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Document 52022PC0305

    Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the sustainable use of plant protection products and amending Regulation (EU) 2021/2115

    COM/2022/305 final

    Brussels, 22.6.2022

    COM(2022) 305 final

    2022/0196(COD)

    Proposal for a

    REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

    on the sustainable use of plant protection products and amending Regulation (EU) 2021/2115

    (Text with EEA relevance)

    {SEC(2022) 257 final} - {SWD(2022) 169 final} - {SWD(2022) 170 final} - {SWD(2022) 171 final}


    EXPLANATORY MEMORANDUM

    1.CONTEXT OF THE PROPOSAL

    Reasons for and objectives of the proposal

    Pesticides 1 are mixtures of one or more formulated active substances and co-formulants that are widely used to protect plants by repelling, mitigating or destroying harmful organisms. They are mainly used in agriculture but also in forestry and green urban areas and along transport networks such as roads and railways. Since pesticides can have harmful effects on the environment and on human health they are strictly regulated at EU level. For the purpose of this proposal, the term ‘pesticides’ will be used synonymously with the term ‘plant-protection products’.

    The Sustainable Use of Pesticides Directive (SUD) 2 was adopted in 2009 as one of the follow-up actions of the Commission thematic strategy on the sustainable use of pesticides 3 . Member States were required to bring into force the national provisions transposing the SUD into their domestic law by 26 November 2011. The Commission considered it appropriate to carry out an evaluation of the SUD that also considered the problems identified with its implementation, enforcement and application in Member States. This work was performed as a back-to-back assessment, incorporating both an evaluation and an impact assessment. The Commission hoped to use the assessment to help bring forward a new legislative proposal to revise the SUD by Q1 2022 as stated in the farm-to-fork strategy 4 .

    There are currently weaknesses in the implementation, application and enforcement of the SUD. These weaknesses have been highlighted by Commission audits and fact-finding visits to Member States and implementation reports by:

    (i)the Commission;

    (ii)the European Parliamentary Research Service study on the implementation of the SUD; and

    (iii)a recent report of the European Court of Auditors on plant-protection products. In addition, growing societal concerns about the use of pesticides can be seen in the many petitions, two European citizens’ initiatives 5 , and European Parliamentary questions on this issue.

    Feedback received during the public consultation on the Commission’s evaluation roadmap and inception impact assessment pointed to serious deficiencies in the implementation of the SUD in some Member States. This feedback also urged the Commission to introduce stricter rules, for example in the form of a regulation at EU level to increase coherence and introduce more effective policies in individual Member States. The harmonisation of national pesticide-use policies could help improve the functioning of the internal market and reduce trade distortions between Member States.

    Achieving safe, sustainable, just, climate responsible, and affordable production of food, respecting sustainability principles, the environment, safeguarding biodiversity and ecosystems, while ensuring food security, is of great concern for citizens and feature among the 49 proposals included in the final report of the Conference on the Future of Europe 6 , published on 9 May 2022. Citizens also ask the Union to protect and restore biodiversity, the landscape and oceans, and eliminate pollution, as well as to take decisive measures to promote and guarantee a more ecological and climate-oriented agriculture 7 .

    As part of the European Green Deal 8 , the Commission’s farm-to-fork 9 strategy highlights the need to transition to a fair, healthy and environmentally-friendly food system. The farm-to-fork strategy also stresses the importance of improving the position of farmers (who are key to managing this transition) in the value chain. It proposes two specific targets to reduce the use of – and risk from – chemical pesticides and more hazardous pesticides by 2030. EU regulation in this area is a crucial tool to achieve the targets outlined in the farm-to-fork strategy and should therefore be strengthened.

    As explained in the accompanying impact assessment, and taking account of the supporting evaluation, the proposal has the following four objectives.

    The first objective is to:

    (i)reduce the use and risk of chemical pesticides, in particular those containing more hazardous active substances;

    (ii)increase the application and enforcement of integrated pest management (IPM); and

    (iii)increase the use of less hazardous and non-chemical alternatives to chemical pesticides for pest control.

    The second objective is to improve the availability of monitoring data, including on:

    (i)the application, use of, and risk from pesticides; and

    (ii)health and environmental monitoring. This will ensure a better framework to measure progress.

    The third objective is to improve the implementation, application and enforcement of legal provisions across all Member States to improve policy effectiveness and efficiency.

    The fourth objective is to promote the adoption of new technologies, such as precision farming that makes use of space data and services (including geospatial localisation techniques), with the aim of reducing the overall use and risk of pesticides.

    The recent evaluation of the SUD confirmed the long-standing difficulties identified in its application, implementation and enforcement. Given these difficulties, this proposal for a regulation on the sustainable use of plant-protection products (SUR) aims to:

    (i)replace the SUD in regulating the use of pesticides; and

    (ii)better align with the objectives of the European Green Deal and farm-to-fork strategy.

    This proposal aims to reduce the risks from – and impacts of – pesticide use on human health and the environment by:

    (i)achieving pesticide-reduction targets contained in the farm-to-fork strategy; and

    (ii)promoting the use of IPM and alternatives to chemical pesticides.

    A regulation is appropriate to both ensure that the level of ambition in the farm-to-fork strategy is met and remedy the problems identified with the implementation of the SUD by providing clear and uniform rules.

    Consistency with existing policy provisions in the policy area

    The proposal is consistent with the European Green Deal’s objective that all EU policies should contribute to preserving and restoring Europe’s natural capital. It is also consistent with the aims of:

    (i)reducing the use of – and risk from – chemical pesticides; and

    (ii)reducing the use of more hazardous pesticides.

    These aims are present in the following documents:

    (i)the farm-to-fork strategy;

    (ii)the biodiversity strategy 10 ;

    (iii)the zero-pollution 11 action plan; and

    (iv)the soil strategy 12 .

    This aim is also consistent with meeting the objectives of the EU pollinators initiative 13 , the EU chemicals strategy 14 for sustainability and the EU strategic framework on health and safety at work 2021-2027 15 .

    The proposal is also consistent with European Commission targets to have at least 25% of the EU’s agricultural land under organic farming – and a significant increase in organic aquaculture – by 2030. The proposal also complements other current initiatives. For example, Regulation xxx/xxx on statistics on agricultural inputs and outputs of the agricultural sector [reference to adopted act to be inserted] will allow the Commission to publish more data on the sale and use of pesticides broken down by individual active substances. As part of the farm-to-fork action plan, the Commission has prepared four draft Regulations regarding the data requirements, the approval criteria and evaluation principles for active substances that are micro-organisms and the plant protection products containing them with the objective of facilitating access to the market for alternative products to chemical pesticides. These texts will be adopted and become applicable in the autumn of 2022. The objective is to provide farmers with tools to substitute chemical plant protection products. By facilitating the placing on the market of these biological plant protection products, farmers – including those producing organic crops - will have more alternatives available for sustainable crop protection.

    The proposal is also relevant to the EU’s outermost regions, as listed in Article 349 of the Treaty on the Functioning of the European Union (TFEU), located in the Atlantic, Caribbean and Indian Ocean. Due to permanent constraints such as their remoteness to the EU continent, insularity and dependence on few products and high exposure to climate change, they are entitled to specific measures to support their socio-economic development. As also provided for in the EU biodiversity strategy for 2030, a particular focus should be placed on protecting and restoring the outermost regions’ ecosystems, given their exceptionally rich biodiversity value.

    Consistency with other Union policies

    Common agricultural policy (CAP)

    Under the new CAP 16 (due to be implemented from 1 January 2023), Member States will be helped to: (i) fund actions in line with the pesticide-reduction targets in the farm-to-fork strategy; and (ii) promote sustainable farming practices. Relevant elements of the current SUD are already included in the system of conditionality under the CAP. The new CAP also includes various instruments to promote precision farming. Member States can use eco-schemes and environmental, climate and other management commitments to support the implementation of precision farming practices. Furthermore, the CAP includes the possibility to fund investments, for instance in machinery equipment, and risk management tools as well as technical knowledge building support such as training, advice, cooperation and knowledge exchange. More specifically, through the CAP’s farm advisory services, Member States are to offer advice to farmers on the sustainable use of pesticides, innovation, digital technologies, reduction of exposure to pesticides and sustainable management of nutrients. Capacity building for the uptake and effective deployment of digital technologies by farmers can also be reinforced through support, cooperation and the European Innovation Partnership for Agricultural Productivity and Sustainability (EIP-AGRI). In addition, in their CAP strategic plans, Member States are to explain how they will use CAP instruments to meet relevant needs and objectives.

    Environmental and chemicals policy

    This proposal interacts with a number of environmental policies and legislative acts, for example:

    (i)planned nature-restoration targets 17 ;

    (ii)the pollinators initiative 18 to address the decline of pollinators in the EU and contribute to global conservation efforts;

    (iii)the lists of pollutants and regulatory standards in the Environmental Quality Standards Directive 19 , the Groundwater Directive 20 and the Drinking Water Directive 21 .

    It is key to delivering on the objectives set out in the EU water laws including the Water Framework Directive 22 . It also links with the nature conservation requirements in the Habitats and Birds Directives.

    EU policy on Occupational Health and Safety

    The proposal is complementary to the provisions of the relevant EU occupational health and safety acquis, in particular Framework Directive 89/391/EEC 23 , Directive 98/24/EC 24 , Directive 2004/37/EC 25 , Directive 2009/104/EC 26 and Directive 89/656/EEC 27 . It is in line with the EU strategic framework on health and safety at work 2021-2027, which draws specific attention to the need to strengthen training to increase farmers’ skills and awareness on the health and safety rules on farms, including safe use of chemical substances, in particular plant protection products. 

    Initiative for a Sustainable Union Food System

    This proposal is complementary to the planned legislative initiative on a sustainable food system framework, which aims to promote policy coherence at EU and national level, mainstream sustainability in all food-related policies and strengthen the resilience of the Union food system. This planned initiative is based on a horizontal approach that will introduce sustainability-related objectives, common definitions, general principles as well as requirements for a Union sustainable food system, while addressing the responsibilities of all actors in the food system. Combined with labelling on the sustainability performance of food products and with targeted incentives, the framework will allow operators to benefit from sustainable practices and ensure that food in the EU market and food-related operations increasingly become sustainable. The provisions of this regulation will act as lex specialis in relation to the requirements set out by the planned initiative to the extent that the provisions of this regulation include more specific provisions with the same objective, nature and effect compared with those to be laid down in the planned initiative.

    2.LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

    Legal basis

    The legal basis for action in this area is Article 192(1) of the TFEU, which empowers the European Union to take action to preserve, protect and improve the quality of the environment and to protect human health. EU action in this area is justified by the environmental and public health issues at stake.

    Subsidiarity

    The SUD created a framework to achieve the sustainable use of pesticides. Continued inconsistency in the measures taken in Member States combined with varying/incomplete implementation of the SUD (as outlined in the evaluation accompanying this proposal) would lead to different levels of protection of health and the environment. This would also lead to diverging conditions for the main users of pesticides, contrary to the objectives of the Treaties 28 . The threat to biodiversity and ecosystems linked to the use of pesticides crosses borders and requires strong action at EU level. A level playing field across the internal market is being hampered by current variations in the levels of action taken in different Member States.

    Coordinated EU action can effectively supplement and strengthen national and local actions on the sustainable use of pesticides. The EU also possesses other key instruments in agricultural and food policies which have synergies with the measures set out in the proposal. Combined with incentives and possible risk mitigation measures, it is expected that stronger action at EU level on pesticides (including in association with related policies such as the CAP) can:

    (i)help to reduce current variations in national approaches; and

    (ii)contribute to a more homogenous approach in the future.

    These objectives cannot be set by the Member States acting on their own: the scale of the action required means that these objectives can be better achieved at EU level. Uniform EU action is therefore justified and necessary.

    Proportionality

    This proposal complies with the proportionality principle because it does not go beyond what is necessary to ensure:

    (i)an appropriate level of ambition; and

    (ii)improved policy efficiency and effectiveness.

    It achieves this by taking into account the findings of the evaluation accompanying this proposal. The proposal provides for both improved data, and better monitoring/implementation of measures to reduce the use of – and risk from – pesticides.

    On Member State targets, this proposal avoids fixing uniform mandatory targets for Member States. This is because the current baseline of pesticide use varies widely between Member States. The proportionality of the target-setting process has been ensured by providing for a legislative formula that allows differences in progress and in intensity of pesticide use between Member States to be taken into account.

    Choice of the instrument

    The available evidence on deficiencies in implementing the SUD in Member States shows that the previous approach of leaving the detailed rules to national transposition under a Directive has not worked to the extent envisaged by the original SUD proposal. The findings of the SUD evaluation confirm the divergent and uneven implementation, application and enforcement of the SUD across Member States. These findings were confirmed by a Commission compliance-monitoring index described in the evaluation. The European Court of Auditors also found that there was a need for clearer criteria and more specific requirements on IPM to help ensure enforcement and assess compliance 29 . Because there are so many complex agricultural variables in pest management, rules that are clear and uniform should simplify compliance and improve enforcement. The consistent application of the policy across Member States is better achieved by means of a regulation, as opposed to a directive. In addition, a regulation would facilitate a more level playing field among pesticide users, as different rules on pesticide use across Member States tend to create unfair competition and undermine the proper functioning of the single market.

    3.RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS

    Ex-post evaluations/fitness checks of existing legislation

    The evaluation accompanying this proposal found that the internal and external coherence of the SUD with other EU policies and instruments is generally strong, with no major inconsistencies or overlaps. The objectives of the SUD were, and still are, highly relevant to address the risks that pesticide use poses to the environment and human health. However, the SUD has only been moderately effective. Weaknesses identified by the Commission and others concern the implementation and enforcement of IPM, and the limited effectiveness of Member State national action plans (NAPs). Many Member States do not set quantitative targets or indicators in their NAPs to promote the sustainable use of pesticides or better protect human health and the environment. There is also no effective monitoring system, which has resulted in limited data on the use of pesticides. This has made it difficult to reach a conclusion on the extent to which the SUD has protected human health and the environment from the adverse effects of pesticides. Previously introduced measures under the CAP were not able to incentivise farmers to achieve the more sustainable use of pesticides.

    The Commission’s Regulatory Scrutiny Board (RSB) gave a negative opinion on the Commission’s draft impact assessment for this proposal on 26 November 2021. The draft impact assessment was in the form of a staff working document. The RSB requested that the document be revised to:

    (i)be clearer on the available data and evidence for the initiative;

    (ii)provide a more robust analysis or narrative for the pesticide-use and risk-reduction targets;

    (iii)be clearer on the availability and affordability of precision-farming techniques and less hazardous alternatives to chemical pesticides; and

    (iv)identify and better analyse the impacts and trade-offs of the initiative for the environment, health and the economy.

    The RSB gave a second opinion – this time positive with reservations – on 26 January 2022 on the revised impact assessment staff working document. After this second opinion, the document was further amended to address the RSB’s reservations so that the document would:

    explain clearly both the lack of evidence on pesticide sales and use and the corresponding limitations this lack of evidence places for the problem definition, option formulation and impact analysis;

    better justify the choice for the twin 50% binding reduction targets and how they relate to each other;

    specify the level of progress necessary in individual Member States for them to be compliant with the twin binding EU reduction targets, and specify how this will be measured, allocated, or result in a fair burden sharing;

    clarify the flanking initiatives included in the baseline for the impact assessment; and

    set out a more credible basis and timeframe for the future evaluation of the initiative.

    The final impact assessment was produced in the form of a Commission staff working document and has been revised in line with these RSB opinions, comments and points for improvement.

    Stakeholder consultations

    A combined evaluation roadmap and inception impact assessment on this proposal was published and made open for public feedback from 29 May to 7 August 2020. In total, 360 responses were received. The public consultation ran from 18 January to 12 April 2021 and received a total of 1 699 responses. The feedback received represented a wide spectrum of views, as outlined in the synopsis report that summarised the stakeholder consultation (this synopsis report is annexed to the impact assessment accompanying this proposal). Professional users of pesticides emphasised the need to protect crop yield and crop quality. Other stakeholders emphasised the need to promote IPM, increase the availability of alternatives to chemical pesticides, and better assess the health and environmental impacts of using chemical pesticides. The Commission organised remote stakeholder events on this initiative on 19 January, 25 June and 5 October 2021. A number of issues emerged at these stakeholder events, including:

    (i)concerns from pesticide users about the possibility of fewer pesticides being available on the market;

    (ii)the limited financial support under the CAP for implementing IPM;

    (iii)the need to protect farmers’ incomes;

    (iv)promoting the role of new technologies; 

    (v)protecting human health and the environment; and

    (vi)whether to continue a prohibition on aerial application of pesticides. Most NGOs stressed the importance of achieving the European Green Deal’s ambitions and related targets. Another issue emphasised at the stakeholder events was the need to improve implementation of the NAPs.

    Targeted surveys, workshops and case-studies were also carried out in:

    (i)a Commission-contracted external study supporting the evaluation and impact assessment; and

    (ii)a supplementary foresight study on future vision scenarios on the sustainable use of pesticides.

    Details of the stakeholder consultations have been published on the Commission’s website 30 and the Better Regulation Portal 31 . Stakeholders who were involved and contributed to these consultation activities included:

    (i)farmers and contractors applying pesticides;

    (ii)non-agricultural users of pesticides;

    (iii)health and environmental NGOs;

    (iv)professional associations representing industry and economic actors in relevant sectors (e.g. beekeepers, the chemical industry, the pesticide-application equipment industry, the seed industry etc.);

    (v)consumer associations;

    (vi)social partners (employers and workers organisations);

    (vii)the general public;

    (viii)EU and non-EU national and regional competent authorities; and

    (ix)scientific experts.

    Responses to the different activities showed that stakeholder views were largely divided into two broad points of view. The first group was of the view that pesticide use should be reduced in line with the goal of risk reduction in a manner which works with users of plant-protection products. The second group was of the view that pesticide use should be reduced significantly if not completely. The proposal has been developed as a proportionate and realistic – yet still ambitious – approach to addressing societal concerns around the use and risk of pesticides. It is an approach that:

    (i)still allows pesticides to be used when necessary and appropriate and in a safe manner; and

    (ii)promotes training and advisory systems for alternative pest-control techniques and the better implementation of IPM.

    As described in the impact assessment, a number of policy options were discarded based on stakeholder feedback. The level of ambition of the finally selected policy options also took into account the feedback received from stakeholders.

    European citizens’ initiatives

    Two European citizens’ initiatives address the use of pesticides and call for ambitious reduction targets. The successful European citizens’ initiative ‘ Ban glyphosate and protect people and the environment from toxic pesticides ’ called on the Commission, under its third aim, ‘to set EU-wide mandatory reduction targets for pesticide use, with a view to achieving a pesticide-free future’. In its reply adopted on 12 December 2017 , the Commission stated that it would re-evaluate the need for EU-wide mandatory targets for pesticides.

    The initiative ‘ Save bees and farmers! Towards a bee-friendly agriculture for a healthy environment ’ calls on the Commission ‘to propose legal acts to phase out synthetic pesticides in EU agriculture by 80% by 2030, starting with the most hazardous, and to become free of synthetic by 2035.’ The initiative has collected over 1 million statements of support by 30 September 2021, which are currently being verified by Member States authorities. If validated and officially submitted, the Commission will outline the actions it intends to take, if any, in a communication.

    Collection and use of expertise

    The initiative was supported by two Commission-contracted external studies, which included an in-depth literature review, workshops, case-studies, and surveys.

    The impact assessment also drew on additional information from a number of other studies that used economic modelling to estimate the potential impact of achieving the targets in the farm-to-fork strategy, including the targets for pesticide use and risk reduction.

    Impact assessment

    The executive summary sheet for the impact assessment is available  here . The positive opinion of the RSB is available here .

    The proposal’s aim of reducing the use of – and risk from pesticides – to protect health, biodiversity and the environment is relevant to the Commission’s ambition to deliver on the UN sustainable development goals. In particular, it is relevant to goals 3 (health and wellbeing), 6 (clean water), 8 (decent work and economic growth), 11 (sustainable cities), 12 (sustainable consumption and production), 14 (life below water) and 15 (life on land).

    In line with the objectives of the European Green Deal, the proposal also complies with the ‘do no significant harm’ principle. According to this principle, activities should not do significant harm to any of the six environmental objectives, within the meaning of Article 17 in accordance with Article 9 of the Taxonomy Regulation 32 . The six objectives are: climate-change mitigation; climate-change adaptation; sustainable use and protection of water and marine resources; transition to a circular economy; pollution prevention and control; and protection and restoration of biodiversity and ecosystems.

    The following main policy options were assessed against a likely baseline scenario where the SUD remains unchanged.

    Option 1: The EU targets to reduce pesticide use by 50% and reduce pesticide risks by 50% to be achieved by 2030 remain non-legally binding. Advisory systems and guidance for pesticide users would be improved. Precision-farming techniques would be promoted to cut the use of – and risk from – chemical pesticides.

    Option 2: The 50% reduction targets would become legally binding at EU level. Member States would set their own national reduction targets using established criteria. These national targets would then be legally binding (under national law) and subject to governance mechanisms linked to regular annual reporting by Member States. The use of more hazardous pesticides would be prohibited in sensitive areas such as urban green areas. Professional pesticide users would need to keep electronic records on pesticide use and on IPM to help reduce pesticide use. National authorities would collect and analyse those records to monitor progress and devise corrective measures at national level if necessary. Independent advisory services would advise pesticide users on alternative techniques and IPM.

    Option 3 would be similar to option 2. However, under option 3, the 50% reduction targets would become legally binding at both EU and national level. The use of all chemical pesticides would be prohibited in sensitive areas such as urban areas and protected areas in accordance with Directive 2000/60/EC, Natura 2000 areas etc.

