2002/628/EC: Council Decision of 25 June 2002 concerning the conclusion, on behalf of the European Community, of the Cartagena Protocol on Biosafety
Date: 2002-06-25
Institutions: Council of the European Union
Subjects: UN convention, biotechnology, common commercial policy, environmental protection, environmental risk prevention, genetically modified organism, protocol to an agreement, public safety

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II

(Acts whose publication is not obligatory)

COUNCIL

COUNCIL DECISION

of 25 June 2002

concerning the conclusion, on behalf of the European Community, of the Cartagena Protocol on
Biosafety

(2002/628/EC)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Commu-
nity, and in particular Article 175(1), in conjunction with the
first sentence of the first subparagraph of Article 300(2) and
the first subparagraph of Article 300(3) thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Parliament (2),

Whereas:

(1)

(2)

(3)

(4)

(5)

The promotion of measures at international level to deal
with regional or worldwide environmental problems,
including the conservation and sustainable use of biolo-
gical diversity, is one of the objectives of the European
Community’s policy on the environment, in accordance
with Article 174 of the Treaty.

By Decision 93/626/EEC (3) the European Community
concluded the Convention on Biological Diversity under
the United Nations Environment
the
Programme.

auspices of

In 1995 the Council authorised the Commission to parti-
cipate, on behalf of the Community, in the negotiations
on a Protocol on Biosafety, under Article 19(3) of the
Convention on Biological Diversity. The Commission
participated in those negotiations,
together with the
Member States.

The Cartagena Protocol on Biosafety was adopted in
Montreal on 29 January 2000.

The Protocol provides a framework, based on the
precautionary principle, for the safe transfer, handling

(1) OJ C 181 E, 30.7.2002, p. 258.
(2) Opinion delivered on 11 June 2002 (not yet published in the Offi-

cial Journal).

(3) OJ L 309, 13.12.1993, p. 1.

and use of
living modified organisms resulting from
modern biotechnology that may have adverse effects on
the conservation and sustainable use of biological diver-
sity, taking also into account risks to human health and
specifically focussing on transboundary movements.

The European Community and fourteen Members States
signed the Protocol on 24 May 2000, during the fifth
meeting of the Parties to the Convention on Biological
Diversity held in Nairobi. Luxembourg signed the
Protocol on 11 July 2000.

According to Article 34 of the Convention on Biological
Diversity, any protocol to that Convention is subject to
ratification, acceptance or approval by States and by
regional economic integration organisations.

The Cartagena Protocol on Biosafety contributes to the
achievement of
the environmental
policy of the Community. It is therefore appropriate that
this Protocol be concluded on behalf of the Community
as soon as possible,

the objectives of

(6)

(7)

(8)

HAS DECIDED AS FOLLOWS:

Article 1

The Cartagena Protocol on Biosafety to the Convention on
Biological Diversity is hereby approved on behalf of
the
European Community.

The text of the Protocol is set out in Annex A to this Decision.

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Article 2

1.
The President of the Council is authorised to designate the
person or persons empowered to deposit the instrument of
approval on behalf of the European Community with the Secre-
tary General of the United Nations, in accordance with Articles
34 and 41 of the Convention on Biological Diversity.

2.
The President of the Council is hereby authorised to desig-
nate the person or persons empowered to deposit, on behalf of
the European Community, the declaration of competence set

out in Annex B to this Decision, in accordance with Article
34(3) of the Convention on Biological Diversity.

Done at Luxembourg, 25 June 2002.

For the Council

The President

J. MATAS i PALOU

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ANNEX A

CARTAGENA PROTOCOL ON BIOSAFETY

to the convention on biological diversity

The Parties to this Protocol,

B ei ng Parties to the Convention on Biological Diversity, hereinafter referred to as ‘the Convention’,

R e c a lli ng Article 19, paragraphs 3 and 4, Article 8(g) and Article 17 of the Convention,

R e c a lli ng 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,

R e a f fi rm i n g the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Devel-
opment,

A w a re 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,

R e c og n i z i n g that modern biotechnology has great potential for human well-being if developed and used with adequate
safety measures for the environment and human health,

