(This note is not part of the Regulations)
These Regulations, in respect of Northern Ireland, 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 also provide for the enforcement, in respect of Northern Ireland, of the Biocides Regulation and the CLP Regulation and of certain provisions of these Regulations.
These Regulations additionally make provision for the competent authority in Northern Ireland 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 L 325, 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 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.
Provision is made for the coming into operation of the Regulations and to extend the application of the Regulations outside Northern Ireland in regulations 2 and 3 and Schedule 5.
Most of the terms and expressions used in these Regulations are defined in regulation 4.
Regulations 5 and 6 provide that the Health and Safety Executive for Northern Ireland (“the Executive”) and the Department of Enterprise, Trade and Investment are designated as the competent authority in relation to the Biocides Regulation and the CLP Regulation respectively.
Regulation 7 makes provision for the enforcement of the Biocides Regulation and regulations 11 and 12(2) of these Regulations by applying enforcement and penalty provisions of the Health and Safety At Work (Northern Ireland) Order 1978 (“the 1978 Order”) to the Biocides Regulation and regulations 11 and 12(2) of these Regulations as if they were health and safety regulations for the purposes of the 1978 Order.
Regulation 8 provides that the Biocides Regulation and regulations 11 and 12(2) are enforced either by the Executive or the district council, depending on the circumstances as set out in the regulation.
Regulation 9 limits the powers of an inspector to enter domestic premises in exercise of that inspector’s powers under the 1978 Order, as applied to the Biocides Regulation and regulations 11 and 12(2) of these Regulations by regulation 7.
Regulation 10 ensures that information provided to the competent authority under the Biocides Regulation is not treated as relevant information for the purposes of Article 30 of the 1978 Order.
Regulation 11 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 12 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 13 provides a right of appeal in relation to certain decisions of the competent authority made under the Biocides Regulation which is available to a class of persons defined in regulation 13.
Regulations 14 and 15 and Schedule 1 provide transitional measures to enable the continuation of existing procedures for a limited period of time.
Regulation 16 makes provision for the enforcement of the CLP Regulation by applying enforcement and penalty provisions of the 1978 Order to the CLP Regulation as if it were health and safety regulations for the purposes of the 1978 Order.
Regulation 17 provides that the CLP Regulation is enforced by the Executive, the district council or the Department of Health, Social Services and Public Safety, depending on the circumstances set out in the regulation. In the case of enforcement by the district council or the Department of Health, Social Services and Public Safety, the provisions of section 12 of the Consumer Protection Act 1987 shall apply to the CLP Regulation as if it were a safety regulation for the purposes of that Act.
Regulation 18 and Schedule 2 make provision for defence exemption certificates in respect of requirements and prohibitions contained in the Biocides Regulation and the CLP Regulation.
Regulation 19 disapplies the provisions of these Regulations where an enforcing authority takes a sample of a substance or mixture for enforcement purposes.
Regulation 20 sets out the penalties that apply for an offence under Article 31 of the 1978 Order, as applied to these Regulations and the Biocides Regulation and the CLP Regulation by provisions in these Regulations.
Regulation 21 provides for a defence of due diligence in any proceedings for an offence in respect of a breach of a requirement of regulations 11 and 12(2) of these Regulations, the Biocides Regulation and the CLP Regulation.
Regulation 22 revokes, or partially revokes, instruments that implemented Directive 98/8/EC in relation to biocidal products.
Regulation 23 and Schedule 3 amend the 2009 Regulations. These amendments provide for references to the EU Regulation on the export and import of hazardous chemicals to replace the references to the 2008 Regulation. The amendments also make provision for the advertising of dangerous preparations and bring penalties in line with the European Communities Act 1972. These amendments will have effect until the 2009 Regulations are revoked in accordance with Regulation 24.
Regulation 24 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 25 and Schedule 4 make consequential amendments to primary and secondary legislation.
In Great Britain the corresponding legislation is the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013 (S.I. 2013/1506). The Great Britain Health and Safety Executive has prepared a full impact assessment of the effect that the Regulations will have on the costs of business and the voluntary sector. A copy of that assessment is available from the Health and Safety Executive for Northern Ireland, 83 Ladas Drive, Belfast, BT6 9FR. A copy of the impact assessment has been placed in the library of the Northern Ireland Assembly and is annexed to the Explanatory Memorandum which is available alongside these Regulations at www.legislation.gov.uk.