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Original text
(Status on 3 February 2015)
The Parties to this Protocol,
Being Parties to the Convention of 5 June 1992 on Biological Diversity 2 Hereinafter referred to as "the Convention",
Recalling paras. 3 and 4 of Art. 19, art. 8 G And art. 17 of the Convention,
Recalling also decision II/5 of 17 November 1995 of the Conference of the Parties to the Convention requesting the elaboration of a protocol on the prevention of biotechnological risks that would specifically address transboundary movements Modified living organisms resulting from modern biotechnology which may have adverse effects on the conservation and sustainable use of biological diversity, and which would consider, in particular, an appropriate procedure for agreement Prior knowledge of cause,
Reaffirming the precautionary approach enshrined in Principle 15 of the Rio Declaration on Environment and Development,
Aware that modern biotechnology is developing rapidly and that the general public is increasingly concerned about the adverse effects it may have on biological diversity, including the risks that it could entail for the Human health,
Recognising that modern biotechnology offers considerable potential for human well-being as long as it is developed and used in safe conditions for the environment and human health,
Conscious also of the crucial importance to humanity of the centres of origin and the centres of genetic diversity,
Taking into account the fact that many countries, including developing countries, have limited means to deal with the nature and extent of the known and potential risks of living modified organisms,
Believing that trade and environment agreements should be mutually supportive with a view to achieving sustainable development,
Underlining that this Protocol shall not be construed as implying any change in the rights and obligations of a Party under other international agreements in force,
Whereas it is understood that the present preamble is not intended to subordinate the Protocol to other international agreements,
Agreed to the following:
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 transfer, Safe handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, also taking into account Risks to human health, with a specific focus on movements Transborder.
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 living modified organism is done in such a way as to prevent or reduce the risks to biological diversity, in Also taking into account the risks to human health.
Nothing in this Protocol shall affect, in any way, the sovereignty of States over their territorial waters as established under international law or the sovereign rights or jurisdiction exercised by them in their area 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 instruments Relevant international.
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, to Condition that they are compatible with the objective and provisions of the Protocol and in accordance with the other obligations imposed on that Party by international law.
5. The Parties are encouraged to take appropriate account of the available expertise, existing instruments and the work undertaken by the relevant international bodies in relation to risks to human health.
For the purposes of the Protocol:
This Protocol shall apply to transboundary movements, transit, handling and use of any living modified organism which may have adverse effects on the conservation and sustainable use of diversity Also taking into account the risks to human health.
Notwithstanding Art. 4 and without prejudice to the right of the Parties to submit any living modified organism to a risk assessment before taking a decision on its importation, this Protocol shall not apply to transboundary movements of organisms Living modified products that are pharmaceuticals for human use under other relevant international agreements or bodies.
1. Notwithstanding s. 4 and without prejudice to the right of a transit Party to regulate the transport of living modified organisms on its territory and to notify the Biosafety Clearing-Office of any decision it has taken, pursuant to From s. 3 of Art. 2, concerning transit in its territory of a specified living modified organism, the provisions of this Protocol concerning the prior informed consent procedure shall not apply to living modified organisms in transit.
2. Notwithstanding s. 4 and without prejudice to the right of any Party to submit a living modified organism regardless of its risk assessment before taking a decision on its importation and setting standards for environmental uses Confined within the limits of its jurisdiction, the provisions of this Protocol relating to the prior informed consent procedure shall not apply to transboundary movements of living modified organisms intended to be Used in a confined environment that is carried out in accordance with the standards of the importing Party.
1. Subject to s. 5 and 6, the prior informed consent procedure under Art. 8, 9, 10 and 12 applies before the first intentional transboundary movement of living modified organisms intended to be intentionally introduced into the environment of the importing Party.
2. The intentional introduction into the environment referred to in s. 1 above does not apply to living modified organisms intended to be used directly for food or feed, or to be processed.
3. Art. 11 applies before the first transboundary movement of living modified organisms intended for use directly for human or animal feed or for processing.
4. The prior informed consent procedure shall not apply to intentional transboundary movements of living modified organisms which, in a decision of the Conference of the Parties serving as the Meeting of the Parties to the Protocol, are defined as unlikely to have adverse effects on the conservation and sustainable use of biological diversity, taking into account also the risks to human health.
1. The exporting Party shall address, or require the exporter to notify, in writing, to the competent national authority of the importing Party, a notification prior to the intentional transboundary movement of a living modified organism referred to in the By. 1 of the art. 7. The notification shall contain at least the information specified in Annex I.
2. The exporting Party shall ensure that there is legal responsibility for the accuracy of the information provided by the exporter.
The importing Party shall, in writing, send to the author of the notification, within ninety days, an acknowledgement of receipt of the notification.
