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Chile: Crops / Food

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Determined: No Unique Regulations*

Gene-edited crops that do not contain DNA from another species are regulated as conventional plants, so they don’t face the tighter restrictions of transgenic GMOs.

Gene-edited crops are regulated as conventional plants unless they contain foreign DNA, after a form is submitted to determine if they are exempt. Gene edited crops are assessed on a case-by-case basis by the Ministry of Agriculture’s Agricultural and Livestock Services (SAG).

In 2017, SAG published a regulatory approach on new breeding techniques (NBTs), stating that gene-edited crops that do not contain “a new combination of genetic material” are not subjected to GMO regulations.

The Minister of Health regulates food products and SAG regulates feeds. Food and feed products that contain genetically engineered ingredients can be imported, but imports of seeds for environmental release are only allowed for seed reproduction that will be re-exported under SAG’s supervision.

Chile is the fifth largest producer of seeds in the world. Seed developers and researchers can use genetic engineering technology for research and export only.

Products/Research

Regulatory Timeline

2018: Ministries of Agriculture of the South Agricultural Council (Argentina, Brazil, Chile, Paraguay and Uruguay) publish declaration stating they would avoid arbitrary and unjustifiable distinctions between agricultural products obtained by gene editing and those obtained through other methods, share information about the development of products and regulatory frameworks, explore opportunities for regional and international harmonization, and work together including with other countries to avoid obstacles.

2017: SAG published a regulatory approach for NBTs, deciding to regulate them on a case-by-case basis and exempt them from regulation when there is no insertion of foreign genes.

2017: Minister of Agriculture of Chile, Paraguay and Uruguay signed a declaration on new breeding techniques (NBTs), recognizing the need to harmonize approval policies and promote approval of new products developed through biotechnology.

2017: Minister of Agriculture signs a declaration that calls for the need to “intensify the exchange of information in the approval of GM products…” at the XXXIV Ordinary Meeting of the Southern Agricultural Council (CAS) in São Paulo, Brazil.

2015: Resolution 3928 creates a Technical Secretariat and the Advisory Committee for the Release of genetically modified crops, which is tasked with creating biosafety measures for the environment and looking into possible future deregulation.

2013: Ministry of Environment (MOE) states that the use of genetically modified organisms for agricultural purposes different than seed production to export and research or development activities, must be subject to an environmental risk evaluation.

2007: Ministry of Health publishes Resolution 83, setting up a procedure for the evaluation of new food products.

2003: Ministry of Health issues Decree 115 addressing GM Food Labelling. Genetically modified foods require labeling if they are significantly different to the non-GM version of the product (for instance, if there are changes in the nutritional values).

2001: Resolution 1523 modifies the regulations for genetically modified crops, introducing a  traceability system, biosafety measures and documentation requirements for all seeds and the fields where they are planted. Law 20116 gives the sub-secretary of Fisheries, Ministry of Economy oversight of the authorization and evaluation of aquatic GMOs, both plants and animals.

1993: Ministry of Agriculture’s Agricultural and Livestock Service publishes regulations for genetically modified crops.

NGO Reaction

None

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.

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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
Prohibited0
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.

Crops/Food:
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.
Animals:
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
Japan888
Brazil101010
Canada888
Russia555
Argentina101010
Israel1057.5
Australia888
China555
US1047
Chile1015.5
New Zealand444
Ukraine111
Central America666
Paraguay101010
Uruguay666
India666
UK222
Mexico111
EU222
Colombia1015.5

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.