Explanatory Memorandum to COM(2006)373 - Framework for Community action to achieve a sustainable use of pesticides - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2006)373 - Framework for Community action to achieve a sustainable use of pesticides. |
|---|---|
| source | COM(2006)373  |
| date | 12-07-2006 |
· Grounds for and objectives of the proposal
Pesticides are active substances and products designed to influence fundamental processes in living organisms and, therefore, have the potential to kill or control harmful organisms such as pests. Consequently, these products can cause undesirable adverse effects on non-target organisms, human health and the environment. Because of the particular circumstances of pesticide use (in particular for plant protection purposes)-deliberate release into the environment-, they are subject to regulation in Member States and the Community. Over the years, a highly elaborate system has been developed for evaluating the risks to human health and the environment.
Despite the existing regulatory framework, undesirable amounts of certain pesticides can still be found in environmental media (in particular soil, air and water), and residues exceeding the regulatory limits can still be detected in agricultural products. New and emerging scientific findings-such as the potential of certain chemicals, among them pesticides, to disrupt the functioning of the endocrine system even at low concentrations-underline the possible risks for humans and the environment from the use of such substances.
With the Decision adopting the 6th Environment Action Programme (6EAP), the European Parliament and the Council recognised that the impact of pesticides on human health and the environment, in particular those of plant protection products, must be reduced further. They underlined the need to achieve a more sustainable use of pesticides and outlined a two-track approach:
– Full implementation and appropriate revision of the relevant legal framework,
– Developing a Thematic Strategy on the Sustainable Use of Pesticides.
In its Communication A Thematic Strategy on the Sustainable Use of Pesticides [COM(2006) 372], the Commission presents the various measures that could be part of the strategy. These are, as far as possible, integrated into existing legal instruments and policies. The objective of the attached draft Directive is to implement those parts of the Thematic Strategy that require new legislation.
Although the term “pesticides” is used throughout all documents being part of the Thematic Strategy, the current proposal focuses on plant protection products for the time being. There are various reasons for this limitation, including the fact that plant protection products are the most important group of pesticides with the longest history of legislation. Legislation concerning placing of biocidal products on the market has only recently been introduced through Directive 98/8/EC and experience of the Commission and Member States is not yet sufficient to propose further measures. Furthermore, it is clear from the Decision of the European Parliament and the Council adopting the 6EAP that, although the term ‘pesticides’ is used, the main concerns are related to plant protection products. This is underlined by the fifth indent of Article 7 i, calling for ‘a significant overall reduction in risks and of the use of pesticides consistent with the necessary crop protection’, as well as by Article 7(2)(c), specifying Directive 91/414/EEC as the applicable legal framework that is to be complemented by the Thematic Strategy. Consequently, this proposal will focus on the use of plant protection products for the time being. However, should comparable measures be considered necessary for biocides in the future, they will be incorporated in the Thematic Strategy as appropriate.
· General context
Despite the risks for human health and the environment linked to pesticides, their use generates various benefits-mostly economic-in particular for farmers. Pesticides maximise agricultural yields and the quality of agricultural products, and minimise labour input. They can contribute to limit soil erosion by allowing reduced tillage cultivation, and they help to ensure reliable supplies of a wide choice of affordable agricultural produce. Plant protection products are also an important means to meet plant health requirements and allow international trade of agricultural products. These are the main reasons why pesticides are widely used in agriculture. Outside the agricultural sector, pesticides also have a wide range of uses, from wood or fabric preservation to public health protection.
