FOOD AND DRUGS ACTMarketing Authorization for Food Additives That May Be Used as Food EnzymesThe Minister of Health, pursuant to subsections 30.3(1)a and 30.5(1)a of the Food and Drugs Actb, issues the annexed Marketing Authorization for Food Additives That May Be Used as Food Enzymes.S.C. 2012, c. 19, s. 416R.S., c. F-27Ottawa, October 2, 2012LEONA AGLUKKAQMinister of HealthInterpretationDefinitionsThe following definitions apply in this Marketing Authorization.food enzyme means an enzyme that is capable of catalyzing a chemical reaction and that is used as a food additive. (enzyme alimentaire)infant food has the same meaning as in section B.25.001 of the Food and Drug Regulations. (aliment pour bébés)infant formula[Repealed, SOR/2021-176, s. 1]List means the List of Permitted Food Enzymes published by the Department of Health on its website, as amended from time to time. (Liste)Food and Drug RegulationsUnless 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 meaningWords and expressions used in the List have the same meaning as in Part B of the Food and Drug Regulations.SOR/2021-176, s. 1ExemptionsFood — generalWhen 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, other than an infant 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.Infant foodWhen 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 an infant food that is set out in column 3, the infant food is exempt from the application of paragraphs 4(1)(a) and (d) of the Food and Drugs Act and sections B.01.043 and B.16.007 and subsection B.25.062(1), 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 infant 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”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.[Repealed, SOR/2021-176, s. 2][Repealed, SOR/2021-176, s. 2]Labelling or packaging requirementSubsection (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.SOR/2021-176, s. 2Food additivesA 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 ForceComing into forceThis 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.[Note: Authorization in force October 25, 2012, see SI/2012-84.]SOR/2021-1762021-08-04