Vol. 146, No. 12 — June 6, 2012

Registration

SOR/2012-104 May 17, 2012

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1635 — Food Additives)

P.C. 2012-639 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 (1635 — Food Additives).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1635 — FOOD ADDITIVES)

AMENDMENTS

1. Section B.11.051 of the Food and Drug Regulations (see footnote 1) is amended by adding the following after paragraph (h.1):

  1. (h.2) sucralose;

2. Paragraph B.11.101(c) of the Regulations is amended by striking out “and” at the end of subparagraphs (iii) and (iv) and by adding the following after subparagraph (iv):

  1. (v) acesulfame-potassium, and

    (vi) sucralose; and

3. (1) The portion of item A.10 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

A.10

Essential oils; Pie filling mixes; Pudding mixes; Unstandardized beverage bases; Unstandardized beverage mixes; Unstandardized dressings

(2) The portion of item A.10 of Table IV to section B.16.100 of the English version of the Regulations in column III is replaced by the following:

Item No.

Column III

Maximum Level of Use

A.10

Good Manufacturing Practice

4. The portion of items C.7 and C.8 of Table IV to section B.16.100 of the French version of the Regulations in column II is replaced by the following:

Article

Colonne II

Permis dans ou sur

C.7

Mélanges pour desserts non normalisés

C.8

Mélanges pour desserts non normalisés

5. (1) The portion of subitem G.2(2) 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.2

  1. (2) Aspics; Unstandardized fruit spreads; Unstandardized processed fruit products

(2) The portion of subitems G.2(4) to (9) 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.2

  1. (4) Unstandardized dairy products
  2. (5) Filling mixes; Fillings; French dressing; Pudding mixes; Puddings; Salad dressing; Unstandardized dressings; Unstandardized gelatins
  3. (6) Baking mixes; Unstandardized bakery products
  4. (7) Topping mixes; Toppings; Unstandardized sauces; Unstandardized table syrups
  5. (8) Unstandardized beverages
  6. (9) Snack foods

6. (1) The portion of subitem P.2(4) 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

P.2

  1. (4) Unstandardized beverage bases; Unstandardized beverage mixes

(2) The portion of subitem P.2(19) 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

P.2

  1. (19) Unstandardized salad dressings

7. (1) The portion of subitem P.3(6) 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

P.3

  1. (6) Pie fillings; Puddings

(2) The portion of subitem P.3(7) 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

P.3

  1. (7) Unstandardized beverage bases; Unstandardized beverage mixes

(3) The portion of subitem P.3(9) of Table IV to section B.16.100 of the French version of the Regulations in column II is replaced by the following:

Article

Colonne II

Permis dans ou sur

P.4

  1. (9) Sauces cuisinées, non normalisées, en conserve; sauces d’assaisonnement non normalisées

8. The portion of subitem P.4(6) 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

P.4

  1. (6) Unstandardized beverage bases; Unstandardized beverage mixes

9. (1) The portion of subitem S.18(5) 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

S.18

  1. (5) Unstandardized beverage bases; Unstandardized beverage mixes

(2) The portion of subitem S.18(5) of Table IV to section B.16.100 of the French version of the Regulations in column III is replaced by the following:

Article

Colonne III

Limites de tolérance

S.18

  1. (5) 0,05 % de la boisson. Si l’on emploie aussi le mono-oléate polyoxyéthylénique (20) de sorbitan, le total ne doit pas dépasser 0,05 % de la boisson. Si l’on emploie aussi le monostéarate polyoxyéthylénique (20) de sorbitan, le total ne doit pas dépasser 0,05 % de la boisson. Si l’on emploie aussi le tristéarate polyoxyéthylénique (20) de sorbitan, le total ne doit pas dépasser 0,05 % de la boisson

10. The portion of subitem A.1(6) of Table V to section B.16.100 of the Regulations in column III opposite the permitted source beginning with “ Aspergillus niger var.;” is replaced by the following:

Item No.

Column II

Permitted in or Upon

A.1

  1. (6) Malt-flavoured dried breakfast cereals

11. (1) The portion of subitems A.01(3) and (4) of Table IX to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II

Permitted in or on

A.01

  1. (3) Unstandardized beverage concentrates; Unstandardized beverage mixes; Unstandardized beverages; Unstandardized dairy beverages
  2. (4) Filling mixes; Fillings; Topping mixes; Toppings; Unstandardized dessert mixes; Unstandardized desserts; Yogurt

(2) The portion of subitems A.01(6) and (7) of Table IX to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II

Permitted in or on

A.01

  1. (6) Unstandardized fruit spreads
  2. (7) Unstandardized salad dressings

(3) The portion of subitem A.01(9) of Table IX to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II

Permitted in or on

A.01

  1. (9) Baking mixes; Unstandardized bakery products

(4) Item A.01 of Table IX to section B.16.100 of the Regulations in columns II and III is amended by adding the following after subitem (9):

Item No.

