Opinion of the European Economic and Social Committee on the "Proposal for a Regulation of the European Parliament and of the Council on maximum residue levels of pesticides in products of plant and animal origin" (COM(2003) 117 final — 2003/0052 (COD))
Date: 2003-07-16
Institutions: European Economic and Social Committee
Subjects: animal product, consumer protection, crop production, food standard, pesticide residue

30.9.2003

EN

Official Journal of the European Union

C 234/33

Opinion of the European Economic and Social Committee on the ‘Proposal for a Regulation of
the European Parliament and of the Council on maximum residue levels of pesticides in products
of plant and animal origin’

(COM(2003) 117 final — 2003/0052 (COD))

(2003/C 234/10)

On 26 March 2003 the Council decided to consult the European Economic and Social Committee, under
Articles 37, 95 and 152 of the Treaty establishing the European Community, on the above-mentioned
proposal.

The Section for Agriculture, Rural Development and the Environment, which was responsible for
preparing the Committee’s work on the subject, adopted its opinion on 27 June 2003. The rapporteur
was Mrs Cassina.

At its 401st Plenary Session on 16 and 17 July 2003 (meeting of 16 July), the European Economic and
Social Committee adopted the following opinion by 110 votes to one with five abstentions.

1.

Introduction and objectives of the proposal

The main objectives of the draft regulation are to
1.1.
minimise the health and environmental risks arising from
the use of pesticides, and to carry forward the process of
harmonising maximum residue levels (MRLs) at Community
level
for all plant-protection products. Under the current
legislation, the Member States can set different levels in their
individual national laws.

1.2.
In the broader context of the Sixth Environment Action
Programme, the proposal should also be read in the light of
the Communication from the Commission to the Council, the
European Parliament and the Economic and Social Committee
Towards a thematic strategy on the sustainable use of pesticid-
es (1). The Committee essentially welcomed this communi-
cation in its opinion (2), in which a more detailed analysis is
provided.

1.3.
The proposal takes the form of a single regulation
replacing the four directives which currently govern the issue
at Community level (3). In preparing the draft regulation, the
Commission has taken account of (i) problems occurring in
transposing the above-mentioned directives, (ii) the sugges-
tions on implementation made in the SLIM V (simpler
legislation for the internal market) exercise, (iii) the relevant
guideline comments made at the Agriculture Council of
20 November 2001 and the Environment Council of
12 December 2001, and (iv) the resolution of the European
Parliament of 30 May 2002.

1.4.
Under the proposed regulation, the Commission will
be mainly responsible for risk management connected with
the use of pesticides, with an important role in risk assessment
being assigned to the European Food Safety Authority (EFSA).
The EFSA would work through a network of experts in each
of the Member States in order to provide the information
required for risk assessments and independent scientific advice
on the subject, in accordance with the provisions of the White
Paper on Food Safety (4).

1.5.
In moving from the present procedure to the new one
under the draft regulation, data which have not yet been
harmonised concerning both existing and new substances —
for which MRLs have so far been set at national level — will
be compiled by the EFSA, assessed according to safety criteria,
and introduced as temporary MRLs. They will subsequently be
assessed individually on the basis of Directive 91/414/EEC on
the placing of plant-protection products on the market.
This directive remains the basic reference for Community
legislation, although it is shortly to be updated.

1.5.1.
The proposal which, once finally adopted, will
prevent the Member States from setting MRLs themselves,
comes in the run-up to the deadline for withdrawing a series
of more than 400 plant-protection products, use of which will
be completely prohibited by 2004 in accordance with the
current legislation.

1.5.2.
The proposal opens up the possibility of using
monitoring data to set MRLs in special cases where there are
no authorised uses for environmentally persistent substances
which can give rise to residue problems or substances in use
for minor commodities such as spices.

( 1) COM(2002) 349 final of 1.7.2002.
( 2) OJ C 85 of 28.4.2003.
( 3) Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/

EEC.

(4) COM(1999) 719 final, OJ C 204 of 18.7.2000.

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1.5.3.
Account will also be taken of the Commission’s
Proposal for a Regulation of the European Parliament and of
the Council on official feed and food controls.

ing all the interconnected issues contained in the proposal. In
particular, it welcomes the compulsory nature of the proposal,
to apply directly in all the Member States from 1 January 2005
for fresh products and 1 July 2005 for stored products.

1.6. With a view to achieving the highest possible level of
consumer protection, the regulation as a whole is based on the
principle of a default MRL of 0,01 mg/kg of residues which
may not be exceeded. The only exception to the default limit
will be if this limit might pose a risk for consumers, in which
case a lower MRL will be set.

