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 17 is not a revision of Fact Sheets Nos.1-16 but instead provides supplementary information and advice. If you would like a copy of earlier Fact Sheets, these can be downloaded from our website. It you cannot do this, then please contact us at the address given at the end of this Fact Sheet.
At its 11th June 2003 meeting the Standing Committee on Biocidal Products delivered a favourable opinion on the amended text of the 2nd Review Regulation. Subject to translation into the Member States’ official languages, the Commission expects the final text to be published in the Official Journal in September 2003. The 2nd Review Regulation will then come into force 20 days later.
Points to note include:
The lists of notified and identified active substances will be included as Annexes to the Regulation.
2. Scope issues arising from the competent authorities meeting on 12th June 2003
The main issue outstanding was whether teat dips were veterinary medicinal products or biocidal products. During the course of the Competent Authorities (CA) meeting a joint session of the relevant CAs agreed that teat dips are not excluded from the Biocidal Products Directive unless they satisfy all the requirements for a medicinal product, including product definition, appropriate trials and efficacy data. It is unlikely that many will be able to do so.
The Guidance Document was approved at the CA meeting and is now available on the EU website at: http://europa.eu.int/comm/environment/biocides/pdf/prodmilk.pdf
There was no consensus at the CA meeting among Member States (MS), and the issue remains whether a cosmetic can have secondary claims as a biocide (e.g. a sunscreen that is also an insect repellent) and still be dealt with under the cosmetics legislation. There seemed to be divergent views between the Cosmetic Products Directive and Biocidal Products Directive authorities in some MS, and all MS were asked to send co-ordinated views to the Commission by 31 July so that an overview table could be prepared along similar lines to that used to resolve the teat dips issues. The UK position is unchanged: we maintain that a product satisfying the definition of ‘cosmetic’ is excluded from 98/8 regardless of secondary biocidal functions.
A proposal presented by the Commission for a new structure for the Manual
of decisions that would present the ever-growing content in a more user-friendly
format was endorsed at the CA meeting, and a new version will be prepared
accordingly. The current version is available on the EU website at:
http://europa.eu.int/comm/environment/biocides/manual.htm
It was agreed that the references to treated articles would be removed temporarily and amended.
The Commission’s December 2001 data protection paper, on which only the UK had submitted comments, was presented for endorsement at the 12 June Competent Authority meeting. Several basic issues were raised, including from those who earlier had expressed contentment with the paper. Those points were to be submitted in writing in full no later than 15 July 2003 so that they could be put to the Commission Legal Service.
Article 12 may need to be tidied up to take account of the final guidance. In addition the UK Regulations will probably need to be modified.
5. Competent authorities meeting with accession and candidate countries
There was a very detailed agenda for this special session. The acceding and candidate countries briefly reported on the status of implementation of the Biocidal Products Directive in their countries. They were at different stages of implementation. CEFIC noted that different countries (including the current 15 Member States) were implementing different parts of Biocidal Products Directive at different times. There was no harmonisation during the transition phase and this was causing problems with Industry. CEFIC had produced a table of the implementation state in the different Member States
The major problems that the acceding and candidate countries noted were resource
constraints, especially technical expertise, and difficulties in identifying
all existing active substances currently used in their countries.
6. Implementation of the second review regulation
Suppliers of active substances and biocidal products are reminded that where active substances have been neither Identified nor Notified, biocidal products containing these active substances must not be placed on the market after the Second Review Regulation comes into force. This date is expected to be in September 2003, with the exact date being when the 2nd Review Regulation enters into force.
Now that the Standing Committee on Biocides has given a favourable opinion on the second Review Regulation, the Biocides & Pesticides Unit (BPU) is able to press ahead with a number of initiatives.
1. We are finalising a ‘Guide to Participants’.
This is primarily intended for those Participants in the Review Programme who will be submitting dossiers to the UK in the 1st and 2nd Priority Lists. It will also be of interest to other Participants who may be submitting dossiers to other Member States or those who may be considering making an application for the inclusion in Annex I of a new active substance. We have already initiated contacts with Participants from the 1st Priority List and sent a draft version to them. The document will be finalised once the 2nd Review Regulation is published and will then be made more widely available.
2. Input into EC/EU Initiatives
At the next Biocides Technical Meeting, scheduled for early October, there will be discussions on two important issues:
We will keep you informed of developments in these areas, which hopefully will be completed before our Guide to Participants is finalised.
3. Discussions on data requirements etc
BPU is available to discuss data requirements, waiving issues etc with those Participants who will be submitting dossiers to the UK. The same applies for those who may be considering making an application, using the UK as rapporteur, for the inclusion in Annex I of a new active substance. We may also be able to answer small technical and procedural questions.
However, where another Member State is rapporteur for a particular dossier or your intention is to submit an application for the inclusion in Annex I of a new active substance to another Member State, then you should contact that Member State for advice.
7. Compliance with regulations - non-identified active substances and declarations of liability to pay the general industry charge.
BPU intends to initiate shortly a study to check that:
In the first instance a small feasibility study will be conducted to determine if it will be cost-effective to undertake a full survey.
8. Consultation of risk assessments for mixtures of pesticides and similar substances.
A consultation exercise is being carried out by the Food Standards Agency, seeking comments on proposals for work to be done to examine the risks to people from ‘combined’ exposures to pesticides and similar substances. Non-agricultural pesticides and biocides may contain more than one active substance and some active substances are also used in other products such as veterinary medicines and agricultural/horticultural pesticides. It is therefore possible that individuals might be exposed to a number of active substances which act in the same way, or to the same active substance in several different products. You may wish to comment on the proposals made, since they may eventually have an impact on the regulation of both non-agricultural pesticides and biocides.
