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Second Regular National Report on the Implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
102573
Status
Published
Date of creation
2011-10-21 15:55 UTC (andrew.bowers@cbd.int)
Date of last update
2011-11-09 20:36 UTC (andrew.bowers@cbd.int)
Date of publication
2011-11-09 20:36 UTC (andrew.bowers@cbd.int)

This document is also available in the following languages:
Origin of report
Country
  • China
Contact officer for report
Coordinates
Mr. Wang Jie
Deputy Director
Ministry of Environmental Protection
115 Xizhimennei Nanxiaojie
Beijing
China
Phone:+86 10 6655 6325
Fax:+86 10 6655 6327
Email:wang.jie@mep.gov.cn
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
Ministry of Environmental Protection,
Ministry of Foreign Affairs,
Ministry of Science and Technology,
Ministry of Agriculture,
Ministry of Health,
General Customs Administration,
General Administration of Quality Supervision, Inspection and Quarantine,
State Forestry Administration,
Chinese Academy of Sciences,
Nanjing Institute of Environmental Sciences,
Biotechnology Research Institute of CAAS, Chinese Research Academy of Environmental Sciences,
Chinese Academy of Inspection and Quarantine,
Chinese Academy of Forestry,
Institute of Botany of CAS
Submission
10. Date of submission
2011-09-30
11. Time period covered by this report
Start date
2007-09-30
Time period covered by this report
End date
2011-09-30
Party to the Cartagena Protocol on Biosafety
12. Is your country a Party to the Cartagena Protocol on Biosafety (CPB)?
  • Yes
Article 2 – General provisions
15. Has your country introduced the necessary legal, administrative and other measures for the implementation of the Protocol?
  • A domestic regulatory framework is fully in place
16. Which specific instruments are in place for the implementation of your national biosafety framework?
  • One or more national biosafety regulations
  • One or more sets of biosafety guidelines
17. Has your country established a mechanism for the budgetary allocations of funds for the operation of its national biosafety framework?
  • No
18. Does your country have permanent staff to administer functions directly related to the national biosafety framework?
  • Yes
19. If you answered Yes to question 18, how many permanent staff members are in place whose functions are directly related to the national biosafety framework?
  • More than 10
20. Has your country’s biosafety framework / laws / regulations / guidelines been submitted to the Biosafety Clearing-House (BCH)?
  • Partially
21. Here you may provide further details on the implementation of Article 2 in your country:
While developing modern biotechnology, China pays great attention to the potential adverse impacts of genetically modified organisms (GMOs) on the environment, biodiversity and human health. Currently, a number of competent national authorities are involved in the biosafety management. Their respective responsibilities are outlined below.

The National Biosafety Administration Office of MEP, with four permanent staff, serves as the national focal point for the Protocol and BCH and coordinates domestic environmental management related to biotechnology.

The Biosafety Office of Agricultural GMOs of MOA, with four permanent staff, is responsible for the safety management on the research, testing, production, processing, marketing and import/export of agricultural GMOs.

The Department for Supervision on Animal & Plant Quarantine of AQSIQ, with ten permanent staff, is responsible for national-level management of inspection and quarantine of import and export of GMOs and products thereof, as well as inspection, detection and monitoring of these GMOs. Local branches of AQSIQ in provinces are in charge of inspection, quarantine and supervision on imported/exported GMOs under their respective jurisdictions.

The State Forestry Administration has set up a Forestry Biosafety Office, with four permanent staff, which is responsible for the safety management of genetically modified trees or forests, such as research, testing, production, processing, marketing and import/export etc. A Safety Committee for Forestry Genetic Engineering has also been set up, which is responsible for the safety assessment of genetically modified trees or forests.

The General Administration of Customs is the national authority for supervision of import and export activities. GAC inspects and verifies the goods containing transgenic components, as well as the Commodity Inspection Certificates issued by AQSIQ and other certificates issued by relevant competent authorities, and handles customs clearance.

In order to effectively implement "National Biosafety Framework of China", relevant departments at national level, particularly those national authorities referred above, as well as provincial departments of agriculture and environmental protection in provinces where the GMOs are released, have had annual budget for the management, research, supervision, assessment and public education of biosafety.

Following Orders and Notices on biosafety have been promulgated since 2007:

On 7 March 2007, MOA issued Notice No 822-Requirements for Application for Safety Assessment of Agricultural GM Crops for testing in Hai'nan Province, South China.

On 4 June 2007, SFA promulgated Technical Guidelines for the Safety Assessment of Genetically Modified Forest Plants and Their Products.

On 13 September 2007, MOA promulgated Notice on the Matters Related to Application for the Safety Assessment of Genetically Modified Organisms.

On 26 February 2008, MOA issued Notice No 989. Simplified Procedures for Applications for Transgenic Pest-Resistant Cotton with the Safety Production Certificate.

In addition, Chinese government has issued a series of technical standards on the labeling, risk assessment, and detection methods of GMOs (See Supplementary Table 1 in Annex I).
Article 5 – Pharmaceuticals
22. Does your country regulate the transboundary movement, handling and use of living modified organisms (LMOs) which are pharmaceuticals?
  • Yes, to some extent
23. If you answered Yes to question 22, has this information been submitted to the BCH?
  • Partially
24. Here you may provide further details on the implementation of Article 5 in your country:
Genetically modified veterinary vaccines as animal pharmaceuticals are included within the scope of the Regulation on Biosafety Management of Agricultural GMOs (RS-AGMOs, submitted to BCH in January 2006 by MEP), and their transboundary movement, handling and use should meet the requirements of the Regulation.
Article 6 – Transit and Contained use
25. Does your country regulate the transit of LMOs?
  • Yes
26. Does your country regulate the contained use of LMOs?
  • Yes
27. If you answered Yes to questions 25 or 26, has this information been submitted to the BCH?
  • Yes
28. Here you may provide further details on the implementation of Article 6 in your country:
The management on the import/export of agricultural GMOs is specified in Chapter 5 of the RS-AGMOs. The management on the research, testing, production and processing of agricultural GMOs are specified in Chapter 2, Chapter 3 or Chapter 4, respectively in the "Implementation Regulations on the Safety of Import of Agricultural GMOs" (IRSI-AGMOs).

