Commission Regulation (EC) No 645/2000
of 28 March 2000
setting out detailed implementing rules necessary for the proper functioning of certain provisions of Article 7 of Council Directive 86/362/EEC and of Article 4 of Council Directive 90/642/EEC concerning the arrangements for monitoring the maximum levels of pesticide residues in and on cereals and products of plant origin, including fruit and vegetables, respectively
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 Commission Directive 1999/71/EC(2), and in particular Article 7 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 products of plant origin, including fruit and vegetables(3), as last amended by Directive 1999/71/EC, and in particular Article 4 thereof,
Whereas:
(1) Article 7 of Directive 86/362/EEC and Article 4 of Directive 90/642/EEC respectively set out basic provisions concerning the monitoring of pesticides in and on cereals and fruit and vegetables respectively.
(2) Experience in setting out and implementing Commission recommendations has shown that multiannual planning, with the possibility of annual adjustment, would be the most effective approach to establishing European Community coordinated monitoring programmes.
(3) Article 7 of Directive 86/362/EEC and Article 4 of Directive 90/642/EEC provide for review and adoption of any necessary measures, such as the publication by the Commission of European Community reports containing collated and compiled information of the Member States and the adoption of action to be taken at Community level in the case of reported infringements of the maximum levels. Experience has confirmed that in order that their reported results can be used with confidence, laboratories undertaking analyses of pesticide residues must operate with high levels of quality assurance. The participation of laboratories in regular proficiency tests and their implementation of common quality control procedures, may serve to fulfil the accreditation requirements of Article 3 of Council Directive 93/99/EEC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs(4).
(4) Because the Commission, in collating and compiling the information submitted by the Member States for presentation as European Community reports, must have confidence in the quality, accuracy and comparability of that information it is appropriate, that the Commission should contribute financially to actions which support the undertaking at the highest standards achievable of the monitoring programmes. In particular the regular proficiency tests of laboratories and the review and development of quality control procedure guidelines at regular specialist meetings should be supported.
(5) It is appropriate that the Commission should contribute financially to actions which support other aspects of the coordination of pesticide residue monitoring at Community level. In particular work should be supported to allow the Commission to respond to the requirement that it should work progressively towards a system which would permit the estimation of actual dietary exposure from monitoring data.
(6) The communication from the Commission on consumer health and food safety (COM(97) 183) describes the operation of the food; veterinary and phytosanitary control and inspection services. The monitoring of pesticide residues in and on cereals and fruit and vegetables is an activity which should be covered by the inspection service.
(7) The monitoring exercises for 1996 and 1997 demonstrated infringements of the maximum levels as laid down in Directive 90/642/EEC as amended.
(8) Directive 90/642/EEC, as amended, as well as Directive 86/362/EEC, as amended provide for the adoption of actions to be taken at Community level in the case of reported infringements and for detailed implementing rules necessary for the proper functioning of the monitoring.
(9) A summary overview of the monitoring systems in all Member States is necessary to improve the monitoring of pesticide residues in the Community and to assist in its proper functioning.
(10) Detailed implementing rules necessary for the proper functioning of the monitoring provisions should be made. These rules should clearly set out the actions to, and procedures by, which the Commission may make financial contributions, within the available budgetary allocations.
(11) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plant Health,
1. Commission recommendations made in accordance with the provisions of Article 7(2)(b) of Directive 86/362/EEC and Article 4(2)(b) of Directive 90/642/EEC may cover periods between one and five years.
2. In order to permit the effective year-to-year management of multiannual monitoring programmes, the Commission may submit annual confirmatory and supplementary draft recommendations; these shall be submitted to the Standing Committee on Plant Health as provided for in Article 7(2)(b) of Directive 86/362/EEC and Article 4(2)(b) of Directive 90/642/EEC.
