- Fruit
- Edible Oil
- Stuffed Pasta
- Crops Grains Oilseeds and Rice
- Grain Milling and Malt
- Vegetable Dried Beans
- Natural Plant Spices
- Nuts and Seeds
- Dried Fruits
- Unroasted coffee&cocoa beans
- Special Dietary Foods
- Functional foods
- Eggs and egg products
- Meat and meat products
- Aquatic products
- Aquatic Animals
- Dairy
- Casings
- Bird's Nest
- Bee products
- GMO
- Non-edible animal products
- Chinese herbal medicine
- Self-registration
- GACC Evaluates CA
- Cotton Supplier Registration
GMO
Agricultural genetically modified organisms (GMOs) refer to plants, animals, microorganisms and their products whose genome composition are modified by genetic engineering technology for agricultural production or agricultural product processing, mainly including:
(1) Genetically modified animals and plants (including seeds, species of livestock and poultry, aquatic seedlings) and microorganisms;
(2) Genetically modified animal, plant and microbial products;
(3) Directly processed products of genetically modified agricultural products;
(4) Seeds, breeding livestock and poultry, aquatic seedlings, pesticides, veterinary drugs, fertilizers, additives and other products containing genetically modified animals, plants, microorganisms or components of their products.
Agricultural genetically modified plants are plants and their products whose genome composition are modified by genetic engineering technology for agricultural production or agricultural product processing. Genetically modified (GM) traits: including improved yield traits, improved quality traits, improved physiological traits, improved heterosis, stress resistance, disease resistance, insect resistance, herbicide resistance, bioreactors, etc. Wherein, improved yield traits refer to improved plant height, plant type, grain quantity, grain size, quantity of cotton bolls, etc.; improved quality traits refer to the improved starch composition, protein composition, trace element content, glucosinolate content, erucic acid content, saturated fatty acid content, fiber quality, oil content, etc.; improved physiological traits refer to improved growth period, photosynthetic efficiency, nutrient utilization rate, seed storage activity, root activity, etc.; improved heterosis refers to male sterility, fertility recovery and improved fertility recovery ability; stress resistance refers to improved drought resistance, flood resistance, cold resistance, salt tolerance, etc.
Imported agricultural GMOs are managed according to three purposes: for research and testing, for production, and as raw materials for processing. It shall be noted that agricultural GM edited plants introducing exogenous genes and gene edited plants without introducing exogenous genes have different requirements for application materials and stage requirements when applying for import as raw materials or agricultural GMO safety certificate for application in production.Mainly aim at agricultural GMOs used as raw materials for processing and direct consumer goods, such as: insect-resistant and herbicide-tolerant soybean, rape, corn, cotton, sugar beet, sugarcane, alfalfa, cassava, papaya, pumpkin, etc.
Where an overseas company exports agricultural GMOs to the People's Republic of China for being used as raw materials for processing, it shall apply to the Ministry of Agriculture and Rural Affairs for the agricultural GMO safety certificate. After receiving the application, the Ministry of Agriculture and Rural Affairs shall organize the Agricultural GMO Safety Committee to conduct safety evaluation, and entrust technical testing institutions with testing conditions and capabilities to carry out testing; If the overseas company passes the safety evaluation, it will be issued with the agricultural GMO safety certificate only after the approval of the Ministry of Agriculture and Rural Affairs.
Information required for first time application for agricultural GMO Safety Certificate (Import) by overseas R&D Providers:
1. Application Form for Agricultural GMO Import Safety Certificate. (Self-prepared by the Applicant)
2. Declaration Form for Safety Evaluation of Agricultural GMO in accordance with the requirements of the Guidelines for Safety Evaluation of Agricultural GMOs.(Self-prepared by the Applicant)
3. Safety level of the agricultural GMO and the basis for determining the safety level. (Self-prepared by the Applicant)
4. Materials that the exporting country or region has allowed to be used for corresponding purposes and put on the market. (Self-prepared by the Applicant)
5. Materials that have been proved by scientific tests in the exporting country or region to be harmless to human beings, animals, plants, microorganisms and the ecological environment. (Self-prepared by the Applicant)
6. Agricultural GMO samples and control samples as required. (Self-prepared by the Applicant)
7. Test reports issued by technical testing institutions entrusted by the Ministry of Agriculture and Rural Areas with testing conditions and capabilities (directly submitted by technical testing institutions to the Ministry of Agriculture and Rural Areas). (Self-prepared by the Applicant)
8. Publicly available safety evaluation data. For safety evaluation data that cannot be disclosed, a statement should be provided and the reasons and basis should be fully explained. Genes, components, technologies, data, etc. that have been disclosed through papers, patents (applications), etc., shall not be withheld under the pretext of technical or commercial secrets. (Self-prepared by the Applicant)
Genetically edited plants for agricultural use refer to plants and their products obtained by targeted modification of specific loci in the genome using genetic engineering technology for agricultural production or agricultural product processing. Information required by overseas R&D providers of genetically edited plants without introducing exogenous genes to apply for safety certificate of agricultural genetically modified organisms (import) :
(1) Provide a comprehensive safety evaluation report.
(2) Provide information on the molecular characteristics of gene-edited plants, including target gene editing, carrier sequence residue and off-target.
(3) Provide specific detection data of gene-edited plants.
(4) Provide environmental safety assessment and food safety assessment data. (Based on the specific risks that may arise)
(5) Information that has been proved by scientific tests to be harmless to human beings, animals, plants, microorganisms and the ecological environment in the exporting country or region.
