Method of Production Claims
Novel Foods, Including Novel Foods that are Products of Genetic Modification
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As defined in the Food and Drug Regulations (FDR), "novel food" means,
- a substance, including a microorganism, that does not have a history of safe use as a food;
- a food that has been manufactured, prepared, preserved or packaged by a process that
- has not been previously applied to that food, and
- causes the food to undergo a major change; and
- a food that is derived from a plant, animal or microorganism that has been genetically modified such that
- the plant, animal or microorganism exhibits characteristics that were not previously observed in that plant, animal or microorganism,
- the plant, animal or microorganism no longer exhibits characteristics that were previously observed in that plant, animal or microorganism, or
- one or more characteristics of the plant, animal or microorganism no longer fall within the anticipated range for the plant, animal or microorganism [B.28.001, FDR].
Genetically modify means to change the heritable traits of a plant, animal or microorganism by means of intentional manipulation [B.28.001, FDR]. Genetically engineered foods are one type of genetically modified foods.
The FDR require that, prior to the sale or advertisement of a novel food, Health Canada be notified with sufficient accompanying information, as outlined in B.28.002(2) of the FDR, to conduct a safety assessment. If Health Canada deems the novel food to be safe for consumption, a letter of no-objection is issued notifying the petitioner to that effect.
Health Canada may require, for those novel foods that result in a health or safety change or a significant change in nutrition or composition, a declaration on the label that details the manner in which the novel food differs from its non-modified counterpart. This applies to any novel foods, including products of genetic modification. This statement then becomes mandatory on the novel food.
For additional information including the safety assessment process and regulation of novel foods, fact sheets, frequently asked questions, lists of recent Health Canada approvals of novel foods, and other resources, consult Health Canada's webpage on Genetically Modified Foods and Other Novel Foods.
Voluntary Labelling and Advertising of Foods That Are and Are Not Products of Genetic Engineering
In the Canadian General Standards Board (CGSB) National Standard for Voluntary Labelling and Advertising of Foods That Are and Are Not Products of Genetic Engineering:
"Genetic Engineering" refers to a technique by which the genetic material of an organism is changed in a way that does not occur naturally by multiplication and/or natural recombination.
"Product of Genetic Engineering" refers to food consisting of organisms that have undergone genetic engineering and to food derived from these organisms.
Novel foods, as described in the previous section, include products of genetic engineering.
In Canada, voluntary claims on foods that are and are not products of genetic engineering may be made provided such claims are truthful, not misleading or deceptive, and not likely to create an erroneous impression of a food's character, value, composition, merit or safety, and in compliance with all other requirements set out under the FDA, the CPLA and other applicable legislation.
The National Standard of Canada for Voluntary Labelling and Advertising of Foods that Are and Are Not Products of Genetic Engineering (Standard) provides criteria for making voluntary labelling and advertising claims that identify foods sold in Canada that are or are not products of genetic engineering. It includes detailed information including criteria for claims on both single and multi-ingredient foods, verification, and examples of claims. It provides guidance on the appropriate use of the terms such as "genetically engineered" and "product of genetic engineering".
For more information on genetically engineered foods, please see the Labelling of Genetically Engineered Foods in Canada Factsheet.
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