Existing policies and legislation were first introduced at Community level in 1979 and have evolved considerably over the years, culminating in the adoption of Directive 91/414/EEC concerning the placing of plant protection products on the market and of Directive 98/8/EC concerning the placing of biocidal products on the market. They require that all plant protection and biocidal products need to be evaluated and authorised before they can be placed on the market. Despite the increasing costs involved in this process and the decreasing number of active substances on the market, actual consumption and use of pesticides in the EU has not decreased within the last ten years. At the same time, the percentage of food and feed samples where residues of pesticides exceed maximum regulatory limits is not declining, but remains around 5%. In addition, certain pesticides are commonly found in the aquatic environment at concentrations well above the regulatory limit, and there is no sign of any decrease. Over the last fifteen years, significant but uneven changes in pesticide use have been observed amongst Member States. Whilst pesticide use declines in some Member States, a sharp increase has been observed in others. Such diverging trends, which indicate differences in policy amongst Member States, justify action at Community level, in particular in order to harmonise the level of protection of human health and the environment.
Pursuant to Article 7 i of Decision No 1600/2002/EC defining the 6EAP, the overall objective of the Thematic Strategy is to reduce the impacts of pesticides on human health and the environment, and more generally to achieve a more sustainable use of pesticides as well as a significant overall reduction in risks and of the use of pesticides consistent with the necessary level of protection against pests.
Pursuant to Article 7(2)(c) of Decision No 1600/2002/EC, the specific objectives of the Thematic Strategy are:
– to minimise the hazards and risks to health and environment from the use of pesticides
– to improve controls on the use and distribution of pesticides
– to reduce the levels of harmful active substances including through substituting the most dangerous with safer (including non-chemical) alternatives
– to encourage the use of low-input or pesticide-free crop farming, in particular by raising users' awareness, by promoting codes of good practices and consideration of the possible application of financial instruments
– to establish a transparent system for reporting and monitoring the progress made towards the achievement of the objectives of the strategy, including the development of suitable indicators.
Thematic Strategies are new tools, which follow a holistic concept in addressing a specific topic. Integration of the measures of the Strategy in existing policies and legislation is a key element. Appropriate measures will, therefore, preferably be taken in the framework of these policies. In this respect, specific measures to promote low-input farming are already foreseen in the Common Agricultural Policy (CAP), in particular Regulation (EC) No 1698/2005 on support for rural development. The recently adopted new Regulation (EC) No 396/2005 on Maximum Residue Levels (MRLs) of pesticides in food and feed provides for a reinforcement of annual monitoring programmes. Environmental monitoring for pesticides will, inter alia, be part of the monitoring activities required within the Water Framework Directive.
However, from the preparation of the Thematic Strategy, in particular the consultation process and the impact assessment, it has emerged that some of the envisaged measures cannot be integrated into existing legislation or policies. For several of them, it has been shown that legislative proposals are the most effective means of implementation. The attached draft Directive contains all measures for which new legislation was deemed necessary, with two exceptions:
– the collection and reporting of statistics regarding placing on the market and use of plant protection products, for which the Commission will propose a separate Regulation,
– the certification of pesticide application equipment placed on the market, for which the Commission will propose a separate Directive, which will possibly amend Directive 2006/42/EC of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast) i.
In addition to these three proposals, the Commission will propose a comprehensive revision of Directive 91/414/EEC which, inter alia, will implement two of the five objectives of the Thematic Strategy on the Sustainable Use of Pesticides: reinforcement of provisions on official controls of compliance with all conditions attached to the use of plant protection products at market and user level; and provisions for application of comparative assessment and the substitution principle in the authorisation of plant protection products.
· Existing provisions in the area of the proposal
The Community regulatory framework concerning pesticides focuses particularly on the beginning and the end of the life cycle of such products. The most relevant legislation is:
Directive 91/414/EEC concerning the placing on the market of plant protection products,
Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin.
The aim of Directives 91/414/EEC and 98/8/EC is to prevent risks at source through a very comprehensive risk assessment of each active substance and the products containing the substance, before they can be authorised for marketing and use. Regulation (EC) No 396/2005 sets maximum residue levels (MRLs) of active substances in agricultural produce, thus contributing to limiting the risks to consumers at the end of the food chain. In addition, monitoring the respect of MRLs is an important tool to assess whether EU farmers have correctly applied the instructions and restrictions related to the authorisation of plant protection products.
