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

1.1. The main objectives of the draft regulation are to 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 pesticides(1). The Committee essentially welcomed this communication 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 suggestions 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.

1.5.3. 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.

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

2.1. The EESC considers that the proposal for a single regulation to replace the existing four directives represents a major contribution to implementing the strategy for sustainable 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.

2.2. 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 protection and is fully in keeping with the communication on a thematic strategy on the sustainable use of pesticides(5). 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 subparagraph of Article 37(2), Article 95(1) and Article 152(4)(b)) to be both appropriate and effective, covering 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.

2.4. In putting forward these initial, general views, the EESC 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(6) 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 perceptible 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.

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.

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 principle.

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.

3.3. 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.

3.4. The EESC is concerned at the possible risks of monitoring 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.

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.

3.4.3. Similarly, national laboratories must adjust their analysis methods and criteria to a new common reference framework.

3.5. Careful attention must also remain focused on safety 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.

3.6. 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.

3.7. 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.

3.8. Food products imported into the Community from 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.

3.9. 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 arrangements with the ACP countries(7) 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.

3.11. When setting new harmonised limits, the Commission 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

(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.

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

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

(7) Pesticides Initiative Programme (PIP): for information on the programme, see www.coleacp.org.