EXPOSE REASONS

In the wake of the United Nations Conference on Environment and Development, held in Rio de Janeiro, Brazil, in 1992, the Convention on Biological Diversity was adopted.

The Convention, which entered into force on 29 December 1993, remains the main international legal instrument to address the issue of biological diversity, including the adoption of a comprehensive approach to the sustainable use of Natural resources and fair and equitable sharing from the exploitation of genetic resources.

In order to complement the Rio de Janeiro Convention, the Conference of the Parties decided, in November 1995, to form an open-ended ad hoc working group to prepare a draft Protocol on Risk Prevention Biotechnology and specifically related to the transboundary movement of any living organism (LMOs) resulting from biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity.

For example, the Cartagena Protocol on Biosafety to the Convention on Biological Diversity was adopted in Montreal, Canada.
January 29, 2000.

The main objective of the above Protocol is to contribute to ensuring an adequate level of protection for the safe transfer, handling and use of LMOs resulting from biotechnology and presenting risks to health Human.

Thus, the Cartagena Protocol creates a favourable environment for the proper use of the environment of biotechnology, enabling maximum benefit to be derived while reducing the potential risks to the environment and health Human.

In addition to the Conference of the Parties serving as the meeting of the Parties, the Protocol provides for other bodies, including an exchange centre for the prevention of biotechnological risks and a secretariat.

Different obligations are placed on the contracting parties, including the adoption of legal and administrative measures in accordance with the provisions of the Protocol and the security of any manipulation, transport, use, transfer and Release of LMOs.

A financing mechanism for the provision of financial resources to member states, particularly developing countries, is foreseen and the transfer of technology to the same countries is also favoured.

The Protocol shall enter into force on the 90th day after the date of the deposit of the 50th instrument of ratification by the States or regional economic integration organizations which are Parties to the Rio de Janeiro Convention.

Senegal, which has already approved the aforementioned Convention and signed the Cartagena Protocol on Biosafety, would derive substantial benefits in terms of trade security and the protection of its environment and Human health, by ratifying the Protocol.

This is the economy of this bill.

The National Assembly adopted, at its meeting on Monday, 19 May 2003;

The President of the Republic enacts the following legislation:

Sole Article. -The President of the Republic is authorized to ratify the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, signed at
Montreal, Canada, January 29, 2000.
This Law shall be enforced as the law of the State.

Done at Dakar on 28 May 2003.

By the President of the Republic:

Abdoulaye WADE.

The Prime Minister,

Idrissa SECK.

CARTAGENA PROTOCOL
THE PREVENTION OF RELATIVE BIOTECHNOLOGICAL RISKS
THE CONVENTION ON DIVERSITY
BIOLOGIC

INTRODUCTION

The Convention on Biological Diversity was established in Nairobi in May 1992 and opened for signature at the United Nations Conference on Environment and Development (UNCED) in Rio de Janeiro on 5 June 1992. The Convention entered into force on 29 December 1993. Today, it is the main international instrument to address issues of biological diversity. It takes a comprehensive approach to the conservation of biological diversity, the sustainable use of natural resources and the fair and equitable sharing of the benefits arising from the exploitation of genetic resources.
The prevention of biotechnological risks is one of the problems that the Convention is tackling. This concept relates to the need to protect human health and the environment from the potentially adverse effects of biotechnology-related products. At the same time, modern biotechnology is considered to have a huge potential that can promote the well-being of humanity, including solutions to urgent food, agriculture and health care needs. The Convention clearly recognizes these two facets of modern biotechnology. On the one hand, it provides access to technologies, including biotechnology, necessary for the conservation and sustainable use of biological diversity, as well as the transfer of biological diversity (see, for example, Article 16 (1) and Article 19 (1) and (2). On the other hand, Articles 8 (g) and 19 (3) of the Convention aim to establish appropriate procedures for improving the safety of biotechnology in accordance with the general objective of the Convention, which is to reduce all Potential threats to biological diversity, also taking into account risks to human health. Article 8 (g) deals with measures that Parties should take at the national level, while Article 19, paragraph 3, sets out the way forward for the development of a legally binding international instrument to address the The issue of biosafety.

At its second meeting, held in November 1995, the Conference of the Parties to the Convention established an Ad Hoc Open-ended Working Group on Biosafety

In order to develop a draft protocol on the prevention of biotechnological risks, focusing specifically on the transboundary movement of any modified living organism resulting from biotechnology which could adversely affect the Conservation and sustainable use of biological diversity. After several years of negotiations, the Protocol, known as the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, was developed and adopted in Montreal on 29 January 2000. At an extraordinary meeting of the Conference of the Parties.

The conclusion of the Biosafety Protocol was welcomed as an important step because it establishes an international regulatory framework to balance commercial imperatives with the protection of The environment in relation to the fast-growing biotechnology industry in the world. The Cartagena Protocol also creates a favourable context for the sensible and environmentally friendly use of biotechnology, thus making it possible to maximise their potential while reducing possible risks to the environment. Environment and human health.

CARTAGENA PROTOCOL
THE PREVENTION OF RELATIVE BIOTECHNOLOGICAL RISKS
THE CONVENTION ON BIOLOGICAL DIVERSITY

The Parties to this Protocol.
Being Parties to the Convention on Diversity
Biological, hereinafter referred to as " The Convention.
Recalling Article 19, paragraphs 3 and 4, Article 8 (g) and Article 17 of the Convention.
Recalling also decision II/5 of 17 November 1995 of the Conference of the Parties to the Convention requesting the elaboration of a protocol on the prevention of biotechnological risks that would specifically address transboundary movements Modified living organisms resulting from modern biotechnology which may have adverse effects on the conservation and sustainable use of biological diversity, and which would consider, in particular, an appropriate procedure for agreement Prior knowledge of cause.

Reaffirming the precautionary approach enshrined in Principle 15 of the Rio Declaration on Environment and Development.

Aware that modern biotechnology is developing rapidly and that the general public is increasingly concerned about the adverse effects of modern biotechnology
May have an impact on biological diversity, including potential risks to human health.
Recognising that modern biotechnology offers considerable potential for human well-being as long as it is developed and used in safe conditions for the environment and human health.

