Health and Safety
Executive / Commission
Biocides &
pesticides
These Fact Sheets provide briefings for manufacturers, 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 and the Biocidal Products Regulations 2001
Fact Sheet 16 is not a revision of Fact Sheets Nos.1-15 but instead provides supplementary information and advice. If you would like a copy of earlier Fact Sheets, these can be downloaded from our website. It you cannot do this, then please contact us at the address given at the end of this Fact Sheet.
Suppliers of active substances and biocidal products are reminded that where active substances have been neither Identified nor Notified, biocidal products containing these active substances must not be placed on the market after autumn 2003. The exact date will be when the 2nd Review Regulation enters into force.
The Biocides & Pesticides Unit has checked the provisional list of Identified active substances and a small number of active substances currently used in pesticide products approved under the Control of Pesticides Regulations (COPR) are not included in this list. We will be taking any relevant action against these products in due course. With respect to biocidal products that are not subject to COPR we are investigating the feasibility of undertaking a product survey to see if there are any products being placed on the market that contain non-identified active substances.
To be within scope of the Biocidal Products Directive (Biocidal Products Directive), a biocidal product must act by biological or chemical means. There have been a number of enquiries to the Member States about products that Industry consider to act by non-chemical/non-biological (i.e. physical) means, and so out of scope. When the EC and Member States finalise their decision on a particular question, this is included in the 'Manual of Decisions' (available on the European Commission's Environment website at http://europa.eu.int/comm/environment/biocides/index.htm).
At present, most of the conclusions on such enquiries have been that the mode of action is chemical/biological and thus within scope of Biocidal Products Directive. In some cases, the case has been referred back to the enquirer to provide more evidence to support their view that the product is out of scope.
The key messages are:
The European Commission and Member States are tending to conclude that, for most products, the mode of action is chemical/biological.
The 24-25 March 2003 meetings of the biocides Competent Authorities (CA) and the Standing Committee on Biocidal Products (SCBP) were postponed, and have been rescheduled for 11-12 June 2003. The main business for the CA meeting will be the finalisation of the 2nd Review Regulation for progression to a vote at the SCBP meeting.
In December 2001 the UK responded to the Commission's document 'General Note on Data Protection in the framework of Directive 98/8/EC', The UK welcomed the Commission's work on the interpretation of article 12 of the Biocidal Products Directive, and its efforts to come to a common understanding between Member States, and raised a number of questions and concerns. The main points were:
Applications for inclusion of active substances in Annex I that are not in the review programme for the notified product type are treated as if the active substance were new. Data protection for such active substances will be as for new, rather than existing, active substances
For existing data, currently protected under national legislation, on existing active substances, data protection under Biocidal Products Directive would be until 10 years after first inclusion in Annex I.
The Commission has recently replied to the UK on these points and the issues may be added to the agenda of the Competent Authorities meeting of 11-12 June 2003.
Industry concerns on the problem of 'free-riding' companies after the inclusion of an active substance in Annex I were raised at the 12 November 2002 Competent Authorities (CA) meeting. The issue - that there was nothing to prevent those having obtained an authorisation with a Letter of Access from companies owning the data included in the dossier on the active substance then buying an identical active substance from a different supplier - has yet to be resolved despite subsequent correspondence between the trade association CEFIC, the Commission and CAs.
The UK had conjectured at the meeting that since the Annex I entry specified the supplier of the active substance, then Member States could not allow a change of supplier without a new application and a positive decision on it. It seems clear however that Annex I is simply a list of active substances, not linked to a particular supplier, closing this escape route. The UK had also suggested that 'free-riding' could be a commercial matter between the supplier of the active substance and the product formulator (and thus not a matter for biocides legislation), though it appears that contract law does not permit the sort of 'buy from me only' clause that would be required. It might be possible to address the issue by an amendment to the Biocidal Products Directive, though it is unclear at this stage exactly what this amendment might be.
