CELEX: 22013A0219(01)
Language: en
Date: 2010-10-15 00:00:00
Title: Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety

L 46/4                  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
                                                                                          nearest equivalent; and where the competent
2.     In addition, for the purposes of this Supplementary
                                                                                          authority determines this is not possible;
Protocol:
                                                                                       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.
                                                                              3.     A ‘significant’ adverse effect is to be determined on the
(b) ‘Damage’ means an adverse effect on the conservation and
                                                                              basis of factors, such as:
    sustainable use of biological diversity, taking also into
    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
                                                                              (b) The extent of the qualitative or quantitative changes that
         takes into account any other human induced variation
                                                                                  adversely affect the components of biological diversity;
         and natural variation; and
                                                                              (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;
 ---pagebreak--- 19.2.2013               EN                         Official Journal of the European Union                                              L 46/5
(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
                                                                           following exemptions:
1.     Parties shall require the appropriate operator or operators,
in the event of damage, subject to any requirements of the
competent authority, to:                                                   (a) Act of God or force majeure; and
 ---pagebreak--- L 46/6                 EN                           Official Journal of the European Union                                           19.2.2013
(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.
 ---pagebreak--- 19.2.2013             EN                          Official Journal of the European Union                                            L 46/7
                             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
                                                                          economic integration organization deposits its instrument of
2.     The Conference of the Parties serving as the meeting of
                                                                          ratification, acceptance, approval, or accession, or on the date
the Parties to the Protocol shall keep under regular review the
                                                                          on which the Protocol enters into force for that State or
implementation of this Supplementary Protocol and shall make,
                                                                          regional economic integration organization, whichever shall be
within its mandate, the decisions necessary to promote its
                                                                          the later.
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             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
                                                                          later date as may be specified in the notification of the with­
3.     Except as otherwise provided in this Supplementary
                                                                          drawal.
Protocol, the provisions of the Convention and the Protocol
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.