CARTAGENA PROTOCOL ON BIOSAFETY TO THE CONVENTION ON
BIOLOGICAL DIVERSITY
The Parties to this Protocol,
Being Parties to the Convention on Biological Diversity, hereinafterreferred 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, specificallyfocusing on transboundary movement of any living modified organism resulting
from modern biotechnology that may have adverse effect on the conservation andsustainable use of biological diversity, setting out for consideration, inparticular, 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 biotechnology and the growing
public concern over its potential adverse effects on biological diversity,
taking also into account risks to human health,
Recognizing that modern biotechnology has great potential for humanwell-being if developed and used with adequate safety measures for theenvironment and human health,
Recognizing also the crucial importance to humankind of centres oforigin 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 agreements should be mutually
supportive with a view to achieving sustainable development,
Emphasizing that this Protocol shall not be interpreted as implying achange in the rights and obligations of a Party under any existing
international agreements,
Understanding that the above recital is not intended to subordinate thisProtocol to other international agreements,
Have agreed as follows:
Article 1
OBJECTIVE
In accordance with the precautionary approach contained in Principle 15of the Rio Declaration on Environment and Development, the objective of thisProtocol is to contribute to ensuring an adequate level of protection in thefield of the safe transfer, handling and use of living modified organisms
resulting from modern biotechnology that may have adverse effects on the/...

- 2 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, administrativeand 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 amanner 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 way the sovereignty ofStates over their territorial sea established in accordance with internationallaw, and the sovereign rights and the jurisdiction which States have in their
exclusive economic zones and their continental shelves in accordance withinternational law, and the exercise by ships and aircraft of all States ofnavigational rights and freedoms as provided for in international law and asreflected in relevant international instruments.
4.
Nothing in this Protocol shall be interpreted as restricting the rightof a Party to take action that is more protective of the conservation andsustainable use of biological diversity than that called for in this Protocol,
provided that such action is consistent with the objective and the provisionsof 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 thejurisdiction of the Party of export, who arranges for a living modified
organism to be exported;(e)"Import" means intentional transboundary movement into one Party
from another Party;/...

- 3 (f)"Importer" means any legal or natural person, under thejurisdiction of the Party of import, who arranges for a living modified
organism to be imported;(g)"Living modified organism" means any living organism thatpossesses a novel combination of genetic material obtained through the use ofmodern biotechnology;(h)"Living organism" means any biological entity capable oftransferring 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 acidinto cells or organelles, orb. Fusion of cells beyond the taxonomic family,that overcome natural physiological reproductive or recombination barriers andthat are not techniques used in traditional breeding and selection;(j)"Regional economic integration organization" means an organization
constituted by sovereign States of a given region, to which its member States
have transferred competence in respect of matters governed by this Protocol
and which has been duly authorized, in accordance with its internal
procedures, to sign, ratify, accept, approve or accede to it;(k)"Transboundary movement" means the movement of a living modified
organism from one Party to another Party, save that for the purposes of
Articles 17 and 24 transboundary 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 themaking of decisions on import, this Protocol shall not apply to thetransboundary movement of living modified organisms which are pharmaceuticals
for humans that are addressed by other relevant international agreements ororganisations.

/...

- 4 Article 6
TRANSIT AND CONTAINED USE
1.
Notwithstanding Article 4 and without prejudice to any right of a Partyof transit to regulate the transport of living modified organisms through its
territory and make available to the Biosafety Clearing-House, any decision ofthat Party, subject to Article 2, paragraph 3, regarding the transit throughits territory of a specific living modified organism, the provisions of thisProtocol with respect to the advance informed agreement procedure shall not
apply to living modified organisms in transit.
2.
Notwithstanding Article 4 and without prejudice to any right of a Party
to subject all living modified organisms to risk assessment prior to decisions
on import and to set standards for contained use within its jurisdiction, theprovisions of this Protocol with respect to the advance informed agreement
procedure shall not apply to the transboundary movement of living modified
organisms destined for contained use undertaken in accordance with thestandards of the Party of import.
Article 7
APPLICATION OF THE ADVANCE INFORMED AGREEMENT PROCEDURE
1.
Subject to Articles 5 and 6, the advance informed agreement procedure in
Articles 8 to 10 and 12 shall apply prior to the first intentionaltransboundary movement of living modified organisms for intentional
introduction into the environment of the Party of import.
2.
"Intentional introduction into the environment" in paragraph 1 above,
does not refer to living modified organisms intended for direct use as food or
feed, or for processing.
3.
Article 11 shall apply prior to the first transboundary movement ofliving modified organisms intended for direct use as food or feed, or forprocessing.
4.
The advance informed agreement procedure shall not apply to theintentional transboundary movement of living modified organisms identified ina decision of the Conference of the Parties serving as the meeting of theParties to this Protocol as being not likely to have adverse effects on theconservation 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 ofimport 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.
/...

