L 127/104 Official Journal of the European Union 29.4.2004 COMMISSION DIRECTIVE 2004/71/EC of 28 April 2004 amending Council Directive 91/414/EEC to include Pseudomonas chlororaphis as active substance (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 (!), and in particular Article 6(1) thereof, Whereas: In accordance with Article 6(2) of Directive 91/414/EEC the Swedish authorities received on 15 December 1994 an application from Bio Agri AB, hereafter referred to as the applicant, for the inclusion of the active substance Pseudomonas chlororaphis in Annex I to the Directive. Decision 97/248/EC (*) of 25 March 1997 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 Il and III to Direc- tive 91/414/EEC. For this active substance, 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 State submitted a draft assessment report concerning the substance to the Commission on 7 April 1998. The draft assessment report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 30 March 2004 in the format of the Commission review report for Pseudomonas chlorora- phis. The dossier and the information from the review were also submitted to the Scientific Committee for Plants. The Committee was asked to comment (a) on residue levels in food and feed; (b) on operator exposure; (c) whether with regard to possible hazard to humans a tiered approach should include repeated dosing as part of the primary data set; (d) on the toxicological safety of the antibiotic metabolites of the active substance; (¢) on (") OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commis- sion Directive 2004/20/EC (O] L 70, 9.3.2004, p. 32). () OJL 98, 15.4.1997, p. 15. the necessity to monitor the health of workers; and (f) on a potential of Pseudomonas chlororaphis to cause wound infection or other pathogenic effects. In its opinion (*) the Committee concluded that (a) the issue of residues has been adequately addressed that there is no cause for concern; (b) operator exposure to Pseudomonas  chlororaphis ~ formulations has  been adequately addressed; (c) in the specific case of Pseudo- monas chlororaphis, and in the light of the results of the available studies, repeated dosing is not necessary to assess hazard to humans; (d) more studies would be needed for a more complete assessment of the mutageni- city potential of the metabolite 2,3-deepoxy-2,3-dide- hydro-rhizoxin (DDR). However, the Committee consid- ered the potential for human exposure to DDR as well as to other possible antibiotic metabolites so low that, even in the absence of further information, no major concern exists for consumer and operator safety; () a study based on the medical surveillance of workers should be conveniently carried out when introducing this agent in the field as a microbial pesticide; (f) there is no cause for concern for human safety with regard to wound infection. The recommendations of the Scientific Committee as well as further information by the notifier were taken into account during the further review and in this Direc- tive and in the Review Report, where the need for moni- toring of operators and worker based on medical surveil- lance to detect negative effects without delay as well as monitoring studies to quantify DDR contamination under practical conditions is stressed. The evaluation within the Standing Committee concluded that there would be no unacceptable risk for operators if appro- priate risk mitigation measures are applied. It has appeared from the various examinations made that plant protection products containing Pseudomonas chlororaphis may be expected to satisfy, in general, the requirements laid down in Article 5(1) (a) and (b) of Directive 91/414/EEC in the light of Article 5(3) thereof, in particular with regard to the uses which were exam- ined and detailed in the Commission review report. It is therefore appropriate to include this active substances in Annex |, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive. (*) Opinion of the Scientific Committee on Plants on specific questions from the Commission regarding the evaluation of pseudomonas chlor- oraphis in the context of Council Directive 91/414/EEC scp/ pseudom/002-final adpoted on 20 December 2001.