Conscious also of the crucial importance to humanity of the centres of origin and the centres of genetic diversity.

Taking into account the fact that many countries, including developing countries, have limited means to deal with the nature and extent of the known and potential risks of living modified organisms.

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

Stressing that this Protocol shall not be construed as implying a change in the rights and obligations of a Party under other international agreements in
Vigor.

Considering that it is understood that the present preamble is not intended to subordinate the Protocol to other international agreements.

Have agreed as follows:

Article 1. -OBJECTIVE

In accordance with the precautionary approach enshrined in Principle 15 of the Rio Declaration on Environment and Development, the objective of this Protocol is to contribute to ensuring an adequate level of protection for transfer, Safe handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and use of biological diversity, also taking into account the risks For human health, with a more specific focus on transboundary movements .

Article 2. -GENERAL PROVISIONS

Each Party shall take the necessary and appropriate legal, administrative and other measures to fulfil its obligations under the Protocol.

2. The Parties shall ensure that the development, handling, transport, use, transfer and release of any living modified organism is done in such a way as to prevent or reduce risks
For biological diversity, taking into account also risks to human health.

Nothing in this Protocol shall affect, in any way, the sovereignty of States over their territorial waters as established under international law or the sovereign rights or jurisdiction exercised by them in their area And on their continental shelf under international law or the exercise by ships and aircraft of all States of the rights and freedoms of navigation conferred by international law and enshrined in instruments Relevant international.

Nothing in this Protocol shall be construed as restricting the right of a Party to take more stringent measures for the conservation and sustainable use of biological diversity than those provided for in the Protocol, to Condition that they are compatible with the objective and provisions of the Protocol and in accordance with the other obligations imposed on that Party by international law.

5. The Parties are encouraged to take appropriate account of the available expertise, existing instruments and the work undertaken by the relevant international bodies in relation to risks to human health.

Article 3. -DEFINITIONS

For the purposes of the Protocol:

(a) " Conference of the Parties Means the Conference of the Parties to the Convention;

(b) " Confined Use Means any operation, undertaking in a device, an installation, or any other physical structure, involving modified living organisms that are regulated by specific measures that effectively limit contact With the external environment, and the impact on that environment;

(c) " Exporting Means any intentional transboundary movement from one Party to another Party;

(d) " Exporter Means any legal or natural person, within the jurisdiction of the exporting Party, who makes arrangements for an amended living organism to be exported;

(e) " Importing Means any intentional transboundary movement to a Party and from another Party:

(f) " Importer Means any legal person or
Physical, under the jurisdiction of the importing Party, which makes arrangements for an amended living organism to be imported;

(g) " Living modified organism Means any living organism with a combination of novel genetic material obtained through the use of modern biotechnology:

(h) " Living organization Means any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids:

(i) " Modern Biotechnology Means:

(a) The application of in vitro techniques to nucleic acids, including the recombination of deoxyribonucleic acid (DNA) and the direct introduction of nucleic acids into cells or organelles,

(b) Cellular fusion of organisms that do not belong to the same taxonomic family that overcome the natural barriers of reproductive or recombination physiology and are not techniques used for reproduction And the classic type selection;

(j) " Regional Economic Integration Organization Any organisation constituted by sovereign states of a given region, to which its Member States have transferred their competence for all matters falling within the scope of the Protocol, and which has been duly authorised, in accordance with its Internal procedures, to sign, ratify, accept, approve or accede to the Protocol

(k) " Cross-border movement Means any movement of a living modified organism From a Party and to another Party, except for the purposes of Articles 17 and 24 " Transboundary movement Extends to movements between Parties and non-Parties.

Article 4. -SCOPE OF APPLICATION

This Protocol shall apply to transboundary movements, transit, handling and use of any living modified organism which may have adverse effects on the conservation and sustainable use of diversity Also taking into account the risks to human health.

Article 5. -PHARMACEUTICALS

Notwithstanding Article 4 and without prejudice to the right of the Parties to submit any living modified organism to a risk assessment before making a decision on its importation? The present
Protocol shall not apply to transboundary movements of living modified organisms which are
Pharmaceutical products for human use
Other relevant international agreements or bodies.

Article 6. -TRANSIT AND USE
IN A CONFINED ENVIRONMENT

Notwithstanding Article 4 and without prejudice to the right of a transit Party to regulate the transport of living modified organisms on its territory and to notify the exchange centre for the prevention of biotechnological risks of any decision It has taken, in accordance with Article 2, paragraph 3, concerning transit through its territory of a specified living modified organism, the provisions of this Protocol concerning the prior informed consent procedure shall not Do not apply to living modified organisms in transit.

Notwithstanding Article 4 and without prejudice to the right of any Party to submit a living modified organism regardless of its risk assessment before taking a decision on its importation and setting standards applicable to the Within the limits of its jurisdiction, the provisions of this Protocol

Relating to the prior informed consent procedure shall not apply to transboundary movements of living modified organisms intended for use in a confined environment that are carried out in accordance with the standards of the Party Importer.

Article 7. -APPLICATION OF
PREALABLE AGREEMENT PROCEDURE
IN KNOWLEDGE OF CAUSE

1-Subject to Articles 5 and 6, the prior informed consent procedure provided for in Articles 8, 9, 10 and 12 shall apply before the first intentional transboundary movement of living modified organisms intended to be introduced Intentionally in the environment of the importing Party.

2-The intentional introduction into the environment referred to in paragraph 1 above does not apply to living modified organisms intended for use directly for human or animal feed or to be processed.

3-Article 11 applies before the first transboundary movement of living modified organisms
Intended to be used directly for human or animal feed or to be processed.

4-The prior informed consent procedure shall not apply to intentional transboundary movements of living modified organisms which, in a decision of the Conference of the Parties serving as the Meeting of the Parties to the Protocol, are defined as unlikely to have adverse effects on the conservation and sustainable use of biological diversity, taking into account also the risks to human health.

Article 8. -NOTIFICATION

1. The exporting Party shall, or require the exporter to address, in writing, to the competent national authority of the importing Party. A notification before the intentional transboundary movement of a living modified organism referred to in paragraph 1 of

Article 7. The notification shall contain at least the information specified in Annex I.

