EN

Brussels, 12.7.2006

SEC(2006) 894

COMMISSION STAFF WORKING PAPER

Accompanying 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

{COM(2006) 373 final}

THE IMPACT ASSESSMENT OF THE THEMATIC STRATEGY ON THE SUSTAINABLE USE OF PESTICIDES

TABLE OF CONTENTS

Executive Summary (...)5

1. Procedural issues and consultation of interested Parties (...)16

2. Problem definition (...)18

2.1. Scope of the Thematic Strategy (...)18

2.2. The Pesticides Life-Cycle (...)19

2.3. Who is affected (...)20

2.4. Benefits associated with the use of PPP (...)21

2.5. Risks from pesticide use (...)22

2.6. The Legal Situation (...)25

2.7. Current pesticide use in the Member States (...)32

2.8. Need for EU action (...)33

3. Objectives (...)34

3.1. Sixth Environment Action Programme (6th EAP) (...)34

3.2. Other Community strategies (...)34

4. Policy Options (...)35

4.1. Measures and options that have been assessed in detail (...)35

4.2. Measures that have been assessed in lesser detail in this impact assessment (...)51

5. Analysis of Impacts and Methodology used (...)56

5.1. Analysis of impacts (...)56

5.2. General methodology (...)65

5.3. Specific challenges to apply the general methodology to the measures constituting the Thematic Strategy (...)68

6. Comparing the options (...)84

6.1. Status quo situation in Member States (...)84

6.2. Assessment of the impacts of the various measures and their options (...)139

7. Measures proposed in the Thematic Strategy and overall impact (...)178

7.1. Summary of the evaluations and recommendations (...)179

7.2. Combination of recommended measures (...)185

8. Monitoring and evaluation (...)189

8.1. How will the strategy be implemented? (...)189

8.2. How will the strategy be monitored and reviewed? (...)190

9. Annex 1: Results of the Stakeholders consultation on the Communication ‘Towards a Thematic Strategy on the Sustainable Use of Pesticides’ (...)192

9.1. National Plans to reduce hazards, risks and dependence on chemical control (National Action Plans) (...)192

9.2. Enhanced protection of the aquatic environment (...)193

9.3. Defining areas of strongly reduced or zero pesticide use (...)194

9.4. Ban of aerial spraying (...)194

9.5. Epidemiological and residue monitoring studies (...)194

9.6. Research programmes (...)195

9.7. Quantitative use reduction targets (...)195

9.8. Improved systems for the collection of information on production, import/export, distribution and use and enhanced monitoring measures on compliance including annual reporting (...)196

9.9. Collection of PPP packaging and unused products and other measures connected to the handling of products (...)197

9.10. Compulsory control of application equipment (...)197

9.11. Creation of a system of mandatory education, awareness raising, training and certification for all PPP users (farmers, local authorities, workers, distributors, traders and extension services) (...)198

9.12. Comparative assessment and Substitution principle (...)198

9.13. Promotion of low-input farming and cross-compliance for CAP support measures (...)200

9.14. Taxes/levies (...)201

9.15. Harmonisation of VAT (...)202

9.16. Development and use of indicators (...)202

9.17. Involvement of stakeholders (...)203

9.18. Candidate countries (...)203

9.19. International aspects (...)204

9.20. Format of the Thematic Strategy (...)204

10. Annex 2: Results of the final stakeholders consultation (Interactive Policy Making) (...)206

10.1. National Action Plans (...)208

10.2. Training and awareness raising (...)210

10.3. Compulsory control and standardisation of application equipment (sprayers) (...)212

10.4. Specific measures on aerial spraying (...)213

10.5. Areas of strongly reduced or zero PPP use (...)214

10.6. Collection of PPP packaging and unused (obsolete) products (...)214

10.7. Monitoring and reporting (...)215

10.8. Compliance controls (...)216

10.9. Comparative assessment and substitution principle (...)216

10.10. Integrated Pest Management (IPM) (...)217

10.11. Taxation (...)217

Executive Summary

This Impact Assessment (IA) has been prepared by the Commission services to support the Thematic Strategy on the Sustainable Use of Pesticides, which is presented in a separate Communication from the Commission [1]. Based on an in depth study carried out for the Commission by an outside contractant [2], it investigated in great detail the economic, social, health and environmental impacts of the measures proposed in the Thematic Strategy in order to achieve the overall objective of reducing the risks from pesticide use to human health and the environment.

1. Consultation of interested parties

The development of the Thematic Strategy on the Sustainable Use of Pesticides fully respected the minimum standards for consultation [3]: four rounds of consultations were organised by the Commission, so that all stakeholders concerned had the possibility to contribute to the development of the Thematic Strategy. First, a Communication ‘Towards a Thematic Strategy on the Sustainable Use of Pesticides’ [4] was submitted to the European Parliament, the Council, and the Economic and Social Committee, and was published on the internet for consultation of the general public. Secondly, specific meetings and conferences on various specific issues raised were organised or attended to by the Commission. Then a study was elaborated in parallel by an external consultant (BiPRO) on the basis of surveys and interviews among the Member States and key stakeholders in order to assess economic impacts of the specific measures to be part of the Thematic Strategy. The final report of this study was published on the Commission’s website to receive comments. And lastly a final consultation was launched on the Internet in 2005. It outlined the main actions that have been considered for inclusion in the proposal for a Thematic Strategy.

2. Problem definition

Pesticides are active substances and products designed to influence fundamental processes in living organisms and, therefore, may have the potential to kill or control harmful organisms such as pests, whether used in agriculture or to control the growth of plants on non-agricultural surfaces (plant protection products) or for other purposes (biocidal products). Given their much greater importance (both in terms of quantities used and related economic turnover) and although using the term “pesticides”, the Thematic Strategy will deal for the time being with plant protection products (PPP) only. However, biocidal products may also be concerned at a later stage if estimated necessary.

There are significant economic and social benefits associated with the use of PPPs. They improve or safeguard yields by eliminating or reducing competition from weeds and attacks by pests; they protect and preserve plant products against harmful organisms; they improve or protect quality of the produce and they minimise labour input. PPPs also play an essential role in ensuring reliable supplies of agricultural products each year, by contributing to prevent fluctuations of annual yields. Moreover, the responsible use of PPPs contributes to ensuring the availability of low-priced fruits and vegetables of good quality, which makes them affordable for all consumers. The use of PPPs reduces demand for land for food production [5] and enables the regional production of a wider variety of food, which in turn can reduce transport costs and make more land available for other uses, e.g. amenity, natural parks and protection of biodiversity. Conservation tillage, which reduces erosion, and minimum tillage techniques, which reduce the demand for fossil energy in agriculture and decrease the leaching of nutrients, partly depend on the use of herbicides. Last but not least, the European plant protection industry is a significant economic player on the world market and an important employer in Europe with around 26.000 employees in the EU-25. Three of the five largest global companies are based in Europe. In addition, there are many other companies involved in the use of PPPs (e.g. manufacturers of spraying equipment, service companies for aerial spraying and others).

However, by nature pesticides are often deliberately released into the environment during use, which may lead to exposure of humans and the environment.

Risks to human health can occur through direct exposure (industrial workers producing pesticides and operators – in particular farmers - using them), and indirect exposure (consumers, residents and bystanders), in particular during or after use in agriculture, landscaping, on golf courses, schools and public building maintenance, road and highway weed control, lawn care and other activities.

A particular pesticide will have an adverse impact on human health when the level of exposure exceeds levels considered as safe. The risks related to each individual active substance contained in pesticides are evaluated during the relevant authorisation procedures, but there is no satisfactory assessment of the effects of exposure to complicated mixtures of chemicals (epidemiological studies are lacking and causal chains are too complex). Thus, it is impossible to evaluate the overall effective impact on human health of all substances currently in use.

According to a survey of the European Federation of Agricultural Workers’ Unions (EAF), the most common observed adverse effects of pesticides on workers and operators are acute and include headaches, vomiting, stomach-aches, and diarrhoea, caused by exposure during application, preparation or mixing and handling of containers [6]. Chronic health impairment results from a low but constant exposure level and has a long-term character (e.g. cancer, birth defects reproductive problems, sensitisation). Major incidents, in particular clear correlations between exposure and chronic effects, are often not recognised immediately since no obvious symptoms of poisoning exist.

Indirect exposure of bystanders, residents (via spray drift) and consumers (via residual amounts in agricultural produce or water), can be amplified for especially vulnerable population groups, such as children (particularly sensitive to suspected ‘cocktail effects’), the elderly, or other particular risk groups (immunologically compromised people, chronically sick, etc.), and workers (due to their possible intensive exposure). At present, the scientific Community sees possible gaps in knowledge for children. Evidence is emerging to document combination effects, but adequate risk assessment methodology to predict their consequences is not available.

Risks to the environment from unintended and excessive flows of chemical substances to water, air and soil result in adverse effects on plants, wildlife, quality of the environmental compartments and biodiversity in general (although the latter is also influenced by a number of other factors). In particular, spray drift, leaching or run-off are diffuse sources of uncontrolled dissemination of plant protection products (PPPs) into the environment leading to pollution of soil and water compartments (surface water and ground water [7]). Environmental contamination can also occur during and after application, cleaning of equipment or uncontrolled, illegal disposal of PPPs or their containers (point sources). According to the European water suppliers organisation [8], pesticide contamination of raw water is very severe in lowland rivers, with a high proportion of contamination exceeding the 0,1 µg/L threshold value and, therefore, imposing pesticide removal treatment before the water can be distributed as drinking water. The potential contamination of surface and groundwater requires constant efforts to monitor and – taking into account the long time scale of contamination and remediation – high scrutiny in the regulatory process.

