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The Cartagena Protocol On Biosafety, Annexed To The Convention On Biological Diversity

Original Language Title: Par Kartahenas protokolu par bioloģisko drošību, kas pievienots Konvencijai par bioloģisko daudzveidību

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The Saeima has adopted and the President promulgated the following laws: for the Cartagena Protocol on Biosafety, annexed to the Convention on biological diversity article 1. January 29, 2000 Cartagena Protocol on Biosafety, annexed to the Convention on biological diversity (hereinafter referred to as the Protocol), with this law is adopted and approved.
2. article. In accordance with article 19 of the Protocol, the functions of the coordination centres fulfil the Latvian food centre. The competent institution functions according to specific regulations to fulfil the competence of the Ministry of the environment and the Ministry of health.
3. article. The law shall enter into force on the date of its promulgation. With the law put the Protocol in English, and its translation into Latvian language.
4. article. The Protocol shall enter into force in article 37 on time and in order, and the Ministry of Foreign Affairs shall notify the newspaper "journal".
The Parliament adopted the law of 22 January 2004.
State v. President Vaira Vīķe-Freiberga in Riga on 11 February 2004, in the Editorial Note: the law shall enter into force on 11 February 2004.
 

Cartagena PROTOCOL ON BIOSAFETY TO the CONVENTION ON BIOLOGICAL DIVERSITY the parties to this Protocol, Being parties to the Convention on Biological Diversity, hereinafter referred to as "the Convention", Recalling article 19, paragraphs 3 and 4, and articles 8 (g) and 17 of the Convention, Recalling also decision II/5 of 17 February 1995 of the Conference of the parties to the Convention to develop a Protocol on biosafety , specifically focusing on transboundary movement of any living modified organism resulting from modern biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity, setting out for considerations, in particular, appropriate procedures for advance informed agreement, Reaffirming the Principles of the banks approach led in 15 of the Rio Declaration on environment and development, Aware of the rapid expansion of modern biotechnology and the growing public concern over its potential adverse effects on biological diversity , taking also into account risks to human health, Recognizing that modern biotechnology has great potential for human well-being if developed and used with adequat safety measure for the environment and human health, Recognizing also the crucial importanc to humankind of centres of origin and centres of genetic diversity, Taking into account the limited capabilities of many countries, particularly developing countries, to cope with the nature and scale of the known and potential risks associated with living modified organisms , Recognizing that trade and environment agreements should be mutually supportive with a view to achieving sustainable development, Emphasizing that this Protocol shall not be interpreted as implying a change in the rights and obligations of a Party under any existing international agreements, Understanding that the above recital is not intended to this Protocol the subordinat others international agreements, have agreed as follows : article 1 objective In accordanc with the banks approach led in 15 Principles of the Rio Declaration on environment and development, the objective of this Protocol is to contribute to ensuring an adequat level of protection in the field of the safe transfer, 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 , taking also into account risks to human health, and specifically focusing on transboundary movement.
Article 2 GENERAL PROVISION 1. Each Party shall take appropriate legal, cessary and not administrative and others measure it implementations that its obligation under this Protocol.
2. The Parties shall ensur that the development, handling, transport, use, transfer and release of any living modified organism with the undertaken in a manner that prevents or reduce the risks to biological diversity, taking also into account risks to human health.
3. Nothing in this Protocol shall in any way be affec the sovereignty of States over their territorial sea established in accordanc with international law, and the sovereign rights and the jurisdiction which States have in their exclusive economic zones and their continental shelves in accordanc with international law, and the exercise by ships and aircraft of all States of navigational rights and freedom as provided for in international law and as reflected in relevant international instruments.
4. Nothing in this Protocol shall be interpreted as restricting the right of a Party to take action that is more protective of the conservation and sustainable use of biological diversity than that called for in this Protocol, provided that such action is consistent with the objective and the provision of this Protocol and is in accordanc with that Party's other obligations under international law.
5. The parties are encouraged to take into account, as appropriate, available expertise, instruments and work undertaken in international forums with competence in the area of risk to human health.
Article 3 use OF terms For the purpose of this Protocol: (a) "Conference of the parties" means the Conference of the parties to the Convention;
(b) "Led use" means any operation, undertaken within a facility, installation or other physical structure, which the living modified organism involv you with controlled by the specific measure of that effectively limit their contact with, and their impact on, the external environment;
(c) "export" means intentional transboundary movement from one Party to another Party;
(d) the "Exporters" means any legal or natural person, under the jurisdiction of the Party of export, who (a) living modified organisms arrang for to be exported;
(e) "import" means intentional transboundary movement into one Party from another Party;
(f) "Importer" means any legal or natural person, under the jurisdiction of the Party of import, who (a) living modified organisms for arrang to be imported;
(g) "Living modified organism" means any living organism that who's a combination of genetic material obtained through the novel, the use of modern biotechnology;
(h) "Living organism" means any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and the viroid;
(i) "Modern biotechnology" means the application of: a. In vitro nucleic acid techniques, including recombinan the deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or b. Fusion of cells beyond the taxonomic family, that the natural physiological overcom reproductive or recombination barriers and that are not techniques used in traditional breeding and selection;
(j) "Regional economic integration organization" means an organization constituted by sovereign States of a given region, to which its member States have transferred competence in respect of matters governed by this Protocol and which has been duly authorized, in accordanc with its internal procedures, to sign, accept, approve, ratify.â or accede to it;
(k) "Transboundary Movement" means the movement of a living modified organism from one Party to another Party, save that for the purpose of articles 17 and 24 transboundary movement extend to movement between parties and non-parties.
Article 4 scope this Protocol shall apply to the transboundary movement, transit, handling and use of all living modified organisms that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.
Article 5 pharmaceuticals Notwithstanding article 4 and without prejudice to any right of a Party to subject all living modified organisms to risk assessment prior to the making of decisions on import, this Protocol shall not apply to the transboundary movement of living modified organisms which are pharmaceuticals for humans that are addressed by other relevant international agreements or organisations.
Article 6 transit AND LED US 1. Notwithstanding article 4 and without prejudice to any right of a Party of transit to regulat the transport of living modified organisms through its territory and make available to the Biosafety Clearing-House, any decision of that Party, subject to article 2, paragraph 3, regarding the transit through its territory of a specific living modified organism , the provision of this Protocol with respect to the advance informed agreement procedure shall not apply to living modified organisms in transit.
2. Notwithstanding article 4 and without prejudice to any right of a Party to subject all living modified organisms to risk assessment prior to decisions on import and to set standards for use within its jurisdiction led to the provision of this Protocol with respect to the advance informed agreement procedure shall not apply to the transboundary movement of living modified organisms destined for use in accordanc led undertaken with the standards of the Party of import.
Article 7 APPLICATION OF the advance INFORMED agreement procedure 1. Subject to articles 5 and 6, the advance informed agreement procedure in articles 8 to 10 and 12 shall apply prior to the first intentional transboundary movement of living modified organisms for intentional introduction into the environment of the Party of import.
2. "Intentional introduction into the environment" in paragraph 1 above, does not refer to living modified organisms intended for direct use as food or feed, or for processing.
3. Article 11 shall apply prior to the first transboundary movement of a living modified organism intended for direct use as food or feed, or for processing.