2. The acknowledgement indicates:
3. The national regulatory framework referred to in s. 2, para. c, above shall be in conformity with the Protocol.
4. The fact, for the importing Party, not to acknowledge receipt of a notification, does not mean that it consents to the intentional transboundary movement.
1. The decisions taken by the importing Party shall be in accordance with Art. 15.
(2) The importing Party shall, within the period prescribed in s. 9, indicate in writing to the notifier whether the intentional transboundary movement may take place:
3. Within two hundred and seventy days from the date of receipt of the notification, the importing Party shall communicate in writing, to the notifier and the Biosafety Clearing-Centre, the relevant decision To par. 2, para. a, above:
4. Except in the case of unconditional consent, the decisions referred to in s. 3 above shall indicate the reasons for the reasons.
5. The fact, for the importing Party, not to communicate its decision within two hundred and seventy days after the date of receipt of the notification does not mean that it consents to the intentional transboundary movement.
The lack of scientific certainty due to insufficient scientific information and knowledge concerning the extent of the potential adverse effects of an altered 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 taking the appropriate decision concerning the importation of the living modified organism as Indicated in par. 3 above, to avoid or minimize these potential adverse effects.
The Conference of the Parties serving as the Meeting of the Parties to the Protocol shall, at its first meeting, decide on appropriate procedures and mechanisms to assist the importing Parties in making a decision.
1. Any Party which makes a final decision concerning the use in the national territory, including the placing on the market, of a living modified organism which may be the subject of a transboundary movement and which is intended to be used Directly for human or animal feed or to be processed, shall, within 15 days thereafter, inform the other Parties, through the Biotechnology Risk Prevention Centre. This information shall contain at least the information requested in Annex II. The Party shall provide, in writing, a copy of this information to the national correspondents of the Parties who have informed the Secretariat in advance of the fact that they do not have access to the Biosafety Clearinghouse. This provision shall not apply to decisions concerning field testing.
(2) Any Party taking a decision in accordance with par. 1 above ensures 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 para. B of Annex II.
(4) Any Party may take, within the framework of its national rules, a decision concerning the import of a living modified organism intended for use directly for human or animal feed or to be processed, subject to reservation That this decision be in accordance with the objective of this Protocol.
5. Each Party shall make available to the Biosafety Clearinghouse a copy of all national laws, regulations and guidelines applicable to the importation of living modified organisms intended to be Used directly for human or animal feed or to be processed, if available.
6. Any developing country or country with economies in transition Party to this Protocol may, in the absence of the national regulatory framework referred to in s. 4 above, when exercising its national competence, declare, through the Biosafety Clearing Centre, that its decision prior to the first importation of a living modified organism intended to be Used directly for human or animal feed or to be processed, for which information has been provided in application of s. 1 above will be taken:
7. The fact that a Party does not communicate its decision in accordance with s. 6 above does not mean that it consents to import or refuses to import the modified living organism considered to be used directly for human or animal feed or to be processed, unless it has specified it Also.
The lack of scientific certainty due to insufficient scientific information and knowledge concerning the extent of the potential adverse effects of a living modified 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 taking the appropriate decision concerning the importation of this living modified organism if it is intended to Be used directly for human or animal nutrition or to be used To avoid or minimize these potential adverse effects.
9. Any Party may make known its needs for financial and technical assistance and capacity development in respect of living modified organisms intended for direct use in human or animal nutrition or Be transformed. The Parties shall cooperate to meet these needs, in accordance with Art. 22 and 28 of this Protocol.
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, also taking into account the risks to health Review and modify its decision on intentional transboundary movement. In such a case, within 30 days, it shall inform the authors of previous notifications of movements of the living modified organism in question, as well as the Clearing Centre for Biosafety, indicating The reasons for the decision.
(2) An exporting Party or the author of a notification may request an importing Party to reconsider its decision concerning it, pursuant to s. 10, where the exporting Party or the notifier considers:
The importing Party shall reply 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.
1. An importing Party may, provided that adequate measures are applied to ensure the safe intentional transboundary movement of living modified organisms, in accordance with the objective of the Protocol, specify in advance Biotechnological Risk Prevention Clearinghouse:
The notifications referred to in para. A above may be claimed for similar subsequent movements to the same Party.
2. Information concerning an intentional transboundary movement to be included in the notification referred to in s. 1, para. a, above are those indicated in Annex I.
Parties may conclude bilateral, regional and multilateral agreements and arrangements on intentional transboundary movements of living modified organisms, if they are consistent 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 inform each other, through the Biotechnology Risk Prevention Exchange Centre, of any bilateral, regional or multilateral agreements or arrangements that they have concluded before or after the date of entry into Of the Protocol.
3. The provisions of the Protocol shall have no effect on intentional transboundary movements which take place under one of these agreements or arrangements between the Parties to that agreement or arrangement.
