Required Report: Required - Public Distribution

Date: December 13, 2023
Report Number:CH2023-0143

Report Name: Agricultural Biotechnology Annual
Country: China - People's Republic ofPost: Beijing
Report Category: Biotechnology and Other New Production Technologies

Prepared By:

FAS Beijing Staff

Approved By: Adam Branson
Report Highlights:
The People's Republic of China (PRC) continues to advance toward commercial cultivation ofdomestically developed genetically engineered (GE) corn and soybean crops. Since the last report, the
PRC made significant regulatory changes to facilitate the cultivation of GE crops, including publishing
the first variety registration list for GE corn and soybeans and an updated draft measure on labeling
agricultural GE products. Additionally, the Ministry of Agriculture and Rural Affairs (MARA) issued
nine new biosafety certificates and two renewed biosafety certificates for GE crops approved for importas processing materials, clarified the classification criteria and requirements for evaluating gene-edited
plants, and approved the country’s first ever gene-edited plant for domestic cultivation. The PRC’s
prohibition on foreign investment in GE seeds and its opaque, unpredictable review processes forforeign products favors domestic biotech developers and undercuts access to GE varieties developed
outside China.

THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILYSTATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICYTable of Contents
Executive Summary ................................................................................................4
Chapter 1: Plant Biotechnology ............................................................................7
Part A: Production and Trade ..................................................................................................7a) Research and Product Development ................................................................................7b) Commercial Production ....................................................................................................8c) Exports.................................................................................................................................9d) Imports ...............................................................................................................10
China is a large importer of GE soybeans, cotton, corn, Distiller's Dried
Grains with Solubles (DDGS), rapeseed/rapeseed meal/ rapeseed oil, andsugar beet pulp for feed and processing. These products are imported fromnumerous trading partners, including the United States, Brazil, Argentina,
Canada, and India, among others. Please refer to Appendix 1 for China’s
trade in biotech crops. The PRC’s burdensome and unpredictable approval
process for GE products imported for feed and processing poses numerous
challenges for foreign developers. Additionally, China’s lack of a low-level
presence (LLP) policy may result in detained and rejected shipments,
including those that may be considered “non-GMO”. China does not allow
the importation of GE seeds for commercial cultivation. Please refer to the“Import Approval Procedures” section of this report for additional
information on the regulatory process for biosafety approval for importing
GE products for feed and processing. .................................................................10e) Food Aid ............................................................................................................................10f) Trade Barriers ...................................................................................................................10
Part B: Policy ............................................................................................................................11a) Regulatory Framework....................................................................................................11b) Approvals ..........................................................................................................................17c) Stacked or Pyramided Event Approvals ........................................................................17d) Field Testing .....................................................................................................................18e) Innovative Biotechnologies ..............................................................................................18f) Coexistence ........................................................................................................................18g) Labeling and Traceability ...............................................................................................19h) Monitoring and Testing ...................................................................................................19i) Low Level Presence (LLP) Policy ....................................................................................20j) Additional Regulatory Requirements .............................................................................20k) Intellectual Property Rights (IPR) .................................................................................20
On March 2, 2022, the Supreme People's Court of China issued an opinion clarifying therequirements for criminal trials related to seeds. Entitled "Guiding Opinions on Further
Strengthening the Criminal Trial Work Involving Seeds", the opinion covers the applicationof law to seed-related crimes, and improvement of relevant enforcement mechanisms. This
Opinion is latest in a trend of messaging and polices by the PRC to strengthen variety
protection and encourage a market environment for the seed industry with intellectual
property protections for the seed industry. Please refer to GAIN Report CH2022-0031
2Supreme People's Court Strengthens Seed Variety Protections for more information on the
Guiding Opinions. ..................................................................................................................21l) Cartagena Protocol Ratification ......................................................................................21m) International Treaties and Forums ...............................................................................22n) Related Issues ...................................................................................................................22
Part C: Marketing ....................................................................................................................23

Chapter Two: Animal Biotechnology ..................................................................23
Part D: Production and Trade ................................................................................................24a) Product Development .......................................................................................................24b) Commercial Production ..................................................................................................25c) Exports...............................................................................................................................25d) Imports ..............................................................................................................................25e) Trade Barriers ..................................................................................................................25
Part E Policy .............................................................................................................................25b) Approvals ..........................................................................................................................25c) Innovative Biotechnologies ..............................................................................................25d) Labeling and Traceability ...............................................................................................26f) Intellectual Property Rights (IPR) ..................................................................................26g) International Treaties and Forums ................................................................................26h) Related Issues ...................................................................................................................26
Part F: Marketing ....................................................................................................................26a) Public/Private Opinions ...................................................................................................26b) Market Acceptance/Studies.............................................................................................26

Chapter Three: Microbial Biotechnology ...........................................................26
Part G: Production and Trade ................................................................................................27a) Commercial Production ...................................................................................................27b) Exports ..............................................................................................................................27c) Imports ..............................................................................................................................27d) Trade Barriers ..................................................................................................................27
Part H: Policy ...........................................................................................................................27a) Regulatory Framework....................................................................................................27b) Approvals ..........................................................................................................................28c) Labeling and Traceability................................................................................................33d) Monitoring and Testing ...................................................................................................33e) Additional Regulatory Requirements .............................................................................33f) Intellectual Property Rights (IPR) ..................................................................................34g) Related Issues....................................................................................................................34
Part I: Marketing .....................................................................................................................34a) Public/Private Opinions ...................................................................................................34b) Market Acceptance/Studies.............................................................................................34

Appendix 1: China’s Trade in Biotech Crops (Source: GACC) .......................34
Appendix 2: Biotech Crops Approved for Import as Processing Materials ...37
Appendix 3: Biotech Crops Approved for Cultivation ......................................43

3

Executive Summary
The People's Republic of China (PRC) continues to advance its agricultural biotechnology
development and regulatory framework in preparation for commercial cultivation ofdomestically developed genetically engineered (GE) food and feed crops, specifically corn andsoybeans. However, with the exception of GE cotton and papaya, the PRC has not yet approved
any GE food or feed products for domestic commercial cultivation outside of designated pilot
areas..
The PRC continues to prohibit foreign agricultural biotechnology developers’ foreign direct
investment in the biotech sector by placing GE variety breeding and GE seed production on
Negative Lists for the nation and its Free Trade Zones. Additionally, the PRC prohibits thecultivation of foreign-developed biotech products in China. Accordingly, the PRC divides its
biosafety assessment process between foreign developers who may apply for a biosafety
certificate for “Import for Processing Material” and domestic developers who may apply for abiosafety certificate for “cultivation and application.”
Since the publication of the 2022 Agricultural Biotechnology Annual report, the PRC has taken
meaningful regulatory steps towards commercial cultivation of GE crops and in developing
regulatory frameworks for gene-edited products, including the first ever biosafety certificate for agene-edited event. Major updates include:

On January 13, 2023, MARA published a finalized revised Guideline for Safety
Assessment of Genetically Modified (GM) Plants. The Guideline applies to bio-safety
certificate application for both domestic cultivation and importation of processing
materials. The finalized Guideline makes only minor changes to the draft version, which
was published for public comments in July 2022 (see GAIN Report CH2022-0084).
Substantive changes compared with the previous version of the Guideline in effectinclude:1) The new Guideline changes the nature of biosafety assessments from being on a “cropvariety and event” basis to solely on an “event” basis, bringing it into alignment with
the Administrative Measures for the Safety Assessment of Agriculture GMOs asrevised in January 2022.
2) In addition to Polymerase chain reaction (PCR) and Southern blotting, sequence
determination is added as a method to analyze integration of a/an inserted sequence inplant genomes.
3) Suitable ecological areas for major GM crops are newly listed in the Guideline. It is
required that at least one production trial site should be set in each major ecologicalarea for the application of cultivation safety certificate of an event.



On April 28, 2023, MARA issued the Rules for Review of Gene-Edited Plants for
Agricultural Use (Trial) (link in Chinese), which clarifies the classification criteria andrequirements for evaluating gene-edited plants. The Guideline released in January 2022
classified gene-edited plants into four categories based on the risk profile of the target trait
but did not indicate a process for determining how to classify gene-edited products withineach risk category or provide specific types of acceptable data. The Review Rules expand
4

upon the processes established under the Guideline by providing additional information inthree areas: molecular characteristics, environmental safety, and food safety.
The Review Rules also state that evaluations in these three areas can all be carried out inthe intermediate test stage. If data from the test stage show that the target trait does notincrease the environmental safety risk, the safety certificate can be applied for
immediately after passing the evaluation. If the data obtained in the intermediate test stage
indicate that the target trait may increase environmental safety risks, environmental
release or production tests need to be carried out, and safety certificates can only beapplied after passing the safety evaluation. For additional information, please see GAIN
Report MARA Updates Rules for Review of Gene-Edited Plants for Agricultural Use |CH2023-0080.


On October 17, 2023, the PRC National Crop Variety Registration Committee(CNCVRC) published the first-ever variety registration list for genetically modified (GM)
corn and soybeans. The list includes 37 GM corn varieties and 14 GM soybean varieties
and is open for public comment for 30 days, or until November 15, 2023. Once finalized,
listed GM corn and soybean varieties will be eligible for planting in approved areas.

On October 17, 2023, MARA published on its website a draft revision of the"Administrative Measures on Labeling Agricultural Genetically Modified Organisms(GMOs)" for a 30-day public comment period. Significant updates in the proposed
revision include the establishment of a three percent labeling threshold for products listed
in Agricultural GMOs Labeling Catalog, changes to the products listed in the catalog, andrequirements for “non-GMO” labeling. On November 24, 2023, the PRC notified thesame draft revision to the WTO as G/TBT/N/CHN/1775.

Since the publication of the 2022 Agricultural Biotechnology Annual report, the PRC has issued
three tranches of new and renewed biosafety certificates. These include:

On January 13, 2023, MARA issued biosafety certificates for 10 biotech crops approved
for import as processing materials (including three new GE cotton events, one new GE
rapeseed event, two new GE sugarcane events, two new GE alfalfa events, and two
renewed GE cotton events), and 38 certificates for domestic cultivation and production(including two new GE corn events, one new GE soybean event, three new animal
vaccines, 29 renewed GE cotton events, and three renewed animal vaccines).



On April 28, 2023, MARA issued 113 certificates for domestic cultivation and production(including one new GE soybean event and 112 renewed GE cotton events) and the firstever biosafety certificate for a gene-edited soybean event. The approval of China’s firstever gene-edited plant for domestic cultivation comes just over a year after MARA issued
Guidelines for Safety Evaluation of Gene-edited Plants for Agricultural Use (Trial) which
established application procedures and requirements for gene-edited plants.

On October 17, 2023, MARA issued biosafety certificates for one new biotech canola
event approved for import as processing materials, 162 biosafety certificates for renewed
GE cotton events for domestic cultivation and production, and 21 new and renewedbiosafety certificates for genetically modified microorganisms (GMMs) for animal use.
For the first time, MARA issued a separate list of GMMs for animal use, rather than5

including them in the same table as GE crop events for domestic cultivation andapplication.
In addition, on October 7, 2023, the National Health Commission (NHC) announced approval of2’-fucosyllactose (2’-FL), a purified human milk oligosaccharide (HMO), for use as a foodnutrition fortifier, particularly in infant formula. The approval is NHC’s first for a GMM-derived
food ingredient outside the enzyme category.
The PRC committed to several reforms of its agricultural biotechnology policies and procedures
under Chapter 3, Annex 16 of the Phase One Economic and Trade Agreement, which enteredinto force on February 15, 2020. Some of these commitments, including the 24-month timelinefrom submission of a formal application for agricultural biotechnology products for feed or
further processing to the final decision on approval or disapproval of the product, remainunfulfilled.
The below list contains links to all FAS China agricultural biotechnology related GAIN Reports
issued since the publication of the 2022 China Agricultural Biotechnology Annual report:
1.
2.
3.
4.
5.

