Biotechnology allows for the development of new food products through a variety of scientific tools and techniques. These new foods are part of what are commonly known as novel foods.
Novel foods are:
Health Canada establishes science-based regulation, guidelines and public health policies for these novel foods. It is also Health Canada's responsibility to assess the safety of these products. The main concern in regulating biotechnology products is the health and safety of Canadians, animals and our environment. If there are any questions about the safety of a product, it is not approved.
In this section, you will find information on the following:
Health Canada and the Canadian Food Inspection Agency (CFIA) require product developers to follow regulatory directives and guidelines to get approval for the commercialization of novel foods, novel feeds and for environmental release. They must supply evaluators with thorough and detailed information about their novel food products before they can receive approval to sell or advertise them in Canada.
The novel foods guidelines and regulations outlining requirements for data to support safety assessment and the protocol for notification are well known by industry. When a product developer believes he has enough information about the safety of a novel food to meet the guidelines, he makes a submission to Health Canada's Novel Foods Section. The office coordinates a full safety assessment of the product, which involves a rigorous scientific assessment by Health Canada evaluators. Please refer to our Standard operating procedures for the processing a novel food notification/submission for more details.
The safety assessment of genetically modified foods includes:
Sometimes, products are submitted which do not meet Health Canada's criteria (for example, incomplete data or inconclusive studies); regulators will then request further data or studies to satisfyingly address these deficiencies.
Once the evaluation of the product is completed, a Food Rulings Proposal is prepared. This proposal is reviewed by senior staff (Directors and Director General) in the Food Directorate to ensure that all issues have been addressed. Once this has been done, a decision is made whether or not to approve the product.
If a product successfully passes the assessment process, and the other regulatory approvals for environmental and feed safety (when applicable) are in place, a "letter of no objection" is sent to the product developer. This letter indicates that the product can be sold in Canada for the intended uses, which have been listed in the submission. It also outlines any restrictions or requirements relevant to the Health Canada decision.
As part of the joint Health Canada/Canadian Food Inspection Agency Notices of Submission Project, you may comment on the safety assessments where the submissions for approval of a novel food are posted on the web.
To date, over 70 novel and genetically modified (GM) foods have been approved for sale in Canada. A listing of all approved novel food products is available and includes foods such as genetically modified corn, genetically altered soybeans, potatoes resistant to the Colorado Potato Beetle and omega-3 enhanced pork.
When a product has been issued a "letter of no objection", a Decision Document is posted. This document includes background information on the novel food, highlights of the assessment and any labeling requirements.
You can find more information about approved products of biotechnology by consulting the Biotech Product Database of the Organisation for Economic Co-operation and Development.
Health Canada is responsible for ensuring that all novel foods, including those derived from biotechnology, are safe before they enter the Canadian food system.
According to the Novel Foods Regulation, product developers must notify Health Canada's Health Products and Food Branch of its intention to advertise or sell a novel food. This pre-market notification lets Health Canada conduct a thorough safety assessment of all biotechnology-derived foods to demonstrate that a novel food is safe and nutritious before it is allowed into the Canadian marketplace.
Health Canada's guidelines reflect the recent international standards adopted by Codex Alimentarius Commission and are based on scientific principles developed over the last 10 years through expert international consultation with agencies such as the World Health Organization, the Food and Agriculture Organization and the Organization for Economic Co-operation and Development.
Currently in Canada, labelling is mandatory if there is a health or safety issue with a food. For example, if the nutritional value or composition of the food has been changed, or if there is an allergen present in the food, the food must be labelled as such. In this situation, special labelling is required to alert consumers or susceptible groups in the population. This applies to all foods, including GM foods.
Health Canada and the Canadian Food Inspection Agency (CFIA) share the responsibility for food labelling policies under the Food and Drugs Act. Health Canada's responsibilities for food labelling fall within the Department's mandate to safeguard health and safety, while CFIA leads the federal program to develop general food labelling policies and regulations. In particular, the CFIA is responsible for protecting consumers from misrepresentation and fraud with respect to food labelling, packaging and advertising, and for prescribing basic food labelling and advertising requirements.
The Government of Canada recognizes that for many Canadians, labelling of foods derived from biotechnology is an important issue of consumer preference or choice. Under a standards committee established by the Canadian General Standards Board, a Canadian standard for voluntary labelling of GE foods entitled Voluntary Labelling and Advertising of Foods that Are and Are Not Products of Genetic Engineering was developed to address non-health and safety concerns (rather, labelling for method of production, e.g., whether a food has or has not been produced through genetic engineering).
In April 2004, the national standard was adopted by the Standards Council of Canada. The objectives of the national standard are to provide meaningful criteria for labelling, understandable messages for consumers, and a consistent policy to verify the truthfulness of labels.
Public involvement is an ongoing part of Health Canada's activities. It includes consultations with consumer groups, industry groups, academia and other interested parties on common issues involving biotechnology and food from a regulatory standpoint.
The following are some of Health Canada's biotechnology-related public consultations: