Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (Text with EEA relevance)

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 Article 6(5) thereof,

Whereas:

1. Article 8(2) of the Directive 91/414/EEC provides that the Commission undertakes a programme of work for the gradual examination of active substances on the market two years after the date of notification of this Directive. This programme has been divided into four phases, the last of which is due to expire on 31 December 2008 in accordance with Commission Decision 2003/565/EC of 25 July 2003 extending the time period provided for in Article 8(2) of Council Directive 91/414/EEC⁽²⁾.

2. The first stage of this programme was laid down by Commission Regulation (EEC) No 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⁽³⁾. The second and third stages of work were laid down by Commission Regulation (EC) No 451/2000 of 28 February 2000 laying down the detailed rules for the implementation of the second and third stages of the work programme referred to in Article 8(2) of Council Directive 91/414/EEC⁽⁴⁾ and Commission Regulation (EC) No 1490/2002⁽⁵⁾. The fourth stage was laid down by Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down the detailed rules for the implementation of the fourth stage of the work programme referred to in Article 8(2) of Council Directive 91/414/EEC⁽⁶⁾.

3. For the inclusion of active substances in Annex I to Directive 91/414/EEC which were part of the first, second, third and fourth programme of work as referred to in Article 8(2) of that Directive it is necessary to provide for detailed rules for the re-submission of applications which avoid duplication of work, maintain a high safety standard and ensure that a decision is taken quickly. Furthermore, the relationship between applicants, Member States, the European Food Safety Authority, hereinafter ‘the Authority’, and the Commission and the obligations on each of the parties for the application of the procedure should be laid down.

4. For the substances included in the first stage the dossiers were submitted in 1995 and 1996. No peer review was carried out by the Authority. Given the age of the original dossiers and the changes in scientific knowledge, reflected in guidance documents from the Commission services, a complete and up to date dossier should be required for these substances and the Authority should in principle carry out a peer review. The same provisions should in principle apply for substances of stage 2, 3 and 4 of the review programme but in cases where a draft assessment report has been prepared and an application is submitted within a reasonable time after the decision providing that the substance was not to be included in Annex I to Directive 91/414/EEC an accelerated procedure may be implemented.

5. For substances covered by the second stage strict deadlines applied and therefore it was necessary to decide on the basis of the available information peer reviewed by the Authority. In a number of cases issues were identified which led to the substance not being included in Annex I to Directive 91/414/EEC. For those substances the original dossiers were submitted at the latest in April 2002. Authority peer reviews were carried out between 2003 and 2006 and therefore the dossiers are up to date. In some of these cases only a limited number of studies might be required to form a complete dossier for re-submission of applications concerning possible Annex I inclusions, based on the same or more restricted supported uses. It is appropriate to provide for an accelerated procedure for re-submission and peer review in cases where the dossier was compiled and discussed recently. The same should apply to third and fourth stage substances of the review programme for which the procedures were last amended in Regulation (EC) No 1095/2007.

6. Additional data should only be taken into account if they are submitted within the time period set.

7. The possibility to submit a new application for the same substance at any time should be provided for.

8. The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Food Chain and Animal Health,

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