With regard to the potential for exposure of humans and direct emissions into the environment, the use and post-use stages are the riskiest steps in pesticide life-cycle. Emissions can occur in a diffuse way or at more concentrated points of incidental discharges. Producers and distributors are currently liable for the safe delivery and for the quality of the products sold to the final user, but their possibilities to influence activities regarding diffuse or point emissions are relatively limited. The user who is finally taking the decision on the ‘why, ‘what’, ‘when’ and ‘how’ of any pesticide use – more or less influenced by the information received from the producers and distributors or other advisory bodies like extension services or food producers – is obviously the key actor for limiting unacceptable pesticide contamination of the environment at large.

The Legal Situation

The Community regulatory framework concerning plant protection products focuses primarily on the placing on the market and the end of the life cycle of such products. The most relevant pieces of legislation are:

Directive 91/414/EEC on the placing of plant protection products on the market, which intends to prevent risks at source through a very comprehensive risk assessment procedure for each active substance and the products containing the substance, before they can be authorised for marketing and use.

Regulation (EC) No 396/2005 on maximum residue levels in food and feed of plant and animal origin, which sets maximum residue limits (MRLs) of active substances in agricultural produce, thus intending to limit the risks to consumers when entering the food chain. Monitoring residues is decisive to know if recommendations and restrictions have been respected.

One of the shortcomings of the current legal framework concerning pesticides is that the actual use phase, which is a key element for the determination of the overall risks that they pose, is not sufficiently addressed. The very purpose of this Thematic Strategy is to address this deficiency (see Figure 1).

The international context

In view of the global and transboundary nature of the problems caused by pesticides, significant action has been taken at international level. The United Nations Food and Agriculture Organisation (FAO) adopted for the first time in 1985 the International Code of Conduct on the Distribution and Use of Pesticides, which contains guidance on pesticide management for all public and private entities engaged in or associated with these activities.

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Figure 1: Deficiency in current legislation concerning pesticide use phase

The Environment Programme of the Organisation for Economic Co-operation and Development (OECD) has developed tools for chemical testing and assessment that promote international harmonisation, helps countries find ways to share the work of evaluating different types of chemicals, and, since 1992, provides a forum through which countries exchange information about regulatory approaches and decisions. A Pesticide Risk Reduction Steering Group was initiated in 1994.

A number of countries outside the EU have already put into place measures with regard to pesticides that are comparable to all or part of those now envisaged in the Thematic Strategy. Among these are the USA, Canada, Australia, Switzerland, Norway, and also developing countries such as Brazil.

Many particularly hazardous pesticides are also subject to international Conventions to protect human health and the environment such as the Rotterdam Convention on the Prior Informed Consent (PIC) procedure for certain hazardous industrial chemicals and pesticides in international trade, implemented in the Community by Regulation (EC) No 304/2003 [9] and the Stockholm Convention on Persistant Organic Pollutants (POPs), implemented through Regulation (EC) No 850/2004 [10].

Need for EU action

Since no harmonised risk indicators are yet available at Community level in order to assess trends in the risks from pesticide use, the only proxy we currently have is trends in pesticide use. The current situation regarding pesticide use in the Member States is marked by large variations, not only in overall use, but also in the prevailing trends. These can be partly explained by the diverging structures of the agricultural sector and different climatic conditions (leading to different needs in terms of plant protection), but also by efforts undertaken in several Member States to reduce the need for pesticides and the correlated risks to human health and the environment through National Action Plans.

Currently, some Member States have already adopted measures to reduce the risks for health and the environment linked to pesticide use, while others have not yet taken such action. This creates a situation where there is no level playing field for pesticide users and 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 or the environment throughout the Community and pesticide use shows diverging trends between Member States.

Without any Community intervention, this trend towards divergence in the Member States is very likely to continue, leading to totally different levels of protection of health and environment and diverging conditions for the main users of pesticides (i.e. farmers) in the Member States, which would be against one of the fundamental objectives of the Treaty. Setting equal standards and objectives to be achieved in all Member States can only be done by the Community. Otherwise the current situation with unequal obligations for economic operators will continue.

Besides, placing of pesticides on the market as well as monitoring of pesticide residues are already harmonised through Community legislation. The same should therefore apply to other aspects of pesticides policy.

3. Objectives

This Strategy positions itself within the Sixth Environment Action Programme (6th EAP), where its overall and specific objectives are underlined.

Pursuant to Article 7(1) of Directive 1600/2002/EC establishing the 6th EAP, the overall objective of the Thematic Strategy is to reduce the impact 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 crop protection.

The specific objectives of the Thematic Strategy on the Sustainable Use of Pesticides outlined in Article 7(2) (c) of the above-mentioned directive are:

(i) to minimise the hazards and risks to health and environment from the use of pesticides;

(ii) to improve controls on the use and distribution of pesticides;

(iii) to reduce the levels of harmful active substances including through substituting the most dangerous with safer (including non-chemical) alternatives;

(iv) to encourage the use of low-input or pesticide-free farming, in particular by raising users' awareness, by promoting codes of good practices and consideration of the possible application of financial instruments;

(v) to establish a transparent system for reporting and monitoring the progress made in the achievement of the objectives of the strategy including the development of suitable indicators.

By selecting measures optimising the economic, social, environmental and health impacts, the Strategy is fully coherent with the Lisbon objectives of growth and employment.

Besides, the goal to reduce significant threats from pesticide use is fully in line with the guiding precautionary principle for sustainable development.

4. Methodology used

Due to the holistic approach followed by Thematic Strategies in addressing a specific topic, a lot of emphasis has been put on integration of the measures of the Strategy in existing policies and legislation. The Thematic Strategy on the Sustainable Use of Pesticides is actually composed of a number of individual measures that, in accordance with this concept of integration, will either be implemented using existing instruments or, if not feasible, will be proposed as new legislation, which will be presented in parallel or partly subsequent to this Communication.

So the basic approach is threefold:

– incorporation of a number of measures into the existing legal framework, in particular Directive 91/414/EEC and its revision, and policy frameworks such as the CAP or Research and Development

– new legislative proposals: a Framework Directive on the sustainable use of pesticides that will incorporate all measures, where a legislative solution was found necessary but which cannot be integrated into existing legislation. The Directive will set out goals and objectives, leaving the necessary freedom to Member States to adapt the measures to their specific situations, and foresees a system of reporting with appropriate risk indicators and information exchange for reviewing the national measures in order to develop guidance and best practices. In addition, there will be a proposal for a Regulation addressing the collection of statistical information on the use of pesticides

– recommendation to Member States to take certain further measures as appropriate, for which Community intervention was not found adequate or practicable (in the spirit of the subsidiarity principle).

This impact assessment focuses on measures and related options that cannot be integrated in existing legislation / policies, that are expected to be of major relevance for achieving the objectives of the Thematic Strategy, or that were very controversial during the consultation process.

For each of the measures studied in detail in this IA, several options to put them into practice have been developed- ranging from ‘no-action’ to mandatory highly prescriptive legally binding options, via voluntary or partially binding options. It is to be stressed that the 'no-action' option has been systematically listed, and refers to a strict status quo: no improvement in the existing framework, but not alignment to the lower degree either ('no-action' is not 'no-acting'). As a consequence of this, by definition, the 'cost of no action' is equal in absolute terms but opposite in sign to the excepted benefit associated to the proposed strategy. All options have then been analysed in the following way:

– determination and documentation of the current situation (status quo) in EU Member States related to the key measures and options,

– identification of causalities and relations,

– assessment of the impacts of the various options,

– recommendation of most appropriate options.

Impacts were assessed with respect to:

– economic consequences (where possible measured in € additional costs or additional income compared to status quo for the actors concerned),

– social consequences (where possible measured in number and quality of jobs; based on average correlations income to jobs or costs to jobs),

– environmental consequences (mainly assessed on the basis of expected reduction in tons of PPP used, taking into consideration possible effects of PPP substitution and other consequences that are not correlated to use reduction but nevertheless constitute a risk reduction, e.g. buffer zones to protect water),

– health consequences (not quantified but qualitatively assessed taking into consideration avoided adverse health impacts on operators, consumers, bystanders as an effect of reduced exposure or reduced number of accidents).

The expected benefits are mainly improvements in the situation with regard to adverse impacts on the environment or health, or other societal benefits (i.e. reduced external costs due to PPP use) by a more sustainable use of pesticides. Conversion of such expected benefits to monetary terms is difficult as they are the outcome of a complex causal chain or it is impossible to estimate the value of the benefits for society, such as increased food quality due to lower contamination of feed and food products, enhanced biodiversity or higher quality of life due to decreased occurrence of diseases.

These positive societal effects are expected as a result from the implementation of the measures proposed under the Thematic Strategy. It has to be recalled that there is no simple correlation in the sense “use reduction of PPP = benefits for society”. If not specifically targeted at risk reduction and this in a proportionate manner, a use reduction may cause unwanted effects such as yield losses, degradation of valuable man-made landscape, shift to use of highly active and riskier PPP or other unwanted impacts.

