The Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations, in respect of Great Britain, provide for the appointment of competent authorities in relation to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (“the Biocides Regulation”; OJ No L167, 27.06.12, p.1) and Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (“the CLP Regulation”; OJ No. L353, 31.12.08, p.1).

These Regulations, in respect of the United Kingdom, provide for the appointment of designated national authorities in relation to Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (“the PIC Regulation”; OJ No. L201, 27.07.12, p.60).

These Regulations also provide for the enforcement, in respect of Great Britain, of the Biocides Regulation and the CLP Regulation and in respect of the United Kingdom, of the PIC Regulation, and of certain provisions of these Regulations.

These Regulations additionally make provision for the competent authorities in Great Britain to authorise biocidal products for essential use, following the granting of a derogation by the European Commission under Commission Regulation (EC) No 1451/2007 (OJ No. L325, 11.12.2007, p. 3).

The Biocides Regulation repeals Directive 98/8/EC of 16 February 1998 (OJ No. L123, 24.4.98, p.1) concerning the placing of biocidal products on the market, which laid down harmonised rules for the placing on the market of biocidal products. The Biocides Regulation lays down revised harmonised rules for the approval of active substances and the making available on the market of biocidal products. Its main purpose is to improve the free movement of biocidal products within the European Union, while maintaining the high level of protection of both human and animal health and the environment established in Directive 98/8/EC.

The CLP Regulation replaces Council Directive 67/548/EEC (OJ No L196 16.8.67, p.1) and Council Directive 1999/45/EC (OJ No L200 30.7.99, p.1). The main purpose of the CLP Regulation is to adopt within the European Community the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) published by the UN Social and Economic Council (Fourth Revised Edition ISBN-978-92-1-117042-9). The UN GHS is a result of an international agreement made at the United World Conference on Environment and Development in Rio de Janeiro in 1992, and the World Summit on Sustainable Development in Johannesburg in 2002. It sets out internationally accepted definitions and criteria to identify the hazards of chemicals and to communicate those hazards via labels and safety data sheets. The GHS is a voluntary international agreement and countries may keep national requirements that are not covered by the GHS provided that they do not contradict it. The CLP Regulation requires dutyholders to classify, label and package hazardous chemicals before placing them on the market in accordance with its provisions.

The PIC Regulation is a recast of Regulation (EC) No 689/2008 (OJ L204, 31.7.08, p.1), deemed necessary in the interests of clarity as a result of several substantial amendments to other European chemicals legislation. The PIC Regulation implements the UN Rotterdam Convention on the prior informed consent procedure for certain hazardous chemicals and pesticides in international trade, establishes a procedure by which chemicals qualify for prior informed consent (‘PIC’) status and maintains in force a common export notification procedure for chemicals either banned or severely restricted within the European Union. The European Commission acts, on behalf of all Member States, as the central administrative authority for contact with the secretariat, other parties and non-parties to the Convention.

Provision is made for the coming into force of the Regulations and to extend the application of the Regulations outside Great Britain in Regulations 2 and 3.

Most of the terms and expressions used in these Regulations are defined in regulation 4.

Regulations 5 and 6 provide that the Secretary of State in relation to England, the Scottish Ministers in relation to Scotland, and the Welsh Ministers in relation to Wales are designated as the competent authorities in relation to the Biocides Regulation and the CLP Regulation. Where a matter is outside the competence of the Scottish Ministers or the Welsh Ministers, the competent authority is the Secretary of State.

Regulation 7 provides that the Great Britain Executive and the Northern Ireland Executive are the designated national authorities with responsibility for the performance of administrative functions required by the PIC Regulation and for controlling the import and export of chemicals listed in Annex I of the PIC Regulation. Regulation 4 provides that the “Great Britain Executive” means the Health and Safety Executive and the “Northern Ireland Executive” means the Health and Safety Executive for Northern Ireland.

Regulation 8 makes provision for the enforcement of the Biocides Regulation and regulations 12 and 13(2) of these Regulations by applying enforcement and penalty provisions of the Health and Safety at Work etc. Act 1974 (“the 1974 Act”) to the Biocides Regulation and regulations 12 and 13(2) of these Regulations as if they were health and safety regulations for the purposes of the 1974 Act, subject to the exceptions in the regulation.

Regulation 9 provides that the Biocides Regulation and regulations 12 and 13(2) are enforced either by the Health and Safety Executive, the Office of Rail Regulation, the local weights and measures authority or the local authority, depending on the circumstances as set out in the regulation.

Regulation 10 limits the powers of an inspector to enter domestic premises in exercise of that inspector’s powers under the 1974 Act, as applied to the Biocides Regulation and regulations 12 and 13(2) of these Regulations by Regulation 8.

Regulation 11 ensures that information provided to the competent authorities under the Biocides Regulation is not treated as relevant information for the purposes of section 28 of the 1974 Act.

Regulation 12 requires that information required to be shown on the label of a biocidal product by Article 69(2) of the Biocides Regulation must be in English.