Agricultural Biotechnology Annual 2022 | CH2022-0112
China Releases Plant Variety Protection Regulations for Comment | CH2022-0127
MARA Issues New and Renewed GE Biosafety Certificates | CH2023-0007
MARA Finalizes GE Safety Assessment | CH2023-0011
NHC Approves New Food Materials and Additives including GMM Derived Enzymes |CH2023-0037
6. Administrative Measures for Non-major Crops Variety Record Open for Comment | CH20230041
7. Plant Variety Protection Office Clarifies Sexual Propagation Material Submission
Requirements | CH2023-0064
8. MARA Publishes Information to Improve Public Awareness of Essentially Derived Varieties |CH2023-0065
9. Draft Implementation Opinions for Crop Seed Certification | CH2023-0072
10. New and Renewed Biosafety Certificates Issued Including First Ever For Gene-Edited Event |CH2023-0078
11. MARA Updates Rules for Review of Gene-Edited Plants for Agricultural Use | CH2023-0080
12. Planting Seed 2023 Annual | CH2023-0099
13. MARA Publishes Q and A on Agricultural Biotechnology | CH2023-0118
14. PRC Issues Final Implementation Opinions for Crop Seed Certification | CH2023-0127
15. WTO Notified Measures for Plant Propagation Materials | CH2023-0133
16. Revised Draft Measures on Labeling Agricultural GMOs Published for Comments | CH20230147
17. MARA Issues New and Renewed Biosafety Certificates | CH2023-0148
18. Inaugural Genetically Modified Corn and Soybean Variety Registration List Published Comment Period Opened | CH2023-0149

6

Chapter 1: Plant Biotechnology
Part A: Production and Tradea) Research and Product Development
Despite decades of research by PRC biotech developers, China has not commercialized any GE
products, with the exception of cotton and papaya. However, local developers have applied forand received biosafety certificates for the cultivation of GE rice, corn, and soybeans in regions
across China (see Appendix 3 for a list of biotech crops approved for cultivation). The PRC
amended Administrative Measures for Major Crops Variety Registration in January 2022, which
added application procedures and requirements for GE variety registration, and introduced the
National Registration Standards for Genetically Engineered Soybean Varieties (Trial) andNational Registration Standards for Genetically Engineered Corn Varieties (Trial) in June 2022.
In October 2023, the first-ever variety registration list for GM corn and soybeans for publiccomments (see GAIN Report CH2023-0149). The list includes 37 GM corn varieties and 14 GM
soybean varieties.
As a result of these updated regulations, industry sources initially expected GE corn to reach fullcommercial cultivation in 2023. However, the February 2023 issuance of the PRC’s No. 1
Document, a top-level policy document that provides broad guidance for resource allocation anddevelopment goals in China’s agricultural sector, cast doubt on that possibility. In reference tocommercialization of GE crops, the document stated China will “accelerate the pace ofindustrialization of corn and soybean bio-breeding, orderly expand the pilot areas”, suggesting
existing pilot programs would be expanded rather than approval of full commercialization.
Chinese developers have pursued various forms of biosafety approvals and other reviews abroad,including voluntary consultations with the U.S. Food and Drug Administration (FDA). In 2018,
Huazhong Agricultural University completed its consultation with FDA on its Huahui No.1 riceproduct, which received a biosafety certificate from MARA in 2009 (the biosafety certificate wasrenewed in 2014 and 2021). Additionally, Beijing Da-Bei-Nong Technology Group (DBN),
completed a consultation with FDA in July 2021 and October 2021 for two corn events,
DBN9936 and DBN9858.
Chinese developers have also received several safety approvals for cultivation in Argentina. On
February 27, 2019, DBN received approval from Argentina to cultivate its herbicide-resistantsoybean DBN09004-6. Following the approval, this event obtained a biosafety certificate forfood, feed, and processing (import) in China in June 2020, meaning it can be exported to China
from Argentina. DBN’s pest resistant soybean event DBN8002 received cultivation approval
from Argentina in November 2022 and from China in April 2023. On October 4, 2023, DBN
received cultivation approval from Argentina for its stacked event DBN9004×DBN8002.
The PRC has provided significant support to the development of GE technology and continues tohighlight advancements in agricultural biotechnology as key components of national plans
focusing on agricultural productivity and food security. For example, since 2008 the National
Major Science and Technology Projects of China for Breeding New Biotech Varieties hasreceived a total of 24 billion yuan (about $3.3 billion1), approximately half of which came from1

The exchange rate used in this report is US$1=7.2 Yuan

7central and local governments and half from private sector investment. Industry contacts reportthese projects continue under the 14th Five-Year Plan (2021-2025).
In February 2021, MARA issued a public notice (link in Chinese) containing six articles for the
purpose of encouraging the indigenous innovation and regulating the transfer of biologicalmaterials. The notice, a guiding document rather than a binding rule, sets the tone for researchand transfer of biological materials, and emphasizes the accountability of biosafety certificate
bearers. Recently published research articles include:








In March 2023, National Science Review published Genetic modification of Gγ subunit
AT1 enhances salt-alkali tolerance in main graminaceous crops. The article by Chinesescientists discusses the discovery of a gene related to crop salt-alkali tolerance. The
research indicates the gene, AT1/GS3, has great potential for breeding salt-alkali–
resistant crops to grow in salt-alkaline soils.
On March 8, 2023, a Chinese paper titled Blocking gene that inhibits root growth may
enhance drought resistance in crops was published in the journal New Phytologist. The
article reports that that blocking a negative regulator gene of root development leads toenhanced root growth in plants. The gene, called RRS1 (Robust Root System 1), encodes
an R2R3-type MYB family transcription factor that activates the expression of anothergene (OsIAA3) that inhibits root growth. Knocking out RRS1 in plants led to longer root
length, longer lateral root length, and larger lateral root density. Also, a natural variant of
RRS1 that changes the activity of the RSS1 protein had a similarly beneficial effect onroots. According to the author, RRS1 is a new gene resource for improving root systems
and cultivating drought-resistant rice varieties through gene-editing or marker-assisted
breeding processes.
On May 8, 2023, the Plant Biotechnology Journal published online research of theInstitute of Plant Protection of the Chinese Academy of Agricultural Sciences (CAAS) on
Gene-editing technology creates new rice material with enhanced disease resistance (linkin Chinese). The researchers identified two new genes related to rice blast susceptibility
from rice, and through gene editing of the two genes, combined with the results of disease
resistance identification, it was confirmed that the two genes were susceptibility genes.
The editing and transformation of the two genes can improve the rice resistance to rice
blast and bacterial blight without adverse effects on other major agronomic traits.
In an August 7, 2023 study, the Agricultural Genomics Institute at Shenzhen (AGIS)
cooperated with the China National Rice Research Institute, the Institute of Crop Scienceof Chinese Academy of Agricultural Sciences and Yangzhou University to produce acomplete assembly of the rice reference genome T2T-NIP, which contains 12.5 million
base pairs of newly identified sequence, and achieved a complete sequence of thisimportant rice reference genome with 385.7 million base pairs.

b) Commercial Production
MARA’s 2016 roadmap for the commercialization of GE crops prioritized non-food use GE
crops (such as cotton), then GE crops for indirect food use (such as soybeans and corn), andfinally GE food use crops (such as rice and wheat). Since 1997, China has commercialized six
GE products (cotton, tomato, sweet pepper, petunia, poplar, and papaya), but only cotton andpapaya are in commercial production today.
8On August 24, 2023, MARA published a report titled “Head of the Science and Technology
Development Center and the National Agricultural Technology Extension Service Center of
MARA Answering reporters' questions on promoting the pilot project of biological breeding
Commercialization” (link in Chinese) on its website. According to the report, the PRC launcheda pilot project for the commercialization of GE corn and soybeans in 2021, which was carried out
in scientific research and experimental fields. In 2022, it expanded the pilot project to farmer
fields in Inner Mongolia and Yunnan. In 2023, the pilot project was expanded to 20 counties in 5
provinces including Hebei, Inner Mongolia, Jilin, Sichuan and Yunnan, and GE seed production
was arranged in Gansu. The report also praises the performance of the GE crops, noting the traits
of insect resistance and herbicide tolerance of GE corn and soybean are “outstanding.” Thecontrol effect on Lepidoptera pests such as Spodoptera frugiperda is over 90 percent, and theweeding effect is over 95 percent. The yield of GE corn and soybean increases by 5.6-11.6
percent.
The area of GE crops under cultivation increased slightly to 3.2 million hectares in 2019,according to the International Service for the Acquisition of Agro-Biotech Applications (ISAAA)
report titled “Biotech Crops Drive Socio-Economic Development and Sustainable
Environment in the New Frontier.” (Note: This is the most recent ISAAA report available on
China’s GE cultivation area, which was published in 2019). This area only includes GE cottonand papaya and makes China the 7th largest producer of GE crops by area in the world. GE
cotton adoption in China remains steady at around 95 percent of total area. According to ISAAA
statistics, the economic benefits China gained from planting biotech crops from 1996 to 2018
totaled $23.2 billion).
The GE products approved for commercial production in China can be found on MARA’s
website (link in Chinese). Most biosafety certificates for cultivation are for domesticallydeveloped varieties of Bt cotton, which are approved for cultivation in three agroecologicalzones (Xinjiang, Yellow River Basin, and Yangtze River Basin). GM corn and soybean areapproved for cultivation in most of China’s major producing areas, including North China spring
corn/soybean area, South China corn/soybean area, Yellow River Basin, Huaihe River Basin.
See Appendix 3 for more information on agroecological zones of China’s biotech crops approvedfor cultivation.
Note: When developers apply for a biosafety certificate for cultivation, they are required toindicate the agro-ecological zone(s) where the product will be grown. Accordingly, field trials
will be conducted in that region, and the agro-ecological zone(s) will be included in the final
biosafety certificate application.
c) Exports
China exports limited volumes of GE products. In 2022, China exported 33,703 tons of cotton
valued at $105 million, a high percentage of which can be assumed to be GE cotton – as GE
cotton accounts for approximately 95 percent of planted area. The figures do not reflect China’s
textile and apparel exports, many of which contain both domestic and imported GE cotton fiber.
In 2022, China exported 8,003 tons of papaya, valued at $9 million. Over 80 percent of papaya
exports were shipped to Hong Kong. China does not export cotton or papaya to the UnitedStates.
9d) Imports
China is a large importer of GE soybeans, cotton, corn, Distiller's Dried Grains with Solubles(DDGS), rapeseed/rapeseed meal/ rapeseed oil, and sugar beet pulp for feed and processing.
These products are imported from numerous trading partners, including the United States, Brazil,
Argentina, Canada, and India, among others. Please refer to Appendix 1 for China’s trade inbiotech crops. The PRC’s burdensome and unpredictable approval process for GE products
imported for feed and processing poses numerous challenges for foreign developers.
Additionally, China’s lack of a low-level presence (LLP) policy may result in detained andrejected shipments, including those that may be considered “non-GMO”. China does not allow
the importation of GE seeds for commercial cultivation. Please refer to the “Import Approval
Procedures” section of this report for additional information on the regulatory process forbiosafety approval for importing GE products for feed and processing.
e) Food Aid
The PRC provides limited volumes of food aid, primarily corn, rice, and sorghum to SubSaharan African countries and officials have made donations to Southeast Asia nations whendroughts and disasters affect local food and agricultural product distribution and availability.
Given the limited scale of pilot GE cultivation, it is believe that all food aid is comprised ofconventional products. China is not a recipient of food aid.
f) Trade Barriers
The PRC’s prohibition of foreign investment in the biotechnology sector remains the mostsignificant barrier to overseas seed development companies. Business organizations, such as theAmerican Chamber of Commerce in China, have cited the PRC’s prohibition in recent annual
reports. The 2021 Special Administrative Measures for Foreign Investment Access (also known
as the “Negative List”, link in Chinese) was jointly issued by NDRC and MOFCOM on
December 27, 2021. The Measures continue the prohibition on foreign biotech developers fromconducting research or seed production in China.
On November 5, 2021, MOFCOM released the Catalogue of Technologies Prohibited or
Restricted to be Imported (link in Chinese). The catalogue of technologies restricted for imports
includes: “GE plant seeds and seedlings, seedlings of livestock and poultry, aquatic fingerings,
and strains of agricultural microorganisms obtained through modern biotechnology means.”
Several aspects of China’s regulatory approval process for GE traits decrease predictability andtransparency, causing unnecessary delays and additional costs, particularly for foreign
developers. These include requirements that events already be approved in their country of origin
and that environmental safety trials and feeding trials be conducted in China by MARAdesignated institutions. Throughout the review process, applicants are subject to requests for
additional material and data that can delay season sensitive plantings for field trials.
Additionally, the National Biosafety Committee (NBC), which typically only convenes twice per
year, frequently rejects applications or requests further information from developers resulting insome applications languishing for more than a decade in the approval process. Subsequent
applications are not reviewed by the same NBC panels and can result in new NBC members
asking previously answered questions. Dates for NBC meetings are also closely held by MARA,
10

with members themselves called to attend on short notice. Once approved by the NBC,applications must still undergo a final MARA review. Post contacts have reported that on
numerous occasions, despite being approved by the NBC, MARA has returned applications to
the review process for additional information.
Additionally, the lack of an LLP policy in China means the world’s largest importer of animal
feed has a zero tolerance for unapproved GE events, which is a significant barrier to trade (seeChapter 1, Part B, Section (i) of this report for further information).
Part B: Policya) Regulatory Framework
The PRC’s agricultural biotech regulatory framework is outlined in the State Council’s 2Administrative Rules for Safety of Agriculture GMOs (issued in 2001 and revised in 2017).
According to the Rules, MARA holds the primary responsibility for the approval of biotech
products for import and domestic cultivation, as well as the development of agricultural biotech
policies and regulations.
The State Council’s Rules are implemented by the following Measures:
•
•
•
•
•

Administrative Measures for the Safety Assessment of Agriculture GMOs (issued on January
5, 2002; revisions issued on November 30, 2017, and January 21, 2022);
Administrative Measures for Safety of Agriculture GMO Imports (issued on January 5, 2002;
revision issued on November 30, 2017);
Administrative Measures on Labelling of Agriculture GMOs (issued on January 5, 2002;
revision issued on November 30, 2017, and October 17, 2023 for public comments);
Measures for the Review and Approval of Agricultural GMOs for Processing (issued on July
1, 2006; latest revision issued on April 25, 2019);
Technical guidance, standards, and procedures released through MARA public notices;
AQSIQ Decree 62, Administrative Measures of Inspection and Quarantine on Entry-Exit GM
Products (implemented on May 24, 2004; updated 2019 (link above), latest revision issued in
March, 2023).

