Proposal for a Council Decision concerning the conclusion, on behalf of the Community, of the Cartagena Protocol on Biosafety
Date: 2002-03-13
Institutions: European Commission
Subjects: EU environmental policy, biodiversity, biotechnology, conservation of resources, environmental protection, environmental risk prevention, genetic engineering

C 181 E/258

EN

Official Journal of the European Communities

30.7.2002

Proposal for a Council Decision concerning the conclusion, on behalf of the Community, of the
Cartagena Protocol on Biosafety

(2002/C 181 E/10)

COM(2002) 127 final — 2002/0062(CNS)

(Submitted by the Commission on 13 March 2002)

THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament,

Whereas:

(1) The promotion of measures at international level to deal
environmental problems,
with regional or worldwide
including the conservation and sustainable use of biological
diversity,
the Community's
is one of
policy on the environment,
in accordance with Article
174 of the Treaty;

the objectives of

(2) By Council Decision 93/626/EEC of 25 October 1993
concerning the conclusion of the Convention on Biological
Diversity (1) the Community concluded the Convention on
Biological Diversity under
the United
Nations Environment Programme;

the auspices of

on behalf of

(3) In 1995 the Council authorised the Commission (2)

to
participate,
in the
negotiations on a Protocol on Biosafety, under Article
the Convention on Biological Diversity. The
19(3) of
Commission participated in those negotiations,
together
with the Member States;

the Community,

(4) The Cartagena Protocol on Biosafety was adopted in

Montreal on 29 January 2000;

taking also into account
specifically focussing on transboundary movements;

to human health and

risks

(6) The 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;

(7) 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;

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

HAS DECIDED AS FOLLOWS:

Article 1

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

The text of the Protocol is attached to this Decision.

Article 2

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

framework, based on the
(5) The Protocol provides
the safe transfer, handling
precautionary principle,
and use of
resulting from
modern biotechnology that may have adverse effects on
the conservation and sustainable use of biological diversity,

a
for
living modified organisms

2.
The President of the Council is authorised to designate
the person or persons empowered to deposit, on behalf of the
Community,
in the
Annex to this Decision,
in accordance with Article 34(3) of
the Convention on Biological Diversity.

the declaration of competence set out

(1) OJ L 309, 13.12.1993, p. 1.
(2) Council Document 10887/95 ENV 265.

30.7.2002

EN

Official Journal of the European Communities

C 181 E/259

PROTOCOL

Cartagena on biosafety to the Convention on Biological Diversity

THE PARTIES TO THIS PROTOCOL,

BEING Parties to the Convention on Biological Diversity, hereinafter referred to as ‘the Convention’,

RECALLING Article 19, paragraphs 3 and 4, and Articles 8(g) and 17 of the Convention,

RECALLING also decision II/5 of 17 November 1995 of the Conference of the Parties to the Convention to
develop a Protocol on biosafety, specifically focusing on transboundary movement of any living modified
organism resulting from modern biotechnology that may have adverse effect on the conservation and
sustainable use of biological diversity, setting out for consideration, in particular, appropriate procedures
for advance informed agreement,

REAFFIRMING the precautionary approach contained in Principle 15 of the Rio Declaration on Environment
and Development,

AWARE OF the rapid expansion of modern biotechnology and the growing public concern over its
potential adverse effects on biological diversity, taking also into account risks to human health,

RECOGNISING that modern biotechnology has great potential for human well-being if developed and used
with adequate safety measures for the environment and human health,

RECOGNISING ALSO the crucial
diversity,

importance to humankind of centres of origin and centres of genetic

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,

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

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

UNDERSTANDING that the above recital is not intended to 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.

The Parties shall ensure that the development, handling,
transfer and release of any living modified
that prevents or
taking also into

2.
transport, use,
organisms are undertaken in a manner
reduces
the risks to biological diversity,
account risks to human health.

