Vol. 141, No. 9 — May 2, 2007

Registration
SOR/2007-76 April 19, 2007

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1158 — Food Additives)

P.C. 2007-556 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 (1158 — Food Additives).

REGULATIONS AMENDING THE FOOD AND DRUG
REGULATIONS (1158 — FOOD ADDITIVES)

AMENDMENTS

1. Item C.11 of Table IV to section B.16.100 of the Food and Drug Regulations (see footnote 1) 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
C.11	(6) A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n)	(6) 0.06 %

2. Item T.3 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
T.3	(8) Comminuted prepared fish or prepared meat, other than lumpfish caviar; Comminuted preserved fish or preserved meat (Division 21)	(8) 0.75 %

3. The portion of subitem S.1(1) of Table IX 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) 6.0 %

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

(s) in the case of comminuted products, other than lumpfish caviar, contain tragacanth gum at a level of use not exceeding 0.75 per cent.

5. Section B.21.021 of the Regulations is amended by striking out the word "and" at the end of paragraph (c), by adding the word "and" at the end of paragraph (d) and by adding the following after paragraph (d):

(e) comminuted products may contain tragacanth gum at a level of use not exceeding 0.75 per cent.

COMING INTO FORCE

6. 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 or new levels of use of the following food additives that are already listed in the Tables to Division 16 of Part B of these Regulations:

- calcium sulphate as a binding agent in a blend of prepared fish or meat as described in paragraph B.21.006(n) of the Regulations, for example surimi, to enhance the gel forming capabilities of the product throughout its shelf life, at a maximum level of use of 0.06%;

- to increase the permitted level of use of sorbitol in a blend of prepared fish or meat as described in paragraph B.21.006(n) of the Regulations to provide the desired sweetening effect; the level would be increased from 3.5% to 6.0%; and

- tragacanth gum as a stabilizing agent in anchovy sauce at a maximum level of use of 0.75%.

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 (IMA) to permit the immediate use of these food additives while the regulatory process was 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.

In addition, the use of tragacanth gum will be allowed in all comminuted prepared fish or prepared meat and comminuted preserved fish or preserved meat under the standards prescribed for these products under Division 21 of the Regulations at a maximum level of use of 0.75%. The data demonstrated the safety of the use of this stabilizing agent in these foods. This amendment for tragacanth gum does not change the current maximum level of use of 1.0% allowed for tragacanth gum in lumpfish caviar.

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 calcium sulphate, tragacanth gum and a new maximum level of use of sorbitol in fish products which are subject to a standard under Division 21 of the Regulations, were the subject of a targeted consultation with the sectors that may be impacted by the amendments. Hence, the Fisheries Council of Canada and the Canadian Food Inspection Agency were consulted and expressed their support for the 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 January 30, 1999, for calcium sulphate in surimi;

- on August 25, 2001, for sorbitol in a blend of prepared fish and prepared meat as described in paragraph B.21.006(n); and

- on March 8, 2003, for tragacanth gum in anchovy sauce.

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
A.L. 0702C1
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

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