Health and Safety
Executive / Commission
Biocides &
pesticides
The Health & Safety Executive has recently been undergoing a 'change programme' to try to better target the work of the organisation for the challenges of the changing working environment, as well as to adapt to the changing ways of working developing across government. As part of this programme, the Health Directorate, of which the Biocides & Pesticides Assessment Unit was a part, has essentially been disbanded, with the units within the Directorate being re-allocated within HSE.
The Biocides & Pesticides Assessment Unit has moved to a new Central Specialist Division within the Field Operations Directorate - which means we will now be working within the same Directorate as the HSE Inspectors. This has not involved any physical movement of staff, and we are still based in our offices in Magdalen House in Bootle. Nor should there be any financial costs to Approval Holders from this administrative change. As part of the move to the new Directorate, the Unit's name has also been changed as it was thought that Biocides & Pesticides Assessment Unit was limiting and did not really reflect the range of work carried out in the unit, so it has been shortened to simply the 'Biocides & Pesticides Unit'.
Our staff will be using the new name for the Unit (BPU) and our new title within the Field Operations Directorate Central Sciences Division (FOD CSD2) immediately, though Approval Holders may still receive letters on 'Health Directorate' headed paper for a brief period as we believe it is financially sensible to use up old stocks of stationary rather than throwing them away.
On the 21st of November 2002 the Biocides & Pesticides Unit held a one-day seminar at the Liverpool Maritime Museum for the non-agricultural pesticide and biocides industry. This was the latest in a series of such seminar that have been run over the last 9 years. The event was very well attended this year, with over 150 delegates, which is nearly double the number of delegates who have attended in previous years.
The aim of the day was to bring people from all sectors of the industry together and provide updates and new information on the Control of Pesticides Regulations scheme and the Biocidal Products Regulations scheme. The day centred around a series of presentations covering topics on COPR in the morning, including labelling to CHIP3, fees and charges and the review and approvals programmes, whilst the rest of the day covered developments in the biocides area, including scope, the Biocides Consultative Committee, technical guidance, the review programme and UK implementation.
As well as being on-hand to answer questions during breaks and lunch, an open forum session was run at the end of the day to allow delegates to discuss issues of interest and concern directly with members of BPU staff.
The event went well on the day and delegates were invited to complete a questionnaire on the seminar, of which around a third returned these to BPU. Around 90% of these replied that the seminar had met their needs. We are grateful to those delegates who returned their questionnaires, as the feedback is very useful in organising future events.
As companies will be aware, the first Review Regulation (EC 1896/2000) established the processes and the timetable that had to be followed in order that the active substance(s) you supply, or use in your product(s), were either Identified or Notified for inclusion within the Biocidal Products Directive review programme. Essentially, it required that you Identify and/or Notify existing active ingredients. This Regulation stated that for non-identified active substances, as well as biocidal products containing them, there would be no phase-out period once the list of existing active substances had been established (please note that actives that have been successfully notified will also have been automatically identified).
The list of existing active substances will be published in the second Review Regulation and whilst the exact date that the second Review Regulation will come into force is not yet known, but it could be around September 2003. As a consequence, at the date on entry into force of this Regulation, non-Identified active substances, and biocidal products containing them (which may include pesticides approved under the Control of Pesticides Regulations), will have to have been withdrawn from the European Union (EU) market. You should note that if there were a delay in the second Review Regulation being published then this withdrawal date would also be delayed.
BPU will up-date Approval Holders on the Second Review Regulation implementation in the June Newsletter.
If you require any further information on this issue, please contact Jennifer Hopkins on 015 951 3735, by e-mail to jennifer.hopkins@hse.gsi.gov.uk, or by letter to the address given at the end of this Newsletter.
The closing dates for Identification of existing active substances in accordance with the 1st Review Regulation (1896/2000) or Notification in accordance with this or the Prolongation Regulation (1687/2002) have now passed. The Biocides & Pesticides Unit occasionally has discussions with companies who might be interested in obtaining a UK approval under the existing national legislation for pesticides i.e. COPR for products containing active substances that have been either Identified or Notified that are not currently used in UK-approved products. Because of the emerging timetable for the next phase of the EU Review Programme and the time periods needed to evaluate applications under CoPR, then it is necessary for BPU to issue guidance on handling such applications.