(4) Any Party may decide that its national rules shall apply to certain specific imports intended for it and shall notify its decision to the Biosafety Clearing-Office.
1. The risk assessments undertaken under this Protocol shall be carried out in accordance with established scientific methods, in accordance with Annex III and taking into account the methods of risk assessment recognised. These risk assessments shall be based on the information provided in accordance with Art. 8 and other available scientific evidence to determine and assess the potential adverse effects of living modified organisms on the conservation and sustainable use of biological diversity, also taking into account Risks to human health.
2. The importing Party shall ensure that a risk assessment is conducted to make a decision under s. 10. The exporter may require the exporter to carry out the risk assessment.
3. The cost of the risk assessment shall be borne by the notifier if required by the importing Party.
1. Taking into account s. 8, para. g, of the Convention, the Parties shall establish and implement appropriate mechanisms, measures and strategies to regulate, manage and control the risks identified in the provisions of the Protocol relating to the evaluation of Risks associated with the use, handling and transboundary movement of living modified organisms.
2. Measures based on risk assessment shall be imposed to the extent necessary to prevent adverse effects of the living modified organism on the conservation and sustainable use of biological diversity, including risks For human health, on the territory of the importing Party.
Each Party shall take appropriate measures to prevent unintentional transboundary movements of living modified organisms, including measures prescribing a risk assessment prior to the first release of a living organism Changed.
4. Without prejudice to s. 2 above, each Party shall ensure that any living modified, imported or locally developed organism has been subjected to an appropriate observation period corresponding to its life cycle or training time before being used as a Expected.
5. The Parties shall cooperate in order to:
Each Party shall take appropriate measures to notify the States actually affected or may be affected, at the Biosafety Clearing-Office and, if necessary, the relevant international organizations, all Knowledge that falls within its jurisdiction and that results in a release that results in or can result in an unintentional transboundary movement of a living modified organism likely to have adverse effects Important conservation and sustainable use of biological diversity, There are also risks to human health in these states. Notification shall be given as soon as the Party concerned becomes aware of this situation.
2. Each Party shall communicate to the Biosafety Clearing Centre, no later than the date of entry into force of this Protocol in respect of that Party, the contact details of the person entitled to receive the Notifications under this Article.
3. Any notification given under s. 1 above should include the following:
4. In order to minimise any significant adverse effects on the conservation and sustainable use of biological diversity, also taking into account the risks to human health, each Party under the jurisdiction of the Release of the living modified organism referred to in s. 1 above shall immediately consult the States actually affected or which may be affected, in order to enable them to determine the appropriate interventions and take the necessary measures, including emergency measures.
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 the bodies Modified live animals which are the subject of an intentional transboundary movement under this Protocol shall be handled, packed and transported in safety conditions, taking into account relevant international rules and standards.
2. Each Party shall take measures to require that the accompanying documentation:
3. The Conference of the Parties serving as the Meeting of the Parties to the Protocol shall determine whether it is necessary to develop standards for identification, handling, packaging and transport, and sets out the modalities for such elaboration, in Consulting with other relevant international bodies.
Each Party shall designate a national focal point to liaise with the Secretariat on its behalf. Each Party shall also designate one or more competent national authorities responsible for carrying out the administrative functions referred to in the Protocol and authorized to act on its behalf in the performance of those functions. A Party may entrust to a single entity the functions of a national correspondent and a competent national authority.
Each Party shall communicate to the Secretariat, no later than the date of entry into force of the Protocol as far as it is concerned, the names and addresses of its national correspondent and the competent national authority or authorities. Where a Party designates more than one competent national authority, it shall indicate to the Secretariat, with its notification to that effect, the respective areas of responsibility of those authorities. Where appropriate, it will at least be specified the competent authority for each type of living modified organism. Each Party shall immediately notify the Secretariat of any change in the designation of its national correspondent or of the name, address, or responsibilities of its competent national authority or authorities.
The Secretariat shall forthwith inform the Parties of the notifications received under s. 2 above and also makes this information available through the Biosafety Clearinghouse.
1. An Exchange Centre for Biosafety is established within the framework of the exchange mechanism provided for in par. 3 of Art. 18 of the Convention, for:
2. The Biosafety Clearinghouse is a means of making information available for the purposes identified in s. 1 above. It provides access to information relevant to the implementation of the Protocol provided by the Parties. It also provides access to other international mechanisms for the exchange of information on the prevention of biotechnological risks, if possible.
3. Without prejudice to the protection of confidential information, each Party shall communicate to the Biosafety Clearinghouse any information it is required to provide under the Protocol, and shall:
4. The modalities of operation of the Biosafety Clearing-Centre, including its activity reports, shall be reviewed and adopted by the Conference of the Parties serving as the Meeting of the Parties to the Protocol to its First meeting and are subject to subsequent reviews.
