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Vol. 138, No. 19 — May 8, 2004 Regulations Amending the Food and Drug Regulations (1014 — Wine Standard)Statutory Authority Food and Drugs Act Sponsoring Department Department of Health REGULATORY IMPACT Description Wine is a standardized food under the Food and Drug Regulations. The wine standard detailed in section B.02.100 of these Regulations includes a definition for wine and lists the food ingredients and food additives that can be used in the production of wine. The addition of new ingredients or food additives to this standard or changes to the definition of wine can only be accomplished by regulatory amendments. Health Canada has received a submission to request the use of additional food ingredients and food additives during wine production to enable Canadian wine makers to follow wine-making practices recognized internationally and allowed in other countries. In addition, a request was made to modify the definition of wine to reflect modern practices in wine production and to maintain consistency with the definition of wine in international agreements signed by Canada. The submission included the indicated purpose of use and the maximum levels of use for the following food additives which require amendments to the Tables to Division 16 of Part B of the Regulations: — Fining agents: acacia gum at a maximum level of use consistent with good manufacturing practice; and copper sulphate such that the maximum level of copper shall not exceed 0.0001 percent in the finished product; and — pH adjusting agents: fumaric acid, lactic acid, malic acid, potassium bicarbonate, potassium carbonate and potassium citrate at maximum levels of use consistent with good manufacturing practice; metatartaric acid up to a maximum level of use of 0.01 percent; and potassium acid tartrate up to a maximum level of use of 0.42 percent. The submission also requested amendments to the Regulations to allow the use of the following ingredients in the production of wine: oak chips and particles (fining agent); polyvinylpolypyrrolidone (fining agent); silicon dioxide (fining agent); malolactic bacteria from the genera Lactobacillus, Leuconostoc and Pediococcus (fermentation aids); fructose (sweetening agent); and nitrogen (flushing agent). In addition to the use of the above-listed ingredients and food additives, the submission also requested an increase in the permitted level of volatile acidity in wine from the current value of 0.13 percent to 0.21 percent weight per volume. The additional use of these food ingredients and food additives and the change in volatile acidity were evaluated from the standpoint of safety and efficacy. Available data support the safety and effectiveness of the use of these substances in the production of wine and the increase in permitted volatile acidity. Therefore, Health Canada proposes that amendments be made to the Food and Drug Regulations to permit the use of the above-listed substances in the production of wine, at the permitted levels of use indicated, and to increase the maximum level of volatile acidity in wine. Health Canada also proposes to amend the definition of wine to better reflect the definition agreed upon at the international level, namely that wine shall be an alcoholic beverage that contains not less than 7 percent and not more than 24 percent alcohol by volume, produced by the complete or partial fermentation of fresh grapes, grape must or products derived solely from fresh grapes, or any combination of them. Alternatives Under the Food and Drug Regulations, provision for changes to a food standard, including the listing of new ingredients, extension of use for approved food additives and use of new food additives, can only be accommodated by regulatory amendment. Maintaining the status quo was rejected, as this would preclude the use of ingredients and food additives which have been shown to be both safe and effective. Benefits and costs These proposed amendments would benefit the consumers through the increased availability of quality wines. They would also benefit the industry through more efficient and improved wine production conditions, while establishing a standard for wine that reflects the international consensus on oenological practices and the following trade agreements signed recently: — between Canada and Argentina, Australia, Chile, New Zealand, South Africa, and the United States of America (Agreement on Mutual Acceptance of Oenological Practices). — between Canada and the member countries of the European Union (Agreement Between the European Community and Canada on Trade in Wines and Spirit Drinks). The cost of administering these proposed amendments is not expected to be greater than the cost of administering the existing Regulations. Consultation Because of the proprietary nature of submissions which deal with food additives, consultation on proposed amendments prior to publication in the Canada Gazette, Part I, is not carried out. An Interim Marketing Authorization (IMA) was published in the Canada Gazette, Part I, on January 26, 2002. This IMA permitted the immediate use of acacia gum, fructose, fumaric acid, lactic acid, malic acid, malolactic bacteria (from the genera Lactobacillus, Leuconostoc and Pediococcus), nitrogen, oak chips and particles, polyvinylpolypyrrolidone, potassium acid tartrate, potassium bicarbonate, potassium carbonate, potassium citrate and silicon dioxide, for the purposes and at the levels outlined above. This IMA also permitted the increase in the level of volatile acidity in wine to 0.21 percent. No problems or complaints associated with the use of these ingredients and food additives in the production of wine have been reported to Health Canada since the issuance of the IMA. Compliance and enforcement If these proposed amendments are adopted, compliance would be monitored by ongoing domestic and import inspection programs. 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 proposes, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act, to make the annexed Regulations Amending the Food and Drug Regulations (1014 — Wine Standard). 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, Building No. 7, Room 2395, 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 3, 2004