C 181 E/260

EN

Official Journal of the European Communities

30.7.2002

Nothing in this Protocol shall affect in any way the sover-
3.
territorial
sea established in
eignty of States over
their
accordance 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 international law, and the exercise by ships and aircraft
of all States of navigational rights and freedoms as provided for
in international law and as reflected in relevant international
instruments.

4.
Nothing in this Protocol shall be interpreted as restricting
the right of a Party to take action that is more protective of the
conservation and sustainable use of biological diversity than
that called for in this Protocol, provided that such action is
consistent with the objective and the provisions of
this
Protocol and is in accordance with that Party's other obli-
gations under international law.

The Parties are encouraged to take into account, as
5.
appropriate,
and work
undertaken in international forums with competence in the
area of risks to human health.

instruments

expertise,

available

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;

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;

(h) ‘Living organism’ means any biological entity capable of
including

replicating genetic material,

transferring or
sterile organisms, viruses and viroids;

(i)

‘Modern biotechnology’ means the application of:

(a)

In vitro nucleic acid techniques, including recombinant
deoxyribonucleic acid (DNA) and direct
injection of
nucleic acid into cells or organelles, or

(b) Fusion of cells beyond the taxonomic family,

that overcome natural physiological reproductive or
recombination barriers and that are not
techniques
used in traditional breeding and selection.

(j)

‘Regional economic integration organisation’ means an
organisation constituted by sovereign States of a given
to which its member States have transferred
region,
in respect of matters governed by this
competence
authorised,
Protocol
in
and which has been duly
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.

(c)

‘Export’ means intentional transboundary movement from
one Party to another Party;

Article 4

Scope

(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;

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

Article 5

Pharmaceuticals

Notwithstanding Article 4 and without prejudice to any right
living modified organisms to risk
of a Party to subject all
assessment prior to the making of decisions on import, this
Protocol shall not apply to the transboundary movement of
for
living modified organisms which are pharmaceuticals
humans that are addressed by other relevant
international
agreements or organisations.

30.7.2002

EN

Official Journal of the European Communities

C 181 E/261

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
territory of a specific living modified organism, the provisions
of
informed
agreement procedure shall not apply to living modified
organisms in transit.

this Protocol with respect

to the advance

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
use
undertaken in accordance with the standards of the Party of
import.

contained

destined

for

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 1.

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
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;

Article 7

Application of the advance informed agreement procedure

(b) Whether

the notification, prima
information referred to in Article 8;

facie,

contains

the

Subject

to Articles 5 and 6,

1.
the advance informed
agreement procedure in Articles 8 to 10 and 12 shall apply
prior to the first intentional transboundary movement of living
modified organisms
introduction into the
intentional
environment of the Party of import.

for

‘Intentional

introduction into the

environment’
in
2.
paragraph 1 above, does not
to living modified
organisms intended for direct use as food or feed, or for
processing.

refer

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

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.

(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
3.
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

Decisions taken by the Party of

1.
accordance with Article 15.

import shall be in

2.
The Party of
referred to in Article 9,
intentional
whether
proceed:

the

import shall, within the period of time
inform the notifier,
in writing,
transboundary movement may

Article 8

Notification

(a) Only after the Party of import has given its written consent;

or

1.
to ensure notification to,

The Party of export shall notify, or require the exporter
in writing, the competent national

(b) After no less than ninety days without a subsequent written

consent.

C 181 E/262

EN

Official Journal of the European Communities

30.7.2002

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

(a) Approving the

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
with its domestic regulatory framework or Annex 1;
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

organism that may be subject to transboundary movement
for direct use as food or feed, or for processing shall, within
fifteen days of making that decision, inform the Parties through
the Biosafety Clearing-House. This information shall contain, at
a minimum, the information specified in Annex 2. 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 2.

(d) Informing the notifier that

the period specified in this

paragraph is extended by a defined period of time.

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.

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

A failure by the Party of

5.
import to communicate its
decision within two hundred and seventy days of the date of
receipt of the notification shall not imply its consent to an
intentional transboundary movement.

