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EN
Official Journal of the European Union
19.2.2013
NAGOYA-KUALA LUMPUR SUPPLEMENTARY PROTOCOL ON LIABILITY AND REDRESS TO
THE CARTAGENA PROTOCOL ON BIOSAFETY
THE PARTIES TO THIS SUPPLEMENTARY PROTOCOL,
BEING Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, hereinafter referred to as
‘the Protocol’,
TAKING INTO ACCOUNT Principle 13 of the Rio Declaration on Environment and Development,
REAFFIRMING the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and
Development,
RECOGNIZING the need to provide for appropriate response measures where there is damage or sufficient likelihood of
damage, consistent with the Protocol,
RECALLING Article 27 of the Protocol,
HAVE AGREED AS FOLLOWS:
Article 1
(c) ‘Operator’ means any person in direct or indirect control of
the living modified organism which could, as appropriate
Objective
and as determined by domestic law, include, inter alia, the
The objective of this Supplementary Protocol is to contribute to
permit holder, person who placed the living modified
the conservation and sustainable use of biological diversity,
organism on the market, developer, producer, notifier,
taking also into account risks to human health, by providing
exporter, importer, carrier or supplier;
international rules and procedures in the field of liability and
redress relating to living modified organisms.
(d) ‘Response measures’ means reasonable actions to:
Article 2
(i) Prevent, minimize, contain, mitigate, or otherwise avoid
damage, as appropriate;
Use of terms
1. The
terms
used
in
Article
2
of
the
Convention
on
(ii) Restore biological diversity through actions to be
Biological Diversity, hereinafter referred to as ‘the Convention’,
undertaken in the following order of preference:
and Article 3 of the Protocol shall apply to this Supplementary
Protocol.
a. Restoration of biological diversity to the condition
that existed before the damage occurred, or its
2. In
addition,
for
the
purposes
of
this
Supplementary
nearest equivalent; and where the competent
Protocol:
authority determines this is not possible;
b. Restoration by, inter alia, replacing the loss of
(a) ‘Conference of the Parties serving as the meeting of the
biological diversity with other components of
Parties to the Protocol’ means the Conference of the
biological diversity for the same, or for another
Parties to the Convention serving as the meeting of the
type of use either at the same or, as appropriate, at
Parties to the Protocol;
an alternative location.
(b) ‘Damage’ means an adverse effect on the conservation and
3. A
‘significant’
adverse
effect
is
to
be
determined
on
the
sustainable use of biological diversity, taking also into
basis of factors, such as:
account risks to human health, that:
(a) The long-term or permanent change, to be understood as
change that will not be redressed through natural recovery
(i) Is measurable or otherwise observable taking into
within a reasonable period of time;
account, wherever available, scientifically-established
baselines recognized by a competent authority that
takes into account any other human induced variation
(b) The extent of the qualitative or quantitative changes that
and natural variation; and
adversely affect the components of biological diversity;
(c) The reduction of the ability of components of biological
(ii) Is significant as set out in paragraph 3 below;
diversity to provide goods and services;

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(d) The extent of any adverse effects on human health in the
(a) Immediately inform the competent authority;
context of the Protocol.
(b) Evaluate the damage; and
Article 3
Scope
(c) Take appropriate response measures.
1. This
Supplementary
Protocol
applies
to
damage
resulting
from living modified organisms which find their origin in a
2. The
competent
authority
shall:
transboundary movement. The living modified organisms
referred to are those:
(a) Identify the operator which has caused the damage;
(a) Intended for direct use as food or feed, or for processing;
(b) Evaluate the damage; and
(b) Destined for contained use;
(c) Determine which response measures should be taken by the
operator.
(c) Intended for intentional introduction into the environment.
3. Where
relevant
information,
including
available
scientific
information or information available in the Biosafety Clearing-
2. With
respect
to
intentional
transboundary
movements, House, indicates that there is a sufficient likelihood that damage
this Supplementary Protocol applies to damage resulting from
will result if timely response measures are not taken, the
any authorized use of the living modified organisms referred to
operator shall be required to take appropriate response
in paragraph 1 above.
measures so as to avoid such damage.
3. This
Supplementary
Protocol
also
applies
to
damage 4. The
competent
authority
may
implement
appropriate
resulting from unintentional transboundary movements as
response measures, including, in particular, when the operator
referred to in Article 17 of the Protocol as well as damage
has failed to do so.
resulting from illegal transboundary movements as referred to
in Article 25 of the Protocol.
