Health and Safety
Executive / Commission
Biocides &
pesticides
To all HSE COPR Approval Holders
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 glad to know that in the period 2000-2001, no applications were held-up by queuing.
The graph below shows the number of Secretariat Approvals we expected to receive and complete in 2000-2001, compared with the actual numbers received and completed.
As you can see we received less secretariat approvals than expected in this
year, but the number of amendments was significantly higher than expected.
Our target for processing secretariat approvals is 90 working days, and
in the year 2000-2001, 98% of secretariat applications were completed within
this target. However, we are always aiming to improve the service we provide
to the industry as far as is possible, and we have therefore reduced the
timetable for carrying out Secretariat approvals to a new target of 70 working
days, which we hope will be of benefit to the industry.
The following graph shows the number of Departmental Approvals expected to be completed during the period 2000-2001, 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 in 2000-2001 we met this target for all the certificates we produced. The graph overleaf shows the number of certificates that were predicted to be received and completed in 2000-2001, compared to the actual number received and completed.
Our targets for dealing with enquiries from customers are that all enquiries, whether written (letter, fax, e-mail) or by telephone should be responded to within 10 working days. All written enquiries were responded to within this time-frame, and for telephone enquiries 78% were dealt with on the day they were received, with the remainder being completed within the 10 day deadline.
We always welcome comments from our approval holders, and if you 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.
On Tuesday 22nd May 2001, the Biocides & Pesticides Assessment Unit held a one day seminar at the Liverpool Maritime Museum for the non-agricultural pesticide industry. Delegates attended from all sectors of the industry for a programme set out to inform people of recent developments in regulatory affairs and to encourage discussion of various topics relevant to industry. The day centered around a series of presentations and discussions planned to represent the views of both industry and the regulatory authority.
Presentations in the morning session were given on current issues on:
During lunch, BPU staff were on-hand to answer questions and give advice to delegates. The afternoon session focused on Biocides and dealt with the progress of the Biocidal Products Directive in terms of the EU review programme, technical guidance and scope issues.
Approximately 100 delegates attended the seminar and were asked to complete a short questionnaire to enable us to assess how successful the programme of events had been. A third of the questionnaires were returned and out of those that replied 93% felt that the seminar had met their needs. The Biocide presentations were highly favoured in that 87% of delegates found the topics presented to be both useful and relevant to them.
Overall, it was a successful day, providing an open forum in which to exchange views and for BPU staff to meet representatives from companies to reinforce working relationships.
We would like to thank all those delegates who returned the questionnaire as all feedback is very welcome. All the comments we received will be considered for improving any future events run by BPU.
Summaries of the seminar presentations which were held, and copies of the slides can be found on the BPU website under 'Industry Seminar'.
Each year the fees charged by the Biocides & Pesticides Assessment Unit for pesticide approvals work, that is the fees approval holders pay for secretariats, departmentals etc., are set based on the amount of work required to carry out these different types of approvals. BPU reviews the procedures used for carrying out this work to seek improvements and efficiency gains through an on-going Business Improvement Programme and we are pleased to announce that the effects of inflation have been countered by efficiency gains within the unit. Therefore the fees for the financial year 2001-2002 have been held at the level from the previous year. The fees will therefore remain at:
| Approval Type | Fee | |
|---|---|---|
| New Active Ingredient (AI) | £ | 50,000 |
| Resubmission of New AI | £ | 25,000 |
| Small Data Package | £ | 7,000 |
| Minimal Data Package | £ | 4,200 |
| Departmental | £ | 2,500 |
| Secretariat | £ | 500 |
| Back-to-Back | £ | 300 |
| Amendment | £ | 150 |
For Rodenticide applications, BPU are currently using the fee structure previously used for these products by the Pesticides Safety Directorate, though again the fees involved have not been increased for the 2001-2002 period and remain as:
| Approval Type | Fee | |
|---|---|---|
| Departmental | £ | 4,700 |
| Normal Stream | £ | 2,350 |
| Fast Stream | £ | 630 |
| Admin. Fast | £ | 285 |
As mentioned in previous issues of the Newsletter, BPU would like to remind Approval Holders that we are now collecting the fees directly, so payments should be made to HSE rather than to the Pesticides Safety Directorate at DEFRA (previously MAFF). Details are given on the invoice you received when applying for a product approval.
HSE is currently updating its legislation for the classification and labelling of hazardous substances - the Chemicals (Hazard Information & Packaging for Supply) Regulations 1994 (CHIP).
The new Regulations - 'CHIP 3' - will implement the Dangerous Preparations Directive (1999/45/EC) thus extending the scope of CHIP to biocides and pesticides. The Dangerous Preparations Directive will also introduce classification for environmental effects (which already exists for substances) for preparations.
CHIP 3 will also:
HSC/E plans to issue a Consultation Document in the Autumn so that the new Regulations can be brought into effect in the early 2002. For suppliers of biocides (including non-agricultural pesticides currently approved under COPR) and plant protection products this will allow until 30th July 2004 for businesses to re-label products according to the new CHIP3 regulations (suppliers of general chemicals must comply by 30 July 2002). Further details can be found on the CHIP website, (www.hse.gov.uk/hthdir/noframes/chip/chip3.htm).