Figure 2 illustrates the correlation between benefits for the society and a targeted PPP use reduction in a schematic way.

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Figure 2: Schematic correlation between benefits for society and a targeted PPP use reduction

The curve represents marginal values and not total values. It intends to illustrate that probably the current situation regarding PPP use in the European Community is not at its optimum with respect to benefits for society, and that appropriate measures might allow to approach this optimum without adverse effects on output or explicit/implicit compensatory transfers among actors. For instance, it is quite clear that some farmers apply too high quantities of pesticides and they could achieve the same farm output with a lower consumption of PPP.

Making farmers have their equipment inspected and well maintained and reduce their PPP consumption is overall economically better for society. However, if arguments about competitiveness or other political considerations prevent authorities to oblige farmers to bear the full costs of their activities, the costs for having the equipment inspected and maintained for the individual farmer could be compensated by society, so that overall a better equilibrium is achieved without losses for a particular group. This could be achieved through various measures such as providing incentives, regulation, market based instruments, etc. It is precisely the purpose of the impact assessment to compare all possible options and identify the best one. By selecting measures optimising the economic, social, environmental and health impacts, the Strategy is fully coherent with the Lisbon objectives of growth and employment.

5. Measures proposed

In the light of the outcome of the impact assessment, it is recommended to propose as part of the Thematic Strategy:

– Training and certification of users

It is recommended to establish mandatory training and qualification requirements for distributors and professional pesticide users in all Member States with minimum requirements agreed at Community level.

– Certification and technical check of spraying equipment

It is recommended to establish certification systems for new application equipment mandatory to be placed on the market, as well as regular inspection of equipment in use in all Member States.

– General ban of aerial Spraying

Following an intensive assessment and detailed studies, it has finally been decided to propose a general prohibition of aerial spraying, but Member States should allow for derogations in situations where it can be proved that aerial spraying offers clear advantages and also environmental benefits compared to other spraying methods, or where there are no viable alternatives.

– Enhanced Protection of Water

The impact assessment shows clear socio-economic benefits for the measures ‘installing buffer strips’ and reducing spray drift through ‘appropriate technical equipment’. These are even bigger, when considering that other non-quantifiable benefits such as positive impacts on biodiversity, landscaping, river bank management, and one of the main objectives of the Water Framework Directive (maintaining good chemical status of water) are taken into account.

– PPP free or reduced zones

In the light of the outcome of the impact assessment it is recommended to put into practice a legally binding designation of zones of reduced or zero PPP use. Specific guidance and best practise for those areas have to be developed in cooperation between Member States and the Commission. Best practice and guidance should include elements of other discussed measures like Integrated Pest Management (IPM), inspection of equipment and training of users but also specific use reduction objectives.

– Collection of pesticide packaging and unused (obsolete) products

In the light of the outcome of the impact assessment, it is recommended that all Member States should create, if not already done, collection schemes for empty pesticide packaging and unused (obsolete) pesticides. Organisational details should be left to the Member States.

– Systematic data collection on pesticides sales and use

In the light of the outcome of the impact assessment for the four options examined, it is recommended that all Member States establish collection schemes for data on the placing on the market and use of PPP. Member States should remain free to decide on the optimum way on how to organise data collection, as this will depend strongly on the structure of the agricultural sector (number of farms, diversity in production etc.).

– Common framework for Integrated Pest Management (IPM)

In the light of the outcome of the impact assessment it is recommended to put into practice the option "Harmonisation of the minimum general requirements through an amendment of the definition of integrated control in Directive 91/414/EEC" in combination with the option "Development of specific guidelines for IPM".

The impact assessment led to the rejection of both legally binding quantitative use reduction targets and setting up of taxes / levies at Community level.

6. Costs and benefits expected

The proposed measures target a reduction of the risks for the environment and human health linked to the use of plant protection products. Society at large, in particular operators, consumers and the environment will benefit from the various effects of reduced risks from PPP use. It is very difficult to monetise these benefits consistently at a general level. Extrapolation from a comprehensive (but very conservative) study in Germany leads to the conclusion that the optimised use in pesticides should create an overall benefit to the EU which would exceed € 200 million each year, through reduced externalities such as adverse effects on the environment and human health. Much more partial data from the UK and the Netherlands (see Chapter 5.1) give further evidence of the costs of the contamination of water supplies by pesticides.

By construction, losses (for the PPP industry, and for farmers paying for training and the certification and maintenance of application equipment) and benefits (for less consuming farmers, and training, maintenance or certificating firms) are equal. The net expected overall impact, which equals the above-mentioned reduced externalities (as it is the only benefit which is not compensated by any loss), is thus clearly positive.

Overall costs and benefits of the implementation of the measures proposed in the Thematic Strategy are summarised in Table 1. Benefits for humans and the environment are very difficult to quantify for different reasons: (i) because of a lack of pertinent available data, (ii) because some of them have only a qualitative and relative value, and (iii) because quantifying methodologies are not always available. For instance there is a scientifically proved link between PPP use and lower fertility. However, fertility decrease is not exclusively related to PPP use, data are lacking, causality chains are still largely unexplored and there is thus no available methodology to assess the share of fertility loss to be attributed to PPP use. Moreover, what is exactly the social cost of fertility decrease? The cost of infertility treatment? The cost of (lost) human lives? The value of the moral prejudice caused to infertile parents?

Although not an objective per se, the measures are expected to reduce overall quantities used by 11% to 16% (i.e. 31,000 to 44,000 tons of active substances) per year. Corresponding savings for farmers should be between € 770 million and 1100 million, which will also mean lower turnover for the plant protection product industry.

Even if the total cost of the measures (except the € 40 to 80 million necessary for setting up container management schemes, which should logically be supported by the pesticide industry) is left to farmers, net benefits for them would remain significant, of the order of € 380 million to 710 million (including support under rural development). The costs relate to around € 250 million for training, € 90 million for testing and control of sprayers, € 40 million for equipment maintenance, € 2-4.5 million extra costs for purchasing certified new equipment, € 2 million for detailed record-keeping and reporting on pesticide use. Further costs in terms of extra working time (ca. € 210 million) and more intensive use of advisory services (around € 130 million) could be compensated under rural development measures of the CAP. The only case where a significant administrative burden for MS authorities was possible to assess and quantify is the collection of data on pesticide sales and use, which would cost about € 9 million / year.

In terms of jobs, the balance is expected to be highly positive, an overall net increase of ca. 3000. A loss of 1700 to 2000 (at worst) jobs in the manufacturing and distribution industries will be offset by the creation of new posts in other sectors: 200 related to the container management schemes, 2500 to training and certification, 1000 to testing and control of sprayers, 500 to equipment maintenance, and 900-1300 jobs in agricultural advisory services. Moreover, the Thematic Strategy will stimulate research and innovation for the development of more selective active substances. This would present a market opportunity for the most innovative companies, and would be fully compatible with the Lisbon strategy.

As the current situation in the Member States varies, it is expected that in nine Member States impacts will be minor to medium, in eight they will be medium, and in eight Member States they will be medium to strong.

Table 1: Overall costs and benefits of the Thematic Strategy

| Benefits | Costs | Balance |

Farmers | M€ 1110 up to 1440 /yrReduced health impacts | M€ 725 /yr | + M€ 380 up to 710 /yrReduced health impacts |

Industries | + 3000 jobs | M€ 300 up to 670 /yr(could be contained through more advisory services and development of more innovative products) | M€ - 670 up to - 300 /yr+ 3000 jobsHigher competitivity |

MS Authorities | M€ 200 /yr (savings for health and environment costs)+ 180 jobsPositive impacts on humans and the environment | M€ 9 /yr | + M€ 191 /yr+ 180 jobsPositive impacts on humans and the environment |

1. Procedural issues and consultation of interested Parties

This Impact Assessment (IA) has been prepared by the Commission services to inform the development of the Community Thematic Strategy on the Sustainable Use of Pesticides, which is presented in a separate Communication from the Commission [11]. It is based on information that was made available during an extensive consultation process involving the European institutions, Member States and other stakeholders, and a specific study undertaken for the Commission by an outside contractant [12].

Any measure proposed in the Thematic Strategy may impact a variety of individuals and groups concerned with pesticides, and potentially affect them positively, negatively, or even sometimes both ways. In order to give all stakeholders concerned the possibility to contribute to the development of the Thematic Strategy, the Commission undertook four rounds of consultation, and the minimum standards for consultation were fully respected [13].

