Fact sheet
Biocidal products directive 98/8/EC

Issue No. 3 - Nov 1998

Purpose

This Fact Sheet provides briefing for the makers and users of active substances and biocidal products to keep them 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 and 2 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 either Fact Sheet No.1 (containing definitions of a biocidal product and the 23 product types, and the aims of the Directive) and/or Fact Sheet No. 2 (which outlined progress between July 97 and May 98) please contact us at the address given on page 3 of this Fact Sheet.

Progress of the Directive in Europe

Existing active substances

• The first round of additions and corrections to the provisional list of existing biocidal active substances has ended. HSE has returned an amended list to the European Chemical Bureau (ECB) - and other Member States should have done the same by now. We believe that there might still be some existing active substances on the UK market that have not yet been notified to the ECB - in particular in "niche markets". If you think that your existing active substance has not been notified then contact us as soon as possible at the address given on page 3 of this Fact Sheet. At the moment we do not have any information about when the updated list will be available for distribution and further amendment, but we will keep you informed.

Competent authority meetings

• The first meeting of the Member States' competent authorities, together with representatives from industry, was held in Brussels on 16/17 July. This meeting considered priority areas for action in relation to the Directive, a European Commission proposal for the review programme; some key issues in the drafting of the Technical Guidance Documents and reviewed other activities.
• At the meeting the concept of 'waiving' data requirements for mammalian toxicology was accepted. The European Commission also informed competent authorities of contracts it was putting out to tender on:
  • developing prioritisation procedures for the review of existing biocidal active substances within the product types and
  • developing practical procedures for preparing dossiers.

• Finally the European Commission set up 6 Expert Working Groups - 4 to take forward different aspects of the Technical Guidance Documents: toxicology, ecotoxicology, environmental fate and behaviour and general issues. The other 2 Groups will look at scope/boundary issues and waiving data requirements. Each Group will be made up of representatives from 5 member states, together with a representative each from industry and a non-governmental organisation. Industry will be represented on all 6 groups - CEFIC will decide appropriate representation. The UK (HSE) has representation on the scope/boundary issues, general issues and ecotoxicology Groups.

• The minutes of the 1st competent authority meeting have been circulated to CEFIC and the CIA.

Next steps in Europe

• The next meeting of Member States' competent authorities is scheduled for 21/22 January 1999 in Brussels and there will be further discussion of the European Commission's proposal for the review programme at this meeting.
• Meetings of the Expert Working Groups have started, and these will continue into next year.

Progress on implementing the Directive in the UK

Draft Regulations & guidance

• We have started to draft the Biocidal Products Regulations (BPR) that will implement the Directive and the main guidance that will explain the new regime. We plan to start public consultation in Spring 1999, as a Health and Safety Commission (HSC) Consultative Document. At the same time we will also consult on the draft transitional arrangements guidance. This provides guidance on the review period during which there will be a gradual changeover from the current regulatory control regime - principally the Control of Pesticides Regulations - to the BPR.
• As part of the public consultation exercise we plan to be out and about, meeting all sectors of the biocides industry to tell you about the draft Regulations and guidance and listening to how you think the Regulations will work and any concerns you may have. So if you are organising a trade show or trade association meeting during March to June 1999 and you would like us to make a presentation or discuss the new biocides regime please contact Philip Clarke in our Biocides Policy Section. His address is on page 3 of this Fact Sheet.

Fees & charges

• To implement Article 25 of the Biocidal Products Directive, HSE plan to introduce a system of fees and charges to recover appropriate costs from industry. Where there is a clearly identifiable customer, they will be charged a fee; examples are companies which apply for authorisation of a product or listing of an active substance on Annex I.
• The cost of appropriate work carried out by the competent authority for which there is no clearly identifiable customer will be charged to a General Industry Charge (GIC); an example of costs recovered in this fashion is the monitoring of biocides. The structure of the GIC is under discussion with industry representatives and might be a levy on product sales or some form of tiered maintenance charge.
• The GIC may start as early as May 2000. To ensure that the recovery of such costs is on an equitable basis from all appropriate parties, it may be necessary to introduce a biocidal product notification scheme. Such a notification scheme would ask manufacturers of biocidal products to tell us what products you currently have on the market.

