Report from the Commission to the Council on the application of Article 7 of Council Directive 86/362/EEC and Article 4 of Council Directive 90/642/EEC, concerning the monitoring of pesticide residues
Date: 2000-03-01
Institutions: European Commission
Subjects: consumer protection, foodstuff, pesticide residue, plant health control

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 01.03.2000
COM(2000) 98 final

REPORT FROM THE COMMISSION TO THE COUNCIL

on the application of Article 7 of Council Directive 86/362/EEC and Article 4
of Council Directive 90/642/EEC, concerning the monitoring of pesticide residues

REPORT FROM THE COMMISSION TO THE COUNCIL

on the application of Article 7 of Council Directive 86/362/EEC and Article 4
of Council Directive 90/642/EEC, concerning the monitoring of pesticide residues

Introduction

Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide
residues in and on cereals1 and 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 vegetables2 both contain Articles providing for the monitoring of the levels
of pesticides residues.

In particular, Article 7(5) of Council Directive 86/362/EEC and Article 4(5) of Council
Directive 90/642/EEC (as last amended by Directive 1999/71/EC3) stipulate that
the
Commission shall forward to the Council, before the end of 1999, a report on the application
of these Articles concerning the monitoring of pesticide residues. This Report is submitted to
the Council in accordance with those provisions. It contains the following elements:

1.

2.

3.

4.

5.

6.

7.

8.

9.

Objectives of the monitoring,

The authorities carrying out the monitoring,

Planning the monitoring,

Organisation of the monitoring,

Reporting the results,

Actions by the Commission,

Missions by the Food and Veterinary Office

Points of concern,

Conclusions and Recommendations.

(1)

Objectives of the monitoring

The general objective of the monitoring is to enable the Commission to work towards a
system that could permit the estimation of actual dietary exposure. Other objectives include
the estimation of the extent of infringements of maximum residue levels and the actual levels
of residues with respect to the maximum residue levels established.

1

2

3

OJ L 221 of 7.8.1986, p. 37.
OJ L 350 of 14.12.1990, p. 71.
OJ L 194, 27.7.1999, p. 36.

2

(2)

The authorities carrying out the monitoring

The Directives stipulate that Member States shall designate an authority to ensure that
monitoring specified in Article 4(4) of Council Directive 86/362/EEC and in Article 3(4) of
Council Directive 90/642/EEC is carried out.

Member States have designated the appropriate authorities to carry out the monitoring.

The Articles also stipulate that monitoring is to be carried out in accordance with Council
Directives 89/397/EEC4 and 93/99/EEC5 on the official control of foodstuffs. The latter
directive requires that laboratories are accredited by 1 November 1998.

(3)

Planning the monitoring

It was originally provided for that Member States submit their national plans for the following
year to the Commission by 30 June each year. This caused difficulties for many Member
States because their forward planning is, to various extents, contingent on the analysis of the
monitoring results from the previous year. The problem was foreseen in the original Council
Directives that delegated the power to change the dates to the Commission. The problem was
solved by Commission Directive 1999/65/EC6 that changed the deadline from 30 June to
30 September. This should enable Member States to submit their national plans in the future
in time to the Commission.

The Commission has since 1996 submitted annually draft Monitoring Recommendations to
the Standing Committee on Plant Health for opinions. Following positive opinions, these were
then adopted by the Commission and were published in the Official Journal as Monitoring
Recommendations 96/199/EC7 (for 1996), 96/738/EC8 (for 1997), 97/822/EC9 (for 1998),
1999/333/EC10,
time, guidance on quality control
(for 1999,
procedures), and for 200011.

including,

the first

for

These Monitoring Recommendations define the product/pesticide combinations to be
monitored in the year in question. These combinations are chosen to be in line with a larger
overall strategy to monitor over a 5-year period a sufficient variety of products for groups of
pesticides to enable the Commission and the Member States to get a view on the actual
dietary intake of these pesticides. In 2001, the first 5-year cycle will be complete and it should
then be possible to make a first Community-wide estimation of the actual intake of the first
group of 5 pesticides during this period, for the main fruit and vegetable components of the
diet that contain these pesticides. This will be followed by similar activities in the succeeding
years.

