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Canada: Animals

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Lightly Regulated

Gene edited products with novel traits, including gene edited animals, are regulated regardless of the process used to genetically engineer the animal.

Canada takes a unique stance on gene editing by regulating any products that contain novel traits, including gene edited animals, regardless of the process (e.g. conventional breeding, mutagenesis, transgenesis or gene editing) used to develop the product. Any animals that contain novel traits require environmental and safety assessments to be approved. Most mutagenic products currently being developed are not considered organisms with novel traits, and it is likely that this will also be the case for most gene edited organisms, which will therefore be regulated as conventional. In 2018, Canada and 12 other nations, including Argentina, Australia, Brazil and the US, issued a joint statement to the World Trade Organization supporting relaxed regulations for gene editing, stating that governments should “avoid arbitrary and unjustifiable distinctions” between animals developed through gene editing and animals developed through conventional breeding.

Environment and Climate Change Canada (ECCC) governs genetic technology in animals for research and release using the Canadian Environmental Protection Act of 1999 and the New Substances Notification Regulations (Organisms). The ECCC requires environmental and human risk assessments during the development of animals using biotechnology.

The Canadian Food Inspection Agency (CFIA) and Health Canada regulate gene edited food, including animals, through the Food and Drugs Act and Regulations. Any food that contains novel traits require environmental and safety assessments to be approved. Safety assessment criteria for novel foods derived from animals are under development. Health Canada also uses the Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals to review and regulate gene edited animals developed for food, which requires extensive safety assessments to be completed before any genetically engineered (GE) food is approved.

There is as yet no commercial production of a gene edited or GE animal in Canada. However, AquaBounty’s GMO salmon that grows twice as fast as conventional salmon was approved as food and animal feed in 2016. Clones, derived from DNA transfer from embryonic and somatic (mature) cells, their offspring and the products derived from clones and their offspring would be subject to the same requirements and regulations as those applicable to GE animals and animal products. Health Canada has maintained an interim policy on this issue since 2003, and currently includes these food products under the novel foods definition.

Synthetic biology, including gene editing of animals, has become a contentious issue, with researchers and government agencies pushing for Canada to invest more in synthetic biology to stay competitive within the international biotechnology space.


Regulatory Timeline

2018: Canada and 12 other nations, including Argentina, Australia, Brazil and the US, issue a joint statement supporting agricultural applications of precision biotechnology, stating that governments should “avoid arbitrary and unjustifiable distinctions between end products derived from precision biotechnology and similar end products, obtained through other production methods.”

2011: Food and Drug Regulations amended.

1999: Canada releases the Canadian Environmental Protection Act to regulate animals developed using biotechnology.

1985: Canada passes Food and Drugs Act, Feeds Act and Seeds Act, which together form the regulations for food, feed, and plants.

NGO Reaction

NGO’s, led by the ETC Group (an international organization based in Canada), consider synthetic biology and gene editing to be “extreme genetic engineering.” They have extensively campaigned against biotechnology in Canada and elsewhere, demanding that they should be strictly regulated as older genetic modification techniques such as GMOs.

Additional Resources

Click on a country (eg. Brazil, US) or region (eg. European Union) below to find which agriculture products and processes are approved or in development and their regulatory status. The regulations on genetically engineered crops and animals are emerging out of the regulatory landscape developed for transgenic GMOs.

European Union

European Union


New Zealand

New Zealand

United States

United States





United Kingdom

United Kingdom













Southeast Asia

Southeast Asia

Central America

Central America




Agriculture Gene Editing Index
Compare Regulatory Restrictions Country-to-Country

Gene editing regulations worldwide are evolving. The Gene Editing Index ratings below represent the current status of gene editing regulations and will be updated as new regulations are passed.

