SOR/2016-143: Regulations Amending the Food and Drug Regulations (Food Additives)
REGISTRATION OF FEDERAL REGULATION - VIA OIC DATABASE, PRIOR TO PART II OF THE GAZETTE
June 14, 2016
REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Regulations.) Issues The tables of food additives in Division 16 of the Food and Drug Regulations (FDR) became redundant in 2012 with the implementation of the Lists of Permitted Food Additives which are incorporated by reference into associated Marketing Authorizations (MAs). The Department of Health (the Department) is deve... (Click for more)
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Published on June 14, 2016
SOR/2016-143: Regulations Amending the Food and Drug Regulations (Food Additives)
REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Regulations.) Issues The tables of food additives in Division 16 of the Food and Drug Regulations (FDR) became redundant in 2012 with the implementation of the Lists of Permitted Food Additives which are incorporated by reference into associated Marketing Authorizations (MAs). The Department of Health (the Department) is developing a regulatory proposal to repeal the existing tables of food additives from Division 16 of the FDR. In the meantime, removal of any food additive from an incorporated List without repealing it from the applicable Table in the FDR could lead to confusion among industry stakeholders and potentially result in risks to public health if a manufacturer uses a non-approved food additive. Based on recent scientific assessments and an internal review, the Department plans to amend the Lists of Permitted Food Additives to remove three food additives — namely epichlorohydrin, 2-nitropropane and ethylene oxide. In order to minimize any potential risks associated with discrepancies between the tables in the FDR and the incorporated lists, there is a need to proceed with targeted amendments to repeal the applicable food additives from the tables. Background Regulation of food additives in Canada Food additives are strictly regulated in Canada. In order to be used in food, a food additive must be approved for use by the Department. This approval process entails a detailed and rigorous pre-market safety evaluation. Food additives must be of suitable quality, must be effective for their intended purpose, and must not pose a hazard to the health of the consumer. Historically, permitted food additives have been listed in 15 tables housed under Part B, Division 16 of the FDR. However, a new structure was introduced in 2012 following the enactment of Bill C-38 — the Jobs, Growth and Long-term Prosperity Act — which resulted in amendments to the Food and Drugs Act, providing the Minister of Health with new Marketing Authorizations (MAs) and Incorporation by Reference (IbR) authorities. Under the new system, the 15 tables of food additives in the FDR were effectively replaced by 15 lists that are incorporated by reference into corresponding MAs and are published by the Department on its Web site. The Department’s intent is to repeal the now redundant tables in the FDR, but such work will take some time given the complexity of the consequential amendments required to sections throughout the FDR that refer to these tables. For this reason, in the interim, the tables in the FDR and the incorporated lists will continue to co-exist. Removal of food additives from incorporated lists Some substances with food additive uses have been the subject of screening assessments by Health Canada and Environment Canada (now Environment and Climate Change Canada) over the past few years as part of commitments made under Canada’s Chemicals Management Plan to examine high priority substances. The findings from this process have determined that two substances, namely epichlorohydrin and 2-nitropropane, may be harmful to human health. Consequently, these substances were added to the List of Toxic Substances in Schedule 1 to the Canadian Environmental Protection Act, 1999 (CEPA). (see footnote 2) As these two substances currently have permitted food additive uses in Canada, the Department is proceeding with the process to remove epichlorohydrin and 2-nitropropane from the incorporated List of Permitted Starch-Modifying Agents and the List of Permitted Carrier or Extraction Solvents, respectively. The Department will also be removing ethylene oxide from the List of Permitted Food Additives with Other Generally Accepted Uses. This substance is also currently regulated as a fumigant for spices under both the FDR and the Pest Control Products Act (PCPA). As ethylene oxide meets the regulatory definition of a pest control product under the PCPA when used for the purpose of fumigation, provisions should therefore fall under the oversight of the PCPA, which is administered by the Pest Management Regulatory Agency (PMRA). As a result, by removing ethylene oxide from the List of Permitted Food Additives with Other Generally Accepted Uses as well as from the FDR, the current regulatory duplication in respect of this substance will be removed. Objectives The objective of these regulatory amendments is to reduce the potential for confusion among stakeholders as well as mitigate potential risk to public health arising from conflicting food additive provisions appearing in the tables of food additives in the FDR and those set out in the incorporated Lists of Permitted Food Additives. This objective will be accomplished by repealing provisions for three food additives — epichlorohydrin, 2-nitropropane and ethylene oxide — from the tables in the FDR. Description These regulatory amendments bring forward the following changes to the FDR: Repealing Ethylene Oxide from Table VIII to section B.16.100. Repealing Epichlorohydrin from Table XIII to section B.16.100. Repealing 2-Nitropropane from Table XV to section B.16.100. “One-for-one” Rule Since the tables of food additives in the FDR are now considered