"Implementation Regulations for Inspection and Quarantine of Import & Export of GMOs and Products thereof"(IRIQIE-GMOsP)stipulates in Article 12, that for transit of genetically modified products, the owner or its agent(s) shall submit an application in advance to AQSIQ with relevant accompanying documents to get a permission for transit.
Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
29. Has your country adopted law(s) / regulations / administrative measures for the operation of the AIA procedure of the Protocol?
  • Yes
30. Has your country adopted a domestic regulatory framework consistent with the Protocol regarding the transboundary movement of LMOs for intentional introduction into the environment?
  • Yes
31. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
32. If you answered Yes to question 31, does the mechanism also apply to cases of intentional introduction of LMOs into the environment that were not subject to transboundary movement?
  • Yes
33. Has your country established a mechanism for monitoring potential effects of LMOs that are released into the environment?
  • Yes
34. Does your country have the capacity to detect and identify LMOs?
  • Yes, to some extent
35. Has your country established legal requirements for exporters under its jurisdiction to notify in writing the competent national authority of the Party of import prior to the intentional transboundary movement of an LMO that falls within the scope of the AIA procedure?
  • No
36. Has your country established legal requirements for the accuracy of information contained in the notification?
  • Yes
37. Has your country ever received an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
38. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
39. If you answered Yes to question 38, how many LMOs has your country approved to date for import for intentional introduction into the environment?
  • More than 10
40. If you answered Yes to question 38, how many LMOs, not imported, has your country approved to date for intentional introduction into the environment?
  • More than 10
41. In the current reporting period, how many applications/notifications has your country received regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • More than 10
42. In the current reporting period, how many decisions has your country taken regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • More than 10
43. With reference to the decisions taken on intentional transboundary movements of LMOs for intentional introduction into the environment, has your country received a notification from the Party(ies) of export or from the exporter(s) prior to the transboundary movement?
  • Yes, always
44. Did the notifications contain complete information (at a minimum the information specified in Annex I of the Cartagena Protocol on Biosafety)?
  • Yes, always
45. Has your country acknowledged receipt of the notifications to the notifier within ninety days of receipt?
  • Yes, always
46. Has your country informed the notifier(s) and the BCH of its decision(s)?
  • In some cases only the notifier
47. Has your country informed the notifier(s) and the BCH of its decision(s) in due time (within 270 days or the period specified in your communication to the notifier)?
  • In some cases only
48. What percentage of your country’s decisions fall into the following categories?
  • Approval of the import/use of the LMO(s) with conditions
30%
  • Request for additional relevant information
70%
49. In cases where your country approved an import with conditions or prohibited an import, did it provide reasons on which its decisions were based to the notifier and the BCH?
  • In some cases only
50. Here you may provide further details on the implementation of Articles 7-10 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs for intentional introduction to the environment:
Based on RS-AGMOs, IRSI-AGMOs, and the "Implementation Regulations on Safety Assessment of Agricultural Genetically Modified Organisms" (IRSA-AGMOs), MOA is responsible for accepting, assessing and approving agricultural GMOs application. Results should be given within time limit and be posted on the website of MOA. With coordination by MOA, safety assessments on agricultural GMOs shall be conducted by a panel of specialists consisting of those from MEP, SFA, AQSIQ, the Ministry of Health (MOH), the Ministry of Education (MOE), CAS and other relevant sectors and institutions. Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of LMOs, shall prevent the intentional introduction into the environment until more scientific information is provided. Up to now MOA has already authorized thirty five institutions to undertake detection of transgenic components and assessment of environment safety and food safety.

In IRIQIE-GMOsP, requirements are specified for the inspection and quarantine of genetically modified animals/plants and products thereof, genetically modified micro-organisms and products thereof and genetically modified food. Only those that have successfully passed the transgenic tests can be allowed to be imported into China. The Center of GMOs Detection affiliated to AQSIQ is responsible for research on technology of safety assessment and inspection of products mentioned above, collecting international and domestic information of laws and regulations on GM commodities, developing and supplying reference materials, and providing relevant technological training. The local Inspection and Quarantine Technology Centres at ports are responsible for inspecting imported and exported GM commodities in their respective jurisdictions.

Up to 2011, main imports of GMOs to China as raw material for processing are GM-soybeans, GM-corn, GM-cotton, GM-canola, GM-sugar beet, including herbicide-tolerant transgenic soybean MON89788, herbicide-tolerant transgenic cotton GHB614, insect-resistant transgenic cotton 15985, insect-resistant and herbicide-tolerant transgenic maize MON88017, Roundup-tolerant transgenic canola GT73, Roundup-tolerant transgenic sugar beet H7-1, insect-resistant and herbicide-tolerant transgenic maize 59122, herbicide-tolerant transgenic cotton 1445 and insect-resistant transgenic corn MON810 etc.

Up to July 2011, main non-imported LMOs intended for environmental release in China include transgenic cotton (Cry1AB/Cry1AC, Cry1AC, Cry1AB, Cry1AC+CPTI,Cry1AC/AP1), papaya, corn, rice, pimiento, chili, tomato, petunias, poplar, micro-organism, and micro-organism feed additive etc.