The latest revision of the Administrative Measures of Inspection and Quarantine for Entry-Exit
GM Products revised the permit system for agricultural GE products that are transferred to othermarkets through the PRC territory. The revision removes requirements that GE products passing
through China to other markets receive a permit to do so. Article 11 of the revised Measures
stipulates the inspection and quarantine requirements for GE products that transit through China.
On January 13, 2023, MARA published a finalized revised Guideline for Safety Assessment of
Genetically Modified (GM) Plants. The Guideline applies to bio-safety certificate applications forboth domestic production/cultivation and importation for processing use. The finalized Guideline
makes only minor changes to the draft version, which was published for public comments in July
2

The State Council is the chief administrative authority of the PRC government and is comprised of the Premier,Vice Premiers, State Councilors, and Ministers responsible for the Council’s constituent departments. MARA’s
Minister is a member of the State Council.

112022 (see GAIN Report CH2022-0084). Substantive changes compared with the previous
Guideline include:
1) The new Guideline changes the nature of biosafety assessments from being on a “cropvariety and event” basis to solely on an “event” basis, bringing it into alignment with
the Administrative Measures for the Safety Assessment of Agriculture GMOs asrevised in January 2022.
2) In addition to Polymerase chain reaction (PCR) and Southern blotting, sequence
determination is added as a method to analyze integration of a/an inserted sequence inplant genomes.
3) Suitable ecological areas for major GM crops are newly listed in the Guideline. It is
required that at least one production trial site should be set in each major ecologicalarea for the application of cultivation safety certificate of an event.

Legal
Term (inChinese)Legal Term (inEnglish)Laws and
Regulations
Where Term is
Used
Administrative
Rules for Safety ofAgriculture GMOs

农业转基
因生物

Agricultural
geneticallymodifiedorganisms(GMOs)

农业转基
因生物安
全

The safety ofagricultural
GMOs

Administrative
Rules for Safety ofAgriculture GMOs

基因工程
技术

Genetic
engineering
technologies

基因

Gene

基因组

Genetic group

目的基因

Purpose genes

Administrative
Measures for the
Safety Assessmentof Agriculture
GMOs
Administrative
Measures for the
Safety Assessmentof Agriculture
GMOs
Administrative
Measures for the
Safety Assessmentof Agriculture
GMOs
Administrative
Measures for the
Safety Assessmentof Agriculture

Legal Definition (in English)

Agricultural genetically modified organisms
refer to animals, plants, microorganisms andtheir products whose genetic structures havebeen modified by genetic engineering
technology for the use of agricultural
production or processing.
The safety of agricultural GMOs refers to theprevention of dangers or potential risks posedby agricultural GMOs to humans, animals,
plants, microorganisms and the ecologicalenvironment.
Genetic engineering technologies:
technologies that input reconstructed DNA
molecules by using DNA reconstruction
technology or by physical, chemical, or
biological methods.
Gene: structural unit that controls the functionof biological genetic substances, mainlyreferring to a DNA segment with genetic
information.
Genetic group: sum of chromosomes and nonchromosome genetic substances of a given
organism.

Purpose genes: genes that modify the genetic
composition of receptor cells and deliver their
genetic effect.
12

受体生物

Receptororganisms

农业用基
因编辑植
物

Gene-edited
plants

GMOs
Administrative
Measures for the
Safety Assessmentof Agriculture
GMOs
Guidelines for
Safety Evaluationof Gene-EditedPlants for
Agricultural Use(Trial)Receptor organisms: organisms into which
reconstructed DNA molecules are input.

Gene-edited plants for agricultural use refer toplants and their products obtained by targeted
modification of specific genomic sites withgenetic engineering technology and used for
agricultural production or agricultural productprocessing.

The National Biosafety Committee (NBC)
Article 9 of the Administrative Rules for Safety of Agriculture GMOs stipulates that “theagricultural competent authority of the State Council shall strengthen the safety assessment andmanagement of agricultural GMO research and testing and establish the NBC to be responsible
for the safety assessment of agricultural GMOs. The NBC is composed of experts engaged inagricultural GMO research, production, processing, inspection and quarantine, sanitation, andenvironmental protection.” Article 5 of the Administrative Measures for the Safety Assessmentof Agriculture GMOs stipulates that the term limit of NBC members is five years.
The NBC conducts reviews of domestic and foreign applications for biosafety certificates forcultivation and import. Government officials no longer hold positions on the NBC; however, theDevelopment Center for Science and Technology (DCST), an affiliate of MARA, serves as theCommittee’s Secretariat.
The NBC is divided into two expert groups: 1) biotech plants and microbial biotechnology, and2) animals and animal-use microorganisms. “Administrative Measures for the Safety Assessmentof Agriculture GMOs” stipulates that the NBC shall hold no less than two meetings per year.
On December 7, 2021, MARA announced the member list for the Sixth NBC (link in Chinese),
which is composed of 76 scientists.
Additional Responsibilities Held by MARA
In addition to its primary responsibility of approving biotech products for import and domestic
production, MARA leads development of overall government policy and technical guidance
related to agricultural biotechnology. In July 2017, MARA announced the establishment of the
National Technical Committee for the Standardization of Biosafety Management of Agricultural
GMOs (link in Chinese), which is responsible for drafting and revising technical standards forbiotech products, including standards for safety assessments, testing, and detections. It consistsof three technical working groups, namely ingredients, food, and environment, with 37 experts
from Chinese research institutes and universities. Similar to the NBC, the DCST, an affiliate of
MARA, serves as the Committee’s Secretariat. On September 22, 2023, the second TechnicalCommittee for Standardization was elected in Beijing. MARA has not issued a public notice13

announcing the members of the committee. MARA also manages and distributes government
funds to Chinese institutes and universities for the research and development of biotech crops.
There are approximately 40 MARA-designated institutes that conduct environmental and foodsafety testing. Provincial level agricultural departments are responsible for monitoring fieldtrials, GE plant processing facilities, the seed market, and labeling.
Other Government Agencies








The General Administration of Customs of the People’s Republic of China (GACC) is
responsible for testing agricultural and food products for GE content at Chinese ports ofentry.
The National Forestry and Grassland Administration (NFGA) is responsible for theapproval of forestry products for research, domestic production, and import based on its
own biotech regulatory policies related to wood products.
The Ministry of Ecology and Environment (MEE) is the lead agency in the negotiationand implementation of the Cartagena Biosafety Protocol, which China ratified on April
27, 2005.
The Joint-Ministerial Conference for Biosafety Management of Agricultural Genetically
Modified Organisms, which is stipulated in Article 5 of the Administrative Rules for
Safety of Agriculture GMOs, is an overarching coordinating body which meets
irregularly to discuss and coordinate major issues in biosafety management of agricultural
biotech products. The group consists of 12 government bodies under the State Council
that include: MARA, MEE, GACC, Ministry of Science and Technology (MOST),
NDRC, MOFCOM, the National Health Commission (NHC), and others.
NHC reviews and approves ingredients derived from genetically modified
microorganisms (GMMs) for food use. See Chapter 3 for more.
The State Administration for Market Regulation (SAMR) is the authority forcomprehensive market oversight, law enforcement with respect of market supervision andadministration, and coordination on the supervision and administration of food safety
nationwide. When GE foods are distributed in the Chinese market, SAMR reviews the
product labels to ensure compliance with labelling requirements.

Import Approval Procedures
Biosafety Certificate for Agricultural Biotech (Import) Issued to Foreign Developers
MARA is responsible for the review and issuance of biosafety certificates for imported biotech
products for food, feed, and processing (FFP). The Administrative Measures for Safety ofAgriculture GMO Imports outline the requirements for importing biotech products. The
Measures require a foreign seed developer to apply for a biosafety certificate to the
Administrative Service Hall, commonly known as MARA’s “Front Desk.” This office is
responsible for accepting applications and issuing responses to applicants. The application must
contain materials and certifications proving the exporting country allows for the use and sale ofthe product in its domestic market and that the product has undergone studies showing no harm
to animals, plants, or the environment.
After receiving the application, MARA’s GMO Biosafety Office will designate domestic
institutions to conduct environmental safety (field trials) and food safety (feeding studies) tests
14

to verify data provided by the seed developer. These tests are government funded. The reports
generated from verification tests and the application are then reviewed by the NBC. According
to industry sources, some applications have been exempted from field trials in recent years, as
products that obtain biosafety certificates for import for processing will not be planted and thus
do not pose a similar level of environmental risk.
After each meeting, the NBC informs MARA of its decisions. The products that pass NBC
review are subject to a final MARA administrative review before receiving the biosafety
certificate (it is not uncommon for MARA to return applications to the NBC). If the NBC
requests additional data or information on an application, the developer must resubmit theapplication dossier with the required data or explanation to be reviewed at a subsequent NBC
meeting. Timely submission of additional information does not guarantee the application will be
reviewed at the following NBC meeting.
MARA’s guidance on the process, application form, on-line-application process, and status ofapplications can be found at the MARA official website’s page for administrative approvals. The
specific timing of NBC meetings is not formalized, remains highly variable, and is dependent on
external political factors.
Simplified Flow Chart of the Approval for Biosafety Certificate

NBC Review, andDetermination of Index
for Verification

Applicant Import
Materials for
Verification

MARA Conducts Verificationof Environmental and Food
SafetyIssue Biosafety
Certificate forDevelopers

NBC
Review

Applicant Submits Dossier/
MARA Entrusted Lab Submits
Verification Report

Biosafety Certificate for Agricultural Biotechnology (Import) Issued to Overseas Traders
Each consignment of a GE product must obtain a “Biosafety Certificate for Agricultural
Biotechnology (Import)” issued by MARA for customs clearance. According to the Guideline
How the Overseas Traders Apply for Biosafety Certificate for Agricultural Biotechnology(import) (link in Chinese), the applicant of the certificate must be an enterprise or institution
outside of China. Each certificate can only be used for one consignment and is valid for six
months from date of issuance.
MARA’s guideline states that the following materials are required to apply for the certificate:
BEGIN UNOFFICIAL TRANSLATION
Catalog of application materials (one copy of the paper materials, and one copy of the scanned
PDF version of the paper materials on a CD)
15

1. Agricultural GMOs Import Safety Management Registration Form3(Used for Processing
Materials) (original copy)
2. The Biosafety Certificate for Agricultural GMOs (Import) Issued by MARA to Foreign
Developers (copy);
3. Corresponding safety management and preventive measures (original copy);
4. For overseas companies who export an agricultural GMO event from a country or region to
China for the first time, they shall provide a license document that the exporting country or
region has allowed the agricultural GMO event to be used for the corresponding purpose and put
on the market (need to provide official documents and Chinese translations), except for those
provided by overseas developers during the import safety assessment process. (Post Comment:
this requirement is applied on a per event basis and not a per exporting company basis. Thisrequirement is often fulfilled by the developer during the application process).
5. GE soybean imports can apply for trade and physical delivery of futures on the premise of
ensuring that the final use of the product is raw materials for processing. To do so, the applicantsneed to tick the “processing raw materials (used for trade and physical delivery of futures” in thecommodity use column of the "Agricultural GMOs Import Safety Management Registration
Form ". (Post Comment: This clause applies to imported GE soybeans that are not directly
imported for crushing. For example, the GE soybeans imported for state reserves may be held instorage for an extended period before being crushed. This option allows for import of the GE
soybeans without providing processing plant information at time of import.)
END UNOFFICIAL TRANSLATION
From the date of submission, MARA has 25 working days to review the application and issue thecertificate.
In December 2020, MARA issued Public Notice [2020] No. 376 (link in Chinese), announcingthat applications for Biosafety Certificate for Agricultural Biotechnology (Import) to overseas
traders can be submitted on-line (link in Chinese). From October 2021, this biosafety certificate
can also be applied from the Single Window of GACC (in Chinese). Both portals are in Chinese.
Accordingly, exporters may need assistance from a local agent or representative to ensure
required information is entered correctly.
Domestic Cultivation Approval Procedures
A domestic developer wanting to cultivate a new GE product in China requires a MARA
biosafety certificate for cultivation. After obtaining the biosafety certificate for cultivation, thedeveloper needs to apply for plant variety registration with MARA’s Seed Industry Management
Department. After completion of variety registration, the product can be commercially cultivatedin the geographical regions designated in the variety’s registration records. Foreign developers
are prohibited from conducting research, seed production, or cultivation of GE products in
China.