In July 2002, the Commission adopted the Communication ‘Towards a Thematic Strategy on the Sustainable Use of Pesticides’ [14], which presented a list of possible measures to achieve the specific objectives of the Thematic Strategy as outlined in Article 7(2) (c) of Directive 1600/2002/EC defining the 6th EAP:

– Establishment of national action plans to reduce hazards, risks and dependance on chemical control

– Enhanced protection of the aquatic environment

– Defining areas of strongly reduced or zero pesticide use

– General ban of aerial spraying

– Epidemiological and residue monitoring studies

– Further research and develoment

– Quantitative use reduction targets

– Improved systems for the collection of information on production, import/export, distribution and use and enhanced monitoring measures on compliance including annual reporting

– Collection of PPP packaging and unused products and other measures connected to the handling of products

– Compulsory control of application equipment

– Creation of a system of mandatory education, awareness raising, training and certification of all PPP users (farmers, local authorities, workers, distributors, traders and extension services)

– Comparative assessment and substitution principle

– Promotion of low-input farming and cross-compliance for CAP support measures

– Introduction of taxes/levies for pesticides

– Harmonisation of VAT

– Development and use of indicators

– Involvement of stakeholders

– Cooperation with candidate countries

– International aspects

– Format of the Thematic Strategy

The Communication was submitted to the European Parliament, the Council, and the Economic and Social Committee, and published on the internet for consultation of the general public. In November 2002, the Commission organised a Stakeholders Conference with more than 190 participants. More than 150 contributions were submitted during this consultation round. Overall, there was a lot of support from institutions and stakeholders for most of the measures proposed. However there were some controversies concerning certain measures (e.g. quantitative use reduction), and the way to implement the measures (at Community or Member State level; on a voluntary or a mandatory basis). The conclusions of the Council, the Resolution of the Parliament, the opinion of the Economic and Social Committee as well as these public contributions are summarised in Annex 1 to this report.

Thereafter, DG Environment organised ad hoc meetings on aerial spraying, on standards for spraying equipments and participated to numerous conferences on various specific issues to be part of the Thematic Strategy (e.g. comparative assessment, spraying equipment, IPM/ICM, etc.) and seminars organised by the OECD on compliance, container management ant others [15].

In parallel, the Commission contracted a study to a consultant (BiPRO) with the purpose of ‘Assessing economic impacts of the specific measures to be part of the Thematic Strategy on the Sustainable Use of Pesticides’. This study was elaborated on the basis of surveys and interviews among the Member States (22 answered) and key stakeholders. It was accompanied from the inception to the final report by an interservices group involving all relevant Directorates-General and its final report was published on the Commission’s website. 28 organisations submitted comments on the conclusions of the study [16].

A final Interactive Policy Making consultation was launched from March until 12 May 2005, which built on and focused on the results of the previous stakeholder consultations. It outlined the main actions that have been considered for inclusion in the proposal for a Thematic Strategy. 1767 answers were gathered from the public and stakeholders. The large majority of the measures proposed were regarded as of high or medium priority by all stakeholders. The answers received are summarised in Annex 2 to this report.

2. Problem definition

Pesticides are active substances and products designed to influence fundamental processes in living organisms and, therefore, may have the potential to kill or control harmful organisms such as pests. Plant protection products (PPP) are pesticides used to protect plants or plant products against harmful organisms (pests) or prevent the action of such organisms. They can function in many ways e.g. by killing pests, but also in other ways such as by creating a physical barrier, by repelling, by attracting pests away from plants, by regulating the growth of the plants etc. PPP are used in a wide spectrum of applications, such as agriculture, landscape gardening and along transport routes. PPP are also used to some extent in forestry and domestic gardening. Biocidal products are pesticides used in non-agricultural sectors, e.g. for purposes such as wood preservation or disinfection, household uses, etc.

2.1. Scope of the Thematic Strategy

The largest users of pesticides in the EU for plant protection purposes are farmers - agricultural uses represent 86 % of total uses [17]. The quantities of pesticides sold in the European Union (15 Member States) in 2001 was approximately 330,000 [18] tonnes of active substances. This figure represents an increase of ca. 13% compared to the quantities sold in 1992 (and a decline of 8% compared to 1998/1999, where maximum quantities were sold). Figures of pesticide use in agriculture are notoriously difficult to obtain – only few Member States carry out regular surveys, whereas at Community level, available figures rely mostly on estimates from the most important industry association (European Crop Protection Association - ECPA). ECPA’s estimates are based on sales and marketing information from its member companies that do, however, not control the complete pesticides markets in the Member States. In addition, the figures do not systematically include all types of products. A comparison of Member States’ surveys and ECPA’s figures showed that the industry figures were at a minimum around 20% lower than those from the authorities. ECPA’s estimates for 1999 are at 232.000 tonnes, which suggests that real use in agriculture is probably more around 280.000 tonnes active substances. In 2002 ECPA companies sold 260,000 tonnes of active substances with a market value of € 5,908 million [19], which suggests that overall sales (including non-members of ECPA) were at 315.000 tonnes with a value of € 7 billion.

For biocidal products, the UK Pesticides industry association estimated recently that the existing market in the EU-15 represents about € 1,700 million, which is only about 25% of the value of plant protection products. In addition, as biocidal products achieve higher prices per volume, the tonnage of substances involved is comparatively even lower.

So, in comparison to PPP, biocides represent only a small share of the overall use in terms of tonnage. Many uses of biocides do not directly lead to intentional emissions into the environment. In addition, the reassessment of all biocides present on the market in accordance with Directive 98/8/EC has only started recently and the effects of this relatively new legislation will not become visible until well after 2006, when the first evaluations of active substances for use in biocidal products will be finalised. Therefore neither the Commission nor most Member States have currently sufficient knowledge or experience to propose further measures regarding biocides.

Consequently, the proposal for a Thematic Strategy on the Sustainable Use of Pesticides will first only address the use of Plant Protection Products – both in agriculture and for other purposes. Should it be necessary at a later stage that similar measures are developed for biocides the scope of the Thematic Strategy will be widened accordingly.

2.2. The Pesticides Life-Cycle

The lifecycle of pesticides comprises the following major steps:

– production: main actors are manufacturers/producers of active substances and of the formulated preparations (PPP) which are actually placed on the market. The producers of an active substance and the PPP containing it can be the same company or can be different ones. Although overall, a number of companies are producing and selling PPP, the market is dominated by a nine globally operating companies. When a substance is not protected by a patent, it can also be produced by other companies. On the market, the research-based companies co-exist with these so-called ‘generic producers’. Both are liable for the quality of their products, the recommendations for safe use and the general information and use instructions addressed to the user.

– distribution: includes transport, storage and sales operations carried out by specialised (in dangerous goods) transport companies, wholesalers, distributors/vendors. They are generally responsible for the pre-marketing operations (storage, transport) but rarely liable for the information provided to the user regarding the use phase. In some Member States, they are also taking care of the safe collection of empty PPP-packaging and obsolete products.

– the placing on the market of final products themselves occurs via distributors and vendors or via professional user organisations (cooperatives). Authorised products are normally sold in their original single-use packaging (in general no re-packaging is authorised) with an appropriate label and accompanying documents such as use instructions. The user acquires normally the appropriate quantities fitting with his yearly needs. Limited storage occurs at farm level except for products where the use is systematic from one to another year and which are sufficiently stable.

– the use step includes all the operations carried out by the actual users, like the temporary storage at farm level, the management/calibration of spraying equipment, protection of operators with appropriate personal protection equipment (gloves, glasses, clothes, mask,…), preparation of the spraying solution (handling of PPP, mixing, and filling the sprayer tank), and the application itself. Products can be applied from the ground with ‘horizontal’ or ‘vertical’ (air-assisted) sprayers or from airplanes or helicopters in certain cases. For plant protection products, the user is in general an independent farmer (self-employed) but small service enterprises are also active in the sector. The choice of the products applied, the time and conditions for application and therefore the compliance with conditions of the authorisation is therefore mostly the responsibility of individuals. Their behaviour will strongly influence the quality and the adequacy of the treatment as well as the safety or adverse impacts on human health and the environment. At this stage, the user himself, bystanders and the environment (soil, surface and groundwater, wildlife,…) can be exposed to PPP or to their degradation products (metabolites) via several mechanisms (drift, run-off, leaching).

– post-use operations include management of spraying residues, cleaning of contaminated protective equipment and application equipment, storage and disposal of empty packaging, and disposal of waste. These operations can lead to unintentional release into the environment of more or less concentrated pesticide residues (‘point source’ pollution). PPP producers and distributors can play an active role during this post-use phase by organising collection and safe disposal of empty packaging and obsolete pesticides.

– the harvest, transformation, and eventually consumption of agricultural produce constitute the final goal of many farming activities but also the most important way of pesticides exposure for consumers via residues on produce. Feed and food retailers are buying the PPP-treated agricultural produces directly from the farmers or via cooperatives. With or without transformation, the food products potentially containing pesticides residues are then sold to the food retailer (distributor) and then to the final consumer. Food retailers do impose certain quality standards regarding the use of PPP, going frequently beyond the legal requirements regarding maximum residue levels, for instance, or refusing to buy produce having been treated with certain pesticides.

An analysis of the pesticides life cycle clearly shows that with regard to the potential for exposure of humans and direct emissions into the environment, the use and post-use stages are the riskiest steps. Emissions can occur in a diffuse way or at more concentrated points of incidental discharges. Producers and distributors are currently liable for the safe delivery and for the quality of the sold products to the final user but their possibilities to influence activities regarding diffuse or point emissions are relatively limited. The user who is finally taking the decision on the ‘why, ‘what’, ‘when’ and ‘how’ of any pesticide use – more or less influenced by the information received from the producers and distributors or other advisory bodies like extension services or food producers – is obviously the key actor for limiting unacceptable pesticide contamination of the environment at large.

2.3. Who is affected

(...PICT...)

Figure 2-1: General material flow and concerned stakeholders

A variety of people, groups and individuals are concerned with pesticides, and therefore are potentially affected by the Thematic Strategy on their sustainable use. Some are affected positively, some negatively, and some both ways.

