Key Benefits:
740 OF 2002
(May 24)
Official Journal 44.816 of 29 May 2002
By means of which the "Cartagena Protocol on Biosafety of the Convention on Biological Diversity" is approved, made in Montreal, the twenty-nine (29) January of two thousand (2000).
The Congress of Colombia
Having regard to the text of the "Cartagena Protocol on Biosafety of the Convention on Biological Diversity", made in Montreal, the twenty-nine (29) January of two thousand (2000), which the letter says:
(To be transcribed: photocopy of the full text of the international instrument mentioned).
CARTAGENA PROTOCOL ON SECURITY
OF CONVENTION BIOTECHNOLOGY
ABOUT BIOLOGICAL DIVERSITY
The Parties to this Protocol,
Being Parties to the Convention on Biological Diversity, hereinafter "the Convention",
Remembering paragraphs 3 and 4 of Article 19 and paragraph g of Article 8o. and Article 17 of the Convention,
recalling also Decision II/5 of the Conference of the Parties to the Convention of 17 November 1995 on the development of a protocol on the security of biotechnology, focusing specifically on the cross-border movement of any modified living organisms resulting from modern biotechnology which may have adverse effects on the conservation and sustainable use of biological diversity, which it establishes in particular for its examination; appropriate for a prior informed agreement,
Reaffirming the precautionary approach set out in Principle 15 of the Rio Declaration on Environment and Development,
Aware of the rapid expansion of modern biotechnology and growing public concern about its potential adverse effects on biological diversity, also taking into account the risks to human health,
Acknowledging that modern biotechnology has great potential to contribute to human well-being if developed and used with appropriate safety measures for the environment and human health,
Recognizing also the crucial importance that centers of origin and centers of genetic diversity have for humanity,
Taking into account the reduced capacity of many countries, especially developing countries, to control the nature and magnitude of known and potential risks arising from modified living organisms,
Recognising that trade and environmental agreements must support each other with a view to achieving sustainable development,
Stressing that this Protocol cannot be interpreted as modifying the rights and obligations of a Party under other international agreements already in force,
In the understanding that the foregoing paragraphs are not intended to subordinate this Protocol to other international agreements,
Have agreed to the following:
In accordance with the precautionary approach set out 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 environmental protection. the safe transfer, handling and use of modified living organisms resulting from modern biotechnology which may have adverse effects on the conservation and sustainable use of biological diversity, also taking into account the risks to human health, and focusing specifically on movements Cross-border.
ARTICLE 2. GENERAL PROVISIONS.
1. Each Party shall take the necessary and appropriate legislative, administrative and other measures to fulfil its obligations under this Protocol.
2. The Parties shall ensure that the development, handling, transport, use, transfer and release of any modified living organisms are carried out in such a way as to avoid or reduce the risks to diversity. biological, also taking into account the risks to human health.
3. This Protocol shall in no way affect the sovereignty of States over their territorial sea established in accordance with international law, or the sovereign rights or the jurisdiction of States over their economic zones. exclusive and their continental platforms in accordance with international law, or to the exercise by vessels and aircraft of all States of the rights and freedoms of navigation established in international law and collected in the relevant international instruments.
4. Nothing in this Protocol shall be construed as restricting the right of a Party to take more stringent measures to protect the conservation and sustainable use of biological diversity than those laid down in this Protocol. the Protocol, provided that such measures are compatible with the objective and provisions of this Protocol and in accordance with the other obligations of that Party in international law.
5. The Parties are encouraged to take into account, as appropriate, the expertise, available instruments, and the work undertaken in the relevant international fora in the field of risks to human health.
For the purposes of this Protocol:
(a) "Conference of the Parties" means the Conference of the Parties to the Convention;
(b) By "confined use" means any operation, carried out within a premises, facility or other physical structure, involving the handling of modified living organisms controlled by specific measures which limit effective their contact with the outside environment or its effects on such means;
(c) "Export" means intentional cross-border movement from one Party to another Party;
(d) By "exporter" means any natural or legal person subject to the jurisdiction of the Export Party that organizes the export of a modified living organism;
e) "Import" means intentional cross-border movement to a Party from another Party;
(f) By "importer" means any natural or legal person subject to the jurisdiction of the Party of import which arranges the importation of a modified living organism;
g) By "modified living organism" means any living organism possessing a new combination of genetic material that has been obtained by applying modern biotechnology;
h) By "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:
(a) In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organules, or
b) The fusion of cells beyond the taxonomic family, which exceed the natural physiological barriers of reproduction or re-combination and which are not techniques used in traditional reproduction and selection;
(j) "Regional economic integration organisation" means an organisation consisting of sovereign States of a given region, to which the Member States have transferred the jurisdiction in relation to matters governed by the this Protocol and that it is duly authorised, in accordance with its internal procedures, to sign, ratify, accept, approve or accede to it;
k) By "cross-border movement" means the movement of a modified living organism from one Party to another, with the exception that for the purposes of Articles 17 and 24 the cross-border movement also includes movement between Parties and States that are not Parties.
This Protocol shall apply to cross-border movement, transit, handling and use of all modified living organisms which may have adverse effects on the conservation and sustainable use of the biological diversity, also taking into account the risks to human health.
ARTICLE 5. PHARMACEUTICAL PRODUCTS.
Without prejudice to the provisions of Article 4. and without prejudice to any rights of a Party to submit all modified living organisms to a risk assessment before taking a decision on its importation, this Protocol shall not apply to the cross-border movement of Modified living organisms which are pharmaceutical products intended for human beings which are already covered by other relevant international agreements or organisations.
ARTICLE 6. TRANSIT AND CONFINED USE.
