WORLD TRADE
ORGANIZATIONWT/CTE/W/136
30 March 2000
(00-1302)
Committee on Trade and Environment Original:  English/
                  French/
                  Spanish
CARTAGENA PROTOCOL ON BIOSAFETY
TO THE CONVENTION ON BIOLOGICAL DIVERSITY
Communication from the Convention on Biological Diversity
This document reproduces the text of the Cartagena Protocol on Biosafety, which was
negotiated under the Convention on Biological Diversity (CBD) and adopted in Montreal on29 January 2000.  The Protocol will be opened for signature at the United Nations Office at Nairobi
by States and regional economic integration organizations from 15 to 26 May 2000, and at the
United Nations Headquarters in New York from 5 June 2000 to 4 June 2001.  The text is also
available on the website of the CBD:  http://www.biodiv.org/biosaf e/BIOSAFETY-PROTOCOL.htm .WT/CTE/W/136
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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 November 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 consideration, in particular,
appropriate procedures for advance informed agreement,
Reaffirming the precautionary approach contained in Principle 15 of the Rio Declaration on
Environment and Development,
Aware of the rapid expansion of modern bi otechnology 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 ha s great potential for human well-being if
developed and used with adequate safety measures for the environment and human health,
Recognizing also the crucial importance 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 known and potential risks associated with living
modified organisms,
Recognizing that trade and environment agreem ents should be mutually supportive with a
view to achieving sustainable development,
Emphasizing that this Protocol shall not be inte rpreted 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 subordinate this Protocol to other
international agreements,Have agreed as follows:WT/CTE/W/136
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Article 1
OBJECTIVE
In accordance with the precautionary approach contained in Principle 15 of the Rio
Declaration on Environment and Development, the objective of this Protocol is to contribute to
ensuring an adequate level of protection in the field of the safe transfer, handling and use of livingmodified 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 movements.
Article 2
GENERAL PROVISIONS
1. Each Party shall take necessary and appropriate legal, administrative and other measures to
implement its obligations under this Protocol.
2. The Parties shall ensure that the development, handling, transport, use, transfer and release of
any living modified organisms are undertaken in a manner that prevents or reduces the risks to
biological diversity, taking also into account risks to human health.
3. Nothing in this Protocol shall affect in any wa y the sovereignty of States over their territorial
sea established in accordance with international law, and the sovereign rights and the jurisdictionwhich States have in their exclusive economic zones and their continental shelves in accordance with
international law, and the exercise by ships and aircraft of all States of navigational rights and
freedoms 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 provisions of
this Protocol and is in accordance 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 risks to
human health.
Article 3
USE OF TERMS
For the purposes of this 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, installation or
other physical structure, which involves living modified organisms that are controlled
by specific measures 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) "Exporter" means any legal or natural person, under the jurisdiction of the Party of
export, who arranges for a living modified organism to be exported;WT/CTE/W/136
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(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 arranges for a living modified organism to be imported;
(g) "Living modified organism" means any living organism that possesses a novel 
combination of genetic material obtained through the use of modern biotechnology;
(h) "Living organism" means any biological entity capable of transferring or replicating 
genetic material, including sterile organisms, viruses and viroids;
(i) "Modern biotechnology" means the application of:
(a) In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid
(DNA) and direct injection of nucleic  acid into cells or organelles, or
(b) Fusion of cells beyond the taxonomic family,
(j) that overcome natural physiological reproductive or recombination barriers and that 
are not techniques used in traditional breeding and selection;
(k) "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 dulyauthorized, in accordance with its internal procedures, to sign, ratify, accept, approve
or accede to it;
(l) "Transboundary movement" means the movement of a living modified organism from
one Party to another Party, save that for the purposes of Articles 17 and 24transboundary movement extends 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 livi ng modified organisms which are pharmaceuticals for
humans that are addressed by other relevant international agreements or organisations.WT/CTE/W/136
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Article 6
TRANSIT AND CONTAINED USE
1. Notwithstanding Article 4 and without prejudice to any right of a Party of transit to regulate
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 transitthrough its territory of a specific living modified organism, the provisions of this Protocol with
respect to the advance informed agreement procedur e 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 contained
use within its jurisdiction, the provisions of this Protocol with respect to the advance informedagreement procedure shall not apply to the transboundary movement of living modified organisms
destined for contained use undertaken in accordance 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 s hall 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 transb oundary movement of living modified organisms
intended for direct use as food or feed, or for processing.
