EUROPE: Publication of the supporting study for the ‘REFIT’ of Reg. (EC) No. 1107/2009 and No. 396/2005

The European Commission started in 2016 the application of the Regulatory Fitness and Performance programme (REFIT) to the European Regulation on pesticides (Regulation (EC) No. 1107/2009) and their residues (Regulation (EC) No. 396/2005). The aim of applying the REFIT programme is to assess if the current Regulations are ‘fit for purpose’ and meet the needs of citizens, businesses and public institutions in an efficient manner. In particular, the evaluation addresses synergies, gaps, inefficiencies and administrative burdens.

The main evaluation criteria set out to be addressed in relation to this REFIT Evaluation are:

  • 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.

The evaluation study, based on those criteria, which will support the REFIT evaluation was conducted between 2017 and 2018 by external contractors. The final report of the study was recently published (18 October 2018) and can be downloaded from the links below.

The analysis is based on data collected via case studies and consultation of stakeholders (EFSA, European Commission, Member State competent authorities, SME panel, etc.) and via an open public consultation which involved almost 10,000 citizens. The data analysis notably included timeline tracking and an analysis of the costs and benefits of the Regulations.

The main conclusions of the external evaluation study are:

  • The pesticide Regulation (EC) No. 1107/2009 led to an improved harmonisation of active substance and plant protection product (PPP) registration procedures in the EU, and it contributes to the protection of both human health and the environment. Nevertheless, important issues affecting the regulatory processes were identified. The lack of capacity and resources in MSs and at EFSA and the zonal system (in particular mutual recognition) not delivering as expected are among the key issues identified.
  • The MRL Regulation (EC) No. 396/2005 is generally effective in achieving its objectives. It ensures a high level of consumer protection and facilitates the functioning of the internal EU market. The main difficulties identified are related to the MRL revision procedure according to Art. 12, which is considered not ‘fit for purpose’. Besides, the current provisions for setting MRLs for non-chemical active substances are deemed inadequate.

The following issues were also underlined for both Regulations:

  • The delay for implementing and applying several provisions (e.g. assessment of the cumulative risk for consumers) creates obstacles to ensuring a high level of protection for both human health and the environment.
  • Active substances and PPPs not assessed in a timely manner often lead to unsatisfactory evaluations in light of the latest scientific and technical knowledge. The delays also lead to uncertainty and unpredictability which affect companies, particularly SMEs, in their capacity to innovate and to propose alternative solutions to replace hazardous substances.

The Commission REFIT evaluation, based on the results of this external evaluation study, is foreseen to be finalised in the first half of 2019.


To download:

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)

Executive summary

Final report

Annexe I : Synopsis report

Annexe II : Methodology and cost calculations

Annexe III : Consultation activities – surveys and interviews


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