Column II


Permitted in or on

Column III

Maximum Level of Use

A.01

  1. (10) Canned (naming the fruit); Unstandardized canned fruit

(10) 0.007%

12. (1) The portion of subitem A.1(2) of Table IX to section B.16.100 of the French version of the Regulations in column II is replaced by the following:

Article

Colonne II

Permis dans ou sur

A.1

  1. (2) Céréales à déjeuner

(2) The portion of subitems A.1(3) and (4) of Table IX to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II

Permitted in or on

A.1

  1. (3) Unstandardized beverage concentrates; Unstandardized beverage mixes; Unstandardized beverages
  2. (4) Filling mixes; Fillings; Topping mixes; Toppings; Unstandardized dessert mixes; Unstandardized desserts; Yogurt

(3) The portion of subitems A.1(6) to (8) of Table IX to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II

Permitted in or on

A.1

  1. (6) Unstandardized fruit spreads; Unstandardized purées; Unstandardized sauces; Unstandardized table syrups
  2. (7) Nut spreads; Peanut spreads; Unstandardized salad dressings
  3. (8) Unstandardized condiments

(4) The portion of subitem A.1(9) of Table IX to section B.16.100 of the French version of the Regulations in column II is replaced by the following:

Article

Colonne II

Permis dans ou sur

A.1

  1. (9) Assaisonnements sucrés ou mélanges pour enrobage des grignotines; glaçages à confiserie pour grignotines

13. The portion of item A.2 of Table IX to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II

Permitted in or on

A.2

Baking mixes; Unstandardized bakery products

14. (1) The portion of subitems N.1(3) and (4) of Table IX to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II

Permitted in or on

N.1

  1. (3) Unstandardized beverage concentrates; Unstandardized beverage mixes; Unstandardized beverages
  2. (4) Filling mixes; Fillings; Topping mixes; Toppings; Unstandardized dessert mixes; Unstandardized desserts; Yogurt

(2) The portion of subitems N.1(6) and (7) of Table IX to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II

Permitted in or on

N.1

  1. (6) Unstandardized fruit spreads; Unstandardized purées; Unstandardized sauces; Unstandardized table syrups
  2. (7) Nut spreads; Peanut spreads; Unstandardized salad dressings

(3) The portion of subitem N.1(8) of Table IX to section B.16.100 of the French version of the Regulations in column II is replaced by the following:

Article

Colonne II

Permis dans ou sur

N.1

  1. (8) Condiments non normalisés

(4) The portion of subitem N.1(9) of Table IX to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II

Permitted in or on

N.1

  1. (9) Confectionery glazes for snack foods; Sweetened seasonings or coating mixes for snack foods

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

Item No.

Column II

Permitted in or on

N.1

  1. (11) Baking mixes; Unstandardized bakery products

15. (1) The portion of subitem S.2(2) of Table IX to section B.16.100 of the French version of the Regulations in column II is replaced by the following:

Article

Colonne II

Permis dans ou sur

S.2

  1. (2) Céréales à déjeuner

(2) The portion of subitems S.2(3) and (4) of Table IX to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II

Permitted in or on

S.2

  1. (3) Unstandardized beverage concentrates; Unstandardized beverage mixes; Unstandardized beverages; Unstandardized dairy beverages
  2. (4) Filling mixes; Fillings; Topping mixes; Toppings; Unstandardized dessert mixes; Unstandardized desserts; Yogurt

(3) The portion of subitems S.2(6) and (7) of Table IX to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II

Permitted in or on

S.2

  1. (6) Unstandardized fruit spreads
  2. (7) Unstandardized condiments; Unstandardized salad dressings

(4) The portion of subitem S.2(8) of Table IX to section B.16.100 of the French version of the Regulations in column II is replaced by the following:

Article

Colonne II

Permis dans ou sur

S.2

  1. (8) Assaisonnements sucrés ou mélanges pour enrobage des grignotines; confiseries non normalisées; enrobages de confiserie non normalisés; glaçages à confiserie pour grignotines

(5) The portion of subitems S.2(9) to (11) of Table IX to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II

Permitted in or on

S.2

  1. (9) Baking mixes; Unstandardized bakery products
  2. (10) Unstandardized processed fruit and vegetable products, except unstandardized canned fruit
  3. (11) Unstandardized alcoholic beverages

(6) The portion of subitem S.2(13) of Table IX to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II

Permitted in or on

S.2

  1. (13) Unstandardized table syrups

(7) Item S.2 of Table IX to section B.16.100 of the Regulations in columns II and III is amended by adding the following after subitem (13):

Item No.