The Department of Health’s Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) carried out a review of the risk assessment of mixtures of pesticides and similar substances and its Report was published on 15 October 2002. The report concluded that the probability of any human health hazard from exposure to mixtures of chemicals (combined exposure), each present at a low level, was likely to be small and that effects of mixtures of substances were unlikely to be other than additive. However, it recommended certain changes to the regulatory process to take account of the possible implications of combined exposure.
Following the publication of the draft report, the Food Standards Agency (FSA) has discussed with officials from those Agencies and Departments with responsibilities for the approval of agricultural pesticides, biocides and veterinary medicines and the surveillance of food for their residues, how to take forward these recommendations. Following the publication of the final report, a proposed action plan has been produced by the FSA in response to these discussions. It is now consulting stakeholders before Ministers respond formally to the report’s recommendations.
The FSA is seeking the views of stakeholders on the proposed Action Plan to implement the COT's recommendations. A copy of the consultation letter and draft Action Plan is available on the FSA website at www.food.gov.uk. At the time of writing the consultation is mentioned on the homepage but otherwise can be accessed by selecting ‘your views’, then ‘consultations’ and ‘UK wide consultations’. The deadline for comments to reach FSA is 30th October 2003.
9. Insect repellents used on animals and national legislation.
In preparation for the Biocidal Products Directive, the Health and Safety Executive has recently taken over responsibility for animal husbandry insecticides and repellents under the existing national legislation, the Control of Pesticides Regulations 1986 (COPR) from the Pesticides Safety Directorate (PSD) (an executive agency of DEFRA). Following this HSE has discovered that there are insect repellents that are used on animals that require approval under COPR, but that are not currently approved. HSE, in consultation with the independent Advisory Committee on Pesticides, has agreed to approve such products via the quickest route available under the regulations. Companies who market insect repellents that are used on animals are urged to contact the HSE for further advice at the address below. Please note that if you market insect repellents for use on animals that already hold authorisation through the Veterinary Medicines Directorate, such products should not be affected by this action.
For further information, please see the article on insect repellents in issue 58 of the HSE Pesticides Newsletter and if you then require further advice, contact Andrew Edwards at HSE by email: andrew.edwards@hse.gsi.gov.uk or telephone 0151 951 3219 or in writing to the address at the end of this Fact Sheet.
10. Publications readership survey
With this issue of the Biocides Fact Sheet there is a short questionnaire.
We are seeking your views, as a reader, on the content and format of this
Fact Sheet - which we produce for all parties interested in the Biocidal Products
Directive - and on the Pesticides Newsletter we produce specifically for those
interested in pesticides approved under the Control of Pesticides Regulations.
We would value your feedback to help us improve the information we provide
to you via these publications. The questionnaire should only take a few moments
to complete, and details of how to return it are included on the questionnaire
itself. The questionnaire is at Appendix 1.
We would also ask that if you no longer wish to receive copies of the Biocides
Fact Sheet, please let us know, either in writing to the address at the end
of this Fact Sheet, or by email to: biocides@hse.gsi.gov.uk
As information on the Directive and the UK legislation is held on a number of websites in Europe, the following list details the main sites and gives some of the information available on each of those sites.
European Chemicals Bureau: http://ecb.jrc.it/biocides/ Contains:
a copy of the Biocidal Products Directive (98/8/EC), the First Review Regulations
(1896/2000); the Prolongation Regulation (1687/2002);
Technical Notes for Guidance (TNsG) for Data Requirements;
TNsG on Annex I Inclusion;
TNsG on Dossier Preparation and Study Evaluation;
TNsG on Product Evaluation;
TNsG Human Exposure to Biocidal Product – Guidance on Exposure Estimation;
Environmental Emission Scenario Documents;
Competent Authority Contact Points in the Member States;
the provisional lists of identified and notified active substances.; Information
on IUCLID.
European Commission Environment Directorate website: http://europa.eu.int/comm/environment/biocides/index.htm
Contains:
The Manual of Decisions relating to the scope of the Directive;
Scope Borderline Documents between the Biocidal Products Directive and other
Directives;
specific guidance on the scope of the Directive in relation to, for example,
in-situ generation of active substances;
general information on the implementation of the Directive.
HSE Biocides & Pesticides Unit website: hse.gov.uk/biocides
Contains:
The Biocidal Products Regulations Guide to Applicants;
all issues of the Biocides Fact Sheet;
Guidance on Research and Development, Process-Orientated Research and Experimental
Authorisations;
Information on the Biocides scheme in the UK, including the General Industry
Charge;
Her Majesty’s Stationery Office: http://www.hmso.gov.uk
Contains downloadable versions of :
The Biocidal Products Regulations 2001 (Statutory Instrument 2001 No. 880)
The Biocidal Products (Amendment) Regulations 2003 (Statutory Instrument 2003
No. 429)
HSE Books: http://www.hsebooks.com
Providers of HSE’s priced publications including:
Guide to the Biocidal Products Regulations for Importers and Suppliers of Biocidal Products. Ref HSG208, price £11.00
A Guide to the Biocidal Products Regulations for Users of Biocidal Products. Ref HSG215, price £5.00
Our address:
Chemicals Assessment Schemes Unit (CASU)
Health & Safety Executive
Building 1, 3rd Floor
Redgrave Court
Merton Road
Bootle
Merseyside
L20 7HS
Our biocide webpages: hse.gov.uk/biocides
HSE Books:
Tel: 01787 881165
Fax: 01787 313995
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Thank you for taking the time to complete this questionnaire.