FEDERAL REG

SOR/2017-67: Food Additives with Other Generally Accepted Uses — Marketing Authorization Amending the Marketing Authorization Food and Drugs Act

REGISTRATION OF FEDERAL REGULATION - VIA PART II OF THE GAZETTE

Registered
April 21, 2017


REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Marketing Authorization.) Issues and objectives Background Food additives are regulated in Canada under both Part B of the Food and Drug Regulations (FDR) and the Marketing Authorizations for food additives (MAs). There are currently 15 MAs for food additives. Each MA defines the class of food additives to which it applies (e... (Click for more)


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Published on May 8, 2017

Bill Summary

SOR/2017-67: Food Additives with Other Generally Accepted Uses — Marketing Authorization Amending the Marketing Authorization Food and Drugs Act

REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Marketing Authorization.) Issues and objectives Background Food additives are regulated in Canada under both Part B of the Food and Drug Regulations (FDR) and the Marketing Authorizations for food additives (MAs). There are currently 15 MAs for food additives. Each MA defines the class of food additives to which it applies (e.g. anticaking agents, preservatives, glazing agents, etc.); sets out the specific exemptions for that class of food additives; and incorporates by reference an administrative list of the permitted food additives within that class. Collectively, the 15 incorporated Lists of Permitted Food Additives set out the food additives that are approved for use in Canada. Health Canada’s Food Directorate is responsible for assessing the safety and efficacy of food additives and permitting their use in Canada. The framework described above was brought into force on October 25, 2012, as a result of the Jobs, Growth and Long-term Prosperity Act, which aimed, among other things, to bring greater efficiency and responsiveness to the federal regulation of substances in or on foods. Prior to 2012, implementing food additive decisions required lengthy Governor in Council (GIC) regulatory amendments to amend the Food and Drug Regulations as all permitted food additives were set out in tables to Division 16 of Part B. Under the new framework, GIC amendments are no longer required to implement food additive decisions. Instead, decisions to, for instance, permit the use of a new food additive or extend the use of an existing food additive, are now implemented in a timelier and more efficient manner through administrative changes to the incorporated Lists of Permitted Food Additives. Issues The Marketing Authorization for Food Additives with Other Generally Accepted Uses (MA 8) and its incorporated list — the List of Permitted Food Additives with Other Generally Accepted Uses (the List) — set out permitted food additives that have purposes of use that cannot be classified in any of the other 14 MAs for food additives. Unique to MA 8 is a restriction set out in paragraph 2(1)(a), which limits the purposes of use that can be set out in the incorporated list to those that were mentioned in column III of Table VIII to Division 16 of Part B of the Food and Drug Regulations on the day on which MA 8 came into force (i.e. October 25, 2012). Consequently, Health Canada’s Food Directorate is unable to amend List 8 administratively to permit the use of food additives for new purposes of use that it had assessed as safe. Specifically, there are three food additives that cannot be administratively added to the incorporated List because of the restriction set out in paragraph 2(1)(a). These are: calcium lactate and calcium chloride (both existing food additives, but with new purposes of use) and lactococcus lactis DSM 11307 (a new food additive for a new purpose of use). Given the broad scope of the purposes of use that could fall under MA 8, the exemption set out in paragraph 2(1)(a) was limited to purposes of use that were already permitted in order to limit the types of amendments that could be made administratively to the incorporated list. This allowed the Department to proceed in 2012 with the timely implementation of the new regulatory framework for food additives. Under this framework, certain food additive decisions could be enabled through the established administrative process, but certain others could not. Objectives To bring greater cohesion to the overall food additives framework, paragraph 2(1)(a) of MA 8 is being repealed and section 2 is being amended to align — to the greatest extent possible — the process by which food additive decisions are enabled in the List of Permitted Food Additives with Other Accepted Uses with the administrative process currently used for the other 14 incorporated lists of permitted food additives. Rationale and description With a view to ensuring prudent oversight and consistency in approach, Health Canada considered a range of amendments to MA 8 and the appropriate levels of approval required for enabling new additives or purposes of use which have been assessed to be safe. However, given the broad scope of MA 8 (miscellaneous purposes of use), which would require a higher degree of regulatory oversight, in scenarios where the Food Directorate wishes to permit a new food additive with a new purpose of use, it has been determined that approval by the Minister of Health should be obtained by means of a regulatory amendment to the MA. In line with the policy intent of the modernized food additives framework brought into force in 2012, the amendments to this MA intend — to the greatest extent possible — to ensure that food additive decisions are brought into force in an efficient and timely manner. Therefore, section 2 of MA 8 is being amended so that an existing food additive with a new purpose of use