# CE2004078EN.01026001.xml

| 27.3.2004 | EN | Official Journal of the European Union | CE 78/260 |
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27.3.2004

EN

Official Journal of the European Union

CE 78/260

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(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)

Subject:

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.

| 1. | In view of the possible cross-border impact of blackhead, will the Commission introduce European provisions regulating measures against the disease? |
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1.

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

| 4. | Is the Commission aware that the antibiotic Metronidazole is currently approved for the treatment of parasitic infections in human beings but its use is not permitted in veterinary medicine? Will the Commission authorise the use of Metronidazole to treat the disease? If not, why not? |
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4.

Is the Commission aware that the antibiotic Metronidazole is currently approved for the treatment of parasitic infections in human beings but its use is not permitted in veterinary medicine? Will the Commission authorise the use of Metronidazole to treat the disease? If not, why not?

Answer given by Mr Liikanen on behalf of the Commission

(18 December 2003)

(18 December 2003)

| 1. | At present the Commission does not intend to present any proposal concerning the control of Histomoniasis (blackhead) in the Community due to the following reasons:






  (a) | Histomoniasis is not an epidemic disease; |
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1.

At present the Commission does not intend to present any proposal concerning the control of 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; |
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(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; |
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(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. |
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(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.

| 2. | Nifursol was banned as feed additive with effect from 31 March 2003 in order to protect consumers 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. |
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2.

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

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| 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. |
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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.

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| 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. |
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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.

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(1)  OJ L 265, 3.10.2002.

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(2)  OJ L 311, 28.11.2001.

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(3)  OJ L 214, 24.8.1993.

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(4)  OJ L 224, 18.8.1990.

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