2. The exporting party shall ensure that there is legal liability for the accuracy of the
Information provided by the exporter.

Article. -9 ACCUSED OF RECEPTION
FROM NOTIFICATION

1. The important Party shall send the author of the notification in writing. Within ninety days. An acknowledgement of receipt of the notification.

2. The acknowledgement indicates:

(a) The date of receipt of the notification:

(b) If the notification contains at first sight the information referred to in Article 8:

(c) If it is appropriate to proceed in accordance with the national regulatory framework of the importing Party or in accordance with the procedure laid down in Article 10.

The national regulatory framework referred to in paragraph 2 (c) above shall be consistent with the
Protocol.

4. The fact that the importing Party does not acknowledge receipt of a notification does not mean that it consents to the intentional transboundary movement.

Article 10. -DECISION PROCEDURE

The decisions taken by the importing Party shall be in accordance with Article 15.

2. The importing Party shall, within the time limit prescribed in Article 9, indicate in writing to the notifier whether the intentional transboundary movement may take place.

(a) Only when the importing Party has given its consent in writing:
Or

(b) At the end of a period of at least ninety days without further written consent

3. Within two hundred and seventy days from the date of receipt of the notification, the importing Party shall communicate in writing, to the notifier and the Biosafety Clearing-Centre, the relevant decision In paragraph 2 (a) above:

(a) Authorizing the import, with or without conditions, and indicating how the decision will apply to subsequent imports of the same living modified organism:

(b) Ban the importation;

(c) Requesting additional relevant information in accordance with its national regulations or Annex 1: the number of days between the time the importing Party requests additional relevant information and The one in which it obtains them is not included in the calculation of the period of time available to reply:

(d) Informing the notifier that the period specified in this paragraph is extended for a specified period of time.

4. Except in the case of unconditional consent, the decisions referred to in paragraph 3 above shall state the reasons for the decisions.

5. The fact, for the importing Party, not to communicate its decision within two hundred and seventy days after the date of receipt of the notification does not mean that it consents to the intentional transboundary movement.

The lack of scientific certainty due to insufficient scientific information and knowledge concerning the extent of the potential adverse effects of an altered living organism on the conservation and sustainable use of Biological diversity in the importing Party, also taking into account the risks to human health, does not prevent this party from taking the appropriate decision concerning the importation of the living modified organism as As indicated in paragraph 3 above, to avoid or minimize such effects Potential adverse effects.

7. The Conference of the Parties serving as the Meeting of the Protocols shall, at its first meeting, decide on appropriate procedures and mechanisms to assist the importing Parties in making a decision.

Article 11. -PROCEDURE FOR LIVING ORGANISMS MODIFIED
DESTINES TO BE USED DIRECTLY FOR HUMAN CONSUMPTION OR
ANIMAL, OR TO BE TRANSFORMS

1. Any party making a final decision concerning the use in the national territory.
Including placing on the market, of a living modified organism which may be the subject of a transboundary movement and which is intended to be used directly for human or animal feed or to be processed, shall, within 15 days after the Follow, inform the other parties through the Biotechnology Risk Prevention Exchange Centre. This information shall contain at least the information requested in Schedule 11. The part provided in writing shall provide a copy of this information to the national correspondents of the parties who have informed the Secretariat in advance of the fact that they do not have access to the Biosafety Exchange Centre. This provision shall not apply to decisions concerning field testing.

(2) Any party making a decision in accordance with paragraph 1 above shall ensure that legal provisions ensure the accuracy of the information provided by the applicant.

(3) Any Party may request additional information from the authority referred to in paragraph (b) of Annex II

(4) Any Party may take, within the framework of its national rules, a decision concerning the import of a living modified organism intended for use directly for human or animal feed or to be processed, subject to reservation That this decision be in accordance with the objective of this Protocol.

5. Each Party shall make available to the Biosafety Clearinghouse a copy of all national laws, regulations and guidelines applicable to the importation of living modified organisms intended to be Used directly for human or animal feed or to be processed, if available.

6. Any developing country or economy in transition Party to this Protocol may, in the absence of the national regulatory framework referred to in paragraph 4 above, where it exercises its national competence, declare, through the Biotechnological Risk Prevention Clearinghouse, that its decision prior to the first importation of a living modified organism intended for use directly for human or animal feed or to be processed, on the subject
Which information has been provided in accordance with paragraph I above shall be taken:

(a) following an assessment of the risks undertaken in accordance with Annex III;
And

(b) within a foreseeable period of not more than two hundred and seventy days.

7. The fact that a Party does not communicate its decision in accordance with paragraph 6 above does not mean that it consents to import or refuses to import the modified living organism which is considered to be used directly for Human or animal feed or to be processed, unless otherwise specified.

Lack of scientific certainty due to insufficient scientific information and knowledge relevant to the extent of the potential adverse effects of a living modified organism on conservation and sustainable use Of biological diversity in the importing Party, taking into account also the risks to human health, does not prevent that Party from taking the appropriate decision concerning the importation of that living modified organism if it is intended To be used directly for human or animal nutrition or to be used To avoid or minimize these potential adverse effects.

9. Any Party may make known its needs for financial and technical assistance and capacity development in respect of living modified organisms intended for direct use in human or animal nutrition or Be transformed. The Parties shall cooperate to meet these needs, in accordance with Articles 22 and 28 of this Protocol.

Article. -12 REVIEW OF DECISIONS

1. An importing Party may at any time, in the light of new scientific information on the potential adverse effects on the conservation and sustainable use of biological diversity, also taking into account the risks to health Review and modify its decision on intentional transboundary movement. In such a case, within 30 days, it shall inform the authors of previous notifications of movements of the living modified organism in question, as well as the Centre d' échanges pour la prévention des risques biotech, indicating The reasons for the decision.

2. An exporting Party or the author of a notification may request an importing Party to reconsider its decision concerning it,
Under Article 10, where the exporting Party or the notifier considers:

(a) That there is a change in circumstances that would affect the results of the risk assessment that led to the decision:

Or

(b) Additional scientific or technical information is available.

