Subject matter and scope
1. This Regulation lays down:
(a)
further detailed rules for the implementation of the fourth stage of the programme of work referred to in the second subparagraph of Article 8(2) of Directive 91/414/EEC (the programme of work) with respect to the continued evaluation of the active substances notified under Regulation (EC) No 1112/2002;
(b)
rules covering the active substances that were on the market before 1 May 2004 in the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia and which are not included in stages one to three of the programme of work and which are not covered by Regulation (EC) No 1112/2002.
2. Article 6(2) and (3) and the second paragraph of Article 6(4) of Directive 91/414/EEC shall not apply to active substances listed in Annex I to this Regulation as long as the procedures provided for in this Regulation with regard to such substances have not been finalised.
3. This Regulation shall apply without prejudice to:
(a)
reviews by Member States of active substances listed in Annex I to this Regulation in particular pursuant to renewals of authorisations in accordance with Article 4(4) of Directive 91/414/EEC;
(b)
reviews by the Commission in accordance with Article 5(5) of Directive 91/414/EEC;
(c)
assessments carried out under Directive 79/117/EEC.
Definitions
For the purpose of this Regulation, the definitions set out in Article 2 of Directive 91/414/EEC and Article 2 of Regulation (EC) No 1112/2002 shall apply.
The following definitions shall also apply:
(a)
‘notifier’ means the natural or legal person who has submitted a notification in accordance with:
(i)
Regulation (EC) No 1112/2002, as listed in Annex II to this Regulation, or
(ii)
Article 4 of this Regulation;
(b)
‘rapporteur Member State’ means the rapporteur Member State for the active substance as set out in Annex I.
(c)
‘summary dossier’ means a dossier containing the information required under Article 10(2), where summaries are given of the results of the tests and studies referred to in that paragraph.
(d)
‘complete dossier’ means a dossier containing the information required under Article 10(3), where the results of the tests and study reports referred to in the summary dossier are given in full.
Designated Member State authority
1. Each Member State shall designate an authority or authorities to carry out the obligations of the Member States as defined in this Regulation.
2. The national authorities listed in Annex III shall coordinate and ensure all necessary contacts with notifiers, other Member States, the Commission and the European Food Safety Authority (EFSA) in accordance with this Regulation.
Each Member State shall give the details concerning the designated coordinating national authority to the Commission, the EFSA and the designated coordinating national authority of each other Member State and inform them of any modifications thereof.