Column II


Permitted in or on

Column III

Maximum Level of Use

S.2

  1. (14) Canned (naming the fruit); Unstandardized canned fruit
  2. (15) Pickles; Relishes

(14) 0.025%

(15) 0.015%

16. The portion of subitem S.9(5) of Part Ⅱ of Table XI to section B.16.100 of the French version of the Regulations in column II is replaced by the following:

Article

Colonne II

Permis dans ou sur

S.9

  1. (5) Sauces à salade non normalisées

17. The portion of subitem S.10(4) of Part Ⅱ of Table XI to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II

Permitted in or Upon

S.10

  1. (4) Unstandardized beverages

18. The portion of subitem B.1(8) of Part ⅠV of Table XI to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II

Permitted in or Upon

B.1

  1. (8) Dry beverage mixes; Dry dessert and confectionery mixes

19. The portion of subitem C.2(2) of Table XII to section B.16.100 of the French version of the Regulations in column II is replaced by the following:

Article

Colonne II

Permis dans ou sur

C.2

  1. (2) Mayonnaise; sauce à salade; sauces d’assaisonnement non normalisées; sauces non normalisées; sauce vinaigrette

20. The French version of the Regulations is amended by replacing “du breuvage” with “de la boisson” in the following provisions:

  1. (a) the portion of subitem P.2(4) of Table IV to section B.16.100 in column III;

  2. (b) the portion of subitem P.3(7) of Table IV to section B.16.100 in column III; and

  3. (c) the portion of subitem P.4(6) of Table IV to section B.16.100 in column III.

21. The Regulations are amended by replacing “Precooked (instant) cereals” with “Pre-cooked (instant) breakfast cereals” in the following provisions:

  1. (a) the portion of subitem A.1(8) of Table V to section B.16.100 in column III opposite the permitted source beginning with “ Aspergillus niger var.;”;

  2. (b) the portion of subitem G.1(5) of Table V to section B.16.100 in column III opposite the permitted source beginning with “ Aspergillus niger var.;”;

  3. (c) the portion of subitem P.1(2) of Table V to section B.16.100 in column III;

  4. (d) the portion of subitem P.2(7) of Table V to section B.16.100 in column III;

  5. (e) the portion of subitem P.5(4) of Table V to section B.16.100 in column III; and

  6. (f) the portion of subitem P.6(10) of Table V to section B.16.100 in column III opposite the permitted source beginning with “ Aspergillus oryzae var.;”.

COMING INTO FORCE

22. 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 submissions from industry requesting that the Regulations be amended to enable new uses of the following food additives:

  • — acesulfame-potassium and sucralose as sweeteners in standardized canned fruit, including canned apples, grapefruit, mandarin oranges, peaches, pears and pineapple, and in unstandardized canned fruit, including canned fruit cocktail and tropical salad, at a maximum level of use for acesulfame-potassium and sucralose of 0.007% and 0.025%, respectively; and
  • — sucralose as a sweetener in pickles at a maximum level of use of 0.015%.

The evaluation of the available data supports the safety and efficacy of these food additives in the above specified uses. Therefore, the Regulations are amended to permit the use of the above noted food additives as described. Since there are no safety concerns regarding the use of sucralose as a sweetener in standardized relishes, the amendments also permit its use in this food which is not currently the subject of a submission to Health Canada.

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 by facilitating the manufacture of food products.

Description and rationale

These amendments to the Regulations enable the use of the food additives as described above.

There is no anticipated increase in cost to government from the administration of these amendments to the Regulations. Furthermore, compliance costs incurred by manufacturers are not considered to be a factor because the use of food additives is optional.

Interim Marketing Authorizations (“IMAs”) were issued to permit the immediate use of these food additives as proposed in the submissions while the regulatory process was undertaken to amend the Regulations. They were published in the government notices section of the Canada Gazette, Part Ⅰ, on

  • — October 6, 2007, for the use of acesulfame-potassium and sucralose as sweeteners in standardized canned fruit, including canned apples, grapefruit, mandarin oranges, peaches, pears and pineapple, and in unstandardized canned fruit, including canned fruit cocktail and tropical salad, at a maximum level of use for acesulfame-potassium and sucralose of 0.007% and 0.025%, respectively; and
  • — June 13, 2009, for the use of sucralose as a sweetener in pickles at a maximum level of use of 0.015%.

