WRITTEN QUESTION E-3811/02

by Charles Tannock (PPE-DE) to the Commission

(9 January 2003)

Subject: The ongoing problem relating to the evaluation of fenthion

On 16 January 2000, Commissioner Byrne, in answer to Written Question E-3552/00(1) by the Greek Member Mr Papayannakis, stated that Article 8 of Directive 91/414/EEC(2) provides for a derogation during a period of 12 years (until 25 July 2003) for Member States to continue to authorise plant protection products containing active substances not included in Annex 1 of the Directive on the basis of the general safety requirements of Article 4 of the Directive and national data requirements, that during this period the Commission shall implement a program for gradual examination of the active substances, that fenthion is one of the active substances currently being evaluated under Commission Regulation (EEC) No 3600/92(3) and that it was expected that the Commission will be able to adopt a decision on fenthion in early 2001. The Commission also indicated that it would inform the Parliament and Council by July 2001 on progress with the re-evaluation programme.

On 22 October 2001, in answer to my Written Question E-2883/01(4), Commissioner Byrne stated that the Community evaluation of fenthion has almost been finalised and the Commission will, after consultation of the Scientific Committee on Plants, propose as soon as possible a decision on fenthion, which will also address the acceptable ways of application.

On 15 March 2002, in answer to Written Question E-0749/02(5), Commissioner Byrne confirmed that the evaluation of fenthion had now indeed been completed, with the exception of one study which had only very recently been submitted to the (unspecified) rapporteur Member State, that the evaluation of that study would be available in April 2002 but should not delay the decision making process. The Commission added that it would submit the result of its evaluation to the Scientific Committee on Plants in April 2002 and that it was expected that the Committee would deliver its opinion within two months.

On 4 December 2002, in answer to Written Question E-3116/02(6) requesting an update on the findings of the Scientific Committee, the Commission stated that it had asked the opinion of the Scientific Committee on Plants several questions arising from the evaluation of fenthion, and that given the complexity of the issues surrounding the substance the Committee has taken longer than expected to finalise its opinion.

How many more months or years will it take for the Committee to give a final opinion on the central issue of delayed neurotoxicity and the concerns of Member States such as Britain and France concerning the clastogenic properties of fenthion? Are these delays a foretaste of what is to come with the impending Chemicals Directive or is the Commission prepared to set a time limit for a final decision from the Scientific Committee? Finally, what role does the Commission believe that the precautionary principle should play?

(1) OJ C 174 E, 19.6.2001, p. 76.

(2) OJ L 230, 19.8.1991, p. 1.

(3) OJ L 366, 15.12.1992, p. 10.

(4) OJ C 115 E, 16.5.2002, p. 187.

(5) OJ C 172 E, 18.7.2002, p. 225.

(6) OJ C 110 E, 8.5.2003, p. 166.

Answer given by Mr Byrne on behalf of the Commission

(3 February 2003)

The notifier has submitted to the rapporteur Member State (Greece) all the information requested for fenthion in relation to use of fenthion as a bait application in olives and citrus. The Commission submitted the result of the evaluation of that new information to the Scientific Committee on Plants in April 2002. The Scientific Committee on Plants delivered its opinion on 17 December 2002. The Committee was asked to comment on the relevance of the new data and arguments related to the risk assessment to birds and to the toxicological properties of fenthion.

The Committee concluded that the available new toxicological information does not alter the Committee's previous opinion regarding the mutagenic properties of fenthion. In particular, that available new data indicates that fenthion is unlikely to pose a risk of delayed neurotoxicity in humans.

The Committee however also concluded that, despite a change of the application method and the provision of new studies, risks to birds from the proposed use of fenthion are very uncertain and that therefore the concerns raised in the Committee's previous opinion remain unresolved. As a result, the Committee has made some recommendations in order to improve the risk assessment for birds.

The Commission is of the opinion that the legislation on plant protection products takes into account the precautionary principle. A plant protection product can only be authorized provided it is demonstrated, in the light of current scientific and technical knowledge, that its residues and its use, consequent on application consistent with good plant protection practice, does not have any harmful effects on human or animal health or any unacceptable influence on the environment.

The Commission will follow the procedures established in Commission Regulation (EEC) 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market. After all consultations are finalized, the Commission will forward a proposal for fenthion to the Standing Committee on the Food Chain and Animal Health, as soon as possible, most likely at its meeting in April 2003.