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 Consultation

A Consultative Document (CD) containing:

- THE DRAFT REGULATIONS

- THE BIOCIDAL PRODUCTS DIRECTIVE

- THE DRAFT GUIDANCE

- THE REGULATORY IMPACT ASSESSMENT

- A LIST OF CONSULTEES

- A REPLY PRO-FORMA

was published on 2 July 1999 and comments were invited from industry, other government departments, non-governmental organisations and the general public up to 1 October 1999.

After this date the draft Regulations and Guidance will be amended in the light of comments received and then a submission made to Ministers asking them to accept the Regulations. They will then be laid before Parliament.

It is anticipated that the Regulations and Guidance will be in place by the required date of 14 May 2000.

Even though the Regulations are in place on 14 May 2000 there will be no immediate effect on product authorisations as the Regulations (and the parent Directive) depend on active substances being listed in annex I of the Directive. On 14 May 2000 Annex I will be empty.

3.5 Transitional arrangements

- BPR DO NOT APPLY UNTIL ACTIVES ARE ON ANNEX I

- ANNEX I IS EMPTY ON 14 MAY 2000

- ANNEX I IS FILLED ESSENTIALLY BY THE REVIEW PROGRAMME

There will be a long transitional period (the Directive foresees 10 years) before the Regulations come fully into effect. During the transition period existing national rules will contine to apply - that means CoPR will continue until all biocidal active substances have been reviewed under the biocides programme.

3.6 The Review Programme

There are approximately 2000 existing active substances to be reviewed over a 10 year period. The European Commission and member states are currently working on producing a review Regulation which is expected to be in two parts. Part one will outline the process and may be accompanied by a list of existing active substances on the market. It is anticipated to be published by the end of this year. Part two of the review Regulation will follow some 18 months later and will contain the first list of active substances to be reviewed.

The review programme is likely to be fairly similar to that operating for agricultural pesticides under Directive 91/414/EEC and its main features are:

- REVIEWS WILL BE CARRIED OUT BY MEMBER STATES

- ANNEX I ENTRY WILL BE DECIDED BY THE COMMUNITY

- THE PROGRAMME IS DUE TO BE COMPLETED IN 10 YEARS

4 EFFECTS ON INDUSTRY

The Directive, and implementing Regulations require that risk assessments are carried out on biocidal active substances and the products containing them. This requires the submission, and in many cases the generation of data and industry has to provide this.

4.1 What does industry have to do?

Industry has to consider the following key questions:

- WHAT ACTIVE SUBSTANCES ARE USED?

- WHAT ARE THE DATA GAPS?

- WILL THE DATA GAPS BE FILLED?

Industry has to decide which of the existing active substances it will support and supply the necessary data to the competent authorities. Data must also be submitted on any new active substances (not on the market on 14 May 2000).

Individual companies should try to get together to form task forces to help with the gathering and submission of data. The Directive encourages this and gives member states the power to require this by law.

Industry should also continue to work with the European commission and other member states on the many working groups which are working on clarification of aspects related to the Directive. These groups cover topics such as the scope of the Directive, thhe exact data requirements an various European guidance documents but most importantly the review programme.

In summary, even though the Directive itself has been agreed, industry can still influence:

- THE REVIEW PROCESS

- THE DATA REQUIREMENTS

- THE GUIDANCE DOCUMENTS

5 THE TIME SCALE

Assuming that everything goes according to plan and that agreements are quickly reached the timetable looks like this:

- IMPLEMENTATION IN MEMBER STATES - May 2000

- FIRST REVIEW REGULATION - Jan 2000

- GUIDANCE DOCUMENTS - May 2002

- SECOND REVIEW REGULATION - July 2002

- REVIEW PROGRAMME STARTS - Aug. 2002

- FIRST ACTIVE ON ANNEX I - Aug. 2003

- ALL ACTIVES ON ANNEX I - Aug. 2012

It has to be said that this is a very optimistic timetable and the author's view is that there is likely to be significant slippage in all phases but especially in the operation of the review programme.

6 SUMMARY

6.1 Positive aspects of the Directive

These are:

- STANDARDISATION OF THE DATA REQUIREMENTS

- MUTUAL RECOGNITION OF PRODUCT AUTHORISATIONS

6.2 Negative aspects of the Directive

These are:

- THE DATA REQUIREMENTS THEMSELVES

- THE AUTHORISATION COSTS

- A RESTRICTED CHOICE OF ACTIVES AS A RESULT

7 CONCLUSION

In conclusion the Biocidal Products Directive will have the following effects:

- NEW REGULATIONS IN PLACE IN THE UK BY 14 MAY 2000

- NO IMMEDIATE EFFECT ON PRODUCT AUTHORISATIONS

- THE REQUIREMENTS COME IN GRADUALLY OVER 10 YEARS

BIOCIDES IN THE PULP & PAPER INDUSTRY: AN OVERVIEW

Dr Pamela Simpson

Whitewater Technologies Ltd, P.O.Box 1153, Stourbridge, West Midlands DY8 2GB

1 INTRODUCTION

Growth of microorganisms in paper manufacturing processes can cause major technical, economic and hygienic problems, mainly due to slime formation. The chemical-physical conditions, and the composition of microorganisms, may vary widely in one process and between processes. Resistant strains can evolve following repeated treatment by certain biocide technologies. Furthermore the regulations for paper intended for food packaging and environmental labelling systems limit the choice of biocide active ingredients.

