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

Issue No. 4 - June 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.1-3 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 contact Alex Tsavalos at the address on page 3. 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.

Progress of the Directive in Europe

Provisional list of biocidal active substances

• HSE sent a further set of additions and corrections to the provisional list of biocidal active substances to the European Chemical Bureau (ECB) in March. This list now stands at over 1500 entries and the ECB plans to circulate it to competent authorities by the end of June. It is intended to have the list available on the Internet by the end of November 1999. Active substances on the list and products containing them will be subject to the transitional arrangements of the Directive. This means that the products will remain subject to existing legislation in each Member State until all the active substances in an individual product have been considered under the Biocidal Products Directive review programme. Any active substance not included on the above list will be considered as new and both it, and any biocidal product containing it, will have to meet all the appropriate provisions of the Biocidal Products Directive before they can be supplied anywhere within the EU. 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.

Competent authority meetings

• The Member States' competent authorities met on 18 May. The two main topics discussed were:
• Scope - there is still a need for further discussion, but we hope that the European Commission (COM) will ultimately produce a manual of decisions providing guidance on the scope of the Directive.
• Review Regulation - COM intends to adhere to its original timetable and to have the Review Regulation in place by May 2000. A first draft was tabled at this meeting.

• All 4 Expert Working Groups examining the Technical Guidance Documents (TGDs) and that on waiving data requirements have now met and in some cases had joint meetings with each other. They have recommended various changes to the TGDs which are being considered by the COM and the Member States. The priority objective is to finalise the TGD covering data requirements.
• COM has now placed a number of contracts to develop further some of the features required for the functioning of the Biocidal Products Directive, such as dossier submission format, prioritisation procedures for the review of existing biocidal active substances and pilot reviews of active substances. Contracts for the latter have been awarded to Denmark and Finland.

Other Member State competent authorities

• If you have a question relating to the implementation of the Biocidal Products Directive in an other Member State, or you supply an active substance into another Member State and not the UK, you should contact the competent authority in that country. Whilst some countries have yet to formally identify their national competent authority, If you contact Alex Tsavalos using the addresses given on page 3 he will provide you with the most current contact details we have available.

Next steps in Europe

• The next key events will be:
  • Competent authority meetings scheduled to discuss the draft data requirements TGD and Review Regulation (8-9 July) and the annex I listing criteria and product authorisation TGDs and the Review Regulation (16-17 November).

• The first meeting of the EU Biocides Standing Committee is expected before the end of 1999. Its first discussions are expected to include a consideration of the draft Review Regulation.

Progress on implementing the Directive in the UK

Draft Biocidal Products Regulations & guidance - Public consultation

• The Health and Safety Commission plan to start public consultation on the draft Biocidal Products Regulations on 2 July. Apart from the draft Regulations the consultative document (CD) will contain a Regulatory Impact Assessment and two HSE guidance documents to help explain the draft Regulations - guidance for suppliers and importers of active substances and biocidal products, and guidance for users - both professional and amateur - of biocidal products.

• The CD is circulated free of charge by HSE Books and you will automatically get a copy if you have previously expressed an interest in the progress of the Directive. If however you do not receive a CD by mid July please contact HSE Books at the address given below. From early July, the full CD will be available.
• From early June to mid September we will also consult on the draft guidance on transitional arrangements. This provides guidance on the review period during which there will be a gradual changeover from the current regulatory regime - principally the Control of Pesticides Regulations - to the BPR. If you have not received a copy by mid June please contact Gill Smith at the address given below and a copy will be sent to you free of charge.

• On the front of this Fact Sheet is the logo for the GB guidance. This will be used to help identify all our planned publications about the new biocides regime.

What should you do now

• The outstanding actions for biocide formulators producers are the same as those identified in Fact Sheet 3. If you have still not acted, we suggest you should do so as soon as possible.
• If you have any questions on any aspects of the Directive and how we are implementing it in the UK please contact Nicola Gregg using the addresses given below. Annex 1 of this fact sheet contains a brief summary of the progress so far.

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 have any questions regarding the public consultation exercise for the Biocidal Products Regulations:

Ms Pat Le-Bruin
Biocides Policy Section
Health and Safety Executive Rose Court
2 Southwark Bridge
London SE1 9HS
Tel: 0171 717 6335
Fax. 0171 717 6199
pat.le-bruin@hse.gov.uk

For a copy of the main consultation document (after mid July):

HSE Books
PO Box 1999
Sudbury
Suffolk CO 10 6FS
Tel: 01787 881165
Fax. 01787 313995

For a copy of the Transitional Guidance consultation document (after mid June):

Ms Gill Smith
Biocides - Transitional Guidance consultation
Pesticide Registration Section
Health and Safety Executive
Room 123
Magdalen House
Merseyside L20 3QZ
Tel: 0151 951 4919
Fax: 0151 951 3317

Annex 1 - UK implementation of the Biocidal Products Directive: summary

GB proposes to implement the Biocidal Products Directive by new Regulations, to be known as the Biocidal Products Regulations (BPR). These will be made under the Health and Safety at Work Act 1974 and the European Communities Act 1972. Similar regulations will be made in Northern Ireland. Existing controls on biocides will eventually be replaced. The agreed implementation strategy is that the regulatory controls should be:

• efficient and effective;
• transparent and accountable;
• self financing, as far as possible

Competent Authority (c.a.)

HSE will be the c.a. in practice, although for legal purposes Ministers will be named in the BPR. We plan to establish two committees to provide the c.a with advice: one consisting of representatives from other Government Departments who have an interest in biocides; the second will be an independent committee of experts.

Timetable

The UK is on target to implement the Directive on time; we expect the BPR to come into effect on 14 May 2000.

Fees and charges

The BPR will introduce fees to enable appropriate costs related to individual approvals to be recovered from the applicant. Other costs of the c.a. (for example monitoring and European work) can only be recovered by a General Industry Charge, or levy, for which new primary legislation is required.

Enforcement

It is proposed that the main enforcing authorities for the BPR will be HSE and local authorities. Penalties for breaches of the BPR will be in line with other UK health and safety legislation.

Public consultation

Industry and non-government organisations have been extensively consulted on the implementation proposals as HSE has developed them. HSE is legally obliged to undertake wider public consultation. This is planned for a period of 3 months from 2 July. It will take the form of a consultative document (CD) containing the draft BPR and two sets of guidance that explain the BPR.

The CD also has to contain an assessment of the costs and benefits of the proposed new regime in the UK.

Difficulties

It may be difficult to get Parliamentary time for new legislation on finance. It is therefore possible that costs will initially have to be covered by general taxation.

The ongoing activity in Europe on the nature of the data requirements, criteria for the acceptance of active substances, methodology for granting authorisations and issues of scope has led to difficulties in certain areas of implementation in the UK. It has meant that the UK has had to make certain assumptions, for example about which products are covered by the Biocidal Products Directive.

Updated on the HSE website 4 December 2000