Biocidal products and articles treated with such products are regulated in the EU by Regulation (EU) No 528/2012, Biocidal Products Regulation (BPR).
Biocidal products are used to control unwanted organisms that are harmful to human or animal health or to the environment, or that cause damage to materials or human activities, including pests (for example, insects, rats or mice) and microorganisms (for example, bacteria, viruses or mould).
The Regulation aims to improve the functioning of the internal market for biocidal products while ensuring a high level of protection of human, animal health and the environment.
Applicable since 1 September 2013, the Biocidal Products Regulation (BPR) maintains a two-step approach already set out in its predecessor (Directive 98/8/EC), consisting of approval of active substances at EU level and subsequent authorisation - at national or EU level - of biocidal products containing such active substances.
Under Article 65(4) of the Biocidal Products Regulation (BPR), a Report on the implementation of Regulation (EU) No 528/2012 was adopted by the Commission in June 2021. It identified several issues that hinder the proper functioning of the rules, in particular the continuous substantial delays in both active substance approval and product authorisation processes.
The report also pointed to limited innovation regarding new biocidal active substances. It announced that, instead of preparing a second implementation report five years later, an evaluation of the BPR will take place to assess if the current rules are fit for purpose.
Evaluations are evidence-based assessments allowing to find out about the functioning of EU interventions, to assess the performance of those interventions against initial expectations and to take a critical look at whether EU activities are fit for purpose and deliver their intended objectives at minimum cost (that is, without unnecessary burden.
The evaluation process consists of different steps following the Better Regulation guidelines and toolbox, of which the initial ones are outlined below. The evaluation of the Biocidal Products Regulation is foreseen to be finalised around mid-2027. After the finalisation of the evaluation and depending on its findings, an impact assessment for a potential revision of the Biocidal Products Regulation might follow.
Call for evidence and public consultation
The Commission has published on the ‘Have your say’ web portal a call for evidence on the evaluation of the Biocidal Products Regulation (BPR) for twelve weeks.
The call for evidence 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 assessed in relation to this evaluation:
- effectiveness of the intervention
- efficiency in relation to resources used
- relevance in relation to identified needs and problems
- coherence with other interventions with a common objective
- EU added value compared to what could have been achieved by Member States alone.
At the same time, a public consultation was published on the same page, aimed at getting feedback from stakeholders through answers to specific questions. The public consultation questionnaire is divided into two parts, one aimed for the general public and one aimed for members of the public with certain knowledge about the Biocidal Products Regulation.
Stakeholders can submit their feedback on the call for evidence and public consultation on the ‘Have your say’ portal. The two documents are available for feedback for twelve weeks from the date of publication.
Terms of Reference
The Commission has prepared the Terms of Reference for an independent external study to support the evaluation of the Biocidal Products Regulation. The Terms of Reference set out the Commission’s services requests to the contractor under the framework contract.
Launching of the External Study
The kick-off meeting with the contractor is expected in the coming months and will mark the official launch of the external study.
Consultation Strategy
The evaluation is an evidence-based assessment of the implementation of the Biocidal Products Regulation. The consultation aims to:
- collect information, data and knowledge on the application of the Biocidal Products Regulation.
- collect views and opinions on different aspects of the BPR and their effects.
- draw on the experience of different stakeholders.
Gathering evidence, data and information is a crucial part of this evaluation exercise. The main stakeholders identified are Member States’ national competent authorities, companies, consultancies, industry associations (at EU and national level), the European Chemicals Agency (ECHA), non-governmental organisations and the public.
The following consultation tools and processes are envisaged:
- publication of the call for evidence together with the public consultation for 12 weeks on the Commission’s Have Your Say portal (Q4 2025). A factual summary report will be published on the consultation page within eight weeks of the consultation deadline
- targeted consultation activities will be carried out during the evaluation process. They will concern certain stakeholders, including Member States’ competent authorities, companies (including SMEs, as many companies in the sector are SMEs), the European Chemicals Agency (ECHA), and civil society organisations. They will be carried out in the form of questionnaires, targeted interviews and workshops.