The IMAs ceased to have effect on June 16, 2010, and June 13, 2011, respectively. Health Canada confirms that the results of the pre-market safety assessments that were conducted prior to the publication of these IMAs 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 the safety and efficacy assessment and the history of safe use of these food additives since the publication of the IMAs, the Minister is recommending that the Regulations be amended to enable the new uses of these food additives.

These amendments enable new uses for the sweeteners acesulfame-potassium and sucralose which are currently listed in Table IX to section B.16.100 of the Regulations, by allowing their use in standardized canned fruit, unstandardized canned fruit, and pickles and relishes. The standards for “Canned (naming the fruit)” and “Pickles and relishes” in Division 11 (Fruits, Vegetables, their Products and Substitutes) of the Regulations are amended to permit the use of sucralose in these standardized products. The standard for “Canned (naming the fruit)” is also amended to permit the use of acesulfame-potassium in standardized canned fruit.

Provision exists in the Regulations for the use of sucralose as a sweetener in unstandardized processed fruit and vegetable products at a maximum level of use of 0.015%. The Regulations are amended to increase the maximum level of use of sucralose in unstandardized canned fruit to 0.025%.

These amendments address an inconsistency in the terminology used in the French version of Table IX to section B.16.100 of the Regulations that was raised by the Standing Joint Committee for the Scrutiny of Regulations with respect to the use of the expression “tartinades de noix” as the equivalent of the English expression “nut spreads” in subitem A.1(7) of Table IX. The Regulations are amended to replace the expression “tartinades de noix” with “tartinades de fruits à écale.”

These amendments also correct inconsistencies between the English and French versions of the Regulations, as well as spelling errors in the sections of the Regulations that are amended. They also add clarity and consistency to the expressions used to describe certain foods in Tables IV, V, IX, XI and XII to section B.16.100 of the Regulations. For example, in the French version of the provisions of the Regulations that are amended, the following expressions are modified as follows:

  • The expression “sauces à salade non normalisées” is replaced by “sauces d’assaisonnement non normalisées” in item P.3 of Table IV to section B.16.100;
  • The expression “Céréales précuites (instantanées)” is replaced by “Céréales à déjeuner précuites (instantanées)” in Table V to section B.16.100;
  • The expressions “shellacs de confiserie pour les friandises” and “glaçages à confiserie pour friandises” are replaced by “glaçages à confiserie pour grignotines” in items A.1, N.1 and S.2 of Table IX to section B.16.100, respectively; and
  • The expression “vinaigrettes non normalisées” is replaced by “sauces à salade non normalisées” in item S.9 of Part Ⅱ of Table XI to section B.16.100.

In the English version of the provisions of the Regulations that are amended, the following expressions are modified as follows:

  • The expression “Unstandardized salad dressing” is replaced by “Unstandardized salad dressings” in item P.2 of Table IV to section B.16.100;
  • The expression “Precooked (instant) cereals” is replaced by “Pre-cooked (instant) breakfast cereals” in Table V to section B.16.100;
  • The expression “Confectionary glazes for snack foods” is replaced by “Confectionery glazes for snack foods” in item N.1 of Table IX to section B.16.100; and
  • The expression “Dry dessert and confection mixes” is replaced by “Dry dessert and confectionery mixes” in item B.1 of Part ⅠV of Table XI to section B.16.100.

Consultation

These amendments permit the use of acesulfame-potassium and sucralose in foods for which there are standards set out in Division 11 (Fruits, Vegetables, their Products and Substitutes) of the Regulations. These food additives have a long history of safe use as permitted sweeteners in Canada in various other foods. Input regarding the use of acesulfame-potassium and sucralose in standardized canned fruit and the use of sucralose in standardized pickles and relishes was sought from the Food Processors of Canada and the Canadian Food Inspection Agency (“CFIA”). These organizations expressed support for these amendments.

In addition, Health Canada has announced the publication of the IMAs for these food additives through postings on its Web site. Health Canada has also notified World Trade Organization members about the IMAs and the proposed regulatory amendments at the time of publication of these IMAs in the Canada Gazette, Part Ⅰ. These publications were followed by a 75-day comment period.

Comments were received from two countries regarding the lower maximum levels of use proposed by Health Canada for these food additives compared to international standards. Health Canada responded that the proposed maximum levels of use are based on the acceptable daily intakes for these food additives in the uses specified above, as determined by the safety and efficacy assessment.

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 the 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
KIA 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