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  
Objective  
The objective of this Supplementary Protocol is to contribute to 
the conservation and sustainable use of biological diversity, 
taking also into account risks to human health, by providing 
international rules and procedures in the field of liability and 
redress relating to living modified organisms.  
Article 2  
Use of terms  
1. The terms used in Article 2 of the Convention on 
Biological Diversity, hereinafter referred to as ‘the Convention’, 
and Article 3 of the Protocol shall apply to this Supplementary 
Protocol.  
2. In addition, for the purposes of this Supplementary 
Protocol:  
(a) ‘Conference of the Parties serving as the meeting of the 
Parties to the Protocol’ means the Conference of the 
Parties to the Convention serving as the meeting of the 
Parties to the Protocol;  
(b) ‘Damage’ means an adverse effect on the conservation and 
sustainable use of biological diversity, taking also into 
account risks to human health, that:  
(i) Is measurable or otherwise observable taking into 
account, wherever available, scientifically-established 
baselines recognized by a competent authority that 
takes into account any other human induced variation 
and natural variation; and  
(ii) Is significant as set out in paragraph 3 below;  (c) ‘Operator’ means any person in direct or indirect control of 
the living modified organism which could, as appropriate 
and as determined by domestic law, include, inter alia, the 
permit holder, person who placed the living modified 
organism on the market, developer, producer, notifier, 
exporter, importer, carrier or supplier;  
(d) ‘Response measures’ means reasonable actions to:  
(i) Prevent, minimize, contain, mitigate, or otherwise avoid 
damage, as appropriate;  
(ii) Restore biological diversity through actions to be 
undertaken in the following order of preference:  
a. Restoration of biological diversity to the condition 
that existed before the damage occurred, or its 
nearest equivalent; and where the competent 
authority determines this is not possible;  
b. Restoration by, inter alia, replacing the loss of 
biological diversity with other components of 
biological diversity for the same, or for another 
type of use either at the same or, as appropriate, at 
an alternative location.  
3. A ‘significant’ adverse effect is to be determined on the 
basis of factors, such as:  
(a) The long-term or permanent change, to be understood as 
change that will not be redressed through natural recovery 
within a reasonable period of time;  
(b) The extent of the qualitative or quantitative changes that 
adversely affect the components of biological diversity;  
(c) The reduction of the ability of components of biological 
diversity to provide goods and services;EN L 46/4 Official Journal of the European Union 19.2.2013
(d) The extent of any adverse effects on human health in the 
context of the Protocol.  
Article 3  
Scope  
1. This Supplementary Protocol applies to damage resulting 
from living modified organisms which find their origin in a 
transboundary movement. The living modified organisms 
referred to are those:  
(a) Intended for direct use as food or feed, or for processing;  
(b) Destined for contained use;  
(c) Intended for intentional introduction into the environment.  
2. With respect to intentional transboundary movements, 
this Supplementary Protocol applies to damage resulting from 
any authorized use of the living modified organisms referred to 
in paragraph 1 above.  
3. This Supplementary Protocol also applies to damage 
resulting from unintentional transboundary movements as 
referred to in Article 17 of the Protocol as well as damage 
resulting from illegal transboundary movements as referred to 
in Article 25 of the Protocol.  
4. This Supplementary Protocol applies to damage resulting 
from a transboundary movement of living modified organisms 
that started after the entry into force of this Supplementary 
Protocol for the Party into whose jurisdiction the transboundary 
movement was made.  
5. This Supplementary Protocol applies to damage that 
occurred in areas within the limits of the national jurisdiction 
of Parties.  
6. Parties may use criteria set out in their domestic law to 
address damage that occurs within the limits of their national 
jurisdiction.  
7. Domestic law implementing this Supplementary Protocol 
shall also apply to damage resulting from transboundary 
movements of living modified organisms from non-Parties.  
Article 4  
Causation  
A causal link shall be established between the damage and the 
living modified organism in question in accordance with 
domestic law.  
Article 5  
Response measures  
1. Parties shall require the appropriate operator or operators, 
in the event of damage, subject to any requirements of the 
competent authority, to:  (a) Immediately inform the competent authority;  
(b) Evaluate the damage; and  
(c) Take appropriate response measures.  
