Common Position (EC) No 17/2003 of 4 March 2003 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a Regulation of the European Parliament and of the Council on transboundary movements of genetically modified organisms (Text with EEA relevance)
Date: 2003-03-04
Institutions: Council of the European Union
Subjects: biotechnology, cross-border transport, environmental risk prevention, export, genetically modified organism, information system, third country, transfrontier pollution

6.5.2003

EN

Official Journal of the European Union

C 107 E/1

I

(Information)

COUNCIL

COMMON POSITION (EC) No 17/2003

adopted by the Council on 4 March 2003

with a view to adopting Regulation (EC) No . . ./2003 of the European Parliament and of the
Council of . . . on transboundary movements of genetically modified organisms

(2003/C 107 E/01)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL
OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community, and in particular Article 175(1) thereof,

Having regard to the proposal from the Commission (1),

Having regard to the Opinion of the European Economic and
Social Committee (2),

Having regard to the Opinion of
Regions (3),

the Committee of

the

Acting in accordance with the procedure laid down in Article
251 of the Treaty (4),

Whereas:

(1) The Cartagena Protocol on Biosafety to the Convention on
Biological Diversity
the
(hereinafter
Protocol), was signed by the Community and its Member
States in 2000 and Decision 2002/628/EC (5) to conclude
the Protocol, on behalf of the Community, was taken on
25 June 2002.

referred to as

(2) Article 1 of the Protocol specifies that, in accordance with
the precautionary approach contained in Principle 15 of
the Rio Declaration on Environment and Development,
the objective of the Protocol is to contribute to ensuring
an adequate level of protection in the field of safe transfer,
handling and use of genetically modified organisms
(GMOs) resulting from modern biotechnology that may
have adverse effects on the conservation and sustainable

(1) OJ C 151 E, 25.6.2002, p. 121.
(2) OJ C 241, 7.10.2002, p. 62.
(3) OJ C 278, 14.11.2002, p. 31.
(4) Opinion of the European Parliament of 24 September 2002 (not yet
published in the Official
Journal), Council Common Position of
4 March 2003 and Decision of the European Parliament of . . .
(not yet published in the Official Journal).

use of biological diversity, taking also into account risks to
human health and specifically focusing on transboundary
movements.

the European Parliament and of

(3) The Protocol requires each Party to take necessary and
appropriate legal, administrative and other measures to
implement its obligations under the Protocol. Directive
2001/18/EC of
the
Council of 12 March 2001 on the deliberate release into
the environment of genetically modified organisms (6)
invited the Commission to bring forward a legislative
proposal for implementing the procedures laid down in
in accordance with the Protocol,
the Protocol and,
to ensure
requiring Community
all
requirements of
Informed Agreement
Procedure, as set out in Articles 7 to 10, 12 and 14 of
the Protocol, are fulfilled.

exporters
the Advance

that

(4)

It is important to organise the supervision and control of
transboundary movements of GMOs in order to contribute
to ensuring the conservation and sustainable use of
risks to
biological diversity,
human health, and so as to enable citizens to make a
free and informed choice in regard to GMOs.

taking also into account

(5) Since Community legislation does not contain specific
requirements for exports of GMOs to third countries,
and in order to ensure compliance with the obligations
in the Protocol regarding transboundary movements of
GMOs, a common legal framework should be established
for such exports.

(6) Exports of GMOs intended for deliberate release into the
environment should be notified to the Party or non-Party
of import, allowing it to make an informed decision, based
on a risk assessment carried out in a scientifically sound
manner.

(7) The notification should be ensured by the exporter. The
exporter should be responsible for the accuracy of the
information provided in the notification.

(5) OJ L 201, 31.7.2002, p. 48.

(6) OJ L 106, 17.4.2001, p. 1.

C 107 E/2

EN

Official Journal of the European Union

6.5.2003

(8) Exporters should await the express consent of the Party or
non-Party of import before proceeding with the first trans-
boundary movement of a GMO intended for deliberate
release into the environment.

labelling and identification of
regard to traceability,
imports into the Community, such GMOs are subject to
rules in Community legislation. With regard to exports
similar rules should apply.

(9) Recognising that some developing countries, and some
countries with economies in transition, may lack the
such
capacities which would enable
informed decisions, the Commission and Member States
should make sustained efforts to enable them to develop
and
institutional
capacities.

them to take

strengthen

resources

human

and

(10) According to the Protocol, the Community or any other
the
Party may take action that
conservation and sustainable use of biological diversity
than that called for in the Protocol, provided that such
action is consistent with the objective and the provisions
of the Protocol and in accordance with that Party's other
obligations under international law.

is more protective of

(11) According to the Protocol, the Community may apply its
domestic legislation in respect of the movements of GMOs
within its customs territory.

(12) As existing Community legislation, and in particular
legislation providing
Directive 2001/18/EC and sectoral
for a specific risk assessment
in
accordance with the principles set out in that Directive,
already contain rules which are in line with the objective
of the Protocol, there is no need to adopt supplementary
provisions with regard to imports of GMOs into the
Community.

to be carried out

(13) It is necessary to ensure the safe transport, handling and
packaging of GMOs. As existing Community legislation, in
particular Council Directive 94/55/EC of 21 November
1994 on the approximation of the laws of the Member
States with regard to the transport of dangerous goods by
road (1) and Council Directive 96/49/EC of 23 July 1996
on the approximation of the laws of the Member States
with regard to the transport of dangerous goods by rail (2),
already contain appropriate rules,
there is no need to
adopt supplementary provisions in this respect.