The importing Party shall allow the author of the notification to indicate, among the information communicated in accordance with the procedures laid down in the Protocol or required by the importing Party under the agreement procedure Prior knowledge of the Protocol, those which must be considered confidential. In such cases, a justification is provided upon request.
2. The importing Party shall consult the notifier when it decides that the information considered by the Party as confidential does not meet the requirements for processing as such and, before disclosing the information, It shall inform it of its decision, stating its reasons on request and providing for the possibility of consultations and an internal 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 in place to protect such information and to protect the confidentiality of such information in such a favorable manner as it uses for confidential information relating to Living modified organisms of national origin.
4. The importing Party shall not use this information for commercial purposes, except with the written consent of the notifier.
5. If the author of the notification withdraws or withdraws the notification, the importing Party shall respect the confidentiality of all commercial or industrial information, including information on research and development, and Confidentiality is the subject of a disagreement between that Party and the notifier.
6. Without prejudice to s. 5 above, the following information is not kept confidential:
1. The Parties shall cooperate in the development and strengthening of human resources and institutional capacity in the field of biosafety, including biotechnology insofar as it relates to Prevention of biotechnological risks, with a view to the effective implementation of the Protocol in developing country Parties, in particular in the least developed countries and small island developing States, as well as in the Parties with economies in transition, including through institutions and organizations Global, regional, sub-regional and national levels and, where appropriate, by encouraging private sector participation.
2. For the purposes of application of s. 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 Know-how and transfer of technology and know-how in accordance with the relevant provisions of the Convention are fully taken into account in the creation of capacities for the prevention of biotechnological risks. Cooperation in capacity-building shall include, subject to differences between the situations, the means and the needs of each Party: scientific and technical training for the rational and safe use of Biotechnology and the use of risk assessments and techniques for the management of biotechnological risks, as well as the strengthening of technical and institutional capacity in the field of biosafety. The needs of Parties with economies in transition are also fully taken into account in building capacity for the prevention of biotechnological risks.
1. The Parties:
2. The Parties shall, in accordance with their respective laws and regulations, consult the public when making decisions relating to living modified organisms and make available to the public the outcome of those decisions, while respecting the Confidentiality of information in accordance with s. 21.
Each Party shall endeavour to inform the public about the means of access to the Biosafety Clearinghouse.
The transboundary movement of living modified organisms between Parties and non-Parties shall be consistent with the objective of the Protocol. The Parties may enter into bilateral, regional or multilateral agreements and arrangements with non-Parties on such transboundary movements.
2. The Parties shall encourage non-Parties to accede to the Protocol and to communicate to the Biosafety Clearing Centre appropriate information on living modified organisms released on their territory, or Subject to movements to or from areas within their national jurisdiction.
Each Party shall adopt national measures to prevent and punish, as appropriate, transboundary movements of living modified organisms in contravention of the national measures it has taken to implement this Protocol. Such movements will be deemed to be illegal transboundary movements.
(2) In the case of an illicit transboundary movement, the affected Party may request the Party of origin to eliminate, at its own expense, the living modified organisms concerned, by repatriating or destroying them, as appropriate.
(3) Each Party shall make available to the Centre for Biosafety Clearing the information relating to the cases of illicit transboundary movements concerning it.
1. The Parties, when making an import decision under this Protocol or under the national measures they have taken to implement the Protocol, may take into account, in accordance with their obligations Socio-economic impacts of the impact of living modified organisms on the conservation and sustainable use of biological diversity, having regard to the value of biological diversity for indigenous communities and Local, in particular.
2. Parties are encouraged to cooperate in research and exchange of information on the socio-economic impact of living modified organisms, in particular for indigenous and local communities.
The Conference of the Parties, serving as the Meeting of the Parties to this Protocol, shall, at its first meeting, undertake a process to develop appropriate international rules and procedures for liability and reparation for Damage resulting from transboundary movements of living modified organisms, by analysing and taking due account of the ongoing work in international law on these issues, and striving to complete this process within four years.
When considering the question of financial resources for the implementation of the Protocol, the Parties shall take into account the provisions of Art. 20 of the Convention.
2. The funding mechanism established by s. 21 of the Convention is, through its institutional structure, the mechanism for the financing of the Protocol.
3. With respect to capacity-building under s. 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 financing mechanism referred to in s. 2 above, for consideration by the Conference of the Parties, of the need for financial resources of developing country Parties, in particular the least developed countries and small island developing States.
4. Under s. 1 above, the Parties shall also take into account the needs of developing country Parties, in particular those of the least developed countries and small island developing States, as well as those of Parties with economies in transition, When they seek to identify and meet their capacity-building needs for the purposes of the Protocol.