After obtaining a biosafety certificate of GMO (i.e., GMO passes safety assessment in accordance with relevant laws and regulations and a safety certificate by  department of agriculture is obtained. After GMO meets other relevant requirements, it could be commercialized.), relevant agricultural departments shall organize various administrative authorities to carry out joint inspections sometimes. In addition, scientific research projects are established for the long-term tracing and monitoring of GMOs. Any organization or person that releases GMOs not in accordance with relevant requirements, or conducts research or testing on GMOs illegally, shall be punished.
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
51. Has your country adopted specific law(s) or regulation(s) for decision-making regarding domestic use, including placing on the market, of LMOs-FFP?
  • Yes
52. Has your country established legal requirements for the accuracy of information to be provided by the applicant?
  • Yes
53. Has your country established a mechanism to ensure that decisions regarding LMOs-FFP that may be subject to transboundary movement will be communicated to the Parties through the BCH?
  • Yes
54. Has your country established a mechanism for taking decisions on the import of LMOs-FFP?
  • Yes
55. Has your country declared through the BCH that in the absence of a regulatory framework its decisions prior to the first import of an LMO-FFP will be taken according to Article 11.6 of the Cartagena Protocol on Biosafety?
  • No
56. Has your country indicated its needs for financial and technical assistance and capacity building in respect of LMOs-FFP?
  • No
57. Has your country ever taken a decision on LMOs-FFP (either on import or domestic use)?
  • Yes
58. How many LMOs-FFP has your country approved to date?
  • More than 10
59. In the current reporting period, how many decisions has your country taken regarding the import of LMOs-FFP?
  • More than 10
60. In the current reporting period, how many decisions has your country taken regarding domestic use, including placing on the market, of LMOs-FFP?
  • More than 10
61. Has your country informed the Parties through the BCH of its decision(s) regarding import, of LMOs-FFP?
  • In some cases only
62. Has your country informed the Parties through the BCH of its decision(s) regarding domestic use, including placing on the market, of LMOs-FFP within 15 days?
  • No
63. Here you may provide further details on the implementation of Article 11 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs-FFP:
In line with RS-AGMOs and IRSI-AGMOs, The Biosafety Office of Agricultural GMOs is responsible for accepting, reviewing and approving application of GMOs import. Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of LMOs, shall prevent the intentional introduction into the environment until more scientific information is provided.
Article 12 – Review of decision
64. Has your country established a mechanism for the review and change of a decision regarding an intentional transboundary movement of LMOs?
  • Yes
65. Has your country ever received a request for a review of a decision?
  • Yes
66. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?
  • Yes, decision reviewed
67. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?
  • More than 5
68. Has your country informed the notifier and the BCH of the review and/or changes in the decision?
  • In some cases only the notifier
69. Has your country informed the notifier and the BCH of the review and changes in the decision within thirty days?
  • No
70. Has your country provided reasons to the notifier and the BCH for the review and/or changes in the decision?
  • In some cases only the notifier
71. Here you may provide further details on the implementation of Article 12 in your country:
According to relevant regulations, after the expiration date of Safety Certificate for GMOs intended for use for food, feed and processing, it is necessary to renew it for their placing on the market.

China is importing a large amount of genetically modified soybean, corn, rape and cotton for processing and for animal feed annually. The import volume continued to grow and exceeded fifty million tons in 2010. Under IRIQIE-GMOsP and the Law on the Quarantine for Import and Export of Animals and Plants , relevant departments of inspection and quarantine accept, review and approve applications of LMOs import intended for direct use as food or feed, or for processing. For other products, if they are genetically modified commodities, application for import licensing and labeling is required.
Article 13 – Simplified procedure
72. Has your country established a system for the application of the simplified procedure regarding an intentional transboundary movement of LMOs?
  • Yes
73. Has your country ever applied the simplified procedure?
  • No
75. In the current reporting period, how many LMOs has your country applied the simplified procedure to?
  • None
76. Here you may provide further details on the implementation of Article 13 in your country:
In RS-AGMOs and other relevant regulations, the circumstances where the simplified procedures may apply are clearly specified. And for all import applications applicable to simplified procedures, there are clear-cut procedures of accepting, reviewing and approving applications.

In October 2006, MOA issued Notice No 736. For agricultural GMOs already awarded with Safety Certificate (for commercialization and for import) and would continue to be used in the same area, the simplified procedure followed will continue to apply after the certificate expires.

In February 2008, MOA issued Notice No 989. For insect-resistant transgenic cotton strains already awarded with Safety Certificate (for commercialization), and for new pest-resistant transgenic cotton strains cultivated by using the former transgenic cotton strains, the simplified procedure will apply. Applications beyond the scope of the Notice No 989 will be subject to the requirements specified in the Regulations on Biosafety Management of Agricultural GMOs. Notice No 410 issued by MOA on 28 September 2004 was abolished in the meantime.

For import of GMOs, application will be subject to the simplified procedure specified above. However, no such application for imports has been made to date.
Article 14 – Bilateral, regional and multilateral agreements and arrangements
77. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?
  • No
80. Here you may provide further details on the implementation of Article 14 in your country:
Not applicable.
Article 15 – Risk assessment
81. Has your country established a mechanism for conducting risk assessments prior to taking decisions regarding LMOs?
  • Yes
82. If you answered Yes to question 81, does this mechanism include procedures for identifying experts to conduct the risk assessments?
  • Yes
83. Has your country established guidelines for how to conduct risk assessments prior to taking decisions regarding LMOs?
  • Yes
84. Has your country acquired the necessary domestic capacity to conduct risk assessment?
  • Yes
85. Has your country established a mechanism for training national experts to conduct risk assessments?
  • Yes
86. Has your country ever conducted a risk assessment of an LMO for intentional introduction into the environment?
  • Yes
87. Has your country ever conducted a risk assessment of an LMO intended for direct use as food or feed, or for processing?
  • Yes
88. If your country has taken decision(s) on LMOs for intentional introduction into the environment or on domestic use of LMOs-FFP, were risk assessments conducted for all decisions taken?
  • Yes, always
89. Has your country submitted summary reports of the risk assessments to the BCH?
  • No
90. In the current reporting period, if your country has taken decisions regarding LMOs, how many risk assessments were conducted in the context of these decisions?
  • More than 10
91. Has your country ever required the exporter to conduct the risk assessment(s)?
  • Not applicable
92. Has your country ever required the notifier to bear the cost of the risk assessment(s) of LMOs?
  • Yes, always
93. Here you may provide further details on the implementation of Article 15 in your country:
IRSA-AGMOs and IREAF-GEA specify the requirements of safety assessment of agricultural and forest GMOs. The Safety Committee for Agricultural GMOs reviews the risk assessment reports of agricultural GMOs intended for environmental release. The Safety Committee for Forest Genetic Engineering is responsible for reviewing the applications intended to conduct the research and testing of genetically modified forests and trees. MEP participates in important decision-making on environmental release of GMOs through Joint Inter-ministry Meeting of Biological Species Resources, and designating experts in safety assessment of GMOs. According to RS-AGMOs and IRIQIE-GMOsP, AQSIQ carries out inspection and quarantine on import/export and transit of GMOs and products thereof, so as to ensure that transboundary movement of GMOs will be safe and smooth while protecting China's ecological environment, agriculture/forestry production and health of human beings and animals.