(14) It is necessary to ensure the identification of GMOs being
exported from or imported into the Community. With

(1) OJ L 319, 12.12.1994, p. 7. Directive as

last amended by
Commission Decision 2002/886/EC (OJ L 308, 9.11.2002, p. 45).
last amended by
Commission Decision 2002/885/EC (OJ L 308, 9.11.2002, p. 44).

(2) OJ L 235, 17.9.1996, p. 25. Directive as

(15) The Commission and Member States support the process
with respect to the appropriate elaboration of international
rules and procedures in the field of liability and redress for
damage
resulting from transboundary movements of
GMOs, to be agreed, as provided for in Article 27 of
the Protocol, at the first meeting of the Conference of
the Parties to the Convention serving as the meeting of
the Parties to the Protocol.

(16) The Commission and the Member States support

the
further development and the application of the common
formats for accompanying documentation on identifi-
cation of GMOs, which is undertaken in accordance
with Article 18 of the Protocol.

(17) In order to respond efficiently to unintentional

adverse

trans-
boundary movements of GMOs that are likely to have a
conservation and
significant
effect on the
sustainable use of biological diversity,
into
taking
account risks to human health, a Member State should,
as soon as it becomes aware of an event under its juris-
diction resulting in a release that may lead to an uninten-
tional transboundary movement of a GMO that is likely to
have such effects, take the appropriate measures to inform
the public and inform without delay the Commission, all
other Member States, affected or potentially affected States,
the Biosafety Clearing-House (BCH) and, where appro-
priate,
that
Member State should consult without delay affected or
potentially affected States to enable them to determine
appropriate responses and initiate necessary action.

international organisations. Also,

relevant

(18) In order to help develop the BCH, the Community and its
Member States should ensure that relevant information is
communicated to the BCH, and that monitoring and
reporting on the implementation of the Protocol in the
Community are performed.

(19) Member States

should lay down rules on penalties
applicable to infringements of this Regulation and ensure
that
they are implemented. Those penalties should be
effective, proportionate and dissuasive.

6.5.2003

EN

Official Journal of the European Union

C 107 E/3

(20) The precautionary principle should be taken into account

when applying this Regulation.

of Directive 2001/18/EC, excluding organisms obtained
through the techniques of genetic modification listed in
Annex IB to Directive 2001/18/EC;

(21) This Regulation respects

rights and
observes the principles recognised in particular by the
Charter of Fundamental Rights of the European Union,

the fundamental

HAVE ADOPTED THIS REGULATION:

3.

‘deliberate release’ means deliberate release as defined in
Article 2(3) of Directive 2001/18/EC;

4.

‘placing on the market’ means placing on the market as
defined in Article 2(4) of Directive 2001/18/EC;

5.

‘contained use’ means:

CHAPTER I

(a) activities

defined

in Article

2(c)

of Directive

OBJECTIVES, SCOPE AND DEFINITIONS

90/219/EEC (1);

Article 1

Objectives

In accordance with the precautionary principle, and without
prejudice to the provisions of Directive 2001/18/EC,
the
this Regulation are to establish a common
objectives of
system of notification and information for
transboundary
movements of genetically modified organisms (GMOs) and to
ensure coherent
the
Protocol on behalf of the Community in order to contribute
to ensuring an adequate level of protection in the field of the
safe transfer, handling and use of GMOs that may have adverse
effects on the conservation and sustainable use of biological
diversity, taking also into account risks to human health.

implementation of

the provisions of

Article 2

Scope

This Regulation shall

1.
transboundary
movements of all GMOs that may have adverse effects on
the conservation and sustainable use of biological diversity,
also taking into account risks to human health.

to the

apply

(b) activities

in which organisms other

than micro-
organisms are genetically modified or in which such
GMOs are cultured, stored,
transported, destroyed,
disposed of or used in any other way, and for which
specific containment measures, based on the same
principles of containment as in Directive 90/219/EEC,
are used appropriately to limit their contact with the
general population and the environment;

6.

‘food’ means food as defined in Article 2 of Regulation
(EC) No 178/2002 (2);

7.

‘feed’ means feed as defined in Article 3(4) of Regulation
(EC) No 178/2002;

8.

‘notification’ means the submission of
the information
required from the exporter under this Regulation to the
competent authority of a Party to the Protocol or to the
competent authority of a non-Party;

9.

‘the Biosafety Clearing-House’ or ‘the BCH’ means the
Biosafety Clearing-House established under Article 20 of
the Protocol;

2.
Pharmaceuticals for humans that are addressed by other
relevant international agreements or organisations are excluded
from the scope of this Regulation.

10.

‘export’ means:

Article 3

Definitions

For the purpose of this Regulation, the following definitions
shall apply:

1.

‘organism’ means organism as defined in Article 2(1) of
Directive 2001/18/EC;

2.

‘genetically modified
‘GMO’, means
organism’,
genetically modified organism as defined in Article 2(2)

or

(a) the permanent or temporary leaving of the customs
the Community of GMOs meeting the

territory of
conditions of Article 23(2) of the Treaty;

(b) the re-export of GMOs not meeting the conditions
referred to in (a) which are placed under a customs
procedure other than transit procedure;

(1) Council Directive 90/219/EEC of 23 April 1990 on the contained
use of genetically modified micro-organisms (OJ L 117, 8.5.1990,
p. 1). Directive as last amended by Decision 2001/204/EC (OJ L 73,
15.3.2001, p. 32).

(2) Regulation (EC) No 178/2002 of the European Parliament and of
the Council of 28 January 2002 laying down the general principles
and requirements of
food law, establishing the European Food
Safety Authority and laying down procedures in matters of food
safety (OJ L 31, 1.2.2002, p. 1).

