# EUR-Lex - 52012PC0236 - EN

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# 52012PC0236

**ANNEX to the Proposal for a Decision of the European Parliament and of the Council on the conclusion of the Nagoya-Kuala Lumpur Supplementary protocol on Liability and Redress to the Cartagena Protocol on Biosafety Text of the Agreement NAGOYA-KUALA LUMPUR SUPPLEMENTARY PROTOCOL ON LIABILITY AND REDRESS TO THE CARTAGENA PROTOCOL ON BIOSAFETY /* COM/2012/0236 final - NLE 2012/0120 */**

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EXPLANATORY MEMORANDUM

The
Convention on Biological Diversity (CBD), which entered into force on 29
December 1993, is today's main international instrument for addressing
biodiversity issues. The three objectives pursued by the Convention are the
conservation of biological diversity, the sustainable use of its components,
and the fair and equitable sharing of benefits arising from the use of genetic
resources.

Biosafety,
one of the issues addressed by the Convention, concerns the need to protect
human health and the environment from the potential adverse effects of the
products of modern biotechnology.

The Conference of
the Parties to the Convention on Biological Diversity (COP), at its second
meeting, held in November 1995 pursuant to Article 19, paragraph 3 of the CBD,
established an Open-ended Ad Hoc Working Group on Biosafety to develop a draft
protocol on biosafety, specifically focusing on transboundary movement of any living
modified organism. The Working
Group held six meetings between July 1996 and February 1999.

The Cartagena
Protocol on Biosafety to the
Convention on Biological Diversity was adopted on 29 January 2000 as a
supplementary agreement to the CBD and entered into force on 11 September 2003.
This international treaty provides
a framework, based on the precautionary principle, for the safe transfer,
handling and use of living modified organisms (LMOs) resulting from modern
biotechnology that may have adverse effects on the conservation and sustainable
use of biological diversity, or pose risks to human health.

Article 27 of the
Cartagena Protocol mandated the Conference of the Parties serving as the
Meeting of the Parties (COP/MOP) to establish at its first meeting a formal
process with respect to the appropriate elaboration of international rules and
procedures on liability and redress for damage resulting from transboundary
movements of LMOs, with a view to endeavour to conclude this work within 4
years (i.e. by 2008).

During COP/MOP1,
held in Kuala Lumpur from 23 to 27 February 2004, an Ad Hoc Open-ended Working
Group of Legal and Technical Experts on Liability and Redress in the context of
the Cartagena Protocol on Biosafety was established to analyse issues,
elaborate options, and propose international rules and procedures on the subject.

In May 2008, the
COP/MOP4, held in Bonn, achieved a political breakthrough in the negotiations,
although it did not finalise the drafting of the agreed results. Therefore, the
Parties agreed to work on the completion of a legally binding instrument at
COP/MOP5 in Nagoya, Japan in October 2010, as well as to develop guidelines on
civil liability. This legally binding instrument, largely inspired by the EU
Environmental Liability Directive (ELD)[1],
would allow national authorities to act on behalf of the collective good and
ask operators for remedial measures in case of damage to biodiversity from
LMOs, a novelty particularly in many developing countries.

Final negotiations
on the legally binding instrument and on the civil liability guidelines took
place in a "Friends of the Co-Chairs" (FoC) group involving 26 of 157
Parties to the Cartagena Protocol, as well as advisors from other Parties. The
EU had two seats at the negotiating table. The Commission acted as the EU
negotiator for the legally binding instrument on the basis of a formal
authorisation adopted by the Council in June 2007 and extended in time after
COP/MOP4. The negotiating directives were refined various times and instructed
the Commission to ensure that the results of the negotiation are consistent
with relevant Union legislation and with the basic principles of Member States'
law on liability and redress, and that it could be implemented in the EU
without introducing or amending substantive rules on civil liability.

On 15 October
2010, as a result of final negotiations in Nagoya, the plenary of COP/MOP5
successfully adopted an international agreement, known as the
"Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to
the Cartagena Protocol on Biosafety"[2].

The COP/MOP5 decision
adopting the Nagoya-Kuala Lumpur Supplementary Protocol calls upon the Parties
to the CBD to sign the Protocol at the earliest opportunity and to deposit
instruments of ratification, acceptance or approval or instruments of
accession, as appropriate, as soon as possible.

On 20 December
2010, the Council welcomed the adoption of the Nagoya-Kuala Lumpur Protocol[3] and on 11 May 2011 the European
Union signed the Supplementary Protocol.

In the European Union, the provisions of the Cartagena Protocol on Biosafety
are covered by the European legislation on Biosafety which is maintaining as a central
cornerstone the precautionary principle. The liability provisions of the
Nagoya-Kuala Lumpur Supplementary Protocol are covered by the Directive
2004/35/CE of the European Parliament and of the
Council of 21 April 2004, on environmental liability with regard to the
prevention and remedying of environmental damage, which establishes a framework
based on the "polluter pays" principle, according to which the
polluter pays when environmental damage occurs. After the Directive entered
into force on 30 April 2004, three years were given to the EU Member States
(MS) to transpose the Directive in domestic law. By July 2010, the last MS
finalised its transposition. The ELD was already amended twice through Directive
2006/21/EC on the management of waste from extractive industries and
through Directive
2009/31/EC on the geological storage of carbon dioxide and amending
several directives.