redundant and will eventually be repealed in their entirety from Division 16, targeted amendments to those tables are only necessary for the time being to prevent stakeholder confusion from inconsistencies with the official incorporated Lists. As a result, the “One-for-One” Rule does not apply. Small business lens Since these amendments simply remove provisions for three food additives from the now redundant tables of food additives in the FDR, which will have no impact on the food industry, the small business lens does not apply. Consultation Consultations with stakeholders have occurred on various occasions within the context of activities associated with the Chemicals Management Plan. Between 2009 and 2012, draft screening assessments and risk management options related to 2-nitropropane and epichlorohydrin were published in the Canada Gazette, Part I, for public comment. (see footnote 3), (see footnote 4), (see footnote 5), (see footnote 6), (see footnote 7), (see footnote 8), (see footnote 9) Based on the assessments concluding that these two substances may be harmful to human health, and following public consultations, both substances were added to the List of Toxic Substances in Schedule 1 of CEPA. The government’s plans to remove these as permitted food additives are publicly stated on the Chemicals Management Plan Web site. (see footnote 10), (see footnote 11) On March 31, 2016, the Department issued a Notice of Proposal for the removal of 2-nitropropane and epichlorohydrin from their respective Lists, (see footnote 12) in accordance with the standard procedure when making changes to the incorporated Lists. If no new scientific information comes to light during the 75-day comment period, the Department will publish the changes in the incorporated Lists. This will be announced by way of a Notice of Modification on the Department’s Web site. The Department’s plan to remove food additive provisions for ethylene oxide is related to duplication in regulatory oversight of this substance. The Department is of the view that the PCPA is the more appropriate instrument for controlling use of this fumigant. As a result, this substance will be removed from the incorporated List of Permitted Food Additives with Other Generally Accepted Uses. It is not anticipated that the removal will have an impact on stakeholders, as use of ethylene oxide as a fumigant for spices will simply continue to be regulated under the PCPA. Consistent with standard procedures, the Department plans to issue a Notice of Proposal for public consultation prior to making this change to the List. Rationale Anticipated changes to the incorporated Lists would involve, for the first time, removing provisions for the use of food additives that also appear in the tables in Division 16. Two of the three changes would be required to protect public health. Although the Government has consistently communicated to stakeholders that the incorporated Lists are the official repository of food additives, there is a risk that removal of a food additive from a List without repealing it from its corresponding Table in the FDR could create confusion as to which conditions must be followed. These regulatory amendments will alleviate any potential risk of confusion that could ensue upon completion of the Department’s process to remove the three food additives from the incorporated Lists by also removing these substances from the applicable tables in Division 16. While it is likely that these regulatory amendments will precede the necessary changes to the incorporated Lists, this timing is not expected to have any impact on the food industry. Moving forward with a repeal of these three food additives from the tables in the FDR will simply lay the groundwork for the Department’s forthcoming changes to the incorporated Lists. Communication from the Department and the Canadian Food Inspection Agency (CFIA) will continue to reinforce that the incorporated Lists contain the official food additive provisions. Implementation, enforcement and service standards These amendments do not alter existing compliance mechanisms under the provisions of the FDA and its Regulations or other applicable food-related legislation enforced by the CFIA. Furthermore, until the broader plan to remove the fifteen tables of food additives from the FDR is complete, communication from the Department and the CFIA will continue to direct the food industry to the incorporated Lists for the official food additive provisions. Contact Bruno Rodrigue Office of Legislative and Regulatory Modernization Policy, Planning & International Affairs Directorate Health Canada Address Locator: 3105A Holland Cross, Tower B, 5th Floor 1600 Scott Street Ottawa, Ontario K1A 0K9 Fax: 613-941-7104 Email: [email protected] Footnote a S.C. 2014, c. 24, s. 6 Footnote b R.S., c. F-27 Footnote 1 C.R.C., c. 870 Footnote 2 http://canadagazette.gc.ca/rp-pr/p2/2011/2011-02-16/html/sor-dors25-eng.html Footnote 3 http://www.gazette.gc.ca/rp-pr/p1/2010/2010-01-30/html/sup-eng.html Footnote 4 http://www.gazette.gc.ca/rp-pr/p1/2012/2012-07-28/html/notice-avis-eng.html Footnote 5 http://publications.gc.ca/collections/collection_2012/gazette/SP2-1-146-30.pdf Footnote 6 http://publications.gc.ca/collections/collection_2009/canadagazette/SP2-1-143-20.pdf Footnote 7 http://publications.gc.ca/gazette/archives/p1/2009/2009-01-31/pdf/g1-14305.pdf Footnote 8 http://publications.gc.ca/gazette/archives/p1/2008/2008-05-17/pdf/g1-14220.pdf Footnote 9 http://www.gazette.gc.ca/rp-pr/p1/2011/2011-01-22/html/notice-avis-eng.html#d103 Footnote 10 http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/summary-sommaire/batch-lot-8/action-tab-eng.php#a1 Footnote 11 http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/summary-sommaire/batch-lot-2/action-tab-eng.php Footnote 12 http://www.hc-sc.gc.ca/fn-an/consult/nop-adp-0015/index-eng.php
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