Fact sheet
Biocidal products directive (Biocidal Products Directive), 98/8/EC

Issue No. 5 - Dec. 1999

Purpose

This Fact Sheet provides briefing for the makers and users of active substances and biocidal products to keep you up to date with the implementation of the Biocidal Products Directive (Biocidal Products Directive) 98/8/EC. All Member States have to implement the Directive by 14th May 2000.

This is not a revision of Fact Sheets Nos.1 - 4 but instead provides supplementary information and advice. Further issues will be produced at intervals to take account of significant developments. If you would like a copy of earlier fact sheets please contact us at the address at the end of this fact sheet. The earlier fact sheets covered:

• Fact Sheet No.1: Definitions of a biocidal product and the 23 product types, and the aims of the Directive;
• Fact Sheet No. 2 : Progress between July 97 and May 98;
• Fact Sheet No. 3 : Progress between June 98 and Nov. 98 and answers to some common Biocidal Products Directive questions.
• Fact Sheet No. 4 : Progress between Dec. 98 and June 99 and a summary of the progress on UK implementation of the Biocidal Products Directive.

Progress of the Directive in Europe

Provisional list of biocidal active substances

• This list now stands at more than 2000 entries and is available on a Commission web-site. A further version is expected before the end of 1999. It is referred to by the Commission as "a working document containing a non-exhaustive list with examples of active substances which could possibly be on the market before 14 May 2000".
  
  The legal standing of this list is very different from our original understanding. Principally due to the resources that would be required to translate the list into all Member State languages, this list is now unlikely to have any legal status. It is probable that it will now only exist as guidance to the first Review Regulation (see over) for which producers might wish to submit data on a substance. The information contained in this list will be useful for industry, the Commission and regulatory bodies, particularly with respect to the review programme, and hence HSE is still advising companies to send us details of the biocidal active substances they supply into the UK (Sean McCarthy - address at end of this fact sheet).

The Commission intend to eventually release a paper version of the list, although this is unlikely to be before May 2000. In the meantime, if you do not have access to the internet, you can obtain a copy from us (contact address at the end of this fact sheet).

The Review Programme

The Commission and Member States continue to discuss proposals for a Review Regulation to start the review programme. The Commission hope that the Review Regulation will be adopted early in 2000.

Much of the detail is still open to debate. However, it is likely that producers and/or formulators of existing active substances will be required to provide information and data to the Commission within a fixed time period (perhaps 12 - 18 months) from publication of the Review Regulation. The information/data provided will need to be linked to (a) specific product type(s).

It is likely that if these data and information are not provided on particular active substances then they will have to be removed from the market within a "reasonable time period"; the length of which will be determined by the Commission.

Therefore, from spring next year action will be required from producers and suppliers of active substances, including those who intend to support active substances through the review programme. The information/data required will be provided to the ECB using software which is being developed for this purpose.

Once we have clear information from the Commission, which is no longer subject to change, we will be able to provide you with more detailed guidance and advice in this area.

Competent authority meetings

• The Member States' competent authorities met on 16-17 Nov. The main topics discussed were:

• Review Regulation (see above)
• Technical Notes for Guidance (TN'sG, a.k.a TGDs) - The TNG on "Data Requirements for active substances and biocidal products" (The Finnish document) was discussed. It was agreed that this would be published as a Commission document in English only at present. It was acknowledged that there were still some gaps - including the waiving of data requirements - in the document and other areas where practical experience was needed. These gaps will be filled when everyone has gained experience from using the document.

  Guidelines on the structure and format of application dossiers and Member State evaluations are currently being finalised. These are due to be published next year, probably also as Commission documents in English only.

• Scope - Two "working" documents were tabled at this meeting concerning the overlap between the Biocidal Products Directive (Biocidal Products Directive) (98/8/EC) and the Plant Protection Products Directive (91/414/EEC), and also between the Biocidal Products Directive and the Medicinal Products Directive (65/65/EEC) and the Veterinary Medicinal Products Directive (81/851/EEC). These are still subject to further discussion. A document regarding Biocidal Products Directive overlap with the Cosmetics Directive (76/768/EEC) has yet to be produced.

Next steps in Europe

• The next key events will be:
  • The publication of the TNG on "Data Requirements for active substances and biocidal products" as a Commission document in English.
  • The first meeting of the Standing Committee on Biocides (SCB) is envisaged at the end of February 2000. This will coincide with a competent authority meeting. The Commission hope that the Review Regulation will be adopted at this meeting.
  • A further competent authority meeting is planned for April 2000

Progress on implementing the Directive in the UK

Biocidal Products Regulations & guidance

• Public consultation - the consultation period closed on the 1st October. Many thanks to all those who responded. 51 sets of comments were received which covered a whole spectrum of opinion. HSE is considering all of these prior to making recommendations to HSC, who will in turn make recommendations to Ministers over how to handle the comments received. Results of the consultation exercise will be made public in due course.
• Transitional arrangements guidance - Once again many thanks to all those who commented. We had hoped to make this guidance publicly available within the next few weeks. However, as the proposed details of the Review Regulation are still evolving, the detail in our guidance is also subject to change. Therefore early publication in January, as anticipated, would have resulted in the guidance being out of date soon after its release. We therefore do not plan to publish our guidance until we are certain that the Review Regulation is no longer subject to change.
• HSE Guidance - The main guidance, drafts of which were in the consultation exercise, are being amended in the light of comments received. We plan to publish both of them in May 2000.
  
  Work is also progressing on the Applicants Handbook and we hope to have the essential parts of it available by May 2000.

For further information contact:

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

Updated on the HSE website 4 December 2000