Figure 2-1 contains a scheme presenting the general material flow and the concerned stakeholders. It will be refined when detailing the envisaged measures of the Thematic Strategy.

Table 2-2: Numbers of stakeholders concerned by plant protection products in EU-25

Sector/activity | Number of people concerned |

PPP Manufacturing | +/- 20,000 |

PPP Distribution | +/- 5,000 |

User: AgricultureNon-Ag | 10,419,000 |

| Not available |

Food Production | 3,000,000 |

Food Consumption | 470,000,000 |

Table 2-2 gives an overview of the numbers of actors/users/stakeholders involved or affected by plant protection products (the main group of pesticides) in EU-25. These have been estimated on the basis of information collected via pesticide industry federation, statistics on the farming sector and general Community statistics.

Any measure proposed in the Thematic Strategy will have impacts on these stakeholders. Obviously some are more directly affected than others due to their direct or indirect contact with pesticides.

2.4. Benefits associated with the use of PPP

There are significant economic and social benefits associated with the use of PPPs. They are used by farmers to improve or safeguard yields by eliminating or reducing competition from weeds and attacks by pests, to protect and preserve plant products against harmful organisms, to improve or protect quality of the produce, and to minimise labour input. PPPs also play an essential role in ensuring reliable supplies of agricultural products each year, by contributing to prevent fluctuations of annual yields. Moreover, the responsible use of PPPs contributes to ensuring the availability of low-priced fruits and vegetables of good quality, which makes them affordable for all consumers.

According to some sources, the use of fungicides also helps to reduce mycotoxins in food, such as aflatoxin or ergotamin. However, the Scientific Committee on Plants (SCP) examined the relationship between the use of PPPs on food plants and the occurrence of mycotoxins in foods. It concluded that there is not sufficient evidence that pesticides play a prominent and consistent role in preventing or inhibiting the production of mycotoxins by toxicogenic fungi. Data from field studies are equivocal and the SCP recommended further research on the issue.

The use of PPPs reduces demand for land for food production [20] and enables the production of a wider variety of foods regionally, which in turn can reduce transport costs and make more land available for other uses, e.g. amenity, natural parks, protection of biodiversity.

Conservation tillage, which reduces erosion, and minimum tillage techniques, which reduce the demand for fossil energy in agriculture and decrease the leaching of nutrients, also partly depend on the use of herbicides.

The European plant protection industry is a significant economic player on the world market and an important employer in Europe with around 26.000 employees in the EU-25. Three of the five largest global companies are based in Europe. In addition, there are a number of other companies involved with the use of PPP (e.g. manufacturers of spraying equipment, service companies for aerial spraying and others).

2.5. Risks from pesticide use

By definition, PPP are used in order to kill pests and modify crop growth conditions in a given environment. For this purpose, they are deliberately released into the environment during use, although most of them have inherent properties that make them hazardous to health and environment. For example, they can affect non-target organisms in the areas treated, and after treatment remain and move in environmental media such as soil and water.

2.5.1. Potential problems for human health

Risks to human health can occur through direct exposure (industrial workers producing pesticides and operators using them), and indirect exposure (consumers, residents and bystanders). Farmers and workers are exposed to pesticides in agriculture, landscaping, on golf courses, schools and public building maintenance, road and highway weed control, lawn care and other activities.

A particular pesticide will have an adverse impact on human health when the level of exposure exceeds levels considered as safe. Exceedance of this level will depend on:

– the content of active substances in a PPP and their inherent toxicity (No observed adverse effect levels – NOAELs),

– transport and fate and the concentration of the pesticide in water or environmental compartments contributing to human exposure

– the degree of uptake by organisms,

– the duration of exposure

– how quickly the PPP is metabolised and excreted.

The risks related to the individual active substance contained in PPPs are evaluated during the PPP authorisation procedures (Directive 91/414/EEC). It is however very difficult to evaluate the overall effective impact on human health of all PPP substances currently in use as the necessary methodology for assessing the effects of exposure to complicated mixtures of chemicals are not available yet. Epidemiological studies demonstrating clear links between cause and effect are lacking and the complexity of causal chains of observed effects impedes repartition of an observed impact to a particular chemical when exposure has been to a mixture of many chemicals.

According to a survey of the European Federation of Agricultural Workers’ Unions (EAF), the most common observed adverse effects of pesticides on workers and operators are headaches, vomiting, stomach-aches, and diarrhoea, caused by exposure during application, preparation or mixing and handling of containers [21].

In general, adverse health effects can be divided into acute or chronic effects.

· Acute impairment of health

Short-time exposure to pesticides can cause severe acute health effects, including diarrhoea, nausea, vomiting, abdominal pain, profuse sweating, salivation, blurred vision, irritation of skin and death are examples that have been reported in various publications.

· Chronic impairment of health

Chronic health impairment results from a low but constant exposure level and has a long-term character. Major incidents, in particular clear correlations between exposure and chronic effects, are not often recognised immediately since no obvious symptoms of poisoning exist.

There are various sources for continuous exposure, like the consumption of polluted water, pesticide residues in food, regular application of PPP over many years, or residential proximity to it and consequently direct exposure via air. People regularly or repeatedly exposed to or working with pesticides, may have a higher risk of incidence of:

– cancer or other chronic diseases,

– birth defects, cancer in offspring, stillbirths and reproductive problems,

– skin rashes and disorders, disturbed enzyme and nervous system.

Under real life conditions, acute and chronic adverse effects associated with exposure to the common classes of pesticides can vary a lot for a given substance or substance class. Conversely, different substances or substance classes can cause similar symptoms. For example, the following have been reported for certain classes of insecticides:

– ORGANOPHOSPHATES can cause headaches, pain, weakness, numbness in extremities, dizziness, damage to memory, mood control, chest tightness, loss of coordination, uncontrolled urination, seizures, death due to respiratory failure;

– CARBAMATES can cause headaches, genetic mutations, vomiting, birth defects, dizziness, reduced fertility, seizures, kidney damage, shortness of breath, nervous system damage;

– PYRETHRINS and PYRETHROIDS can cause lack of coordination, deep lung allergy, convulsions, pneumonia, muscle paralysis, vomiting, asthma and death due to respiratory failure.

Consumers and bystanders can also be subject to indirect exposure, due to the presence of PPP via residual amounts in agricultural produce. Effects could be amplified for especially sensitive population groups, such as children (due to specific physiological and developmental factors), the elderly (due to their possibly compromised metabolic capacity), or other particular risk groups (immunologically compromised people, chronically sick, etc.), and workers (due to their possible intensive exposure). At present, the scientific community sees possible gaps in knowledge for children, which are probably also the most sensitive group with regard to suspected ‘cocktail effects’ (i.e. mixtures of several substances) [22]. Evidence is emerging to document combination effects, such as additive or synergistic effects due to this multiple exposure to several pesticides while adequate risk assessment methodology to predict their consequences is not available.

2.5.2. Impacts on the environment

In addition to the intended use, pesticide application might lead to an unintended material flow of chemical substances into the environment. Due to the inherent properties of the active substances it is obvious that emissions to water, air and soil typically do not cause benefits but disadvantages and should be avoided. These disadvantages can be seen in the form of adverse effects on plants, wildlife, quality of the environmental compartments, and also biodiversity in general.

Risks to the environment consist of acute and/or chronic adverse effects on non-target species. Acute effects are mainly due to the high toxicity of certain PPPs. Chronic effects which might affect the fitness of exposed populations include those due to bioaccumulation and persistence of substances, irreversible effects such as adverse effects on the immune or endocrine systems of mammals, fish or birds.

In recent years, the emergence of a new type of hazard, endocrine disruption, has intensified the debate on health and environment protection. Endocrine disrupters are substances (including several pesticides), which are suspected of interfering with the endocrine systems of both humans and wildlife, and which may cause adverse health effects such as cancer, behavioural changes and reproductive abnormalities even through exposure to extremely low doses.

Spray drift, leaching or run-off are diffuse sources of uncontrolled dissemination of PPPs into the environment leading to pollution of soil and water compartments (surface water and ground water [23]). Environmental contamination can also occur during and after application, cleaning of equipment or uncontrolled, illegal disposal of PPPs or their containers (point sources). According to the European water suppliers organisation [24], pesticide contamination of raw water is very severe in lowland rivers, with a high proportion of contamination exceeding the 0,1 µg/L threshold value, where pesticide removal treatment is then usually necessary. Exposure via drinking water, although strictly limited by the EU Drinking Water Directive, requires constant efforts to monitor and – taking into account the long time scale of contamination and remediation – high scrutiny in the regulatory process.

PPP use may also lead to additional indirect effects on the ecosystem, e.g. loss of biodiversity. If weed control is less systematic, the resulting increase in insect populations is beneficial for the populations of insect-feeding birds [25]. Over-efficient weed control means that such birds may suffer from shortage of food. Biodiversity, however, is also influenced by a number of other factors, such as agricultural practices, plot sizes, type of crops, etc.

2.6. The Legal Situation

2.6.1. The Community policy context

The Community regulatory framework concerning plant protection products focuses primarily on the placing on the market and the end of the life cycle of such products. The most relevant pieces of legislation are:

(1) Directive 91/414/EEC [26] concerning the placing on the market of plant protection products.

