Canada Considering Positive List System for Food-Contact Materials
Speaking at the 13th Biennial International Symposium on Worldwide Regulation of Food Packaging in Baltimore last month, Mr. Anastase Rulibikiye, Section Head of Health Canada’s Health Products and Food Branch, said that Canada is considering implementing a positive list system for the regulation of food-contact materials. After the meeting, he provided PackagingLaw.com with the following comments on the current status and future direction of the regulation of food-contact materials in Canada.
Letters of No Objection
In Canada, packaging materials in which food is sold must comply with safety provisions set out under Division 23 of the Canadian Food and Drug Regulations (FDR). Division 23 prohibits the sale of foods in packages that may impart to the food any substance that may be injurious to human health. The responsibility to meet this requirement rests with the food seller. “Packaging”, as it relates food, is defined in the Canadian Food and Drugs Act as “anything in which any food…is wholly or partly contained, placed or packaged”.
Under the FDR, there are no general provisions in place that require the mandatory review of food packaging materials prior to their use in the manufacture of food (except as part of the mandatory premarket review requirement of infant formulae and some novel food processes). In part as a consequence of the onus placed on food sellers to ensure the safety of food packaging materials, the food industry began, in the 1960s, to submit requests to what was then the Department of National Health and Welfare for the safety review of food packaging materials, formulated products, and components used in the manufacture of food packaging materials. In the case of a favourable assessment, a “Letter of No Objection” (LONO) is issued.
Manufacturers of food packaging materials may use LONOs to assure their prospective business customers (food sellers) that their products have been evaluated and deemed acceptable from a chemical safety standpoint for use in specified food packaging applications.
Between 1997 and 2014, the Canadian Food Inspection Agency (CFIA), which verifies compliance of food with Canadian standards and regulations, relied on LONOs issued by Health Canada as a primary source of evidence to support the the Agency’s mandatory pre-approval process for packaging materials. Pre-approval was mandatory under various regulations administered by the CFIA, including the Meat Inspection Regulations, the Fish Inspection Regulations and the Egg Regulations. If accepted, the food packaging material was registered on the CFIA’s Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products. Although the CFIA’s pre-approval process is no longer in place, the Reference Listing continues to be available (but not updated), and LONOs are still an option for manufacturers wishing to demonstrate to the CFIA that pre-packaged foods they intend to sell in Canada are packaged in a food packaging material that would not be in violation of Division 23 of the FDR. Another option for demonstrating acceptability and safe intended use of food packaging materials is a Letter of Guarantee (LOG) from the supplier or manufacturer of the packaging material that is intended to come in direct or indirect contact with food products. Additional details on the options for demonstrating to the CFIA the acceptability of food packaging materials, as well as details on the information that an LOG should contain can be found in the CFIA’s “Guidance for Food Establishments Concerning Construction Materials and Packaging Materials and Non-Food Chemicals.”
Looking to the Future
The repeal in 2014 of the CFIA’s requirements for pre-market registration of food packaging materials presented an opportunity for Health Canada to re-examine its non-mandatory program for the assessment of food packaging materials. The Bureau of Chemical Safety within Health Canada’s Food Directorate has been reviewing its current pre-market safety assessment activities and considering what degree of oversight the government should have over the safety of materials used to package foods sold in Canada. Different options to manage the oversight of food packaging materials were considered with a view to identifying an option that is most likely to be sustainable and responsive.
The Bureau of Chemical Safety sought input from targeted stakeholders. Based on the comments provided by stakeholders and the Department’s own review, the Bureau is considering the establishment of a mandatory pre-market assessment program and the development of “positive lists”. Stakeholders will be asked to provide suggestions and comments on specific aspects of a future mandatory pre-market program. A mandatory pre-market safety assessment program for food packaging materials would require amendments to Division 23 of the Food and Drug Regulations. As per standard procedure, any proposed amendments to the Regulations will be accompanied by broad consultation.
In the meantime, the Food Directorate’s Bureau of Chemical Safety continues to accept and assess requests for opinions on the acceptability, from a food safety perspective, of food packaging materials, formulated products, and components used in the manufacture of food packaging materials.