can be added to the incorporated list through the established administrative process. The capacity under section 2 of MA 8 to administratively add a new food additive with an existing purpose of use to the List remains unchanged. Section 2 is also being amended to require that in the case of a new food additive with a new purpose of use, that additive and purpose of use must both be set out in the new Schedule to the MA as well as in the incorporated list. Adding items to the new Schedule requires approval from the Minister of Health and a formal amendment to the MA. Immediately following this, the Food Directorate would then proceed with administratively enabling the decision in the incorporated list, thus meeting both conditions to establish a valid exemption for this novel combination. There are no changes to the method by which stakeholders will be notified of changes to the List, and they will be apprised via Notices of Proposal and Notices of Modification for enabling new additives with existing purposes of use or existing additives with new purposes of use, and publication in the Canada Gazette for new additives with new purposes of use. The approach described above ensures a greater level of regulatory oversight when dealing with a novel combination (within the Canadian context) of a new food additive with a new purpose of use, and ensures consistency in the approach for existing additives with new uses to the established administrative process used for the 14 Lists of food additives. The table below summarizes how changes to the List of Permitted Food Additives with Other Accepted Uses operate under the amended MA 8. This table shows changes to the List of Permitted Food Additives with Other Accepted Uses. Scenario Summary Scenario 1 Health Canada’s Food Directorate has completed its scientific assessment and wishes to enable a new food additive for an existing purpose of use: No amendment to the Schedule is required. The Food Directorate can proceed with enabling the decision in the incorporated list following the established administrative process. Note: This has always been the case and remains unchanged. Scenario 2 Health Canada’s Food Directorate has completed its scientific assessment and wishes to enable an existing food additive for a new purpose of use: No amendment to the Schedule is required. The Food Directorate can proceed with enabling the decision in the incorporated list following the established administrative process. Scenario 3 Health Canada’s Food Directorate has completed its scientific assessment and wishes to enable a new food additive with a new purpose of use: the MA must be amended to include the new additive and new purpose of use in the Schedule and the incorporated list must be administratively modified to include the new additive and new purpose of use, in order to meet the conditions necessary to establish a valid exemption for the novel combination. In addition to amending section 2 of the MA, the term “generally” has been removed from both the title of the MA and its incorporated list. The MA and its incorporated list are now titled: Marketing Authorization for Food Additives with Other Accepted Uses and the List of Permitted Food Additives with Other Accepted Uses. Consultation Information about the proposed amendments to this MA was provided in a Notice of Intent (NOI) published on the Health Canada website on September 9, 2016, for a 75-day comment period. One comment, which supported the proposal, was received from a major industry association. New Schedule — Lactococcus lactis (L. lactis) DSM 11037 as an oxygen scavenger Following the publication of the NOI, Health Canada published on its website a separate Notice of Proposal (NOP/AVP-0021), on September 20, 2016, informing stakeholders of its intent to enable the use of the food additive Lactococcus lactis (L. lactis) DSM 11037 as an oxygen scavenger. A 75-day comment period was provided during which no comments were received. As this decision falls within the scope of MA 8 and is a combination of a new food additive for a new purpose of use, Lactococcus lactis (L. lactis) DSM 11037 as an oxygen scavenger is added to the new Schedule to MA 8. With the publication of this amended MA, Health Canada will proceed with enabling this additive for its intended purpose of use in the List of Permitted Food Additives with Other Accepted Uses. “One-for-One” Rule The “One-for-One” Rule does not apply to this regulation, since the administrative costs remain the same for businesses and the impact of the MA is neutral. Small business lens The small business lens does not apply to this regulation, since the MA creates an exemption to a prohibition in the FDR if certain conditions are met and it does not impose additional costs on small businesses. Implementation, enforcement and service standards The amended MA is incorporated into existing compliance and enforcement activities carried out by the Canadian Food Inspection Agency (CFIA) under the provisions of the Food and Drugs Act and its regulations, and other applicable food related legislation enforced by the CFIA. Health Canada will notify stakeholders about the amendments to this MA through publication in the Canada Gazette, Part II, and will notify stakeholders about amendments to the incorporated list by means of a Notice of Modification published on its website. Information regarding both amendments will be posted on the Department’s website. Contact Bruno Rodrigue Policy, Planning and International Affairs Directorate Health Products and Food Branch Health Canada Holland Cross, Suite 14 1600 Scott Street Ottawa, Ontario K1A 0K9 Email: [email protected] Footnote a S.C. 2012, c. 19, s. 416 Footnote b S.C. 2014, c. 24, s. 7 Footnote c R.S., c. F-27 Footnote 1 SOR/2012-209

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