C 107 E/4

EN

Official Journal of the European Union

6.5.2003

11.

‘import’ means the placing under a customs procedure,
other than transit procedure, of GMOs introduced into
the customs territory of a Party or non-Party outside the
Community from a Party within the Community;

21.

‘Secretariat’ means the Secretariat to the Protocol.

12.

‘exporter’ means any natural or legal person by whom or
on whose behalf a notification is made, that is to say the
person who, at the time when the notification is sent,
holds
the contract with the consignee in the third
country and has the power to determine that the GMO
is
the
Community. If no export contract has been concluded or
if the holder of the contract does not act on its own
behalf, the power to determine that the GMO is to be
sent out of the customs territory of the Community shall
be decisive;

to be sent out of

the customs

territory of

13.

‘importer’ means any natural or legal person, under the
jurisdiction of
Import, who
the Party or non-Party of
arranges for a GMO to be imported;

CHAPTER II

EXPORTS OF GMOs TO THIRD COUNTRIES

S e c t i o n 1

GMOs intended for deliberate release into the environment

Article 4

Notification to Parties and non-Parties of import

in writing,
the Party or non-Party of

to the
The exporter shall ensure notification,
competent authority of
import
prior to the first intentional transboundary movement of a
GMO intended for deliberate release into the environment
and destined for the use specified in accordance with Annex
I, point (i). The notification shall contain, as a minimum, the
information specified in Annex I. The exporter shall ensure the
accuracy of the information contained in the notification.

14.

‘transboundary movement’ means the intentional or unin-
tentional movement of a GMO between one Party or
non-Party and another Party or non-Party, excluding inten-
tional movements between Parties within the Community;

Article 5

Cases of non-decision

15.

‘Party’ means any country or regional economic inte-
gration organisation being a Party to the Protocol;

16.

‘non-Party’ means any country or regional economic inte-
gration organisation not being a Party to the Protocol;

17.

18.

19.

‘the Protocol’ means the Cartagena Protocol on Biosafety
to
(‘the
Convention’);

Biological Diversity

the Convention

on

‘biological diversity’ means the variability among living
organisms from all sources including, inter alia, terrestrial,
marine and other aquatic ecosystems and the ecological
complexes of which they are part; this includes diversity
within species, between species and of ecosystems;

a

competent

authority’ means

‘competent
authority
designated by a Party to the Protocol, or the relevant
equivalent body of a non-Party, which is responsible for
performing the administrative functions required by the
Protocol, or
case of a
non-Party, and is authorised to act on its behalf with
respect to those functions;

equivalent

functions

in the

20.

‘focal point’ means the entity designated by a Party to be
responsible on its behalf for liaising with the Secretariat;

1.
A failure by the Party of import to acknowledge receipt
of a notification or to communicate its decision shall not imply
its consent to an intentional transboundary movement. No first
intentional transboundary movement may be made without
express consent of the Party or, where appropriate, non-Party
of import.

2.
In cases where the Party of import does not communicate
its decisions in response to a notification within 270 days from
the date of receiving the notification, the exporter shall send a
written reminder, with a deadline for response of 60 days from
receipt of this reminder, to the competent authority of that
Party of
to the
import, with a copy to the Secretariat,
Member State of export, and to the Commission. In calculating
the time within which a Party of import is to respond, the
relevant
to wait
it has
number of days
information shall not be taken into account.

for additional

3.
The exporter shall not proceed with the first intentional
transboundary movement of a GMO intended for deliberate
release unless the procedures determined by the Party of
import in accordance with Articles 9 and 10 of the Protocol
or, where appropriate, equivalent procedures required by a
non-Party of import have been followed.

4.
Paragraphs 1, 2 and 3 shall not apply to cases of trans-
boundary movements covered by simplified procedures or
bilateral, regional and multilateral agreements or arrangements
entered into in accordance with Article 13 and 14 of the
Protocol.

6.5.2003

EN

Official Journal of the European Union

C 107 E/5

The Commission and the Member States shall, in consul-
5.
tation with the Secretariat,
action in
take
accordance with any appropriate procedures and mechanisms
to facilitate decision-making or to promote compliance with
the provisions of the Protocol by the Parties of import as
decided by the Conference of the Parties to the Convention
serving as the meeting of the Parties to the Protocol.

appropriate

The obligations referred to in section 1 of this Chapter
3.
shall not apply if the Party of import has specified in advance
to the BCH, in accordance with Articles 13(1)(b) and 14(3) of
the Protocol, that such imports of GMOs are to be exempted
from the Advance Informed Agreement Procedure, as set out in
Articles 7 to 10, 12 and 14 of the Protocol, provided that
adequate measures are applied to ensure their safe intentional
transboundary movement in accordance with the objective of
the Protocol.

Article 6

Informing the Party of export

The exporter shall for a period of a minimum of five years
keep a record of the notification referred to in Article 4 and
the acknowledgement of receipt and the decision of the Party
or, where appropriate, non-Party of import and send a copy of
these documents to the competent authority of the Member
State from which the GMO is exported and to the Commission.

Article 7

Review of decisions

If the exporter considers that a change in circumstances
1.
the risk
has occurred that may influence the outcome of
that
assessment upon which the decision was based or
additional
information has
scientific or
become available, he may ask the Party or, where appropriate,
non-Party of
to review a decision it has made
concerning notification pursuant to Article 10 of the Protocol.

technical

relevant

import

2. Where a Party or non-Party of import does not respond
to such a request within 90 days, the exporter shall send a
written reminder to the competent authority of that Party or,
where appropriate, non-Party of import, with a copy to the
Secretariat, requesting a response within a set period following
receipt of the reminder.