Further industry views are welcomed, preferably in advance of the June 2003 CA meeting, and comments on this issue should be sent to Garry Wiles, HSE, CFPD3, 6NW Rose Court, 2 Southwark Bridge, London SE1 9HS, e-mail garry.wiles@hse.gsi.gov.uk
The European Commission and Member States (MS) have established the biocides working group on testing strategies for environmental and toxicological data, with experts covering both environmental and toxicological specialisms. This group is a forum for discussions between MS on questions from Industry on data requirements, and waiving issues relating to the preparation of dossiers, for applications for Annex I inclusions and similar technical issues. It is intended that discussions will take place by e-mail in addition to formal meetings. When Industry has a query on the data requirements, or other technical issues, they should, in the first instance, approach the rapporteur MS for their dossier (if the query relates to an active substance in the review programme) or the MS to which they intend to submit the application (for other applications).
The first meeting, primarily to discuss data requirements for PT 14 rodenticides, was held at the European Chemicals Bureau (ECB), Ispra in April 2003. The group considered a proposal from CEFIC regarding non-submission of certain long-term toxicological studies, in particular carcinogenicity and multigeneration studies, for anti-coagulant rodenticides. The group concluded that, without prejudice to Articles 5(2) and 10(1) of the Biocidal Products Directive, waiving of certain toxicological studies on rodenticidal active substances may be possible provided that pre-requisites for human exposure and toxicological profile are satisfied. These pre-requisites are detailed in the Technical Notes for Guidance (TNsG) on data requirements, available on the ECB website (http://ecb.jrc.it/biocides/). If, however, the pre-requisites were not satisfied it would not be possible to waive the data.
The Biocidal Products Directive requires that a full dossier of data must be submitted in an application for inclusion of an active substance on Annex I. The European Commission (EC) intends that such dossiers (which must be prepared in accordance with the Technical Notes for Guidance (TNsG) on Dossier Preparation and Study Evaluation) can be submitted by electronic means. At present the database formats for submitting data for biocides by electronic means (HEDSET or IUCLID export files for submission of data to the IUCLID database) are only partly applicable and further work is required. The EC also intends that these database formats should be compatible with Organisation for Economic Cooperation and Development (OECD) Robust Study Formats so that, once prepared, they can be used for submissions to other Regulatory Authorities. A meeting organised by the European Chemicals Bureau (ECB) and the German Federal Environmental Agency for the Environment (UBA) in Berlin, was held in May 2003. Experts on toxicology, ecotoxicology, physical chemistry and exposure from both Member States and Industry have established 3 separate working groups. Members of these groups have been preparing the necessary data formats. The main purpose of the meeting was to discuss the progress to date and to identify areas for further work. Further discussions are expected to take place by e-mail as well as at future formal meetings if necessary.
These formats will not be available for those who have to submit dossiers on active substances used in wood preservation or as rodenticides. Those preparing dossiers on these product types will be able to use the currently available formats and, when necessary, attaching documents to the relevant part of the IUCLID database.
Progress on implementing the Directive in the UK
The Biocidal Products (Amendment) Regulations 2003 (SI 2003/429) came into force on 1 April 2003. The amendment sets out the detailed rules specifying who must pay the charges, how and by when they must notify their liability and how the amount is calculated.
The deadline for notifying HSE of a liability under this amendment is 30 June 2003.
Companies who have a liability, but have yet to notify HSE are urged to do so as soon as possible. A template that you can use to notify us is enclosed with the Fact Sheet. Further information is available on our website at http://www.hse.gov.uk/hthdir/noframes/bioindex.htm
The work required to complete the EU review programme according to the timetable in the 2nd Review Regulation requires the Biocides & Pesticides Unit to plan our work programme with care. If we were to receive a dossier on a new active substance during the review period, the assessment of that dossier will take a substantial resource and will need to be planned for in advance. Consequently, it would be very helpful to know as early as possible if we are to receive a dossier on a new active substance. If you expect to submit such a dossier to us, to act as rapporteur, before the end of 2004, then we would like you to contact us, so that we can discuss possible submission dates etc with you as early as possible.
Published on HSE web site 30 May 2003