Questions and Answers
Compliance to the new Food and Drug Regulations on Enhanced Labelling of Food Allergens, Gluten Sources and Added Sulphites

The New Regulations and their Application

The New Regulations: Coming into Force

When will Health Canada's new regulations take effect?

The coming into force date is set for August 4, 2012, which is 18 months after the day on which the amendments were registered for publication in Canada Gazette, Part II. Any applicable prepackaged foods being offered for sale on August 4, 2012 must be in compliance with the new regulations.

Are imported products in warehouses or in transit to Canada prior to effective date, required to comply with the new regulations by the effective date?

On the effective date (August 4, 2012), any products sold in Canada are required to comply with the new regulations. Section 2 of the Food and Drugs Act defines "sell" as including offer for sale, expose for sale, have in possession for sale and distribute, whether or not the distribution is made for consideration. This does not include products that are not ready for sale such as products held for reworking, reconditioning or relabelling.

The importer is responsible for ensuring that foods imported into Canada are compliant with the Canadian regulations. Products with non-compliant labels can be imported provided that the importer gives the CFIA notification of the proposed importation of the food and the food is re-labelled or modified as may be necessary to enable its sale to be lawful in Canada, within three months after the importation or prior to leaving the warehouse [A.01.044, Food and Drug Regulations (FDR)]. It is important to note that the food cannot be sold in Canada until it is compliant with Canadian regulations, including providing mandatory information in both English and French where required. Please note that other federal legislation may have specific requirements for the labelling of imported products, including mandatory label registration for processed meat products.

Are prepackaged foods that are already in retail stores, prior to the effective date, required to comply with the new regulations?

Yes, any applicable prepackaged foods being offered for sale at any level of trade on August 4, 2012 must be in compliance with the new regulations.

The new regulations take effect on August 4, 2012. Does this means that added priority allergens, gluten sources or sulphites do not have to be declared until the effective date?

Companies should always consider risk to allergic individuals and indicate the presence of all ingredients. The new regulations make declaration of the priority allergens mandatory even when these are an ingredient of another ingredient. A pre-packaged food product labelled with a list of ingredients is considered unsafe for people with food allergies if some of those ingredients or components are priority allergens and are not declared on the label. Failure to declare allergenic ingredients or components deemed to be a health risk may be contrary to subsection 5.(1) of the Food and Drugs Act and subsection 7(1) of the Consumer Packaging and Labelling Act. These products may therefore be subject to regulatory measures taken by the CFIA, including product recall.

What does industry need to do between now and the coming into force date?

All companies will need to make the necessary changes to labels and packaging or reformulate products, where necessary, to ensure that the products are fully compliant with new regulations on the effective date.

Compliance and Enforcement

What is the Canadian Food Inspection Agency's role in allergen regulations?

The CFIA is responsible for enforcement of the Food and Drug Regulations. The CFIA will develop guidance documents and assessment tools which will assist industry with compliance to the new regulations. The CFIA will remind industry of the steps they must take to comply during the coming into force period.

What enforcement actions will the CFIA take during the coming into force period?

Prior to the effective date, the CFIA will continue its existing enforcement practices. When undeclared allergens are identified as posing a health risk, prior to the new regulations coming into force, these products will continue to be subject to enforcement action by the CFIA under subsection 5.(1) of the Food and Drugs Act and section 7(1) of the Consumer Packaging and Labelling Act. Enforcement action can include follow-up inspections, further directed sampling according to a surveillance plan, or even seizure and recall of products.

How does the CFIA deal with enforcement? What criteria are used by the CFIA?

The CFIA is responsible for enforcing the food labelling and composition provisions of the Food and Drugs Act and the Food and Drug Regulations, as well as the parts of the Consumer Packaging and Labelling Act that deal with food. The CFIA's enforcement policy takes into consideration the severity of the non compliance such as health risk, as well as the company's past compliance history. Appropriate follow-up actions may include directed or compliance sampling and testing, follow-up inspections, and product recall.

Allergen Sampling and Monitoring

Is there a list of approved test methods for food allergens?

No, there is not a published list of all "approved" methods for food allergen testing. Some allergen methods as well as guidance to test kit manufacturers can be found on the Health Canada website at www.hc-sc.gc.ca/fn-an/res-rech/analy-meth/allergen/index-eng.php; however, this is not a complete list of methods used by the CFIA.

Is there a procedure to have test methods recognized by the Canadian government?

The Canadian government recognizes allergen test methods that may have been validated through independent third party standards organizations such as AOAC International or International Organization for Standardization (ISO). Methods validated through such organizations meet internationally agreed upon criteria and would be validated. In addition, the government also recognizes that test kit manufacturers do undergo extensive validation studies before making the methods commercially available. It is the responsibility of testing labs to ensure the test method they use has been validated in their laboratory and shown to be fit for purpose before offering allergen testing services to their clients.

Is there a minimum required allergen concentration for test methods?

There is only a sensitivity requirement of 10 mg/kg (ppm) for sulfite testing by the Monier-Williams method. Methods for allergenic proteins do not have such a requirement. Most allergen test kits from reputable companies have suitable sensitivity to detect low levels of the allergen that are of concern and would be considered fit for the purpose in an allergen control program.

Additional Information

The following guidance information is available to help companies comply with the new allergen labelling regulations: