Fact sheet
Biocidal IOCIDAL PRODUCTS DIRECTIVE (Biocidal Products Directive), 98/8/EC

Issue No. 6 June 2000

Purpose

This Fact Sheet provides 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.

This is not a revision of Fact Sheets Nos.1-5 but instead provides supplementary information and advice. If you would like a copy of earlier fact sheets please contact us at the address at the end of this fact sheet.

Please note that this is the last Biocidal Products Directive Fact Sheet that will be produced in this format. In future we aim to provide information in a style more in line with a Newsletter (see section "Update on Biocides Guidance").

Progress of the Directive in Europe

The Review Regulation

• The Standing Committee on Biocides, at its first meeting on 18 May, adopted the first Review Regulation. The agreed text, in all Member State languages, will be published (probably in late August) in the Official Journal of the European Communities and will come into force 20 days later.
• The brief details of the requirements of the Review Regulation, as described in Fact Sheet 5, remain valid, with one exception:
  As final agreement on the Review Regulation has been delayed from that originally intended by the European Commission, the data submission period will not start until September, NOT this Spring, as indicated in Fact Sheet 5.
• Full details of the data requirements are outlined in Annexes I and II of the Regulation. You should be able to obtain a draft copy of this from your trade association. We are in the process of preparing guidance (see section "Update on Biocides Guidance") which will be circulated once the Review Regulation is published, but if you require further advice on the data requirements of this Regulation please contact us.

Provisional list of biocidal active substances

• As the implementation date of the Directive has passed, HSE will no longer be accepting any more additions for this list. We remind you that the list is still available on a Commission website.
  If a substance has not been included in the list this does not necessarily mean that it will not be considered as "existing". But proof that an active substance was on the market before 14 May 2000 will be required for all substances if they are to be considered "existing" active substances under the biocides regime.

  If you wish to discuss any aspects of the list, please ask for Dr. Sean McCarthy when contacting us.

European Guidance

• The Technical Notes for Guidance (TN'sG) on "Data Requirements for active substances and biocidal products" is now is available, in English only, on a Commission website. A hard-copy version, also in English only, will be available at the end of this year. The EC acknowledges that it will need to be amended in due course, based on experience in use. For this reason it will not be published in the OJ for now. In addition to this, the section on "waiving" is currently being reconsidered
• Guidelines on the structure and format of application dossiers and Member State evaluations are currently being finalised. These are due to be discussed, and should be agreed, at the next Competent Authority meeting in October.

Competent Authority meetings

• The Member States' Competent Authorities met on 17 March and again on 17-18 May. The main topics discussed were:

• Review Regulation (see above)
• Scope - The Commission intends that all guidance on scope will eventually be available in a 'manual of decisions'. This will NOT be a legally binding document, but will give guidance on borderline products.
  Many issues continue to be discussed. In particular the borderline between biocidal and medicinal products which are applied to the skin.
  The EC is keen that other scope issues, which need clarification, are brought to their attention. Consequently, if you have any examples that need to be resolved, then please let us know. Please ask for
  Clare Bowling when contacting us.
• Pilot Review Projects - Work has now started on the Pilot Review Projects. These are projects to test the procedures needed to run the Review Programme. The Finnish and Danish Competent Authorities will be evaluating dossiers on glutaraldehyde (used as a slimicide and a preservative in recirculating cooling systems) and tebuconazole (a wood preservative), respectively. Work is already under way and a meeting of all Member States is planned for 21-22 September 2000.

Next steps in Europe

• The next key events will be :

• The EC Review Regulation will be published end of August/September and come into force 20 days later.
• Member States will meet to discuss the new draft of the section on waiving of data from the TN'sG on Data Requirements.
• Member States will meet in September to discuss progress with the pilot review projects.
• A further Competent Authority meeting is planned for 11-12 October.

Progress on implementing the Directive in the UK

Biocidal Products Regulations

• As you know the UK has been working towards implementing the Biocidal Products Directive by the due date of 14^th May 2000.

  The Health and Safety Commission (HSC) undertook a public consultation exercise last autumn on proposals to implement all aspects of this very complex and technical Directive. We are currently working on amendments to the draft Regulations but unfortunately are running a little late and currently expect implementation will be by late summer. Many other EU Member States have also indicated that they too are behind schedule.

  To coincide with the GB Regulations coming into force we have decided to run a series of seminars across the country as follows;

  Glasgow 13 September

  Edinburgh 14 September

  Newcastle 22 September

  Cardiff 28 September

  Birmingham 5 October

  London 12 October

  Details on the venue and timetable will be circulated nearer the time.

UK Committees

• Advertisements were posted for members of the Biocides Consultative Committee (BCC) in January and the response was very positive. Interviews are due to take place in June 2000 and recommendations for appointments will then be made to Ministers. Subject to successful appointments it is hoped that an inaugural meeting of the BCC will be held towards the end of this year.

  Once this Committee is in place work will commence on setting up the Interdepartmental Committee on Biocides (ICB).
  

