Key Benefits:
President of the Republic,
On the report of the Prime Minister and the Minister for Foreign Affairs,
Considering articles 52 to 55 of the Constitution;
Considering Act No. 2003-206 of 12 March 2003 authorizing the approval of the Cartagena Protocol on Biosafety for the Convention on Biological Diversity, adopted in Montreal on 29 January 2000;
Having regard to the amended Decree No. 53-192 of 14 March 1953 concerning the ratification and publication of the international commitments undertaken by France;
In view of Decree No. 95-140 of 6 February 1995 on the publication of the Convention on Biological Diversity, adopted at Rio de Janeiro on 22 May 1992 and signed by France on 13 June 1992,
Decrete:
The Cartagena Protocol on Biosafety for the Convention on Biological Diversity, adopted in Montreal on 29 January 2000, will be published in the Official Journal of the French Republic.
The Prime Minister and the Minister for Foreign Affairs are responsible for the execution of this Order, which will be published in the Official Journal of the French Republic.
P R O T O C O L E D E C A R T H A G È N E
ON THE PREVENTION OF BIOTECHNOLOGICAL RISKS
TO THE CONVENTION ON BIOLOGICAL DIVERSITY
The Parties to this Protocol,
Being Parties to the Convention on Biological Diversity, below referred to as the Convention,
Recalling Article 19, paragraphs 3 and 4, Article 8 (g) and Article 17 of the Convention,
Recalling also decision II/5 of 17 November 1995 of the Conference of the Parties to the Convention calling for the development of a protocol on the prevention of biosafety that would specifically address the transboundary movements of modified living organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, and that would, in particular, consider an appropriate procedure for prior informed consent,
Reaffirming the precautionary approach enshrined in Principle 15 of the Rio Declaration on Environment and Development,
Aware that modern biotechnology is growing rapidly and that the general public is increasingly concerned about the adverse effects it may have on biological diversity, including the risks it may have for human health,
Recognizing that modern biotechnology offers considerable potential for the well-being of the human being as long as it is developed and used in satisfactory safety conditions for the environment and human health,
Recognizing also the crucial importance for humanity of the centres of origin and centres of genetic diversity,
Taking into account the limited capacity of many countries, including developing countries, to cope with the nature and importance of known and potential risks posed by modified living organisms,
Believing that trade and environment agreements should support each other in order to achieve sustainable development,
Stressing that this Protocol shall not be construed as implying a modification of the rights and obligations of a Party under other international agreements in force,
Considering that it is understood that this preamble is not intended to subordinate the Protocol to other international agreements,
agreed that:
Article 1
Objective
In accordance with the precautionary approach enshrined 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 for the safe transfer, handling and use of modified living organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account also the risks to human health, with a particular focus on the conservation and sustainable use of biological diversity.
Article 2
General provisions
1. Each Party shall take the necessary and appropriate legal, administrative and other measures to fulfil its obligations under the Protocol.
2. The Parties shall ensure that the development, handling, transport, use, transfer and release of any modified living organisms are carried out in a manner that prevents or reduces the risks to biological diversity, taking into account also the risks to human health.
3. Nothing in this Protocol affects, in any way, the sovereignty of States over their territorial waters as established in international law, or the sovereign rights or jurisdiction they exercise on their exclusive economic zone and on their continental shelf under international law, or the exercise, by ships and aircraft of all States, of the rights and freedoms of navigation conferred by international law and enshrined in relevant international instruments.
4. Nothing in this Protocol shall be construed as restricting the right of a Party to take more stringent measures for the conservation and sustainable use of biological diversity than those provided for in the Protocol, provided that they are consistent with the objective and provisions of the Protocol and in accordance with the other obligations imposed on that Party by international law.
5. Parties are encouraged to take appropriately into account available expertise, existing instruments and work undertaken by relevant international bodies with regard to human health risks.
Article 3
Definitions
For the purpose of the Protocol:
(a) "COP" means the Conference of the Parties to the Convention;
(b) "Use in confined environments" means any operation, undertaken in a device, installation, or any other physical structure, involving modified living organisms that are regulated by specific measures that effectively limit contact with the outside environment, and the impact on that environment;
(c) "Exportation" means any intentional transboundary movement from a Party and to another Party;
(d) "Exporter" means any legal or physical person within the jurisdiction of the Exporting Party, who makes arrangements for an amended living organism to be exported;
(e) "Importion" means any intentional transboundary movement to a Party and from another Party;
(f) "importer" means any legal or physical person within the jurisdiction of the importing Party, who makes arrangements for an amended living organism to be imported;
(g) "Modified living organism" means any living organism with a combination of unpublished genetic material obtained through modern biotechnology;
(h) "Life Organization" means any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids;
i) "Modern Biotechnology" means:
(a) the application of in vitro techniques to nucleic acids, including the recombination of deoxyribonucleic acid (ADN) and the direct introduction of nucleic acids into cells or organites;
(b) cell fusion of organisms not belonging to the same taxonomic family,
which overcome the natural barriers of the physiology of reproduction or recombination and which are not techniques used for reproduction and selection of classic type;
(j) "Regional Economic Integration Organization" means any organization constituted by sovereign States of a particular region, to which its member States have transferred their jurisdiction over all matters within the Protocol and which has been duly authorized, in accordance with its internal procedures, to sign, ratify, accept or approve the Protocol, or to accede to it;
(k) "Transboundary Movement" means any movement of a modified living organism from a Party and to another Party, to this close that, for the purposes of Articles 17 and 24, "Transboundary Movement" extends to movements between Parties and non-Parties.