6.
Lack of scientific certainty due to insufficient relevant
scientific information and knowledge regarding the 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 minimise 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.

Each Party

shall make

to the Biosafety
5.
laws, regulations and
Clearing-House copies of any national
guidelines
living modified
organisms intended for direct use as food or feed, or for
processing, if available.

import of

applicable

available

to the

jurisdiction, declare

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
through the Biosafety
its domestic
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 two hundred and seventy days.

Article 11

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

1.
use,

A Party that makes a final decision regarding domestic
including placing on the market, of a living modified

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
for processing, unless otherwise
specified by the Party.

feed, or

30.7.2002

EN

Official Journal of the European Communities

C 181 E/263

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
processing,
to avoid or minimise such potential
adverse effects.

in order

Article 13

Simplified procedure

1.
A Party of import may, provided that adequate measures
transboundary
are applied to ensure the safe intentional
movement of living modified organisms in accordance with
the objective of
this Protocol, specify in advance to the
Biosafety Clearing-House:

A Party may indicate its needs for financial and technical
9.
assistance and capacity-building with respect to living modified
organisms intended for direct use as food or feed, or for
processing. Parties shall cooperate to meet
these needs in
accordance with Articles 22 and 28.

(a) Cases in which intentional transboundary movement to it
is

the same time as the movement

may take place at
notified to the Party of import; and

(b) Imports of living modified organisms to it to be exempted

from the advance informed agreement procedure.

Article 12

Review of decisions

Notifications under subparagraph (a) above, may apply to
subsequent similar movements to the same Party.

A Party of import may, at any time,

1.
in light of new
scientific information on potential adverse effects on the
conservation and sustainable use of biological diversity,
taking also into account the risks to human health, review
and change a decision regarding an intentional transboundary
movement. In such case, the Party shall, within 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 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 risk assessment upon which the

the outcome of
decision was based; or

(b) Additional relevant scientific or technical information has

become available.

The Party of

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

import shall respond to such a request

The information relating to an intentional transboundary
2.
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

2.
The Parties shall inform each other, through the Biosafety
Clearing-House, of any such bilateral, regional and multilateral
they have entered into
agreements and arrangements that
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.

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

4.
assessment for subsequent imports.

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.

C 181 E/264

EN

Official Journal of the European Communities

30.7.2002

Article 15

Risk assessment

in a scientifically sound manner,

1.
Risk assessments undertaken pursuant to this Protocol
in
shall be carried out
accordance with Annex III and taking into account recognised
risk assessment
techniques. Such risk assessments shall be
based, at a minimum, on information provided in accordance
with Article 8 and other available scientific evidence in order
to identify and evaluate the possible adverse effects of living
modified organisms on the conservation and sustainable use 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.

The cost of risk assessment shall be borne by the notifier

3.
if the Party of import so requires.

Article 16

Risk management

1.
The Parties shall, taking into account Article 8(g) of the
Convention, establish and maintain appropriate mechanisms,
measures and strategies to regulate, manage and control risks
identified in the risk assessment provisions of this Protocol
associated with
transboundary
handling
the
movement of living modified organisms.

use,

and

(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 17

Unintentional transboundary movements and emergency
measures

or

the

States,

potentially

Each Party shall

take appropriate measures to notify
1.
affected
Biosafety
affected
Clearing-House and, where appropriate, relevant international
organisations, when it knows of an occurrence under its juris-
diction 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.

this Protocol

Each Party shall, no later than the date of entry into force
2.
it, make available to the Biosafety
of
Clearing-House the relevant details setting out
its point of
contact for the purposes of receiving notifications under this
Article.

for

Any notification arising from paragraph l above, should

3.
include:

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,
to
risks
human health, within the territory of the Party of import.

taking also into account

(a) Available relevant information on the estimated quantities
the living

traits of

and relevant characteristics and/or
modified organism;

Each Party shall take appropriate measures to prevent
3.
living modified
unintentional
organisms,
risk
requiring
assessments to be carried out prior to the first release of a
living modified organism.

transboundary movements of
as

such measures

including

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.