3

When filling out the form online, if the product being applied for is not listed in the product catalog, such as alfalfa,
the applicant can select the last "Customize" option and enter the product name.

16According to China’s Seed Law, five major crops (rice, wheat, corn, cotton, and soybean) are
subject to variety registration in China. On January 21, 2022, MARA published Decree No. 2 of2022, which amended Administrative Measures for Major Crops Variety Registration. The
amended Measures add application procedures and requirements for GE variety registration.
They also amended the Administrative Measures for Crop Seed Production and Operation
License with additional requirements for GE seed production and operation. These amendments,
for the first time, provide a pathway for commercial cultivation of GE food crops in China. Pleaserefer to GAIN Report CH2022-0013 Final Seed Regulations Published for more information of
the amendments of the regulations.
Following the updates to GE variety registrations, on June 8, 2022, the PRC’s National Crop
Variety Registration Committee (NCVRC) published the National Registration Standards for
Genetically Engineered Soybean Varieties (Trial) and National Registration Standards for
Genetically Engineered Corn Varieties (Trial) (link in Chinese) with immediate effect. The
publication of these standards established a clear set of requirements for local developers
applying for variety registration of GE corn and soybeans, further indicating the PRC’s intention
to move towards commercial cultivation of GE food crops in the near term. Please refer to GAIN
Report CH2002-0070 GE Soybean and Corn Variety Registration Standards Issued for unofficialtranslations of the two standards.
b) Approvals
Since the publication of the 2022 Agricultural Biotechnology Annual report, the PRC has issued
two tranches of new and renewed biosafety certificates. As required under the Phase One
Agreement, the validity period of newly issued and renewed certificates is 5 years.
On January 13, 2023, MARA issued biosafety certificates for 10 biotech crops approved forimport as processing materials (including three new GE cotton events, one new GE rapeseed
event, two new GE sugarcane events, two new GE alfalfa events, and two renewed GE cotton
events), and 38 certificates for domestic cultivation and production (including two new GE corn
events, one new GE soybean event, three new animal vaccines, 29 renewed GE cotton events, andthree renewed animal vaccines).
On April 28, 2023, MARA issued 113 certificates for domestic cultivation and production(including one new GE soybean event and 112 renewed GE cotton events) and the first everbiosafety certificate for a gene-edited soybean event. The approval of China’s first ever geneedited plant for domestic cultivation comes just over a year after MARA issued Guidelines for
Safety Evaluation of Gene-Edited Plants for Agricultural Use (Trial), which for the first time
established application procedures and requirements for gene-edited plants.
Since MARA began approving import of GE products for FFP use in 2004, China has approved
six different crops: soybeans, corn, canola, cotton, sugar beet and papaya. A full list of biotech
products approved for FFP import is in Appendix 2.
c) Stacked or Pyramided Event Approvals
The PRC does not have a specific policy for approving stacked events. MARA Decree No. 2 of2022, on revised “Administrative Measures for the Safety Assessment of Agricultural GMOs”
changed the nature of biosafety assessments from being on a “crop variety and event” basis to17solely on an “event” basis, which industry sources believes provides for the biosafety assessmentof GE crops containing “stacked” traits. Please refer to GAIN Report CH2022-0014 Agricultural
GMOs Safety Assessment Administrative Measures Finalized.
d) Field Testing
The PRC requires field trials of biotech products for the purpose of import approval, research,and domestic cultivation, but it does not publicly release information on the number of field trials
or types of products or traits tested.
e) Innovative Biotechnologies
On January 24, 2022, MARA issued “Guidelines for Safety Evaluation of Gene-Edited Plants for
Agricultural Use (Trial)”, which for the first time establish application procedures andrequirements for gene-edited plants. The Guidelines establish application procedures andrequirements for genome-edited plants that do not introduce exogenous genes. For genomeedited plants that introduce exogenous genes, application for safety evaluation must still bemade in accordance with the Guideline for Safety Evaluation of Genetically Modified Plants(link in Chinese). The Guidelines define genome-edited plants for agricultural use as plants andtheir products obtained by targeted modification of specific genomic sites with genetic
engineering technology, which are used for agricultural production or agricultural productprocessing. For additional information, please see USDA GAIN Report CH2022-0015 MARA
Issues First Ever Gene-Editing Guidelines.
MARA has said that genome edited products fall within the scope of China’s “GMO” regulations
and will be regulated as “GMOs” but have held out the possibility of a streamlined process forgene-edited plants that do not pose a risk to food, feed, or environmental safety.
On April 28, 2023, MARA issued the Rules for Review of Gene-Edited Plants for AgriculturalUse (Trial) (link in Chinese), which clarifies the classification criteria and requirements forevaluating gene-edited plants. The Guideline released in January 2022 classified gene-edited
plants into four categories based on the risk profile of the target trait but did not indicate a process
for determining how to classify gene-edited products within each risk category or provide specifictypes of acceptable data. The Review Rules expand upon the processes established under the
Guideline by providing additional information in three areas: molecular characteristics,
environmental safety, and food safety.
The Review Rules also state that evaluations of molecular characteristics, environmental safety,
and food safety can all be carried out in the intermediate test stage. If data from the test stage
show that the target trait does not increase the environmental safety risk, the safety certificate canbe applied directly after passing the evaluation. If the data obtained in the intermediate test stage
indicate that the target trait may increase environmental safety risks, environmental release or
production tests need to be carried out, and safety certificates can only be applied after passing thesafety evaluation. For additional information, please see GAIN Report MARA Updates Rules for
Review of Gene-Edited Plants for Agricultural Use | CH2023-0080.
f) Coexistence
The PRC does not have a coexistence policy.
18g) Labeling and Traceability
The PRC’s biotech labeling regulations, governed by the Administrative Measures on Labelingof Agriculture GMOs, require mandatory labeling of products that are produced from GE
materials or contain the following GE substances:
1. Soybean seeds, soybeans, soybean flour, soybean oil, and soybean meal;
2. Corn seeds, corn, corn oil, and corn flour (including corn flour under HS codes
11022000, 11031300, and 110423004);
3. Rapeseed for planting, rapeseeds, rapeseed oil, and rapeseed meal;
4. Cottonseed; and5. Tomato seed, fresh tomato, and tomato paste.
These measures are expected to be updated based on Administrative Measures on Labeling
Agricultural Genetically Modified Organisms (GMOs) (Draft for Comments), published by
MARA on October 17, 2023. The draft measures update product listings in the Agricultural
GMOs Labeling Catalog, removing soybean planting seeds, corn planting seeds, rapeseed/canola
planting seeds, cotton planting seeds, tomato planting seeds, fresh tomatoes, and tomato paste andadding soy protein, soybean dregs, kibbled/broken corn, corn meal, cottonseed oil, cottonseed
meal, alfalfa, and papaya. Other significant updates the establishment of a three percent labelingthreshold for products listed in the catalog.
The revised draft also requires that “organisms that China has not issued agricultural GMO
biosafety certificates, the word 'non-GMO' must not be used on product label and manual.” This
revision aligns with the revised Measures on Supervision and Management of Food Labeling,which was released by the State Administration for Market Regulation (SAMR) for publiccomments in July 2020. The SAMR measures prohibit using “Not containing GMO,” “NonGMO,” or similar text to introduce foods that do not use genetically modified food materials.
The Implementing Regulations of the Food Safety Law released in October 2019 state:“Production and trading of genetically modified foods (in China) should be conspicuously
marked; the measures for marking (the production and trading) will be developed by the foodsafety supervision and administrative department of the State Council together with theagricultural administrative department of the State Council.” As such, the production facilities
that process GE crops, such as the production lines that crush oil from GE soy, or the countersselling GE foods need to have clear signs that they are processing/selling GE products.
h) Monitoring and Testing
Testing of biotechnology products is carried out primarily by GACC, MARA, and MEE throughtheir designated testing institutes. GACC is responsible for testing products at ports of entry andmay reject any cargoes found to contain unapproved biotech products. MARA tests domestic
crops and conducts food and feed safety assessments. MEE conducts environmental safety tests.
While submitting applications for biosafety certificates, foreign developers are required toprovide testing methods and reference materials along with the application.

According to the China’s Customs Import and Export Tariff, HS codes 11022000, 11031300, and 11042300 refer tomaize (corn) flour, corn groats/meal/pellets, and corn hulled/rolled/flaked/pearled/sliced/kibbled).
4

19

On March 6, 2020, Standardization Administration of China (under SAMR) issued National
Standard GB/T38505-2020: General Detection Methods of Genetically Modified Products,
which specifies the qualitative testing methods for genetically modified products. This standard
is applicable to the general testing of genetically modified components in rice, corn, soybean,rapeseeds, potato, sugar beet, alfalfa, and their processed products by real-time fluorescent PCR.
Though not official guidance, scientists from the Chinese Academy of Inspection and Quarantine(CAIQ) and China Agricultural University (CAU) published a paper titled A Universal
Analytical Approach for Screening and Monitoring of Authorized and Unauthorized GMOs in
the LWT-Food Science and Technology journal in May 2020, which introduces a universal
analytical approach for screening GE presence in food and feed products.
i) Low Level Presence (LLP) Policy
The PRC does not have an LLP policy for biotech imports. Considering the PRC’s zero tolerance
for unapproved biotech products in imports and the large volume of imported GE products, thisis a significant barrier to trade. The PRC has participated in the Global LLP Initiative as anobserver; most recently at the virtual meeting in 2020.
Under the Phase One Economic and Trade Agreement (see Annex 16, sections 8 – 10), the PRC
made certain commitments in how it would address LLP occurrences to facilitate trade. The
United States and the PRC also agreed to organize experts to conduct further studies on the issueof LLP and to collaborate internationally on practical approaches to addressing LLP.
To avoid customs clearance issues, U.S. exporters of non-GMO crops for food use should ensure
products exported to China do not contain GE materials and ensure importers are aware of PRC
policies on unapproved biotech products.
j) Additional Regulatory Requirements
Please refer to the Agricultural Biotechnology Annual 2022 | CH2022-0112 which covers seedvariety registration issues and policy.
k) Intellectual Property Rights (IPR)
Article 25 of the Patent Law of the People's Republic of China provides that patent rights shallnot be granted for animal and plant varieties; while the patent rights may be granted for the
production methods of the animal and plant variety products. Therefore, in China, intellectual
property rights for plants, including GE plants, are protected by plant variety rights (Plant Variety
Protection). However, events and their associated gene fragments, proteins, etc. are patentable.
According to the China National Intellectual Property Administration's Patent Search andAnalysis database, some foreign and domestic events have been granted patents.
On December 24, 2021, the NPC published the amended Seed Law. The new law came into effecton March 1, 2022. The full text of the amended law can be found on the NPC’s website (link in
Chinese). The amendments to the Seed Law strengthen provisions for the protection of
intellectual property rights in the following aspects:201) Expanded the protection scope: The new seed law stipulates that the scope of protection for
new plant varieties extends from the propagation material of the authorized variety to theharvesting material obtained without permission using the propagation material of theauthorized variety.
2) Expands the protection links: Compared with the original seed law, the protection links ofvariety rights have been expanded from the original three links (production, reproduction, andsales) to eight links by adding links for "processing for reproduction, promising sales, import,
export, and storage" have been added, providing more opportunities for variety rights holders
to claim their rights.
3) Establishes the essentially derived varieties (EDV) system: establishes a benefit sharing
mechanism between the owner of the original variety and the owner of the derived variety,and further encourages original innovation of plant breeding.
4) Improves the compensation system for infringement on new plant variety rights: increases thecompensation standard, and increases the protection for the owner of the variety rights.
Please refer to GAIN Report CH2021-0185 Final Seed Law Published for more information of
the amended Seed Law.
On March 2, 2022, the Supreme People's Court of China issued an opinion clarifying therequirements for criminal trials related to seeds. Entitled "Guiding Opinions on Further
Strengthening the Criminal Trial Work Involving Seeds", the opinion covers the application oflaw to seed-related crimes, and improvement of relevant enforcement mechanisms. This Opinionis latest in a trend of messaging and polices by the PRC to strengthen variety protection andencourage a market environment for the seed industry with intellectual property protections forthe seed industry. Please refer to GAIN Report CH2022-0031 Supreme People's Court
Strengthens Seed Variety Protections for more information on the Guiding Opinions.
On November 21, 2022, MARA released the People's Republic of China Plant Variety Protection
Regulations (Revised Draft for Comments) (link in Chinese) for public comment. The
amendments to the PVP regulations strengthen provisions for the protection of variety rights inthe following aspects:(1) Make provisions on the Essentially Derived Varieties (EDV) system;(2) Expand the scope of protection and the links of protection;(3) Extend the term of protection. The revised draft extends the protection period of variety rights,
from 20 years to 25 years for woody and vine plants, and from 15 years to 20 years for otherplants;(4) Improving measures for handling infringement and counterfeiting cases;(5) Clarify the circumstances of the restoration of rights.
MARA has not issued a final or updated version of the draft. Please refer to USDA GAIN Report
China Releases Plant Variety Protection Regulations for Comment | CH2022-0127 for more
information on the revision of the PVP regulations.
l) Cartagena Protocol Ratification
The PRC signed the Cartagena Protocol on Biosafety (CPB) to the United Nation’s Convention
on Biological Diversity in 2000 and ratified it in 2005. In 2011, the PRC announced that the21