Article 4
Scope
This Protocol applies to transboundary movements, transit, handling and use of any modified living organism that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account also the risks to human health.
Article 5
Pharmaceutical products
Notwithstanding Article 4 and without prejudice to the right of the Parties to submit any modified living organisms to a risk assessment before making a decision on its importation, this Protocol does not apply to the transboundary movements of modified living organisms that are pharmaceutical products intended for humans under other relevant international agreements or bodies.
Article 6
Transit and confined uses
1. Notwithstanding section 4 and without prejudice to the right of a transit Party to regulate the transport of modified living organisms in its territory and to notify the Exchange Centre for Biosafety of any decision it has made, pursuant to paragraph 3 of Article 2, concerning the transit in its territory of a specified living organism, the provisions of this Protocol relating to the procedure of living prior agreement shall apply
2. Notwithstanding Article 4 and without prejudice to the right of any Party to submit a modified living body to any risk assessment before making a decision on its importation and setting standards for confined environmental uses within its jurisdiction, the provisions of this Protocol relating to the prior informed consent procedure shall not apply to transboundary movements of modified living organisms intended to be used in confined environments.
Article 7
Application of the agreement procedure
prior knowledge of cause
1. Subject to Articles 5 and 6, the prior informed consent procedure provided for in Articles 8, 9, 10 and 12 shall apply before the first intentional transboundary movement of modified living organisms intended to be intentionally introduced into the environment of the importing Party.
2. The intentional introduction to the environment referred to in paragraph 1 above does not concern the modified living organisms intended to be used directly for human or animal feed, or to be transformed.
3. Section 11 applies before the first transboundary movement of modified living organisms intended to be used directly for human or animal feed or to be processed.
4. The prior informed consent procedure does not apply to intentional transboundary movements of modified living organisms that, in a decision of the Conference of the Parties serving as the Meeting of the Parties to the Protocol, are defined as not likely to have adverse effects on the conservation and sustainable use of biological diversity, also given the risks to human health.
Article 8
Notification
1. The Exporting Party shall address, or require that the exporter ensure, in writing, that a notification is sent to the competent national authority of the importing Party before the intentional transboundary movement of a modified living organism referred to in paragraph 1 of Article 7. The notification shall contain at least the information specified in Annex I.
2. The Exporting Party shall ensure that there is legal liability for the accuracy of the information provided by the exporter.
Article 9
Acknowledgement of receipt of notification
1. The importing Party shall, within 90 days, send a notice in writing to the notification author.
2. The acknowledgement of receipt indicates:
(a) The date of receipt of the notification;
(b) If the notification contains at first sight the information referred to in Article 8;
(c) If it is appropriate to proceed in accordance with the national regulatory framework of the importing Party or following the procedure provided for in Article 10.
3. The national regulatory framework referred to in paragraph 2 (c) above must comply with the Protocol.
4. The fact that the importing Party does not acknowledge receipt of a notification does not mean that it consents to the intentional transboundary movement.
Article 10
Decision procedure
1. The decisions taken by the importing Party are in accordance with Article 15.
2. The importing Party shall, within the time limit prescribed in Article 9, indicate in writing to the notification author whether the intentional transboundary movement may take place:
(a) Only where the importing Party has given its consent in writing; or
(b) After a period of at least 90 days without further written consent.
3. Within 270 days of the date of receipt of the notification, the importing Party shall communicate in writing to the notification author and the Biosafety Exchange Centre, the decision referred to in paragraph 2 (a) above:
(a) Authorizing import, with or without condition, and indicating how the decision will apply to subsequent imports of the same modified living organism;
(b) Prohibition of import;
(c) Requesting additional relevant information in accordance with its national regulations or Annex I; the number of days between the time the importing Party requests additional relevant information and the time it obtains it does not come into account in calculating the time it has to respond;
(d) Informing the communicant that the period specified in this paragraph is extended for a specified period of time.
4. Except in the case of unconditional consent, the decisions referred to in paragraph 3 above shall indicate the reasons for their reasons.
5. The fact that the importing Party does not disclose its decision within 270 days of the date of receipt of the notification does not mean that it consents to the intentional transboundary movement.
6. The lack of scientific certainty due to the insufficient scientific information and knowledge relevant to the extent of potential adverse effects of a modified living organism on the conservation and sustainable use of biological diversity in the importing Party, also taking into account the risks to human health, does not prevent this party from making appropriate decisions regarding the importation of the affected living organism as indicated in paragraph 3 above, to avoid or reduce adverse effects.
7. The Conference of the Parties serving as the meeting of the Parties to the Protocol shall, at its first meeting, decide appropriate procedures and mechanisms to assist importing Parties in making a decision.
Article 11
Procedure for modified living organisms intended to be used directly for human or animal feed, or to be processed
1. Any Party that makes a final determination regarding the use of a modified living organism on the national territory, including the placing on the market, that may be subject to a transboundary movement and that is intended to be used directly for human or animal food or to be processed, shall, within fifteen days after that, inform other Parties, through the Biosafety Exchange Centre. This information must contain at least the information requested in Appendix II. The Party shall, in writing, provide a copy of this information to the national focal points of the Parties that have informed the secretariat in advance that they do not have access to the Biosafety Exchange Centre. This provision does not apply to decisions regarding field trials.