4. The advance informed agreement procedure shall not apply to the intentional transboundary movement of living modified organisms identified in a decision of the Conference of the Parties serving as the meeting of the parties to this Protocol as being not likely to have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.
Article 8 NOTIFICATION 1. The Party of export shall notify, or require the exporters to ensur notifications it, in writing, the competent national authority of the Party of import prior to the intentional transboundary movement of a living modified organism that falls within the scope of article 7, paragraph 1. The notification shall contain, at a minimum, the information specified in Annex i. 2. The Party of export shall ensur that there is a legal requirement for the accuracy of information provided by the exporters.
Article 9 acknowledgement OF receipt OF NOTIFICATION 1. The Party of import shall acknowledg the receipt of the notification, in writing, to the notifier within ninety days of its receipt.
2. The acknowledgement shall state: (a) the date of receipt of the notification;
(b) the Whethers the notification, prima facie, contains the information referred to in article 8;
(c) the Whethers to proceed according to the domestic regulatory framework of the Party of import or according to the procedure specified in article 10. The domestic regulatory framework referred to in paragraph 2 (c) above, shall be consistent with this Protocol.
4. A failure by the Party of import to the receipt of a notification acknowledg shall not imply its consent to an intentional transboundary movement.
Article 10 DECISION procedure 1. Decision taken by the Party of import shall be in accordanc with article 15. The Party of import shall, within the period of time referred to in article 9, inform the notifier, in writing, the intentional transboundary whethers movement may proceed: (a) Only after the Party of import has given its written consent; or (b) of less than ninety days After, without a subsequent written consent.
3. Within two hundred and seventy days of the date of receipt of the notification, the Party of import shall communicate, in writing, to the notifier and to the Biosafety Clearing-House the decision referred to in paragraph 2 (a) above: (a) Approving the import, with or without conditions, including how the decision will apply to subsequent imports of the same living modified organism;
(b) Prohibiting the import;
(c) Requesting additional relevant information in accordanc with its domestic regulatory framework or Annex I; in calculating the time within which the Party of import is it responds, the number of days it has to wait for additional relevant information shall not be taken into account; or (d) Informing the notifier that the period specified in this paragraph is extended by a defined period of time.
4. Except in a case in which consent is unconditional, a decision under paragraph 3 above, shall set out the reasons on which it is based.
5. A failure by the Party of import to communicate its decision within two hundred and seventy days of the date of receipt of the notification shall not imply its consent to an intentional transboundary movement.
6. Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the exten of the potential adverse effects of a living modified organism on the conservation and sustainable use of biological diversity in the Party of import, taking also into account risks to human health, shall not prevent that Party from taking a decision, as appropriate, with regard to the import of the living modified organism in the questions referred to in paragraph 3 as above , in order to avoid or minimize such potential adverse effects.
7. The Conference of the Parties serving as the meeting of the Parties shall, at its first meeting, decide upon appropriate procedures and mechanisms of decision making by the facilitat-parties of import.
Article 11 procedure FOR LIVING MODIFIED organisms INTENDED FOR direct use AS FOOD OR FEED, OR FOR PROCESSING 1. A Party that makes a final decision regarding domestic use, including placing on the market, of a living modified organism that may be subject to transboundary movement for direct use as food or feed, or for processing shall, within fifteen days of making that decision informed the parties through the Biosafety Clearing-House. This information shall contain, at a minimum, the information specified in Annex II. The Party shall provide a copy of the information, in writing, to the national focal point of each Party that informs the Secretariat in advance that it does not have access to the Biosafety Clearing-House. This provision shall not apply to decisions regarding the field trials.
2. The Party making a decision under paragraph 1 above, shall ensur that there is a legal requirement for the accuracy of information provided by the applicant.
3. Any Party may request additional information from the authority identified in paragraph (b) of Annex II. 4. A Party may take a decision on the import of a living modified organism intended for direct use as food or feed, or for processing, under its domestic regulatory framework that is consistent with the objective of this Protocol.
5. Each Party shall make available to the Biosafety Clearing-House to the national law of any cop, regulations and guidelines applicable to the import of a living modified organism intended for direct use as food or feed, or for processing, if available.
6. A developing country Party or a Party with an economy in transition may, in the absence of the domestic regulatory framework referred to in paragraph 4 above, and in exercise of its domestic jurisdiction, declare through the Biosafety Clearing-House the that its decision prior to the first import of a living modified organism intended for direct use as food or feed , or for processing, on which information has been provided under paragraph 1 above, will be taken according to the following: (a) A risk assessment undertaken in accordanc with Annexe III; and (b) A decision made within a timeframe of predictabl, not exceeding two hundred and seventy days.
7. Failure by a Party to communicate its decision according to paragraph 6 above, shall not imply its consent or refusal to the import of a living modified organism intended for direct use as food or feed, or for processing, unless otherwise is specified by the Party.
8. Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the exten of the potential adverse effects of a living modified organism on the conservation and sustainable use of biological diversity in the Party of import, taking also into account risks to human health, shall not prevent that Party from taking a decision, as appropriate, with regard to the import of the living modified organism intended for direct you use as food or feed , or for processing, in order to avoid or minimize such potential adverse effects.
9. A Party may indicates it needs for financial and technical assistance and capacity-building with respect to living modified organisms intended for direct use as food or feed, or for processing. Parties shall cooperate to meet these needs in accordanc with articles 22 and 28 article 12 REVIEW OF DECISIONS 1. A Party of import may, at any time, in the light of new scientific information on potential adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health the, review and change a decision regarding an intentional transboundary movement. In such case, the Party shall, within thirty days, inform any notifier that has previously notified movement of the living modified organism referred to in such decision, as well as the Biosafety Clearing-House, and shall set out the reasons for its decision.
2. A Party of export or a notifier may request the Party of import to review a decision it has made in respect of it under article 10 where the Party of export or the notifier consider that: (a) A change in the of has occurred that circumstanc may influence the outcome of the risk assessment upon which the decision was based; or (b) Additional relevant scientific or technical information has become available.
3. The Party of import shall in writing to such a request responds to within ninety days and set out the reasons for its decision.
4. The Party of import may, at its discretion, require a risk assessment for subsequent imports.
Article 13 SIMPLIFIED procedure 1 A Party of import may, provided that the measure with adequat applied to ensur the safe intentional transboundary movement of living modified organisms in accordanc with the objective of this Protocol, specify in advance to the Biosafety Clearing-House: (a) cases in which intentional transboundary movement to it may take place at the same time as the movement is notified to the Party of import; and (b) imports of living modified organisms to it to be exempted from the advance informed agreement procedure.
Notification under subparagraph (a) above, may apply to subsequent similar movement to the same Party.
2. The information relating to an intentional transboundary movement that is 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 MULTILATERALS agreements AND ARRANGEMENTS 1. Parties may enter into bilateral, regional and multilaterals and arrangements regarding intentional agreements for transboundary movement of living modified organisms , consistent with the objective of this Protocol and provided that such agreements and arrangements do not result in a lower level of protection than that provided for by the Protocol.

2. The Parties shall inform each other, through the Biosafety Clearing-House, of any such bilateral, regional and multilaterals agreements and arrangements that they have entered into before or after the date of entry into force of this Protocol.
3. The provision of this Protocol shall not be intentional transboundary movement affec that take place to such agreements and pursuan arrangements as between the parties to those agreements or arrangements.
4. Any Party may determin that its domestic regulations shall apply with respect to specific imports to it and shall notify the Biosafety Clearing-House of its decision.
Article 15 RISK assessment 1. Risk assessments undertaken pursuan to this Protocol shall be carried out in a scientifically sound manner, in accordanc with Annex III and taking into account recognized risk assessment techniques. Such risk assessments shall be based, at a minimum, on information provided in accordanc with article 8 and other available scientific evidence in order to identify and evaluate the possible adverse effects of a living modified organism on the conservation and sustainable use of biological diversity, taking also into account risks to human health.
2. The Party of import shall ensur that risk assessments are carried out for decisions taken under article 10 It may require the exporters to carry out the risk assessment.
3. The cost of risk assessment shall be borne by the notifier if the Party of import so requires.
Article 16 RISK Management 1. The Parties shall, taking into account article 8 (g) of the Convention, establish and maintain appropriate mechanisms to measure and strategies it regulat, manage and control risks identified in the risk assessment of the provision of this Protocol associated with the use, handling and transboundary movement of living modified organisms.
2. based on the risk assessment of the Measure shall be imposed to the exten cessary to prevent the adverse effects of a living modified organism on the conservation and sustainable use of the of biological diversity, taking also into account risks to human health, within the territory of the Party of import.
3. Each Party shall take the appropriate measure to prevent unintentional transboundary movement of living modified organisms, including such measure requiring a risk assessment of the axis to be carried out prior to the first release of a living modified organism.
4. Without prejudice to paragraph 2 above, each Party shall endeavour to ensur that any living modified organisms, imported or locally developed, whethers has undergon an appropriate period of observation that is commensurat with its life-cycle or generation time before it is put to its intended use.
5. the Parties shall cooperate with a view to: (a) Identifying living modified organisms or specific traits of living modified organisms that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health; and (b) Taking appropriate measure regarding the treatment of such living modified organisms or of specific traits.
Article 17 UNINTENTIONAL TRANSBOUNDARY MOVEMENT AND EMERGENCY MEASURE 1. Each Party shall take the appropriate measure to notify affected or potentially affected States, the Biosafety Clearing-House and, where appropriate, relevant international organizations, when it knows of an occurrence under its jurisdiction resulting in a release that in leads, or may lead, to an unintentional transboundary movement of a living modified organism that is likely to have significant adverse effects on the conservation and sustainable use of biological diversity , taking also into account risks to human health in such States. The notification shall be provided as soon as the Party knows of the above situation.
2. Each Party shall, no later than the date of entry into force of this Protocol for it, make available to the Biosafety Clearing-House the relevant details setting out its point of contact for the purpose of receiving notifications under this article.
3. Any notification arising from paragraph 1 above, should include: (a) available relevant information on the estimated quantit and relevant characteristics and/or traits of the living modified organism the;
(b) Information on the circumstanc and estimated data of the release, and on the use of the living modified organism in the originating Party;
(c) Any available information about the possible adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, as well as available information about possible risk management measure;
(d) Any other relevant information; and (e) A point of contact for further information.
4. In order to minimize any significant adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, each Party, under whose jurisdiction the release of the living modified organism referred to in paragraph 1 above, shall immediately consult the occure, the affected or potentially affected States to enable them to determin appropriate responses and not cessary initiat action , including the emergency measure.
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 risks to human health, each Party shall take measure to require cessary not that living modified organisms that are subject to intentional transboundary movement within the scope of this Protocol are handled, packaged and transported under conditions of safety, taking into considerations relevant international rules and standards.
2. Each Party shall take measure to require that documentation accompanying: (a) Living modified organisms that are intended for direct use as food or feed, or for processing, clearly identify that they "may contain" living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information. The Conference of the Parties serving as the meeting of the parties to this Protocol shall take a decision on the detailed requirements for this purpose, including specification of their identity and any unique identification, from the later than two years after the date of entry into force of this Protocol;
(b) Living modified organisms that are destined for use in led clearly identify them as living modified organisms; and specifi c to any requirements for the safe handling, storage, transport and use, the contact point for further information, including the name and address of the individual and institution to whom the living modified organism is consigned with; and (c) Living modified organisms that are intended for intentional introduction into the environment of the Party of import and any other living modified organisms within the scope of the Protocol, to clearly identify them as living modified organisms; specifi c to the identity and relevant traits and/or characteristics, any requirements for the safe handling, storage, transport and use, the contact point for further information and, as appropriate, the name and address of the importer and exporters; and contains a declaration that the movement is in conformity with the requirements of this Protocol applicable to the exporters.
3. The Conference of the Parties serving as the meeting of the parties to this Protocol shall consider the need for and to developing standards of the modalit with regards to identification, handling, packaging and transport practices, in consultation with other relevant international bodies.
Article 19 COMPETENT NATIONAL authorities AND NATIONAL FOCAL points 1. Each Party shall designat one national focal point to be responsible on its behalf for liason with the Secretariat. Each Party shall also designat one or more competent national authorities, which shall be responsible for performing the administrative functions required by this Protocol and which shall be authorized to act on its behalf with respect to those functions. A Party may file a single entity designat to fulfil the functions of both focal point and competent national authority.
2. Each Party shall, no later than the date of entry into force of this Protocol for it, notify the Secretariat of the names and addresses of its focal point and its competent national authority or authorities. Where a Party of more than one designat competent national authority, it shall convey to the Secretariat, with its notification thereof, relevant information on the responsibilities of the respectiv those authorities. Where applicable, such information shall, at a minimum, specify which competent authority is responsible for which type of living modified organisms. Each Party shall forthwith notify the Secretariat of any changes in the designation of its national focal point or in the name and address or responsibilities of the competent national authority or its authorities.
3. the Secretariat shall forthwith notify the the parties of the notifications it receive the under paragraph 2 above, and shall also make such information available through the Biosafety Clearing-House.
Article 20 INFORMATION SHARING AND the BIOSAFETY CLEARING-House 1. A Biosafety Clearing-House is hereby established as part of the clearing-house mechanism under article 18, paragraph 3, of the Convention, in order to: (a) the exchange of Facilitat scientific, technical, environmental and legal information on, and experience with, living modified organisms; and (b) assist Parties to the Protocol implementations that, taking into account the special needs of developing country Parties, in particular the least developed and small island developing States among them, and countries with economies in transition as well as countries that are centres of origin and centres of genetic diversity.

