Health and Safety
Executive / Commission
Biocides &
pesticides
This new Committee will provide HSE, the Health and Safety Commission (HSC) and Ministers with independent scientific advice on the evaluation of biocidal products which will be regulated under the new Biocidal Products Regulations due to come into force this year.
The BCC will be made up of an independent Chair, and independent scientific experts in the fields of toxicology, ecotoxicology, occupational hygiene, efficacy, and microbiology plus a number of lay members to represent consumer, environmental and employee interests.
HSE is following the guidelines set down by the Office of the Commissioner for Public Appointments (OCPA) in the selection of nominations to put to the HSC and Ministers.
Advertisements for Members of this Committee were placed in the national press and scientific journals at the beginning of the year and the response was very positive. Interviews are due to take place in June 2000 and recommendations for appointments will then be made to Ministers.
Subject to successful appointments it is hoped that an inaugural meeting of the BCC will be held towards the end of this year. Meetings will initially be held in London but may in time move to Liverpool.
If you have any further questions on any of this issue please contact the Information Group on 0151 951 3535, fax 0151 951 3317 or e:mail info.prs@hse.gsi.gov.uk
In March 2000, the Pesticides Registration Section sent a letter to all approval holders and interested parties inviting comments on new procedures which were being introduced by the ACP, in accordance with the government's best practice guidelines for the operation of advisory committees. Since then the ACP has been publishing the agendas and summary minutes of corresponding meetings on the Internet. These may be currently accessed via the PSD site at http://www.maff.gov.uk/aboutmaf/agency/psd/psdhome.htm - the address is due to change in the near future and will be http://www.pesticides.gov.uk
If you have any further questions on any of this issue please contact the Information Group on 0151 951 3535, fax 0151 951 3317 or e:mail infoprs@hse.gsi.gov.uk
Approval holders were informed some time ago about the intention to split the levy into separate agricultural and non-agricultural fractions. Following a consultation exercise in 1997, Ministers agreed that the levy would split in April 2000.
The potential effect of splitting the levy has been described in previous Newsletters, and was detailed at the Industry seminar at the Albert Dock on 11 November 1999.
At the March fees and charges meeting it was announced that the estimate figure for the year 2000-2001 is 2.09%. This was in spite of a 7.3% fall in HSE's overall costs to the pesticides industry. This figure takes into account the turnover of rodenticide approvals which were transferred to HSE from the Pesticides Safety Directorate, without which the levy would have been higher.
The projections for the levy over the following two years show the levy decreasing each year. This accounts for work under the Control of Pesticides Regulations (COPR) reducing gradually as the Biocidal Products Regulations come on line, but also assumes that Ministers do not instigate any further emergency reviews.
The COPR levy is based on a turnover of UK sales, and sales in the non-agricultural sector amount to approximately £79m, compared to the agricultural turnover of approximately £572m. The agricultural levy is calculated at 1.21%.
The Pesticides Registration Section make every attempt to keep costs to industry as low as possible, and we will continue in our efforts to maintain efficiency savings. Any non-agricultural products being sold without approval add to the cost of the levy for those which are approved. We are sensitive to this and are making every effort to ensure that such products are brought within the system. Your co-operation in this matter is essential.
Industry representatives are kept informed of all matters related to fees and levy at the fees and charges meetings.
If you have any further questions on any of these issues please contact Irene O'Neill on 0151 951 3535, fax 0151 951 3317 or e:mail info.prs@hse.gsi.gov.uk
In Issue 46 of Newsletter we informed you that MAFF would continue to collect HSE's fees for applications of non-agricultural pesticides until the problem of arranging agency agreements between Ministers and devolved administrations has been resolved. Unfortunately, the agency agreements between the respective parties are still not in place. In the interim MAFF WILL CONTINUE to collect fees on our behalf.
If you have any further questions on any of these issues please contact the Information Group on 0151 951 3535, fax 0151 951 3317 or e:mail info.prs@hse.gsi.gov.uk
Approval holders will be aware that the following CHIP phrase appears on anti-fouling products.
1547 IN ACCORDANCE WITH THE CHEMICALS (HAZARD INFORMATION AND PACKAGING FOR SUPPLY) REGULATIONS 1996, AS FROM TIME TO TIME AMENDED.
These regulations have undergone subsequent amendments and have now been updated to CHIP 99 (2) Regulations. Approval Holders should note that their products should now be updated in accordance with these regulations and that the following phrase will need to be changed to reflect this. Pesticides Registration Section (PRS) will be amending our records, but we will not be issuing amended Notices and Schedules at this time. Approval Holders are requested to incorporate the updated phrase for all their anti-fouling products at their next label reprint.
i.e.
