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Pesticides Newsletter

Issue 50, March 2001

To all HSE Approval Holders

Contents:

General

Approvals

Reviews

Efficacy

Biocides

General

1. Industry seminar 2001

The biocides and pesticides unit will be holding a one day seminar for the industry on the 22nd of May 2001. The aim of the seminar is to bring companies up-to-date on developments in the regulatory process, promote discussion and to gather feedback from the industry on issues of concern. The venue for the seminar will again be the Maritime Museum at the Albert Dock in Liverpool. As well as presentations, there will be the opportunity for industry to talk informally to members of BPU staff during an open forum session.

Enclosed with this Newsletter is a leaflet which gives details of the programme and includes a booking form. Approval Holders should note that whilst the seminar is mainly aimed at the non-agricultural pesticides industry, the wider biocides industry will also be given to opportunity to attend the seminar, so early booking would be advisable to avoid disappointment.

For further information on the seminar please follow the link below or contact Alison Wightman by e-mail to biocides@hse.gsi.gov.uk or by telephone on 0151 951 3927, fax 0151 951 3317 or by letter to the address given at the end of this Newsletter. Please note that your completed booking form should be returned to the address given on the form, and NOT to BPU.

2. New biocides and pesticides assessment unit website goes live

The Biocides & Pesticides Assessment Unit has launched its revised webpages, this month, as the first step towards providing a wider range of information and services on-line.

The new webpages include:

We will look to continually update, improve and develop the webspages as time progresses.

In the meantime, if you have any comments or suggestions for the new webpages then please send them to us by writing to the address given at the end of this newsletter or to our e-mail address: biocides@hse.gsi.gov.uk.

3. Certificates of free sale

The Biocides & Pesticides Assessment Unit has been working on revising the Certificates of Free Sale which we issue to companies on behalf of the Department of Trade and Industry. Interested parties, including trade associations, were consulted on these revisions and the wording of the new style certificates has now been agreed. As a result of this process, the new certificates will be printed on yellow paper and will be embossed with the HSE logo in the top right hand corner to help prevent unauthorised copying and amending of certificates. We will no longer amend the wording of certificates and will not provide certificates for products which are exempt from the Control of Pesticides Regulations.

The new style Certificates will be issued as from the 2nd of April 2001. If you require any further information on this subject, please contact Mrs Pauline Stenhouse by e-mail to pauline.stenhouse@hse.gsi.gov.uk, telephone 0151 951 4290 or fax 0151 951 3317 or by letter to the address given at the end of this Newsletter.

Approvals

4. 16th Amendment to the marketing and use directive - carcinogens, mutagens and reprotoxins

As you might recall your attention was drawn to the 16th Amendment to the Marketing and Use Directive in December's Newsletter. This article is to remind Approval Holders of their obligation to inform BPU of any substances of concern that may be in their products.

The 16th Amendment (97/56/EC) to the Marketing and Use Directive expands the list of carcinogenic, mutagenic or reprotoxic (CMR) substances. The vast majority of substances added to the list by the 16th Amendment are petroleum extracts. We believe that some of these may be present in approved pesticide products sold in the UK. The Marketing and Use Directive requires that these substances, and preparations (products) containing more than certain amounts, are labelled with the name of the substance and the phrase "Restricted to professional users." In addition, the Directive prohibits the sale of such substances and preparations to the general public. The concentration limits are usually > 0.1% for the carcinogenic and mutagenic substances and > 0.5% for reprotoxins.

The 16th Amendment has been implemented by the Chemicals (Hazard Information and Packaging for Supply) (Amendment) (No.3) Regulations 1999 [1] (CHIP99(3)) and the Dangerous Substances and Preparations (Safety) (Consolidation) (Amendment) (No.2) Regulations 1999[2]. These Regulations enforce the labelling aspects and the ban on amateur use, respectively. The Regulations are available from The Stationery Office (tel: 0870 600 5522) or can be downloaded free of charge from www.legislation.hmso.gov.uk .

As mentioned in December's Newsletter it is not possible for BPU to identify with certainty, whether these substances are present in approved pesticide products. We would therefore ask you again to let us know of any products that you believe are affected. You should also check any new product applications in BPU's system. We will then take any appropriate action necessary.