2. The Biosafety Clearing-House shall serve as a means through which information is made available for the purpose of paragraph 1 above. It shall provide access to information made available by the Parties relevant to the implementation of the Protocol. It shall also provide access, where possible, to other international biosafety information exchange mechanisms.
3. Without prejudice to the protection of confidential information, each Party shall make available to the Biosafety Clearing-House any information required to be made available to the Biosafety Clearing-House under this Protocol, and: (a) Any existing laws, regulations and guidelines for implementation of the Protocol, as well as information required by the parties for the advance informed agreement procedure;
(b) Any bilateral, regional and multilaterals agreements and arrangements;
(c) summaries of its risk assessments or environmental reviews of living modified organisms generated by its regulatory process, and carried out in accordanc with article 15, including, where appropriate, relevant information regarding products thereof, namely, processed materials that are of living modified organism origin, containing a detectabl novel combinations of materials obtained through genetics replicabl the use of modern biotechnology;
(d) its final decision is regarding the importation or release of living modified organisms; and (e) reports submitted by it to article 33 pursuan, including those on implementation of the advance informed agreement procedure.
4. The modalit in of the operations of the Biosafety Clearing-House, including reports on its activities, shall be considered and decided upon by the Conference of the Parties serving as the meeting of the parties to this Protocol at its first meeting, and the skipper under review thereafter.
Article 21 CONFIDENTIAL INFORMATION 1. The Party of import shall permit the notifier to identify information submitted under the procedures of this Protocol or required by the Party of import as part of the advance informed agreement procedure of the Protocol that is to be treated as confidential. Justification shall be given in such cases upon request.
2. The Party of import shall consult the notifier if it decide that the information identified by the notifier as confidential does not qualify for such treatment and shall, prior to any disclosure, inform the notifier of its decision, providing reasons on request, as well as an opportunity for consultation and for an internal review of the decision prior to disclosure.
3. Each Party shall protect confidential information received under this Protocol, including any confidential information received in the context of the advance informed agreement procedure of the Protocol. Each Party shall ensur that it has procedures to protect such information and shall protect the confidentiality of such information in a manner of less than its favourabl treatment of confidential information in connection with domestically produced living modified organism.
4. The Party of import shall not use such information for a commercial purpose, except with the written consent of the notifier.
5. If a notifier has withdrawn a withdraw or notification, the Party of import shall respect the confidentiality of commercial and industrial information, including research and development information as well as information on which the Party and the notifier disagree as to its confidentiality.
6. Without prejudice to paragraph 5 above, the following information shall not be considered confidential: (a) the name and address of the notifier;
(b) A general description of the living modified organism or organisms;
(c) A summary of the risk assessment of the effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health; and (d) Any methods and plans for emergency response.
Article 22 CAPACITY-BUILDING 1. The Parties shall cooperate in the development and/or strengthening of human resources and institutional capacities in biosafety, including biotechnology to the exten the that it is required for biosafety, for the purpose of the effective implementation of this Protocol, in developing country Parties, in particular the least developed and small island developing States among them, and in parties with economies in transition , including through existing global, regional, subregional and national institutions and organizations and, as appropriate, through facilitating private sector involvement.
2. For the purpose of implementing paragraph 1 above, in relations to their cooperation, the needs of developing country Parties, in particular the least developed and small island developing States among them, for financial resources and access to and transfer of technology and know-how in accordanc with the relevant provision of the Convention, shall be taken fully into account for capacity-building in biosafety. Cooperation in capacity-building shall, subject to the different situation, capabilities and requirements of each Party, include scientific and technical training in the proper and safe management of biotechnology, and in the use of risk assessment and risk management for biosafety, and the enhancement of technological and institutional capacities in biosafety. The needs of parties with economies in transition shall also be taken fully into account for such capacity-building in biosafety.
Article 23 PUBLIC awareness AND PARTICIPATION 1. The Parties shall: (a) promote public awareness and facilitat, education and participation concerning the safe transfer, handling and use of living modified organisms in relations to the conservation and sustainable use of biological diversity, taking also into account risks to human health. In doing so, the Parties shall cooperate, as appropriate, with other States and international bodies;
(b) Endeavour to ensur that public awareness and education encompass access to information on living modified organisms identified in accordanc with this Protocol that may be imported.
2. The Parties shall, in accordanc with their respectiv law and regulations, consult the public in the decision-making process regarding living modified organisms and shall make the results of such decisions available to the public, while respecting confidential information in accordanc with article 21. Each Party shall endeavour to 3 to keep its public about the means of public access to the Biosafety Clearing-House.
Article 24 NON-parties 1. Transboundary movement of living modified organisms between parties and non-Parties shall be consistent with the objective of this Protocol. The parties may enter into bilateral, regional and multilaterals agreements and arrangements with non-parties regarding such transboundary movement.
2. The Parties shall encourag non-parties to adher to this Protocol and to contribute appropriate information to the Biosafety Clearing-House on living modified organisms released in, or moved into or out of, areas within their national jurisdiction.
Article 25 ILLEGAL TRANSBOUNDARY MOVEMENT 1. Each Party shall be the appropriate measure of domestics adop aimed at preventing and, if appropriate, penalizing transboundary movement of living modified organisms carried out in contravention of its domestic measure it implementations that this Protocol. Such a movement shall be deemed illegal transboundary movement.
2. In the case of an illegal transboundary movement, the affected Party may request the Party of origin to its own dispos, at the expense of the living modified organism in question by repatriation or destruction, as appropriate.
3. Each Party shall make available to the Biosafety Clearing-House information concerning cases of illegal transboundary movement of pertaining to it. Article 26 socio-ECONOMIC considerations 1. The parties, in reaching a decision on import under this Protocol or under its domestic measure for implementing the Protocol, may take into account, consistent with their international obligations, socio-economic considerations arising from the impact of living modified organisms on the conservation and sustainable use of biological diversity, especially with regards to the value of biological diversity to indigenous Australians and local communities.
2. The parties are encouraged to cooperate on research and information exchange on any socio-economic impacts of living modified organisms, especially on indigenous Australians and local communities.
Article 27 LIABILITY AND REDRES the Conference of the Parties serving as the meeting of the parties to this Protocol shall, at its first meeting, a process with respect to adop it the appropriate elaborations of international rules and procedures in the field of liability and for damage resulting from redres transboundary movement of living modified organisms, analysing and taking due account of the ongoing processes in international law on these matters , and shall endeavour to complete this process within four years.
Article 28 FINANCIAL MECHANISM AND resources 1. In considering financial resources for the implementation of this Protocol, the Parties shall take into account the provision of article 20 of the Convention.
2. The financial mechanism established in article 21 of the Convention shall, through the institutional structure entrusted with its operation, be the financial mechanism for this Protocol.
3. Regarding the capacity-building referred to in article 22 of this Protocol, the Conference of the Parties serving as the meeting of the parties to this Protocol, in providing guidance with respect to the financial mechanism referred to in paragraph 2 above, for considerations by the Conference of the parties, shall take into account the need for financial resources by developing country Parties , in particular the least developed and the small island developing States among them.

