ARCHIVED — Vol. 145, No. 26 — December 21, 2011

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Registration

SOR/2011-278 December 2, 2011

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1603 — Guar Gum and Corrective Amendments)

P.C. 2011-1386 December 1, 2011

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 (1603 — Guar Gum and Corrective Amendments).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS
(1603 — GUAR GUM AND CORRECTIVE AMENDMENTS)

AMENDMENTS

1. (1) The definition “parts per million” or “p.p.m.” in section B.01.001 of the Food and Drug Regulations (see footnote 1) is repealed.

(2) Subsection B.01.001(1) of the Regulations is amended by adding the following in alphabetical order:

“parts per million” or “p.p.m.” means parts per million by weight unless otherwise stated; (parties par million ou p.p.m.)

2. Clauses B.08.037(1)(a)(ii)(B) and (C) of the Regulations are replaced by the following:

  • (B) chocolate, condiments, flavouring preparations, seasonings or spices,

  • (C) fruits, nuts, pickles, relishes or vegetables,

3. Clauses B.08.039(1)(a)(ii)(B) and (C) of the Regulations are replaced by the following:

  • (B) chocolate, condiments, flavouring preparations, seasonings or spices,

  • (C) fruits, nuts, pickles, relishes or vegetables,

4. (1) Subparagraph B.08.041(1)(a)(ii) of the English version of the Regulations is replaced by the following:

  1. (ii) contain the named added ingredients which shall be one or more of the following ingredients in amounts sufficient to differentiate the product from processed (naming the variety) cheese but not in amounts so large as to change the basic nature of the product:

    • (A) flavouring preparations other than such preparations that resemble the flavour of the varieties of cheese used in the product,
    • (B) chocolate, condiments, seasonings or spices,
    • (C) fruits, nuts, pickles, relishes or vegetables,
    • (D) prepared or preserved meat, or
    • (E) prepared or preserved fish,

(2) Clauses B.08.041(1)(a)(ii)(B) and (C) of the French version of the Regulations are replaced by the following:

  • (B) des assaisonnements, du chocolat, des condiments ou des épices,

  • (C) des achards, des cornichons, des fruits, des légumes ou des noix,

5. Clauses B.08.041.2(1)(a)(ii)(A) and (B) of the Regulations are replaced by the following:

  • (A) chocolate, condiments, flavouring preparations, seasonings or spices,

  • (B) fruits, nuts, pickles, relishes or vegetables,

6. Clauses B.08.041.4(1)(a)(ii)(A) and (B) of the Regulations are replaced by the following:

  • (A) chocolate, condiments, flavouring preparations, seasonings or spices,

  • (B) fruits, nuts, pickles, relishes or vegetables,

7. (1) Subparagraph B.08.041.6(1)(a)(ii) of the English version of the Regulations is replaced by the following:

  1. (ii) contain the named added ingredients which shall be one or more of the following ingredients in amounts sufficient to differentiate the product from cold-pack (naming the variety) cheese but not in amounts so large as to change the basic nature of the product:
    • (A) flavouring preparations other than such preparations that resemble the flavour of the varieties of cheese used in the product,

    • (B) chocolate, condiments, seasonings or spices,

    • (C) fruits, nuts, pickles, relishes or vegetables,

    • (D) prepared or preserved meat, or

    • (E) prepared or preserved fish, and

(2) Clauses B.08.041.6(1)(a)(ii)(B) and (C) of the French version of the Regulations are replaced by the following:

  • (B) des assaisonnements, du chocolat, des condiments ou des épices,

  • (C) des achards, des cornichons, des fruits, des légumes ou des noix,

8. Clauses B.08.041.8(1)(a)(ii)(A) and (B) of the Regulations are replaced by the following:

  • (A) chocolate, condiments, flavouring preparations, seasonings or spices,

  • (B) fruits, nuts, pickles, relishes or vegetables,

9. (1) The heading before section B.11.250 of the Regulations is replaced by the following:

Mincemeat

(2) The portion of section B.11.250 of the Regulations before paragraph (a) is replaced by the following:

B.11.250.[S]. Mincemeat, Mince Meat, Mince or Fruit Mince

10. Section B.13.021 of the Regulations is amended by striking out “and” at the end of paragraph (aa), by adding “and” at the end of paragraph (bb) and by adding the following after paragraph (bb):

  • (cc) guar gum.

