Vol. 141, No. 9 — May 2, 2007

Registration
SOR/2007-75 April 19, 2007

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1082 — Food Additives)

P.C. 2007-555 April 19, 2007

Her 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, hereby makes the annexed Regulations Amending the Food and Drug Regulations (1082 — Food Additives).

REGULATIONS AMENDING THE FOOD AND DRUG
REGULATIONS (1082 — FOOD ADDITIVES)

AMENDMENTS

1. Paragraph B.06.002(a) of the Food and Drug Regulations (see footnote 1) is replaced by the following:

(a) 300 parts per million of Allura Red, Amaranth, Erythrosine, Indigotine, Sunset Yellow FCF or Tartrazine or any combination of those colours unless a higher maximum level of use is specified in column III of item 3 of Table III to section B.16.100;

2. Paragraph B.08.061(b) of the Regulations is amended by striking out the word "and" at the end of subparagraph (viii) and by adding the following after subparagraph (ix):

3. Item 3 of Table III to section B.16.100 of the Regulations 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
3.	(7) Cheese-flavoured corn snacks (sunset yellow FCF only)	(7) 600 p.p.m. singly. If used in combination with other colours listed in column I of this item and of item 4 of this table, the maximum level of use is 300 p.p.m. in accordance with paragraph B.06.002(c)

4. The portion of item P.14 of Table IV to section B.16.100 of the Regulations in columns II and III is replaced by the following:

Item No.	Column II Permitted in or Upon	Column III Maximum Level of Use
P.14	(1) Ice cream mix	(1) 0.35% of the ice cream made from the mix
	(2) Unstandardized foods	(2) Good Manufacturing Practice

5. Item S.18 of Table IV to section B.16.100 of the Regulations is amended by adding the following, in columns II and III, after subitem (8):

Item No.	Column II Permitted in or Upon	Column III Maximum Level of Use
S.18	(9) Puddings	(9) 0.5%

6. Item S.18B of Table IV to section B.16.100 of the Regulations is amended by adding the following, in columns II and III, after subitem (2):

Item No.	Column II Permitted in or Upon	Column III Maximum Level of Use
S.18B	(3) Ice cream mix	(3) 0.035% of the ice cream made from the mix
	(4) Unstandardized frozen desserts	(4) 0.035%

7. Table VIII to section B.16.100 of the Regulations is amended by adding the following after item C.13:

Item No.	Column I Additive	Column II Permitted in or Upon	Column III Purpose of Use	Column IV Maximum Level of Use
C.13.1	Cellulose, Powdered	(1) Batter and breading	(1) Bulking agent	(1) 1%
		(2) Canapé toast	(2) Bulking agent	(2) 2%
		(3) Confectionery (Calorie-reduced)	(3) Bulking agent	(3) 25%
		(4) Unstandardized edible ices	(4) Bulking agent	(4) 3%
		(5) Fillings	(5) Bulking agent	(5) 0.5%
		(6) Foods sold in tablet form	(6) Bulking agent	(6) 50%
		(7) Icings	(7) Bulking agent	(7) 1%
		(8) Seasonings	(8) Bulking agent	(8) 3%
		(9) Sweet baked goods	(9) Bulking agent	(9) 8%

8. The portion of item S.7 of Table X to section B.16.100 of the Regulations in columns II and III is replaced by the following:

Item No.	Column II Permitted in or Upon	Column III Maximum Level of Use
S.7	(1) Ale; Beer; Light beer; Malt liquor; Porter; Stout	(1) Good Manufacturing Practice
	(2) Unstandardized bakery products	(2) Good Manufacturing Practice

COMING INTO FORCE

9. 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.)

