ARCHIVED — Vol. 146, No. 22 — October 24, 2012

Registration

SOR/2012-206 October 3, 2012

FOOD AND DRUGS ACT

Marketing Authorization for Food Additives That May Be Used as Food Enzymes

The Minister of Health, pursuant to subsections 30.3(1) (see footnote a) and 30.5(1) (see footnote b) of the Food and Drugs Act (see footnote c), issues the annexed Marketing Authorization for Food Additives That May Be Used as Food Enzymes.

Ottawa, October 2, 2012

LEONA AGLUKKAQ
Minister of Health

MARKETING AUTHORIZATION FOR FOOD ADDITIVES THAT MAY BE USED AS FOOD ENZYMES

INTERPRETATION

Definitions

1. (1) The following definitions apply in this Marketing Authorization.

“food enzyme”
« enzyme alimentaire »

“food enzyme” means an enzyme that is capable of catalyzing a chemical reaction and that is used as a food additive.

“infant formula”
« préparation pour nourissons »

“infant formula” has the meaning assigned by the definitions “human milk substitute” and “new human milk substitute” in section B.25.001 of the Food and Drug Regulations.

“List”
« Liste »

“List” means the List of Permitted Food Enzymes published by the Department of Health on its website, as amended from time to time.

Food and Drug Regulations

(2) Unless otherwise indicated, a reference in the List to a provision or division is a reference to a provision or division of Part B of the Food and Drug Regulations.

Same meaning

(3) Words and expressions used in the List have the same meaning as in Part B of the Food and Drug Regulations.

EXEMPTIONS

Food

2. (1) When a food enzyme that is set out in column 1 of the List and that is obtained from a source that is set out in column 2 is added to a food that is set out in column 3, the food is exempt from the application of paragraphs 4(1)(a) and (d) and sections 6 and 6.1 of the Food and Drugs Act and sections B.01.042, B.01.043 and B.16.007, as applicable, of the Food and Drug Regulations, in respect of the use or presence of the enzyme only, if the amount of the enzyme does not exceed the maximum level of use for that food that is set out in column 4 and if any other condition that is set out in that column is met.

“Good manufacturing practice”

(2) When the words “good manufacturing practice” appear in column 4, the exemption applies if the amount of the food enzyme that is added to the food in manufacturing and processing does not exceed the amount required to accomplish the purpose for which it has been added and if any other condition that is set out in that column is met.

Infant formula

(3) Infant formula that contains one or more ingredients that are manufactured with a food enzyme is exempt from the application of sections B.01.043 and B.16.007 and subsection B.25.062(1) of the Food and Drug Regulations, in respect of the presence or use of the enzyme only, if each ingredient is exempt from the applicable provisions in subsection (1) in respect of the use or presence of the enzyme.

Infant cereal products

(4) An infant cereal product that contains amylase in accordance with the List is exempt from the application of subsection B.25.062(1) of the Food and Drug Regulations.

Labelling or packaging requirement

(5) Subsection (1) does not exempt a food for which a standard is prescribed in Part B of the Food and Drug Regulations from the application of any labelling or packaging requirement that is set out in the standard.

Food additives

3. A food enzyme that is set out in column 1 of the List and that is obtained from a source set out in column 2 is exempt from the application of section B.16.100 of the Food and Drug Regulations if, at the time of sale, all of the other requirements in those Regulations that apply in respect of the enzyme are met.

COMING INTO FORCE

Coming into force

4. This Marketing Authorization comes into force on the day on which section 416 of the Jobs, Growth and Long-term Prosperity Act, chapter 19 of the Statutes of Canada, 2012, comes into force but if the Marketing Authorization is registered after that day, it comes into force on the day on which it is registered.

N.B. The Regulatory Impact Analysis Statement for this Marketing Authorization appears following SOR/2012-202, Marketing Authorization for Food Additives That May Be Used as Anticaking Agents.

Footnote a
S.C. 2012, c. 19, s. 416

Footnote b
S.C. 2012, c. 19, s. 416

Footnote c
R.S., c. F-27