R e c og n i z i n g also the crucial importance to humankind of centres of origin and centres of genetic diversity,

T a ki ng i n to a cc ou nt 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,

R e c og n i z i n g that trade and environment agreements should be mutually supportive with a view to achieving sustain-
able development,

E mph a si zi ng that this Protocol shall not be interpreted as implying a change in the rights and obligations of a Party
under any existing international agreements,

U nde rsta ndi n g that the above recital is not intended to subordinate this Protocol to other international agreements,

Have agreed as follows:

Article 1

Objective

this Protocol

the objective of

In accordance with the precautionary approach contained in
Principle 15 of the Rio Declaration on Environment and Devel-
opment,
is to contribute to
ensuring an adequate level of protection in the field of the safe
transfer, handling and use of
living modified organisms
resulting from modern biotechnology that may have adverse
effects on the conservation and sustainable use of biological
diversity, taking also into account risks to human health, and
specifically focusing on transboundary 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.

risks to biological diversity, taking also into account risks to
human health.

3.
Nothing in this Protocol shall affect in any way the sover-
eignty of States over their territorial sea established in accor-
dance with international law, and the sovereign rights and the
jurisdiction which States have in their exclusive economic
zones and their continental shelves in accordance with interna-
tional law, and the exercise by ships and aircraft of all States of
navigational rights and freedoms as provided for in interna-
tional 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.

2.
The Parties shall ensure that the development, handling,
transport, use, transfer and release of any living modified organ-
isms are undertaken in a manner that prevents or reduces the

5.
The Parties are encouraged to take into account, as appro-
priate, available expertise, instruments and work undertaken in
international forums with competence in the area of risks to
human health.

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Article 3

Use of terms

Article 4

Scope

For the purposes of this Protocol:

(a) ‘Conference of the Parties’ means the Conference of the

Parties to the Convention;

installation or other physical

(b) ‘Contained use’ means any operation, undertaken within a
facility,
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;

(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:

— in vitro nucleic acid techniques, including recombinant
injection of

deoxyribonucleic acid (DNA) and direct
nucleic acid into cells or organelles, or

— fusion of cells beyond the taxonomic family,

that overcome natural physiological reproductive or recom-
bination barriers and that are not techniques used in tradi-
tional 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 compe-
tence 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;

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 assess-
ment prior to the making of decisions on import, this Protocol
shall not apply to the transboundary movement of living modi-
fied organisms which are pharmaceuticals for humans that are
addressed by other relevant international agreements or organi-
sations.

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 transit through its terri-
tory of a specific living modified organism, the provisions of
this Protocol with respect to the advance informed agreement
procedure shall not apply to living modified organisms in
transit.

2.
Notwithstanding Article 4 and without prejudice to any
right of a Party to subject all living modified organisms to risk
assessment prior to decisions on import and to set standards
for contained use within its jurisdiction, the provisions 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 under-
taken in accordance with the standards of the Party of import.

Article 7

Application of the advance informed agreement procedure

(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 trans-
boundary movement extends to movement between Parties
and non-Parties.

1.
Subject to Articles 5 and 6, the advance informed agree-
ment procedure in Articles 8 to 10 and 12 shall apply prior to
the first intentional transboundary movement of living modified
organisms for intentional introduction into the environment of
the Party of import.

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‘Intentional introduction into the environment’ in para-
2.
graph 1 above, does not refer to living modified organisms
intended for direct use as food or feed, or for processing.

Article 10

Decision procedure

Article 11 shall apply prior to the first transboundary
3.
movement of living modified organisms intended for direct use
as food or feed, or for processing.

Decisions taken by the Party of import shall be in accor-

1.
dance with Article 15.

The advance informed agreement procedure shall not
4.
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

The Party of export shall notify, or require the exporter to
1.
ensure notification to,
the competent national
in writing,
authority of the Party of import prior to the intentional trans-
boundary 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.

Article 9

Acknowledgement of receipt of notification

1.
The Party of import shall acknowledge receipt of the noti-
fication, in writing, to the notifier within 90 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 informa-

tion referred to in Article 8;

(c) whether to proceed according to the domestic regulatory
import or according to the

framework of the Party of
procedure specified in Article 10.