Regulation 13 enables the competent authority to grant an authorisation to place a product on the market where the active substance in the product has been approved for an essential use under Article 5 of Commission Regulation (EC) No 1451/2007 (OJ L 325, 11.12.2007, p. 3).

Regulation 14 and Schedule 1 provide a right of appeal and the appeal procedure in relation to certain decisions of the competent authorities made under the Biocides Regulation which is available to a class of persons defined in regulation 14.

Regulations 15 and 16 and Schedule 2 provide transitional measures to enable the continuation of existing procedures for a limited period of time.

Regulation 17 makes provision for the enforcement of the CLP Regulation by applying enforcement and penalty provisions of the 1974 Act to the CLP Regulation as if it were health and safety regulations for the purposes of the 1974 Act.

Regulation 18 provides that the CLP Regulation is enforced by the Health and Safety Executive, the Office of Rail Regulation, the local weights and measures authority or the General Pharmaceutical Council, depending on the circumstances set out in the regulation. In the case of enforcement by the local weights and measures authority or the General Pharmaceutical Council, the provisions of section 12 of the Consumer Protection Act 1987 apply to the CLP Regulation as if it were a safety regulation for the purposes of that Act.

Regulations 19 and 20 provide that the PIC Regulation and regulation 28 of these Regulations are enforced by the Great Britain Executive in Great Britain and the Northern Ireland Executive in Northern Ireland and that the provisions of the 1974 Act, as regards Great Britain, and the 1978 Order, as regards Northern Ireland, are applied to the PIC Regulation and regulation 28 as if they were health and safety regulations for the purposes of the 1974 Act in Great Britain and the Health and Safety at Work (Northern Ireland) Order 1978 (“the 1978 Order”) in Northern Ireland. The powers of officers in relation to chemicals or articles under section 25A of the 1974 Act and Article 27A of the 1978 Order, as applied to the PIC Regulation by regulations 19 and 20, enables them to withhold customs clearance pending examination or further action by the Great Britain Executive or the Northern Ireland Executive, who will take charge of the chemical or article from the point that it is handed over.

Regulation 21 provides that a failure to discharge a duty placed by the PIC Regulation on a designated national authority or Member State is not an offence under section 33(1)(c) of the 1974 Act or under Article 31(1)(c) of the 1978 Order.

Regulation 22 provides that the Great Britain Executive and Northern Ireland Executive must make adequate arrangements for the enforcement of regulation 28 of these Regulations and the PIC Regulation.

Regulations 23 to 28 make provision for enforcement notices to be served by inspectors in respect of a contravention of a provision in the PIC Regulation, and for an appeal process in respect of enforcement notices.

Regulation 29 provides for service of enforcement notices.

Regulation 30 and Schedule 3 make provision for defence exemption certificates in respect of requirements and prohibitions contained in the Biocides Regulation and CLP Regulation.

Regulation 31 disapplies the provisions of these Regulations where an enforcing authority takes a sample of a substance or mixture for enforcement purposes.

Regulation 32 sets out the penalties that apply for an offence under section 33 of the 1974 Act and Article 31 of the 1978 Order, as applied to these Regulations and the Biocides Regulation, the CLP Regulation and the PIC Regulation by provisions in these Regulations.

Regulation 33 provides for a defence of due diligence in any proceedings for an offence in respect of a breach of a requirement of regulations 12 and 13(2) of these Regulations, the Biocides Regulation, the CLP Regulation and the PIC Regulation.

Regulations 34 revokes, or partially revokes, instruments that implemented Directive 98/8/EC in relation to biocidal products, and the Export and Import of Dangerous Chemicals Regulations 2008, which provided for the enforcement and appointment of designated national authorities in respect of Regulation (EC) No 689/2008.

Regulation 35 and Schedule 4 amend the 2009 Regulations. These amendments update references to the PIC Regulation, make provision for the advertising of dangerous preparations and provide for penalties in line with the European Communities Act 1972. These amendments will have effect until the 2009 Regulations are revoked in accordance with Regulation 36.

Regulation 36 revokes provisions of the 2009 Regulations on various dates so that the domestic provisions which implemented Council Directive 67/548/EEC and Council Directive 1999/45/EC are revoked in accordance with the time periods allowed for the transition to the CLP Regulation.

Regulation 37 and Schedule 5 make consequential amendments to primary and secondary legislation.

Regulation 38 requires the Secretary of State to review the operation and effect of these Regulations and to publish a report within five years after they come into force and within five years thereafter. Following each review, the Secretary of State, in consultation with the devolved administrations, will decide whether the Regulations should remain as they are, or be revoked or amended. A further instrument would be needed to revoke the Regulations or to amend them.

A full regulatory impact assessment of the effect that this instrument will have on the costs of business and the voluntary sector is available from the Health and Safety Executive, Redgrave Court, Merton Road, Bootle, Merseyside, L20 7HS. A copy of this document has been placed in the Library of each House of Parliament and is annexed to the Explanatory Memorandum which is available alongside these Regulations at www.legislation.gov.uk.