Fact sheet
Biocidal products directive

Issue No. 2 - May 1998

Purpose

This note provides briefing for makers and users of biocidal products to keep them up to date with the implementation of this Directive in the UK. It is not a revision of Fact Sheet No.1 (July 1997) but instead provides supplementary information. Further issues will be produced at intervals to take account of significant developments. If you do not have a copy of Fact Sheet No.1 (containing definitions of a biocidal product and the 23 product types, and the aims of the Directive), and would like one, then please contact the name at the end of this Fact Sheet.

Progress of the Directive since the last Fact Sheet

• The Directive has now completed all its negotiation stages and the final text has been adopted by both the European Council and European Parliament. The number of the Directive is 98/8/EC and the final text has been published in the Official Journal of the European Communities, Vol. 123, 24 April 1998 (copies can be viewed in major libraries or bought from the Stationery Office, Tel: 0171 873 9090). The Directive has to be implemented in Member States by May 2000.
• There have been a few minor changes from the previously published Common Position text (EC no. 10/97, Official Journal of the European Communities, C69, Vol. 40, 5 March 1997). A summary is given at the end of this sheet.

Next steps in Europe

• In order for the Directive to work, biocidal active substances currently in use will have to be reviewed for possible addition to the (empty, at present) Annex I list. This means that in addition to the Directive, both a list of existing active substances and a Review Regulation are needed:

(a) Existing active substances list - A provisional list has been produced by the European Chemicals Bureau and has been sent to contacts in each member state. The UK contact is the HSE and we will formulate a strategy to amend and cross check this list against the active substances used within the UK. In the meanwhile, you might wish to contact your trade association (if you are in one) to ensure they are aware of the active substances that you trade. Remember, the list of existing active substances is not the Annex I list. Also, active substances that are not on the existing list when the Directive is implemented will be considered to be new and must therefore be assessed for Annex I listing before products can be sold as biocides.

(b) Review Regulation - this will set out the principles by which biocidal active substances will be reviewed. The European Commission is expected to produce a draft proposal soon, and HSE will consult industry and UK Government Departments as negotiations progress. Remember, until an existing active substance is reviewed for Annex I listing, products containing it will be subject to the same legislation as they are now (e.g. in the UK wood preservatives are classified and labelled under the Control of Pesticides Regulations 1986, as amended 1997 (COPR) and disinfectants are labelled in accordance with the Chemicals (Hazard Information and Packaging) Regulations 1993 (CHIP 2 )). The review programme is intended to take 10 years to complete, which means that most products will not become subject to the Directive until some years after the implementation date. There is no provision to 'grandfather in' active substances, as happened under COPR.

Progress on implementation in the UK since the last Fact Sheet

• HSE has begun drafting the Biocidal Product Regulations, and we expect to put them, together with associated guidance, to public consultation early in 1999.
• In addition, several guidance documents are being prepared to accompany the Directive and UK Regulations:

1. At European level.

(a) Technical guidance for regulatory bodies and applicants.

Three Technical Guidance Documents are being prepared by Finland, Sweden and the UK (HSE) under contract for the European Commission. These cover, respectively, data requirements for the 23 products types, procedures for assessment and listing of active substances on Annex I/IA/IB and principles for the authorisation and registration of biocidal products. The final versions should be available in the first half of 1999. Similar guidance documents will be produced for microbiological active substances and products.

(b) Other European guidance.

Practical guidance on the format and structure of dossiers on active substances and biocidal products will certainly be needed and guidance on issues such as Experimental Authorisations, research and development, information exchange and labelling are likely to be needed.

HSE aims to ensure that appropriate attention is given to these, although work has not started yet.

2. UK national guidance documents.

(a) Full guidance to explain the Regulations. This will be drafted in consultation with an Ad-Hoc Industry group (with around 40 members representing all product types) and the document will be put to public consultation early in 1999;

(b) Transitional arrangements guidance to describe the review period during which there will be a gradual changeover from the current regulatory control to the new. A subgroup to the full Ad-Hoc Industry group is assisting HSE in this work and public consultation is planned for early 1999; and

(c) Guidance for applicants seeking authorisation/registration of products. The HSE anticipates commencing work sometime in late 1998.

HSE will ensure that all interested parties and the public are consulted before these documents are issued.

• UK charging regime.

Government policy is that those who benefit from the work done by the regulators or produce the risks which need controlling should pay for the work involved. A sub-group of the main Ad-Hoc Industry group is assisting HSE in developing a charging regime to ensure that appropriate costs for running the biocides scheme in the UK are recovered as far as possible and in the most equitable way possible. HSE is also consulting widely within government on this issue.

What do you/industry need to do now?

If you are a manufacturer, formulator or importer of biocidal products, you should write to HSE now at the address at the end of this fact sheet to register your interest (through your trade association, if you are in one), if you have not already done so. If you are a product supplier, you should ensure that the company that makes your active substance is aware of the existence of the active substance list, and that they respond to HSE's request for information when this occurs.

For further information contact:

Biocides & Pesticides Assessment Unit
Health and Safety Executive
Magdalen House, Stanley Precinct
Bootle L20 3QZ
Tel. 0151 951 3535
Fax. 0151 951 3317
e-mail: biocides@hse.gsi.gov.uk

Summary of changes made to the common position text

1. The name 'commodity substance' is now 'basic substance', solely for ease of translation. Also the diluent used with a basic substance cannot be a substance of concern. There is now a provisional indicative list of basic substances (article 2(c)), i.e. carbon dioxide, nitrogen, ethanol, 2-propanol, acetic acid and kieselguhr.
2. The definition of a "substance of concern" has been expanded (article 2(e)).
3. Article 11 has been clarified to confirm that a full data set is required when first seeking an Annex IA listing for an active substance for use in low risk products (article 11(a)(ii)). The reduced data requirements (waiving toxicological and environmental data) remain as before for product registration.
4. Reference is now made to Annex IVA/B concerning data requirements for microbiological active substances and products in appropriate parts of the text.

Updated on the HSE website 4 December 2000