One of the shortcomings of the legal framework is that the actual use phase, which is key to the determination of the overall risks that pesticides pose, is not sufficiently addressed. Because of their scope, the existing legal instruments will not be able, even when revised, to achieve all the objectives outlined in the 6EAP. Therefore, the measures in the Thematic Strategy-and in particular in this draft Directive-attempt to fill this gap.
· Consistency with other policies and objectives of the Union
The proposal is fully coherent with the objectives and aims of the 6th Environment Action Programme, such as protection of nature and biodiversity, environment and health and quality of life. It is also in line with the Lisbon Strategy, the European Union strategy for sustainable development, with other thematic strategies (in particular the Soil and the Marine Strategies), the EU policy on water protection, food safety and consumer protection.
· Consultation of interested parties
In accordance with the 6th Environment Action Programme, Thematic Strategies are to be developed in a two-step process involving all stakeholders. With its Communication Towards a Thematic Strategy on the Sustainable Use of Pesticides i, the Commission launched a wide-ranging consultation exercise.
The Communication recalled the shortcomings of the current regulatory framework with regard to the use phase in the life-cycle of plant protection products. It included extensive background information on the benefits and risks of using pesticides and presented a list of essential issues to be addressed. It discussed possible measures to reverse negative trends and to address the use phase more specifically.
Consultation encompassed the European Parliament, the Council, the European Economic and Social Committee and the general public (via internet). More than 150 contributions were received. In addition, the Commission organised a Stakeholders Conference in November 2002 with more than 200 participants from all relevant stakeholder groups such as pesticide industry, farmer organisations, authorities, consumer and environmental organisations.
Further consultation took place through Commission participation at numerous outside conferences dedicated to various specific issues (e.g. comparative assessment / substitution, application equipment, the concept of Integrated Pest Management) and specific meetings organised by the Commission (e.g. on aerial spraying). In a final consultation step, the Commission launched a further internet consultation via Your voice in Europe on the measures to be included in the attached draft Directive.
The objectives and many of the possible measures, as outlined in chapter VI of the Communication of 2002, were broadly supported by the consulted stakeholders and institutions. All comments are available at:
europa.eu.int/commenvironment/ppps
The documents and reports from the Stakeholder consultation are available at: europa.eu.int/comm/environment/ppps/1st_step_conf.
A more detailed summary of the consultation process and its outcome can be found in the Impact Assessment, which is presented together with this draft Directive. All contributions have been fully considered in the preparation of the various elements of the Thematic Strategy, including the attached Directive and the Impact Assessment.
An open consultation was conducted over the internet from 17 March 2005 to 12 May 2005. The Commission received nearly 1 800 responses. The results are available at
europa.eu.int/comm/environment/ppps/pdf
· Collection and use of expertise
Agriculture, plant protection, machinery and engineering (application equipment, in particular sprayers and related equipment), aerial spraying, analysis of economic, social and environmental impacts.
Bilateral consultations with stakeholders, organisation of meetings, participation at conferences, study by consultant.
Member State authorities, pesticide industry, farmer organisations, academia, European Standard Organisation (CEN), environmental organisations.
The advice received confirmed that additional measures regarding aerial spraying, the standardisation and regular inspection of pesticide application equipment, indicators and the collection and disposal of empty packaging are necessary, and such requirements have been integrated into the draft Directive.
As all other contributions during the consultation, expert advice has been made available on the website of the Commission at:
europa.eu.int/comm/environment/ppps/2nd_step_tech.
· Impact assessment
For each of the measures proposed in the draft Directive, three to five options ranging from voluntary to mandatory measures have been examined with regard to their economic, social and environmental impacts on the various stakeholders and authorities.
In addition, a no-option scenario was considered as a reference against which to appraise the costs and benefits anticipated from the measures proposed.
