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 14 is not a revision of Fact Sheets Nos.1-13 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) Active substances identified and notified
The table below summarises the available information on the numbers of active substances identified or notified under the 1st Review Regulation. However, a few more active substances may be notified as a consequence of the Prolongation Regulation (1687/2002).
| Received | Substances | |
|---|---|---|
Identifications |
Approx 2700 |
759 |
Notifications |
553 |
372 |
The ECB is continuing to check these and final numbers will be available around the end of January. Lists of those active substances that have been notified (together with the accepted notifier(s)) and those identified are on the ECB Website.
B) Prioritisation of active substances for review and allocation to member states for review
In 1998 the European Commission and the Member States agreed that active
substances would be reviewed by product type and that wood preservatives (Product
type 8) and rodenticides (Product type 14) would be those reviewed first.
The active substances notified for use in these product types are listed at
Appendix 1 
of this Fact Sheet. The allocation to Member States for review (listed under
'RMS' in the Appendix) was essentially agreed at the November Competent Authorities
(CA) meeting. However, there may be minor alterations if notifications are
rejected or further notifications are accepted as a consequence of Regulation
1687/2002 (the 'Prolongation Regulation'). The lists will be finalised prior
to the Standing Committee meeting, scheduled for 24 March 2003, at which the
committee will deliver its opinion on the 2nd Review Regulation.
The CA's have also agreed the allocation of product types to future review
lists. This can be found in Appendix 2 .
Again, we expect that this will be finalised prior to the Standing Committee
meeting. The EC and the Member States are actively progressing the allocation
of active substances for the 2nd priority list and will soon start on the
3rd and 4th priority lists. The active substances on these latter lists are
likely to be shared amongst the current 15 Member States and the 10 countries
that will join the EU in 2004. Norway and Switzerland are also likely to be
involved. We will let you know more when the information is available
A) Update on the Second Review Regulation
Following discussion at an earlier Competent Authorities' (CA) meeting and subsequent comments from Member States (MS), a simplified revised draft of the 2nd Review Regulation was discussed in-depth at the 12th CA meeting on 18/19 November. It includes a new provision at Article 9(2), proposed by the UK, by which MS may require advance payment of charges obviating the need for national transposing legislation to enable charging. The requirement at Article 7 for product dossiers to cover 'representative uses' in the specified product type has been deleted. The relation between the range of product data submitted with an Annex I application for an active substance, and the nature of the Annex I entry itself, has yet to be clarified. But when providing a dossier on a product containing the active substance, under Art 11.1(a)(ii) of the Biocidal Products Directive, notifiers may wish to consider submitting data on a product or products at the higher end of the risk spectrum, so that other, less 'risky' products would then have a better prospect of being accepted by other MS for mutual recognition.
The text was agreed with only minor amendments. The EC has scheduled a further meeting of the Member States on 23 January 2003 if needed, specifically to discuss remaining issues on the 2nd Review Regulation. It is planned for the Regulation to then go for a Standing Committee opinion at a meeting on 24 March 2003, subject to which it could be brought into force in April 2003.
B) Deadline for Products containing Non-Identified/Notified Active Substances to be removed from the Market
Products containing active substances that have not been identified (or notified) in line with the First Review Regulation will have to be removed from the market following the entry into force of the Second Review Regulation. It had been believed that there would be a phase-out period for this to take place and that the deadline for removal from the market would be approximately May 2004.
However, at the Competent Authorities meeting on 18/19 November 2002 the European Commission made it clear that products containing those active substances that have not been identified/notified must be subject to the authorisation requirements of the Directive immediately after the Second Review Regulation enters into force, which will mean that such products will have to be removed from the market when the Second Review Regulation comes into force in 2003. As mentioned above, it is planned for the Regulation to go for a Standing Committee on Biocides opinion at a meeting on 24 March 2003, following which it could be brought into force as early as April 2003.
The European Commission has indicated that it is prepared to consider amendment of the Directive in a few areas. Authorisation for use without placing on the market; definitions, especially of "active substance" and "biocidal product"; exclusions, especially for cosmetics; imported articles; basic substances; addressing minor uses; data protection; supply by way of service provision; and updating Annex V are areas identified so far. Member States have been asked to indicate further areas for amendment by 31 December 2002.
