26.2.2011 Official Journal of the European Union L 53/51 COMMISSION REGULATION (EU) No 188/2011 of 25 February 2011 laying down detailed rules for the implementation of Council Directive 91/414/EEC as regards the procedure for the assessment of active substances which were not on the market 2 years after the date of notification of that Directive (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market ('), and in particular Article 6(5) thereof, Whereas: (1) It is necessary to adopt rules on a procedure for the submission and appraisal of applications for inclusion in Annex I to Directive 91/414/EEC of active substances which were not yet on the market 2 years after the date of notification of that Directive. In particular periods should be set for the different steps of that procedure to ensure that they are carried out rapidly. (2)  Additional information submitted after the application and the dossiers should only be taken into account if it was requested by the European Food Safety Authority, hereinafter ‘the Authority, or the rapporteur Member State and submitted within the time period set. (3)  As regards applications submitted before the entry into force of this Regulation transitional measures should be provided for. In particular, it is appropriate to extend the period which may be granted to the applicant to submit additional information requested by the Authority or the rapporteur Member State. As regards such applications, it is further necessary to set periods for the circulation of the draft assessment report by the Authority and the submission of comments by the Member States, other than the rapporteur Member State, and the applicant. (4)  The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, (") OJ L 230, 19.8.1991, p. 1. HAS ADOPTED THIS REGULATION: Article 1 Scope This Regulation lays down detailed rules for the submission and appraisal of applications for inclusion in Annex I to Directive 91/414/[EEC of active substances which were not on the market on 26 July 1993. Atrticle 2 Application 1. An applicant wishing to secure the inclusion in Annex I to Directive 91/414/EEC of an active substance covered by Article 1 shall submit an application for that active substance to a Member State, hereinafter referred to as ‘rapporteur Member State’, together with a summary dossier and a complete dossier, as provided for in Article 3, or a scientifically reasoned justification for not providing certain parts of those dossiers, demonstrating that the active substance fulfils the criteria provided for in Article 5 of that Directive. For the purposes of this Regulation ‘applicant’ means the person who manufactures the active substance himself or who contracts out the manufacturing to another party or a person designated by the manufacturer as his sole representative for the purpose of compliance with this Regulation. 2. When submitting his application, the applicant may, pursuant to Article 14 of Directive 91/414/EEC, request certain parts of the dossiers referred to in paragraph 1 of this Article to be kept confidential. The applicant shall explain for each document or each part of a document why it is to be considered as confidential. Member States shall assess the confidentiality requests. Upon a request for access to information, the rapporteur Member State shall decide what information is to be kept confidential. The applicant shall submit separately the information to be kept confidential. The applicant shall at the same time submit any claims for data protection pursuant to Article 13 of Directive 91/414/EEC.