Article 8

Exceptions to section 1 of this Chapter

for

GMOs

release

intended

deliberate

1.
the
environment identified in a decision of the Conference of the
Parties to the Convention serving as the Meeting of the Parties
to the 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, shall be
excluded from the scope of section 1 of this Chapter.

into

Section 1 of

2.
intended for direct use as food or feed, or for processing.

this Chapter shall not apply to GMOs

S e c t i o n 2

GMOs intended for direct use as food or feed, or for
processing

Article 9

Information to the BCH

1.
The Commission on behalf of the Community or, where
appropriate, the Member State which made the decision shall
inform the BCH and other Parties through the BCH of any final
decision regarding use, including placing on the market, within
the Community or use within a Member State, of a GMO that
may be subject to transboundary movements for direct use as
food or feed or for processing. This information shall be sent
to the BCH within fifteen days of the adoption of that decision.

This paragraph shall not apply to decisions regarding the
deliberate release in accordance with Part B of Directive
2001/18/EC of a GMO which is not intended for direct use
as food or feed or for processing in a third country without a
subsequent decision.

2.
The information referred to in paragraph 1 and sent to
the BCH shall contain as a minimum the information specified
in Annex II.

3.
The Commission or the Member State referred to in
paragraph 1 shall process requests submitted to them by any
Party or non-Party for additional
information regarding the
decisions referred to in paragraph 1.

4.
A copy of the information referred to in paragraphs 1, 2
and 3 shall be sent by the Commission or the Member State
referred to in paragraph 1, in writing, to the focal point of
each Party that informs the Secretariat in advance that it does
not have access to the BCH.

C 107 E/6

EN

Official Journal of the European Union

6.5.2003

Article 10

Parties' and non-Parties' national decisions on import

intended for direct use as

1.
The exporter shall respect any decision on the import of
for
GMOs
processing, taken by a Party in accordance with Article 11(4)
of the Protocol, or by a non-Party of import under its domestic
regulatory framework that is consistent with the objective of
the Protocol.

feed, or

food or

2.
If a developing country Party or non-Party of import or a
Party or non-Party of import with an economy in transition
has declared through the BCH that it will take a decision prior
to an import of a specific GMO intended for direct use as food
or feed, or for processing, in accordance with Article 11(6) of
the Protocol, the exporter shall not proceed with the first
export of such GMO unless
the procedure provided for
under that provision has been followed.

import

Failure by the Party or non-Party of

3.
to
acknowledge receipt of a notification or to communicate its
decision in accordance with paragraph 2 shall not imply its
consent or refusal to the import of a GMO intended for direct
use as food or feed, or for processing. No GMO that may be
subject to transboundary movements for direct use as food or
feed or for processing may be exported, unless it is authorised
within the Community or the competent authority of a third
country has expressly agreed to the import as required under
Article 12 of Regulation (EC) No 178/2002.

S e c t i o n 3

GMOs intended for contained use

Article 11

S e c t i o n 4

Common provisions

Article 12

Identification and accompanying documentation

1.
Exporters shall ensure that the following information is
stated in a document accompanying the GMO and is trans-
mitted to the importer receiving the GMO:

(a) that it contains or consists of GMOs;

(b) the unique identification code(s) assigned to those GMOs if

such codes exist.

For GMOs intended for direct use as food or feed, or for
2.
processing, the information referred to in paragraph 1 shall be
supplemented by a declaration by the exporter:

(a) stating that the GMOs are intended for direct use as food
or feed, or for processing and indicating clearly that they
the
are
environment; and

deliberate

intended

release

into

not

for

(b) giving details of the contact point for further information.

Paragraph 1(b) shall not apply to products consisting of or
containing mixtures of GMOs to be used only and directly as
food or feed, or for processing. These products shall be subject
to the traceability requirements of Directive 2001/18/EC and,
when applicable, future Community legislation covering tracea-
bility, labelling and identification of such GMOs.

The provisions of Chapter II, section 1 shall not apply to
1.
transboundary movements of GMOs intended for contained use
where such transboundary movements are undertaken in
accordance with the standards of the Party or non-Party of
import.

For GMOs intended for contained use, the information
3.
referred to in paragraph 1 shall be supplemented by a
declaration by the exporter which shall specify:

(a) any requirements for the safe handling, storage, transport

and use of these GMOs;

2.
Paragraph 1 shall be without prejudice to any right of a
Party or non-Party to subject all GMOs to risk assessment prior
to decisions on import and to set standards for contained use
within their jurisdiction.

(b) the contact point for further information,
name and address of
the individual or
whom or which the GMOs are consigned.

including the
institution to

6.5.2003

EN

Official Journal of the European Union

C 107 E/7

For GMOs

intended for deliberate release into the
4.
environment and any other GMO to which this Regulation
applies, the information referred to in paragraph 1 shall be
supplemented by a declaration by the exporter which shall
set out:

(b) without delay consult the affected or potentially affected
States to enable them to determine appropriate responses
and
emergency
action,
measures in order to minimise any significant adverse
effects.

necessary

including

initiate

(a) the identity and relevant traits and characteristics of the

GMOs;

Any information arising from paragraph 2 shall include

3.
the information specified in Annex III.

(b) any requirements for the safe handling, storage, transport

and use of these GMOs;

CHAPTER IV

COMMON PROVISIONS

Article 15

(c) the contact point for further information and, as appro-
priate, the name and address of the importer and exporter;

Participation in the international information procedure

(d) a declaration that the movement is in conformity with the
requirements of the Protocol applicable to the exporter.

