WRITTEN QUESTION P-2576/99 by Michael Cashman (PSE) to the Commission. Dietary and natural health products.
Date: 1999-12-16
Institutions: European Parliament, Provisional data
Subjects: EU law, approximation of laws, competence of the Member States, dietary product, drugs classification, food supplement, marketing, medicinal product

8.8.2000

EN

Official Journal of the European Communities

C 225 E/171

Answer given by Mr Byrne on behalf of the Commission

(4 February 2000)

The Belgian authorities were asked to send comments on the facts reported by the Commission(cid:146)s food and
veterinary office (FVO) in relation to a mission to Belgium on the protection of animals during transport.
Although a reminder was sent and a new date of 30 August 1999 was fixed by which the authorities were
to inform the Commission of measures taken to rectify the deficiencies, a reply has still not been received.

The Commission will shortly take a decision with regard to opening infringement proceedings under
Article 226 (ex-Article 169)of the EC Treaty in respect of the reported breaches by Belgium of its
obligations under Council Directive 91/628/EEC as amended by Directive 95/29/EC of
June 1995,
concerning the protection of animals during transport (1).

Concerning the recommendations of the report of the FVO mission to Ireland on the protection of animals
during transport carried out during 1998 and 1999, the Commission was informed by the Irish authorities
that a programme would be initiated targeting in particular the deficiencies highlighted within the country.
The Commission has not yet received this programme.

The Commission has recently convened a new working group on the protection of animals during long
distance transport which aims to consider all the problems involved in the enforcement of the relevant
directives and possible solutions to these problems. Representatives of the authorities from Belgium and
Ireland are both participating in this working group.

(1) OJ L 148, 30.6.1995.

(2000/C 225 E/189)

WRITTEN QUESTION P-2576/99

by Michael Cashman (PSE) to the Commission

(16 December 1999)

Subject: Dietary and natural health products

Could the Commission please indicate whether there is any intention to harmonise legislation with regard
to dietary supplements and natural health products?

Could the Commission also outline the differing positions of the Member States regarding the classification
of health products as medicines?

Answer given by Mr Liikanen on behalf of the Commission

(12 January 2000)

The Commission had intended to put forward a proposal for a Parliament and Council directive on food
supplements containing vitamins and minerals early in the year 2000.

The term (cid:145)natural health product(cid:146) is not defined in Community legislation and the Commission has no
intention to propose specific measures regarding these products. Existing Community pharmaceutical
legislation makes no distinction between (cid:145)natural(cid:146) or (cid:145)non-natural(cid:146) products. According to Article 1 of
Council Directive 65/65/EEC, of 26 January 1965 on the approximation of provisions laid down by law,
regulation or administrative action relating to proprietary medicinal products (1), any substance or
combination of substances presented for treating or preventing disease in human beings or animals shall
be regarded as a medicinal product. Likewise, any substance or combination of substances which may be
administered to human beings or animals with a view to making a medicinal diagnosis or to restoring,
correcting or modifying physiological functions in human beings or animals, has to be considered a
medicinal product. The decision whether a (cid:145)natural health product(cid:146) falls under the above definition of
medicinal product and therefore needs to be authorised as medicinal product must be taken by the
national authorities on a case by case approach, taking into account both the ingredients and the
presentation of a concrete (cid:145)health product(cid:146).

C 225 E/172

Official Journal of the European Communities

EN

8.8.2000

It is up to the regulatory authorities in Member States to apply the above principles of Community
pharmaceutical legislation and to take concrete decisions on authorisations and restrictions (e.g. medical
prescription) for specific products. The Commission is not considering a proposal to change that approach.

In the context of this question, the attention of the Honourable Member is also drawn to the answer
already delivered by the Commission to Written Question P-2317/99 by Mr Fitzsimons (2) on regulatory
control on herbal medicinal products in the Community.

(1) OJ 22, 9.2.1965.
(2)
See page 97.

(2000/C 225 E/190)

WRITTEN QUESTION P-2577/99

by Alexander de Roo (Verts/ALE) to the Commission

(16 December 1999)

Subject: Transport of animals

It is clear from recent television pictures of horse transport that the provisions of the Transport of Animals
Directive are not being properly enforced in many Member States.

The Commission has a duty to monitor the way that Member States are enforcing this Directive. However,
for some years now, only one Inspector from the Food and Veterinary Office has been given this task.
When will the Commission take its responsibilities in this area more seriously and increase the number of
Inspectors to 12, as demanded by the Council of Agriculture Ministers in June 1995?

Answer given by Mr Byrne on behalf of the Commission

(27 January 2000)

The Commission is aware of the problems in relation to animal welfare reported by different television
broadcasters in Europe. Reports by its food and veterinary office (FVO) and complaints from various
animal welfare organisations also indicate that problems continue to exist in this domain.

The Commission fully shares the Honourable Member(cid:146)s views on the importance of protecting animal
welfare in the field of transport.

The Commission is still in the process of recruiting inspection personnel and a number of new staff have
specific responsibilities for monitoring the implementation of animal welfare legislation which applies in
the Member States. The Commission is aware of the increasing importance attached to animal welfare by
consumers and will continue to ensure that, amongst its other responsibilities, animal welfare will be given
corresponding importance.

Given the importance of the issue, inspectors take account of animal welfare issues during missions in
Member States. The practice of performing combined inspections will increase the level of information
available concerning the enforcement of Community legislation in this field.