Health and Safety
Executive / Commission
Biocides &
pesticides
The Biocides & Pesticides Unit believes that it is important to inform approval holders on how well we perform against the standards agreed with industry. Therefore we are pleased to publish the performance standards that we met against our targets during the year 2002-2003. The Unit continues to assess the work processes we use to seek possible improvements.
We always aim to limit the amount of time products spend 'queuing', that is applications spending a significant period of time waiting to be assessed. In the past this had been identified by our approval holders as being a serious impediment, and approval holders will be happy to hear that in the period 2002-2003, no applications were held-up by queuing.
The graph below shows the number of Secretariat approvals we expected to receive and completed during the year, compared with the actual numbers received and completed.
As you can see the number of amendments was high this year, whilst Secretariats were on target. In 2000-2001 we reduced our timescale for completing Secretariat approvals from 90 working days to 70 working days, and in the last year 90% of Secretariats were completed within 70 working days, meeting our target for these approvals.
The following graph shows the number of Departmental Approvals expected to be completed during the period 2002-2003, compared to the actual number completed.
Certificates of Free Sale are granted on request when a company wishes to export an approved pesticide to a country that requires evidence that the pesticide has UK approval. As we are aware of the tight deadlines industry often faces when exporting products, we try to assist by setting ourselves a short deadline for production of certificates. Our target for processing Certificates of Free Sale is 2 working days and we met this target in the 2002-2003 period. The graph below shows the number of certificates we expected to receive, compared to the actual number received and completed.
Our targets for dealing with enquiries from customers are that all enquires, whether written or by telephone should be responded to within 10 working days, and we met this standard in the 2002-03 period, which was a very busy for the Unit. Of all enquiries, 63% were answered the same day, whilst for telephone enquiries in particular this figure rises to 76%.
We welcome comments from our approval holders, and if your wish to provide feedback on how you believe the service we provide could be improved, please write to the address given at the end of this Newsletter.
We informed readers in our December 2002 Pesticides Newsletter of guidance on our website outlining how you, your products and their COPR Approvals will be affected by the requirement to classify and label products according to the Chemicals (Hazard Information for Packaging and Supply) Regulations 2002 (CHIP 3), as well as labelling in accordance with the COPR Approval. We stated then that we intended to expand the content of this guidance.
This expanded guidance is now available on our website.
The guidance includes the following sections :
This is very similar to the previous guidance at this website address, although some changes to the previous version have been made. In particular the section on 'How will my label change?' is new. It states in this section that there is no requirement to change the format of a COPR-Approved product label. It also details that CHIP S phrases should be listed along with the COPR labelling phrases; there is no requirement to present them in a separate CHIP section of the label.
This section refers the reader to specific guidance for CHIP 3 and COPR labelling and outlines how you should go about ensuring that you meet all the necessary requirements. It outlines how COPR labelling phrases should not be removed from current labels, but explains that it may be possible to delete some CHIP S phrases; either when they duplicate a COPR phrase or, if not obligatory under CHIP, are already addressed by a similar COPR phrase.
We have taken this opportunity to revise several of the COPR labelling phrases. Some have been changed to be exactly the same as a CHIP S phrase so that there is greater opportunity for deletion of duplicated CHIP S phrases. If a COPR label phrase is not included in this section, then that COPR phrase has not been altered and should continue to be used as before.
This section of the guidance tabulates all the CHIP S phrases and indicates which, if required on a COPR product label, should be placed in the Statutory Box and which should be placed outside.
As the classification and labelling of preparations for environmental effects is new to CHIP 3 and therefore new to us in the Biocides & Pesticides Unit, we have drafted our own internal guidance. We thought that this internal guidance may also be helpful to you when considering classification and labelling for environmental endpoints under CHIP 3. Therefore we have included this BPU internal guidance on our website.
This example outlines the steps that should be followed when determining the CHIP classification of any preparation including a COPR-Approved product.
For further information, contact our Approvals Section on Tel 0151 951 3535, by e-mail to approvals@hse.gsi.gov.uk or by letter to the address at the end of this Newsletter.