The importing Party shall reply in writing to that request within ninety days, indicating the reasons for its decision.

4. The importing Party may, at its discretion, require a risk assessment for subsequent imports.

Article. -13 SIMPLIFIED PROCEDURE

1. An importing Party may, provided that adequate measures are applied to ensure the safe intentional transboundary movement of living modified organisms, in accordance with the objective of the Protocol, specify in advance Biotechnological Risk Prevention Clearinghouse:

(a) Cases where an intentional transboundary movement of which it is the destination may take place at the same time as the movement is notified to it;

(b) Imports of living modified organisms exempted from the prior informed consent procedure.
The notifications referred to in subparagraph (a) above may be submitted for subsequent similar movements to the same Party.

2. The information concerning an intentional transboundary movement to be included in the notification referred to in paragraph 1 (a) above shall be those indicated in Annex 1.

Article. -14 BILATERAL AGREEMENTS AND ARRANGEMENTS, REGIONAL
AND MULTILATERAL

Parties may conclude bilateral, regional and multilateral agreements and arrangements on intentional transboundary movements of living modified organisms, if they are consistent with the objective of the Protocol and provided that such Agreements and arrangements do not result in a lesser degree of protection than that provided for in the Protocol.

2. The Parties shall inform each other, through the Clearinghouse for the Prevention of
Biotechnological risks, any bilateral, regional or multilateral agreements or arrangements that they have entered into before or after the date of entry into force of the Protocol.

3. The provisions of the Protocol shall have no effect on intentional transboundary movements which take place under one of these agreements or arrangements between the Parties to that agreement or arrangement.

(4) Any Party may decide that its national rules shall apply to certain specific imports intended for it and shall notify its decision to the Biosafety Clearing-Office.

Article 15. -RISK ASSESSMENT

1. The risk assessments undertaken pursuant to this Protocol shall be carried out in accordance with established scientific methods, in accordance with Annex III and taking into account the methods of risk assessment recognised. Rely on the information provided in accordance with Article 8 and other available scientific evidence to determine and assess the potential adverse effects of living modified organisms on conservation And the sustainable use of biological diversity, also taking into account the risks For human health.

2. The importing Party shall ensure that a risk assessment is carried out in order to make a decision under Article 10. The exporter may require the exporter to carry out the risk assessment.

3. The cost of the risk assessment shall be borne by the notifier if required by the importing Party.

Article 16. -RISK MANAGEMENT.

1. Taking into account Article 8 (g) of the Convention, the Parties shall establish and implement appropriate mechanisms, measures and strategies to regulate, manage and control the risks identified in the provisions of the Protocol Relating to the assessment of risks associated with the use, manipulation and transboundary movement of organisms
Living modified.

2. Measures based on risk assessment shall be imposed to the extent necessary to prevent adverse effects of the living modified organism on the conservation and sustainable use of biological diversity, including risks For human health, on the territory of the importing Party.

Each Party shall take appropriate measures to prevent unintentional transboundary movements of living modified organisms, including measures prescribing a risk assessment prior to the first release of a living organism Changed.

4. Without prejudice to paragraph 2 above, each Party shall ensure that any living modified, imported or locally developed organism has been subjected to an appropriate observation period corresponding to its life cycle or its time of Training before being used as intended.

5. The Parties shall cooperate in

(a) The identification of living modified organisms or the characters of living modified organisms which may adversely affect the conservation and sustainable use of biological diversity, taking into account also the risks to Human health;

(b) Take appropriate measures to treat these living modified organisms or characters
Specific.

Article 17. -UNINTENTIONAL CROSS-BORDER MOVEMENTS
AND EMERGENCY MEASURES

Each Party shall take appropriate measures to modify or possibly affect the States in effect, at the exchange centre for the prevention of biotechnological risks and, if necessary, the relevant international organizations, all Knowledge that falls within its jurisdiction and that results in a release that results in or can result in an unintentional transboundary movement of a living modified organism likely to have adverse effects Important conservation and sustainable use of biological diversity, There are also risks to human health in these states. Notification shall be given that the Party concerned is aware of this situation.

2. Each Party shall communicate to the Biosafety Clearing Centre, no later than the date of entry into force of this Protocol in respect of that Party, the contact details of the person entitled to receive the Notifications under this Article.

3. Any notification given under paragraph 1 above should include the following:

(a) Any relevant information available on the estimated quantities and relevant characteristics and characteristics of living modified organisms;

(b) Information on the circumstances and expected date of release, as well as on the use of the living modified organism in the Party of origin;

(c) Any available information on potential adverse effects on the conservation and sustainable use of biological diversity, including risks to human health, as well as any available information on possible measures Risk management:

(d) Any other relevant information:

(e) Contact information for further information.

4. In order to minimise any significant adverse effects on the conservation and sustainable use of biological diversity, also taking into account the risks to human health, each Party under the jurisdiction of the Release of the living modified organism referred to in paragraph 1 above shall immediately consult the States actually affected or which may be affected, in order to enable them to determine the appropriate interventions and take the necessary measures, Including emergency measures.

Article 18. -HANDLING, TRANSPORT,
PACKAGING AND IDENTIFICATION

In order to avoid adverse effects on the conservation and sustainable use of biological diversity, taking into account also the risks to human health, each Party shall take the necessary measures to require that the bodies Modified live animals which are the subject of an intentional transboundary movement under this Protocol shall be handled, packed and transported in safety conditions, taking into account relevant international rules and standards:

2. Each Party shall take measures to require that the accompanying documentation:

(a) Living modified organisms intended to be used directly for human and animal feed, or intended for processing, clearly indicate that they " May contain Living modified organisms and are not intended to be intentionally introduced into the environment, and indicate contact information for further information. The Conference of the Parties serving as the Meeting of the Parties to the Protocol shall take a decision setting out in detail the modalities of this obligation, in particular the manner in which it will be necessary to specify the identity of these bodies and all Specific identification, no later than two years after the entry into force of the Protocol:

(b) Living modified organisms intended for use in a confined environment clearly indicate this
Living modified organisms, specifying the safety rules to be observed for the handling, storage, transport and use of such organisms, and the contact details for any further information, including the Name and address of the person and institution to which the living modified organisms are shipped:

(c) Living modified organisms intended to be intentionally introduced into the environment of the importing Party, as well as any other living modified organism covered by the Protocol, clearly indicate that they are living organisms Shall specify their identity and their relevant characteristics and characteristics, as well as any safety rules to be observed for the handling, storage, transport and use of such organisms, and shall indicate the contact details of the person to be Contact for any additional information, and, where applicable, the name and The address of the importer and exporter; and contain a declaration certifying that the transaction complies with the requirements of the Protocol applicable to the exporter.