In the Notice of the National Development and Reform Commission (NDRC) and the Ministry of Finance (MOF) on the Charging Rates for Biosafety Assessment and Inspection Fee of Agricultural GMOs and Other Relevant Issues(No. 3704 [2007] of NDRC), the notifier bears the costs of the risk assessments of agricultural GMOs.
Article 16 – Risk management
94. Has your country established and maintained appropriate and operational mechanisms, measures and strategies to regulate, manage and control risks identified in risk assessments for:
94.1) LMOs for intentional introduction into the environment?
  • Yes
94.2) LMOs intended for direct use as food or feed, or for processing?
  • Yes
95. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?
  • Yes, to some extent
96. Has your country taken measures to ensure that any LMO, whether imported or locally developed, undergoes an appropriate period of observation that is commensurate with its life-cycle or generation time before it is put to its intended use?
  • Yes
97. Has your country cooperated with other Parties with a view to identifying LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
  • No
98. Has your country cooperated with other Parties with a view to taking measures regarding the treatment of LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
  • No
99. Here you may provide further details on the implementation of Article 16 in your country, including any details regarding risk management strategies, also in case of lack of scientific certainty on potential adverse effects of LMOs:
China ensures that any LMOs, whether imported or locally developed, has undergone an appropriate period of observation commensurate with its life-cycle or generation time before they are put to their intended use. LMOs which are at stages of pilot experiment, environmental release or production trial in China must undergo at least a period of two-year safety assessment per stage.
Article 17 – Unintentional transboundary movements and emergency measures
100. Has your country made available to the BCH the relevant details setting out its point of contact for the purposes of receiving notifications under Article 17?
  • Yes
101. Has your country established a mechanism for addressing emergency measures in case of unintentional transboundary movements of LMOs that are likely to have significant adverse effect on biological diversity?
  • Yes
102. Has your country implemented emergency measures in response to information about releases that led, or may have led, to unintentional transboundary movements of LMOs?
  • No
103. In the current reporting period, how many times has your country received information concerning occurrences that led, or may have led, to unintentional transboundary movement(s) of one or more LMOs to or from territories under its jurisdiction?
  • Never
107. Here you may provide further details on the implementation of Article 17 in your country:
As required by the State Council of China, MOA has formulated Contingency Plans for Accidents Caused by Agricultural GMOs (CP-AGMOs). The provincial, municipal or county governments have formulated appropriate local plans for emergency of agricultural GMOs, in accordance with regulations such as CP-AGMOs, RS-AGMOs and other relevant guidelines.

In addition to regular inspection on transgenic components, AQSIQ began to monitor the imported genetically modified commodities since 2009, especially those imported without permission.
Article 18 – Handling, transport, packaging and identification
108. Has your country taken measures to require that LMOs that are subject to transboundary movement are handled, packaged and transported under conditions of safety, taking into account relevant international rules and standards?
  • Yes
109. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is not known through means such as identity preservation systems, they may contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
  • No
110. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is known through means such as identity preservation systems, they contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
  • Yes, to some extent
111. Has your country taken measures to require that documentation accompanying LMOs that are destined for contained use clearly identifies them as living modified organisms and specifies any requirements for the safe handling, storage, transport and use, the contact point for further information, including the name and address of the individual and institution to whom the LMO are consigned?
  • Yes, to some extent
112. Has your country taken measures to require that documentation accompanying LMOs that are intended for intentional introduction into the environment of the Party of import, clearly identifies them as living modified organisms; specifies the identity and relevant traits and/or characteristics, any requirements for the safe handling, storage, transport and use, the contact point for further information and, as appropriate, the name and address of the importer and exporter; and contains a declaration that the movement is in conformity with the requirements of this Protocol applicable to the exporter?
  • Yes, to some extent
113. Does your country have the capacity to enforce the requirements of identification and documentation of LMOs?
  • Yes, to some extent
114. Has your country established procedures for the sampling and detection of LMOs?
  • Yes
115. Here you may provide further details on the implementation of Article 18 in your country:
RS-AGMOs issued by the State Council and IRL-AGMOs issued by MOA specify the requirements for the transportation, packaging and labelling of GMOs. In the meantime MOA formulated of Procedures for Review and Approval on Labelling of Agricultural GMOs. Forty-four national/industrial standards and guidelines on detection and monitoring of agricultural GMOs have been issued by relevant authorities since September 2007.

According to relevant import/export regulations, the owner or its consignee should, at customs declaration, specify under Name of the Declaration Form of Import Commodities whether the product is genetically modified. If the commodity is declared as GMOs, Biosafety Certificate of agricultural GMOs (or relevant documents) issued by MOA (or other related approval documents) should be provided, along with the documents regarding review, recognition and approval of Labelling of Agricultural GMOs.