5.
Paragraph 1 to 4 shall be without prejudice to other
specific requirements imposed by Community legislation and
to international identification requirements to be developed in
accordance with Article 18 of the Protocol.

Article 13

Transit

The exporter shall ensure notification of the transit of GMOs to
Parties that have taken the decision to regulate transit of GMOs
through their territory and have informed the BCH of this
decision.

CHAPTER III

UNINTENTIONAL TRANSBOUNDARY MOVEMENT OF GMOs

Article 14

1. Member States shall take appropriate measures to prevent
unintentional transboundary movements of GMOs.

leads, or may lead,

2.
As soon as a Member State becomes aware of an
occurrence, under its jurisdiction, resulting in a release of
GMOs that
trans-
boundary movement that is likely to have significant adverse
effects on the conservation and sustainable use of biological
diversity,
that
Member State shall:

taking into account risks to human health,

to an unintentional

(a) take the appropriate measures to inform the public and
inform without delay the Commission, all other Member
States, affected or potentially affected States, the BCH, and,
where appropriate, relevant international organisations;

The Member States

shall, without prejudice to the
1.
protection of confidential information in accordance with the
provisions of
inform the BCH and the
Commission of:

the Protocol,

(a) national

legislation and

guidelines

implementation of
Article 11(5) and Article 20(3)(a) of the Protocol;

the Protocol,

relevant

to the
in accordance with

(b) national contact points for notification of unintentional
transboundary movements, in accordance with Article 17
of the Protocol;

(c) any bilateral,

regional and multilateral agreement and
arrangements entered into by the Member State regarding
in
intentional
accordance with Article 20(3)(b) of the Protocol;

transboundary movements of GMOs,

(d) any information concerning cases of unintentional or illegal
in

transboundary movements
them,
accordance with Articles 17 and 25 of the Protocol;

pertaining

to

(e) any final decision taken by a Member State, on the use of
GMOs within that Member State, including decisions:

— on contained use classified in risk class 3 or 4 of GMOs
to transboundary

likely to be subject

which are
movements,

— on the deliberate release of GMOs in accordance with

part B of Directive 2001/18/EC, or

— on import into the Community of GMOs,

in accordance with Articles 11 and 20(3)(d) of the Protocol,
within 15 days of the adoption of that decision;

C 107 E/8

EN

Official Journal of the European Union

6.5.2003

including,

in accordance with Article 15 of

(f) any summary of risk assessments or environmental reviews
of GMOs generated by the Community's regulatory process
the
and carried out
Protocol,
relevant
where
information regarding products thereof, namely, processed
materials that are of GMO origin, containing detectable
genetic material
novel
obtained through the use of modern biotechnology,
in
accordance with Article 20(3)(c) of the Protocol;

combinations

appropriate,

replicable

of

GMOs within the Community and imports of GMOs into
the Community in accordance with Article 14(3) and (4) of
the Protocol;

(g) reports submitted pursuant to Article 19 of this Regulation,
advanced
in accordance with

including those on implementation of
informed
Article 20(3)(e) of the Protocol.

agreement procedure,

the

(g) any review of national decisions regarding an intentional
transboundary movement, in accordance with Article 12 of
the Protocol;

Article 16

Confidentiality

(h) any decision taken by a Member State on safeguard
measures under Article 23 of Directive 2001/18/EC or
emergency measures taken by a Member State under
Community legislation on genetically modified food and
feed.

The Commission shall in accordance with the provisions
2.
of the Protocol inform, on behalf of the Community, the BCH
of:

(a) Community legislation and guidelines

implementation of
Article 11(5) and Article 20(3)(a) of the Protocol;

the Protocol,

relevant

the
in accordance with

for

(b) any bilateral,

regional and multilateral agreement and
arrangements at Community level regarding intentional
transboundary movements of GMOs,
in accordance with
Article 20(3)(b) of the Protocol;

(c) any final decision taken at Community level regarding the
use of a GMO within the Community, including decisions
on the placing on the market or the importation of a
GMO, in accordance with Articles 11 and 20(3)(d) of the
Protocol;

(d) any summary of risk assessments or environmental review
of GMOs generated by the Community regulatory process
and carried out in accordance with procedures similar to
to Directive 2001/18/EC,
those laid down in Annex II
information
including, where
regarding products thereof, namely, processed materials
that are of GMO origin, containing detectable novel combi-
nations of replicable genetic material obtained through the
use of modern biotechnology, in accordance with Article
20(3)(c) of the Protocol;

appropriate,

relevant

The Commission and the Member States shall not divulge
information received or

1.
to third parties any confidential
exchanged under this Regulation.

2.
The exporter may indicate the information in the notifi-
cation submitted under Article 4 which should be treated as
confidential.
Justification shall be given in such cases upon
request.

3.
The Party or, where appropriate, the non-Party of import
shall, after consultation with the exporter, decide which
information will be kept confidential and shall
inform the
exporter of its decisions.

In no case may the

following information when
4.
submitted according to Articles 4, 9 or 12 be kept confidential:

(a) name and address of the exporter,

(b) general description of the GMO or GMOs,

(c) a summary of the risk assessment of the effects on the
conservation and sustainable use of biological diversity,
taking also into account risks to human health, and

(d) any methods and plans for emergency response.

for whatever reasons,

the exporter withdraws the
If,
5.
the Member States and the Commission must
notification,
respect
and industrial
confidentiality of
the
information, including research and development information,
as well as information on which the Party or non-Party of
import and the exporter disagree as to its confidentiality.

commercial

(e) any review of decisions at Community level regarding an
in accordance with

intentional transboundary movement,
Article 12 of the Protocol;

Article 17

Competent authorities and focal points

(f) any application of Community legislation instead of the
procedures of the Protocol for intentional movements of

The Commission shall designate a Community focal point
any Community

appropriate,

identify

1.
and shall, where
competent authority.