    The preferred option is option 3, except for the targets, where option 2 is preferred. In this case, the targets to reduce both pesticide use and pesticide risk by 50% would become legally binding at EU level, with Member States setting their own national reduction targets under national law. The options have been assessed against a likely baseline scenario where the SUD remains unchanged. Prohibiting the use of all plant protection products in sensitive areas will maximise associated health and environmental benefits.

    The preferred option is consistent with the ambitions of the European Green Deal, the farm-to-fork strategy, the biodiversity strategy, and the zero-pollution action plan. This preferred option will provide a range of benefits to society, biodiversity and ecosystems by reducing risks to human health and the environment from pesticide use. Protecting biodiversity will also help to reduce CO2 emissions. This is consistent with the EU-wide 2050 carbon-neutrality objective and the intermediate target to reduce emissions by 55% by 2030, set out in Articles 2(1) and 4(1) of the European Climate Law 33 . Under this preferred option, pesticide users will be better informed about effective alternatives to chemical pesticides, enabling them to reduce their pesticide use and related expenses, while still producing food products that are competitive on the market. Thanks to more detailed data on pesticide use and IPM under this preferred option, Member State authorities can ensure that national measures benefit farmers, the public, other stakeholders and the environment as much as possible. The preferred option also ensures that Member State actions would be more transparent and clear.

    Consistent with the objectives of the Green Deal, the Farm to Fork strategy and the Biodiversity strategy, the reduction of the use of chemical plant protection products aims not only at ensuring public health, but also at preserving biodiversity and protecting the environment, particularly where global issues are at stake, like safeguarding pollinator populations.

    Under this preferred option, production costs per unit will increase due to:

    (i)stricter and more detailed reporting requirements;

    (ii)the expected reduction of yields due to lower pesticide use; and

    (iii)the inclusion of an additional cost layer for those professional users not currently using advisers.

    Under this proposal, Member States will be able to provide support under the CAP to cover the costs to farmers of complying with all legal requirements imposed by this proposal for a period of 5 years. This should prevent any increases in food prices arising from new obligations set out in this proposal. Many of the provisions contained in this proposal already existed under the SUD and therefore should have no impact on food prices or crop yields. The changes introduced by this proposal will be gradual, therefore further minimising any impact on food security.

    Potential off-setting and risk mitigation measures would also be needed to counter any undesired negative consequences for non-EU countries, especially developing countries. Such EU measures could support the FAO’s work to:

    (i)reduce the risk from pesticides through a sound lifecycle-management approach;

    (ii)help governments and stakeholders in the developing world to adopt ecosystem-based practices; and

    (iii)improve the management of pesticides in agriculture globally.

    The SMEs affected will include:

    (i)farmers and other SMEs using and selling pesticides and pesticide-application equipment;

    (ii)handlers of agricultural produce and pesticides;

    (iii)food processors and intermediaries;

    (iv)agricultural contractors; and

    (v)agricultural advisers.

    Different costs and benefits will accrue to SMEs under the preferred policy option. Member States may apply incentives or mitigation, including under the CAP, to address some of the option’s impacts. Furthermore, more consistent and uniform application of the rules on pesticide use will reduce market distortions between pesticide users across Member States, which currently apply the existing rules to varying degrees.

    There will be control and administration costs for Member States in implementing and enforcing the updated rules and in collecting and analysing the relevant monitoring data. This is especially true for any initial set-up costs to introduce a data collection system.

    Regulatory fitness and simplification

    In line with the Commission commitment to better regulation, the proposal has been prepared inclusively, based on transparency and continuous engagement with stakeholders. The evaluation did not identify possible legislative simplifications or reductions of regulatory burden that would make it easier to achieve the objectives of sustainable pesticide use. Micro-enterprises are not exempted from this proposal given the importance of uniform implementation of measures to reduce both the use of pesticides and the risk they pose to human health and the environment.

    This proposal is in line with a digital-ready policy by promoting electronic record-keeping and online publication of trends in progress towards meeting:

    (i)pesticide-reduction targets;

    (ii)implementation of NAPs;

    (iii)annual progress and implementation reports;

    (iv)Commission recommendations; and

    (v)Member State responses.

    Relevant provisions for cost-efficient, user-centric and interoperable digital services will be considered in implementing rules for the electronic registers that will be created as a result of the proposal.

    Fundamental rights

    The proposal respects fundamental rights and observes the principles recognised by the Charter of Fundamental Rights of the European Union 34 . In particular, it contributes to the objective of a high level of environmental protection in accordance with the principle of sustainable development as laid down in Article 37 of the Charter of Fundamental Rights of the European Union. Better policy enforcement to reduce the risk from pesticide use and protect health could also contribute to the fundamental right of ‘fair and just working conditions’ (Article 31, Charter of Fundamental Rights of the EU). In particular, it could contribute to the right to working conditions that respect workers’ health, safety and dignity.

    4.BUDGETARY IMPLICATIONS

    This proposal does not have an impact on the EU budget.

    5.OTHER ELEMENTS

    Implementation plans and monitoring, evaluation and reporting arrangements

    The existing indicator to measure the achievement of the two pesticide targets in the farm-to-fork strategy will form the basis of the annual central monitoring of progress towards these targets at EU and Member-State levels. It should be noted that data indicating whether the 2030 targets on reducing the use and risk of pesticides have been achieved will likely only become available in 2032.

    Member States will need to monitor:

    the set-up and use of independent advisory services;

    the implementation of IPM rules at farm level through the electronic integrated pest management and plant protection product use register;

    the inspection of application equipment in professional use through specific registers;

    the training of professional users, distributors and advisers;

    the use of plant protection products through an electronic register.

    Member States will report information gathered through this monitoring annually to the Commission. The Commission will assess the information and supplement it with its own audits.

    To supplement this annual monitoring, the Commission proposes that it formally evaluates this initiative at the earliest 7 years after the planned legal proposal becomes applicable.

    Moreover, the monitoring data as described here and in the accompanying impact assessment can also be used directly to monitor the overall policy objectives set out under the European Green Deal and the 8th Environment Action Programme, including: the farm-to-fork strategy; the biodiversity strategy; and the zero-pollution monitoring and outlook.

    Detailed explanation of the specific provisions of the proposal

    Chapter I sets out the subject matter, scope and definitions.

    Chapter II sets out the EU’s targets to reduce the use of – and risk from – pesticides by 50% in line with the farm–to-fork strategy and to which Member States shall (collectively) contribute. It provides that Member State should adopt targets binding under their national law that may deviate from the 50% level of EU targets within the parameters of a binding formula. This formula permits Member States to take account of historical progress and intensity of pesticide use in setting national targets. Provision is made for the Commission to issue recommendations to set increasing targets in certain cases and to publish trends towards meeting the EU’s 2030 reduction targets.

    Chapter III describes what NAPs should contain as well as the requirements for:

    (i)public consultation on these NAPs; and

    (ii)these NAPs to be coherent with CAP strategic plans.

    This chapter also sets out the details to be included on indicative targets for alternatives to chemical pesticides. It provides for:

    (i)Member States to include in annual progress and implementation reports their trends on progress to meeting the two targets as well as other quantitative data; and

    (ii)the Commission to analyse these reports and make recommendations.

    Chapter IV sets out the requirements for professional users in IPM in cases where crop-specific rules have or have not been adopted by Member States. It requires record-keeping by professional users on IPM and the use of independent advisers. It provides for the adoption and oversight of crop-specific rules for IPM that must be followed by professional users. It also provides for the creation of an electronic IPM register.

    Chapter V sets out requirements for professional users, distributors and advisers to hold a certificate of training in certain circumstances. It also sets out general requirements for the use of pesticides and application equipment. In addition, it contains provisions on:

    (i)    the use of pesticides in sensitive areas;

    (ii)    the protection of the aquatic environment and drinking water;

    (iii)    aerial application;

    (iv)    storage, disposal and handling; and

    (v)    advice on the use of pesticides.

    Chapter VI sets out requirements for the sale of plant protection products. It also sets out the type of information on pesticides that must be provided to purchasers at the time of sale.

    Chapter VII requires Member States to set up a system for the training and certification of professional users, advisers and distributors. It provides for the creation of an independent advisory system. It requires Member States to raise awareness of pesticide issues and publish key information online. It also requires Member States to gather information on acute and chronic poisoning incidents due to pesticides.

    Chapter VIII relates to pesticide application equipment. It lays down requirements for the inspection of application equipment in professional use. It provides for an electronic register(s) to record information on all application equipment in professional use. It sets out notification requirements for transfer of ownership or withdrawal from use. It requires inspections at three year intervals, with the possibility of derogating from those inspection requirements for certain application equipment.

    Chapter IX sets out the methodology for calculating harmonised risk indicators and for calculating progress towards the 2030 reduction targets.

    Chapter X sets out administrative and financial provisions for:

    (i)notifying the relevant competent authorities to the Commission;

    (ii)penalties; and

    (iii)fees and charges.

    Chapter XI provides the conditions for the adoption of delegated and implementing acts under the SUR.

    Chapter XII repeals the SUD and provides for the entry into force and into application of the SUR.

    2022/0196 (COD)

    Proposal for a

    REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

    on the sustainable use of plant protection products and amending Regulation (EU) 2021/2115

    (Text with EEA relevance)

    THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

    Having regard to the Treaty on the Functioning of the European Union, and in particular Article 192(1) thereof,

    Having regard to the proposal from the European Commission,

    After transmission of the draft legislative act to the national parliaments,

    Having regard to the opinion of the European Economic and Social Committee 35 ,

    Having regard to the opinion of the Committee of the Regions 36 ,

    Acting in accordance with the ordinary legislative procedure,

    Whereas:

    (1)The Treaty requires a high level of protection of human health and of the environment to be ensured in the definition and the implementation of all Union policies and activities and provides that Union policy on the environment is to aim at a high level of protection.

    (2)Directive 2009/128/EC of the European Parliament and of the Council 37  established a framework to achieve a sustainable use of pesticides by reducing the risks and impacts of the use of pesticides on human health and the environment. The evaluation 38 of that Directive found that it has not achieved its overall objectives and that the Member States did not implement it in a satisfactory manner. This conclusion was confirmed in reports from the Commission to the European Parliament and Council in 2017 39 and 2020 40 . 

    (3)The European Parliament resolution of 12 February 2019 on the implementation of Directive 2009/128/EC on the sustainable use of pesticides 41 noted that the Union must act without delay to transition to a more sustainable use of pesticides and called on the Commission to propose an ambitious Union-wide binding target for the reduction of pesticide use. The European Parliament re-affirmed its call for binding reduction targets in its resolution of 20 October 2021 on a Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system 42 .

    (4)In 2018, a study 43 by the European Parliament Research Service (EPRS) found progress in many Member States but a limited overall achievement of the objectives of Directive 2009/128/EC. A 2020 special report 44 from the European Court of Auditors (ECA) on the sustainable use of plant protection products found that there is limited progress in measuring and reducing the risks of plant protection product use and identified weaknesses in the current Union framework. As noted in its information report in relation to evaluation of Directive 2009/128/EC 45 , the European Economic and Social Committee also considers it essential to reassess the requirements, targets, conditions and timetables set under national action plans.

    (5)In order to ensure full attainment of the objectives of the Union legal framework on sustainable use of plant protection products, it needs to be adapted by laying down clearer and directly applicable rules for operators. In addition, a number of rules should be clarified, including the rules on the application of integrated pest management, restrictions of use of plant protection products and the inspections of equipment used to apply plant protection products. It is therefore appropriate to repeal Directive 2009/128/EC and replace it with a regulation.

    (6)The rules concerning biocidal products are laid down in Regulation (EU) No 528/2012 of the European Parliament and of the Council 46 , and an evaluation of that Regulation is planned. It is therefore not appropriate to introduce new rules on the use of biocidal products in this Regulation.

    (7)The Commission Communication entitled ‘the European Green Deal 47 set out a roadmap of key measures, including legislative, to significantly reduce the use and risk of chemical pesticides. In the Farm to Fork Strategy 48 , EU Biodiversity Strategy for 2030 49  and the Zero Pollution Action Plan 50 , the Commission committed to take action to reduce by 50% the overall use and risk from chemical pesticides by 2030 and reduce by 50% the use of more hazardous pesticides (plant protection products containing one or more active substances approved as candidates for substitution in accordance with Article 24 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council 51 and listed in Part E of the Annex to Commission Implementing Regulation (EU) No 540/2011 52 , or containing one or more active substances listed in the Annex to Commission Implementing Regulation (EU) 2015/408 53 ) by 2030. The sustainable use of plant protection products is also complementary to the promotion of organic farming and achieving the Farm to Fork Strategy target of at least 25% of the Union’s agricultural land under organic farming by 2030. It supports the objectives of the EU strategic framework on health and safety at work 54  and thereby contributes to the implementation of principle 10 of the European Pillar of Social Rights on a healthy, safe and well-adapted work environment.

    (8)Two European citizens’ initiatives address the use of pesticides and call for ambitious reduction targets. The initiative ‘ Ban glyphosate and protect people and the environment from toxic pesticides ’ submitted to the Commission on 6 October 2017 called on the Commission, under its third aim, ‘to set EU-wide mandatory reduction targets for pesticide use, with a view to achieving a pesticide-free future’. In its reply adopted on 12 December 2017 , the Commission stated that it would re-evaluate the need for EU-wide mandatory targets for pesticides. More recently, the initiative ‘ Save bees and farmers! Towards a bee-friendly agriculture for a healthy environment ’ calls on the Commission ‘to propose legal acts to phase out synthetic pesticides in EU agriculture by 80% by 2030, starting with the most hazardous, and to become free of synthetic by 2035.’ The initiative has collected over 1 million statements of support by 30 September 2021 which are currently being verified by Member States authorities.

    (9)In the final report of the Conference on the Future of Europe, published on 9 May 2022, when it comes to the proposals on agriculture, food production, biodiversity and ecosystems, pollution, citizens ask the Union in particular to significantly reduce the use of chemical pesticides and fertilizers, in line with the existing targets, while still ensuring food security, and support for research to develop more sustainable and natural-based alternatives. Citizens ask for more research and innovations, including in technological solutions for sustainable production, plant resistance, and precision farming, and more communication, advisory systems, and training for and from farmers as well as asking the Union to protect insects, in particular indigenous and pollinating insects. 55  

    (10)In its conclusions of 19 October 2020 56 , the Council of the European Union, when taking note of the Commission’s reduction targets for the use of pesticides set out in the Farm to Fork Strategy, pointed out that achieving those targets will require efforts from Member States and all stakeholders and intensive co-operation, consultation and collaboration. The Council also requested the Commission to ensure that these targets are Union targets to which all Member States must contribute through action at national level. The Council conclusions request such targets to be set taking into account achievements to date, as well as Member States' different starting points, circumstances and conditions.

    (11)Biological control agents are a sustainable control alternative to the use of chemical products for the control of harmful organisms. As noted in Council Decision (EU) 2021/1102 57 , biological control agents have a growing importance in sustainable agriculture and forestry and have an instrumental role to play in the success of integrated pest management and organic farming. Access to biological controls facilitates moving away from chemical plant protection products. It is appropriate to encourage farmers to switch to low input agricultural methods including organic farming.  It is therefore appropriate to define the concept of biological control as a basis for Member States to set indicative targets to increase the percentage of crops on which biological control agents are used.

    (12)The objective of the Farm to Fork Strategy is to make substantial progress in the reduction of the use of chemical plant protection products in an economically viable way. In order to achieve that aim, it is necessary to set quantified targets at Union and Member State levels for the reduction in the use and risk of chemical plant protection products and the use of more hazardous plant protection products to monitor progress. National targets should be established by national law in order to ensure adequate progress and accountability in relation to them. These binding national targets should also be achieved by Member States by 2030. The reduction in the use of chemical plant protection products is expected to significantly reduce occupational safety and health risks for professional users.

    (13)    Given the different levels of historical progress and differences in intensity of pesticide use between Member States, it is necessary to allow Member States some flexibility when setting their own binding national targets (“national 2030 reduction targets”). Intensity of use is best measured by dividing the total quantity of active substances placed on the market, and therefore used, in the form of plant protection products in a particular Member State by the surface area over which the active substances were applied. Intensity in the use of chemical pesticides, and in particular of the more hazardous pesticides, correlates with greater dependency on chemical pesticides, greater risks to human health and the environment and less sustainable farming practices. It is therefore appropriate to allow Member States to take their lower intensity of use of chemical pesticides than the Union average into account in setting their national 2030 reduction targets. It is also appropriate to require them to take their higher intensity of use of chemical pesticides than the Union average into account in setting their national 2030 reduction targets. In addition, in order to give recognition to past efforts by Member States, they should also be allowed to take into account historical progress prior to the adoption of the Farm to Fork Strategy when setting national 2030 reduction targets. Conversely, where Member States have increased, or made only limited reductions in, their use and risk of chemical plant protection products, they should now make a greater contribution to the achievement of the Union 2030 reduction targets, while also taking account of their intensity of pesticide use. In order to ensure a fair and collective effort towards the achievement of Union-wide targets and an adequate level of ambition, minimum limits should be laid down for national 2030 reduction targets. The EU’s outermost regions, as listed in Article 349 of the Treaty, are located in the Atlantic, Caribbean and Indian Ocean. Due to permanent constraints such as their remoteness to the European continent, insularity and high exposure to climate change, it is appropriate to allow Member States to take into account the specific needs of these regions as regards the use of plant protection products and measures tailored to specific climatic conditions and crops. In order to ensure a fair and collective effort towards the achievement of Union-wide targets, where a Member State reaches the level of its 2030 national reduction target before 2030, it should not be required to undertake additional reduction efforts, but it should closely monitor annual fluctuations in the use and risk of chemical plant protection products and in the use of more hazardous plant protection products to ensure progress towards meeting the respective 2030 national reduction target. In the interests of transparency, Member State responses to any Commission recommendations in relation to the level of ambition of national targets and the annual progress made towards them should be publicly accessible. 

    (14)    Member States should draft and publish national action plans. In order for the Member State national action plans to be effective, they should contain quantitative objectives, references to binding national 2030 reduction targets as set out in national law, together with related indicative targets set out in the national action plans, measures, timetables and indicators to reduce risks and impacts of pesticide use on human health and the environment. This will allow for a structured approach to the setting of quantitative objectives and targets, with a clear link to the national 2030 reduction targets. In order to monitor compliance with the provisions of this Regulation, Member States should also be required to report annually on targets and precise quantitative data relating to compliance with provisions on use, training, application equipment and integrated pest management.

    (13)In order to achieve the Union-wide reduction targets (‘Union 2030 reduction targets’) as well as national 2030 reduction targets, it is necessary to increase the availability and use of biological control and other non-chemical alternatives. Availability of these alternatives will incentivise the adoption of low pesticide-input pest management practices such as organic farming.

    (14)The implementation of policies and measures in the areas of sustainable use of plant protection products has an impact on the environment, public health and working conditions. Member States should therefore ensure that the public and social partners are given sufficient opportunities to participate in and to be consulted on the preparation of Member State national action plans in accordance, where applicable, with Directive 2001/42/EC of the European Parliament and of the Council 58 .

    (15)In order to ensure consistency and complementarity with related legislation, Member State national action plans should take into account Directive 2009/147/EC of the European Parliament and of the Council 59 , Council Directive 92/43/EEC 60 , Directive 2000/60/EC of the European Parliament and of the Council 61 , Council Directive 91/676/EEC 62 , Directive 2008/50/EC of the European Parliament and of the Council 63 , Directive (EU) 2016/2284 of the European Parliament and of the Council 64  and Regulation xxx/xxx on nature restoration [reference to adopted act to be inserted] and should be consistent with the Common Agricultural Policy (“CAP”) Strategic Plans drawn-up in accordance with Regulation (EU) 2021/2115 of the European Parliament and of the Council 65 .

    (16)Economic instruments, including those under the CAP that provide support to farmers, can play a crucial role in the achievement of objectives relating to the sustainable use of plant protection products and, in particular, reducing the use of chemical plant protection products. Member States have to show in their national CAP Strategic Plans that their implementation of the CAP contributes to and supports other relevant Union legislation and their objectives, including objectives under this Regulation.

    (17)For the sake of transparency and in order to encourage greater progress, it is necessary to measure the progress made by Member States in relation to the achievement of the national 2030 reduction targets and other national indicative reduction targets. This should be done on an annual basis by means of annual progress and implementation reports. In order to monitor the level of compliance with this Regulation in a streamlined, easily comparable manner, Member States should also include quantitative data in relation to the implementation of this Regulation as regards use, training, application equipment and integrated pest management. In order for the Commission to encourage progress towards achieving national 2030 reduction targets and other national indicative reduction targets, including any measures in support of such achievement, the Commission should analyse such progress and measures every 2 years.

    (18)An approach to pest control that follows integrated pest management in ensuring careful consideration of all available means that discourage the development of populations of harmful organisms, while keeping the use of chemical plant protection products to levels that are economically and ecologically justified and minimising risks to human health and the environment is necessary for the protection of human health and the environment. ‘Integrated pest management’ emphasises the growth of a healthy crop with the least possible disruption to agro-ecosystems, encourages natural pest control mechanisms and uses chemical control only when all other control means are exhausted. To ensure that integrated pest management is implemented consistently on the ground, it is necessary to lay down clear rules in this Regulation. In order to comply with the obligation to follow integrated pest management, a professional user should consider and implement all methods and practices that avoid the use of plant protection products. Chemical plant protection products should only be used when all other control means have been exhausted. In order to ensure and monitor compliance with this requirement, it is important that professional users keep a record of the reasons why they apply plant protection products or the reasons for any other action taken in line with integrated pest management and of advice received in support of their implementation of integrated pest management from independent advisors. These records are also required for aerial applications. 

    (19)To avoid unnecessary duplication, the Commission should establish a standard template for Member States to integrate records kept by professional users of actions taken in line with integrated pest management with those kept under Article 67 of Regulation (EC) No 1107/2009.