Purpose of safety certificate: To create compliance conditions for overseas traders to apply for Agricultural GMO Safety Certificate (Import).
China has issued the list of "Safety Certificate for Agricultural GMOs (Import)" for overseas R&D manufacturers as follows:
2020 Agricultural GMO Safety Certificate (Import) Approval List (I)
2020 Agricultural GMO Safety Certificate (Import) Approval List (II)
2021 Agricultural GMO Safety Certificate (Import) Approval List
2022 Agricultural GMO Safety Certificate (Import) Approval List (1)
2022 Agricultural GMO Safety Certificate (Import) Approval List (II)
Mainly aim at agricultural GMOs used as raw materials for processing, such as: insect-resistant and herbicide-resistant soybean, rape, corn, cotton, beet, sugar cane, alfalfa, cassava, papaya, pumpkin and so on.
Where agricultural genetically modified organisms are imported for production or used as raw materials for processing, the contract can only be signed after obtaining the agricultural GMO safety certificate issued by the Ministry of Agriculture and Rural Affairs.
To export agricultural GMOs to China, the overseas company shall, based on the Agricultural GMO Safety Certificate and relevant approval documents issued by the competent department of agricultural administration under The State Council, report to the entry-exit inspection and quarantine authority at the port for inspection; Only after passing the quarantine inspection can an application be made to the Customs to go through the relevant formalities.
If an agricultural GMO is imported without an agricultural GMO safety certificate and relevant approval documents issued by the competent department of agricultural administration under The State Council, or if it does not conform to the certificate or approval documents, it shall be returned or destroyed.
Overseas traders apply for Agricultural GMO Safety Certificate (Import)
(I) To be used as raw materials for processing:
1. Registration Form for Import Safety Management of Agricultural Genetically Modified Organisms (Used as raw materials for Processing) (original). (Self-prepared by the applicant)
2. Agricultural GMO Safety Certificate (Import) issued by the Ministry of Agriculture and Rural Affairs (photocopy). (Self-prepared by the applicant)
3. Corresponding safety management and preventive measures (original). (Self-prepared by the applicant)
4. If an overseas trader exports an agricultural GMO transformation from a certain country or region to China for the first time, it shall provide a license document that the exporting country or region has allowed such agricultural GMO transformation to be used for the corresponding purpose and put on the market (official documents and Chinese translation are required), except for those that the overseas R&D provider has provided in the import safety evaluation process.
5. Those importing GM soybeans may apply for use in trade and physical delivery of futures on the premise that the final use of the commodity is raw material for processing, and tick "raw material for processing" (for trade and physical delivery of futures) in the column of "Commodity Use" in the Registration Form for Import Safety Management of Agricultural GMOs.
(II) Direct Use as Consumer Goods
1. Registration Form for Import Safety Management of Agricultural Genetically Modified Organisms (Direct Use as Consumer Goods) (original). (Self-prepared by the applicant)
2. Agricultural GMO Safety Certificate (Import) issued by the Ministry of Agriculture and Rural Affairs. (Self-prepared by the applicant)
3. Corresponding safety management and preventive measures (original). (Self-prepared by the applicant)
4. If an overseas trader exports an agricultural GMO transformation from a certain country or region to China for the first time, it shall provide the license that the exporting country or region has allowed such agricultural GMO transformation to be used for corresponding purposes and put on the market (official documents and Chinese translation are required). Except for those provided by overseas R&D Providers in the process of import safety evaluation.
After the application has been approved, when applying again to the People's Republic of China, if the applicant meets the conditions of the same company and the same agricultural GMO, the application procedures for safety evaluation may be simplified and the following materials shall be provided: (1) Registration Form for Import Safety Management (see Annex); (2) A copy of the agricultural GMO safety certificate issued for the first time by the Ministry of Agriculture and Rural Affairs; (3) Safety precautions to be taken by the overseas company in the process of exporting to the People's Republic of China.
After passing the examination, the Ministry of Agriculture and Rural Affairs will issue the agricultural GMO safety certificate (import).
Application principles: One-batch-one-certificate, valid for 6 months.
Purpose of safety certificate: Making the holder qualified for direct export of agricultural GM products to China and it a necessary procedure for customs declaration and inspection.
The consignor or his agent shall indicate whether the products are genetically modified products in the "Commodity Name" column of the Entry Declaration Form when handling the entry declaration formalities. For the declaration of GM products, in addition to providing relevant documents as required, the Agricultural GMO Safety Certificate issued by the competent authorities as required by laws and regulations or relevant approval documents shall also be obtained. The Customs will automatically compare and check the electronic data of the Agricultural GMO Safety Certificate. For imported genetically modified products listed in the Catalogue of Agricultural GMOs Subject to Labeling Administration, the Customs shall carry out compliance test of GM items if they are declared to be genetically modified, and shall carry out random test of GM items if they are declared to be non-genetically modified.
The companies that have obtained the "Agricultural GMO Safety Certificate (Import)" from overseas traders and are active in exporting GMO products are as follows:
TGO TRADING (SINGAPORE) PTE.LTD
DDT HOLDINGS PTY LTD
CL Commodities Pty Ltd
Scents Cereals & Oils (H.K.) Limited
Gavilon China (HK) Limited
COFCO TRADING (HONG KONG) LIMITED
INTOP INTERNATIONAL (SINGAPORE) PTE. LTD.