The draft 2nd Review Regulation proposes that biocidal products containing existing active substances that have been Identified, or Notified but not in the product type, be withdrawn from the market before 01/09/06. If such biocidal products were to be placed on the market after 01/09/06 then their active substance would be treated as if it were a new active substance in the EU. If a company is interested in obtaining a CoPR approval for an existing active substance in this category, then, given the processing time for a new UK application (12-18 months) we would advise potential applicants to consider submitting an application to us under the Biocidal Products Regulations (BPR) as a new active substance rather than CoPR. This application will have to comply with all the requirements of the Biocidal Products Directive (BPD) (e.g. data requirements, dossier structure and format) and the application fee will be higher. However, if the application is successful, then the active substance can be included in Annex I of BPD and products can be authorised in all Member States following applications, using the Mutual Recognition provisions of BPD where appropriate.
The overall structure of the EU Review Programme has been finalised and the 23 Product Types have been prioritised for review in four priority lists (see Fact Sheet No. 14 for details). Participants are required to submit their dossiers to the appointed rapporteur Member State in accordance with the timetable to be published in the 2nd Review Regulation. Whilst BPU cannot refuse to accept an application for approval under CoPR, we would encourage potential applicants, wherever possible, to work to the EU programme and timetable and obtain authorisations for products in the UK, under BPR, following the inclusion of the active substance in Annex I. Potential applicants will need to be aware that we will still charge the full application fee for the work done under CoPR and that the approvals may need to be amended once the active substance has been included on Annex I (or revoked if inclusion is not obtained).
There may be occasions when applicants wish to obtain a UK approval in advance of the Annex I inclusion. In these situations, there may be opportunities for efficiency savings, for example:
If the applicant has access to the active substance data that have been reviewed by the rapporteur Member State and the rapporteur has made a recommendation for inclusion on Annex I, then it is possible for BPU to use this assessment rather than undertake a separate assessment. Whilst this may reduce the fee for the UK CoPR application, the UK applicant must wait until the active substance review has reached the stage where the rapporteur's report and recommendations have been sent to the EC and other Member States.
If, in the application to the UK under CoPR, the product data are presented as a BPD dossier, then it may be possible to 'fast track' the first applications for authorisation under BPR via the UK and then obtain Mutual Recognitions elsewhere.
For further information, please contact our Approvals Section on 0151 951 3535.
As part of BPU's continued commitment to streamlining the approvals process, work is ongoing to facilitate the electronic submission of the FEPA 1 application form within HSE's global evaluation of the submission of forms. This work is taking place in 2 stages and this Article notifies Approval Holders of the completion of the first phase.
Double clicking on the link to the application form from the BPAU website will now take you to the electronic forms site within the HSE website where you will be able to access the updated FEPA 1 form. The guidance completing the form has been removed from the form and can be viewed and printed by clicking the "click here for guidance" text located at the top right of the first page of the form.
The form can be printed and completed by hand as before, but now it can also be completed electronically. Approval Holders can input information into the appropriate boxes (noting that a box with a red heading must be completed, even if the entry is "none" or "n/a"). When the form is complete click the "continue" box at the bottom of page 7 and the form will be saved as a .pdf file which can the be printed and submitted by post to the usual address. The .pdf file can also be saved for your records. Please note that you must complete the form in one session as you will be unable to go back to a saved record and edit it (unless you have the appropriate software to enable you to write to a .pdf file).
It is possible to submit the completed form as an attachment to an E:Mail. However you should be aware of the security implications of sending this information electronically and we suggest at this stage to continue to send them via the post. If you do choose to submit the form electronically it should be sent to the following address:
and NOT to an individual's account.
The second phase of this exercise will allow for electronic submission of the form upon completion and we will inform Approval Holders via the Newsletter when this function is available. If you have any questions regarding this issue, please contact Mike Potts on 0151 951 3268, e-mail mike.potts@hse.gsi.gov.uk or by letter to the address given at the end of this Newsletter.
We have a service agreement to process 90% of Secretarial applications within 70 working days once the appropriate fee has been paid. Within this agreement we always try to process your application quickly and efficiently while maintaining our scientific quality and safety standards.
We hope that many of you will have experience of applications being processed in less than 70 working days. However, when busy, as we have been this last quarter, applications may come very close to this service agreement. We therefore ask you to note that 70 working days is a genuine possibility and to factor this into your timetables.
We also advise that if any of the information provided by you on the FEPA 1 product approval application form is unclear or missing, we may "stop the clock" on the 70 day agreement. The clock is not restarted until all the relevant information has been received. It is therefore in your interests to ensure that the FEPA 1 has been completed fully and clearly. Please find below some common omissions and advice on how to produce a complete application.
Detailed advice on how to fill in the FEPA 1 can be found on the HSE's website and also within the form itself. Or for further advice, contact our Approvals Section on 0151 951 3535 or at the address at the end of this Newsletter.