- 5 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 informationreferred to in Article 8;(c)Whether to proceed according to the domestic regulatory frameworkof 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 intentionaltransboundary movement may proceed:(a)(b)
consent.

Only after the Party of import has given its written consent; orAfter no less than ninety days without a subsequent written

3.
Within two hundred and seventy days of the date of receipt of
notification, the Party of import shall communicate, in writing, to thenotifier and to the Biosafety Clearing-House the decision referred to inparagraph 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 shall not be taken into account; or/...

- 6 (d)Informing the notifier that the period specified in this paragraphis extended by a defined period of time.
4.
Except in a case in which consent is unconditional, a decision underparagraph 3 above, shall set out the reasons on which it is based.
5.
A failure by the Party of import to communicate its decision within two
hundred and seventy days of the date of receipt of the notification shall not
imply its consent to an intentional transboundary movement.
6.
Lack of scientific certainty due to insufficient relevant scientificinformation and knowledge regarding the extent of the potential adverse
effects of a living modified organism on the conservation and sustainable useof 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 inquestion as referred to in paragraph 3 above, in order to avoid or minimize
such potential adverse effects.
7.
The Conference of the Parties serving as the meeting of the Parties
shall, at its first meeting, decide upon appropriate procedures and mechanisms
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 totransboundary movement for direct use as food or feed, or for processing
shall, within fifteen days of making that decision, inform the Parties throughthe Biosafety Clearing-House. This information shall contain, at a minimum,
the information specified in Annex II. The Party shall provide a copy of theinformation, in writing, to the national focal point of each Party that
informs the Secretariat in advance that it does not have access to the
Biosafety Clearing-House. This provision shall not apply to decisions
regarding 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 theapplicant.
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 with the 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 ofliving modified organisms intended for direct use as food or feed, or forprocessing, 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/...

- 7 above, and in exercise of its domestic jurisdiction, declare through the
Biosafety Clearing-House that its decision prior to the first import of aliving modified organism intended for direct use as food or feed, or forprocessing, on which information has been provided under paragraph 1 above,
will be taken according to the following:(a)

A risk assessment undertaken in accordance with Annex III; and(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 scientificinformation and knowledge regarding the extent of the potential adverse
effects of a living modified organism on the conservation and sustainable useof 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 assistanceand capacity-building with respect to living modified organisms intended for
direct use as food or feed, or for processing. Parties shall cooperate tomeet 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 scientificinformation on potential adverse effects on the conservation and sustainable
use of biological diversity, taking also into account the risks to humanhealth, review and change a decision regarding an intentional transboundary
movement. In such case, the Party shall, within thirty days, inform any
notifier that has previously notified movements of the living modified
organism referred to in such decision, as well as the Biosafety ClearingHouse, and shall set out the reasons for its decision.
2.
A Party of export or a notifier may request the Party of import toreview a decision it has made in respect of it under Article 10 where theParty of export or the notifier considers that:(a)
A change in circumstances has occurred that may influence theoutcome 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.

/...

- 8 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 toensure the safe intentional transboundary movement of living modified
organisms in accordance with the objective of this Protocol, specify inadvance to the Biosafety Clearing-House:(a)Cases in which intentional transboundary movement to it may takeplace at the same time as the movement is notified to the Party of import; and(b)
Imports of living modified organisms to it to be exempted from theadvance 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 transboundary movement thatis to be provided in the notifications referred to in paragraph 1 (a) above,
shall be the information specified in Annex I.
Article 14
BILATERAL, REGIONAL AND MULTILATERAL AGREEMENTS AND ARRANGEMENTS
1.
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 andprovided that such agreements and arrangements do not result in a lower levelof protection than that provided for by the Protocol.
2.
The Parties shall inform each other, through the Biosafety ClearingHouse, of any such bilateral, regional and multilateral agreements andarrangements 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 affect intentionaltransboundary movements that take place pursuant to such agreements andarrangements as between the parties to those agreements or arrangements.
4.
Any Party may determine that its domestic regulations shall apply withrespect to specific imports to it and shall notify the Biosafety ClearingHouse of its decision.
Article 15
RISK ASSESSMENT
1.
Risk assessments undertaken pursuant to this Protocol shall be carriedout 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/...