protocol would also apply to the Hong Kong Special Administrative Region. As a party to theProtocol, the PRC adopted the Biosecurity Law on October 17, 2020. The Biosecurity Law cameinto force on April 15, 2021. China submitted the Fourth National Reports on Implementation of
the Cartagena Protocol on Biosafety in October 2019, covering China’s implementation of CPB
from September 2015 to September 2019.
Adopted as a supplementary agreement to the CPB, the Nagoya Protocol on Access to Genetic
Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization aims tocontribute to the conservation and sustainable use of biodiversity by providing international rules
and procedures in the field of liability and redress relating to living modified organisms. The
Nagoya Protocol was adopted on October 29, 2010 and entered into force on October 12, 2014.
The PRC acceded to the Protocol on June 8, 2016. The Protocol entered into force for China on
September 6, 2016 and does not apply to the Hong Kong or Macao Special Administrative
Regions.
m) International Treaties and Forums
In recent years, Chinese participants have attended workshops as part of the APEC High Level
Policy Dialogue on Agricultural Biotechnology (HLPDAB), including participants from MARA
and CAAS at the July 2023 meeting in the United States.
Biotech Working Group (BWG) and Technical Working Group (TWG)
In years past, the U.S. and China frequently held bilateral discussions on agricultural
biotechnology. The U.S.-China High-Level Biotechnology Joint Working Group (BWG) wasestablished in 2002 to address bilateral biotechnology issues of mutual interest and was attended
by FAS and MARA. Similarly, a Technical Working Group (TWG) was established in 2003 tosupplement policy discussions and was attended by the Animal and Plant Health Inspection
Service (APHIS), FDA, Environmental Protection Agency (EPA), and MARA. The location
typically alternated between the U.S. and China. Neither the BWG nor TWG have been held
since 2018.
n) Related Issues
Oversight and Enforcement
Each year, MARA releases an annual Biosafety Oversight Working Plan that includes reports ofdetected violations. On April 28, 2023, MARA released its 2023 Biosafety Oversight Working
Plan (link in Chinese), which listed five key tasks: 1) Strengthen the supervision of research andexperimentation; 2) Strictly manage variety registration; 3) Strengthen the supervision of seedproduction and operation; 4) Strict import processing supervision; and 5) Intensify efforts topopularize genetically modified science. Previous incident report highlights include:2022 – There were six cases reported, including 2 unapproved environmental release
experiments with corn, 2 GE soybean sales violating GE labelling rules, and 2 illegal GE
corn experiments conducted.
2021 - There were nine cases reported, including four cases of illegal corn seed sales in
Liaoning, Jilin, Heilongjiang, and Xinjiang, four cases of research institutes/seed
22






developers violating rules about cotton research and trials, and one case of research
institute violating rules about GE wheat intermediate trials.
2019 - MARA announced ten cases of violations to the agriculture biosafety rules,
including four intermediary experiments (two corn and two cotton), and five cases ofillegal production of corn seeds (in Shaanxi, Xinjiang, Heilongjiang, Liaoning, and Jilin).
The last case was a grains/oil processing company, which spilt GE soy when it wastransported from port to the processing facility.
2018- MARA announced seven cases of seed companies conducted trails of GE corns
without proper registering/reporting with MOA.
2017 – MARA announced eleven cases of research institutes conducting trials of GE
corns, rice, and sugar cane without proper registering/reporting with MOA.

Part C: Marketinga) Public/Private Opinions
Years of efforts by the PRC to address public misperceptions towards biotech through press
conferences and training for journalists and local government officials, and mainstream media
reports about agriculture biotechnology appear to have reduced negative perceptions among the
public. Both traditional and social media are used to explain the PRC’s biosafety regulatory work
to the public and MARA is working with its peer ministries to eliminate misleading claims orstatements in product labels and advertisements. On the MARA website, a special Scientific
Publicity of Biotechnology promotes biotechnology knowledge, such as the safety of GM foods,
and the PRC’s labeling regulations on GM products.
As the PRC moves closer to commercial cultivation of GE corn and soybeans, which will enter
the food chain, state media has taken leading role in promoting the advantages and safety of GE
technologies, as in this CCTV video.
b) Market Acceptance/Studies
No new nation-wide surveys of public acceptance of biotech in China have been released inrecent years. Please refer to the 2018 Agricultural Biotechnology Annual for previous studies.
Chapter Two: Animal Biotechnology
China is a leader in animal biotech research. The Key Scientific and Technological Grant ofChina for Breeding New Biotech Varieties was launched in 2008 and supports research on GE
animal species including swine, cattle, and sheep. Despite heavy investment and advanced
research, China has not approved any livestock clones, GE animals, or products derived fromanimal biotech for commercial use.
Multiple Chinese research teams have announced progress in research of transplantation usingorgans from gene-edited pigs; in recent years, Chinese scientists have successfully cloned avariety of animals, including mules, cats, rats, and ferrets. The technology of feline cloning is
expected to play a role in studying animal diseases, developing new drugs, and protecting
endangered species. According to ISAAA, researchers from China used CRISPR technology on
silkworms to produce stronger silk. The resulting fiber is considered better compared to other23

commercial synthetic fibers. Other reports indicate extensive use of CRISPR and other new
technologies in animal research.
Part D: Production and Tradea) Product Development
The PRC has invested in basic research for animal biotech. Research institutes can apply to
MARA and the Ministry of Finance for research funding. Research is focused on medicine
production, improving the quantity and quality of milk, and improving quality of meat and wool.
A list of the research projects funded by the Key Scientific and Technological Grant of China for
Breeding New Biotech Varieties can be found at the National Science and Technology Report
Service (link in Chinese).
Recent research includes scientists from Guangzhou Institute of Biomedicine and Health whodeveloped a human-like kidney in pigs using engineered human pluripotent cells and injecting
them into the genetically engineered embryo of a pig. The research result was published in Cell
Stem Cell in August 2023. See Scientists Take a Step Closer to Growing Human Organs forTransplants.
Scientists from the Chinese Academy of Agricultural Sciences (CAAS), Huazhong Agricultural
University, and University of Guelph, Canada, research in the international biology journal eLife
Journal in September 2020 about a pig species that can resist three major infectious diseases
using gene-editing technology. The research suggests that it can resist porcine reproductive andrespiratory syndrome (PRRS) virus and transmissible gastroenteritis virus and show decreased
susceptibility to porcine deltacoronavirus. Meanwhile, the GE pig has normal meat-production
and reproductive performance. Since the occurrence of African Swine Fever (ASF) in summer
2018, biotechnology is being considered as a possible solution to resist the disease. See: GARAGAP Analysis Report of November 2018.
Scientists from Shenzhen Institute of Agricultural Genomics of CAAS and their collaborators
published Safety evaluation of transgenic and genome-edited food animals in “Trends in
Biotechnology” in late November 2021. The article proposes to rationally optimize the regulatory
system of gene editing products according to the characteristics of gene editing products andpromote the industrialization of gene edited animal products. The article points out that after thecompletion of gene editing, agricultural breeding can eliminate unintended effects such as offtargets through multi-level screening, until the optimal individual is selected for production
applications.
In May 2021, the journal Nature-Communications published research by a team from the Schoolof Animal Science and Technology, Yangzhou University. The article introduces theoreticalresearch on methodological system of reversing chicken somatic cells (fibroblasts) into
primordial germ cells to reproduce progeny and solving the problem of somatic cell cloning inavian animals.

24b) Commercial Production
Some GE animal projects have long been ready to apply for biosafety certificates forcommercialization. However, they remain in the research stage because MARA does not havedefinitive regulatory guidelines for animal biotech.
c) Exports
The PRC does not export GE animals, livestock clones, or products from these animals.
d) Imports
The PRC does not import GE animals, livestock clones, or products from these animals.
e) Trade Barriers
N/APart E Policya) Regulatory Framework
Animal biotechnology is subject to the State Council’s “Administrative Rules for Safety ofAgriculture GMOs (revised in 2017)”. The MARA guidance, application form, on-line
application process, and the status of applications can be found at the MARA’s website foradministrative approvals (link in Chinese). However, this regulation lacks implementation rules
or specific policies for animal biotech research, production, or trade. MARA has not issued
further direction on regulatory approvals for animal biotech. Like plant biotech, MARA starts thereview of dossiers for foreign developed animal biotech products only after a trait is deregulated
in an exporting country.
In April 2021, the Biosecurity Law (link in Chinese) came into effect. The law addresses several
biosecurity elements, including bioterrorism, infectious disease management, biotechnology
development, biodiversity protection, microbial resistance, and human and biological resource
management. MARA indicated that MARA rules for agriculture biotechnology will be revised
pursuant to the Law, but no revisions have been announced. The law and its implementing
regulations may affect laboratory research on GE animals.
b) Approvals
The PRC has not approved any GE animals for domestic commercialization, nor has China
approved the importation of GE animals for processing.
c) Innovative Biotechnologies
Chinese scientists are making progress in the research of genome edited animals using innovative
biotechnologies, particularly for medical purposes. However, the government has not yet
developed policies/regulations to regulate innovative biotechnologies in animals.
25d) Labeling and Traceability
GE animal labeling is subject to the Administrative Measures on Labelling of Agriculture GMOs
(issued on January 5, 2002; latest revision issued on November 30, 2017). China has notcommercialized any GE animals and specific measures for GE animal labeling are not available.
e) Additional Regulatory Requirements N/A.
f) Intellectual Property Rights (IPR)
Currently, gene and DNA fragments are subject to protection provided by the Patent Law ofChina. However, GE animals fall into a legal gap in China’s IPR protection regulations. The
existing regulations for biotech focus on safety and do not address IPR protection for developers
or breeders.
g) International Treaties and Forums
The PRC sends officials to high-level conferences for GE animals but mainly as observers.
Chinese scientists maintain frequent and close contact with foreign peers. In May 2021, the 88th
Annual General Session of the World Organization for Animal Health (OIE) was held virtually.
Dr. Huang Baoxu, OIE Delegate from China and a researcher with the China Animal Health andEpidemiology Center (CAHEC), was elected chairman of OIE Regional Commission for Asia,
the Far East and Oceania (AFEO) on May 28, 2021.

h) Related Issues
N/APart F: Marketinga) Public/Private Opinions
Public concern and underdeveloped pathways between public research institutes and industry
make commercialization of GE animals challenging in China.
b) Market Acceptance/Studies
Although no official surveys are available, the market/public acceptance towards the sale and useof livestock clones, offspring of clones, GE animals, genome-edited animals, and products islow. The acceptance for such products for medical purposes is more positive.
Chapter Three: Microbial Biotechnology
On October 7, 2023, the National Health Commission (NHC) announced approval of 2’fucosyllactose (2’-FL), a purified human milk oligosaccharide (HMO) derived from geneticallymodified microorganisms (GMMs), for use as a food nutrition fortifier in infant formula. The
approval is NHC’s first for a GMM-derived food ingredient outside the enzyme category. Since
the issuance of the last biotech annual report, the NHC also has approved the use of 12 GMM26

derived enzymes to be used as food additives in food production, and MARA has approved theuse of 9 GMMs for animal use. The PRC’s regulatory process to approve all categories of GMMderived food ingredients is a topic addressed in Annex 16 (Agricultural Biotechnology) to
Chapter 3 of the Economic and Trade Agreement.5
Part G: Production and Tradea) Commercial Production
At present, the PRC only permits the commercial use of GMM-derived food ingredients whenthose ingredients are purified.
b) Exports
There are neither official statistics nor estimates of China’s export of microbial biotechnology
products. However, China exports alcoholic beverages, dairy products, and processed productsthat may contain microbial biotech-derived food ingredients.
c) Imports
Trade data not available. Microbial biotech-derived food ingredients likely are in Chinese
imports of alcoholic beverages, dairy products, and processed products, where microbial biotech
derived ingredients are commonly used in global production.
d) Trade Barriers
As part of the Economic and Trade Agreement, the PRC committed to establish a regulatory
process for all food ingredients derived from microbial biotechnology by February 2021. No new
regulations have been released, however reviews of enzymes produced from microbial
biotechnology are conducted regularly.
Part H: Policya) Regulatory Framework
Applying for Approval of GMM-Derived Food Ingredients
Outside the enzyme category, the PRC has not yet clarified the application requirements andevaluation process for new varieties of GMM-derived food ingredients.
For enzymes, the application process for new GMM-derived varieties is the same as that for new
varieties of all other food additives. An application should be submitted to the NHC pursuant to
the Administrative Measures for New Variety of Food Additives [Ministry of Health (MOH,
now NHC) Decree 73], the Provisions for Application Submission and Acceptance of New
Variety of Food Additives, and the Notice Concerning Regulating Approving of New Food
5

Paragraph 6 of the Annex 16: China shall, within 12 months of the date of entry into force of this Agreement,
establish and make public a simplified, predictable, science- and risk-based, and efficient safety assessment
procedure for approval of food ingredients derived from genetically modified microorganisms.