1. Without prejudice to the provisions of Article 4. and without prejudice to any rights of a Party of transit to regulate the transport of modified living organisms through its territory and to communicate to the Information Exchange Centre on Biotechnology, any Decision of that Party, subject to paragraph 3 of Article 2 (3), concerning transit through its territory of a specific modified living organism the provisions of this Protocol in relation to the procedure of agreement Prior informed consent shall not apply to live modified organisms in transit.
2. Without prejudice to the provisions of Article 4. and without prejudice to any rights of a Party to submit all modified living organisms to a risk assessment in advance of the adoption of import decisions and to establish rules for the confined use within its territory. jurisdiction, the provisions of this Protocol in respect of the prior informed agreement procedure shall not apply to the transboundary movement of modified live organisms intended for confined use carried out in accordance with the provisions of this Protocol. rules of the Party of import.
ARTICLE 7. APPLICATION OF THE PRIOR INFORMED AGREEMENT PROCEDURE.
1. Subject to the provisions of Articles 5o. and 6., the procedure for the prior informed consent procedure set out in Articles 8 or 8. 10 and 12 shall apply before the first intentional transboundary movement of a modified living organism intended for the deliberate introduction into the environment of the Party of import.
2. The "deliberate introduction into the environment" referred to in paragraph 1 above does not refer to the modified living organisms which are intended to be used directly as human or animal food or for processing.
3. Article 11 shall apply before the first transboundary movement of modified living organisms intended for direct use as human or animal food or for processing.
4. The prior informed consent procedure shall not apply to the intentional transboundary movement of the modified living organisms included in a decision taken by the Conference of the Parties acting as a meeting of the Parties in the this Protocol stating that they are not likely to have adverse effects on the conservation and sustainable use of biological diversity, also taking into account the risks to human health.
1. The exporting Party shall notify, or require the exporter to ensure the written notification, to the competent national authority of the importing Party prior to the intentional transboundary movement of a modified living organism. referred to in paragraph 1 of Article 7o. The notification shall contain at least the information specified in Annex I.
2. The exporting Party shall ensure that the accuracy of the information provided by the exporter is a legal prescription.
ARTICLE 9. ACKNOWLEDGEMENT OF RECEIPT OF THE NOTIFICATION.
1. The Party of import shall acknowledge receipt of the notification in writing to the notifier within 90 days of receipt.
2. The acknowledgement of receipt shall state the following:
a) The date the notification was received;
b) If the notification contains, prima facie, the information specified in Article 8o.;
(c) Whether to proceed in accordance with the national regulatory framework of the Party of import or in accordance with the procedure laid down in Article 10.
3. The national regulatory framework referred to in paragraph 2 (c) above shall be compatible with this Protocol.
4. The absence of acknowledgement of receipt of the notification by the importing Party shall not be construed as its consent to an intentional cross-border movement.
ARTICLE 10. DECISION-MAKING PROCEDURE.
1. The decisions taken by the Party of import shall comply with the provisions of Article 15.
2. The Party of import, within the period referred to in Article 9o, shall notify the notifier in writing if the intentional transboundary movement can be carried out:
a) Only after the Import Party has granted its written consent, or
b) Translate at least 90 days without written consent.
3. The Party of import, within 270 days of the acknowledgement of receipt of the notification, shall communicate to the notifier and to the Centre for the Exchange of Information on Biotechnology Security, in writing, the decision referred to in paragraph 1. in paragraph 2 (a) above, of the following:
a) Approve the import, with or without conditions, including how the decision will be applied to subsequent imports of the same modified live organism;
b) Prohibit the import;
(c) Request additional relevant information in accordance with its national regulatory framework or Annex I. When calculating the time limit on which the Party of import is to respond, the number of days when the Party of import has been to the waiting for the relevant additional information, or
d) Communicate to the notifier that the time limit specified in this paragraph has been extended for a specified period of time.
4. Except in the case of unconditional consent, the reasons on which it is based shall be laid down in the decision taken pursuant to paragraph 3 above.
5. The fact that the Party of import does not communicate its decision within 270 days of receipt of the notification shall not be construed as its consent to an intentional cross-border movement.
6. The fact that there is no scientific certainty due to lack of sufficient relevant scientific information or knowledge on the extent of the possible adverse effects of a modified living organism on the conservation and sustainable use of the biological diversity in the Party of import, taking into account also the risks to human health, shall not prevent the Party of import, in order to avoid or minimise such possible adverse effects, to take a decision, as where appropriate, in relation to the import of the modified live organism concerned as indicated in the paragraph 3 above.
7. The Conference of the Parties acting as a meeting of the Parties shall decide, at its first meeting, on appropriate procedures and mechanisms to facilitate the adoption of decisions by the Parties of Import.
1. A Party which has taken a final decision on national use, including placing on the market, of a modified live organism which may be the subject of a cross-border movement for direct use as human food or animal or for processing, shall report to all Parties, through the Biosafety Information Exchange Centre, within 15 days. That information shall include at least the information specified in Annex II. The Party shall provide a printed copy of the information to the focal point of each Party that has informed the Secretariat in advance that it does not have access to the Biotechnology Security Information Exchange Center. This provision shall not apply to decisions relating to practical tests.
2. The Party referred to in paragraph 1 above when taking a decision shall ensure that there is a legal prescription which provides for the degree of accuracy of the information to be provided by the applicant.
3. A Party may request additional information from the governmental body specified in point (b) of Annex II.
4. A Party may adopt a decision on the importation of modified live organisms intended for direct use as human or animal food or for processing under its national regulatory framework which is compatible with the objective of the Protocol.
5. The Parties shall make available to the Centre for the Exchange of Information on Biosafety copies of the laws, regulations and national guidelines applicable to the importation of live modified organisms intended for direct use as human or animal food, or for processing, if they exist.