IRL-AGMOs is applicable to agricultural GMOs for placing on the market or import. For GMOs imported, Information Feedback Form for Imported Agricultural GMOs should be provided. But for those domestic GMOs specific provisions are yet to be made. However, labelling is required for those GMOs to be placed on the market.
Article 19 – Competent National Authorities and National Focal Points
116. Has your country designated one national focal point for the Cartagena Protocol to be responsible for liaison with the Secretariat?
  • Yes
117. Has your country designated one national focal point for the Biosafety Clearing-House to liaise with the Secretariat regarding issues of relevance to the development and implementation of the BCH?
  • Yes
118. Has your country designated one or more competent national authorities, which are responsible for performing the administrative functions required by the Cartagena Protocol on Biosafety and are authorized to act on your country’s behalf with respect to those functions?
  • Yes, more than one
119. In case your country designated more than one competent national authority, has your country conveyed to the Secretariat the respective responsibilities of those authorities?
  • Yes
120. Has your country made available the required information referred in questions 116-119 to the BCH?
  • Yes, all information
121. In case your country has designated more than one competent national authority, has your country established a mechanism for the coordination of their actions prior to taking decisions regarding LMOs?
  • Yes
122. Has your country established adequate institutional capacity to enable the competent national authority(ies) to perform the administrative functions required by the Cartagena Protocol on Biosafety?
  • Yes, to some extent
123. Here you may provide further details on the implementation of Article 19 in your country:
On 12 October 2007, the State Council issued Notice on the restructured system of Joint Inter-ministerial Meeting for the Safety Management of Agricultural GMOs (JIM-AGMOs). Its main responsibilities include: to implement important decisions on biosafety management of agricultural GMOs, which are formulated by the State Council; to study  major policies and put forward recommendations on biosafety management of agricultural GMOs; to revise and improve RS-AGMOs and other supporting regulations; to lead coordination and strength joint law enforcement and administrative supervision among government departments; to strengthen capacity-building in the field of biosafety management of agricultural GMOs; to guide the coordination of emergency responses to agricultural GMOs; to formulate and update the labelling list of GMOs, and to undertake other assignments designated by the State Council. The JIM-AGMOs is composed of officials from NDRC, MOE, MOST, MOF, MEP, MOA, Ministry of Commerce(MOC), MOH, General Administration for Industry and Commerce(GAIC), AQSIQ and SFA.

However, necessary efforts will be made to further improve relevant systems and mechanisms in the decision-making process and coordination in biosafety management of GMOs, especially biosafety information sharing among different government departments.
Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
124. Please provide an overview of the status of the information provided by your country to the BCH by specifying for each category of information whether it is available and whether it has been submitted to the BCH.
124.a) Existing national legislation, regulations and guidelines for implementing the Protocol, as well as information required by Parties for the advance informed agreement procedure (Article 20, paragraph 3 (a))
  • Information available and in the BCH
124.b) National laws, regulations and guidelines applicable to the import of LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 5)
  • Information available and in the BCH
124.c) Bilateral, multilateral and regional agreements and arrangements (Articles 14, paragraph 2 and 20, paragraph 3 (b))
  • Information not available
124.d) Contact details for competent national authorities (Article 19, paragraphs 2 and 3), national focal points (Article 19, paragraphs 1 and 3), and emergency contacts (Article 17, paragraph 3 (e))
  • Information available and in the BCH
124.e) Reports submitted by the Parties on the operation of the Protocol (Article 20, paragraph 3 (e))
  • Information available and in the BCH
124.f) Decisions by a Party on regulating the transit of specific living modified organisms (LMOs) (Article 6, paragraph 1)
  • Information not available
124.g) Occurrence of unintentional transboundary movements that are likely to have significant adverse effects on biological diversity (Article 17, paragraph 1)
  • Information not available
124.h) Illegal transboundary movements of LMOs (Article 25, paragraph 3)
  • Information not available
124.i) Final decisions regarding the importation or release of LMOs (i.e. approval or prohibition, any conditions, requests for further information, extensions granted, reasons for decision) (Articles 10, paragraph 3 and 20, paragraph 3(d))
  • Information available and in the BCH
124.j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information available and in the BCH
124.k) Final decisions regarding the domestic use of LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing (Article 11, paragraph 1)
  • Information available and in the BCH
124.l) Final decisions regarding the import of LMOs intended for direct use as food or feed, or for processing that are taken under domestic regulatory frameworks (Article 11, paragraph 4) or in accordance with annex III (Article 11, paragraph 6) (requirement of Article 20, paragraph 3(d))
  • Information available and in the BCH
124.m) Declarations regarding the framework to be used for LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 6)
  • Information available and in the BCH
124.n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)
  • Information not available
124.o) LMOs granted exemption status by each Party (Article 13, paragraph 1)
  • Information not available
124.p) Cases where intentional transboundary movement may take place at the same time as the movement is notified to the Party of import (Article 13, paragraph 1)
  • Information not available
124.q) Summaries of risk assessments or environmental reviews of LMOs generated by regulatory processes and relevant information regarding products thereof (Article 20, paragraph 3 (c))
  • Information available but not in the BCH
125. Has your country established a mechanism for strengthening the capacity of the BCH National Focal Point to perform its administrative functions?
  • Yes
126. Has your country established a mechanism for the coordination among the BCH National Focal Point, the Cartagena Protocol focal point, and the competent national authority(ies) for making information available to the BCH?
  • Yes
127. Does your country use the information available in the BCH in its decision making processes on LMOs?
  • Yes, in some cases
128. Has your country experienced difficulties accessing or using the BCH?
  • Yes
129. If you answered Yes to question 128, has your country reported these problems to the BCH or the Secretariat?
  • Yes
130. Is the information submitted by your country to the BCH complete and up-to date?
  • No
131. Here you may provide further details on the implementation of Article 20 in your country:
China is in the initial stage of developing and establishing the Biosafety Clearing-House Mechanism. Competent authorities release information related to GMOs and products thereof through their own websites. Main problem at present is that an information exchanging mechanism among different departments is not quite in place and thus such information could not be exchanged smoothly.
Article 21 – Confidential information
132. Has your country established procedures to protect confidential information received under the Protocol?
  • Yes
133. Does your country allow the notifier to identify information that is to be treated as confidential?
  • Yes, always
134. Here you may provide further details on the implementation of Article 21 in your country:
The administrative authorities responsible for biosafety management have strictly followed requirements in relevant laws and regulations to protect the legitimate rights of applicants.
Article 22 – Capacity-building
135. Has your country received external support or benefited from collaborative activities with other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
136. If you answered Yes to question 135, how were these resources made available?
  • Bilateral channels
137. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
138. If you answered Yes to question 137, how were these resources made available?
  • Bilateral channels
139. Is your country eligible to receive funding from the Global Environment Facility (GEF)?
  • Yes
140. Has your country ever initiated a process to access GEF funds for building capacity in biosafety?
  • Yes
141. If you answered Yes to question 140, how would you characterize the process?
Please add further details about your experience in accessing GEF funds under question 150.
  • Average
142. Has your country ever received funding from the GEF for building capacity in biosafety?
  • Development of national biosafety frameworks
  • Implementation of national biosafety frameworks
  • Building Capacity for Effective Participation in the BCH (Phase I)
143. During the current reporting period, has your country undertaken activities for the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
144. If you answered Yes to question 143, in which of the following areas were these activities undertaken?
  • Institutional capacity
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Risk management
  • Public awareness, participation and education in biosafety
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Scientific, technical and institutional collaboration at subregional, regional and international levels
  • Identification of LMOs, including their detection
  • Socio-economic considerations
  • Scientific biosafety research relating to LMOs
  • Taking into account risks to human health
145. During the current reporting period, has your country carried out a capacity-building needs assessment?
  • No
146. Does your country still have capacity-building needs?
  • Yes
147. If you answered Yes to question 146, indicate which of the following areas still need capacity-building.
  • Institutional capacity
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Risk management
  • Public awareness, participation and education in biosafety
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Scientific, technical and institutional collaboration at subregional, regional and international levels
  • Identification of LMOs, including their detection
  • Socio-economic considerations
  • Implementation of the documentation requirements under Article 18.2 of the Protocol
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
  • Scientific biosafety research relating to LMOs
  • Taking into account risks to human health
148. Has your country developed a capacity-building strategy or action plan?
  • Yes
149. Has your country submitted the details of national biosafety experts to the Roster of Experts in the BCH?
  • No
150. Here you may provide further details on the implementation of Article 22 in your country, including further details about your experience in accessing GEF funds:
Since 2009 China has put forward special plans for medium- and long-term scientific and technological development, through which MOA conducts capability building of GMOs inspection, monitoring and assessment, organizes training, publicity and education on GMOs biosafety, sets up centres of detection and monitoring in national scientific research institutions, and invests funds in infrastructure, relevant facilities and equipment.

