Commission Directive 2000/48/EC
of 25 July 2000
amending the Annexes to Council Directives 86/362/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on cereals and certain products of plant origin, including fruit and vegetables respectively
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals(1), as last amended by Directive 2000/42/EC(2), and in particular Article 10 thereof,
Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin including fruit and vegetables(3), as last amended by Directive 2000/42/EC, and in particular Article 7 thereof,
Having regard to Council Directive 91/414/EEC of 15 July 1991 on the placing of plant protection products on the market(4), as last amended by Commission Directive 2000/10/EC(5), and in particular Article 4(1)(f) thereof,
Whereas:
(1) The new active substance, azoxystrobin, was included in Annex I to Directive 91/414/EEC by Commission Directive 98/47/EC(6) for use as fungicide only, without specifying particular conditions having an impact on crops which may be treated with plant protection products containing azoxystrobin.
(2) Maximum levels for azoxystrobin residues in and on all commodities covered by Directives 86/362/EEC and 90/642/EEC were fixed by Commission Directive 1999/71/EC(7).
(3) In fixing the said maximum levels for azoxystrobin residues, it was recognised that these levels should be kept under review and should be changed to take account of new information and data. Directive 1999/71/EC acknowledged that national provisional maximum residue levels for other cereals and fruit and vegetables should be fixed by Member States as a part of their authorisation of plant protection products containing azoxystrobin and should be notified to the Commission under the requirements of Article 4(1)(f) to Directive 91/414/EEC. To facilitate this eventuality, some of the levels set in Directive 1999/71/EC were fixed on a provisional basis, enabling Member States to grant further authorisations for new uses and to notify the Commission under the procedure described by the said Article. This Article provides that where a provisional Community maximum residue level exists and where the new authorised use would lead to higher levels, the authorising Member State shall establish a national provisional maximum residue level in accordance with Article 4(1)(f) of Directive 91/414/EEC before the authorisation may be granted.
(4) To ensure that the consumer is adequately protected from exposure to residues in or on products for which no authorisations have been granted, it was considered prudent, in adopting Directive 1999/71/EC, to set provisional maximum residue levels at the lower level of analytical determination for such products. The setting at Community level of such provisional maximum residue levels is without prejudice to the granting of provisional authorisations by the Member States for the use of azoxystrobin on such products in accordance with Article 4(1)(f) of Directive 91/414/EEC.
(5) In order to authorise a plant protection product, Member States must apply the uniform principles provided for in Annex VI to Directive 91/414/EEC in evaluating, in particular, a dossier conforming to the requirements of Annex III to Directive 91/414/EEC, submitted by the applicant for authorisation. Annex III, Part A, Section 8 of Directive 91/414/EEC requires applicants to submit certain information including proposed maximum residue levels together with full justification and estimations of the potential and actual exposure through diet and other means. Annex VI, Part B, Section 2.4.2 and Part C, Section 2.5 of Directive 91/414/EEC provides for Member States to evaluate the information submitted concerning impact on human or animal health arising from residues and the impact on the environment and to take decisions on authorisations which ensure that residues occurring reflect the minimum quantities of the plant protection product necessary to achieve adequate control corresponding to good agricultural practice, applied in such a manner that the residues at harvest, slaughter or after storage, as appropriate, are reduced to a minimum.
(6) New data has been provided for uses of azoxystrobin on rice, bananas, tomatoes and cucurbits with edible and inedible peel. This new data has been evaluated and it is considered appropriate to revise the provisional maximum residue levels fixed for these products in Directive 1999/71/EC.
(7) At the inclusion in Annex I to Directive 91/414/EEC the technical and scientific evaluation of azoxystrobin was finalised on 22 April 1998 in the format of the Commission review report for azoxystrobin. In this review report the acceptable daily intake (ADI) for azoxystrobin was set at 0,1 mg/kg bw/day. The lifetime exposure of consumers of food products treated with azoxystrobin has been assessed and evaluated in accordance with the procedures and practices used within the European Community, taking account of guidelines published by the World Health Organisation(8) and it has been calculated that the maximum residue levels fixed in this Directive do not give rise to an exceedence of this ADI.
(8) Acute toxic effects requiring the setting of an acute reference dose were not noted during the evaluation and discussion that preceded the inclusion of azoxystrobin in Annex I to Directive 91/414/EEC.
(9) The Community's trading partners have been consulted about the levels set out in this Directive through the World Trade Organisation and their comments on these levels have been considered. The possibility of fixing import tolerance maximum residue levels for specific pesticide/crop combinations will be examined by the Commission on the basis of the submission of acceptable data.
(10) The advice and recommendations of the Scientific Committee for Plants, in particular concerning the protection of consumers of food products treated with pesticides, have been taken into account.
(11) 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
The following shall be added to part A of Annex II to Directive 86/362/EEC:
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Article 2
The maximum residues levels in the Annex to this Directive shall replace those listed for azoxystrobin in Annex II to Directive 90/642/EEC.
Article 3
1. This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Communities.
2. Member States shall adopt and publish the legislative, regulatory or administrative measures to comply with this Directive by 31 March 2001 at the latest. They shall forthwith inform the Commission thereof.
3. They shall apply these measures as from 1 April 2001.
4. 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 is addressed to the Member States.
Done at Brussels, 25 July 2000.