6. A Party that is a developing country or a Party that is a country with a transitional economy may declare, in the absence of the national regulatory framework referred to in paragraph 4 above and in the exercise of its internal jurisdiction, by the Biosafety Information Exchange Centre, which has its decision prior to the first importation of a modified live organism intended for direct use as human or animal food, or for processing, on which has supplied information pursuant to paragraph 1 above shall be adopted in accordance with the next:
(a) A risk assessment carried out in accordance with Annex III, and
(b) A decision taken in predictable periods not exceeding two hundred and seventy days.
7. The fact that a Party has not communicated its decision pursuant to paragraph 6 above shall not be understood as its consent or refusal to import a modified live organism intended for direct use as human or animal food or for processing unless that Party specifies otherwise.
8. The fact that there is no scientific certainty due to lack of sufficient information and relevant knowledge on the extent of the possible adverse effects of a modified living organism on the conservation and sustainable use of the biological diversity in the Party of import, taking into account also the risks to human health, shall not prevent that Party, in order to avoid or minimise such possible adverse effects, to take a decision, as appropriate, in relation to the import of that modified live organism intended for direct use as human or animal food; or for processing.
9. A Party may express its need for financial and technical assistance and capacity building in relation to modified living organisms intended for direct use as human or animal food or for processing. The Parties shall cooperate to meet these needs in accordance with Articles 22 and 28.
ARTICLE 12. REVIEW OF DECISIONS.
1. A Party of import may at any time, on the basis of new scientific information on possible adverse effects on the conservation and sustainable use of biological diversity, taking into account also the risks involved. for human health, review and modify a decision on an intentional transboundary movement.
In that case, that Party shall, within 30 days, report to any notifier that has previously notified movements of the modified live organism referred to in that decision and to the Information Exchange Center. on the Safety of Biotechnology, and shall state the reasons for which it has taken such a decision.
2. An Export Party or a notifier may request the Party of Import to review a decision taken pursuant to Article 10 with respect to that Party or exporter, where the Export Party or the notifier considers that:
a) There has been a change in circumstances that may influence the outcome of the risk assessment on which the decision was based, or
b) New relevant scientific or technical information is available.
3. The Party of import shall respond in writing to such requests within 90 days and shall state the reasons for which it has taken such a decision.
4. The Party of import may, at its discretion, require a risk assessment for subsequent imports.
ARTICLE 13. SIMPLIFIED PROCEDURE.
1. An import Party may, provided appropriate measures are applied to ensure the safety of the intentional transboundary movement of living modified organisms in accordance with the objectives of this Protocol, specify with Prior notice to the Biotechnology Security Information Exchange Center:
(a) Cases where the intentional cross-border movements to that Party may be effected at the same time as the movement to the Import Party is reported; and
(b) Imports to that Party of modified living organisms which may be exempted from the prior informed agreement procedure.
Notifications under point (a) above may be applied to subsequent movements similar to the same Party.
2. The information concerning an intentional transboundary movement to be provided in the notifications referred to in paragraph 1 (a) above shall be the information specified in Annex I.
ARTICLE 14. BILATERAL, REGIONAL AND MULTILATERAL AGREEMENTS AND ARRANGEMENTS.
1. The Parties may conclude bilateral, regional and multilateral agreements and arrangements concerning the intentional transboundary movements of modified living organisms, provided that such agreements and arrangements are compatible with the objective of the this Protocol and do not constitute a reduction in the level of protection established by the Protocol.
2. The Parties shall notify each other, through the Biotechnology Security Information Exchange Centre, of bilateral, regional and multilateral agreements and arrangements which have been concluded before or after the date of entry into force. This Protocol shall apply.
3. The provisions of this Protocol shall not affect the intentional cross-border movements to be carried out in accordance with those agreements and arrangements between the Parties to those agreements or arrangements.
4. The Parties may determine that their national regulations shall apply to specific imports and shall notify their decision to the Biotechnology Security Information Exchange Centre.
1. Risk assessments carried out under this Protocol shall be carried out in accordance with sound scientific procedures in accordance with Annex III and taking into account the recognised risk assessment techniques. Those risk assessments shall be based at least on the information provided in accordance with Article 8. and other available scientific evidence to determine and assess the potential adverse effects of living organisms modified for the conservation and sustainable use of biological diversity, taking into account also the risks to human health.
2. The Party of import shall ensure that risk assessments are carried out in order to take decisions under Article 10. The Party of import may require the exporter to carry out the risk assessment.
3. The notifier shall bear the costs of the risk assessment if the Party of import so requires.
1. The Parties, taking into account Article 8 (g), the Convention, establish and maintain appropriate mechanisms, measures and strategies to regulate, manage and control the risks identified in accordance with the provisions on risk assessment of this Protocol relating to the use, handling and cross-border movement of living modified organisms.
2. Measures based on the risk assessment shall be imposed to the extent necessary to avoid adverse effects of the modified living organisms on the conservation and sustainable use of biological diversity, taking into account also the risks to human health, in the territory of the importing Party.
3. Each Party shall take appropriate measures to prevent inadvertent transboundary movements of modified living organisms, including measures such as the requirement for a risk assessment to be carried out prior to the first release of a Modified live organism.
4. Without prejudice to paragraph 2 above, each Party shall seek to ensure that any modified living organism, whether imported or developed in the country, has undergone a period of observation appropriate to its life cycle or its time of life. generation before it is given its intended use.
5. The Parties shall cooperate with a view to:
(a) Determine the modified living organisms or the specific traits of modified living organisms which may have adverse effects on the conservation and sustainable use of biological diversity, taking into account also the risks to human health, and
b) Adopt appropriate measures for the treatment of these modified living organisms or specific traits.
ARTICLE 17. INVOLUNTARY TRANSBOUNDARY MOVEMENTS AND EMERGENCY MEASURES.