6.5.2003

EN

Official Journal of the European Union

C 107 E/9

Each Member State shall designate one focal point, as
2.
well as one or more competent authorities. A single entity
may fulfil the functions of both focal point and competent
authority.

their

authorities. Where

a Member State or

shall, when conveying this

The Commission, on behalf of the Community, and each
3.
Member State respectively shall, no later than the date of entry
into force of the Protocol for them, inform the Secretariat of
focal points and their
the names and addresses of
the
competent
Commission designates more than one competent authority,
it
include
relevant
information on the respective responsibilities of
those authorities. Where applicable, such information shall,
is
as
responsible for which type of GMO. The Commission and
the Member States shall forthwith inform the Secretariat of
any changes in the designation of their focal points or in the
name and address or
their competent
authority or authorities.

specify which competent

to the Secretariat,

responsibilities of

a minimum,

authority

Article 18

Penalties

The Member States shall
lay down the rules on penalties
applicable to infringements of the provisions of this Regulation
and shall take all measures necessary to ensure that they are
implemented. The penalties provided for must be effective,
proportionate and dissuasive. The Member States shall notify
those provisions to the Commission, by not later than . . . (*)

and shall notify it without delay of any subsequent amendment
affecting them.

Article 19

Monitoring and reporting

At regular intervals and at least every 3 years, unless
1.
otherwise determined under Article 33 of
the Protocol,
Member States shall forward to the Commission a report on
the implementation of this Regulation.

2.
The Commission shall, at intervals to be determined by
the Conference of the Parties to the Convention serving as the
meeting of the Parties to the Protocol, compile a report on the
basis of the information provided by the Member States and
present it to the Conference of the Parties to the Convention
serving as the meeting of the Parties to the Protocol.

Article 20

Entry into force

This Regulation shall enter into force on the twentieth
1.
day following that of its publication in the Official Journal of the
European Union.

2.
This Regulation shall apply from the date of entry into
force of the Protocol, in accordance with Article 37(1) of the
Protocol, or from the date of entry into force of this Regu-
lation, whichever shall be the later.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at . . .

For the European Parliament

The President

For the Council

The President

(*) 12 months following the date of publication of this Regulation in

the Official Journal of the European Union.

C 107 E/10

EN

Official Journal of the European Union

6.5.2003

INFORMATION REQUIRED IN NOTIFICATIONS UNDER ARTICLE 4

ANNEX I

(a) Name, address and contact details of the exporter.

(b) Name, address and contact details of the importer.

(c) Name and identity of the GMO, as well as the domestic classification, if any, of the biosafety level of the GMO in

the State of export.

(d)

Intended date or dates of the transboundary movement, if known.

(e) Taxonomic status, common name, point of collection or acquisition, and characteristics of recipient organism or

parental organisms related to biosafety.

(f) Centres of origin and centres of genetic diversity, if known, of the recipient organism and/or the parental organisms

and a description of the habitats where the organisms may persist or proliferate.

(g) Taxonomic status, common name, point of collection or acquisition, and characteristics of the donor organism or

organisms related to biosafety.

(h) Description of the nucleic acid or the modification introduced, the technique used, and the resulting characteristics

of the GMO.

(i)

Intended use of the GMO or products thereof, namely, processed materials that are of GMO origin, containing
detectable novel combinations of replicable genetic material obtained through techniques listed in Annex I A, Part 1
of Directive 2001/18/EC.

(j) Quantity or volume of the GMO to be transferred.

(k) A previous and existing risk assessment report consistent with Annex II of Directive 2001/18/EC.

(l)

Suggested methods for the safe handling, storage, transport and use, including packaging, labelling, documentation,
disposal and contingency procedures, where appropriate.

(m) Regulatory status of the GMO within the State of export (for example, whether it is prohibited in the State of
export, whether there are other restrictions, or whether it has been approved for general release) and, if the GMO is
banned in the State of export, the reason or reasons for the ban.

(n) Result and purpose of any notification by the exporter to other States regarding the GMO to be transferred.

(o) A declaration that the abovementioned information is factually correct.

6.5.2003

EN

Official Journal of the European Union

C 107 E/11

ANNEX II

INFORMATION REQUIRED UNDER ARTICLE 9

(a) The name and contact details of the applicant for a decision for domestic use.

(b) The name and contact details of the authority responsible for the decision.

(c) Name and identity of the GMO.

(d) Description of the gene modification, the technique used, and the resulting characteristics of the GMO.

(e) Any unique identification of the GMO.

(f) Taxonomic status, common name, point of collection or acquisition, and characteristics of recipient organism or

parental organisms related to biosafety.

(g) Centres of origin and centres of genetic diversity, if known, of the recipient organism and/or the parental organisms

and a description of the habitats where the organisms may persist or proliferate.

(h) Taxonomic status, common name, point of collection or acquisition, and characteristics of the donor organism or

organisms related to biosafety.

(i) Approved uses of the GMO.

(j) A risk assessment report consistent with Annex II to Directive 2001/18/EC.

(k) Suggested methods for the safe handling, storage, transport and use, including packaging, labelling, documentation,

disposal and contingency procedures, where appropriate.