In order to prepare for the move from the Control of Pesticides Regulations to the Biocidal Products Directive/Regulations and the Plant Protection Products Directive/Regulations, HSE and the Pesticides Safety Directorate have been rationalising which authority takes the lead on different product types. HSE has therefore recently taken the lead on animal husbandry products as they will fall within the remit of the BPD and not the PPPD.
Following this we have received enquiries from companies who wish to market insect repellents for use on animals. COPR specifically excludes products which fall within the remit of the veterinary medicines legislation, and PSD's advice to enquirers had been to contact the Veterinary Medicines Directorate (VMD) on such products. PSD had not required that companies marketing such products have their products approved under COPR. However, on further investigation with VMD we have discovered that products which do not kill insects, but just repel them, and which do not make medicinal or therapeutic claims do not fall within the scope of the veterinary legislation, and therefore the exclusion from COPR does not apply.
Insect repellents for use on animals are within the scope of the Biocidal Products Directive (BPD), and active substances that are being supported for this use will be reviewed under the BPD beginning in 2006, whilst those actives that have only been identified under the Directive will be allowed to be marketed until around 2006. It is likely that many of the actives may not have been identified or notified under the Directive, in which case products will have to be removed from the market this summer. Until action takes place under the Directive, national rules still (i.e. COPR) still apply.
Due to the fact that:
The companies that are marketing such products may not have received entirely
accurate advice from the registration authority and subsequently marketed
their products in good faith; and
w action will begin to be taken on these products under the BPD this summer,
with the latest date that products will be fully assessed being following
the review in 2006.
HSE does not feel that it would be fair to demand full data packages on these products at this time. We are therefore going to require that these products gain secretarial approval under COPR, with any new actives being 'grandfather-in' to the system. The ACP are aware of this action, and once products are within the COPR system can of course set data requirements or initiate reviews as they feel are necessary. We therefore ask that companies who market insect repellents for use on animals submit applications for approval where necessary using the FEPA1 application form available on our website (www.hse.gov.uk/forms/pesticides/index.htm). Before submitting your application under COPR, you should check with the Veterinary Medicines Directorate (tel. 01932 336911) that your product does not fall within their remit - if it does require authorisation via the Veterinary Medicines Directorate then it will not also require approval under COPR, if it does not require authorisation via VMD then COPR will normally apply and you should seek approval via HSE. Applications will be treated as Secretarial applications with the associated fee of £500. Applications should be received by HSE by 31st October 2003, which allows companies time to check whether their active substances have been included in the lists of identified and notified active substances in the BPD Second Review Regulation due to be published later this year. If they are not on either of these lists then their products will have to be removed from the market this summer/autumn anyway (date to be set in the Second Review Regulation) so approvals under COPR would not be required.
If you have any questions on this issue, please contact Andrew Edwards at the Biocides & Pesticides Unit on 0151 951 3219, e-mail andrew.edwards@hse.gsi.gov.uk or by letter at the address at the end of this newsletter.
Comments are still invited for the following draft guidance document which is available on our website:
This document is available on our website as a final draft to allow for comments from our stakeholders (http://www.hse.gov.uk/hthdir/noframes/bpau.htm). Due to initial difficulties in downloading the document from the website (this has now been rectified) the deadline for comments on this document has been extended to the 01/04/03.
If you have any comments or questions regarding this document then please contact Steven Buchanan on 0151 951 4494, fax: 0151 951 3317, e-mail: steven.buchanan@hse.gsi.gov.uk or by letter to the address at the end of this newsletter.
As reported in the September and December 2002 Pesticides Newsletters, action is being taken under the 'Marketing and Use Directive' (76/769/EEC) against creosote/coal tar creosote wood preservative products. Approval Holders will have received Notices informing them that advertisement and sale of amateur products containing creoste/coal tar creosote by the Approval Holder or their agents has been revoked. Approval for sale and advertisement of amateur products by people other than the approval holder or their agents will be revoked from 30 April 2003, and the approvals for supply, storage and use of amateur cresote 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 are allowed to continue subject to the following restrictions:
Approval Holders for professional/industrial use products will be receiving Notices to this effect in the next few weeks. The DTI, who are the lead department for this area, will be implementing further legislation to restrict the use of creosote treated wood.
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 Irene O'Neill at HSE on 0151 951 4054.
BPU would like to thank all the approval holders who paid this years' levy promptly. We will be pursuing outstanding invoices, and we will continue to take action against companies who fail to pay by suspending products.