4. The advance informed agreement procedure sh all 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 exporter to ensure notification to, 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 ensure that there is a legal requirement for the accuracy of
information provided by the exporter.WT/CTE/W/136
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Article 9
ACKNOWLEDGEMENT OF RECEIPT OF NOTIFICATION
1. The Party of import shall acknowledge 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) Whether the notification, prima facie, contains the information referred to in 
Article 8;
(c) Whether to proceed according to the domestic regulatory framework of the 
Party of import or according to the procedure specified in Article 10.
3. 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 acknowledge receipt of a notification shall not imply its
consent to an intentional transboundary movement.
Article 10
DECISION PROCEDURE
1. Decisions taken by the Party of import shall be in accordance with Article 15.2. The Party of import shall, within the period of  time referred to in Article 9, inform the
notifier, in writing, whether the intentional transboundary movement may proceed:
(a) Only after the Party of import has given its written consent; or
(b) After no less than ninety days without a subsequent written consent.
3. Within two hundred and seventy days of the date  of receipt of 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 accordance with its domestic regulatory
framework or Annex I; in calculating the time within which the Party of import is to
respond, the number of days it has to wait for additional relevant information shallnot be taken into account; or
(d) Informing the notifier that the period spec ified in this paragraph is extended by a
defined period of time.WT/CTE/W/136
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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 intentionaltransboundary movement.
6. Lack of scientific certainty due to insufficient relevant scientific information and knowledge
regarding the extent 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 question as referred to in paragraph 3 above, in order toavoid 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 to facilitate decision-making by 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, inform the Parties through
the Biosafety Clearing-House.  This information shall contain, at a minimum, the informationspecified in Annex II.  The Party shall provide a copy  of th e information, in writing, to the national
focal point of each Party that informs the Secretaria t in advance that it does not have access to the
Biosafety Clearing-House. This provision shall not apply to decisions regarding field trials.
2. The Party making a decision under paragraph 1 above, shall ensure 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 living modified organisms intended for direct
use as food or feed, or for processing, under its domestic regulatory framework that is consistent withthe objective of this Protocol.
5. Each Party shall make available to the Biosafety Clearing-House copies of any national laws,
regulations and guidelines applicable to the import of living modified organisms 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 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 whichinformation has been provided under paragraph 1 above, will be taken according to the following:
(a) A risk assessment undertaken in accordance with Annex III; andWT/CTE/W/136
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(b) A decision made within a predictable timeframe, 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 specified by the Party.
8. Lack of scientific certainty due to insufficient relevant scientific information and knowledge
regarding the extent 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 that living modified organism intended for direct use as food or feed, or for processing, in
order to avoid or minimize such potential adverse effects.
9. A Party may indicate its needs for financial and technical assistance and capacity-building
with respect to living modified organisms intended fo r direct use as food or feed, or for processing.
Parties shall cooperate to meet these needs in accordance with Articles 22 and 28.
Article 12
REVIEW OF DECISIONS
1. A Party of import may, at any time, in light of new scientific information on potential adverse
effects on the conservation and sustainable use of biol ogical diversity, taking also into account the
risks to human health, review and change a decision regarding an intentional transboundary
movement. In such case, the Party shall, within th irty days, inform any notifier that has previously
notified movements 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 considers that:
(a) A change in circumstances has occurred that 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 respond in writing to such a request 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 adequate measures are applied to ensure the safe
intentional transboundary movement of living modified organisms in accordance 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; andWT/CTE/W/136
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(b) Imports of living modified organisms to it to be exempted from the advance informed
agreement procedure.
Notifications under subparagraph (a) above, may apply to subsequent similar movements to
the same Party.
2. The information relating to an intentional tran sboundary movement that is to be provided in
the notifications referred to in paragraph 1 (a) a bove, shall be the information specified in Annex I.
Article 14
BILATERAL, REGIONAL AND MULTILATERAL AGREEMENTS AND ARRANGEMENTS
1. Parties may enter into bilateral, regional and multilateral agreements and arrangements
regarding intentional transboundary movements 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 multilateral agreements and arrangements that they have entered into before or
after the date of entry into force of this Protocol.
3. The provisions of this Protocol shall not af fect intentional transboundary movements that take
place pursuant to such agreements and arrangements as between the parties to those agreements orarrangements.
