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 12 is not a revision of Fact Sheets Nos.1-11 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. Progress on the Technical Notes for Guidance (TnG's)
a. TnG on inclusion of active substances in Annex I
It is expected that the final draft will be placed on the European Chemicals Bureau (ECB) website shortly ( http://ecb.jrc.it/biocides). Whilst there are still a few areas remaining to be agreed by Member States, as the document will remain as a draft until there is practical experience of its use, further discussion and amendment at this time is considered unnecessary.
b. TnG's on practicalities (dossier structure and format) and authorisation of products
These two TnG's were discussed at the recent Technical Meeting held on 6-8th May.
For the TnG on practicalities (dossier structure and format), the ECB asked for any further editorial comments from the Member States by 21 May. The document will be revised and then sent to the Member States for agreement through a written procedure.
For the TnG on product authorisation the ECB asked for further comments from the Member States before the end of May. Following amendment, the TnG will then be sent to the Competent Authority (CA) meeting in July, hopefully to obtain their agreement to its use as a draft.
The 28 March 2002 deadline has now passed. This was the date by which those wishing to support existing active substances in the EC review must have Notified their substances under 1896/2000; or Identified for possible extended phase-out those substances they no longer wished to continue to market.
We understand that approximately 450 Notifications (covering approx 350 active substances) and approximately 3000 Identifications have been received by the ECB.
The ECB is starting to check these and, should there be problems loading the Notification information onto the ECB computer systems, anticipates entering discussions with Notifiers as soon as possible. However, the ECB anticipates working towards having a single date for informing Notifiers where their Notifications are incomplete.
The current timetable indicates that lists of Identified and Notified active substances will most likely be available to the Member States in August 2002. Following this, the next stage will be to prioritise for review. It is anticipated that the next Technical Meeting, scheduled for late September, will have this as its main substantive agenda item.
The most recent draft of the second review regulation contained provisions relaxing to some extent the Notification deadline set by the first review regulation (1896/2000). They allowed for eligible notifiers to:
(i) convert into a Notification an Identification for an active substance that had not been Notified;
(ii) add to the range of product types for which an active substance had been Notified.
The relaxation was proposed in recognition of the difficulty faced by potential Notifiers in deciding what to do without any knowledge of what Notifications had been made by others.
There was broad agreement among Competent Authorities (CAs) that some such derogation should be introduced. But, following advice from its Legal Service, the European Commission (EC) has now proposed that such amendment should be made by way of a separate piece of legislation, with a deadline independent of the coming into force of the second review regulation. CAs noted that the legislation would have to refer to provisional lists of Identified and Notified active substances, since definitive lists could not be established except by the second review regulation itself.
The EC is actively progressing the draft of this legislation, which will create an additional period for notifying active substances currently only Identified; and extending the range of product types for an already Notified active substance, with a deadline of six months after the legislation enters into force. The provisional lists of Identified and Notified active substances are introduced in the definitions of those terms, and by reference to the ECB website. The EC intends to put this legislation to a Standing Committee vote in July.
The UK has responded positively to the proposal.
4. COPR Experimental Permits and BPR
There is some confusion as to what will happen to Experimental Permits under the Control of Pesticides Regulations (CoPR) now that the Biocidal Products Regulations (BPR) are in place. Under BPR, authorisations are required for placing on the market (which includes sale, supply and storage) for use. However, CoPR also places controls on the use of products that have not been placed on the market.
This means that CoPR Experimental Permits will still be required for experimental activities where products, subject to control under CoPR, are used but not placed on the market.
5. Industry Seminar 2002
Further to the article in the March edition of the Biocide Fact sheet (Issue Number 11), the Biocides & Pesticides Assessment Unit have decided on a date for this years seminar.
The event is to be held on Thursday 21st November at the Liverpool Maritime Museum. This venue proved popular with those of you who attended last year.
The seminar is open to delegates from all sectors of the pesticide and biocide industry. There will be presentations relating to the Control of Pesticides Regulations and the Biocidal Products Regulations and also an opportunity to talk to BPU staff throughout the day and at an open forum session.
A leaflet has been enclosed with this newsletter, which gives you details of the programme and includes a booking form. Places for the seminar will cost £35 and will be allocated on a first-come-first served basis.
All booking forms should be returned to the address given on the leaflet and NOT to BPU.
For further information on the seminar, please contact Alison Wightman at BPU by e-mail on biocides@hse.gsi.gov.uk, telephone on 0151 951 3927, fax 0151 951 3927 or by letter at the address given at the end of this Newsletter.Published on HSE web site 19 June 2002