Health and Safety
Executive / Commission
Biocides &
pesticides
As part of our on-going commitment to improve efficiency, HSE and the Pesticides Safety Directorate have examined the procedures for issuing approval documents. Previously all approval documents were signed by both HSE and PSD, on behalf of Ministers, which required documents to be sent back and forth between the two departments. However, both departments have now agreed to a single signature by the issuing department for secretariat approvals. This will make better use of resources and help to prevent delays towards the end of the approval process.
We would like to point out that this action does not undermine the involvement of the other Government Departments and Agencies in the approval process, as any actions which require the approval of all the Departments that are signatories to the Control of Pesticides Regulations, such as agreeing the recommendations of the Advisory Committee on Pesticides, have not been changed.
If you have any questions on this issue, please contact our Approvals Group at the address at the end of this Newsletter.
On 1 April 2001 the responsibility for the COPR registration of a number of products used solely for purposes other than plant protection (and therefore not falling under the scope of Directive 91/414/EEC) transferred from the Pesticides Safety Directorate (PSD) to the Biocides and Pesticides Unit (BPU). Such products fall under the scope of The Biocidal Products Directive 98/8/EC (BPD) that in the UK is administered by us at BPU.
This transfer continued recently when Approvals for the remainder of PSD
products falling into this category were transferred to BPU on 25/07/2003.
The transfer means that when we start to Authorise products under BPD, the
products will already be 'homed' with the appropriate regulatory
authority.
The types of product encompassed by this category are:
. Where a product is for use in one of the above areas but additionally has plant protection uses, the responsibility for registration will, for the time being, remain with PSD.
An HSE number has been issued to the transferred products and a suitable 'wind-down' period given for the MAFF/MAPP labelled stock. Amendment Notices of Approval including the new HSE number, have been sent by PSD to the affected Approval Holders. In addition, within the next few months we will send BPU confirmatory notices specifying the new HSE number and where appropriate, revised label amendments. This will not affect the wind-down period specified for the MAFF/MAPP number, although new amendments required by BPU will not be required to be incorporated until the next label re-print.
From 25/07/2003 all applications for amendments to existing products or for approval of new products in these categories should be made to BPU. Also, outstanding data requirements, originally set by PSD, should be sent to BPU.
Further guidance on the distinction between Biocidal and Plant Protection products can be found on the European Commission website at http://www.europa.eu.int/comm/food/fs/ph_ps/pro/wrkdoc/wrkdoc17_en.html or for other questions on this issue contact Nicola Gregg on 0151 951 3859, email: nicola.gregg@hse.gsi.gov.uk or by letter to the address at the end of this Newsletter.
Further to the article that appeared in the June 2001 Newsletter (Issue 51), and subsequent articles in the September 2001 Newsletter (Issue 52), and December 2001 Newsletter (Issue 53) regarding technical specifications of active ingredients it has now been agreed that from 1 October 2003 it will be a requirement for all new product applicants to submit (as a minimum), with any new product application, an up-to-date manufacturer's technical specification for the active ingredient(s) included in their product. The technical specification must also detail the name of the active ingredient manufacturer and the manufacturing site address.
It will also be a continuing requirement for approval holders to confirm the source of the active ingredient(s) in their approved product(s) as part of our annual product update.
If you have any comments or questions then please contact Dr Julie Robinson on 0151 951 3279, fax: 0151 951 3317, e-mail: julie.robinson@hse.gsi.gov.uk or by letter to the address at the end of this newsletter.
In addition, applicants should note that in all cases BPU now require a letter of confirmation from the manufacturing source of the active ingredient that the product contains active ingredients from the site / supplier specified in the application. This has become necessary following a number of concerns raised by active ingredient manufacturers who have not recognised approval holders / marketers who claim to be using material purchased from them. Ultimately, if BPU are unsure of the source of material and its impurities etc, then we cannot be sure that risk assessments undertaken provide appropriate margins of safety and therefore approval cannot be granted. This requirement is valid as 1st September 2003.
If you have any comments or questions on this second issue, then please contact our Approvals Group at the address at the end of this newsletter.
The following guidance document is now available on our website: http://www.hse.gov.uk/hthdir/noframes/bpau.htm:
This document has had its draft status removed and is now a full working document. We would like to take this opportunity to thank all stakeholders for their comments. Any further comments, are of course, still welcome.
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.
Approval holders should be aware of a recent amendment to the EU Marketing & Use Directive (76/769/EEC) affecting products containing Nonyl Phenol (NP) and/or Nonyl Phenol Ethoxylate (NPE). The 26th amendment to the Directive states that no pesticidal or biocidal product may be placed upon the market or used if it contains 0.1% w/w or more of either compound. As a result, any new application for a pesticidal product containing NP or NPE will not be considered for approval by BPU until the applicant has modified the formulation to replace these materials with an alternate but acceptable emulsifier / surfactant.
With regard to currently approved pesticides, the 26th amendment to Directive 76/769/EEC states that such products "shall not be affected by this Directive" until their national authorisations expire (i.e. when current expiry dates for COPR approved products run out). Therefore, it is vital that approval holders take steps to submit applications for reformulation of affected products to BPU ahead of existing expiry dates, as failure to do so will result in revocation of relevant product approvals.
