Explanatory Memorandum to COM(2006)388 - Placing of plant protection products on the market - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2006)388 - Placing of plant protection products on the market. |
|---|---|
| source | COM(2006)388  |
| date | 12-07-2006 |
(a) Grounds for and objectives of the proposalOn 26 July 2001, the Commission submitted a progress report to Council and Parliament on the functioning of Directive 91/414/EEC [COM(2001) 444]. The report highlighted a number of areas where the Directive could be improved. The Commission concluded in its report that reform of the current legislation was necessary in order to achieve the following:reinforce the high level of protection of human health and the environment,improve functioning of the internal market,maintain and enhance the competitiveness of the EU chemical industry,harmonise availability of plant protection products between farmers in different Member States,increase transparency,avoid repetition of animal testing,update the procedures in particular to take account of the creation of the European Food Safety Authority,define the role of the European Food Safety Authority.
(b) General contextBoth Council and the European Parliament, in reacting to the progress report, called on the Commission to bring forward proposals to amend the Directive.The Council moreover called the Commission inter alia to consider rules in order to:avoid repetition of testing on vertebratesprotect non-professional userspresent criteria for approval of active substancesfurther strengthen the rules for substances with a very hazardous profileintroduce a simplified procedure for low risk substances and products. The European Parliament stressed also aspects such as:the principle of comparative assessment and substitutionexclusion of substances with a very hazardous profileincreased transparencyimprovement of mutual recognition by introducing product authorisation zones.Both the European Parliament and the Council called the Commission to propose a thematic strategy for the sustainable use of pesticides and to make further progress on establishing maximum residue levels.
(c) Existing provisions in the area of the proposalThe Community regulatory framework concerning plant protection products includes:(1) Directive 91/414/EEC of 15 July 1991 concerning the placing on the market of plant protection products which intends to prevent risks at source through a very comprehensive risk assessment procedure of each active substance and the products containing the substance, before they can be authorised for marketing and use.(2) Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances, which provides for a list of substances which have been banned in the EU and which may not be included in plant protection products.(3) Regulation (EC) No 396/2005 of the European Parliament and of the Council on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC which sets maximum residue levels (MRLs) of active substances in agricultural produce, thus intending to limit the risks to consumers. In addition, monitoring the respect of MRLs is an important tool to assess whether farmers have correctly applied the instructions and restrictions outlined in the authorisations of plant protection products.(4) Together with this proposed Regulation, a proposal is presented for a Directive of the European Parliament and of the Council establishing a framework for Community action to achieve a sustainable use of pesticides. It intends to cover the use and distribution phase in so far as they are not addressed in the current proposal.
(d) Consistency with other policiesIn preparing its proposal the Commission has taken into account key elements of the Lisbon strategy in order to extend and deepen the single market, to ensure open and competitive markets inside and outside Europe, to encourage and stimulate investment in research, development and innovation within the EU and to improve regulation and cut red-tape.The Commission has been careful to avoid duplication of the provisions of other legislation, while avoiding loopholes and ensuring that necessary information is made available to other sectors.Certain aspects concerning use and distribution of plant protection products are covered by the proposal for a Directive of the European Parliament and of the Council establishing a framework for Community action to achieve a sustainable use of pesticides. Coherence with the legislation on setting maximum residue limits has been ensured. The proposal will also ensure coherence with two recently adopted Regulations: Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls. Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety.The proposed provisions are in line with the principles of Regulation (EC) No 1049/2001 of the European Parliament and of the Council regarding public access to European Parliament, Council and Commission documents.
