Explanatory Memorandum to COM(2006)778 - Statistics on plant protection products

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dossier COM(2006)778 - Statistics on plant protection products.
source COM(2006)778 EN
date 11-12-2006
1) CONTEXT OF THE PROPOSAL

3.

1.1. Grounds for and objectives of the proposal


Monitoring of risks related to the use of pesticides, in particular the risks for the environment associated with the use of plant protection products, needs appropriate indicators; the Member States, the European Commission and the Organisation for Economic Co-operation and Development (OECD) have therefore conducted preliminary studies aimed at establishing such indicators. The calculation of risk indicators is possible only on the basis of suitable data, such as data on pesticide use, but experts have expressed their concerns about the accessibility, transparency, adequacy and reliability of these data.

With Decision 1600/2002/EC adopting the Sixth Environment Action Programme (6EAP), the European Parliament and the Council recognised that the impact of pesticides on human health and the environment, in particular from plant protection products used in agriculture, must be reduced further. They underlined the need to achieve more sustainable use of pesticides and called for a significant overall reduction of risks and the use of pesticides consistent with the necessary crop protection.

In its Communication to the Council, the European Parliament and the European Economic and Social Committee entitled Towards a Thematic Strategy on the Sustainable Use of Pesticides i, the Commission recognised the need for detailed, harmonised and up-to-date statistics on sales and use of pesticides at Community level, and proposed to establish relevant mandatory requirements within two years of the adoption of the Thematic Strategy, thereby consolidating current work on the collection of data concerning the use of pesticides.

By requesting mandatory data collection, the main objective of this Regulation is to ensure that comparable data are collected in all the Member States, making it possible to calculate harmonised risk indicators and to measure the progress made towards more sustainable use of plant protection products throughout the Community.

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1.2. General context


In the context of the 6EAP, the Thematic Strategy on the Sustainable Use of Pesticides aims at reducing the impact of pesticides on human health and the environment, and more generally at achieving more sustainable use of pesticides and a significant overall reduction of risks, while ensuring necessary crop protection. Given that the existing legislative framework mainly concentrates on the start and end-of-life phases of pesticides, i.e. the authorisation for placing plant protection products on the market and the control of their residues in food and feedstuff, the Thematic Strategy is designed to complement the existing legislative framework by targeting the use phase of plant protection products.

One clearly stated objective of the Thematic Strategy is to establish a transparent system for reporting and monitoring progress, including the development of appropriate indicators. To this end, the Commission proposed to establish relevant mandatory requirements within two years of the adoption of the Thematic Strategy, thus consolidating current work on the collection of data concerning pesticide use.

In parallel, the Commission has revised existing legislation concerning the placing of plant protection products on the market and residues of pesticides, examined and proposed a set of measures to underpin the Thematic Strategy, and supported a research programme for the development of a harmonised set of indicators on the risks of pesticides for the environment (HAIR).

Since the effects of the relatively new legislation on biocides i will not become apparent until well after 2006, when the first evaluation of active substances for use in biocidal products will be finalised, neither the Commission nor most Member States currently have sufficient knowledge or experience to propose further measures regarding biocides. The scope of the Thematic Strategy and the scope of this proposal have thus been limited to plant protection products. However, both scopes may be expanded in the future, if similar measures were considered necessary for biocides.

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1.3. Existing provisions in the area of the proposal


Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC i.

Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs i, in particular Annex I, part A, point 9 establishing an obligation for food business operators producing or harvesting plant products to keep records on any use of plant protection products or biocides.

Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy i.

Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market i currently under revision i.

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1.4. Consistency with the other policies and objectives of the Union


In the overall context of the 6EAP, this Regulation concerning statistics on plant protection products must be considered as a fundamental part of the whole Thematic Strategy proposed by the Commission, encompassing different kinds of measures concerning practical aspects of pesticide use and more systematic collection of data on pesticides i. The core of this Strategy is the Directive of the European Parliament and of the Council establishing a framework for Community action to achieve a sustainable use of pesticides i. To complete this legislative set, the Commission has presented to the European Parliament and the Council a proposal for the revision of Directive 91/414/EEC.

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2) CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT


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2.1 Consultation of interested parties


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2.1.1. Consultation methods, main sectors targeted and general profile of respondents


The different measures proposed in the Communication Towards a Thematic Strategy on the Sustainable Use of Pesticides have been the subject of wide public consultation, beginning with consultation of the stakeholders from July to December 2002. The views of the European Institutions were sought in April 2003.

A wide Internet-based consultation was then organised from December 2004 until January 2005 on the report concerning the impact assessment of the different measures proposed.

