Vol. 142, No. 38 — September 20, 2008

GOVERNMENT NOTICES

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Ministerial Condition No. 15223

Whereas the Minister of the Environment and the Minister of Health have assessed information pertaining to the substance Butanamide, 3-oxo-, Chemical Abstracts Service No. 5977-14-0;

And whereas the Ministers suspect that the substance is toxic;

The Minister of the Environment, pursuant to paragraph 84(1)(a) of the Canadian Environmental Protection Act, 1999, hereby permits the manufacture or import of the substance in accordance with the conditions of the following annex.

JOHN BAIRD
Minister of the Environment

ANNEX

Conditions

(Section 84 of the Canadian Environmental
Protection Act, 1999)

The person who complies with subsection 81(1) of the Canadian Environmental Protection Act, 1999 (the Notifier hereafter) may manufacture or import the substance if that person also complies with the following conditions:

Restrictions

1. The Notifier may import the substance as a component of laundry products, at a concentration of no more than 0.07% weight/weight in the final laundry product.

2. The Notifier may import or manufacture the substance for inclusion in laundry products at a concentration of no more than 0.07% weight/weight in the final laundry product.

3. The Notifier may not sell or distribute the substance except as part of a final laundry product, in which the final concentration of the substance does not exceed 0.07% weight/weight of the final laundry product.

Record-keeping Requirements

4. (1) The Notifier shall maintain electronic or paper records, with any documentation supporting the validity of the information contained in these records, indicating the quantity of the substance that the Notifier imports, manufactures, purchases and uses.

4. (2) The Notifier shall maintain electronic or paper records described in subitem (1) at the Notifier’s principal place of business in Canada.

Information Requirements

5. The Minister considers that the public will significantly be exposed to the substance and as such, for greater certainty, it is specified that the Notifier has to comply with subsection 7(3) of the New Substances Notification Regulations (Chemicals and Polymers).

Coming into Force

6. This Ministerial Condition comes into force on September 19, 2008.

[38-1-o]

DEPARTMENT OF HEALTH

FOOD AND DRUGS ACT

Food and Drug Regulations — Amendments

Interim Marketing Authorization

Provision currently exists in the Food and Drug Regulations for the use of allura red, sunset yellow FCF and tartrazine as colouring agents in a variety of food products, including fish roe (caviar) at a maximum level of use of 300 ppm, singly or in combination. Brilliant blue FCF is permitted as a colouring agent in various foods, including fish roe (caviar) at a maximum level of use of 100 ppm, singly or in combination with fast green FCF.

Health Canada has received a submission to permit the use of a blend of allura red, brilliant blue FCF, sunset yellow FCF and tartrazine as colouring agents in lumpfish caviar at a level of 800 ppm. The maximum level of use for allura red, sunset yellow FCF and tartrazine, singly or in combination, would be 550 ppm and the maximum level of use for brilliant blue FCF would be 300 ppm. Evaluation of available data supports the safety and effectiveness of allura red, brilliant blue FCF, sunset yellow FCF and tartrazine as colouring agents in the production of lumpfish caviar.

The use of allura red, brilliant blue FCF, sunset yellow FCF and tartrazine will benefit consumers by increasing the availability of quality food products. It will also benefit industry through more efficient and improved manufacturing conditions.

Therefore, it is the intention of Health Canada to recommend that the Food and Drug Regulations be amended to permit the use of allura red, sunset yellow FCF and tartrazine as colouring agents in the production of lumpfish caviar, singly or in combination, at a maximum level of use of 550 ppm, and to permit the use of brilliant blue FCF as a colouring agent in the production of lumpfish caviar at a maximum level of use of 300 ppm with a total level of the four colours not to exceed 800 ppm.

As a means to improve the responsiveness of the regulatory system, an Interim Marketing Authorization (IMA) is being issued to permit the immediate use of allura red, sunset yellow FCF and tartrazine up to a maximum level of use of 550 ppm and to permit the use of brilliant blue FCF up to a maximum level of use of 300 ppm in the production of lumpfish caviar, while the regulatory process is undertaken to formally amend the Regulations. The total level of use of the four colours should not exceed 800 ppm. The food described above is exempted from the application of sections 6 and 6.1 of the Food and Drugs Act, paragraphs B.01.042(a) and (c), section B.16.007, and paragraph B.21.006(m) of the Food and Drug Regulations.

