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Third National Report on the Implementation of the Cartagena Protocol on Biosafety (NR3)
  |  
BCH-NR3-JP-109091-1   |   PDF   |   Print   |  
last updated: 28 Oct 2015
General Information

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Japanese seven government ministries responsible for the implementation of the Cartagena Protocol on Biodiversity
EN

01 Oct 2011
31 Oct 2015
Party to the Cartagena Protocol on Biosafety
Yes
EN
Article 2 – General provisions
A domestic regulatory framework is fully in place
EN
2004
EN
  • One or more national biosafety laws
Yes
EN
Yes
EN
More than 10
EN
Yes
EN
Japanese seven government ministries responsible for the implementation of the Cartagena Protocol on Biosafety are full-time staffed and secure a budget to operate the domestic law for the implementation of the Protocol.
EN
Article 5 - Pharmaceuticals
Yes
EN
Yes
EN
Under the domestic law for the implementation of the Protocol, biological diversity risk assessment regarding domestic use of LMOs including which are pharmaceuticals for human is carried out on the basis of the Biological Diversity Risk Assessment Report submitted by the applicant, and approval is given if it is recognized that there is no possibility of adverse effect on biodiversity. However, LMOs which are pharmaceuticals for human are excluded from stipulation on notification of export and indication for export.
EN
Article 6 – Transit and Contained use
No
EN
Yes
EN
Yes
EN
Under the domestic law for the implementation of the Protocol, the domestic uses of LMOs with containment measured to prevent to disposal of LMOs in the environment are possible when the containment measures are stipulated in the ordinance of the competent ministries or confirmed in advance by the competent minister.<br />Japan does not regulate the transit of LMOs.
EN
Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Less than 10
EN
None
EN
Less than 5
EN
Less than 5
EN
Yes
EN
Yes
EN
Yes
EN
Yes, always
EN
  • Approval of the import/use of the LMO(s) without conditions (100)
No
EN
Under the Protocol and its relevant domestic law, biological diversity risk assessments had been carried out regarding use of three LMOs (two soybeans,one maize).&nbsp; Approvals for these three were given without condition during the current period by the Japanese government. Accordingly, BCH was notified to the effect that three LMOs were approved.
EN
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
Yes
EN
Yes
EN
Yes
EN
Yes
EN
No
EN
Yes
EN
More than 10
EN
None
EN
More than 10
EN
No
EN
Yes, always
EN
Under the domestic law for the implementation of the Protocol, biological diversity risk assessment regarding domestic use of LMOs intended for direct use as food or feed, or for processing is carried out on the basis of the Biological Diversity Risk Assessment Report submitted by the applicant, and approval is given if it is recognized that there is no possibility of adverse effect on biodiversity. When Japanese government&nbsp; approved LMOs, the information of the LMOs has been notified to the BCH with relevant information.
EN
Article 12 – Review of decision
Yes
EN
No
EN
No
EN
None
EN
Japan has not reviewed/changed a decision regarding an intentional transboundary movement of LMOs.
EN
Article 13 – Simplified procedure
No
EN
No
EN
None
EN
Japan has not used simplified procedure.
EN
Article 14 – Bilateral, regional and multilateral agreements and arrangements
No
EN
Japan has not entered into any agreement or arrangement in question.
EN
Articles 15 & 16 – Risk Assessment and Risk Management
Yes
EN
Yes
EN
100 or more
EN
100 or more
EN
100 or more
EN
Yes
EN
No
EN
No
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
No
EN
Yes
EN
No
EN
Yes
EN
  • Commercial production
  • Field trial
  • LMOs for Contained use
  • LMOs for direct use as food
  • LMOs for direct use as feed
  • LMOs for processing
In some cases only
EN
Yes, always
EN
More than 10
EN
Yes
EN
Yes
EN
Yes
EN
Under the domestic law for the implementation of the Protocol, persons who wish to use new LMOs in the environment (developers and importers, etc.) must carry out a prior risk assessment of adverse effect on biological diversity in accordance with the Guidance of Implementation of Assessment of Adverse effect on Biological Diversity. The competent ministers may grant approval when recognizing, taking account of the content of consultation with experts, that no adverse effect on biological diversity could arise. Persons who wish to export LMOs to Japan from a foreign country and to make them used in Japanese environment, may appoint a Domestic Manager who has an address in Japan and obtain such approval.
EN
Article 17 – Unintentional transboundary movements and emergency measures
Yes
EN
Yes
EN
Yes
EN
Never
EN
No such case has been reported.
