Plant protection products (PPPs) are used to protect plants against pests or diseases. PPPs and their residues are regulated in the EU by Regulation (EC) No 1107/2009 and Regulation (EC) No 396/2005. The Commission approves active substances, i.e., the agent used to achieve the protective effect, for the use in PPPs, which are authorised by the Member States. In order to protect consumers, the Commission also sets maximum residue levels (MRLs) for pesticides, i.e. the highest levels of pesticide residues that are legally tolerated in or on food or feed, including imported products.
Evaluations and Fitness Checks are tools that are used to implement the Regulatory Fitness and Performance programme (REFIT). REFIT is a rolling programme to keep the entire stock of EU legislation under review and ensure that it is 'fit for purpose'; that regulatory burdens are minimised and that all simplification options are identified and applied.
Starting in November 2016, the Commission has conducted a REFIT evaluation of the EU pesticides legislation in a process described further down in order to assess if the regulations meet the needs of citizens, businesses and public institutions in an efficient manner. The Commission has adopted on 20 May 2020 – together with the Farm to Fork Strategy, the Biodiversity Strategy and the 2nd report on the implementation of the Sustainable Use Directive - report to the European Parliament and the Council, which outlines the main findings of the evaluation. The detailed findings of the evaluation are presented in an accompanying Staff Working Document.
The evaluation found that stakeholders from across the spectrum consider that the regulatory requirements for pesticides in the EU are among the strictest in the world. It shows that the PPP and MRL Regulation provide for the protection of human health and the environment and are generally effective, although implementation can be further improved. The Regulations have a recognised added value at EU level and are relevant for the evolving needs of society. Ccoherence is mostly ensured, both internally within and between the Regulations, and externally with other EU legislation and international rules.
Efficiency stands out as the critical area requiring attention. Due to a lack of resources and capacity in the Member States, most of the procedures set out in the Regulations are suffering from severe delays, in particular those related to the renewal of approval of active substances and the authorisation of PPP containing approved substances, which in turn negatively affects their effectiveness. Surveys were conducted on the performance of Member States competent authorities in complying with the deadlines set for product authorisations in Regulation (EC) No 1107/2009. The procedures evaluated include authorisations of plant protection products (including for minor uses, containing a low-risk active substance or a candidate for substitution), renewals of active substances, mutual recognition and grating on parallel permits.
The immediate focus for follow-up of this evaluation will be on improving the implementation of the existing legislative framework. Sixteen areas have been identified where implementation in the short and medium term could be improved. These actions are expected to deliver substantial improvements in the effective implementation of the two Regulations in a short timeframe, which will bring substantial contribution to the achievement of the objectives of the European Green Deal, the Farm to Fork Strategy and the Biodiversity Strategy.
The different steps of the REFIT evaluation of the EU pesticides legislation
The Roadmap
The Commission published on 17 November 2016, a Roadmap on the REFIT Evaluation of the EU legislation on plant protection products and pesticides residues. This Roadmap is a first step in the evaluation process and outlines the purpose, content and scope of the evaluation. Moreover, it sets out the main evaluation criteria to be addressed in relation to this REFIT Evaluation:
- Effectiveness of the intervention
- Efficiency in relation to resources used
- Relevance in relation to identified needs and problems
- Coherence with other interventions with common objective
- EU added value compared to what could have been achieved by EU country or international action.
Stakeholders submitted their feedback on the roadmap via a dedicated web page. Feedback received during the first four weeks after publication of the roadmap was considered in the design of the evaluation (i.e. in the Terms of Reference for the external study). Whether feedback received after that period can be taken into account will depend on the type of feedback and the status of the evaluation process at the time of receipt.
Feedback received may be accessed here.
Terms of Reference
The Commission has prepared the Terms of Reference for the external independent study that will be the basis for the REFIT evaluation. The Terms of Reference sets out what the Commission services’ asks from the contractor to do under the framework contract.
The external evaluation study
The kick-off meeting with the Commission services and the contractor was held on 3 July 2017 and marked the official launching of the external study. The study supporting the REFIT Evaluation of the EU legislation on plant protection products and pesticides residues (Regulation (EC) No 1107/2009 and Regulation (EC) No 396/2005) was finalised and published on 18 October 2018.
- Executive Summary
- Study supporting the REFIT Evaluation - Final report
- Annex I: synopsis report
- Annex II: methodology and cost calculations
- Annex III: consultation activities – surveys and interviews
Consultation Strategy
The evaluation is an evidence-based assessment of the implementation of the PPP and MRL regulations. The consultation aims at collecting factual information, data and knowledge on the application of the Regulations. It also aims at drawing upon the experience of different stakeholders and collecting particular views and opinions on different aspects of the Regulations and their effects.
