of the whole sausage

COMING INTO FORCE

2. 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 enable the use of the food additive disodium ethylenediaminetetraacetate (disodium EDTA) as a sequestering agent in edible coatings for sausages at a maximum level of use of 77 parts per million (p.p.m.) in fresh coated sausages.

Provision currently exists in Table XII to section B.16.100 for the use of disodium EDTA as a sequestering agent in a variety of food products, including dressing and sauces, and canned red kidney beans at maximum levels of use of 70 and 150 p.p.m. respectively.

Evaluation of available data supports the safety and effectiveness of this food additive in the above specified use at a maximum level of use of 80 p.p.m. Therefore, the Regulations are amended to permit the use of the above noted food additive as a sequestering agent in edible coatings for sausages, at a maximum level of use of 80 p.p.m. in the edible coating, calculated on the basis of the whole sausage. Disodium EDTA is used to stabilize the structure of the edible coating.

These amendments benefit consumers by allowing greater availability of food products in the marketplace while continuing to help protect their health and safety. In addition, these amendments benefit industry by facilitating the manufacture of food products.

Description and rationale

These amendments enable the use of disodium EDTA as a sequestering agent in edible coatings for sausages as described above.

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.

An Interim Marketing Authorization (“IMA”) was issued to permit the immediate use of this food additive in the production of edible coatings for fresh, pre-cooked or other form of sausages, at a maximum level of use of 80 p.p.m. in the coated sausage 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 September 27, 2008.

The IMA for disodium EDTA in edible coatings for sausages ceased to have effect on September 27, 2010. Health Canada confirms that the results of the pre-market safety assessment that was conducted prior to the issuance of the IMA remain valid.

Based on its safety and efficacy assessment and the history of safe use of disodium EDTA as a sequestering agent in edible coatings for sausages since the publication of the IMA, the Minister is recommending that amendments be made to enable to enable the new use of this food additive as described above.

Consultation

Health Canada has announced the publication of the IMA for this food additive through posting 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 publication was followed by a 75-day comment period. Health Canada has received no comments regarding the safety of the use of this food additive.

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 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