(b) Information on the circumstances and estimated date of the
release, and on the use of the living modified organism in
the originating Party;

(c) Any available information about the possible adverse effects
on the conservation and sustainable use of biological
diversity, taking also into account risks to human health,
as well as available
information about possible risk
management measures;

(d) Any other relevant information; and

5.

Parties shall cooperate with a view to:

(e) A point of contact for further information.

30.7.2002

EN

Official Journal of the European Communities

C 181 E/265

In order to minimise any significant adverse effects on
4.
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
shall
organism referred to in paragraph l above, occurs,
immediately consult the affected or potentially affected States
to enable them to determine appropriate responses and initiate
necessary action, including emergency measures.

Article 18

Handling, transport, packaging and identification

1.
In order to avoid adverse effects on the conservation and
sustainable use of biological diversity, taking also into account
risks to human health, each Party shall take necessary measures
to require that living modified organisms that are subject to
intentional transboundary movement within the scope of this
Protocol
are handled, packaged and transported under
conditions of safety, taking into consideration relevant inter-
national rules and standards.

Each Party shall take measures to require that documen-

2.
tation accompanying:

(a) Living modified organisms that are intended for direct use
as food or feed, or for processing, clearly identifies that
they ‘may contain’ living modified organisms and are not
intended for intentional introduction into the environment,
as well as a contact point for further information. The
Conference of the Parties serving as the meeting of the
take a decision on the
Parties
to this Protocol shall
detailed requirements for this purpose,
including specifi-
cation 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
the safe handling,
storage, transport and use, the contact point for further
information, including the name and address of the indi-
vidual 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 identifi-
cation, handling, packaging and transport practices, in consul-
tation with other relevant international bodies.

Article 19

Competent national authorities and national focal points

Each Party shall designate one national focal point to be
1.
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 authorised 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
competent national authority, it shall convey to the Secretariat,
information on the
with its notification thereof,
respective
authorities. Where
of
applicable, such information shall, at a minimum, specify
which competent authority is responsible for which type of
forthwith notify
living modified organism. Each Party shall
the Secretariat of any changes
its
national focal point or in the name and address or responsi-
bilities of its competent national authority or authorities.

in the designation of

relevant
those

responsibilities

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

Article 20

Information sharing and the Biosafety Clearing-House

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

(a) Facilitate the exchange of scientific,

technical, environ-
information on, and experience with,

mental and legal
living modified organisms; and

C 181 E/266

EN

Official Journal of the European Communities

30.7.2002

(b) Assist Parties

the Protocol,

to implement

taking into
account the special needs of developing country Parties,
in particular
island
the
developing States
and countries with
economies in transition as well as countries that are
centres of origin and centres of genetic diversity.

least developed and small
among them,

The Biosafety Clearing-House shall serve as a means
2.
the
available
through which information is made
It shall provide access to
purposes of paragraph 1 above.
information made available by the Parties relevant
to the
implementation of the Protocol. It shall also provide access,
where possible, to other international biosafety information
exchange mechanisms.

for

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
the advance
informed agreement procedure of the Protocol that is to be
treated as confidential. Justification shall be given in such cases
upon request.

import as part of

2.
The Party of import shall consult the notifier if it decides
that information identified by the notifier as confidential does
to any
not qualify for
disclosure,
its decision, providing
reasons on request, as well as an opportunity for consultation
and for an internal review of the decision prior to disclosure.

such treatment and shall, prior

inform the notifier of

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

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

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
such information in a manner no less
confidentiality of
information in
favourable than its treatment of confidential
living modified
connection with domestically produced
organisms.

(b) Any bilateral, regional and multilateral agreements and

arrangements;

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

(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
genetic
combinations of
material obtained through the use of modern biotech-
nology;

appropriate,

replicable

relevant

import

If a notifier withdraws or has withdrawn a notification,
5.
the confidentiality of
respect
the Party of
shall
including research
commercial and industrial
and development
information on
information as well as
which the Party and the notifier disagree as to its confiden-
tiality.

information,

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

living modified organisms; and

(a) The name and address of the notifier;

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

(e) Reports submitted by it pursuant to Article 33, including
informed

advance

the

those on implementation of
agreement procedure.

