ARCHIVED — Vol. 146, No. 13 — June 20, 2012

Registration

SOR/2012-111 June 1, 2012

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1633 — Food Additives)

P.C. 2012-743 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 (1633 — Food Additives).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1633 — FOOD ADDITIVES)

AMENDMENTS

1. (1) Paragraph B.14.032(b) of the Food and Drug Regulations (see footnote 1) is replaced by the following:

  • (b) may be enclosed in a casing or have an edible coating;

(2) Paragraph B.14.032(d) of the Regulations is amended by striking out “and” at the end of clause (xvi)(C), by adding “and” at the end of subparagraph (xvii) and by adding the following after subparagraph (xvii):

  • (xviii) in the case of sausage having an edible coating, calcium chloride or calcium lactate;

2. Table VIII to section B.16.100 of the Regulations is amended by adding the following after item C.3:

Item No. Column I


Additive
Column II

Permitted in or Upon
Column III


Purpose of Use
Column IV

Maximum Level of Use

C.3.01

Calcium Chloride

Sausage having an edible coating

To stabilize the edible coating

Good Manufacturing Practice

3. Item C.3A of Table VIII to section B.16.100 of the Regulations is amended by adding the following in columns II to IV after subitem (2):

Item No. Column II

Permitted in or Upon
Column III

Purpose of Use
Column IV

Maximum Level of Use

C.3A

(3)

Sausage having an edible coating

(3)

To stabilize the edible coating

(3)

Good Manufacturing Practice

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 calcium lactate and calcium chloride in fresh comminuted meat for sausages with an edible coating, at a maximum level of use of 1% of final product weight for calcium lactate and at a maximum level of use of 0.5% of final product weight for calcium chloride to stabilize the edible coatings.

Provisions currently exist in Tables VI, VIII, X and XIV to section B.16.100 for the use of calcium lactate in a variety of food products. Provisions also exist in Tables VI, X and XIV to section B.16.100 for the use of calcium chloride in a variety of food products.

Evaluation of available data supports the safety and effectiveness of these food additives in the above specified uses. The safety evaluation has also concluded that these food additives are safe for use in preserved comminuted meat for sausages having an edible coating at a maximum level of use consistent with good manufacturing practice. Therefore, the amendments to the Regulations permit the extended use of these food additives to all sausages of section B.14.032 having an edible coating, at a maximum level of use consistent with good manufacturing practice. These food additives are used in sausages to prevent the deterioration of the edible coating used to encase certain sausages, improving the stability of the edible coating.

These amendments benefit consumers by allowing greater availability of food products while continuing to help protect their health and safety. In addition, these amendments benefit industry through more efficient and improved manufacturing conditions.

Description and rationale

These amendments enable the use of calcium chloride and calcium lactate 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”) has been issued to permit the immediate use of these food additives 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

  • March 28, 2009, enabling the use of calcium lactate and calcium chloride in fresh comminuted meat for sausages having an edible coating to stabilize the edible coating, at a maximum level of use of 1% of final product weight for calcium lactate and at a maximum level of use of 0.5% of final product weight for calcium chloride.

The IMA for calcium lactate and calcium chloride in fresh comminuted meat for sausages having an edible coating ceased to have effect on March 28, 2011. Health Canada confirms that the results of the pre-market safety assessment that was conducted prior to the issuance of the IMA remain valid.

The Minister has the option to recommend or not to the Governor in Council that the Regulations be amended to permit the new uses as described above for these food additives. Based on its safety and efficacy assessment and the history of safe use of calcium lactate and calcium chloride in fresh comminuted meat for sausages having an edible coating since the issuance of the IMA, the Minister is recommending that amendments be made to enable the new uses of these food additives as described above.

Consultation

These amendments permit the use of these food additives in foods for which there is a standard set out in Division 14 (Meat, its Preparations and Products). Consequently, input regarding the use of these food additives was sought from the Canadian Meat Council and the Canadian Food Inspection Agency (CFIA). Both groups have expressed their support for these amendments to the Regulations.

In addition, Health Canada has announced the publication of the IMA for these food additives 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 expressing concern regarding the safety of the use of these food additives as described above.

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