Vol. 146, No. 22 — October 24, 2012
SOR/2012-202 October 3, 2012
FOOD AND DRUGS ACT
Marketing Authorization for Food Additives That May Be Used as Anticaking Agents
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 Anticaking Agents.
Ottawa, October 2, 2012
Minister of Health
MARKETING AUTHORIZATION FOR FOOD ADDITIVES THAT MAY BE USED AS ANTICAKING AGENTS
1. (1) The following definitions apply in this Marketing Authorization.
« agent antiagglomérant »
“anticaking agent” means a food additive that reduces adhesion of particles to maintain the texture of food.
« Liste »
“List” means the List of Permitted Anticaking Agents 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.
(3) Words and expressions used in the List have the same meaning as in Part B of the Food and Drug Regulations.
2. (1) When an anticaking agent that is set out in column 1 of the List is added to a food that is set out in column 2, 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 agent only, if the amount of the agent does not exceed the maximum level of use for that food that is set out in column 3 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 3, the exemption applies if the amount of the agent 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.
Labelling or packaging requirement
(3) 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.
3. An anticaking agent that is set out in column 1 of the List 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 agent 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.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the marketing authorizations.)
Issue and objectives
Recent updates to the Food and Drugs Act that were introduced in sections 30.2 to 30.4 as part of the Jobs, Growth and Long-term Prosperity Act, 2012 (Bill C-38) give the Minister of Health the power to issue Marketing Authorizations and incorporate documents by reference.
Marketing Authorizations (MAs) for food additives are needed to realize the efficiencies from Bill C-38. They will permit the Department of Health to allow more timely access to innovative and safe products for Canadians, and to respond more efficiently to new scientific information that impacts the health and safety of Canadians. The MAs exempt certain foods and food additives that would otherwise be prohibited from sale in the Food and Drugs Act and the Food and Drug Regulations and allow for the incorporation of Lists of Permitted Food Additives. These lists are based upon the existing Tables I to XV of permitted food additives of Part B, Division 16 of the Food and Drug Regulations and initially reflect the current rules for food additives set out in these tables.
Description and rationale
Marketing Authorizations are regulations made by the Minister of Health that permit the sale of foods that contain specified substances at specified levels or the use of substantiated health claims for food. Marketing Authorizations are limited in what they can do; they cannot set new prohibitions, only exempt a food, or a substance added in or on a food, from an existing prohibition in the Food and Drugs Act or in the Food and Drug Regulations. Conditions of the exemption may be set by the Minister and documents may be incorporated by reference. Incorporated documents have the force of law and are enforceable.
The 15 Marketing Authorizations for food additives will
- Define the functional class of food additive to match the existing tables of permitted food additives found in Part B, Division 16 of the Food and Drug Regulations. In the case of Table VIII, the existing title, “Miscellaneous Food Additives,” is replaced by the more accurate description “List of Permitted Food Additives with Other Generally Accepted Uses.”
- Exempt the food from 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 of the Food and Drug Regulations and, where applicable, from sections B.06.002 and B.25.062.
- Exempt the food additive from section B.16.100 of the Food and Drug Regulations.
- Require that when “good manufacturing practice” is specified as the maximum level of use that the amount of a food additive added to food during manufacturing and processing must not exceed the amount required to achieve the function for which it has been added.
- Incorporate by reference Lists of Permitted Food Additives as documents published by the Department of Health on its Web site as amended from time to time, based on assessments of petitions for additive use, new scientific information, or housekeeping. These lists will accurately reflect the existing tables found in the Food and Drug Regulations and incorporate previously issued Interim Marketing Authorizations (IMAs) that have already been consulted on. The lists will follow the format currently in regulation that classifies food additives by functional use (e.g. emulsifiers, preservatives) with the exception of the list created from Table VIII. In reasserting Table VIII as the List of Permitted Food Additives with Other Generally Accepted Uses that incorporates multiple purposes of use, any new purpose of use that is not currently present at the time of coming into force will require an amendment to the MA. For all the other lists, any changes to the lists will be permitted for food additives that fall within the definitions of the classes established in the MA.
The requirements for the supporting scientific information and the review and consultation process to maintain and amend these lists will be described in a guidance document made available on the Health Canada Web site. The rigour of the scientific assessment of safety has not changed. Further to this “reset” of the food additives framework, Governor in Council regulations are planned to be prepublished at a later date in order to repeal existing Tables in Part B, Division 16 of the Food and Drug Regulations and provide criteria to guide the issuance of new MAs. These Governor in Council regulations would make the MA making and amendment process for food additives predictable and transparent for all stakeholders.
The regulation of food additives has been identified by stakeholders through the Government’s Red Tape Reduction Commission (RTRC) as an area in which unnecessary delays negatively impact the Canadian industry and the public. In its report, the RTRC encouraged Health Canada to respond to this issue.
Following the introduction of the Jobs, Growth and Long-term Prosperity Act, numerous stakeholders have indicated in their press releases strong support for the new initiative that will proactively streamline the approval process for food additives as long as its foundations remain science-based. One stakeholder has indicated that they would prefer to see these types of changes in stand-alone legislation rather than in a budget bill. A number of health and consumer groups have also expressed their support for these provisions to enable Health Canada to better respond to emerging health and safety risks, without compromising the rigour of scientific assessment.
Further consultation is not considered necessary at this time as the MAs and associated lists reproduce existing rules of general application for food additives that have previously undergone public consultation.
Implementation, enforcement and service standards
The Marketing Authorizations will come into force through an order that will bring into force certain provisions of Bill C-38. As part of the implementation, Health Canada will make available the Lists of Permitted Food Additives and updated guidance document on its Web site.
Administrative procedures for maintaining and amending the lists will also include the ability to track changes over time such that the lists as they existed at any specific time can be reproduced. Timelines for all activities will be included in the guidance document to allow the Department to monitor and maintain a performance standard when amending the lists.
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
1600 Scott Street
Holland Cross, Tower B, 5th Floor
S.C. 2012, c. 19, s. 416
S.C. 2012, c. 19, s. 416
R.S., c. F-27