    (20)In order to facilitate compliance with integrated pest management, it is necessary to lay down crop-specific rules that a professional user must follow in relation to the specific crop and region in which the professional user operates. Such rules should convert the requirements of integrated pest management into verifiable criteria that apply to the specific crop. To ensure that the crop-specific rules are in accordance with the requirements of integrated pest management, detailed rules should be laid down as to what they should contain and the Commission should verify their development, implementation and enforcement on the ground.

    (21)In order to verify compliance by professional users with integrated pest management, an electronic integrated pest management and plant protection product use register should be maintained with the aim of verifying compliance with the rules on integrated pest management set out in this Regulation and supporting the development of Union policy. Access to the register should also be granted to national statistical authorities for the development, production and dissemination of official statistics in accordance with Chapter V of Regulation (EC) No 223/2009 of the European Parliament and of the Council 66 . This register should record any preventative measure or intervention and the reasons for that preventative measure or intervention. This will provide the competent authorities with the information necessary to verify whether a professional user has carried out a decision-making process, in accordance with integrated pest management, before determining the specific preventative measure or intervention. The register should also contain details in relation to advice required annually in support of integrated pest management in order to verify that such strategic longer term planning in relation to integrated pest management is taking place.

    (22)In order to ensure that plant protection products and related application equipment are used in a manner that protects human health and the environment, it is necessary to provide for general requirements on professional users in relation to the training required to use certain plant protection products or application equipment, the use of more hazardous plant protection products and the need to comply with inspection requirements for application equipment in professional use.

    (23)Use of plant protection products may have particularly negative impacts in certain areas that are frequently used by the general public or by vulnerable groups, communities in which people live and work and ecologically sensitive areas, such as Natura 2000 sites protected in accordance with Directive 2009/147/EC of the European Parliament and of the Council 67 and Council Directive 92/43/EEC 68 . If plant protection products are used in areas used by the general public, the possibility of exposure of humans to such plant protection products is high. In order to protect human health and the environment, the use of plant protection products in sensitive areas and within 3 metres of such areas, should therefore be prohibited. Derogations from the prohibition should only be allowed under certain conditions and on a case-by-case basis.

    (24)The aquatic environment and drinking water supplies are especially sensitive to plant protection products. In order to protect the aquatic environment, the use of plant protection products in and around surface waters areas should therefore be prohibited. Member States should have in place appropriate measures to avoid deterioration of surface and groundwater as well as coastal and marine waters and allow achievement of good surface and groundwater status, to protect the aquatic environment and drinking water supplies from the impact of plant protection products. In addition, it is important that professional users are trained in how to minimise or eliminate applications of certain plant protection products classified as “harmful to aquatic life with long lasting effects”, “very toxic to aquatic life with long lasting effects” or “toxic to aquatic life with long lasting effects”. It is also important that professional users are trained on the importance of giving preference to low risk plant protection products or non-chemical alternatives, use of drift reducing technology and risk mitigation measures.

    (25)Precision farming refers to agricultural management systems carefully tailoring crop management to fit localised conditions such as those found within land parcels. The application of existing technology, including the use of Union space data and services (Galileo and Copernicus), has the potential to significantly reduce pesticide usage. It is therefore necessary to provide for a legislative framework that incentivises the development of precision farming. Application of plant protection products from an aircraft, including application by planes, helicopters and drones, is usually less precise than other means of application and may therefore potentially cause adverse impacts on human health and the environment. Aerial application should therefore be prohibited, with limited derogations on a case-by-case basis where it has a less negative impact on human health and the environment than any alternative application method or there is no viable alternative application method. It is also necessary to record the numbers of aerial applications carried out on the basis of permits granted for aerial application in order to have clear data on how many aerial applications for which permits were granted actually took place.

    (26)It is however likely that certain unmanned aircraft (including drones) will allow for the targeted aerial application of plant protection products. Such unmanned aircraft are likely to help reduce the use of plant protection products due to targeted application and consequently help reduce the risks to human health and the environment compared to use of land-based application equipment. It is therefore appropriate to set criteria in this Regulation for an exemption of certain unmanned aircraft from the prohibition of aerial application. It is also appropriate to defer the application of this exemption for 3 years given the current state of scientific uncertainty. 

    (27)Handling of plant protection products, including storage, dilution and mixing of such products, cleaning of application equipment after use, recovery and disposal of tank mixtures and disposal of empty packaging and remnants of plant protection products pose particular risks of exposure to humans and to the environment. Therefore it is appropriate to provide for specific measures addressing these activities. To the extent that the use, storage and disposal of plant protection products require compliance with minimum health and safety requirements at the workplace, those requirements are laid down by, inter alia, Council Directive 89/391/EEC 69 , Council Directive 89/656/EEC 70 , Council Directive 98/24/EC 71 , Directive 2004/37/EC of the European Parliament and of the Council 72 and Directive 2009/104/EC of the European Parliament and of the Council 73 . 

    (28)Given the importance of advice on the use of plant protection products as a means to support their use in a manner that protects human health and the environment in accordance with integrated pest management, it is important that advisors are adequately trained.

    (29)Sale of a plant protection product is an important element in the distribution chain because it allows distributors to provide the necessary information to support its proper use. Specific advice on safety instructions for human health and the environment should be available to the purchaser or end user at the time of sale in order to allow questions to be answered that will facilitate the correct use of the relevant plant protection product. For non-professional users, general information should be available at point of sale on safe use, handling and storage of plant protection products and on disposal of the packaging of such products, since those users do not generally have the same practical knowledge as professional users.

    (30)It is essential that Member States establish and maintain systems of both initial and follow-up training for distributors, advisors and professional users of plant protection products and certification systems to record such training, in order to ensure that those operators are fully aware of the potential risks to human health and the environment and of the appropriate measures to reduce those risks as much as possible. The training for advisors should be more extensive than that of distributors and professional users since they need to be able to support the proper implementation of integrated pest management and crop-specific rules. The use or purchase of a plant protection product authorised for professional use must be limited to persons in possession of a training certificate. In addition, in order to ensure safe use of plant protection products for human health and the environment, distributors should be required to provide both professional and non-professional purchasers of plant protection products with product specific information at point of sale.

    (31)In order to ensure a planned approach to harmful organism control techniques across a number of growing seasons with a view to minimising the use of chemical plant protection products as much as possible and to ensure a proper implementation of integrated pest management, professional users should be required to regularly consult trained, independent advisors on pest management, so that plant protection products are only used as a last resort.

    (32)Considering the possible risks to human health and the environment from the use of plant protection products, the public should have access to better information on the overall impacts of the use of such products through awareness-raising programmes, information passed on through distributors and other appropriate measures.

    (33)In order to better understand the trends regarding acute poisoning incidents and chronic poisoning arising from exposure of persons to plant protection products, information on such trends should be compiled by each Member State. The Commission should also monitor the overall trends at Union level.

    (34)In order to minimise the adverse impacts of plant protection products on human health and the environment, it is necessary to provide for systems for regular technical inspection of application equipment in professional use. Given the potentially reduced impact of application equipment in professional use which represents a very low scale of use, it is also appropriate to allow Member States to lay down less stringent inspection requirements and provide for different inspection intervals in relation to such equipment. In addition, due to the relatively low cost of purchasing new handheld application equipment and knapsack sprayers compared to the costs of inspection, it is appropriate to provide for the possibility of national derogations from the mandatory inspection of such equipment, subject to the carrying out of a risk assessment covering the risks to human health and the environment posed by such equipment. That assessment should include an estimation of the scale of use of the equipment. To ensure compliance with the inspection requirements, it is necessary to require that each Member State establish a register of application equipment in professional use and keep that register up to date. As some of the application equipment does not have unique IDs, it is necessary to make provision for the supply of a unique ID to such application equipment to ensure that all equipment is physically identified.

    (35)In order to monitor progress achieved in the reduction of risks and adverse impacts to human health and the environment from the use of plant protection products it is necessary to continue using the system of harmonised risk indicators established under Directive (EU) 2009/128/EC.

    (36)Statistical data on plant protection products collected in accordance with Regulation (EC) No 1185/2009 of the European Parliament and of the Council 74 should be used in calculating these harmonised risk indicators and progress towards achieving binding Union and national targets based on the Farm to Fork Strategy. Given that pesticide use fluctuates between years depending, in particular, on the weather, a three year baseline period is appropriate to take account of such fluctuations. The baseline period for the calculation of harmonised risk indicators 1 and 2 is 2011–2013, as this was the first three year period for which data was received by the Commission under Regulation (EC) No 1185/2009 and coincides with the entry into force of Directive 2009/128/EC. The baseline period for the calculation of progress towards the Union 2030 reduction targets is 2015–2017, as this was the three most recent years for which data was available at the time of the announcement of the Farm to Fork Strategy. The baseline period for the calculation of a new harmonised risk indicator 2a is 2022–2024, as this will be the first three year period for which data on the areas treated under each authorisation for an emergency situation in plant protection will be available.

    (37)For the moment, the only robust statistical data available at Union level relating to the marketing and use of plant protection products are the statistics on the quantities of active substances in plant protection products placed on the market, and the data on the number of authorisations for emergency situations in plant protection granted under Regulation (EC) No 1107/2009. Those statistics are used in the calculation of harmonised risk indicators 1 and 2 under Directive 2009/128/EC and in calculating progress towards the binding Union 2030 reduction targets and national 2030 reduction targets based on the Farm to Fork Strategy. The new harmonised risk indicator 2a will be calculated using statistics on the number of authorisations for emergency situations in plant protection, the properties of the active substances in plant protection products subject to these authorisations, and the areas treated under these authorisations to better quantify the risks arising from authorisations for emergency situations in plant protection.

    (38)For reasons of transparency, and to ensure uniform implementation by all Member States, the methodology for calculating progress towards achieving the two Union and two national 2030 reduction targets and the methodology for the calculation of harmonised risk indicators at Union and national level should be set out in an Annex to this Regulation. 

    (39)The EU Biodiversity Strategy for 2030 recognises the need for urgent action to protect biodiversity. There is evidence of a widespread reduction of species, in particular insects and pollinators, in the Union. Biodiversity loss is, amongst other factors, driven by the use of plant protection products, while Member States actions under current Union policy instruments have not yet been able to stop this trend of biodiversity loss. It is therefore essential to ensure that plant protection products are used in such a way as to mitigate the risk of harmful effects of such products on wildlife, through a number of measures including training, inspection of application equipment in professional use and protection of the aquatic environment and sensitive areas.

    (40)In order to facilitate communication between the Commission and competent authorities responsible for the implementation of this Regulation at national level, Member States should inform the Commission of the competent authorities designated under this Regulation.

    (41)In order to enforce the obligations set out in this Regulation, Member States should lay down rules on penalties applicable to infringements of this Regulation and ensure that those rules are enforced. The penalties should be effective, proportionate and dissuasive. It is also important to provide for Member States to recover costs related to carrying out obligations under this Regulation by means of fees or charges in order to ensure that adequate financial resources are available to competent authorities.

    (42)Since the objective of this Regulation, namely to protect human health and the environment from risks and impacts associated with the use of plant protection products and to achieve the targets set out in the Farm to Fork Strategy and the EU Biodiversity Strategy, cannot be sufficiently achieved by the Member States, but can rather, by reason of the scale of their use and the complexity and effects of the risk profiles associated with them, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

    (43)Activities performed by the competent authorities, or by other bodies or natural persons to which official control tasks have been delegated, in order to verify compliance by operators with this Regulation, are, with the exception of control tasks related to equipment used to apply plant protection products, regulated by Regulation (EU) 2017/625 of the European Parliament and of the Council. 75 Therefore, this Regulation only needs to provide for controls and audits in respect of inspection of application equipment in professional use.

    (44)In order to take into account technical progress and scientific developments, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to amend the provisions on obligations of professional users and advisors related to integrated pest management, inspection of application equipment in professional use, calculation of harmonised risk indicators, the data to be provided in annual progress and implementation reports and the notification form in relation to application equipment as well as Annexes II III, IV, V and VI. Likewise, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to supplement this Regulation by specifying precise criteria in relation to certain factors regarding unmanned aircraft, once technical progress and scientific developments allow for the development of such precise criteria. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Inter-institutional Agreement of 13 April 2016 on Better Law-Making 76 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

    (45)In order to assess whether this Regulation reaches its objectives effectively and efficiently, is coherent and still relevant and provides added value at Union level the Commission should carry out an evaluation of this Regulation.

    (46)In order to ensure uniform conditions for the implementation of the provisions of this Regulation on the entries to be made by professional users in the electronic integrated pest management and plant protection product use register, for the summary and analysis by the competent authorities of the information in that register and provision of information on acute poisoning incidents and chronic poisoning, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council 77 .

    (47)The implementation of this Regulation by Member States will result in new and enhanced obligations for farmers and other pesticides users. Some of them constitute statutory management requirements and standards of good agricultural and environmental conditions of land as listed in Annex III to Regulation (EU) 2021/2115 of the European Parliament and of the Council 78 , which, in accordance with that Regulation, farmers must comply with to receive CAP payments, whereas other requirements, which go beyond the baseline of mandatory requirements, may be rewarded with additional payments under voluntary regimes like eco-schemes pursuant to Article 31 of Regulation (EU) 2021/2115. Article 31(5), points (a) and (b), and Article 70(3), points (a) and (b), of Regulation (EU) 2021/2115 provide that the CAP funding is only available for practices implemented under an eco-scheme or agri-environmental-climate commitment which go beyond the relevant statutory management requirements and the standards of good agricultural and environmental conditions of land established under that Regulation and the relevant minimum requirements for the use of fertiliser and plant protection products, animal welfare, as well as other relevant mandatory requirements established by national and Union law. Since farmers and other users need to be financially supported in their transition toward a more sustainable use of pesticides, Regulation (EU) 2021/2115 needs to be amended to allow the financing of requirements imposed in accordance with this Regulation during a transitional period. This exceptional option for Member States to provide additional funding for measures taken in implementing this Regulation should apply to any obligation for farmers and other users resulting from the application of this Regulation, including compulsory farming practices imposed by the crop-specific rules for integrated pest management. Further, pursuant to Article 73(5) of Regulation (EU) 2021/2115, investments by farmers to comply with new requirements imposed by Union law may be supported for a maximum of 24 months from the date on which they become mandatory for the holding. Similarly, a longer transition period should be set out for investments complying with requirements imposed on farmers in accordance with this Regulation. Regulation (EU) 2021/2115 should therefore be amended accordingly.

    (48)The application of this Regulation should be deferred in order to allow competent authorities and operators to prepare for the requirements introduced by it,

    HAVE ADOPTED THIS REGULATION:

    CHAPTER I

    GENERAL PROVISIONS

    Article 1

    Subject matter

    This Regulation lays down rules for the sustainable use of plant protection products by providing for the setting, and achievement by 2030, of reduction targets for the use and risk of chemical plant protection products, establishing requirements for use, storage, sale and disposal of plant protection products and for application equipment, providing for training and awareness raising, and providing for implementation of integrated pest management.

    Article 2

    Scope

    This Regulation shall apply to products, in the form in which they are supplied to the user, consisting of or containing active substances, safeners or synergists, and intended for one of the following uses:

    (a)protecting plants or plant products against all harmful organisms or preventing the action of such organisms, unless the main purpose of these products is considered to be for reasons of hygiene rather than for the protection of plants or plant products;

    (b)influencing the life processes of plants, such as substances influencing their growth, other than as a nutrient or a plant biostimulant;

    (c)preserving plant products, in so far as such substances or products are not subject to special Union provisions on preservatives;

    (d)destroying undesired plants or parts of plants, except algae unless the products are applied on soil or water to protect plants;

    (e)checking or preventing undesired growth of plants, except algae unless the products are applied on soil or water to protect plants.

    These products are referred to as ‘plant protection products’.

    Article 3

    Definitions

    For the purposes of this Regulation, the following definitions apply:

    (1)‘chemical plant protection product’ means a plant protection product containing a chemical active substance excluding plant products using natural means of biological origin or substances identical to them, such as micro-organisms, semiochemicals, extracts from plant products as defined in Article 3(6) of Regulation (EC) No 1107/2009, or invertebrate macro-organisms; 

    (2)‘low-risk plant protection product’ means a plant protection product authorised in accordance with Article 47(1) of Regulation (EC) No 1107/2009;

    (3)‘chemical active substance’ means an active substance other than a micro-organism, a semiochemical or an extracts from a plant product as defined in Article 3(6) of Regulation (EC) No 1107/2009; 

    (4)‘biodiversity’ means biodiversity as defined in Article 3(29) of Regulation (EC) No 1107/2009;

    (5)‘more hazardous plant protection product’ means a plant protection product containing one or more active substances approved as candidates for substitution in accordance with Article 24 of Regulation (EC) No 1107/2009 and listed in Part E of the Annex to Implementing Regulation (EU) No 540/2011, or containing one or more active substances listed in the Annex to Implementing Regulation (EU) 2015/408;

    (6)‘utilised agricultural area’ means utilised agricultural area as defined in Article 2, point (e) of Regulation (EU) 2018/1091 of the European Parliament and of the Council 79 ; 

    (7)‘professional user’ means any person who uses a plant protection product in the course of their professional activities;

    (8)‘distributor’ means any person who makes a plant protection product available on the market, including a wholesaler, a supplier or retailer;

    (9)‘advisor’ means any person who advises on integrated pest management and the safe use of plant protection products, in the context of a professional capacity or commercial service, including private and public advisory services;

    (10)‘application equipment’ means any equipment the use of which for the application of a plant protection product is reasonably foreseeable at the time of manufacture and accessories that are essential for the effective operation of such equipment, with the exception of equipment designed for the sowing or planting of propagating material treated with plant protection products;

    (11)‘application equipment in professional use’ means any of the following:

    (a)application equipment which is used by a professional user for the application of plant protection products;

    (b)application equipment with horizontal or vertical booms or orchard blast sprayers, irrespective of whether it is being used for the application of plant protection products; 

    (12)‘aerial application’ means application of a plant protection product from an aircraft;

    (13)‘unmanned aircraft’ means any aircraft operating or designed to operate autonomously or to be piloted remotely without a pilot on board;

    (14)‘plant protection product authorised for professional use’ means a plant protection product that has been authorised for professional users only in accordance with Article 31 of Regulation (EC) No 1107/2009;

    (15)‘integrated pest management’ means careful consideration of all available means that discourage the development of populations of harmful organisms, while keeping the use of chemical plant protection products to levels that are economically and ecologically justified and minimise risks to human health and the environment; 

    (16)‘sensitive area’ means any of the following:

    (a)an area used by the general public, such as a public park or garden, recreation or sports grounds, or a public path;

    (b)an area used predominantly by a vulnerable group as defined in Article 3(14) of Regulation (EC) No 1107/ 2009;

    (c)human settlements (community in which people live and work), defined as the most up to date CORINE (Coordination of information on the Environment) system maintained by the EEA Land Cover Level 1 classification (Artificial Surfaces) (excluding Level 2 – 1.2: Industrial, commercial and transport units and Level 2 – 1.3: Mine, dump and construction sites) 80 ;

    (d)an urban area covered by a watercourse or water feature;

    (e)non-productive areas as defined under the EU standards on good agricultural and environmental condition of land (GAEC), GAEC standard 8 listed in Annex III to Regulation (EU) 2021/2115.

    (f)an ecologically sensitive area, which means any of the following:

    (i)any protected area under Directive 2000/60/EC, including possible safeguard zones as well as modifications of those areas following the risk assessment results for drinking water abstraction points under Directive (EU) 2020/2184 of the European Parliament and of the Council 81 ;

    (ii)sites of Community importance in the list referred to in Article 4(2) of Directive 92/43/EEC and the special areas of conservation designated in accordance with Article 4(4) of that Directive, and special protection areas classified pursuant to Article 4 of Directive 2009/147/EC, and any other national, regional, or local protected area reported by the Member States to the Nationally designated protected areas inventory (CDDA); 

    (iii)any area for which the monitoring of pollinator species carried out in accordance with Article 17(1), point (f), of Regulation xxx/xxx [reference to adopted act to be inserted] establishes that it sustains one or more pollinator species which the European Red Lists classify as being threatened with extinction.

    (17)‘quarantine pest’ means quarantine pest as defined in Article 3 of Regulation (EU) 2016/2031 of the European Parliament of the Council 82 ;

    (18)invasive alien species’ means invasive alien species as defined in Article 3, point (2), of Regulation (EU) No 1143/2014 of the European Parliament and of the Council 83 ;

    (19)‘surface water’ means a body of surface water as defined in Article 2, point (1), of Directive 2000/60/EC;

    (20)‘groundwater’ means a body of groundwater as defined in Article 2, point (2), of Directive 2000/60/EC

    (21)‘risk indicator’ means a measurement indicating the relative change in risks for human health or the environment associated with the use of plant protection products, and calculated in accordance with the methodology set out in Annex VI;

    (22)‘non-chemical methods’ means alternatives to chemical plant protection products;

    (23)‘biological control’ means the control of organisms harmful to plants or plant products using natural means of biological origin or substances identical to them, such as micro-organisms, semiochemicals, extracts from plant products as defined in Article 3(6) of Regulation (EC) No 1107/2009, or invertebrate macro-organisms.

    CHAPTER II

    REDUCTION TARGETS FOR CHEMICAL PLANT PROTECTION PRODUCTS

    Article 4

    Union 2030 reduction targets for chemical plant protection products

    1.Each Member State shall contribute, through the adoption and achievement of national targets in accordance with Article 5 to achieving by 2030 a 50 % Union-wide reduction of both the use and risk of chemical plant protection products (‘Union 2030 reduction target 1’) and the use of more hazardous plant protection products (‘Union 2030 reduction target 2’), compared to the average of the years 2015, 2016 and 2017 (collectively referred to as ‘the Union 2030 reduction targets’).

    2.Progress towards achieving the Union 2030 reduction targets shall be calculated annually by the Commission in accordance with the methodology set out in Annex I.