3. The Conference of the Parties serving as the Meeting of the Parties to the Protocol shall determine whether it is necessary to develop standards of identification, handling, packaging and transport and shall determine the modalities of such elaboration, in Consulting with other relevant international bodies.

Article 19. -NATIONAL AUTHORITIES
COMPETENCE AND CORRESPONDING
NATIONALS

Each Party shall designate a national focal point to liaise with the Secretariat on its behalf. Each Party shall also designate one or more competent national authorities responsible for carrying out the administrative functions referred to in the Protocol and authorized to act on its behalf in the performance of those functions. A Party may entrust to a single entity the functions of a national correspondent and a competent national authority.

Each Party shall communicate to the Secretariat, no later than the date of entry into force of the Protocol as far as it is concerned, the names and addresses of its national correspondent and the competent national authority or authorities. Where a Party designates more than one competent national authority, it shall indicate to the Secretariat, with its notification to that effect, the respective areas of responsibility of those authorities. Where appropriate, it will at least be specified the competent authority for each type of living modified organism. Each Party shall immediately notify the Secretariat of any change in the designation of its national correspondent or of the name, address, or responsibilities of its competent national authority or authorities.

The Secretariat shall immediately inform the Parties of the notifications received pursuant to paragraph 2 above and shall also make this information available through the Risk Prevention Clearinghouse Biotechnology.

Article 20. -INFORMATION EXCHANGE
AND AN EXCHANGE CENTRE FOR THE PREVENTION OF BIOTECHNOLOGY RISKS

1. An Exchange Centre for Biosafety is established within the framework of the exchange mechanism provided for in Article 18, paragraph 3, of the Convention, for:

(a) facilitate the exchange of scientific, technical, ecological and legal information, as well as experience, relating to living modified organisms:

(b) to assist Parties in the implementation of the Protocol, taking into account the specific needs of developing countries, including the least developed countries and small island developing States, and countries with economies in transition, as well as Countries that are centres of origin and centres of diversity
Genetics.

2. The Clearinghouse for Risk Prevention
Biotechnology is a means of making information available for the purposes specified in paragraph I above. It provides access to relevant information for the implementation of the Protocol.
Provide the Parties. It also provides access to other international mechanisms for the exchange of information on the prevention of biotechnological risks, if possible.

3. Without prejudice to the protection of confidential information, each Party shall communicate to the exchange centre for the prevention of biotechnology risks any information it is required to provide under the Protocol, and

(a) all applicable national laws, regulations and guidelines for the implementation of the Protocol, as well as the information required by the Parties in the context of the prior informed consent procedure:

(b) any bilateral, regional or multilateral agreement or arrangement:

(c) a summary of risk assessments or environmental studies of living modified organisms carried out pursuant to its regulations and carried out in accordance with Article 15, including, where appropriate, relevant information Concerning the products derived from it, namely
Transformed material from living modified organisms that contains new detectable combinations of replicable genetic material obtained through the use of modern biotechnology;

(d) its final decisions concerning the importation or release of living modified organisms;

(e) reports submitted under article 33, including reports on the application of the prior informed consent procedure.

4. The modalities of operation of the Biosafety Clearinghouse, including its activity reports, shall be reviewed and adopted by the Conference of the Parties serving as the Meeting of the Parties to the Protocol to its First meeting and subject to reviews
Later.

Article 21. -INFORMATION
CONFIDENTIAL

1. The importing Party shall allow the author of the notification to indicate which of the information communicated in accordance with the procedures provided for in the Protocol or required by the importing Party under the agreement procedure Prior knowledge of the Protocol, those which must be considered confidential. In such cases, a justification is provided upon request.

2. The importing Party shall consult the notifier when it decides that the information considered by the Party as confidential does not meet the requirements for processing as such and, before disclosing the information, It shall inform it of its decision, stating its reasons on request and providing for the possibility of consultations and an internal review of the decision.

Each Party shall protect confidential information received under the Protocol, including confidential information received under the Protocol.
Prior informed consent procedure of the Protocol. Each Party shall have procedures in place to protect such information and to protect the confidentiality of such information in such a favorable manner as it uses for confidential information relating to the Living modified organisms of national origin.

4. The importing Party shall not use this information in commercial fines, except with the written consent of the notifier.

5. If the author of the notification withdraws or withdraws the notification, the importing Party shall respect the confidentiality of all commercial or industrial information, including information on research and development, and Confidentiality is the subject of a disagreement between that Party and the notifier.

6. Without prejudice to paragraph 5 above, the following information shall not be kept confidential:

(a) the name and address of the notifier;

(b) a general description of the organization or
Living modified organisms:

(c) a summary of the impact risk assessment on the conservation and sustainable use of biological diversity, taking into account also the risks to human health:

(d) emergency response procedures and plans.

Article 22. -CAPACITY CREATION

1. The Parties shall cooperate in the development and strengthening of human resources and institutional capacity in the field of biosafety, including biotechnology, to the extent that it relates to Biosafety risk prevention. With a view to the effective implementation of the Protocol in developing country Parties, in particular in the least developed countries and small island developing States .as well as in Parties with economies in transition, including Through global, regional, subregional and national institutions and organizations, and where appropriate, through the promotion of private sector participation.

2. For the purposes of paragraph 1 above, in respect of cooperation, the needs of developing countries Parties, in particular those of the least developed countries of small island developing States, in respect of resources Financial, access to technology and know-how and technology transfer in accordance with the relevant provisions of the Convention are fully taken into account in the creation of capacity for risk prevention Cooperation in capacity-building includes, subject to Differences between the situations, the means and the needs of each Party: scientific and technical training for the rational and safe use of biotechnology and the use of risk assessments and Biotechnolic risk management techniques and the strengthening of technical and institutional capacity in the field of biosafety. The needs of Parties with economies in transition are also fully taken into account in the creation of capacity for the prevention of biotechnical risks.