1.7.
The Commission believes that implementation of the
draft regulation’s provisions following the transitional period
will constitute a major step forward in consolidating and
simplifying the existing legislation, by removing non-tariff
barriers to trade within the single market and with third
countries, and directly helping to safeguard human and animal
health as well as the environment.

2. General comments

In putting forward these initial, general views, the EESC
2.4.
wishes to acknowledge, as it has done in the past, that
intelligent use of plant-protection products can still play an
important role as part of a broad spectrum of applications,
mainly in agriculture, focusing on protection of plants and
plant products, generating significant economic benefits. At
the same time, it believes that the objective of progressively
replacing such products with safer, alternative substances and/
or methods should be consistently and clearly upheld (2)
against a backdrop of scientific and technological progress.

2.5.
In view of the subject’s strategic importance, the EESC
stresses that funds and scientific skills must be brought to
bear on Community research projects to identify and apply
alternative substances and production methods which can
maintain high levels of crop production and produce percep-
tible benefits in terms of environmental and health protection
in general. This should be done on the basis of the relevant
provisions of the sixth Framework Programme for research
and technology development.

The EESC considers that the proposal for a single
2.1.
regulation to replace the existing four directives represents a
major contribution to implementing the strategy for sustaina-
ble use of pesticides, insofar as the regulation successfully
dovetails the safeguarding of human health with the protection
that crops need. It also believes that the regulation could
remove the potential for distortion of competition on the
internal market.

2.6.
The Committee is convinced that more careful and
responsible management of the use of chemical products in
the Community can offer an important benchmark for the
accession countries and, in particular, for developing countries,
whose focus on staple crops in combating hunger could be
based, from the outset, on a high level of protection for the
environment and both human and animal health.

2.2.
On this basis, the Committee once again states its
general support for the sustainable use of pesticides, reducing
the use and/or the risk posed by the use of chemical substances
in agriculture so as to respect as far as possible the natural
processes governing agricultural production, and consequently
endorses this Community strategy. The proposed EC regulation
represents a vital advance in harmonisation and health protec-
tion and is fully in keeping with the communication on a
thematic strategy on the sustainable use of pesticides (1). The
EESC is pleased to note that the comments made in its opinion
on the communication have largely been addressed in the
present proposal.

2.3.
The EESC considers the legal basis selected (third
and
subparagraph
Article 152(4)(b)) to be both appropriate and effective, cover-

37(2), Article

of Article

95(1)

3. Specific comments

3.1.
The EESC welcomes the proposal to set the maximum
residue level, in accordance with convention, at 0,01 mg/kg,
and notes that this MRL is already used in the legislation
covering babyfood which must by its nature entail almost
complete safeguards, according to the assessment of the
Scientific Committee on Food.

3.1.1.
Although ‘zero’ risk, however desirable, cannot be
identified using present-day analysis methods, a clear trend
should be established towards progressive reduction of the
maximum levels for certain potentially hazardous substances,
by constantly updating analytical methods — as is already, in
part, the case — in line with technological and scientific
advances and consistently applying the precautionary prin-
ciple.

( 1) COM(2002) 349 final of 1.7.2002.

(2) See also opinion NAT/156, OJ C 85 of 28.4.2003.

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3.2.
The EESC urges that the EFSA start work as soon as
possible in order to provide a broad, representative scientific
basis, given that the agency is entrusted with important
scientific support and coordination functions. The EESC hopes
that the EFSA, although not yet operating at full capacity, will
view the pesticides issue as one of its priorities.

3.6.
Assuming that the indications set out in the two
preceding points are duly implemented, it will then become
necessary to establish a clear, transparent set of rules on
penalties ensuring certainty and uniformity in all the Member
States. In this way they can be effective, proportionate and act
as a real deterrent, preventing any subsequent opportunities
for distorting competition.

3.3.
The EESC is pleased to note that the draft regulation
retains a number of tried and tested procedures, such as the
committee procedure, believing that under the proposal these
implementing mechanisms, although incurring some costs for
certain actors, will bring about significant simplification of the
existing legislation and that this can only serve to make the
internal market operate more smoothly.

3.7.
The EESC considers that, in order to move as rapidly
as possible from temporary to final MRLs, the regulation must
be adopted at the same time as Directive 91/414/EEC is
reviewed, and that the two must be fully compatible. The EESC
will take a close interest in the review proposal which should
be presented in the second half of the year, and which should
be referred to it.

3.4.
The EESC is concerned at the possible risks of monitor-
ing being carried out by the Member States, in the event of
significant differences between national implementing criteria.
It therefore urges the Commission to indicate how such risks
can be avoided. It is particularly important that specific tests
be introduced to detect
the presence of any prohibited
substances in the period immediately following the withdrawal
of products under Directive 91/414/EEC.