2. Any Party making a decision in accordance with paragraph 1 above shall ensure that legal provisions guarantee the accuracy of the information provided by the applicant.
3. Any Party may request additional information from the authority referred to in paragraph (b) of Annex II.
4. Any Party may make, within the framework of its national regulations, a decision concerning the importation of a living modified organism intended to be used directly for human or animal food or to be processed, provided that this decision is consistent with the objective of this Protocol.
5. Each Party shall make available to the Biosafety Exchange Centre a copy of all national laws, regulations and directives applicable to the importation of modified living organisms intended to be used directly for human or animal food or to be processed, if available.
6. Any developing countries or countries with economies in transition Party to this Protocol may, in the absence of the national regulatory framework referred to in paragraph 4 above, in exercising its national jurisdiction, declare, through the Biosafety Exchange Centre, that its decision before the first importation of a living modified organism intended to be used directly for human or animal food or to be processed, in respect of which information has been provided above:
(a) Following a risk assessment undertaken in accordance with Appendix III; and
(b) In a predictable period not exceeding 270 days.
7. The fact that a Party does not communicate its decision in accordance with paragraph 6 above does not mean that it consents to import or refuses to import the affected living organism to be used directly for human or animal feed or to be processed, unless it has otherwise specified it.
8. The lack of scientific certainty due to the insufficient scientific information and knowledge relevant to the extent of potential adverse effects of a modified living organism on the conservation and sustainable use of biological diversity in the importing Party, also taking into account the risks to human health, does not prevent that Party from making appropriate decisions regarding the importation of that modified living organism if it is intended to be used directly for human or animal feed
9. Any Party may make known its needs in terms of financial and technical assistance and capacity development, in respect of modified living organisms intended to be used directly for human or animal food or to be processed. The Parties shall cooperate to meet these needs in accordance with Articles 22 and 28 of this Protocol.
Article 12
Review of decisions
1. An importing Party may at any time, in the light of new scientific information on the potential adverse effects on the conservation and sustainable use of biological diversity, taking into account also the risks to human health, reconsider and amend its decision on an intentional transboundary movement. In such a case, within thirty days, it shall inform the authors of previous notifications of movements of the affected living organism, as well as the Biosafety Exchange Centre, indicating the reasons for its decision.
2. An exporting Party or the person making a notification may request an importing Party to reconsider its decision under Article 10 when the exporting Party or the person making the notification considers:
(a) That there is a change in circumstances that may affect the results of the risk assessment that founded the decision; or
(b) That additional scientific or technical information is available.
3. The importing Party shall respond in writing to that request within ninety days, indicating the reasons for its decision.
4. The importing Party may, at its discretion, require a risk assessment for subsequent imports.
Article 13
Simplified procedure
1. An importing Party may, provided that adequate measures are applied to ensure the safe and intentional transboundary movement of modified living organisms, in accordance with the objective of the Protocol, specify in advance to the Biosafety Exchange Centre:
(a) Cases where an intentional transboundary movement of which it is the destination may take place at the very moment when the movement is notified to it;
(b) Imports of modified living organisms exempted from the prior informed consent procedure.
Notifications referred to in paragraph (a) above may be used for subsequent similar movements to the same Party.
2. The information regarding an intentional transboundary movement to be included in the notification referred to in paragraph 1 (a) above is indicated in Appendix I.
Article 14
Bilateral agreements and arrangements,
regional and multilateral
1. Parties may enter into bilateral, regional and multilateral agreements and arrangements concerning the intentional transboundary movements of modified living organisms, if they are in conformity with the objective of the Protocol and provided that such agreements and arrangements do not result in a lesser degree of protection than that provided for in the Protocol.
2. The Parties shall, through the Biosafety Exchange Centre, provide mutual support for any bilateral, regional or multilateral agreement or arrangement that they have entered into before or after the date of entry into force of the Protocol.
3. The provisions of the Protocol have no effect on intentional transboundary movements that take place under any of these agreements or arrangements between the Parties to that Agreement or Arrangement.
4. Any Party may decide that its national regulations apply to specific imports intended for it and notify its decision at the Biosafety Exchange Centre.
Article 15
Risk assessment
1. The risk assessments under this Protocol are based on proven scientific methods, in accordance with Annex III and taking into account recognized risk assessment methods. These risk assessments are based on the information provided in accordance with Article 8 and other available scientific evidence to determine and evaluate the potential adverse effects of modified living organisms on the conservation and sustainable use of biological diversity, also taking into account the risks to human health.
2. The importing Party shall ensure that a risk assessment is made to make a decision under Article 10. It may require that the exporter conduct the risk assessment.
3. The cost of risk assessment shall be borne by the notification author if required by the importing Party.
Article 16
Risk management
1. Taking into account Article 8 (g) of the Convention, Parties shall establish and implement appropriate mechanisms, measures and strategies to regulate, manage and control the risks defined by the Protocol's provisions relating to the assessment of risks associated with the use, handling and transboundary movements of modified living organisms.
2. Risk-based measures are imposed to the extent necessary to prevent the adverse effects of the modified living organism on the conservation and sustainable use of biological diversity, including risks to human health, on the territory of the importing Party.
