Chapter IV. Treaties concerning international law concluded under the auspices of the United Nations and related intergovernmental organizations

TreaTIes ConCernIng InTernaTIonal law ConCluded under The auspICes of The unITed naTIons and relaTed InTergoVernmenTal organIzaTIons

1. Treaties concerning international law concluded under the auspices of the united nations

   1. CARTAGENA PROTOCOL ON BIOSAFETY TO THE CONVENTION ON BIOLOGICAL DIVERSITY.1 DONE AT MONTREAL ON 29 JANUARY 20002

      The Parties to this Protocol,

      Being Parties to the Convention on Biological Diversity, hereinafter referred to as “the Convention”,

      Recalling article 19, paragraphs 3 and 4, and articles 8 (g) and 17 of the Convention,

      Recalling also decision II/5 of 17 November 1995 of the Conference of the Parties to the Convention to develop a Protocol on biosafety, specifically focusing on transboundary movement of any living modified organism resulting from modern biotechnology that may have an adverse effect on the conservation and sustainable use of biological diversity, setting out for consideration, in particular, appropriate procedures for advance informed agreement,

      Reaffirming the precautionary approach contained in principle 15 of the Rio Declaration on Environment and Development,

      Aware of the rapid expansion of modern biotechnology and the growing public concern over its potential adverse effects on biological diversity, taking also into account risks to human health,

      Recognizing that modern biotechnology has great potential for human well-being if developed and used with adequate safety measures for the environment and human health,

      Recognizing also the crucial importance to humankind of centres of origin and centres of genetic diversity,

      Taking into account the limited capabilities of many countries, particularly developing countries, to cope with the nature and scale of known and potential risks associated with living modified organisms,

      Recognizing that trade and environment agreements should be mutually supportive with a view to achieving sustainable development,

      Emphasizing that this Protocol shall not be interpreted as implying a change in the rights and obligations of a Party under any existing international agreements,

      Understanding that the above recital is not intended to subordinate this Protocol to other international agreements,

      Have agreed as follows:

      Article 1

      Objective

      In accordance with the precautionary approach contained in principle 15 of the Rio Declaration on Environment and Development, the objective of this Protocol is to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern bio-technology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements.

      Article 2

      General prOvisiOns

   1. Each Party shall take necessary and appropriate legal, administrative and other measures to implement its obligations under this Protocol.

   2. The Parties shall ensure that the development, handling, transport, use, transfer and release of any living modified organisms are undertaken in a manner that prevents or reduces the risks to biological diversity, taking also into account risks to human health.

   3. Nothing in this Protocol shall affect in any way the sovereignty of States over their territorial sea established in accordance with international law, and the sovereign rights and the jurisdiction which States have in their exclusive economic zones and their continental shelves in accordance with international law, and the exercise by ships and aircraft of all States of navigational rights and freedoms as provided for in international law and as reflected in relevant international instruments.

   4. Nothing in this Protocol shall be interpreted as restricting the right of a Party to take action that is more protective of the conservation and sustainable use of biological diversity than that called for in this Protocol, provided that such action is consistent with the objective and the provisions of this Protocol and is in accordance with that Party’s other obligations under international law.

   5. The Parties are encouraged to take into account, as appropriate, available expertise, instruments and work undertaken in international forums with competence in the area of risks to human health.

      Article 3

      Use Of terms

      For the purposes of this Protocol:

      (a) “Conference of the Parties” means the Conference of the Parties to the Convention;

      (b) “Contained use” means any operation, undertaken within a facility, installation or other physical structure, which involves living modified organisms that are controlled by specific measures that effectively limit their contact with, and their impact on, the external environment;

      (c) “Export” means intentional transboundary movement from one Party to another Party;

      (d) “Exporter” means any legal or natural person, under the jurisdiction of the Party of export, who arranges for a living modified organism to be exported;

      (e) “Import” means intentional transboundary movement into one Party from another Party;

      (f) “Importer” means any legal or natural person, under the jurisdiction of the Party of import, who arranges for a living modified organism to be imported;

      (g) “Living modified organism” means any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology;

      (h) “Living organism” means any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids;

      (i) “Modern biotechnology” means the application of:

1. In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or

2. Fusion of cells beyond the taxonomic family,

   that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection;

   (j) “Regional economic integration organization” means an organization constituted by sovereign States of a given region, to which its member States have transferred competence in respect of matters governed by this Protocol and which has been duly authorized, in accordance with its internal procedures, to sign, ratify, accept, approve or accede to it;

   (k) “Transboundary movement” means the movement of a living modified organism from one Party to another Party, save that for the purposes of articles 17 and 24 transboundary movement extends to movement between Parties and non-Parties.

   Article 4

   scOpe

   This Protocol shall apply to the transboundary movement, transit, handling and use of all living modified organisms that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.

   Article 5

   pharmaceUticals

   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 organizations.

   Article 6

   transit and cOntained Use

   1. Notwithstanding article 4 and without prejudice to any right of a Party of transit to regulate the transport of living modified organisms through its territory and make available to the Biosafety Clearing-House, any decision of that Party, subject to article 2, paragraph 3, regarding the transit through its territory of a specific living modified organism, the provisions of this Protocol with respect to the advance informed agreement procedure shall not apply to living modified organisms in transit.

   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 7

      applicatiOn Of the advance infOrmed aGreement prOcedUre

   1. Subject to articles 5 and 6, the advance informed agreement procedure in articles 8 to 10 and 12 shall apply prior to the first intentional transboundary movement of living modified organisms for intentional introduction into the environment of the Party of import.

   2. “Intentional introduction into the environment” in paragraph 1 above does not refer to living modified organisms intended for direct use as food or feed, or for processing.

   3. Article 11 shall apply prior to the first transboundary movement of living modified organisms intended for direct use as food or feed, or for processing.

   4. The advance informed agreement procedure shall not apply to the intentional transboundary movement of living modified organisms identified in a decision of the Conference of the Parties serving as the meeting of the Parties to this Protocol as being not likely to have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.

      Article 8

      nOtificatiOn

   1. The Party of export shall notify, or require the exporter to ensure notification to, in writing, the competent national authority of the Party of import prior to the intentional transboundary movement of a living modified organism that falls within the scope of article 7, paragraph 1. The notification shall contain, at a minimum, the information specified in annex I.

   2. The Party of export shall ensure that there is a legal requirement for the accuracy of information provided by the exporter.

      Article 9

      acknOwledGement Of receipt Of nOtificatiOn

   1. The Party of import shall acknowledge receipt of the notification, in...