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Vol. 138, No. 20 — May 15, 2004 Regulations Amending the Food and Drug Regulations (1170 — Food Additives)Statutory Authority Food and Drugs Act Sponsoring Department Department of Health REGULATORY IMPACT 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: — disodium ethylene-diamine-tetraacetate (EDTA) to stabilize the viscosity of aqueous suspensions of colour pigments for use in coating confectionery tablets at a maximum level of use of 1 percent of the colour preparation; — disodium EDTA and calcium disodium EDTA in pasteurized sous-vide potatoes to stabilize the colour of the potatoes at a maximum level of use of 100 parts per million (p.p.m.), singly or in combination; — sodium stearoyl-2-lactylate as an emulsifying agent in puddings and pudding mixes, salad dressing, French dressing, and soups at maximum levels of use of 0.2 percent, 0.4 percent and 0.2 percent of the finished product, respectively; — sodium erythorbate and sodium tripolyphosphate in canned clams, the first substance to stabilize the colour and the second one to tenderize the products, at maximum levels of use of 350 p.p.m. and 5 000 p.p.m., respectively; — sodium tripolyphosphate as a sequestering agent in canned whelks at a maximum level of use of 0.5 percent, calculated as sodium phosphate, dibasic, when used singly or in combination with sodium acid pyrophosphate or sodium hexametaphosphate, or both; — to increase the levels of use of potassium sorbate and calcium propionate in soft flour tortillas in order to extend the durable life of these foods without the use of special packaging materials; their respective levels of use would be increased from 1 000 p.p.m. and 2 000 p.p.m. to 5 000 p.p.m. and 4 000 p.p.m.; — talc as a dusting agent in the manufacture of chewing gum at a maximum level of use consistent with good manufacturing practice. Evaluation of available data supports the safety and effecttiveness of these food additives in the specific uses described above. Therefore, Health Canada recommends that the proposed amendments be made to the Regulations to 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, it is proposed to allow the use of this sequestering agent in all canned seafoods. 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 proposed regulatory amendments would benefit the consumers through greater availability of quality food products in the Canadian marketplace. They would 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 proposed 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 would be 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 publication in Part I of the Canada Gazette. Nevertheless, because it is proposed to permit 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, targeted consultation was conducted with the sectors that may be impacted by the proposed amendments. Hence, the Fisheries Council of Canada and the Canadian Food Inspection Agency were consulted; they 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: — on August 28, 1999, for sodium erythorbate and sodium tripolyphosphate in canned clams, disodium EDTA and calcium disodium EDTA in pasteurized sous-vide potatoes, disodium EDTA in aqueous suspensions of colour lake pigments used in coating confectionary tablets, and sodium stearoyl-2-lactylate in salad dressing, French dressing and soups; — on December 4, 1999, for potassium sorbate and calcium propionate in soft flour tortillas; — on June 21, 2003, for sodium tripolyphosphate in canned whelks; and — on August 16, 2003, for sodium stearoyl-2-lactylate in puddings and pudding mixes, and for talc in the manufacture of chewing gum. Compliance and enforcement If these proposed amendments are adopted, compliance will be monitored by ongoing domestic and import inspection programs conducted by the Canadian Food Inspection Agency. Mr. Ronald Burke, Director, Bureau of Food Regulatory, International and Interagency Affairs, Health Canada, Address Locator 0702C1, Ottawa, Ontario K1A 0L2, (613) 957-1828 (telephone), (613) 941-3537 (facsimile), sche-ann@hc-sc.gc.ca (electronic mail). Notice is hereby given that the Governor in Council, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1170 — Food Additives). Interested persons may make representations with respect to the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Ronald Burke, Director, Bureau of Food Regulatory, International and Interagency Affairs, Department of Health, Room 2395, Building No.7, Address Locator 0702C1, Tunney's Pasture, Ottawa, Ontario K1A 0L2 (tel.: (613) 957-1828; fax: (613) 941-3537; E-mail: sche-ann@hc-sc.gc.ca). Persons making representations should identify any of those representations the disclosure of which should be refused under the Access to Information Act, in particular under sections 19 and 20 of that Act, and should indicate the reasons why and the period during which the representations should not be disclosed. They should also identify any representations for which there is consent to disclosure for the purposes of that Act. Ottawa, May 10, 2004
EILEEN BOYD
REGULATIONS AMENDING THE 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:
(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:
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:
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:
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:
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:
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:
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:
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:
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:
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:
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. [20-1-o] S.C. 1999, c. 33, s. 347 C.R.C., c. 870 |
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