(a) Consultation of interested parties
Consultation methods, main sectors targeted and general profile of respondentsFollowing the presentation of the Commission's progress report, there was a wide consensus on the need for reform. Both the Council and the European Parliament clearly favoured development of more effective mechanisms and procedures, to strengthen the criteria for acceptance of substances and products and to ensure that they would be used more safely. Industry welcomed the reflection on more effective evaluation and authorisation procedures. Industry also expressed interest that any new rules on data protection should keep a fair balance between the interests of research and generic companies. Environmental non-governmental organisations (NGOs) and consumer organisations were strongly supportive of the need for change, in particular to increase transparency and to strengthen the criteria for acceptance of active substances.The Commission organised a brainstorming meeting with Member States on 27 February 2002 in which a number of areas were identified as requiring discussion and possible amendment. The Commission subsequently organised a workshop with the Presidency in Corfu in July 2002. Member States, Accession countries, the European Parliament and NGOs were invited to participate, to prepare background papers on each of the topics identified and to suggest other topics important to them. The report of the workshop formed the basis for further discussions. The Commission organised a further meeting with stakeholders in Brussels on 30 January 2004.The objectives of this meeting were (i) to report back to stakeholders on the orientations of the Commission in handling all of the topics discussed at Corfu, (ii) to exchange views on a possible compromise approach to data protection and on centralisation of the system for authorisation of plant protection products and (iii) inform stakeholders on planned next steps in the process. Also the status and plans for the Thematic Strategy on the Sustainable Use of Pesticides were discussed. The Commission consulted stakeholders again by mail on 18 April 2005 on a first draft proposal and a draft impact assessment on which written contributions were made. From 10 March to 10 May 2005 the Commission carried out an Interactive Policy Making consultation with the general public.A further consultation on the impact assessment was organised at a meeting with stakeholders on 25 January 2006.Among the stakeholders consulted were:AUDACE (Association of Users and Distributors of AgroChemicals in Europe)BEUC (Bureau Européen des Unions des Consommateurs)BUAV (British Union Against Vivisection)CEFIC (European Chemical Industry Council)CELCAA (Comité Européen de Liaison des Commerces Agricoles et Agro-Alimentaires)COCERAL (Comité du Commerce des céréales, aliments du bétail, oléagineux, huile d'olive, huiles et graisses et agrofournitures)COLEACP (Europe-Africa-Caribbean-Pacific Liaison Committee)COPA/COGECA (Committee of Professional Agricultural Organisations in the European Union/General Confederation of Agricultural Co-operatives in the European Union)ECCA (The European Crop Care Association)ECPA (The European Crop Protection Association)EEB (European Environmental Bureau)EFTA (European Free Trade Association)ESA (European Seed Association)EPPO (European and Mediterranean Plant Protection Organisation)EUREAU (European Union of National Associations of Water Suppliers and Waste Water Services)EUREPGAP (Euro-Retailer Produce working Group – Good Agricultural Practice)Eurogroup for Animal WelfareFEFAC (Fédération européenne des Fabricants d’Aliments Composés)Freshfel Europe (Forum for the European fresh fruits and vegetables chain)Friends of the EarthIBMA (International Biocontrol Manufacturers Association)Member States of E.U. + Bulgaria, Romania OECD (Organisation for Economic Co-operation and Development)PAN (Pesticides Action Network Europe)UEAPME (Union Européenne de l'Artisanat et des Petites et Moyennes Entreprises)WWF (World Wildlife Fund)
Summary of responses and how they have been taken into account.A large number of comments were received. The input from stakeholders was considered when preparing the final proposal. The following are the main points that were raised and comments considered as follows:Mutual recognition of authorisations: there was no consensus on the best approach for further harmonization of authorisation of plant protection products. Some stakeholders are opposed because they fear that local conditions can not be taken into account sufficiently, whilst other stakeholders would be in favour of a fully centralized authorisation system. The proposed system is a compromise between the current situation and a fully centralised authorisation. It should avoid unnecessary duplication of work, speed up decision making and ensure a more harmonized availability of plant protection products in the different Member States.Data protection and data sharing: Member States complain that the current system is too complicated and a major administrative burden. The research industry complains that the data protection period is too short and that it should be extended to all data; data sharing is accepted but only for data involving vertebrate animals. The generic industry complains that no fair competition is possible because of data protection, in particular at the 10 year review of an active substance. It is proposed to simplify the system. Data protection for 10 years after the first authorisation is maintained. Provisions on data protection at review of an active substance are removed.Comparative assessment: The European Parliament, some Member States and Environmental and Consumer organisations are very much in favour. Other Member States, industry and farmer organisations are against because they fear that the availability of products will be reduced with subsequent problems to deal with pest resistance; they prefer the principle to be applied at farmer level. The proposed system provides that certain active substances are identified as candidates for substitution and that Member States have to apply comparative assessment and substitution when authorizing plant protection products. The problem of development of resistance will have to be considered before substituting a product. Criteria for approval of active substances: most stakeholders agree that criteria have to be established but do not necessarily agree on the criteria themselves. Such criteria are established in an annex of the proposal, taking into account the high level of protection of human and animal health and of the environment requested by the European Parliament and the Council. The establishment of criteria will also enable industry to take an informed decision before investing in the development of new active substances or to support the renewal of approval of existing active substances. Provisional authorisations: industry and some Member States do not agree with the abolishment of provisional authorisations. The principle of provisional authorisation is however incompatible with Regulation (EC) No 396/2005 which establishes a harmonised Community system for establishing MRLs. Moreover the strict deadlines introduced for assessing an active substance will substantially reduce the period for decision making, which will compensate for the abolishment of provisional authorisations. In addition Member States must already start to evaluate applications for authorisation of plant protection products during the EU evaluation of the active substance.Comments were also raised on several aspects of the proposed Regulation; these comments have been considered and taken into account as far as possible. It should however be noted that views were sometimes totally opposed between stakeholders.
