Vol. 140, No. 11 — May 31, 2006

Registration
SOR/2006-91 May 11, 2006

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1014 — Wine Standard)

P.C. 2006-370 May 11, 2006

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 (1014 — Wine Standard).

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 is 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:

(3) Subparagraphs B.02.100( b )(viii) to (xiii) of the Regulations are replaced by the following:

(4) Subparagraph B.02.100( b )(xv) of the Regulations is replaced by the following:

(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:

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 0.24 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:

Item No.	Column I Additive	Column II Permitted in or Upon
A.1	Acacia Gum	(1) Cream; French dressing; (naming the flavour) Milk; Mustard pickles; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; Relishes; Salad dressing; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids;

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 Item T.2 of Table IV to section B.16.100 of the Regulations is repealed.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:

Item No.	Column I Additive	Column II Permitted in or Upon	Column III Purpose of Use	Column IV Maximum Level of Use
A.01	Acacia Gum	Ale; Beer; Light beer; Malt liquor; Porter; Stout; Wine	Fining agent	Good Manufacturing Practice

7. Table VIII to section B.16.100 of the Regulations is amended by adding the following after item A.1:

Item No.	Column I Additive	Column II Permitted in or Upon	Column III Purpose of Use	Column IV Maximum Level of Use
A.1.01	Agar	Wine	Fining agent	Good Manufacturing Practice

8. Table VIII to section B.16.100 of the Regulations is amended by adding the following after item C.16:

Item No.	Column I Additive	Column II Permitted in or Upon	Column III Purpose of Use	Column IV Maximum Level of Use
C.17	Copper Sulphate	Wine	Fining agent	0.0001%, calculated as copper, in the finished product

9. Table VIII to section B.16.100 of the Regulations is amended by adding the following after item F.1:

Item No.	Column I Additive	Column II Permitted in or Upon	Column III Purpose of Use	Column IV Maximum Level of Use
G.1	Gelatin	Beer; Cider; Wine	Fining agent	Good Manufacturing Practice

10. (1) The portion of subitem P.3(1) of Table VIII to section B.16.100 of the French version of the Regulations in columns II and III is replaced by the following:

Article	Colonne I Additifs	Colonne II Permis dans ou sur	Colonne III But de l'emploi
P.3	Polyvinyl- pyrrolidone	(1) Ale; bière; bière légère; cidre; liqueur de malt; porter; stout; vin	(1) Agent de collage

(2) The portion of subitem P.3(1) of Table VIII to section B.16.100 of the English version of the Regulations in column III is replaced by the following:

Item No.	Column I Additive	Column II Permitted in or Upon	Column III Purpose of Use
P.3	Polyvinyl- pyrrolidone	(1) Ale; Beer; Cider; Light beer; Malt liquor; Porter; Stout; Wine	(1) Fining agent

11. Table VIII to section B.16.100 of the Regulations is amended by adding the following after item P.4:

Item No.	Column I Additive	Column II Permitted in or Upon	Column III Purpose of Use	Column IV Maximum Level of Use
P.4.1	Potassium Ferrocyanide	Wine	Fining agent	Good Manufacturing Practice

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:

Item No.	Column I Additive	Column II Permitted in or Upon	Column III Purpose of Use	Column IV Maximum Level of Use
T.2	Tannic Acid	(1) Chewing gum	(1) To reduce adhesion	(1) Good Manufacturing Practice
		(2) Cider; Honey wine; Wine	(2) Fining agent	(2) 200 p.p.m.

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):

Item No.	Column I Additive	Column II Permitted in or Upon	Column III Maximum Level of Use
F.1	Fumaric Acid	(3) Wine	(3) Good Manufacturing Practice

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):

Item No.	Column I Additive	Column II Permitted in or Upon	Column III Maximum Level of Use
L.1	Lactic Acid	(6) Wine	(6) Good Manufacturing Practice

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):

Item No.	Column I Additive	Column II Permitted in or Upon	Column III Maximum Level of Use
M.8	Malic Acid	(5) Wine	(5) Good Manufacturing Practice

16. Table X to section B.16.100 of the Regulations is amended by adding the following after item M.8A:

Item No.	Column I Additive	Column II Permitted in or Upon	Column III Maximum Level of Use
M.9	Metatartaric Acid	Wine	0.01%

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):