In the Monitoring Recommendation for 1999, another new element - the variability exercise
was introduced. This should allow the Commission and the Member States to address acute
intake concerns for certain acutely toxic pesticides. In practice the exercise involves, for
pesticide/product combinations two samples are taken, one is analysed as a composite sample

4

5

6

7

8

9

10

11

OJ L 186 of 30.6.1989, p. 23.
OJ L 290 of 24.11.1993, p. 14.
OJ L172 of 8.7.1999, p. 40.
OJ L 64 of 14.3.1996, p. 18.
OJ L 335 of 24.12.1996, p. 54.
OJ L 337 of 9.12.1997, p. 14.
OJ L 128 of 21.5.1999, p. 25.
Favourable opinion by SCPH on 28.9.1999.

3

and the second is divided into individual items, which are individually analysed in order to be
able to evaluate the variability within the sample.

(4)

Organisation of the Monitoring

There is a wide variation among the Member States in the amount of samples analysed each
year. In 1997,
it varied from 220 samples in Luxembourg to 9,540 samples in The
Netherlands. Since the Directives only stipulate the obligation to sample and do not mention a
minimum number of samples to be taken, it is up to each Member State to define for itself the
number of samples necessary to ensure compliance. Most of the annual national monitoring
reports received by the Commission described the criteria used for the products to be
analysed. The number of samples and pesticide residues monitored is mainly based on
analytical capabilities. The resources and the state of the art of the laboratories in the Member
States have not always been satisfactory in the countries visited to date. These issues were
also discussed during various missions to the Member States’ authorities (see 7 below).
Criteria are also given for the choice of crops. In general the authorities try to monitor
they try to respect the
according to what products are on the market and in addition,
imported/domestic production ratio in their planning. The Commission does not, however,
have information from all Member States on these aspects. Even where criteria are provided,
that does not always mean that the situation is satisfactory, as often, the main criterion driving
the sampling is the availability of resources and this tends to be limited.

(5)

Reporting the results

The Directives stipulated that the Member States had to report the results of the previous year
to the Commission by 31 August. The Commission,
in turn, then had to forward this
information to the Standing Committee on Plant Health by 30 September. As with the
deadline for the planning (see 3 above) there were difficulties meeting the latter deadline each
year. The problem was also solved by Commission Directive 1999/65/EC that changed the
deadline from 30 September to 31 December.

At an early stage in the annual monitoring activity there was consensus among the Member
States and the Commission about making the information available to the general public. To
date, reports on monitoring for pesticides residues in the European Union are available for the
first two annual exercises (1996 and 1997) and these have been published on the public
Internet site of DG SANCO (http://europa.eu.int/comm/dg24/health/fnaoi/reports/pesticides/
mon_rep/index_en.html). At the time of publication, the Commission issued Press Releases
with statements from the competent Commissioners.

The actual levels of pesticides residues detected in the 1996 and 1997 exercises were
examined in relation to the Community MRL’s that were set for them. The results were
consistent from one year to the next. In about 60 % of the analysed samples in national
programmes, no detectable residues were found. Less than 4% of samples contained
pesticides residues in excedence of an MRL. In the Community co-ordinated programme, 0.3-
0.5% of samples contained pesticides residues exceeding MRLs. In one case, a product
contained such a high level of residue that the ADI was temporarily exceeded but this has to
be interpreted in conjunction with the WHO conclusion12
that short-term temporary
excedences of the ADI are not a cause for concern. Realistic intake calculations using the
available actual data showed that there is no chronic or acute health concern for any of the
limited number of pesticide-product combinations analysed. Therefore it was considered

12

Guidelines for predicting dietary intake of pesticide residues, WHO/FSF/FOS/97.7.

