The Biocidal Products Regulations 2001

Explanatory Note

(This note is not part of the Regulations)

1.  These Regulations have effect with a view, first, to enabling applications to be made for agreement at Community level that an active substance can be used in a biocidal product and, secondly, to authorising the placing on the market and use of biocidal products to which these Regulations apply.

2.  These Regulations implement as regards Great Britain Directive 98/8 of the European Parliament and the Council of 16 February 1998 concerning the placing of biocidal products on the market (O.J. No. L 123, 24.4.98), (“the Directive”). Schedule 1 of these Regulations is based on Annex V of that Directive. The principle provisions are as follows.

3.  These Regulations do not apply to certain biocidal products nor to the carriage of biocidal products by rail, road, inland waterway, sea or air. (Regulation 3 and Schedule 2.)

4.  No person shall place on the market a new active substance for use in a biocidal product unless an application to a competent authority has been made for inclusion of that new active substance in Annex I, IA or IB of the Directive. The Ministers are designated as the competent authority in Great Britain. An application must be accompanied by dossiers containing information which the Ministers must evaluate, following which they must recommend to the European Commission whether or not an active substance should be included in Annex I, IA or IB of the Directive. (Regulations 4, 5 and 6.) (The terms “active substance”, “biocidal product”, “competent authority”, “new active substance” and “place on the market” are defined in regulation 2(1). “The Ministers” is defined in regulation 2(2).)

5.  No person shall place on the market or use a biocidal product unless that biocidal product has been authorised in accordance with the provisions of the Regulations. Where a biocidal product is a low-risk biocidal product, then a registration is required. Where a biocidal product contains an active substance which is included in Annex IB of the directive then that biocidal product may only be used in a particular manner. (Regulation 8.) (The term “low-risk biocidal product” is defined in regulation 2(1).)

6.  To obtain an authorisation or a registration, a person must submit an application to the Ministers together with the information specified in the Regulations. The Ministers may grant a mutual authorisation or registration where another member State has granted an authorisation or a registration in respect of the same biocidal product and the Ministers may also grant provisional authorisations and registrations. An authorisation and a registration may be granted subjected to conditions. (Regulations 9 to 14.)

7.  The Ministers may grant an emergency authorisation where such authorisation appears necessary because of an unforeseen danger. (Regulation 15.)

8.  Provision is made for a biocidal product to be placed on the market for use in tests and experiments, including those involving the release into the environment of a biocidal product. (Regulations 16 and 17.)

9.  The Ministers may revoke an authorisation or a registration in certain circumstances. They may also modify the conditions of use subject to which an authorisation or a registration is granted and review an authorisation or a registration. (Regulations 19 and 20.)

10.  Provision is made requiring a person to whom an authorisation or a registration has been granted to notify the Ministers of information of which he is aware relating to the biocidal product in question. (Regulation 21.)

11.  The Ministers may prohibit or restrict the sale or use of a biocidal product if they consider that the biocidal product constitutes an unacceptable risk to human or animal health or to the environment. (Regulation 22.)

12.  The Ministers shall not make use of information submitted to them under the Regulations except in certain circumstances. A person providing information to the Ministers may claim confidentiality in respect of that information if he considers that disclosure might harm his industrial or commercial position. (Regulations 23, 24 and 26.)

13.  Provision is made for co-operation between applicants for, and the holders of, authorisations or registrations regarding information relating to biocidal products. Provision is also made for the exchange of information between the Ministers and the European Commission and the competent authorities in other member States. (Regulations 25 and 28.)

14.  The person responsible for first placing a biocidal product on the market is responsible for providing information to the National Poisons Information Service. The information may only be disclosed for the purposes of medical treatment of a person affected by the biocidal product. (Regulation 29.)

15.  The Regulations impose obligations concerning the packaging, labelling and advertisement of a biocidal product. (Regulations 30, 31 and 33.)

16.  An application for an authorisation or a registration of a biocidal product is to be made by, or on behalf of, the person who first places the biocidal product on the market. An applicant must have a permanent office within the Community and the application must be in English. (Regulation 34.)

17.  The Ministers must ensure that a file is kept in respect of every application for an authorisation or a registration made under the Regulations. (Regulation 35.)

18.  There is a right of appeal for any person aggrieved by certain decisions of the Ministers made under the Regulations. (Regulation 36 and Schedule 10.)

19.  Provision is made for the enforcement of the Regulations, for the payment of fees and for transitional measures. (Regulations 38, 39, and 40 and Schedules 11, 12 and 13.)

20.  A copy of the regulatory impact assessment prepared in respect of these Regulations can be obtained from the Health and Safety Executive, Economic Adviser’s Unit, Rose Court, 2 Southwark Bridge, London SE1 9HS. A copy has been placed in the Library of each House of Parliament.