The domestic regulatory framework referred to in para-

3.
graph 2(c) above, shall be consistent with this Protocol.

The Party of

import shall, within the period of time
2.
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 90 days without a subsequent written

consent.

3. Within 270 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

conditions,
including how the decision will apply to subsequent
imports of the same living modified organism;

import, with or without

(b) prohibiting the import;

(c) requesting additional relevant information in accordance
in
with its domestic regulatory framework or Annex I;
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

(d) informing the notifier that the period specified in this para-

graph is extended by a defined period of time.

Except in a case in which consent is unconditional, a deci-
4.
sion under paragraph 3 above, shall set out the reasons on
which it is based.

A failure by the Party of import to communicate its deci-
5.
sion within 270 days of the date of receipt of the notification
shall not imply its consent to an intentional transboundary
movement.

6.
Lack of scientific certainty due to insufficient relevant
scientific information and knowledge regarding the 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 to avoid or minimize such potential adverse effects.

4.
A failure by the Party of import to acknowledge receipt of
a notification shall not imply its consent to an intentional trans-
boundary movement.

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.

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Article 11

Procedure for living modified organisms intended for
direct use as food or feed, or for processing

A Party that makes a final decision regarding domestic
1.
including placing on the market, of a living modified
use,
organism that may be subject to transboundary movement for
direct use as food or feed, or for processing shall, within 15
days of making that decision, inform the Parties through the
Biosafety Clearing-House. This information shall contain, at a
minimum, the information specified in Annex II. The Party
shall provide a copy of the information,
in writing, to the
national focal point of each Party that informs the Secretariat in
advance that it does not have access to the Biosafety Clearing-
House. This provision shall not apply to decisions regarding
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.

Any Party may request additional information from the

3.
authority identified in paragraph (b) of Annex II.

4.
A Party may take a decision on the import of living modi-
fied 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 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 which information has been provided under
paragraph 1 above, will be taken according to the following:

(a) a risk assessment undertaken in accordance with Article 15;

and

(b) a decision made within a predictable timeframe, not

exceeding 270 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.

Lack of scientific certainty due to insufficient relevant
8.
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 proces-
sing,
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 for direct use as food or feed, or for proces-
sing. 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 scien-
tific information on potential adverse effects on the conserva-
tion and sustainable use of biological diversity, taking also into
account the risks to human health, review and change a deci-
sion regarding an intentional transboundary movement. In such
case, the Party shall, within 30 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 deci-
sion was based; or

(b) additional relevant scientific or technical

information has

become available.

The Party of

3.
within 90 days and set out the reasons for its decision.

import shall respond to such a request

The Party of import may, at its discretion, require a risk

4.
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 move-
living modified organisms in accordance with the
ment of

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objective of this Protocol, specify in advance to the Biosafety
Clearing-House:

The cost of risk assessment shall be borne by the notifier

3.
if the Party of import so requires.

(a) cases in which intentional transboundary movement to it
may take place at the same time as the movement is noti-
fied to the Party of import; and

(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 transboundary
movement that is to be provided in the notifications referred to
in paragraph 1(a) above shall be the information specified in
Annex I.

Article 14

Bilateral,

regional

and multilateral
arrangements

agreements

and

Parties may enter into bilateral, regional and multilateral
1.
agreements and arrangements
trans-
boundary 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.

regarding intentional

The Parties shall inform each other, through the Biosafety
2.
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.

The provisions of this Protocol shall not affect intentional
3.
transboundary movements that take place pursuant to such
agreements and arrangements as between the parties to those
agreements or arrangements.

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 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.

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.

transboundary movements of

Each Party shall take appropriate measures to prevent
3.
living modified
unintentional
organisms,
including such measures as requiring risk assess-
ments to be carried out prior to the first release of a living
modified organism.

4. Without prejudice to paragraph 2 above, each Party shall
endeavour
to 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 conservation 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 15

Risk assessment

Article 17

1.
Risk assessments undertaken pursuant to this Protocol
shall be carried out in a scientifically sound manner, in accor-
dance 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 modi-
fied organisms on the conservation and sustainable use of
biological diversity, taking also into account risks to human
health.