The Commission carried out an Impact Assessment, the report of which is presented in parallel to this proposal as a Commission Staff Working Paper. It is also available at:
ec.europa.eu/environment/ppps/2nd_step_study.
Contents
- Legal elements of the proposal
- Budgetary implication
- 2. Consultation of interested parties and impact assessment
- Consultation methods, main sectors targeted and general profile of respondents
- Summary of responses and how they have been taken into account
- An open consultation was conducted over the internet from 17 March 2005 to 12 May 2005. The Commission received nearly 1 800 responses. The results are available at
- Scientific/expertise domains concerned
- Methodology used
- Main organisations/experts consulted
- Summary of advice received and used
- Means used to make the expert advice publicly available
- 5. Additional information
- Annexes
· Summary of the proposed action
The proposed Directive of the European Parliament and the Council will implement those provisions of the Thematic Strategy that cannot be included in existing instruments or policies, with the exception of the collection of statistical information regarding the placing on the market and use of plant protection products. The proposed Directive will contain rules on:
– Establishment of National Action Plans to set objectives to reduce hazards, risks and dependence on chemical control for plant protection (National Action Plans-NAPs), which will allow for the necessary flexibility to adapt the measures to the specific situations in the Member States.
– Involvement of stakeholders in the setting up, implementation and adaptation of the NAPs.
– Creation of a system of training and awareness-raising for distributors and professional users of pesticides in order to ensure that they are fully aware of the risks involved. Better information for the general public through awareness-raising campaigns, information passed on through retailers, and other appropriate measures.
– Regular inspection of application equipment in order to reduce adverse impacts of pesticides on human health (in particular as regards operator exposure) and the environment during application.
– Prohibition of aerial spraying with derogation possible, to limit the risks of significant adverse impacts on human health and the environment, in particular from spray drift.
– Specific measures to protect the aquatic environment from pollution by pesticides.
– Defining areas of significantly reduced or zero pesticide use in line with measures taken under other legislation (such as the Water Framework Directive, the Birds Directive, the Habitats Directive, etc.) or to protect sensitive groups.
– Handling and storage of pesticides and their packaging and remnants.
– Development of Community-wide standards on Integrated Pest Management (IPM), and establishment of necessary conditions for implementation of IPM.
– Measuring progress in risk reduction through appropriate harmonised indicators.
– Establishment of a system of information exchange for continuous development and improvement of appropriate guidance, best practices, and recommendations.
· Legal basis
Article 175 i of the EC Treaty is the appropriate legal basis.
· Subsidiarity principle
The subsidiarity principle applies insofar as the proposal does not fall under the exclusive competence of the Community.
The objectives of the proposal cannot be sufficiently achieved by the Member States for the following reasons.
Currently, some Member States have already adopted measures that cover (completely or partly) what is proposed in the Directive. Others have not yet taken such action. This creates a situation where there is no level playing field for farmers and the pesticide industry, which can amount to unfair competition for economic actors in different Member States. Furthermore, there is no equal level of protection of human health and the environment throughout the Community and pesticide use shows diverging trends between Member States.
Community action will better achieve the objectives of the proposal for the following reasons.
Only Community action can improve the current disparate situation in the Member States by implementing harmonised requirements and an equal level of protection of human health and the environment and by completion of the internal market for application equipment.
Placing on the market of pesticides is already harmonised through Community legislation. The same should therefore apply to other aspects of pesticides policy. Currently Member States are developing their national policies in different directions and with different levels of stringency and ambition.
Setting uniform requirements and objectives to be achieved in all Member States can only be done by the Community. Otherwise the current situation with varying obligations for economic operators will continue. The continuous information exchange among Member States and the Commission which is foreseen in the proposal will allow the development of appropriate guidance, best practices and recommendations, taking into account scientific or technical progress. Further information will be collected via the monitoring and control programmes laid down in other Directives and Regulations that are affected by the Thematic Strategy. This cannot be achieved by the Member States alone.