3. Each Party shall take appropriate measures to prevent unintentional transboundary movements of modified living organisms, including measures prescribing a risk assessment prior to the first release of a modified living organism.
4. Without prejudice to paragraph 2 above, each Party shall ensure that any living organism that has been altered, imported or developed locally, has been subjected to an appropriate observation period corresponding to its life cycle or training time before being used as intended.
5. The Parties shall cooperate to:
(a) Identify modified living organisms or characters of modified living organisms that may have adverse effects on the conservation and sustainable use of biological diversity, also taking into account risks to human health;
(b) Take appropriate measures to treat these modified living organisms or specific characters.
Article 17
Non-intentional transboundary movements
and emergency measures
1. Each Party shall take appropriate measures to notify the States effectively affected or capable of being, at the Biosafety Exchange Centre and, if necessary, to the relevant international organizations of any incident that it has knowledge that falls within its competence and which results in a release that results in or may result in a non-intentional transboundary movement of a modified living organism that may have significant adverse effects on the conservation and sustainable use of biological diversity, taking into account the health of the biological diversity, The notification shall be given as soon as the Party concerned becomes aware of this situation.
2. Each party shall communicate to the Biosafety Exchange Centre, by the date of entry into force of this Protocol, the contact information of the person authorized to receive notifications under this section.
3. Any notification given under paragraph 1 above should include the following:
(a) Any relevant information available on the estimated quantities and relevant characteristics and characteristics of the modified living organisms;
(b) Information on the circumstances and expected date of release, as well as on the use of the modified living organism in the Party of origin;
(c) Any available information on potential adverse effects on the conservation and sustainable use of biological diversity, including risks to human health, as well as any available information on possible risk management measures;
(d) Any other relevant information;
(e) Contact details for additional information.
4. In order to minimize any significant adverse effects on the conservation and sustainable use of biological diversity, taking into account also the risks to human health, each Party under the jurisdiction of which the release of the modified living organism referred to in paragraph 1 above shall immediately consult with the States effectively affected or capable of it, to enable them to determine appropriate interventions and to take the necessary measures, including emergency measures.
Article 18
Handling, transport, packaging
and identification
1. In order to avoid adverse effects on the conservation and sustainable use of biological diversity, taking into account also the risks to human health, each Party shall take the necessary measures to require that modified living organisms that are the subject of an intentional transboundary movement under this Protocol be manipulated, packaged and transported in security conditions that take into account relevant international standards and standards.
2. Each Party shall take steps to require the accompanying documentation:
(a) The modified living organisms intended to be used directly for human and animal feed, or intended to be processed, clearly indicates that they "may contain" modified living organisms and that they are not intended to be intentionally introduced into the environment, and indicates the contact point to provide any additional information. The Conference of the Parties serving as the meeting of the Parties to the Protocol shall take a decision detailing the terms and conditions of that obligation, in particular the manner in which the identity of such bodies should be specified and any particular identification no later than two years after the entry into force of the Protocol;
(b) The modified living organisms intended to be used in confined environments clearly indicate that these are modified living organisms, specifying the safety rules to be observed for the handling, storage, transport and use of these organisms, and indicates the point of contact to provide any additional information, including the name and address of the person and institution to which the modified living organisms are sent;
(c) The modified living organisms intended to be intentionally introduced into the environment of the importing Party, as well as any other modified living organisms referred to in the Protocol, clearly indicates that these are modified living organisms, specify their identity and relevant characteristics and any security rules to be observed for the handling, storage, transport and use of such export bodies, and indicate the contact information of the person to be contacted
3. The Conference of the Parties serving as the meeting of the Parties to the Protocol determines whether it is necessary to develop standards of identification, manipulation, packaging and transport and sets out the modalities for such development, by consulting other relevant international bodies.
Article 19
Competent national authorities
National focal points
1. Each party shall designate a national focal point to ensure on its behalf the liaison with the secretariat. Each Party shall also designate one or more competent national authorities to perform the administrative functions called by the Protocol and authorized to act on its behalf in the performance of such functions. A Party may entrust to a single entity the functions of national correspondent and competent national authority.
2. Each party shall communicate to the secretariat, by the date of entry into force of the Protocol, the names and addresses of its national correspondent and the competent national authority or authorities. When a Party designates more than one competent national authority, it shall inform the secretariat, with its notification to that effect, of the respective areas of responsibility of such authorities. Where applicable, it will at least be specified which authority is competent for each type of living organism modified. Each Party shall immediately notify the secretariat of any changes in the designation of its national correspondent or the name, address or responsibilities of its competent national authorities.
3. The secretariat shall immediately notify Parties of notifications received under paragraph 2 above and shall also make this information available through the Biosafety Exchange Centre.
Rule 20
Information exchange and Exchange Centre
for Biosafety
1. A Biosafety Exchange Centre is established as part of the exchange mechanism provided for in Article 18, paragraph 3, of the Convention to:
(a) Facilitate the exchange of scientific, ecological and legal information, as well as experience, relating to modified living organisms;
(b) Assist Parties in implementing the Protocol, taking into account the specific needs of developing countries, including the least developed countries and small island developing States, and countries with economies in transition, as well as countries that are centres of origin and centres of genetic diversity.