EN
Article 18 – Handling, transport, packaging and identification
Yes
EN
Yes
EN
Yes
EN
A stand-alone document
EN
Yes
EN
A stand-alone document
EN
Yes
EN
A stand-alone document
EN
Yes
EN
Yes
EN
100 or more
EN
Yes
EN
100 or more
EN
Yes
EN
5 or more
EN
5 or more
EN
The domestic law for the Protocol stipulates that the package, vessel and invoice, etc. of LMOs intended for export to a Party must be accompanied by the descriptions of the required specific matters. Their specific formats are set forth in the Regulations of the Law. What has to be described differs, based on the provision of the Protocol, depending upon whether they are LMOs intended for contained use, or LMOs intended for use as food or feed or for processing, or LMOs intended for other use.
EN
Article 19 – Competent National Authorities and National Focal Points
n/a
EN
Yes
EN
Japan has been providing relevant information to the BCH.
EN
Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
Information available and in the BCH
EN
Information available and in the BCH
EN
Information not available
EN
Information available and in the BCH
EN
Information available and in the BCH
EN
Information not available
EN
Information not available
EN
Information available and in the BCH
EN
Information available and in the BCH
EN
Information not available
EN
Information available and in the BCH
EN
Information available and in the BCH
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information available and in the BCH
EN
No
EN
Yes
EN
Yes, in some cases
EN
No
EN
Yes
EN
10 or more
EN
100 or more
EN
Any information required to be made available to the BCH under the Protocol has been directly conveyed to the BHC through its management center. As an equivalent to BCH at national level, the Japanese version of the Biosafety Clearing-House (J-BCH) is operated, where information on the Protocol and Japanese legislation as well as database on LMOs approved in Japan are posted. On the website, information on the legal mechanisms under Japanese legislation and on LMOs (the usage of LMOs approved in Japan and the outlines of risk assessments) are also available in English.
EN
Article 21 – Confidential information
Yes
EN
Yes, always
EN
Under the domestic law for the implementation of the Protocol, when biological diversity risk assessment regarding domestic use of LMOs is carried out on the basis of the Biological Diversity Risk Assessment Report submitted by the applicant, confidential information identified by the applicant is to be treated as nondisclosure and the person involved is to be required not to divulge the information.
EN
Article 22 – Capacity-building
Yes
EN
No
EN
Yes
EN
Multilateral channels
EN
No
EN
Yes
EN
  • 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
  • Identification of LMOs, including their detection
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
  • Scientific biosafety research relating to LMOs
No
EN
No
EN
No
EN
No
EN
None
EN
Yes
EN
Japan has been contributing financial resources to the GEF, which has been implementing a number of projects to build capacity on biosafety.<br />Six Japanese experts are inscribed on the Roster of Biosafety Experts posted on the BCH.<br />Japan hashad been contributing financial resources to the SCBD to support a number of projects on capacity building activities under the Cartagena protocol on Biosafety.<br />
EN
Article 23 – Public awareness and participation
Yes
EN
Yes
EN
Yes
EN
Based on the national biodiversity strategy of Japan, the government has been enlightening about&nbsp; japanese legislation and LMOs.
EN
Yes
EN
None
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
  • National website
National website
EN
Yes
EN
10 or more
EN
None
EN
Yes
EN
No
EN
More than 5
EN
Information on LMOs including the status of development and uses of LMOs in Japan is made available on the websites of the ministries concerned and J-BCH.<br />Furthermore, access to the information posted on the BCH is facilitated through links to the BCH. <br />In approving the use of LMOs in the environment, the outline of the Biological Diversity Risk Assessment Report as well as the content of consultation of the experts on the application concerned are released for public comments and the outcome of the decision is also released on J-BCH and other relevant websites.
EN
Article 24 – Non-Parties
No
EN
Yes
EN
No
EN
Yes
EN
Yes, always
EN
Japan imports LMOs-FFP and LMOs intended for contained use from Non-Parties. A person who wishes to use LMOs in the environment in Japan (including the distribution of living seeds as food or as feed) must obtain approval under the domestic law for the Protocol. Therefore, any LMO that has not been approved in Japan can not be used in the environment even if it is imported from a Non-Party.
EN
Article 25 – Illegal transboundary movements
Yes
EN
Yes
EN
Less than 5
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
In the current reporting period, Japanese government received information about one case of illegal import of LMO ( papaya). This case happened because the importer had not recognized that it was genetically modified. To prevent adverse effect on biological diversity, Japanese government took measures such as recall or disposal of the LMOs and required importers to take preventive steps.
EN
Article 26 – Socio-economic considerations
No
EN
No
EN
None
EN
No such case has been reported.
EN
Yes
EN
No such case has been reported.
EN
Article 27 – Liability and Redress
No
EN
Yes
EN
No
EN
No
EN
Conclusion of the Nagoya-Kuala Lumpur Supplementary Protocol is under consideration by Japanese government.
EN
Article 28 – Financial Mechanism and Resources
500,000 USD or more
EN
Article 33 – Monitoring and reporting
Yes
EN
Yes
EN
Yes
EN
Other information
Comments on reporting format