Article 1–Article 3 · 3 articles
Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Scope
1. This Regulation lays down detailed rules for the initial implementation of the fourth stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC concerning the placing of plant protection products on the market, hereinafter referred to as the "Directive".
2. The initial implementation of this fourth stage concerns the notification of the active substances referred to in Annexes I and II to this Regulation with a view to their possible inclusion in a subsequent priority list of active substances with a view to their possible inclusion in Annex I to the Directive. Article 6(2), Article 6(3) and the second subparagraph of Article 6(4) of the Directive shall not apply to a substance listed or referred to in Annexes I and II as long as the procedures provided in this Regulation with regard to these substances have not been finalised.
3. This Regulation shall apply without prejudice to:
(a) reviews by Member States in particular pursuant to renewals of authorisations in accordance with Article 4(4) of the Directive;
(b) reviews by the Commission pursuant to Article 5(5) of the Directive;
(c) assessments carried out under Directive 79/117/EEC.
Definitions
The following definitions shall apply for the purposes of this Regulation:
(a) "Producer" means:
- for active substances produced within the Community, the manufacturer or a person established within the Community designated by the manufacturer as his/her sole representative for the purpose of compliance with this Regulation,
- for active substances produced outside the Community, the person established within the Community and designated by the manufacturer as his/her sole representative within the Community for the purpose of compliance with this Regulation,
- for active substances for which a joint notification or joint dossier is submitted, the association of producers established within the Community and designated by the producers referred to in the first or second indent for the purpose of compliance with this Regulation.
(b) "Manufacturer" means the person who manufactures the active substance on his/her own or who contracts out to another party the manufacturing of the active substance on its behalf.
(c) "Committee" means the Standing Committee on the Food Chain and Animal Health, established by Article 19 of the Directive.
Member State authority
1. Member States shall allocate responsibility for the implementation of their obligations under the programme of work referred to in Article 8(2) of the Directive to an authority or authorities.
2. In each Member State one national authority, referred to in Annex VI, shall coordinate and ensure all necessary contacts with producers, other Member States and the Commission pursuant to this Regulation. Each Member State shall inform the Commission and the designated coordinating national authority of each other Member State of any modifications to the communicated details concerning the designated coordinating national authority.
CHAPTER 2
FOURTH STAGE OF THE PROGRAMME OF WORK
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.