(2) Regulation (EC) No 396/2005 [27] fixing maximum residue limits in several commodities as well as food and feedstuffs.

Directive 91/414/EEC intends to prevent risks at source through a very comprehensive risk assessment procedure for each active substance and the products containing the substance, before they can be authorised for marketing and use. The residues Regulation sets maximum residue limits (MRL) of active substance in agricultural produce, thus intending to limit the risks to consumers when entering the food chain. In addition, monitoring the respect of MRLs is an important tool to assess whether the users (i.e. the farmers) have correctly applied the recommendations and restrictions laid down in the authorisations of plant protection products delivered by the Member States.

Regarding the use of pesticides – and in particular the protection of the health of workers applying pesticides, the following Directives are also relevant:

– Directive 89/399/EEC [28] on the introduction of measures to encourage improvements in the safety and health of workers at work and Directive 98/24/EC [29] on the protection of the health and safety of workers from the risks related to chemical agents at work.

– Directive 89/655/EEC [30] regulating the minimum safety and health requirements for the use of work equipment by workers at work and creating obligation for employers to ensure that workers given the task of using work equipment receive adequate training, including training on any risk which such use may entail.

A number of other pieces of Community legislation and policies do also affect the use of pesticides. These are notably:

(a) The Water Framework Directive (WFD) [31], which changed the Community water policy towards a coherent and integrated framework for assessment, monitoring, and management of all surface water and groundwater based on their ecological and chemical status (among the list of 33 priority substances adopted in 2001 [32], 13 are used as active substances in PPPs). The present limit value (0.1 µg/l) for active substances, which is an exclusion criterion for authorisation purposes, is considered as the maximum permissible concentration for defining good groundwater chemical status.

(b) Since the mid 80ies, and in particular with the 1992 reform, environmental concerns have been integrated into the various Regulations setting up the Common Agricultural Policy (CAP), with an enormous impact on agricultural production methods, their intensification and their impacts on the environment [33]. A study carried out in 1998 suggested that 20% of the variation of PPP use is attributable to the effects of the CAP. This percentage may be higher in sectors with heavy pesticides reliance and large CAP payments such as cotton or tobacco [34].

(c) Pesticides and, in particular, research activities aiming at the reduction and a more sustainable use of pesticides have been supported for many years in the Community Research and Development Framework Programmes [35]. The Commission adopted in 2003 a European Environment and Health Strategy [36] aiming at reducing diseases caused by environmental factors including exposure to chemicals and pesticides, with special emphasis on the most vulnerable groups in society (in particular children). The results of this research programme are also expected to contribute to a more sustainable use of pesticides [37].

(d) The use of pesticides is furthermore subject to a number of Directives aiming at the protection of health and the safety of workers [38]. However, these are not applicable to the largest group of users, self-employed farmers.

One of the shortcomings of the current legal framework concerning pesticides is that the actual use phase, which is a key element for the determination of the overall risks that they pose, is not sufficiently addressed. The very purpose of this Thematic Strategy is to address this deficiency.

2.6.2. The international policy context

In view of the global and transboundary nature of the problems caused by pesticides, significant action has been taken at international level. Any Community action in relation to pesticides has to take into consideration this international work in the area. Conversely, the Community as a major player in international fora is in a position to influence international policies in accordance with its own objectives in particular in the relevant groups of OECD and FAO where similar topics are discussed.

The FAO adopted for the first time in 1985 the International Code of Conduct on the Distribution and Use of Pesticides. The Code contains guidance on pesticide management for all public and private entities engaged in, or associated with, the distribution and use of pesticides. The Code is designed to provide standards of conduct and to serve as a point of reference in relation to sound pesticide management practices, in particular for government authorities and the pesticide industry. This constitutes an approach, leading to sound management of pesticides which focuses on risk reduction, protection of human and environmental health, and support for sustainable agricultural development by using pesticides in an effective manner and applying IPM strategies. In addition, the revised Code includes the ‘life-cycle concept’ of pesticide management to address all major aspects related to the development, regulation, production, management, packaging, labelling, distribution, handling, application, use and control, including post registration activities and disposal of all types of pesticides, including used pesticide containers. The Code addresses the need for a cooperative effort between governments of pesticide exporting and importing countries to promote practices that minimize potential health and environmental risks associated with pesticides, while ensuring their effective use.

Parallel to the FAO activities, the OECD Environment Programme has developed tools for chemical testing and assessment that promote international harmonisation, helps countries find ways to share the work of evaluating different types of chemicals, and provides a forum through which countries exchange information about regulatory approaches and decisions. In 1992, the OECD established the first international forum for OECD regulatory authorities to discuss pesticide issues of common concern. The OECD Pesticide Forum [39] was formed to help countries work together to cope with the increasingly burdensome workload of pesticide reviews. Amongst the 6 topics addressed by the OECD, one aims at helping OECD countries to reduce the risks associated with pesticide use. The Pesticide Risk Reduction Steering Group was initiated in 1994. The objectives of the Groups activities are:

– creating strategic opportunities that facilitate risk reduction,

– giving international credibility to risk reduction tools and measures,

– reaching out to other groups, and

– promoting communication on risk reduction.

In 1995, the FAO and the Risk Reduction Steering Group co-organised a Workshop on Risk Reduction which made recommendations for (1) minimising risks associated with pesticide application and handling, and (2) reducing reliance on chemical pesticides by increasing the use of biologically based farming methods. The survey report “Activities to Reduce Pesticide Risks in OECD and Selected FAO Countries (1996) Part 1” [40] gives an overview of the different approaches, ranging from mandatory reduction of pesticide use to targeted protection of vulnerable environments, priority registration of safer pesticides, participation in international treaties to reduce emissions to lakes and seas, and promotion of integrated pest management (IPM).

Many developing countries and Newly Independent States (NIS) do not have adequate legislation or infrastructure to ensure the safe use of chemicals. This problem is addressed by the Rotterdam Convention on the Prior Informed Consent Procedure (PIC) for certain hazardous industrial chemicals and pesticides in international trade, which was adopted in 1998, and is now implemented in the Community by Regulation (EC) No 304/2003 [41] of the European Parliament and of the Council concerning the export and import of dangerous chemicals. Among other provisions, the Convention obliges exporters of chemicals on the PIC-list to obtain the consent of the receiving country before delivery and to guarantee appropriate labelling of exported chemicals, and establishes a system of information exchange on chemical risks. The Convention also gives the opportunity to developing countries to propose the listing of severely hazardous pesticides formulations, which cause problems under the specific conditions of use in the developing country. Of the current 41 PIC substances 30 are pesticides.

Persistent organic pollutants (POPs) are chemical substances that persist in the environment, bioaccumulate through the food web, and pose a risk of causing adverse effects to human health and the environment. This group of priority pollutants consists of pesticides (such as DDT), industrial chemicals (such as polychlorinated biphenyls, PCBs) and unintentional by-products of industrial processes (such as dioxins and furans). Persistent Organic Pollutants are transported across international boundaries far from their sources, even to regions where they have never been used or produced. Consequently, persistent organic pollutants pose a threat to the environment and to human health all over the globe. The international community has called for actions to reduce and eliminate production, use and releases of these substances. To that end, two international legally binding instruments have been negotiated and concluded:

– The Protocol to the regional UNECE Convention on Long-Range Transboundary Air Pollution (CLRTAP) on POPs (adopted in 1998)

– The global Stockholm Convention on POPs (adopted in 2001)

These instruments establish strict international regimes for initial lists of POPs (16 in the UNECE Protocol and 12 in the Stockholm Convention – in both cases 9 of the substances pesticides). Both aim at the prohibition or severe restriction of the production and use of intentionally produced POPs such as the pesticides concerned, and contain provisions on the safe handling and disposal of stockpiles and wastes. Both instruments are implemented in the Community through Regulation (EC) No 850/2004 [42].

A key objective of several Conventions for the protection of the marine environment (OSPAR, Helsinki, and Barcelona Conventions [43]) is the cessation of discharges, emissions and losses of hazardous substances by 2020. Hazardous substances are defined through criteria on persistence, toxicity and potential to bio-accumulate (PBT). The ‘OSPAR Chemicals for Priority Action’ and the ‘OSPAR Substances of Possible Concern’ include a considerable number of pesticides.

The Intergovernmental Forum on Chemical Safety (IFCS) [44], which is responsible for the implementation of the “chemical chapter” of Agenda 21, has in its programme several activities and some key operational goals directly relevant for pesticides, in particular capacity building, information exchange, networking, risk reduction, illicit trafficking, and others.

Lastly, measures to increase the safe handling and use of pesticides are part of the Community’s development and foreign relations policies. Financial and technical assistance (capacity building) are provided in the framework of numerous bilateral and multilateral programmes such as the Cotonou Agreement with African, Caribbean and Pacific States [45]. Other examples are the initiative to enable developing countries to substitute pesticides no longer authorised in the EU and respect MRL on agricultural produce exported to the EU [46], support to the African Stockpile Programme, which has the objective to clean up and safely dispose of all obsolete pesticide stocks from Africa and establish preventive measures to avoid future accumulation [47], support to NGO’s (such as the Pesticides Action Network - PAN) working with farmers in Africa to support sustainable agriculture solutions [48], and in NIS for projects that could also address pesticides within the Environment Programme for Europe [49] and the European Neighbourhood Policy that the EU is developing with its neighbouring countries [50].