C 107 E/12

EN

Official Journal of the European Union

6.5.2003

ANNEX III

INFORMATION REQUIRED UNDER ARTICLE 14

(a) Available relevant information on the estimated quantities and relevant characteristics and/or traits of the GMO.

(b) Information on the circumstances and estimated date of the release, and on the use of the GMO 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) Any other relevant information; and

(e) A contact point for further information.

6.5.2003

EN

Official Journal of the European Union

C 107 E/13

STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. On 18 February 2002, the Commission submitted to the Council its proposal for a Regulation of
the Council on the transboundary movement of genetically

the European Parliament and of
modified organisms.

2. The Economic and Social Committee delivered its Opinion on 17 July 2002.

3. The Committee of the Regions delivered its Opinion on 16 May 2002.

4. The European Parliament adopted its Opinion at first reading on 24 September 2002.

5. On 4 March 2003, the Council adopted its common position in accordance with Article 251(2) of

the Treaty.

II. OBJECTIVE

This proposal for a regulation on transboundary movements of genetically modified organisms (GMOs)
will be part of the legislation necessary to ensure the implementation of the Cartagena Protocol on
Biosafety (‘the Protocol’), which has been established under the Convention on Biological Diversity.

In accordance with the precautionary principle, the objectives of this Regulation are to establish a
common system of notification and information for transboundary movements of GMOs and to ensure
coherent implementation of the provisions of the Protocol on behalf of the Community in order to
contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use
of GMOs that may have adverse effects on the conservation and sustainable use of biological diversity,
taking also into account risks to human health.

III. ANALYSIS OF THE COMMON POSITION

1. General

In 2002 it was decided, after consultation of the European Parliament, to conclude the Protocol on
behalf of the European Community. The Protocol will enter into force when 50 Parties have deposited
the necessary instrument.

Against this background this proposal, which is based on Article 175(1) of the EC Treaty, is mainly
concerned with the establishment of a common system of notification and information for trans-
boundary movements of GMOs to third countries and with unintentional transboundary movements,
which is needed in order to ensure implementation of the provisions of the Cartagena Protocol relating
to those issues. Other provisions of the Protocol fall under other Community legislation.

In general, the Council has agreed upon an approach where the Protocol is followed closely. Within
that context, there nevertheless are concrete formulations, which follow EU practice where this has
been seen as legally or politically necessary, eg. the term ‘living modified organisms’ used in the
Protocol is not used, since the EU internal terminology ‘genetically modified organism’ is understood
to be an equivalent term and is the generally applicable term within the EU.

The Council finds it relevant to consider the relationship to possible non-Parties under the Regulation,
since not all countries interested in the substance matter regulated under the Protocol nor all signa-
tories to the Protocol will necessarily be Parties to the Protocol at the time of its entry into force. The
Council has agreed, on the basis of the context of the various articles and paragraphs, upon those parts
of the Regulation which should also relate to non-Parties.

The Commission has not accepted the common position agreed by the Council.

C 107 E/14

EN

Official Journal of the European Union

6.5.2003

2. European Parliament Amendments

In its Plenary vote on 24 September 2002, the EP adopted 45 amendments to the proposal.

(a) 33 of these have been incorporated (25 to the Articles and 8 to the recitals), either verbatim, in part

or in spirit, into the Council's common position:

Amendment 1 is reflected in recital 3.

Amendment 2 is reflected in recital 4.

Amendment 3 is reflected in recital 20 setting out the general
principle for this Regulation.

importance of the precautionary

Amendment 4, 14 and 23, first part, are reflected in recital 7, Article 3 and Article 6 respectively.
These amendments relate to the term ‘notifier’, which would not be precise and practical and has
therefore, throughout the text, been replaced with the concrete economic operator in question,
primarily the ‘exporter’.

Amendment 5 is reflected in recital 9 recognising the importance of capacities, which are relevant
for a number of general purposes and also for making the informed decisions necessary under the
Cartagena Protocol. The Council finds that the Commission and Member States should generally
make sustained efforts to enable the relevant countries to further develop their human resources
and institutional capacities. It is not considered appropriate to set out obligations regarding the
general issue of capacity building in a specific regulation such as this. Amendment 47 aims at
introducing such obligations in the operative text of this concrete regulation and was therefore not
accepted.

Amendment 6, 8, 11 together with 56, 12, 13 and 43 are of an editorial nature and they have been
introduced into the text in the most appropriate way with their editorial purpose in mind. These
amendments are reflected, respectively, in recital 10, 17, Article 2(3) (which is deleted) together
with Article 8(1), Article 3, point 6, Article 3, point 7 and Article 15(2)(g).

Amendment 7 is reflected in recital 15 (see also amendment 45 below).

Amendment 10 is reflected in Article 2(2), but in a wording somewhat closer to the Protocol.

Amendment 18 concerns the issue of a precise definition of ‘transboundary movement’ and is as
such reflected in Article 3, point 14.

Amendment 21 and 60 cover some of the same points. Amendment 21 covers four elements and
amendment 60 covers four elements. The first and second elements of amendment 21 (‘. . .
communicate its decision . . .’ and ‘in calculating the time . . .’) are reflected in Article 5(2) of the
common position. The third and fourth elements of amendment 21 (‘A failure by the Party . . .’ and
‘No export may . . .’) and the second element of amendment 60 (‘. . . shall take place without . . .’)
are reflected in Article 5(1).

The first element of amendment 60 (‘directly or indirectly’) has not been accepted, since it is a new
concept departing from the terminology otherwise applied. The third element of amendment 60 is
of an editorial nature, but was not seen as improving the text. The fourth element of amendment
60 (‘exporter’) was accepted in line with amendment 4, 14 and 23 as set out above.

