China's MOA has approved the imported Agricultural genetically modified organisms (GMO) , including genetically modified soybeans, genetically modified corn, genetically modified cotton, genetically modified rape, genetically modified sugar beet etc.
There are three types of "China GMOs Biosafety Certificate":
Production GMOs Biosafety Certificate (For Manufacturer)
1. Initial Imported GMOs Biosafety
Certificate (For Developer)
First of all, the GMOs developers must apply for the
"Initial
Imported GMOs Biosafety Certificate
(For Developer)
" for their seeds (parental GMOs), which can be called
parental GMOs certificate; the Applicant is a Genetic
Modification (GM ) technology research and development enterprise, and the main
Genetic Modification (GM ) R&D companies include Monsanto, Bayer , Syngenta, DuPont Pioneer, Dow, BASF, etc.
Only the parental Genetic Modification (GM ) Crops (GMO seeds) obtained the "Initial
Imported GMOs Biosafety Certificate
(For Developer)
" approved by the MOA, then the Genetic Modification
(GM ) Crops grown from the GMO seeds (parental GMOs) can be permitted to import into China;
By 2020, the Ministry of Agriculture (MOA) of China has approved about 100
"Initial
Imported GMOs Biosafety Certificate
(For Developer)
" to overseas developers.
This type of application is very complicated. It requires a large amount of safety evaluation research data, and it usually takes several years to obtain the "Initial
Imported GMOs Biosafety Certificate
(For Developer)
" , so, won't elaborate on it here;
2. Batch Imported GMOs Biosafety Certificate (For Trader)
The prerequisite for applying for this type of certificate is that the Genetic
Modification (GM ) Crops (parental generation GMOs) have obtained the
"Initial
Imported GMOs Biosafety Certificate
(For Developer)
" approved by the MOA; Only the Genetic Modification (GM ) crops grown from parental generation GMO seeds which approved by
MOA are allowed to be imported into China.
And for each Import Batch, overseas consigners (such as exporters, agents, traders, farms, manufacturers, etc.) must also apply to the
MOA to obtain a
“Batch Imported GMOs Biosafety Certificate (For Trader)” , then the
Genetic Modification (GM ) crops can be allowed to be imported into China.
In import customs clearance process, CIQ also needs to check that the genetic characteristics of the imported GMOs are consistent with the approved "Initial
Imported GMOs Biosafety Certificate (For Developer) " before customs clearance;
In addition, if an overseas exporter exports GMOs to China for the first time, the
MOA needs to conduct a qualification review on all parties involved in the GMOs trade (including exporters, importers, manufacturers, etc.), and each related party needs to establish a safety management system for GMOs . Applicants must provide the relevant management system documents of the three parties to the MOA for review, only meet the requirements of China's GMOs safety regulations, then the “Batch
Imported GMOs Biosafety Certificate (For Trader)” can be issued， Therefore, the first application for the
“Batch Imported GMOs Biosafety Certificate (For Trader)” is required Longer time and higher cost;
Apply for Batch Imported GMOs Biosafety Certificate (For Trader) for the first time，
The time
need about 3-4 months, and the cost is $3000-$4000;
For the Subsequent batch application, the time need about 2-3 months, and the cost is $2000-$3000;
3. Production GMOs Biosafety Certificate(For Manufacturer)
Manufacturers who want to process GMOs into other consumer goods or semi-finished products (including planting)
,need to apply for " Production GMOs Biosafety
Certificate (For Manufacturer)" ; this
is nothing to do with importer and exporter so won’t elaborate on it here;
1.
Initial GMOs
Biosafety certificate:
|
Subject |
Approval to First-time Import of
Agricultural Genetically Modified Organisms by Overseas Developers
境外研发商首次申请农业转基因生物安全证书（进口） |
|
Applicant |
GMOs Overseas Developers (Such
as Monsanto, BASF, Dow, Syngenta, DuPont Pioneer, etc. ) |
|
Certificate valid |
3-5 years |
|
Contents to be examined |
1. Environmental safety of the
GMO
2. Safety of the GMO as food
3. Safety level of the GMO
4. Approval of the GMO
abroad/outside the Chinese mainland
5. Related qualifications of the
applicant |
|
Approval Procedures |
1. Acceptance of application
documents. The General Office for Administrative Examination and
Approval of MOA accepts and preliminarily examines the Application for
Safety Assessment of Agricultural GMOs and related documents submitted
by the applicant.