Finally, through an open consultation which was conducted via the Internet from 17 March 2005 to 12 May 2005, the Commission received 1772 responses. The results are available on europa.eu.int/comm/environment/ppps/home.

The specific measures concerning pesticide statistics were discussed with the Member States in the Statistical Programme Committee (SPC) and its Pesticides Statistics Expert Group from September 2004 until May 2006.

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2.1.2. Summary of responses and how they have been taken into account


During the consultation on the Thematic Strategy, the European Parliament stressed the need to collect data in a harmonised way and to make publicly available the information on every active ingredient. In order to support the development of suitable indicators taking into account the specific risks of plant protection products and national risk mitigation measures, the Council encouraged the Commission to develop a system leading to comparable statistics on plant protection products. According to the European Economic and Social Committee, the information to be provided by users should be of such a kind that they feel it is worthwhile in production terms to collect the information.

Among the other stakeholders, industry and farmers voiced concern that the burden and administrative effort for a much extended mandatory data collection system might not be justified by the benefits that could be gained from obtaining the data. Environmental NGOs requested the introduction of obligations for mandatory record-keeping by pesticide distributors and users. All other stakeholders supported the development of indicators as a necessary tool for measuring progress. The proposals regarding collection of data on sales and use of pesticides received broad support from the public.

When consulted on the proposed Regulation, the Member States generally recognised the need for more harmonised statistics on pesticide use. At the same time, they emphasised the need to focus on achieving harmonised outputs and stressed that they should have maximum flexibility in how they go about collecting the required information. Other points highlighted were that new burdens should be kept to a minimum and priorities should be set according to the limited resources available. New statistical requirements should be balanced wherever possible by reductions in other areas. The relevance and usefulness of transmitting national data on the use of pesticides to the Commission in addition to the reports on the national action plans containing risk assessments based on harmonised indicators was also questioned. The involvement of the Member States in the implementation of the Regulation and in the definition of quality criteria through the Statistical Programme Committee was welcome.

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2.2. Collection and use of expertise


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2.2.1. Scientific/expertise domains concerned


The Commission's proposal draws widely on the expertise of the Pesticide Statistics Experts Group. It is also based on the experience gained through 30 pilot projects conducted between 1999 and 2004 within the technical action plan for improving agricultural statistics (TAPAS) and 10 projects carried out in 2005 in the new Member States and Acceding Countries with the support of the 2002 PHARE Multi-Beneficiary Programme for Statistical Co-operation.

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2.2.2. Methodology used


The definition of common rules for the collection of statistics is based on the 'Guidelines for the collection of pesticide usage statistics within agriculture and horticulture' drawn up by the Pesticide Statistics Experts Group and published by the Commission in 2002, and subsequently adapted as a result of the experience gained with TAPAS and PHARE pilot projects.

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2.2.3. Main organisations/experts consulted


The Pesticide Statistics Expert Group is mandated by the Statistical Programme Committee and composed of representatives from the Member States’ national statistical institutes, ministries of agriculture, environment or public health, plant protection services or research centres in the field of plant protection.

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2.2.4. Summary of advice received and used


This proposal has been discussed several times with the Pesticide Statistics Expert Group and integrates most of their recommendations aiming mainly at ensuring the collection of harmonised and comparable data with sufficient flexibility for the Member States and with the guarantee that these statistics will serve the objectives of the Thematic Strategy.

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2.2.5. Level of scientific certainty


The high level of scientific certainty of this proposal is guaranteed by the participation both of experts on plant protection products and of statisticians in its elaboration.

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2.2.6. Means used to make the expert advice publicly available


All meeting documents as well as guidelines and harmonised questionnaires are available on the free access CIRCA site: forum.europa.eu.int/Public/irc/dsis/pip/library.

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2.3. Impact assessment


The following policy options regarding the collection of data on sales and use of pesticides were examined in the impact assessment on the Thematic Strategy, which was finalised in November 2004:

Option 1: Collection of data on use mandatory for industry and distributors and voluntary for professional users.

Option 2: Mandatory collection of data on sales and use and establishment of a Community compliance programme.

Option 3: Recommendation to collect use data from distributors and users.

Option 4: No action.

