Health and Safety
Executive / Commission
Biocides &
pesticides
These Fact Sheets provide briefings for manufacturers, suppliers and users of active substances and biocidal products to keep you up to date with the implementation of the Biocidal Products Directive (Biocidal Products Directive) 98/8/EC and the Biocidal Products Regulations 2001
Fact Sheet 15 is not a revision of Fact Sheets Nos.1-14 but instead provides supplementary information and advice. If you would like a copy of earlier Fact Sheets please contact us at the address given at the end of this Fact Sheet, or download them from our website, details of which are given at the end of this Fact Sheet.
A revised draft of the 2nd Review Regulation (RR2) was sent to Member States on 22 January and tabled at the Competent Authority (CA) meeting on 23 January. It had been extensively redrafted at the request of the Commission Legal Service, but the amendments are mostly to the form and style rather than substance. The main points of note for the UK are:
Article 2 introduces the definition of 'participant', this being an accepted notifier participating in the review programme or a Member State that has expressed an interest in supporting an active substance.
A new Article 4(3) establishes that unidentified active substances will be treated as though they were new from the date of coming into force of RR2. It gives effect to what was no more than a recital in the previous draft; and avoids the problem of a non-inclusion decision for a group of active substances that cannot be named or enumerated, about which COM Legal Service had raised concerns. NOTE: the intention is that unidentified actives will be treated as new IN ALL RESPECTS, including data protection. The immediate impact is that products containing these actives may not be supplied after the coming into force of RR2.
Article 5(3) has been redrafted. It deals with the troublesome problem of possible early submission of a parallel dossier by a non-participant in the review programme for an active substance that is in the review programme. The UK and other Member States strongly support this approach.
Article 6 includes more on minimisation of animal testing than earlier drafts, but stops short of requiring mandatory data sharing. COM have confirmed that is as far as the Regulation can be taken on the matter.
The identity of notifiers is now omitted from the active substance lists in Annexes I and II, but are available on the ECB website.
Competent Authorities were given two weeks to comment on the latest draft, and the UK comments have been sent to the Commission. Subject to the lists of identified/acceptably notified active substances being ready, the final text will then be put to a vote of the Standing Committee at a meeting now rescheduled for 15/16 April. If this is not possible, then the meeting will be further postponed. The RR2 is currently expected to enter into force in September 2003, though this date may change depending on movement at the EU level. We will update industry on the timetable in the June Fact Sheet.
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 substances. The 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. The list of existing active substances will be published in the second Review Regulation and whilst the exact date that it will come into force is not yet known, as mentioned in the article above, this could be around September 2003. As a consequence, from this date non-Identified active substances, and the supply of biocidal products containing non-Identified active substances, will be prohibited, unless authorised 'from scratch' in accordance with the Directive. You should note that if there were a delay in the second Review Regulation being published then this deadline would also be delayed.
We will update you on the progress of the Second Review Regulation in the June Fact Sheet.
The European Commission (EC) and Member States acknowledge that there is a need to give full and careful consideration to the impact of Biocidal Products Directive on biocidal products with minor uses and those used in low volumes and in niche markets. The Competent Authority Meeting in January 2003 agreed to the establishment of a working group to clarify the problem, study approaches in other regulatory fora and to propose solutions by 01/06/04 so as to meet the EC timetable for possible revisions to Biocidal Products Directive. Member States, Industry and other stakeholders have been asked to provide written comments to the EC before 01/09/03 so that the working group can start work in the autumn.
The Manual of Decisions has now been placed on the EC Website (http://europa.eu.int/comm/environment/biocides/index.htm). It is a living document and will be updated as and when further issues have been discussed and a decision finalised.