2. The competent authority shall:  
(a) Identify the operator which has caused the damage;  
(b) Evaluate the damage; and  
(c) Determine which response measures should be taken by the 
operator.  
3. Where relevant information, including available scientific 
information or information available in the Biosafety Clearing- 
House, indicates that there is a sufficient likelihood that damage 
will result if timely response measures are not taken, the 
operator shall be required to take appropriate response 
measures so as to avoid such damage.  
4. The competent authority may implement appropriate 
response measures, including, in particular, when the operator 
has failed to do so.  
5. The competent authority has the right to recover from the 
operator the costs and expenses of, and incidental to, the 
evaluation of the damage and the implementation of any such 
appropriate response measures. Parties may provide, in their 
domestic law, for other situations in which the operator may 
not be required to bear the costs and expenses.  
6. Decisions of the competent authority requiring the 
operator to take response measures should be reasoned. Such 
decisions should be notified to the operator. Domestic law shall 
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 
the operator of the available remedies. Recourse to such 
remedies shall not impede the competent authority from 
taking response measures in appropriate circumstances, unless 
otherwise provided by domestic law.  
7. In implementing this Article and with a view to defining 
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 
on civil liability.  
8. Response measures shall be implemented in accordance 
with domestic law.  
Article 6  
Exemptions  
1. Parties may provide, in their domestic law, for the 
following exemptions:  
(a) Act of God or force majeure; andEN 19.2.2013 Official Journal of the European Union L 46/5
(b) Act of war or civil unrest.  
2. Parties may provide, in their domestic law, for any other 
exemptions or mitigations as they may deem fit.  
Article 7  
Time limits  
Parties may provide, in their domestic law, for:  
(a) Relative and/or absolute time limits including for actions 
related to response measures; and  
(b) The commencement of the period to which a time limit 
applies.  
Article 8  
Financial limits  
Parties may provide, in their domestic law, for financial limits 
for the recovery of costs and expenses related to response 
measures.  
Article 9  
Right of recourse  
This Supplementary Protocol shall not limit or restrict any right 
of recourse or indemnity that an operator may have against any 
other person.  
Article 10  
Financial security  
1. Parties retain the right to provide, in their domestic law, 
for financial security.  
2. Parties shall exercise the right referred to in paragraph 1 
above in a manner consistent with their rights and obligations 
under international law, taking into account the final three 
preambular paragraphs of the Protocol.  
3. The first meeting of the Conference of the Parties serving 
as the meeting of the Parties to the Protocol after the entry into 
force of the Supplementary Protocol shall request the Secretariat 
to undertake a comprehensive study which shall address, inter 
alia:  
(a) The modalities of financial security mechanisms;  
(b) An assessment of the environmental, economic and social 
impacts of such mechanisms, in particular on developing 
countries; and  
(c) An identification of the appropriate entities to provide 
financial security.  
Article 11  
Responsibility of States for internationally wrongful acts  
This Supplementary Protocol shall not affect the rights and 
obligations of States under the rules of general international 
law with respect to the responsibility of States for inter ­
nationally wrongful acts.  Article 12  
Implementation and relation to civil liability  
1. Parties shall provide, in their domestic law, for rules and 
procedures that address damage. To implement this obligation, 
Parties shall provide for response measures in accordance with 
this Supplementary Protocol and may, as appropriate:  
(a) Apply their existing domestic law, including, where appli ­
cable, general rules and procedures on civil liability;  
(b) Apply or develop civil liability rules and procedures 
specifically for this purpose; or  
(c) Apply or develop a combination of both.  
2. Parties shall, with the aim of providing adequate rules and 
procedures in their domestic law on civil liability for material or 
personal damage associated with the damage as defined in 
Article 2, paragraph 2(b):  
(a) Continue to apply their existing general law on civil liability;  
(b) Develop and apply or continue to apply civil liability law 
specifically for that purpose; or  
(c) Develop and apply or continue to apply a combination of 
both.  
3. When developing civil liability law as referred to in 
subparagraphs (b) or (c) of paragraphs 1 or 2 above, Parties 
shall, as appropriate, address, inter alia, the following elements:  
(a) Damage;  
(b) Standard of liability including strict or fault-based liability;  
(c) Channelling of liability, where appropriate;  
(d) Right to bring claims.  