1457 IN ACCORDANCE WITH THE CHEMICALS (HAZARD INFORMATION AND PACKAGING FOR SUPPLY) REGULATIONS 1999 (2), AS FROM TIME TO TIME AMENDED.
All anti-fouling product applications going through the approvals system will have this updated phrase assigned to them.
Approval Holders are requested to contact PRS if they are aware that the classification of their product has changed as a result CHIP 99 (2).
If you have any further questions on any of this issue please contact the Approvals Group on 0151 951 3535, fax 0151 951 3317 or e:mail info.prs@hse.gsi.gov.uk
Under the Control of Pesticides regulations, responsibility for the registration of rodenticides for which public hygiene is the principal use, transferred from the Ministry of Agriculture, Fisheries and Food's Pesticides Safety Directorate (PSD) to the Health and Safety Executive (HSE) with effect from 1 April 2000. HSE and PSD have been working together to ensure the transfer took place with minimum disruption to the service we provide to Approval Holders.
Although responsibility for the registration of rodenticides formally moved to HSE's Pesticides Registration Section (PRS) on 1 April 2000, it was impractical to transfer those products that were in the process of being evaluated by PSD, particularly those that are still being assessed as part of the upgrade exercise. In these cases PSD will complete the evaluation before transferring the product to HSE.
Conditions of approval for rodenticides products will not change as a result of this transfer, the only change approval holders will notice is that products will now have HSE numbers allocated to them. These numbers will be issued by PRS once products have transferred and should be included on product labels at the next label reprint or by 31 December 2002 at the latest.
From 1 April 2000 all applications for approval of public hygiene rodenticide products should be made to HSE. It should be noted that until products have been upgraded and transferred to HSE, they cannot be used as a template for further applications, for example as a basis for back to back type approval.
If you have any further questions on any of these issues please contact the Approvals Group on 0151 951 3535, fax 0151 951 3317 or e:mail info.prs@hse.gsi.gov.uk
As part of our ongoing commitment to improve our regulatory procedures, Pesticide Registration Section (PRS) has revised the active ingredient information required to be submitted by approval holders when registering non-agricultural pesticide products. Approvals Holders will now be requested to provide names and site addresses for the manufacturers of the active ingredients present in their pesticide products.
PRS can then be assured that the technical active ingredient present in a product can be appropriately compared against the technical active ingredient used in the risk assessment which determines whether the product is acceptable for use. The site of manufacture (associated with a technical specification of active ingredient) will therefore be specified as a condition of approval.
Under the Biocidal Products Directive, the name and address of the manufacturer of any active substances cannot be kept confidential. This requirement will be reflected in our national legislation for biocidal products. Introducing the same policy for non-agricultural pesticide products registered under Control of Pesticides Regulations ensures simplification of our record and a consistency of approach in the lead-up to the regulation of biocidal products.
The requirement for approval holders to provide manufacturer details of active ingredients in non-agricultural pesticide products will take effect from 1 July 2000 and will apply to new product applications.
When applicants complete section 2a of the FEPA 1 application form, the Source box should contain the name and site address for the manufacturer(s) of each active ingredient.
Approval holders should be aware that if the technical specification of an active ingredient present in the products appears to have changed significantly, PRS will be requesting that Approval Holders contact their manufacturer to provide further details.
As the sites of manufacture of an active ingredient (associated with a certain technical specification of active ingredient) in a non-agricultural pesticide product are to be specified as a condition of approval for the product, this information will appear on the legal Schedule. This change will apply to new product applications from 1 July 2000.
If you have any further questions on this issue please contact the Approvals Group on 0151 951 3535, fax 0151 951 3317 or e:mail info.prs@hse.gsi.gov.uk
Since the Biocidal Products Directive (BPD) 98/8/EC came into force, active substances on the EU market before 14 May 2000 are defined as existing active substances. They can remain on the EU market subject to the Transition Arrangements and the Review Regulation Programme. Those not on the EU market before that date are new active substances and must be evaluated under the BPD regime before they can be used in biocidal products.
The Review Regulation will eventually result in the production of lists of existing active substances which are to be supported during the Review Programme. However, these will not be available until around mid 2002.
This means that the Pesticides Registration Section (PRS) can receive an application for approval of a product containing an active substance which is existing in the European Union (and therefore subject to the requirements of the Review Regulation) but which is not currently used in products approved under the Control of Pesticides Regulations (COPR) 1986. However, until the above lists of existing active substances are produced, we will not know whether the active substance has been supported in the Review Programme.
