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C 310/90 EN Official Journal of the European Communities 9. 10.


In order to alleviate the possible social consequences of achieving this central objective of the Community, a
number of measures have been adopted at Community level in recent years with a view to reducing the scope for
abuse resulting from excessive discrepancies between national social systems. The directives in question cover
various areas of labour law (employment conditions, information and consultation of workers, health and safety)
and constitute a hard core of minimum rules to be observed throughout the Community.

The directives adopted in this connection include Directive 93/104/EEC (1) on the organisation of working time,
which lays down a number of minimum requirements which all Member States have to observe. However, this
directive, like all the others in this field, does not rule out more favourable national systems.

Under these circumstances it is the responsibility of each Member State to assess the possible consequences of
initiatives likely to have an effect on production costs and to adopt the measures it considers necessary, whilst in
all cases respecting freedom of movement and freedom to market goods and services.

(1) OJ L 307, 13.12.1993.

(98/C 310/120) WRITTEN QUESTION E-0566/98

by Jonas Sjöstedt (GUE/NGL) to the Commission
(4 March 1998)

Subject: Animal testing ethics committee

Sweden has long required that all animal experimentation be preceded by an examination of its ethical aspects,
by animal testing ethics committees on which both the scientific and public interests are represented. At present
those committees have an advisory function.

The Swedish Government is now proposing to the Swedish Parliament that the advisory nature of these
committees will have to be changed to give them decision-making powers. It claims that this change will be
necessary to ensure that Directive 86/609/EEC (1) may be regarded as having been transposed into Swedish law.

Does the Commission consider that Directive 86/609/EEC requires the Member States to set up regulatory
committees on the ethics of animal testing?

(1) OJ L 358, 18.12.1986, p. 1.

Answer given by Mrs Bjerregaard on behalf of the Commission

(7 April 1998)

Article 12, paragraph 1 of Directive 86/609/EEC on the protection of animals used for experimental and other
scientific purposes states that ‘Member States shall establish procedures whereby experiments themselves or the
details of persons conducting such experiments shall be notified in advance to the authority’ and paragraph 2
‘Where it is planned to subject an animal to an experiment in which it will, or may, experience severe pain which
is likely to be prolonged, that experiment must be specifically declared and justified to, or specifically authorised
by, the authority ...’.

Article 24 states that ‘This Directive shall not restrict the right of the Member States to apply or adopt stricter
measures ... In particular, Member States may require a prior authorisation for experiment or programmes of
work notified in accordance with the provisions of Article 12 (1).’

Pursuant to these provisions it is left to the Member States to determine the actual procedures for the notification
and authorisation of the experiments. A regulatory committee on the ethics of animal testing could form a part of
this procedure.
9. 10. 98 EN Official Journal of the European Communities C 310/91

Ethical aspects on animals experimentation are becoming increasingly important. The Commission is strongly
encouraging Member States to set up ethical committees for animal experimentation on a voluntary basis as part
of their regular review process.

(98/C 310/121) WRITTEN QUESTION E-0569/98

by Kenneth Collins (PSE) to the Commission
(4 March 1998)

Subject: Legal base of the regulation establishing the European Medicines Evaluation Agency

Does the Commission accept, as a consequence of the Amsterdam Treaty and President Santer’s statement to
Parliament in February 1997 on EU health policy following the BSE crisis, that the review which is required of
the regulation establishing the European Medicines Evaluation Agency will be conducted on the basis of Article
100a of the Treaty, rather than Article 235?

Answer given by Mr Santer on behalf of the Commission

(8 April 1998)

According to Article 71 of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community
procedures for the authorization and supervision of medicinal products for human and veterinary use and
establishing a European agency for the evaluation of medicinal products (1) the Commission shall publish a
general report on the experience acquired as a result of the operation of the procedures laid down in the
Regulation within six years. As the Regulation entered into force on 1 January 1995 the Commission will present
the report mentioned in Article 71 in the year 2001.

Based on that report it will be considered whether amendments of the Regulation are required. It is established
case law that the legal base of a Community act should reflect the content of the act. If the Commission on the
basis of the report proposes amendments to the Regulation, the legal base of the proposal would thus reflect the
content of such a proposal.

(1) OJ L 214, 24.8.1993.

(98/C 310/122) WRITTEN QUESTION E-0570/98

by Eryl McNally (PSE) to the Commission
(4 March 1998)

Subject: Plutonium storage

It has been suggested by the Royal Society that the rising stocks of plutonium in Britain pose the threat not only
of environmental damage but also that of being stolen for use in illicit nuclear weapons.

What extra difficulties does the Commission envisage, inn light of the above, for the European Union’s
responsibilities for nuclear safeguards and the monitoring of fissile material?

Answer given by Mr Papoutsis on behalf of the Commission

(7 April 1998)

The Commission in the framework of its obligation under Chapter VII of the Euratom Treaty already invests
substantial financial and human resources in safeguarding plants handling large amounts of plutonium to ensure
that the material is not diverted from its intended use.