Article 23. -AWARENESS
AND PUBLIC PARTICIPATION

1. The Parties:

(a) Encourage and facilitate public awareness, education and participation in the safe transfer, handling and use of living modified organisms for the conservation and sustainable use of Biological diversity, also taking into account risks to human health. The Parties shall, in order to do so, cooperate, as appropriate, with other States and international bodies;
(b) Ensure that public awareness and education includes access to information on living modified organisms, within the meaning of the Protocol, that may be imported.

2. The Parties shall, in accordance with their respective laws and regulations, consult the public when making decisions relating to living modified organisms and make available to the public the outcome of those decisions, while respecting the Confidentiality of information in accordance with section 21.

Each Party shall endeavour to inform the public about the means of access to the Biosafety Clearinghouse.

Article 24. -NON-PARTS

1. Transboundary Movements of Living Organisms
Amendments between Parties and non-Parties must be consistent with the objective of the Protocol. The Parties may enter into bilateral, regional or multilateral agreements and arrangements with non-Parties on such transboundary movements.

2. The Parties shall encourage non-Parties to accede to the Protocol and to communicate to the Biosafety Clearing Centre appropriate information on living modified organisms released on their territory, or Being the object of movement to or from areas within their national jurisdiction.

Article 25. -ILLICIT CROSS-BORDER MOVEMENTS

Each Party shall adopt national measures to prevent and punish, as appropriate, transboundary movements of living modified organisms in contravention of the national measures it has taken to implement this Protocol. Such movements will be deemed to be illegal transboundary movements.

(2) In the case of an illicit transboundary movement, the affected Party may request the Party of origin to eliminate, at its own expense, the living modified organisms concerned, by repatriating or destroying them, as appropriate.

(3) Each Party shall make available to the Centre for Biosafety Clearing the information relating to the cases of illicit transboundary movements concerning it.

Article 26. -CONSIDERATION
SOCIO-ECONOMIC

1. The Parties shall, in accordance with their obligations under this Protocol or in accordance with the national measures they have taken to implement the Protocol, take into account their obligations under this Protocol Socio-economic impacts of the impact of living modified organisms on the conservation and sustainable use of biological diversity, in relation to the value of biological diversity for indigenous communities, and Local, in particular.

2. Parties are encouraged to cooperate in research and exchange of information on the socio-economic impact of living modified organisms, in particular for indigenous and local communities.

Article. -27 RESPONSIBILITIES AND
REDRESS

The Conference of the Parties, serving as the Meeting of the Parties to this Protocol, shall undertake at its first meeting, a living process to develop appropriate international rules and procedures for liability and reparation for Damage resulting from transboundary movements of living modified organisms, by analysing and taking due account of the ongoing work in international law on these issues, and striving to complete this process within four years.

Article 28. -FINANCING MECHANISM AND FINANCIAL RESOURCES

When considering the question of financial resources for the implementation of the Protocol, the Parties shall take into account the provisions of Article 20 of the Convention.

2. The financing mechanism established by Article 21 of the Convention is, through its institutional structure, the mechanism for the financing of the Protocol.

With regard to capacity-building referred to in Article 22 of the Protocol, the Conference of the Parties serving as the Meeting of the Parties to the Protocol shall take into account, when providing guidance on the proposed funding mechanism In paragraph 2 above for consideration by the Conference of the Parties, of the need for financial resources of developing country Parties, in particular the least developed countries and small island developing States.

In the context of paragraph 1 above, the Parties shall also take into account the needs of developing country Parties, in particular those of the least developed countries and small island developing States, as well as those of the Parties to Economies in transition, in their efforts to identify and meet their capacity-building needs for the implementation of the Protocol.

5. The guidelines provided to the financing mechanism of the Convention in the relevant decisions of the Conference of the Parties, including those approved prior to the adoption of the Protocol, shall apply, mutatis mutandis, to the provisions of the Article.

6. Developed country Parties may also provide financial and technological resources for the implementation of the provisions of the Protocol, within the framework of bilateral, regional and multilateral arrangements, including developing countries Parties And Parties with economies in transition will be able to

Article 29. -CONFERENCE OF PARTIES MEETING AS A PARTY TO THE PROTOCOL

The Conference of the Parties shall sit as the Meeting of the Parties to the Protocol.

2. Parties to the Convention which are not Parties to the Protocol may participate as observers in the work of any meeting of the Conference of the Parties serving as the Meeting of the Parties to the Protocol. Where the Conference of the Parties is a meeting of the Parties to the Protocol, decisions taken under the Protocol shall be made only by the Parties to the Protocol.

Where the Conference of the Parties shall sit as the Meeting of the Parties to the Protocol, any member of the Bureau of the Conference of the Parties representing a Party to the Convention that is not yet a Party to the Protocol shall be replaced by a new member Which is elected by the Parties to the Protocol among them.

4. The Conference of the Parties serving as the Meeting of the Parties to the Protocol shall monitor the implementation of the Protocol and shall, within the framework of its mandate,
Decisions needed to promote effective implementation. It shall perform the functions assigned to it by the Protocol; and

(a) make recommendations on any matter relating to the implementation of the Protocol.

(b) establish the subsidiary bodies deemed necessary for the implementation of the Protocol:

(c) appeals and uses, as appropriate, the services, cooperation and information provided by international organizations and relevant governmental and non-governmental bodies;

(d) determines the presentation and periodicity of the transmission of the information to be communicated in
The application of article 33 of the Protocol and reviews such information and the reports submitted by its subsidiary bodies;

(e) consider and adopt, as appropriate, the amendments to the Protocol and its annexes, as well as any new annexes to the Protocol deemed necessary for its implementation; and

(f) performs any other function that may be required by the application of the Protocol.

5. The rules of procedure of the Conference of the Parties and the financial rules of the Convention shall apply mutatis mutandis to the Protocol, unless the Conference of the Parties serving as the Meeting of the Parties to the Protocol decides Otherwise by consensus.

