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C 82/18 EN Official Journal of the European Communities 17. 3.


The administrative formalities required for embarking on a medical specialization vary from country to country
and depend in particular on the medical centre where the practice will be conducted. In the case of language tests,
Member States may, in accordance with Article 20 (3), take steps to see that applicants have the linguistic
knowledge necessary to the exercise of their profession.

For details, the Honourable Member should consult the Commission, which is responsible for following up the
application of Directives.

(98/C 82/25) WRITTEN QUESTION E-1908/97

by Amedeo Amadeo (NI) to the Commission
(4 June 1997)

Subject: Genetically modified organisms

Will the European Union establish a coherent, transparent and reliable procedure for genetically modified
organisms so that it can take a lead in these developments, from which, for political, economic and commercial
reasons, it cannot stand aside?

Will it, in particular, make the authorization of the production, marketing, processing and importing of GMOs
subject to the following principles:
1. strengthening the EU’s R&D policy concerning licencing and monitoring after the release of GMOs;
2. consultation procedure, transparency and information for all operators in the sector, from farmers to
consumers, with an adequate labelling system which can be monitored to enable them to make decisions in
full knowledge of the facts; in this context, the establishment of a coherent licencing, labelling and
monitoring system would seem necessary for imported products as well as for products of Community origin
to ensure that any problems which might arise can be resolved;
3. creation of an independent European scientific agency responsible for guaranteeing consumer safety and
confidence by implementing a transparent and reliable procedure for evaluating possible risks, providing
marketing authorizations for the single market and carrying out controls after the release of GMOs; it should
also have the task of contributing to the creation of an international framework;
4. detailed scientific evaluation, prior to issuing marketing authorizations, based on sufficiently extensive trial
data and, as an essential condition for such authorizations, continual monitoring after the release of GMOs to
ensure optimum guarantees for human health and environmental protection?

Answer given by Mr Santer on behalf of the Commission

(7 October 1997)

The Commission attaches great importance to the potential of genetic modification techniques and agrees that the
development of these new technologies should be considered in the appropriate international context. The rapid
progress of genetic modification technologies is accompanied by close regulatory attention to ensure up-to-date
and coherent approval and marketing procedures as well as the highest safety standards for consumers and the
environment in line with the precautionary principle.

1. Research and development relating to the safety of the release of genetically modified organisms (GMOs)
has been supported under successive Community framework programmes for research and technological
development. Particular attention has been given to biosafety and prenormative research in support of the
Community’s biotechnology regulations. Since 1986 some 175 laboratories have been supported on this topic at
a cost of 25 MECU. The Commission has proposed to strengthen such research under the fifth framework
programme (1).
17. 3. 98 EN Official Journal of the European Communities C 82/19

2. Community approval procedures for placing on the market of GMOs (in particular Directive
90/220/EEC (2) and the novel foods Regulation (EC) 258/97 (3) require a detailed scientific risk assessment and
no GMOs are authorized unless they are considered, on the basis of available scientific evidence, to be safe for
humans and the environment. The scientific basis for such assessment is continually up-dated according to
scientific and technological progress. The Commission recognizes fully that post-release monitoring can, in
some cases, contribute to a precautionary approach. Thus, in December 1996, when the Commission proposed to
approve the deliberate release and marketing of the genetically modified maize (Zea Mays L.), it also decided to
initiate a monitoring project for the possible development of insect resistance to the Bt-toxin.

3. The Commission launched earlier this year a new approach to scientific advice in the field of consumer
health and food safety (4) in order to strengthen the scientific basis of Community initiatives. In particular, this
move aims at ensuring the excellence of the relevant scientific advisory committees, their independence from
socio-economic and political influences as well as transparency of their working procedures and advice.

4. The novel foods Regulation, which entered into force in May 1997, establishes a framework for labelling
novel foods and novel food ingredients produced from GMOs. In addition, the Commission recently introduced a
labelling requirement for GMOs which will be notified for placing on the market under Directive 90/220/EEC.
Labelling requirements are also under consideration by the Commission in agricultural sectors such as animal
feed and seeds. In addition the Commission has decided to develop a general labelling approach which will be
based upon strict science and will include mandatory labelling to indicate the presence of GMO material. It will
be implemented both through existing and new legislation to be introduced as necessary.

(1) COM(97) 142.

(2) OJ L 117, 8.5.1990.
(3) OJ L 43, 14.2.1997.
(4) COM(97) 183 final.

(98/C 82/26) WRITTEN QUESTION E-1914/97

by Amedeo Amadeo (NI) to the Council
(5 June 1997)

Subject: Community system for fisheries and aquaculture

The ‘Proposal for a Council Regulation amending Regulation (EEC) No 3760/92 establishing a Community
system for fisheries and aquaculture’ (COM(96)0350 final − 96/0183 CNS) (1) is approved by the Committee on
the grounds that it clarifies the arrangements laid down by Regulation 3760/92 (2).

Will the Council take rigorous account of the level of resources in Community waters when allocating fishing
catches to third countries and consider how a relative balance between the fishing activities of each Member
State can be guaranteed in allocating catches?

(1) OJ C 316, 25.10.1996, p. 13.

(2) OJ L 389, 31.12.1992, p. 1.

(17 October 1997)

The Council can assure the Honourable Member that it always takes account of the principles of conservation of
ressources and relative stability of Member States’ fishing activities.