1. Each Party shall take appropriate measures to notify the States concerned or likely to be affected, to the Biotechnology Security Information Exchange Centre and, where appropriate, to international organisations. relevant, when aware of a situation within its jurisdiction that has resulted in a release that leads to or may lead to an involuntary cross-border movement of a modified living organism that is likely to have significant adverse effects on the conservation and sustainable use of diversity biological, also taking into account the risks to human health in those States. The notification shall be sent as soon as the Party becomes aware of such a situation.
2. Each Party shall make available to the Information Exchange Centre on Biotechnology, at the latest by the date of entry into force of this Protocol for that Party, the relevant details of the contact point, at the latest. receive notifications as provided for in this Article.
3. Any notification sent pursuant to paragraph 1 above shall include:
(a) Relevant available information on the estimated quantities and the relevant characteristics and/or features of the modified living organism;
(b) Information on the circumstances and the estimated date of the release, as well as the use of the modified living organism in the Party of origin;
c) Any available information on the potential adverse effects on the conservation and sustainable use of biological diversity, taking into account also the risks to human health, as well as information available on the possible risk management measures;
d) Any other relevant information, and
e) A point of contact for additional information.
4. To minimise any significant adverse effects on the conservation and sustainable use of biological diversity, taking also into account the risks to human health, each Party in whose jurisdiction the the release of the modified live organism referred to in paragraph 1 above shall immediately enter into consultation with or be affected by the States concerned so that the States concerned can determine the appropriate responses and The necessary activities, 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 also into account the risks to human health, the Parties shall take the necessary measures to require that the living organisms modified objects of intentional transboundary movements referred to in this Protocol are handled, packaged and transported under security conditions, taking into account the relevant international standards and standards.
2. Each Party shall take the measures to require that the documentation accompanying:
(a) Live modified organisms intended for direct use as human or animal food, or for processing, clearly identify that they 'may contain' live modified organisms and are not intended for intentional introduction in the middle, as well as a point of contact to request additional information. The Conference of the Parties, as the meeting of the Parties to this Protocol, shall take a decision on the detailed requirements for this purpose, including the specification of its identity and any identification exclusive, not later than two years after the date of entry into force of this Protocol;
(b) Modified living organisms intended for confined use clearly identify them as modified living organisms; specifies the requirements for their handling; the point of contact for additional information, including the name and the signs of the person and institution to which the modified living organisms are sent, and
(c) Modified living organisms intended for intentional introduction into the environment of the importing Party and any other modified living organisms referred to in the Protocol clearly identify them as living organisms modified; specifies the identity and the relevant features/characteristics, the requirements for handling, storage, transport and safe use, the point of contact for additional information and, as appropriate, the name and the the management of the importer and the exporter; and contains a statement that the movement is performs in accordance with the provisions of this Protocol applicable to the exporter.
3. The Conference of the Parties serving as the meeting of the Parties to this Protocol shall examine the need for, and modalities for, standards in relation to the practices of identification, handling, packaging and transport in consultation with other relevant international bodies.
ARTICLE 19. COMPETENT NATIONAL AUTHORITIES AND NATIONAL FOCAL POINTS.
1. Each Party shall designate a national focal point which shall be responsible for liaison with the Secretariat on its behalf. Each Party shall also designate one or more competent national authorities which shall be responsible for the administrative functions required by this Protocol and shall be empowered to act on its behalf in relation to those tasks. A Party may designate a single entity to fulfil the functions of the focal centre and competent national authority.
2. Each Party shall communicate to the Secretariat no later than the date of entry into force of the Protocol for that Party, the names and addresses of its focal point and its competent national authority or authorities. If a Party designates more than one competent national authority, it shall communicate to the Secretariat, together with the relevant notification, information on the respective responsibilities of those authorities. Where appropriate, this information shall specify at least which competent authority is responsible for each type of live modified organism. Each Party shall immediately communicate to the Secretariat any changes in the designation of its national focal point, or in the names and addresses or responsibilities of its competent national authority or authorities.
3. The Secretariat shall immediately communicate to the Parties the notifications received under paragraph 2 above and shall also disseminate that information through the Biotechnology Security Information Exchange Centre.
ARTICLE 20. INFORMATION EXCHANGE AND THE INFORMATION EXCHANGE CENTRE ON BIOTECHNOLOGY SAFETY.
1. A Biotechnology Safety Information Exchange Centre is hereby established as part of the facilitation mechanism referred to in Article 18 (3) of the Convention, in order to:
(a) Facilitate the exchange of scientific, technical, environmental and legal information and experience in relation to the modified living organisms, and
b) Provide assistance to the Parties in the implementation of the Protocol, taking into account the special needs of developing countries, in particular the least developed countries and small island developing countries, and of the countries with economies in transition, as well as countries that are centres of origin and centres of genetic diversity.
2. The Centre for the Exchange of Information on Biotechnology Security shall be a means of disseminating information for the purposes of paragraph 1 above. It shall facilitate access to information of interest for the implementation of the Protocol provided by the Parties. It will also facilitate access, where possible, to other international mechanisms for the exchange of information on biotechnology safety.
3. Without prejudice to the protection of confidential information, each Party shall provide to the Biotechnology Security Information Exchange Centre any information to be provided to the Information Exchange Centre. Safety of Biotechnology under this Protocol and also information on:
(a) Existing national laws, regulations and guidelines for the implementation of the Protocol, as well as the information required by the Parties for the prior informed agreement procedure;
b) Bilateral, regional and multilateral agreements and arrangements;
(c) Summaries of their risk assessments or environmental reviews of modified living organisms that have been carried out as a result of their regulatory process and in accordance with Article 15, including, where appropriate, information relevant products derived from the modified living organisms, i.e. processed materials having their origin in a modified living organism, containing new detectable combinations of replicable genetic material obtained through the application of modern biotechnology;
d) Your final decisions on the import or release of modified living organisms, and
e) the reports submitted to it pursuant to Article 33, including reports on the implementation of the prior informed agreement procedure.