The proposed regulatory amendments would be enabling measures to allow the sale of additional foods containing allura red, brilliant blue FCF, sunset yellow FCF and tartrazine as colouring agents. The amendments are supported by the safety assessment and would have low impact on the economy and the environment. Consequently, the regulatory amendments may proceed directly to final approval and publication in the Canada Gazette, Part II.

Interested persons may make representations with respect to Health Canada’s intention to amend the 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 the contact person identified below.

Contact

Marie-Claude Tardif, Associate Director, Bureau of Food Regulatory, International and Interagency Affairs, Health Canada, 200 Tunney’s Pasture Driveway, Address Locator 0702C1, Ottawa, Ontario K1A 0K9, 613-957-1750 (telephone), 613-941-3537 (fax), sche-ann@hc-sc.gc.ca (email).

September 9, 2008

MEENA BALLANTYNE
Assistant Deputy Minister
Health Products and Food Branch

[38-1-o]

DEPARTMENT OF HEALTH

FOOD AND DRUGS ACT

Food and Drug Regulations — Amendments

Interim Marketing Authorization

Provisions currently exist in the Food and Drug Regulations for the use of sodium acetate as a pH adjusting agent in unstandardized foods or as a starch modifying agent in starch at levels consistent with good manufacturing practice.

Health Canada has received a submission to permit the use of sodium acetate as a preservative in standardized and unstandardized preparations of meat, meat by-products, poultry meat and poultry meat by-products, that have been cooked or cured. This would include fresh and frozen prepared meals, salads, spreads and soups containing meat or poultry; flakes of meat; sausages of the type salami, wiener, frankfurter, blood sausage, black pudding, blood pudding, blood and tongue sausage; potted meat; meat pâté; liver paste; liver spread; pâté de foie; meat loaf; meat lunch; luncheon meat; cooked ham; corned beef; cooked meat roll; meat pie, brawn and headcheese, all at levels consistent with good manufacturing practice. Evaluation of available data supports the safety and effectiveness of sodium acetate as a preservative in the production of these food products.

The use of this food additive will benefit consumers by increasing the availability of quality food products. It will also benefit industry through more efficient and improved manufacturing conditions.

Therefore, it is the intention of Health Canada to recommend that the Food and Drug Regulations be amended to permit the use of sodium acetate as a preservative in certain standardized and unstandardized foods containing cooked or cured meat, meat by-products, poultry meat, poultry meat by-products, as listed above, at levels consistent with good manufacturing practice.

As a means to improve the responsiveness of the regulatory system, an Interim Marketing Authorization (IMA) is being issued to permit the immediate use of sodium acetate in the production of standardized of flakes of meat; sausages of the type salami, wiener, frankfurter, blood sausage, black pudding, blood pudding, blood and tongue sausage; potted meat; meat pâté; liver paste; liver spread; pâté de foie; meat loaf; meat lunch; luncheon meat; cooked ham; corned beef; cooked meat roll; meat pie; brawn; headcheese; meat spread and unstandardized foods containing cooked or cured meat or poultry, at levels consistent with good manufacturing practice, while the regulatory process is undertaken to amend the Regulations. The standardized foods described above are exempted from the application of sections 6 and 6.1 of the Food and Drugs Act, paragraphs B.01.042(a) and (c), section B.16.007 and as appropriate for the food product covered under sections B.14.005, B.14.009, B.14.031, B.14.032, B.14.033 to B.14.038, B.22.006 and B.22.021 of the Food and Drug Regulations. The unstandardized foods listed above are exempted from paragraph B.01.043(a) and section B.16.007 of the Food and Drug Regulations.

The proposed regulatory amendments would be enabling measures to allow the sale of additional foods containing sodium acetate as a preservative. The amendments are supported by the safety assessment and would have low impact on the economy and the environment. Consequently, the regulatory amendments may proceed directly to final approval and publication in the Canada Gazette, Part II.

Interested persons may make representations with respect to Health Canada’s intention to amend the 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 the contact person identified below.

Contact

Marie-Claude Tardif, Associate Director, Bureau of Food Regulatory, International and Interagency Affairs, Health Canada, 200 Tunney’s Pasture Driveway, Address Locator 0702C1, Ottawa, Ontario K1A 0K9, 613-957-1750 (telephone), 613-941-3537 (fax), sche-ann@hc-sc.gc.ca (email).