- 9 evaluate the possible adverse effects of living modified organisms on theconservation and sustainable use of biological 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 carryout the risk assessment.
3.
The cost of risk assessment shall be borne by the notifier if the Partyof 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 toregulate, manage and control risks identified in the risk assessment
provisions of this Protocol associated with the use, handling andtransboundary movement of living modified organisms.
2.
Measures based on risk assessment shall be imposed to the extent
necessary to prevent adverse effects of the living modified organism on theconservation 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 unintentionaltransboundary movements of living modified organisms, including such measures
as requiring a risk assessment to be carried out prior to the first release ofa living modified organism.
4.
Without prejudice to paragraph 2 above, each Party shall endeavour toensure that any living modified organism, whether imported or locallydeveloped, has undergone an appropriate period of observation that iscommensurate 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 conservation andsustainable use of biological diversity, taking also into account risks tohuman 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, whereappropriate, 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 organismthat is likely to have significant adverse effects on the conservation and/...

- 10 sustainable use of biological diversity, taking also into account risks tohuman health in such States. The notification shall be provided as soon as theParty knows of the above situation.
2.
Each Party shall, no later than the date of entry into force of thisProtocol for it, make available to the Biosafety Clearing-House the relevant
details setting out its point of contact for the purposes of receiving
notifications under this Article.
3.

Any notification arising from paragraph 1 above, should include:(a)
Available relevant information on the estimated quantities andrelevant characteristics and/or traits of the living modified organism;(b)
Information on the circumstances and estimated date of therelease, 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.

4.
In order to minimize any significant adverse effects on the conservationand sustainable use of biological diversity, taking also into account risks tohuman 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 todetermine 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 subject to intentional transboundary movement within thescope of this Protocol are handled, packaged and transported under conditionsof safety, taking into consideration relevant international rules andstandards.
2.
Each Party shall take measures to require that documentationaccompanying:(a)
Living modified organisms that are intended for direct use as foodor feed, or for processing, clearly identifies that they "may contain" living
modified organisms and are not intended for intentional introduction into theenvironment, as well as a contact point for further information. The
Conference of the Parties serving as the meeting of the Parties to thisProtocol shall take a decision on the detailed requirements for this purpose,/...

- 11 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
point for further information, including the name and address of theindividual and institution to whom the living modified organisms are
consigned; and(c)Living modified organisms that are intended for intentional
introduction into the environment of the Party of import and any other living
modified organisms within the scope of the Protocol, clearly identifies themas living modified organisms; specifies the identity and relevant traits
and/or characteristics, any requirements for the safe handling, storage,transport and use, the contact point for further information and, as
appropriate, the name and address of the importer and exporter; and contains adeclaration that the movement is in conformity with the requirements of thisProtocol applicable to the exporter.
3.
The Conference of the Parties serving as the meeting of the Parties tothis 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 onits behalf for liaison with the Secretariat. Each Party shall also designate
one or more competent national authorities, which shall be responsible for
performing the administrative functions required by this Protocol and whichshall 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 entry into force of thisProtocol 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 to theSecretariat, with its notification thereof, relevant information on therespective responsibilities of those authorities. Where applicable, suchinformation shall, at a minimum, specify which competent authority is
responsible for which type of living modified organism. Each Party shallforthwith 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.

/...

- 12 Article 20
INFORMATION SHARING AND THE BIOSAFETY CLEARING-HOUSE

1.

