92003E0823

WRITTEN QUESTION E-0823/03

by Christel Fiebiger (GUE/NGL) to the Council

(18 March 2003)

Subject: Ban on Nifursol

Authorisation for Nifursol, currently the only substance available as a feed additive for the prevention of blackhead disease in turkeys (Histomoniasis) is to be withdrawn as from 31 March 2003 for reasons linked to consumer protection. This will pose serious problems for turkey farms:

Without prophylactic treatment, turkeys will be unprotected. An outbreak of the disease could take on epidemic proportions with mortality rates of over 50 %. Tens of thousands of turkeys would die from the disease. The economic impact arising from the loss of animals and the non-release of diseased animals for slaughter would jeopardise the existence of specialised turkey farms in particular. Given that blackhead disease is not a notifiable animal disease, no compensation will be paid in Germany from the animal disease insurance scheme. For the same reason, the veterinary authority will not order animals to be slaughtered and there will therefore be no support from the public purse.

Particularly in the new German länder, most turkey farms have been set up only recently and have been almost exclusively financed through borrowing. A single outbreak of the disease would mean the end for these farms. Mecklenburg-Vorpommern alone has fattening capacity for around 800 000 turkeys. Losses on this scale would affect not only the farms themselves, but also slaughterhouses and the animal feed industry, and would consequently hit jobs in structurally weak regions.

1. What is the justification for the ban on Nifursol in feed, given the lack of proof of harmful effects on people and animals and the lack of substitute products for the prevention of blackhead disease?

2. Is it compatible with animal welfare that Nifursol is to be banned even though there is no therapeutic or prophylactic alternative, which means accepting the possibility that sick animals will suffer a painful death?

3. Is the Council prepared, in acknowledgement of the complex implications of the ban on Nifursol, to correct its decision or provide a temporary derogation until alternatives to Nifursol become available?

4. If it is not prepared to do so, is the Council willing to adopt measures to compensate for economic losses as a result of blackhead disease?

Reply

(21 July 2003)

1. The purpose of Council Regulation (EC) No 1756/2002(1) of 23 September 2002 is to withdraw the authorisation for use as an additive in feedingstuffs of the coccidiostat Nifursol, a histomonostat belonging to the nitrofuran group.

2. During the period between 1990 and 1995, both the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the Committee for Veterinary Medicinal Products (CVMP) gave opinions on the use of veterinary medicinal products in food-producing animals of the group of substances known as nitrofurans. They concluded that it was not possible, because of the genotoxicity and carcinogenicity of the substance, to identify an acceptable daily intake (i.e. a level of intake by humans of residues of the substances which could be regarded as safe). Accordingly, it was not possible to set maximum residue levels for the substances.

All nitrofurans were therefore inserted into Annex IV to Council Regulation (EEC) No 2377/90, with the effect of prohibiting throughout the Community the administration of these substances, as veterinary medicinal products, to food-producing animals.

3. The Commission therefore asked the Scientific Committee for Animal Nutrition (SCAN) to make a new scientific risk assessment of Nifursol, which belongs also to the group of nitrofurans.

The SCAN adopted an opinion concerning Nifursol on 11 October 2001, which concluded that on the basis of the genotoxicity studies provided by the person responsible for putting Nifursol into circulation, and because of the lack of data on developmental toxicity, it was not possible to derive an acceptable daily intake for the consumers. The SCAN confirmed this opinion on 18 April 2002 after having examined complementary data submitted by the company.

4. Consequently, as it deemed that the conditions laid down in Article 3(a) of Directive 70/524/EEC(2) were no longer met for the coccidiostat Nifursol, the Commission sought the opinion of the Standing Committee on the Food Chain and Animal Health on a draft Commission Regulation withdrawing the authorisation of Nifursol for the use as feed additive.

5. In the absence of an opinion of the Standing Committee on the Food Chain and Animal Health the Commission made a proposal to the Council which unanimously adopted the proposed regulation making it applicable as from 1 April 2003. An Application for suspension of the Regulation was rejected by Order of the President of the Court of First Instance of 11 April 2003 (Case T-392/02 R Solvay Pharmaceuticals bv v. Council, not yet reported).

6. Any future decision allowing the use of Nifursol could only be taken in accordance with Directive 70/524 by the Commission, or the Council on a proposal from the latter, and could only be taken if it would be proven that, notwithstanding its genetoxic affects in vitro Nifursol is safe and thus meets the requirements of Article 3a of the directive. The Council understands that new data provided by the producer of Nifursol were assessed by SCAN which on 17 March 2003 confirmed, as in its previous opinions, that it was not possible to derive an acceptable daily intake of Nifursol for the consumers.

(1) OJ L 265, 3.10.2002, p. 1.

(2) OJ L 270, 14.12.1970, p. 1.