2.6.3. Activities in third countries

A number of countries outside the EU have already put into place measures with regard to pesticides that are comparable to those now envisaged in the Thematic Strategy.

United States of America [51]

In the USA, risk reduction measures are applied either on federal level or state level. On federal level the EPA's Pesticide Environmental Stewardship Program (PESP) has been designed as a voluntary programme that forms partnerships with pesticide users to reduce the health and environmental risks associated with pesticide use and implements pollution prevention strategies. Integrated Pest Management (IPM) plays an important role. Strategies to reduce pesticide risks by adoption of lower risk alternatives such as bio-pesticides, adoption of IPM practices, and implementation of training programs and demonstrations about ways to lower pesticide use and potential risks will be developed.

Two examples for activities to reduce risks on federal state level are given below, the Utah state certification plan of pesticide applicators and programs implemented in California.

Utah has set up a certification system for pesticide applicators. Depending on the field of application, pesticide applicators will be classified for certification and licensing as in three categories (commercial applicator, non-commercial applicator, and private applicator). All applicators are required to demonstrate or show by examination knowledge about general requirements and in the specific category(s) of application. These categories are inter alia agricultural pest control, forest pest control, and aerial application pest control.

Any person applying to become certified or recertified may be required to demonstrate the ability to: (a) read and understand three or more sets of pesticide label directions, copied or transcribed from pesticide containers randomly chosen by division personnel and (b) demonstrate the mixing and application of pesticides in a safe way. A score of less than 70% on the general test or category examinations shall result in the denial of certification of that test. The applicator is required to have their license in their immediate possession, at all times, when making a pesticide application.

In California, applicators, aircraft pilots, pest control dealers, designated agents, and agricultural pest control advisers are examined and licensed within the Licensing and Certification Program. Specific certification is required for pesticide applicators who use or supervise the use of restricted pesticides. It also licenses businesses that sell or apply pesticides or use pest control methods/devices for hire, i.e., pest control business, maintenance gardener pest control business and pesticide broker.

Current pesticide drift control regulations apply only to restricted materials. The Californian competent authority plans to change the regulations by applying ground and aerial drift control restrictions to both restricted and non-restricted pesticides. Spray drift control activities will be implemented to minimise or limit to the extent possible, non-target crop damage, human exposure, and environmental contamination caused by drift of restricted and non-restricted pesticides.

The California Pesticide Management Plan for Water Quality (Plan) has been set up to protect water quality from the potential adverse effects of pesticides. The Plan contains inter alia provisions for outreach programs, compliance with water quality standards, ground and surface water protection programs, self-regulatory and regulatory compliance. The Surface Water Protection Program addresses both agricultural and non-agricultural sources of pesticide residues in surface waters. It has preventive and response components that reduce the presence of pesticides in surface waters. The plan foresees development of management practices designed to reduce contamination of water bodies, which will usually be implemented initially through voluntary and cooperative efforts. If the revised use practices do not adequately mitigate the impacts, regulatory action could be taken by imposing use restrictions to prevent excessive amounts of residues from reaching surface water.

Australia

The Australian Pesticides and Veterinary Medicines Authority supports, where possible, support IPM in its regulatory approach. For example, initiatives have been developed with relevant government authorities to implement resistance management strategies that incorporate IPM, and to include reference to such strategies on relevant product labels.

Australian legislation requires that registered chemicals will not result in undue risk to the environment. To meet these legislative requirements, continued registration may require environmental monitoring for ground and surface water contamination by pesticides. This enables implementation of measures to reduce water contamination, for example tighter controls and restrictions on product use resulting in the adoption of improved agricultural practices and hence environmental protection.

Australia recently conducted a strategic review of agricultural chemicals management. The review, amongst other things, recommended that Australia develop a pesticide use reporting system by crop/species and region to provide a clear understanding of what and where chemicals are used, which would assist development of consistent monitoring priorities. Additionally, an adverse experience reporting program for agricultural chemicals will be implemented to collect information on suspected adverse reactions from the use of pesticides, which will significantly improve health monitoring.

Brazil

In Brazil, a law regulating the final destination of empty agrochemical containers entered into force in 2002. The law requires farmers to practice triple-rinsing, return empty containers to receiving stations, and keep the vouchers of package delivery and invoice of product purchase. Distributors are required to indicate on invoices where the growers are to return the used containers, construct and manage receiving stations, and implement educational programmes for end users. Pesticide manufacturers are required to provide transport, recycling or disposal services for empty packages collected at receiving stations; change labels to include information about triple-rinsing and returning used containers and implement educational programmes for end users with distributors and government.

Canada [52]

Canada has or aims at implementing several risk reduction measures so as to reduce the negative impact of pesticides on human and animal health or the environment.

The Pesticide Risk Reduction Program highlights priorities for pest management, including biological controls, natural products, and low-risk minor use pesticides. This program aims at increasing the availability and adoption of reduced risk tools and practices to control pests in agriculture. The program will focus on:

– developing and implementing strategies to reduce pesticide risks;

– conducting research into improving methods for pest control;

– developing alternative approaches to pest management, such as integrated pest management, biological control methods, and bio-pesticides; and

– increasing the adoption of reduced-risk technologies by producers.

A comprehensive and refined modelling method for the prediction of pesticide concentration in drinking water sources (ground water and surface water) has been developed. A Federal / Provincial / Territorial drinking water monitoring working group for improved sharing of monitoring information has been established.

More accurate drift functions for predicting drift and deposit to wildlife habitats have been developed. Continued development of a policy allowing pesticide applicator to refine labelled buffer zones based on local application conditions and habitats.

A pesticide sales database framework has been developed, which will provide better estimates of pesticide exposure and risks to humans and the environment, assist in setting priorities for re-evaluation, and determine the extent of use of reduced risk products. A proposed regulation to require the mandatory reporting of annual sales data is under consultation. Increased funding was secured to expand research and monitoring activities, the results of which will better enable the identification of potential problems and allow for the refinement of risk characterization methods. Collaboration is ongoing with Federal departments and stakeholders to find ways to obtain commodity-based pesticide use data.

Pesticide risk indicator models from OECD work have been evaluated aiming at adapting an indicator for the Canadian context, which will provide risk trends by commodity at local, provincial or national levels and harmonize indicator characteristics with other OECD countries. A Federal/Provincial/Territorial Working Group on Pesticide Risk Indicators has been formed and a workshop on risk indicators has been held.

The objective of the National Agri-Environmental Health Analysis and Reporting Program (NAHARP) is to improve and develop a suite of agri-environmental indicators to assess and report on important environmental issues. These issues fall into five main themes: soil quality, water quality, agro-ecosystem atmospheric emissions, agricultural biodiversity, and eco-efficiency. The issues related to pesticides are: Water quality indicators – Pesticide contamination and Eco-efficiency indicators - Integrated pest management adoption.

Switzerland [53]

In recent years, the Swiss Federal Council has passed several measures as part of the legislation on agriculture, which are intended to reduce the use of pesticides. Since 1999, Integrated Production has been a prerequisite for direct payments. Integrated pest management, which is part of integrated production, is therefore de facto mandatory.

In order to be able to make a reliable assessment of the effect of environmental and agricultural policy measures, Switzerland initiated a program to collect data on the use of pesticides in a representative and transparent way. The risk associated with the pesticide applications will be determined using appropriate indicators, which are based on relevant regional or local monitoring. The results will also serve as a basis for targeted monitoring of environmental pollution from pesticides and for advice regarding targeted selection and application of pesticides.

2.7. Current pesticide use in the Member States

Since no harmonised risk indicators are yet available at Community level in order to assess trends in the risks from pesticide use, the only proxy we currently have is trends in pesticide use.

The current situation regarding pesticide use in the Member States is marked by large variations, not only in overall use, but also in the prevailing trends. These can be partly explained by the diverging structures of the agricultural sector and different climatic conditions (leading to different needs in terms of plant protection), but also by efforts undertaken in several Member States to reduce the need for pesticides and the correlated risks to human health and the environment through National Action Plans.

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Figure 2-3: Estimated application rates of pesticides in the Member States (EU-15) in kg/ha

Figure 2-3 summarises the situation with regard to pesticide use in the period 1997-1999 in the Member States (expressed as kg active substance per hectare agricultural surface).

In line with their agricultural surfaces, the main users in overall quantities are France, Italy, Spain, Germany, the UK, and Portugal. However, in terms of kg/ha, which is an indication of the intensity of use, the Member States with the highest consumption are: the Netherlands, Belgium, France, Italy and Portugal. This reflects the different needs for plant protection depending on climate, soil and the crops produced. In particular, production of vine, fruit, and vegetables are by far the most pesticide-intensive agricultural practices.

Developments in the individual Member States have shown significant differences as shown in Figure 2-4. Whereas some Member States have seen significant reductions from the period 1990-92 to 2000-2002 (HU, NL, DK), others (PT, PL, GR) have experienced massive growth in pesticide consumption.

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Figure 2-4: Percentage change in usage of pesticides in OECD member countries between 1990-92 and 2000-02 (Source: OECD Environmental Data Compendium, 2004)

2.8. Need for EU action

Without any Community intervention, this trend towards divergence in the Member States is very likely to continue, leading to totally different levels of protection of health and environment and diverging conditions for the main users of pesticides (i.e. farmers) in the Member States, which would be against one of the fundamental objectives of the Treaty.

