Health and Safety
Executive / Commission
Biocides &
pesticides
Issue No. 8 March 2001
These Fact Sheets provide briefings 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.
Fact Sheet 8 is not a revision of Fact Sheets Nos.1-7 but instead provides supplementary information and advice. If you would like a copy of earlier Fact Sheets please contact us at the address given at the end of this Fact Sheet, or download them from our website, details of which are given at the end of this Fact Sheet.
The European Chemicals Bureau has initiated a series of Technical Meetings to discuss technical issues relating to the implementation of the Directive. The first of these meetings was held on 29 January to 1 February with the purpose of taking forward discussions on two TNG's, one on the inclusion of active substances on Annex I and another in support of Annex VI (ie the authorisation of products). Substantial progress was made on the TNG on the inclusion of active substances on Annex I and a further draft will be available for the next Technical Meeting scheduled for 15 May. There was limited discussion on the TNG in support of Annex VI. Further discussion on this is likely to follow the finalisation of the TNG on the inclusion of active substances on Annex I.
The European Commission, DG-Environment, has let a new contract to TNO, The Netherlands, to prepare Technical Notes for Guidance (TNG) on human exposure to biocidal products.
This TNG is intended to be for use by informed professionals, and by applicants, for biocidal product authorisation. It will set out how to evaluate human exposure, with examples. It will accommodate indoor (residential) exposure and climatic variability. The example outputs will contain a critical explanation of why and how the models and defaults chosen are used.
The timetable requires that research and drafting should be complete by the end of 2001, with consultation over the next six months. There is a good deal of information yet to be gathered, particularly in respect of patterns of use.
The project team has two Industry representatives nominated by CEFIC, and in due course they may contact you for such information. The CEFIC representatives are:
Prof. J Pauluhn, Bayer (juergen.pauluhn.jp@bayer-ag.de) and
Mr D Baur, Rohm & Haas (daniel_baur@rohmhaas.com).
The central CEFIC contact is Dr M Michaux mmi@cefic.be The project secretariat is provided by HSE and the project is being managed on behalf of DG-Environment by the European Chemicals Bureau at Ispra
An early task for the project team is to establish what information is already held by industries and institutions. The information they are interested in includes:
Therefore if you hold information on human exposure that could be used in this project, or if you are commissioning new research into human exposure to biocides, the Secretariat would be very grateful for any help or information you could make available. Please could you respond to the TNG project team's Secretariat, whose address appears below.
Secretariat:
Andrew Garrod
HSE Room 114A Magdalen House, Stanley Precinct, Bootle, Merseyside, UK L20 3QZ Phone (+44) 151 951 4667 Fax (+44) 151 951 3317 Email andrew.garrod@hse.gsi.gov.uk
The scope of the Biocidal Products Directive covers a wide range of products (23 different product types) including wood preservatives, public hygiene insecticides, anti-fouling paints and disinfectants.
In 1998 it was identified that the Biocidal Products Directive had many potential overlaps and interfaces with other Directives. These borderline issues were considered to be a priority by Member States and an 'expert working group' of 5 Member States (including the UK) and Industry was set up to address this matter.
The working group does not make definitive decisions, their remit is to put forward their views as national experts to the Commission, who are then responsible for the final conclusions.
The UK has been proactive in putting forward borderline issues for consideration by the expert group. The group has met 6 times and has already considered borderlines with plant protection products, and medicines. The European Commission are intending to eventually put together a 'manual of decisions'. When this will be published is unknown at present.
The group is currently seeking to clarify the borderline with cosmetics. The next meeting is due to take place in May
We would like to thank all of those who took the time to respond to this letter and provide information on the costs to them of complying with each of the options. The points made by industry during this consultation will be fully considered in HSE's analysis of the advantages and drawbacks of the available options. However, no final decision has yet been made in this area.
HSE are continuing to undertake steps to establish a Charging Review Group to oversee the operation of the charging regime. An initial pre-meeting of this group was held on the 8th December when a number of issues were discussed. The membership of this group has yet to be finalised but will be drawn from stakeholder groups and HSE.
The BCC will include an independent Chair, independent scientific experts in the fields of toxicology, ecotoxicology, occupational hygiene, efficacy and microbiology and a number of lay members to represent consumer, environmental and employee interests.
HSE, as part of the UK Competent Authority, is following guidelines set down by the Office of the Commissioner for Public Appointments (OCPA) in the selection of nominations to put to the Health and Safety Commission and Ministers. Most appointments have now been agreed by the HSC and Ministers, and candidates are being notified of the results. The Committee will hold its inaugural meeting in the Summer.
The GB Regulations have been delayed because of an issue concerning the appropriate competent authority for Scotland. However, in the light of the Reasoned Opinion we anticipate that the Regulations will come into force within six weeks.
BPU's Guidance for Applicants will then also become available and we will contact all relevant parties to ask for their interest in receiving this document.
The road show is designed to raise awareness, particularly among small firms, and provide information about the requirements of the BPR. There will be plenty of time for delegates to ask questions about the new regulations.
You must reserve your place in advance as seats are limited. If you would like to book a place you will need to fill out an application form. These are available on request from Sharon Thompson at HSE Rose Court. Contact her by e-mail at this address: sharon.thompson@hse.gsi.gov.uk, or by telephone on 020 7717 6238.
Over 250 delegates have attended the roadshows to date. If you attended one of the previous roadshows in Newcastle, Birmingham, Edinburgh, London, Cardiff or Liverpool and would like a list of companies represented at the roadshows for possible data sharing purposes, please get in touch with Sharon and she will send you the delegates list.
Enclosed with this Fact Sheet is a leaflet which gives details of the programme and includes a booking form. You should note that some of the content of this seminar is particularly aimed at those industries whose products are already regulated under the Control of Pesticides Regulations, and much of the information covered in the biocides session in the afternoon will be similar to that covered in the recent roadshows. Bearing that in mind, you would be welcome to join us for the day, and it will give you the chance to meet BPU staff in person and to discuss issues of interest to you at the open forum session.
For further information on the seminar, please contact Alison Wightman by e-mail to biocides@hse.gsi.gov.uk, by telephone on 0151 951 3927 or by letter to the address given at the end of this Fact Sheet. Please note that your completed booking form should be returned to the address given on the booking form, and not to BPU.
For general information on the Directive, progress with implementation or to register your interest in Biocides please contact us on:
Biocides & Pesticides Assessment Unit General information number:
Tel: 0151 951 3535
Fax :0151 951 3317
biocides@hse.gsi.gov.uk
Our address:
Biocides & Pesticides Assessment Unit
Health and Safety Executive
Magdalen House
Bootle
Merseyside L20 3QZ
Please note - Clare Bowling of BPU's Biocides Strategy Section - whom many of you will have contacted over the last 18 months - will be leaving the Unit at the end of March following a successful promotion panel. She will be replaced in the short term by Mrs Pauline Stenhouse.
Tel: 01787 881165
Fax: 01787 313995
HSE Cardiff Office
Tel: 02920 263000
Added to the HSE website 22 March 2001