DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
Safety of the Food Chain
Pesticides and Biocides
Note for Guidance
This document is an attempt to provide guidance in the interest of consistency, and has been drafted by the Commission services responsible for biocidal products with the aim of finding an agreement with the Member States' Competent Authorities for biocidal products. Please note,however, that Member States are not legally obliged to follow the approach set out in this document, since only the Court of Justice of the European Union can give authoritative interpretations on the contents of Union law.
Subject:EU structure to discuss BPRenforcement, control and monitoring matters
1. Background and purpose of the document
(1)Once legislation is adopted and implemented, it must also be monitored and enforced and specific tools and structures need to be created to that effect. Enforcementand monitoring of Regulation (EU) No 528/2012 (the BPR) is a national responsibility.
(2)In March 2015, the Commission presented a discussion note[1] on Member States' arrangements for enforcement, controls and monitoring. The purpose of this note was to seek information from Member States on how monitoring and enforcement of the BPRis being organised on their territories and to initiate a discussion whether there is need for a structure at EU level in order to support Member States in their role.
(3)Member States were asked to reflect as to whether a specific structure would be helpful at the EU level to support Member States with these activities, in particular to ensure more and better coordination and to set priorities.
(4)A revised-version of the note wasdiscussed at the meeting of the competent authorities of May 2015 and Member States were invited, before the 1st of July 2015[2], to:
(a)inform the Commission before the September CA meeting about the tools and structures to control, monitor and enforce the BPR on their territory and the applicable national provisions on penalties.
(b)provide their views on the need for a structure at EU level in order to support Member States in their role in relation to enforcement, control and monitoring, the potential tasks of this structure and how it could be organised.
(5)In their responses, most Member States supported the development of a structure at EU level in order to support Member States in their role of controlling and enforcing the BPR. Many Member States indicated in their responses to favour, if possible, using or collaborating with existing structures like:
(a)Forum[3], which coordinates a network of Member State authorities responsible for the enforcement of the REACH, CLP and PIC Regulation,
(b)the CLEEN-network[4], where inspectors are voluntarily collaborating and exchanging information and good practices on control of chemicals,
(c)the European Market Surveillance Forum[5], and
(d)the adaptation of OECD systems used for pesticides, e.g. OECD Network on Illegal Trade of Pesticides.
(6)Based on the information provided, the Commission prepared a revised note for the meeting of September 2015. In this meeting,several Member States pointed out to be reluctant to establish a new group because of the additional resources required at Member States level to participate in these meetings. From that point of view ECHA’sForum was considered as the best use of resources. Representatives also indicated that the functioning, mandate and task description of the EU structure should be more detailed. The Chairman noted that a majority of Member States supported the inclusion of biocides under the umbrella of ECHA’sForum and invited Member States to send written comments before the end of October, in particular on the type of co-ordination that should take place, on the activities and priorities (for example Article 95 and treated articles), and to propose ideas on how to organise the inclusion of biocides in ECHA’sForum (e.g. resources).
2.Feedback of Member States
(5)One Member State provided a written response to the document on control and enforcement[6]and nine Member States and Norway responded to the note concerning enforcement of Article 95[7].The comments can be found in a separate document CA-Nov15-Doc.9.1-Annex. Based on the information provided, the Commission prepared this note for the meeting of November 2015.
3.structure at EU level for enforcement, controls and monitoring
(6)It is important to underline the challenges toachieve a harmonised enforcement of the BPR: different legal systems exist for enforcement in the Member States industry and authorities have relatively limited experience with controlling the new provisions brought by the BPR (e.g. Article 95, treated articles), organisational structures do vary between Member States, and in most Member States competences for controls on biocides are located in several bodies.
(7)Article 76(1)(l) of BPR tasks the European Chemicals Agency (ECHA) to provide support and assistance to Member States with regard to control and enforcement activities.
(8)It is the intention that the Food and Veterinary Office (FVO) of DG SANTE[8] will before June 2016 send a web-based survey to control authorities on biocides. Based on the outcome of that survey FVO is foreseeing tostart fact finding missions to Member States in 2017. An overview report would then be published early 2018. These activities of FVO are intended to support the harmonization of controls in Member States.
(9)Inspectors need access to the information submitted to ECHA. However, inspectors are a different target group compared to Member States competent authorities who have access to R4BP3. Moreover, providing access to the numerous inspectors in Europe involved in biocides to R4BP3 would not be compatible with the very strict security restrictions applying for access to R4BP3. ECHA, having experience with similar systems for other regulations, will contribute to the development of such a system for BPR inspectors.