5. The guidelines provided to the financing mechanism of the Convention in the relevant decisions of the Conference of the Parties, including those approved prior to the adoption of the Protocol, shall apply, Mutatis mutandis , the provisions of this Article.
6. Developed country Parties may also provide financial and technological resources for the implementation of the provisions of the Protocol, through bilateral, regional and multilateral arrangements, including developing countries Parties And Parties with economies in transition will be able to use them.
The Conference of the Parties shall sit as the Meeting of the Parties to the Protocol.
2. Parties to the Convention which are not Parties to the Protocol may participate as observers in the work of any meeting of the Conference of the Parties serving as the Meeting of the Parties to the Protocol. Where the Conference of the Parties is a meeting of the Parties to the Protocol, decisions taken under the Protocol shall be made only by the Parties to the Protocol.
3. Where the Conference of the Parties sits as a 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 Which is 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 monitor the implementation of the Protocol and shall, within the framework of its mandate, take the decisions necessary to promote its effective implementation. It shall perform the functions assigned to it by the Protocol and shall:
5. The rules of procedure of the Conference of the Parties and the financial rules of the Convention shall apply Mutatis mutandis The Protocol, unless the Conference of the Parties serving as the Meeting of the Parties to the Protocol decides otherwise by consensus.
The first meeting of the Conference of the Parties to the Convention sitting as the Meeting of the Parties to the Protocol shall be convened by the Secretariat at the same time as the first meeting of the Conference of the Parties to be held after the date Entry into force of the Protocol. Thereafter, the ordinary 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 ordinary meetings of the Conference of the Parties, unless the Conference of the Parties sitting As a Meeting of the Parties to the Protocol shall not decide 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 deems it Or at the written request of a Party, provided that this 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 to 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, whether 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 the Meeting of the Parties to the Protocol, may be admitted in that capacity unless at least one third of the Parties present oppose it. The admission and participation of observers shall be governed by the rules of procedure referred to in paragraph 1. 5 above, except as otherwise provided in this Article.
(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 Parties shall specify the functions performed by that body.
(2) Parties to the Convention which are not Parties to this Protocol may participate, as an observer, in the work of any meeting of a subsidiary body of the Protocol. Where 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.
Where a subsidiary body of the Convention performs its functions 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 who is elected by the Parties to the Protocol among them.
1. The Secretariat established pursuant to s. 24 of the Convention shall act as the Secretariat of this Protocol.
2. Le par. 1 of the art. 24 of the Convention on the functions of the Secretariat applies Mutatis mutandis To this Protocol.
3. As far as they are distinct, the costs of the secretariat services relating 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, take the financial provisions necessary for that purpose.
Except as otherwise provided in this Protocol, the provisions of the Convention relating to its Protocols shall apply to this Instrument.
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 Parties serving as the Meeting of the Parties to the Protocol on the measures it has taken to implement the provisions of the Protocol.
The Conference of the Parties serving as the Meeting of the Parties to the Protocol shall review and approve, at its first meeting, procedures and institutional mechanisms for cooperation to encourage compliance with the provisions of the Protocol and Treat cases of non-compliance. These procedures and mechanisms include provisions to provide advice or assistance, as appropriate. They are distinct and without prejudice to the procedure and dispute resolution mechanisms established under s. 27 of the Convention.
The Conference of the Parties serving as the Meeting of the Parties to the Protocol shall proceed, five years after the entry into force of the Protocol, and thereafter at least every five years, to an assessment of its effectiveness, including an assessment of its Procedures and annexes.
This Protocol shall be 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 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 after the date of deposit of the fiftieth instrument of ratification, acceptance, approval or accession by States or regional economic integration organizations Who are Parties to the Convention.
(2) This Protocol shall enter into force for a State or a regional economic integration organization which ratifies, accepts, approves or accedes to it after its entry into force in accordance with par. 1 above, that is, the ninetieth day after the date of the deposit, by that State or economic integration organization, of its instrument of ratification, acceptance, approval or accession, or at the time when the Convention enters into force Effective for that State or regional economic integration organization, whichever is later.
3. For the purposes of paras. 1 and 2 above, none of the instruments deposited by a regional economic integration organization is considered to be in addition to the instruments already deposited by the member States of that organisation.
No reservations may be made to this Protocol.
At 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) Such denunciation shall take effect upon the expiration of one year from the date of its receipt by the Depositary, or at any later date which may be specified in the said notification.
The original of this Protocol, of which the Arabic, Chinese, English, French, Russian and Spanish texts are equally authentic, shall be deposited with the Secretary-General of the United Nations.
In witness whereof, The undersigned, to that duly authorized, have signed this Protocol.
Done at Montréal, twenty-nine January two thousand.