MEP organizes annual training on biosafety management for managers from local departments of environmental protection as well as those from local departments of AQSIQ. More than 350 staff has received such training from 2007 to 2011. During the 11th five-year plan period (2006 -2010), the State Key Environmental Laboratory on Biosafety of MEP has received grants of more than RMB 13, 000,000 Yuan (or USD 2,000,000) for infrastructure, new facilities and equipment. NIES and Centre for Biosafety in Norway (GENOK) signed a memorandum of understanding to enhance technical cooperation and scientific exchange. International Biosafety Forum funded by GTZ of Germany has held four sessions to date.

AQSIQ has put in human, material and financial resources in establishing a series of technical standards on biosafety management and testing manuals, set up inspection programmes, established laboratories for GMOs detection, organized seminars and training courses on GMOs sampling and inspection.

SFA provides training on biosafety management of forest GMOs for managerial/technical personnel from local forestry departments/scientific/technical institutions. Since 2007 more than 300 personnel have been trained.
Article 23 – Public awareness and participation
151. Has your country established a strategy or put in place legislation for promoting and facilitating public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes, to some extent
152. Has your country established a biosafety website?
  • Yes
153. Has your country established a mechanism to ensure public access to information on living modified organisms that may be imported?
  • Yes, to a limited extent
154. Has your country established a mechanism to consult the public in the decision-making process regarding LMOs?
  • No
155. Has your country established a mechanism to make available to the public the results of decisions taken on LMOs?
  • Yes, to a limited extent
156. Has your country taken any initiative to inform its public about the means of public access to the Biosafety Clearing-House?
  • Yes
157. In the current reporting period, has your country promoted and facilitated public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes, to a limited extent
158. If you answered Yes to question 157, has your country cooperated with other States and international bodies?
  • No
159. In the current reporting period, how many times has your country consulted the public in the decision-making process regarding LMOs and made the results of such decisions available to the public?
  • None
160. Here you may provide further details on the implementation of Article 23 in your country:
Relevant websites for biosafety of GMOs in China are listed as follows:

National Biosafety Clearing-House Mechanism  http://www.biaosafety.gov.cn/

MOA website for biosafety  http://www.stee.agri.gov.cn/biosafety

Biotechnology information in China  http://www.biotech.org.cn/

In public education, universities such as Southwest University and Hunan Agricultural University offer undergraduate programs on biosafety. Universities such as Central University for Nationalities and Yangzhou University provide courses on GMOs Biosafety. The Chinese Academy of Sciences and Chinese Academy of Agricultural Sciences offer postgraduate programs on biosafety.

In September 2008, the mass media were invited to attend the Third Meeting of the International Biosafety Forum and participated in communication and discussion. In the Fourth Meeting of International Biosafety Forum, mass media, science enthusiasts and citizens were invited for the first time to attend the conference and participate in discussing issues concerning public participation and popularization in biosafety.

