WRITTEN QUESTION E-0617/97 by Heinz Kindermann (PSE) to the Commission (4 March 1997)

Subject: Use of the nerve agent ivermectin in Scottish salmon farms

According to reports in the New Scientist in September 1996 the use of the nerve agent ivermectin, developed to control parasites in cattle, sheep and pigs, is becoming increasingly widespread in Scottish salmon farms. As far as I am aware, the use of this substance in fish farming was prohibited throughout the EU until September 1996. At that stage the Scottish environmental authority SEPA decided to license ivermectin for use in fish farming. But the illegal use of ivermectin was evidently widespread already. In any event the veterinary department of the British Ministry of Agriculture has according to its own reports over the past three years detected traces of ivermectin in as much as ten per cent of salmon sold in Britain.

Experts take the view that ivermectin fed to salmon or passing into the water could also reach humans, in toxic concentrations. The possibility of damage to the human embryo, the human baby through breastmilk, and the elderly cannot be ruled out. Ivermectin is a very stable chemical, does not dissolve easily in water and accumulates with each step up the food chain in the same way as DDT, as tests with mussels have shown.

1. Is the Commission familiar with these facts?

2. In the view of the Commission, is the SEPA contravening European law by licensing ivermectin for use in fish farms?

3. What steps have been taken or are proposed by the Commission, to stop the use of ivermectin in salmon production and protect European consumers from any possible risks to public health?

4. Does the Commission have information on ivermectin residues in salmon exported from the UK to other EU Member States for human consumption?

Supplementary answer given by Mr Bangemann on behalf of the Commission (12 May 1997)

Further to its answer of 26 March 1997 ((OJ C 186, 18.6.1997, p. 263. )), the Commission is now able to provide the following additional information.

The Scottish environmental protection agency (SEPA) is responsible for granting discharge consents on the basis that what is used in fish will eventually end up in the wider aquatic environment. It does not authorise the administration of veterinary medicinal products.

A veterinary pharmaceutical product has to be authorised for marketing according to Council Directive 81/851/EEC laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin ((Council Directive 81/851/EEC on the approximation of the Member States relating to veterinary medicinal products as amended by Council Directives 90/676/EEC and 93/40/EEC - OJ L 317, 6.11.81; OJ L 373, 31.1290; OJ L 214, 24.8.93. )). One of the conditions to grant a market authorisation for administration to animals whose flesh or products are intended for human consumption is that any pharmacological active substance contained therein is listed in Annexe I, II or III of Council Regulation (EEC) 2377/90 ((OJ L 224, 18.8.1990, amended by Council Regulation (EC) 434, OJ L 67, 7.3.1997. )) or that an application for the establishment of maximum residue limits accompanied by the necessary documentation has been submitted to the European agency for the evaluation of medicinal products (EMEA) before 1 January 1996 in cases where the substance was authorised in a veterinary medicinal product in a Member State before 1 January 1992. The last mentioned exemption is only valid until 1 January 1998 or 1 January 2000 depending on the nature of the substance.

Ivermectin is listed in Annex I for cattle, sheep, pigs and horses ((Commission Reg. 2901/93, OJ L 264, 1993. )). The extension to deer is pending. No application for the use in salmon or any other fish has been submitted to the EMEA.

The only legal possibility to administer a veterinary medicinal product containing ivermectin to salmon in the Community would be the very exceptional circumstances laid down in Article 4 of Council Directive 81/851/EEC ... Where no authorised product for a condition exists the Member States may exceptionally, in particular to avoid causing unacceptable suffering to the animal, permit the administration of another product by a veterinarian on his direct personal responsibility to an animal or to a small number of animals or a particular holding. The product used has to be either authorised in the Member State for another species or another condition, or, if the first two possibilities are not relevant, for use in human beings. If there is no authorised product available, extemporaneously a veterinary medicinal product may be prepared by a person authorised to do so under national legislation in accordance with the terms of a veterinary prescription. In all cases a very extended withdrawal time of not less than 500 degree days (i.e. 50 days at seawater temperature 10°C) has to be observed to ensure that food produced from treated animals does not contain residues harmful to consumers. A new product is likely to obtain a market authorisation in the near future and will displace this possibility.

The British veterinary medicines directorate (BVMD) tests continuously for residues testing salmon produced in its territory. According to the information communicated to the Commission, the percentage of samples considered positive for ivermectin decreased from 11 % in 1994 to 3.1 % in 1995. This year no positive sample was reported.