Regulation of Biotechnology in Canada

Regulation of Agricultural Biotechnology in Canada
by Parnaz Kakhbod :

The most important aim for regulating new products is setting standards for the safety and efficacy for protecting human, animal and environmental health. Regulation also maintains international quality and safety standard which prepare facilities for trading.

The Canadian Food inspection agency is the lead agency that is the responsible for the regulation of all agricultural products. This includes agri-food products that have been genetically engineered, veterinary biologics, plants and animals, fertilizers, livestock feeds and seeds.

Health Canada is responsible for assessing the human health safety of novel products under the Foods and Drug Act. It also identifies hazards and specifics the standards that food inspectors observe.

The authorization comes from federal legislation and CFIA play an important role to ensure that the approach being used in Canada is fair and efficient and is consistent both nationally and internationally.

Why is agricultural regulation important in Canada?

Assessing the safety of new product is necessary in order to protect humans, animals and the environment. Additionally, regulations ensure that manufacturers of new products make accurate performance claims. Regulations also assist Canadian companies in maintaining the efficacy and quality standards of products intended for international trade.

Regulatory directives for evaluation of products

Regulatory directives have been evaluated by product evaluators in CFIA which are consistent with those used by international authorities. Some of the principles in Canada are:

1.     To build on current legislation rather than creating new legislation.
2.     Mostly focus on product characteristics rather than the method of production.
3.     Evaluating products based on unique characteristics and establishing safety levels based on best scientific information.

If products are similar to other products, the assessment follows guidelines. However, if they not, the product will undergo a safety assessment and this product will not be deemed ‘substantially equivalent’.

Substantial equivalence is determined if the species has a history of safe use in Canada, the new characteristic is similar to product have been already accepted as safe in the product and the new characteristic has been derived through technique with history of safe use.

Key activities in regulation

The CFIA is required to review new agricultural products if:

1.     There is potential risk to human, animal or environment safety.
2.     The product contains novel properties and the risk is unknown.
3.     The method of production has created intrinsic novelty, even though the properties of the product are same as that product already commercially available.

Three important questions are asked during pre-regulatory review which are:

  • Is this product similar to other products that are already in the market?
  • Is the substantial equivalent of this product already approved?
  • For substantially equivalent products, does the product need regulation under existing legislation?

Safety assessment process for novel foods and agricultural products of biotechnology

According to the CFIA, safety assessment process for novel foods and agricultural products of biotechnology is rigorous one. The phases of assessment for new biotechnology products are: proven research and development of the new product, evaluation (including field trials and case –by-case assessments prior to commercialization), and finally, the new product must meet registration and marketing standards.

Research and development

In Canada, scientists working with genetically modified organisms adhere to guidelines established by the Medical Research Council, as well as the codes of practice established by their own institution.


Prior to reaching the market, all novel crops and their products are subjected to a thorough environmental, livestock feed and food safety assessment. Scientists from CFIA and Health Canada are responsible for this critical review of data collected from laboratory and field experiments, conducted by the proponent.

Decision documents describing the assessment and its results are published by the CFIA and Health Canada and are available to the public.

Registration and marketing

To ensure only safe and efficacious products are sold, as required by the Seeds Act, Canada’s variety registration system was designed.

The standard requirements can affect novel products for variety regulation and regulatory oversight as it is the case with their traditional counterparts.

Who is responsible for genetically engineered food labeling in Canada?  

Health Canada and the CFIA are responsible for federal food labeling policies in Canada under the Food and Drugs Act. Health Canada is responsible for setting food labeling policies, with respect to health and safety matters. This applies to all foods, including foods that have been derived through genetic engineering.

The government policy on labeling Genetic Engineered products

There have been three major consultations since 1993 in Canada on the labeling of novel foods derived from genetic engineering which includes:

  • Mandatory labeling if there is health and safety concern, i.e. from allergen, compositional change or significant nutrients, based on Health Canada’s decision
  • Make sure labeling is understandable, thoughtful and not misleading
  • Voluntary labeling will be permitted on the condition that the claim is not misleading or deceptive and it is factual
  • Permit voluntary negative labeling on the condition that the claim is not misleading or deceptive and the claim itself is factual.

These policies are all under the food and Drugs Act. The Canadian government also supported the development of national standard for the voluntary labeling of foods derived from biotechnology. 

Dietary restriction based on religious requirement is outside the current mandate of the government and adequately addressed within the present management framework of religious group.

Canada’s labeling practices in comparision with other countries

There is a wide range of views on the labeling of genetically engineered foods. Canada is a member of the Codex alimentarius commission, an international authority for food standards. Codex alimentarius, on the basis of trade, has been recognized by the World Trade Organization and it is important for countries wishing to trade internationally. The Codex committee for food labeling, chaired by Canada, is developing guidelines for foods derived from biotechnology, these development needs to take into account the development standards at the international level.

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