A Biosafety Clearing-House is hereby established as part of theclearing-house mechanism under Article 18, paragraph 3, of the Convention, inorder to:(a)
Facilitate the exchange of scientific, technical, 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 developedand small island developing States among them, and countries with economies intransition as well as countries that are centres of origin and centres ofgenetic 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 shallprovide access to information made available by the Parties relevant to theimplementation 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, eachParty shall make available to the Biosafety Clearing-House any information
required to be made available to the Biosafety Clearing-House under thisProtocol, and:(a)
Any existing laws, regulations and guidelines for implementationof the Protocol, as well as information required by the Parties for theadvance informed agreement procedure;(b)
Any bilateral, regional and multilateral agreements andarrangements;(c)
Summaries of its risk assessments or environmental reviews ofliving modified organisms generated by its regulatory process, and carried out
in accordance with Article 15, including, where appropriate, relevant
information regarding products thereof, namely, processed materials that areof living modified organism origin, containing detectable novel combinationsof replicable genetic material obtained through the use of modern
biotechnology;(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 thisProtocol at its first meeting, and kept under review thereafter.

/...

- 13 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 ofimport as part of the advance informed agreement procedure of the Protocolthat is to be treated as confidential. Justification shall be given in suchcases 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 forsuch 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 thisProtocol, including any confidential information received in the context of
the advance informed agreement procedure of the Protocol. Each Party shallensure that it has procedures to protect such information and shall protect
the confidentiality of such information in a manner no less favourable thanits 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 ofimport shall respect the confidentiality of commercial and industrial
information, including research and development information as well as
information on which the Party and the notifier disagree as to its
confidentiality.
6.
Without prejudice to paragraph 5 above, the following information shallnot be considered confidential:(a)(b)
organisms;

The name and address of the notifier;
A general description of the living modified organism or(c)A summary of the risk assessment of the effects on theconservation and sustainable use of biological diversity, taking also into
account risks to human health; and(d)Any methods and plans for emergency response.
Article 22
CAPACITY-BUILDING

1.
The Parties shall cooperate in the development and/or strengthening of
human resources and institutional capacities in biosafety, including
biotechnology to the extent that it is required for biosafety, for the purposeof the effective implementation of this Protocol, in developing country
Parties, in particular the least developed and small island developing Statesamong them, and in Parties with economies in transition, including through/...

- 14 existing global, regional, subregional and national institutions andorganizations and, as appropriate, through facilitating private sector
involvement.
2.
For the purposes of implementing paragraph 1 above, in relation tocooperation, the needs of developing country Parties, in particular the least
developed and small island developing States among them, for financial
resources and access to and transfer of technology and know-how in accordancewith the relevant provisions of the Convention, shall be taken fully into
account for capacity-building in biosafety. Cooperation in capacity-building
shall, subject to the different situation, capabilities and requirements ofeach 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 andinstitutional capacities in biosafety. The needs of Parties with economies intransition shall also be taken fully into account for such capacity-building
in biosafety.
Article 23
PUBLIC AWARENESS AND PARTICIPATION
1.

The Parties shall:(a)Promote and facilitate public awareness, education andparticipation 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 andinternational bodies;(b)Endeavour to ensure that public awareness and education encompass
access to information on living modified organisms identified in accordancewith this Protocol that may be imported.
2.
The Parties shall, in accordance with their respective laws andregulations, 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 inaccordance with Article 21.
3.
Each Party shall endeavour to inform its public about the means ofpublic access to the Biosafety Clearing-House.
Article 24
NON-PARTIES
1.
Transboundary movements of living modified organisms between Parties andnon-Parties shall be consistent with the objective of this Protocol. The
Parties may enter into bilateral, regional and multilateral agreements andarrangements with non-Parties regarding such transboundary movements.
2.
The Parties shall encourage non-Parties to adhere to this Protocol andto contribute appropriate information to the Biosafety Clearing-House on
living modified organisms released in, or moved into or out of, areas within
their national jurisdictions.
/...

- 15 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 living
modified organism in question by repatriation or destruction, as appropriate.
3.
Each Party shall make available to the Biosafety Clearing-House
information concerning cases of illegal transboundary movements pertaining toit.
Article 26
SOCIO-ECONOMIC CONSIDERATIONS
1.
The Parties, in reaching a decision on import under this Protocol orunder 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 andsustainable use of biological diversity, especially with regard to the valueof biological diversity to indigenous and local communities.
2.
The Parties are encouraged to cooperate on research and informationexchange on any socio-economic impacts of living modified organisms,
especially on indigenous and local communities.
Article 27
LIABILITY AND REDRESSThe Conference of the Parties serving as the meeting of the Parties tothis Protocol shall, at its first meeting, adopt a process with respect to theappropriate elaboration of international rules and procedures in the field of
liability and redress for damage resulting from transboundary movements ofliving modified organisms, analysing and taking due account of the ongoingprocesses in international law on these matters, and shall endeavour tocomplete this process within four years.
Article 28
FINANCIAL MECHANISM AND RESOURCES
1.
In considering financial resources for the implementation of thisProtocol, 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.

