Proposal to Update the Maximum Levels for Lead in Fruit Juice, Fruit Nectar and Water in Sealed Containers in the List of Contaminants and Other Adulterating Substances in Foods

Notice of Proposal - List of Contaminants and Other Adulterating Substances in Foods

Reference Number: [NOP/AVP C-2017-2]

March 1, 2017

Summary

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 maximum levels (MLs) is a form of risk management that may be employed to reduce exposure to a particular chemical contaminant in food sold in Canada. Canadian MLs for chemical contaminants in food are set out in the List of Contaminants and Other Adulterating Substances in Foods, which is incorporated by reference into section B.15.001of Division 15 of the Food and Drug Regulations, and in the List of Maximum Levels for Various Chemical Contaminants in Foods, which has a history of being maintained on Health Canada’s website outside of the Food and Drug Regulations. Health Canada is working towards the consolidation of all MLs into the single regulatory List of Contaminants and Other Adulterating Substances in Foods and is also systematically reviewing and updating, as appropriate, existing MLs in both of these lists. All MLs for contaminants in food are established by Health Canada and are enforceable by the Canadian Food Inspection Agency (CFIA).

The List of Contaminants and Other Adulterating Substances in Foods specifies an ML of 0.2 parts per million (p.p.m.) for lead in fruit juice, fruit nectar, beverages when ready-to-serve, and water in sealed containers (commonly referred to as bottled or prepackaged water) other than mineral or spring water. If these foods contain lead at concentrations above 0.2 p.p.m., they are considered adulterated and in violation of the Food and Drugs Act and Regulations.

Health Canada is proposing to lower the existing ML for lead in fruit juice and fruit nectar to 0.05 p.p.m. and also lower the ML for lead in water in sealed containers to 0.01 p.p.m.. The proposed ML for fruit juice and fruit nectar would also apply to fruit juice and nectar when used as an ingredient in other foods and to juice concentrate when reconstituted to its ready-to-serve form. Furthermore, Health Canada is proposing to extend the ML for lead in water in sealed containers such that it applies to all types of bottled water, including mineral and spring water, which have a standard of identity under Division 12 of the Food and Drug Regulations.

The existing MLs for lead in these beverages were established when there were sources of lead contamination to foods that are no longer relevant in Canada. Therefore, the existing MLs do not reflect concentrations of lead typically found in these types of beverages today and are no longer considered health protective.

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. Substance FoodFootnote 1 Maximum LevelFootnote 2
3 Lead (4) Beverages (4) 0.2 p.p.m.
(7) Fruit juice; Fruit nectar (7) 0.05 p.p.m.
(8) Water in sealed containers (8) 0.01 p.p.m.
1 The maximum level also applies to the food when it is used as an ingredient in other foods.

2 Maximum levels apply to foods on a fresh weight basis. For foods that are dehydrated or require reconstitution, the maximum level applies to the food that is rehydrated or reconstituted to its original form or concentration, unless otherwise specified.

At this time, the existing ML of 0.2 p.p.m. for lead in ‘beverages’ will remain in the List of Contaminants and Other Adulterating Substances in Foods. Health Canada intends to review and update, as appropriate, this and all other MLs for lead in Part 2 of the List.

Corrective modification

To avoid redundancy with proposed footnote 2 in the List of Contaminants and Other Adulterating Substances in Foods, which indicates that the MLs apply to foods on a fresh weight basis that are in their original form or concentration, the wording ‘when ready-to-serve’ is proposed to be removed from the ‘beverages’ listing.

Rationale

Lead has no known function in the human body and it is internationally agreed that measures should be taken to identify methods of reducing exposure to lead. Long-term exposure to elevated levels of lead can cause neurodevelopmental, neurodegenerative, cardiovascular, renal and reproductive effects. Developing infants and young children are most sensitive to the toxic effects of lead as they absorb lead more easily than adults and their nervous systems are particularly susceptible. As fruit juice makes a potentially significant contribution to dietary lead exposure, particularly in infants and young children, this commodity group was identified as a priority for setting an updated lead ML.

The existing MLs for lead were established when there were sources of lead contamination in foods that are no longer relevant in Canada such as the use of leaded gasoline, paint and solder used in food cans. Today, lead is present in the environment at low levels as a result of its natural occurrence in rock and soil and release from industrial activities such as mining, smelting and ore processing.

Canadian monitoring data demonstrate that the proposed lower MLs for lead in fruit juice, fruit nectar and all types of water in sealed containers are readily achievable when good agricultural and manufacturing practices are followed. The proposed lower MLs are more protective of human health relative to the existing MLs and align with the Health Canada’s approach to managing dietary exposure to lead, which aims to reduce exposure to levels that are as low as reasonably achievable (ALARA principle), as well as Health Canada’s Risk Management Strategy for Lead that recommends reducing exposure to lead from all sources.

Other Relevant Information

The proposed lower ML for lead in fruit juice and fruit nectar aligns with the MLs established by the European Union (EU; EC No. 1881/2006) and the United States Food and Drug Administration (US FDA; Juice HACCP Hazards and Controls Guidance). In 2015 the Codex Alimentarius Commission (Codex; CODEX STAN 193-1995) lowered its ML for lead in fruit juices and nectars when ready-to-drink, except those from berries and other small fruits, from 0.05 p.p.m. to 0.03 p.p.m.. Health Canada’s proposed lower ML for lead in fruit juice and fruit nectar aligns with the previous Codex ML. Once the Codex Committee on Contaminants in Food finalizes its review of an updated ML for fruit juice from berries and other small fruits, Health Canada will consider aligning Canadian MLs for lead in all fruit juice and fruit nectar with established Codex ML(s).

Lowering the ML for lead in bottled water and applying it also to those with a standard of identity in Division 12 of the Food and Drug Regulations (i.e., mineral and spring water), aligns with the maximum acceptable concentration for lead set out in the Guideline for Canadian Drinking Water Quality. The proposed lower ML for lead in bottled water also aligns with the Codex ML for lead in natural mineral water (CODEX STAN 108-1981), the EU ML for lead in bottled water (Directive 2003/40/EC) and the World Health Organization drinking water quality guideline for lead, which was also adopted by Food Standards Australia New Zealand for lead in packaged water. The US FDA’s allowable level for lead in bottled water (21 CFR §165.110) is 0.005 ppm.

In 2014, Health Canada’s Food Directorate conducted a technical consultation on the proposed lower MLs for lead in fruit juice and fruit nectar and all types of water in sealed containers. Stakeholders representing the food industry and professional organisations were supportive of the proposed lower MLs. The Summary of Comments and Responses to Health Canada’s Proposed Amendments to the Regulatory Tolerances for Arsenic and Lead in a Variety of Beverages was posted on Health Canada’s website on January 28, 2016.

Implementation and Enforcement

The proposed changes will be effective 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 12 months 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 of Contaminants and Other Adulterating Substances in Foods 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.

Contact Information

For additional information or to submit comments or information related to this proposal, please contact:

Bureau of Chemical Safety, Food Directorate
251 Sir Frederick Banting Driveway
Tunney’s Pasture, PL: 2202C
Ottawa, Ontario K1A 0L2
E-mail: bcs-bipc@hc-sc.gc.ca

If communicating by e-mail, please use the words “Lead MLs for Juice and Bottled Water” in the subject line of your e-mail. Health Canada is able to consider information received by May 14, 2017, 75 days from the date of this posting.

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