Subject: Member States' Arrangements for Enforcement, Controls and Monitoring

CA-March15-Doc.9.1

EUROPEAN COMMISSION 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 all or a majority of 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: Member States' arrangements for enforcement, controls and monitoring

1. 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. Enforcement and monitoring of Regulation (EU) No 528/20112 (the BPR) is a national responsibility. The purpose of this note is to seek information from Member States on how monitoring and enforcement of the BPR is 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.

2. Background

(1) According to Article 65 of the BPR Member States shall make the necessary arrangements for official controls to be carried out in order to enforce compliance with the BPR. These controls shall aim at ensuring that biocidal products and treated articles placed on the market comply with the provisions of the BPR.

(2) Article 87 of the BPR requires that Member States lay down provisions on penalties applicable to infringement of the rules.

(3) In accordance with Article 65(3) Member States have to submit the first report on the implementation of the BPR by 30 June 2020.

Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111 Office: DM24 2/44 - Tel. direct line +32 229-02 2950178 (4) Use of biocidal products may result in residues in food or feed. Regulation (EC) No 882/20041, Directive 96/23/EC2 and the EC proposal on official controls3 provide that Member States shall ensure that official controls are carried out to verify compliance with rules aiming at preventing, eliminating, or reducing to acceptable levels risks to humans and animals. These controls shall aim at ensuring that residues of biocidal products in food or feed do not exceed the limits/levels established at EU level.

(5) It may be necessary to develop appropriate monitoring systems in order to determine for certain substances and/or biocidal products in order to determine whether it would be appropriate to establish limits for residues of biocidal products in food and feed.

(6) It is clear that structures and tools will vary from Member State to Member State. Probably, taking into the account of the scope of the BPR, several bodies will be involved in enforcement and controls of biocidal products and treated articles in Member States.

(7) Appropriate involvement and establishment of procedures with custom authorities also have to be explored, in particular in relation to the requirement for imported treated articles that all active substances contained in the biocidal products that they were treated with or incorporate are approved.

(8) The deadline of 1 September 2015 set by Article 95(2) of the BPR is approaching, for which proper structures to control compliance will need to be in place.

(9) A structure at EU level could be developed in order to support Member States in their role in relation to enforcement, control and monitoring. Co- operation and discussion between enforcement authorities in Member States may increase effectiveness and efficiency of controls and monitoring. A structure at EU level could contribute that the legislation is enforced and monitored consistently in Member States.

(10) This structure at EU level may involve, for example, the following activities: exchanging information and knowledge between national authorities, providing support and practical assistance to national enforcement authorities, exchanging good practices, establishing harmonised enforcement projects, avoiding duplication of work (e.g. with enforcement activities with treated articles, food or feed, which can circulate freely on the EU market),

1 Regulation (EC) No 882/2004 of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules, OJ L 165, 28.5.2004, p. 1. 2 Council Directive 96/23/EC on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC, OJ L 125, 23.51996, p. 10. In the proposal on official controls it is provided to repeal this directive. 3 Proposal for a Regulation of the European Parliament and of the Council 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, plant reproductive material, plant protection products and amending and amending Regulations (EC) No 999/2001, 1829/2003, 1831/2003, 1/2005, 396/2005, 834/2007, 1099/2009, 1069/2009, 1107/2009, Regulations (EU) No 1151/2012, [….]/2013, and Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC, 2008/120/EC and 2009/128/EC (Official controls Regulation), COM (2013)265. liaising with stakeholders on controls and monitoring, developing formats and indicators on controls and monitoring for the report on the implementation of the BPR, and developing harmonised tools and methods for controls and monitoring. Last but not least, this structure should be play a role in co-ordination and priority setting of controls.

(11) Under the auspices of the Chemicals Legislation European Enforcement Network (CLEEN4), chemical inspectors of the EU Member States and other European countries are already collaborating and exchanging information to improve the enforcement of the BPR.

(12) Article 76(l) provides that ECHA shall provide support and assistance with regard to control and enforcement activities.

(13) Such support and assistance could take several forms. In particular, the Forum for Exchange of Information on Enforcement, which current working programme does not include the BPR, could play a role in supporting Member States enforcement and control of biocidal products and treated articles. ECHA IT tools could also be developed or adjusted to respond to the needs of Member States when performing these activities.

(14) However, given the sensitivity and importance of the subject, the CA meeting or an ad hoc group could be a more appropriate structure to discuss initially or permanently certain matters, such as for instance the overall co- ordination and priority setting of controls.

3. Proposed way forward

(15) Member States are invited to:

(a) inform the Commission before the next 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.

4 http://www.cleen-europe.eu