Biocides are added to the wet end process to prevent slime formation. Introduction of neutral or alkaline sizing instead of acidic papermaking, the closed water circuits, and the increasing proportions of recycled paper have required changes in biocide types in order to control different microbial populations.

Biocides are also used in the pulp and paper industry for the protection of processing materials. The main biocides used in this application fall into the preservative range and can be different from others employed within the paper processing.

This paper aims to introduce the problems that exist within the pulp and paper processing and detail how biocides can help to reduce these problems.

2 THE PULP INDUSTRY

2.1 Types of Pulp

The pulp industry is broken down into predominantly two types of fibre types:

2.1.1 Virgin fibre, which can be further, split into two types, e.g. chemical and mechanical. Chemical virgin fibre undergoes treatments that remove most of the lignin; mechanical undergoes treatment that maintains the level of lignin within the pulp. Both these types of pulp are relatively free from microbiological contamination.

2.1.2 Recycled fibre such as newspaper, coloured paper, computer paper and is usually heavily contaminated with microorganisms.

Both of these types of pulps offer a variety of microbiological problems with the most severe being from the recycled paper types. The microbiological problems encountered are both aerobic and anaerobic bacteria which can develop at different stages of the pulping and can lead to the production of "off odours usually associated with hydrogen sulphide. Once produced, hydrogen sulphide can react with free metals to produce pigmented sulphides that cause further problems of discolouration.

Wherever virgin fibres are used for pulp manufacture, although these appear relatively free from microbial problems, there may be fungal spores present which originated from the timber itself. If these are presented with the right growth conditions, germination may take effect, causing hyphal development and surface "mat" formation. As a bi-product of this growth, pigments can also be released from the fungal species, which again can cause pigmentation of the pulp.

2.2 Biocides Encountered in the Pulp Industry

Over the last few years, the pulp industry has come under extensive pressure to reduce the levels of halogens being discharged in effluent streams. As the pulping process utilises high levels of halogens during their bleaching process, the level of available organic halogen (AOX) is high and thought to be of concern to the environment. Alternatives have therefore been sought which can achieve the bleaching requirements, but have minimal impact on the environment. These also, indirectly, have had a great effect on the level of microorganisms remaining within bleached pulp. Hence non-sterile pulp may be transferred to a paper process and cause problems during manufacture.

Table 1 below represents the types of biocides that were used during the pulping process and subsequent biocides that have been introduced over the last few years to assist in the reduction of microbial contamination. In general, they types of biocides that are now being utilised are fast acting bactericides to prevent the anaerobic activity which results in the production of odours and blackened pulp.

The halogenated hydantoins also form part of the new types of biocides being used. Although these contain halogens, these are released on demand and hence are only available when microbiological activity demands the release of the halogen. Hence the release of halogens is significantly reduced and is seen as a reduced environmental concern.

3 COATINGS AND ADDITIVES FOR PAPER MAKING

3.1 Types of Coatings and Additives

The coatings and additives utilised during paper processing are also a significant source of microbiological contamination. The types that are frequently used are:

Fillers: e.g. calcium carbonate, kaolin, titanium dioxide
Sizing agents, starches
Natural dyes,
brighteners Retention aids

All these components are from natural sources and are frequently contaminated by aerobic and anaerobic bacteria which utilise these as their food source. The problems encountered are not too dissimilar to those encountered in the pulp industry with colouration being of great concern. Other problems however are due to the loss of viscosity of these products once microbiological digestion is underway. If this occurs during storage in tanks, the whole product is rendered ineffective and cannot be used within the paper process as the microbiological digestion has altered their properties.

Any product that is utilised during paper production will cause paper sheet colouration or loss of desired properties and hence would cause a significant paper quality failure and lost income. It is therefore important to have a good plant hygiene programme in place to monitor carefully the storage products of such products and ensure that the right preservative chemistry is in place to maintain a microbiological free product for long periods of time.

3.2 Biocides Used in the Coatings and Additives Industry

The types of biocides used in this application vary from the rest of the pulp and paper industry. These require to be longer lasting, i.e. sometimes up to 1 years protection is storage tanks and hence fall into the category of preservatives.

Table 2 represents the types of preservatives that are commonly encountered in these products for use in the paper industry.

Chlorine dioxide has also periodically been encountered in these applications in third world countries, but the effectiveness of this biocide would be short lived.