4.
The modalities of the operation of the Biosafety Clearing-
House, including reports on its activities, shall be considered
and decided upon by the Conference of the Parties serving as
the meeting of the Parties to this Protocol at its first meeting,
and kept under review thereafter.

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

organisms;

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

(d) Any methods and plans for emergency response.

30.7.2002

EN

Official Journal of the European Communities

C 181 E/267

Article 22

Capacity-building

the results of such decisions available to the public, while
respecting confidential information in accordance with Article
21.

for

1.
The Parties shall cooperate in the development and/or
strengthening of human resources and institutional capacities
including biotechnology to the extent that it is
in biosafety,
required for biosafety,
the effective
the purpose of
in developing country
implementation of
island
Parties,
developing
in Parties with
including through existing global,
economies in transition,
regional, subregional and national
institutions and organi-
sations and, as appropriate, through facilitating private sector
involvement.

the least developed and small

in particular
States

this Protocol,

among

them,

and

in particular

to and transfer of

the least developed and small

For the purposes of implementing paragraph 1 above, in
2.
the needs of developing country
relation to cooperation,
island
Parties,
for financial resources and
developing States among them,
access
technology and know-how in
accordance with the relevant provisions of the Convention,
for capacity-building in
shall be taken fully into account
biosafety. Cooperation in capacity-building shall, subject
to
the different situation, capabilities and requirements of each
Party,
include scientific and technical training in the proper
and safe management of biotechnology, and in the use of
risk assessment and risk management for biosafety, and the
enhancement of technological and institutional capacities in
biosafety. The needs of Parties with economies in transition
shall also be taken fully into account for such capacity-building
in biosafety.

Article 23

Public awareness and participation

1.

The Parties shall:

(a) Promote and facilitate public awareness, education and
participation concerning the safe transfer, handling and
use of living modified organisms in relation to the conser-
vation and sustainable use of biological diversity, taking
also into account risks to human health. In doing so, the
Parties shall cooperate, as appropriate, with other States
and international bodies;

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

The Parties shall, in accordance with their respective laws
2.
and regulations, consult
the public in the decision-making
process regarding living modified organisms and shall make

Each Party shall endeavour to inform its public about the

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

Article 24

Non-parties

Transboundary movements of living modified organisms
1.
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 jurisdictions.

Article 25

Illegal transboundary movements

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

In the case of an illegal transboundary movement, the
2.
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.

Each Party

3.
to the Biosafety
Clearing-House information concerning cases of illegal trans-
boundary movements pertaining to it.

shall make

available

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 inter-
national obligations,
socio-economic considerations arising
from the impact of living modified organisms on the conser-
vation and sustainable use of biological diversity, especially
with regard to the value of biological diversity to indigenous
and local communities.

C 181 E/268

EN

Official Journal of the European Communities

30.7.2002

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

financial and technological
transition avail
resources for the implementation of
this
the provisions of
Protocol through bilateral, regional and multilateral channels.

themselves of,

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 inter-
national 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

In considering financial resources for the implementation
the
shall

1.
of
provisions of Article 20 of the Convention.

take into account

this Protocol,

the Parties

2.
The financial mechanism established in Article 21 of the
Convention shall, through the institutional structure entrusted
with its operation, be the financial mechanism for
this
Protocol.

3.
Regarding the capacity-building referred to in Article 22
of this Protocol, the Conference of the Parties serving as the
meeting of the Parties to this Protocol, in providing guidance
with respect
to the financial mechanism referred to in
paragraph 2 above, for consideration by the Conference of
the need for financial
the Parties, shall
the
in particular
resources by developing country Parties,
least developed and the small island developing States among
them.

take into account

the

4.
In the context of paragraph 1 above, the Parties shall also
take into account the needs of the developing country Parties,
in particular
island
the Parties with
developing States among them, and of
to identify and
in their efforts
economies
implement
the
purposes of the implementation of this Protocol.

in transition,
their

least developed and the

capacity-building

requirements

small

for

to the

The guidance

financial mechanism of
the Conference of
including those agreed before the adoption of

the
5.
the
Convention in relevant decisions of
Parties,
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.

