THE BIOCIDAL PRODUCTS DIRECTIVE (98/8/EC)

Geoffrey Wilson

Health & Safety Executive, Rose Court, 2 Southwark Bridge, London SE1 9HS

1 SUMMARY

This paper outlines the content of the Biocidal Products Directive and explains how it will be implemented in the UK. It covers what industry will have to do in compliance, what is currently happening in Europe and gives an estimated timetable for all the activities.

2 BIOCIDAL PRODUCTS DIRECTIVE

A proposal for a European Parliament and Council Directive concerning the placing of biocidal products on the market was adopted on 16 February 1998, numbered 98/8/EC and published in the Official Journal on 24 April 1998 (reference L 123 pp 1-62).

The Directive has to be implemented in all member states by 14 May 2000.

2.1 Aims of the Directive

The Directive is based on article 100a of the Treaty and it has has two key aims: - HARMONISATION OF THE MARKET FOR BIOCIDAL PRODUCTS - A HIGH LEVEL OF PROTECTION FOR HUMANS AND THE ENVIRONMENT

2.2 Operation of the Directive

The Directive will operate by listing all active substances which can be used in biocidal products in a list (annex I to the Directive) and requiring that only those active substances listed can be used in biocidal products. Member states will then authorise biocidal products to a set of common principles (annex V of the Directive) with a system of mutual recognition of authorisations.

2.3 Content of the Directive

A summary of the main contents of the Directive is:

MUTUAL RECOGNITION

SCOPE - there are 23 Product types

MUTUAL RECOGNITION

COMPARATIVE ASSESSMENT

DATA REQUIREMENTS

DATA PROTECTION & CONFIDENTIALITY

SIMPLIFIED PROCEDURES

CLASSIFICATION, PACKAGING and LABELLING

CHARGES

TRANSITIONAL ARRANGEMENTS

GUIDANCE DOCUMENTS

Member states have a number of actions under the Directive. They have to appoint a competent authority (or authorities), transpose the Directive into national law, enforce it and provide information to the European Commission.

3 IMPLEMENTATION OF THE BPD IN THE UK

The UK has set three principles for the implementation of the Directive. These are that the implementing systems must be:

- EFFICIENT & EFFECTIVE

- TRANSPARENT & ACCOUNTABLE

- SELF FINANCING (as far as possible).

In practice it has been agreed that the Health and Safety Executive (HSE) will operate as the de facto competent authority and that new Regulations will be made under the Health & Safety at Work etc. Act and the European Communies Act - the Biocidal Products Regulations (BPR).

Guidance on the new Regulations and on the proposed new systems will also be produced and both the Regulations and the guidance will be circulated for public comment. A number of industry groups have been set up to assist with this process. One group deals with financial issues, another with the transitional arrangements whilst a third group covers optimisation of use - this latter group is known as the Biocides Users Group (BUG).

There is a current control system for certain types of biocidal products (known as non-agricultural pesticides) operated by HSE under the Control of Pesticides Regulations (CoPR). These are antifouling products, insecticides, wood preservatives and surface biocides. Additionally agricultural pesticides are controlled under CoPR but these are administered by the Pesticides Safety Directorate (PSD), an executive agency of the Ministry of Agriculture, Fisheries and Food (MAFF).

Many new product types will be regulated by HSE under the BPR, and these are listed on the next page:

DISINFECTANTS

PRESERVATIVES - In can; Film; Fibre, rubber & polymerised; Liquid cooling & processing; Metalworking; Food & feedstocks preservatives.

SLIMICIDES

EMBALMING & TAXIDERMIST FLUIDS

ATTRACTANTS

(Rodenlicides, Avicides, Molluscicides, Piscicides, Vertebrate control agents).

The last group of products - enclosed in brackets - are currently controlled under CoPR but by PSD rather than HSE.

3.1 Proposals for charges

The Directive (article 25) allows for full cost recovery and HSE's proposals are that this will be collected in two ways: by fees and by a general industry charge (GIC). A fee will be charged to directly identifiable customers e.g. those who apply for authorisation of a biocidal product whilst the GIC will be payable by all with biocidal products on the market. It will cover the costs of work such as monitoring, specific biocides research work etc.; it is likely to start on 14 May 2000.

3.2 The Biocides Consultative Committee (BCC)

This committee will offer advice to the competent authority (HSE) on all aspects involving biocides. It will be composed mainly of independent members and have an independent chairman. Other Government Departments will sit on the committee acting as advisors. There will also be an interdepartmental committee which will work with the competent authority on the scientific assessments and risk assessments.

3.3 Guidance Documents

Five sets of guidance will be produced:

GUIDANCE FOR SUPPLIERS
GUIDANCE FOR USERS
TRANSITIONAL GUIDANCE
GUIDANCE FOR APPLICANTS
A SIMPLE GUIDE

This guidance should all be available before the implementation date of the Directive, with the Transitional Guidance being available first.

3.4 Public...