Health Canada’s Proposal to Add a Maximum Level for Inorganic Arsenic in Rice-based Foods Intended Specifically for Infants and Young Children
Organization: Health Canada
Notice of Proposal - List of Contaminants and Other Adulterating Substances in Foods
Reference Number: NOP/ADP C-2021-1
April 9, 2021
Food contaminants and other adulterating substances are chemicals that may 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 maximum level (ML) is a form of risk management that may be employed to reduce exposure to a particular chemical contaminant in foods. Canadian 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.
Health Canada is proposing to establish a new ML for inorganic arsenic of 0.1 parts per million (ppm) in rice-based foods intended specifically for infants and young children.
It is the intention of Health Canada to modify Part 2 of the List of Contaminants and Other Adulterating Substances in Foods as outlined below.
Proposed Modification to Part 2 of the List of Contaminants and Other Adulterating Substances in Foods
|Item No.||Column 1 Substance||Column 2 FoodFootnote 1||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.|
Arsenic is naturally occurring in the environment and is found at low levels in many types of foods. The concentrations of arsenic in foods sold in Canada are low and have been stable for many years. However, long-term exposure to very high levels of inorganic arsenic may contribute to a possible increased risk of certain cancers and other adverse health effects.
Health Canada is committed to ensuring that dietary exposure to food contaminants is as low as reasonably achievable. Rice-based cereals and rice-containing products intended for infants and young children represent a significant source of exposure to inorganic arsenic in the diet of infants and young children in Canada. To minimize dietary exposure and potential health risks associated with inorganic arsenic for these particular age groups, Health Canada is proposing to establish an ML of 0.1 ppm for inorganic arsenic in rice-based foods intended specifically for infants and young children. Health Canada previously communicated that it was considering more protective risk management measures for these types of foods (refer to NOP/ADP C-2019-2 and NOM/ADM C-2020-1).
The proposed ML is expressed on an inorganic basis given that inorganic forms of arsenic are of greater concern to human health and are most common in rice.
The ML will apply 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 would therefore 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.
Canadian monitoring data demonstrate that this ML is readily achievable for rice-based foods for infants and young children sold in Canada.
Other Relevant Information
The proposed ML for inorganic arsenic in rice-based foods intended specifically for infants and young children aligns with the European Commission's (EC) ML of 0.1 ppm for inorganic arsenic in rice destined for the production of food for infants and young children that was added to Regulation No 1881/2006 in 2015 (Commission Regulation 2015/1006) . It also aligns with the United States Food and Drug Administration's action level of 0.1 ppm for inorganic arsenic in infant rice cereals that was formalized in 2020.
The Codex Alimentarius Commission (CAC) and Food Standards Australia New Zealand have not established MLs for inorganic arsenic in rice-based foods for infants and young children or rice destined for use such foods. However, in 2014 and 2016, respectively, the CAC established MLs for inorganic arsenic in polished (white) and husked (brown) rice (CXS 193-1995). The same MLs for inorganic arsenic in polished and husked rice (NOM/ADM C-2020-1) have been in effect in Canada since June 2020.
Implementation and Enforcement
The proposed changes will be effective on the day on which they are published in Part 2 of the List of Contaminants and Other Adulterating Substances in Foods. Health Canada proposes to publish the changes to the list following the close of the 75-day comment period, provided that no data or information regarding the proposed changes are submitted that would potentially alter the proposal. Changes to the list will be announced via a Notice of Modification, which will be published on Health Canada's website.
The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Drugs Act and its associated regulations with respect to foods.
For additional information or to submit comments related to this proposal, please contact:
If communicating by email, please use the words "Arsenic ML for Infant Rice Foods (NOP/ADP-C-2021-1)" in the subject line of your email. Health Canada is able to consider information received by June 22, 2021, 75 days from the date of this posting.
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