lopez《生物多样性公约》英文版

2021年1月20日发(作者：右手边)
CARTAGENA PROTOCOL ON BIOSAFETY TO THE CONVENTION ON
BIOLOGICAL DIVERSITY
The Parties to this Protocol,

Being Parties to the Convention on Biological Diversity, hereinafter referred to as


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,

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

Recognizing also the crucial importance to humankind of centres of origin and centres
of genetic diversity,

Taking into account the limited capabilities of many countries, particularly
developing countries, to cope with the nature and scale of known and potential risks
associated with living modified organisms,

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

Emphasizing 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

In accordance with the precautionary approach contained in Principle
15 of the Rio
Declaration on Environment and Development, the objective of this Protocol is to contribute
to ensuring an adequate level of protection in the field of the safe transfer, handling and
use of 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.

2.
The Parties shall ensure that the development, handling, transport, use, transfer and
release of any living modified organisms are undertaken in a manner that prevents or reduces
the risks to biological diversity, taking also into account risks to human health.

3.
Nothing in this Protocol shall affect in any way the sovereignty of States over their
territorial sea established in 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 obligations under international law.

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

Article 3

USE OF TERMS

For the purposes of this Protocol:

(a)
Convention;

(b)


installation or other physical structure, which involves living modified organisms that are
controlled by specific measures that effectively limit their contact with, and their impact
on, the external environment;

(c)
Party;

(d)


Party of export, who arranges for a living modified organism to be exported;

(e)
Party;

(f)


Party of import, who arranges for a living modified organism to be imported;

(g)

combination of genetic material obtained through the use of modern biotechnology;

(h)

replicating genetic material, including sterile organisms, viruses and viroids;

(i)



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)

by sovereign States of a given region, to which its member States have transferred
competence in respect of matters governed by this Protocol and which has been duly
authorized, in accordance with its internal procedures, to sign, ratify, accept, approve or
accede to it;

(k)

one Party to another Party, save that for the purposes of Articles 17 and 24 transboundary
movement extends to movement between Parties and non- Parties.

Article 4

SCOPE

This Protocol shall apply to the transboundary movement, transit, handling and use of
all living modified organisms that may have adverse effects on the conservation and
sustainable use of biological diversity, taking also into account risks to human health.

Article 5

PHARMACEUTICALS

Notwithstanding Article 4 and

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

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

Article 7

APPLICATION OF THE ADVANCE INFORMED AGREEMENT PROCEDURE

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

2.

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

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

4.
The advance informed agreement procedure shall not apply to the intentional
transboundary movement of living modified organisms identified in a decision of the
Conference of the Parties serving as the meeting of the Parties to this Protocol as being
not likely to have adverse effects on the conservation and sustainable use of biological
diversity, taking also into account risks to human health.

Article 8

NOTIFICATION

1.
The Party of export shall notify, or require the exporter to ensure notification to,
in writing, the competent national authority of the Party of import prior to the
intentional transboundary movement of a living modified organism that falls within the scope
of Article 7, paragraph 1. The notification shall contain, at a minimum, the information
specified in Annex
I.

2.
The Party of export shall ensure that there is a legal requirement for the accuracy
of information provided by the exporter.

Article 9

ACKNOWLEDGEMENT OF RECEIPT OF NOTIFICATION

1.
The Party of import shall acknowledge receipt of the notification, in writing, to the
notifier within ninety days of its receipt.

2.
The acknowledgement shall state:

(a)
The date of receipt of the notification;

(b)
Article
8;

(c)
Whether the notification, prima facie, contains the information referred to in
Whether to proceed according to the domestic regulatory framework of the Party
of import or according to the procedure specified in Article 10.

3.
The domestic regulatory framework referred to in paragraph 2 (c) above, shall be
consistent with this Protocol.

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

Article 10

DECISION PROCEDURE

1.
2.
Decisions taken by the Party of import shall be in accordance with Article
15.

The Party of import shall, within the period of time referred to in Article
9,
inform the notifier, in writing, whether the intentional transboundary movement may proceed:

(a)
(b)
3.
Only after the Party of import has given its written consent; or

After no less than ninety days without a subsequent written consent.

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

(a)
Approving the import, with or without conditions, including how the decision
will apply to subsequent imports of the same living modified organism;

(b)
(c)
Prohibiting the import;

Requesting additional relevant information in accordance with its domestic
regulatory framework or Annex
I; in calculating the time within which the Party of import
is to respond, the number of days it has to wait for additional relevant information shall
not be taken into account; or

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

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

5.
A failure by the Party of import to communicate its decision within two hundred and
seventy days of the date of receipt of the notification shall not imply its consent to an
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.

7.
The Conference of the Parties serving as the meeting of the Parties shall, at its
first meeting, decide upon appropriate procedures and mechanisms to facilitate decision-
making by Parties of import.

Article 11

PROCEDURE FOR LIVING MODIFIED ORGANISMS INTENDED FOR DIRECT USE AS FOOD OR FEED, OR FOR
PROCESSING

1.
A Party that makes a final decision regarding domestic use, including placing on the
market, of a living modified organism that may be subject to transboundary movement for
direct use as food or feed, or for processing shall, within fifteen days of making that
decision, inform the Parties through the Biosafety Clearing-House. This information shall
contain, at a minimum, the 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.

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

4.
A Party may take a decision on the import of living modified organisms intended for
direct use as food or feed, or for processing, under its domestic regulatory framework that
is consistent with the objective of this Protocol.