Colors and ratings guide

Regulation StatusRating
Determined: No Unique Regulations*10
Lightly Regulated8
Proposed: No Unique Regulations†6
Ongoing Research, Regulations In Development5
Highly Regulated4
Mostly Prohibited2
Limited Research, No Clear Regulations1
Lightly Regulated: Some or all types of gene editing are regulated more strictly than conventional agriculture, but not as strictly as transgenic GMOs.
*Determined: No Unique Regulations: Gene-edited crops that do not incorporate DNA from another species are regulated as conventional plants with no additional restrictions.

†Proposed: No Unique Regulations: Decrees under consideration for gene-edited crops that do not incorporate DNA from another species would no require unique regulations beyond current what is imposed on conventional breeding.

Gene editing of plants and food products. Research and development has mostly focused on disease resistance, drought resistance, and increasing yield, but more recent advances have produced low trans-fat oils and high-fiber grains.
Gene editing of animals, not including animal research for human drugs and therapies. Fewer gene edited animals have been developed than gene edited crops, but scientists have developed hornless and heat-tolerant cattle and fast-growing tilapia may soon be the first gene edited animal to be consumed.

Rating by Country / Region
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Country / RegionFood / CropsAnimalsAg Rating
New Zealand444
Central America666

Global gene editing regulatory landscape

The regulations on genetically engineered crops and animals are emerging out of the regulatory landscape developed for transgenic GMOs. Regulations across 34 countries where transgenic or gene edited crops and animals are commercially allowed (as of 12/19) are guided in part by two factors:
Whether the country has ratified the international agreement that took effect in 2003 that aims to ensure the safe handling, transport and use of living modified organisms (LMOs) resulting from biotechnology that may impact biological diversity, also taking into account potential risks to human health. It entered into force for those nations that signed it in 2003. It applies the ‘precautionary approach as contained in the Rio Declaration on Environment and Development. The US, Canada, Australia and Chile and the Russian Federation have not signed the treaty.
Whether regulations are based on the genetic process used to create the trait (conventional, mutagenesis, transgenesis, gene editing, etc.) or the final product.Transgenic crops and animals (aka GMOs) are product regulated in many countries including the US and Canada, while the EU, India, China and others regulate based on how the product is made. There is almost an equal number of countries with product- and process-based regulations. It’s not clear how much this distinction matters. It’s somewhat true that countries with product-based regulation have more crops approved and the approval process is more streamlined, but there are contradictions. For example, Brazil and Argentina have emerged as GMO super powers using different regulatory concepts, while there is no GMO commercial cultivation in Japan, North Korea, and the Russian Federation, which employ product-based regulations. How this will effect gene editing regulations is also unclear. For example, Japan, which has no commercialized GMOs, is emerging as a leader in the introduction of gene edited crops.
Agricultural Landscape
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Gene editing is a set of techniques that can be used to precisely modify the DNA of almost any organism. It is being used for applications in human health, gene drives and agriculture. There are numerous gene-editing tools besides CRISPR-Cas 9, which gets most of the attention because it is a comparatively easy tool to use.

Gene editing does not usually involve transgenics – moving ‘foreign’ genes between species. It also refers to a specific technique in contrast to the general term GMO, which is scientifically ambiguous, as genetic modification is a process not a product. Most gene editing involves creating new products by deleting very small segments of DNA (sometimes in agriculture called Site-Directed Nuclease 1 or SDN-1 techniques), which can silence a gene or change a gene’s activity. Countries are evaluating whether or not to regulate this type of gene editing, since it is so similar to natural mutations. The GLP’s Gene Editing Index ratings reflect the regulatory status of SDN-1 techniques, which are the most liberally regulated and will generate most products in the near term.

To develop different products, gene editing can change larger segments of DNA or add DNA from other species (a form of transgenics sometimes in agriculture called SDN-2 or SDN-3 techniques). While many countries are not regulating or lightly regulating SDN-1 techniques, most are moving toward tightly regulating or even restricting SDN-2 and SDN-3.

For more background on the various gene editing SDN techniques, read background articles here and here.