In China Science and Technology Museum, a symposium entitled Genetically Modified Technology in Our Daily Life was held on 14 November 2009. This symposium was co-organized by CAAS, Chinese Society of Biological Engineering, China Science and Technology Museum, Chinese Society of Agricultural Biotechnology, Crop Life (China) and BRICAAS. Hundreds of people attended the symposium. On 1st June 2010, the Bureau of Agriculture in Beijing launched the science popularization exhibition entitled "A Closer Look at GMOs", which provides the knowledge of GMOs. On 18 September 2010, the Center for Science and Technology Development affiliated with MOA organized science popularization exhibitions through graphics, pictures, boards and exhibits on the theme of "National Science Popularization Day". It disseminated knowledge on the primary principles and applications of GM technology and biosafety. At the same time, science popularization exhibitions were held in Wuhan, Changchun, Anyang and other cities. MEP organized various public events on the theme of International Day for Biological Diversity annually, with a view to drawing public attention to GMOs biosafety.

People's Daily Online provides a platform for interaction with the netizens on biosafety. Mass media of China (e.g., People's Daily) provides the public with relevant information of biosafety through news release and news report. Popular science books are also published to enhance public awareness of biosafety.
Article 24 – Non-Parties
161. Has your country entered into any bilateral, regional, or multilateral agreement with non-Parties regarding transboundary movements of LMOs?
  • No
162. Has your country ever imported LMOs from a non-Party?
  • Yes
163. Has your country ever exported LMOs to a non-Party?
  • No
164. If you answered Yes to questions 162 or 163, were the transboundary movements of LMOs consistent with the objective of the Cartagena Protocol on Biosafety?
  • Yes, always
165. If you answered Yes to questions 162 or 163, was information about these transboundary movements submitted to the BCH?
  • In some cases only
166. If your country is not a Party to the Cartagena Protocol, has it contributed information to the BCH on LMOs released in, or moved into, or out of, areas within its national jurisdiction?
  • Not applicable
167. Here you may provide further details on the implementation of Article 24 in your country:
During the reporting period, China has followed the requirements of national laws and regulations to ensure the safe transfer and use of LMOs in the transboundary movements between China and non-Parties to the Protocol.
Article 25 – Illegal transboundary movements
168. Has your country adopted domestic measures aimed at preventing and/or penalizing transboundary movements of LMOs carried out in contravention of its domestic measures to implement this Protocol?
  • Yes
169. Has your country established a strategy for detecting illegal transboundary movements of LMOs?
  • Yes
170. In the current reporting period, how many times has your country received information concerning cases of illegal transboundary movements of an LMO to or from territories under its jurisdiction?
  • Never
175. Here you may provide further details on the implementation of Article 25 in your country:
Not applicable.
Article 26 – Socio-economic considerations
176. If your country has taken a decision on import, has it ever taken into account socio-economic considerations arising from the impact of the LMO on the conservation and sustainable use of biological diversity?
  • Only in some cases
177. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?
  • Yes, to a limited extent
178. Here you may provide further details on the implementation of Article 26 in your country:
The majority of the GMOs imported to China, including GM-soybean, GM-corn, GM- canola and GM-cotton, are used for processing, while only a small amount is used for testing and research.

China has conducted research on the socio-economic impacts of GM-cotton, GM-rice, GM-poplars and GM-papaya. For example, with support from International Fund for Agriculture Development (IFAD) and Asian Development Bank (ADB), Institute of Energy and Environmental Protection affiliated to MOA and Stanford University jointly implemented the project of Impacts of Bio-fuel Development on Agriculture, Food Supply, Poverty and Environment in China. The research institutions from China, Netherlands and U.K participated in the project, Agriculture of China in Transition: Impacts of Trade, Society and Environment, which was funded by EU. MEP conducted preliminary research on the socio-economic impacts of GM-papaya.
Article 27 – Liability and Redress
179. Has your country signed the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?
  • No
180. Has your country initiated steps towards ratification, acceptance or approval of the Nagoya-Kuala Lumpur Supplementary Protocol?
  • Yes
181. Here you may provide further details on any activities undertaken in your country towards the implementation of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress:
China participated in the entire process of the negotiations on the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress (hereinafter referred to as the Supplementary Protocol) and took an active role. The Chinese government has organized experts to review the rights, duties, laws and regulations related to the Supplementary Protocol. China is one of the largest developing countries with rich biological diversity and largest population. China attaches great importance on ecological safety with the development of economy. A number of departments are involved in biosafety management of LMOs and a series of laws and regulations have been established. MEP will lead the coordination in the communication among departments to promote steps towards ratification of the Supplementary Protocol.
Article 33 – Monitoring and reporting
182. Has your country submitted the previous national reports (Interim and First National Reports)?
  • Yes, First report only
183. If your country did not submit previous reports, indicate the main challenges that hindered the submission
  • Not applicable
Other information
184. Please use this field to provide any other information on issues related to national implementation of the Protocol, including any obstacles or impediments encountered.
PREFACE

The Cartagena Protocol on Biosafety (hereinafter referred to as the Protocol) specifies in Article 33 that each Party shall, at intervals to be determined by the Conference of the Parties, report to the Conference of the Parties serving as the meeting of the Parties to this Protocol on measures that it has taken to implement the Protocol. The aim of the national report is to describe the progress in implementation of the Protocol, to summarize experiences gained, and to identify weaknesses and constraints. China became a Party to the Protocol on 6 September 2005 and submitted its First National Report on the Implementation of the Cartagena Protocol on Biosafety to the Secretariat of the Convention on Biological Diversity (SCBD) in September 2007.

