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China: Crops / Food

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Ongoing Research, Regulations In Development

Ongoing research, regulations not fully developed, limited approvals on a case-by-case basis, no commercialized products

In April 2023, China’s  Ministry of Agriculture and Rural Affairs (MOA) issued its first safety certificate for plant gene editing for a high oleic acid soybean by Shandong BellaGen Biotechnology Co. BellaGen is the first company in China to initiate industrial-scale plant gene editing. Approval is expected soon on a wheat variety resistant to a fungal disease called powdery mildew and for the general development of gene-edited soybeans. 

The research and approval process for the regulation of both transgenic (GMO) and gene-edited crops is cautious, opaque and not transparent. Long-term food security concerns drive its plant biotechnology policy. China currently disallows the planting of GM food and feed crops, relying significantly on the import of transgenic corn, soybean and other oil crops; 85% of the soybeans it imports are genetically modified, used mostly for animal consumption.

In January 2022, the Ministry of Agriculture and Rural Affairs (MARA) announced that it was loosening regulations on both GMOS and gene edited crops. It revised a set of regulations for seed-makers to seek approval for GM crops. For years, the absence of such regulations has hindered the commercialization process.

Also in January 2022, following consultations with biotechnology experts, the announced guidelines for approving gene edited plants on a case-by-case basis. They stipulate that once gene-edited plants have completed pilot trails, a production certificate can be applied for. This would skip a lengthy field trial, which is still required for the approval of transgenic genetically modified plants. The approval for CRISPR crops is expected to take between one to two years instead of up to six years for GM crops.

China’s ambiguous new rules are more conservative than those in the United States — which does not regulate gene-edited crops that incorporate changes similar to those that could occur naturally — but are more lenient than the rigid European Union stance, now under review, which treats all gene-edited crops as genetically modified (GMO) organisms.

Chinese overall guidelines for GE crops reflect the new Biosecurity law that came into effect in 2021 with the apparent goal of increasing China’s cultivation and commercialization of transgenic and gene edited crops, and increasing spending on GM animal research. The government has spent close to $10 billion funding agricultural research projects over the past decade (versus less than $4 billion in the US). Over the past five years, scientists in China have published more papers concerning crop genomics and plant gene-editing technologies than their peers in any other country.

Gene Editing Products (partial list as products are in development)

  • Increased healthy fat oleic acid soybean, 2023: Developed by the private company Shandong Shunfeng Biotechnology Co., Ltd, China approved its first-ever gene edited crop. 
  • Powdery mildew resistant Maize, 2022: Researchers at Institute of Genetics and Developmental Biology and the Institute of Microbiology from the Chinese Academy of Science developed a maize variant that can maintain powdery mildew resistance with ‘’growth and yield levels similar to standard wheat varieties.’’ 
  • Rice yield increased and cold tolerance, 2020: Researchers in China at the Wuhan university have been able to demonstrate increased yield and cold tolerance in rice through the editing of three genes.
  • Disease resistance rice, 2019: Chinese researchers at the Chinese Academy of Agricultural Sciences have focused on improving disease resistance in rice. 
  • Blight resistant rice, 2019: global collaboration of researchers have focused on using genome editing to improve rice’s resistance to bacterial blight diseases, which reduces rice yields throughout Asia and Africa
  • Heat-tolerant tomato, 2019: China Agricultural University used CRISPR to develop tomatoes that can withstand more heat stress than conventional varieties.
  • High-yield soybean, 2019: CAS created a soybean variety that can grow in warmer climates and produce higher yields.
  • High-yield rice, 2018: The Chinese Academy of Sciences (CAS) developed rice using CRISPR that produces 25-31% more than traditional varieties.
  • High fiber rice, 2017: CAS developed rice with high fiber content. 
  • High-yield wheat, 2013: CAS developed wheat that produces more than conventional varieties.

Regulatory Timeline

2022: Ministry of Agriculture and Rural Affairs in China approved new guidelines regulating gene edited plants.

2021: Biosecurity Law of China comes into effect

2020: China committed to a number of reforms to its agricultural biotechnology policies under the U.S.-China Economic and Trade Agreement (“Phase One Agreement”). Its Ministry of Agriculture and Rural Affairs (MARA) issued biosafety certificates for the import of two new events along with six renewals.

2018: National Center for Biotechnology Development unveiled the “Thirteenth Five-Year Plan for Biotechnology Development,” expressly categorizing gene-editing technologies as a pivotal area for national development. 

2016: Chinese government issues 5-year plan that includes strong support of agricultural gene editing research.

2001: Regulations on Administration of Agricultural Genetically Modified Organisms Safety published, which heavily regulates the import and domestic production of genetically modified crops.

NGO Reaction

None

Additional Resources

Updated: 10/18/2023

 

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
Click each column header and arrow to sort the countries / regions

Swipe right/left if all columns aren't visible

Country / RegionFood / CropsAnimalsAg Rating
Ecuador101010
Norway666
Africa555
Japan888
Brazil101010
Canada888
Russia555
Argentina101010
Israel1057.5
Australia888
Switzerland555
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.