Food products imported into the Community from
3.8.
third countries must meet the same health, quality and food
safety requirements as Community products. For this reason,
the Committee is concerned that Article 29 (authorising
imports from third countries) might allow MRLs different from
those in the Community, due to the possibility of differing
agricultural good practices. It is only acceptable for MRLs to
be set for imported products which are not produced in the
EU.

3.4.1.
The Member States should also be obliged to provide
documentation attesting the sustainable disposal of stocks of
obsolete products.

3.4.2.
The EESC calls for appropriate information and
occupational training measures to be taken during the period
of transition from one regulatory regime to the other (the last
six months of 2003 and the whole of 2004), so that operators
at all levels can adjust promptly to the framework changes in
the new legislation.

Similarly, national

3.4.3.
their
analysis methods and criteria to a new common reference
framework.

laboratories must adjust

Careful attention must also remain focused on safety
3.5.
conditions for users most exposed to risk (workers), on
their training, on clear and comprehensible instructions on
products, and on the definition of responsibilities in this area.
These matters are in part defined in Directive 91/414/EEC, but
the Committee would draw attention to the urgent need to
strengthen and update the directive in response to the concerns
set out above.

3.9.
The new Member States are required to comply with
the acquis communautaire in this area. However, since the
methods and products used in agriculture in these countries
have been, until very recently, significantly different from
those in the EU, the EESC suggests that they be provided with
specific assistance (consultancy and know-how) in adjusting to
the proposed regulation and the thematic strategy on the
sustainable use of pesticides within the deadlines set.
In
particular, the EESC would point to the huge amounts of
pesticides in central and eastern Europe which are obsolete or
which it will no longer be possible to use. The new Member
States must be helped to dispose of these products in a
sustainable manner.

3.10.
As argued above, the EESC is of the view that the
proposal for a regulation may be of major significance to
third countries, especially developing nations, and views the
pesticides initiative launched under the cooperation arrange-
ments with the ACP countries (1) as exemplary. It is essential
to continue with such initiatives — and with adequate funding
— and to extend them to other partners, within frameworks
such as Euromed or cooperation with Mercosur.

(1) Pesticides Initiative Programme (PIP): for information on the

programme, see www.coleacp.org.

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3.11. When setting new harmonised limits,
the Com-
mission should strive to respect the Codex MRLs under the
WTO rules introduced in the late 1990s. Many of these are
not acceptable to the Community, and each of them must be
subject to individual critical examination. The EESC would

stress that these international requirements should not force
the Community into making its own requirements flexible,
and calls upon the European Commission to strive to maintain
the existing high level of health protection.

Brussels, 16 July 2003.

The President

of the European Economic and Social Committee

Roger BRIESCH

Opinion of the European Economic and Social Committee On ‘Healthcare’

(2003/C 234/11)

On 21 January 2003, in accordance with Rule 29(2) of the Rules of Procedure, the Economic and Social
Committee decided to draft an opinion on ‘Healthcare’.

The Section for Employment, Social Affairs and Citizenship, responsible for preparing the Committee’s
work on the subject, adopted its opinion on 30 June 2003. The rapporteur was Mr Bedossa.

At its 401st Plenary Session on 16 and 17 July 2003 (meeting of 16 July), the European Economic and
Social Committee adopted this opinion by 61 votes in favour, 5 votes against and 6 abstentions.

1.

Introduction

in terms of organising healthcare and in terms of
responsibility.

1.1.
The Commission Communication of December
2001 (1), the follow-up to the initiative approved at the Lisbon
European Council of March 2000, and the initial report for
the 2002 European Council boldly address one of the most
difficult aspects, after pensions, involved in building a social
Europe in accordance with the values enshrined in the Charter
of Fundamental Rights.

1.1.1.
Health is often defined as a fundamental asset for
society. This is equally applicable to each individual citizen,
family, and nation.

— Naturally, the approach taken by each individual differs,
as does the approach taken by EU Member States, both

— However, the EU as a whole must tackle a series of
challenges. A solid basis of understanding is needed to
find common, appropriate responses to such challenges,
whilst respecting existing diversity.

— The definition given by the World Health Organisation
(WHO) states that health is a state of complete physical,
mental and social well-being of each individual.

— Healthcare is not limited to treating pathologies, but
must more generally encompass individual and collective
efforts at prevention and promotion of aptitudes and
conditions.

( 1) COM(2001) 723 final on the Future of healthcare and care for the
elderly: guaranteeing accessibility, quality and financial viability.

— Being a fundamental asset, health cannot be considered
solely in terms of social expenditure and latent economic
difficulties.