4. In the context of paragraph 1 above, the Parties shall also take into account the needs of the developing country Parties, in particular the least developed and the small island developing States among them, and of the parties with economies in transition, in their efforts to identify their capacity-building implementations and requirements for the purpose of the implementation of this Protocol.
5. The guidance to the financial mechanism of the Convention in relevant decisions of the Conference of the parties, including those agreed before the adoption of this Protocol, shall apply, mutatis mutandis, to the provision of this article.
6. The developed country Parties may also provide, and developing country Parties and the the parties with economies in transition themselves of, financial and availa ... technological resources for the implementation of the provision of this Protocol through bilateral, regional and multilaterals channel.
Article 29 of the Conference OF the parties SERVING AS the MEETING OF the parties TO this PROTOCOL 1. The Conference of the Parties shall serve as the meeting of the parties to this Protocol.
2. the parties to the Convention that are not parties to this Protocol may participat as observer in the proceedings of any meeting of the Conference of the Parties serving as the meeting of the parties to this Protocol. When the Conference of the Parties to serve as the meeting of the parties to this Protocol, decisions under this Protocol shall be taken only by those that are parties to it. 3. When the Conference of the Parties to serve as the meeting of the parties to this Protocol, any member of the Bureau of the Conference of the parties representing a Party to the Convention but, at that time, not a Party to this Protocol, shall be substituted by a member to be elected by and from among the parties to this Protocol.
4. The Conference of the Parties serving as the meeting of the parties to this Protocol shall keep under regular review the implementation of this Protocol and shall make, within its mandate, the decision not to promote its cessary effective implementation. It shall perform the functions assigned to it by this Protocol and shall: (a) make recommendations on any matters not cessary for the implementation of this Protocol;
(b) Establish such subsidiary bodies as are deemed not cessary for the implementation of this Protocol;
(c) Seek and utilizes, where appropriate, the services and cooperation of, and information provided by, competent international organizations and intergovernmental and non-governmental bodies;
(d) Establish the form and the intervals for transmitting the information to be submitted in accordanc with article 33 of this Protocol and consider such information as well as reports submitted by any subsidiary body;
(e) Consider and adop, as required, amendments to this Protocol and its annex, as well as any additional annex to this Protocol, that are not deemed cessary for the implementation of this Protocol; and (f) exercise such other functions as may be required for the implementation of this Protocol.
5. The rules of procedure of the Conference of the parties and financial rules of the Convention shall be applied, mutatis mutandis, under this Protocol, except as may be otherwise decided by consensus by the Conference of the Parties serving as the meeting of the parties to this Protocol.
6. The first meeting of the Conference of the Parties serving as the meeting of the parties to this Protocol shall be convened by the Secretariat in conjunction with the first meeting of the Conference of the parties that is scheduled after the date of the entry into force of this Protocol. Subsequent ordinary meetings of the Conference of the Parties serving as the meeting of the parties to this Protocol shall be held in conjunction with ordinary meetings of the Conference of the parties, unless otherwise decided by the by the Conference of the Parties serving as the meeting of the parties to this Protocol.
7. Extraordinary meetings of the Conference of the Parties serving as the meeting of the parties to this Protocol shall be held at such other times as may be deemed by the cessary not Conference of the Parties serving as the meeting of the parties to this Protocol, or at the written request of any Party, provided that, within six months of the request being communicated to the parties by the Secretariat it is supported by at least one third of the parties.
8. The United Nations, its specialized agencies and the International Atomic Energy Agency, as well as any State member thereof or the observer is to the theret note party Convention, may be represented as an observer at meetings of the Conference of the Parties serving as the meeting of the parties to this Protocol. Any body or agency, national or international, governmental or whethers non-governmental, that is qualified in matters covered by this Protocol and that has informed the Secretariat of its wish to be represented at a meeting of the Conference of the Parties serving as meeting of the parties to this Protocol as an observer, may be so admitted, unless at least one third of the Parties present object. Except as otherwise provided in this article, the participation of the observer in the admissions and shall be subject to the rules of procedure, as referred to in paragraph 5 above.
Article 30 SUBSIDIARY bodies 1. Any subsidiary body established by or under the Convention may, upon a decision by the Conference of the Parties serving as the meeting of the parties to this Protocol, serve the Protocol, in which case the meeting of the Parties shall specify which functions that body shall exercise.
2. the parties to the Convention that are not parties to this Protocol may participat as observer in the proceedings of any meeting of any such subsidiary bodies. When a subsidiary body of the Convention serve as a subsidiary body to this Protocol, decisions under the Protocol shall be taken only by the parties to the Protocol.
3. When a subsidiary body of the Convention exercises its functions with regard to matters concerning this Protocol, any member of the Bureau of that subsidiary body representing a Party to the Convention but, at that time, not a Party to the Protocol, shall be substituted by a member to be elected by and from among the parties to the Protocol.
Article 31 Secretariat 1. The secretariat established by article 24 of the Convention shall serve as the Secretariat to this Protocol.
2. Article 24, paragraph 1, of the Convention on the functions of the Secretariat shall apply, mutatis mutandis, to this Protocol.
3. To the exten to that ut300r2u distinct, the costs of the secretariat services for this Protocol shall be met by the parties of the heret. The Conference of the Parties serving as the meeting of the parties to this Protocol shall, at its first meeting, decide on the arrangements to the industry the cessary end.
Article 32 RELATIONSHIP WITH the CONVENTION Except as otherwise provided in this Protocol, the provision of the Convention relating to its Protocols shall apply to this Protocol.
Article 33 MONITORING AND REPORTING Each Party shall monitor the implementation of its obligations under this Protocol, and shall, at intervals to be determined by the Conference of the Parties serving as the meeting of the parties to this Protocol, report to the Conference of the Parties serving as the meeting of the parties to this Protocol on the measure that it has taken them to the Protocol implementations.
Article 34 compliance the Conference of the Parties serving as the meeting of the parties to this Protocol shall, at its first meeting, consider and approve cooperative procedures and institutional of mechanisms to promote compliance with the provision of this Protocol and to address cases of non-compliance. These procedures and mechanisms shall include provision to offer advice or assistance, where appropriate. They shall be separate from, and without prejudice to, the dispute settlement procedures and mechanisms established by article 27 of the Convention.
Article 35 assessment AND REVIEW the Conference of the Parties serving as the meeting of the parties to this Protocol shall, will undertak five year after the entry into force of this Protocol and at least every five years thereafter, an evaluation of the effectiveness of the Protocol, including an assessment of its procedures and annex.
Article 36 signature this Protocol shall be open for signature at the United Nations Office at Nairobi by States and regional economic integration organizations from 15 to 26 May 2000, and at United Nations Headquarters in New York from 5 June 2000 to 4 June 2001. Article 37 ENTRY into force this Protocol shall enter 1 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 that are parties to the Convention.
2. This Protocol shall enter into force for a State or regional economic integration organizations that accept or approve ratif, of this Protocol or accede after the entry of theret it into force pursuan to paragraph 1 above, on the ninetieth day after the date on which that State or regional economic integration organization deposits its instrument of ratification, acceptance, approval or accession, or on the date on which the Convention enter into force for that State or regional economic integration organization , whichever shall be the later.
3. For the purpose of paragraphs 1 and 2 above, any instrument deposited by a regional economic integration organization shall not be counted as additional to those deposited by member States of such organization.
Article 38 reservations Of reservations may be made to this Protocol.
Article 39 WITHDRAWALS At any time 1 after two years from the date on which this Protocol has entered into force for a Party, that Party may withdraw from the Protocol by giving written notification to the Depositary.

2. Any such withdrawals shall take place upon expiry of one year after the date of its receipt by the Depositary, or on such later date as may be specified in the notification of the withdrawals.
Article 40 AUTHENTIC texts 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, being duly authorized to that effect, have signed this Protocol.
Done at Montreal on this twenty-ninths day of January, two thousand.
Annex I INFORMATION REQUIRED IN notifications UNDER articles 8, 10 AND 13 (a) the name, address and contact details of the exporters.
(b) the name, address and contact details of the importer.
(c) name and identity of the living modified organism, as well as the domestic classification, if any, of the biosafety level of the living modified organism in the State of export.
(d) Intended date or dates of the transboundary movement, if known.
(e) Taxonomic status, common name, point of collection or acquisition, and characteristics of recipient organism or parental organisms related to biosafety.
(f) Centres of origin and centres of genetic diversity, if known, of the recipient organism and/or the parental organisms and a description of the habitats where the organisms may persist or proliferat.
(g) Taxonomic status, common name, point of collection or acquisition, and characteristics of the donor organism or organisms related to biosafety.
(h) Description of the nucleic acid or the modification introduced, the technique used, and the resulting characteristics of the living modified organism.
(i) Intended use of the living modified organism or products thereof, namely, processed materials that are of living modified organism origin, containing a detectabl novel combinations of materials obtained through genetics replicabl the use of modern biotechnology.
(j) Quantity or volume of the living modified organism to be transferred.
(k) A previous and existing risk assessment report consistent with Annex III. (l) Suggested methods for the safe handling, storage, transport and use, including packaging, labelling, documentation, disposal and contingency procedures, where appropriate.
(m) Regulatory status of the living modified organism within the State of export (for example, whethers it is prohibited in the State of export, whethers there other restriction, or it has been approved for whethers general release) and, if the living modified organism is banned in the State of export, the reason or reasons for the ban.
(n) result and purpose of any notification by the exporters to other States regarding the living modified organism in the to be transferred.
(o) A declaration that the above-mentioned information is factually correct.
Annex II INFORMATION REQUIRED CONCERNING LIVING MODIFIED organisms INTENDED FOR direct use AS FOOD OR FEED, OR FOR PROCESSING UNDER article 11 (a) the name and contact details of the applicant for a decision for domestic use.
(b) the name and contact details of the authority responsible for the decision.
(c) name and identity of the living modified organism.
(d) a Description of the gene modification, the technique used, and the resulting characteristics of the living modified organism.
(e) Any unique identification of the living modified organism.
(f) Taxonomic status, common name, point of collection or acquisition, and characteristics of recipient organism or parental organisms related to biosafety.
(g) Centres of origin and centres of genetic diversity, if known, of the recipient organism and/or the parental organisms and a description of the habitats where the organisms may persist or proliferat.
(h) Taxonomic status, common name, point of collection or acquisition, and characteristics of the donor organism or organisms related to biosafety.
(i) the Approved use of the living modified organism.
(j) A risk assessment report consistent with Annex III. (k) Suggested methods for the safe handling, storage, transport and use, including packaging, labelling, documentation, disposal and contingency procedures, where appropriate.
Annex Iii RISK Assessment Objective 1. The objective of risk assessment, under this Protocol, is to identify and evaluate the potential adverse effects of a living modified organism on the conservation and sustainable use of biological diversity in the likely potential receiving environment, taking also into account risks to human health.
Use of risk assessment Risk assessment ISA 2, inter alia, used by competent authorities to make informed decisions regarding living modified organism is.
General principles 3. Risk assessment should be carried out in a scientifically sound and transparent manner, and can take into account expert advice of, and guidelines developed by, relevant international organizations.
4. Lack of scientific knowledge or scientific consensus should not be interpreted as indicating a particular cessarily level of risk, an absence of risk, or an acceptabl risks.
5. risks associated with living modified organisms or products thereof, namely, processed materials that are of living modified organism origin, containing a detectabl novel combinations of materials obtained through genetics replicabl the use of modern biotechnology, should be considered in the context of the risk posed by the non-modified recipients or parental organisms in the likely potential receiving environment.
6. Risk assessment should be carried out on a case-by-case basis. The required information may vary in nature and level of detail from case to case, depending on the living modified organism concerned, its intended use and the likely potential receiving environment.
Methodology 7. The process of risk assessment may on the one hand give rise to a need for further information about specific subjects, which may be identified and requested during the assessment process, while on the other hand information on other subjects may not be relevant in some instances.
8. To fulfil its objective, risk assessment will entail, as appropriate, the following steps: (a) An identification of any novel genotypic and phenotypic characteristics associated with the living modified organism that may have adverse effects on biological diversity in the likely potential receiving environment, taking also into account risks to human health;
(b) An evaluation of the likelihood of these adverse effects being realized, taking into account the level and kind of exposure of the likely potential receiving environment to the living modified organism the;
(c) An evaluation of the consequences should these adverse effects be realized;
(d) An estimation of the overall risk posed by the living modified organism based on the evaluation of the likelihood and the consequences of the identified adverse effects being realized;
(e) (A) the recommendations as the whethers or not the risks with a acceptabl or manageabl, including, where not, identification of strategies cessary to manage these risks; and (f) where there is uncertainty regarding the level of risk, it may be addressed by requesting further information on the specific issues of concern or by implementing appropriate risk management strategies and/or monitoring the living modified organism in the receiving environment in the.
Points consider 9. Depending on the case, risk assessment takes into account the relevant technical and scientific details regarding the characteristics of the following subjects: (a) recipient organism or parental organisms. The biological characteristics of the recipient organism or parental organisms, including information on taxonomic status, common name, origin, the center of origin and center of genetics diversity, if known, and a description of the Habitat where the organisms may persist or proliferat;
(b) Donor organism or organisms. Taxonomic status and common name, source, and the relevant biological characteristics of the donor organism;
(c) Vector. Characteristics of the vector, including its identity, if any, and its source or origin, and its host range;
(d) insert or inserts and/or characteristics of modification. Genetic characteristics of the inserted nucleic acid and the function it specifi c, and/or characteristics of the modification introduced;
(e) Living modified organism. Identity of the living modified organism, and the difference between the biological characteristics of the living modified organism of the and those of the recipient organism or parental organisms;
(f) Detection and identification of living modified organisms in the. Suggested detection and identification methods and their newspapers for blind, sensitivity and reliability;
(g) Information relating to the intended use. Information relating to the intended use of the living modified organism, including new or changed use compared to the recipient organism or parental organisms; and (h) Receiving environment. Information on the location, location, climatic and ecological characteristics, including relevant information on biological diversity and the center of origin of the likely potential receiving environment.
 

