Proposal for a Regulation of the European Parliament and of the Council on the transboundary movement of genetically modified organisms
Date: 2002-02-18
Institutions: European Commission
Subjects: biotechnology, cross-border transport, environmental risk prevention, genetically modified organism, transfrontier pollution

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Official Journal of the European Communities

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Proposal for a Regulation of the European Parliament and of the Council on the transboundary
movement of genetically modified organisms

(2002/C 151 E/04)

(Text with EEA relevance)

COM(2002) 85 final — 2002/0046(COD)

(Submitted by the Commission on 18 February 2002)

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,

Having regard to the opinion of the Economic and Social
Committee,

Having regard to the opinion of the Committee of the Regions,

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

Whereas:

(1) The Cartagena Protocol on Biosafety to the Convention
on Biological Diversity (hereinafter referred to as the
Protocol), was
signed by the Community and its
Member States on 24 May 2000.

(2) The Cartagena Protocol on Biosafety,

that,

in its Article 1,
specifies
in accordance with the precautionary
approach contained in Principle 15 of the Rio declaration,
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
resulting from modern biotechnology that may have
adverse effects on the conservation and sustainable use
of biological diversity, taking also into account risks to
and specifically focussing on trans-
human health,
boundary 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
and repealing Council Directive 90/220/EC (1), as last
amended by Regulation (EC)
the European
Parliament and of the Council concerning the traceability
and labelling of genetically modified organisms invited the
Commission to bring forward a legislative proposal for
implementing the procedures laid down in the Protocol
and,
requiring
Community exporters to ensure that all requirements of

accordance with

Protocol,

. . . of

the

in

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

the Advance Informed Agreement Procedure, as set out in
Articles 7 to 10, 12 and 14 of the Protocol, are fulfilled.

(4) It is important to organise the supervision and control of
transboundary movements of GMOs in order to take
account of conservation and sustainable use of biological
diversity, taking also into account risks to human health.

(5) Since

does

Community

contain
legislation
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.

not

(6) Exports of GMOs should be notified to the country of
import, allowing it to make an informed decision, based
on risk assessment carried out in a scientifically sound
manner.

(7) The notification should be ensured by the exporter, which
is legally responsible vis-à-vis its contracting party for the
product
it sells. The notifier, normally the exporter,
should be responsible for the accuracy of the information
provided in the notification.

(8) According to the Protocol,

the Community may take
action that is more protective of the 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 the Community's other obligations
under international law.

(9) According to the Protocol, the Community may apply its
the movements of

domestic legislation in respect of
GMOs within its customs territory.

legislation,

(10) The Protocol provides that Parties may decide to apply
either the procedures of the Protocol or their domestic
regulations with respect to imports of GMOs. As existing
and in particular Directive
Community
2001/18/EC and sectoral
legislation providing for a
specific risk assessment to be carried out in accordance
with the principles set out
in that Directive, already
contain rules which are in line with the objectives of
the Protocol, there is no need to adopt supplementary
provisions with regard to imports of GMOs into the
Community.

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as

(11) 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),
last amended by Commission Directive
2001/7/EC (2), 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 (3),
amended by Commission Directive
2001/6/EC (4), already contain appropriate rules, there is
no need to adopt
in this
respect.

supplementary provisions

last

as

to

imports

(12) It is necessary to ensure the identification of GMOs being
exported from or imported into the Community. With
existing
regard
Community legislation, in particular Regulation (EC) . . .
of the European Parliament and of the Council concerning
the traceability and labelling of genetically modified
organisms, already contain appropriate provisions. With
regard to exports similar rules should apply.

the Community

into

(13) In order to respond efficiently to unintentional

adverse

to human health, Member States

trans-
boundary movements of GMOs that are likely to have a
conservation and
significant
effect on the
taking account
sustainable use of biological diversity,
risks
from whose
territory such a movement originates should take appro-
priate measures to inform affected or potentially affected
States, the Biosafety Clearing House (the BCH) and, where
appropriate,
international organisations when
they become aware of such an occurrence under their
jurisdiction.

relevant

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

(15) Member States

should lay down rules on penalties
applicable to infringements of the provisions of this Regu-
lation and ensure that
they are implemented. Those
penalties must be effective, proportionate and dissuasive.

(16) This Regulation respects

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

the fundamental

(1) OJ L 319, 12.12.1994, p. 7.
(2) OJ L 30, 1.2.2001, p. 43.
(3) OJ L 235, 17.9.1996, p. 25.
(4) OJ L 30, 1.2.2001, p. 42.

HAVE ADOPTED THIS REGULATION:

CHAPTER I

OBJECTIVES, SCOPE AND DEFINITIONS

Article 1

Objective

In accordance with the precautionary principle, the objective of
this Regulation is to establish a common system of notification
and information for exports to third countries of genetically
modified organisms (GMOs) 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 the sustainable use of biological diversity,
taking also into account risks to human health.

Article 2

Scope

1.
This Regulation shall apply to the export and uninten-
tional transboundary movement of all GMOs that may have
adverse effects on the conservation and sustainable use of
biological diversity, taking also into account risks to human
health.