4

unnecessary for any action to be taken at Community level on public health grounds with
respect to reported infringements of the maximum levels. In 2001, when we will have a more
complete overview on the dietary intake for the first group of pesticides, this aspect will be
reconsidered. For serious excedences of MRLs and for cases where there are high risks of
acute toxicity the Community Rapid Alert System for foods can be and is used. Discussions
are currently underway between the Commission and the Member States on how to improve
its functioning in the area of pesticides residues in foods.

In reporting infringements of MRL’s the issue was raised when, technically and statistically
speaking, is an MRL exceeded in a way that one can speak of an infringement. In the
Directives this was not specified, and Member States have different views and responses for
such cases. Until now this has not led to trade problems, but potentially problems could arise
and it should be useful to solve this problem.

(6)

Actions by the Commission

the Commission has already,
As described in sections 3 and 5 above,
1999/65/EC, introduced amendments to the dates of notification and reporting.

in Directive

The Commission has also introduced detailed implementing rules in the form of guidance
notes concerning formats and about quality assurance, which were published along with the
Monitoring Recommendation for 1999. These documents are under constant revision and
funding for these activities is foreseen in a draft monitoring Regulation submitted to the
Standing Committee on Plant Health for an opinion on 2 December 1999.

The Member States also participate in the regular proficiency tests that are co-organised and
funded by the Commission. In view of the future enlargement of the Community, the Services
of the Commission have agreed to allow participation of laboratories from Central and
Eastern European countries in these activities.

The draft Regulation also provides for regular proficiency tests, updating of the quality
assurance guidance document and the calculation of the actual consumer intake at the end of
the 5-year monitoring cycle. Accreditation is a matter for national accreditation bodies to do.
Their tasks are facilitated by the Commission through the organisation and sponsoring of
biennial proficiency tests and through the development of quality assurance guidelines.

(7) Missions by the Food and Veterinary Office

Missions are carried out by the Food and Veterinary Office of the Commission to Member
States to check the conditions under which the monitoring is performed and to verify whether
the specifications of Articles 4(4) and 3(4) of Council Directives 86/362/EEC and
90/642/EEC, respectively, are being met. These missions sometimes also include checks to
91/414/EEC
monitor the controls of member states according to Council Directive
(Article 17) on marketing and uses of plant protection products.

The reports of these missions are published on the public Internet site of DG SANCO (see
(5)). Missions to five member states have been undertaken so far. Accreditation of the
laboratories has been and still is a problem and in many countries. In two countries (Portugal
and Ireland) there was no accreditation at all.

5

(8)

Points of concern

1)
Pesticide residues in foods of animal origin are not monitored in the Community co-
ordinated monitoring programme under the above articles in the Directives. They are
monitored in the Member States under the provisions of Directive 96/23/EC (Council
Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues
thereof in live animals and animal products and repealing Directives 85/358/EEC and
86/469/EEC and Decisions 89/187/EEC and 91/664/EEC). This directive also provides that
reports are sent to the Commission by 31 March each year. However, there are no provisions
for the compilation of the results at Community level and for their inclusion in the Annual
Commission Reports provided in the articles of Directive 96/23/EC. Furthermore,
the
objective of the monitoring undertaken within Directive 96/23/EC is to ensure compliance
with Community legislation and neither the scale of the monitoring nor its design lends it to
an easy complementarity with the coordinated community monitoring programme foreseen
under the articles.

MRLs for pesticides in products of animal origin are set by the Commission (Council
2)
Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues
in and on foodstuffs of animal origin13). Some pesticides may have a dual use. When used in
these substances are evaluated according to Council Regulation
veterinary medicines,
2377/90/EEC14, laying down a Community procedure for the establishment of maximum
residue limits of veterinary medicinal products in foodstuffs of animal origin. The evaluation
of the data is made within the EMEA by the Committee for Veterinary Medicinal Products
(CVMP). The MRLs following this evaluation are set up by the Commission.

