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C 26 E/98 Official Journal of the European Communities EN 26.1.


Every medicinal product of whatever origin must comply with specific rules before it can be marketed and
used, whether in organic farming or in conventional animal husbandry. According to the principles laid
down in Article 4 of Directive 81/851/EEC, (2) no veterinary medicinal product may be marketed in a
Member State and no veterinary medicinal product may be administered to animals unless authorization
has previously been issued.

Directive 92/74/EEC (3) provides for a special simplified registration procedure for homeopathic veterinary
medicinal products. Under this simplified registration scheme, demonstration of efficacy of the product is
not required. Article 7 of this Directive, however, explicitly excludes from this simplified procedure
products which are intended for food producing animals.

The term ‘phytotherapeutic’ medicinal product is not known in Community pharmaceutical legislation and
medicinal products containing active herbal ingredients need to be authorised like any other veterinary
medicinal product. Therefore, according to Community pharmaceutical legislation both phytotherapeutic
and homeopathic veterinary medicinal products for food producing animals must be authorized in
accordance with the provisions of Directive 81/851/EEC, including the provisions concerning proof of
therapeutic effect.

These rules are intended to assure the quality, safety and efficacy of veterinary medicinal products. They
apply to anyone who places on the market and administers veterinary medicinal products to animals in the
Community. Neither vets nor farmers are  according to Community law  allowed to use homeopathic
or ‘phytotherapeutic’ veterinary medicinal products unless they have been authorized in accordance with
the provisions of Directive 81/851/EEC, including the provisions on the proof of therapeutic effect.

(1) Council Regulation (EC) No 1804/1999 of 19 July 1999 supplementing Regulation (EEC) No 2092/91 on organic
production of agricultural products and indications referring thereto on agricultural products and foodstuffs to
include livestock production.
(2) Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of theMember States
relating to veterinary medicinal products, OJ L 317, 6.11.1981.
(3) Council Directive 92/74/EEC of 22 September 1992 widening the scope of Directive 81/851/EEC on the
approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal
products and laying down additional provisions on homeopathic veterinary medicinal products, OJ L 297,

(2001/C 26 E/118) WRITTEN QUESTION E-0727/00
by Inger Schörling (Verts/ALE) to the Commission

(17 March 2000)

Subject: Infringement of Directives 85/337/EC and 97/11/EC

Since 1994 there have been plans in the county of Blekinge (Sweden) to construct a road through the
Rolandshav, a wetland area deserving protection whose natural value would be wholly or partially
destroyed by the building of such a road.

In December a complaint was brought before the Commission against the Blekinge county council for lack
of transparency, objective review and quality control in the application of Directive 85/337/EC (1) (as
amended by Directive 97/11/EC (2)). The complaint was also directed against the Ministry of Industry and
Commerce for its uncritical acceptance of a work plan for the construction of the road.

The complainant considers that the environmental impact assessments on which the decision was based
were faulty in a number of respects, and that the decision as taken cannot be considered correct. The
complainant further maintains that the environmental impact assessment did not meet the requirement for
relevant data, nor did it identify, describe or assess the direct or indirect impact of the road construction
on the eco-system within the area of countryside affected. (In the material which has been made public
there are in fact downright inaccuracies. The information material stated that the University of Lund was
responsible for the assessment of natural values in the environmental impact assessment, whereas the
University of Lund was not even involved in the assessment).
26.1.2001 EN Official Journal of the European Communities C 26 E/99

What progress has the Commission made in dealing with this case, and what measures can it take?

What penalties can the Commission impose if Sweden continues to apply Directives 85/337/EC and 97/
11/EC on environmental impact assessments in an incorrect manner?

(1) OJ L 175, 5.7.1985, p. 40.
(2) OJ L 73, 14.3.1997, p. 5.

Answer given by Mrs Wallström on behalf of the Commission

(13 April 2000)

In response to this complaint, the Commission is conducting an investigation in order to assess whether
the relevant Community environmental legislation has been complied with. The investigation concerns the
allegations made by the complainant relating to the content of the environmental impact assessment
carried out and the information which has been provided to the public. As further information is required,
the Commission has requested the observations of the Swedish authorities on this matter.

The Commission has no competence to issue any sanctions against Member States for infringements of
Council Directive 85/337/EEC of 27 June 1985 on the assessment of the effects of certain public and
private projects on the environment as amended by Directive 97/11/EC. Without prejudging its assessment
of the case in question, the Commission may open infringement proceedings against a Member State for
violation of Community law (1). If a Member State does not take the necessary measures to comply with a
judgment of the Court of justice in such a case, the Commission shall after giving that Member State the
opportunity to submit its observations, issue a reasoned opinion specifying the points on which the
Member State concerned has not complied with the judgment. If the Member State fails to take the
necessary measures to comply with the judgment within the time-limit laid down by the Commission, the
latter may bring the case before the Court again. In so doing, it shall specify the amount of the lump sum
or penalty payment to be paid by the Member State concerned. If the Court finds that the Member State
has not complied with its judgment it may impose a lump sum or penalty payment (2).

(1) Article 226 EC Treaty (ex-Article 169).
(2) Article 228 EC Treaty (ex-Article 171).

(2001/C 26 E/119) WRITTEN QUESTION P-0730/00
by Massimo Carraro (PSE) to the Commission

(6 March 2000)

Subject: Provisions in support of poultry breeders affected by avian influenza

In December 1999 poultry farms in a number of regions of Italy, including Lombardy, Friuli, Sardinia,
Emilia Romagna and, in particular, the Veneto, were hit by the spread of ‘avian influenza’.

In compliance with Italian and Community legislation there was an immediate response to the European
Reference Centre’s announcement that the virus was particularly virulent and measures were adopted to
contain and eradicate the epidemic. This resulted in the destruction of all birds on the infected farms and
the demarcation of protection and surveillance areas.

It is estimated that avian influenza has led to the deaths of more than 5 million chickens and laying hens,
which is having enormous repercussions, both social and economic. The damage has affected not only the
infected farms, which have lost income for every bird killed, but has involved the whole poultry sector,
with negative repercussions on exports to international markets.