Parties to the Convention that are not Parties to this
2.
Protocol may participate as observers in the proceedings of
any meeting of the Conference of the Parties serving as the
meeting of the Parties to this Protocol. When the Conference of
the Parties serves as the meeting of the Parties to this Protocol,
decisions under this Protocol shall be taken only by those that
are Parties to it.

3. When the Conference of the Parties serves as the meeting
of the Parties to this Protocol, any member of the bureau of the
Conference of
representing a Party to the
Convention but, at that time, not a Party to this Protocol,
shall be substituted by a member to be elected by and from
among the Parties to this Protocol.

the Parties

4.
The Conference of the Parties serving as the meeting of
the Parties to this Protocol shall keep under regular review the
implementation of this Protocol and shall make, within its
mandate,
the 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;

(b) Establish such subsidiary bodies as are deemed necessary

for the implementation of this Protocol;

(c) Seek and utilise, where appropriate, the services and coop-
eration of, and information provided by, competent inter-
national
and
and
non-governmental bodies;

intergovernmental

organisations

(d) Establish the form and the intervals for transmitting the
information to be submitted in accordance with Article
33 of this Protocol and consider such information as well
as reports submitted by any subsidiary body;

(e) Consider and adopt, as required, amendments to this
Protocol and its annexes, as well as any additional
annexes to this Protocol, that are deemed necessary for
the implementation of this Protocol; and

6.
The developed country Parties may also provide, and the
developing country Parties and the Parties with economies in

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

implementation of this Protocol.

30.7.2002

EN

Official Journal of the European Communities

C 181 E/269

The rules of procedure of the Conference of the Parties
5.
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.

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.

6.
The first meeting of the Conference of the Parties serving
as the meeting of the Parties to this Protocol shall be convened
by the Secretariat in conjunction with the first meeting of the
Conference of the Parties that is scheduled after the date of the
entry into force of this Protocol. Subsequent ordinary meetings
of the Conference of the Parties serving as the meeting of the
Parties to this Protocol shall be held in conjunction with
ordinary meetings of
the 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
the written request of any Party,
to this Protocol, or at
the request being
provided that, within six months of
communicated to the Parties by the Secretariat,
is
supported by at least one third of the Parties.

it

8.
The United Nations, its specialised 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 inter-
national, governmental or non-governmental, that is qualified
in matters covered by this Protocol and that has informed the
Secretariat of its wish to be represented at a meeting of the
Conference of the Parties serving as 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
to the rules of procedure, as
referred to in paragraph 5 above.

shall be subject

Article 30

Subsidiary bodies

1.
the
Any subsidiary body established by or under
Convention may, upon a decision by the Conference of the
Parties serving as the meeting of the Parties to this Protocol,
serve the Protocol, in which case the meeting of the Parties
shall specify which functions that body shall exercise.

Parties to the Convention that are not Parties to this
2.
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

1.
established by Article 24 of
Convention shall serve as the secretariat to this Protocol.

Secretariat

the

Article 24, paragraph 1, of

2.
the Convention on the
functions of the Secretariat shall apply, mutatis mutandis, to
this Protocol.

To the extent that they are distinct, the costs of the
3.
secretariat services for this Protocol shall be met by the
Parties hereto. The Conference of the Parties serving as the
meeting of
its first
meeting, decide on the necessary budgetary arrangements to
this end.

the Parties to this Protocol shall, at

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
the
Parties serving as the meeting of the Parties to this Protocol
on measures that it has taken to implement the Protocol.

to the Conference of

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
assistance, where appropriate. They shall be separate from,
and without prejudice to, the dispute settlement procedures
and mechanisms established by Article 27 of the Convention.