    Article 5

    Member States 2030 reduction targets for chemical plant protection products

    1.By … [OP: please insert the date – 6 months after the date of application of this Regulation] each Member State shall adopt national targets in its national legislation to achieve by 2030 a reduction set in accordance with this Article, from the average of the years 2015, 2016 and 2017, of the following:

    (a)the use and risk of chemical plant protection products as defined in Annex I (‘national 2030 reduction target 1’);

    (b)the use of more hazardous plant protection products as defined in Annex I (‘national 2030 reduction target 2’).

    For the purposes of this Regulation, the two national reduction targets listed in points (a) and (b) of the first subparagraph, are collectively referred to as the ‘national 2030 reduction targets’.

    2.The progress of each Member State towards achieving the national 2030 reduction targets shall be calculated annually by the Commission in accordance with the methodology set out in Annex I.

    3.Each Member State shall reach the targets referred to in paragraph 1 by 2030. A Member State that reaches the level of one of its 2030 national reduction targets before 2030 shall not be required to undertake additional reduction efforts. It shall monitor annual fluctuations in order to maintain the progress achieved in relation to that 2030 national reduction target.

    4.Subject to paragraphs 5 to 8, the national 2030 reduction targets shall be set at such level so as to achieve a reduction between the average of the years 2015, 2016 and 2017 and the year 2030 in the relevant Member State that at least equals 50%.

    5.A Member State may reduce its national target for the use and risk of chemical plant protection products referred to in paragraph 4 to a percentage that is a mid-point between the figure related to intensity as laid down in the second subparagraph of this paragraph and the figure related to the use and risk as laid down in the third subparagraph of this paragraph. Where that percentage is higher than 50%, the Member State shall increase its national target to that percentage.

    The figure related to intensity shall be the following:

    (a)35% where a Member State’s weighted intensity of use and risk of chemical plant protection products during the average of the years 2015, 2016 and 2017 is less than 70% of the Union average;

    (b)50% where a Member State’s weighted intensity of use and risk of chemical plant protection products during the average of the years 2015, 2016 and 2017 is between 70% and 140% of the Union average;

    (c)65% where a Member State’s weighted intensity of use and risk of chemical plant protection products during the average of the years 2015, 2016 and 2017 is more than 140% of the Union average.

    The figure related to the use and risk shall be the following:

    (a)where a Member State has achieved a greater reduction in the use and risk of chemical plant protection products than the Union average between the average of the years 2011, 2012 and 2013 and the average of the years 2015, 2016 and 2017, a figure that is established by subtracting from 50% the difference between the reduction achieved and the Union average reduction;

    (b)where a Member State has increased the use and risk of chemical plant protection products, or has made a smaller reduction than the Union average between the average of the years 2011, 2012 and 2013 and the average of the years 2015, 2016 and 2017, a figure that is established by adding to 50% the difference between the reduction or, as applicable, increase achieved and the Union average reduction, but without surpassing 70%.

    For the purposes of this paragraph ‘weighted intensity of use and risk of chemical plant protection products’ means a value corresponding to the kilograms of chemical active substances in plant protection products sold per year in a Member State, weighted according to their hazard weightings as set out in row (iii) of the Table of Annex I, divided by the number of hectares of utilised agricultural area in that Member State.

    6.A Member State may reduce its national target for the use of the more hazardous plant protection products referred to in paragraph 4 to a percentage that is a mid-point between the figure related to intensity as laid down in the second subparagraph of this paragraph and the figure related to use as laid down in the third subparagraph of this paragraph. Where that percentage is higher than 50%, the Member State shall increase its national target to that percentage.

    The figure related to intensity shall be the following:

    (a)35% where a Member State’s intensity of use of the more hazardous plant protection products during the average of the years 2015, 2016 and 2017 is less than 70% of the Union average;

    (b)50% where a Member State’s intensity of use of the more hazardous plant protection products during the average of the years 2015, 2016 and 2017 is between 70% and 140% of the Union average;

    (c)65% where a Member State’s intensity of use of the more hazardous plant protection products during the average of the years 2015, 2016 and 2017 is more than 140% of the Union average.

    The figure related to the use shall be the following:

    (a)where a Member State has achieved a greater reduction in the use of the more hazardous plant protection products than the Union average between the average of the years 2011, 2012 and 2013 and the average of the years 2015, 2016 and 2017, a figure that is established by subtracting from 50% the difference between the reduction achieved and the Union average reduction;

    (b)where a Member State has increased the use of the more hazardous plant protection products, or has made a smaller reduction than the Union average between the average of the years 2011, 2012 and 2013 and the average of the years 2015, 2016 and 2017, a figure that is established by adding to 50% the difference between the reduction or, as applicable, increase achieved and the Union average reduction, but without surpassing 70%.

    For the purposes of this paragraph ‘intensity of use of the more hazardous plant protection products’ means a value corresponding to the kilograms of chemical active substances in the more hazardous plant protection products sold per year in the Member State concerned divided by the number of hectares of utilised agricultural area in that Member State.

    7.Member States with outermost regions, as listed in Article 349 of the Treaty, may take into account the specific needs of these regions as regards the use of plant protection products when adopting national 2030 reduction targets, due to the particular climatic conditions and crops in these regions.

    8.In no case may the application of paragraph 5, paragraph 6 and paragraph 7 result in either of the 2030 national reduction targets being lower than 35%.

    9.By … [OP: please insert the date – 7 months after the date of application of this Regulation], each Member State shall communicate its national 2030 reduction targets to the Commission.

    10.If a Member State fails to adopt a national 2030 reduction target by … [OJ: please insert the date –6 months after the date of application of this Regulation], that target shall be deemed to be either 50%; or, where the percentage would be above 50% in accordance with paragraph 5 or paragraph 6, that higher percentage.

    Article 6

    Initial assessment of national targets by the Commission

    1.The Commission shall review the national 2030 reduction targets communicated to it in accordance with Article 5(9) and the information explaining any lowering of targets made in accordance with Article 5(5) or Article 5(6).

    2.Where the Commission concludes, on the basis of the information made available to it, that the national 2030 reduction targets communicated by a Member State need to be set at a more ambitious level, it shall, by … [OP: please insert the date – 1 year after the date of application of this Regulation], recommend that Member State to increase the level of its national 2030 reduction targets. The Commission shall make that recommendation public.

    3.Where a Member State adjusts its national 2030 reduction targets as recommended by the Commission, it shall amend the national targets set in its national legislation in accordance with Article 5 and include the adjusted targets in its national action plan together with the Commission’s recommendation. 

    4.Where a Member States decides not to adjust its national 2030 reduction targets, as recommended by the Commission, it shall include the justifications for such decision in its national action plan together with the text of the recommendation.

    5.Member States which have received a Commission recommendation referred to in paragraph 2 shall communicate the adjusted targets, or their justification for not adjusting them, as applicable, to the Commission by… [OP: please insert the date – 18 months after the date of application of this Regulation].

    6.Having assessed the level of national 2030 reduction targets of all Member States set in accordance with Article 5, the Commission shall verify whether their average at least equals 50% so as to achieve the corresponding Union 2030 reduction target.

    7.If the average of national 2030 reduction targets of all Member States is lower than 50%, the Commission shall recommend that one or more Member States increase the level of their national 2030 reduction targets in order to achieve the Union 2030 reduction targets. The Commission shall make any such recommendation public.

    8.Within one month of receiving the recommendation referred to in paragraph 7, a Member State shall take one of the following actions:

    (a)adjust its national 2030 reduction targets as recommended by the Commission, amend the national targets set in its national legislation in accordance with Article 5 and include the adjusted targets in its national action plan together with the Commission recommendation;

    (b)provide justifications for not adjusting its national 2030 reduction targets as recommended by the Commission, and include the justifications for such decision in its national action plan together with the Commission recommendation. 

    Article 7

    Publication of Union and national 2030 reduction targets trends by the Commission

    1.By 31 August of each calendar year, the Commission shall publish on a website the average trends in progress towards achieving the Union 2030 reduction targets. These trends shall be calculated as the difference between the average of the years 2015-2017 and the year ending 20 months prior to the publication. The trends shall be calculated in accordance with the methodology set out in Annex I.

    2.The Commission shall update the website referred to in paragraph 1 at least once a year.

    3.By 31 August of each calendar year, the Commission shall publish information for each Member State on trends in progress towards achieving the national 2030 reduction targets. These trends shall be calculated as the difference between the average of the years 2015-2017 and the year ending 20 months prior to the publication. The trends shall be calculated in accordance with the methodology set out in Annex I, on the website referred to in paragraph 1.  

    CHAPTER III

    NATIONAL ACTION PLANS

    Article 8

    National Action Plans

    1.By … [OP: please insert the date – 18 months after the date of application of this Regulation] each Member State shall draft and publish on a website a national action plan containing the following information:

    (a)the national 2030 reduction targets adopted in accordance with Chapter II;

    (b)information related to national 2030 reduction targets as set out in Article 9;

    (c)details of planned progress in relation to the elements relevant for the implementation of this Regulation listed in Part 2 of Annex II;

    (d)a link to the relevant parts of CAP strategic plans, drawn-up in accordance with Regulation (EU) 2021/2115, which set out plans for an increase in the utilised agricultural area engaged in organic farming and how the plans will contribute to achieving the target set out in the Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions A Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system 84 of having 25% of the utilised agricultural area devoted to organic farming by 2030;

    (e)a list of application equipment in professional use to which the Member State applies different inspection requirements in accordance with Article 32(1);

    (f)information on the estimated annual amounts of plant protection products illegally used or seized via antifraud operations during the preceding 3 years and any planned related measures;

    (g)national measures for encouraging the use of non-chemical methods by professional users through financial incentives, in accordance with Union legislation on State aid;

    (h)planned and adopted measures to support, or ensure through binding requirements laid down in national law, innovation and the development and use of non-chemical pest control methods;

    (i)other planned and adopted measures to support, or ensure through binding requirements laid down in national law, the sustainable use of plant protection products in line with integrated pest management principles, including those contained in crop-specific rules as set out in Article 15(1).

    Each Member State shall notify the Commission without delay of the first publication of its national action plan.

    Each Member State shall review its national action plan at least every 3 years from the first publication. As a result of the review a Member State may amend its national action plan. Member States shall publish amended versions of their national action plans and shall provide amended national action plans to the Commission without delay.

    The updated versions of national action plans published until and including 2030 shall contain the information listed in the first subparagraph, points (a) to (i).

    The updated versions of national action plans published after 2030 shall contain the information listed in the first subparagraph, points (c) to (i).

    2.Each Member State shall carry out a public consultation process prior to the adoption or modification of its national action plan in accordance with the requirements of Directive 2001/42/EC of the European Parliament and of the Council 85 .

    3.National action plans shall contain a summary of the public consultation process carried out before their adoption and list authorities responsible for their implementation.

    4.National action plans shall be consistent with the plans of Member States drawn-up in accordance with Directives 91/676/EEC, 92/43/EEC, 2000/60/EC, 2008/50/EC, 2009/147/EC and (EU) 2016/2284 and Regulation xxx/xxx on nature restoration [reference to adopted act to be inserted], be consistent with the CAP Strategic Plans drawn-up in accordance with Regulation (EU) 2021/2115 and shall contain explanations how the national action plan is consistent with those plans.

    5.Member States with outermost regions may take measures tailored to these regions in their national action plans taking into account the particular needs related to the specific climatic conditions and crops in these regions.

    Article 9

    Information on national 2030 reduction targets in national action plans

    1.National action plans published until and including 2030 shall include all of the following information related to the national 2030 reduction targets:

    (a)a list of at least the 5 active substances that most strongly influence the trend in the reduction in the use and risk of chemical plant protection products, and of the use of the more hazardous plant protection products, as determined by applying the methodology set out in Annex I, during the 3 years preceding the adoption of the national action plan;

    (b)a list of the crops on which each of the active substances referred to in point (a) are most widely used and the number of hectares of each crop treated;

    (c)a list of pests against which the active substances referred to in point (a) are used on the crops referred to in point (b);

    (d)for each of the pests referred to in point (c), a list of non-chemical methods used or likely to be available by 2030.

    2.For each non-chemical method listed in accordance with paragraph 1, point (d), national action plans shall indicate all of the following:

    (a)the estimated scale of its use, based on data on the sale of plant protection products, surveys and expert judgement, during the 3 calendar years preceding the adoption of the national action plan, together with a national indicative target for increasing its use by 2030 and a list of potential obstacles to achieving this increase;

    (b)a list of measures and other actions to be taken by the Member State and by other actors to address the potential obstacles referred to in point (a), with a detailed timeline of intermediary steps and the authorities responsible for each of the steps to be taken by the Member State.

    3.In relation to at least the 5 crops that most strongly influenced the trend in the use and risk of chemical plant protection products, and the trend in the use of the more hazardous plant protection products, as determined by applying the methodology set out in Annex I, during the 3 years preceding the adoption of the national action plan, the national action plan shall indicate all of the following:

    (a)the percentage of all plant protection products used on those crops which were biological controls during the 3 calendar years preceding the adoption of the national action plan, together with the national indicative targets for increasing that percentage by 2030 and a list of the potential obstacles to achieving that increased percentage;

    (b)a list of measures and other actions to be taken by the Member State and by other actors to address the potential obstacles referred to in point (a), with a detailed timeline of intermediary steps and the authorities responsible for each step to be taken by the Member State.

    4.National action plans shall also include national indicative targets for increasing the percentage of overall sales of plant protection products which are not chemical plant protection products from a baseline period of the 3 calendar years preceding the adoption of the national action plan.

    Article 10

    Annual progress and implementation reports

    1.By 31 August every year, but not sooner than [OP: please insert the date – 30 months after the date of application of this Regulation], each Member State shall submit to the Commission an annual progress and implementation report containing the information listed in Annex II.

    2.The annual progress and implementation report shall include:

    (a)all trends in progress towards achieving the national 2030 reduction targets as set out in Part 1 of Annex II, calculated in accordance with the methodology set out in Annex I as the difference between the average of the years 2015-2017 and the year ending 20 months prior to the publication;

    (b)all trends in progress towards achieving national indicative targets set out in Article 9(2), point (a), Article 9(3), point (a), and Article 9(4) ), calculated annually as the difference between the extent of use in the 3 calendar years preceding the adoption of the national action plan in accordance with Article 9(1) and the calendar year ending 20 months prior to the publication of the relevant annual progress and implementation report;

    (c)all other quantitative data in relation to implementation of this Regulation as set out in Part 2 of Annex II;

    (d)the outcome of the evaluation of the results of each harmonised risk indicator carried out in accordance with Article 36(1);

    (e)all trends in progress towards achieving an increase in the utilised agricultural area under organic farming referred to in Article 8(1), point (d).

    3.Each Member State shall publish its annual progress and implementation report on a website and inform the Commission thereof.

    4.The Commission may request a Member State to include further details in its annual progress and implementation report.

    Within 2 months of receipt of the Commission’s request, the Member State concerned shall respond to the request and shall publish its response on the website referred to in paragraph 3.

    5.The Commission shall publish annual progress and implementation reports of the Member States on a website.

    6.The Commission is empowered to adopt delegated acts in accordance with Article 40 amending Annex II in order to take into account data relevant to the sustainable use of plant protection products.

    Article 11

    Commission’s analysis of annual progress and implementation reports

    1.By … [OP: please insert the date – 2 years after the date of application of this Regulation], and every 2 years thereafter until 2030, the Commission shall publish on a website an analysis of:

    (a)the trends in progress towards the Union 2030 reduction targets;

    (b)Member States progress towards achieving the national 2030 reduction targets. 

    2.As from … [OP: please insert the date – 4 years after the date of application of this Regulation], the Commission shall include in the analysis referred to in paragraph 1 an analysis of the information to be provided by Member States in accordance with Article 10(2), points (a), (b) and (c).

    3.Following the analysis referred to in paragraph 2, the Commission may make a recommendation to a Member State to take any of the following actions:

    (a)take additional measures;

    (b)increase the level of ambition of any of national indicative target set out in Article 9(2), point (a), Article 9(3), point (a), and Article 9(4).

    4.A Member State that has received a recommendation from the Commission to take additional measures in accordance with paragraph 3 shall provide one of the following pieces of information in its subsequent annual progress and implementation report:

    (a)a description of measures taken as a response to the recommendation;

    (b)the reasons for not following the Commission’s recommendation.

    5.A Member State that has received a recommendation from the Commission in accordance with paragraph 3, point (b), to increase the level of ambition of a national indicative target set out in Article 9(2), point (a), Article 9(3), point (a),or Article 9(4) shall take one of the following actions:

    (a)change the level of the relevant target as set out in the recommendation by amending its national action plan within 6 months after receiving the recommendation;

    (b)provide reasons for not following the Commission’s recommendation in its subsequent annual progress and implementation report.

    6.Where, on the basis of its analysis of the annual progress and implementation reports, the Commission concludes that the progress achieved is insufficient for the collective achievement of the Union 2030 reduction targets, it shall propose measures and exercise its other powers at Union level in order to ensure the collective achievement of those targets. Such measures shall take into consideration the level of ambition of contributions to the Union 2030 reduction targets by Member States set out in the national 2030 reduction targets adopted by them.

    7.By … [OP: please insert the date – 5 years from the date of application of this Regulation], the Commission shall submit a report on annual progress and implementation reports to the European Parliament and the Council.

    CHAPTER IV

    INTEGRATED PEST MANAGEMENT

    Article 12

    Integrated pest management

    1.Professional users shall apply integrated pest management as follows:

    (a)by applying Article 13 where no crop-specific rules have been adopted for the relevant crop and area in accordance with Article 15 by the Member State in which they operate;

    (b)by applying crop-specific rules adopted by the Member State in which they operate for the relevant crop and area in accordance with Article 15 and performing the actions set out in Article 13(8).

    2.Advisors shall provide advice that is consistent with the applicable crop-specific rules and with integrated pest management.

    Article 13

    Obligations of professional users and advisors related to integrated pest management

    1.Professional users shall first apply measures that do not require the use of chemical plant protection products for the prevention or suppression of harmful organisms before resorting to application of chemical plant protection products.

    2.A professional user’s records referred to in Article 14(1) shall demonstrate that he or she has considered all of the following options:

    crop rotation,

    use of modern cultivation techniques, including stale seedbed technique, sowing dates and densities, under-sowing, intercropping, conservation tillage, pruning and direct sowing,

    use of resistant or tolerant cultivars and high quality or certified seed and planting material,

    use of balanced fertilisation, liming and irrigation or drainage practices,

    preventing the spreading of harmful organisms by hygiene measures, including regular cleansing of machinery and equipment,

    protection and enhancement of important beneficial organisms, including beneficial plant protection measures or the utilisation of ecological infrastructures inside and outside production sites,

    pest exclusion by use of protected structures, nets and other physical barriers.

    Where a professional user has not applied a measure listed in the first subparagraph of this paragraph, the records referred to in Article 14(1) shall contain reasons thereof.

    3.Professional users shall monitor harmful organisms by appropriate methods and tools. Such methods and tools shall include at least one of the following:

    (a)observations in the field;

    (b)scientifically sound warning, forecasting and early diagnosis systems, where feasible;

    (c)the use of advice from professionally qualified advisors. 

    4.Professional users shall use biological controls, physical and other non-chemical methods. Professional users may only use chemical methods if they are necessary to achieve acceptable levels of harmful organism control after all other non-chemical methods as set out in paragraphs 1, 2 and 3 have been exhausted and where any of the following conditions has been satisfied:

    (a)the results of monitoring of harmful organisms show, based on recorded observation, that chemical plant protection measures need to be applied in a timely manner because of the presence of a sufficiently high number of harmful organisms. 

    (b)where justified by a decision-support system, or by an advisor who meets the conditions laid down in Article 23, the professional user decides, by way of a recorded decision, to use chemical plant protection products methods for preventative reasons. 

    5.Professional users shall apply plant protection products that are as specific as possible to control the harmful organisms and have the least side effects on human health, non-target organisms and the environment.

    6.Professional users shall keep the use of chemical plant protection products and other forms of intervention to levels that do not exceed the levels that are absolutely necessary to control the harmful organisms and that do not increase the risk for development of resistance in populations of harmful organisms. Where possible, professional users shall use the following measures:

    (a)reduced rate of application;

    (b)reduced number of applications; 

    (c)partial applications;

    (d)spot application.

    7.Where the risk of resistance against a plant protection measure is known and where the level of harmful organisms requires repeated application of that measure to the crops, professional users shall apply available anti-resistance strategies to maintain the effectiveness of that measure.

    Where a plant protection measure involves repeated use of plant protection products, professional users shall use plant protection products with different modes of action.

    8.Professional users shall perform all of the following actions:

    (a)check and document the level of success of the applied plant protection measures on the basis of the records on the use of plant protection products and other interventions, and the monitoring of harmful organisms;

    (b)apply the information obtained by performing the actions referred to in point (a) as part of the decision-making process regarding future interventions.

    9.The Commission is empowered to adopt delegated acts in accordance with Article 40 amending this Article in order to take into account technical progress and scientific developments.

    Article 14

    Records of preventative measures and interventions for crop protection by professional users, and of advice on use of plant protection products

    1.Where a professional user takes a preventative measure or performs an intervention, the professional user shall enter the following information in the electronic integrated pest management and plant protection product use register referred to in Article 16, which covers the area where the professional user operates:

    (a)any preventative measure or intervention and the reason for that preventative measure or intervention, including the identification and assessment of pest level, where no crop-specific rules have been adopted for the relevant crop and area by the Member State in which the professional user operates; 

    (b)any preventative measure or intervention and the reason for that preventative measure or intervention, including the identification and assessment of pest level, performed with a reference to measurable criteria set out in the applicable crop-specific rules where crop-specific rules have been adopted for the relevant crop and area by the Member State in which the professional user operates.

    2.A professional user shall enter an electronic record in the electronic integrated pest management and plant protection product use register, referred to in Article 16 of the name of its advisor and the dates and the content of the advice received from it in accordance with Article 26(3). The professional user shall make those records available to the competent authority referred to in Article 15(2) upon request.