 
The Cartagena Protocol on Biosafety, annexed to the Convention on biological diversity, as the parties to this Protocol to the Convention on biological diversity (hereinafter referred to as "the Convention"), referring to article 19 of the Convention, the third and fourth subparagraph, article 8, point (g) and article 17 referring also to decision II/5, 1995 November 17, adopted by the Conference of the parties to the Convention and decided to develop a Protocol on Biosafety , paying special attention to any living modified organisms cross-border movement, obtained using modern biotechnology, which could adversely affect the conservation and sustainable use of biological diversity, to develop appropriate procedures for advance information

Reaffirming the precautionary principle laid down in the Rio Declaration on environment and development, principle 15. conscious of the rapid expansion of modern biotechnology and the public's growing concerns about the possible adverse effects on biological diversity, taking also into account risks to human health, recognizing that modern biotechnology provide ample opportunity for improving human welfare if it is developed and used, subject to appropriate safeguards in relation to the environment and human health Recognizing also the origin and centres of genetic diversity of particular importance for humanity, in view of many countries, particularly developing countries, limited possibilities to respond to the known and potential risks associated with living modified organisms, and the scale, recognizing that, in order to achieve sustainable development, agreements on trade and environment mutually supplement each other, stressing that this Protocol is not interpreted so that it intends to change the party's rights and obligations arising from its commitments in existing international agreements, knowing that the purpose of the preceding reasoning is not the Protocol is conditional on the other international agreements, have agreed as follows: article 1 purpose in accordance with the precautionary principle, as reflected in the Rio Declaration on environment and development, principle 15. the objective of the present Protocol is to contribute to the parties, to ensure the appropriate level of protection for the modern biotechnology produced living modified organisms that could lead to adverse effects on the conservation and sustainable use of biological diversity, safe handling, processing and use, taking also into account risks to human health, and paying special attention to the cross-border movement.
Article 2 General provisions 1. the Parties shall take appropriate legal, administrative and other measures necessary to comply with the obligations laid down in this Protocol.
2. the Parties shall ensure that the taking of living modified organisms, treatment, transport, use, transfer and distribution is done by preventing or reducing the risk of biological diversity, taking also into account risks to human health.
3. This Protocol shall not affect the sovereignty of States over their territorial sea established in accordance with international law, and the sovereign rights and jurisdiction, what have these countries in their exclusive economic zones and continental šelfo in accordance with international law, as well as ships and aircraft of all States of navigational rights and freedoms as set out in international law and enshrined in the relevant international instruments.
4. this Protocol does not prejudice the right of parties to take measures to promote the conservation of biodiversity and sustainable use provides a higher level of protection than that provided for in this Protocol, provided that such measures are consistent with the objective of this Protocol and in the rules, as well as other international law provided for a commitment by the party concerned.
5. The parties are encouraged, where appropriate, take account of the conclusions of experts, documents and job descriptions of the international forums with competence in the human health risk.
Article 3 the terms used in the text of the Protocol: (a) "Conference of the parties" means the Conference of the parties to the Convention;
(b) "contained use" means any operation, undertaken within a facility, building or other physical structure with respect to living modified organisms that are controlled through specific measures that effectively limit their contact with the environment and the effects on it;
(c) "export" means intentional transboundary movement from one party to the other party;
(d) "exporter" means the export legal or natural person, under the jurisdiction of the party, who arranges for a living modified organism to be exported;
(e) "import" means intentional transboundary movements into one side of the other side;
(f) "importer" means the import of the legal or natural person, under the jurisdiction of the party, who arranges for a living modified organism to be imported;
(g) "living modified organism" means any living organism with a new combination of genetic material obtained through modern biotechnology;
(h) "living organism" means any biological entity, which has the ability to pass on or reproduce genetic material, including sterile organisms, viruses and viroids;
(i) "modern biotechnology" means: a. in vitro nucleic acid techniques, including recombinant DNA (DNA) and direct injection of nucleic acid into cells or organelles, or b. the methods based on different taxonomic affiliation body cell fusion, which allows to overcome natural physiological reproductive or recombination barriers and that are not traditional propagation and breeding methods;
(j) "regional economic integration organization ' means an organization established by the sovereign States of the region, to which its Member States have transferred powers in the matters governed by this Protocol, and which, in view of the organisation's internal procedures, has the power to sign, ratify, accept and approve the Protocol, as well as join;
(k) "transboundary movement" means the movement of the living modified organism from one party to the other party, provided that, subject to articles 17 and 24 transboundary movement, there are also transfers between parties and non-parties.
Article 4 scope of application of the Protocol this Protocol shall apply to all living modified organisms that may cause adverse effects on the conservation and sustainable use of biological diversity, transboundary movement, transit, handling and use, taking also into account risks to human health.
Article 5 pharmaceuticals are without prejudice to the provisions of article 4 and without prejudice to the right of the parties to carry out risk assessment with respect to living modified organisms until such time as decisions are taken on import, this Protocol shall not apply to living modified organisms intended for human pharmaceutical preparations for the cross-border movement, governed by other relevant international agreements or organisations.
Article 6 transit and contained use 1. without prejudice to the provisions of article 4 and without prejudice to the right of a party of transit to regulate the transport of living modified organisms through its territory and article 2, third paragraph, the right to submit to the Biosafety Clearing-House, any decision of the parties on a specific living modified organism, the transit through its territory of the provisions of this Protocol the prior information procedure does not apply to living modified organisms in transit.
2. without prejudice to the provisions of article 4 and without prejudice to the rights of the parties before the adoption of a decision on imports to carry out risk assessment with respect to living modified organisms and its jurisdiction to set standards to limit the use of this Protocol, subject to the prior notification procedure does not apply to living modified organisms intended for limited use, transboundary movements that are performed in accordance with the standards established by the parties.
Article 7 application of prior information procedure 1. According to article 5 and 6 of the prior information procedure, governed by this Protocol to 8, 10 and 12 shall apply prior to the first living modified organisms for intentional introduction of import to the party environment, deliberate cross-border movement.
2. This article referred to in the first paragraph of "deliberate introduction into the environment" does not apply to living modified organisms intended for direct use as food or feed, or for processing.
3. Article 11 of this Protocol shall apply before the living modified organism in the first intentional transboundary movement for direct use as food or feed, or for processing.
4. Prior information procedure does not apply to living modified organisms for intentional transboundary movement, which the Conference of the parties (the meeting of the parties to this Protocol) decision indicated as such, which may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.
Article 8 notification 1. export the party itself, or require the exporter to ensure that the competent import side a national authority is notified in writing in advance regarding the living modified organism for intentional transboundary movement covered by article 7, paragraph 1. The notice shall, as a minimum, the information specified in annex I.
2. export shall provide the appropriate legal framework that the exporter is responsible for the accuracy of information provided.
Article 9 NOTIFICATION of receipt 1. Within 90 days of receipt of the party of import shall acknowledge receipt of the fact by sending written proof of notification to the sender.
2. The acknowledgement shall state: (a) the date of receipt of the notification;
(b) whether the notification, prima facie contain the information referred to in article 8;
(c) or operate an import-side national regulatory requirements of the law or in accordance with the procedure laid down in article 10.

