Law-ref.org Cartagena Protocol on Biosafety
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risk assessment [Global Index]


ARTICLE-5: Pharmaceuticals     [go to this ARTICLE]
... Notwithstanding Article 4 and without prejudice to any right of a Party to subject all living modified organisms to risk assessment prior to the making of decisions on import, this Protocol shall not apply to the transboundary movement of living modified organisms which are pharmaceuticals for humans that are addressed by other relevant international agreements or organisations. ...


ARTICLE-6: Transit and Contained Use     [go to this ARTICLE]
... 2. Notwithstanding Article 4 and without prejudice to any right of a Party to subject all living modified organisms to risk assessment prior to decisions on import and to set standards for contained use within its jurisdiction, the provisions of this Protocol with respect to the advance informed agreement procedure shall not apply to the transboundary movement of living modified organisms destined for contained use undertaken in accordance with the standards of the Party of import. ...


ARTICLE-11: Procedure for Living Modified Organisms Intended for Direct Use as Food or Feed, Or For Processing     [go to this ARTICLE]
... (a) A risk assessment undertaken in accordance with Annex III; and ...


ARTICLE-12: Review of Decisions     [go to this ARTICLE]
... (a) A change in circumstances has occurred that may influence the outcome of the risk assessment upon which the decision was based; or ...
... 4. The Party of import may, at its discretion, require a risk assessment for subsequent imports. ...


ARTICLE-15: Risk Assessment     [go to this ARTICLE]
... Risk Assessment ...
... 1. Risk assessments undertaken pursuant to this Protocol shall be carried out in a scientifically sound manner, in accordance with Annex III and taking into account recognized risk assessment techniques. Such risk assessments shall be based, at a minimum, on information provided in accordance with Article 8 and other available scientific evidence in order to identify and evaluate the possible adverse effects of living modified organisms on the conservation and sustainable use of biological diversity, taking also into account risks to human health. ...
... 1. Risk assessments undertaken pursuant to this Protocol shall be carried out in a scientifically sound manner, in accordance with Annex III and taking into account recognized risk assessment techniques. Such risk assessments shall be based, at a minimum, on information provided in accordance with Article 8 and other available scientific evidence in order to identify and evaluate the possible adverse effects of living modified organisms on the conservation and sustainable use of biological diversity, taking also into account risks to human health. ...
... 1. Risk assessments undertaken pursuant to this Protocol shall be carried out in a scientifically sound manner, in accordance with Annex III and taking into account recognized risk assessment techniques. Such risk assessments shall be based, at a minimum, on information provided in accordance with Article 8 and other available scientific evidence in order to identify and evaluate the possible adverse effects of living modified organisms on the conservation and sustainable use of biological diversity, taking also into account risks to human health. ...
... 2. The Party of import shall ensure that risk assessments are carried out for decisions taken under Article 10. It may require the exporter to carry out the risk assessment. ...
... 2. The Party of import shall ensure that risk assessments are carried out for decisions taken under Article 10. It may require the exporter to carry out the risk assessment. ...
... 3. The cost of risk assessment shall be borne by the notifier if the Party of import so requires. ...


ARTICLE-16: Risk Management     [go to this ARTICLE]
... 1. The Parties shall, taking into account Article 8 (g) of the Convention, establish and maintain appropriate mechanisms, measures and strategies to regulate, manage and control risks identified in the risk assessment provisions of this Protocol associated with the use, handling and transboundary movement of living modified organisms. ...
... 2. Measures based on risk assessment shall be imposed to the extent necessary to prevent adverse effects of the living modified organism on the conservation and sustainable use of biological diversity, taking also into account risks to human health, within the territory of the Party of import. ...
... 3. Each Party shall take appropriate measures to prevent unintentional transboundary movements of living modified organisms, including such measures as requiring a risk assessment to be carried out prior to the first release of a living modified organism. ...


ARTICLE-20: Information Sharing and the Biosafety Clearing-House     [go to this ARTICLE]
... (c) Summaries of its risk assessments or environmental reviews of living modified organisms generated by its regulatory process, and carried out in accordance with Article 15, including, where appropriate, relevant information regarding products thereof, namely, processed materials that are of living modified organism origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology; ...


ARTICLE-21: Confidential Information     [go to this ARTICLE]
... (c) A summary of the risk assessment of the effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health; and ...


ARTICLE-22: Capacity-Building     [go to this ARTICLE]
... 2. For the purposes of implementing paragraph 1 above, in relation to cooperation, the needs of developing country Parties, in particular the least developed and small island developing States among them, for financial resources and access to and transfer of technology and know-how in accordance with the relevant provisions of the Convention, shall be taken fully into account for capacity-building in biosafety. Cooperation in capacity-building shall, subject to the different situation, capabilities and requirements of each Party, include scientific and technical training in the proper and safe management of biotechnology, and in the use of risk assessment and risk management for biosafety, and the enhancement of technological and institutional capacities in biosafety. The needs of Parties with economies in transition shall also be taken fully into account for such capacity-building in biosafety. ...


ARTICLE-Annex_I: Information Required in Notifications Under Article 8, 10 and 13     [go to this ARTICLE]
... (k) A previous and existing risk assessment report consistent with Annex III. ...


ARTICLE-Annex_II: Information Required Concerning Living Modified Organisms Intended for Direct Use as Food or Feed, or for Processing Under Article 11     [go to this ARTICLE]
... (j) A risk assessment report consistent with Annex III. ...


ARTICLE-Annex_III: Risk Assessment     [go to this ARTICLE]
... Risk Assessment ...
... 1. The objective of risk assessment, under this Protocol, is to identify and evaluate the potential adverse effects of living modified organisms on the conservation and sustainable use of biological diversity in the likely potential receiving environment, taking also into account risks to human health. ...
... Use of risk assessment ...
... 2. Risk assessment is, inter alia , used by competent authorities to make informed decisions regarding living modified organisms. ...
... 3. Risk assessment should be carried out in a scientifically sound and transparent manner, and can take into account expert advice of, and guidelines developed by, relevant international organizations. ...
... 6. Risk assessment should be carried out on a case-by-case basis. The required information may vary in nature and level of detail from case to case, depending on the living modified organism concerned, its intended use and the likely potential receiving environment. ...
... 7. The process of risk assessment may on the one hand give rise to a need for further information about specific subjects, which may be identified and requested during the assessment process, while on the other hand information on other subjects may not be relevant in some instances. ...
... 8. To fulfil its objective, risk assessment entails, as appropriate, the following steps: ...
... 9. Depending on the case, risk assessment takes into account the relevant technical and scientific details regarding the characteristics of the following subjects: ...