    3.A professional user shall enter an electronic record of each application of a plant protection product under Article 67 of Regulation (EC) No 1107/2009 in the electronic integrated pest management and plant protection product use register referred to in Article 16. A professional user shall also enter an electronic record specifying whether the application was done by aerial or land-based equipment. In the case of aerial application, a professional user shall specify the type of equipment used.

    4.In order to ensure a uniform structure of the entries to be made by professional users in the electronic integrated pest management and plant protection product use register in accordance with paragraphs 1, 2 and 3, the Commission may, by means of implementing acts, adopt a standard template for such entries. Any such template shall include fields for inputting records that need to be kept in accordance with Article 67 of Regulation (EC) No 1107/2009 and shall require the use of a recognisable ID. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 41(2).

    Article 15

    Implementation of integrated pest management using crop-specific rules

    1.Member States shall adopt agronomic requirements based on integrated pest management controls that must be adhered to when growing or storing a particular crop and are designed to ensure that chemical crop protection is only used after all other non-chemical methods have been exhausted and when a threshold for intervention is reached (‘crop-specific rules’). The crop-specific rules shall implement the principles of integrated pest management, set out in Article 13, for the relevant crop and be set out in a binding legal act.

    2.Each Member State shall designate a competent authority responsible for ensuring that the crop-specific rules are scientifically robust and comply with this Article.

    3.By … [OP: please insert the date = the first day in the month following 24 months after the date of entry into force of this Regulation] each Member State shall have in place effective and enforceable crop-specific rules, for crops covering an area that accounts for at least 90 % of its utilised agricultural area (excluding kitchen gardens). Member States shall determine the geographic scope of those rules taking account of relevant agronomic conditions, including, the type of soil and crops and the prevailing climatic conditions.

    4.At least 9 months prior to the point in time when a crop-specific rule becomes applicable under national law, the Member State shall perform all of the following actions:

    (a)publish a draft for public consultation;

    (b)take into account comments received from stakeholders and members of the public on the draft in a transparent manner;

    (c)submit the draft that takes into account the comments as referred to in point (b) to the Commission.

    5.Where the Commission is notified of a draft in accordance with paragraph 4, point (c), it may within 6 months of receipt of the draft object to its adoption by a Member State, if it considers that the draft does not comply with the criteria set out in paragraph 6. If the Commission objects, the Member State shall refrain from adopting the draft until it has amended the text so as to remedy the shortcomings identified in the Commissions objections. The absence of a reaction from the Commission in accordance with this paragraph to a draft crop–specific rule shall not prejudice any action or decision which might be taken by the Commission under other Union acts.

    6.The crop-specific rules shall convert the requirements of integrated pest management laid down in Article 13 into verifiable criteria by, among others, specifying the following:

    (a)the most economically significant harmful organisms affecting the crop;

    (b)the non-chemical interventions involving cultural, physical and biological control which are effective against the harmful organisms referred to in point (a) and qualitative criteria or conditions under which these interventions are to be made;

    (c)the low-risk plant protection products or alternatives to chemical plant protection products which are effective against the harmful organisms referred to in point (a) and qualitative criteria or conditions under which these interventions are to be made;

    (d)chemical plant protection products that are not low-risk plant protection products and that are effective against the harmful organisms referred to in point (a) and qualitative criteria or conditions under which these interventions are to be made;

    (e)the quantitative criteria or conditions under which chemical plant protection products may be used after all other means of control that do not require the use of chemical plant protection products have been exhausted;

    (f)the measurable criteria or conditions under which more hazardous plant protection products may be used after all other means of control that do not require the use of chemical plant protection products have been exhausted.

    (g)the obligation to record observations demonstrating that the relevant threshold value has been reached.

    7.Each Member State shall review its crop-specific rules annually and update them where necessary, including when it is needed to reflect changes in the availability of harmful organism control tools.

    8.A Member State that is planning to update a crop-specific rule shall, at least 6 months before the update becomes applicable under national law:

    (a)publish a draft of the updated rules for public consultation;

    (b)take into account comments received from stakeholders and members of the public on the draft in a transparent manner;

    (c)submit the draft that takes into account the comments as referred to in point (b) to the Commission.

    9.Where the Commission is notified of a draft under paragraph 8, it may within 3 months of receipt of the draft object to the updating of the crop-specific rule by a Member State, if it considers that the draft does not comply with the criteria set out in paragraph 6. If the Commission objects, the Member State shall refrain from updating the crop-specific rule until it has amended the text so as to remedy the shortcomings identified in the Commission’s objections. The absence of a reaction from the Commission in accordance with this paragraph to a draft crop–specific rule shall not prejudice any action or decision which might be taken by the Commission under other Union acts.

    10.A Member State with significant climatic or agronomic differences between regions, shall adopt crop-specific rules for each of those regions.

    11.Each Member State shall publish all of its crop-specific rules on a single website.

    12.The Commission shall publish on a website links to the websites referred to in paragraph 11 of the Member States.

    13.By … [OP: please insert the date = the first day of the month following 7 years after the date of entry into force of this Regulation], the Commission shall submit a report to the European Parliament and the Council on the adoption and enforcement of crop-specific rules in the Member States and the compliance of those rules with Article 15.

    Article 16

    Electronic integrated pest management and plant protection product use register

    1.Each Member State shall designate a competent authority or competent authorities to establish and maintain an electronic integrated pest management and plant protection product use register or registers.

    The electronic integrated pest management and plant protection product use register or registers shall contain all of the following information for a period of at least 3 years from date of entry:

    (a)any preventative measure or intervention and the reasons for that preventative measure or intervention entered in accordance with Article 14(1);

    (b)the name of the advisor and dates and content of advice entered in accordance with Article 14(2);

    (c)an electronic record of each application of a plant protection product under Article 67 of Regulation (EC) No 1107/2009 and a report on any aerial application carried out under Article 20, as required by Article 14(3).

    2.The register(s) referred to in paragraph 1 shall be accessible to professional users so that they are able to enter the electronic records in accordance with Article 14.

    3.Competent authorities referred to in paragraph 1 shall verify compliance of professional users with Article 14.

    4.Competent authorities referred to in paragraph 1 shall, once a year submit to the Commission a summary and analysis of the information collected under Article 14 and of any additional data on use of plant protection products gathered in accordance with Article 67 of Regulation (EC) No 1107/2009. 

    5.Competent authorities referred to in paragraph 1 shall share the data gathered under paragraph 1, points (a) and (c), of this Article with the national competent authorities in charge of the implementation of Directives 2000/60/EC and (EU) 2020/2184 for cross-linking that data, in anonymised form, with environmental, groundwater and water quality monitoring data, to enhance the identification, measuring and reduction of risks from the use of plant protection products.

    6.Competent authorities referred to in paragraph 1 shall ensure access to the register(s) referred to in paragraph 1 to national statistical authorities for the development, production and dissemination of official statistics.

    7.In order to ensure a uniform structure of the summary and analysis referred to in paragraph 4, the Commission may, by means of implementing acts, adopt a standard template for such summary and analysis. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 41(2).

    CHAPTER V

    USE, STORAGE AND DISPOSAL OF PLANT PROTECTION PRODUCTS

    Article 17

    General requirements for the use of plant protection products for professional use and of application equipment in professional use

    1.A plant protection product authorised for professional use may only be used by a professional user who: 

    (a)has been issued with a training certificate for following courses for professional users in accordance with Article 25, or has a proof of entry in a central electronic register for following such courses in accordance with Article 25(5), and 

    (b)uses the services of an independent advisor in accordance with Article 26(3).

    2.More hazardous plant protection products may only be used and purchased by professional users. 

    3.Application equipment in professional use may only be used by professional users that hold a training certificate issued to them for following courses for professional users in accordance with Article 25 or have a proof of entry in a central electronic register for following such courses in accordance with Article 25(5).

    4.Within 3 years starting from date of first purchase, and every 3 years thereafter, a professional user shall submit his or her application equipment in professional use for inspection pursuant to Article 31. Where 3 years have passed from the date of first purchase of application equipment in professional use, a professional user may only use it for the application of plant protection products, if that equipment meets any of the following conditions:

    (a)the equipment has successfully passed inspection and the results have been recorded in the electronic register of application equipment in professional use in accordance with Article 31(6);

    (b)a derogation under Article 32(1), or Article 32(3) applies to that equipment.

    At the time of submitting the equipment for inspection, the owner of the equipment or his or her representative shall provide to the competent authority or body carrying out the inspection, the information necessary for the competent authority to comply with its record-keeping obligations pursuant to Article 30(1), point (b).

    5.A professional user shall inspect and operate application equipment in accordance with the manufacturer’s manual of instructions.

    Article 18

    Use of plant protection products in sensitive areas

    1.The use of all plant protection products is prohibited in all sensitive areas and within 3 metres of such areas. This 3 metre buffer zone shall not be reduced by using alternative risk-mitigation techniques.

    2.Member States may establish larger mandatory buffer zones adjacent to sensitive areas.

    3.By way of derogation from paragraph 1, a competent authority designated by a Member State may permit a professional user to use a plant protection product in a sensitive area for a limited period with a precisely defined start and end date that is the shortest possible but does not exceed 60 days, provided that all of the following conditions are met:

    (a)a proven serious and exceptional risk of the spread of quarantine pests or invasive alien species exists;

    (b)there is no technically feasible lower risk alternative control technique to contain the spread of quarantine pests or invasive alien species.

    4.An application by a professional user for a permit for the use of a plant protection product in a sensitive area shall include the information necessary to demonstrate that the conditions set out in paragraph 3 are met.

    5.The competent authority referred to in paragraph 3 shall decide on the application for a permit for the use of a plant protection product within 2 weeks of its submission.

    6.The permit to use a plant protection product in a sensitive area shall indicate all of the following:

    (a)the conditions for limited and controlled use by the applicant;

    (b)the obligation to display notices regarding use of plant protection products on the perimeter of the area to be treated, and any specific form such display is to take;

    (c)risk mitigation measures;

    (d)the duration of validity of the permit.

    7.A professional user that has been granted a permit to use a plant protection product in a sensitive area shall display notices to that regard on the perimeter of the area to be treated in the form indicated in the permit.

    8.Where a permit for use of a plant protection product in a sensitive area is granted, before the first day of its validity, the competent authority referred to in paragraph 3 shall make publicly available the following information:

    (a)the location of the use;

    (b)the evidence for the exceptional circumstances justifying the application of a plant protection product;

    (c)the start and end date of the approval period of the permit, which shall not exceed 60 consecutive days;

    (d)the relevant weather conditions allowing a safe application;

    (e)the name of the plant protection product or products;

    (f)the application equipment to be used and the risk mitigation measures to be taken.

    Article 19

    Measures to protect the aquatic environment and drinking water

    1.The use of all plant protection products is prohibited on all surface waters and within 3 metres of such waters. This 3 metre buffer zone shall not be reduced by using alternative risk-mitigation techniques.

    2.Member States may establish larger mandatory buffer zones adjacent to surface waters.

    3.By … [OP: please insert the date of application of this Regulation], Member States shall have in place appropriate measures to avoid deterioration of surface and groundwater status as well as coastal and marine waters and allow achievement of good surface and groundwater status, to protect the aquatic environment and drinking water supplies from the impact of plant protection products to achieve, at least, the objectives set out in Directives 2000/60/EC, 2006/118/EC, 2008/105/EC, 2008/56/EC and (EU) 2020/2184.

    Article 20

    Aerial application of plant protection products

    1.Aerial application is prohibited.

    2.By way of derogation from paragraph 1, a competent authority designated by a Member State may permit aerial application by a professional user in any of the following situations:

    (a)there is no technically feasible alternative application method to the aerial application due to inaccessible terrain;

    (b)the aerial application has a less negative impact on human health and the environment than any alternative application method either because the aerial application equipment can be deployed on the relevant terrain in a faster timescale than land-based equipment and avoids a situation where the number of plant pests increases due to the longer time period required for land-based deployment or because it minimizes soil erosion when adverse weather conditions make the land unsuitable for land vehicles, and all of the following conditions are met:

    (i)the application equipment installed on the aircraft is registered in the electronic register of application equipment in professional use referred to in Article 33(1);

    (ii)the aircraft is equipped with accessories that constitute the best available technology to accurately apply the plant protection products and to reduce spray drift;

    (iii)the plant protection product is authorised for use via aerial application under Regulation (EC) No 1107/2009.

    3.An application by a professional user for a permit for aerial application shall include the information necessary to demonstrate that the conditions set out in paragraph 2 are met.

    4.Where a permit for aerial application is granted, before the first possible date of aerial application, the competent authority referred to in paragraph 2 shall make public the following information:

    (a)the location and surface area of the aerial application indicated on a map;

    (b)the validity period of the permit for aerial application, which shall be for a limited period with a precisely defined start and end date that is the shortest possible and shall not exceed 60 days;

    (c)the relevant weather conditions allowing a safe application;

    (d)the name of the plant protection product or products;

    (e)the application equipment to be used and the risk mitigation measures to be taken.

    5.    A professional user that has been granted a permit for aerial application shall at least 2 days before the date of each specific aerial application display notices to that effect on the perimeter of the area to be treated.

    Article 21

    Use of plant protection products in aerial application by certain categories of unmanned aircraft

    1.Where certain categories of unmanned aircraft fulfil the criteria set out in paragraph 2, a Member State may exempt aerial application by such unmanned aircraft from the prohibition laid down in Article 20(1) prior to any aerial application of plant protection products.

    2.An aerial application by an unmanned aircraft may be exempted by the Member State from the prohibition laid down in Article 20(1) where factors related to the use of the unmanned aircraft demonstrate that the risks from its use are lower than the risks arising from other aerial equipment and land-based application equipment. These factors shall include criteria relating to:

    (a)the technical specifications of the unmanned aircraft, including in relation to spray drift, number and size of rotors, payload, boom width and overall weight, operating height and speed;

    (b)the weather conditions, including wind speed;

    (c)the area to be sprayed, including its topography;

    (d)the availability of plant protection products authorized for use as ultra-low volume formulations in the relevant Member State;

    (e)potential use of unmanned aircraft in conjunction with real time kinematic precision farming in certain cases;

    (f)the level of training required for pilots operating an unmanned aircraft;

    (g)potential concurrent use of multiple unmanned aircraft in the same area.

    3.The Commission is empowered to adopt delegated acts in accordance with Article 40 supplementing this Regulation to specify precise criteria in relation to the factors set out in paragraph 2 once technical progress and scientific developments allow for the development of such precise criteria.

    Article 22

    Storage, disposal and handling

    1.By … [OP: please insert the date of application of this Regulation], Member States shall have in place effective measures and establish the necessary structures to facilitate in a manner that does not endanger human health or the environment, the safe disposal of any unused plant protection products, any dilute solutions containing plant protection products and any packaging. 

    2.As regards professional users, the measures referred to in paragraph 1 shall include detailed requirements on:

    (a)safe storage and handling of plant protection products, and their dilution and mixing before application;

    (b)handling of packaging and remnants of plant protection products;

    (c)cleaning of the equipment used after application;

    (d)disposal of obsolete plant protection products and remnants and their packaging. 

    3.Member States shall take all necessary measures  regarding plant protection products authorised for non-professional users to prevent and, where prevention is not possible, to limit dangerous handling operations. Those measures may include measures relating to size limits for packaging or containers. Those measures may provide that non-professional users may only use low-risk plant protection products and other plant protection products that are in the form of ready to use formulations and measures for the use of safe closure or a locking device for packaging or containers.

    4.Manufacturers, distributors and professional users shall ensure that plant protection products are stored in specific storage facilities for plant protection products that are constructed in such a way as to prevent unwanted releases.

    Manufacturers, distributors and professional users shall ensure that location, size, ventilation and construction materials of the storage facility are suitable to prevent unwanted releases and to protect human health and the environment.

    Article 23

    Advice on the use of plant protection products

    Advice on the use of a plant protection product to a professional user may only be given by an advisor for whom a training certificate has been issued for following courses for advisors in accordance with Article 25 or who has a proof of entry in a central electronic register for following such courses in accordance with Article 25(5).

    CHAPTER VI

    SALE OF PLANT PROTECTION PRODUCTS

    Article 24

    Requirements for the sale of plant protection products

    1.A distributor shall only sell a plant protection product authorised for professional use to a purchaser or his or her representative when that distributor has checked, at the time of purchase, that the purchaser or representative is a professional user and holds a training certificate for following courses for professional users issued in accordance with Article 25 or has a proof of entry in a central electronic register for following such courses in accordance with Article 25(5).

    2.Where a purchaser is a legal person, a distributor may sell a plant protection product authorised for professional use to a representative of the purchaser of the plant protection product when that distributor has checked, at the time of purchase, that the representative is the holder of a training certificate for following courses for professional users issued in accordance with Article 25 or has a proof of entry in a central electronic register for following such courses in accordance with Article 25(5).

    3.A distributor shall direct a purchaser of a plant protection product to read its label prior to use and to use the product in accordance with the instructions on the label and shall inform the purchaser of the website referred to in Article 27.

    4.A distributor shall provide general information to non-professional users on the risks to human health and the environment of the use of plant protection products, including the information on hazards, exposure, proper storage, handling, application and safe disposal in accordance with Directive 2008/98/EC of the European Parliament and of the Council 86 , and shall recommend alternative low-risk plant protection products and ways in which risks can be mitigated when using plant protection products. 

    5.Each distributor shall ensure that it has sufficient staff that hold a training certificate for following courses for distributors issued in accordance with Article 25 or has a proof of entry in a central electronic register for following such courses in accordance with Article 25(5) available at the time of sale to provide adequate responses to purchasers of plant protection products at the moment of sale on their use, related health and environmental risks and the appropriate safety instructions to manage those risks.

    6.The distributor referred to in paragraph 5 shall inform the purchaser of a plant protection product about less hazardous control techniques before the purchaser buys a plant protection product with a higher risk for human health and the environment.

    CHAPTER VII

    TRAINING, INFORMATION AND AWARENESS RAISING

    Article 25

    Training and Certification

    1.A competent authority designated in accordance with paragraph 2 shall appoint one or more bodies to provide the following training:

    (a)initial and follow up training to professional users and distributors on the subjects listed in Annex III;

    (b)practical training for professional users on the use of application equipment in professional use;

    (c)extensive training for advisors on the subjects listed in Annex III with particular emphasis on the application of integrated pest management.

    2.Each Member State shall designate a competent authority or authorities responsible for the implementation of the system for the training and certification of all training referred to in paragraph 1 and for issuing and renewing training certificates, updating the central electronic register, providing proof of entry in the central electronic register and overseeing that the tasks referred to in paragraph 1 are carried out by the body that provided the training. 

    3.The training referred to in paragraph 1 could form part of the training interventions set up by Member States according to Article 78 of Regulation (EU) No 2021/2115.

    4.A training certificate or an entry in a central electronic register shall contain the following information:

    (a)the name of the professional user, distributor or advisor to whom the training was provided;

    (b)the employer of the professional user, distributor or advisor to whom the training was provided, where that employer is a legal person or a natural person in its professional capacity;

    (c)the type of training provided, where a Member State provides different types of training to different categories of professional users, distributors or advisors;

    (d)the date on which sufficient knowledge of the relevant subjects listed in Annex III was demonstrated;

    (e)the name of the body that provided the training; 

    (f)the number of hours of training;

    (g)the validity period of the training certificate or entry in the central electronic register.

    5.A competent authority designated in accordance with paragraph 2 shall provide electronic proof of entry in a central electronic register to a professional user, distributor or advisor at the time the entry is made. Such electronic proof shall include a record of the period of validity of the entry in the central electronic register.

    6.A training certificate or an entry in a central electronic register shall be valid for 10 years in the case of a distributor or professional user and for 5 years in the case of an advisor.

    7.Subject to paragraph 6, a training certificate or an entry in a central electronic register shall only be made or renewed if the holder of the certificate or the person whose name has been entered in the central electronic register demonstrates satisfactory completion of an initial and follow up training or extensive training referred to in paragraph 1, point (a) or (c). 

    8.Notwithstanding paragraph 6, a training certificate may be issued to a person who can demonstrate prior training through formal qualifications that demonstrate a more extensive knowledge of the subjects listed in Annex III than would be received in the training referred to in paragraph 1.

    9.A competent authority designated in accordance with paragraph 2 or an appointed body referred to in paragraph 1 shall withdraw a training certificate if it was incorrectly issued or renewed or shall correct an entry in the central electronic register if it was incorrectly introduced.

    10.The Commission is empowered to adopt delegated acts in accordance with Article 40 amending Annex III in order to take into account technical progress and scientific developments.

    Article 26

    Independent advisory system

    1.Each Member State shall designate a competent authority to establish, oversee and monitor the operation of a system of independent advisors for professional users. That system may make use of the impartial farm advisors referred to in Article 15 of Regulation (EU) No 2021/2115, who must be regularly trained and can be funded under Article 78 of the same regulation. 

    2.The competent authority referred to in paragraph 1 shall ensure that any advisor registered in the system referred to in that paragraph (‘independent advisor’) is free from any conflict of interest and, in particular, is not in a situation which, directly or indirectly, could affect their ability to carry out their professional duties in an impartial manner.

    3.Each professional user shall consult an independent advisor at least once a year for the purposes of receiving the strategic advice referred to in paragraph 4. 

    4.An advisor referred to in paragraph 3 shall provide strategic advice on the following subjects:

    (a)application of relevant control techniques to prevent harmful organisms;

    (b)implementation of integrated pest management;

    (c)precision farming techniques, including use of space data and services;

    (d)use of non-chemical methods;

    (e)where chemical plant protection products are necessary, measures to effectively minimise risks to human health and the environment, in particular to biodiversity, including pollinators, from such use, including risk mitigation measures and techniques.

    Article 27

    Information and awareness raising

    1.Each Member State shall designate a competent authority to provide information to the public, in particular through awareness-raising programmes, in relation to the risks associated with the use of plant protection products.