3. the second paragraph of this article, (c) referred to in national legislation must comply with the requirements of this Protocol.
4. the fact that the party of import has not provided proof of receipt of the notification, shall not imply its consent to an intentional transboundary movement.
Article 10 decision procedure 1. Decisions taken by the party of import must comply with the requirements of article 15.
2. The Party of Import within the time limits laid down in article 9, inform the notifier in writing, whether the intentional transboundary movement may be: norisē (a) only after the party of import has given written consent; or (b) after no less than ninety days, unless given written consent.
3. Two hundred and seventy days following notification to the party of import in writing to the notifier and to the Biosafety Clearing-House on the second paragraph of this article, (a) the decision referred to in paragraph 1: (a) approving the import, with or without conditions, including how the decision will apply to subsequent of the same living modified organism;
(b) prohibiting the import;
(c) requesting additional relevant information in accordance with its domestic regulatory framework or Annex I; calculating the time within which a party of import is to respond, is not counted in days, during which it is waiting for the relevant additional information; or (d) informing the notifier that the period specified in this paragraph is extended by the following deadline.
4. the third part of this article that are listed in the decision, the considerations on which it is based, except where consent for import is unconditional.
5. the fact that the party of import, two hundred and seventy days of the receipt of the notification is not informed of its decision, shall not imply its consent to an intentional transboundary movement.
6. lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the living modified organism in the potential adverse impact on the import side level the conservation and sustainable use of biological diversity, taking also into account risks to human health, hinder that party where appropriate according to the third paragraph of this article shall be decided on in particular the import of the living modified organism, in order to prevent or minimize such potential adverse effects.
7. The Conference of the Parties serving as the meeting of the parties, at its first meeting determine the appropriate procedures and mechanisms, which facilitate the decision to the party of import.
Article 11 procedure relating to living modified organisms intended for direct use as food or feed, or for processing 1. The Party shall decide on the internal of the living modified organism, including the placement of the market, which may be subject to transboundary movement for direct use as food or feed, or for processing, within fifteen days of such decision, shall inform the other parties through the Biosafety Clearing-House. This information includes the Protocol as a minimum the information specified in annex II. A copy of this information written half of each of the parties submitted national coordination centre that informs the Secretariat in advance, if it does not have access to the Biosafety Clearing-House. This provision shall not apply to decisions on field trials.
2. the parties, acting in accordance with the first paragraph of this article, provide the legal framework that the applicant is responsible for the accuracy of information provided.
3. Any party may request additional information from annex II, point (b) of the designated authority.
4. the decision on the import of living modified organisms intended for direct use as food or feed, or for processing, the party may adopt in accordance with its domestic regulatory framework requirements that meet the objective of this Protocol.
5. Each Party shall make available to the Biosafety Clearing-House any national regulations and guidelines, which apply to the import of living modified organisms that are intended for direct use as food or feed, or for processing.
6. in the case of this article have not been adopted in the fourth paragraph above national laws, regulations, a party that is a developing or transition economy countries, in implementing their domestic jurisdiction, can through the Biosafety Clearing-House that its assistance decision acceptable to before the first living modified organism imports, which intended for direct use as food or feed, or for processing, on which information is provided pursuant to the first paragraph of this article will be accepted as follows: (a) a risk assessment in accordance with annex III to this Protocol; and (b) a decision will be taken during the predicted, not exceeding two hundred and seventy days.
7. the fact that a party under this article the sixth part is not announced his decision, shall not imply its consent or refusal to the import of living modified organisms intended for direct use as food or feed, or for processing, unless that party not otherwise.
8. lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the living modified organism in the potential adverse impact on the import side level the conservation and sustainable use of biological diversity, taking also into account risks to human health, hinder that party in order to prevent or minimize such potential adverse effects, where appropriate, take a decision on a particular living modified organism imports intended for direct use as food feed, or for processing.
9. a party may indicate their need for financial or technical assistance and potential formation in relation to living modified organisms intended for direct use as food or feed, or for processing. To meet this need, the Parties shall cooperate, in accordance with this Protocol and article 28 22.
12. Article 1 of the DECISION of the REVIEWING party of Import to review and amend the decision on the intentional transboundary movement, based on a new scientific information on potential adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health. In such a case, the party concerned shall, within thirty days of its decision to inform any notifier that has previously notified about the decisions that the movement of living modified organisms, as well as the Biosafety Clearing House, indicating the reasons for its decision.
2. export party and each applicant is entitled to request the party of import to review a decision taken by that party with respect to it in accordance with the provisions of article 10, where the party of export or the notifier considers that: (a) the circumstances are such changes have occurred that may influence the outcome of the risk assessment upon which the decision is based; or (b) is made available additional relevant scientific or technical information.
3. The Party of Import in writing within ninety days to reply to such a request and indicate the reasons for its decision.
4. The Party of Import shall at its discretion be entitled to require future imports is carried out a risk assessment.
Article 13 simplified procedure 1. If the appropriate measures are taken, in accordance with this Protocol to ensure secure living modified organisms for intentional transboundary movement, the party of import to the Biosafety Clearing-House: (a) specify the above cases in which intentional transboundary movement to this party can perform simultaneously with the notification of the party of import of such transfers; and (b) imports of living modified organisms, which are exempt from the preliminary information procedure.
This part, (a) the communication referred to in paragraph 1 may relate to future similar movements to the same party.
2. information on intentional transboundary movement that is to be the first part of this article, (a) notices referred to in paragraph 1, have the information specified in annex I.
Article 14 bilateral, regional and MULTILATERAL agreements and arrangements 1. the parties may enter into bilateral, regional and multilateral agreements and arrangements of living modified organisms for intentional transboundary movement, if these agreements and measures to meet the objective of this Protocol and does not generate a lower level of protection than provided for in this Protocol.
2. With the Biosafety Clearing-House via the Parties shall inform each other of such bilateral, regional and multilateral agreements and arrangements, which occurred before or after the entry into force of this Protocol.
3. this Protocol shall not affect the intentional transboundary movements that take place between the parties to the Treaty and measures in accordance with their terms.
4. any party may determine that certain imports subject to its national laws and legislative provisions, and such it shall notify its decision to the Biosafety Clearing-House.
Article 15 RISK assessment

1. the Risk assessment shall be carried out in accordance with this Protocol, implement scientifically sound in accordance with the provisions of annex III and taking into account recognized risk assessment techniques. As a minimum, the risk assessment is based on the information provided in accordance with article 8, as well as other available scientific evidence to identify and assess living modified organisms possible adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.
2. The Party of Import shall ensure that the risk assessment is made for the adoption of the decision referred to in article 10. It may require the risk assessment shall be carried out.
3. If the party of import shall require the risk assessment costs shall be borne by the applicant.
Article 16 RISK Management 1. Pursuant to article 8 of the Convention (g) above, the Parties shall establish and ensure appropriate mechanisms, measures and strategies to regulate, manage and control risks identified in the Protocol rules on risk assessment and associated with the living modified organism, processing and use of cross-border movements.
2. based on the risk assessment measures the extent to prevent the import side of the living modified organism to adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.
3. each Party shall take the necessary measures to prevent the living modified organism to be unintentional transboundary movement, including such measures as requiring risk assessment before the living modified organism in the first distribution.
4. without prejudice to the provisions of the second paragraph, the Parties shall endeavour to ensure that everyone living in the modified organism — imported or obtained locally — before you start using the purpose has been met by an appropriate period of observation, the duration of which will correspond to the life cycle of the organism or the generation of a life time.
5. the Parties shall cooperate in order to: (a) the determination of the living modified organism or organisms for particular characteristics, which may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health; and (b) take appropriate measures regarding the treatment of such living modified organisms or specific traits.
Article 17 unintentional transboundary movements and emergency measures 1. each Party shall take appropriate measures to alert the countries which have suffered or may suffer, the Biosafety Clearing-House and, where appropriate, relevant international organizations, if that party is known for its jurisdiction in the case, and as a result has occurred or may occur in the of the living modified organism unintentional transboundary movements, which could have a material adverse effect on the conservation and sustainable use of biological diversity in these countries taking also into account risks to human health. Notice to be given as soon as the party becomes aware of such a situation.
2. each Party shall, no later than the date of entry into force of this Protocol, the party concerned shall make available to the Biosafety Clearing-House the relevant details of contact details, which shall be provided for in this article.
3. All communications provided under the first paragraph of this article, you must include: (a) relevant information regarding the living modified organism may amount and corresponding signs and/or living modified organism specific features;
(b) information on the conditions of release and its possible date, as well as the use of the living modified organism in the originating Party;
(c) any available information about the possible adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, as well as available information about possible risk management measures;
(d) any other relevant information; and (e) the contact details of where you can get additional information.
4. in order to minimise any significant adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, each party, under whose jurisdiction an distribution of the living modified organism in accordance with the first paragraph of this article shall immediately consult with the countries which have suffered or may suffer, to enable them to identify appropriate responses and initiate necessary action, including emergency measures.
Article 18 handling, TRANSPORT, packaging and identification 1. to prevent the adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, each Party shall take the necessary measures to ensure that living modified organisms, which are in accordance with this Protocol applies a deliberate cross-border movements, to be processed, packaged and transported under conditions of safety, taking into account relevant international rules and standards.
2. each Party shall take measures to ensure that documentation accompanying: (a) living modified organisms intended for direct use as food or feed, or for processing, clearly states that they "may contain" living modified organisms and are not intended for intentional introduction into the environment, as well as contact details of where you can get additional information. The Conference of the Parties serving as the meeting of the parties, no later than two years after the entry into force of the Protocol for this purpose approved detailed requirements, including living modified organisms and identity of any original identification specification;
(b) living modified organisms that are intended for limited use, it is clear that they are living modified organisms, as well as clearly specify the requirements for the safe handling, storage, transport and use, the contact details of where you can get additional information, including the name of the person/institution name and address to whom the living modified organisms are delivered; and (c) living modified organisms that are intended for intentional introduction, the party of import and any other living modified organisms covered by this Protocol, it is clear that they are living modified organisms are listed with their identity and essential characteristics and/or characteristics, as well as any requirements relating to the safe handling, storage, transport and use, the contact details of where you can get additional information and, where appropriate, the importer, and the name and address of the exporter; the dossier also contains a statement that the movement corresponds to the requirements of this Protocol applicable to the exporter.
3. The Conference of the Parties serving as the meeting of the parties to this Protocol shall, in consultation with other relevant international organizations, the need for the identification, handling, packaging and transport, as well as standard the following standard design features.
Article 19 competent national authorities and national focal points 1. Each Party shall authorise one national coordination centre to cooperate with the Secretariat in its name. Each party also indicate one or more of the national competent authorities responsible, as provided for in this Protocol, the implementation of the administrative functions and the exercise of these functions, is entitled to act on behalf of the State. A party may specify one institution performing both focal point and competent national authorities.
2. Each Party shall, no later than the date of entry into force of this Protocol for that party, inform the Secretariat of the coordination centre and the national competent authority or authorities of the name and address. Where a party designates more than one competent authority in the country concerned, together with the statement of the names and addresses of the transfer all information related to the responsibilities of these authorities. If possible, the following information, as a minimum, determine which competent authority is responsible for each of the living modified organism. Each Party shall immediately inform the Secretariat of any changes concerning national focal point or the national competent authority or authorities of the name and address or responsibilities.
3. the Secretariat shall forthwith inform the parties of the notifications it receives under the second subparagraph of this article, as well as to make such information publicly available through the Biosafety Clearing-House.
Article 20 information sharing and the Biosafety Clearing-House 1. is created by this Protocol to the Biosafety Clearing House, which is part of the article 18 of the Convention in the third paragraph, the mediation mechanism provided for and which are: (a) facilitate scientific, technical, environmental and legal information on, and experiences associated with the living modified organisms; and (b) assist Parties to implement the Protocol, taking into account the parties ' — the developing countries — the specific needs, in particular to the parties that are least developed and small island States, as well as countries with economies in transition and countries of origin and centres of genetic diversity, special needs.