4. Any Party may determine 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 pursuant to this Protocol shall be carried out in a scientifically
sound manner, in accordance with Annex III and taking into account recognized risk assessment
techniques. Such risk assessments shall be based, at a minimum, on information provided in
accordance with Article 8 and other available scientific evidence in order to identify and evaluate the
possible adverse effects of living modified organisms on the conservation and sustainable use ofbiological diversity, taking also into account risks to human health.
2. The Party of import shall ensure that risk assessments are carried out for decisions taken
under Article 10.  It may require the exporter 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, measures and strategies to regulate, manage and control risks identified in
the risk assessment provisions of this Protocol associated with the use, handling and transboundary
movement of living modified organisms.WT/CTE/W/136
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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, taking also into account risks to human health, within the territory of the Party of import.
3. Each Party shall take appropriate measures to prevent unintentional transboundary
movements of living modified organisms, including such measures as requiring a risk assessment tobe carried out prior to the first release of a living modified organism.
4. Without prejudice to paragraph 2 above, each Party shall endeavour to ensure that any living
modified organism, whether imported or locally developed, has undergone an appropriate period of
observation that is commensurate with its life-cycle or generation time before it is put to its intended
use.
5. 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 cons ervation and sustainable use of biological
diversity, taking also into account risks to human health; and
(b) Taking 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 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 leads, or may lead, to an
unintentional transboundary movement of a living modified organism that is likely to have significantadverse 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 thepurposes of receiving notifications under this Article.
3. Any notification arising from paragraph 1 above, should include:
(a) Available relevant information on the estimated quantities and relevant characteristics
and/or traits of the living modified organism;
(b) Information on the circumstances and estimated date 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 measures;
(d) Any other relevant information; and
(e) A point of contact for further information.WT/CTE/W/136
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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, occurs, shall
immediately consult the affected or potentially affected States to enable them to determine appropriate
responses and initiate necessary action, including emergency measures.
Article 18
HANDLING, TRANSPORT, PACKAGING AND IDENTIFICATION
1. In order to avoid adverse effects on the conservation and sustainable use of biological
diversity, taking also into account risks to human health, each Party shall take necessary measures to
require that living modified organisms that are su bject to intentional transboundary movement within
the scope of this Protocol are handled, packaged and transported under conditions of safety, taking
into consideration relevant international rules and standards.
2. Each Party shall take measures to require that documentation accompanying:
(a) Living modified organisms that are intended for direct use as food or feed, or for
processing, clearly identifies 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 ofthe Parties to this Protocol shall take a decision on the detailed requirements for this
purpose, including specification of their identity and any unique identification, no
later than two years after the date of entry into force of this Protocol;
(b) Living modified organisms that are destined for contained use clearly identifies them
as living modified organisms; and specifies any requirements for the safe handling,storage, transport and use, the contact po int for further information, including the
name and address of the individual and institution to whom the living modified
organisms are consigned; and
(c) Living modified organisms that are inte nded for intentional introduction into the
environment of the Party of import and any other living modified organisms withinthe scope of the Protocol, clearly identifies them as living modified organisms;
specifies the identity and relevant traits an d/or characteristics, any requirements for
the safe handling, storage, transport and us e, the contact point for further information
and, as appropriate, the name and address of the importer and exporter; and contains a
declaration that the movement is in conformity with 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
consider the need for and modalities of developing standards with regard 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 designate one national focal point to be responsible on its behalf for liaison
with the Secretariat. Each Party shall also desi gnate one or more competent national authorities,
which shall be responsible for performing the administrative functions required by this Protocol andWT/CTE/W/136
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which shall be authorized to act on its behalf with respect to those functions. A Party may designate a
single entity to fulfil the functions of both focal point and competent national authority.
2. Each Party shall, no later than the date of entr y 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 designates more than one competent national authority, it shall convey tothe Secretariat, with its notification thereof, relevant information on the respective responsibilities of
those authorities. Where applicable, such information shall, at a minimum, specify which competent
authority is responsible for which type of living modified organism. 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 its competent national authority or authorities.
3.  The Secretariat shall forthwith inform the Parties of the notifications it receives 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 establ ished as part of the clearing-house mechanism
under Article 18, paragraph 3, of the Convention, in order to:
(a) Facilitate the exchange of scientific, t echnical, environmental and legal information 
on, and experience with, living modified organisms; and
(b) Assist Parties to implement the Protocol, 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 purposes 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 info rmation 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 multilateral 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 accordance withArticle 15, including, where appropriate, relevant information regarding products
thereof, namely, processed materials that are of living modified organism origin,
containing detectable novel combinations of replicable genetic material obtained
through the use of modern biotechnology;WT/CTE/W/136
Page 13
(d) Its final decisions regarding the importation or release of living modified organisms; 
and
(e) Reports submitted by it pursuant to Article 33, including those on implementation of
the advance informed agreement procedure.