2. The Biosafety Exchange Centre is a means of making information available for the purposes specified in paragraph 1 above. It provides access to relevant information for the implementation of the Protocol provided by the Parties. It also provides access to other international information exchange mechanisms on biosafety, if possible.
3. Without prejudice to the protection of confidential information, each Party shall communicate to the Biosafety Exchange Centre any information it is required to provide under the Protocol, and:
(a) All existing national laws, regulations and guidelines for the implementation of the Protocol, as well as information required by Parties in the prior informed consent procedure;
(b) any bilateral, regional or multilateral agreement or arrangement;
(c) A summary of the risk assessments or environmental studies related to the modified living organisms carried out under its regulations and carried out in accordance with Article 15, including, where appropriate, relevant information on the products derived from it, i.e., processed material from modified living organisms that contains new decalable combinations of replicable genetic material obtained by the use of modern biotechnology;
(d) Its final decisions concerning the importation or release of modified living organisms;
(e) Reports submitted under section 33, including reports on the application of the prior informed consent procedure.
4. The modalities for the operation of the Biosafety Exchange Centre, including its activity reports, are reviewed and decided by the Conference of the Parties serving as the meeting of the Parties to the Protocol at its first meeting and are subject to further considerations.
Article 21
Confidential information
1. The importing Party authorizes the notification author to indicate which information provided under the Protocol procedures or required by the importing Party in the context of the prior informed consent procedure of the Protocol should be considered confidential. In such cases, a justification is provided upon request.
2. The importing Party shall consult with the notice author when it determines that the information considered by the notification as confidential does not meet the requirements for processing as such and, prior to disclosing the information, shall inform the decision of the notice, indicating its reasons on request and maintaining the possibility of internal consultation and review of the decision.
3. Each Party shall protect confidential information received under the Protocol, including confidential information received under the prior informed consent procedure of the Protocol. Each Party shall ensure that it has procedures to protect this information and shall protect the confidentiality of this information in such a manner as favourable as that used by the Party for confidential information relating to living organisms of national origin.
4. The importing Party does not use this information for commercial purposes except with the written agreement of the notification author.
5. If the notification author withdraws or has withdrawn the notification, the importing Party shall respect the confidentiality of all commercial or industrial information, including information on research and development, as well as those whose confidentiality is the subject of a disagreement between that Party and the notice author.
6. Without prejudice to paragraph 5 above, the following information is not held for confidential purposes:
(a) The name and address of the author of the notification;
(b) A general description of the modified organism or living organisms;
(c) A summary of the impact risk assessment on the conservation and sustainable use of biological diversity, also taking into account risks to human health;
(d) Emergency response methods and plans.
Article 22
Capacity-building
1. Parties shall cooperate in the development and strengthening of human resources and institutional capacity in the field of biosafety, including biotechnology as it relates to biosafety, with a view to the effective implementation of the Protocol in developing country Parties, in particular in least developed countries and in small island developing States, as well as in Parties with economies of transition, including through regional organizations
2. For the purposes of paragraph 1 above, with regard to cooperation, the needs of developing country Parties, in particular those of the least developed countries and small island developing States, in terms of financial resources, access to technology and know-how, and the transfer of technology and know-how in accordance with the relevant provisions of the Convention, are fully taken into account in capacity-building for biosafety. Capacity-building cooperation includes, subject to differences between the situations, means and needs of each Party: scientific and technical training for the sound and safe use of biotechnology and the use of biosafety risk assessments and biosafety management techniques, as well as the strengthening of technical and institutional capacity in biosafety. The needs of Parties with economies in transition are also fully addressed in capacity-building for biosafety.
Article 23
Public awareness and participation
1. Parties:
(a) Encourage and facilitate public awareness, education and public participation on the safe transfer, handling and use of modified living organisms for the conservation and sustainable use of biological diversity, taking into account also the risks to human health. Parties shall cooperate, as appropriate, with other States and international bodies;
(b) Endeavour to ensure that public awareness and education includes access to information on living modified organisms, within the meaning of the Protocol, that may be imported.
2. The Parties shall, in accordance with their respective laws and regulations, consult with the public at the time of the decision-making of living organisms and make available to the public the outcome of these decisions, while respecting the confidential nature of the information, in accordance with Article 21.
3. Each Party shall endeavour to inform the public on means of access to the Biosafety Exchange Centre.
Article 24
Non-Parties
1. Transboundary movements of modified living organisms between Parties and non-Parties must be consistent with the objective of the Protocol. Parties may conclude bilateral, regional or multilateral agreements and arrangements with non-Parties on these transboundary movements.
2. Parties encourage non-Parties to accede to the Protocol and to provide appropriate information to the Biosafety Exchange Centre on modified living organisms released on their territory, or subject to movement to or from areas within their national jurisdiction.
Rule 25
Illicit transboundary movements
1. Each Party shall adopt national measures to prevent and suppress, where appropriate, the transboundary movements of modified living organisms that contravene the national measures it has taken to implement this Protocol. Such movements will be deemed illicit cross-border movements.
2. In the event of a illicit transboundary movement, the affected Party may request the Party of origin to eliminate the affected living organisms at its own expense, by repatriating or destroying them, as appropriate.
3. Each Party shall make available to the Biosafety Exchange Centre information on cases of illicit transboundary movements.
