Opinion of the Economic and Social Committee on the "Proposal for a Regulation of the European Parliament and of the Council on the transboundary movement of genetically modified organisms" (COM(2002) 85 final — 2002/0046 (COD))
Date: 2002-07-17
Institutions: European Economic and Social Committee
Subjects: biotechnology, cross-border transport, environmental risk prevention, export, genetically modified organism, information system, third country, transfrontier pollution

C 241/62

EN

Official Journal of the European Communities

7.10.2002

Opinion of the Economic and Social Committee on the ‘Proposal for a Regulation of the European
Parliament and of the Council on the transboundary movement of genetically modified organisms’

(COM(2002) 85 final — 2002/0046 (COD))

(2002/C 241/11)

On 1 March 2002 the Council decided to consult the Economic and Social Committee, under Article 175
of the Treaty establishing the European Community, on the above-mentioned proposal.

The Section for Agriculture, Rural Development and the Environment, which was responsible for
preparing the Committee’s work on the subject, adopted its opinion on 21 June 2002. The rapporteur
was Mr Espuny Moyano.

At its 392nd Plenary Session (meeting of 17 July 2002), the Economic and Social Committee adopted the
following opinion by 123 votes to two with two abstentions.

1. Commission proposal

1.1.
In the framework of the Cartagena Protocol on Bio-
safety, the Commission proposes setting up a common system
of notification and information on exports of GMOs to third
countries, with the aim of helping to ensure an adequate level
of protection in the field of safe transfer, handling and use of
GMOs.

The Commission proposal is divided into four chap-
1.1.1.
ters: ‘Objectives, scope and definitions,’ ‘Exports of GMOs to
third countries’, ‘Unintentional transboundary movement’ and
‘Common provisions’.

1.2.

Scope

1.2.1.
The proposed Regulation applies to the export and
unintentional transboundary movement 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.

1.2.2.
The Regulation excludes pharmaceuticals for human
use and GMOs intended for deliberate release into the environ-
ment that are identified in a decision of the parties to the
Protocol as being unlikely to have adverse effects.

acknowledgement of receipt and sends a copy of
these
documents to the competent national authority of the Member
State of export and to the Commission.

1.3.3.
The Commission notifies to the Biosafety Clearing
House (BCH), on behalf of the Community, any final decision
regarding Community use, 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.

Exporters ensure that the operator receiving the
1.3.4.
product is informed that it contains or consists of GMOs and
is given the relevant unique code(s) assigned to those GMOs
or a declaration from the operator that the product will only
be used as food or feed, or for processing, together with the
unique codes for the GMOs that the product may contain.

All the relevant

information must be forwarded
1.3.5.
to the BCH so that it can be properly coordinated and
harmonised.

1.3.

Exports of GMOs to third countries (Chapter II)

1.4. Unintentional transboundary movement

1.3.1.
Before the first transboundary movement of any
GMO intended for deliberate release into the environment, the
exporter must provide notification to the competent national
authority of the Member State of import.

If no reply is received within the proposed number
1.3.2.
of days after reception, the exporter must send a reminder.
The exporter keeps a record of the notification and the

1.4.1. When an incident occurs resulting in unintentional
transboundary movement of GMOs, the Member State takes
the necessary steps to inform the public and notify without
delay the Commission, other Member States, affected or
potentially affected States, the BCH, and, where appropriate,
relevant international organisations and to consult the affected
or potentially affected State. This information must include
the information specified in Annex III of the proposal.

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Official Journal of the European Communities

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1.5. Common provisions

3. Specific comments

The proposal sets out the information that Member
1.5.1.
States must notify to the Commission and that the Commission
must notify to the BCH.

The Commission must designate one focal point and
1.5.2.
each Member State designates its own and the competent
national authority.

1.5.3.
of penalties.

Each Member State establishes an appropriate system

2. General comments

The Committee

2.1.
importance of
implementing the Cartagena Protocol on Biosafety in order to
effectively ensure conservation and sustainable use of biologi-
cal diversity, as well as to avoid risks to human health.

recognises

the

2.2.
The EESC welcomes the Commission proposal because
it represents a further step towards clarifying the legislation
governing GMOs and gives considerable weight to the pre-
cautionary principle.

The EESC believes that the coordinating role given to

2.3.
the BCH will definitely have positive effects.

2.4.
The Commission’s proposal will not have an economic
impact on imports, which will still be subject to Community
rules. It will have a slight effect on exports, but will improve
legal security.

Brussels, 17 July 2002.

Article 23.2 of the Cartagena Protocol stipulates that
3.1.
the parties to the agreement shall endeavour to inform their
public about the means of public access to the Biosafety
Clearing-House (BCH). The EESC notes that the Commission’s
draft proposal makes no mention of this.

3.2.
Article 13 of the proposed Regulation (‘Penalties’)
stipulates that the Member States shall lay down the rules on
take all
penalties applicable to infringements and shall
measures necessary to ensure that they are implemented. The
EESC understands that Member States have sole responsibility
for the system of penalties, but nevertheless suggests that the
necessary steps be taken to harmonise both the definition of
infringements and the level of penalties in the different
countries.

3.3.
The EESC is concerned about the problem that might
arise if there is no response to notifications sent by the
exporter, which could effectively freeze exports and so have
negative economic effects. However, it considers that the long
deadlines allowed (60 days for acknowledging receipt of the
first notification, 270 days for responding to the notification,
plus 60 days for responding to a second notification sent if
there has not been a reply within the above-mentioned
deadline of 270 days) could have a negative effect on trade.
Could the deadlines be shortened?

3.4.
The EESC welcomes the Commission’s strict appli-
cation of the precautionary principle — in accordance with
Article 1 of the Cartagena Protocol — which was already
referred to in Principle 15 of the Rio Declaration on Environ-
ment and Development, in such a controversial sphere as the
deliberate or unintentional release of GMOs.

The President

of the Economic and Social Committee

Göke FRERICHS