27

Additive Variety (MOH Public Notice [2011] No.29).6 NHC will then conduct a risk assessmentof the ingredient and determine whether it can be approved.
GMM-derived enzymes are also reviewed for their safety. Through intra-agency coordination,
the safety assessment is conducted in the following steps:


NHC accepts applications for enzymes produced from microbial biotechnology, reviews
the dossiers, and decides whether MARA technical experts (NBC members) need toassess the product’s safety;o If a biosafety assessment is required for the GE microbe and ingredient, thedossier is passed to MARA for review (not the full set of NBC review, rather anassessment of the product). The assessment is conducted following the provisionsof the State Council’s “Administrative Rules for Safety of Agriculture GMOs”,
the Administrative Measures for the Safety Assessment of Agriculture GMOs andthe Guideline for the Conduct of Food Safety Assessment of Microbial
Biotechnology for Animal Use. The review decision then is sent to NHC for its
approval of the enzyme.
o If the product does not need to be assessed by the NBC, NHC will review the
product as it reviews other enzymes. The whole regulatory process takes
approximately two years to complete.

Once approved by the NHC, enzymes derived from microbial biotechnology will be announced
as new varieties of enzyme preparations used in food processing and can be used in foods. The
newly approved enzymes will gradually be included in the National Food Safety Standard –Standard for Uses of Food Additives (GB 2760) ( see Table C.3) when the standard is revised. In
April 2021, China notified a revised draft of GB 2760 to the WTO SPS Committee for comments,
which contains a list of 60 enzyme preparations for food processing use (page 155 of the report).
Currently, only primary agricultural products have labeling requirements. Industry contacts reportthat the NHC is working on possible labeling requirements for food additives derived from
GMMs.
b) Approvals
Since the publication of the Agricultural Biotechnology Annual 2022, the NHC has issued fourannouncements approving new food ingredients derived from microbial biotechnology.
On March 2, 2023, the NHC released its 2023 No. 1 Announcement on 28 "Three New Foods"7
including Leuconostoc pseudomesenteroides, which approved 28 new food materials andadditives for use in China, including six enzymes derived from GMMs. See NHC Approves New
Food Materials and Additives including GMM Derived Enzymes | CH2023-0037 for more
information of the announcement.

6

Instructions on the application procedures and material requirements can be found on the NHC website (in Chinese,scroll down to New Variety Food Additive Applications - 食品添加剂新品种审批).
7"Three new foods" refers to new food raw materials, new varieties of food-related products and new varieties offood additives.

28

On May 6, 2023, NHC released its 2023 No. 3 Announcement on 14 "Three New Foods"
Including Blueberry Anthocyanins, which approved 14 new food materials and additives for use
in China, including one enzyme derived from GMMs.
On August 1, 2023, NHC released its 2023 No. 5 Announcement on 8 "Three New Foods"
Including Sorbifolia Seed Kernels, which approved 8 new food materials and additives for use in
China, including one enzyme derived from GMMs.
On October 7, 2023, NHC released its 2023 No. 8 Announcement on 15 "Three New Foods"
including Peach Gum, which approved 15 new food materials and additives for use in China,
including one enzyme and two food nutrition fortifier derived from GMMs.
All GMM-derived food ingredients that have received NHC approval since the beginning of 2021
are noted in Table 1 below.

No.
1. (newly
approved in
October2023)

2. (newly
approved in
October
2023)

Table 1. China: Approved GMM-Derived Food Ingredients
Food Nutrition Fortifiers
Name
Host
2’-岩藻糖基乳糖
2′-Fucosyllactose(2′-FL)Donor

大肠杆菌K-12 DH1 MDO E. coli 螺杆菌
K-12 DH1 MDO(Helicobacter spp.)
大肠杆菌K-12 MG1655
E. coli K-12 MG1655

螺杆菌(Helicobacter spp.)

大肠杆菌BL21(DE3) E. coli
BL21(DE3)

奈瑟菌(Neisseria spp.)

乳糖-N-新四糖Lacto- 大肠杆菌K-12 DH1 MDO
N-neotetraose
E. coli K-12 DH1 MDO

奈瑟菌（Neisseriaspp.）和螺杆菌（Helicobacter
spp.

EnzymesNo.

酶 Enzyme

来源 Host

供体 Donor1

葡糖淀粉酶
Glucoamylase

李氏木霉Trichoderma reesei2.

阿拉伯呋喃糖苷酶
Arabinofuranosidease李氏木霉Trichoderma reesei

3.

多聚半乳糖醛酸酶
Polygalacturonase黑曲霉
Aspergillus niger黑曲霉Aspergillus niger

4.

果胶裂解酶
Pectinlyase李氏木霉Trichoderma reesei黑曲霉
Aspergillus niger

5.

麦芽四糖水解酶Maltotetraohydrolase

地衣芽孢杆菌Bacillus licheniformis施氏假单胞菌Pseudomonas stutzeri

29

李氏木霉
Trichoderma reesei
Talaromyces pinophilus

6.

木聚糖酶
Xylanase李氏木霉Trichoderma reesei

Talaromyces leycettanus

7.

α-葡萄糖苷酶
Alpha-glucosidase李氏木霉Trichoderma reesei黑曲霉
Aspergillus niger

8.

乳糖酶
Lactase地衣芽孢杆菌Bacillus licheniformis两歧双歧杆菌
Bifidobacterium bifidum9.

羧肽酶Carboxypeptidase黑曲霉
Aspergillus niger黑曲霉Aspergillus niger

10.

脂肪酶
Lipase黑曲霉Aspergillus niger

黄色镰刀菌Fusarium culmorum

11.

α-淀粉酶
Αlpha-amylase

李氏木霉Trichoderma reesei

白曲霉Aspergillus kawachii

12.

蛋白酶
Protease李氏木霉Trichoderma reesei

李氏木霉Trichoderma reesei

13.

葡糖异构酶
Glucose isomerase锈棕色链球菌Streptomyces
rubiginosus锈棕色链球菌Streptomyces
rubiginosus

14.

脂肪酶
Lipase多行汉逊酵母异孢镰刀菌
Hansenula polymorpha Fusarium hetreosporum

15.

Β-淀粉酶 β-amylase（Novozyme）

地衣芽孢杆菌Bacillus licheniformis弯曲芽孢杆菌Bacillus flexus

16.

α-淀粉酶
Αlpha-amylase

地衣芽孢杆菌Bacillus licheniformis

嗜纤维菌
Cytophaga sp.

17.

乳糖酶
Lactase

枯草芽孢杆菌Bacillus subtiis

两歧双歧杆菌
Bifidobacterium bifidum

18.

蛋白酶
Protease

枯草芽孢杆菌Bacillus subtiis

水生栖热菌
Thermus Aquaticus

19.

蛋白酶
Protease

枯草芽孢杆菌Bacillus subtiis

解淀粉芽孢杆菌
Bacillus amyloliquefaciens20.

磷酸肌醇磷脂酶C
Phosphoinositide
phospholipase C（DSM）荧光假单胞菌Pseudomonas
fluorescens从土壤中分离的编码磷酸肌

21.

α-淀粉酶
α-amylase黑曲霉
Aspergillus niger

微小根毛霉
Rhizomucor pusillus

22.

多聚半乳糖醛酸酶
Polygalacturonase李氏木霉Trichoderma reesei

塔宾曲霉Aspergillus tubingensis

30醇磷脂酶C基因的微生物

23.

果胶酯酶
Pectin esterase

李氏木霉Trichoderma reesei

塔宾曲霉Aspergillus tubingensis

24.

磷酸肌醇磷脂酶C
Phosphoinositide
Phospholipase C

地衣芽孢杆菌Bacillus licheniformis

假单胞菌
Pseudomonas sp.

25.

磷脂酶C
Phospholipase C

地衣芽孢杆菌Bacillus licheniformis苏云金芽孢杆菌
Bacillus thuringiensis

26.

木聚糖酶
Xylanase李氏木霉Trichoderma reesei

柔曲高温多孢菌
Thermopolyspora flexuosa

27.

葡糖淀粉酶
Glucoamylase黑曲霉
Aspergillus niger

密粘褶菌Gloeophyllum trabeum

28.

脂肪酶
Lipase李氏木霉Trichoderma reesei

29.

4-α-糖基转移酶
4-αglucanotransferase苍白空气芽孢杆菌
Aeribacillus pallidus

尖孢镰刀菌
Fusarhum oxysporum
--

30

磷脂酶A1
Phospholipase A1

米曲霉Aspergillus oryzae

红聚颈腔菌
Valsaria rubricosa

31

麦芽糖淀粉酶
Maltogenic amylase

地衣芽孢杆菌Bacillus licheniformis

嗜热脂解地芽孢杆菌
Geobacillus
stearothermophilus

32

葡糖氧化酶
Glucose oxidase李氏木霉Trichoderma reesei

尼崎青霉菌
Penicillium amagasakiense33

脂肪酶Lipase李氏木霉Trichoderma reesei黑曲霉塔宾变种
Aspergillus niger var.
tubingensis

34

β-葡聚糖酶
β-glucanase

枯草芽孢杆菌Bacillus subtilis

枯草芽孢杆菌Bacillus subtilis

35

蛋白酶
Protease

枯草芽孢杆菌Bacillus subtilis

克劳氏碱性卤杆菌
Alkalihalobacillus clausii

36

海藻糖酶
Trehalase李氏木霉Trichoderma reesei

37

磷脂酶A1
Phospholipase A1黑曲霉Aspergillus niger

李氏木霉Trichoderma reesei
Talaromyces
leycettanus

38

葡糖氧化酶
Glucose oxidase黑曲霉
Aspergillus niger
31

产黄青霉
Penicillium chrysogenum

39

乳糖酶
Lactase

枯草芽孢杆菌Bacillus subtilis德氏乳杆菌保加利亚亚种Lactobacillus delbrueckii
subsp. bulgaricus

40

植酸酶
Phytase黑曲霉
Aspergillus niger

塔宾曲霉Aspergillus tubingensis

41

乳糖酶
Lactase黑曲霉
Aspergillus niger

米曲霉Aspergillus oryzae

42 (newly
approvedin March2023)
43(newly
approvedin March2023)
44(newly
approvedin March
2023)
45(newly
approvedin March2023)
46(newly
approvedin March2023)
47(newly
approvedin March2023)
48(newly
approved
in
May
2023)

氨基肽酶
Aminopeptidase

米曲霉Aspergillus oryzae

米曲霉
Aspergillus oryzae

蛋白酶Protease李氏木霉Trichoderma reesei樟绒枝霉Malbranchea sulfurea

磷脂酶 A2
Phospholipase A2

李氏木霉
Trichoderma reesei

烟曲霉Aspergillus fumigatus

麦芽糖淀粉酶
Maltogenic amylase

酿酒酵母
Saccharomyces
cerevisiae

嗜热脂解地芽孢杆菌
Geobacillus
stearothermophilus

木聚糖酶Xylanase

地衣芽孢杆菌Bacillus licheniformis

地衣芽孢杆菌Bacillus licheniformis羧肽酶
Carboxypeptidase

米曲霉Aspergillus oryzae

米曲霉
Aspergillus oryzae

49(newly
approved
in August2023)

溶血磷脂酶（磷脂酶 Lysophospholipase50(newly
approvedin October2023)