/...

- 16 3.
Regarding the capacity-building referred to in Article 22 of thisProtocol, 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, in particular the least developed andthe 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 theParties with economies in transition, in their efforts to identify andimplement their capacity-building requirements for the purposes of theimplementation 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 theadoption 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 the Parties with economies in transition avail themselvesof, financial and technological resources for the implementation of theprovisions of this Protocol through bilateral, regional and multilateralchannels.
Article 29
CONFERENCE OF THE PARTIES SERVING AS THE MEETING OF THE PARTIESTO 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 Conferenceof 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 thisProtocol, 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 thisProtocol, shall be substituted by a member to be elected by and from among theParties to this Protocol.
4.
The Conference of the Parties serving as the meeting of the Parties tothis Protocol shall keep under regular review the implementation of thisProtocol 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;/...

- 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 cooperationof, and information provided by, competent international organizations andintergovernmental and non-governmental bodies;(d)Establish the form and the intervals for transmitting theinformation to be submitted in accordance with Article 33 of this Protocol andconsider such information as well as reports submitted by any subsidiary body;(e)Consider and adopt, as required, amendments to this Protocol andits 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 thisProtocol, except as may be otherwise decided by consensus by the Conference of
the Parties serving as the meeting of the Parties to this Protocol.
6.
The first meeting of the Conference of the Parties serving as themeeting 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 isscheduled after the date of the entry into force of this Protocol. Subsequentordinary 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 themeeting 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 themeeting 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 theParties.
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 thisProtocol. Any body or agency, whether national or international, governmental
or non-governmental, that is qualified in matters covered by this Protocol andthat has informed the Secretariat of its wish to be represented at a meetingof the Conference of the Parties serving as a meeting of the Parties to thisProtocol as an observer, may be so admitted, unless at least one third of theParties present object. Except as otherwise provided in this Article, theadmission and participation of observers shall be subject to the rules ofprocedure, as referred to in paragraph 5 above.

/...

- 18 Article 30
SUBSIDIARY BODIES1.
Any subsidiary body established by or under the Convention may, upon adecision by the Conference of the Parties serving as the meeting of theParties to this Protocol, serve the Protocol, in which case the meeting of theParties 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 withregard to matters concerning this Protocol, any member of the bureau of thatsubsidiary body representing a Party to the Convention but, at that time, nota Party to the Protocol, shall be substituted by a member to be elected by andfrom among the Parties to the Protocol.
Article 31
SECRETARIAT
1.
The Secretariat established by Article 24 of the Convention shall serveas the secretariat to this Protocol.
2.
Article 24, paragraph 1, of the Convention on the functions of theSecretariat shall apply, mutatis mutandis, to this Protocol.
3.
To the extent that they are distinct, the costs of the secretariat
services for this Protocol shall be met by the Parties hereto. The Conferenceof the Parties serving as the meeting of the Parties to this Protocol shall,at its first meeting, decide on the necessary budgetary arrangements to thisend.
Article 32
RELATIONSHIP WITH THE CONVENTION
Except as otherwise provided in this Protocol, the provisions of theConvention relating to its protocols shall apply to this Protocol.
Article 33
MONITORING AND REPORTING
Each Party shall monitor the implementation of its obligations under
this Protocol, and shall, at intervals to be determined by the Conference of
the Parties serving as the meeting of the Parties to this Protocol, report to
the Conference of the Parties serving as the meeting of the Parties to thisProtocol on measures that it has taken to implement the Protocol.

/...

- 19 Article 34
COMPLIANCE
The Conference of the Parties serving as the meeting of the Parties tothis Protocol shall, at its first meeting, consider and approve cooperative
procedures and institutional mechanisms to promote compliance with theprovisions of this Protocol and to address cases of non-compliance. These
procedures and mechanisms shall include provisions to offer advice orassistance, 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 REVIEWThe Conference of the Parties serving as the meeting of the Parties tothis Protocol shall undertake, five years after the entry into force of thisProtocol and at least every five years thereafter, an evaluation of theeffectiveness of the Protocol, including an assessment of its procedures andannexes.
Article 36
SIGNATURE
This Protocol shall be open for signature at the United Nations Officeat 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 dateof deposit of the fiftieth instrument of ratification, acceptance, approval oraccession 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 depositedby a regional economic integration organization shall not be counted asadditional to those deposited by member States of such organization.

