25.5.2007 EN Official Journal of the European Union L 133/42
COMMISSION DECISION
of 21 May 2007
concerning the non-inclusion of trichlorfon in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance
(notified under document number C(2007) 2096)
(Text with EEA relevance)
(2007/356/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES
,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular the fourth subparagraph of Article 8(2) thereof,
Whereas:
(1) Article 8(2) of Directive 91/414/EEC provides that a Member State may, during a period of 12 years following the notification of that Directive, authorise the placing on the market of plant protection products containing active substances not listed in Annex I of that Directive that are already on the market two years after the date of notification, while those substances are gradually being examined within the framework of a programme of work.
(2) Commission Regulations (EC) No 451/2000 (2) and (EC) No 703/2001 (3) lay down the detailed rules for the implementation of the second stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes trichlorfon.
(3) For trichlorfon the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 703/2001 for a range of uses proposed by the notifier. Moreover, those regulations designate the Rapporteur Member States which have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 8(1) of Regulation (EC) No 451/2000. For trichlorfon the Rapporteur Member State was Spain and all relevant information was submitted on 23 August 2004.
(4) The assessment report has been peer reviewed by the Member States and the EFSA within its Working Group Evaluation and presented to the Commission on 12 May 2006 in the format of the EFSA Conclusion regarding the peer review of the pesticide risk assessment of the active substance trichlorfon (4). This report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 29 September 2006 in the format of the Commission review report for trichlorfon.
(5) Due to significant lack of supporting studies, it has not been possible to demonstrate a safe use of the substance. Based on the available information it was not possible to perform the risk assessment of consumers, operators, workers and bystanders exposure. Moreover, the evaluation of fate and behaviour of the substance in the environment was limited and its eco-toxicological properties were not completely assessed.
(6) The Commission invited the notifier to submit its comments within four weeks on the results of the peer review and on its intention or not to further support the substance. The notifier submitted its comments which have been carefully examined. However, despite the arguments advanced, the above concerns remained unsolved, and assessments made on the basis of the information submitted and evaluated during the EFSA expert meetings have not demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing trichlorfon satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC.
(7) Trichlorfon should therefore not be included in Annex I to Directive 91/414/EEC.
(8) Measures should be taken to ensure that existing authorisations for plant protection products containing trichlorfon are withdrawn within a prescribed period and are not renewed and that no new authorisations for such products are granted.
(9) Any period of grace for disposal, storage, placing on the market and use of existing stocks of plant protection products containing trichlorfon allowed by Member States, should be limited to a period no longer than twelve months to allow existing stocks to be used in no more than one further growing season.
(10) This Decision does not prejudice the submission of an application for trichlorfon according to the provisions of Article 6(2) of Directive 91/414/EEC in view of a possible inclusion in its Annex I.
(11) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
Trichlorfon shall not be included as active substance in Annex I to Directive 91/414/EEC.
Member States shall ensure that:
(a) authorisations for plant protection products containing trichlorfon are withdrawn by 21 November 2007;
(b) from 25 May 2007 no authorisations for plant protection products containing trichlorfon are granted or renewed under the derogation provided for in Article 8(2) of Directive 91/414/EEC.
Any period of grace granted by Member States in accordance with the provisions of Article 4(6) of Directive 91/414/EEC, shall be as short as possible and shall expire not later than 21 November 2008.
This Decision is addressed to the Member States.