11. The portion of subitem G.3(1) of Table IV to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II
Permitted in or Upon

G.3

(1) Bread; Cream; French dressing; Mincemeat; Mustard pickles; (naming the flavour) Milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; Relishes; Salad dressing

12. The portion of subitem P.1(1) of Table IV to the English version of section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II
Permitted in or Upon

P.1

(1) Apple (or rhubarb) and (naming the fruit) Jam; Cream; Fig marmalade; Fig marmalade with pectin; French dressing; Mincemeat; Mustard pickles; (naming the citrus fruit) Marmalade with pectin; (naming the flavour) Milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; Pineapple marmalade; Pineapple marmalade with pectin; Relishes; Salad dressing

COMING INTO FORCE

13. 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 guar gum as a stabilizing agent in standardized bread products at levels consistent with good manufacturing practice.

Evaluation of available data supports the safety and efficacy 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.

These amendments benefit the 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 to the Regulations enable the use of guar gum 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 would voluntarily assume 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 this food additive as proposed in the submission while the regulatory process was undertaken to amend the Regulations. The IMA was published in the Government notices section of the Canada Gazette, Part Ⅰ, on May 31, 2008, for the use of guar gum as a stabilizing agent in bread products subject to standards in Division 13 of the Regulations. The IMA expired on June 17, 2010. Health Canada confirms that the results of the pre-market safety assessment that was conducted prior to the issuance of the IMA to permit guar gum in standardized bread 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 described above for this food additive. Based on its safety and efficacy assessment and the history of safe use of guar gum in standardized bread products since the issuance of the IMA, the Minister is recommending to amend the Regulations to enable the use of this food additive.

Corrective amendments are also made due to errors appearing in SOR/2010-94 (Project No. 1353 — Corrective Amendments, Miscellaneous Program). Due to various factors, these amendments added a definition of “parts per million” to section B.01.001 rather than to subsection B.01.001(1). An amendment is made to the Regulations to place the definition of “parts per million” in subsection B.01.001(1).

The English version of subparagraphs B.08.041(1)(a)(ii) and B.08.041.6(1)(a)(ii) was also amended by SOR/2010-94. Clauses (A) to (E) in these subparagraphs were inadvertently omitted when these amendments were made. Amendments are made to the English version of the Regulations to replace subparagraphs B.08.041(1)(a)(ii) and B.08.041.6(1)(a)(ii) with versions that include clauses (A) to (E). Amendments are also made to the English and French versions of the Regulations to place the ingredients in clauses B.08.037(1)(a)(ii)(B) and (C), B.08.039(1)(a)(ii)(B) and (C), B.08.041.2(1)(a)(ii)(A) and (B), B.08.041.4(1)(a)(ii)(A) and (B), and B.08.041.8(1)(a)(ii)(A) and (B) in alphabetical order.

These corrective amendments to the Regulations are non-substantive in nature. It is expected that these changes will have little or no impact on Canadians.

Consultation

These amendments permit the use of this food additive in foods for which there are compositional standards set out in Division 13 (Grain and Bakery Products) of the Regulations. Guar gum has a long history of safe use as a permitted food additive in Canada in infant formula and various other foods, including unstandardized bakery products. Health Canada consulted the Baking Association of Canada and the Canadian Food Inspection Agency (“CFIA”). No objections were raised regarding the proposed amendments.

In addition, 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. These publications were followed by a 75-day comment period. The Government 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 food 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