Currently, some Member States have already adopted measures to reduce the risks for health and the environment linked to pesticide use, while others have not yet taken such action. This creates a situation where there is no level playing field for pesticide users and 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 or the environment throughout the Community and pesticide use shows diverging trends between Member States.

Besides, placing of pesticides on the market as well as monitoring of pesticide residues are already harmonised through Community legislation. The same should therefore apply to other aspects of pesticides policy.

Setting equal standards and objectives to be achieved in all Member States can only be done by the Community. Otherwise the current situation with unequal obligations for economic operators will continue.

3. Objectives

3.1. Sixth Environment Action Programme (6th EAP)

This Strategy positions itself within the 6th EAP.

Overall objective of the Thematic Strategy:

The 6th EAP establishes in its Article 7(1) that the impact of pesticides on human health and the environment must be reduced and more generally that there is a need 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 crop protection.

The specific objectives of the Thematic Strategy on the Sustainable Use of Pesticides identified in the Article 7(2) (c) of Decision 1600/2002/EC establishing the 6th EAP are:

(i) to minimise the hazards and risks to health and environment from the use of pesticides;

(ii) to improve controls on the use and distribution of pesticides;

(iii) to reduce the levels of harmful active substances including through substituting the most dangerous with safer (including non-chemical) alternatives;

(iv) to encourage the use of low-input or pesticide-free farming, in particular by raising users' awareness, by promoting codes of good practices and consideration of the possible application of financial instruments;

(v) to establish a transparent system for reporting and monitoring the progress made in the achievement of the objectives of the strategy including the development of suitable indicators.

3.2. Other Community strategies

3.2.1. Lisbon Strategy

The proposed Thematic Strategy is fully coherent with the objectives of the Lisbon Strategy on growth and employment by selecting cost-effective measures optimising the economic, social, health and environmental impacts.

3.2.2. Sustainable Development Strategy

In 2001, the European Council in Gothenburg adopted the Sustainable Development Strategy. The guiding principles and objectives of sustainable development – economic prosperity, social equity, environment protection and international responsibilities – were reaffirmed by the European Council in June 2005 when they adopted guiding principles for sustainable development.

In the context of the Thematic Strategy on the sustainable use of pesticides, the goal to reduce significant threats from pesticide use contributes to the key objective of ensuring a high level of protection and improvement of the quality of the environment, and the objective of improving public health. It is based on the guiding precautionary principle.

4. Policy Options

In the light of the preparatory work and the results of the various consultations and in the spirit of the holistic approach of Thematic Strategies, it became clear that the Strategy would have to be composed of a number of different measures. The detailed list of all the various options through which these measures could be put into practice, and which have been assessed as possible implementation, is provided below. As a general rule, for each measure, the full range of possibilities has been explored, from those of a rather prescriptive and binding character to those of a relatively voluntary quality, including those based on market based instruments. A no-action scenario was considered as a reference against which to appraise the costs anticipated from the measures proposed.

Thematic Strategies are new tools, which follow a holistic concept in addressing a specific topic. A lot of emphasis has therefore been put on integration of the measures of the Strategy in existing policies and legislation (such as the Common Agricultural Policy - CAP). Only when integration into other instruments or policies is not possible, new legislation – in particular a Framework Directive on the Sustainable Use of Pesticides - or other appropriate instruments are proposed.

This impact assessment therefore focuses on measures and related options that cannot be integrated in existing legislation / policies, that are expected to be of major relevance for achieving the objectives of the Thematic Strategy, or that are were very controversial during the consultation process.

Measures that are best integrated in other instruments / policies, or are of lower relevance are briefly described and assessed in 4.2.

4.1. Measures and options that have been assessed in detail

4.1.1. Creation of a system of mandatory education, awareness raising, training and certification for all PPP users (farmers, local authorities, workers, distributors, traders and extension services)

Awareness about the risks linked to the use of pesticides is considered as the most important factor to improve sustainability of use.

The intention of this measure is to give to all PPP users (farmers, local authorities, workers, distributors, traders and extension services) the necessary knowledge about safe use of pesticides (in addition to the provisions of the Directives 89/399/EEC and 98/24/EEC on the training and education of employees at work), covering both human health and environmental aspects, best plant protection practices, IPM, etc.

· Option 1: Mandatory training and information schemes (not going into detail).

The Strategy would require Member States to establish mandatory training and information schemes but the legislation would not go into any details. Member States would have full discretion to develop all necessary details as they see fit. Exchange of information between Member States on their national programmes, and on the progress observed would be ensured within an Expert Group.

This option is relatively flexible with regard to scope and content of training and information schemes.

· Option 2: Mandatory education and training to PPP retailers, farmers and other professional users and extension services

The Strategy would establish mandatory requirements regarding education and training. This would apply to PPP retailers, farmers and other professional users (if not already covered by Directive 89/391/EEC and 98/24/EC) and extension services. Specific guidance would be established by an Expert Group and should include the elements as outlined above.

The organisational aspects (like the training institutions/organisms involved, financing aspects, certification bodies, etc.) would remain the responsibility of the Member States.

This option is more prescriptive and leaves only little flexibility for Member States specific solutions.

· Option 3: Recommendation to establish enhanced training and information

The Strategy would recommend that Member States establish enhanced training and information schemes. Member States might choose to do this in a mandatory way or on a voluntary basis and with or without certification system. Exchange of information between Member States on their national programmes, and on the progress observed would be encouraged.

This option is mainly voluntary and leaves full flexibility for Member State specific solutions.

· Option 4: Introduction of a general tax on pesticides

The Community and/or the Member States would introduce a general tax on pesticides in order to increase costs for all users of pesticides significantly, which would give further incentives to minimise the use of pesticides including through improving application efficiency by training.

This option is a combination of a mandatory component (general tax) in an overall voluntary approach for training. Possibilities, details and other actions are left to Member States, but it is clear that concrete implementation, expected impacts on farmers’ behaviour, and the related transaction costs are decisive for its practicability. The interest for farmers to participate voluntarily in training would be that they could optimise their pesticides use and thus recover the costs for training by spending less on pesticides, which would be more significant due to the increased prices.

· Option 5: No action

In this option, no particular action would be proposed in addition to already existing legislation.

· Option 6 Combination of specific financial instruments with training and information schemes

The Community and/or the Member States would introduce a system that would provide financial incentives to those users that are successfully attending training courses; or those users not attending training would be sanctioned.

This option remains flexible regarding the scope of the training and the implementation of the incentive/sanction system. A possible implementation could provide incentives to farmers by granting tax breaks for covering training costs, or providing support under rural development measures of the CAP. Alternatively, those users who are not participating in training could be sanctioned by having to pay an extra fee when purchasing pesticides. Again concrete implementation, expected impacts on farmers’ behaviour, and the related transaction costs are decisive for the practicability of such an option.

4.1.2. Standards for control and certification of application equipment

Optimising spraying equipment and guaranteeing its good functioning is an important element to achieve an application of pesticides with minimum adverse effects on the environment. The challenge is to apply the products at the right dosage and on the targets only. Generally, with appropriate training users can identify important shortcomings such as tank leakages or blocked nozzles. But other parameters need more complicated verifications. Pressure control, nozzles and spraying boom have to be well maintained in order to comply with optimal use standards and in order to reduce diffuse contamination.

The intention of this measure is to establish technical checks and certification programmes of spraying machines and equipment in all Member States.

For this purpose, it is necessary to distinguish two types of potential measures:

(a) Control: the control of spraying equipment refers to testing of sprayers, which are already in use.

(b) Certification: the certification of sprayers refers to testing of new spraying equipment that has to be successfully passed before a specific type of sprayer can be placed on the market.

· Option 1: Mandatory certification systems for new application equipment (not going into detail).

The Strategy would only require that Member States establish mandatory certification systems for new application equipment but would not go into any details. Member States would have full discretion to develop all necessary details as they see fit. Exchange of information between Member States on their national actions, and on the progress observed would be encouraged and organised through an Expert Group.

This option sets the objective of the measure in a binding way but leaves flexibility for Member States regarding practical implementation.

· Option 2: Mandatory certification system for new application equipment and control of equipment in use.

The Strategy would require Member States to establish certification systems for new sprayers and equipment like nozzles. Specific standards would be developed for certification to receive a ‘CE-label’ for fulfilment of specific safety requirements. Use of such material would be made compulsory as a risk management method in certain vulnerable situations or for the protection of watercourses (in particular for nozzles, which are decreasing spray-drift).

Member States would also be obliged to establish a system for the mandatory control of spraying equipment in use. This would include equipment already in use in those Member States where an equivalent measure was not implemented before. The legal instrument should establish:

– the objectives of the control (regular and reproducible spraying pattern, elimination of unsuitable apparatus, short training of users, etc.) and the conditions of validity of the certificate delivered by the control body;

– the link with existing CEN or ISO standards for the control methodologies.

This option is more prescriptive, as harmonised standards and control methodology would be binding but it leaves some flexibility for Member States regarding practical implementation.

· Option 3: Voluntary control system

The Strategy would recommend that Member States establish a voluntary control syst