What should you do now

• Manufacturers, formulators or importers of biocidal products: if you have not already done so write to us at the address below to register your interest (through your trade association, if you are in one). If we haven't got your name and address we can not keep you up to date with developments.

• Product suppliers/formulators: contact the company that makes your active substance, and enquire whether they have put their active substances on the list of existing biocidal active substances. If not, they should contact us as soon as possible.
• If you want to check whether the active substance you produce or formulate for the UK market is on the list of existing biocidal active substances you can either:
• Write in with the details of the active substance in question, (please include the CAS / EINECS number, the IUPAC name and usage areas if possible) and we will check the list for you or
• send us a PC formatted 1.4MB floppy disk and we will send the most current listing available, for you to check.
• If you have any questions on any aspects of the Directive and how we are implementing it in the UK please contact us, although you may find the answer to your question on the last page of this Fact Sheet.

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

If you are organising a trade show or trade association meeting during March to June 1999 and you would like HSE to make a presentation or discuss the new biocides regime:

Philip Clarke
Biocides Policy Section
Health and Safety Executive Rose Court
2 Southwark Bridge
London SE1 9HS
Te:0171 717 6976
Fax: 0171 717 6199
philip.clarke@hse.gov.uk

Frequently asked questions about the Biocidal Products Directive

Q: I've heard about the Biocidal Products Directive but I'm not sure if my products come under it, where can I find out?

A: Get in touch with Alex Tsavalos of this Fact Sheet. Whilst some of the questions relating to the scope of the Directive are still unanswered, we will do our best to provide the current position. Also if you bring any new scope questions to our attention we may be able to raise these during Expert Working Group meetings in Brussels.

Q: I am a paint manufacturer producing water based emulsions and use in-can preservatives (biocide product-type 6) to maintain the integrity of the paint. Will my paint require an authorisation under the Biocidal Products Directive.

A: No. As long as the biocide is present only to maintain the integrity of the paint, the paint itself will not require authorisation. The in-can preservatives you use in the paint will however require authorisation - this would be the responsibility of whoever placed the in-can preservative on the market. You may wish to contact the supplier of your in-can preservative to make sure they are aware of the Biocidal Products Directive.

However, if your paint contains significantly more biocide than is required to protect the integrity of the paint or makes claims of biocidal activity (e.g. "kills mould on contact", "keeps surface germ free" or "protects wood"), this would make your paint a biocidal product and it will require authorisation in its own right. [Note this principle may apply to other products not just paints].

Q: My company is developing a new active substance. Can it be placed on the list of existing active substances now?

A: This list is for active substances that are currently on the European Union market for use in biocidal products. HSE, as the competent authority for the UK, is collecting details of all existing active substances on the UK market and passing them to the European Chemicals Bureau (ECB) to be put on the full list. If at any time before 14 May 2000 you put your active substance on the UK market for use in biocidal products, you should contact us to get it on the list. We will pass the details on to the ECB. The same will apply in other Member States - if your active substance is on the market in another Member State before 14 May 2000, contact their competent authority.

Remember that in the UK your new chemical may currently be covered by other legislation such as the Control of Pesticides Regulations (COPR) 1986 (as amended 1997), the Notification of New Substances Regulations (NONS) 1993 and/or the Chemicals (Hazards Information and Packaging for Supply) Regulations (CHIP) 1994 (as amended 1997).

Q: If I develop a new use of an existing active substance and start to produce a new biocidal product after 14 May 2000 - will I have to get an authorisation for it under BPR?

A: You do not need to get a BPR authorisation for your product until the active substance has been assessed for inclusion on Annex I. During this time it will be subject to any other current UK legislation affecting products of that type until such time as it transfers to the Biocidal Products Regulations.

Q: Will I have to pay under the new biocides regime , if so how much will it cost me?

A: Companies which apply to the competent authority for a product to be authorised or for an active substance to be listed on Annex I will be required to pay a fee to cover the costs of the work carried out. There will probably also be either a tiered maintenance charge or levy on product sales turnover to cover costs of other appropriate work carried out by the competent authority: for example the cost of monitoring. The Biocidal Products Regulations will detail the fees.

 

Updated on the HSE website 4 December 2000