    2.The competent authority referred to in paragraph 1 shall establish a website or websites dedicated to providing information on risks associated with the use of plant protection products. That information may be provided directly or by providing links to relevant websites of other national or international bodies.

    3.Websites established in accordance with paragraph 2 shall include information on the following subjects:

    (a)the potential risks to human health and the environment through acute or chronic effects relating to the  use of plant protection products;

    (b)the manner in which the potential risks referred to in point (a) can be mitigated;

    (c)alternatives to chemical plant protection products;

    (d)the procedure for approval of active substances and authorisation of plant protection products;

    (e)permits granted under Article 18 or Article 20;

    (f)a link to the website referred to in Article 7;

    (g)the rights of third parties to request access to information on the use of plant protection products by addressing the relevant competent authority in accordance with Article 67(1) of Regulation (EC) No 1107/2009.

    Article 28

    Information on acute and chronic poisoning

    1.Each Member State shall designate a competent authority to maintain or put in place systems for gathering and keeping the following information on acute and chronic poisoning incidents arising from exposure of persons to plant protection products:

    (a)the name and authorisation number of the plant protection product and the active substances involved in the acute or chronic poisoning incident;

    (b)the number of individuals poisoned;

    (c)the symptoms of poisoning;

    (d)the duration and severity of the symptoms;

    (e)whether a confirmed acute or chronic poisoning incident resulted from:

    (i)correct use of a plant protection product;

    (ii)misuse of a plant protection product;

    (iii)use of a plant protection product that has not been authorised; or

    (iv)deliberate ingestion or exposure.

    2.By 31 August every year, each Member State shall submit to the Commission a report containing the following information:

    (a)the number of acute and chronic poisoning incidents arising from exposure of persons to plant protection products during the preceding calendar year;

    (b)the information referred to in paragraph 1 as regards each poisoning incident.

    3.The Commission shall adopt implementing acts to establish the format for the submission of the information and data referred to in paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 41(2).

    CHAPTER VIII

    APPLICATION EQUIPMENT

    Article 29

    Electronic register of application equipment in professional use 

    1.By … [OP please insert the date = first day of the month following 9 months after the date of entry into force of this Regulation], an owner of application equipment in professional use shall enter the fact that he or she is the owner of the application equipment in the electronic register of application equipment in professional use referred to in Article 33, using the form set out in Annex V, unless the Member State in which the owner uses the equipment has exempted that equipment from inspection in accordance with Article 32(3). 

    2.If application equipment in professional use is sold, the seller and the buyer shall enter the fact of the sale, within 30 days after the sale, in the electronic register of application equipment in professional use referred to in Article 33, using the form set out in Annex V, unless the application equipment in professional use has been exempted from inspection in the relevant Member State(s) in accordance with Article 32(3). A similar obligation to enter a transfer of ownership in the electronic register applies in the case of any other changes of ownership of application equipment in professional use that has not been exempted from inspection in the relevant Member State(s) in accordance with Article 32(3).

    3.If application equipment in professional use is withdrawn from use and is not intended to be used again, its owner shall, within 30 days after the withdrawal from use, enter the fact that the equipment has been withdrawn from use in the electronic register of application equipment in professional use referred to in Article 33, using the form set out in Annex V.

    4.If application equipment in professional use is returned to use, its owner shall, within 30 days after the return to use, enter that fact in the electronic register of application equipment in professional use referred to in Article 33 using the form set out in Annex V.

    5.The Commission is empowered to adopt delegated acts in accordance with Article 40 amending Annex V in order to take into account technical progress and scientific developments

    Article 30

    Collection of information and controls

    1.Each Member State shall designate one or more competent authorities to:

    (a)establish and maintain a central electronic register to record information on all application equipment in professional use in the Member State;

    (b)use the central electronic register to receive and process third party entries regarding ownership, transfer of ownership, sale, withdrawal from use and return to use of application equipment in professional use;  

    (c)inspect, or oversee the inspection of, application equipment in accordance with Article 31(1), (2), (3) and (6);

    (d)issue, or oversee the issuing of, certificates of inspection in accordance with Article 31(7).

    Where the designated competent authority does not carry out the inspection of application equipment in professional use, it shall designate one or more bodies to carry out such inspections.

    2.Each Member State shall carry out official controls to verify compliance by operators with the provisions of this Regulation relating to application equipment. Member States shall take appropriate follow-up measures to remedy any specific or systemic shortcomings identified through controls performed by the Commission experts in accordance with paragraphs 3 and 4. They shall give the necessary assistance to ensure that the Commission experts have access to all premises or parts of premises, and goods, and to information, including computer systems, relevant for the execution of their duties.

    3.Commission experts shall perform controls, including audits, in each Member State to verify the application of the rules relating to application equipment laid down in this Regulation. The experts may investigate and collect information on official controls and enforcement practices in the area of application equipment.

    4.The Commission shall:

    (a)prepare a draft report on the findings and on recommendations addressing the shortcomings identified by its experts during these controls;

    (b)send to the Member State where those controls have been performed a copy of the draft report referred to in point (a) for its comments;

    (c)take the comments of the Member State referred to in point (b) into account in preparing the final report on the findings of the controls performed by its experts in the Member States as provided for in this Article;

    (d)make publicly available the final report referred to in point (c) and the comments of the Member States referred to in point (b).

    Article 31

    Inspection of application equipment in professional use

    1.The competent authority referred to in Article 30 or a body designated by it shall inspect application equipment in professional use every three years, starting from the date of first purchase. The competent authority shall ensure that there is sufficient staff, equipment and other resources necessary for the inspection of all application equipment due for inspection, within the three year cycle.

    2.The inspection referred to in paragraph 1 shall verify whether the application equipment in professional use complies with the requirements set out in Annex IV.

    3.The inspection shall be carried out at a location where the risk of pollution and water contamination can be avoided. The influence of external conditions on the reproducibility of the results of the inspection, such as effects of wind and rain, shall be minimised by the authority or body carrying out the inspection.

    4.All equipment necessary for an inspection and used by the inspector for testing the application equipment shall be accurate, in good condition and checked and, where necessary, calibrated at regular intervals.

    5.The owner of the application equipment in professional use shall ensure that the application equipment is clean and safe before the inspection starts.

    6.The results of each inspection for which application equipment in professional use passes the test shall be recorded by the competent authority referred to in Article 30 in the central electronic register of application equipment in professional use referred to in Article 33. 

    7.A certificate of inspection shall be:

    (a)issued by the competent authority referred to in Article 30 to the owner of application equipment in professional use where that equipment complies with the requirements listed in Annex IV; and

    (b)recorded by that competent authority in the central electronic register of application equipment in professional use referred to in Article 33.

    8.A record as referred to in paragraph 6 shall be valid for three years unless the Member State provides for a different inspection interval pursuant to Article 32.

    9.Each Member State shall recognise a certificate as referred to in paragraph 7 or a record as referred to in paragraph 6 for application equipment in professional use registered in another Member State.

    10.The Commission is empowered to adopt delegated acts in accordance with Article 40 amending this Article and Annex IV in order to take into account technical progress and scientific developments

    11.Application equipment in professional use inspected in compliance with harmonised inspection standards developed in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council 87 shall be presumed to comply with the requirements listed in Annex IV.

    Article 32

    Member State derogations regarding inspection of application equipment in professional use

    1.A Member State may, after carrying out the risk assessment referred to in paragraph 2, lay down less stringent inspection requirements and provide for different inspection intervals than those set out in Article 31 to application equipment in professional use which represents a very low scale of use estimated by way of the risk assessment referred to in paragraph 2 and which is listed in the national action plan referred to in Article 8.

    This paragraph shall not apply to the following application equipment in professional use:

    (a)spraying equipment mounted on trains or aircraft;

    (b)horizontal boom sprayers which are larger than 3 m, including sprayers that are mounted on sowing equipment which is larger than 3 m wide;

    (c)vertical sprayer or orchard blast sprayer.

    2.Before laying down less stringent inspection requirements and different inspection intervals as referred to in paragraph 1, a Member State shall carry out a risk assessment on their potential impacts on human health and the environment. The competent authority referred to in Article 30 shall maintain a copy of the risk assessment for control by the Commission.  

    3.A Member State may exempt from inspection referred to in Article 31 handheld application equipment or knapsack sprayers, in professional use, based on a risk assessment on their potential impact on human health and the environment, which shall include an estimation of the scale of use. The competent authority referred to in Article 30 shall maintain a copy of the risk assessment for control by the Commission. 

    4.Application equipment in professional use that has been exempted from inspection in accordance with paragraph 3 shall not be subject to the requirement to make an entry in the electronic register referred to in Article 29 or the registration requirements referred to in Article 33.

    Article 33

    Electronic register of application equipment in professional use

    1.Each competent authority designated by a Member State pursuant to Article 30 shall establish and maintain a central electronic register to record:

    (a)information entered by third parties pursuant to Article 20(2), point (b)(i), and Article 29; 

    (b)records of inspections and certificates as set out in Article 31(6) and (7)(b); 

    (c)other information as set out in paragraph 2 on application equipment in professional use in its Member State that has not been exempted from inspection under Article 32(3).

    2.The competent authorities referred to in Article 30 shall, at the time of inspection, record the following information:

    (a)the name of the body carrying out the inspections;

    (b)the unique ID of the application equipment, if available;

    (c)the date of manufacture, if available;

    (d)the name and address of the current owner;

    (e)where there has been a transfer of ownership, the date of each transfer and the name and address of previous owners within the last five years;

    (f)the tank size;

    (g)the width of the horizontal spray boom, if applicable;

    (h)the nozzle type(s) present on the application equipment at the time of inspection;

    (i)in the case of boom sprayers, whether section and/or nozzle control through geospatial localisation technology is present or absent on the application equipment;

    (j)for equipment older than three years, the date of each inspection carried out in accordance with Article 31;

    (k)whether the application equipment passed or failed each inspection carried out under Article 31;

    (l)the reasons for any failed inspection. 

    3.Where application equipment does not bear a unique ID as referred to in paragraph 2, point (b), the competent authorities referred to in Article 30 shall supply a unique ID.

    CHAPTER IX

    METHODOLOGY FOR CALCULATING REDUCTION TARGETS AND HARMONISED RISK INDICATORS

    Article 34

    Methodology for calculating progress towards achieving the two national and two Union 2030 reduction targets

    1.The methodology for calculating progress towards achieving the two Union 2030 reduction targets and the two national 2030 reduction targets until and including 2030 is laid down in Annex I. This methodology shall be based on statistical data collected in accordance with Regulation (EC) No 1185/2009.

    2.Using the methodology set out in Annex I, the Commission shall calculate the results of progress towards achieving the two Union and two national 2030 reduction targets annually until and including 2030 and publish those results on the website referred to in Article 7.

    Article 35

    Methodology for calculating harmonised risk indicators 1, 2 and 2a

    1.The methodology for calculating progress in relation to harmonised risk indicators 1, 2 and 2a, at both Union and Member State level, is laid down in Annex VI. This methodology shall be based on statistical data collected in accordance with Regulation (EC) No 1185/2009.

    2.Using the methodology set out in Annex VI, the Commission shall calculate the results of harmonised risk indicators 1, 2 and 2a annually at Union level and shall publish the results of its calculation on the website referred to in Article 7.

    3.Using the methodology set out in Annex VI, each Member State shall calculate the results of harmonised risk indicators 1, 2 and 2a on an annual basis at national level. 

    4.The Commission is empowered to adopt delegated acts in accordance with Article 40 amending this Article and Annex VI in order to take into account technical progress, including progress in the availability of statistical data, and scientific and agronomic developments. Such delegated acts may modify the existing harmonised risk indicators or provide for new harmonised risk indicators, which may take into account Member States’ progress towards achieving the target of having 25% of their utilised agricultural area devoted to organic farming by 2030 as referred to in Article 8(1), point (d).

    5.By… [OP please insert the date = first day of the month following 12 months after the date of entry into force of this Regulation], the Commission shall complete an evaluation of harmonised risk indicators 1, 2 and 2a. This evaluation shall be based on scientific research from the Joint Research Centre and extensive consultation of stakeholders, including Member States, scientific experts and civil society organisations. The evaluation shall include the methodologies to be used in formulating new and modifying existing harmonised risk indicators in accordance with paragraph 4.

    6.Taking into account the results of the evaluation provided for in paragraph 5 and no later than 18 months after the publication of the statistics on the use of plant protection products in agriculture for the first reference period as referred to in Article 9 of Regulation xxx/xxx [reference to adopted act to be inserted], the Commission shall, if it considers it appropriate, establish new harmonised risk indicators or modify the existing ones on the basis of statistical data related to the use of plant protection products in accordance with paragraph 4 of this Article.

    Article 36

    Member State evaluation of progress calculations and harmonised risk indicators

    1.Each Member State shall evaluate the results of each calculation of (a) progress towards achieving each of the two national 2030 reduction targets as referred to in Article 34 and (b) harmonised risk indicators at Member State level, as referred to in Article 35, each time the calculations are performed.

    2.Evaluations of the harmonised risk indicators at Member State level referred to in Article 35 shall:

    (a)identify five active substances influencing the result most significantly;

    (b)specify the crops or situations and the target pests on which the active substances referred to in point (a) are used;

    (c)specify available non-chemical methods to combat those pests;

    (d)summarise the actions taken to reduce the use and risk of the active substances referred to in point (a) and any barriers to the adoption of alternative pest controls.

    3.Member States shall communicate the results of the calculations of harmonised risk indicators at Member State level, as specified in Annex VI, and the associated evaluations carried out pursuant to this Article to the Commission and to the other Member States and shall publish this information and other national indicators or quantifiable objectives referred to in paragraph 4 on the websites referred to in Article 27(2).

    4.Further to harmonised risk indicators specified in Annex VI and the data specified in Annex II, Member States may additionally continue to use existing, or to develop additional, national indicators or quantifiable objectives, and other data collected at a national or regional level, including future data on the use of plant protection products, that relates to the indicators and targets referred to in paragraphs 1 and 2.

    CHAPTER X

    ADMINISTRATIVE AND FINANCIAL PROVISIONS

    Article 37

    Information on designated competent authorities

    By … [OP: please insert the date = the first day of the month following six months after the date of entry into force of this Regulation], each Member State shall inform the Commission of the competent authorities designated in accordance with this Regulation.

    Article 38

    Penalties

    Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take the measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall without delay notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them.

    Article 39

    Fees and charges

    Member States may recover the costs related to carrying out their obligations under this Regulation by means of fees or charges.

    CHAPTER XI

    DELEGATED POWERS AND COMMITTEE PROCEDURE

    Article 40

    Exercise of the delegation

    1.The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

    2.The power to adopt delegated acts referred to in Articles 10(6), 13(9), 21(3), 25(10), 29(5), 31(10) and 35(4) shall be conferred on the Commission for an indeterminate period. 

    3.The delegation of power referred to in Articles 10(6), 13(9), 21(3), 25(10), 29(5), 31(10) and 35(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

    4.Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

    5.As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

    6.A delegated act adopted pursuant to Articles 10(6), 13(9), 21(3), 25(10), 29(5), 31(10) and 35(4) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

    Article 41

    Committee procedure

    1.The Commission shall be assisted by the Standing Committee on Plants, Animals, Food and Feed established by Article 58(1) of Regulation (EC) No 178/2002 of the European Parliament and of the Council 88 . That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

    2.Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

    3.Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and Article 5(4), third subparagraph, of Regulation (EU) No 182/2011 shall apply.

    CHAPTER XII

    TRANSITIONAL AND FINAL PROVISIONS

    Article 42

    Commission evaluation

    1.By … [OP: please insert the date = four years after the date of application of this Regulation], the Commission shall carry out an evaluation of this Regulation based on the following:

    (a)the trends in progress and other quantitative data provided in annual progress and implementation reports in accordance with Article 10(2);

    (b)the analysis of the annual trends and data published by the Commission every two years in accordance with Article 11;

    (c)the report on annual progress and implementation reports previously submitted by the Commission to the European Parliament and Council in accordance with Article 11(7) ;

    (d)any other information necessary for the preparation of the evaluation.

    Member States shall provide the Commission with the information necessary for the preparation of that evaluation.

    2.The Commission shall present a report on the main findings to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions.

    Article 43

    Amendments to Regulation (EU) 2021/2115

    Regulation (EU) 2021/2115 is amended as follows:

    (1)in Article 31(5), the following subparagraph is added:

    ‘By way of derogation from points (a) and (b) of the first subparagraph of this paragraph, where in accordance with Regulation (EU) …/… of the European Parliament and of the Council* 89+ requirements are imposed on farmers, support may be granted to comply with those requirements for a maximum period ending on the later one of the two dates – … [OP: insert the date = 5 years from the date of entry into force of this Regulation] or 5 years from the date on which they become mandatory for the holding.

    *Regulation (EU)…/… of the European Parliament and of the Council … on the sustainable use of plant protection products and amending Regulation (EU) 2021/2115 (OJ …).’;

    (2)In Article 70(3), the following subparagraph is added:

    ‘By way of derogation from points (a) and (b) of the first subparagraph of this paragraph, where in accordance with Regulation (EU) …/… 90++ requirements are imposed on beneficiaries, support may be granted to comply with those requirements for a maximum period ending on the later one of the two dates – … [OP: insert the date = 5 years from the date of entry into force of this Regulation] or 5 years from the date on which they become mandatory for the holding.’;

    (3)in Article 73(5), the following subparagraph is added:

    ‘By way of derogation from the first subparagraph of this paragraph, where in accordance with Regulation (EU) …/… ++ requirements are imposed on farmers, support may be granted to comply with those requirements for a maximum period ending on the later one of the two dates –… [OP: insert the date = 5 years from the date of entry into force of this Regulation] or 5 years from the date on which they become mandatory for the holding. ’.

    Article 44

    Repeal of Directive 2009/128/EC

    1.Directive 2009/128/EC is repealed.

    2.References to Directive 2009/128/EC shall be construed as references to this Regulation and read in accordance with the correlation table set out in Annex VII.

    Article 45

    Entry into force

    This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

    It shall apply from … [OP: please insert the date = the first day of the month following … months after the date of entry into force of this Regulation].

    However, Article 21 shall apply from [OP: please insert the date = 3 years after the date of entry into force of this Regulation].

    This Regulation shall be binding in its entirety and directly applicable in all Member States.

