Health and Safety
Executive / Commission
Biocides &
pesticides
Issue No. 9 June 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 9 is not a revision of Fact Sheets Nos.1-8 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.
Guidance on preparing a Notification of an existing active substance according to Article 4 of the 1st Review Regulation, in particular where the required information can be entered in IUCLID, is being prepared by the ECB. This has been discussed at a Technical Meeting and should soon be placed on the ECB Website.
Recently, we have been asked a number of questions regarding the preparation of Notifications. We have raised some of the points with the EC and summaries of the position are given below.
The 2nd Review Regulation was discussed at the Competent Authorities' meeting in March and again at a specific meeting in April. The Commission intends to finalise discussions on the text of the Regulation in 2001 and for it to enter into force in May 2003. The Regulation will establish lists of active substances which have been Identified or Notified in accordance with the 1st Review Regulation. It will also establish priority lists for the full review of the Notified active substances, together with the rapporteur Member State and the dates by which dossiers must be submitted. Active substances which have not been Identified will have to be withdrawn from the market for use in biocides. The timetable for this will be given either in the 2nd Review Regulations or in a series of Commission Decisions. Active substances which have been Identified, but not Notified, will have to be similarly withdrawn, but will be allowed an extended phase-out period of up to three years.
A further draft of the TnG on the inclusion of active substances on Annex I (revised following the Technical Meeting on 29 Jan-1 Feb) has been discussed at a Technical Meeting on 16 May. The Commission intends to progress the finalisation of the guidance quickly, obtaining the views of its Scientific Committee during the summer and the agreement of the Competent Authorities in November.
The Biocidal Products Directive concerns the placing on the market and use of biocidal products within the EU. It covers a wide range of products within 4 main groups [Main Group 1 - Disinfectants and General Biocidal Products, Main Group 2 Preservatives, Main Group 3 Pest Control and Main Group 4 - Other Biocidal Products] containing 23 different product types.
One of the most frequent questions asked by Industry is - 'is my product /active substance within the scope of the Biocidal Products Directive'?
The first thing to consider is that the Directive does not apply to biocidal products that come within the scope of other EU Directives that were already in place when the Biocidal Products Directive was adopted in February 1998. These Directives are all listed in Article1 of the Biocidal Products Directive, however a number of important examples are listed below :
As explained in the Biocides Fact Sheet 8 (March 2001) it was identified in 1998 that the Biocidal Products Directive had many potential overlaps and borderline cases with these other Directives. The problem was considered to be such a priority issue by Member States that it was agreed to establish an 'expert working group' to help resolve these matters.
The working group cannot make definitive decisions, the group's remit is to put forward their views as national experts. In addition to the borderline issues the group also considers the more unusual questions and issues raised by Member States and other internal discussion papers produced by the Commission. The outcomes of these discussions are then fed back by the Commission to the Competent Authorities for Biocides at one of their regular meetings.
The UK Competent Authority continues to be extremely pro-active in putting forward both its own questions and queries and those raised by industry.
The mechanics of the EU can move slowly and the proposed 'manual of decisions' clarifying scope issues has yet to be produced.
However, substantial progress has been made in a number of areas and the clarification of the borderline between Biocidal Products Directive and the Plant Protection Products Directive has now been agreed and is available on the DG SANCO website at:- http://europa.eu.int/comm/food/fs/ph_ps/pro/wrkdoc/wrkdoc17_en.html and should soon become available on the ECB Website.
Unfortunately the May 2001 meeting of the scope working group was cancelled - the next one is planed for September 2001. However further discussions on scope are anticipated at the Competent Authorities meeting scheduled for 21-22 June 2001.
The next step for the group will be to consider the borderline with cosmetics and medicines.
After discussion, the Commission and Member States have reached a consensus on the following issues, however it must be noted that whilst they represent the current view of the Commission Services, only the Court of Justice can give an authoritative interpretation on the contents of Community law
Pheromones and semiochemicals used in traps to monitor pest populations are not within the scope of the Directive. However if such substances are used to actually control insect populations then they will fall within scope as the purpose of use is biocidal as defined in the Directive.
Article 1 of the Directive states that the scope of the Directive concerns the authorisation and placing on the market for use of a biocidal product.
Ozone is by nature unstable and therefore has to be generated on site using specialist equipment. In this case the use of ozone will be outside the scope of the Directive because, although a biocide is being produced, the biocide itself is not being placed on the market.
There has been no progress on interpretation of Article 12 on Data Protection and which Articles are subject to the Transition Arrangements. The Commission has indicated that there should be a discussion on these at the next Competent Authorities' meeting on 21-22 June.
Both the Directive and 1st Review Regulation encourage companies to submit collective dossiers in order to minimise animal testing. The Commission has been asked whether the formation of such a task force would be viewed as a infringement of competition law or participation in a cartel.
Following internal consultation within the Commission, it is their opinion that common notifications in accordance with the provisions of the 1st Review Regulation do not normally constitute in any way an infringement of competition law or participation in a cartel. This is an opinion of the Commission Services and is not legally binding as only the Court of Justice can give an authoritative interpretation of existing Community law.