(b) Collection and use of expertise
Internal and external expertise was used to contribute to the impact assessment.
(c) Impact assessmentThe Commission carried out an impact assessment listed in the Work Programme, whose report is accessible on europa.eu.int/comm/dgs/health_consumer each of the main measures proposed, three to five options have been examined with regard to their economic and social impacts and their impacts on health and the environment.I. Provisional authorisationsII. Mutual recognitionIII. Comparative assessmentIV. Data protectionV. Informing neighbours of the use of plant protection products.
Contents
(a) Summary of the proposed actionThe proposed Regulation replaces Directive 91/414/EEC concerning the placing of plant protection products on the market and repeals Council Directive 79/117/EEC prohibiting the placing on the market and use of plant protection products containing certain active substances. In a nutshell, it consists of the following elements:Establishment at EU level of a positive list of active substances, safeners, synergists and a negative list of co-formulantsAuthorisation of plant protection products at Member State levelCompulsory mutual recognition of authorisations in Member States belonging to the same authorisation zoneComparative assessment and substitution of products containing substances identified as candidates for substitutionSpecific provisions for basic substances or products containing substances of low concernDetailed rules on data protection and transparencyProvisions on packaging, labelling and advertising Obligation to keep records and to carry out controlsEstablishment of criteria for approval of active substances, safeners or synergists
(b) Legal basisArticle 37 i and Article 152(4)(b)
(c) Subsidiarity principleThe 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 reason(s).
Action by Member States only could lead to different levels of protection for human and animal health and for the environment. Recommendations or self-regulations would not guarantee a sufficient level of protection of human health or the environment.It could also risk creating additional burden to industry when different requirements would apply. Competition conditions between farmers would be unequal if availability of plant protection products is very diverse.
Community action will better achieve the objectives of the proposal for the following reason(s):
Only Community action can lead to improvement of the completion of the internal market for plant protection products.
The large difference in authorisation of existing active substances shows that without further harmonisation the protection levels in Member States may vary a lot.
A positive list of about 500 active substances needs to be managed. This requires a harmonised and centralised approach.
The proposal therefore complies with the subsidiary principle.
(d) Proportionality principleThe proposal complies with the proportionality principle for the following reason:
The proposal fully harmonizes the approval of active substances but leaves it to Member States to authorise plant protection products taking into account harmonised criteria and national conditions.
The administrative and financial burden is reduced because of:the provision of strict deadlines for decisions at all levels, thus increasing predictability and improving access to the marketincreased worksharing at Member State level for assessing applications for authorisation.
(e) Choice of instruments
Proposed instruments: Regulation.
Other means would not be adequate for the following reason:The instrument of a Regulation is justified because it ensures that the provisions are implemented at the same time and in the same way in all 25 Member States, reducing as well administrative burden and ensuring clarity for the economic actors.
The Community may make a financial contribution up to 100% to the establishment of a harmonised policy and system.The appropriations required for the above measures shall be authorised each financial year as part of the budgetary procedure.DG SANCO shall recruit 2 staff for the implementation of the control measures.
(a) SimplificationThe recast and replacement of Directive 91/414/EEC by a Regulation was foreseen in the Simplification Rolling Programme of the Communication of the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions - Implementing the Community Lisbon programme - A strategy for the simplification of the regulatory environment [COM(2005) 535].The proposal fully implements the objectives of clarifying and improving legibility of legislation and reducing administrative costs. Replacing Directive 91/414/EEC by a Regulation brings clear benefits for the Member States, which will no longer have to transpose approval of substances into national legislation. Stakeholders will also benefit from clearer criteria in the legislation and the fact that the Regulation will significantly shorten the approval time for active substances by providing strict deadlines within which the process must be completed.Administrative procedures for authorisation of plant protection products are simplified. The impact of the new mutual recognition rules applicable to the three zones is positive for public authorities leading to better streamlining, increased efficiency and faster administrative procedures. The new rules on data protection are clear and reduce the administrative burden for industry and public authorities. For industry, obligatory zonal mutual recognition will bring benefits of administative and procedural simplification. The deadlines to grant authorisations are much shorter.Farmers will obtain a quicker and more harmonised availability of plant protection products.The proposal is included in the Commission's Work and Legislative Programme under the reference 2003/SANCO/61.
(b) Repeal of existing legislationThe adoption of the proposal will lead to the repeal of existing legislation.
(c) European Economic AreaThe proposed act concerns an EEA matter and should therefore extend to the European Economic Area.