12.9.2003 Official Journal of the European Union L 228/11 COMMISSION DIRECTIVE 2003/82/EC of 11 September 2003 amending Council Directive 91/414/EEC as regards standard phrases for special risks and safety precautions for plant-protection products (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/ 81/EC (%), and in particular Article 16 and Article 18(2) thereof, Whereas: 1 1 2 3 5 6 () O] () O () O] () O] () O] () O Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (*), as last amended by Commission Directive 2001/59/EC (¥), requires that dangerous substances cannot be placed on the market unless their labelling shows standard phrases for special risks (R phrases) and standard phrases relating to the safe use of the substance (S phrases). Directive 91/414/EEC provides for an authorisation for each plant-protection product on the basis of an assess- ment carried out in each Member State. That Directive also provides that Member States are to prescribe that active substances are not to be placed on the market unless they are classified, packaged and labelled in accor- dance with Directive 67/548/EEC. Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approxima- tion of laws, regulations and administrative provisions of the Member States relating to the classification, packa- ging and labelling of dangerous preparations (), as amended by Commission Directive 2001/60/EC (°), applies to plant-protection products. Directive 1999/45/ EC provides that the provisions of that Directive are to apply to preparations falling within the scope of Direc- tive 91/414/EC from 30 July 2004. Directive 91/414/EEC provides that all packaging of plant-protection products is to satisfy certain require- ments as to labelling; inter alia, the packaging is to show the nature of any special risks for humans, animals or the environment, by means of standard phrases selected as appropriate from those set out in Annex IV of that L 230, 19.8.1991, p. 1. L 224, 6.9.2003, p. 29. 196, 16.8.1967, p. 1. L 225, 21.8.2001, p. 1. L 200, 30.7.1999, p. 1. L 226, 22.8.2001, p. 5 ) Directive. As that Annex has not yet been established, it is appropriate to include a list of such standard phrases in Annex IV to that Directive. Directive 91/414EEC provides that all packaging of plant-protection products is to show safety precautions for the protection of humans, animals or the environ- ment, in the form of standard phrases selected as appro- priate from those set out in Annex V of that Directive. As that Annex has not yet been established, it is appro- priate to include a list of such standard phrases in Annex V to that Directive. Directive 1999/45/EEC provides that the general princi- ples of the classification and labelling of preparations of that Directive are to be applied in accordance with the criteria laid down in Annex VI to Directive 67/548EEC. The criteria in Annex VI to Directive 67/548/EEC, which are based on the intrinsic properties of a substance, may not allow a sufficient description of the special risks which may arise during the use of plant-protection products in practice. Accordingly, the standard phrases for special risks and safety precautions to be set out in Annex IV and V to Directive 91/414/EEC should allow a sufficient description of the special risks which may arise during the use of plant-protection production and the safety precautions which should be taken. The standard phrases for special risks and safety precau- tions to be set out in Annexes IV and V to Directive 91/ 414[EEC should be assigned in the light of the assess- ment by the Member States of the active substance(s) of those products in accordance with that Directive. It is, therefore, appropriate that Member States, after inclusion of an individual active substance in Annex I to Directive 91/414[EEC should be allowed a reasonable period to review existing authorisations and implement the provi- sions of Annexes IV and V to that Directive when granting authorisations. The harmonised phrases in Annex IV and Annex V provide the basis for complementary and specific instructions for use according to Article 16(1)(k), (), (m) and (n). A harmonised scheme should be provided also for the classification and labelling of plant-protection products which contain microbial active substances.