5. The
competent
authority
has
the
right
to
recover
from
the
operator the costs and expenses of, and incidental to, the
4. This
Supplementary
Protocol
applies
to
damage
resulting evaluation of the damage and the implementation of any such
from a transboundary movement of living modified organisms
appropriate response measures. Parties may provide, in their
that started after the entry into force of this Supplementary
domestic law, for other situations in which the operator may
Protocol for the Party into whose jurisdiction the transboundary
not be required to bear the costs and expenses.
movement was made.
6. Decisions
of
the
competent
authority
requiring
the
5. This
Supplementary
Protocol
applies
to
damage
that operator to take response measures should be reasoned. Such
occurred in areas within the limits of the national jurisdiction
decisions should be notified to the operator. Domestic law shall
of Parties.
provide for remedies, including the opportunity for adminis
trative or judicial review of such decisions. The competent
authority shall, in accordance with domestic law, also inform
6. Parties
may
use
criteria
set
out
in
their
domestic
law
to the operator of the available remedies. Recourse to such
address damage that occurs within the limits of their national
remedies shall not impede the competent authority from
jurisdiction.
taking response measures in appropriate circumstances, unless
otherwise provided by domestic law.
7. Domestic law implementing this Supplementary Protocol
shall also apply to damage resulting from transboundary
7. In
implementing
this
Article
and
with
a
view
to
defining
movements of living modified organisms from non-Parties.
the specific response measures to be required or taken by the
competent authority, Parties may, as appropriate, assess whether
response measures are already addressed by their domestic law
Article 4
on civil liability.
Causation
A causal link shall be established between the damage and the
8. Response
measures
shall
be
implemented
in
accordance
living modified organism in question in accordance with
with domestic law.
domestic law.
Article 6
Article 5
Exemptions
Response measures
1. Parties
may
provide,
in
their
domestic
law,
for
the
1. Parties
shall
require
the
appropriate
operator
or
operators, following exemptions:
in the event of damage, subject to any requirements of the
competent authority, to:
(a) Act of God or force majeure; and

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Official Journal of the European Union
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(b) Act of war or civil unrest.
Article 12
Implementation and relation to civil liability
2. Parties
may
provide,
in
their
domestic
law,
for
any
other
exemptions or mitigations as they may deem fit.
1. Parties
shall
provide,
in
their
domestic
law,
for
rules
and
procedures that address damage. To implement this obligation,
Article 7
Parties shall provide for response measures in accordance with
this Supplementary Protocol and may, as appropriate:
Time limits
Parties may provide, in their domestic law, for:
(a) Apply their existing domestic law, including, where appli
cable, general rules and procedures on civil liability;
(a) Relative and/or absolute time limits including for actions
related to response measures; and
(b) Apply or develop civil liability rules and procedures
(b) The commencement of the period to which a time limit
specifically for this purpose; or
applies.
Article 8
(c) Apply or develop a combination of both.
Financial limits
Parties may provide, in their domestic law, for financial limits
2. Parties
shall,
with
the
aim
of
providing
adequate
rules
and
for the recovery of costs and expenses related to response
procedures in their domestic law on civil liability for material or
measures.
personal damage associated with the damage as defined in
Article 2, paragraph 2(b):
Article 9
Right of recourse
(a) Continue to apply their existing general law on civil liability;
This Supplementary Protocol shall not limit or restrict any right
of recourse or indemnity that an operator may have against any
(b) Develop and apply or continue to apply civil liability law
other person.
specifically for that purpose; or
Article 10
(c) Develop and apply or continue to apply a combination of
Financial security
both.
1. Parties
retain
the
right
to
provide,
in
their
domestic
law,
for financial security.
3. When developing civil liability law as referred to in
subparagraphs (b) or (c) of paragraphs 1 or 2 above, Parties
2. Parties
shall
exercise
the
right
referred
to
in
paragraph
1 shall, as appropriate, address, inter alia, the following elements:
above in a manner consistent with their rights and obligations
under international law, taking into account the final three
preambular paragraphs of the Protocol.
(a) Damage;
3. The first meeting of the Conference of the Parties serving
as the meeting of the Parties to the Protocol after the entry into
(b) Standard of liability including strict or fault-based liability;
force of the Supplementary Protocol shall request the Secretariat
to undertake a comprehensive study which shall address, inter
alia:
(c) Channelling of liability, where appropriate;
(a) The modalities of financial security mechanisms;
(d) Right to bring claims.