Rule 26
Socio-economic considerations
1. Parties, when making a decision on importation under this Protocol or under the national measures they have taken to implement the Protocol, may take into account, in accordance with their international obligations, the socio-economic implications of the impact of modified living organisms on the conservation and sustainable use of biological diversity, in particular in relation to the value of biological diversity for indigenous and local communities.
2. Parties are encouraged to cooperate in the research and exchange of information on the socio-economic impact of modified living organisms, in particular for indigenous and local communities.
Rule 27
Liability and repair
The Conference of the Parties, sitting as the meeting of the Parties to this Protocol, shall, at its first meeting, initiate a process to develop appropriate international rules and procedures for liability and reparation for damages arising from transboundary movements of modified living organisms, by properly analysing and taking into account the ongoing work in international law on these issues, and shall endeavour to complete this process within four years.
Rule 28
Financing mechanism
Financial resources
1. When considering the issue of financial resources for the implementation of the Protocol, Parties shall take into account the provisions of Article 20 of the Convention.
2. The funding mechanism established by Article 21 of the Convention is, through the institutional structure that ensures its operation, the financing mechanism of the Protocol.
3. With regard to capacity-building referred to in Article 22 of the Protocol, the Conference of the Parties serving as the meeting of the Parties to the Protocol shall take into account, when providing guidance on the funding mechanism referred to in paragraph 2 above, for consideration by the Conference of the Parties, the need for financial resources from developing country Parties, in particular the least developed countries and small island developing States.
4. As part of paragraph 1 above, Parties shall also take into account the needs of developing country Parties, in particular those of least developed countries and small island developing States, as well as those of Parties with economies in transition, in their efforts to identify and meet their capacity-building needs for the implementation of the Protocol.
5. The guidelines provided to the Convention's funding mechanism in the relevant decisions of the Conference of the Parties, including those approved prior to the adoption of the Protocol, apply mutatis mutandis to the provisions of this Article.
6. Developed country Parties may also provide financial and technological resources for the implementation of the Protocol, through bilateral, regional and multilateral arrangements, for which developing country Parties and Parties with economies in transition may use.
Rule 29
Conference of the Parties serving
Meeting of the Parties to the Protocol
1. The Conference of the Parties shall serve as the meeting of the Parties to the Protocol.
2. Parties to the Convention that are not Parties to the Protocol may participate as an observer in any meeting of the Conference of the Parties serving as a meeting of the Parties to the Protocol. When the Conference of the Parties sits as the meeting of the Parties to the Protocol, decisions taken under the Protocol shall be taken only by the Parties to the Protocol.
3. When the Conference of the Parties sits as the meeting of the Parties to the Protocol, any member of the Bureau of the Conference of the Parties representing a Party to the Convention that is not yet a Party to the Protocol shall be replaced by a new member elected by the Parties to the Protocol among them.
4. The Conference of the Parties serving as the meeting of the Parties to the Protocol shall follow the implementation of the Protocol and shall, within its mandate, make the necessary decisions to promote its effective implementation. It performs the functions assigned to it by the Protocol and:
(a) Prepare recommendations on any issues related to the implementation of the Protocol;
(b) Creates subsidiary bodies deemed necessary to enforce the Protocol;
(c) Appeals and uses, as appropriate, services, cooperation and information provided by relevant international organizations and intergovernmental and non-governmental bodies;
(d) Determines the presentation and periodicity of the transmission of information to be communicated pursuant to Article 33 of the Protocol and considers this information and the reports submitted by its subsidiary bodies;
(e) Consider and adopt, as appropriate, amendments to the Protocol and its annexes, as well as any new annex to the Protocol, deemed necessary for its implementation; and
(f) Any other function that may require the application of the Protocol.
5. The rules of procedure of the Conference of the Parties and the financial rules of the Convention shall apply mutatis mutandis to the Protocol, unless the Conference of the Parties serving as the meeting of the Parties to the Protocol decides otherwise by consensus.
6. The first meeting of the Conference of the Parties to the Convention serving as the meeting of the Parties to the Protocol shall be convened by the secretariat together with the first meeting of the Conference of the Parties to be held after the date of entry into force of the Protocol. Subsequently, the regular meetings of the Conference of the Parties serving as the meeting of the Parties to the Protocol shall be held at the same time as the regular meetings of the Conference of the Parties, unless the Conference of the Parties serving as the meeting of the Parties to the Protocol decides otherwise.
7. Extraordinary meetings of the Conference of the Parties serving as the meeting of the Parties to the Protocol may take place at any other time if the Conference of the Parties serving as the meeting of the Parties to the Protocol considers it necessary, or at the written request of a Party, provided that such request is supported by at least one third of the Parties within six months of its submission to the Parties by the secretariat.
8. The United Nations, its specialized agencies and the International Atomic Energy Agency, as well as any member State of such organizations or any observer in such organizations that is not a Party to the Convention, may be represented as an observer at the meetings of the Conference of the Parties serving as the meeting of the Parties to the Protocol. Any body or institution, national or international, governmental or non-governmental, competent in areas covered by this Protocol and having informed the secretariat of its wish to be represented as an observer at a meeting of the Conference of the Parties serving as a meeting of the Parties to the Protocol, may be admitted in that capacity unless at least one third of the Parties present object. The admission and participation of observers shall be governed by the rules of procedure referred to in paragraph 5 above, unless otherwise provided in this section.