2.
The Party of import shall ensure that risk assessments are
carried out for decisions taken under Article 10. It may require
the exporter to carry out the risk assessment.

Unintentional transboundary movements and emergency
measures

Each Party shall

take appropriate measures to notify
1.
affected or potentially affected States, the Biosafety Clearing-
House and, where appropriate, relevant international organiza-
tions, 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 significant adverse effects on the conservation
and sustainable use of biological diversity,
taking also into
account risks to human health in such States. The notification
shall be provided as soon as the Party knows of the above
situation.

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Each Party shall, no later than the date of entry into force
2.
of this Protocol 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.

Any notification arising from paragraph 1 above, should

3.
include:

(a) available relevant information on the estimated quantities
and relevant characteristics and/or traits of the living modi-
fied 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 diver-
sity, 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 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 imme-
diately consult the affected or potentially affected States to
enable them to determine appropriate responses and initiate
necessary action, including emergency measures.

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
the safe handling,
storage, transport and use, the contact point for further
information, including the name and address of the indivi-
dual and institution to whom the living modified organisms
are consigned; and

for

(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 them as 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 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

Article 18

Competent national authorities and national focal points

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 the scope of this
Protocol are handled, packaged and transported under condi-
tions of safety, taking into consideration relevant international
rules and standards.

Each Party shall take measures to require that documenta-

2.
tion accompanying:

(a) living modified organisms that are intended for direct use
as food or feed, or for processing, clearly identifies that they
living modified organisms and are not
‘may contain’
intended for intentional introduction into the environment,
as well as a contact point for further information. The
Conference of the Parties serving as the meeting of the
Parties to this Protocol shall take a decision on the detailed
including specification of
requirements for this purpose,

1.
Each Party shall designate one national focal point to be
responsible on its 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 which
shall be authorized to act on its behalf with respect to those
functions. A Party may designate a single entity to fulfill the
functions of both focal point and competent national authority.

2.
Each Party shall, no later than the date of entry into force
of this Protocol for it, notify the Secretariat of the names and
addresses of its focal point and its competent national authority
or authorities. Where a Party designates more than one compe-
tent national authority, it shall convey to the 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
its competent
the name and address or responsibilities of
national authority or authorities.

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The Secretariat shall forthwith inform the Parties of the
3.
notifications it receives under paragraph 2 above, and shall also
make
through the Biosafety
Clearing-House.

such information available

(e) reports submitted by it pursuant to Article 33, including
those on implementation of the advance informed agree-
ment procedure.

Article 20

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.

Information sharing and the Biosafety Clearing-House

1.
A Biosafety Clearing-House is hereby established as part
of the clearing-house mechanism under Article 18, paragraph
3, of the Convention, in order to:

(a) facilitate the exchange of scientific, technical, environmental
and legal information on, and experience with, living modi-
fied 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.

The Biosafety Clearing-House shall serve as a means
2.
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 mechan-
isms.

3. Without prejudice to the protection of confidential infor-
mation, each Party shall make available to the Biosafety
Clearing-House any information required to be made available
to the Biosafety Clearing-House under this Protocol, and:

Article 21

Confidential information

1.
The Party of import shall permit the notifier to identify
information submitted under the procedures of this Protocol or
required by the Party of import as part of the advance informed
agreement procedure of the Protocol that is to be treated as
confidential.
Justification shall be given in such cases upon
request.

2.
The Party of import shall consult the notifier if it 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.

including any confidential

Each Party shall protect confidential information received
3.
under this Protocol,
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 favour-
able than its treatment of confidential information in connec-
tion with domestically produced living modified organisms.

(a) any existing laws, regulations and guidelines for implemen-
tation of the Protocol, as well as information required by
the Parties for the advance informed agreement procedure;

The Party of import shall not use such information for a
4.
commercial purpose, except with the written consent of the
notifier.

