RATIFIED INTERNATIONAL INSTRUMENTS

ZMB_Legal Hub_ International Instruments_Picture © Brent Stirton

Cartagena Protocol on Biosafety

Art. 2-1

The legal framework requires that the development, handling, transport, use, transfer and release of any living modified organism (LMO) be done in a way that prevents or reduces risks to biological diversity, in particular taking into account risks to human health.

Art 7.1

For LMOs intended to be intentionally introduced into the environment of the importing State, the legal framework provides for a prior informed agreement procedure (APCC) applying before the first intentional transboundary movement of LMOs.

Art. 8-1

The legal framework provides:
- provides for a written notification from the exporting State (or the exporter directly) to the competent national authority of the importing State before the intentional transboundary movement of an LMO referred to in Article 7-1.
- requires that the notification contain at least the information specified in Annex I to the Protocol.

Art. 8-2

The legal framework provides for legal responsibility for the accuracy of the information communicated by the exporter as part of the notification provided for in Article 8-1.

Art. 10-3

The legal framework requires that the importing State communicate to the notifier and to the Biosafety Clearing-House (BCH), within 270 days of the date of receipt of the notification, the decision:
- authorizing the import, with or without conditions, of the LMO and indicating how this decision will apply to subsequent imports of the same LMO; or
- prohibiting import.

Art. 11-1

For LMOs used directly for food (human or animal) or processed and which are likely to be the subject of a transboundary movement, the legal framework provides for an information procedure and requires that:
- any final decision concerning the use on national territory (including the placing on the market) of such an LMO must be communicated within 15 days to the BCH;
- the information communicated to the BCH contains at least the information requested in Annex II to the Protocol.

Art. 15-2

The legal framework requires the importing State to ensure that a risk assessment is carried out before taking a decision under Article 10 (LMOs intended to be intentionally introduced into the environment).

Art. 16-1

The legal framework requires the establishment of appropriate mechanisms, measures and strategies aimed at regulating, managing and controlling the risks linked to the use, handling and transboundary movements of LMOs.

Art. 16-2

The legal framework requires the establishment of risk-based measures to prevent the adverse effects of the LMO on the conservation and sustainable use of biological diversity (including risks to human health) on the territory of the importing State.

Art. 16-3

The legal framework provides for appropriate measures to prevent unintentional transboundary movements of LMOs.

Art. 16-4

The legal framework requires that any LMO, imported or developed locally, be subjected before use to an appropriate observation period corresponding to its life cycle or training time.

Art. 18-1

 The legal framework provides that LMOs that are the subject of an intentional transboundary movement under the Protocol are to be handled, packaged and transported under conditions of safety taking into account the relevant international rules and standards.

Art. 18-2

The legal framework requires:
a) For LMOs used directly for food or processed: documentation clearly indicating:
- that they “may contain” LMOs;
- they are not intended to be intentionally introduced into the environment;
- the contact details of the person to contact for any further information.
c) For LMOs intended to be intentionally introduced into the environment of the importing State as well as any other LMOs covered by the Protocol: documentation:
- clearly indicating that they are LMOs;
- specifying their identity and relevant traits and characteristics;
- indicating any safety rule to be observed for the handling, storage, transport and use of these organisms;
- indicating the contact details of the person to be contacted for any further information and, where applicable, the name and address of the importer and exporter;
- containing a declaration certifying that the movement complies with the requirements of the Protocol applicable to the exporter.

Art. 21 - 3

The legal framework protects confidential information received under the Protocol (including confidential information received under the PIAP procedure provided for in Articles 7, 8 9 and 10) as favorably as confidential information relating to LMOs of national origin.

Art. 23-1

The legal framework provides for measures to encourage:
(a) public awareness, education and participation regarding the safe transfer, handling and use of LMOs for the conservation and sustainable use of biological diversity, taking also into account the risks for human health;
b) access to information on LMOs that can be imported.

Art. 23-2

The legal framework provides:
a) public consultation when taking decisions relating to LMOs;
(b) making the outcome of these decisions available to the public, while respecting the confidentiality of the information.

Art. 25-1

The legal framework provides for national measures to prevent and suppress illicit transboundary movements of LMOs.