2. Examination. The Office for
Agricultural GMO Safety of MOA examines the application documents
according to related national regulations.
3. Issue of approval document on
entry of GMO materials. The Office for Agricultural GMO Safety issues
the Approval Document on Entry of Agricultural GMO Materials to a
qualified applicant according to the examination findings as well as the
procedures for issue of the document so that the developer from outside
the Chinese mainland could import the agricultural GMO materials.
4. Technical testing. The
institution for technical testing of agricultural GMOs entrusted by MOA
performs the environmental and edible safety testing and produces a test
report.
5. Expert examination. The
Office for Agricultural GMO Safety of MOA designates the National
Committee on Safety of Agricultural GMOs to examine the application
documents and the test report.
6. Reply. The Office for
Agricultural GMO Safety makes a proposal according to the examination
results, submits it to the minister for final examination and then gives
a written reply to the applicant. |
|
Application Dossiers |
Abbreviation,Inquire us for detail. |
|
Time |
1-2 years |
|
Cost (USD) |
Inquire us for detail. |
|
Note |
For each subsequent import, a
copy of this certificate is required. |
2.
Batch GMOs
Biosafety
certificate for each import :
|
Subject |
Approval to Import of
Agricultural Genetically Modified Organisms By Overseas Traders
境外贸易商申请农业转基因生物安全证书（进口） |
|
Applicant |
GMOs Overseas Traders (Such as
exporters, agents, traders, farms, manufacturers, etc.) |
|
Contents to be examined |
1. Characteristics of the GMO
2. Purpose of the GMO and safety
in the process of transportation
3. Destination of the GMO
4. Approval of the GMO in the
country of origin |
|
Approval Procedures |
1. Acceptance of application
documents. The General Office for Administrative Examination and
Approval of MOA accepts and preliminarily examines the Registration Form
for Safety of Import of Agricultural GMOs (used as raw materials for
processing) and related documents submitted by the applicant.
2. Expert examination. The
Office for Agricultural GMO Safety of MOA designates an expert team to
examine the application documents.
3. Reply. The Office for
Agricultural GMO Safety makes a proposal according to the examination
findings, submits it to the minister for final examination and then
gives a written reply to the applicant. |
|
Application Dossiers |
Abbreviation,
Inquire us for detail. |
|
Time |
2-3 months |
|
Cost (USD) |
Inquire us for detail. |
|
Note |
Copy of Initial Imported GMOs
Biosafety Certificate is required. |
3.
GMOs Biosafety certificate for Production:
|
Subject |
Approval to Application for
Biosafety Certificate of Agricultural Genetically Modified Organisms
(for Production)
农业转基因生物安全证书〔生产应用〕 |
|
Applicant |
China local farms,
manufacturers, Processor etc. |
|
Contents to be examined |
1. Safety assessment and safety
level of the GMO
2. Testing of the GMO
3. Related qualifications of the
applicant |
|
Approval Procedures |
1. Acceptance of application
documents. The General Office for Administrative Examination and
Approval of MOA accepts and preliminarily examines the Application for
Safety Assessment of Agricultural GMO and related documents submitted by
the applicant.
2. Expert examination. The
Office for Agricultural GMO Safety of MOA designates the National
Agricultural GMO Safety Committee to examine the application documents.
3. Reply. The Office for
Agricultural GMO Safety makes a proposal according to the examination
results, submits it to the minister for final examination and then gives
a written reply to the applicant. |
|
Application Dossiers |
Abbreviation,
Inquire us for detail. |
|
Time |
1-2 years |
|
Cost (USD) |
Inquire us for detail. |
|
Note |
Such as plant seeds, animal
seedlings, manufacturing materials, etc. |
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