The information, to be submitted in accordance with point 5 and 6 of Annex I and Annex II, relating to market share and quantities of active substances placed on the market could be regarded as sensitive from a competition point of view (the exchange of such information between competing companies can constitute a violation of Article 81 of the Treaty, especially when companies have an important market share and/or they act in an oligopolistic market). Although the Review Regulation encourages notifiers to present a common notification, in whole or in part, in order to minimise animal testing, it does not in any way oblige notifiers to exchange sensitive data on market share and quantities of active substances placed on the market. In order to respect community competition law, these data must be submitted separately by each notifier.
The Biocidal Products Regulations 2001 (SI 880/2001) came into force on 6 April 2001. They implement the Directive in Great Britain (GB). The designated Competent Authority responsible for carrying out in GB the duties imposed on Member States pursuant to the Directive will be the Ministers, which in or as regards Scotland means the Secretary of State and the Scottish Ministers, acting jointly; and for the rest of Great Britain, the Secretary of State and the Minister of Agriculture, Fisheries and Food, acting jointly.
Northern Ireland (NI) will make its own Regulations, and it is expected that the Directive will be implemented in NI in June/July 2001 by the Biocidal Products Regulations (Northern Ireland) 2001. HSE will carry out the competent authority functions in both GB and NI.
Copies of the Regulations can be obtained from The Stationery Office, PO Box 29, Norwich NR3 1GN, Tel: 0870 600 5522, Fax: 0870 600 5533, website address - www.thestationeryoffice.com
On 9 May 2001 HSE published three Health and Safety Guidance documents that explain in detail to those involved with the marketing and use of biocidal products how they are affected by the provisions of the BPR.
"A guide to the Biocidal Products Regulations for importers and suppliers of biocides" (Ref. HSG208, ISBN 0-7176-1822-6, price £11.00) sets out the duties placed on suppliers and importers of active substances and biocidal products new to the European market; and on those carrying out research and development on them. It explains how data protection rules will apply to the information supplied by applicants for authorisation of a biocidal product, and what information can be treated as confidential. The guidance also sets out the service levels they can expect from HSE as the competent authority responsible for authorising and registering biocidal products under the Regulations; and explains the appeals process for those aggrieved by any decision made under the Regulations.
Guidance on the arrangements that will apply to active substances already on the market and the biocidal products they are used in is available in "The transitional arrangements for the Biocidal Products Regulations: A guide for importers and suppliers of biocides" (Ref. HSG198, ISBN 0-7176-1736-X, price £3.50).
All the above publications, and also the free HSE leaflet "A simple guide to the Biocidal Products Regulations" (Ref. INDG321), are available from HSE Books (see contact details at the end of the Fact Sheet).
The Biocides & Pesticides Assessment Unit of HSE has also published 'The Biocidal Products Regulations - A Guide to Applicants'. The complete guide will be in three parts:
Currently only Parts A and B are available, as HSE has concentrated on producing advice on the Annex I listing of active substances which is a prerequisite for product authorisation/registration. Part C on products will be available at a later date. Therefore, at this stage, the guide is aimed at companies that are intending to either support active substances for review, or submit a new active substance to the HSE. For biocidal product formulators/manufacturers who are not intending to support an active substance at review or submit a new active substance, Part C will be the area which will be of most use to you, and we will contact you again when it becomes available.
You should note that there are areas in the guide which are reliant on other European publications and initiatives, and in some cases these are not yet available so there will be some gaps in the publication. These will be filled as the European guidance becomes available, but we felt that it was better to provide as much information as is available now, rather than waiting for all the European guidance to become available.
This is a free publication, and if you are intending to support an active substance or submit a new active substance and would like a copy of the 'BPR Guide to Applicants', it is available on our website at
http://www.hse.gov.uk/hthdir/noframes/bpau.htm in the 'Biocides' section.
If you do not have access to the Internet, please write to the Biocides & Pesticides Assessment Unit at the address at the end of this Fact Sheet to request a copy. If you intend to keep your copy of the guide in a ring binder, a 'BPR Guide to Applicants' cover page and spine insert are available from BPU, again by writing to BPU.
The full public consultation which took place in summer 2000 highlighted a number of concerns on the options for implementing the General Industry Charge. A further information gathering exercise requested factual information on the administrative costs of complying with both a turnover and a per company charging option. Information was received early in 2001.
The issues raised have required careful consideration by HSE and we are behind schedule to introduce the General Industry Charge in July 2001 as we had first hoped.
The last in the current round of Roadshows designed to raise awareness and provide information about the requirements of the BPR took place in London on 21 May. Aimed in particular at small firms, the Roadshows attracted over 300 delegates and generally received positive feedback.
If you attended one of the Roadshows in Birmingham, Cardiff, Edinburgh, Liverpool, London or Newcastle and would like a list of the companies represented for possible data sharing purposes, please contact Sharon Thompson by either e-mail at this address: sharon.thompson@hse.gsi.gov.uk or by telephone on 020 7717 6238.
Added to the HSE website 20 June 2001