Details on how the changes introduced as a consequence of CHIP 3 will be incorporated onto pesticides labels are currently being considered, views from Approval Holders would be appreciated. If you wish to submit your views or comments, please send them to the BPU Approvals Group at the address given at the end of this Newsletter, or by e-mail to: biocides@hse.gsi.gov.uk
As part of BPU's ongoing commitment to approval holders the Chemistry Section (of the Efficacy and Chemistry Group) are in the process of producing guidance on the following subject areas:
These documents are intended to supplement the existing chemistry data requirements and aid approval holders with applications to BPU. It is stressed that we are not increasing the quantity of data required from industry to support an application/review under COPR but to clarify the extent and quality of data required for different types of product applications and reviews.
Once these documents are prepared it is intended to make the draft available to approval holders, trade associations and other interested parties for their comments.
It is envisaged that these draft documents will be available in the third quarter of 2001. Additionally an overview document amplifying the core chemistry data requirements will also be available shortly on our website. If you have any further questions regarding this please contact the BPU Efficacy and Chemistry Group on 0151 951 3535, fax: 0151 951 3317, or by letter to the address at the end of this newsletter.
Further to the article that appeared in the June Newsletter (Issue 51, June 2001) this is a reminder to Approval Holders of BPU's request for data on the active ingredients used within their products. BPU require a 5 batch analysis of the active ingredient and/or a technical specification of that active ingredient.
Approval holders who have submitted this data need not respond further but for outstanding technical specifications the deadline for submission is 31 December 2001. Approval Holders should note that BPU will not collect this data on their behalf. Where manufacturers of active ingredients have concerns regarding the confidentiality of their data Approval Holders should stress that this information can be submitted directly to BPU and will be treated as "commercial in confidence".
If you have any further queries please contact the BPU Efficacy and Chemistry Group on 0151 951 3535, fax 0151 951 3317, or by letter to the address at the end of this newsletter.
As explained in an article in our last newsletter (Issue 51, June 2001), the information we had on the packaging of products was too generalised, leading to overestimates of exposure. To overcome this problem, information on the volume of containers, design of packaging and materials has been requested for all products since the beginning of the year, with this information being included on the legal documentation for each product.
Industry have raised some concerns over the inclusion of this information on the legal documents, it will mean they will have to seek an amendment to the approval if they wish to change the packaging of a product, reducing their flexibility in this area.
As it was our intention to inform the risk assessment process, not to limit flexibility, a proposal was put forward to change the way the information is included so that a general approval condition will be set, requiring companies to inform us if any changes to product packaging are made, and the detailed information on the packaging will be removed from the schedule and held on file. Industry's views on this proposal were sought and feedback received supports the proposed changes.
As from 1 November a general approval condition will be included on the legal document requiring Approval Holders to notify us if changes are made to their packaging so that we can update our records. Exceptions to this situation are when a specific design and type of packaging material have been identified as a result of a risk assessment on a product, then this will be included in the relevant section, it should be noted that the majority of rodenticides fall into this category. It is the responsibility of Approval Holders to ensure packaging is fit for purpose and complies with relevant standards.
For further information on this subject, please contact the BPU Approvals Group at the address given at the end of this Newsletter.
In the March 2001 issue of the 'Pesticides Newsletter' (Issue Number 50) BPU outlined to you its plans to revise the PSD Efficacy Guideline document for rodenticides (Part Three/A3/Appendix 3 of the previous PSD/HSE Registration Handbook, formerly working document 10/2).
It was originally planned for this document to be circulated around the middle of the year to approval holders, the BPCA and other interested parties. Although the draft document is at advanced stage, circulation will now be later than previously planned. It is envisaged that the document will now be circulated for comment towards the end of the year.
If you require any further information on this issue, please contact the BPU Efficacy and Chemistry Group by telephone on 0151 951 3535 or by letter to the address given at the end of this Newsletter.
The review of the industrial wood preservative use of Copper Chrome Arsenic carried out by the HSE on behalf of the Advisory Committee on Pesticides (ACP) has recently been published. As with all published evaluation documents, it is available as a priced publication from the ACP Secretariat.
The evaluation gives details of the data that was considered during the review, including that on physical chemistry, mammalian toxicology, environmental fate and behaviour, environmental toxicology, efficacy and the environmental monitoring of UK timber treatment plants. Details of the risk assessments carried out for human health and the environment are provided, and the recommendations made to Ministers are presented. The document reflects the outcomes of the 270th, 274th and 280th meetings of the ACP.
The evaluation, reference 'Advisory Committee on Pesticides Published Evaluation No. 200 - Review of Copper Chrome Arsenic : Use as an Industrial Wood Preservative', is available priced £25.00 from:
ACP Secretariat
Room 202 Mallard House
Kings Pool
3 Peasholme Green
York
YO1 7PX
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
Published on HSE web site 16 November 2001