4. The Conference of the Parties serving as the meeting of the Parties to this Protocol, at its first meeting, shall examine the modalities of operation of the Information Exchange Centre on Biotechnology, including the reports on its activities, shall take decisions in respect of those modalities and shall keep them under review.
ARTICLE 21. CONFIDENTIAL INFORMATION.
1. The Party of import shall allow the notifier to determine which information submitted under the procedures laid down in this Protocol or required by the Party of import as part of the agreed procedure. It should be treated as confidential information provided for in the Protocol. In such cases, where requested, the reasons for such treatment should be provided.
2. The Party of import shall enter into consultations with the notifier if it considers that the information classified as confidential by the notifier does not merit such treatment and shall communicate its decision to the notifier before releasing the information, explaining, when requested, their motives and giving an opportunity for the holding of consultations and the internal review of the decision before disclosing the information.
3. Each Party shall protect confidential information received under this Protocol, including confidential information received in the context of the prior informed consent procedure provided for in the Protocol. Each Party shall ensure that it has procedures in place to protect that information and shall protect the confidentiality of that information in a manner that is no less favourable than that applicable to confidential information relating to living organisms. internally produced modified.
4. The Party of import shall not use such information for commercial purposes unless it has the written consent of the notifier.
5. If a notifier withdraws or has withdrawn a notification, the Party of import shall respect the confidentiality of all commercial and industrial information classified as confidential, including information on the investigation and the development, as well as information about the confidentiality of which the Party and the notifier disagree.
6. Without prejudice to paragraph 5 above, the following information shall not be considered as confidential:
a) The name and address of the notifier;
b) A general description of the modified living organism or organisms;
(c) A summary of the risk assessment of the effects for the conservation and sustainable use of biological diversity, also taking into account the risks to human health, and
d) The methods and response plans in case of emergency.
ARTICLE 22. CAPACITY BUILDING.
1. The Parties shall cooperate in the development and/or strengthening of human resources and the institutional capacity in the field of biotechnology safety, including biotechnology to the extent that it is necessary for the security of the biotechnology, with a view to the effective implementation of this Protocol in the Parties which are developing countries, in particular the least developed countries and small island developing States, and the Parties which are countries with economies in transition, through global, regional, sub-regional and national institutions and organisations and, where appropriate, by facilitating the participation of the private sector.
2. For the purposes of applying paragraph 1 above, in relation to cooperation for capacity-building activities in the field of safety of biotechnology, the needs of the Parties which are countries in the field of biotechnology shall be fully taken into account. development, in particular the least developed countries and small island developing states, financial resources and access to technology and expertise, and their transfer, in accordance with the relevant provisions of the Convention. Cooperation in the field of capacity building shall include, taking into account the different situations, capacity and needs of each Party, scientific and technical training in the appropriate and safe management of biotechnology and in the use of the risk assessment and risk management for the safety of biotechnology and the promotion of technological and institutional capacity in the field of biotechnology safety. The needs of the Parties with economies in transition for that capacity building in the security of biotechnology will also be fully taken into account.
ARTICLE 23. PUBLIC AWARENESS AND PARTICIPATION.
1. The Parties:
(a) Promote and facilitate the awareness, education and participation of the public concerning the security of the transfer, handling and use of living modified organisms in relation to conservation and use the sustainable nature of biological diversity, taking into account the risks to human health. To this end, the Parties shall cooperate, as appropriate, with other States and international bodies;
(b) Seek to ensure that public awareness and education includes access to information on modified living organisms identified in accordance with this Protocol that may be imported.
2. The Parties shall, in accordance with their respective laws and regulations, hold consultations with the public in the decision-making process in relation to modified living organisms and shall make known to the public the results of such decisions. decisions, while respecting confidential information as provided for in Article 21.
3. Each Party shall ensure that its population is aware of how to access the Biotechnology Safety Information Exchange Centre.
ARTICLE 24. STATES THAT ARE NOT PARTS.
1. Cross-border movements of living modified organisms between Parties and States which are not Parties shall be compatible with the objective of this Protocol. The Parties may conclude bilateral, regional and multilateral agreements and arrangements with States that are not Parties in relation to these cross-border movements.
2. The Parties shall encourage States which are not Parties to accede to the Protocol and to provide the Information Exchange Centre on Biotechnology Security with relevant information on the modified living organisms released or introduced into areas within their national jurisdiction or transported outside their jurisdiction.
ARTICLE 25. ILLICIT CROSS-BORDER MOVEMENTS.
1. Each Party shall adopt appropriate national measures to prevent and, where appropriate, penalise the transboundary movements of modified living organisms carried out in contravention of the national measures governing the application of the Protocol. Such movements shall be considered as illegal cross-border movements.
2. In the event of an illegal cross-border movement, the Party of origin may require the Party of origin to withdraw the modified living organism at its expense, by repatriating or destroying it, as appropriate.
3. Each Party shall make available to the Biotechnology Security Information Exchange Centre information on the cases of illicit cross-border movements in that Party.
ARTICLE 26. SOCIOECONOMIC CONSIDERATIONS.
1. The Parties shall, when adopting a decision on importation in accordance with the national measures governing the application of this Protocol, take into account, in a manner compatible with their international obligations, the socioeconomic effects resulting from the effects of living organisms modified for the conservation and sustainable use of biological diversity, especially in relation to the value that biological diversity has for communities indigenous and local.
2. The Parties are encouraged to cooperate in the field of information and research exchange on the socio-economic effects of modified living organisms, especially in indigenous and local communities.
ARTICLE 27. LIABILITY AND COMPENSATION.