Rule 30
Subsidiary bodies
1. Any subsidiary body established by, or under, the Convention may, by decision of the Conference of the Parties serving as the meeting of the Parties to this Protocol, perform functions under the Protocol, in which case the Meeting of the Parties specifies the functions performed by that body.
2. Parties to the Convention that are not Parties to this Protocol may participate as an observer in any meeting of a subsidiary body of the Protocol. When a subsidiary body of the Convention acts as a subsidiary body of the Protocol, decisions under the Protocol shall be taken only by the Parties to the Protocol.
3. When a subsidiary body of the Convention acts as a subsidiary body of the Protocol, any member of the bureau of that subsidiary body representing a Party to the Convention that is not yet a Party to the Protocol shall be replaced by a new member elected by the Parties to the Protocol among them.
Rule 31
Secretariat
1. The secretariat established under Article 24 of the Convention shall act as the secretariat of this Protocol.
2. Article 24, paragraph 1, of the Convention relating to the functions of the secretariat shall apply mutatis mutandis to this Protocol.
3. As long as they are distinct, the costs of secretariat services related to this Protocol shall be borne by the Parties to the Protocol. The Conference of the Parties serving as the meeting of the Parties to the Protocol shall, at its first meeting, make the necessary financial arrangements.
Rule 32
Relationship to the convention
Unless otherwise stated in this Protocol, the provisions of the Convention relating to its Protocols shall apply to this Protocol.
Rule 33
Monitoring and reporting
Each Party shall ensure compliance with its obligations under this Protocol and, at regular intervals decided by the Conference of the Parties serving as the meeting of the Parties to the Protocol, shall report to the Conference of the Parties serving as the meeting of the Parties to the Protocol on the measures it has taken to implement its provisions.
Rule 34
Compliance
The Conference of the Parties serving as the meeting of the Parties to the Protocol shall consider and approve, at its first meeting, procedures and institutional mechanisms for cooperation to promote compliance with the Protocol and to deal with non-compliance. These procedures and mechanisms include provisions to provide advice or assistance, where appropriate. They are distinct and without prejudice to the dispute settlement procedure and mechanisms established under Article 27 of the Convention.
Rule 35
Evaluation and review
The Conference of the Parties serving as the meeting of the Parties to the Protocol shall, five years after the entry into force of the Protocol, and then at least every five years thereafter, conduct an assessment of its effectiveness, including an assessment of its procedures and annexes.
Rule 36
Signature
This Protocol is open for signature by States and regional economic integration organizations at the United Nations Office at Nairobi from 15 to 26 May 2000, and at the United Nations Headquarters in New York from 5 June 2000 to 4 June 2001.
Rule 37
Entry into force
1. This Protocol shall enter into force on the ninetieth day after the date of deposit of the fiftieth instrument of ratification, acceptance, approval or accession by the States or regional economic integration organizations that are Parties to the Convention.
2. This Protocol shall enter into force for a State or regional economic integration organization that ratifies, accepts, approves or accedes to it after its entry into force in accordance with paragraph 1 above, i.e. the ninetieth day after the date of deposit, by that State or organization of economic integration, of its instrument of ratification, acceptance, approval or regional integration, at the time that the Convention enters into force
3. For the purposes of paragraphs 1 and 2 above, none of the instruments deposited by a regional economic integration organization is considered to be added to the instruments already deposited by the member States of that organization.
Rule 38
Reservations
No reservation may be made to this Protocol.
Rule 39
Denunciation
1. Upon the expiration of two years from the date of entry into force of this Protocol in respect of a Party, that Party may denounce the Protocol by written notification to the Depositary.
2. This denunciation shall take effect upon the expiration of one year from the date of its receipt by the Depositary, or at any later date that may be specified in that notification.
Rule 40
Faithful texts
The original of this Protocol, of which the Arabic, Chinese, English, French, Russian and Spanish texts are equally authentic, will be deposited with the Secretary-General of the United Nations.
In the belief that the undersigned, with due authority, have signed this Protocol.
Done in Montreal on January 29, 2000.
A N N E X E I
INFORMATION TO FIGURTHER IN NOTIFICATIONS
ARTICLES 8, 10 AND 13
(a) Name, address and contact information of the exporter;
(b) Name, address and contact information of the importer;
(c) Name and identity of the modified living organism and its classification according to the degree of biological security, in the export State, if it exists;
(d) Scheduled date or dates of the transboundary movement if known.
(e) Common name and taxonomy, collection or acquisition point, and characteristics of the receiving organism or parent organizations relevant to the prevention of biotechnological risks;
(f) Centres of origin and centres of genetic diversity, when known, of the receiving organism and/or parent organisms and description of habitats where organisms may persist or proliferate;
(g) Common name and taxonomy, collection or acquisition point, and characteristics of the organism or donor organizations relevant to the prevention of biotechnological risks;
(h) Description of the nucleic acid or modification introduced, the technique used and the characteristics of the resulting modified living organism.
(i) The intended use of the modified living organism or the products derived from it, i.e., the processed material originating in the modified living organism, which contains new decalable combinations of replicable genetic material obtained by the use of modern biotechnology;
(j) Quantity or volume of modified living organisms to be transferred.
