WRITTEN QUESTION E-1548/97 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:

When will the burden of proof at last be reversed throughout Europe where injury is suffered as a result of the marketing of these and similarly dangerous products, the dubious benefit of which bears no relation to the risk they entail?

Joint answer to Written Questions E-1546/97 and E-1548/97 given by Mr Monti on behalf of the Commission (11 July 1997)

Community legislation on manufacturers' liability for damage caused by defective products was first introduced in 1985 ((Council Directive 85/374/EEC of 25July1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (OJ L 210, 7.8.1985, p.29). )) and has been incorporated into national law in all the Member States except France. The enacting measure in Germany is the Produkthaftungsgesetz (Product Liability Law) of 15 December 1989, published in Bundesgesetzblatt (Federal Law Gazette) 1989 I 2198 ((Liability for death or personal injury resulting from a pharmaceutical product intended for human use is governed by the Arzneimittelgesetz (Medicinal Products Law) of 24.8.1976. )). In 1995 the Commission presented to Parliament and the Council its first report on the application of the Directive ((COM(95) 617 final. )), stating that the Directive is generally perceived as an important piece of legislation which has helped to increase awareness of product safety and to ease the burden of proof on the injured party (who no longer has to prove that the producer was at fault).

The Directive has added a system of liability without fault to the Member States' existing systems of contractual and non-contractual liability. Under the new arrangements, liability for damage caused by a defective product rests with the producer and cannot be excluded or limited because the parties so wish.

Legal proceedings may be instituted by any injured person who is able to prove the damage, the defect and the causal relationship between the two. Once an injured person has furnished proof of each of these elements, the producer may refute liability only on the basis of one of the exemptions provided for in Article 7 of the Directive (e.g. the state of scientific and technical knowledge at the time when the product was put into circulation was not such as to enable the existence of the defect to be discovered: 'development risks' ((European Court of Justice ruling of 29.5.1997 in Case C-300/95 Commission v United Kingdom (not yet published). ))).

It should be pointed out that, under the Directive, a product is deemed to be defective when it does not provide the safety which a person is entitled to expect, taking all circumstances into account, including: the presentation of the product; the use to which it could reasonably be expected that the product would be put; the time when the product was put into circulation. The Directive covers, among other things, damage caused by death or personal injuries occurring within ten years of the product in question being put into circulation.

Community legislation does not provide for the establishment of a system to cover the risks (either a 'pool' insurance scheme or a state-funded compensation scheme).

Since it is required to present a report to Parliament and the Council every five years, the Commission will continue to monitor the Directive's application and its effects on the operation of the internal market and on consumer protection. This monitoring work will include consultation of interested parties with a view to assessing the need for changes to the Directive (as regards, for example, development risks and the financial limit of full liability).