Amendment 24 and 25 are reflected in Article 16, which follows the Protocol's provisions regarding
confidential and non-confidential information.

6.5.2003

EN

Official Journal of the European Union

C 107 E/15

Amendment 28 is reflected in Article 9(1).

Amendment 29 covers a number of elements, which are reflected in Article 10 of the common
position with some modifications in the formulation bringing the text closer to the Protocol. In
addition, the requirement regarding authorisation within the Community has been supplemented by
the option that the competent authority of a third country has expressly agreed to the import in
question.

Amendment 34, 35 and 36 are reflected in Article 12(4).

Amendment 37 is reflected in Article 10(1).

Amendment 38 and 59 are reflected in Article 14(1).

Amendment 40 is reflected in Article 14(2)(b), with the addition of the word ‘significant’.

Amendment 46 is reflected in Article 19(1).

Amendment 50 and 51 contain three elements. The third element (‘intended for contained use or for
transit’) is reflected in Article 11(1) together with Article 13 of the common position.

(b) 12 amendments have not been incorporated and another 4 have only been partially incorporated.

These 16 can be grouped as follows:

Amendment 9 seems to aim at the somewhat diffuse concept of ‘facilitation’ and at respect for any
element of importing country's regulatory framework. The Council finds that these elements could
give rise to a number of problems of interpretation and has decided to focus on respect for the
concrete decision by the Party or non-Party of Import (see amendment 21 and 60 together with
Article 5(1) of the common position)

Amendment 15 is close to the text of the Protocol, but is not accepted, since the Council has agreed
to follow the principle of keeping the text close to the Community's Custom Code in order to avoid
special wording on this point in this concrete Regulation.

Amendment 16 and 17 are of an editorial nature and suggest to use the term ‘ratified’ rather than the
broader ‘concluded’, which formally encompasses a.o. ratification and approval, and which has been
generally used by the Community. The Council does not find it appropriate to use ‘ratified’ on an
ad hoc basis.

Amendment 23, second part, is not accepted. This concerns an obligation for the Commission to
make notifications by exporters to Parties or non-Parties of Import publicly available, but the
Commission does not possess those notifications.

Amendment 27 is not accepted, since the Council finds that such an additional notification to the
BCH is not necessary in the light of the obligations under the Protocol. The Council finds it relevant
to point out that provisions regarding the relevant information to the BCH are set out in Article
15(1)(e) and Article 15(2)(c).

Amendment 30 is not accepted, since it addresses special cases of notification of items which do not
contain GMOs or GMOs intended for contained use, which is not necessary having regard to the
obligations under the Protocol. Moreover, this amendment seems to address issues of compliance
by an exporter with the possible legislation of a Party or non-Party of
Import, where such
compliance could be expected to be inherently required,
if the legislation in question has been
correctly adopted and is consistent with the Protocol.

C 107 E/16

EN

Official Journal of the European Union

6.5.2003

Amendment 31 and 53 are not accepted as such, since these amendments seem to address issues of
compliance by an exporter with the possible legislation of a Party or non-Party of transit. Such
compliance could be expected to be inherently required,
if the legislation in question has been
correctly adopted and is consistent with the Protocol. The Council finds it relevant to point out that
Article 13 of the common position covers notification of transit of GMOs in a formulation closely
following the Protocol.

Amendment 32 is not accepted, since the main additional wording contained in this amendment
addresses transit and periods of storage interrupting transit, and these are not considered to be
particular situations, which should be addressed with exceptional attention, as compared with other
steps during the transboundary movement of a GMO.

Amendment 44 is not accepted, since it goes beyond the general conditions applying to the
establishment of national penalties.

Amendment 45 is not accepted, since it does not constitute an operational legal provision. The
Council finds it relevant to point out that the Community and Member States do already support
the process in question, which is set out in recital 15 thus also reflecting amendment 7.

Amendment 47 is not accepted, since it aims at introducing obligations regarding the general issue
of capacity building in a specific regulation such as this. The Council finds that the Commission
and Member States should generally make sustained efforts to enable the relevant countries to
further develop their human resources and institutional capacities, whereas it is not considered
appropriate to set out obligations on this general issue in this concrete regulation. Amendment 5
aims introducing a recital with regard to the general issue and is accepted by the Council (see
above).

Amendment 50 and 51 contain three elements. The first and second element (‘for which approval for
deliberate release has been provided by that country’) are not accepted, since they could bring about
a conflict with the general principle in Article 4 of the common position formulated as ‘. . . shall
ensure notification . . . prior to the first intentional transboundary movement . . .’ regardless of any
already existing approval by the Party of Import. Furthermore, the amendment does not qualify the
approval in question, whereas the common position has added ‘the use specified in accordance with
Annex I, point (i)’.

Amendment 60 has, in part, not been accepted as stated above under amendment 21. The first
element of amendment 60 (‘directly or indirectly’) has not been accepted, since it is a new concept
departing from the terminology otherwise applied. The third element of amendment 60 is of an
editorial nature, but was not seen as improving the text. The fourth element of amendment 60
(‘exporter’) was accepted in line with amendment 4, 14 and 23 as set out above.

IV. CONCLUSION

The Council considers that its common position takes account of the Opinion of the European
Parliament at first reading to a large extent. The Council's common position represents a balanced
solution with the combined aim of ensuring that the Community and its Member States can live up to
their obligations under the Protocol by establishing a regime for transboundary movements of GMOs
taking into account of the important principles of proportionality and precaution as well as respect for
the concrete decisions by possible importing countries.