(Suivent signatures)
Objective
For the purposes of this Protocol, the purpose of the risk assessment is to identify and assess the potential adverse effects of living modified organisms on the conservation and sustainable use of biological diversity in the environment Potential receptor, taking into account also risks to human health.
Use of risk assessments
2. The risk assessment shall be used, inter alia, by the competent authorities to make an informed decision concerning living modified organisms.
General Principles
3. The risk assessment should be based on sound scientific methods and transparency and may take into account technical advice and guidance from relevant international organizations.
4. Do not necessarily deduce from the absence of scientific knowledge or consensus the seriousness of a risk, the absence of risk, or the existence of an acceptable risk.
5. The risks associated with living modified organisms or products derived from them, namely, transformed material from living modified organisms that contains new detectable combinations of replicable genetic material obtained Through the use of modern biotechnology, should be considered in relation to the risks posed by unmodified receptor or parent organisms in the likely potential receiving environment.
6. The risk assessment should be done on a case-by-case basis. The nature and degree of accuracy of the information required may vary, depending on the case, depending on the affected living organism affected, its intended use, and the likely potential receiving environment.
Methods
7. Risk assessment may require additional information on specific issues, which may be defined and requested during the evaluation; however, information on other issues may not be relevant. In some cases.
8. In order to achieve its objective, the risk assessment will include, where appropriate, the following steps:
Items to be considered
9. Depending on the case, the risk assessment takes into account relevant technical and scientific data concerning:
| States Parties |
Ratification Accession (A) |
Entry into force |
||
| Afghanistan |
20 February |
2013 A |
21 May |
2013 |
| South Africa |
August 14 |
2003 A |
12 November |
2003 |
| Albania |
February 8 |
2005 A |
9 May |
2005 |
| Algeria |
August 5 |
2004 |
3 November |
2004 |
| Germany |
20 November |
2003 |
18 February |
2004 |
| Angola |
February 27 |
2009 A |
28 May |
2009 |
| Antigua and Barbuda |
10 September |
2003 |
9 December |
2003 |
| Saudi Arabia |
August 9 |
2007 A |
7 November |
2007 |
| Armenia |
April 30 |
2004 A |
July 29 |
2004 |
| Austria |
August 27 |
2002 |
11 September |
2003 |
| Azerbaijan |
1 Er April |
2005 A |
30 June |
2005 |
| Bahamas |
15 January |
2004 |
April 14 |
2004 |
| Bahrain |
7 February |
2012 A |
7 May |
2012 |
| Bangladesh |
5 February |
2004 |
5 May |
2004 |
| Barbados |
September 6 |
2002 A |
11 September |
2003 |
| Belarus |
26 August |
2002 A |
11 September |
2003 |
| Belgium |
15 April |
2004 |
July 14 |
2004 |
| Belize |
12 February |
2004 A |
12 May |
2004 |
| Benin |
2 March |
2005 |
May 31 |
2005 |
| Bhutan |
26 August |
2002 A |
11 September |
2003 |
| Bolivia |
22 April |
2002 |
11 September |
2003 |
| Bosnia and Herzegovina |
1 October |
2009 A |
December 30 |
2009 |
| Botswana |
11 June |
2002 |
11 September |
2003 |
| Brazil |
24 November |
2003 A |
22 February |
2004 |
| Bulgaria |
13 October |
2000 |
11 September |
2003 |
| Burkina Faso |
August 4 |
2003 |
2 November |
2003 |
| Burundi |
2 October |
2008 A |
31 December |
2008 |
| Cambodia |
September 17 |
2003 A |
16 December |
2003 |
| Cameroon |
20 February |
2003 |
11 September |
2003 |
| Cape Verde |
1 Er November |
2005 A |
30 January |
2006 |
| China A |
8 June |
2005 |
September 6 |
2005 |
| Hong Kong |
9 May |
2011 |
9 May |
2011 |
| Cyprus |
5 December |
2003 A |
March 4 |
2004 |
| Colombia |