Description

Provision currently exists in the Food and Drug Regulations for the use of various food additives in a wide variety of foods. Health Canada has received submissions to amend the Regulations to permit new uses of the following food additives that are already listed in the Tables to Division 16 of Part B of these Regulations:

- sunset yellow FCF as a colouring agent in cheese-flavoured corn snacks at a maximum level of use of 600 parts per million (p.p.m.) if used singly; if used in combination with other synthetic food colours, the maximum level of use is 300 p.p.m. in accordance with paragraph B.06.002(c) of the Regulations;

- propylene glycol mono fatty acid esters (propylene glycol monostearate) as an emulsifying agent in ice cream at a maximum level of use of 0.35%; sorbitan tristearate as an emulsifying agent in unstandardized frozen desserts and ice cream at a maximum level of use of 0.035%;

- sorbitan monostearate as an emulsifying agent in puddings at a maximum level of use of 0.5%;

- powdered cellulose as a bulking agent in the following foods at the respective maximum levels of use: (1) Batter and breading - 1%, (2) Canapé toast - 2%, (3) Confectionery (calorie-reduced) - 25%, (4) Unstandardized edible ices - 3%, (5) Fillings - 0.5%, (6) Foods sold in tablet form - 50%, (7) Icings - 1%, (8) Seasonings - 3%, (9) Sweet baked goods - 8%; and

- sodium bisulphate as a pH adjusting agent in unstandardized bakery products at a maximum level of use consistent with good manufacturing practice.

These food additives have been subjected to a thorough safety assessment. The conclusion was that the sale of foods containing the food additives, as specified in the amendments, will not pose a hazard to the health of Canadian consumers. On this basis, the Health Products and Food Branch has issued Interim Marketing Authorizations (IMAs) to permit the immediate use of these food additives while the regulatory process is undertaken to formally amend the Regulations. No safety concerns have been noted from the sale of food products containing these food additives. Therefore, the Food and Drug Regulations are amended to permit the use of the above noted additives in the specified foods at the prescribed maximum levels of use.

Alternatives

Under the Food and Drug Regulations, provision for new uses of food additives can only be accommodated by regulatory amendment. Maintaining the status quo was rejected as this would preclude the use of food additives which have been shown to be both safe and effective.

Consultation

Because of the proprietary nature of submissions which deal with food additives, consultation on regulatory amendments is not normally carried out prior to publication in the Canada Gazette. However, when an amendment affects a food subject to a standard, targeted consultation is carried out with appropriate stakeholders.

Consequently, the use of propylene glycol monostearate and sorbitan tristearate in ice cream mix, which is a food subject to a standard under section B.08.061 of the Regulations, was the subject of a targeted consultation with the sectors that may be impacted by the amendments. Hence, the Canadian Food Inspection Agency, the Food and Consumer Products of Canada and representatives of the Canadian dairy industry were consulted and expressed their support for these amendments.

Interim Marketing Authorizations were issued to permit the immediate use of these food additives, as indicated above, while the regulatory process is undertaken to formally amend the Regulations. They were pre-published in the Government notices section of the Canada Gazette, Part I, as follows:

- on November 29, 1997 for sunset yellow FCF;

- on August 28, 1999 and November 3, 2001 for powdered cellulose;

- on November 17, 2001 for sorbitan monostearate;

- on January 5, 2002 for propylene glycol monostearate and sorbitan tristearate; and

- on March 30, 2002 for sodium bisulphate.

In addition, when these IMAs were issued, they were notified to the World Trade Organization Sanitary and Phytosanitary Secretariat by the Standards Council of Canada.

These IMAs will be revoked on the date on which these amendments come into force.

Compliance and enforcement

Compliance will be monitored by ongoing domestic and import inspection programs conducted by the Canadian Food Inspection Agency.

Contact

Ronald Burke
Director
Bureau of Food Regulatory, International and Interagency Affairs
Health Canada
200 Tunney's Pasture Driveway
Ottawa, Ontario
K1A 0L2
Telephone: 613-957-1828
Fax: 613-941-3537
Email: sche-ann@hc-sc.gc.ca

Footnote a

S.C. 1999, c. 33, s. 347

Footnote 1

C.R.C., c. 870

NOTICE:
The format of the electronic version of this issue of the Canada Gazette was modified in order to be compatible with extensible hypertext markup language (XHTML 1.0 Strict).