EILEEN BOYD
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1014 — WINE STANDARD) AMENDMENTS 1. (1) Paragraph B.02.100(a) of the Food and Drug Regulations (see footnote 1) is replaced by the following: (a) shall be an alcoholic beverage that contains not less than 7 per cent and not more than 24 per cent alcohol by volume produced by the complete or partial alcoholic fermentation of fresh grapes, grape must, products derived solely from fresh grapes, or any combination of them; (2) Subparagraphs B.02.100(b)(iii) and (iv) of the Regulations are replaced by the following:
(iv) yeast foods, in accordance with Table XIV to section B.16.100, (3) Subparagraphs B.02.100(b)(viii) to (xiii) of the Regulations are replaced by the following:
(B) metatartaric acid at a maximum level of use of 0.01 per cent, and (C) potassium acid tartrate at a maximum level of use of 0.42 per cent, (x) ascorbic acid or erythorbic acid, or their salts, at a maximum level of use consistent with good manufacturing practice, (xi) antifoaming agents, in accordance with Table VIII to section B.16.100, (xii) any of the following fining agents:
(B) acacia gum, agar, gelatin and potassium ferrocyanide, at a maximum level of use consistent with good manufacturing practice, (C) tannic acid at a maximum level of use of 200 parts per million, and (D) polyvinylpyrrolidone in an amount that does not exceed 2 parts per million in the finished product, (4) Subparagraph B.02.100(b)(xv) of the Regulations is replaced by the following:
(B) oxygen, (5) Paragraph B.02.100(b) of the Regulations is amended by striking out the word "and" at the end of subparagraph (xvi) and by adding the following after that subparagraph:
(xviii) copper sulphate in such a quantity that the content of copper in the finished product shall not exceed 0.0001 per cent, (xix) nitrogen, and (xx) oak chips and particles; and 2. Section B.02.101 of the Regulations is replaced by the following: B.02.101. No person shall sell wine that contains more than 0.21 per cent weight by volume of volatile acidity calculated as acetic acid, as determined by official method FO-2, Determination of Volatile Acidity of Wine, Cider and Champagne Cider, October 15, 1981. 3. Subparagraph B.02.130(b)(xviii) of the Regulations is replaced by the following:
4. The portion of subitem A.1(1) of Table IV to section B.16.100 of the Regulations in column II is replaced by the following:
5. Item T.2 of Table IV to section B.16.100 of the Regulations is repealed. 6. Table VIII to section B.16.100 of the Regulations is amended by adding the following before item A.1:
7. Table VIII to section B.16.100 of the Regulations is amended by adding the following after item A.1:
8. Table VIII to section B.16.100 of the Regulations is amended by adding the following after item C.16:
9. Table VIII to section B.16.100 of the Regulations is amended by adding the following after item F.1:
10. The portion of subitem P.3(1) of Table VIII to section B.16.100 of the Regulations in column III is replaced by the following:
11. Table VIII to section B.16.100 of the Regulations is amended by adding the following after item P.4:
12. The portion of item T.2 of Table VIII to section B.16.100 of the Regulations in columns II to IV is replaced by the following:
13. Item F.1 of Table X to section B.16.100 of the Regulations is amended by adding the following in columns II and III after subitem (2):
14. Item L.1 of Table X to section B.16.100 of the Regulations is amended by adding the following in columns II and III after subitem (5):
15. Item M.8 of Table X to section B.16.100 of the Regulations is amended by adding the following in columns II and III after subitem (4):
16. Table X to section B.16.100 of the Regulations is amended by adding the following after item M.8A:
17. Item P.2 of Table X to section B.16.100 of the Regulations is amended by adding the following in columns II and III after subitem (2):
18. Item P.4 of Table X to section B.16.100 of the Regulations is amended by adding the following in columns II and III after subitem (6):
19. Item P.5 of Table X to section B.16.100 of the Regulations is amended by adding the following in columns II and III after subitem (5):
20. (1) The portion of item P.7 of Table X to section B.16.100 of the French version of the Regulations in column I is replaced by the following:
(2) Item P.7 of Table X to section B.16.100 of the Regulations is amended by adding the following in columns II and III after subitem (3):
COMING INTO FORCE 21. These Regulations come into force on the day on which they are registered. [19-1-o] S.C. 1999, c. 33, s. 347 C.R.C., c. 870 |
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