20 May |
2003 |
11 September |
2003 |
| Comoros |
25 March |
2009 A |
23 June |
2009 |
| Congo (Brazzaville) |
July 13 |
2006 |
11 October |
2006 |
| Congo, Kinshasa |
23 March |
2005 A |
21 June |
2005 |
| Korea (North) |
July 29 |
2003 |
27 October |
2003 |
| Korea (South) |
3 October |
2007 |
1 Er January |
2008 |
| Costa Rica |
February 6 |
2007 |
7 May |
2007 |
| Croatia |
29 August |
2002 |
11 September |
2003 |
| Cuba |
September 17 |
2002 |
11 September |
2003 |
| Denmark B |
August 27 |
2002 |
11 September |
2003 |
| Djibouti |
April 8 |
2002 A |
11 September |
2003 |
| Dominica |
July 13 |
2004 A |
11 October |
2004 |
| Egypt |
December 23 |
2003 |
22 March |
2004 |
| El Salvador |
26 September |
2003 |
25 December |
2003 |
| United Arab Emirates |
12 September |
2014 A |
11 December |
2014 |
| Ecuador |
30 January |
2003 |
11 September |
2003 |
| Eritrea |
10 March |
2005 A |
8 June |
2005 |
| Spain * |
16 January |
2002 |
11 September |
2003 |
| Estonia |
24 March |
2004 |
22 June |
2004 |
| Ethiopia |
9 October |
2003 |
7 January |
2004 |
| Fiji |
5 June |
2001 |
11 September |
2003 |
| Finland |
July 9 |
2004 |
7 October |
2004 |
| France |
7 April |
2003 |
11 September |
2003 |
| Gabon |
2 May |
2007 A |
July 31 |
2007 |
| Gambia |
9 June |
2004 |
7 September |
2004 |
| Georgia |
4 November |
2008 A |
2 February |
2009 |
| Ghana |
30 May |
2003 A |
11 September |
2003 |
| Greece |
21 May |
2004 |
19 August |
2004 |
| Grenada |
5 February |
2004 |
5 May |
2004 |
| Guatemala |
28 October |
2004 A |
26 January |
2005 |
| Guinea |
11 December |
2007 |
10 March |
2008 |
| Guinea-Bissau |
19 May |
2010 A |
August 17 |
2010 |
| Guyana |
18 March |
2008 A |
June 16 |
2008 |
| Honduras |
18 November |
2008 |
February 16 |
2009 |
| Hungary |
13 January |
2004 |
12 April |
2004 |
| Marshall Islands |
27 January |
2003 A |
11 September |
2003 |
| India |
17 January |
2003 |
11 September |
2003 |
| Indonesia |
3 December |
2004 |
3 March |
2005 |
| Iraq |
3 March |
2014 A |
1 Er June |
2014 |
| Iran |
20 November |
2003 |
18 February |
2004 |
| Ireland |
14 November |
2003 |
12 February |
2004 |
| Italy |
24 March |
2004 |
22 June |
2004 |
| Jamaica |
September 25 |
2012 |
24 December |
2012 |
| Japan |
21 November |
2003 A |
19 February |
2004 |
| Jordan |
11 November |
2003 |
February 9 |
2004 |
| Kazakhstan |
8 September |
2008 A |
7 December |
2008 |
| Kenya |
24 January |
2002 |
11 September |
2003 |
| Kyrgyzstan |
5 October |
2005 A |
3 January |
2006 |
| Kiribati |
20 April |
2004 |
19 July |
2004 |
| Laos |
August 3 |
2004 A |
1 Er November |
2004 |
| Lesotho |
September 20 |
2001 A |
11 September |
2003 |
| Latvia |
13 February |
2004 A |
13 May |
2004 |
| Lebanon |
February 6 |
2013 A |
7 May |
2013 |
| Liberia |
February 15 |
2002 A |
11 September |
2003 |
| Libya |
14 June |
2005 A |
12 September |
2005 |
| Lithuania |
7 November |
2003 |
5 February |
2004 |
| Luxembourg |
August 28 |
2002 |
11 September |
2003 |
| Macedonia |
14 June |
2005 |
12 September |
2005 |
| Madagascar |
24 November |
2003 |
22 February |
2004 |
| Malaysia |
3 September |
2003 |
2 December |
2003 |
| Malawi |
February 27 |
2009 |
27 May |
2009 |
| Maldives |
3 September |
2002 A |
11 September |
2003 |
| Mali |
August 28 |
2002 |
11 September |
2003 |
| Malta |
5 January |
2007 A |
5 April |
2007 |
| Morocco |
April 25 |
2011 |
24 July |
2011 |
| Mauritius |
April 11 |
2002 A |
11 September |
2003 |
| Mauritania |
July 22 |
2005 A |
20 October |
2005 |
| Mexico |
August 27 |
2002 |
11 September |
2003 |
| Moldova |
March 4 |
2003 |
11 September |
2003 |
| Mongolia |
July 22 |
2003 A |
20 October |
2003 |
| Montenegro |
23 October |
2006 S |
3 June |
2006 |
| Mozambique |
21 October |
2002 |
11 September |
2003 |
| Myanmar |
13 February |
2008 |
13 May |
2008 |
| Namibia |
10 February |
2005 |
11 May |
2005 |