Consequently after 14 May 2000 and until the lists of supported active substances/product types are supported and published by the EU, an application received by PRS for an active substance which is new to us under COPR, will require the following information:
is within the ELINCS/EINECS specification
was on the market in the EU before 14 May 2000 for use in
biocidal products by way, for example, of an invoice and the
composition of a product and/or label.
NB: It will not be sufficient to demonstrate that it is
on the ECB indicative list of potential active
substances.
Active substances which are not supported during the Review Programme will have to be withdrawn from the market for use as biocides. The timetable for this withdrawal will be published in a subsequent Review Regulation. Consequently, to ensure that PRS do not issue approvals under COPR which extend beyond the date for withdrawal of unsupported active substances, we will require:
confirmation that the applicant under COPR intends to support the active substance during the BPD Review Programme (or that they are unaware that another company has/that they are part of a task force).
If the applicant cannot confirm or says that they do not intend to support the active substance under the BPD Review Programme then:
a time-limited COPR approval will be given such that the active substance will not be approved beyond the likely withdrawal date allowed under BPD. This may be extended if the outcome of the first Review Regulation demonstrates that the active substance has indeed been supported from another source.
If you have any further questions on this issue please contact the Approvals Group on 0151 951 3535, fax 0151 951 3317 or e:mail info.prs@hse.gsi.gov.uk
A full review of the uses of Copper Chrome Arsenic (CCA) as an industrial wood preservative was initiated in 1996, this review was considered by the Advisory Committee Pesticides (ACP) in September 1999 when Ministers agreed to continued provisional approval for products containing CCA subject to further data requirements, which related to physical chemistry, human health, environment and efficacy. The ACP will be reconsidering one aspect of the human health part of the review again later this year in order to offer further advice on proposals associated with monitoring of workers.
In November 1995 the Advisory Committee on Pesticides (ACP) considered an evaluation of triorganotin (TOT) compounds which was a first update to the review of their environmental effects. The Committee agreed that further changes and restrictions in the use of TOT based anti-foulings may increase the environmental loading of the "organic booster biocides". Part of the ACP recommendation was that a review of the "organic booster biocides" should be undertaken as part of HSE's routine review programme for existing substances. In February 1997, the ACP recommended that a review of the "organic booster biocides" in anti-fouling products should be completed in 1999-2000. As a result of this full reviews of the following active ingredients have been carried out:
These reviews were considered by the Inter Departmental Secretariat (IDS) in March 2000 and will be presented to the ACP later this year. Data holders have been informed of the proposals made by the IDS and any comments will be brought to the attention of the ACP. Approval holders have been advised to contact their suppliers for further information.
In June 1999 at the request of the Advisory Committee on Pesticides (ACP), Pesticides Registration Section initiated an environmental review of lindane in HSE approved products. During the Data Call-In stage of this review industrial wood preservative uses of lindane were not supported.
Therefore, all industrial wood preservative products containing lindane have been issued with notices of revocation. The revocation periods for these products are:
It should be noted than any new application for the use of lindane as an industrial wood preservative will be treated as an application for a new area of use and will, therefore, attract the associated fee.
The environmental review of lindane was considered by the ACP in March 2000. The recommendations of the ACP, regarding the remaining approved uses of lindane, are still with Ministers and will be sent to the approval holders affected as soon as possible.
If you have any further questions on the reviews mentioned please contact Reviews Group on 0151 951 3535, fax 0151 951 3317 or e:mail info.prs@hse.gsi.gov.uk
There have been no new developments over the past quarter. We will continue to keep you updated, and to contact the relevant companies if there is a need.
If you have any further questions on the reviews please contact Irene O'Neill on 0151 951 3535, fax 0151 951 3317 or e:mail info.prs@hse.gsi.gov.uk
A copy of fact sheet 6 for the BPR should be accompanying this issue of the Newsletter. If you have not received a copy, please contact the Pesticides Registration Section's Administration Group on 0151 951 3535, fax 0151 951 3317 or e:mail info.prs@hse.gsi.gov.uk
If you require any further advice or information about any of the articles in this issue of the Newsletter, please contact the Pesticides Registration Section by telephone on 0151 951 3535, by fax on 0151 951 3317 or by letter to Pesticides Registration Section, Health and Safety Executive, Magdalen House, Stanley Precinct, Bootle, Merseyside L20 3QZ. Alternatively we can be contacted via e:mail at info.prs@hse.gsi.gov.uk