A pesticide product containing an active substance that is new to non-agricultural pesticide products in the UK, but was in use in biocidal products elsewhere in the EU on 14 May 2000, and has been either Identified or has had a Notification accepted under the 1st Review Regulation for the Biocidal Products Directive (BPD), may be considered by the Advisory Committee on Pesticides (ACP) for a UK approval under the Control of Pesticides Regulations (COPR). The standard application process for products containing new active substances would apply and the COPR UK fees and data requirements would remain valid. If approval is granted under COPR, products containing the active substance could be placed on the UK market until a decision on the inclusion of the active substance in Annex I of the BPD has been taken at the EU level
An application for authorisation of a biocidal product containing an active substance that is new to the EU or that has been neither Identified or Notified under the first Review Regulation cannot be processed under COPR, but must be processed according to the BPD. Whilst an application for approval of a product containing an active substance that is new to non-agricultural pesticide products in the UK that has been Identified but not Notified under the first Review Regulation in that product type can be processed under COPR, you should note that any approval issued under COPR could only be granted until 30/09/06. After this date a decision to have included the active substance in Annex I of the BPD will have to have been taken, and products will require authorisation under the BPD.
Anyone who is considering making an application should note that the processing timescales are likely to be extended beyond the current UK standard of 9-12 months. This is because of HSE's commitment of resource to finalising preparations for, and subsequently undertaking work on, the EU reviews for the BPD.
HSE intends to continue to meet and advise prospective applicants, and will endeavour to provide timely feedback on the likely acceptability of submitted data packages once the 'sift' fee has been paid. However, during the financial year 2003-04, we anticipate that no more than two applications for new active ingredients can be processed beyond the sift stage. These are likely to be the first two for which the data package has been deemed acceptable and for which the full fee has subsequently been paid. Full payment in advance of a data package being deemed acceptable will not secure the evaluation 'slot'.
Subsequent applications for approval of products containing active substances new to non-agricultural pesticides products under COPR are unlikely to be evaluated during 2004. HSE will inform applicants of estimated timescales for evaluation during preliminary discussions and after a data package has been deemed acceptable. Applicants can then consider at each stage whether they wish to continue the application.
You can view the provisional lists of Identified and Notified active substances on the European Chemicals Bureau website at http://ecb.jrc.it/biocides/
As reported in previous issues of the Pesticides Newsletter, readers are reminded that action has been taken under the 'Marketing and Use Directive' (76/769/EEC) against amateur use creosote/coal tar creosote wood preservative products. Advertisement and sale of such products by Approval Holders or their agents was revoked on 28 February 2003. Approval for sale and advertisement of amateur products by people other than the approval holder or their agents was revoked on 30 April 2003, so no amateur products should still be on sale. Approvals for supply, storage and use of amateur creosote products will be revoked from 30 June 2003. Approval for the advertisement, sale, supply and storage of amateur creosote products for the purposes of disposal only will continue under 30 June 2004.
Professional and Industrial uses of creosote have been allowed to continue subject to the following restrictions:
The DTI, who are the lead department for this area, will be implementing further legislation to restrict the use of creosote treated wood, in-line with the requirements of the Directive.
For further information on the Marketing and Use Directive and creosote, please contact David Jenkinson at the DTI on 020 7215 0366, for further information on the revocation of COPR amateur uses, please contact Mike Potts at HSE on 0151 951 3268, or by letter to the address at the end of this Newsletter.
The Advisory Committee on Pesticide's (ACP) Evaluation of the active substance Azamethiphos was published in April 2003. This review was carried out as part of the Anticholinesterase reviews carried out by HSE for public hygiene insecticides and wood preservatives, and by the Pesticides Safety Directorate for agricultural products. The review considered the physical-chemistry, mammalian toxicology and efficacy of azamethiphos, and includes the risk assessments carried out for operator and consumer exposure. The Evaluation reflects the outcome of the 288th meeting of the ACP in November 2001.
The ACP's Evaluation of the antifouling active ingredient Zinc Pyrithione was published in May 2003. This review was conducted as part of the review of the 'Booster Biocides' used in antifouling products. The evaluation gives details of the data that was considered during the review, including physical-chemistry, mammalian toxicity, operator exposure, environmental fate and behaviour, ecotoxicology and efficacy. The evaluation of this active ingredient was considered by the ACP at its 278th meeting in September 2000.
Both documents are available as priced publications from :
Mrs Diane Wells,
Finance & Corporate Services Branch,
Pesticides Safety Directorate,
Room 313,
Mallard House,
Kings Pool,
3 Peasholme Green,
York YO1 7PX
Or can be viewed on-line free of charge at http://www.pesticides.gov.uk/citizen/Evaluations/evallist.htm
If you require any further advice or information about any of the articles in this issue of the Pesticides Newsletter, please contact the Biocides & Pesticides Unit by telephone on 0151 951 3535, by fax on 0151 951 3317, or by letter to: Biocides & Pesticides Unit, Health & Safety Executive, Magdalen House, Trinity Road, Bootle, Merseyside L20 3QZ. Alternatively we can be contacted via e-mail at biocides@hse.gsi.gov.uk
Published on HSE web site 30 May 2003