丝氨酸蛋白酶

地衣芽孢杆菌葱绿拟诺卡氏菌

Serine protease

Bacillus licheniformis

Nocardiopsis prasina

D-阿洛酮糖-3-差向异构酶
D-psicose 3-epimerase
B）枯草芽孢杆菌Bacillus subtilis

瘤胃球菌 CAG55
Ruminococcus sp.
CAG55

Trichoderma reesei
Aspergillus nishimurae（lecithinase B）李氏木霉32c) Labeling and Traceability
As the enzymes derived from microbial biotechnology are considered common enzymes, there
are no specific labeling requirements.
d) Monitoring and Testing
There are no additional monitoring or testing requirements specific to GMM-derived foodingredients.
e) Additional Regulatory Requirements
Food ingredients derived from microbial biotechnology, after approval, are considered to be foodadditives produced by traditional methods. Thus, they are subject to the following food additive
requirements.
Food Additive Production
Food additive production is subject to licensing requirements. Only facilities that have “foodadditive production” listed in their operating licenses can produce food additives.
National Food Safety Standard - Standards for Uses of Food Additives (GB 2760)
Enzyme preparations used in food processing are listed in Table C.3 - List of Enzyme
Preparation for Foods and Their Sources. Table C.3 specifies that enzymes can be used in foodprocessing and the sources of the enzymes. The current GB 2760 in effect was released in 2014
and implemented in May 2015 (please refer to GAIN Report CH2015-3508 for full translation of
the standard); enzymes produced from microbial biotechnology, which were approved
subsequent to the release of GB 2760 are likely to be included in the updated GB 2760 currently
under development. After the release of the standard GB 2760, China published a series ofsupplementary announcements (link in Chinese) to add new food additives including enzyme
preparations to the list, which have been included in Table 1 above.
On April 13, 2021, China notified a revised draft of the National Food Safety Standard for Use of
Food Additives (GB2760) to the WTO SPS Committee as G/SPS/N/CHN/1217. The comment
period has ended and the final updated version hasn’t been officially published.
National Food Safety Standard for Food Additive - Enzyme Preparations Used in Food
Processing (GB 1886.174)
The Standard applies to enzyme preparations for foods that are permitted for use in GB 2760. It
provides the terms and definitions of enzyme preparations used in food processing, enzyme
activity, and antibacterial activity; the standard also provides the product categorization (solidand liquid), and technical requirements (for raw materials and for product). It is not the guidance
for the use of such enzymes.

33f) Intellectual Property Rights (IPR)
N/A.
g) Related Issues
N/A.
Part I: Marketinga) Public/Private Opinions
FAS China does not know of any opposition or concern by the public towards such products.
b) Market Acceptance/Studies
There is no distinction between the approved enzymes derived from microbial biotechnology andfrom the common food additives in use, thus there is no known study about market acceptance ofsuch ingredients available in China.

Appendix 1: China’s Trade in Biotech Crops (Source: GACC)
China: Cotton Exports (HS 520100)
Quantity (1,000 Tons)
Partner Country
2020
2021
2022
2023 (Jan.-Aug.)
World
4
9
34
5
Bangladesh
00152Vietnam1
7
10
2
Thailand0100Indonesia
0111China: Cotton Imports (HS 520100)
Quantity (1,000 Tons)
Partner Country
2020
2021
2022
2023 (Jan-Aug)
World
2,158
2,142
1,927
858
United States
978
829
1,132
466
Brazil
618
644
577
154
India
253
409
31
24
Australia
117
35
20
98
Sudan
32
26
22
27

34

China: Corn Imports (HS 100590)
Quantity (Million Tons)
Partner Country

2020

2021

2022

2023 (Jan-Aug)

World

11.24

28.35

20.62

14.91

United States

4.34

19.83

14.86

6.02

Ukraine

6.24

8.2

5.26

5.21

China: Soybean Imports (HS 120190)
Quantity (Million Tons)
PartnerCountry
2020
2021
2022

2023 (Jan-Aug)World

100.31

96.47

90.29

71.67

Brazil

64.28

58.15

54.39

48.00

United States

25.87

32.27

28.74

19.97

Argentina

7.46

3.78

3.65

1.55

Uruguay

1.66

0.87

1.79

0

Russia

0.69

0.55

0.69

0.93

China: Distillers Dried Grains Imports (HS 230330)
Quantity (1,000 Tons)
PartnerCountry
2020
2021
2022
2023 (Jan-Aug)
World

182

307

83

53

United States

182

307

83

53

China: Rapeseed Imports (HS 12051090)
Quantity (1,000 Tons)
Partner Country
2020
2021
2022

2023 (Jan-Aug)

World

3,756

2,531

1,868

3,677

Canada

2,315

2,438

1,868

3,677

Australia

439

93

Russia

1

1

0
0

0
0

China: Rapeseed Meal Imports (HS 230641)
Quantity (1,000 Tons)
Partner Country
2020
2021
2022
35

2023 (Jan-Aug)World

1,886

2,032

2,213

1,386

Canada

1,496

1,579

1,736

1,104

United ArabEmirates

335

418

430

244

China: Rapeseed Oil Imports (HS 151411, 151419, 151491, 151499)
Quantity (1,000 Tons)
Partner Country
2020
2021
2022
2023 (Jan-Aug.)
World

1,931

2,153

1,061

1,489

Russia

217

339

545

854

362

366

185

161

1,034

914

227

107

United ArabEmirates
CanadaChina: Sugar Beet Pulp Imports (HS 230320)
Quantity (1,000 Tons)
Partner Country
2020
2021
2022
World
165
404
317
Egypt
106
350
256
Russia41
37
55
Ukraine
18
17
6

36

2023 (Jan-Aug)
263
133
126
3

No.

1

2

3

4

5

6

7

8

Appendix 2: Biotech Crops Approved for Import as Processing Materials
Event
Approval
IssuedDeveloper
Date
Trans bar, barnase and barstar genes
tolerant to herbicides, improved canola September 28, 2023
BASF
MS11
Trans- 2mepsps and hppdPfW336-1Pa
gene herbicide tolerant cotton GHB811 January 5, 2023
BASF
(new approval in January 2023)
Trans- dmo and bar gene herbicide
tolerant cotton MON88701 (new January 5, 2023
Bayer CropScience
approval in January 2023)
Trans- aad-12 gene herbicide tolerantcotton DAS-81910-7 (new approval in January 5, 2023
Corteva
January 2023)
Trans-c gat4621gene herbicide tolerant
Pioneer International Seed
Canola DP73496 (new approval in January 5, 2023
Company*
January 2023)
Trans- cry1Ab gene insect resistantBrazilian Sugar Cane Technology
sugarcane H7-1 CTC175-A (new January 5, 2023
Centerapproval in January 2023)
Trans- cry1Ab gene insect resistantBrazilian Sugar Cane Technology
sugarcane CTC91087-6 (new approval January 5, 2023
Centerin January 2023)
Trans- cp4epsps gene herbicide tolerant
alfalfa J101 (new approval in January January 5, 2023
Bayer CropScience Land O’ Lakes
2023)

37

Biosafety certificate validity
Sept. 28, 2023-Sept. 27,
2028
Jan. 5, 2023-Jan.4, 2028

Jan. 5, 2023-Jan.4, 2028

Jan. 5, 2023-Jan.4, 2028

Jan. 5, 2023-Jan.4, 2028

Jan. 5, 2023-Jan.4, 2028

Jan. 5, 2023-Jan.4, 2028

Jan. 5, 2023-Jan.4, 2028

9Trans- cp4epsps gene herbicide tolerant
alfalfa J163 (new approval in January January 5, 2023
2023)

Jan. 5, 2023-Jan.4, 2028
Bayer CropScience Land O’ Lakes

10

HaHB4 genetically resistant soybean
April 22, 2022
IND-ØØ41Ø-5

Rosario Agricultural Biotechnology
Apr. 22, 2022-Apr.21, 2027
Institute Inc. (Bioceres)

11

Transgenic cp4epsps Herbicide Tolerant
August 28, 2008
Soybean MON89788 (renewal)

Bayer CropScience

Apr. 22, 2022-Apr.21, 2027

12

Transgenic Insect-Resistant Soybean
DAS-81419-2 (renewal)

December 2, 2019

Corteva

Apr. 22, 2022-Apr.21, 2027

13

Transgenic improves soybean quality
traits 305423 (renewal)

November 3, 2011

Corteva

Apr. 22, 2022-Apr.21, 2027

14

Herbicide-tolerantsoybeanDecember 11, 2014
305423×GTS40-3-2 Advance (renewal)

Corteva

Apr. 22, 2022-Apr.21, 2027

15

Herbicide Tolerant Soybean A5547-127
December 11, 2014
(renewal)

BASF

Apr. 22, 2022-Apr.21, 2027

16

Herbicide Tolerant Corn T25 (renewal) April 6, 2004

BASF

Apr. 22, 2022-Apr.21, 2027

17

Herbicide-tolerant sugar beet H7-1
(renewal)

April 20, 2009

Bayer CropScience
Kowalsch Seeds Europe AG

Apr. 22, 2022-Apr.21, 2027

18

Herbicide tolerant oilseed Canola
Ms8Rf3 (renewal)

April 6, 2004

BASF

Apr. 22, 2022-Apr.21, 2027

19

Herbicide-tolerant Canola T45 (renewal) April 6, 2004

BASF

Apr. 22, 2022-Apr.21, 2027

20

Terbicide-tolerant Canola Oxy-235(renewal)

BASF

Apr. 22, 2022-Apr.21, 2027

21

Insect resistant corn MON810(renewal) February 20, 2004

Bayer CropScienceDec.17, 2021 - Dec.16, 2026

April 6, 2004

38

22
23
24
25
26
27
28
29
30
31
32
33

Drought Tolerant corn MON87460
May 21, 2013
(renewal)
Insect resistant and herbicide tolerance
December 20, 2007
corn MON88017 (renewal)
Insect resistant corn MON89034
December 30, 2010
(renewal)
Herbicide tolerant corn NK603
July 8, 2005
(renewal)
Herbicide tolerant soybean GTS40-3-2
February 20, 2004
(renewal)
Insect resistant soybean MON 87701
June 6, 2013
(renewal)
Quality-Improved Soybean MON 87769
December 31, 2015
(renewal)
Insect resistant soybean MON87701 x
June 6, 2013
MON89788 (renewal)
Herbicide tolerant Soybean MON 87708
December 31, 2015
(renewal)
Herbicide tolerant Canola GT73
(renewal)

April 6, 2004

Herbicide tolerant canola MON 88302
December 20, 2018
(renewal)
Pest resistant and herbicide tolerant corn
December 20, 2018
DP4114 (renewal)

Bayer CropScienceDec.17, 2021 - Dec.16, 2026

Bayer CropScienceDec.17, 2021 - Dec.16, 2026

Bayer CropScienceDec.17, 2021 - Dec.16, 2026

Bayer CropScienceDec.17, 2021 - Dec.16, 2026

Bayer CropScienceDec.17, 2021 - Dec.16, 2026

Bayer CropScienceDec.17, 2021 - Dec.16, 2026

Bayer CropScienceDec.17, 2021 - Dec.16, 2026

Bayer CropScienceDec.17, 2021 - Dec.16, 2026

Bayer CropScienceDec.17, 2021 - Dec.16, 2026

Bayer CropScienceDec.17, 2021 - Dec.16, 2026

Bayer CropScienceDec.17, 2021 - Dec.16, 2026

Corteva AgriscienceDec.17, 2021 - Dec.16, 2026

34

Insect resistant corn 59122 (renewal)

December 20, 2006

Corteva AgriscienceDec.17, 2021 - Dec.16, 2026

35

Insect resistant corn TC1507 (renewal)

April 6, 2004

Corteva AgriscienceDec.17, 2021 - Dec.16, 2026

36

Herbicide tolerant Soybean CV127

June 6, 2013

BASF AgriChem

Dec.17, 2021 - Dec.16, 2026

39

(renewal)
37
38
39
40

Herbicide tolerant soybean A2704-12(renewal)
Herbicide tolerance soybean DAS44406-6 (renewal)
Herbicide tolerant Canola Ms1Rf1(renewal)
Herbicide tolerant Canola Ms1Rf2(renewal)

December 20, 2007

BASF Seed

Dec.17, 2021 - Dec.16, 2026

December 20, 2018

Corteva AgriscienceDec.17, 2021 - Dec.16, 2026

April 6, 2004

BASF Seed

Dec.17, 2021 - Dec.16, 2026

April 6, 2004

BASF Seed

Dec.17, 2021 - Dec.16, 2026

41

Herbicide tolerant canola RF3 (renewal) December 20, 2018

BASF Seed

Dec.17, 2021 - Dec.16, 2026

42

Herbicide tolerant Canola Topas19/2
April 6, 2004
(renewal)

BASF Seed

Dec.17, 2021 - Dec.16, 2026

43

Insect resistant corn Bt11 (renewal)

April 6, 2004

Syngenta Crop Protection

Dec.17, 2021 - Dec.16, 2026

44

Insect resistant corn BT176 (renewal)

April 6, 2004

Syngenta Crop Protection

Dec.17, 2021 - Dec.16, 2026

45

Herbicide resistant corn GA21 (renewal) February 20, 2004

Syngenta Crop Protection

Dec.17, 2021 - Dec.16, 2026

46

Quality improved corn 3272 (renewal)

May 21, 2013

Syngenta Crop Protection

Dec.17, 2021 - Dec.16, 2026

47

Insect resistant corn MIR604(renewal)

August 28, 2008

Syngenta Crop Protection

Dec.17, 2021 - Dec.16, 2026

48

Herbicide tolerance soybean SYHT0H2
December 20, 2018
(renewal)

Syngenta Crop Protection, BASF
Seed

Dec.17, 2021 - Dec.16, 2026

49

Herbicide tolerant corn FG72(renewal)

Syngenta Crop Protection

Dec.17, 2021 - Dec.16, 2026

50

Pest resistant and herbicide tolerant corn
December 29, 2020
MON87411 (renewal)
Pest resistant and herbicide tolerant corn
December 29, 2020
MZIR098 (renewal)

Bayer CropScience

Dec. 29, 2020-Dec. 28, 2025

Syngenta Crop Protection

Dec. 29, 2020-Dec. 28, 2025

Beijing DaBeiNong Biotechnology

Jun. 11, 2020-Jun. 11, 2025

51
52

Soybean DBN-09004-6 (renewal)

December 31, 2016

Jun. 11, 202040

Co., Ltd.
53
54

Insect-Resistant soybean MON87751(renewal)
Herbicide-tolerant corn MON87427(renewal)

55

Jun. 11, 2020

Monsanto Far East Ltd.