2. The Biosafety Clearing-House is the means by which access to information is given in the first paragraph of this article as intended. The Center provides access to information that the parties made available and which is essential for the implementation of the Protocol.
The Centre provides access to other international mechanisms of information exchange in the field of biological safety.
3. without prejudice to the protection of confidential information, each Party shall make available to the Biosafety Clearing-House information in accordance with this Protocol shall be required to make available to the Biosafety Clearing-House: (a) as well as all applicable laws, legislation and guidelines relating to the implementation of the Protocol, as well as information that the parties must be given in accordance with the prior information procedure;
(b) any bilateral, regional and multilateral agreements and arrangements governing documents;
(c) risk assessment summaries or reviews of living modified organisms on the environment formed by the parties in accordance with the relevant legislative requirements of the law and implemented in accordance with article 15, including, in certain cases, information related to living modified organisms in products, namely, living modified organism origin for processed products, which include the use of modern biotechnology in the resulting detectable quantity of new combinations of genetic material reproducible;
(d) the parties concerned final decisions on imports of living modified organisms or release; and (e) pursuant to article 33 of the reports submitted, including messages relating to the prior information procedure implementation.
4. Issues related to biosafety clearing-house operation conditions, including reports on its activities at its first session, and further examined and decided by the Conference of the Parties serving as the meeting of the parties to this Protocol.
Article 21 confidential information 1. The Party of Import shall permit the notifier shall indicate which information submitted under the procedures of this Protocol or required by the party of import shall, in implementing this Protocol of the advance informed agreement procedure, is considered as confidential. In such cases, the applicant shall, upon the request of the party of import shall provide a statement of reasons.
2. If the party of import considers that the information supplied by the notifier as confidential does not meet this qualification, it shall consult the notifier, and before the disclosure, inform the notifier of its decision upon request, giving reasons, and the opportunity to discuss and review the decision.
3. the Parties shall protect, according to the Protocol received confidential information, including any confidential information received under this Protocol of the advance informed agreement procedure. Each Party shall ensure that the procedures to protect such information and to protect the confidentiality of such information at least as safe as it protects the confidential information related to the findings of the relevant Party living modified organisms.
4. The Party of Import shall not use such information for commercial purposes, unless the applicant agrees in writing to it.
5. If the applicant withdraws or has withdrawn his notice, the party of import shall respect of commercial and industrial information, including research and development information, as well as the confidentiality of the information on which the party concerned and the Notifier there is controversy.
6. without prejudice to the provisions of part v, shall not be considered as confidential: (a) the applicant's name and address;
(b) the living modified organism or organisms;
(c) a summary of the risk assessment of the effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health; and (d) any methods and plans related to emergency response.
Article 22 the POTENTIAL formation 1. the Parties shall cooperate, including through existing global, regional, subregional and national institutions and organizations and, where appropriate, encouraging private sector involvement to the sides, which are developing countries, particularly those which are least developed, small island countries, as well as to the sides that are transitional economies develop and/or strengthen human resources and institutional potential of biological security , including biotechnology to the extent necessary for the purpose of biological security, to the effective implementation of this Protocol.
2. Implementation of the first part of this article, the biological safety potential formation according to the relevant provisions of the Convention are fully taken into account by the parties that are developing countries, in particular those that are least developed and small island States need financial resources and access to technology and know-how, as well as their transfer to these countries. Taking into account the different situations of the parties, the possibilities and requirements, potential areas of cooperation also includes the generation of scientific and technical training for biotechnology management properly and safely with respect to risk assessment and risk management for biosafety, as well as technological and institutional potential of biological safety. When you create the potential for biological security, fully take into account the needs, what are the parties that are countries with economies in transition.
Article 23 public awareness and participation in the 1st part: (a) develop and facilitate public awareness, education and participation in the living modified organism in the safe handling, treatment and use in relation to the conservation and sustainable use of biological diversity, taking also into account risks to human health. In doing so, the Parties shall cooperate with other States and international organisations;
(b) endeavour to ensure that public awareness and education encompass issues associated with access to information on living modified organisms identified pursuant to this Protocol and can be imported.
2. The Parties shall, in accordance with their respective legislation, regulations, consult the public when making decisions about living modified organisms, and such decisions shall be made available to the public, while respecting confidential information in accordance with article 21 of this Protocol.
3. the Parties shall endeavour to inform the public about its potential to access the Biosafety Clearing-House.
Article 24 States that are not parties to the Protocol 1. Living modified organisms cross-border movement between parties and non-parties to the present Protocol, must meet the objective of this Protocol. On the cross-border transfer of such parties with the countries which are not parties to this Protocol may enter into bilateral, regional and multilateral agreements and arrangements.
2. The Parties shall promote, in the countries which are not parties to the Protocol, accession to this Protocol, as well as the Biosafety Clearing-House of information on living modified organisms that are under the jurisdiction of the party concerned, common, or moved to or from it.
Article 25 illegal transboundary movements 1. Each Party shall adopt appropriate domestic measures aimed at preventing cross-border living modified organisms and, where appropriate, punish, if such transfer is made in accordance with that party's domestic arrangements, the implementation of this Protocol. Such a move deemed illegal transboundary movements.
2. In the case of illegal cross-border movement, the party that such movements affected, may require that the party of origin shall, at its own expense, a particular living modified organism makes harmless, it either returns the originating Party or destroying.
3. the Parties shall make available to the Biosafety Clearing-House information about any illegal cross-border movements, which relate to a specific party.
Article 26 socio-economic considerations 1. According to this Protocol or domestic measures to implement this Protocol, the parties, in reaching a decision on import, can take into account socio-economic considerations arising from the living modified organism to adverse effects on the conservation and sustainable use of biological diversity, in particular in relation to the value of biological diversity to indigenous and local communities. The parties should comply with their international commitments.
2. the parties are encouraged to cooperate on research and information exchange in relation to questions about any socio-economic impacts might be living modified organisms, especially on indigenous and local communities.
Article 27 liability and indemnification

At its first meeting, the Conference of the Parties serving as the meeting of the parties, analysing and taking due account of the ongoing processes in international law in this area, confirm the process associated with the international rules and procedures on liability and damages, which are created by living modified organisms cross-border movements. The Parties shall endeavour to complete this process within four years.
Article 28 financial mechanism and financial resources 1. Deciding on financial resources, the implementation of this Protocol, the Parties shall take into account the provisions of article 20 of the Convention.
2. The funding mechanism set out in article 21 of the Convention, is also the funding mechanism of the Protocol, with the institutional structure entrusted the management of that facility.
3. with regard to the potential creation in accordance with article 22 of the Protocol, the Conference of the Parties serving as the meeting of the parties to this Protocol, in developing guidelines in relation to this article referred to in the second paragraph of the financing mechanisms, Parties shall take into account the need for financial resources to developing countries, and in particular those which are the least developed and the small island States.
4. In the context of the first part of this article, the Parties shall also take into account what needs in connection with efforts to identify potential building requirements for the implementation of this Protocol is that parties are developing countries, in particular those which are the least developed and the small island countries, as well as parties that are transitional economy countries.
5. Guidelines for the financing of the Convention mechanism is contained in the relevant decisions of the Conference of the parties, including its guidelines on which agreement is reached before the adoption of this Protocol, shall apply mutatis mutandis to the provisions of this article.
6. Through bilateral, regional and multilateral measures, parties that are developed countries, can provide, and the parties that are developing countries and parties with economies in transition can use financial and technological resources for the implementation of the provisions of this Protocol.
Article 29 of the Conference of the Parties serving as the meeting of the parties to this Protocol 1. The Conference of the parties, the meeting of the parties to this Protocol.
2. the parties to the Convention that are not parties to this Protocol may participate as observers with the right to all of the Conference of the Parties serving as the meeting of the parties to this Protocol. When the Conference of the parties, the meeting of the parties to this Protocol, decisions provided for in this Protocol shall be adopted only for the parties to this Protocol.
3. When the Conference of the parties, the meeting of the parties to this Protocol, any member of the Bureau of the Conference of the parties representing a party to the Convention not party to this Protocol, shall be substituted by a member to be elected by and from among the parties to this Protocol.
4. The Conference of the Parties serving as the meeting of the parties to this Protocol shall regularly monitor the implementation of this Protocol and in accordance with their competence, adopt the decisions necessary to promote its effective implementation. It performs the functions laid down in the Protocol and: (a) make recommendations on any matters necessary for the implementation of this Protocol;
(b) establish such subsidiary body it deems necessary for the implementation of this Protocol;
(c) if necessary, please and use the competent international, intergovernmental and non-governmental organizations service and liaison, as well as the information provided;
(d) determine the form of the information, and transfer interval, submitted in accordance with article 33 of this Protocol and consider such information as well as the reports submitted by the subsidiary bodies;
(e) consider and adopt, as required, amendments to this Protocol and its annexes, as well as any additional attachments to this Protocol as it deems necessary for the implementation of this Protocol; and (f) perform such other functions as may be necessary for the implementation of this Protocol.
5. the rules of procedure of the Conference of the parties and financial rules of the Convention shall apply mutatis mutandis to this Protocol, unless the Conference of the Parties serving as the meeting of the parties to this Protocol Agreement decides otherwise.
6. the Conference of the Parties serving as the meeting of the parties to this Protocol shall be convened by the Secretariat of the first session of the Conference of the parties at the same time, planned after the date of entry into force of the present Protocol. Subsequent ordinary meeting of the Conference of the Parties serving as the meeting of the parties to this Protocol shall sit at the ordinary session of the Conference of the parties, unless the Conference of the Parties serving as the meeting of the parties to this Protocol, decides otherwise.
7. The Conference of the Parties serving as the meeting of the parties to this Protocol shall sit in emergency such time as deemed necessary by the Conference of the Parties serving as the meeting of the parties to this Protocol, or at the written request of any party provided that, within six months after the parties by the Secretariat of such a request, it has supported at least one third of the parties.
8. The United Nations, its specialized agencies and the International Atomic Energy Agency, as well as any State which is a member of the organizations or observers and not party to the Convention, with observer rights can participate in the Conference of the Parties serving as the meeting of the parties to this Protocol. Any body or agency, national or international, governmental or non-governmental, which is competent for the matters covered by this Protocol and which has informed the Secretariat of their wish to participate as an observer in any meeting of the Conference of the Parties serving as the meeting of the parties to this Protocol, may allow this unless the objection of at least one third of the parties. Except as provided by this article, to allow the participation of observers and the participation rules of procedure applies, as laid down in the fifth subparagraph of this article.
Article 30 subsidiary body 1 of the Conference of the Parties serving as the meeting of the parties to this Protocol, the decision all subsidiaries, created on the basis of the Convention or under it — can perform this Protocol subsidiary bodies also features, in which case the meeting of the Parties shall determine the functions that perform the body concerned.
2. the parties to the Convention that are not parties to this Protocol may participate as observers with the rights of such a subsidiary body. If a subsidiary body of the Convention's subsidiary bodies of this Protocol, performs functions concerning the Protocol, decisions shall be taken only by the parties to the Protocol.
3. in cases where a subsidiary body of the Convention carries out its functions in relation to matters related to the Protocol, each Member of the Bureau of the subsidiary bodies representing a party to the Convention, which is not a party to this Protocol, shall be substituted by a member to be elected by and from among the parties to this Protocol.
Article 31 Secretariat 1. the secretariat established by article 24 of the Convention, this Protocol performs secretariat functions.
2. Article 24 of the Convention the first part about the functions of the Secretariat shall apply mutatis mutandis to this Protocol.
3. Costs associated with the secretariat services for this Protocol shall be borne by the parties to the Protocol, in so far as such costs are distinct from other costs. The Conference of the Parties serving as the meeting of the parties to this Protocol shall, at its first session, decide on the necessary budget for this purpose.
Article 32 relationship with the Convention if this Protocol does not, apply to this Protocol the provisions of the Convention relating to its protocols.
Article 33 MONITORING and reporting each Party shall monitor the obligations provided for in this Protocol, and shall, at intervals to be determined by the Conference of the Parties serving as the meeting of the parties to this Protocol, report to the Conference of the Parties serving as the meeting of the parties to this Protocol, the measures taken for the implementation of this Protocol.
Article 34 compliance the Conference of the Parties serving as the meeting of the parties to this Protocol shall, at its first meeting, consider and approve cooperative procedures and institutional mechanisms to promote compliance with the provisions of this Protocol and in the event of non-compliance. These procedures and mechanisms shall include rules on offering advice or help. They are separate from the dispute resolution procedures and mechanisms established in accordance with article 27 of the Convention, and does not affect those mechanisms.
Article 35 assessment and review the Conference of the Parties serving as the meeting of the parties to this Protocol shall, five years after the entry into force of this Protocol and following at least once every five years conducted evaluation of the effectiveness of this Protocol, including its annexes and the evaluation procedure.
Article 36 signature by States and by regional economic integration organisations may sign this Protocol, the United Nations Office at Nairobi from 15 to 2000 May 26 and United Nations Headquarters in New York from 5 June 2000 to 4 June 2001.
Article 37 entry into force 1 this Protocol shall enter into force on the ninetieth day after the deposit of the 50th is national or regional economic integration organisation that is a party to the Convention, of the deposit of instruments of ratification, acceptance, approval or accession.