(b) any bilateral,
arrangements;

regional and multilateral agreements and

(c) summaries of its risk assessments or environmental reviews
of living modified organisms generated by its regulatory
process, and carried out in accordance with Article 15,
including, where
information
regarding products thereof, namely, processed materials
living modified organism origin, containing
that are of
detectable novel combinations of replicable genetic material
obtained through the use of modern biotechnology;

appropriate,

relevant

5.
If a notifier withdraws or has withdrawn a notification,
the Party of import shall respect the confidentiality of commer-
cial and industrial information, including research and develop-
ment information as well as information on which the Party
and the notifier disagree as to its confidentiality.

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

(a) the name and address of the notifier;

(d) its final decisions regarding the importation or release of

(b) a general description of the living modified organism or

living modified organisms; and

organisms;

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(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

process regarding living modified organisms and shall make the
such decisions available to the public, while
results of
respecting
information in accordance with
confidential
Article 21.

(d) any methods and plans for emergency response.

Each Party shall endeavour to inform its public about the

3.
means of public access to the Biosafety Clearing-House.

Article 22

Capacity-building

The Parties shall cooperate in the development and/or
1.
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 imple-
mentation of this Protocol, in developing country Parties,
in
particular the least developed and small island developing States
among them, and in Parties with economies in transition,
including through existing global, regional, subregional and
national
institutions and organizations and, as appropriate,
through facilitating private sector involvement.

2.
For the 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 in accordance with the
relevant provisions of the Convention, shall be taken fully into
account for capacity-building in biosafety. Cooperation in capa-
city-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 institu-
tional capacities in biosafety. The needs of Parties with econo-
mies in transition shall also be taken fully into account for such
capacity-building in biosafety.

Article 23

Public awareness and participation

1.

The Parties shall:

(a) promote 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 interna-
tional bodies;

(b) endeavour to ensure that public awareness and education
encompass access to information on living modified organ-
isms identified in accordance with this Protocol that may be
imported.

2.
and regulations, consult

The Parties shall, in accordance with their respective laws
the public in the decision-making

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 transboundary movements.

2.
The Parties shall encourage non-Parties to adhere to this
Protocol and to contribute appropriate information to the
Biosafety Clearing-House on living modified organisms released
in, or moved into or out of, areas within their national juris-
dictions.

Article 25

Illegal transboundary movements

Each Party shall adopt appropriate domestic measures
1.
aimed at preventing and,
if appropriate, penalizing trans-
boundary movements of living modified organisms carried out
in contravention of its domestic measures to implement this
Protocol. Such movements
trans-
boundary movements.

shall be deemed illegal

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 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 interna-
tional 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.

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The Parties are encouraged to cooperate on research and
2.
information exchange on any socio-economic impacts of living
modified organisms,
and local
communities.

especially on indigenous

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 international law on these matters, and
shall endeavour to complete this process within four years.

Article 28

Financial mechanism and resources

1.
In considering financial resources for the implementation
of this Protocol, the Parties shall take into account the provi-
sions 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 para-
graph 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
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 transi-
tion, in their efforts to identify and implement their capacity-
building requirements for the purposes of the implementation
of this Protocol.

The guidance to the financial mechanism of the Conven-
5.
tion 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.

Article 29

Conference of the Parties serving as the meeting of the
Parties to this Protocol

The Conference of the Parties shall serve as the meeting

1.
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, deci-
sions 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 Conven-
tion 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.

The Conference of the Parties serving as the meeting of
4.
the Parties to this Protocol shall keep under regular review the
implementation of this Protocol and shall make, within its
mandate, the decisions necessary to promote its effective imple-
mentation. 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;

(b) establish such subsidiary bodies as are deemed necessary for

the implementation of this Protocol;

(c) seek and utilize, where appropriate, the services and coop-
eration of, and information provided by, competent interna-
tional organizations
and non-
governmental bodies;

and intergovernmental

(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 imple-
mentation of this Protocol; and

(f) exercise such other functions as may be required for the

implementation of this Protocol.

6.
The developed country Parties may also provide, and the
developing country Parties and the Parties with economies in
financial and technological
transition avail
the provisions of this
resources for the implementation of
Protocol through bilateral, regional and multilateral channels.

themselves of,

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.