RICH STRONG INTERNATIONAL LIMITED
HONGKONG PLENTIFUL TAY CO., LIMITED
SINGAPORE JY SUPPLY CHAIN MANAGEMENT PTE. LTD.
CARGILL INTERNATIONAL SA
NORAG LLC
The Delong Co., Inc.
Robinson Grain Trading Co PTY LTD
POINTER INVESTMENT (HONG KONG) LTD
Edible Oil Co (D) (L.L.C)
HONGKONG NATURAL RESOURCES TRADING COMPANY LIMITED
Al Ghurair Resources Oils & Proteins L.L.C.
HANG TUNG RESOURCES LIMITED
The Andersons Inc.
CJ International Asia Pte. Ltd.
BUNGE S.A.
Cutrale Trading Brasil LTDA
CNCGC Australian Pty Ltd
MITSUI&CO.(ASIA PACIFIC)PTE.LTD.
BEANGO INTERNATIONAL LIMITED
CJS TRADING CO.
ADM Asia-Pacific Trading Pte. Ltd.
WILMAR TRADING(ASIA)PTE.LTD.
TOP POINT INTERNATIONAL INC.
HAMLET PROTEIN A/S
Triple A A/S
OLAM GLOBAL AGRI PTE.LTD.
C&D (USA) INC.
BTG Pactual Commodities (CH) SA
Frey P/S
BG SINGAPORE INTERNATIONAL TRADING PTE.LTD.
SANYOU INTERNATIONAL PTY LTD
Perdue Agribusiness LLC
New Hope Singapore Pte. Ltd.
Sierentz&Cie SARL
Crownton Grain Company Limited
CHS INC.
ZEN-NOH GRAIN CORPORATION
Viterra B.V.
Louis Dreyfus Company Suisse SA
Corvalis Agriculture Pty Ltd
TALLGRASS COMMODITIES LLC
Golden Agri International Pte.Ltd.
Northwest Grains International, LLC
TOYOTA TSUSHO CORPORATION
QUEENSLAND COTTON CORPORATION PTY LTD
NAMOI COTTON LIMITED
Richardson International Limited
HONGKONG TOPWAY TRADING Co., LIMITED
XIANG LIANG INDUSTRIAL CO., LIMITED
Chester Commodities Pty Ltd
Agrex Inc.
BOHI (HK) TRADING CO., LIMITED
ThriveAgri Pty Ltd
THE SCOULAR COMPANY
Farmers Feed Mill, Inc., USA
WISDOM (HK) TRADING CO., LIMITED
POSCO INTERNATIONAL CORPORATION
ZINPRO ANIMAL NUTRITION (INTERNATONAL) INC.
STEP INDUSTRIAL HOLDING PTE.LTD.
AMAGGI SA
Joosten Products B.V.
……
Where an overseas company intends to export genetically modified plant seeds, breeding livestock and poultry, and aquatic seedings, as well as plant seeds, breeding livestock and poultry, aquatic seedlings, pesticides, veterinary drugs, fertilizers and additives manufactured from agricultural GMOs or containing agricultural GMO ingredients to the People's Republic of China for application in production, it shall file an application with the Ministry of Agriculture and Rural Affairs.
When making the above application, the overseas company shall apply before the beginning of the intermediate test, and the test materials shall only be allowed to entry after being approved, and then go through the three test stages namely intermediate test, environmental release test, production test and the stage of applying for agricultural GMO safety certificate.
After passing the examination of the application in the intermediate test stage, the Ministry of Agriculture and Rural Affairs shall issue an approval document for the import of agricultural GMOs, and the overseas company shall go through relevant procedures with the approval document according to law. The Ministry of Agriculture and Rural Affairs shall issue an approval letter for the safety of agricultural GMOs after the application in the stage of environmental release and productive test has passed the safety evaluation, and the overseas company shall go through relevant formalities with the relevant departments according to law. After the application for safety certificate passes the safety evaluation, the Ministry of Agriculture and Rural Affairs shall issue the agricultural GMO safety certificate, and the overseas company shall go through relevant procedures with the certificate according to law.