Item No.	Column I Additive	Column II Permitted in or Upon	Column III Maximum Level of Use
P.2	Potassium Acid Tartrate	(3) Wine	(3) 0.42%

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):

Item No.	Column I Additive	Column II Permitted in or Upon	Column III Maximum Level of Use
P.4	Potassium Bicarbonate	(7) Wine	(7) Good Manufacturing Practice

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):

Item No.	Column I Additive	Column II Permitted in or Upon	Column III Maximum Level of Use
P.5	Potassium Carbonate	(6) Wine	(6) Good Manufacturing Practice

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:

Article	Colonne I Additifs
P.7	Citrate de potassium

(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):

Item No.	Column I Additive	Column II Permitted in or Upon	Column III Maximum Level of Use
P.7	Potassium Citrate	(4) Wine	(4) Good Manufacturing Practice

COMING INTO FORCE

21. 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

Wine is a standardized food under the Food and Drug Regulations. The wine standard detailed in section B.02.100 of these Regulations 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 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 description of wine to reflect modern practices in wine production while maintaining the safety of the product sold in 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:

The submission also requested amendments to the Regulationsto 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), nitrogen (flushing agent).

In addition to the use of the above listed ingredients and food additives, the submission also requested an increase in the maximum level of volatile acidity permitted in wine.

The additional use of these food ingredients and food additives and the increase in the permitted level of 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 the maximum level of volatile acidity in wine.

Therefore, the Food and Drug Regulations are amended to change the description of wine, permit the use of the above listed substances in the production of wine, at the permitted levels of use indicated, and to increase the permitted maximum level of volatile acidity in wine from the current level of 0.13 per cent to 0.24 per cent.

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 amendments benefit consumers through the increased availability of quality wines. They also benefit the industry through more efficient and improved wine production conditions, while maintaining the safety of the product sold in Canada. A secondary benefit of these amendments is that the standard for wine reflects the international consensus on oenological practices and the trade agreements signed recently by Canada.

The cost of administering these 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 pre-publication in the Canada Gazette, Part I, is not carried out.

A proposed amendment was pre-published in the Canada Gazette, Part I on May 8, 2004. Interested parties were invited to comment on the proposal. Comments were received from the following organizations: the Canada Revenue Agency (CRA), the Canada Border Services Agency (CBSA) and the Canadian Food Inspection Agency (CFIA). The comments were generally supportive of the proposed amendments but did raise two issues.

The comments from the CRA indicated that the specification of minimum and maximum levels of alcohol in the description of wine under the Regulations would create a discrepancy with the definition of wine in the Excise Act, 2001, which specifies a minimum alcohol content of 0.5 per cent. The comments expressed concern that this discrepancy would cause confusion in the application of Excise duties on wine products with alcohol levels between 0.5 per cent and the minimum alcohol level of 7 per cent proposed under the Food and Drug Regulations. The letter from the CBSA also expressed concerns about the proposed maximum and minimum levels of alcohol and possible confusion for importers of wine. Health Canada agrees with both of these comments and has withdrawn the proposed maximum and minimum levels of alcohol content from the final description of wine in the Regulations.

The comments from the CFIA also focused on the proposed standard for wine and the maximum and minimum levels of alcohol specified in it with regard to compatibility with the national wine standard being developed under the Canada Agricultural Products Act administered by the CFIA. The maximum and minimum levels of alcohol have been removed from the amendments to the standard for wine under the Food and Drugs Act to avoid any inconsistencies with the National Wine Standard being developed by the CFIA.

Health Canada has consulted with the CFIA, the Canadian Vintners Association and International Trade Canada on the implications of removing the maximum and minimum levels of alcohol from the amendments to the wine standard. There were no objections to this change in the amendments as a result of the consultation.

The CFIA comments also addressed the issue of volatile acidity, which is a measure of the oxidation of the alcohol in wines in the presence of air. The proposed level of 0.21 per cent would not be considered adequate for all wines to be sold in Canada. The CFIA suggested that the level be revised to 0.24 per cent. This is a minor change that has no safety concerns and would avoid inconsistencies with the National Wine Standard being developed by the CFIA. Therefore, the Regulations specify a maximum level of volatile acidity of 0.24 per cent.

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. 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. This IMA is revoked upon the coming into force of these regulatory amendments.

Compliance and Enforcement

Compliance will be monitored by ongoing domestic and import inspection programs of the CFIA.

Contact

Mr. 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

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