Some discrepancies in residue definitions and the products to which they apply reflect
differences in the methodology of calculation resulting on different residue levels for the
same substance in the same foodstuff. It was noted that the values proposed by the scientific
Committee for Veterinary Medicinal Products are stricter than those adopted for pesticides.

These discrepancies were also found at global level of the Codex Alimentarius work. The
Services of the Commission are therefore working to resolve these differences both within the
Community and in the work of the Codex Alimentarius.

However, any further adjustment will require the modification of the current legislation.
Therefore a parallel review of the Annexes of the Residue Directives and the Annexes of
Regulation 2377/90 would be desirable to improve the transparency and applicability of
Community legislation.

Council Directive 97/41/EC (of 25 June 1997 amending Directives 76/895/EEC,
3)
86/362/EEC, 86/363/EEC and 90/642/EEC relating to the fixing of maximum levels for
pesticide residues in and on, respectively, fruit and vegetables, cereals, foodstuffs of animal
origin, and certain products of plant origin, including fruit and vegetables)15 extended the
scope of Community MRL’s to include animal feedingstuffs. However, residues in animal
feedstuffs are not monitored to the extent that primary agricultural products are. It is only
when feedingstuffs also happen to be primary agricultural products (e.g. cereals) that there is
sampling compliance with the Directives although potentially, feedingstuffs can be monitored
under Directive 96/23/EC.

13

14

15

OJ L 221 of 7.8.1986, p. 43.
OJ L 224 of 18.8.1990, p. 1 as last amended by Commission Regulation (EEC) no 1570/98 (OJ L 205,
22.7.1998, p. 10).
OJ L 184 of 12.7.1997, p. 33.

6

4)
Member States have an obligation to monitor the levels of pesticides residues in food
and agricultural commodities but there are no “minimum” requirements and the monitoring
activity varies considerably among them. Because of the limited number of commodities to be
analysed in the co-ordinated programme, it takes five years before intake estimates can be
carried out and then even only for a limited number of pesticides. There are also a limited
number of accredited laboratories capable of monitoring in the Member States.

5)
The rate of excedence of Community MRLs, although limited, is a matter for concern
and for further investigation. It may be linked to the way that Community MRL’s are set
(whereby there is a finite statistical probability of excedence) but it may also be linked to
unauthorised uses of the pesticides. There has been a concern about excedences in tropical
fruits, but this may have been caused by the few non-zero import tolerances granted and the
lack of guidance about submission of data for these. This situation may improve following the
issuance of guidelines by the Commission in October 1999.

The competence of the Commission to make inspections in the Member States is

6)
limited.

7)
In working towards a system permitting estimation of the actual exposure to pesticides
residues, complementary data is required whose collection is not provided for in the
Directives. This data mainly concerns actual diets of the population and of population
subgroups and exposure to pesticides from other sources that are not monitored under the
articles (e.g. water, occupational, domestic, products of animal origin).

The Commission addresses many of these points in its White Paper on Food Safety and is
addressing the others already in legislation in preparation.

(9)

Conclusions and Recommendations.

The application of Article 7 of Council Directive 86/362/EEC and Article 4 of Council
Directive 90/642/EEC, concerning the monitoring of pesticide residues generally works well
throughout the Community and has enabled, for the first time, an appreciation of the actual
situation in the Community regarding the exposure of consumers to pesticide residues in fruit
and vegetables. It is encouraging to note that the levels of pesticides residues detected to date
do not pose a health risk to the consumer. Nonetheless, there is no room for complacency and
the Commission should, with the Member States, continue to monitor closely the levels of
pesticides residues in food and to address the points of concern listed in section 8, above. In
particular, the Commission favours an integrated approach, as proposed in the White Paper on
Food Safety. This approach by which the Commission should eventually be able to evaluate
the presence of all kinds of substances such as residues of contaminants, pesticides, additives,
veterinary medicines etc. in food, can only be achieved if there are integrated community
monitoring programmes for all of these types of substances, and a set of standard diets for
several types of European consumers by which the presence of these substances can be
evaluated.

7