The collection of evidence, data and information is a crucial part of this REFIT Evaluation exercise. In this respect, extensive consultation of all stakeholders directly or indirectly affected by these issues will be consulted, including the EU countries' competent authorities, the European Food Safety Authority (EFSA), organisations representing the food and chemical industry (including SMEs), farmers and other users of plant protection products, importers, consumers and non-governmental organisations (NGOs), in particular those dealing with public health and environmental protection as well as the relevant scientific community and third countries. Stakeholder's views, practical experience and supporting evidence will ensure a high quality and credible evaluation.
We invite all citizens and stakeholders to contribute to the evaluation. Received contributions may be published on the Internet. It is important that you read the specific privacy statement for information on how your personal data and contribution will be dealt with.
The consultation strategy for this REFIT evaluation includes a combination of consultation methods and tools. The main data collection tools include:
- Public Consultation
- Online survey of stakeholders
- Online survey of EU Member State Competent Authorities
- SME survey via the Europe Enterprise Network
- Focus groups
- In-depth interviews - following the online surveys
- Case studies - following the online surveys
- First Workshop – 12 September 2017
- Second Workshop – 16 May 2018
Public Consultation
All EU as well as non-EU citizens were welcome to contribute to the Consultation. The questionnaire was accessible in all official EU languages.
The public consultation aims to collect the views of citizens on the EU legislation on pesticides and pesticides residues. It seeks to receive information on how citizens view the strengths and weaknesses of the legislation and the perceived level of protection of human and animal health and the environment.
A factual summary report gives an overview of the responses received.
The public consultation closed on 12 February 2018.
Online survey of stakeholders
The online survey closed on 12 January 2018.
We invite all stakeholders and trading partners to respond to the survey. Please note that it is not compulsory to answer to all the questions for your contribution to be taken into account, as the survey is addressed to all stakeholders of the legislation and not all chapters are expected to be of the same importance for all stakeholder groups.
For your answer to be properly considered your organisation needs to be registered in the Transparency Register. If your organisation is not registered, we invite you to register here.
Online survey of EU Member State Competent Authorities
Member State Competent Authorities are consulted via an online survey. The survey aims to collect factual information as well as perceptions and will be followed up with in-depth interviews.
SME survey via the Europe Enterprise Network
An SME survey, targeting individual companies, and more specifically SMEs (including micro-enterprises), is launched via the Europe Enterprise Network SME Panel. The consultation aims at allowing, in the context of this evaluation, to consider how easy it has been for SMEs to comply with the legislation and whether they incurred disproportionate costs in comparison with their size and turnover.
The factual summary report gives an overview of the responses received.
The consultation closed on 15 january 2018.
Focus groups
Focus groups will be organised in January, February and March 2018. The focus groups are held in order to bring together all stakeholders involved in a specific process of the legislation, i.e., risk assessment, risk management and decision making, MRL setting and PPP authorisation.
In-depth interviews - following the online surveys
In-depth interviews will be conducted with the purpose to further investigate, clarify and analyse elements that will come up in the context of the online surveys. Interviews will be carried out with key stakeholders both at Member states' level and at EU level as well as with selected third countries.
Case studies - following the online surveys
Case studies aim to provide more in-depth investigation on certain issues in order to shed light on the complexity and practical details of the legislation. The case studies will have a geographical focus (Member State /third country) and/or be active substance, crop or pest specific.
First Workshop – 12 September 2017
The first workshop brought together the Contractor carrying out the external study, the Commission services, several stakeholder associations, Member State Competent Authorities, the Minor Uses Coordination Facility and the European Food Safety Authority. The general objectives of the legislations and the methodology of the evaluation, including the questionnaires for Member States and stakeholders, were discussed in order to validate the approach of the evaluation study.
Second Workshop – 16 May 2018
The second workshop served as an opportunity for the external Contractor to present the draft study and validate the preliminary results with stakeholders, experts and regulators.
The bigger picture and links with other ongoing Commission initiatives
The Commission is currently carrying out a fitness check on the most relevant chemicals legislation (excluding REACH) led by DG Growth and DG Environment. The REFIT evaluation on REACH, which is relevant for plant protection products as the classification of substances is done under REACH was published in March 2018. The fitness check on the General Food Law Regulation, which establishes the fundamental pillars of the food and feed law, is finalised and the Commission Staff Working Document was published in January 2018. Directive 2009/128/EC on the sustainable use of pesticides will be the object of a separate assessment in the future. However, a report from the Commission on Member State National Action Plans and on progress in the implementation of Directive 2009/128/EC on the sustainable use of pesticides was published in October 2017.
Contact
Directorate E (Food and feed safety, innovation)
Unit E4: Pesticides and biocides