/...

- 20 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 bygiving written notification to the Depositary.
2.
Any such withdrawal shall take place upon expiry of one year after thedate of its receipt by the Depositary, or on such later date as may be
specified in the notification of the withdrawal.
Article 40
AUTHENTIC TEXTSThe original of this Protocol, of which the Arabic, Chinese, English,
French, Russian and Spanish texts are equally authentic, shall be deposited
with the Secretary-General of the United Nations.

IN WITNESS WHEREOF the undersigned, being duly authorized to that effect, havesigned this Protocol.
DONE at Montreal on this twenty-ninth day of January, two thousand.

/...

- 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 thedomestic 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 tobiosafety.
(f)Centres of origin and centres of genetic diversity, if known, of
the recipient organism and/or the parental organisms and a description of thehabitats 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 betransferred.
(k)Annex III.

A previous and existing risk assessment report consistent with(l)Suggested methods for the safe handling, storage, transport anduse, including packaging, labelling, documentation, disposal and contingency
procedures, where appropriate.
(m)
Regulatory status of the living modified organism within the Stateof export (for example, whether it is prohibited in the State of export,
whether there are other restrictions, or whether it has been approved forgeneral release) and, if the living modified organism is banned in the Stateof export, the reason or reasons for the ban.
(n)Result and purpose of any notification by the exporter to otherStates regarding the living modified organism to be transferred.
(o)correct.

A declaration that the above-mentioned information is factually/...

- 22 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 fordomestic use.
(b)
decision.
(c)

The name and contact details of the authority responsible for theName and identity of the living modified organism.

(d)Description of the gene modification, the technique used, and theresulting 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 tobiosafety.
(g)Centres of origin and centres of genetic diversity, if known, of
the recipient organism and/or the parental organisms and a description of thehabitats 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 anduse, including packaging, labelling, documentation, disposal and contingency
procedures, where appropriate.

/...

- 23 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 theconservation and sustainable use of biological diversity in the likely
potential receiving environment, taking also into account risks to humanhealth.
Use of risk assessment
2.
Risk assessment is, inter alia, used by competent authorities to makeinformed decisions regarding living modified organisms.
General principles
3.
Risk assessment should be carried out in a scientifically sound andtransparent manner, and can take into account expert advice of, and guidelines
developed by, relevant international organizations.
4.
Lack of scientific knowledge or scientific consensus should notnecessarily be interpreted as indicating a particular level of risk, anabsence of risk, or an acceptable risk.
5.
Risks associated with living modified organisms 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, should be considered in thecontext of the risks posed by the non-modified recipients or parentalorganisms in the likely potential receiving environment.
6.
Risk assessment should be carried out on a case-by-case basis. The
required information may vary in nature and level of detail from case to case,depending on the living modified organism concerned, its intended use and thelikely potential receiving environment.
Methodology
7.
The process of risk assessment may on the one hand give rise to a needfor further information about specific subjects, which may be identified andrequested during the assessment process, while on the other hand informationon other subjects may not be relevant in some instances.
8.
To fulfil its objective, risk assessment entails, as appropriate, thefollowing steps:(a)
An identification of any novel genotypic and phenotypiccharacteristics associated with the living modified organism that may haveadverse effects on biological diversity in the likely potential receiving
environment, taking also into account risks to human health;(b)
An evaluation of the likelihood of these adverse effects being
realized, taking into account the level and kind of exposure of the likely
potential receiving environment to the living modified organism;/...

- 24 (c)realized;

An evaluation of the consequences should these adverse effects be(d)An estimation of the overall risk posed by the living modified
organism based on the evaluation of the likelihood and consequences of theidentified adverse effects being realized;(e)
A recommendation as to whether or not the risks are acceptable ormanageable, 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 thefollowing subjects:(a) Recipient organism or parental organisms. The biologicalcharacteristics of the recipient organism or parental organisms, including
information on taxonomic status, common name, origin, centres of origin andcentres 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, ifany, 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 theliving modified organism and those of the recipient organism or parentalorganisms;(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.
-----