Where imported test materials are used for conducting intermediate tests, environmental release and productive tests, the following materials shall be provided:
1. Registration Form for Import Safety Management of Agricultural GMOs (for entry of materials). (Self-prepared by the applicant)
2. Materials that have been allowed to be put on the market for the corresponding use in the exporting country or region. (Self-prepared by the applicant)
3. Materials that have been proved harmless to human beings, animals, plants, microorganisms and the ecological environment by scientific tests in the exporting country or region. (Self-prepared by the applicant)
4. Materials required for the corresponding stages stipulated in the Administrative Measures for Safety Evaluation of Agricultural GMOs. (Self-prepared by the applicant)
5. Description of safety precautions in the process of import. (Self-prepared by the applicant)
Where an overseas company exports agricultural GMOs to the People's Republic of China as raw materials for processing, and a safety test on using imported materials in agricultural GMOs is required, it shall provide the following materials:
1. Registration Form for Import Safety Management of Agricultural GMOs (for entry of materials). (Self-prepared by the applicant)
2. Materials that have been allowed to be put on the market for the corresponding use in the exporting country or region. (Self-prepared by the applicant)
3. Materials that have been proved harmless to human beings, animals, plants, microorganisms and the ecological environment by scientific tests in the exporting country or region. (Self-prepared by the applicant)
4. The Agricultural GMO Safety Assessment Declaration and testing methods to be provided according to the requirements of the Guidelines for Safety Assessment of Agricultural GMOs. (Self-prepared by the applicant)
5. Description of safety precautions in the process of import. (Self-prepared by the applicant)
Genetically edited plants for agricultural use refer to plants and their products obtained by targeted modification of specific loci in the genome using genetic engineering technology for agricultural production or agricultural product processing. The following information are required by an overseas R&D provider of gene edited plants without introducing exogenous genes when applying for agricultural GMO safety certificate (application in production):
(1) Summarize the data of previous trial stages and provide a comprehensive safety evaluation report. (2) Provide genetic stability data for at least 3 generations of gene-edited plants, including the stability of target gene editing and the stability of target trait expression. (3) Provide evaluation data of target traits and functional efficiency. (4) Provide specific detection data of gene-edited plants. (5) Provide environmental safety assessment and food safety assessment data. (Depending on the specific risks that may arise)
Before applying introduced agricultural GMOs in production, an agricultural GMO safety certificate shall be obtained in order to go through the procedures of examination and approval, registration or evaluation and approval in accordance with relevant laws and administrative regulations on seeds, breeding livestock and poultry, aquatic seedlings, pesticides, veterinary drugs, fertilizers and additives. (Such as variety certification certificates of genetically modified plant seeds, livestock and poultry, aquatic seedlings, imported pesticide registration certificate, imported fertilizer registration certificate, imported food/feed additive registration certificate, imported new veterinary medicine registration certificate and production license and operation certificate, etc.)
Purpose of Safety Certificate:
1. Pre-formalities for administrative examination and approval of variety certification certificates of genetically modified plant seeds, livestock and poultry, aquatic seedlings, imported pesticide registration certificate, imported fertilizer registration certificate, imported food/feed additive registration certificate, imported new veterinary medicine registration certificate and other qualifications, creating compliance conditions for large-scale application of products.
2. Customs declaration and inspection procedures must be carried out for the import of genetically modified products after registration or approval.
3. Necessary procedures an importer must go through for applying for Quarantine Permit for Imported Animals and Plants.
4. Necessary procedures for applying for Documents for Labeling, Examination, Recognition and Approval of Agricultural GMOs, such as some plant seeds in the Catalogue of Agricultural GMOs Subject to Labeling Administration.
It has obtained the list of "Agricultural GMO Safety Certificate (Production and Application)" from overseas research and development manufacturers
NO. |
Approval Number |
Company Name |
Project Name |
valid |
1 |
农基安证字(2018)第044号(续申请) |
英特威国际有限公司 |
重组苜蓿银纹夜蛾核型多角体病毒AcMNPV(pAcAS3-ORF2)表达的猪圆环病毒2型ORF2蛋白基因工程亚单位疫苗生产应用的安全证书(续申请) |
2018年12月20日至 2023年12月20日 |
2 |
农基安证字(2020)第022号(续申请) |
英特威国际有限公司 默沙东(宁波)动物保健科技有限公司 |
