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
Date: 2000-03-28
Institutions: European Commission
Subjects: EU control, European Commission, cereals, crop production, foodstuffs legislation, pesticide residue

29.3.2000

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Official Journal of the European Communities

L 78/7

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)

(2)

(3)

Article 7 of Directive 86/362/EEC and Article 4 of
Directive 90/642/EEC respectively set out basic provi-
sions concerning the monitoring of pesticides in and on
cereals and fruit and vegetables respectively.

Experience in setting out and implementing Commission
recommendations has shown that multiannual planning,
with the possibility of annual adjustment, would be the
approach to establishing European
most
Community coordinated monitoring programmes.

effective

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 confi-
dence,
laboratories undertaking analyses of pesticide
residues must operate with high levels of quality assur-
ance. The participation of laboratories in regular profi-
implementation of common
ciency tests and their
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 presen-
tation as European Community reports, must have

(1) OJ L 221, 7.8.1986, p. 37.
(2) OJ L 194, 27.7.1999, p. 36.
(3) OJ L 350, 14.12.1990, p. 71.
(4) OJ L 290, 24.11.1993, p. 14.

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.

pesticide

of
level.

It is appropriate that the Commission should contribute
financially to actions which support other aspects of the
coordination
at
Community
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.

residue monitoring

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 pesti-
cide residues in and on cereals and fruit and vegetables is
an activity which should be covered by the inspection
service.

The monitoring exercises for 1996 and 1997 demon-
strated infringements of the maximum levels as laid
down in Directive 90/642/EEC as amended.

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
the
the proper
rules necessary for
monitoring.

functioning of

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.

(5)

(6)

(7)

(8)

(9)

(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,

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Official Journal of the European Communities

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HAS ADOPTED THIS REGULATION:

Article 1

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 recom-
mendations;
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.

shall be

these

Article 2

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 Commis-
sion 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 proced-
ures for pesticide residue analysis (1) and the working docu-
ment for guidance to the Member States with regard to
the Commission recommendations
implementation of
concerning
monitoring
programmes (2);

Community

coordinated

2. make financial contributions, within the appropriate alloca-

tions available in the European Community budget:

(a) to the regular organisation of proficiency tests, in prin-
ciple 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 publica-
tion by the Commission in accordance with the provi-
sions 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

(1) OJ L 128, 21.5.1999, p. 30.
(2) OJ L 128, 21.5.1999, p. 48.

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
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

estimation of

the

(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.

Article 3

1.
The Commission shall designate the beneficiary or benefi-
ciaries 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.
shall

The Commission decision, provided for in paragraph 1,
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.

Article 4

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 proced-
ures 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 labo-
ratories which have participated in a previous, or which shall
participate in the next round of the relevant Community profi-
ciency tests provided for in Article 2(2)(a) of this Regulation.

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Article 5

1.
The Commission shall appoint special, suitably qualified
officials to monitor in the Member States, together with the
national authorities,
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.

the carrying out of

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
the Commission's
experts from the Member State visited,
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 adminis-
trative rules.

After each visit, the Commission shall prepare a written
4.
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,
the visits to each Member State. The
on the outcome of
Commission shall
inform the European Parliament. The
Commission shall also make the reports publicly available on a
regular basis.

The provisions of this Article shall be re-examined by 31

6.
October 2001.

This Regulation shall enter into force on 1 April 2000.

Article 6

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 28 March 2000.

For the Commission

David BYRNE

Member of the Commission