    Done at Brussels,

    For the European Parliament    For the Council

    The President    The President

    (1)    The legal definition of pesticides laid down in Article 3(10) of the Sustainable Use Directive includes plant-protection products and biocides, but since the scope of the Sustainable Use Directive was never extended to biocides, this proposal is restricted to plant-protection products only.
    (2)    Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides (OJ L 309, 24.11.2009, p. 71).
    (3)    Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions, ‘A thematic strategy on the sustainable use of pesticides’, COM(2006) 373 final, Document 52006DC0372,  www.eur-lex.europa.eu .
    (4)    Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, A Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system’, COM/2020/381 final.
    (5)    The successful initiative ‘ Ban glyphosate and protect people and the environment from toxic pesticides called on the Commission, under its third aim, ‘to set EU-wide mandatory reduction targets for pesticide use, with a view to achieving a pesticide-free future’. In its reply adopted on 12 December 2017 , the Commission stated that it would re-evaluate the need for EU-wide mandatory targets for pesticides. The initiative Save bees and farmers! Towards a bee-friendly agriculture for a healthy environment calls on the Commission to propose legal acts to phase out synthetic pesticides by 2035, to restore biodiversity, and to support farmers in the transition; the initiative has collected over 1 million statements of support by 30 September 2021 which are currently being verified by Member States authorities.
    (6)      Conference on the Future of Europe – Report on the Final Outcome, May 2022, Proposal 1, p. 43. The Conference on the Future of Europe was held between April 2021 and May 2022. It was a unique, citizen-led exercise of deliberative democracy at the pan-european level, involving thousands of European citizens as well as political actors, social partners, civil society representatives and key stakeholders.
    (7) Ibid., Proposal 2 p. 44, and Proposal 30, p 72.
    (8)    Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions, ‘The European Green Deal’ COM/2019/640 final, EUR-Lex - 52019DC0640 - EN - EUR-Lex (europa.eu)
    (9)    Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, A Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system’, COM/2020/381 final.
    (10)    Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, EU Biodiversity Strategy for 2030 Bringing nature back into our lives , COM/2020/380 final.
    (11)    Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, ‘ Pathway to a Healthy Planet for All – EU action plan: Towards Zero Pollution for Air, Water and Soil’, COM(2021) 400 final.
    (12)    Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, ‘ EU Soil Strategy for 2030 – Reaping the benefits of healthy soils for people, food, nature and climate’, COM(2021) 699 final.
    (13)     EU Pollinators Initiative - Environment - European Commission (europa.eu) .
    (14)    Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions Chemicals Strategy for Sustainability Towards a Toxic-Free Environment’, COM/2020/667 final.
    (15)    Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, EU strategic framework on health and safety at work 2021-2027 Occupational safety and health in a changing world of work, COM/2021/323 final.
    (16)    Regulation (EU) 2021/2115 of the European Parliament and of the Council of 2 December 2021establishing rules on support for strategic plans to be drawn up by Member States under the common agricultural policy (CAP Strategic Plans) and financed by the European Agricultural Guarantee Fund (EAGF) and by the European Agricultural Fund for Rural Development (EAFRD) and repealing Regulations (EU) No 1305/2013 and (EU) No 1307/2013 (OJ L 435, 6.12.2021, p. 1).
    (17)     EU nature restoration targets (europa.eu) .
    (18)     Commission .
    (19)     Directive 2013/39/EU of the European Parliament and of the Council of 12 August 2013 amending Directives 2000/60/EC and 2008/105/EC as regards priority substances in the field of water policy .
    (20)     Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy, amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the Council, OJ L 348, 24.12.2008, p. 84-97.
    (21)    Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (recast), OJ L 435, 23.12.2020, p. 1.
    (22)     Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy, OJ L 327, 22.12.2000, p. 1.
    (23)    Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work, OJ L 183, 29.6.1989, p. 1.
    (24)    Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work, OJ L 131, 5.5.1998, p. 11.
    (25)    Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (OJ L 158, 30.4.2004, p. 50), p. 50.
    (26)    Directive 2009/104/EC of the European Parliament and of the Council of 16 September 2009 concerning the minimum safety and health requirements for the use of work equipment by workers at work (second individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (Text with EEA relevance), OJ L 260, 3.10.2009, p. 5.
    (27)    Council Directive 89/656/EEC of 30 November 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace (third individual directive within the meaning of Article 16 (1) of Directive 89/391/EEC), OJ L 393, 30.12.1989, p. 18.
    (28)    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 , p. 8.
    (29)     Special Report 05/2020: Sustainable use of plant protection products: limited progress in measuring and reducing risks (europa.eu) .
    (30)     Evaluation and Impact Assessment (europa.eu) .
    (31)     Pesticides – sustainable use (updated EU rules) (europa.eu) .
    (32)    Regulation (EU) 2020/852 of the European Parliament and of the Council of 18 June 2020 on the establishment of a framework to facilitate sustainable investment, and amending Regulation (EU) 2019/2088, OJ L 198, 22.6.2020, p. 13.
    (33)    Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing the framework for achieving climate neutrality and amending Regulations (EC) No 401/2009 and (EU) 2018/1999 (‘European Climate Law’) (OJ L 243, 9.7.2021, p. 1).
    (34)    OJ C 202, 7.6.2016, p. 389.
    (35)    OJ C , , p. .
    (36)    OJ C […], […], p. […].
    (37)    Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides (OJ L 309, 24.11.2009, p. 71).
    (38)    [Reference to be inserted.]
    (39)    Report from the Commission to the European Parliament and the Council on Member State National Action Plans and on progress in the implementation of Directive 2009/128/EC on the sustainable use of pesticides COM(2017)587 final.
    (40)    Report from the Commission to the European Parliament and the Council on the experience gained by Member States on the implementation of national targets established in their National Action Plans and on progress in the implementation of Directive 2009/128/EC on the sustainable use of pesticides COM(2020) 204 final.
    (41)    P8_TA(2019)0082, 12 February 2019.
    (42)    P9_TA(2021)0425, 20 October 2021.
    (43)    European Parliamentary Research Service, Directive 2009/128/EC on the sustainable use of pesticides –European Implementation Assessment, October 2018.
    (44)    Sustainable use of plant protection products: limited progress in measuring and reducing risks, Special Report European Court of Auditors, ISBN:978-92-847-4206-6, Publications Office of the European Union, Luxemburg, 2020.
    (45)    European Economic and Social Committee, Evaluation on Directive on the Sustainable Use of Pesticides (Information report), adopted on 27 April 2021.
    (46)    Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).
    (47)    Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions The European Green Deal COM/2019/640 final.
    (48)    Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions A Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system, COM/2020/381 final.
    (49)    Communication from the Commission to the European Parliament the Council, the European Economic and Social Committee and the Committee of the Regions, EU Biodiversity Strategy for 2030 Bringing nature back into our lives, COM/2020/380 final.
    (50)    Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Pathway to a Healthy Planet for All EU Action Plan: 'Towards Zero Pollution for Air, Water and Soil', COM(2021) 400 final.
    (51)    Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).
    (52)    Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).
    (53)    Commission Implementing Regulation (EU) 2015/408 of 11 March 2015 on implementing Article 80(7) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and establishing a list of candidates for substitution (OJ L 67, 12.3.2015, p. 18).
    (54)    Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, EU strategic framework on health and safety at work 2021-2027 Occupational safety and health in a changing world of work, COM/2021/323 final.
    (55)    Conference on the Future of Europe – Report on the Final Outcome, May 2022, Proposals 1 and 2, pp. 43-44.
    (56)    Brussels, 19 October 2020, 12099/20.
    (57)    Council Decision (EU) 2021/1102 of 28 June 2021 requesting the Commission to submit a study on the Union’s situation and options regarding the introduction, evaluation, production, marketing and use of invertebrate biological control agents within the territory of the Union and a proposal, if appropriate in view of the outcomes of the study (OJ L 238, 6.7.2021, p. 81).
    (58)    Directive 2001/42/EC of the European Parliament and of the Council of 27 June 2001 on the assessment of the effects of certain plans and programmes on the environment (OJ L 197, 21.7.2001, p. 30).
    (59)    Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7).
    (60)    Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7).
    (61)    Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1).
    (62)    Council Directive 91/676/EEC of 12 December 1991 concerning the protection of waters against pollution caused by nitrates from agricultural sources (OJ L 375, 31.12.1991, p. 1).
    (63)    Directive 2008/50/EC of the European Parliament and of the Council of 21 May 2008 on ambient air quality and cleaner air for Europe (OJ L 152, 11.6.2008, p. 1).
    (64)    Directive (EU) 2016/2284 of the European Parliament and of the Council of 14 December 2016 on the reduction of national emissions of certain atmospheric pollutants, amending Directive 2003/35/EC and repealing Directive 2001/81/EC (OJ L 344, 17.12.2016, p. 1).
    (65)    Regulation (EU) 2021/2115 of the European Parliament and of the Council of 2 December 2021establishing rules on support for strategic plans to be drawn up by Member States under the common agricultural policy (CAP Strategic Plans) and financed by the European Agricultural    Guarantee Fund (EAGF) and by the European Agricultural Fund for Rural Development (EAFRD) and repealing Regulations (EU) No 1305/2013 and (EU) No 1307/2013 (OJ L 435, 6.12.2021, p. 1).
    (66)    Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, p. 164). 
    (67)    Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7).
    (68)    Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7).
    (69)    Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (OJ L 183, 29.6.1989, p. 1).
    (70)    Council Directive 89/656/EEC of 30 November 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace (third individual directive within the meaning of Article 16 (1) of Directive 89/391/EEC) (OJ L 393, 30.12.1989, p. 18).
    (71)    Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
    (72)    Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (OJ L 158, 30.4.2004, p. 50).
    (73)    Directive 2009/104/EC of the European Parliament and of the Council of 16 September 2009 concerning the minimum safety and health requirements for the use of work equipment by workers at work (second individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 260, 3.10.2009, p. 5).
    (74)    Regulation (EC) No 1185/2009 of the European Parliament and of the Council of 25 November 2009 concerning statistics on pesticides (OJ L 324, 10.12.2009, p. 1).
    (75)    Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).
    (76)    OJ L 123, 12.5.2016, p. 1.
    (77)    Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
    (78)    Regulation (EU) 2021/2115 of the European Parliament and of the Council of 2 December 2021 establishing rules on support for strategic plans to be drawn up by Member States under the common agricultural policy (CAP Strategic Plans) and financed by the European Agricultural Guarantee Fund (EAGF) and by the European Agricultural Fund for Rural Development (EAFRD) and repealing Regulations (EU) No 1305/2013 and (EU) No 1307/2013, OJ L 435, 6.12.2021, p. 1.
    (79)    Regulation (EU) 2018/1091 of the European Parliament and of the Council of 18 July 2018 on integrated farm statistics and repealing Regulations (EC) No 1166/2008 and (EU) No 1337/2011 (OJ L 200, 7.8.2018, p. 1).
    (80)    See CORINE Land Cover nomenclature conversion to Land Cover Classification system ( https://land.copernicus.eu/user-corner/technical-library/corine-land-cover-nomenclature-guidelines/html ) and CORINE Land Cover (CLC) inventory ( CORINE Land Cover — Copernicus Land Monitoring Service ).
    (81)    Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (OJ L 435, 23.12.2020, p. 1).
    (82)    Regulation (EU) 2016/2031 of the European Parliament of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC (OJ L 317 23.11.2016, p. 4).
    (83)    Regulation (EU) No 1143/2014 of the European Parliament and of the Council of 22 October 2014 on the prevention and management of the introduction and spread of invasive alien species (OJ L 317, 4.11.2014, p. 35).
    (84)    Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions A Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system (COM/2020/381 final).
    (85)    Directive 2001/42/EC of the European Parliament and of the Council of 27 June 2001 on the assessment of the effects of certain plans and programmes on the environment (OJ L 197, 21.7.2001, p. 30).
    (86)    Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312 22.11.2008, p. 3).
    (87)    Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation (OJ L 316, 14.11.2012, p. 12).
    (88)    Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
    (89) +    OJ: Please insert in the text the number of the Regulation contained in document … and insert the number, date and the OJ reference of that Regulation in the footnote.
    (90) ++    OJ: Please insert in the text the number of the Regulation contained in document … .
    Top

    Brussels, 22.6.2022

    COM(2022) 305 final

    ANNEXES

    to the proposal for a

    REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

    on the sustainable use of plant protection products and amending Regulation (EU) 2021/2115

    {SEC(2022) 257 final} - {SWD(2022) 169 final} - {SWD(2022) 170 final} - {SWD(2022) 171 final}


    ANNEX I
    referred to in Article 4

    METHODOLOGY FOR CALCULATING PROGRESS TOWARDS ACHIEVING THE TWO UNION AND TWO NATIONAL 2030 REDUCTION TARGETS

    This Regulation is the instrument used to achieve the pesticide reduction targets contained in the Farm to Fork Strategy by requiring each Member State to contribute to achieving by 2030 a 50 % Union-wide reduction of both the use and risk of chemical plant protection products (‘Union 2030 reduction target 1’) and the use of more hazardous plant protection products (‘Union 2030 reduction target 2’). This Regulation also regulates the contribution of each Member State to these Union targets. Each Member State contribution, set in the form of a national target, to Union 2030 reduction target 1 is referred to as a ‘national 2030 reduction target 1’, while a Member State contribution to Union 2030 reduction target 2 is referred to as a ‘national 2030 reduction target 2’. The methodology for calculating progress towards achieving these targets is set out below:

    SECTION 1

    National 2030 reduction target 1: methodology for estimating progress towards the reduction in use and risk of chemical plant protection products

    1.The methodology shall be based on statistics on the quantities of chemical active substances placed on the market in plant protection products under Regulation (EC) No 1107/2009, provided to the Commission (Eurostat) under Annex I to Regulation (EC) No 1185/2009 of the European Parliament and of the Council 1 .

    2.The following general rules shall apply for the calculation of progress towards achieving reduction target 1:

    (a)progress shall be calculated on the basis of the categorisation of chemical active substances into the 4 groups set out in the Table in this Annex;

    (b)the chemical active substances in group 1 shall be those listed in Part D of the Annex to Commission Implementing Regulation (EU) No 540/2011 2 ;

    (c)the chemical active substances in group 2 shall be those listed in Parts A and B of the Annex to Implementing Regulation (EU) No 540/2011;

    (d)the chemical active substances in group 3 shall be chemical active substances that are approved as candidates for substitution in accordance with Article 24 of Regulation (EC) No 1107/2009 and are listed in Part E of the Annex to Implementing Regulation (EU) No 540/2011, or that are listed in the Annex to Implementing Regulation (EU) 2015/408;

    (e)the chemical active substances in group 4 shall be those not approved under Regulation (EC) No 1107/2009, and therefore not listed in the Annex to Implementing Regulation (EU) No 540/2011;

    (f)the weightings in row (iii) in the Table in this Annex shall apply.

    3.Progress towards achieving reduction target 1 shall be calculated by multiplying the annual quantities of active substances in plant protection products placed on the market for each group in the Table in this Annex by the relevant hazard weighting set out in row (iii), followed by the aggregation of the results of these calculations.

    Table

    Categorisation of active substances and hazard weightings for the purpose of calculating progress towards national 2030 reduction target 1

    Row

    Groups

    1

    2

    3

    4

    (i)

    Low-risk chemical active substances which are approved or deemed to be approved under Article 22 of Regulation (EC) No 1107/2009, and which are listed in Part D of the Annex to Implementing Regulation (EU) No 540/2011

    Chemical active substances approved or deemed to be approved under Regulation (EC) No 1107/2009, and not falling in other categories, and which are listed in Parts A and B of the Annex to Implementing Regulation (EU) No 540/2011

    Chemical active substances that are approved as candidates for substitution in accordance with Article 24 of Regulation (EC) No 1107/2009 and listed in Part E of the Annex to Implementing Regulation (EU) No 540/2011, or that are listed in the Annex to Implementing Regulation (EU) 2015/408.

    Chemical active substances which are not approved under Regulation (EC) No 1107/2009, and therefore which are not listed in the Annex to Implementing Regulation (EU) No 540/2011

    (ii)

    Hazard Weightings applicable to quantities of chemical active substances placed on the market in products authorised under Regulation (EC) No 1107/2009

    (iii)

    1

    8

    16

    64

    4.The baseline for reduction target 1 shall be set at 100, and is equal to the average result of the above calculation for the period 2015-2017.

    5.The progress towards achieving reduction target 1 shall be expressed by reference to the baseline.

    6.The Commission shall calculate the progress towards achieving reduction target 1 in accordance with Article 34(2) of this Regulation for each calendar year and at the latest 20 months after the end of the year for which progress towards the reduction target 1 is being calculated.

    SECTION 2

    National reduction reduction target 2: methodology for estimating progress towards reduction in the use the more hazardous plant protection products

    1.The methodology shall be based on statistics on the quantities of active substances placed on the market in plant protection products under Regulation (EC) No 1107/2009, provided to the Commission under Annex I to Regulation (EC) No 1185/2009.

    2.Progress towards achieving target 2 shall be calculated by adding together the annual quantities of chemical active substances contained in more hazardous plant protection products placed on the market each year.

    3.The baseline for reduction target 2 shall be set at 100, and is equal to the average result of the above calculation for the period 2015-2017.

    4.Progress towards achieving reduction target 2 shall be expressed by reference to the baseline.

    5.The Commission shall calculate progress towards achieving reduction target 2 in accordance with Article 34(2) of this Regulation for each calendar year and at the latest 20 months after the end of the year for which progress towards reduction target 2 is being calculated.

    SECTION 3

    Union reduction targets

    1.The methodology for calculating trends towards the two Union 2030 reduction targets shall be the same as the methodology for calculating trends at national level as set out in Sections 1 and 2.

    2.The trend at national level shall be calculated using national statistics on the quantities of chemical active substances as defined in point 3 of Article 3 of this Regulation placed on the market in plant protection products under Regulation (EC) No 1107/2009, provided to the Commission under Annex I (Statistics on the placing on the market of pesticides) to Regulation (EC) No 1185/2009.

    3.The trend at Union level shall be calculated using Union statistics on the quantities of chemical active substances as defined in point 3 of Article 3 of this Regulation placed on the market in plant protection products under Regulation (EC) No 1107/2009, provided to the Commission under Annex I (Statistics on the placing on the market of pesticides) to Regulation (EC) No 1185/2009.

    ANNEX II

    DATA TO BE PROVIDED IN ANNUAL PROGRESS AND IMPLEMENTATION REPORTS BY 31 AUGUST OF EACH CALENDAR YEAR

    Part 1: Annual trends in progress towards achieving national 2030 reduction targets

    1.the trends in a Member State’s progress towards achieving the two national 2030 reduction targets referred to in Article 10(2), point (a);

    2.all other national indicative targets indicated in Article 9(2), point (a), Article 9(3), point (a) and Article 9(4).

    Part 2: All other quantitative data relevant to implementation of this Regulation and level of compliance with it

    Use of plant protection products:

    1.the percentage of professional users controlled for integrated pest management implementation;

    2.the percentage of professional users failing to comply with the obligation to keep electronic records on integrated pest management implementation;

    3.the percentage of professional users that failed to comply with the obligation to keep pesticide use data electronically;

    4.the number of aerial application permits, the validity period of the permit, as well as the size and the location of the areas concerned, and reasons for the permit granted;

    5.the percentage of utilised agricultural areas and other areas covered by aerial application permits;

    6.the number of permits for use of plant protection products in sensitive areas;

    7.the percentage of utilised agricultural area and other areas covered by permits for use of plant protection products in sensitive areas;

    8.the estimated quantities of illegal plant protection products used and the quantities of illegal plant protection products detected;  

    9.whether Member States have applied derogations allowing for

    (a)different inspection requirements to application equipment in professional use that represents a very low scale of use, or

    (b)exemptions from inspection for handheld application equipment or knapsack sprayers, in professional use.

    Training and advisory services:

    10.the percentage of professional users, advisors and distributors trained in the subjects listed in Annex III and holding a training certificate in accordance with Article 25 or who has a proof of entry in a central electronic register in accordance with Article 25(5), broken down by professional users, advisors and distributors;

    11.the percentage of professional users that failed to comply with the obligation to use independent advisory services at least once a year.

    Application equipment in professional use:

    12.the estimated percentage of application equipment in professional use registered on the electronic register of application equipment in professional use;

    13.the percentage of registered application equipment in professional use and due for inspection that has been inspected;

    14.the percentage, at time of inspection, of application equipment in professional use fitted with risk mitigation devices.

    Member State further measures to implement integrated pest management:

    15.the percentage of utilised agricultural area in each Member State that is covered by crop-specific rules that have been made legally binding under national legislation.

    ANNEX III

    TRAINING SUBJECTS REFERRED TO IN ARTICLE 25

    1.All relevant legislation regarding plant protection products and their use and risk and in particular this Regulation. While not exclusive, the following legislation is relevant:

    Regulation (EC) No 1107/2009 of the European Parliament and of the Council 3

    Regulation (EC) No 396/2005 of the European Parliament and of the Council  4

    Regulation (EU) No 528/2012 of the European Parliament and of the Council 5

    Regulation (EC) No 1185/2009 of the European Parliament and of the Council  6

    Regulation EC No 1272/2008 of the European Parliament and of the Council  7

    Regulation (EU) 2017/625 of the European Parliament and of the Council 8

    Regulation (EU) 2021/2115 of the European Parliament and of the Council 9

    Directive 2006/42/EC of the European Parliament and of the Council 10

    Directive 2009/127/EC of the European Parliament and of the Council 11

    Directive 2000/60/EC of the European Parliament and of the Council 12

    Council Directive 89/391/EEC 13

    Council Directive 89/656/EEC 14  

    Council Directive 98/24/EC 15  

    Directive 2004/37/EC of the European Parliament and of the Council 16

    Directive 2009/104/EC of the European Parliament and of the Council 17

    Regulation (EC) No 1907/2006 of the European Parliament and of the Council 18

    Directive 2008/68/EC of the European Parliament and of the Council 19

    2.The existence and risks of illegal and counterfeit plant protection products, the methods to identify such products, and the penalties associated with sale or use of illegal plant protection products.

    3.The hazards of and risks associated with plant protection products, and how to identify and control them, including the following subjects:

    (a)risks to human health;

    (b)symptoms of plant protection product poisoning and appropriate first aid measures in case of such poisoning;

    (c)risks to non-target plants and insects, wildlife, biodiversity and the environment in general.

    4.Integrated pest management strategies and techniques, integrated crop management strategies and techniques, organic farming principles, biological pest control methods, harmful organism control methods, the obligation to apply integrated pest management as set out in Articles 12 and 13 of this Regulation, and the obligation to enter records in the electronic integrated pest management and plant protection product use register, as set out in Article 14 of this Regulation.

    5.When plant protection products are needed, how to choose the plant protection products with the least side effects on human health, non-target organisms and the environment among all authorised products for a given pest problem, in a given situation.

    6.Measures to minimise risks to humans, non-target organisms and the environment, including:

    (a)safe working practices for storing, handling and mixing plant protection products;

    (b)safe working practices for disposing of empty packaging, other contaminated materials and surplus plant protection products (including tank mixes), whether in concentrate or dilute form;

    (c)the recommended way to control operator exposure (including personal protection equipment);

    (d)information on the correct and safe disposal of plant protection products that are no longer authorised and where any grace period for their use under Article 20(2) or 46 of Regulation 1107/2009 has expired.

    7.Procedures for preparing application equipment for operation, including its calibration, with minimum risks to the user, other persons, non-target animal and plant species, biodiversity and the environment, including water resources.

    8.Practical training on the use of application equipment and its maintenance, and on risk mitigation measures including specific spraying techniques, use of new technology including precision farming techniques, as well as the technical check of sprayers in use and ways to improve spray quality. In this subject special attention shall be paid to the drift-reduction nozzles and the recommendations made by the manufacturers concerning optimal conditions of their use. Specific risks linked to use of handheld application equipment or knapsack sprayers and the relevant risk management measures. Practical training shall also cover the specific risks linked to the sowing of seeds treated with plant protection products.

    9.Emergency action to protect human health and the environment, including water resources in case of accidental spillage and contamination and extreme weather events that would result in plant protection products leaching risks.

    10.Special care in sensitive areas as defined in Article 2(15) of this Regulation and protection areas established under Articles 6 and 7 of Directive 2000/60/EC and an awareness of contamination caused by particular plant protection products in their respective region.

    11.Facilities providing health monitoring and access to health care to which information on acute and chronic poisoning incidents can be reported..

    12.Record keeping of the sale, purchase and use of plant protection products, in accordance with the relevant legislation.

    13.How to minimise or eliminate applications of certain plant protection products classified as “harmful to aquatic life with long lasting effects”, “very toxic to aquatic life with long lasting effects” or “toxic to aquatic life with long lasting effects” pursuant to Regulation (EC) 1272/2008 on or along roads, railway lines, very permeable surfaces or other infrastructure close to surface water or groundwater or on sealed surfaces with a high risk of run-off into surface water or sewage systems.

