Commission Directive 2001/36/EC
of 16 May 2001
amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market
(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(1), as last amended by Commission Directive 2001/28/EC(2), and in particular Article 18(2) thereof,
Whereas:
(1) Annexes IIB and IIIB to Directive 91/414/EEC set out the requirements for the dossier to be submitted by an applicant respectively for the inclusion of an active substance consisting of micro-organisms or viruses in Annex I to that Directive and for the authorisation of a plant protection product based on preparations of micro-organisms or viruses.
(2) It is necessary to indicate, in Annexes IIB and IIIB to applicants, as precisely as possible, any details on the required information, such as the circumstances, conditions and technical protocols, under which certain data have to be generated; these provisions should be introduced as soon as available in order to permit applicants to use them in preparation of their dossiers.
(3) It is appropriate to differentiate data requirements for chemical substances and micro-organisms in some respects, as several requirements, e.g. on some issues concerning fate and behaviour in the environment and residues, are specific to chemicals while others, such as those on infectiveness, are specific to micro-organisms.
(4) It is now possible to introduce more precision with regard to the data requirements as experience was gained during the evaluation of several new active substances consisting of micro-organisms. In particular the areas of occupational health, consumer exposure, environmental risk have been subject to major changes.
(5) The Scientific Committee on Plants provided an opinion which dealt with the principles associated with the use of micro-organisms as plant protection products and the Committee provided comments on an early draft of the data requirements. The recommendations made by the Committee in the opinion(3), including the proposed amendments to the text of the draft data requirements were taken into account by the Commission.
(6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Annex II to Directive 91/414/EEC shall be amended as set out in Annex I to this Directive.
Article 2
Annex III to Directive 91/414/EEC shall be amended as set out in Annex II to this Directive.
Article 3
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 May 2002 at the latest. They shall forthwith inform the Commission thereof.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
Article 4
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.
Article 5
This Directive is addressed to the Member States.
Done at Brussels, 16 May 2001.