ARCHIVED — Vol. 146, No. 7 — March 28, 2012

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Registration

SOR/2012-44 March 15, 2012

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1571 — Food Additives)

P.C. 2012-293 March 15, 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 (1571 — Food Additives).

REGULATIONS AMENDING THE FOOD AND DRUG
REGULATIONS (1571 — FOOD ADDITIVES)

AMENDMENTS

1. Table VIII to section B.16.100 of the Food and Drug Regulations (see footnote 1) is amended by adding the following after item C.11:

Item No.

Column I


Additive

Column II

Permitted
in or Upon

Column III

Purpose
of Use

Column IV

Maximum
Level of Use

C.11.1

Carboxymethyl Cellulose,
cross-linked
(Sodium Carboxymethyl Cellulose,
cross-linked)

Table-top sweetener
tablets that contain acesulfame-potassium, aspartame, erythritol, neotame or sucralose

Tablet disintegration

Good Manufacturing Practice

2. The portion of item L.4 of Table VIII to section B.16.100 of the Regulations in columns II to IV is replaced by the following:

Item No.

Column II


Permitted in or Upon

Column III

Purpose
of Use

Column IV

Maximum
Level of Use

L.4

Table-top sweetener tablets that contain acesulfame-potassium, aspartame, erythritol, neotame or sucralose

Lubricant or
binder in tablet manufacture

Good Manufacturing Practice

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”) control 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 two food additives: (1) L-leucine to be used as a lubricant and/or binder in the production of table-top sweetener tablets containing sucralose, at a maximum level of use of 10% of tablet weight; and (2) carboxymethyl cellulose, cross-linked, also called sodium carboxymethyl cellulose, cross-linked, to be used for tablet disintegration in table-top sweetener tablets containing sucralose, at a maximum level of use of 2% of tablet weight.

Provision currently exists in Table VIII to section B.16.100 of the Regulations for the use of L-leucine as lubricant at a maximum level of use of 3% of tablet weight in the manufacture of table-top sweetener tablets containing aspartame. Carboxymethyl cellulose, cross-linked, is a new food additive and is not listed in Table VIII to section B.16.100 of the Regulations.

Evaluation of available data supports the safety and effectiveness of these food additives in the above specified uses. Since there are no safety concerns regarding the use of these food additives in table-top sweetener tablets, the amendments permit the extended use of L-leucine as lubricant or binder in table-top sweetener tablets containing the following sweeteners which are listed in Table IX to section B.16.100: acesulfame-potassium, aspartame, erythritol, neotame or sucralose, at a maximum level of use consistent with good manufacturing practice. In addition, the amendments permit the use of a new food additive, carboxymethyl cellulose, cross-linked (sodium carboxymethyl cellulose, cross-linked), to be used for tablet disintegration in table-top sweetener tablets containing acesulfame-potassium, aspartame, erythritol, neotame or sucralose, at a maximum level of use consistent with good manufacturing practice.

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 facilitating the manufacture of food products.

Description and rationale

These amendments to the Regulations enable a broader use of L-leucine as a lubricant and/or binder in table-top sweetener tablets containing the sweeteners listed above. In addition, these amendments enable the use of a new food additive, carboxymethyl cellulose, cross-linked (sodium carboxymethyl cellulose, cross-linked), for tablet disintegration in table-top sweetener tablets containing the sweeteners listed 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 L-leucine as proposed in the submission while the regulatory process was undertaken to amend the Regulations. The IMA for L-leucine was published in the government notices section of the Canada Gazette, Part Ⅰ, on

  • May 10, 2008 — L-leucine as a lubricant and/or binder in table-top sweetener tablets containing sucralose.

The IMA expired on June 16, 2010, for L-leucine in table-top sweetener tablets containing sucralose. Health Canada confirms that the results of the pre-market safety assessment that was conducted prior to the issuance of this 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 uses described above for these food additives. Based on its safety and efficacy assessment and the history of safe use of L-leucine in table-top sweetener tablets containing sucralose since the publication of the IMA and the absence of comments received following the 75-day consultation period regarding the use of carboxymethyl cellulose, cross-linked, as described below, the Minister is recommending to amend the Regulations to enable the uses of these food additives.

Consultation

These amendments permit the use of these food additives in table-top sweetener tablets containing the sweeteners listed above. Health Canada has announced the publication of an IMA for L-leucine and proposed regulatory amendments in the Canada Gazette, Part Ⅰ, through postings on their Web site. Since the IMA was published in Canada Gazette, Part Ⅰ, on May 10, 2008, Health Canada has received no comments regarding the safety of the use of L-leucine.

As a new food additive, carboxymethyl cellulose, cross-linked (sodium carboxymethyl cellulose, cross-linked), did not meet the IMA eligibility requirements. Consequently, a public consultation on the proposal to amend the Regulations to permit the use of carboxymethyl cellulose, cross-linked (sodium carboxymethyl cellulose, cross-linked) in table-top sweetener tablets containing acesulfame-potassium, aspartame, erythritol, neotame or sucralose, at a maximum level of use consistent with good manufacturing practice was conducted through postings on Health Canada’s Web site from July 28, 2011, to October 11, 2011. Health Canada also notified World Trade Organization members about the public consultation and the proposed regulatory amendments. Health Canada has received no comments regarding the safety of the use of this food additive.

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