缺失Tk和gE基因的猪伪狂犬病病毒疫苗BegoniaΔTK/ΔgE生产应用的安全证书 |
2020年6月11日至 2025年6月11日 |
3 |
农基安证字(2020)第019号(续申请) |
丹尼斯克美国有限公司 |
重组李氏木霉MorphΔE8BP174c表达的植酸酶生产应用的安全证书 |
2020年6月11日至 2025年6月11日 |
4 |
农基安证字(2020)第020号(续申请) |
丹尼斯克美国有限公司 |
重组李氏木霉Morph-Y5#2表达的木聚糖酶生产应用的安全证书 |
2020年6月11日至 2025年6月11日 |
5 |
农基安证字(2020)第015号(续申请) |
美国诗华-百妙动物保健公司 |
表达鸡新城疫病毒F基因的重组马立克氏病毒活载体疫苗VectormuneHVTNDV生产应用的安全证书 |
2020年6月11日至 2025年6月11日 |
6 |
农基安证字(2020)第016号(续申请) |
美国诗华-百妙动物保健公司 |
表达禽流感病毒HA基因的重组马立克氏病毒活载体疫苗VectormuneHVTAIV生产应用的安全证书 |
2020年6月11日至 2025年6月11日 |
7 |
农基安证字(2020)第013号(续申请) |
法国诗华动物保健公司 |
表达鸡毒支原体病毒40K和mgc3基因的重组鸡痘病毒活载体疫苗VectormuneFP-Mg生产应用的安全证书 |
2020年6月11日至 2025年6月11日 |
8 |
农基安证字(2020)第014号(续申请) |
法国诗华动物保健公司 |
表达鸡传染性喉气管炎病毒gB和UL32基因的重组鸡痘病毒活载体疫苗VectormuneFP-LT生产应用的安全证书 |
2020年6月11日至 2025年6月11日 |
9 |
农基安证字(2020)第010号 |
德国勃林格殷格翰动物保健有限公司 |
缺失Npro和Erns基因的牛病毒性腹泻病毒1型弱毒疫苗BVDV-1-KE-9-ΔNpro/ΔErns生产应用的安全证书 |
2020年6月11日至 2025年6月11日 |
10 |
农基安证字(2020)第011号 |
德国勃林格殷格翰动物保健有限公司 |
缺失Npro和Erns基因的牛病毒性腹泻病毒2型弱毒疫苗BVDV-2-NY-93-ΔNpro/ΔErns生产应用的安全证书 |
2020年6月11日至 2025年6月11日 |
11 |
农基安证字(2020)第209号(续申请) |
丹尼斯克美国有限公司 |
重组地衣芽孢杆菌BML612-LATorilCAP75表达的α-淀粉酶生产应用的安全证书 |
2020年12月29日至 2025年12月28日 |
12 |
农基安证字(2020)第210号(续申请) |
丹尼斯克美国有限公司 |
重组枯草芽孢杆菌BG3600-1425-3D表达的蛋白酶生产应用的安全证书 |
2020年12月29日至 2025年12月28日 |
13 |
农基安证字(2020)第204号 |
诺维信公司 |
重组地衣芽孢杆菌S10-34zEK4表达的丝氨酸蛋白酶生产应用的安全证书 |
2020年12月29日至 2025年12月28日 |
14 |
农基安证字(2020)第205号 |
诺维信公司 |
重组地衣芽孢杆菌SJ10402表达的α-淀粉酶生产应用的安全证书 |
2020年12月29日至 2025年12月28日 |
15 |
农基安证字(2020)第206号 |
诺维信公司 |
重组米曲霉COls741表达的植酸酶生产应用的安全证书 |
2020年12月29日至 2025年12月28日 |
16 |
农基安证字(2020)第207号 |
诺维信公司 |
重组米曲霉JaL339表达的木聚糖酶生产应用的安全证书 |
2020年12月29日至 2025年12月28日 |
17 |
农基安证字(2021)第160号(续申请) |
英特威国际有限公司 默沙东(宁波)动物保健科技有限公司 |
表达鸡传染性喉气管炎病毒gD和gI基因的重组火鸡疱疹病毒活载体疫苗HVT/ILT-138生产应用的安全证书 |
2021年9月14日至 2026年9月13日 |
18 |
农基安证字(2021)第161号(续申请) |
英特威国际有限公司 默沙东(宁波)动物保健科技有限公司 |
表达鸡新城疫病毒F基因的重组火鸡疱疹病毒活载体疫苗HVT/NDV-F生产应用的安全证书 |
2021年9月14日至 2026年9月13日 |
19 |
农基安证字(2021)第158号 |
德国勃林格殷格翰动物保健有限公司 |
表达猫白血病病毒gag/pol(部分)和env基因的重组金丝雀痘病毒活载体疫苗vCP97安全证书 |
2021年9月14日至 2026年9月13日 |
20 |
农基安证字(2021)第354号(续申请) |
德国勃林格殷格翰动物保健有限公司 |
重组杆状病毒AcMNPV(pVL1392-ORF2)表达的猪圆环病毒Ⅱ型ORF2蛋白基因工程亚单位疫苗生产应用的安全证书 |
2021年12月17日至 2026年12月16日 |
21 |
农基安证字(2022)第093号 |
硕腾公司 |
表达鸡传染性法氏囊病病毒VP2基因重组火鸡疱疹病毒活载体疫苗HVT-IBD生产应用的安全证书 |
2023年1月5日至 2028年1月4日 |
Where agricultural GMOs of safety grade I and II are imported from outside the People's Republic of China for experimental research, the importing unit shall file an application with the Agricultural GMO Safety Administration Office, and after passing the examination, the Ministry of Agriculture and Rural Affairs shall issue the import approval document of agricultural GMOs. The importing unit shall go through relevant formalities with the relevant authorities according to law based on this approval document.
Where agricultural GMOs of safety levels III and IV are imported from outside the People's Republic of China for experimental research and agricultural GMOs of all safety levels are imported for intermediate test, the importing unit shall fill an application with the Ministry of Agriculture and Rural Affairs, and after passing the examination, the Ministry of Agriculture and Rural Affairs shall issue an approval document for the import of agricultural GMOs. The importing unit shall go through relevant formalities with the relevant departments according to law based on this approval document.
Where agricultural genetically modified organisms are introduced from outside the People's Republic of China for environmental release and production tests, the importing unit shall fill an application with the Ministry of Agriculture and Rural Affairs, and after passing the examination, the Ministry of Agriculture and Rural Affairs shall issue a safety approval letter for agricultural GMOs. The importing unit shall go through relevant formalities with relevant departments according to law based on this approval document. The materials required for the application of the approval letter for the safety of agricultural GMOs are as follows:
1. Application form for agricultural GMO test. (Self-prepared by the applicant)
2. The Agricultural GMO Safety Assessment Declaration to be provided according to the requirements of the Guidelines for Safety Assessment of Agricultural GMOs. (Self-prepared by the applicant)
3. Safety level of agricultural genetically modified organisms and the basis for determining the safety level. (Self-prepared by the applicant)
4. For the application of productive test, test reports issued by the technical testing institutions with testing conditions and capabilities shall be submitted as required; the agricultural samples, control samples and test methods shall be submitted as required. (Self-prepared by the applicant)
5. Description of corresponding research content, safety management and preventive measures. (Self-prepared by the applicant)
6. Summary report of the tests in the previous test stage. (Self-prepared by the applicant)
Where agricultural GMOs are imported from outside the People's Republic of China for experiments, the importing unit shall apply to the Ministry of Agriculture and Rural Affairs stage by stage starting from the intermediate test stage.