Each Party shall submit the Second National Report (hereinafter referred to as the Report) to SCBD by the end of 30 September 2011, as determined at the fifth meeting of the Conference of the Parties in October 2010. The Report shall cover activities undertaken between the submission of the first and second national reports. The Report followed the format determined in the decision of the Conference of the Parties. Most of the questions asked in the Report require only a tick in one or more boxes and for each question, space is provided to allow the provision of further details on its implementation. Although there is no set limit on the length of text, in order to assist with the review and synthesis of the information in the Report, respondents are asked to ensure that answers are as relevant and succinct as possible.

The Department of Nature and Ecological Conservation (DNEC) of the Ministry of Environmental Protection (MEP) initiated the compilation of the Report in January 2011. Its process is described as follows:

1. Early-stage surveys prior to writing of the Report
Commissioned by the National Biosafety Administration Office of MEP in January 2011, the Nanjing Institute of Environmental Sciences (NIES) affiliated to MEP started the early-stage surveys and developed a work plan for drafting the Second National Report on the Implementation of the Cartagena Protocol on Biosafety.

2. Development of work plan and task assignment

In February 2011, DNEC accepted the proposed work plan, which specified the organizational form, activity arrangements, technical approaches and deadlines for each activity. Under the leadership of the Co-ordination Group for Implementation of CBD, consisting of Ministry of Foreign Affairs(MFA), Ministry of Science and Technology(MOST), MEP, Ministry of Agriculture(MOA), Ministry of Health(MOH), General Administration of Customs(GAC), General Administration of Quality Supervision, Inspection and Quarantine(AQSIQ), State Forestry Administration(SFA)and Chinese Academy of Sciences(CAS), DNEC was responsible for organization and coordination of relevant central governmental sectors to ensure that all of them would be fully involved in drafting the Report while NIES was responsible for its writing. All relevant sectors actively supported the work and recommended qualified experts from within their sectors as requested.

3. Project initiation for information collection and drafting of the Report
On 15 March 2011, DNEC held a kick-off meeting, attended by the sector officials concerned and their recommended experts. An Expert Group for Report Development was established, composed of experts from NIES, Biotechnology Research Institute (BRI) of Chinese Academy of Agricultural Sciences (CAAS), Chinese Research Academy of Environmental Sciences (CRAES), Chinese Academy of Inspection and Quarantine (CAIQ), Chinese Academy of Forestry (CAF) and Institute of Botany of CAS. According to the accepted work plan, detailed tasks were assigned to the experts at the kick-off meeting.

After the meeting, the experts started to collect data and information from their sectoral sources concerning measures taken, achievements made, experience gained and lessons learned in implementation of the Protocol. On that basis, they identified the issues, difficulties and needs for capacity building in implementation of the Protocol and prepared departmental reports, from which the Report was drafted.

4. Convening expert group meetings to discuss about and revise the Report
The second expert group meeting, which was held in Beijing on 30 May 2011, compiled all draft thematic reports from different sectors and prepared an initial draft Report by synthesizing data and information provided by different sectors.

The second liaison officers meeting and the third expert group meeting, which were held in Beijing on 5 July 2011, had a full discussion about the draft Report and agreed on a version that could be sent for comments from relevant sectors.

5. Soliciting comments from various sectors
From July to August 2011, all comments from all relevant sectors were collected on the basis of which the draft Report was revised and improved.

6. Adoption of the Report
On 18 August 2011, a meeting of the Co-ordination Group was held in Beijing to review and adopt the Report.

7. Finalization, translation and submission of the Second National Report
Based on the Co-ordination Group's comments and suggestions, the Report was further revised, improved and submitted for approval. After that, the Report was translated into English, and submitted to SCBD as requested.

Government departments and research institutions participating in writing the report:
Ministry of Environmental Protection (MEP)
Ministry of Foreign Affairs (MFA)
Ministry of Science and Technology (MOST)
Ministry of Agriculture (MOA)
Ministry of Health (MOH)
General Administration of Customs (GAC)
General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ)
State Forestry Administration (SFA)
Chinese Academy of Sciences (CAS)
Nanjing Institute of Environmental Sciences (NIES)
Biotechnology Research Institute of Chinese Academy of Agricultural Sciences (BRICAAS)
Chinese Research Academy of Environmental Sciences (CRAES)
Chinese Academy of Inspection and Quarantine (CAIQ)
Chinese Academy of Forestry (CAF)
Institute of Botany of Chinese Academy of Sciences (IBCAS)

Literatures and documents referred to in writing the report

[1] MEP. Research and Risk Assessment on biosafety of genetically modified organisms in China. Beijing: China Environmental Science Press, 2008.

[2] SFA. Technical Guidelines for the Safety Assessment of Genetically Modified Forest Plants and Products. 2007.

[3] AQSIQ. Ten industry standards issued from 2008 to 2011, including methods and protocols of conventional PCR AND real-time fluorescence PCR for detection of genetically modified components in familiar edible fungi, etc.

[4] MOA. Notice No 953 1-2007~12-2007. Twelve national standards came into force from March 1st of 2008, including Detection of Genetically Modified Plants and Derived Products-Qualitative PCR Methods for Insect-resistant Maize Bt10 and Its Derivatives, etc.

[5] MOA. Notice No 1193 1-2009~3-2009. Three industry standards came into force from April 23 of 2009, including Detection of Genetically Modified Plants and Derived Products-Qualitative PCR Methods for Ripen-delay Tomato D2 and Its Derivatives, etc.

[6] MOA. Notice No 1485 1-2010~19-2010. Nineteen national standards came into force from January 1st of 2011, including Detection of Genetically Modified Plants and Derived Products-Qualitative PCR Methods for Herbicide-tolerant Cotton MON1445 and Its Derivatives, etc.

Re: Q. 14 - China has been a Party of CPB since 6 September 2005.

Re: Q. 136 & 138 - Multilateral channels also
Comments on reporting format
185. Please use this field to provide any other information on difficulties that you have encountered in filling in this report.
There are a few mistakes in Chinese translation of the Format for the Second National Report, e.g. Q16, Q99.