The first meeting of the Conference of the Parties to the Convention sitting as the Meeting of the Parties to the Protocol shall be convened by the Secretariat at the same time as the first meeting of the Conference of the Parties to be held after the Entry into force of the Protocol. Thereafter, the ordinary meetings of the Conference of the Parties serving as the Meeting of the Parties to the Protocol shall be held at the same time as the ordinary meetings of the Conference of the Parties, unless the Conference of the Parties sitting As a Meeting of the Parties to the Protocol shall not decide otherwise.

7. Extraordinary meetings of the Conference of the Parties serving as the Meeting of the Parties to the Protocol may take place at any other time if the Conference of the Parties serving as the Meeting of the Parties to the Protocol deems it Or at the written request of a Party, provided that this request is supported by at least one third of the Parties within six months of its submission to the Parties by the Secretariat.

8. The United Nations, its specialized agencies and the International Energy Agency
May be represented as an observer in the meetings of the Conference of the Parties serving as an observer at the meetings of the Conference of the Parties. As the Meeting of the Parties to the Protocol. Any body or institution, whether national or international, governmental or non-governmental, competent in areas covered by this Protocol and having informed the Secretariat of its wish to be represented as an observer At a meeting of the Conference of the Parties serving as the Meeting of the Parties to the Protocol, may be admitted in that capacity unless at least one third of the Parties present oppose it. The admission and participation of observers shall be governed by the rules of procedure referred to in paragraph 5, above, except as otherwise provided in this Article.

Article 30. -SUBSIDIARY BODIES

Any subsidiary body established by, or virtue of, the Convention may, by decision of the Conference of
Parties serving as the Meeting of the Parties to this Protocol, perform functions under the Protocol, in which case the Meeting of the Parties shall specify the functions performed by that body.

(2) Parties to the Convention which are not Parties to this Protocol may participate, as an observer, in the work of any meeting of a subsidiary body of the Protocol. Where a subsidiary body of the Convention acts as a subsidiary body of the Protocol, decisions under the Protocol shall be taken only by the Parties to the Protocol.

Where a subsidiary body of the Convention performs its functions as a subsidiary body of the Protocol, any member of the Bureau of that subsidiary body representing a Party to the Convention that is not yet a Party to the Protocol shall be replaced By a new member who is elected by the Parties to the Protocol among them.

Article 31. -SECRETARIAT

The Secretariat established under Article 24 of the Convention shall act as the Secretariat of this Protocol.

2. Article 24, paragraph 1, of the Convention relating to the functions of the Secretariat shall apply mutatis mutandis to this Protocol.

3. As far as they are distinct, the costs of the secretariat services relating to this Protocol shall be borne by the Parties to the Protocol. The Conference of the Parties serving as the Meeting of the Parties to the Protocol shall, at its first meeting, take the financial provisions necessary for that purpose.

Article 32. -RELATIONSHIPS WITH
THE CONVENTION

Except as otherwise provided in this Protocol, the provisions of the Convention relating to its Protocols shall apply to this Instrument.

Article 33. -MONITORING AND REPORTING
Each Party shall ensure compliance with its obligations under this Protocol and, at regular intervals decided by the Conference of the Parties serving as the Meeting of the Parties to the Protocol, shall report to the Conference Parties serving as the Meeting of the Parties to the Protocol on the measures it has taken to implement the provisions of the Protocol.

Article 34. -COMPLIANCE WITH OBLIGATIONS
The Conference of the Parties serving as the Meeting of the Parties to the Protocol shall review and approve, at its first meeting, procedures and institutional mechanisms for cooperation to encourage compliance with the provisions of the Protocol and Treat cases of non-compliance. These procedures and mechanisms include provisions to provide advice or assistance, as appropriate. They are distinct and without prejudice to the dispute settlement procedure and mechanisms established under article 27 of the Convention.

Article 35. -EVALUATION AND REVIEW

The Conference of the Parties serving as the Meeting of the Parties to the Protocol shall proceed, five years after the entry into force of the Protocol, and thereafter at least every five years, to an assessment of its effectiveness, including an assessment of its Procedures and annexes.

Article 36. -SIGNATURE
This Protocol shall be open for signature by States and regional economic integration organizations at the United Nations Office at Nairobi from 15 to 26 May 2000, and at the United Nations Headquarters in New York from 5 June 2000 to 4 June 2001.

Article 37. -ENTERED INTO FORCE

(1) This Protocol shall enter into force on the ninetieth day after the date of deposit of the fiftieth instrument of ratification, acceptance, approval or accession by States or regional economic integration organizations Who are Parties to the Convention.

2. This Protocol shall enter into force for a State or regional economic integration organization which ratifies, accepts, approves or accedes to it after its entry into force in accordance with paragraph 1 above, namely Ninetieth day after the date of deposit by that State or organization of economic integration of its instrument of ratification, acceptance, approval or accession, or at the time when the Convention enters into force for that State or This regional economic integration organization, whichever is later.

3. For the purposes of paragraphs 1 and 2 above, none of the instruments deposited by a regional economic integration organization shall be considered to be in addition to the instruments already deposited by the member States of that organisation.

Article 38. -REVERSES
No reservations may be made to this Protocol.

Article 39. -DENUNCIATION

At the expiration of two years from the date of entry into force of this Protocol in respect of a Party, that Party may denounce the Protocol by written notification to the Depositary.

(2) Such denunciation shall take effect upon the expiration of one year from the date of its receipt by the depositary, or at any later date which may be specified in the notification.

Article 40. -AUTHENTIC TEXT
The original of this Protocol, of which the Arabic, Chinese, English, French, Russian and Spanish texts are equally authentic, shall be deposited with the Secretary-General of the United Nations.

In witness whereof the undersigned, to that duly authorized, have signed this Protocol.

Done at Montréal on January 19, 2000.

Annex I
INFORMATION TO APPEAR
IN NOTIFICATIONS A PRESENTER TO SECTIONS 8, 10 and 13

(a) Name, address and contact information of the exporter

(b) Name, address and contact information of the importer.