The proposal therefore complies with the subsidiarity principle.
· Proportionality principle
The proposal complies with the proportionality principle for the following reasons.
The proposed Directive creates the legal framework with the essential requirements and objectives. Member States retain a significant amount of flexibility to determine the details of the necessary implementing measures appropriate to their specific geographic, agricultural and climatic situations. The Commission intends to establish a specific expert group, composed of Member States and all other relevant stakeholders, to assess regularly the reported information and data in order to draft appropriate guidance and recommendations. This 'Expert Group on the Thematic Strategy on the sustainable use of pesticides' (hereinafter the 'Expert Group') will be formally established by a Commission decision at a later stage. When necessary, the Commission will adopt amendments to the Annexes of the proposed Directive, following a regulatory committee procedure within the framework of the Standing Committee on the Food Chain and Animal Health established by Article 58 of Regulation (EC) No 178/2002.
The detailed analysis of the economic, social and environmental impacts (including administrative burdens) that has been carried out for all measures has enabled the Commission to identify those options that represent minimum costs to all stakeholders, and overall these costs are lower than the expected estimated benefits.
· Choice of instruments
A framework directive is proposed.
Other means would not be adequate for the following reasons.
A highly prescriptive Regulation or Directive would not have been appropriate as the starting points for each issue are very different from one Member State to another, e.g. structure of the agricultural sector, climatic and geographical conditions, existing national legislation and programmes. On the other hand, simple recommendations would not be efficient to achieve the envisaged objectives as these could not be enforced. Where deemed feasible (i.e. for the collection of empty packaging), the Directive leaves the possibility of self-regulation for the stakeholders concerned.
It is proposed to create one permanent Commission post to administer and co-ordinate the Strategy and organise all meetings of the Expert Group for the development of guidance, further measures and the calculation and reporting of indicators. Further expenditure relating to activities under this Directive will be covered by the financial instrument for the environment (LIFE+ for the 2007-2013 period). No additional amount is requested.
· Simulation, pilot phase and transitory period
There will be no transitory period for the proposal.
· Review/revision/sunset clause
The proposal includes a review clause.
· European Economic Area
The proposed act concerns an EEA matter and should therefore extend to the European Economic Area.
· Detailed explanation of the proposal
Article 1 outlines the subject matter of the Directive.
Article 2 outlines the scope of the Directive.
Article 3 contains the definitions deemed necessary for the purposes of the Directive.
Article 4 requires Member States to set up national action plans (NAPs) to identify crops, activities or areas for which risks are worrying and should be addressed in priority and set objectives and timetables to achieve them. Experience in several Member States has shown that coherent action plans are the best tool to achieve the intended objectives. In the light of the widely varying situations in the Member States and in line with the principle of subsidiarity, NAPs shall be adopted at national and/or regional level. When setting up or amending NAPs, the public shall be given early and effective opportunities to participate in the process, in line with the spirit of Directive 2003/35/EC providing for public participation in respect of the drawing up of certain plans and programmes relating to the environment i. This will be important to ensure successful and efficient implementation. Member States will have to pay attention to maintain coherence with what is included in other relevant plans and could have an influence on the use of pesticides, such as river basin management and rural development plans.
Article 5 requires Member States to set up systems of training for distributors and professional users of pesticides, in order to ensure full awareness about the risks involved. Attendance to trainings, proven by certificates, should not be a prerequisite for establishment or employment of professional pesticide users. Details regarding procedures and administrative provisions are left to the Member States, but Annex I will spell out the subjects that these training programmes have to address.
Article 6 calls on Member States to ensure that at least one person in the employment of distributors selling toxic or very toxic pesticides is available to provide information to customers, and that only those professional users fulfilling the necessary requirements shall have access to pesticides. Member States are required to prescribe that only specifically authorised products will be available for sale to non-professional users, as they are not as well aware of the risks as professional users.
