28.6.2001 Official Journal of the European Communities L175/21 COMMISSION DIRECTIVE 2001/47EC of 25 June 2001 amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include Paecilomyces fumosoroseus (Apopka strain 97, PFR 97 or CG 170, ATCC20874) as an active substance 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 ('), as last amended by Commission Directive 2001/ 28/EC (3), and in particular Article 6(1) thereof, PFR 97 or CG 170, ATCC20874). If this review report has to be updated to take account of technical and scientific developments, the conditions for the inclusion of DPX KE 459 Paecilomyces fumosoroseus (Apopka strain 97, PFR 97 or CG 170, ATCC20874) in Annex I to the Directive will also need to be amended in accordance with the Directive. (6)  The dossier and the information from the review of Wh ) Paecilomyces fumosoroseus (Apopka strain 97, PFR 97 or creas: CG 170, ATCC20874) were also submitted to the Scientific Committee on Plants for opinion on 16 (1) In accordance with Article 6(2) of Directive 91/414/EEC December 1999. This Committee has given its opinion (hereinafter referred to as ‘the Directive) Belgium on 30 November 2000 (¥). received on 18 May 1994 an application from Thermo Trilogy Corporation, (the applicant) for the inclusion of the active substance Paecilomyces fumosoroseus (Apopka h 4§ h . L d strain 97, PFR 97 or CG 170, ATCC20874) in Annex I (7) It has appeared from the various examinations made - that plant protection products containing the active to the Directive. : ' substance concerned may be expected to satisfy, in ) - ) general, the requirements laid down in Article 5(1)(a), (b) @ o ol b prodng o fede S e of e D, s i v o ' uses which were examined and detailed in the Commis- 97[164/EC () that the dossier submitted for Paecilomyces sion review report. It is therefore appropriate to include fumosoroseus (Apopka strain 97, PFR 97 or CG 170, the active substance concerned in Annex [, in order to ATCC20874) could be considered as satisfying, in prin- ensure that in all Member States the authorisations of ciple, the data and information requirements of Annex II plant protection products containing the active and, for a plant protection product containing this active substance concerned can be granted in accordance with substance, of Annex IIl to the Directive. the provisions of the said Directive. (3) In accordance with Article 5(1) of the Directive, an acet:j‘;% ?(?tszirécei d?ﬁoulk(i) b:arlsnicfhffrcllamb??;e:ctle dfot;ai (8)  After inclusion, a reasonable period is necessary to pe g 1hye y P X permit Member States to implement the provisions of neither the use (,)f’ or res@ues from, plant. protection the Directive on plant protection products containing products containing the active subsFance will have any Paccilomyces fumosoroseus (Apopka strain 97, PFR 97 or harmful effects on human or animal health or on CG 170, ATCC20874) and in particular to review groundwater or any unacceptable influence on the envir- existing provisional authorisations or to grant, by the onment. end of this period at the latest, new authorisations in accordance with the provisions of the Directive. A (4)  For Paecilomyces fumosoroseus (Apopka strain 97, PFR 97 longer period may also be required for plant protection ordCC};1 170’,ATCC208}174)’ {)he effects 0(111 human l(llealth produc;s contaigning Pcaécilomgcez flérg(;s(())gosegts (ﬁpo;})lka and the environment have been assessed, in accordance strain 97, PFR 97 or 170, AT 74) and other with the provisions of Article 6(2) and (4) of the active substances included in Annex I Directive, for the uses proposed by the applicant. Belgium acting as nominated rapporteur Member State submitted a draft assessment report concerning the . L . substance to the Commission on 9 December 1997. ©)  As the un1f9rm pr.mc.lples have ,Stlll to be adopted for micro-organisms, it is appropriate that the Member . States should apply the general provisions of Article 4 of (5 The draft assessment report has been reviewed by the the Directive when granting authorisations. It is also Member States and the Commission within the Standing Committee on Plant Health. This review was finalised on 27 April 2001 in the format of the Commission review report for Paecilomyces fumosoroseus (Apopka strain 97, appropriate to provide Member States a reasonable period of time to re-evaluate authorisations granted in the light of the uniform principles after their adoption. (*) Opinion of the Scientific Committee on Plants regarding the evalua- OJ L 230, 19.8.1991, p. 1. tion Paecilomyces fumosoroseus in the context of Council Directive 91 () O] L 113, 24.4.2001, p. 5. 414((EEC concerning the placing of plant protection products on the O] L 64, 5.3.1997, p. 17. market. SCP/PAECIL/002 final dated 11 December 2000.