The European Commission intends that dossiers, prepared in accordance with
the TNsG on Data Submission, can be submitted by electronic means. To achieve
this there is a need to define the structure of the electronic data submission
formats for robust study summaries. The EC also intends that the formats should
be compatible with Organisation for Economic Cooperation and Development (OECD)
robust study formats so that, once prepared, the summaries can be used for
submissions to other Regulatory Authorities. A meeting, organised by the European
Chemicals Bureau (ECB) and hosted by the German Federal Environmental Agency
in Berlin, was held in January 2003. Experts on toxicology, ecotoxicology,
physical chemistry and exposure from Member States and Industry agreed to
establish separate working groups. Members of these groups would be responsible
for preparing the data formats for the individual end points (as defined in
the TNsG). Once the formats are defined the ECB will provide the necessary
software to enable the forms to be used by Industry for data submission and
by the Member States for data evaluations. Further discussions are expected
to take place by e-mail as well as at formal meetings if necessary. The UK
is very concerned about the lack of a clear timetable for the completion of
this work, especially if these formats need to be available for use with the
1st Priority List. The UK intends to raise this with the EC.
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 national legislation for pesticides, the Control of Pesticides Regulations 1986 (as amended) (CoPR) for products containing active substances that have been either Identified or Notified and 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, it is necessary for BPU to issue guidance on handling such applications.
1. Applications for products containing an active substance that has been Identified, or Notified but not in the product type
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 (Biocidal Products Directive) (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 Biocidal Products Directive and products can be authorised in all Member States following applications, using the Mutual Recognition provisions of Biocidal Products Directive where appropriate.
2. Applications for products containing active substances that have been Notified in the product type
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:
(i) For evaluation of active substance data
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 one. 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.
(ii) For evaluation of product data
If, in the application to the UK under CoPR, the product data are presented as a Biocidal Products Directive 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.
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 been 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 Industry 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 Industry 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.
The Regulations to introduce the General Industry Charge (the Biocidal Products (Amendments) Regulations 2003) were published on the 5th of March (SI 2003/429) and will come into force on the 1st April 2003. The principles of the charge were outlined in the December 2002 Fact Sheet (No 14).
We are preparing an Information Note to all interested parties on the introduction of the charge, together with a Q&A briefing section. Also included in this will be a template that those liable under the Regulations can use, if they wish, to provide us with the necessary information.
Regulation 29 of the Biocidal Products Regulations requires certain information on biocidal products to be supplied to the National Poisons Information Service (NPIS). The information required, as listed in Schedule 8 of the Regulations is:
1. The name of the biocidal product.
2. If the biocidal product is authorised or registered under the regulations
a. the use for which it is so authorised or registered; and
b. the name, address and telephone number and any e-mail address and any
fax number of the person to whom the authorisation or registration was
granted.
3. The date on which the biocidal product was first placed on the market
in Great Britain.
4. The name, address and telephone number and any e-mail address and any
fax number of -
a. the manufacturer of the biocidal product;
b. any importer of the biocidal product; and
c. the individual to be contacted in an emergency in the event of an individual
being affected by the biocidal product.
5. A description of the packaging of the biocidal product, including its
size and type.
6. The pH, physical state and colour of the biocidal product.
7. The identity of the ingredients of the biocidal product, and their concentration
in metric units.
8. The effects on human health of contact with the biocidal product.
9. Particulars of the likely direct or indirect adverse side effects of
the biocidal product and any directions for first aid.
10. Any other information relating to the health and safety of humans which
is given on the label of the biocidal product.
For biocidal products that were on the market in Great Britain on 14 May 2000 this information has to be submitted to the NPIS by 13 May 2003. For new biocidal products that were not on the market on 14 May 2000, this information has to be submitted within one month of the product being placed on the market.
The information should be sent to: NPIS Birmingham Centre, City Hospital NHS Trust, Dudley Road, Birmingham B18 7QH. NPIS will accept a copy of the product's Safety Data Sheet plus the additional required information.
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 CHIP, fees and charges and the review and approvals programme, whilst the rest of the day covered developments in the biocides arena, 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, and 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.
At the Biocides and Pesticides Unit Industry Seminar in November 2002 HSE outlined to attendees the possibility of running a seminar in 6 months time (April/May 2003). The content of the seminar was likely to include the practical issues of preparing an active substance dossier for inclusion in Annex I. However, due to delays within the EU with finalising guidance and the IUCLID formats, HSE considers that there is insufficient material to justify a seminar at this time.
HSE is likely to hold an Industry Seminar, similar to that held in November 2002, later in the year.
Published on HSE web site 20 March 2003