Where an overseas company intends to export genetically modified plant seeds, breeding livestock and poultry, and aquatic seedings, as well as plant seeds, breeding livestock and poultry, aquatic seedlings, pesticides, veterinary drugs, fertilizers and additives manufactured from agricultural GMOs or containing agricultural GMO ingredients to the People's Republic of China, it shall import test materials for conducting intermediate tests, environmental release and productive tests.
If an overseas company exports agricultural Gmos to the People's Republic of China as raw materials for processing, it is required to import the materials for safety testing of agricultural GMOs. Where agricultural genetically modified organisms are imported from abroad for research and experiment, the following materials shall be provided:
1. Registration Form for Import Safety Management of Agricultural GMOs (for entry of materials). (Self-prepared by the applicant)
2. Materials that the imported agricultural GMOs have been studied or tested overseas. (Self-prepared by the applicant)
3. Materials required for the corresponding stages stipulated in the Administrative Measures for Safety Evaluation of Agricultural GMOs. (Self-prepared by the applicant)
4. Description of safety precautions in the process of import. (Self-prepared by the applicant)
Use of approval Documents and Test Safety Approval Letter:
In the stage of research and intermediate test, it shall apply for the import approval documents of agricultural GMOs issued by the Ministry of Agriculture and Rural Affairs; In the stage of environmental release and productive tests, it shall apply for the safety approval leter of agricultural GMOs issued by the Ministry of Agriculture and Rural Affairs; When applying for import as raw materials, the Ministry of Agriculture and Rural Affairs shall require imported materials for the safety testing of agricultural GMO inspection by testing institutions;These documents are the core information for the Customs clearance of agricultural GMOs at entry ports.
Core Regulatory Measures:
1. Country and product access (access required by bilateral agreements, protocols or quarantine agreements)
2. Registration of overseas manufacturers (required by bilateral agreements, protocols or quarantine agreements)
3. The "Agricultural GMO Safety Certificate (Import)" or "Agricultural GMO Safety Certificate (Application in Production)" of overseas R&D Providers shall be determined according to the type and use of imported agricultural GMOs.(except for research and test stage)
4. Agricultural GMO Safety Certificate (Import) for overseas traders (applicable to GM plant products as raw materials for processing, one certificate for one batch)
5. For product registration (such as variety certification certificate genetically modified plant seeds, breeding livestock and poultry, aquatic seedlings, imported pesticide registration certificate, imported fertilizer registration certificate, imported food/feed additives registration certificate, imported new veterinary drug registration certificate, etc.), corresponding review, registration or evaluation, approval procedures shall be handled in accordance with relevant laws and administrative regulations. (GMOs for application in production)
6. Record-keeping for overseas exporters
7. Record-keeping for domestic importers
8. Domestic importers shall apply for Quarantine Permit for Imported Animals and Plants (additives, grains, beans, potatoes, etc.)
9. Inspection and quarantine certificate issued by the officials of the exporting country
10. Domestic importers shall apply for the Documents for Labeling, Examination and Approval of Agricultural GMOs (agricultural GMOs listed in the Catalogue of Agricultural GMOs Subject to Labeling Administration), and the validity period is 6 months.
11. Designated entry ports and supervision and quarantine places (determine whether there is a designation according to different products)
12. Supervision of designated manufacturing and processing enterprises and the process of handling, warehousing and processing (whether it is designated according to different products)
Let's explain the import process with imported GM beans as the example:
I. Goods Classification
Beans belong to food grain.
II. Quarantine Access
Check the access status of the country and product, refer to the Directory of Permitted Types of Grain (including Seed and Tuber Grain, Oilseeds) and Plant-derived Feed for Import and Exporting Countries or Regions and confirm that the exporting countries of soybean are in the list.
III. Registration of Overseas Enterprises
Overseas enterprises shall register with the GACC through the official recommendation of the exporting country to confirm that the enterprise is in the registration list.
IV. Agricultural GMO Safety Certificate
Agricultural GMO Safety Certificate (Import) for overseas traders.
V. Record-keeping for importers and exporters
Submit the application through "Internet + Customs" - "Record System for Importers and Exporters of Imported Food".
VI. Quarantine examination and approval
Importers shall apply for Quarantine Permit for Imported Animals and Plants through "Internet + Customs" before the implementation of import or signing of trade contracts.
VII. Documents for Labeling, Examination, Recognition and Approval of Agricultural GMOs,
Importers shall apply for the Documents for Labeling, Examination, Recognition and Approval of Agricultural GMOs before the implementation of import or signing of trade contracts (soybean is in the Catalogue of Agricultural GMOs Subject to Labeling Administration).
Formalities for import declaration:
1. Contract
2. Invoice
3. Packing list
4. Bill of Lading
5. Agricultural GMO Safety Certificate (Import) for overseas traders
6. Quarantine Permit for Imported Animals and Plants
7. Documents for Labeling, Examination, Recognition and Approval of Agricultural GMOs for domestic importers
8. Plant quarantine certificate issued by the official of the exporting country (if there are requirements on the format in bilateral agreements, protocols or quarantine agreements, such provisions shall prevail)
9. Automatic import license
10. Quality certificate (only for barley, wheat, soybeans and other products listed in the Catalogue of Entry and Exit Commodities subject to inspection and quarantine and subject to import quality inspection requirements)
Inspection and quarantine conformity assessment:
The Customs shall test the GM items in accordance with the testing methods and standards recognized by the State, and those who pass the GM test shall be allowed to enter the country. In any of the following circumstances, the Customs shall notify the consignor or his agent to return the goods or destroy them:
(I) products that declared as genetically modified but have been tested that their GM ingredients are not consistent with the "Agricultural GMO Safety Certificate";
(II) products that declared as non-genetically modified but have been tested to contain genetically modified ingredients.Regulations on the Safety Management of Agricultural Genetically Modified Organisms
Measures for the management of safety assessment of agricultural genetically modified organisms
Guidelines for the safety evaluation of gene-edited plants for agricultural use
Measures for the management of the labeling of agricultural genetically modified organisms
Measures for the approval of the processing of agricultural genetically modified organisms
Measures for the Safety Management of Import of Agricultural Genetically Modified Organisms
2. How many levels are agricultural genetically modified organisms divided into according to their danger to humans, animals and plants, microorganisms and the ecological environment?