September 9, 2008

MEENA BALLANTYNE
Assistant Deputy Minister
Health Products and Food Branch

[38-1-o]

DEPARTMENT OF HEALTH

FOOD AND DRUGS ACT

Food and Drug Regulations — Amendments

Interim Marketing Authorization

Provisions currently exist in the Food and Drug Regulations for the use of sodium diacetate as a preservative in bread and unstandardized foods at a maximum level of use of 3 000 ppm.

Health Canada has received submissions to permit the use of sodium diacetate as a preservative in standardized and unstandardized preparations of meat, meat by-products, poultry meat, poultry meat by-products, prepared and preserved fish products, including fresh and frozen prepared meals, salads, spreads and soups containing meat, poultry or fish; flakes of meat; sausages including fresh uncooked sausage, preserved or cured sausage, salami, wiener, frankfurter, blood sausage, black pudding, blood pudding, blood and tongue sausage; potted meat; meat pâté; liver paste; liver spread; pâté de foie; meat loaf; meat lunch; luncheon meat; corned beef; ham; bacon; meat roll; meat pie, brawn and headcheese, all at a maximum level of use of 0.25% of final product weight. Evaluation of available data supports the safety and effectiveness of sodium diacetate as a preservative in the production of these food products.

The use of this food additive will benefit consumers by increasing the availability of quality food products. It will also benefit industry through more efficient and improved manufacturing conditions.

Therefore, it is the intention of Health Canada to recommend that the Food and Drug Regulations be amended to permit the use of sodium diacetate as a preservative in standardized and unstandardized preparations of meat, meat by-products, poultry meat, poultry meat by-products, prepared and preserved fish products, at a maximum level of use of 0.25% of final product weight.

As a means to improve the responsiveness of the regulatory system, an Interim Marketing Authorization (IMA) is being issued to permit the immediate use of sodium diacetate in the production of standardized flakes of meat, sausages including fresh uncooked sausage, preserved or cured sausage, salami, wiener, frankfurter, blood sausage, black pudding, blood pudding, blood and tongue sausage; potted meat; meat pâté; liver paste; liver spread; pâté de foie; meat loaf; meat lunch; luncheon meat; corned beef; ham; bacon; meat roll; meat pie; brawn; headcheese and meat spread, and unstandardized cooked and uncooked foods containing meat, poultry and fish, all at a maximum level of use of 0.25% of final product weight, while the regulatory process is undertaken to amend the Regulations. The standardized foods described above are exempted from the application of sections 6 and 6.1 of the Food and Drugs Act, paragraphs B.01.042(a) and (c), section B.16.007 and as appropriate for the food product covered under sections B.14.005, B.14.009, B.14.031, B.14.032, B.14.033 to B.14.038, B.21.006, B.21.021, B.22.006 and B.22.021 of the Food and Drug Regulations. The unstandardized foods listed above are exempted from paragraph B.01.043(a) and section B.16.007 of the Food and Drug Regulations.

The proposed regulatory amendments would be enabling measures to allow the sale of additional foods containing sodium diacetate as a preservative. The amendments are supported by the safety assessment and would have low impact on the economy and the environment. Consequently, the regulatory amendments may proceed directly to final approval and publication in the Canada Gazette, Part II.

Interested persons may make representations with respect to Health Canada’s intention to amend the 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 the contact person identified below.

Contact

Marie-Claude Tardif, Associate Director, Bureau of Food Regulatory, International and Interagency Affairs, Health Canada, 200 Tunney’s Pasture Driveway, Address Locator 0702C1, Ottawa, Ontario K1A 0K9, 613-957-1750 (telephone), 613-941-3537 (fax), sche-ann@hc-sc.gc.ca (email).

September 9, 2008

MEENA BALLANTYNE
Assistant Deputy Minister
Health Products and Food Branch

[38-1-o]

DEPARTMENT OF INDUSTRY

OFFICE OF THE REGISTRAR GENERAL

Appointments

September 12, 2008

JACQUELINE GRAVELLE
Manager

[38-1-o]

DEPARTMENT OF INDUSTRY

OFFICE OF THE REGISTRAR GENERAL

Appointments

September 12, 2008

JACQUELINE GRAVELLE
Manager

[38-1-o]