(10)A voluntary organisation like CLEEN does not have the status to effectively set priorities or to coordinate activities.
(11)The ECHA Forumis specifically developed for chemicals and could, in principle, include biocides as well. The Forumconcluded in its last meeting that its remit could be expanded to include coordination of BPR enforcement if it is accompanied by an appropriate legal basis. Also the expansion would need to be provisioned with resourcing to allow additional experts to attend the Forum and strengthening of the ForumSecretariat.
(12)It is clear that the Forum faces more and more challenges for the implementation of the REACH, CLP and PIC Regulation the coming years and it has to set clear priorities to live up to all the requirements. Adding BPR tasks in the short term would provide practical challenges to the Forum to include these in the meeting schedule and the multi-annual work programme. Moreover, organising additional resources for the Forum for the BPR-task cannot be arranged in short term.
(13)Regulation (EC) No 765/2008 sets out the framework for monitoring of non-food products in the European market to guarantee that they meet requirements. This regulation obliges Member States to guarantee effective surveillance of their market and they are required to organise and carry out close monitoring so that the products covered by the Union harmonisation legislation meet the requirements for protection of public interests such as health and safety.
(14)Regulation (EC) No 765/2008 also provides for a framework that helps cooperation of competent authorities at national level and across borders in exchanging information, investigating infringements and taking action. The purpose of cross-border cooperation is to make sure that EU product legislation can be effectively enforced in the internal market, despite the fact that the enforcement powers of individual authorities are limited by national boundaries. For example, on the basis of this regulation the Information and Communication System on Market Surveillance (ICSMS) is established. This is an IT platform to facilitate communication between authorities in the EU and in EFTA countries on non-compliant products and it should avoid duplication of work and speed up the removal of unsafe products from the market. The Commission also provides financial support to Administrative Cooperation Groups and grants for joint actions.
(15)Article 65 of the BPR provides that Regulation (EC) No 765/2008 applies for products and treated articles in the scope of the BPR. However, it is not possible to utilize on short term the financial support provided under that Regulation for Administrative Cooperation Groups. It is emphasised that Member States have an obligation to comply with the obligations of Regulation (EC) No 765/2008. Member States competent authorities for the implementation of the BPR were however already encouraged using ICSMS[9].
(16)Until further development on the possible involvement of theForum in biocides activities, it is proposed to follow a practical approachand to establish a BPR Enforcement Group (BEG) as a working group of the CA meeting. The establishment of such a working group would allow to kick-start the co-operation on enforcement of BPR.
(17)The BEG will be a working group of the Competent Authorities and will meet about 2-4 times a year. The Members will be appointed by the Member States.
Stakeholders will be invited to have regular meetings with the BEG. The BEG shall develop a system to integrate stakeholders in their discussions.
(18)In the last CA meeting, Member States pointed out that integrating biocides enforcement tasks in ECHA’sForum was considered the best use of resources. The BEG meetings should therefore be organisedback-to-back to the meetings of the Forum in Helsinki.
(19)The organisation of the meetings of the BEG would be under the responsibility of the Commission, but in consultation with the Agency.Reimbursement of travel expenses would be covered by the Agency for participants attending both BEG and ECHA Forum meetings and by the Commission for those attending only the BEG meetings.
In 2016, 3 meetings of the ECHA Forum are scheduled on 15-17 March, 14-16 June and 7-11 November. A half-day or a full-day could be used on these occasions for the BEG meetings.
(20)Up to now Member States provided limited feedback on the activities and priorities for the enforcement group. Therefore, up to now, the objectives of the BEG are not detailed.
(21)However, it is suggested that the focus of the BEG would be the enforcement of the deadlines established in Article 95(2) for biocidal products and Article 94(2) for treated articles. Another task would be to develop and advice the Commission and the CA meeting within 3 years on the integration within or co-operation with other enforcement platforms, such as in particular the Forum.
(22)The first meeting of the BEG shall set the priorities for the coming years.
4.Action requested
(23)The Commission services invite the CA meeting to discuss and endorse the way forward outlined in this paper, in particular that a BPR Enforcement Group will be established as a working group of the Competent Authorities and that the group will aim at meeting back-to-back withECHA’sForum as established under REACH.
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[1] Reference:
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[4]Chemical Legislation European Enforcement;
[5] Article 25 of the proposal for a Regulation on consumer product safety establishes a forum for products presenting a risk
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[9]By letter of 30 November 2012.