Vol. 139, No. 23 — November 16, 2005

Registration
SOR/2005-316 October 25, 2005

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1170 — Food Additives)

P.C. 2005-1825 October 25, 2005

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 (1170 - Food Additives).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1170 — FOOD ADDITIVES)

AMENDMENTS

1. (1) The portion of subitem S.15A(3) of Table IV to section B.16.100 of the Food and Drug Regulations (see footnote 1) in column III is replaced by the following:

Item No.	Column III Maximum Level of Use
S.15A	(3) 0.2% of the finished product

(2) Item S.15A of Table IV to section B.16.100 of the Regulations is amended by adding the following after subitem (7) in columns II and III:

Item No.	Column II Permitted in or Upon	Column III Maximum Level of Use
S.15A	(8) Salad dressing; French dressing	(8) 0.4% of the finished product
	(9) Soups	(9) 0.2% of the finished product

2. Table VIII to section B.16.100 of the French version of the Regulations is amended in column III by replacing the word "Poudrer" with the expression "Agent de saupoudrage" in the following provisions:

(a) item M.1; and

(b) subitem M.3(2).

3. Item T.1 of Table VIII to section B.16.100 of the Regulations is amended by adding the following after subitem (2) in columns II to IV:

Item No.	Column II Permitted in or Upon	Column III Purpose of Use	Column IV Maximum Level of Use
T.1	(3) Chewing gum	(3) Dusting agent	(3) Good Manufacturing Practice

4. The portion of item S.2 of Part I of Table XI 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.2	(1) Same foods as listed for Erythorbic Acid	(1) Same levels as prescribed for Erythorbic Acid
	(2) Canned clams	(2) 350 p.p.m.

5. The portion of item C.1 of Part III of Table XI 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
C.1	(1) Same foods as listed for Propionic Acid	(1) 2,000 p.p.m. calculated as Propionic Acid
	(2) Soft flour tortillas	(2) 4,000 p.p.m.

6. The portion of item P.1 of Part III of Table XI 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.1	(1) Same foods as listed for Sorbic Acid	(1) Same maximum levels of use as listed for Sorbic Acid
	(2) Soft flour tortillas	(2) 5,000 p.p.m.

7. Item C.2 of Table XII to section B.16.100 of the Regulations is amended by adding the following after subitem (11) in columns II and III:

Item No.	Column II Permitted in or Upon	Column III Maximum Level of Use
C.2	(12) Pasteurized sous-vide potatoes	(12) 100 p.p.m., singly or in combination with disodium EDTA, calculated as anhydrous disodium EDTA

8. Item D.1 of Table XII to section B.16.100 of the Regulations is amended by adding the following after subitem (4) in columns II and III:

Item No.	Column II Permitted in or Upon	Column III Maximum Level of Use
D.1	(5) Aqueous suspensions of colour lake preparations for use in coating confectionery tablets	(5) 1% of the colour preparation
	(6) Pasteurized sous-vide potatoes	(6) 100 p.p.m., singly or in combination with calcium disodium EDTA, calculated as anhydrous disodium EDTA

9. The portion of subitem S.1(1) of Table XII to section B.16.100 of the Regulations in column III is replaced by the following:

Item No.	Column III Maximum Level of Use
S.1	(1) Used singly or in combination with sodium hexametaphosphate or sodium tripolyphosphate, or both, total added phosphate not to exceed 0.5% calculated as sodium phosphate, dibasic

10. The portion of subitem S.3(1) of Table XII to section B.16.100 of the Regulations in column III is replaced by the following:

Item No.	Column III Maximum Level of Use
S.3	(1) Used singly or in combination with sodium acid pyrophosphate or sodium tripolyphosphate, or both, total added phosphate not to exceed 0.5% calculated as sodium phosphate, dibasic

11. Item S.7 of Table XII to section B.16.100 of the Regulations is amended by adding the following after subitem (5) in columns II and III:

Item No.	Column II Permitted in or Upon	Column III Maximum Level of Use
S.7	(6) Canned seafoods	(6) Used singly or in combination with sodium acid pyrophosphate or sodium hexametaphosphate, or both, total added phosphate not to exceed 0.5% calculated as sodium phosphate, dibasic

12. (1) Paragraph B.21.006(f) of the Regulations is replaced by the following:

(f) in the case of canned seafoods, contain sodium acid pyrophosphate, sodium hexametaphosphate or sodium tripolyphosphate, singly, or in combination, at a maximum level of total added phosphate not to exceed 0.5%, calculated as sodium phosphate, dibasic;

(2) Section B.21.006 of the Regulations is amended by striking out the word "and" at the end of paragraph (p), by adding the word "and" at the end of paragraph (q) and by adding the following after paragraph (q):

(r) in the case of canned clams, contain sodium erythorbate at a level of use not exceeding 350 parts per million.

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.)

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 request amendments to 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:

Evaluation of available data supports the safety and effectiveness of these food additives in the specific uses described above. These amendments to the Regulations permit the use of the above noted additives in the specified foods at the prescribed maximum levels of use. In addition, because the data demonstrated the safety of the use of sodium tripolyphosphate in all canned seafoods, the use of this sequestering agent in all canned seafoods is allowed.

Alternatives

Under the Food and Drug Regulations, provision for new uses of an approved food additive 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.

Benefits and Costs

These regulatory amendments will benefit the consumers through greater availability of quality food products in the Canadian marketplace. They will also benefit the industry by allowing more efficient and improved manufacturing conditions.

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 as the use of these food additives by manufacturers is optional.

Consultation

Because of the proprietary nature of submissions which deal with food additives, consultation on proposed amendments is not usually carried out prior to pre-publication in the Canada Gazette, Part I. Nevertheless, the use of sodium erythorbate in canned clams and sodium tripolyphosphate in canned seafoods, including canned clams and canned whelks which are standardized food products under section B.21.006 of the Regulations, was the subject of a targeted consultation conducted prior to pre-publication in the Canada Gazette, Part I, with the sectors that may be impacted by the proposed amendments. Hence, the Canadian Food Inspection Agency and the Fisheries Council of Canada were consulted and expressed their support for the proposed amendments.

Interim Marketing Authorizations (IMAs) were issued to permit the immediate use of these food additives, as indicated above, while the regulatory process was undertaken to formally amend the Regulations. These IMAs were published in the Canada Gazette, Part I, as follows:

These IMAs will be revoked on the date of the coming into force of these amendments to the Regulations.

The proposed amendments were published in the Canada Gazette, Part I, on May 15, 2004. Interested parties were invited to provide comments on these proposals. No comments were received.

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
A.L. 0702C1
Ottawa, Ontario
K1A 0L2
Telephone: (613) 957-1828
FAX: (613) 941-3537
E-mail: sche-ann@hc-sc.gc.ca

Footnote a

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

Footnote 1

C.R.C., c. 870

NOTICE:
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