Approval holders and applicants should submit the relevant details to the Approvals Group, biocides and pesticides unit, Room 113, Magdalen House, Stanley Precinct, Bootle, Merseyside L20 3QZ, as soon as possible.

Approval Holders should note that it is a requirement under FEPA that Approval Holders should notify BPU of this information and that enforcement action can be taken if products are labelled incorrectly. If you have any queries concerning this article, or would like a copy of the letter which accompanied December's Newsletter Article, then please contact Mrs Pauline Stenhouse by - E-mail to pauline.stenhouse@hse.gov.uk, telephone: 0151 951 4290, or by fax: 0151 951 3317.

[1] SI 1999 No. 3194, ISBN 0 11 085982 0, £10-30.

[2]SI 1999 No. 3193 ISBN 0 11 085981 0, £10-30.

Reviews

5.Outcome of the reviews of lindane (Gamma-HCH)

Approval holders may recall that the Advisory Committee on Pesticides considered environmental data in March 2000 and human health risk assessments for smoke generator products containing lindane in October 2000. The Committee recommended revocation of all lindane-containing non-agricultural products. Ministers have now agreed these recommendations and, as a consequence, all remaining products are undergoing revocation. All relevant approval holders should have received revocation notices. The revocation periods for these products are:

It should be noted that any new application for the use of lindane will be treated as an application for a new active ingredient and will, therefore, require a full data package.

If you have any further queries about the reviews please contact Anne Marie Grey on Tel: 0151 951 3795, Fax: 0151 951 3317 or e-mail: anne.marie.grey@hse.gsi.gov.uk or by letter to the address given at the end of this Newsletter.

Specific product queries should be addressed to Mike Potts on Tel: 0151 951 3859, Fax 0151 951 3317, or by letter to the address given at the end of this Newsletter.

Efficacy

6. Preparation and drafting of efficacy guidelines for rodenticides

Following the transfer of registration authority for rodenticides from MAFF PSD to HSE, the Efficacy Section of BPU is currently looking to place an updated guidance document in HSE's Registration Handbook.

Whilst it is acknowledged that a PSD Guideline document does exist (Part Three/A3/Appendix 3 of the previous PSD/HSE Registration Handbook, formerly working document 10/2), it is now 10 years old and in need of revision to bring into accord with other efficacy guidance documents produced by BPU.

It is stressed that BPU are not looking to radically alter the nature and extent of data currently required to support product applications for rodenticides. However, it is considered that the existing guidance can be improved in a number of ways to make the document more user-friendly and to add clarity with regard the extent of data required for different types of product application.

Once a draft document has been prepared by BPU it is intended to make the draft available to approval holders, the BPCA and other interested parties for their comments.

It is envisaged that a draft document will be circulated for comment around the middle of the year. If you have any questions on this issue, please contact Dave Dillon by e-mail to dave.dillon@hse.gsi.gov.uk, by telephone on 0151 951 4104 or by letter to the address given at the end of this Newsletter.

Biocides

7. Technical notes for guidance - Information on human exposure to biocides

The European Commission DG-Environment has issued a contract, (B4-3040/2000/291079/MAR/E2) to prepare Technical Notes for Guidance (TNG), to address the evaluation of human exposure to biocidal products. The project is supported by CEFIC, the European Association for the Chemical Industries.

It will codify the process of making human exposure estimates for risk assessment as required under the Biocidal Products Directive, and give extensive guidance on evaluating exposure, with many examples.

An early task for the project team is to establish what information is already held by industries and institutions. The information we are interested in includes:

Therefore if you hold information on human exposure that could be used in this project, or if you are commissioning new research into human exposure to non-agricultural pesticides, we would be very grateful for any help or information you could make available. Please could you respond to the TNG project team's Secretariat, whose address appears below.

Secretariat:

Andrew Garrod
HSE Room 114A Magdalen House Stanley Precinct Bootle UK L20 3QZ Phone (+44) 151 951 4667 Fax (+44) 151 951 3317 Email andrew.garrod@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 & Pesticides Assessment Unit by telephone on 0151 951 3535, by fax on 0151 951 3317, or by letter to: Biocides & Pesticides Assessment Unit, Health & Safety Executive, Magdalen House, Stanley Precinct, Bootle, Merseyside L20 3QZ. Alternatively we can be contacted via e-mail at biocides@hse.gsi.gov.uk

Updated on the HSE website 11 June 2001