Article 13  
Assessment and review  
The Conference of the Parties serving as the meeting of the 
Parties to the Protocol shall undertake a review of the effec ­
tiveness of this Supplementary Protocol five years after its entry 
into force and every five years thereafter, provided information 
requiring such a review has been made available by Parties. The 
review shall be undertaken in the context of the assessment and 
review of the Protocol as specified in Article 35 of the Protocol, 
unless otherwise decided by the Parties to this Supplementary 
Protocol. The first review shall include a review of the effec ­
tiveness of Articles 10 and 12.EN L 46/6 Official Journal of the European Union 19.2.2013
Article 14  
Conference of the Parties serving as the meeting of the 
Parties to the Protocol  
1. Subject to paragraph 2 of Article 32 of the Convention, 
the Conference of the Parties serving as the meeting of the 
Parties to the Protocol shall serve as the meeting of the 
Parties to this Supplementary Protocol.  
2. The Conference of the Parties serving as the meeting of 
the Parties to the Protocol shall keep under regular review the 
implementation of this Supplementary 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 Supplementary Protocol and,  mutatis 
mutandis , the functions assigned to it by paragraphs 4(a) and 
(f) of Article 29 of the Protocol.  
Article 15  
Secretariat  
The Secretariat established by Article 24 of the Convention shall 
serve as the secretariat to this Supplementary Protocol.  
Article 16  
Relationship with the Convention and the Protocol  
1. This Supplementary Protocol shall supplement the 
Protocol and shall neither modify nor amend the Protocol.  
2. This Supplementary Protocol shall not affect the rights 
and obligations of the Parties to this Supplementary Protocol 
under the Convention and the Protocol.  
3. Except as otherwise provided in this Supplementary 
Protocol, the provisions of the Convention and the Protocol 
shall apply,  mutatis mutandis , to this Supplementary Protocol.  
4. Without prejudice to paragraph 3 above, this Supple ­
mentary Protocol shall not affect the rights and obligations of 
a Party under international law.  
Article 17  
Signature  
This Supplementary Protocol shall be open for signature by 
Parties to the Protocol at the United Nations Headquarters in 
New York from 7 March 2011 to 6 March 2012.  
Article 18  
Entry into force  
1. This Supplementary Protocol shall enter into force on the 
ninetieth day after the date of deposit of the fortieth instrument of ratification, acceptance, approval or accession by States or 
regional economic integration organizations that are Parties to 
the Protocol.  
2. This Supplementary Protocol shall enter into force for a 
State or regional economic integration organization that ratifies, 
accepts or approves it or accedes thereto after the deposit of the 
fortieth instrument as referred to in paragraph 1 above, on the 
ninetieth day after the date on which that State or regional 
economic integration organization deposits its instrument of 
ratification, acceptance, approval, or accession, or on the date 
on which the Protocol enters into force for that State or 
regional economic integration organization, whichever shall be 
the later.  
3. For the purposes of paragraphs 1 and 2 above, any 
instrument deposited by a regional economic integration organ ­
ization shall not be counted as additional to those deposited by 
member States of such organization.  
Article 19  
Reservations  
No reservations may be made to this Supplementary Protocol.  
Article 20  
Withdrawal  
1. At any time after two years from the date on which this 
Supplementary Protocol has entered into force for a Party, that 
Party may withdraw from this Supplementary Protocol by 
giving written notification to the Depositary.  
2. Any such withdrawal shall take place upon expiry of one 
year after the date of its receipt by the Depositary, or on such 
later date as may be specified in the notification of the with ­
drawal.  
3. Any Party which withdraws from the Protocol in 
accordance with Article 39 of the Protocol shall be considered 
as also having withdrawn from this Supplementary Protocol.  
Article 21  
Authentic texts  
The original of this Supplementary Protocol, of which the 
Arabic, Chinese, English, French, Russian and Spanish texts 
are equally authentic, shall be deposited with the Secretary- 
General of the United Nations.  
IN WITNESS WHEREOF  the undersigned, being duly authorized to 
that effect, have signed this Supplementary Protocol.  
DONE  at Nagoya on this fifteenth day of October two thousand 
and ten.EN 19.2.2013 Official Journal of the European Union L 46/7