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

Issue No. 7 December 2000

Purpose

Fact Sheets provide briefing for the makers, suppliers 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.

Fact Sheet 7 is not a revision of Fact Sheets Nos.1-6 but instead provides supplementary information and advice. If you would like a copy of earlier fact sheets please contact us at the address given at the end of this fact sheet.

Progress of the Directive in Europe

The first Review Regulation

• The first Review Regulation (EC No. 1896/2000), which will control the review of existing active substances, was published in the Official Journal on 8 September (OJ L228 vol. 43, p6). This Regulation came into force on 28 September, and producers and/or formulators of biocidal active substances have until April 2002 to inform the Commission of their intentions with respect to the review programme. HSE guidance to the Review Regulation was issued on 29 September to all CoPR Approval Holders and biocide interested parties.

Technical Notes for Guidance (TN's G)

• Following a meeting of toxicology experts the waiving section of the guidance on "Data Requirements for Active Substances and Biocidal Products" has now been revised. Both the CSTEE and the Competent Authorities have endorsed the revision. This will now be included in the draft document available on the Commission web-site and as a hard copy. These documents are available in English only.

• The Commission will shortly start work finalising the TN'sG on Annex I listing and Product Authorisations. The draft TNG on Annex I listing should be sent to all Member States by 1 December and on Product Authorisations by 22 December. It is intended that discussions on the TNG on Annex I listing will start at a Technical Meeting to be held in late January 2001.

• The Guidelines on the structure and format of application dossiers and Member State evaluations are being tested in the "Pilot Project" (see below). A few issues are being identified during this Pilot Project and will be discussed at the January 2001 Technical Meeting.

Pilot Review Project

• This project is intended to test the procedures needed to run the Review Programme. The Finnish Environment Institute is evaluating glutaraldehyde (as a slimicide and preservative in recirculating cooling systems) and the Danish EPA tebuconazole as a wood preservative. A first meeting of all Member States, to discuss primarily issues relating to dossier submission and completeness checking, was held on 28-29 September 2000. A draft report has been circulated to attendees for review and the final report should be publicly available by the end of the year. A further meeting is planned for May 2001, at which the risk assessments will be discussed. It is intended that the final report will be sent to the Commission by the end of October 2001.

Competent Authority Meetings

The Member States' Competent Authorities met on 11-12 October. The main topics discussed (other than those mentioned above) were:

The 2nd Review Regulation

The Commission intends that the 2nd Review Regulation will be published in April 2003 and enter into force in May 2003. They are already considering the provisions it must contain, including to ensure that those active substances not Identified or Notified will be withdrawn from the market. The proposals also include the timetable for submission of dossiers in the latter phases of the Review Programme. The deadline for submission of dossiers for active substances used in wood preservatives and rodenticides was set at 28 March 2004 by the 1st Review Regulation. The deadlines for stages 2-4 of the Review Programme are proposed for 1 May 2006, 1 August 2007 and the last on 1 November 2008.

Scope

The Commission presented a proposal to modify the product-type descriptions in Annex V. This is intended to reflect agreements on scope, in particular with respect to the borderline with other Directives. There was a lot of discussion, particularly around the amount of detail and the use of examples in a legal text. The Commission will reflect on the discussions and present a further proposal in due course.

A further draft of the detailed guidance on the boundary between the Biocidal Products and Plant Protection Products Directives was presented by the Commission. This was, subject to a few changes, agreed by all Competent Authorities. The Commission will now finalise the document for inclusion in the Biocides "Manual of Decisions".

Progress on implementing the Directive in the UK

The Biocidal Products Regulations

• A final draft of the Biocidal Products Regulations (BPR), which implement the Directive in Great Britain, was considered by the Health and Safety Commission on 7 November, and they have agreed to put forward proposals to Ministers.

Implementation of the Charging Regime

A full public consultation on the options for the structure of the General Industry Charge (GIC) took place over the summer. We would like to thank those who responded to the exercise. We are now analysing the responses to this and will shortly be initiating the procedures necessary to introduce the GIC from 1 April 2001.

