WRITTEN QUESTION E-3327/03 by Albert Maat (PPE-DE) and Jan Mulder (ELDR) to the Commission. Histomoniasis (blackhead).
Date: 2003-11-12
Institutions: European Parliament, Provisional data
Subjects: animal disease, consumer protection, pharmaceutical legislation, poultry, veterinary drug, veterinary legislation

C 78 E/260

Official Journal of the European Union

EN

27.3.2004

Answer given by Mr Bolkestein on behalf of the Commission

(27 November 2003)

The Commission does not, at present, have the necessary information to assess whether the award of the
public contract by the ATAC public corporation mentioned by the Honourable Member was carried out in
accordance with Community law.

The Commission will therefore contact the Italian government to obtain the information required in order
to ascertain whether ATAC complied with Community rules and principles on public procurement in the
case in question. On the basis of the information provided by the Honourable Member, the Commission
will, in particular, check whether the procedures followed by ATAC on this occasion comply with Council
Directive 93/38/EEC of 14 June 1993 coordinating the procurement procedures of entities operating in
the water, energy, transport and telecommunications sectors, which applies to public contracts awarded by
contracting entities which operate public urban transport networks. It will also check whether they comply
with the rules and principles in the EC Treaty relating to the completion of the internal market.

On the other hand, given that the question relates to public contract award procedures and not to
agreements which may be anti-competitive under competition law, the Commission does not consider that
Article 81 of that Directive is applicable in this particular case.

(2004/C 78 E/0261)

WRITTEN QUESTION E-3327/03

by Albert Maat (PPE-DE) and Jan Mulder (ELDR) to the Commission

(12 November 2003)

Subject: Histomoniasis (blackhead)

At present, various European countries are affected by outbreaks of blackhead (histomoniasis). Infection
with this disease causes serious suffering to turkeys and ultimately massive mortality among them. As the
disease is not classified as an ‘A’ disease, there are no European rules on combating it and paying
compensation. However, there are European rules concerning possible prophylactics or treatments. Yet
since 31 March 2003, the last remaining remedy against the disease has been prohibited.

In view of the possible cross-border impact of blackhead, will the Commission introduce European

1.
provisions regulating measures against the disease?

2. Will the Commission under certain conditions (e.g. additional scientific information) temporarily
permit the use of the prophylactic Nifursol again?

3.
In the United States, Nitarsone (Histostat-50) is used to prevent blackhead. Will the Commission
shorten the test phase procedure for this new medicine so that, if the results are favourable, it can be used
as soon as possible? If so, when might it be possible for this product to be used?

Is the Commission aware that the antibiotic Metronidazole is currently approved for the treatment of
the

4.
parasitic infections in human beings but its use is not permitted in veterinary medicine? Will
Commission authorise the use of Metronidazole to treat the disease? If not, why not?

27.3.2004

EN

Official Journal of the European Union

C 78 E/261

Answer given by Mr Liikanen on behalf of the Commission

(18 December 2003)

At present the Commission does not intend to present any proposal concerning the control of

1.
Histomoniasis (blackhead) in the Community, due to the following reasons:

(a) Histomoniasis is not an epidemic disease;

(b) no international standards on trade are established by the Office International des Epizoozies in

relation to this disease;

(c)

the Commission considers that the control of diseases fulfilling the above criteria should be a primary
responsibility of the farmers;

(d)

the veterinary authorities of the Member States do not apply national rules to control this disease and
have never indicated that it should be subjected to Community harmonised legislation.

Nifursol was banned as feed additive with effect from 31 March 2003 in order to protect consumers

2.
and following the opinion of the Scientific Committee on Animal Nutrition.

By case law T-392/02, the European Court of First Instance recently determined that the decision of the
Commission, which is at the basis of Council Regulation (EC) No 1756/2002 of 23 September 2002
amending Directive 70/524/EEC concerning additives in feedingstuffs as regards withdrawal of
the
authorisation of an additive and amending Commission Regulation (EC) No 2430/1999 (1), was well
founded and did not find any grounds to suspend or change such measure. Under these conditions, the
Commission will not permit the use of Nifursol without guarantee that the substance is safe.

3.
Veterinary medicinal products intended for use in the Union must be authorised in accordance with
Directive 2001/82/EC of the Parliament and of the Council of 6 November 2001 on the Community code
relating to veterinary medicinal products (2) for applications made by pharmaceutical companies to the
competent authorities of the Member States or in accordance with Council Regulation (EEC) No 2309/93
of 22 July 1993 (3) for applications for Community authorisations made to the European Agency for
Evaluation of Medicinal Products. The Commission is not aware of any application submitted concerning
any product containing Nitarsone. In that case, such an application would be made by the company that
owns this product, a prerequisite for such an application is that maximum residue limits are established in
accordance with Council Regulation (EEC) No 2377/90 of 26 June 1990 (4). No such application has been
received to date.

4.
The Commission is aware that medicinal products containing Metronidazole are authorised for use
for particular indications for treatment of human beings and possibly also companion animal species.
Metronidazole is, however, included in Annex IV of Regulation (EEC) No 2377/90, i.e. forbidden for use in
veterinary medicinal products intended for use in food producing animal species since 1998. The
substance is genotoxic and residues in food from treated animals might constitute a hazard to the health of
the consumer at whatever limit.

The benefit/risk assessment made for use of substances in human medicine is not applicable in the same
way for veterinary medicinal products, where residues may be considered harmful for the consumer. As
Metronidazole is forbidden for use in food producing animal species, the Commission can under no
circumstances authorise such use in the Union.

(1) OJ L 265, 3.10.2002.
(2) OJ L 311, 28.11.2001.
(3) OJ L 214, 24.8.1993.
(4) OJ L 224, 18.8.1990.