4. The modalities of the operation 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 kept 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 insuch cases upon request.
2. The Party of import shall consult the notifier if it decides that 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 ensure that it has procedures to protect such information and shall protect
the confidentiality of such information in a manner no less favourable than its treatment of
confidential information in connection with domestically produced living modified organisms.
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 withdraws or has withdrawn a 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 itsconfidentiality.
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.WT/CTE/W/136
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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 extent that it is required for
biosafety, for the purpose of the effective implementation of this Protocol, in developing countryParties, 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 purposes of implementing paragraph 1 above, in relation to 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 inaccordance with the relevant provisions of the C onvention, shall be taken fully into account for
capacity-building in biosafety.  Cooperation in cap acity-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.  Theneeds of Parties with economies in transition sh all also be taken fully into account for such
capacity-building in biosafety.
Article 23
PUBLIC AWARENESS AND PARTICIPATION
1. The Parties shall:
(a) Promote and facilitate public awareness, education and participation concerning the
safe transfer, handling and use of living modified organisms 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, as appropriate, with other
States and international bodies;
(b) Endeavour to ensure that public awareness and education encompass access to
information on living modified organisms identified in accordance with this Protocol
that may be imported.
2. The Parties shall, in accordance with their respective laws 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 accordance with
Article 21.
3. Each Party shall endeavour to inform its public about the means of public access to the
Biosafety Clearing-House.WT/CTE/W/136
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Article 24
NON-PARTIES
1. Transboundary movements 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 multilateral agreements and arrangements with non-Parties regarding such transboundarymovements.
2. The Parties shall encourage non-Parties to adhere to this Protocol and to contribute
appropriate information to the Biosafety Clearing-H ouse on living modified organisms released in, or
moved into or out of, areas within their national jurisdictions.
Article 25
ILLEGAL TRANSBOUNDARY MOVEMENTS
1. Each Party shall adopt appropriate domestic measures aimed at preventing and, if appropriate,
penalizing transboundary movements of living modified organisms carried out in contravention of its
domestic measures to implement this Protocol. Such movements shall be deemed illegal
transboundary movements.
2. In the case of an illegal transboundary movement, the affected Party may request the Party of
origin to dispose, at its own expense, of the liv ing 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 movements pertaining to it.
Article 26
SOCIO-ECONOMIC CONSIDERATIONS
1. The Parties, in reaching a decision on import under this Protocol or under its domestic
measures 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 regard to the value of
biological diversity to indigenous 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 and local
communities.
Article 27
LIABILITY AND REDRESS
The Conference of the Parties serving as the meeting of the Parties to this Protocol shall, at its
first meeting, adopt a process with respect to the appropriate elaboration of international rules and
procedures in the field of liability and redress for damage resulting from transboundary movements of
living modified organisms, analysing and taking due account of the ongoing processes in internationallaw on these matters, and shall endeavour to complete this process within four years.WT/CTE/W/136
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Article 28
FINANCIAL MECHANISM AND RESOURCES
1. In considering financial resources for the implementation of this Protocol, the Parties shall
take into account the provisions 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 consideration by the Conference of the
Parties, shall take into account the need for financial resources by developing country Parties, inparticular 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 and implement
their capacity-building requirements for the purpo ses 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 provisions of this Article.
6. The developed country Parties may also provide, and the developing country Parties and theParties with economies in transition avail themselves of, financial and technological resources for theimplementation of the provisions of this Protocol through bilateral, regional and multilateral channels.
Article 29
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. Parties to the Convention that are not Parties to this Protocol may participate as observers 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 serves 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 serves 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 Pr otocol and shall make, within its mandate, the
decisions necessary to promote its effective implementation. It shall perform the functions assigned to
it by this Protocol and shall:
(a) Make recommendations on any matters necessary for the implementation of this
Protocol;WT/CTE/W/136
Page 17
(b) Establish such subsidiary bodies as are deemed necessary for the implementation of
this Protocol;
(c) Seek and utilize, 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 accordance with Article 33 of this Protocol and consider such information as well
as reports submitted by any subsidiary body;
(e) Consider and adopt, as required, amendments to this Protocol and its annexes, as well
as any additional annexes to this Protocol, that are deemed necessary 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 Partie s 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 Conference of the Parties serving as the meeting of the Parties to thisProtocol.