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The first meeting of the Conference of the Parties serving
6.
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 Parties, unless
otherwise decided by the Conference of the Parties serving as
the meeting of the Parties to this Protocol.

the Conference of

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 Inter-
national 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, whether national or international, govern-
is qualified in matters
mental or non-governmental,
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 a meeting of the Parties to this Protocol as
an observer, may be so admitted, unless at least one third of the
Parties present object. Except as otherwise provided in this
Article, the admission and participation of observers shall be
subject to the rules of procedure, as referred to in paragraph 5
above.

that

Article 30

Subsidiary bodies

Any subsidiary body established by or under the Conven-
1.
tion 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.

Article 31

Secretariat

The Secretariat established by Article 24 of the Conven-

1.
tion shall serve as the secretariat to this Protocol.

2.
Article 24, paragraph 1, of the Convention on the func-
tions of the Secretariat shall apply, mutatis mutandis, to this
Protocol.

3.
To the extent that they are distinct, the costs of the secre-
tariat services for this Protocol shall be 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, the 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 Parties
the Parties to this Protocol on
serving as the meeting of
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. These procedures and
mechanisms shall include provisions to offer advice or assis-
tance, 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

3. When a subsidiary body of the Convention exercises its
functions with regard to matters concerning this Protocol, any
member of the bureau of that subsidiary body representing a
Party to the Convention but, at that time, not a Party to the
Protocol, shall be substituted by a member to be elected by and
from among the Parties to the Protocol.

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 there-
the Protocol,
after, an evaluation of
including an assessment of its procedures and annexes.

the effectiveness of

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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,
regional
acceptance, approval or accession by States or
economic integration organizations that are Parties to the
Convention.

This Protocol shall enter into force for a State or regional
2.
ratifies, accepts or
economic integration organization that
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 instru-
ment deposited by a regional economic integration organiza-
tion 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 with-
draw 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 with-
drawal.

Article 40

Authentic texts

The original of this Protocol, of which the Arabic, Chinese,
English,
equally
authentic, shall be deposited with the Secretary-General of the
United Nations.

French, Russian and Spanish texts

are

IN WITNESS WHEREOF the undersigned, being duly authorized
to that effect, have signed this Protocol.

DONE at Montreal on this twenty-ninth day of January, two
thousand.

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Annex I to Annex A

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 other restrictions, or whether it has been approved for general release) and, if
the living modified organism is banned in the State of export, the reason 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 abovementioned information is factually correct.

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Annex II to Annex A

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.

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Annex III to Annex A

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
environment, 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 international organizations.

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 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 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 organism concerned, its intended use and the likely
potential receiving environment.

Methodology

7. The process of risk assessment may on the one hand give rise to a need for further information about specific
subjects, which may be identified and requested during the assessment process, while on the other hand information
on other subjects may not be relevant in some instances.

8. To fulfil its objective, risk assessment 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 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;

(c) an evaluation of the consequences should these adverse effects be realized;

(d) an estimation of the overall risk posed by the living modified organism based on the evaluation of the likelihood

and 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, iden-

tification 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 organ-
isms, 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 characteris-

tics of the donor organisms;

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(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 func-

tion 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 char-

acteristics 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.

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ANNEX B

DECLARATION BY THE EUROPEAN COMMUNITY IN ACCORDANCE WITH ARTICLE 34(3) OF THE
CONVENTION ON BIOLOGICAL DIVERSITY

The European Community declares that, in accordance with the Treaty establishing the European Commu-
nity, and in particular Article 175(1) thereof, it is competent for entering into international agreements,
and for implementing the obligations resulting therefrom, which contribute to the pursuit of the following
objectives:

— preserving, protecting and improving the quality of the environment,

— protecting human health,

— prudent and rational utilisation of natural resources,

— promoting measures at international level to deal with regional or worldwide environmental problems.

Moreover, the European Community declares that it has already adopted legal instruments, binding on its
Member States, covering matters governed by this Protocol, and will submit and update, as appropriate, a
list of those legal instruments to the Biosafety Clearing House in accordance with Article 20(3)(a) of the
Cartagena Protocol on Biosafety.

The European Community is responsible for the performance of those obligations resulting from the Carta-
gena Protocol on Biosafety which are covered by Community law in force.

The exercise of Community competence is, by its nature, subject to continuous development.