Article 7 obliges Member States to facilitate and promote awareness programmes and availability of information to the public relating to pesticides and their alternatives, in order to inform non-professional users about all relevant risks and precautionary measures.
Article 8 requires Member States to set up a system for regular technical inspection and maintenance of application equipment in use. Well maintained and properly functioning application equipment is key to continuously guaranteeing a high level of protection of human health (in particular the operators) and the environment when applying pesticides. In order to ensure equally stringent technical inspections throughout the Community, common and harmonised standards shall be used, based on the essential requirements defined in Annex II. The organisational aspects (like public or private inspection systems, quality control of inspection bodies involved, inspection frequency, financing aspects, etc.) remain at the discretion of the Member States, who will have to report to the Commission.
Article 9 obliges Member States to prohibit aerial spraying but allows for derogations. Aerial spraying should be prohibited because of its high potential to cause adverse effects on human health and the environment from spray drift. Derogations could be granted where aerial spraying has clear advantages and environmental benefits compared to other spraying methods or where there are no viable alternatives. Detailed requirements for derogation will be adopted at the level of the Member States, on which they shall report to the Commission.
Article 10 obliges Member States to require farmers and other professional pesticide users to pay particular attention to the protection of the aquatic environment through measures such as buffer strips and hedges along water courses or other appropriate measures aiming at limiting drifts.
Article 11 obliges Member States to designate areas where greatly reduced or zero use of pesticides is to be allowed in coherence with measures taken under other legislation (such as the Water Framework Directive, the Birds Directive, the Habitats Directive, etc.). Such areas shall also be designated so as to address the specific protection needed by vulnerable groups such as children. Member States shall report on the measures taken in order to develop guidance, criteria for selecting areas and best practices.
Article 12 obliges Member States to adopt measures to address 'point source' emissions, in particular from mixing, loading and cleaning. They shall also be required to take measures to avoid dangerous handling operations by non-professional users. Exchange of information between the Member States on their national initiatives and on the progress achieved will be organised through reporting, involving also stakeholders that are particularly active in this area.
Article 13 requests Member States to take the necessary measures in order to establish the conditions essential for implementation of Integrated Pest Management. General standards for integrated pest management shall be developed and shall become mandatory as of 2014. Additionally, Community-wide specific IPM standards shall be developed for particular crops, but their implementation shall remain voluntary. Member States shall report on the measures taken in order to establish the conditions for implementation of Integrated Pest Management, to ensure implementation of general standards of IPM, and to encourage the implementation of crop-specific standards of IPM by pesticide users.
Article 14 states that Member States will be obliged to collect and report statistical information on placing on the market and use of pesticides-the details are proposed in the Regulation concerning statistics on plant protection products. This information will be the basis for calculating appropriate risk indicators, which are necessary to monitor progress in the reduction of overall risks from the use of pesticides. Work on the development of harmonised risk indicators is ongoing. When finalised, a common set of risk indicators will eventually be agreed by the Commission and the Member States. Until then, Member States can continue to use their current indicators. In order to evaluate the impact of this Directive and other measures of the Thematic Strategy in reducing overall risks, the Commission shall draw up reports analysing the trends in the development of the indicators reported by the Member States.
Article 15 requires the Commission to regularly report to the European Parliament and the Council, based on the reports provided by Member States on the measures that they adopt to achieve the objectives of this Framework Directive.
Articles 16 to 22 contain standard provisions regarding Comitology, standardisation, penalties and entry into force.
The Annexes contain details regarding various measures that Member States have to adopt in accordance with the Articles of the Directive. Annexes may be modified in accordance with Article 18, in the light of experience and needs identified from the system of information exchange and the discussions in the Expert Group.
Annex I lists the elements that have to be addressed in the training programmes.
Annex II contains the essential requirements for the inspections and maintenance verifications to be carried out for application equipment in use.