Japan | BCH-NR3-JP-109091 | Third National Report on the Implementation of the Cartagena Protocol on Biosafety | Biosafety Clearing-House

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Third National Report on the Implementation of the Cartagena Protocol on Biosafety (NR3)

last updated: 28 Oct 2015
General Information


Japanese seven government ministries responsible for the implementation of the Cartagena Protocol on Biodiversity
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01 Oct 2011
31 Oct 2015
Party to the Cartagena Protocol on Biosafety
Yes
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Article 2 – General provisions
A domestic regulatory framework is fully in place
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2004
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  • One or more national biosafety laws
Yes
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Yes
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More than 10
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Yes
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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.
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Article 5 - Pharmaceuticals
Yes
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Yes
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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.
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Article 6 – Transit and Contained use
No
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Yes
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Yes
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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.
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Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
Yes
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Yes
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Yes
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Yes
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Yes
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Yes
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Yes
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Less than 10
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None
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Less than 5
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Less than 5
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Yes
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Yes
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Yes
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Yes, always
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  • Approval of the import/use of the LMO(s) without conditions (100)
No
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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.
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Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
Yes
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Yes
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Yes
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Yes
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No
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Yes
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More than 10
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None
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More than 10
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No
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Yes, always
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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.
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Article 12 – Review of decision
Yes
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No
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No
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None
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Japan has not reviewed/changed a decision regarding an intentional transboundary movement of LMOs.
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Article 13 – Simplified procedure
No
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No
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None
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Japan has not used simplified procedure.
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