WRITTEN QUESTION E-1544/97 by Hiltrud Breyer (V) to the Commission (5 May 1997)

Subject: Phosphate ester poisoning due to the use of Tiguvon (Fenthion) manufactured by Bayer Leverkusen

The flea-repellant Tiguvon (Fenthion) manufactured by Bayer Leverkusen can be administered in different forms. Tiguvon 10 is intended for cats over 2 kg in weight. The use of Tiguvon 20 is recommended for dogs weighing between 3 and 10 kg, while dogs with a body weight of more than 10 kg should be treated with Tiguvon 20 G. People who have repeatedly treated their pets with Tiguvon (Fenthion) have suffered serious phosphate ester poisoning. As it was unable to answer my Question E-1470/96 ((OJ C 345, 15.11.1996, p. 76. )) on the same subject, I would ask the Commission to answer the following questions as a matter of urgency:

Which institution examines the mode of action of ethical and freely available antiparasitics, especially for their harmlessness to humans and animals and their compatibility with the environment? Is the Commission aware that manufacturers wishing to continue marketing products registered before 1978 were required to submit the results of all tests by the end of 1996? Did they do so? Is this governed by EU legislation? Were products authorized after 1978 adequately tested?

Supplementary joint answer to Written Questions E-1534/97, E-1540/97 and E-1544/97 given by Mr Bangemann on behalf of the Commission (26 September 1997)

Veterinary medicinal products are authorised in the Community either according to Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products ((OJ L 317, 6.11.1981, as amended by Council Directives 90/676/EEC OJ L 373, 31.12.1990 and 93/40/EEC OJ L 214, 24.8.1993. )) (decentralised procedure) or since 1 January 1995 according to Council Regulation (EEC) No 2309/93 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European agency for the evaluation of medicinal products ((OJ L 214, 24.08.1993. )) (centralised procedure).

In both cases the safety assessment is carried out in accordance with the requirements of Council Directive 81/852/EEC on the approximation of the laws of Member States relating to analytical, pharmatoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products ((OJ L 317, 6.11.1981. )). Part 3 of the Annex to this Directive contains detailed requirements on the performance and documentation of tests and evaluations for the applicant. For example 'a thorough discussion of any risks for persons preparing the medicinal product or administering it to animals followed by proposals for appropriate measures to reduce such risks' and the assessment of 'the potential harmful effects which the use of the product may cause to the environment' is required.

The scientific evaluation is performed by the scientific committee for veterinary medicinal products (CVMP) at the European agency for medicinal products (EMEA) in London in case of the centralised procedure or by the national authorities in case of the decentralised procedure. The CVMP will only get involved in the decentralised procedure if arbitration is necessary for mutual recognition.

The provisions of Council Directives 81/851/EEC and 81/852/EEC had to be applied progressively to products authorised before the notification of these Directives. In Germany the authority for this task is the Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin (Federal institute for consumer health protection and veterinary medicine). The Commission normally assumes that Member States fulfil their obligations under Community law.

Tiguvon for cats and dogs was authorised firstly in Germany in 1983 by the Federal office for health (Bundesgesundheitsamt) after Council Directives 81/851/EEC and 81/852/EEC came into force. Therefore it had to be evaluated in accordance with the requirements of these Directives before a marketing authorisation was granted.

Interaction with other cholinase inhibitors, phenothiazin derivates (e.g. neuroleptics) or muscle relaxation agents (e.g. succinyldicholin) may give power to side effects of Fenthion in mammals. The package insert contains consequent warnings.