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 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 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 observers thereto not party to the Convention, may be
represented as observers at meetings of the Conference of the Parties serving as the meeting of the
Parties to this Protocol. Any body or agency, wh ether national or international, governmental or
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 ameeting 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 admission and
participation of observers shall be subject to the rules of procedure, as referred to in paragraph 5
above.WT/CTE/W/136
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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. Parties to the Convention that are not Parties to this Protocol may participate as observers in
the proceedings of any meeting of any such subsidiary bodies. When a subsidiary body of the
Convention serves 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 beelected 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 extent that they are distinct, the costs of the secretariat services for this Protocol shallbe met by the Parties hereto. The Conference of the Parties serving as the meeting of the Parties to
this Protocol shall, at its first meeting, decide on the necessary budgetary arrangements to this end.
Article 32
RELATIONSHIP WITH THE CONVENTION
Except as otherwise provided in this Protocol, th e provisions 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 Pa rties serving as the meeting of the Parties to this
Protocol on measures that it has taken to implement the 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 to address cases of non-compliance. TheseWT/CTE/W/136
Page 19
procedures and mechanisms shall include provisions 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
undertake, five years 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
annexes.
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
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 that are Parties to the Convention.
2. This Protocol shall enter into force for a State or regional economic integration organization
that ratifies, accepts or approves this Protocol or accedes thereto after its entry into force pursuant 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 enters into force for that State or regional economic integration
organization, whichever shall be the later.
3. For the purposes 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
No reservations may be made to this Protocol.
Article 39
WITHDRAWAL
1. At any time 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 withdrawal 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 withdrawal.WT/CTE/W/136
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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 au thorized to that effect, have signed this
Protocol.
DONE at Montreal on this twenty-ninth day of January, two thousand.WT/CTE/W/136
Page 21
ANNEX I
INFORMATION REQUIRED IN NOTIFICATIONS UNDER ARTICLES 8, 10 AND 13
(a) Name, address and contact details of the exporter.(b) 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 proliferate.
(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 detectable novel
combinations of replicable genetic material obtained through 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, whether it is prohibited in the State of export, whether there are otherrestrictions, or whether it has been approved for 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 exporter to other States regarding the
living modified organism to be transferred.
(o) A declaration that the above-mentioned information is factually correct.WT/CTE/W/136
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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) 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 proliferate.
(h) Taxonomic status, common name, point of collection or acquisition, and
characteristics of the donor organism or organisms related to biosafety.
(i) Approved uses 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.WT/CTE/W/136
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ANNEX III
RISK ASSESSMENT
Objective
1. The objective of risk assessment, under this Protocol, is to identify and evaluate the potential
adverse effects of living modified organisms on the conservation and sustainable use of biological
diversity in the likely potential receiving environmen t, taking also into account risks to human health.
Use of risk assessment
2. Risk assessment is, inter alia , used by competent authorities to make informed decisions
regarding living modified organisms.
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 internationalorganizations.
4. Lack of scientific knowledge or scientific consensus should not necessarily be interpreted as
indicating a particular level of risk, an absence of risk, or an acceptable risk.
5. Risks associated with living modified orga nisms or products thereof, namely, processed
materials that are of living modified organism or igin, containing detectable novel combinations of
replicable genetic material obtained through the use of modern biotechnology, should be considered
in the context of the risks 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 organismconcerned, 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 entails, 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 risksto 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;
(c) An evaluation of the consequences should these adverse effects be realized;WT/CTE/W/136
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(d) An estimation of the overall risk posed by the living modified organism based on the
evaluation of the likelihood and consequences of the identified adverse effects being
realized;
(e) A recommendation as to whether or not the risks are acceptable or manageable,
including, where necessary, identification of strategies 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.
Points to 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, centres of origin and centres of genetic diversity, if known,
and a description of the habitat where the organisms may persist or proliferate;
(b) Donor organism or organisms.  Taxonomic status and common name, source, and the
relevant biological characteristics of the donor organisms;
(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 specifies, and/or characteristics of the
modification introduced;
(e) Living modified organism.  Identity of the living modified organism, and the
differences between the biological characteristics of the living modified organism and
those of the recipient organism or parental organisms;
(f) Detection and identification of the living modified organism. Suggested detection and
identification methods and their specificity, 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, geographical, climatic and
ecological characteristics, including relevant  information on biological diversity and
centres of origin of the likely potential receiving environment.
__________