Jun. 11, 2020-Jun. 11, 2025

July 16, 2017

Monsanto Far East Ltd.

Jun. 11, 2020-Jun. 11, 2025

Virus Resistant Papaya 55-1

USDA ARS,
U.S. Pacific Basin Agricultural
December 2, 2019
Research Center,
University of Hawaii

Dec. 02, 2019-Dec. 02, 2022

56

Improved quality soybean MON87705(renewal)

June 12, 2017

Monsanto Far East Ltd.

June 11, 2020-June 11, 2025

57

Herbicide resistant corn DAS-40278-9(renewal)

June 12, 2017

Dow AgroSciences

June 11, 2020-June 11, 2025

58

Insect resistance and herbicide tolerance
November 3, 2011
corn Bt11×GA21 (renewal)

Syngenta Crop Protection

June 11, 2020-June 11, 2025

59

Insect resistance corn MIR162 (renewal) December 11, 2014

Syngenta Crop Protection

June 11, 2020 – June 11, 2025

60

Insect resistant corn 5307 (renewal)

July 16, 2017

Syngenta Crop Protection

June 11, 2020 – June 11, 2025

61

Insect resistant cotton DAS-24236-5(new approval in December 2021)
Insect resistant cotton DAS-21023-5(new approval in December 2021)

December 17, 2021

Corteva Agriscience

Dec. 17, 2021-Dec. 16, 2026

December 17, 2021

Corteva AgriscienceDec.17, 2021-Dec. 16, 2026

63

Herbicide tolerant cotton 1445 (renewal) February 20, 2004

Bayer CropScienceDec.17, 2021 - Dec.16, 2026

64

Herbicide tolerant Flex cotton MON
88913 (renewal)

December 20, 2007

Bayer CropScienceDec.17, 2021 - Dec.16, 2026

65

Insect resistant cotton 531(renewal)

February 20, 2004

Bayer CropScienceDec.17, 2021 - Dec.16, 2026

66

Insect resistant cotton 15985 (renewal)

July 20, 2006

Monsanto Far East Ltd.

Dec. 02, 2019-Dec. 02, 2024

62

41

67
68
69
70
71
72

Herbicide tolerant cotton GHB614
December 30, 2010
(renewal)
Insect resistant cotton COT102
December 31, 2015
(renewal)
Herbicide tolerant cotton LLCotton25
December 20, 2006
(renewal)
Insect resistant and herbicide tolerant
April 10, 2014
cotton GHB119 (renewal)
Insect resistant and herbicide tolerant
April 10, 2014
cotton T304-40 (renewal)
Insect resistant corn MON863 (renewal) June 25, 2004

73

BASF

Dec. 29, 2020-Dec. 28, 2025

Syngenta Crop Protection

Dec. 29, 2020-Dec. 28, 2025

BASF

Dec. 29, 2020-Dec. 28, 2025

BASF

Jan. 5, 2023-Jan.4, 2028

BASF

Jan. 5, 2023-Jan.4, 2028

Monsanto

Certificate expired

Herbicide resistant soybean 356043
December 30, 2010
DuPontCertificate expired(renewal)
Note: Due to mergers and acquisitions of developers, the owner of some of the certificates may have changed

42Appendix 3: Biotech Crops Approved for Cultivation(Rice, Corn, Soybean and Papaya, excluding Cotton)
No.

1

Event

Developer

Insect resistant rice Hua Hui Hua Zhong Agriculture
1
University

2

Insect resistant rice XianYou 63

Hua Zhong Agriculture
University

3

Biotech Research Institute of
Phytase Corn BVLA430101 China Academy ofAgricultural Sciences
South China Agriculture
University

Ecological Zone

Biosafety certificate validity

Hubei Province

August 17, 2009 – August 17, 2014
(renewed in 2014; expired in 2019;
renewed in 2021: Feb. 10, 2021-Feb. 9,2026)

Hubei Province

August 17, 2009 – August 17, 2014
(renewed in 2014; expired in 2019;
renewed in 2021: Feb. 10, 2021-Feb. 9,
2026)

Shandong Province

August 17, 2009 – August 17, 2014
(renewed in 2014; expired in 2019)

Guangdong Province (expanded
to South China since 2010)

July 20, 2006, renewed in 2010, 2015
and 2020; current certificate valid forDec. 29, 2020-Dec. 28, 2025

4

Virus resistant Papaya

5

Pest resistant and herbicide
tolerant corn DBN9936

Beijing DaBeiNong
Biotechnology Co., Ltd.

North China spring corn area

Dec. 2, 2019 – Dec. 2, 2024

6

Pest-resistant and herbicide
tolerant corn Ruifeng 125(former Shuangkang 12-5)

Hangzhou Ruifeng
Biotechnology Co., Ltd. andZhejiang University

North China spring corn area

Dec. 2, 2019 – Dec. 2, 2024

7

Pest-resistant and herbicide
tolerant corn Ruifeng 125

Hangzhou Ruifeng
Biotechnology Co. Ltd.

Summer corn area covering the
Yellow River, Huaihe River,
Haihe River region

Feb. 10, 2021-Feb. 9, 2026

Pest-resistant and herbicide
tolerant corn Ruifeng 125

Hangzhou Ruifeng
Biotechnology Co.

Northwest corn area

Feb. 10, 2021-Feb. 9, 2026

8

43

9

Herbicide-resistant soybean
Shanghai Jiaotong University
SHZD32-01

South China soybean area

Dec. 2, 2019 – Dec. 2, 2024

10

Herbicide-tolerant corn
DBN 9858

Beijing DaBeiNong
Biotechnology Co., Ltd.

North China spring corn area

Jun. 11, 2020 – June 11, 2025

11

Herbicide-tolerant
Zhonghuang 6106

soybean Crop Science Institute of
CAAS

Huanghuaihai summer soybean
areaJun. 11, 2020 – June 11, 2025

12

Herbicide-tolerant
Zhonghuang 6106

soybean Crop Science Institute of
CAAS

North China spring soy area

Feb. 10, 2021-Feb. 9, 2026

13

Herbicide-tolerant corn
DBN 9858

Beijing DaBeiNong
Biotechnology Co., Ltd.

Summer corn area covering the
Yellow River, Huaihe River,
Haihe River region

Dec. 29, 2020-Dec. 28, 2025

14

Herbicide-tolerant corn
DBN 9858

Beijing DaBeiNong
Biotechnology Co., Ltd.

South China corn area

15

Herbicide-tolerant corn
DBN 9858

Beijing DaBeiNong
Biotechnology Co., Ltd.

Southeast China corn area

16

Herbicide-tolerant corn
DBN 9858

Beijing DaBeiNong
Biotechnology Co., Ltd.

Northwest corn area

17

Pest resistant and herbicide
tolerant corn DBN 9936

Beijing DaBeiNong
Biotechnology Co., Ltd.

Summer corn area covering the
Yellow River, Huaihe River,
Haihe River region

18

Pest resistant and herbicide
tolerant corn DBN 9936

Beijing DaBeiNong
Biotechnology Co., Ltd.

South China corn area

19

Pest resistant and herbicide
tolerant corn DBN 9936

Beijing DaBeiNong
Biotechnology Co., Ltd.

Southeast China corn area

20

Pest resistant and herbicide Beijing DaBeiNong
tolerant corn DBN 9936
Biotechnology Co., Ltd.

Northwest corn area

44

Dec. 29, 2020-Dec. 28, 2025
Dec. 29, 2020-Dec. 28, 2025
Dec. 29, 2020-Dec. 28, 2025
Dec. 29, 2020-Dec. 28, 2025

Dec. 29, 2020-Dec. 28, 2025
Dec. 29, 2020-Dec. 28, 2025
Dec. 29, 2020-Dec. 28, 2025

21

Pest-resistant and herbicide Beijing DaBeiNong
tolerant corn DBN9501
Biotechnology Co., Ltd.

22

Herbicide tolerant soybean
DBN9004

Beijing DaBeiNong
Bioechnology Co., Ltd.

23

Pest resistant corn ND207(GMO formerly known as"2A-7")

China Forestry Seed Group
Co., Ltd.
North China spring corn area
China Agricultural University
China Forestry Seed Group
Summer corn area covering theCo., Ltd.
Yellow River, Huaihe River,
China Agricultural University
Haihe River region

24

25

26

27

Pest resistant corn ND207(GMO formerly known as"2A-7")
Pest resistant corn Zheda
Hangzhou Ruifeng
Ruifeng 8 (GMO formerly
Biotechnology Co.Ltd.
known as "GAB-3")
Pest resistant and herbicide Beijing DaBeiNong
tolerant corn DBN3601T
Bioechnology Co., Ltd.
(GMO formerly known as"DBN9936×DBN9501")
Herbicide resistant corn
Hangzhou Ruifeng
nCX-1 transgenic CdP450
Biotechnology Co., Ltd.
and cp4epsps

North China spring corn area

Dec. 29, 2020-Dec. 28, 2025

North China spring soybean area

Dec. 29, 2020-Dec. 28, 2025

Dec. 17,2021-Dec. 16. 2026

Dec. 17,2021-Dec. 16. 2026

South China corn area

Dec. 17,2021-Dec. 16. 2026

Southwest corn area

Dec. 17,2021-Dec. 16. 2026

South China corn area

Apr. 22, 2022-Apr.21, 2027

28

Pest resistant and herbicide
tolerant corn Bt11xGA21

China Seed Group Co., Ltd.

North China spring corn area

Apr. 22, 2022-Apr.21, 2027

29

Pest resistant and herbicide
tolerant corn
Bt11xMIR162xGA21

China Seed Group Co., Ltd.

South China corn area,
Southwest China corn area

Apr. 22, 2022-Apr.21, 2027

30

Hherbicide-tolerant corn
GA21

China Seed Group Co., Ltd.

North China spring corn area

Apr. 22, 2022-Apr.21, 2027

North Spring Corn Area

Jan. 5, 2023-Jan.4, 2028

Yuanlongping Agricultural
Trans- cry1Ab, cry1F and31 cp4epsp gene insect-resistant High Technology Company;and herbicide tolerant corn Institute of Biotechnology,45

BFL4-2 (new approval in
January 2023)

Chinese Academy ofAgricultural Sciences

Trans- maroACC gene
China Forestry Seed Group
North Spring Corn Area
herbicide tolerant corn CC-2 Co., Ltd.
32
(new approval in January
China Agricultural University
2023)
Trans- cry1Ab/vip3Da gene Shanghai Academy ofSouth Soybean Area
insect-resistant soybean
Agricultural Sciences
33
CAL16 (new approval in
January 2023)
Trans-mvip3Aa and pat
Beijing Dabeinong
Huanghuaihai Summer Soybean
Biotechnology Co., Ltd.
Area
genes insect resistant and
34 herbicide tolerance soybean
DBN8002(new approval in
April 2023)

No.

Event

1

Mutations gmfad2-1a andgmfad2-1b genes improve
quality in soybean AE1518-1

Jan. 5, 2023-Jan.4, 2028

Jan. 5, 2023-Jan.4, 2028

Apr. 21, 2023-Apr.20, 2028

Appendix 4: Gene-Edited Events Approved for Cultivation/Production(Rice, Corn, Soybean and Papaya, excluding Cotton)
Developer
Ecological Zone
Biosafety Certificate Validity

Shandong Shunfeng
Biotechnology Co., Ltd.

/

Apr. 21, 2023-Apr.20, 2028

Attachments:
No Attachments

46