The Conference of the Parties acting as a meeting of the Parties to this Protocol shall, at its first meeting, adopt a process in relation to the appropriate elaboration of international standards and procedures in the sphere of the liability and compensation for damages resulting from the transboundary movements of modified living organisms, for which the ongoing processes in the field of international law on those organisms will be analysed and duly taken into account areas, and will try to complete this process within four years.
ARTICLE 28. FINANCIAL MECHANISM AND FINANCIAL RESOURCES.
1. When examining the financial resources for the implementation of the Protocol, the Parties shall take into account the provisions of Article 20 of the Convention.
2. The financial mechanism established pursuant to Article 21 of the Convention shall be, through the institutional structure to which its operation is entrusted, the financial mechanism of this Protocol.
3. With regard to the creation of capacity referred to in Article 22 of this Protocol, the Conference of the Parties acting as the meeting of the Parties to this Protocol, providing guidance on the financial mechanism referred to in paragraph 2 above for examination by the Conference of the Parties shall take into account the need for financial resources of the Parties which are developing countries, in particular the least developed countries advanced and small island developing states.
4. In the context of paragraph 1 above, the Parties shall also take into account the needs of the Parties which are developing countries, in particular the least developed countries and small island developing States, as well as the Parties. which are countries with economies in transition, in their efforts to determine and meet their capacity building requirements for the implementation of this Protocol.
5. The guidance provided to the financial mechanism of the Convention in the relevant decisions of the Conference of the Parties, including those agreed prior to the adoption of this Protocol, shall apply mutatis mutandis, to the provisions of this Article.
6. The Parties which are developed countries may also provide financial and technological resources for the implementation of the provisions of this Protocol through bilateral, regional and multilateral channels, and the Parties which are countries in Development and countries with economies in transition will be able to access these resources.
ARTICLE 29. CONFERENCE OF THE PARTIES ACTING AS A MEETING OF THE PARTIES TO THIS PROTOCOL.
1. The Conference of the Parties shall act as a meeting of the Parties to this Protocol.
2. The Parties to the Convention which are not Parties to this Protocol may participate as observers in the deliberations of the meetings of the Conference of the Parties acting as a meeting of the Parties to this Protocol. Where the Conference of the Parties acts as a meeting of the Parties to this Protocol, decisions taken pursuant to this Protocol shall only be taken by the Parties to this Protocol.
3. When the Conference of the Parties acts as a meeting of the Parties to this Protocol, the members of the Bureau of the Conference of the Parties representing Parties to the Convention shall, at that time, not be Parties to this Protocol, shall be replaced by members to be elected by and from the Parties to this Protocol.
4. The Conference of the Parties acting as a meeting of the Parties to this Protocol shall regularly review the implementation of this Protocol and shall, in accordance with its mandate, adopt the decisions necessary to promote its implementation. effective. The Conference of the Parties shall carry out the tasks assigned to it in this Protocol and shall:
(a) Make recommendations on matters deemed necessary for the implementation of this Protocol;
(b) Establish the subsidiary bodies deemed necessary for the implementation of this Protocol;
c) To collect and use, where appropriate, the services, cooperation and information that international organisations and competent non-governmental and intergovernmental bodies may provide;
(d) Establish the form and periodicity to transmit the information to be submitted in accordance with Article 33 of this Protocol and to examine that information, as well as the reports submitted by the subsidiary bodies;
(e) Examine and approve, where appropriate, the amendments to this Protocol and its Annexes, as well as to other additional Annexes to this Protocol, which are deemed necessary for the implementation of this Protocol;
f) To perform the other functions necessary for the implementation of this Protocol.
5. The Regulation of the Conference of the Parties and the Financial Regulation of the Convention shall apply mutatis mutandis to this Protocol, unless otherwise decided by consensus at the Conference of the Parties acting as a meeting of the Parties. in this Protocol.
6. The first meeting of the Conference of the Parties acting as a meeting of the Parties to this Protocol shall be convened by the Secretariat, together with the first meeting of the Conference of the Parties to be held after the Conference of the Parties. date of entry into force of this Protocol. Successive regular meetings of the Conference of the Parties acting as a meeting of the Conference of the Parties to this Protocol shall be held in conjunction with the ordinary meetings of the Conference of the Parties, unless the Conference of the Parties Conference of the Parties acting as the meeting of the Parties to this Protocol decides otherwise.
7. The extraordinary meetings of the Conference of the Parties serving as the meeting of the Parties to this Protocol shall be held when it is deemed necessary by the Conference of the Parties acting as a meeting of the Parties to this Protocol. Protocol, or when requested in writing by a Party, provided that, within six months of the date on which the Secretariat has communicated the request to the Parties, the Party shall have the support of at least one third of the Parties.
8. The United Nations, its specialized agencies and the International Atomic Energy Agency, as well as States which are members or observers of such organizations which are not Parties to the Convention, may be represented as observers at meetings of the Conference of the Parties acting as a meeting of the Parties to this Protocol. Any body or body, whether national or international, governmental or non-governmental with competence in matters covered by this Protocol and which has communicated to the secretariat its interest in being represented as a observer at a meeting of the Conference of the Parties acting as a meeting of the Parties to this Protocol, may be accepted as such unless at least one third of the Parties present are opposed to it. Unless otherwise provided for in this Article, the acceptance and participation of observers shall be governed by the regulation referred to in paragraph 5 above.
ARTICLE 30. SUBSIDIARY BODIES.
1. Any subsidiary body established by or under the Convention may, when so decided by the meeting of the Conference of the Parties acting as a meeting of the Parties to this Protocol, provide services to the Protocol, in which The meeting of the Parties shall specify the functions to be performed by that body.