| Nauru |
12 November |
2001 A |
11 September |
2003 |
| Nicaragua |
August 28 |
2002 |
11 September |
2003 |
| Niger |
September 30 |
2004 |
29 December |
2004 |
| Nigeria |
July 15 |
2003 |
13 October |
2003 |
| Niue |
July 8 |
2002 A |
11 September |
2003 |
| Norway |
10 May |
2001 |
11 September |
2003 |
| New Zealand C |
24 February |
2005 |
25 May |
2005 |
| Oman |
April 11 |
2003 A |
11 September |
2003 |
| Uganda |
30 November |
2001 |
11 September |
2003 |
| Pakistan |
2 March |
2009 |
May 31 |
2009 |
| Palau |
13 June |
2003 |
11 September |
2003 |
| Palestine |
2 January |
2015 A |
2 April |
2015 |
| Panama |
1 Er May |
2002 |
11 September |
2003 |
| Papua New Guinea |
14 October |
2005 A |
12 January |
2006 |
| Paraguay |
10 March |
2004 |
8 June |
2004 |
| Netherlands |
8 January |
2002 |
11 September |
2003 |
| Peru |
April 14 |
2004 |
July 13 |
2004 |
| Philippines |
5 October |
2006 |
3 January |
2007 |
| Poland |
10 December |
2003 |
March 9 |
2004 |
| Portugal |
September 30 |
2004 |
29 December |
2004 |
| Qatar |
March 14 |
2007 A |
12 June |
2007 |
| Central African Republic |
18 November |
2008 |
February 16 |
2009 |
| Dominican Republic |
20 June |
2006 A |
18 September |
2006 |
| Czech Republic |
8 October |
2001 |
11 September |
2003 |
| Romania |
30 June |
2003 |
28 September |
2003 |
| United Kingdom |
19 November |
2003 |
17 February |
2004 |
| Gibraltar |
30 May |
2014 |
30 May |
2014 |
| Rwanda |
July 22 |
2004 |
20 October |
2004 |
| Saint Lucia |
June 16 |
2005 A |
September 14 |
2005 |
| Saint Kitts and Nevis |
23 May |
2001 A |
11 September |
2003 |
| Saint Vincent and the Grenadines |
August 27 |
2003 A |
25 November |
2003 |
| Solomon Islands |
28 July |
2004 A |
26 October |
2004 |
| Samoa |
30 May |
2002 |
11 September |
2003 |
| Senegal |
8 October |
2003 |
6 January |
2004 |
| Serbia |
February 8 |
2006 A |
9 May |
2006 |
| Seychelles |
13 May |
2004 |
August 11 |
2004 |
| Slovakia |
24 November |
2003 |
22 February |
2004 |
| Slovenia |
20 November |
2002 |
11 September |
2003 |
| Somalia |
26 July |
2010 A |
24 October |
2010 |
| Sudan |
13 June |
2005 A |
11 September |
2005 |
| Sri Lanka |
28 April |
2004 |
26 July |
2004 |
| Sweden |
8 August |
2002 |
11 September |
2003 |
| Switzerland |
26 March |
2002 |
11 September |
2003 |
| Suriname |
March 27 |
2008 A |
25 June |
2008 |
| Swaziland |
13 January |
2006 A |
13 April |
2006 |
| Syria |
1 Er April |
2004 A |
30 June |
2004 |
| Tajikistan |
12 February |
2004 A |
12 May |
2004 |
| Tanzania |
24 April |
2003 A |
11 September |
2003 |
| Chad |
1 Er November |
2006 |
30 January |
2007 |
| Thailand |
10 November |
2005 A |
February 8 |
2006 |
| Togo |
July 2 |
2004 |
September 30 |
2004 |
| Tonga |
18 September |
2003 A |
17 December |
2003 |
| Trinidad and Tobago |
5 October |
2000 A |
11 September |
2003 |
| Tunisia |
22 January |
2003 |
11 September |
2003 |
| Turkmenistan |
August 21 |
2008 A |
19 November |
2008 |
| Turkey |
24 October |
2003 |
24 January |
2004 |
| Ukraine |
6 December |
2002 A |
11 September |
2003 |
|
August 27 |
2002 |
11 September |
2003 |
| Uruguay |
2 November |
2011 |
31 January |
2012 |
| Venezuela |
13 May |
2002 |
11 September |
2003 |
| Vietnam |
21 January |
2004 A |
20 April |
2004 |
| Yemen |
1 Er December |
2005 A |
1 Er March |
2006 |
| Zambia |
April 27 |
2004 A |
July 25 |
2004 |
| Zimbabwe |
25 February |
2005 |
26 May |
2005 |
|
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|
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|
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| C The Protocol does not apply to Tokelau. |
1 RO 2004 577
2 RS 0.451.43
3 RO 2004 606 3713, 2005 2335, 2006 791 4451, 2007 1401, 2008 4121, 2010 17, 2011 4887, 2013 1485, 2015 591. A version of the updated scope of application is published on the DFAE website (www.dfae.admin.ch/traites).