The levy rate for 2002/2003 is 1.89% which is in keeping with the commitment made to industry to increase efficiency and to keep levy costs on a downward trend. If you have any questions on levy issues please contact the Levy team on 0151 951 4685 or e-mail bpau.levy@hse.gsi.gov.uk, or the Approvals group on 0151 951 3865. Alternatively, you can contact them at the address given at the end of the newsletter.
As you will be aware, an important part of the levy collection process is to obtain auditor certificates from a percentage of companies who made declarations. This allows HSE to demonstrate to the National Audit Office (NAO) that a proper audit trail exists to verify that sales declarations made (nil or otherwise) are true and fair. To-date, many of the companies asked to submit auditor certificates have failed to do so. If this problem is not resolved in the near future, HSE may have to revert to a full verification exercise for the 2003/04 levy.
Advice has been provided on what is required from the auditor's certificates,
but despite this, some companies still appear to have difficulty in meeting
the request. We would urge you to contact HSE as in most cases the difficulties
can be resolved on advice from BPU staff. It is also worth noting that having
to continually chase up companies for auditor certificates adds an extra
cost burden to the levy. To resolve this issue, Approval Holders who were
asked to supply certificates and who have not yet submitted them to HSE
are requested to do so promptly.
If you have any questions about the auditors certificates please contact
BPU on 0151 951 4685 or e-mail bpau.levy@hse.gsi.gov.uk.
Evaluation documents are published when a new pesticide active ingredient is first considered by the Advisory Committee on Pesticides (ACP) or when an existing active ingredient is reviewed by the Committee. They consist of a summary of the data and other information that was considered by the Committee.
These evaluations - often referred to as 'disclosure documents' - have been produced since 1987 and currently over 200 are available, covering a wide range of active ingredients and reviews evaluated by both the Health & Safety Executive and the Pesticides Safety Directorate (PSD).
Evaluation documents are subject to the provisions of Regulation 8 of the Control of Pesticides Regulations 1986 (as amended). Regulation 8(1) allows Ministers to make evaluations available 'at such reasonable time an place as they may determine'. Regulation 8(2) allows Ministers to charge a fee for a copy of an evaluation. PSD, as the ACP Secretariat, therefore makes paper copies available on request but this service is subject to a small charge designed to cover some of the administrative costs plus postage and printing.
As a large proportion of our stakeholders will now have access to the internet it has been decided to make copies of evaluation documents available electronically, free of charge. These will be available in the Public area of the PSD website at http://www.pesticides.gov.uk/citizen/evaluations/evallist.htm. The first document to be made available in this way is Evaluation No. 205 'Environmental Risk Assessment of Booster Biocides in Antifouling Products'. This will be followed by copies of other already published evaluations in due course, as resources allow these to be converted into an electronic format.
Paper copies of the evaluation documents will still be made available from PSD on request.
Regulation 8(4) of COPR requires anyone who has been furnished with a copy of an evaluation document not to make any commercial use of it, nor, unless authorised in writing by Ministers, to publish any part of it. Currently, evaluation documents are supplied with a copy of a letter reminding recipients of their obligations under this regulation. In order to ensure that anyone accessing an evaluation document electronically is also aware of these obligations, they will be required to click a dialogue box on their computer screen before viewing an evaluation. Clicking on the box will indicate that a viewer accepts these conditions.
If you require further information on this issue, please contact Andrew Edwards (tel. 0151 951 3219, andrew.edwards@hse.gsi.gov.uk) or by letter to the address given at the end of this Newsletter.
HSE has undertaken a survey of antifouling paints (AFPs) in freshwaters. The survey was undertaken to verify that AFPs were of greater environmental concern in coastal waters than freshwaters and to target future monitoring, in support of the risk assessment strategy that HSE had developed for the biocidal actives in AFPs; the REMA model (Regulatory Environmental Modelling of Antifoulants).
The research was conducted in 2 phases;
Only 8 out of ~100 of the sites contacted were used by more than a couple of boats treated with AFPs. The sites were: Lakes Coniston and Lake Windermere, Derwentwater and Ullswater in the Lake District National Park, Carsington, Grafham and Rutland waters in the Midlands and the Norfolk Broads. The Norfolk Broads and Windermere produced the highest estimates of AFP usage per annum (16,000 - 20,000 l and 4000 l respectively), whilst Grafham Water produced the lowest (15 -20 l).
The results will be published on the HSE website shortly. For further information on this research, please contact our Environment Section on 0151 951 3850 or by letter to the address at the end of this Newsletter.
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 20 March 2003