A) Manual of decisions
The European Commission presented a revised draft of the 'Manual of Decisions' to the November CA meeting. The Member States have been given a short period in which they can make further comments after which the document will be placed on the EC Website
B) Teat Dips
Because of concerns over the setting of Maximum Residue Levels (MRLs), there has been concern, particularly amongst the Competent Authorities (CA) for Veterinary Medicines, that products used as teat dips should be regulated in the veterinary medicines regime rather than as biocides. However, the EC and CA's for Biocides consider that teat dips are unlikely to meet the requirements of the Veterinary Medicinal Products Directive, especially with respect to manufacturing quality and efficacy. The Commission intends to have a further discussion with the CA's for Veterinary Medicines.
A) Dossier preparation and evaluation
The ECB requested final comments on Parts II and III of this TNsG before 1 November. Following final editing, the document will be placed on the ECB Website as a draft for use. It can then be subject to possible subsequent amendment following experience of its use.
B) TNsG on Human Exposure
There has been debate over the acceptability of the percentiles used in assessments. This issue was reconsidered at an expert meeting on 12 November. It has been agreed that the TNsG will be placed on the ECB Website as a draft, with a clear statement in the introduction indicating where agreement is currently not possible.
C) TNsG on Data Submission
The ECB is working on the production of an electronic data submission format for robust study summaries that are required with applications for inclusion in Annex I of active substances. The ECB organised a meeting on this topic with the Member States and Industry on 15 November. In co-operation with experts in both toxicology and environmental sciences from both the Member States and Industry, the ECB is now working to finalise these.
The EC and Member States have agreed to establish an expert group on data waiving. This group will be a forum for discussions between the Member States on questions from Industry on data requirements relating to dossiers for Annex I inclusions and similar technical issues. Discussions are intended to be by e-mail as well as at formal meetings. The EC has requested nominations from the Member States to cover both toxicological and environmental specialisms. When Industry has a query on the data required, or other technical issues, they should, in the first instance, approach the rapporteur Member State for their dossier (if the query relates to an active substance in the review programme) or the Member State to which they intend to submit the application (other applications).
The draft Biocidal Products (Amendment) Regulations [2003] were put to the industry Charging Review Group for consideration at its 26 November 2002 meeting. The amendment regulations aim to bring about the General Industry Charge (GIC) as a single scheme covering the whole of the UK. The proposal would introduce a flat-rate charge from 1 April 2003 for those liable, including anyone supporting active substances for entry onto Annex I of the Biocidal Products Directive (where the active substance appears on the UK market, either in its own right or in a product); those first placing a product on the market; and anyone with an authorisation to place a product on the market. A consortium will be deemed to be a single entity for this purpose, and its members should specify which of them will pay the GIC. Nobody will be liable to pay the GIC more than once each year, unless they have a liability in their own right and have also been nominated by a consortium; or have been nominated by more than one consortium. Payment will be charged in arrears, and it is expected that the first collection will take place in mid-2004.
A discussion document 'The Biocides Consultative Framework' was circulated for comment to all members of the Ad Hoc Working Group on Biocides (AWGB). The document set out HSE's proposals for the UK consultative framework in support of the European and UK biocides regimes. The constitution and Terms of Reference for the group are set out below:
The AWGB comprises representatives of industry, including the major trade associations for antifouling products, healthcare, water, chemicals, coatings, pest control, wood preservation, wool and textiles, knitwear, footwear and apparel, speciality biocides, crop protection, dairy industry, embalmers, heating and ventilating contractors, preserving specialists, shipbuilders and repairers, timber research and development, forest products, in vitro diagnostics, and lubricants; trade unions, NGOs and other bodies including the NFU, UNISON, CBI, TUC and Pesticides Action Network (PAN).
To provide a forum in which:
The group will operate largely via Email, but will continue to meet when necessary, e.g. in preparation for CA meetings. HSE is keen to ensure the major industry groups are represented; and in particular would like to secure greater involvement of the trade unions, NGOs and other bodies. For further information on the work of the AWGB, or to nominate a representative to the group, please contact:
Garry Wiles
Health and Safety Executive
HDB Biocides Policy Unit
6NW Rose Court
2 Southwark Bridge
London SE1 9HS
Tel. 020 7717 6267
Fax. 020 7717 6199
Email. garry.wiles@hse.gsi.gov.uk
Published on HSE web site 3 January 2003