2. The Parties to the Convention which are not Parties to this Protocol may participate as observers in the discussions of the meetings of the subsidiary bodies of this Protocol. Where a subsidiary body of the Convention acts as a subsidiary body of this Protocol, decisions relating to it shall be taken by the Parties to the Protocol only.
3. Where a subsidiary body of the Convention carries out its duties in relation to matters relating to this Protocol, the members of the Bureau of that subsidiary body representing Parties to the Convention shall not be Parties to the Convention at that time. the Protocol shall be replaced by members to be elected by and from the Parties to the Protocol.
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, concerning the functions of the Secretariat, shall apply mutatis mutandis to this Protocol.
3. To the extent that they can be differentiated, the expenditure of the Secretariat services for the Protocol shall be borne by the Parties to the Protocol.
The Conference of the Parties serving as the meeting of the Parties to this Protocol shall decide, at its first meeting, on the necessary budgetary arrangements for that purpose.
ARTICLE 32. RELATIONSHIP TO THE CONVENTION.
Unless otherwise provided for in this Protocol, the provisions of the Convention relating to its protocols shall apply to this Protocol.
ARTICLE 33. MONITORING AND REPORTING.
Each Party shall monitor compliance with its obligations under this Protocol and shall report to the Conference of the Parties acting as a meeting of the Parties to this Protocol, at the intervals determined by it, on the measures to be taken for the implementation of the Protocol.
The Conference of the Parties serving as the meeting of the Parties to this Protocol shall, at its first meeting, examine and approve institutional mechanisms and cooperation procedures to promote compliance with the provisions of this Protocol. This Protocol and to deal with cases of non-compliance. Those procedures and mechanisms shall include provisions for the provision of advice or assistance, as appropriate. Those procedures and mechanisms shall be established without prejudice to the dispute settlement procedures and mechanisms laid down in Article 27 of the Convention and shall be different from them.
ARTICLE 35. ASSESSMENT AND REVIEW.
The Conference of the Parties serving as the meeting of the Parties to this Protocol shall take place, five years after the entry into force of this Protocol, and thereafter at least every five years, an assessment of the effectiveness of the Protocol, including an assessment of its procedures and annexes.
This Protocol shall be open for signature by the States and regional economic integration organisations at the United Nations Office in Nairobi from 15 to 26 May 2000 and at the United Nations Headquarters in New York. from 5 June 2000 to 4 June 2001.
1. This Protocol shall enter into force on the ninetieth day from the date on which the fiftieth instrument of ratification, acceptance, approval or accession by the States or regional integration organisations has been deposited. economic as Parties to the Convention.
2. This Protocol shall enter into force for each State or regional economic integration organisation ratifying, accepting or approving this Protocol or acceding to it after its entry into force in accordance with paragraph 1 above, (i) ninetieth day from the date on which that State or regional economic integration organisation has deposited its instrument of ratification, acceptance, approval or accession, or on the date on which the Convention enters into force for that purpose; Regional economic integration status or organisation, if that second date is later.
3. For the purposes of paragraphs 1 and 2 above, instruments deposited by a regional economic integration organisation shall not be considered as additional to those deposited by the Member States of that organisation.
No reservations may be made to this Protocol.
1. At any time after two years from the date of entry into force of this Protocol for a Party, that Party may denounce the Protocol by written notification to the Depositary.
2. The complaint shall be effective after one year from the date on which the Depositary has received the notification, or at a later date specified in the notification of the complaint.
The original of this Protocol, whose Arabic, Chinese, Spanish, French, English, and Russian texts are equally authentic, shall be deposited with the Secretary-General of the United Nations.
In testimony of which, the undersigned, duly authorized to that effect, sign this Protocol.
Made in Montreal the twenty-nine January of two thousand.
INFORMATION REQUIRED IN NOTIFICATIONS PURSUANT TO 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, as well as the national classification, if any, of the safety level of the biotechnology, of the modified living organism in the State of export;
d) Expected date or dates of cross-border movement, if known;
(e) Taxonomic situation, common name, collection or acquisition site and characteristics of the receiving agency or parental organisms that are related to the safety of biotechnology;
(f) Centres of origin and centres of genetic diversity, if known, of the receiving organism and/or parental organisms and description of the habitats in which organisms may persist or proliferate;
g) Taxonomic situation, common name, place of collection or acquisition and characteristics of the donor body or bodies that are related to the safety of biotechnology;
h) Description of the nucleic acid or modification introduced, the technique used, and the resulting characteristics of the modified living organism;
i) The intended use of the modified live organism or its products, e.g. processed materials having their origin in modified living organisms, containing new detectable combinations of replicable genetic material obtained through the use of modern biotechnology;
j) Quantity or volume of the modified live organism to be transferred;
k) A report on the known and available risk assessment that has been carried out in accordance with Annex III;
l) Suggested methods for safe handling, storage, transport and use, including packaging, labelling, documentation, disposal procedures and in case of emergency, as appropriate;
m) Regulatory status of the modified living organism concerned in the State of export (e.g. if prohibited in the State of export, if subject to other restrictions, or if it has been approved for general release) and, if the modified living organism is prohibited in the State of export, the reasons for such prohibition;
n) The result and purpose of any notification to other governments by the exporter in relation to the modified live organism that is intended to be transferred;
o) A declaration that the data included in the above information is correct.
(a) The name and address of the applicant for a decision for national use;
(b) The name and address of the decision-making authority;
c) The name and identity of the modified living organism;
d) The description of the modification of the gene, the technique used and the resulting characteristics of the modified living organism;
e) Any unique identification of the modified living organism;
(f) the taxonomic situation, the common name, the place of collection or acquisition and the characteristics of the receiving agency or of the parental organisms which are related to the safety of biotechnology;
g) Centres of origin and centres of genetic diversity, if known, of the receiving organism and/or parental organisms and description of the habitats in which organisms may persist or proliferate;
(h) The taxonomic situation, the common name, the place of collection or acquisition and the characteristics of the donor agency or bodies that relate to the safety of biotechnology;
i) The approved uses of the modified living organism;
j) A report on the risk assessment in accordance with Annex III;
k) Suggested methods for safe handling, storage, transport and use, including packaging, labelling, documentation, disposal procedures and in case of emergency, as appropriate.