(k) Pre-existing risk assessment report in accordance with Annex III;
(i) Proposed methods to ensure safe handling, storage, transportation and use, including packaging, labelling, documentation, disposal methods and procedures to be followed in the event of an emergency, if any;
(m) The situation of the living organism modified in relation to regulation in the export State (e.g., if prohibited in the exporting State, if there are other restrictions, or if its general circulation has been authorized); if the modified living organism is prohibited in the exporting State, the reason(s) for that prohibition;
(n) The result and purpose of any notification from the exporter to other States with respect to the living organism modified to be transferred;
(o) Declaration that the above information is accurate.
A N N E X E I
FURTHER INFORMATION FOR ALL MODIFIED ORGANIZED ORGANIZING TO BE USED FOR HUMAINE OR ANIMAL AGREEMENT, OR TO BE TRANSFORMED, IN ACCORDANCE WITH ARTICLE 11
(a) The name and contact information of the person requesting authorization for use in the national territory;
(b) The name and contact information of the authority responsible for the decision;
(c) The name and identity of the modified living organism;
(d) A description of the genetic modification, the technique used and the characteristics of the resulting modified living organism;
(e) Any unique identification of the modified living organism;
(f) Taxonomy, common name, point of collection or acquisition and characteristics of the receiving organism or parent organizations relevant to the prevention of biotechnological risks;
(g) Centres of origin and centres of genetic diversity, when known, of the receiving organism and/or parent organisms and a description of habitats where organisms may persist or proliferate;
(h) Taxonomy, common name, point of collection and acquisition, and characteristics of the organism or donor organizations relevant to the prevention of biotechnological risks;
(i) Authorized uses of the modified living organism;
(j) A risk assessment report in accordance with Appendix III;
(k) Proposed methods to ensure safe handling, storage, transportation and use, including packaging, labelling, documentation, disposal methods and procedures to be followed in the event of an emergency, if any.
A N N E X E I I
RISK ASSESSMENT
Objective
1. For the purposes of this Protocol, the objective of the risk assessment is to determine and evaluate the potential adverse effects of modified living organisms on the conservation and sustainable use of biological diversity in the likely potential receptor environment, also taking into account the risks to human health.
Use of risk assessments
2. The risk assessment is used, in particular, by the competent authorities to make an informed decision on the modified living organisms.
General principles
3. Risk assessment should be conducted using proven scientific methods and transparency and may take into account technical advice and guidance from relevant international organizations.
4. The absence of scientific knowledge or consensus should not necessarily be deduced from the gravity of a risk, the absence of risks or the existence of an acceptable risk.
5. Risks associated with modified living organisms or products derived from them, i.e. processed material from modified living organisms that contain new detectable combinations of replicable genetic material obtained by the use of modern biotechnology, should be considered against the risks posed by receptor organisms or unmodified parents in the likely potential receptor environment.
6. The risk assessment should be carried out on a case-by-case basis. The nature and accuracy of the required information may vary depending on the case, depending on the affected living organism, its intended use and the likely potential receiver environment.
Methods
7. Risk assessment may require additional information on specific issues, which may be defined and requested in the evaluation; However, information on other issues may not be relevant in some cases.
8. To achieve its objective, the risk assessment will include, where applicable, the following steps:
(a) Identifying any new genotypical and phenotypic characteristics related to the modified living organism that may have adverse effects on biological diversity in the likely potential receptor environment, and also include risks to human health;
(b) Assessing the probability that these adverse effects occur, taking into account the degree and type of exposure of the likely potential receptor environment of the modified living organism;
(c) The assessment of the consequences of these adverse effects if they occurred;
(d) The overall risk estimate submitted by the modified living organism based on the assessment of the probability of adverse effects identified and their consequences;
(e) A recommendation indicating whether risks are acceptable or manageable, including, where appropriate, the definition of risk management strategies; and
(f) Where there is uncertainty as to the severity of the risk, additional information may be requested on specific issues of concern, or appropriate risk management strategies and/or control the organism that is modified in the receiving environment.
Items to be considered
9. Depending on the case, the risk assessment takes into account relevant technical and scientific data concerning:
(a) Receptor organism or parent organisms: the biological characteristics of the receptor organism or parent organisms, including details of taxonomy, common name, origin, centres of origin and centres of genetic diversity, when known, and a description of habitat where organisms may persist or proliferate;
(b) The donor organism or organisms: taxonomy and common name, source and relevant biological characteristics of donor organisms;
(c) The vector: the characteristics of the vector, including its identity, if any, its source or origin, and the ranges of its hosts;
(d) Insert or inserts and/or characteristics of the modification: the genetic characteristics of the inserted nucleic acid and the function it determines, and/or the characteristics of the introduced modification;
(e) The modified living organism: identity of the modified living organism and those of the receiving organism or parent organisms;
(f) The detection and identification of the modified living organism: proposed detection and identification methods and their particularity, accuracy and reliability;
(g) Information on intended use: information relating to the intended use of the modified living organism, including any new use or use different from that of the receiving or parent organism; and
(h) Receptor environment: information on the location and geographical, climatic and ecological characteristics of the likely potential receptor environment, including relevant information on biological diversity and the centres of origin found therein.
Done in Paris on 12 September 2003.
Jacques Chirac
By the President of the Republic:
The Prime Minister,
Jean-Pierre Raffarin
Minister of Foreign Affairs,
Dominique de Villepin