(b) An assessment of the environmental, economic and social
impacts of such mechanisms, in particular on developing
Article 13
countries; and
Assessment and review
(c) An identification of the appropriate entities to provide
The Conference of the Parties serving as the meeting of the
financial security.
Parties to the Protocol shall undertake a review of the effec
tiveness of this Supplementary Protocol five years after its entry
Article 11
into force and every five years thereafter, provided information
Responsibility of States for internationally wrongful acts
requiring such a review has been made available by Parties. The
review shall be undertaken in the context of the assessment and
This Supplementary Protocol shall not affect the rights and
review of the Protocol as specified in Article 35 of the Protocol,
obligations of States under the rules of general international
unless otherwise decided by the Parties to this Supplementary
law with respect to the responsibility of States for inter
Protocol. The first review shall include a review of the effec
nationally wrongful acts.
tiveness of Articles 10 and 12.

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Article 14
of ratification, acceptance, approval or accession by States or
regional economic integration organizations that are Parties to
Conference of the Parties serving as the meeting of the
the Protocol.
Parties to the Protocol
1. Subject to paragraph 2 of Article 32 of the Convention,
2. This
Supplementary
Protocol
shall
enter
into
force
for
a
the Conference of the Parties serving as the meeting of the
State or regional economic integration organization that ratifies,
Parties to the Protocol shall serve as the meeting of the
accepts or approves it or accedes thereto after the deposit of the
Parties to this Supplementary Protocol.
fortieth instrument as referred to in paragraph 1 above, on the
ninetieth day after the date on which that State or regional
2. The
Conference
of
the
Parties
serving
as
the
meeting
of economic integration organization deposits its instrument of
the Parties to the Protocol shall keep under regular review the
ratification, acceptance, approval, or accession, or on the date
implementation of this Supplementary Protocol and shall make,
on which the Protocol enters into force for that State or
within its mandate, the decisions necessary to promote its
regional economic integration organization, whichever shall be
effective implementation. It shall perform the functions
the later.
assigned to it by this Supplementary Protocol and, mutatis
mutandis, the functions assigned to it by paragraphs 4(a) and
3. For the purposes of paragraphs 1 and 2 above, any
(f) of Article 29 of the Protocol.
instrument deposited by a regional economic integration organ
ization shall not be counted as additional to those deposited by
member States of such organization.
Article 15
Secretariat
Article 19
The Secretariat established by Article 24 of the Convention shall
Reservations
serve as the secretariat to this Supplementary Protocol.
No reservations may be made to this Supplementary Protocol.
Article 16
Article 20
Relationship with the Convention and the Protocol
Withdrawal
1. This Supplementary Protocol shall supplement the 1. At
any
time
after
two
years
from
the
date
on
which
this
Protocol and shall neither modify nor amend the Protocol.
Supplementary Protocol has entered into force for a Party, that
Party may withdraw from this Supplementary Protocol by
2. This
Supplementary
Protocol
shall
not
affect
the
rights giving written notification to the Depositary.
and obligations of the Parties to this Supplementary Protocol
under the Convention and the Protocol.
2. Any
such
withdrawal
shall
take
place
upon
expiry
of
one
year after the date of its receipt by the Depositary, or on such
3. Except
as
otherwise
provided
in
this
Supplementary later date as may be specified in the notification of the with
Protocol, the provisions of the Convention and the Protocol
drawal.
shall apply, mutatis mutandis, to this Supplementary Protocol.
3. Any
Party
which
withdraws
from
the
Protocol
in
accordance with Article 39 of the Protocol shall be considered
4. Without
prejudice
to
paragraph
3
above,
this
Supple
as also having withdrawn from this Supplementary Protocol.
mentary Protocol shall not affect the rights and obligations of
a Party under international law.
Article 21
Article 17
Authentic texts
Signature
The original of this Supplementary Protocol, of which the
Arabic, Chinese, English, French, Russian and Spanish texts
This Supplementary Protocol shall be open for signature by
are equally authentic, shall be deposited with the Secretary-
Parties to the Protocol at the United Nations Headquarters in
General of the United Nations.
New York from 7 March 2011 to 6 March 2012.
IN WITNESS WHEREOF the undersigned, being duly authorized to
Article 18
that effect, have signed this Supplementary Protocol.
Entry into force
1. This
Supplementary
Protocol
shall
enter
into
force
on
the DONE at Nagoya on this fifteenth day of October two thousand
ninetieth day after the date of deposit of the fortieth instrument
and ten.

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