Health Canada’s Notice of Modification to Add a Maximum Level for Inorganic Arsenic in Rice-based Foods Intended Specifically for Infants and Young Children

Notice of Modification – List of Contaminants and Other Adulterating Substances in Foods

Reference Number: NOM/ADM C-2022-2

August 17, 2022

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Summary

Food contaminants and other adulterating substances are chemicals that should not be present in foods at levels that could impact the overall safety and/or quality of foods. These substances can either be inadvertently present in foods or in some cases intentionally added for fraudulent purposes. Establishing a prohibition or a maximum level (ML) are forms of risk management that may be employed to eliminate or reduce exposure to a particular chemical contaminant in foods sold in Canada. Prohibitions and MLs for chemical contaminants in food are set out in Part 1 and Part 2, respectively, of the List of Contaminants and Other Adulterating Substances in Foods, which is incorporated by reference into section B.15.001 of Division 15 of the Food and Drug Regulations (the Regulations). Maximum levels are also set out in the List of Maximum Levels for Various Chemical Contaminants in Foods, which is maintained on Health Canada's website. All prohibitions and MLs for contaminants in food are established by Health Canada's Food Directorate based on scientific evidence and in consultation with stakeholders and are enforceable by the Canadian Food Inspection Agency.

On April 9, 2021, Health Canada published a Proposal to Add a Maximum Level for Inorganic Arsenic in Rice-based Foods Intended Specifically for Infants and Young Children to the List of Contaminants and Other Adulterating Substances in Foods (NOP/ADP C-2021-1). The proposal was open for public comment for 75 days and closed on June 22, 2021. Comments submitted to Health Canada are summarized in the "Notification – Summary of Comments and Health Canada's Responses" section, below.

As no new scientific information was received that would alter the approach described in the Notice of Proposal, Health Canada has added an ML of 0.1 ppm for inorganic arsenic in rice-based foods intended specifically for infants and young children, to Part 2 of the List of Contaminants and Other Adulterating Substances in Foods, as shown in the table below.

Modification to Part 2 of the List of Contaminants and Other Adulterating Substances in Foods
Item No. Column 1
Substance
Column 2
Food
Column 3
Maximum Level
1.2 Arsenic, inorganic (sum of arsenite (As III) and arsenate (As V)) (3) Rice-based foods intended specifically for infants and young children (3) 0.1 p.p.m.

The ML applies to foods where rice is a primary ingredient and that are specifically intended for, and marketed to, infants and young children, such as rice infant cereals, rice teething biscuits and quick dissolving puffed rice snacks. The ML therefore does not apply to rice-based foods that are commonly consumed by all ages of the Canadian population (e.g. puffed rice breakfast cereals, rice cakes, rice crackers). Health Canada has already established MLs for inorganic arsenic in polished (white) and husked (brown) rice in the List of Contaminants and Other Adulterating Substances in Foods. These MLs also apply to white and brown rice when used as ingredients in other rice-based foods sold in Canada.

Rationale

Health Canada is committed to minimizing dietary exposure to inorganic arsenic in food to as low as reasonably achievable. Long-term exposure to elevated levels of inorganic arsenic can contribute to a possible increased risk of certain cancers and other health effects such as neurotoxicity, skin lesions and diseases of the circulatory system. Elevated exposure during early stages of life may also increase the risk of adverse effects experienced later in life.

Rice-based foods represent a significant source of exposure to inorganic arsenic in the diets of infants and young children in Canada. Surveillance data available to Health Canada indicate that the ML is readily achievable for rice-based­ products intended for infants and young children. The ML of 0.1 ppm for rice-based products will help minimize inorganic arsenic exposures for infants and young children, by requiring that the levels in such products sold in Canada remain as low as possible.

For more information, you can access Health Canada's supporting assessment here.

Other Relevant Information

Other food safety organizations worldwide have implemented risk management measures for arsenic in rice-based foods for infants. Health Canada's ML of 0.1 ppm for inorganic arsenic (sum of As III and As V) in rice-based foods intended specifically for infants and young children aligns with the ML established by the European Commission (EC) for inorganic arsenic in rice destined for the production of food for infants and young children (Commission Regulation 2015/1006). Health Canada's ML also aligns with the United States Food and Drug Administration's (U.S. FDA) action level of 0.1 ppm for inorganic arsenic in all types of infant rice cereals.

Notification – Summary of Comments and Health Canada's Responses

Health Canada received comments from the Canadian Celiac Association (CCA), the Ontario Dieticians in Public Health (ODPH), the Dieticians of Canada (DC) and the Canadian Paediatric Society (CPS), following the publication of the Department's Proposal to Add a Maximum Level for Inorganic Arsenic in Rice-based Foods Intended Specifically for Infants and Young Children to the List of Contaminants and Other Adulterating Substances in Foods (NOP/ADP C-2021-1) on April 9, 2021. The comments submitted to Health Canada all supported the proposal to establish an ML for inorganic arsenic in rice-based foods intended specifically for infants and young children, and to align the ML with that of the EC and the U.S. FDA action level.

Implementation and Enforcement

The above modification came into force on August 17, 2022, the day it was published in Part 2 of the List of Contaminants and Other Adulterating Substances in Foods.

The Canadian Food Inspection Agency is responsible for the enforcement of the food-related aspects of the Food and Drugs Act and its associated regulations.

Contact Information

Health Canada's Food Directorate is committed to reviewing any new scientific information on the chemical safety of foods. Anyone wishing to submit new scientific information relating to inorganic arsenic in rice-based foods intended for infants and young children may do so in writing, by postal mail or email. If you wish to email the Food Directorate, please include "Arsenic in rice-based infant foods (NOM C-2022-2)" in the subject line.

Bureau of Chemical Safety, Food Directorate
251 Sir Frederick Banting Driveway
Tunney's Pasture, PL: 2202C
Ottawa, Ontario K1A 0K9
E-mail: bcs-bipc@hc-sc.gc.ca

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