Objective
1. The objective of the risk assessment, in the framework of this Protocol, is to identify and assess the possible adverse effects of the modified living organisms on the conservation and sustainable use of biological diversity in the probable (a) means a recipient, also taking into account the risks to human health.
Using Risk Assessment
2. The competent authorities shall use the risk assessment for inter alia to take informed decisions in relation to the modified living organisms.
General principles
3. The risk assessment shall be carried out in a transparent and scientifically competent manner, and the advice of experts and guidelines drawn up by the relevant international organisations shall be taken into account.
4. The lack of scientific knowledge or scientific consensus shall not necessarily be construed as indicators of a particular level of risk, absence of risk, or the existence of an acceptable risk.
5. The risks related to the modified living organisms or their products, e.g. processed materials having their origin in modified living organisms, containing new detectable combinations of replicable genetic material have been obtained through the use of modern biotechnology, should be taken into account in the context of the risks posed by unmodified receptors or by parental organisms in the likely receiving medium.
6. The risk assessment shall be carried out on a case-by-case basis. The nature and level of detail of the information required may vary from case to case, depending on the modified live organism concerned, its intended use and the likely medium recipient.
Methodology
7. The risk assessment process may give rise, on the one hand, to the need for more information on specific aspects, which may be determined and requested during the evaluation process, and on the other hand, the information on other aspects may lack interest in some cases.
8. In order to meet its objectives, the risk assessment involves, as appropriate, the following stages:
(a) An identification of any new genotypic and phenotypic characteristics related to the modified living organism which may have adverse effects on biological diversity and the likely receptor medium, also taking into account risks to human health;
(b) An assessment of the likelihood of such adverse effects actually occurring, taking into account the level and type of exposure of the likely receiving medium to the modified living organism;
c) An assessment of the consequences if these adverse effects actually occurred;
d) An estimate of the overall risk posed by the modified living organism based on the assessment of the likelihood that the particular adverse effects will actually occur and the consequences in that case;
e) A recommendation on whether the risks are acceptable or manageable or not, including, where necessary, the determination of strategies to manage those risks, and
f) When there is uncertainty about the level of risk, it will be possible to remedy this uncertainty by requesting additional information on specific issues of concern, or by putting into practice risk management tegias appropriate and/or monitoring the modified living organism at the receiving medium.
Aspects that need to be taken into account
9. As the case may be, the risk assessment takes into account the relevant technical and scientific data on the characteristics of the following elements:
(a) A receiving agency or parent organisation. The biological characteristics of the receiving organism or parental organisms, including information on the taxonomic situation, the common name, the origin, the centres of origin and the centres of genetic diversity, if known, and a description of the habitat in which organisms may persist or proliferate;
b) Donor body or agencies. Taxonomic status and common name, source and relevant biological characteristics of donor agencies;
c) Vector. Characteristics of the vector, including its identity, if any, its source of origin and the range of its guests;
d) Inserting or inserts and/or features of the modification. Genetic characteristics of the inserted nucleic acid and the function it specifies, and/or characteristics of the modification introduced;
e) Live modified body. Identity of the modified living organism and differences between the biological characteristics of the modified living organism and those of the receiving organism or parental organisms;
f) Detection and identification of the modified living organism. Suggested methods of detection and identification and their specificity, sensitivity and reliability;
g) Information about the intended use. Information on the intended use of the living or modified organism, including a new or different use compared to those of the receiving agency or parental organisms, and
h) Middle receiver. Information on the location and geographical, climatic and ecological characteristics, including relevant information on the biological diversity and the centres of origin of the likely receiving medium. '
EXECUTIVE BRANCH OF PUBLIC POWER
PRESIDENCY OF THE REPUBLIC
Bogotá, D. C., November 29, 2000
Approved, subject to the consideration of the honorable National Congress for constitutional effects.
(Fdo.) ANDRES PASTRANA ARANGO
The Foreign Minister,
(Fdo.) Guillermo Fernandez De Soto.
DECRETA:
ARTICLE 1o. Approve the "Cartagena Protocol on Biosafety of the Convention on Biological Diversity", made in Montreal, the twenty-nine (29) January of two thousand (2000).
ARTICLE 2o. In accordance with the provisions of Article 1o. of Law 7a. In 1944, the "Cartagena Protocol on Biosafety of the Convention on Biological Diversity", made in Montreal, the twenty-nine (29) of January 2000, which was established by Article 1. of this law shall be adopted, shall bind the country from the date on which the international link with respect to the law is perfected.
ARTICLE 3o. This law governs from the date of its publication.
The President of the honorable Senate of the Republic,
Carlos Garcia Orjuela.
The Secretary General (E.) of the honorable Senate of the Republic,
Luis Francisco Boada Gomez.
The President of the honorable House of Representatives,
Guillermo Gaviria Zapata.
The Secretary General of the honorable House of Representatives,
Angelino Lizcano Rivera.
REPUBLIC OF COLOMBIA-NATIONAL GOVERNMENT.
Communicate and comply.
Execute, upon revision of the Constitutional Court, in accordance with Article 241-10 of the Political Constitution.
Dada in Bogotá, D. C., on May 24, 2002.
ANDRES PASTRANA ARANGO
The Foreign Minister,
Guillermo Fernandez De Soto.
The Deputy Minister of the Environment, in charge of the office of the Environment Minister,
Claudia Martinez Zuleta.
