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 13 is not a revision of Fact Sheets Nos.1-12 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.
1. Standing Committee on Biocides Meeting, 8 July 2002 :- 'Prolongation Regulation' for the notification of active substances
At this meeting the Standing Committee on Biocides voted in favour of the adoption of the 'Regulation on an additional period for notification of certain active substances already on the market for biocidal use as established in Article 4(1) of Commission Regulation (EC) No 1896/2000'.
This Regulation allows producers, formulators and associations an additional period until 31 January 2003 to:
The lists of active substances that have been Identified or acceptably Notified under Regulation 1896/2000, and the product types for which they have been acceptably Notified, have been placed on the ECB Website (http://ecb.jrc.it/biocides/). Companies that wish to make use of this additional period should check this list before proceeding. Any company that wishes to make use of this additional period should ensure that a Notification, completed in accordance with the requirements of Article 4.1 of Regulation 1896/2000, reaches the European Chemicals Bureau on or before 31 January 2003.
2 . Competent Authorities' Meeting 8-9 July 2002 :- Scope
The Competent Authorities (CAs) discussed a number of topics concerning scope. The deadlocked position with respect to cosmetics (where the view of the EC and some Member States, including the UK, is that secondary claims are legally possible while other Member States have the opposite view) was acknowledged. A meeting between the CAs for biocides and cosmetics was needed, but could not take place in the foreseeable future because the EC's resource for cosmetics was fully stretched with the amendment to the cosmetics directive.
The meeting noted that biocides that are used without being placed on the market are not subject to Biocidal Products Directive but that a simple amendment to Biocidal Products Directive would rectify this.
The provision of a service where biocides are used and then left at the premises was clarified. The European Commission (EC) legal services have reservations about cases, in which the product is taken to the point of application by the service provider, remains entirely under the provider's hands-on control throughout, and is then entirely taken away again. Otherwise, it accepted that biocidal products that are not placed on the market directly but are used as part of a service are within scope.
The Commission indicated that it was prepared to consider amending Biocidal Products Directive in certain areas, and had identified the following items:
In addition, minor uses and updating Annex V (biocidal product types and their descriptions), were proposed by the Member States.
The Commission asked that Member States respond before 31 December 2002, indicating areas where Biocidal Products Directive could be amended. The Commission also made clear that there would be no resource available to take any amendments forward until after the 2nd Review Regulation had been adopted.
The EC presented a draft of the Manual of Decisions. The Member States welcomed it, but it was not discussed in detail. The Commission requested comments from Member States by 15 September.
Provisional Lists of Active Substances and Prioritisation for Review
The ECB indicated that the list of identified active substances could be placed on the ECB Website within 2 weeks – although this will be longer if the name of the identifier was also needed.
For notified active substances this would take longer. All notified active substances would be included. As notifications were checked the list would be updated with their current status and the names of the accepted notifiers.
Since the meeting the ECB has placed the list of identified active substances on their website, along with a provisional list of notified active substances. These can be viewed at http://ecb.jrc.it/biocides
There was an initial discussion of the proposals for determining the order of review of the product types, balancing the workloads and the mechanisms of allocating active substances to Rapporteurs.
The Commission asked for comments from Member States by 1 September 2002. There will be an in-depth discussion of the paper and comments at the Technical Meeting scheduled for 23-24 September 2002.
The text presented by the EC was welcomed. There was an in-depth discussion article by article and the Member States were asked for further comments by 1 September 2002. The EC is still working to a timetable for entry into force in May 2003.
IV. Technical Notes for Guidance on Annex VI (common principles for the evaluation of dossiers for biocidal products)
Following a few minor amendments the document has now been placed on the ECB website.
There was a lengthy discussion over the acceptability of the percentiles used in assessments. This issue will be reconsidered at either an expert meeting (if it can be arranged before the next CA Meeting or at the autumn Technical Meeting). Member States were asked to nominate experts for the expert group.
3. Notification of Information to the National Poisons Information Service
Suppliers of biocidal products that were on the market on 14 May 2000 are reminded that they have until 6 May 2003 to comply with the requirements of Biocidal Products Regulations, Regulation 29. The information specified in Schedule 8 of BPR has to be submitted, before this date, to the National Poisons Information Service.
Suppliers of new biocidal products that contain existing active substances (i.e. active substances that were on the market as biocides at 14 May 2000) are reminded that they have to supply the information specified in Schedule 8 of BPR when they first put their new product onto the market.
The address to send the information to is :
National Poisons Information Service,
NPIS Birmingham Centre,
City Hospital NHS Trust,
Dudley Road,
Birmingham B18 7QHor e:mail w.harrison@npis.org
4. The General Industry Charge
HSE solicitors are being consulted on draft regulations for the General Industry Charge, which it is intended will introduce a single scheme for the whole of the UK. We are currently exploring further the constitutional and jurisdictional implications for Scotland and Northern Ireland.
The aim is to consult on the draft regulations via the industry Charging Review Group in October, and for the Regulations to come into force by April 2003. It should be possible to charge payments in arrears so that first collection can take place in mid-2004.
5. Industry Seminar 2002
Following on from the article in Fact Sheet number 12, the Biocides & Pesticides Assessment Unit (BPU) will be hosting a seminar for the biocides and pesticides industry on 21st November at the Liverpool Maritime Museum. There will be presentations relating to both the Control of Pesticides Regulations and the Biocidal Products Regulations/Directive, and BPU staff will be on-hand for discussions throughout the day and in an 'open forum' session at the end of the day.
A leaflet is enclosed with this Fact Sheet giving further details and includes a booking form, and places for the seminar will cost £35 - please note that the booking forms should be returned to the address given on the booking form and not directly to BPU.
For further information on the seminar, please contact Alison Wightman at BPU by e-mail via biocides@hse.gsi.gov.uk, or by telephone on 0151 951 3927, fax 0151 951 3317 or by letter at the address at the end of this Fact Sheet.
Published on HSE web site 6 September 2002