Any protocol
to the Convention on Biological Diversity, pursuant to Article 34 thereof, is
open for ratification, acceptance or approval by Member States and by regional
economic integration organisations. In accordance with Article 34, paragraph 3,
of the Convention, regional economic integration organisations must declare the
extent of their competence with respect to the matters governed by the relevant
protocol. To fulfill this obligation, the Commission has prepared the
Declaration annexed to the present proposal.

In accordance
with the advisory opinion of the Court of Justice[4], the
Decision on the conclusion should be based on Article 192 (1) TFEU, in
conjunction with Article 218(6)(a) TFEU (.

In view of the above the Commission proposes that the
Council authorizes the President to designate the person(s) empowered to
deposit the instrument of approval of the Nagoya-Kuala
Lumpur Supplementary Protocol on behalf of the Union and to confer on them the necessary powers thereto.

2012/0120 (NLE)

Proposal for a

COUNCIL DECISION

on the conclusion of the Nagoya-Kuala
Lumpur Supplementary Protocol on Liability and Redress to the Cartagena
Protocol on Biosafety

(Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the
Functioning of the European Union, and in particular Article 192, in
conjunction with Article 218(6) (a) thereof,

Having regard to the proposal from the
European Commission,[5]

Having regard to the consent of the
European Parliament, [6]

Whereas:

(1)       Article 27 of the
Cartagena Protocol on Biosafety bound the first meeting of the Conference of the
Parties serving as the Meeting of the Parties to the Protocol (COP/MOP) to
initiate a process with respect to the elaboration of international rules and
procedures in the field of liability and redress for damage resulting from
transboundary movements of living modified organisms.

(2)       In June 2007, the Council
adopted a Decision authorising the Commission to participate in the liability
and redress negotiations on behalf of the Union as regards matters falling
within Union competence, in accordance with certain negotiating directives.
That authorisation was extended in October 2008 to cover the final stages of
the negotiations.

(3)       On 11 October 2010, during
the fifth Conference of the Parties serving as the Meeting of the Parties to
the Protocol in Nagoya, Japan, the EU unanimously supported the final
compromise reached on the Nagoya-Kuala Lumpur Supplementary Protocol on
Liability and Redress, following consideration that it was within the limits of
the agreed EU positions and negotiating directives addressed to the Commission.

(4)       On 15 October 2010, the final
plenary of COP/MOP5 successfully adopted the Nagoya-Kuala Lumpur Supplementary
Protocol on Liability and Redress to the Cartagena Protocol on Biosafety.

(5)       On 20 December 2010, the
Council welcomed the adoption of the Nagoya-Kuala Lumpur Supplementary Protocol.

(6)       In accordance with Council
Decision of 6 May 2011[7],
the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the
Cartagena Protocol on Biosafety was signed by the Union on 11 May 2011, subject
to its conclusion at a later date.

(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 Nagoya-Kuala Lumpur
Supplementary Protocol on Liability and Redress to the Cartagena Protocol on
Biosafety contributes to the achievement of the objectives of the environmental
policy of the Union. It is therefore appropriate that this Protocol be
concluded on behalf of the Union as soon as possible.

(9)       The agreement should be
approved on behalf of the European Union.

HAS ADOPTED THIS DECISION:

Article 1

The Nagoya-Kuala
Lumpur Supplementary Protocol on Liability and Redress to the Cartagena
Protocol on Biosafety is hereby approved on behalf of the
Union.

The text of the Agreement is attached to
this Decision.

Article 2

The President of the Council shall
designate the person empowered to proceed, on behalf of the European Union, to
the deposit of the instrument of approval provided for in Article 18 of the
Agreement, in order to express the consent of the European Union to be bound by
the Agreement. The deposit of the instrument of approval shall take place
simultaneously with those of the Member States. At the
same time, the designated person shall deposit the declaration set out in the
Annex to this Decision, in accordance with Article 34(3) of the Convention on
Biological Diversity.

Article 3

This
Decision shall be published in the Official Journal of the European Union.

Done at Brussels,

For
the Council

The
President

ANNEX

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

"The European Union declares that, in accordance with
the Treaty on the Functioning of the European Union, and in particular Article
191 thereof, it is competent for entering into international agreements, and
for implementing the obligations resulting therefrom, which contribute to the
pursuit of the following objectives:

–
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, including climate
change.

Moreover, the European Union adopts measures at European Union
level in the area of judicial cooperation in civil
matters for the proper functioning of its
internal market

The European Union declares that it has
already adopted legal instruments, binding on its Member States, covering all
matters governed by this Protocol.

[1]               Directive 2004/35/CE of the European Parliament and of
the Council of 21 April 2004 on environmental liability with regard to the
prevention and remedying of environmental damage

[2]               http://bch.cbd.int/protocol/NKL_text.shtml

[3]               See Council Conclusions "Convention on Biological Diversity: outcome of and follow-up to the
Nagoya Conference (11-29 October 2010)" of 20
December 2010, paragraph 2.

[4]               ECJ Opinion 2/2000, 6 December 2001.

[5]               ...

[6]               ...

[7]               Decision not yet published

ANNEX

to the
Proposal for a Decision of the European Parliament and of the Council on the
conclusion of the Nagoya-Kuala Lumpur Supplementary protocol on Liability and
Redress to the Cartagena Protocol on Biosafety

Text of the Agreement
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;

(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 administrative 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; and

(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
internationally 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 applicable, 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
effectiveness 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
effectiveness of Articles 10 and 12.

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
Supplementary 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 organization 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 withdrawal.

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.