The comparison of the different options showed that the net economic impact would range from 0 million €/year for the no action option to 0-7 million €/year for option 3, 1-12 million €/year for option 1 and 3-15 million €/year for option 2. The social impact and the creation of new jobs was equivalent between options 1 and 2. The main difference observed between options 1 and 2 was in the quality of the data achieved. Option 2 is indeed the one that best fits with the objective of the Thematic Strategy to establish a data reporting system in order to assess the level of risk linked to pesticide use. The mandatory collection of data on sales and use with the establishment of a Community compliance programme was finally recommended on the grounds that the resulting economic impact, estimated on the base of case studies in a few Member states, would be moderate and the collection of accurate and reliable data on the use of plant protection products could be carried out quickly and cost-efficiently. The overall net financial impact of mandatory data collection with a high level of accuracy at Community level is estimated at 15 million €/year per year. This measure is likely to impact most significantly on authorities (9 million €/year additional burden), while the additional cost to industry of collecting more detailed data on sales could reach 2 million €/year. The economic impact on users (mainly farmers) is estimated at 4 million €/year, as mandatory collection of data on use would require a significant contribution on their part.

The Commission carried out an impact assessment listed in the Work Programme, and the report is accessible on europa.eu.int/comm/environment/ppps/home.

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1.

LEGAL ELEMENTS OF THE PROPOSAL



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3.1. Summary of the proposed action


In order to establish a transparent system for reporting and monitoring the progress made towards the objectives of the Strategy, including the development of suitable indicators, it is necessary to enhance and harmonise the current data collection and reporting systems and to put them on a legal footing.

The proposed Regulation creates a legal framework and lays down harmonised rules for the collection and dissemination of data concerning the placing on the market and use of plant protection products. In particular, it instructs the Member States:

– to collect data regularly (annually as regards placing on the market - every five years as regards use);

– on how to collect data, whether by representative surveys, statistical estimation procedures on the basis of expert judgements or models, reporting obligations imposed on the distribution chain for plant protection products, reporting obligations imposed on professional users, from administrative sources or by a combination of these means;

– on how to transmit data to the Commission.

It also entrusts the Commission with the tasks of adapting some technical aspects and defining the quality evaluation criteria and the data transmission format.

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3.2. Legal basis


Article 285 provides the legal basis for Community statistics. The Council, acting in accordance with the co-decision procedure, shall adopt measures for the production of statistics where necessary for the performance of the activities of the Community. This Article sets out requirements relating to the production of Community statistics and requires conformity to standards of impartiality, reliability, objectivity, scientific independence, cost-effectiveness and statistical confidentiality.

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3.3. Subsidiarity principle


The objectives of the proposed action, namely the production of Community statistics on the placing on the market and use of plant protection products, cannot be sufficiently achieved by the Member States. They can be better achieved at Community level on the basis of a Community legal act because only the Commission can coordinate the necessary harmonisation of statistical information at Community level while the collection of data and compilation of comparable statistics on plant protection products can be organised by the Member States. Therefore the Community may adopt these measures, in accordance with the principle of subsidiary as set out in Article 5 of the Treaty.

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3.4. Proportionality principle


The proposal complies with the proportionality principle for the following reasons.

In accordance with the principle of proportionality this Regulation confines itself to the minimum required to achieve this objective and does not go beyond what is necessary for that purpose.

There will be an increase of the costs, in particular in a first stage of the implementation and mainly for those countries not conducting surveys on plant protection products for the time being, or for those that need to adapt their surveys to meet the legal requirements.

However, the extent of this impact has been limited by careful preparation in respect to the principle of cost-efficiency and implementation of the legislative measures, in particular this Regulation gives the Member States a lot of flexibility in the choice of instruments (including administrative data and expert estimates) and in the timing for collecting data. This gives the Member States an opportunity to take national requirements into account or to satisfy specific national interests.

The Impact Assessment of the Thematic Strategy indicated that mandatory data collection with a high degree of precision is the way to achieve an optimum outcome in terms of comparability of data and synergy (maximum cost savings), since the same details will be applied at all levels of information collection.

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3.5. Choice of instruments


Proposed instrument: Regulation.

Other means would not be adequate for the following reasons.

It is generally recognised that an EP/Council regulation is appropriate for the majority of statistical action which requires detailed and uniformed application throughout the Community.

A regulation is preferable to a directive as basic act as, in contrast with the directive, the regulation lays down the same law throughout the Community, leaving the Member States with no power to apply it incompletely or selectively and no choice in the form and methods to be used to obtain the objectives. Moreover a regulation is directly applicable, which means that it needs not be transposed into national law, avoiding the delays associated with transposition of directives into national legislation and would lead to better and faster legislation.

The proposal is included in the Commission's Work and Legislative Programme under the reference 2006/ESTAT/006.

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2.

BUDGETARY IMPLICATION



The financing of actions for statistics on plant protection products will be covered by the Community statistical programme 2003 to 2007 (Decision no 2367/2002/EC of the European Parliament and of the Council) and the future Community statistical programme 2008-2012.

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5) EUROPEAN ECONOMIC AREA


The proposed act has EEA relevance and should therefore extend to the European Economic Area.