Update on Biocides Guidance

As the implementation of the Biocidal Products Regulations in Great Britain and the publication of the Review Regulation by the EC are imminent, it is timely to summarise the state of play concerning the publication of guidance and information on the new regime.

Guidance to be available from HSE Books :

• Biocidal Products Regulations Transitional Arrangements guidance for the suppliers and importers of biocides. (priced)
• The Guidance for Suppliers and Importers of Active Substances and Biocidal Products. (priced)
• The Guidance for Users of Biocides. (priced)
• A simple guide to the regime. (free)

  All of these publications will be available from August 2000

Guidance and information available from PRS :

• Guide for Applicants
  We are preparing a Guide for those who wish to apply for Annex I listing of active substances or authorisation of biocidal products. This will be a loose-leaf guide for filing in a ring-binder. Such a format will allow for easy updating and amendment. Our initial priority has been the completion of the sections covering the background (Part A) and applications for Annex I listing (Part B). We hope to have these available by this summer. The section on applications for product authorisations (Part C) will be available at a later date.
  This Guide for Applicants will cross-reference appropriate EU Guidance (e.g. Guidance on Data Requirements and on the Structure and Content of Dossiers).
• Guidance on the First EC Review Regulation
  A short guidance document targeted at suppliers of active substances and formulators who wish to Identify or Notify active substances in the first phase of the Review Programme is being finalised. We will send it to you immediately after the Review Regulation has been published by the EC in the Official Journal and it will also be available from us on request.
• Other Activities
  We will be ensuring that all guidance and information that you receive from us is suitably referenced. We also intend to make as much information as possible available on the Internet. We hope to make guidance, similar to that for the First EC Review Regulation, available on other issues (e.g. on scope, once the EC has finalised the boundaries between the Directive and certain other Directives)
• As the GB Biocidal Products Regulations (2000) are soon to come into force we have decided that it is no longer appropriate to provide information in this format. Therefore, as stated at the beginning of this Fact Sheet, this will be the last Biocidal Products Directive Fact Sheet. In the future we shall be producing periodic "BPR Newsletters", similar to those received by the pesticides industry, regulated by CoPR. The first of these is expected to be sent to all our contacts in December 2000.

Update on Recent Industry Consultations

We would also like to take this opportunity to explain the situation regarding requests from us to industry for information and to explain the consultation exercise that we will be conducting in the near future.

Requests to Industry for Information

• On 5 April 2000 (our ref. PST 2888) we wrote to companies seeking clarification as to whether or not they supply biocidal products onto the UK market (CoPR Approval Holders were excluded from this exercise).
• We shall shortly be writing again to those who do supply biocidal products onto the UK market (including CoPR Approval Holders) seeking further information on the products they supply.

Consultation on Charging

• We plan to consult industry on the structure of the General Industry Charge (GIC) and, as part of this process, there will be a meeting of the finance subgroup of the ad hoc working group on 21 June.

Research and Development (R&D) Activities under Biocidal Products Directive

• Quantities placed on the market and data requirements
  Article 17 of the Directive details the procedures for R&D activities. Article 17.5 states that the EC will bring forward proposals for common conditions, in particular maximum quantities that may be released and the minimum data to be submitted. However, at the present time the EC Commission does not see an urgent need to have an EU-wide agreement on these conditions.
  
  We see R&D as being an important early activity under Biocidal Products Directive. Active substances not currently on the market for use in biocidal products will need to be subject to these procedures before applications for Provisional Authorisation or Annex I listing are made. Consequently, we are considering our needs in this area and anticipate consulting the Biocides Consultative Committee before the end of the year. When the requirements are finalised, they will be available for inclusion in Part C of the Guide for Applicants.
• Consumer trials
  We have been asked whether consumer trials would be considered to be an R&D, Process-orientated R&D (PORD) or an Experimental Authorisation activity. Our current view is that, as the definitions of R&D and PORD are taken from the Dangerous Substances Directive (DSD) (92/32/EEC), then the conditions imposed by DSD should also inform those imposed by Biocidal Products Directive.
  
  Our current view is that an Experimental Authorisation would be needed. Such activities are not considered to be R&D under the DSD. Article 13.2 of DSD makes it quite clear that a PORD substance can only be handled by customers' staff in controlled conditions and cannot be made available to the general public at any time either on its own or in a preparation.

What should you do now

REMINDER: All companies who place biocidal products on the market would have a duty under BPR to inform the National Poison Information Service (NPIS) in Birmingham (draft Regulation 29 lists the information required). This will need to be done immediately when placing a product on the market for the first time, but those products already on the market on 14 May 2000 will have three years from this date (i.e. until 14 May 2003) to let NPIS have the information. If you prefer, NPIS will accept a copy of the product's Safety Data Sheet (if there is one) plus the additional required information.

You can send the information by post or electronically to;

NPIS Birmingham Centre,
City Hospital NHS Trust,
Dudley Road,
Birmingham,
B18 7QH
e-mail: w.harrison@npis.org.

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
biocides@hse.gsi.gov.uk

Updated on the HSE website 4 December 2000