2. in relation to a State or regional economic integration organisation that after the entry into force of this Protocol pursuant to the first subparagraph of this article, adopted, ratified approved this Protocol or acceded to it, this Protocol shall enter into force on the 90th day after the date on which that State or regional economic integration organization of the deposit of its instrument of ratification, acceptance, approval or accession, or the day after for that State or regional economic integration organisation shall put into force the Convention , whichever occurs later.
3. the first and second part of the document, within the meaning of the instrument deposited by a regional economic integration organisation shall not be considered as documents that complements the reports submitted by the Member States of this organization.
Article 38 reservations no reservations to this Protocol is allowed.
Article 39 denunciation 1. two years after the Protocol entered into force for a party, that party may at any time denounce the Protocol by giving written notification to the depositary.
2. Such denunciation shall take effect when it is received from the depositary is one year, or on such later date as specified in the notice of denunciation.
Article 40 authentic texts the original of this Protocol, of which the authentic are Arabic, Chinese, English, French, Russian and Spanish languages, are deposited with the Secretary-General of the United Nations.
In witness whereof, the respective Plenipotentiaries have signed this Protocol.
In Montreal, two thousand twenty-ninth day of January.
Annex I information required 8, 10 and 13 of the communications provided for in (a) the exporter's name and contact details.
(b) the importer's name and contact details.
(c) living modified organism name and identification data, as well as the living modified organism in biological safety level the domestic classification in the State of export, if one exists.
(d) cross-border transfer the due date or the date, if known.
(e) the recipient organism or parental organisms in the taxonomic status, common name, point of collection or acquisition, and characteristics which pertain to biological security.
(f) the recipient organism and/or the parental organisms centres of origin and centres of genetic diversity, if known, and a description of the habitats where the organisms may persist or proliferate.
(g) Taxonomic status or organisms, common name, point of collection or acquisition, and characteristics which pertain to biological security.
(h) the nucleic acid or the modification introduced, the technique used, the description and the resulting characteristics of the living modified organism.
(i) the living modified organism or its intended use of the products, namely living modified organisms processing of the origin of products with a determination is the use of modern biotechnology in the resulting new replicable genetic material combinations.
(j) the transportable living modified organism quantity or volume.
(k) a previous and existing risk assessment report consistent with annex III.
(l) suggested methods for the safe handling, storage, transport and use, including packaging, labelling procedure, documentation and the response in the event of unforeseen circumstances, which it is appropriate.
(m) regulating the living modified organism status the State of export (for example, whether it is prohibited in the State of export, whether there are other restrictions, or whether it has been approved for general release) and, if the living modified organism is banned in the State of export, the reason of such a ban.
(n) notification of the outcome of the exporter and of the other target countries other than transportable living modified organisms.
(o) a declaration that the above information is accurate.
Annex II information pursuant to article 11 of the Protocol does not provide for living modified organisms intended for direct use as food or feed, or for processing (a) the name and contact details of the person who asked to take a decision for domestic use.
(b) the name and contact details of the authority responsible for making the decision.
(c) living modified organism name and identification data.
(d) a description of the gene modification, the technique used, and the resulting characteristics of the living modified organism.
(e) any unique identification of the living modified organism.
(f) the recipient organism or parental organisms in the taxonomic status, common name, point of collection or acquisition, and characteristics which pertain to biological security.
(g) the recipient organism and/or the parental organisms centres of origin and centres of genetic diversity, if known, and a description of the habitats where the organisms may persist or proliferate.
(h) Taxonomic status or organisms, common name, point of collection or acquisition, and characteristics which pertain to biological security.
(i) living modified organism authorised use, intelligent.
(j) existing risk assessment report consistent with annex III.
(k) suggested methods for the safe handling, storage, transport and use, including packaging, labelling procedure, documentation and the response in the event of unforeseen circumstances, which it is appropriate.
Annex III RISK assessment objective 1. Under this Protocol the objective of risk assessment is to identify and evaluate the living modified organism to potential adverse effects on the conservation and sustainable use of biological diversity in an environment where it could be izlatīt, taking also into account risks to human health.
The use of risk assessment Risk assessment 2, inter alia, used by competent authorities to make informed decisions regarding living modified organisms.
3. General principles for the Risk assessment should be conducted scientifically sound and transparent manner, and can take into account the relevant international experts and organisations develop guidelines.
4. Scientific information or a lack of scientific consensus should not necessarily be interpreted as indicating a particular level of risk, or the absence of risk to unacceptable risk.
5. Risks associated with living modified organisms or products thereof, namely, the living modified organism origin for processed products, which include the use of modern biotechnology in the resulting detectable quantity of new combinations of genetic material for reproduction, should be taken in context with the risk posed by the unmodified recipient organism or parental organisms in the distribution environment potential.
6. Risk assessment must be carried out in each case individually. The information required in different cases may vary in nature and by how detailed it is, depending on the living modified organism, its intended use and the potential receiving environment.
7. Methodology of the Risk assessment process, on the one hand, you can create the need for additional information on specific issues that can be identified and request a risk assessment process, while on the other hand, information on other issues, in some cases, may not be relevant to the topic.
8. To fulfil its objective, risk assessment, where necessary, include the following steps: (a) identify all the new genotype and phenotype characteristics associated with the living modified organisms that may have adverse effects on biological diversity in potential distribution environment, taking also into account risks to human health;
(b) following the implementation of undesirable impacts an evaluation of the likelihood, given the level of exposure and the type of that living modified organism create potential distribution environment;
(c) assessment of the consequences if such adverse effects are detected;
(d) living modified organism produced overall risk assessment, on the basis of the identified adverse effects probability of detection and the effects of this impact assessment;
(e) making recommendations as to whether the risks are acceptable or manageable, including, where appropriate, the risk management strategies; and (f) where there is uncertainty about the level of risk, the situation can be resolved by requesting further information on the confusing scientific issues or implementing appropriate risk management strategies and/or monitoring the living modified organism in the environment of the release.
9. Issues to be considered, depending on the case, risk assessment takes into account the relevant technical and scientific data related to the following characteristics: (a) recipient organism or parental organisms. The recipient organism or parental organisms, biological signs including information on taxonomic affiliation, common name, origin, centres of origin and centres of genetic diversity, if known, as well as a description of the habitats where the organisms may persist or proliferate;
(b) the Taxonomic or organisms. Taxonomic status of nationality and common name, source, as well as in the biological characteristics;

(c) vector. Vector signs including identification data, if any, as well as its source or origin, and its host range;
(d) the inclusion or inclusion and/or genetic modification. Nucleic acid entered genetic features and functions which it lays down, and/or modification introduced;
(e) living modified organism. Identification of the living modified organism data and biological signs of differences between the living modified organism, and the recipient organism or parental organisms;
(f) living modified organism detection and identification. The suggested detection and identification methods and their precision, sensitivity and compliance;
(g) information relating to the intended use. Information regarding the living modified organism, including the intended use of new or changed use compared to the recipient organism or parental organisms; and (h) a distribution environment. Information on the location, geographical, climatic and ecological characteristics, including information relating to biological diversity and centres of origin possible distribution environment.