As part of establishing the Charging Regime, we will be establishing a Charging Review Group. Membership of this group will be drawn from stakeholder groups and HSE. Its purpose will be to review the effectiveness, consistency and operation of the GIC's financial and administrative arrangements and consequences. This group will not be formally set up until after the amendment Regulations enter into force. However, a premeeting has been arranged for 8 December 2000.

UK Committees

The Biocides Consultative Committee (BCC)

This new Committee will provide the UK Competent Authority with independent expert advice on the evaluation of biocidal products under the UK's Biocidal Products Regulations (BPR).

The BCC will include an independent Chair, independent scientific experts in the fields of toxicology, ecotoxicology, occupational hygiene, efficacy and microbiology and a number of lay members to represent consumer, environmental and employee interests.

HSE, as part of the UK Competent Authority, is following guidelines set down by the Office of the Commissioner for Public Appointments (OCPA) in the selection of nominations to put to the Health and Safety Commission and Ministers.

Advertisements for members of this committee were placed in the national press and scientific journals at the beginning of the year and the response was very positive. Interviews have taken place but appointments have yet to be agreed.

BCC meetings will initially be held in London but may in time move to Liverpool.

Roadshows

A series of road shows is planned to raise awareness of the new BPR, the new fees and charges regime, assesment/authorisation of your products and transitional arrangements. There will also be time for you to ask questions about the new regulations.

The road shows will take place at different locations around the country as follows;

Location	Date	Time
Newcastle	Friday 19 January 2001	10am-1pm
Birmingham	Monday 22 January 2001	10am-1pm
Glasgow	Thursday 1 February 2001	2pm-5pm
Edinburgh	Friday 2 February 2001	10am-1pm
London	Wednesday 7 February 2001	10am-1pm
Cardiff	Monday 19 February 2001	2pm -5pm

You must reserve your place in advance as seats are limited, although we will run additional road shows if there is sufficient demand. Please contact :

Ms Sharon Thompson, HSE, Biocides Policy Unit, Rose Court, 2 Southwark Bridge London SE1 9HS. Tel: 020 7 717 6238, Fax: 020 7 717 6199, or

e-mail: sharon.thompson@hse.gsi.gov.uk

Other Seminars

HSE's Biocides & Pesticides Assessment Unit (BPU) has been holding one day seminars for the non-agricultural pesticides industry for some years. The aim of these seminars has been to bring companies up-to-date on developments in the Regulatory process, promote discussion - both between the industry and HSE, and within the industry itself - and to gather feedback from the industry on issues of concern. These seminars have previously been aimed solely at the non-agricultural pesticides industry regulated under the Control of Pesticides Regulations (COPR), but with the advent of the Biocidal Products Directive we will also be happy to welcome other members of the biocides industry (but please remember that some of the topics discussed will be on COPR issues rather than general biocides issues).

We are seeking industry's views to see if there are any topics that they would wish to have discussed at the seminar - but please bear in mind that we would not be aiming to repeat in the Roadshow all the information given at those seminars mentioned above.

The provisional topics for BPU industry seminar are:

Biocides - scope

Biocides - implementation of the charging regime

Biocides - progress with technical guidance and the pilot project

Biocides - progress with the EU review programme.

COPR - the split levy and fees & charges.

COPR - guidance on submitting environmental data in support of non-agricultural pesticides under the control of pesticides regulations 1986.

COPR - pesticides labelling

If you have any other topics you wish to have discussed at the seminar, please send the details to : Paul Heeney, Biocides & Pesticides Assessment Unit, Room 132 Magdalen House, Stanley Precinct, Bootle, Merseyside L20 3QZ., or e-mail biocides@hse.gsi.gov.uk by the end of December. Further details and booking information on the seminar will be sent out in the New Year.

HSE Biocides Contacts

For general information on the Directive, progress with implementation or to register your interest in Biocides please contact us on:

BPU General information number:

Tel: 0151 951 3535
Fax: 0151 951 3317
biocides@hse.gsi.gov.uk

Our address:

Biocides & Pestcides Assessment Unit
Health and Safety Executive
Magdalen House
Merseyside L20 3QZ

HSE Books:

Tel: 01787 881165

Fax: 01787 313995

 

Added to  the HSE website 4 December 2000