C 181 E/270

EN

Official Journal of the European Communities

30.7.2002

Article 35

Assessment and review

The Conference of the Parties serving as the meeting of the
Parties to this Protocol shall undertake, five years after the
entry into force of this Protocol and at least every five years
thereafter, an evaluation of the effectiveness of the Protocol,
including an assessment of its procedures and annexes.

For the purposes of paragraphs 1 and 2 above, any
3.
instrument deposited by a regional economic integration
organisation shall not be counted as additional
to those
deposited by member States of such organisation

Article 38

Reservations

No reservations may be made to this Protocol.

Article 36

Signature

This Protocol shall be open for signature at the United Nations
Office at Nairobi by States and regional economic integration
organisations 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 ratifi-
accession by States or
cation,
regional economic integration organisations that are Parties
to the Convention.

approval or

acceptance,

2.
This Protocol shall enter into force for a State or regional
ratifies, accepts or
economic integration organisation 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
organisation 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
organisation, whichever shall be the later.

Article 39

Withdrawal

At any time after two years from the date on which this
1.
Protocol has entered into force for a Party, that Party may
withdraw from the Protocol by giving written notification to
the Depositary.

Any such withdrawal shall take place upon expiry of one
2.
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,
equally
English,
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 authorised to
that effect, have signed this Protocol.

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

30.7.2002

EN

Official Journal of the European Communities

C 181 E/271

Information required in notifications under Articles 8, 10 and 13

Annex 1

(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 3.

(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.

C 181 E/272

EN

Official Journal of the European Communities

30.7.2002

Information required concerning living modified organisms intended for direct use as food or feed, or for
processing under Article 11

Annex 2

(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 3.

(k) Suggested methods for the safe handling, storage, transport and use, including packaging, labelling, documentation,

disposal and contingency procedures, where appropriate.

Annex 3

Risk assessment under Article 15

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 organisations.

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.

30.7.2002

EN

Official Journal of the European Communities

C 181 E/273

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 realised, 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 realised;

(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 realised;

(e) A recommendation as to whether or not the risks are acceptable or manageable, including, where necessary,

identification of strategies to manage these risks; and

(f) Where there is uncertainty regarding the level of risk, it may be addressed by requesting further information on
the specific issues of concern or by implementing appropriate risk management strategies and/or monitoring the
living modified organism in the receiving environment.

Points to consider

9. Depending on the case, risk assessment takes into account the relevant technical and scientific details regarding the

characteristics of the following subjects:

(a) Recipient organism or parental organisms. The biological characteristics of the recipient organism or parental
organisms, including information on taxonomic status, common name, origin, centres of origin and centres of
genetic diversity, if known, and a description of the habitat where the organisms may persist or proliferate;

(b) Donor organism or organisms. Taxonomic status and common name, source, and the relevant biological charac-

teristics of the donor organisms;

(c) Vector. Characteristics of the vector, including its identity, if any, and its source or origin, and its host range;

(d) Insert or inserts and/or characteristics of modification. Genetic characteristics of the inserted nucleic acid and the

function it specifies, and/or characteristics of the modification introduced;

(e) Living modified organism. Identity of the living modified organism, and the differences between the biological
characteristics of the living modified organism and those of the recipient organism or parental organisms;

(f) Detection and identification of the living modified organism. Suggested detection and identification methods and

their specificity, sensitivity and reliability;

(g)

Information relating to the intended use.
organism, including new or changed use compared to the recipient organism or parental organisms; and

Information relating to the intended use of the living modified

(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.

C 181 E/274

EN

Official Journal of the European Communities

30.7.2002

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

in accordance with the Treaty establishing the European
‘The European Community declares that,
for entering into international
Community, and in particular Article 175 thereof,
agreements, and for implementing the obligations resulting therefrom, which contribute to the pursuit
of the following objectives:

is competent

it

— 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 all matters governed by this Protocol’.