In order to facilitate the proper functioning of the provisions of paragraphs 2 and 3 of Article 7 of Directive 86/362/EEC and of Article 4 of Directive 90/642/EEC respectively, the Commission shall:
1. coordinate the activities of the Member States in so far as the requirements for generating, recording, handling and transmitting information on monitoring and monitoring programmes is concerned, as appropriate by means of guidance notes of the Standing Committee on Plant Health, in particular guidelines concerning quality control procedures for pesticide residue analysis(5) and the working document for guidance to the Member States with regard to implementation of the Commission recommendations concerning coordinated Community monitoring programmes(6);
2. make financial contributions, within the appropriate allocations available in the European Community budget:
(a) to the regular organisation of proficiency tests, in principle every two years, of all laboratories performing analyses in order to assure the quality, accuracy and comparability of the information sent by the Member States to the Commission and to the other Member States annually and collated and compiled for publication by the Commission in accordance with the provisions of Article 7(3) of Directive 86/362/EEC and Article 4(3) of Directive 90/642/EEC;
(b) to the organisation of the development of quality control procedures for pesticide residue analysis, in the form of guidance notes of the Standing Committee on Plant Health, and to the organisation of the regular review, in principle at two-yearly intervals in specialist meetings, of the application of such procedures in the residue analytical laboratories of the Member States in order to assure the quality, accuracy and comparability of the information sent by the Member States to the Commission and to the other Member States annually and collated and compiled for publication by the Commission in accordance with the provisions of Article 7(3) of Directive 86/362/EEC and Article 4(3) of Directive 90/642/EEC;
(c) to the yearly organisation of studies, consultations and other preparations necessary to allow the Commission to work progressively towards a system which could permit the estimation of actual pesticide dietary exposure from monitoring data, as required by the second subparagraph of Article 7(3) of Directive 86/362/EEC and of Article 4(3) of Directive 90/642/EEC; and
(d) to the organisation of other actions at Community level necessary for the proper implementation of paragraphs 2 and 3 of Article 7 of Directive 86/362/EEC and of Article 4 of Directive 90/642/EEC respectively which may be identified by the Commission and the Standing Committee on Plant Health.
1. The Commission shall designate the beneficiary or beneficiaries of the financial contributions provided for in Article 2(2) by means of a decision adopted in accordance with the procedures set out in Article 12 of Directive 86/362/EEC and of Article 10 of Directive 90/642/EEC.
2. The Commission decision, provided for in paragraph 1, shall in particular set out:
- the name of the beneficiary or beneficiaries of the Community financial contribution,
- the total cost of the action to be undertaken, and the contributions of the parties involved in undertaking the action, including the European Community,
- a summary description of the action to be undertaken,
- a timetable for the completion of the action.
Member States shall ensure that the analytical results sent to the Commission and to the other Member States annually, in accordance with the provisions of Article 7(3) of Directive 86/362/EEC and Article 4(3) of Directive 90/642/EEC have been obtained by laboratories which:
- are in compliance with the requirements of Article 3 of Directive 93/99/EEC, and
- make every effort to implement the quality control procedures for pesticide residue analysis provided for in Article 2(2)(b) of this Regulation.
In addition, Member States shall ensure that participation in the coordinated Community programme shall be restricted to laboratories which have participated in a previous, or which shall participate in the next round of the relevant Community proficiency tests provided for in Article 2(2)(a) of this Regulation.
1. The Commission shall appoint special, suitably qualified officials to monitor in the Member States, together with the national authorities, the carrying out of the national and Community monitoring programmes for pesticide residues in and on foodstuffs of plant origin. This includes sampling and the performance of the relevant laboratories.
2. The officials will visit the national authorities in each of the Member States, who will cooperate with the Commission's designated officials and give all necessary assistance to enable them to accomplish their tasks. The programmes of the visits shall be organised and carried out in collaboration with the Member State concerned. In any event, the national authorities shall remain responsible for the carrying out of the control operations.
3. The Commission shall arrange for these visits with the national officials within a suitable time-frame. In addition to experts from the Member State visited, the Commission's experts may be accompanied during the visits by one or more experts from one or more other Member States. During the visits, the Member State expert or experts appointed by the Commission shall comply with the Commission's administrative rules.
4. After each visit, the Commission shall prepare a written report. The Member State visited will be given the opportunity to comment on this report.
5. The Commission shall regularly notify by written report all Member States, in the Standing Committee on Plant Health, on the outcome of the visits to each Member State. The Commission shall inform the European Parliament. The Commission shall also make the reports publicly available on a regular basis.
6. The provisions of this Article shall be re-examined by 31 October 2001.
This Regulation shall enter into force on 1 April 2000.
This Regulation shall be binding in its entirety and directly applicable in all Member States.