    14.The protection of the aquatic environment and drinking water supplies from the impact of plant protection products, including in relation to the following subjects:

    (a)the use of plant protection products in accordance with the restrictions indicated on the label in accordance with Article 31, point (4)(a) of Regulation (EC) No 1107/2009, while giving preference to plant protection products that are not classified as “(very) persistent”, “(very) bioaccumulative”,

    “very toxic to aquatic life with long lasting effects”, “toxic to aquatic life with long lasting effects” or “harmful to aquatic life with long lasting effects” pursuant to Regulation (EC) No 1272/2008 20 or containing priority substances included in the list adopted by the Commission in accordance with Article 16 of Directive 2000/60/EC implemented via Directives 2008/105/EC and 2013/39/EU, or pesticides having been identified as river basin specific pollutants under Annex V, point 1.2.6 of Directive 2000/60/EC, in particular those affecting water used for the abstraction of drinking water in accordance with Article 7 of Directive 2000/60/EC and Directive (EU) 2020/2184;

    (b)potential hazards of and risks for human health and the environment from the use of plant protection products, as well as methods to minimise emissions to the environment and occupational exposure to more hazardous plant protection products;

    (c)use of drift reducing technology in all field crops;

    (d)use of other mitigation measures which minimise the risk of off-site pollution caused by spray drift, drain-flow and run-off, including in particular mandatory buffer zones adjacent to surface waters courses and groundwater and aquifers;

    (e)how to comply with restrictions set out in Regulation (EC) 1107/2009 for minimising or substituting uses of the plant protection products classified as “harmful to aquatic life with long lasting effects”, “very toxic to aquatic life with long lasting effects” or “toxic to aquatic life with long lasting effects”  pursuant to Regulation (EC) No 1272/2008, on or along roads, railway lines, very permeable surfaces or other infrastructure close to surface water or groundwater or on sealed surfaces with a high risk of run-off into surface water or sewage systems.

    ANNEX IV

    INSPECTION OF APPLICATION EQUIPMENT IN PROFESSIONAL USE

    The inspection of application equipment in professional use shall cover all aspects important to ensure a high level of safety and protection of human health and the environment. Full effectiveness and safety of the application operation shall be ensured by proper performance of any device or apparatus of the equipment to guarantee the following objectives are met.

    The application equipment in professional use shall function reliably and be used only in accordance with its manual of operation for its intended purpose ensuring that plant protection products can be accurately applied in line with good agricultural practice (GAP) as defined in Article 3(2), point (a), of Regulation (EC) 396/2005 of the European Parliament and the Council 21 .

    The equipment shall be in such a condition to allow it to be filled and emptied safely, easily and completely and to prevent any leakage of either spray solution or concentrated product. It shall permit easy and thorough cleaning. It shall also allow for safe operation, and be capable of being immediately stopped from the position of the operator. It shall be simple to perform any necessary adjustments. Such adjustments shall be accurate and capable of being reproduced.

    During inspection, compliance with the following requirements shall be checked:

    1.Safety

    The equipment shall be clean and safe before the inspection starts. The following shall be checked:

    the power take off driveshaft guard and all protective devices for the power take off and other rotating power transmission parts,

    leakage from the hydraulic system and general condition of hydraulic cylinders and pipes,

    safety and functioning of all electrical parts, including solenoid switches,

    functioning of safety valves,

    condition of structural parts, framework, and booms/nozzle holders,

    locking of foldable parts, and

    in the case of any equipment that uses air assistance, the guards and condition of the blower, including the physical condition of the blower unit, fan and sleeves.

    2.Leakage

    Both in stationary and working conditions there shall be no leakage or dripping from any part of the equipment. There shall be no dripping or unintended application after the equipment has been switched off. For equipment to apply liquid products there shall be no leakages from pipes or hoses when running at the maximum obtainable pressure for the system and no liquid shall have been applied directly to the sprayer itself.

    3.Pump (for equipment used to apply liquid products)

    The pump capacity shall be suited to the needs of the application equipment and the pump shall function properly in order to ensure a stable and reliable application rate.

    4.Agitation or mixing (for equipment to apply liquid products)

    Agitation or mixing devices shall ensure a proper recirculation in order to achieve an even concentration of the whole volume of the liquid spray mixture in the tank.

    5.Spray liquid tank/hopper

    Spray tanks and hoppers including filling level indicators, filling devices, filters, emptying and rinsing systems and mixing devices shall operate in such a way as to minimise accidental spillage, uneven concentration distribution, operator exposure and residual content.

    6.Measuring systems, control and regulation systems

    All devices for measuring, switching on and off and adjusting pressure or flow rate shall be properly calibrated and work correctly. The controls to be operated during the application operation shall be operable from the operator’s position, the necessary instruments to control the operation shall be present and accurate and the instrument displays shall be readable from the operator’s position. For equipment to apply liquid products, pressure adjustment devices shall maintain a constant working pressure at constant revolutions of the pump, in order to ensure that a stable volume application rate is applied. Additional equipment to dose or inject plant protection products shall function accurately and correctly.

    7.Pipes and hoses

    Pipes and hoses shall be in properly functioning condition to avoid disturbance of product flow or accidental spillage in case of failure. Pipes and hoses shall not be kinked, excessively worn or in a position which would allow stretching.

    8.Filtering (for equipment to apply liquid products)

    In order to avoid turbulence and heterogeneity in spray patterns, filters shall be present and in good condition and the mesh size of the filters shall correspond and be appropriate to the size of nozzles fitted on the sprayer. Where applicable the filter blockage indication system shall operate correctly.

    9.Spray boom (for equipment applying plant protection products by means of a horizontally or vertically positioned boom, located close to the crop or the material to be treated)

    The boom shall be in good condition and stable in all directions. The fixation and adjustment systems and the devices for damping unintended movements and slope compensation shall work correctly.

    10.Nozzles (for equipment to distribute liquid products)/ outlets (for solid products)

    Nozzles and outlets shall work properly. The flow rate of each individual nozzle and outlet shall not deviate significantly from the data of the flow rate tables provided by the manufacturer.

    11.Distribution

    Where relevant, the longitudinal, transversal and vertical (in case of applications in vertical crops) distribution of the product in the target area shall be even.

    12.Blower (for equipment distributing plant protection products by air assistance)

    The blower shall be in good condition and shall ensure a stable and reliable air stream.

    13.Cleaning

    If present, the rinsing/cleaning systems for emptied containers, e.g. fitted on induction hoppers of application equipment, shall work reliably. Moreover, if provided, tank cleaning devices, devices for external cleaning, devices for cleaning of induction hoppers and devices for the internal cleaning of the complete application equipment shall function correctly.

    ANNEX V

    NOTIFICATION FORM

    Reason for notification (Please tick)

    New equipment or first registration of used equipment

    Removal from use

    Change of ownership

    Return to use

    Current owner

    Name:

    Unique personal / company identifier:
    (Tax Number)

    Address 1:

    Address 2:

    Occupation:
    (Farmer, Landscaper, Contractor, other please specify)

    Address 3:

    Address 4:

    Country:

    Previous owner if applicable

    Name:

    Address 1:

    Address 2:

    Address 3:

    Address 4:

    Country:

    Pesticide application equipment type (Please tick most appropriate)

    Boom sprayer

    PPP application equipment which produces droplets and which uses a fan to distribute these droplets vertically and/or laterally

    Fogger (cold & hot)

    Seed dresser

    Granule applicator

    Vapour generator

    Vertical sprayer

    Aircraft (winged)

    Aircraft (rotor)

    Unmanned aircraft (e.g. drone)

    Handheld application equipment

    Other

    Please describe:

    Is equipment air assisted?

    Is equipment fitted with GPS controlled nozzle or section shut off?

    Pesticide application equipment

    Make:

    Model:

    Chassis No.:

    Tank/hopper capacity:

    Manufacture year:

    Working width:

    Other information:

    ANNEX VI
    referred to in Article 35

    METHODOLOGY FOR CALCULATING HARMONISED RISK INDICATORS AT UNION AND NATIONAL LEVEL

    SECTION 1

    Harmonised risk indicators

    The methodology for calculating harmonised risk indicators at both Union and national levels is listed in Sections 2 to 4 of this Annex. While the methodology for both Union and national indicators is the same, the former is based on Union wide statistics while the latter are based on national statistics. These indicators shall be calculated annually.

    SECTION 2

    Harmonised risk indicator 1: hazard-based harmonised risk indicator based on the quantities of active substances placed on the market in plant protection products under Regulation (EC) No 1107/2009

    1.This indicator shall be based on statistics on the quantities of active substances placed on the market in plant protection products under Regulation (EC) No 1107/2009, provided to the Commission (Eurostat) under Annex I of Regulation (EC) No 1185/2009. Those data are categorised into 4 groups.

    2.The following general rules shall apply for the calculation of harmonised risk indicator 1:

    (a)harmonised risk indicator 1 shall be calculated on the basis of the categorisation of all active substances into the 4 groups set out in Table 1;

    (b)the active substances in group 1 shall be those listed in Part D of the Annex to Implementing Regulation (EU) No 540/2011;

    (c)the active substances in group 2 shall be those listed in Parts A and B of the Annex to Implementing Regulation (EU) No 540/2011;

    (d)the active substances in group 3 shall be chemical active substances that are approved as candidates for substitution in accordance with Article 24 of Regulation (EC) No 1107/2009 and are listed in Part E of the Annex to Implementing Regulation (EU) No 540/2011, or that are listed in the Annex to Implementing Regulation (EU) 2015/408;

    (e)the active substances in group 4 shall be those not approved under Regulation (EC) No 1107/2009, and therefore not listed in the Annex to Implementing Regulation (EU) No 540/2011;

    (f)the weightings in row (iii) in Table 1 shall apply.

    3.Harmonised risk indicator 1 shall be calculated by multiplying the annual quantities of active substances in plant protection products placed on the market for each group in Table 1 by the relevant hazard weighting set out in row (iii), followed by the aggregation of the results of these calculations.

    Table 1

    Categorisation of active substances and hazard weightings for the purpose of calculating harmonised risk indicator 1

    Row

    Groups

    1

    2

    3

    4

    (i)

    Low-risk active substances which are approved or deemed to be approved under Article 22 of Regulation (EC) No 1107/2009, and which are listed in Part D of the Annex to Implementing Regulation (EU) No 540/2011

    Active substances approved or deemed to be approved under Regulation (EC) No 1107/2009, and not falling in other categories, and which are listed in Parts A and B of the Annex to Implementing Regulation (EU) No 540/2011

    Active substances that are approved as candidates for substitution in accordance with Article 24 of Regulation (EC) No 1107/2009 and listed in Part E of the Annex to Implementing Regulation (EU) No 540/2011, or that are listed in the Annex to Implementing Regulation (EU) 2015/408.

    Active substances which are not approved under Regulation (EC) No 1107/2009, and therefore which are not listed in the Annex to Implementing Regulation (EU) No 540/2011

    (ii)

    Hazard weightings applicable to quantities of active substances placed on the market in products authorised under Regulation (EC) No 1107/2009

    (iii)

    1

    8

    16

    64

    4.The baseline for harmonised risk indicator 1 shall be set at 100, and is equal to the average result of the above calculation for the period 2011-2013.

    5.The result of harmonised risk indicator 1 shall be expressed by reference to the baseline.

    6.The Commission shall calculate and publish the results of harmonised risk indicator 1 at Union level in accordance with Article 35(2) of this Regulation for each calendar year and at the latest 20 months after the end of the year for which harmonised risk indicator 1 is being calculated.

    7.The Member States shall calculate and publish the results of harmonised risk indicator 1 at national level in accordance with Article 35(3) of this Regulation for each calendar year and at the latest 20 months after the end of the year for which harmonised risk indicator 1 is being calculated.

    SECTION 3

    Harmonised risk indicator 2: harmonised risk indicator based on the number of authorisations granted under Article 53 of Regulation (EC) No 1107/2009

    1.This indicator shall be based on the number of authorisations granted for plant protection products under Article 53 of Regulation (EC) No 1107/2009 as communicated to the Commission in accordance with Article 53(1) of that Regulation. Those data are categorised into 4 groups. 

    2.The following general rules shall apply for the calculation of harmonised risk indicator 2:

    (a)harmonised risk indicator 2 shall be based on the number of authorisations granted under Article 53 of Regulation (EC) No 1107/2009, and it shall be calculated on the basis of the categorisation of active substances into the 4 groups set out in Table 2 of this Section;

    (b)the active substances in group 1 shall be those listed in Part D of the Annex to Implementing Regulation (EU) No 540/2011;

    (c)the active substances in group 2 shall be those listed in Parts A and B of the Annex to Implementing Regulation (EU) No 540/2011;

    (d)the active substances in group 3 shall be chemical active substances that are approved as candidates for substitution in accordance with Article 24 of Regulation (EC) No 1107/2009 and are listed in Part E of the Annex to Implementing Regulation (EU) No 540/2011, or that are listed in the Annex to Implementing Regulation (EU) 2015/408; 

    (e)the active substances in group 4 shall be those not approved under Regulation (EC) No 1107/2009, and therefore not listed in the Annex to Implementing Regulation (EU) No 540/2011;

    (f)The weightings in row (iii) in Table 2 of this Section shall apply.

    3.Harmonised risk indicator 2 shall be calculated by multiplying the number of authorisations granted for plant protection products under Article 53 of Regulation (EC) No 1107/2009 for each group in Table 2 by the relevant hazard weighting set out in row (iii), followed by the aggregation of the results of these calculations.

    Table 2

    Categorisation of active substances and hazard weightings for the purpose of calculating harmonised risk indicator 2

    Row

    Groups

    1

    2

    3

    4

    (i)

    Low-risk active substances which are approved or deemed to be approved under Article 22 of Regulation (EC) No 1107/2009, and which are listed in Part D of the Annex to Implementing Regulation (EU) No 540/2011

    Active substances approved or deemed to be approved under Regulation (EC) No 1107/2009, and not falling in other categories, and which are listed in Parts A and B of the Annex to Implementing Regulation (EU) No 540/2011

    Active substances that are approved as candidates for substitution in accordance with Article 24 of Regulation (EC) No 1107/2009 and listed in Part E of the Annex to Implementing Regulation (EU) No 540/2011, or that are listed in the Annex to Implementing Regulation (EU) 2015/408.

    Active substances which are not approved under Regulation (EC) No 1107/2009, and therefore which are not listed in the Annex to Implementing Regulation (EU) No 540/2011

    (ii)

    Hazard weightings applicable to quantities of active substances placed on the market in products authorised under Regulation (EC) No 1107/2009

    (iii)

    1

    8

    16

    64

    4.The baseline for harmonised risk indicator 2 shall be set at 100, and is equal to the average result of the above calculation for the period 2011-2013.

    5.The result of harmonised risk indicator 2 shall be expressed by reference to the baseline.

    6.The Commission shall calculate and publish the results of harmonised risk indicator 2 at Union level in accordance with Article 35(2) of this Regulation for each calendar year and at the latest 20 months after the end of the year for which harmonised risk indicator 2 is being calculated.

    7.The Member States shall calculate and publish the results of harmonised risk indicator 2 at national level in accordance with Article 35(3) of this Regulation for each calendar year and at the latest 20 months after the end of the year for which harmonised risk indicator 2 is being calculated.

    8.With effect from 1 January 2027, the methodology of harmonised risk indicator 2 shall be replaced by the methodology of harmonised risk indicator 2a referred to in section 4 of this Annex.

    SECTION 4

    Harmonised risk indicator 2a: harmonised risk indicator based on the number of and areas treated under authorisations granted under Article 53 of Regulation (EC) No 1107/2009

    1.This indicator shall be based on the number of authorisations granted for plant protection products under Article 53 of Regulation (EC) No 1107/2009, and the extent of the areas treated under these authorisations, as communicated to the Commission in accordance with Article 53(1) of that Regulation.

    2.The following general rules shall apply for the calculation of harmonised risk indicator 2a:

    (a)harmonised risk indicator 2a shall be based on the number of authorisations granted under Article 53 of Regulation (EC) No 1107/2009 and the extent of the areas treated under these authorisations. It shall be calculated on the basis of the categorisation of active substances into the 4 groups set out in Table 3 of this Section;

    (b)the areas treated shall be in hectares;

    (c)the active substances in group 1  shall be those listed in Part D of the Annex to Implementing Regulation (EU) No 540/2011;

    (d)the active substances in group 2 shall be those listed in Parts A and B of the Annex to Implementing Regulation (EU) No 540/2011;

    (e)the active substances in group 3 shall be chemical active substances that are approved as candidates for substitution in accordance with Article 24 of Regulation (EC) No 1107/2009 and are listed in Part E of the Annex to Implementing Regulation (EU) No 540/2011, or that are listed in the Annex to Implementing Regulation (EU) 2015/408; 

    (f)the active substances in group 4 shall be those not approved under Regulation (EC) No 1107/2009, and therefore not listed in the Annex to Implementing Regulation (EU) No 540/2011;

    (g)The weightings in row (iii) in Table 3 of this Section shall apply.

    3.Harmonised risk indicator 2a shall be calculated by multiplying the number of authorisations granted for plant protection products under Article 53 of Regulation (EC) No 1107/2009 for each group in Table 3 by the relevant hazard weighting set out in row (iii), and by the areas treated under these authorisations, followed by the aggregation of the results of these calculations.

    Table 3

    Categorisation of active substances and hazard weightings for the purpose of calculating harmonised risk indicator 2a

    Row

    Groups

    1

    2

    3

    4

    (i)

    Low-risk active substances which are approved or deemed to be approved under Article 22 of Regulation (EC) No 1107/2009, and which are listed in Part D of the Annex to Implementing Regulation (EU) No 540/2011

    Active substances approved or deemed to be approved under Regulation (EC) No 1107/2009, and not falling in other categories, and which are listed in Parts A and B of the Annex to Implementing Regulation (EU) No 540/2011

    Active substances that are approved as candidates for substitution in accordance with Article 24 of Regulation (EC) No 1107/2009 and listed in Part E of the Annex to Implementing Regulation (EU) No 540/2011, or that are listed in the Annex to Implementing Regulation (EU) 2015/408.

    Active substances which are not approved under Regulation (EC) No 1107/2009, and therefore which are not listed in the Annex to Implementing Regulation (EU) No 540/2011

    (ii)

    Hazard weightings applicable to quantities of active substances placed on the market in products authorised under Regulation (EC) No 1107/2009

    (iii)

    1

    8

    16

    64

    4.The baseline for harmonised risk indicator 2a shall be set at 100, and is equal to the average result of the above calculation for the period 2022-2024.

    5.The result of harmonised risk indicator 2a shall be expressed by reference to the baseline.

    6.The Commission shall calculate and publish the results of harmonised risk indicator 2a at Union level in accordance with Article 35(2) of this Regulation. This shall be done for the first time in 2027 using data from calendar years 2022 to 2025, and subsequently for each calendar year, at the latest 20 months after the end of the year for which harmonised risk indicator 2a is being calculated.

    7.The Member States shall calculate and publish the results of harmonised risk indicator 2a at national level in accordance with Article 35(3) of this Regulation. This shall be done for the first time in 2027 using data from calendar years 2022 to 2025, and subsequently for each calendar year, at the latest 20 months after the end of the year for which harmonised risk indicator 2a is being calculated.

    ANNEX VII

    CORRELATION TABLE REFERRED TO IN ARTICLE 43(2)

    Directive 2009/128/EC

    This Regulation

    Article 1

    Article 1

    Article 2

    Article 2

    Article 3

    Article 3

    Article 4

    Articles 8 to 9

    Article 5

    Articles 17(1), 23 and 25

    Article 6

    Article 24

    Article 7

    Article 27

    Article 8

    Article 17(3) to (5) and Articles 29 to 33

    Article 9

    Articles 20 to 21

    Article 10

    Article 11

    Article 19

    Article 12

    Article 18

    Article 13

    Article 22

    Article 14

    Articles 12 to 16

    Article 15

    Articles 35 and 36

    Article 16

    Articles 11(7), 15(13) and 42(2)

    Article 17

    Article 38

    Article 18

    Article 19

    Article 39

    Article 20

    Article 31(11)

    Article 21

    Article 41

    Article 22

    Article 23

    Article 24

    Article 44

    Article 25

    Annex I

    Annex III

    Annex II

    Annex IV

    Annex III

    Annex IV

    Annex VI

    (1)    Regulation (EC) No 1185/2009 of the European Parliament and of the Council of 25 November 2009 concerning statistics on pesticides (OJ L 324, 10.12.2009, p. 1).
    (2)    Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).
    (3)    Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).
    (4)    Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).
    (5)    Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).
    (6)    Regulation (EC) No 1185/2009 of the European Parliament and of the Council of 25 November 2009 concerning statistics on pesticides (OJ L 324, 10.12.2009, p. 1).
    (7)    Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
    (8)    Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).
    (9)    Regulation (EU) 2021/2115 of the European Parliament and of the Council of 2 December 2021 establishing rules on support for strategic plans to be drawn up by Member States under the common agricultural policy (CAP Strategic Plans) and financed by the European Agricultural Guarantee Fund (EAGF) and by the European Agricultural Fund for Rural Development (EAFRD) and repealing Regulations (EU) No 1305/2013 and (EU) No 1307/2013 OJ L 435, 6.12.2021, p. 1).
    (10)    Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24).
    (11)    Directive 2009/127/EC of the European Parliament and of the Council of 21 October 2009 amending Directive 2006/42/EC with regard to machinery for pesticide application (OJ L 310, 25.11.2009, p. 29).
    (12)    Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1).
    (13)    Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (OJ L 183, 29.6.1989, p. 1).
    (14)    Council Directive 89/656/EEC of 30 November 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace (third individual directive within the meaning of Article 16 (1) of Directive 89/391/EEC) (OJ L 393, 30.12.1989, p. 18).
    (15)    Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (OJ L 131, 5.5.1998, p. 11).
    (16)    Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to their exposure to carcinogens or mutagens at work (OJ L 158, 30.4.2004, p. 50).
    (17)    Directive 2009/104/EC of the European Parliament and of the Council of 16 September 2009 concerning the minimum safety and health requirements for the use of work equipment by workers at work (second individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 260, 3.10.2009, p. 5).
    (18)    Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
    (19)    Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (OJ L 260, 30.9.2008, p. 13).
    (20)    Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
    (21)    Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).
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