(c) Name and identity of the living modified organism and its classification according to the degree of biological safety, in the State of export, if it exists.

(d) The date or dates of the transboundary movement if known.

(e) Common name and taxonomy, point of collection or acquisition, and characteristics and of the receiving body or parent bodies relevant to the prevention of biotechnological risks.

(f) Centres of origin and centres of genetic diversity, when known to the receiving organism and/or parent organisms and description of habitats where organisms may persist or proliferate.

(g) Common name and taxonomy, point of collection or acquisition and characteristics of the organism or donor agencies relevant to the prevention of biotechnological risks.

(h) Description of the nucleic acid or modification introduced, the technique used and the characteristics of the resulting modified living organism.

(i) Intended use of the living modified organism or of the products derived from it, namely the transformed material having the origin of the modified living organism which contains new detectable combinations of replicable genetic material Achieved through the use of modern biotechnology.

(j) Quantity or volume of living modified organisms to be transferred.

(k) Pre-existing risk assessment report in accordance with Annex III.

(l) Proposed methods for safe handling, storage, transport and use, including packaging, labelling, documentation, disposal methods and emergency procedures, where applicable.

(m) Situation of the living modified organism in relation to the regulations in the State of export (for example, if it is prohibited in the exporting State, if there are other restrictions, or if its general circulation has been authorised): if The living modified organism is prohibited in the exporting State, the reason or reasons for the prohibition.

(n) Result and purpose of any notification by the exporter to other States with respect to the living modified organism to be transferred.

(o) Declaration that information
Above are accurate.

Annex II

INFORMATION TO PROVIDE FOR ANY LIVING ORGANISM MODIFIES DESTINE
TO BE USED DIRECTLY FOR
FOOD OR FEED, OR TO BE PROCESSED, PURSUANT TO SECTION 11

(a) The name and contact information of the person requesting authorization for use in the national territory.

(b) The name and contact details of the authority responsible for the decision.

(c) The name and identity of the living modified organism.

(d) A description of the genetic modification, the technique used, and the characteristics of the resulting modified living organism.

(e) Any unique identification of the living modified organism.

(f) Taxonomy, common name, point of collection or acquisition, and characteristics of the receiving organism or persistent parent organisms for the prevention of biotechnological risks.

(g) The centres of origin and centres of genetic diversity, when known, of the receiving organism and/or parent organisms, and a description of habitats where organisms may persist or proliferate.

(h) Taxonomy, common name, collection and acquisition point, and characteristics of the organism or donor agencies relevant to the prevention of biotechnological risks.

(i) The authorized uses of the living modified organism.

(j) A report on risk assessment in Annex III.

(k) The proposed methods for safe handling, storage, transport and use, including packaging, labelling, documentation, disposal methods and emergency procedures, where applicable.

Annex III
RISK ASSESSMENT

Objective

For the purposes of this Protocol, the purpose of the risk assessment is to identify and assess the potential adverse effects of living modified organisms on the conservation and sustainable use of biological diversity in the environment Potential receiver
Likely, taking into account also risks to human health.

Use of risk assessments

2. The risk assessment shall be used, inter alia, by the competent authorities to make an informed decision concerning living modified organisms.

General Principles

3. Risk assessment should be carried out according to sound scientific methods and transparency and may take into account technical advice and guidance from relevant international organizations

4. It is not necessarily necessary to infer from the absence of scientific knowledge or consensus the seriousness of a risk, the absence of risk, or the existence of an acceptable risk.

5. The risks associated with living modified organisms or products derived from them, namely, transformed material from living modified organisms that contains new detectable combinations of replicable genetic material obtained Through the use of modern biotechnology, should be considered in relation to the risks posed by unmodified receptor or parent organisms in the likely potential receiving environment.

6. The risk assessment should be done on a case-by-case basis. The nature and degree of accuracy of the information required may vary, depending on the case, depending on the affected living organism affected, its intended use, and the likely potential receiving environment.

Methods

7. The risk assessment may require additional information on specific issues, which may be defined and requested in the evaluation, but information on other issues may not be relevant, In some cases.

8. In order to achieve its objective, the risk assessment will include, where appropriate, the following steps:

(a) identification of any novel genotypic and phenotypic characteristics associated with the modified living organism that may have adverse effects on biological diversity in the likely potential receiving environment, and Risks to human health;

(b) the assessment of the likelihood that these adverse effects will occur, taking into account the degree and type of exposure of the likely receiving environment of the living modified organism;

(c) the assessment of the consequences of such adverse effects if they arise;

(d) the estimate of the overall risk presented by the living modified organism on the basis of the assessment of the probability of occurrence of the adverse effects identified and their consequences;

(e) a recommendation as to whether the risks are acceptable or manageable, including, where appropriate, the identification of strategies for managing these risks; and

F) where there is uncertainty about the severity of the risk, additional information on specific areas of concern, or the implementation of appropriate risk management strategies and/or control of the living organism, may be requested Modified in the receiving environment.

Items to be considered

9. Depending on the case, the risk assessment takes into account relevant technical and scientific data concerning:

(a) the receiving body or parent organisms: The biological characteristics of the receiving body or parent bodies, including details concerning the taxonomy, common name, origin, centres of origin and centres of origin Genetic diversity, when known, and a description of the habitat
Organizations may persist or proliferate:

(b) the donor organism or organism: Taxonomy and common name, source and relevant biological characteristics of the donor agencies.

(c) the vector: the characteristics of the vector, including its identity, if any, its source or origin, and the ranges of its hosts;

(d) insert or insert and/or characteristics of the modification: The genetic characteristics of the inserted nucleic acid and the function it determines, and/or the characteristics of the modification introduced:

(e) the living modified organism, the identity of the living modified organism, and the differences between the biological characteristics of the living modified organism and those of the receiving organism or parent organisms:

(f) The detection and identification of the living modified organism: proposed detection and identification methods and their particularity, accuracy and reliability;

(g) information relating to the intended use:
Information on the intended use of the living modified organism, including any new use or use that is different from that of the receiving or parent organization; and

(h) receiving environment: Information on the location and geographic, climatic and ecological characteristics of the potential receiving environment, including relevant information on biological diversity and the centres of origin Find.