5.
Each Party shall make available to the Biosafety Clearing-House copies of any
national laws, regulations and guidelines applicable to the import 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)
(b)
A risk assessment undertaken in accordance with Annex
III; and

A decision made within a predictable timeframe, not exceeding two hundred and
seventy days.

7.
Failure by a Party to communicate its decision according to paragraph 6 above, shall
not imply its consent or refusal to the import of a living modified organism intended for
direct use as food or feed, or for processing, unless otherwise specified by the Party.

8.
Lack of scientific certainty due to insufficient relevant scientific information and
knowledge regarding the extent of the potential adverse effects of a living modified
organism on the conservation and sustainable use of biological diversity in the Party of
import, taking also into account risks to human health, shall not prevent that Party from
taking a decision, as appropriate, with regard to the import of that living modified
organism intended for direct use as food or feed, or for processing, in order to avoid or
minimize such potential adverse effects.

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

Article
12

REVIEW OF DECISIONS

1.
A Party of import may, at any time, in light of new scientific information on
potential adverse effects on the conservation and sustainable use of 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 outcome of the
risk assessment upon which the decision was based; or

(b)
3.
Additional relevant scientific or technical information has become available.

The Party of import shall respond in writing to such a request within ninety days and
set out the reasons for its decision.

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

Article 13

SIMPLIFIED PROCEDURE

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

(a)
Cases in which intentional transboundary movement to it may take place at the
same time as the movement is notified to the Party of import; 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 AGREEMENTS AND ARRANGEMENTS

1.
Parties may enter into bilateral, regional and multilateral agreements and
arrangements regarding intentional transboundary movements of living modified organisms,
consistent with the objective of this Protocol and provided that such agreements and
arrangements do not result in a lower level of protection than that provided for by the
Protocol.

2.
The Parties shall inform each other, through the Biosafety Clearing-House, of any
such bilateral, regional and multilateral agreements and arrangements that they have entered
into before or after the date of entry into force of this Protocol.

3.
The provisions of this Protocol shall not affect intentional 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 15

RISK ASSESSMENT

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

3.
The cost of risk assessment shall be borne by the notifier if the Party of import so
requires.

Article 16

RISK MANAGEMENT

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

2.
Measures based on risk assessment shall be imposed to the extent necessary to prevent
adverse effects of the living modified organism on the conservation and sustainable use of
biological diversity, taking also into account risks to human health, within the territory
of the Party of import.

3.
Each Party shall take appropriate measures to prevent unintentional transboundary
movements of living modified organisms, including such measures as requiring a risk
assessment 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 17

UNINTENTIONAL TRANSBOUNDARY MOVEMENTS AND EMERGENCY MEASURES

1.
Each Party shall take appropriate measures to notify affected or potentially
affected States, the Biosafety Clearing-House and, where appropriate, relevant international
organizations, when it knows of an occurrence under its jurisdiction resulting in a release
that leads, or may lead, to an unintentional transboundary movement of a living modified
organism that is likely to have 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.

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

3.
Any notification arising from paragraph
1 above, should include:

(a)
Available relevant information on the estimated quantities and relevant
characteristics and/or traits of the living modified organism;

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

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

(d)
(e)
4.
Any other relevant information; and

A point of contact for further information.

In order to minimize any significant adverse effects on the conservation and
sustainable use of biological diversity, taking also into account risks to human health,
each Party, under whose jurisdiction the release of the living modified organism referred to
in paragraph
1 above, occurs, shall immediately consult the affected or potentially
affected States to enable them to determine appropriate responses and initiate necessary
action, including emergency measures.

Article 18

HANDLING, TRANSPORT, PACKAGING AND IDENTIFICATION

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

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

(a)
Living modified organisms that are intended for direct use as food or feed, or
for processing, clearly identifies that they
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
Parties to this Protocol shall take a decision on the detailed requirements for this
purpose, including specification of their identity and any unique identification, no later
than two years after the date of entry into force of this Protocol;

(b)
Living modified organisms that are destined for contained use clearly
identifies them as living modified organisms; and specifies any requirements for the safe
handling, storage, transport and use, the contact point for further information, including
the name and address of the individual and institution to whom the living modified organisms
are consigned; and

(c)
Living modified organisms that are 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

COMPETENT NATIONAL AUTHORITIES AND NATIONAL FOCAL POINTS

1.
Each Party shall designate one national focal point to be responsible on its behalf
for liaison with the Secretariat. Each Party shall also 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 fulfil the functions of both focal
point and competent national authority.

2.
Each Party shall, no later than the date of entry into force of 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, with its notification thereof, relevant
information on the respective responsibilities of those authorities. Where applicable, such
information shall, at a minimum, specify which competent authority is responsible for which
type of living modified organism. Each Party shall forthwith notify the Secretariat of any
changes in the designation of its national focal point or in the name and address or
responsibilities of its competent national authority or authorities.

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

Article 20

INFORMATION SHARING AND THE BIOSAFETY CLEARING-HOUSE

1.

A Biosafety Clearing-House is hereby 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 modified organisms; and

(b)
Assist Parties to implement the Protocol, taking into account the special
needs of developing country Parties, in particular the least developed and small island
developing States among them, and countries with economies in transition as well as
countries that are centres of origin and centres of genetic diversity.

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

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

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

(b)
(c)
Any bilateral, regional and multilateral agreements and arrangements;

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 appropriate, relevant information regarding products thereof,
namely, processed materials that are of living modified organism origin, containing
detectable novel combinations of replicable genetic material obtained through the use of
modern biotechnology;

(d)
Its final decisions regarding the importation or release of living modified
organisms; and

(e)
Reports submitted by it pursuant to Article 33, including those on
implementation of the advance informed agreement procedure.

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