Pharmaceuticals for human use are excluded from the

2.
scope of this Regulation.

for

GMOs

release

intended

deliberate

3.
the
environment identified in a decision of the Conference of the
Parties 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 are excluded from the scope of Section 1
of this Regulation.

into

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

or

3.

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

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4.

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

(a) the permanent or temporary leaving of the customs
territory of the Community of products meeting the
conditions of Article 23(2) of the Treaty,

5.

‘Contained use’ means:

(a) activities

defined

of Directive
in Article
90/219/EEC on the contained use of genetically
modified micro-organisms (1), as
last amended by
Directive 98/81/EC,

2(c)

(b) the re-export of products not meeting the conditions
referred to in (a) which are placed under a custom
procedure other than transit procedure.

13.

‘Import’ means the placing under a customs procedure
other than transit procedure of products introduced into
the customs territory of the Community;

(b) activities in which GMOs 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 to
limit their contact with the general population and the
environment.

14.

6.

‘Product’ means product as defined in Article 2(7) of
Directive 2001/18/EC;

‘Exporter’ means any natural or legal person 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 for determining the sending of the item out of
the customs territory of
If no export
the
contract has been concluded or if
contract does not act on its own behalf, the power for
determining the sending of the item out of the customs
territory of the Community shall be decisive;

the Community.

the holder of

7.

8.

9.

‘Food’ means food as defined in [Article 2 of the Proposal
for a Regulation laying down the general principles and
requirements of food law, establishing the European Food
Authority, and laying down procedures in matters of
food (2)];

‘Feed’ means feed as defined in [Article 3(4) of the Proposal
for a Regulation laying down the general principles and
requirements of food law, establishing the European Food
Authority, and laying down procedures in matters of
food];

the information
‘Notification’ means the submission of
competent
required
authority of a Party to the Protocol or to the relevant
authorities of non-Parties;

this Regulation to the

under

10.

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

11.

‘Notifier’ means the natural or legal person submitting the
notification;

12.

‘Export’ means:

(1) OJ L 117, 8.5.1990, p. 1.
(2) OJ C 96 E, 27.3.2001, p. 247.

15.

‘Party’ means any country or regional organisation having
concluded the Protocol;

16.

‘non-Party’ means any country or regional organisation not
having concluded the Protocol;

17.

‘The Protocol’ means the Cartagena Protocol on Biosafety
to the Convention on Biological Diversity;

18.

‘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;

19.

‘Competent national authority’ means
competent
authority designated by the Parties to the Protocol which
is responsible for performing the administrative functions
required by the Protocol and which shall be authorised to
act on its behalf with respect to those functions;

the

20.

‘Focal point’ means the entity designed by a Party to be
responsible on its behalf for liaisons with the Secretariat;

21.

‘Secretariat’ means the Secretariat to the Protocol.

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CHAPTER II

EXPORTS OF GMOs TO THIRD COUNTRIES

S e c t i o n 1

including placing on the market, of a GMO that may be
subject to transboundary movements for direct use as food
or feed or for processing. This notification shall be sent to
the BCH within fifteen days of the adoption of that decision.

Exports of GMOs intended for deliberate release into the
environment

This paragraph shall not apply to decisions regarding field
trials.

Article 4

Notification to Parties and non-Parties of Import

a GMO intended for deliberate

The exporter shall ensure notification, in writing, to the
1.
the Party or non-Party of
competent national authority of
Import prior to the first intentional transboundary movement
of
into their
environment. The notification shall contain, at a minimum,
the information specified in Annex I. The notifier
shall
ensure that the information contained in the notification is
accurate.

release

Section 1 shall not apply to GMOs intended for direct use

2.
as food or feed, or for processing.

Article 5

Cases of non-reply to notifications

In cases where the Party or non-Party of Import does not reply
to a notification within 270 days from the date of receiving the
notification, the exporter shall send a written reminder to the
competent national authority of that Party or non-Party of
Import, with copy to the Secretariat, with a deadline of 60
days from receipt for response.

2.
The information referred to in paragraph 1 to the
Biosafety Clearing House shall contain as a minimum the
information specified in Annex II.

The Commission shall process requests made by any
information regarding the decisions

3.
Party for additional
referred to in paragraph 1.

4.
A copy of this information shall be sent, in writing, to
the national focal point of each Party that informs the Secre-
tariat in advance that it does not have access to the BCH.

S e c t i o n 3

Common provisions

Article 9

Identification

Exporters shall ensure that the following information is

1.
transmitted to the operator receiving the product:

Article 6

(a) that it contains or consists of GMOs,

Informing the Party of Export

(b) the relevant unique code(s) assigned to those GMOs.

The exporter, or the notifier, shall keep a record of the notifi-
cation and the acknowledgement of receipt and send a copy of
these documents to the competent national authority of the
Member State of Export and to the Commission.

Article 7

Transit

the transit of GMOs
The exporter ensures notification of
intended for deliberate
to
environment
Parties that have taken the decision to regulate transit of
GMOs through their territory and have notified this decision
to the Biosafety Clearing House (the BCH).

into the

release

However, the information under (b) above may be replaced by
a declaration by the operator that the product shall only be
used as food or feed, or for processing, together with the
unique codes for the GMOs that the product may contain.

