If you make biocidal products or the active substances that go into them, or place either on the British market, you should read this document.
It introduces the new Biocidal Products Regulations (BPR). These regulations implement the Biocidal Products Directive whose aim is to ensure that all biocidal products on sale are safe when used properly and can be freely traded within the European Union (EU).
BPR applies in Great Britain, and also offshore. There are separate regulations in Northern Ireland.
The Health and Safety Executive (HSE) is producing more detailed information about BPR; details of the guidance and where to obtain it are listed at the end of this leaflet. BPR aims to:
- provide a high level of protection for humans, animals and the environment; and
- contribute to the harmonisation of the European market for biocidal products and their active substances.
Who has duties under BPR?
Anyone who supplies biocidal products or active substances to the British market whether in return for payment or not. Users of products also have duties and separate guidance will be available for them.
What is a biocidal product?
Biocidal products are any chemicals or micro-organisms, or mixtures of either or both, intended to control unwanted organisms, such as animals, insects, bacteria, viruses and fungi.
Some categories of product are excluded from the Regulations however, notably medicines and products used to kill weeds or protect plants from pests. The biocidal products covered by these Regulations are widely used in industry and in the home. They include:
- products for preserving wood;
- products for preventing barnacles and algae from settling on ship's hulls;
- products for controlling mice and rats; and
- products for controlling insects such as cockroaches and ants.
Many industrial processes rely on biocides either during the course of manufacture or to improve product performance while in use - for example in paint, metal working fluids, adhesives, plastics, leather and paper. Household biocides include disinfectants and fly sprays.
Biocidal products contain one or more active substance - the ingredient in the product that controls or kills the unwanted organisms.
BPR's scope is very wide. If you are unsure about whether a product is covered, please contact HSE - our address and telephone number are at the end of this leaflet.
What does BPR do?
It establishes an authorisation scheme to ensure that active substances and biocidal products are assessed so that they are safe for people to use, and will not harm the environment, before they are placed on the market.
Who authorises these products?
Each Member State in the European Community must appoint a competent authority to carry out the work required by the BPD. In the UK, the competent authority functions are carried out by HSE. An independent committee, the Biocides Consultative Committee (BCC) gives HSE advice. Members of the BCC are independent scientific experts and lay people who represent the interests of consumers, workers and the environment.
What if I currently market an active substance in the EU?
From May 2000, all active substances currently marketed and used in biocidal products will be assessed. This process is governed by a Biocides Review Regulation which came into force on 28 September 2000 across the EU. This was published in the Official Journal on 8 September (OJL 228 43, p6). The review is scheduled to take up to 10 years.
In Britain, some biocidal products have, since 1986, been subject to an existing national approval scheme. Antifoulants, public hygiene insecticides, surface biocides and wood preservatives require approval under the Control of Pesticides Regulations 1986 (COPR). These products will continue to be approved under COPR until their active substances have been reviewed under the biocides regime.
Similarly, pending review of the active substance, biocidal products not within scope of COPR can continue to be sold and used subject to other relevant health and safety regulations, such as the Control of Substances Hazardous to Health Regulations 1994, (COSHH) and the Chemicals (Hazard Information and Packaging for Supply) Regulations 1994 (CHIP).
Marketing a new active substance in the EU
A new active substance is defined as a substance not on the market on 14 May 2000. New active substances will be assessed when suppliers seek authorisation. If you manufacture new active substances or import them from outside the EU, you will have to provide scientific data to a competent authority. This is to enable the active substance to be assessed to see if it poses any unacceptable risk. The data will be evaluated by the competent authority, but the final decision as to whether it can be used in biocidal products will be made by the European Commission acting on the advice of a committee made up of representatives of all Member States.
Once an active substance has been evaluated, biocidal products containing that active substance will in turn be assessed by individual Member States, who will then authorise products in accordance with the requirements of the BPD.
Fees and charges
BPR includes provisions to charge fees to applicants. To cover costs not attributable to a single applicant, a general industry charge will be introduced from 1 April 2001.
Ill health effects
When placing your product on the market for the first time, you will need to send information to the National Poison Information Service (NPIS) in Birmingham. Regulation 29 of BPR lists the information that you need to send them. NPIS will accept a copy of the product's Safety Data Sheet plus the additional required information, if you prefer. You can let them have the information by post or electronically - for example on CD Rom. If your product is on the market on 14 May 2000 you will have three years (ie until 14 May 2003) to let NPIS have the information.
Who enforces BPR?
HSE enforces the regulations concerning the supply of biocidal products and active substances, except in shops and other retail outlets. Enforcement there is by Trading Standards Officers who also have responsibility for enforcing the regulation about advertisements. The proper use of products in commercial and industrial undertakings is enforced by HSE and Local Authority inspectors as determined by the Health and Safety (Enforcing Authority) Regulations 1998.
Further advice and information
For further information about BPR, please contact HSE's Biocides and Pesticides Assessment Unit (BPAU) on 0151 951 3535.© Crown Copyright 2001 Originally Produced & Published by the Health and Safety Executive 01/01.