Answer: I., II., III., IV. four levels, safety level I: there is no danger yet; Safety level II.: low risk; Safety level III.: moderately hazardous; Safety level IV: Highly dangerous. The safety assessment and safety level determination of agricultural genetically modified organisms shall be carried out in accordance with the following steps: (1) Determine the safety level of recipient organisms; (2) determine the type of impact of gene manipulation on the recipient's biosafety level; (3) Determining the safety level of genetically modified organisms; (4) Determine the impact of production and processing activities on the safety of genetically modified organisms; (5) Determine the safety level of genetically modified products.
3. What are the specific provisions for research and testing?
Answer: Domestic units engaged in the research of Class I and II agricultural genetically modified organisms shall be approved by the safety group of agricultural genetically modified organisms of the unit, and those engaged in the research of Class III and IV agricultural genetically modified organisms shall report to the competent administrative department of agriculture under the State Council before the start of the research. However, where Chinese-foreign cooperation, joint ventures or wholly foreign-owned parties engage in research and testing of agricultural genetically modified organisms within the territory of the People's Republic of China, approval shall be obtained from the competent administrative department for agriculture under the State Council. Agricultural genetically modified organism tests should generally go through three stages: intermediate tests, environmental release and productive tests. Where agricultural genetically modified organisms need to be transferred to intermediate testing after the completion of laboratory research, the experimental unit shall report to the competent administrative department for agriculture under the State Council. Where the experiment of agricultural genetically modified organisms needs to be transferred from the previous experimental stage to the next experimental stage, the experimental unit shall submit an application to the competent administrative department for agriculture under the State Council; Those who pass the safety assessment conducted by the Safety Committee of Agricultural Genetically Modified Organisms shall be approved by the competent administrative department for agriculture under the State Council to transfer to the next experimental stage. Units engaged in agricultural genetically modified organism testing may apply to the competent administrative department of agriculture under the State Council to obtain an agricultural genetically modified organism safety certificate after the completion of the productive test. After receiving the application, the competent administrative department for agriculture under the State Council shall entrust a technical testing institution with testing conditions and capabilities to conduct testing, and organize the Agricultural Genetically Modified Organisms Safety Committee to conduct a safety assessment; Only those who pass the safety assessment can be issued a safety certificate for agricultural genetically modified organisms.
4. What are the licenses for production and operation applications?
Answer: The production of seeds, breeding animals and aquatic seeds of genetically modified plants shall obtain a production license for seeds, breeding animals and poultry and aquatic seeds issued by the competent administrative department of agriculture under the State Council. Those engaged in the production or processing of other agricultural genetically modified organisms shall be approved by the competent administrative department for agriculture under the State Council or the competent administrative department for agriculture of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government. Units dealing in seeds of genetically modified plants, breeding animals and poultry, and aquatic seeds shall obtain a business license for seeds, breeding animals and poultry, and aquatic seeds issued by the competent administrative department for agriculture under the State Council.
5. What is the catalog of agricultural genetically modified organisms that implement labeling management?
Answer: All agricultural genetically modified organisms listed in the labeling management catalogue and used for sale shall be labeled; Those that are not marked or not marked in accordance with the provisions shall not be imported or sold. Specifically: (1) 1, soybean seeds, soybeans, soybean flour, soybean oil, soybean meal (2) corn seeds, corn, corn oil, corn flour (including corn flour with tax number 11022000, 11031300, 11042300) (3) rapeseed seed, rapeseed, rapeseed oil, rapeseed meal (4) cotton seed (5) tomato seed, fresh tomato, tomato paste
6. What are the approval regulations for the processing of agricultural genetically modified organisms?
A: Agricultural GMO processing refers to the production of agricultural GMO products using active agricultural GMOs as raw materials. That is, direct processed products of genetically modified animals and plants, microbial products and genetically modified agricultural products. Units and individuals engaged in the processing of agricultural genetically modified organisms within the territory of the People's Republic of China shall obtain the "Agricultural Genetically Modified Organism Processing License" issued by the competent administrative department of agriculture of the provincial-level people's government where the processing is located
7. What are the regulatory measures for GMO products used in exhibitions?
Answer: Genetically modified products imported for exhibition generally adopt the centralized supervision mode of customs transfer at the port of import and declaration and inspection at the place of exhibition, and the "safety certificate of agricultural genetically modified organisms" issued by the Ministry of Agriculture and Rural Affairs should be provided, and the supervision of customs should be accepted during the exhibition. After the exhibition, all GM products must be returned or destroyed.