If you have any comments or questions on this matter, then please contact our Approvals Group to the address at the end of this newsletter.
The Health and Safety Executive has recently taken over responsibility for animal husbandry insecticides and repellents under the Control of Pesticides Regulations 1986 (COPR) from the Pesticides Safety Directorate (PSD) (an executive agency of DEFRA). Following this HSE has discovered that there are insect repellents that are used on animals that require approval under COPR, but that are not currently approved. HSE, in consultation with the Advisory Committee on Pesticides, has decided to approve such products via the quickest route available under the regulations. Companies who market insect repellents that are used on animal skin are urged to contact the HSE for further advice at the address below. Please note that if you market insect repellents for use on animals that already hold authorisation through the Veterinary Medicines Directorate, such products should not be affected by this action.
For further information, please see the article on insect repellents in issue 58 of the Pesticides Newsletter which is available at the following web address: http://www.hse.gov.uk/hthdir/noframes/pest58.htm#7 and if you then require further advice, contact Andrew Edwards at HSE by email andrew.edwards@hse.gsi.gov.uk, or telephone 0151 951 3219 or in writing to the address at the end of this Newsletter.
A consultation exercise is being carried out by the Food Standards Agency, seeking comments on proposals for work to be done to examine the risks to people from 'combined' exposures to pesticides and similar substances. Non-agricultural pesticides and biocides may contain more than one active substance and some active substances are also used in other products such as veterinary medicines and agricultural/horticultural pesticides. It is therefore possible that individuals might be exposed to a number of active substances which act in the same way, or to the same active substance in several different products. You may wish to comment on the proposals made, since they may eventually have an impact on the regulation of both non-agricultural pesticides and biocides.
The Department of Health's Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) carried out a review of the risk assessment of mixtures of pesticides and similar substances and its Report was published on 15 October 2002. The report concluded that the probability of any human health hazard from exposure to mixtures of chemicals (combined exposure), each present at a low level, was likely to be small and that effects of mixtures of substances were unlikely to be other than additive. However, it recommended certain changes to the regulatory process to take account of the possible implications of combined exposure.
Following the publication of the draft report, the Food Standards Agency (FSA) has discussed with officials from those Agencies and Departments with responsibilities for the approval of agricultural pesticides, biocides and veterinary medicines and the surveillance of food for their residues, how to take forward these recommendations. Following the publication of the final report, a proposed action plan has been produced by the FSA in response to these discussions. It is now consulting stakeholders before Ministers respond formally to the report's recommendations.
The FSA is seeking the views of stakeholders on the proposed Action Plan to implement the COT's recommendations. A copy of the consultation letter and draft Action Plan is available on the FSA website at: http://www.food.gov.uk. At the time of writing the consultation is mentioned on the homepage but otherwise can be accessed by selecting 'your views', then 'consultations' and 'UK wide consultations'. The deadline for comments to reach FSA is 30th October 2003.
With this issue of the Pesticides Newsletter there is a short questionnaire seeking your views, as a reader, on the content and format of this Newsletter and on the Biocides Fact Sheets also produced by the Biocides and Pesticides Unit. We would value your feedback to help us improve the information we provide to you via these publications. The questionnaire should only take a few moments to complete, and details of how to return it are included on the questionnaire itself. The questionnaire is at Appendix 1.
We would also ask that if you no longer wish to receive copies of the Pesticides Newsletter, please let us know, either in writing to the address at the end of this Newsletter, or by email to: BPU Admin@hse.gsi.gov.uk
If you require any further advice or information about any of the articles in this issue of the Pesticides Newsletter, please contact the Biocides and 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.ukBack issues of the Pesticides Newsletter and further information on pesticides
and biocides can be found on the BPU webpages at :
http://www.hse.gov.uk/hthdir/noframes/bpau.htm
The Biocides and Pesticide Unit of HSE has been producing publications such as the Pesticides Newsletter and the Biocides Fact Sheet for a number of years. The aim of the publications is to provide information on the regulatory systems to help the industry involved and inform interested parties. We are currently re-viewing these publications and are seeking views from readers on their future direction. This is especially important as the Control of Pesticides Regulations system will begin to wind down over the next few years as products transfer to the Biocidal Products Regulations. Therefore, to help inform the review process we would be grateful if you could complete the following questionnaire.
Please return this questionnaire to : Andrew Edwards, Biocides & Pesticides Unit, Health & Safety Executive, Room 131 Magdalen House, Trinity Road, Bootle, Merseyside L20 3QZ, or fax 0151 951 3317. Alternatively you can email your comments to: biocides@hse.gsi.gov.uk
The Pesticides Newsletter
Yes
No
The Biocides Fact Sheet
Yes
No
Yes
No
Yes
No
Industry affected by the legislation
Campaign/Public Interest Group
Enforcement Authority
Government Department
Other (please specify)
Never
useful
Rarely useful
Usually useful
Always useful
Never
useful
Rarely useful
Usually useful
Always useful
Yes
No
(if 'Yes' please give details of your concerns)
Thank you for taking the time to complete this questionnaire.
Published on HSE web site 4 September 2003