Paragraph 1 is without prejudice to other

2.
specific
requirements in Community legislation and to international
identification requirement
to be developed in accordance
with Article 18 of the Protocol.

CHAPTER III

S e c t i o n 2

UNINTENTIONAL TRANSBOUNDARY MOVEMENT

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

Article 8

Notification to the BCH

1.
The Commission shall notify to the BCH, on behalf of the
Community, any final decision regarding Community use,

Article 10

leads, or may lead,

1.
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 take the following action:

taking into account risks to human health,

to an unintentional

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(a) take the appropriate measures to inform the public and
notify without delay the Commission, other Member
States, affected or potentially affected States,
the BCH,
and, where appropriate,
international organi-
sations,

relevant

(b) consult the affected or potentially affected State to enable it
to determine appropriate responses and initiate necessary
action, including emergency measures.

Any information arising from paragraph 1 shall include

2.
the information specified in Annex III.

CHAPTER IV

COMMON PROVISIONS

Article 11

Participation to the international information procedure

(e) 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

(f) any information concerning cases of unintentional or illegal
transboundary movements, in accordance with Articles 17
and 25 of the Protocol;

(g) Community contact point for notification of unintentional
transboundary movement, in accordance with Article 17 of
the Protocol;

The Member States

1.
provisions of the Protocol notify to the Commission:

in accordance with the

shall

(h) any review of decisions regarding an intentional

trans-
in accordance with Article 12 of

boundary movement,
the Protocol;

(a) national

legislation and guidelines

implementation of
Article 20.3(a) of the Protocol;

the Protocol,

relevant

the
in accordance with

for

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

(j)

regional and multilateral agreement and
(c) any bilateral,
arrangements
transboundary
movements of GMOs, in accordance with Article 20.3(b)
of the Protocol;

intentional

regarding

(i) application of Community legislation instead of

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

the Protocol

reports submitted pursuant to Article 20 of this Regulation,
including those on implementation of
advanced
informed
in accordance with
Article 20.3(e) of the Protocol.

agreement procedure,

the

(d) information concerning cases of
movements pertaining to them,
Article 25 of the Protocol.

illegal
transboundary
in accordance with

Competent national authorities and focal points

1.

The Commission shall designate one focal point.

Article 12

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

(a)

information notified by the Member States pursuant
paragraph 1;

to

(b) Community legislation and guidelines

implementation of
Article 20.3(a) of the Protocol;

the Protocol,

relevant

the
in accordance with

for

(c) any bilateral,

regional and multilateral agreement and
arrangements at the Community level regarding intentional
transboundary movements of GMOs,
in accordance with
Article 20.3(b) of the Protocol;

(d) any final decision regarding the use within the Community,
in accordance

the release or the importation of a GMO,
with Articles 11 and 20.3(d) of the Protocol;

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

The Commission, on behalf of the EC, and the Member
3.
States shall, no later than the date of entry into force of the
Protocol for them, notify the Secretariat of the names and
addresses of their focal points and their competent national
authority or authorities. Where a Member State designates
more than one competent national authority, it shall convey
to the Secretariat, with its notification, relevant information on
the respective responsibilities of
those authorities. Where
applicable, such information shall, at a minimum, specify
which competent national authority is responsible for which
type of GMO. The Commission and the Member States shall
forthwith notify the Secretariat of any changes in the desig-
nation of their national focal points or in the name and address
or responsibilities of
their competent national authority or
authorities.

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Article 13

Penalties

The Member States shall
lay down the rules on penalties
applicable to infringements of the provisions of this Regulation
and shall take all measure 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 (date) at the latest [180
days following the date of publication of this Regulation in the
Official Journal of the European Communities] and shall notify it
without delay of any subsequent amendment affecting them.

Article 14

Monitoring and reporting

1. Member States shall regularly forward to the Commission
information on the implementation of the present Regulation.

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 serving as the meeting of the
Parties to the Protocol.

Article 15

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 Communities.

This Regulation shall apply from the day of entry into
2.
force of
the
the Protocol, according to Article 37(1) of
Protocol, or ninety days after the date of the deposit of the
instrument of ratification by the Community, whichever shall
be the later.

2.
The Commission shall, at intervals to be determined by
the Conference of the Parties serving as the meeting of the

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

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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 genetically modified organism, as well as the domestic classification,

if any, of the

biosafety level of the genetically modified organism 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 genetically modified organism.

(i)

Intended use of the genetically modified organism or products thereof, namely, processed materials that are of
genetically modified organism 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 genetically modified organism 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 genetically modified organism 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 genetically modified organism 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 genetically modified organism

to be transferred.

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

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ANNEX II

INFORMATION REQUIRED UNDER ARTICLE 8

(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 genetically modified organism.

(d) Description of the gene modification, the technique used, and the resulting characteristics of the genetically modified

organism.

(e) Any unique identification of the genetically modified organism.

(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 genetically modified organism.

(j) A risk assessment report consistent with Annex II of 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.

ANNEX III

INFORMATION REQUIRED UNDER ARTICLE 10

(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 point of contact for further information.