L177/12 Official Journal of the European Union 16.7.2003 COMMISSION DIRECTIVE 2003/68/EC of 11 July 2003 amending Council Directive 91/414/EEC to include trifloxystrobin, carfentrazone-ethyl, meso- trione, fenamidone and isoxaflutole as active substances (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 (), as last amended by Commission Directive 2003/ 39/EC (3, and in particular Article 6(1) thereof, Whereas: 1 0 & () (9 () (9 () In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 28 January 1998 an application from Novartis Crop Protection UK Ltd for the inclusion of the active substance trifloxystrobin in Annex I to Directive 91/414/EEC. The substance was subsequently transferred to Bayer CropScience, which is now acting as the applicant. Commission Decision 1999/43EC () confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC. France received an application under Article 6(2) of Directive 91/414/EEC on 14 February 1996 from FMC Europe NV (now FMC Chemical sprl) concerning carfen- trazone-cthyl. This application was declared complete by Commission Decision 97/362[EC (%). The United Kingdom received an application under Article 6(2) of Directive 91/414/EEC on 23 April 1998 from Zeneca Agrochemicals UK (now Syngenta) concerning mesotrione. This application was declared complete by Commission Decision 1999/392/EC (°). France received an application under Article 6(2) of Directive 91/414[/EEC on 15 September 1999 from Rhone Poulenc Agri SA (now Bayer CropScience) concerning fenamidone. This application was declared complete by Commission Decision 2000/251/EC (°). The Netherlands received an application under Article 6(2) of Directive 91/414/EEC on 6 March 1996 Rhone- Poulenc Agro (now Bayer CropScience) concerning isoxaflutole. This application was declared complete by Commission Decision 96/524/EC (). L 230, 19.8.1991, p. 1. L 124, 20.5.2003, p. 30. L 14, 19.1.1999, p. 30. L 152, 11.6.1999, p. 31. L 148, 15.6.1999, p. 44. L 78, 29.3.2000, p. 26. L 220, 30.8.1996, p. 27. (6) For those active substances, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414[EEC, for the uses proposed by the applicants. The nominated rapporteur Member States, submitted a draft assessment report concerning the substance to the Commission on 19 April 2000 (trifloxystrobin), 14 May 1998 (carfentrazone-ethyl), 17 December 1999 (meso- trione), 14 May 1998 (fenamidone) and 20 February 1997 (isoxaflutole). The draft assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 15 April 2003 in the format of the Commission review reports for mesotrione, trifloxy- strobin, carfentrazone-ethyl, fenamidone and isoxaflu- tole. The review of trifloxystrobin and fenamidone did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee for Plants. For carfentrazone-ethyl the review and information were also submitted to the Scientific Committee for Plants for separate consultation. The Committee was asked to comment on the relevance for humans of the elevated levels of specific porphyrins detected in test animals. The Committee expressed the opinion (¥) that the effects of the substance detected in test animals on porphyrin levels are relevant for humans but saw no evidence that humans are more sensitive to the effect than animals. In addition, the Scientific Committee noted that three unknown polar compounds were detected in a lysimeter. The notifier was therefore requested to comment on the relevance of these three compounds. Additional informa- tion was subsequently provided by the notifier and eval- uated by the Committee. In its assessment of the new data the Committee concluded that those polar compounds will not cause an unacceptable ecotoxicolo- gical or toxicological risk. (*) Opinion of the Scientific Committee for Plants regarding the evalua- tion of carfentrazone-ethyl in the context of Directive 91/414/EEC concerning the placing of plant protection products on the market. SCP/CARFEN/002-final adopted 26 January 2001.