8. Regulations on the approval of agricultural GMO advertising?
A: Advertisements for agricultural genetically modified organisms shall be reviewed, broadcast, set up and posted only after being reviewed and approved by the competent administrative department of agriculture under the State Council. The application conditions shall meet (1) Agricultural genetically modified organisms have been approved for marketing in accordance with the law, including having obtained pesticide registration certificates, fertilizer registration certificates, crop seed production and operation licenses, feed or feed additive registration certificates, veterinary drug registration certificates, veterinary drug registration certificates, aquatic seed production and operation licenses, etc. (2) The applicant for publishing an advertisement of agricultural genetically modified organisms must be the holder of the approval document for agricultural genetically modified organisms or the citizens, legal persons and other organizations entrusted by him. (3) The application materials are complete, valid, complete and clear, and those who require signature need to be signed by hand, printed or copied on A4 paper, and compiled into a book.
9. After receiving the application, the competent administrative department of agriculture under the State Council shall entrust a technical testing institution with testing conditions and capabilities to conduct testing.
A: List of agricultural genetically modified organisms safety supervision and testing institutions
10. What is the process of "Agricultural GMO Labeling Review and Approval Document"?
A: The Ministry of Agriculture and Rural Affairs issued a permit document to overseas traders to prove that the import label of agricultural genetically modified organisms has passed the examination
Accepting organization
Comprehensive Office of Administrative Examination and Approval, Ministry of Agriculture and Rural Affairs
Approval content:
(1) Characteristics of genetically modified organisms
(2) Identification content
(3) Marking the part
(4) Information on the entry of genetically modified organisms
Application conditions and preparation materials:
3.1 The applicant should be a domestic company;
3.2 The following documents must be submitted:
(1) Application Form for Review and Accreditation of Agricultural Genetically Modified Organisms Labeling;
(2) Label specifications or other explanatory documents;
(3) Identification description (such as logo size, size ratio, color, part on the product packaging, firmness, adhesion, etc.)
(4) Instructions for the use of the logo during transportation;
(5) Agricultural GMO Safety Certificate [import] and relevant approval documents issued by overseas traders issued by the Ministry of Agriculture and Rural Affairs (all copies);
(6) Other relevant approval documents (such as variety approval certificate, pesticide registration certificate, fertilizer registration certificate, new veterinary drug certificate and its production license certificate and business certificate, all are copies);
(7) The applicant shall submit the "Agricultural Genetically Modified Organisms Import Information Feedback Form" to the Ministry of Agriculture and Rural Affairs within 30 days after the inspection application, and return the unused import mark to the Ministry of Agriculture and Rural Affairs within 30 days after the validity period.
11. What is the validity period of the "Agricultural GMO Safety Certificate (Import)" of overseas traders and the "Agricultural GMO Labeling Review and Approval Document" of the importer?
A: 6 months.
Your Business Opportunities:
China is the largest consumer and application market of GM products in the world. Whether to apply for agricultural GM safety certificate is of great importance for developing the market of China, it plays an obvious role in promoting the export of overseas enterprises. It is inevitable to get rich economic returns after overcoming technical barriers. The reasons are as follows:
1. For GM crops used as raw materials for processing, such as soybeans, corn, rape, cotton, etc., after applying for agricultural GM safety certificates, the R&D Providers will be noticed by and cooprated with many overseas traders, exporters, Chinese buyers, processing and business enterprises, thus directly stimulating the export volume of the planting areas of the exporting countries. Correspondingly, it will greatly increase the use of GM products by R&D providers for production and obtain rich economic returns. It has become a high probability event for traders to apply for agricultural GMO safety certificates and obtain considerable profits by using physical or futures trading of bulk commodities.
2. For GM products for which overseas enterprises have applied for production application certificates, such as GM plant seeds, breeding livestock and poultry, aquatic seedlings, pesticides, veterinary drugs, fertilizers and additives, after obtaining the GM safety certificate, the specific product will be registered or approved, and the competitors with technical strength to overcome technical barriers and willing to spend time to register will become rare. China's huge demand market will open its arms to these products, and it is inevitable to obtain an unimaginable return on investment.
3. We hope that in addition to Bayer, BASF, Monsanto, Syngenta, Boehringer Ingelheim and other large enterprises, other overseas GMO research institutions or R&D enterprises can apply for agricultural GMO safety certificates with excellent GMO products and take the initiative to develop the Chinese market.We Supports:
1. Assist overseas traders to apply for agricultural transgenic safety certificates, or provide technical support for program and data interpretation. And pay attention to the entire trade and customs clearance process, timely analyze and solve unexpected problems, so that the whole process meets the requirements of agricultural administrative departments and customs supervision.
2. Assist developers to apply for agricultural transgenic safety certificates, or provide procedural and explanatory technical support, so that the whole process is smooth and without detours.
3. Assist overseas enterprises to apply for production and application of transgenic safety certificates, or provide technical support for program and data interpretation; Do the necessary reports and applications, obtain customs clearance approval documents or approval letters, so that the test materials can be cleared smoothly and the test at all stages can be carried out smoothly.
4. Assist in product registration or approval of specific transgenic products, or provide partial technical support.
5. Assist the exporting country to initiate the access application, and make the registration of overseas enterprises possible in time.
6. Assist overseas enterprises in customs registration and obtain the qualification to directly export relevant GM products to China.
7. Provide the enterprise credit report of Chinese buyers or processing and utilization units, and make objective analysis of their procurement or processing capacity, performance ability, and honest behavior based on multi-dimensional data for reference.