Fact sheet
Biocidal products directive (Biocidal Products Directive), 98/8/EC

Issue No.  10 September 2001

Purpose

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.

Fact Sheet 10 is not a revision of Fact Sheets Nos.1-9 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.

Progress /of the Directive in Europe

Progress with the first Review Regulation

• Guidance has been published by the European Chemicals Bureau (ECB) on preparing a Notification of an existing active substance in accordance with Article 4 of the 1st Review Regulation (1896/2000); and in particular where the required information can be entered in IUCLID. This is now on the ECB Website. http://ecb.jrc.it/biocides/
  
  The ECB has also clarified that when an active substance is Notified in a limited number of product types, and in accordance with Article 4, then it will be automatically considered that the active has been identified as far as other product types are concerned. This is conditional upon the notification providing the basic information necessary for an identification.

Progress with the second Review Regulation

• There has been no further progress on the 2nd Review Regulation since the discussions at the Competent Authorities’ meeting in March and at a specific meeting in April. The Commission still intends to finalise discussions on the text of the Regulation in 2001 and for it to enter into force in May 2003. Please see Factsheet 9 for the most up-to-date information.

Technical Meetings and Progress with the Technical Notes for Guidance (TNG).

• The Commission is finalising the TnG on the inclusion of active substances in Annex I. It intends to obtain the views of its Scientific Committee during the summer, discuss this at a biocides Technical Meeting in September and obtain the agreement of the Competent Authorities in November.
     Finalisation of the TnG on the authorisation of products should start this autumn.

Scope

• The next scope working group meeting will take place on September 25th in Ispra, Italy

Staff Changes at the Commission

• DG Environment has seen a number of changes in staff dealing with biocides: Walter Cortellini, Lars Fock and Marc Dubois have all moved on; and Klaus Berend and Ulla Falk will carry on the work on the Biocidal Products Directive while a replacement is found for Walter Cortellini.

Progress on implementing the Directive in the UK

Biocidal Products Regulations

• The Biocidal Products Regulations (BPR) 2001, which came into force on 6 April 2001 implement the Directive in Great Britain (GB). Implementation in Northern Ireland (NI) has been delayed. It is now expected that the BPR (NI) will implement the Directive in October 2001.

It is planned that HSE will carry out the competent authority functions in both GB and NI.

General Industry Charge

• Following consideration of the issues raised by the public consultation on the General Industry Charge (GIC), and of the subsequent information gathering exercise with industry, HSE is intending to progress the GIC on the basis that those supporting Annex 1 entries should be required to contribute (along with those supplying biocidal products), and the structure of the charge should be a flat rate per company (rather than a levy on sales turnover). Regulations are required to implement the GIC and it is hoped that these will be ready before the end of the current financial year.

Chemical Classification & Labelling – CHIP 3

• HSE is currently updating the legislation for the classification and labelling of hazardous substances – the Chemicals (Hazard Information & Packaging for Supply) Regulations 1994 (CHIP).
    
  The existing regulations – CHIP 2 – will be replaced in April 2002 by CHIP3 which will implement the Dangerous Preparations Directive (1999/45/EC) and will introduce a number of new requirements, including extending to preparations the requirement for classification for environmental effects (which is already a requirement for substances). CHIP3 will also consolidate CHIP and its numerous amendments, implement the 28th adaption of the Dangerous Substances Directive (67/548/EEC) and implement changes to the safety data sheets Approved Code of Practice. It is proposed that suppliers of biocidal products will have until the end of July 2004 to comply with CHIP3.

HSE plans to issue a Consultation Document (CD) in the Autumn and this will be published on the HSE website, www.hse.gov.uk/consult/live.htm. Interested parties will have the opportunity to comment and the CD will give details of where to send your comments. Further details on CHIP3 can be found on the CHIP website.

Biocides Roadshows & Proposed Biocides Industry Seminar

• HSE considers that, with the rapid development in the implementation of the Directive, it would be appropriate to hold 2 half day Roadshows early in 2002. The Roadshows will run from 1.30pm to 4.30pm, and will be held in Bootle (1103 Daniel House) on the 16th January and in London (Rose & Globe Rooms, Rose Court) on the 23rd January. They will update Industry on Scope issues, the Review Regulations, other EU issues (technical and competent authority meetings) and any issues arising from implementation in the UK. If you wish to attend one of these free Roadshows please complete the booking form attached to this Factsheet. If the Roadshows are vastly oversubscribed we will consider running some in the mornings on the same dates.
    
  We also propose to hold a full or half day Biocides Industry Seminar in 2002 to complement the annual non-agricultural pesticides Industry Seminar organised by BPU. This was supported at the last meeting of the Ad Hoc Working Group on Biocides, at which Industry were invited to suggest topics for the seminar. We are yet to finalise topics for discussion at the seminar, and welcome further suggestions, which should be sent to the address at the end of the Factsheet.

Frequently asked questions about the Biocidal Products Directive and the Biocidal Products Regulations.
  

Have the Biocidal Products Regulations (BPR) had any effect on disinfectants yet?

• These products will be affected by the requirements of the Biocidal Products Directive within the next few years. In accordance with the First Review Regulation (1896/2000) producers and/or formulators of biocidal active substances have until 28 March 2002 to inform the Commission of their intentions with respect to the review programme. The EC will draw up a list of existing active substances that have been identified or notified and in which of the 23 product types (PT) they have been identified or notified.
    
  Following publication of this list, if an active substance has been neither identified nor notified in a particular disinfectant PT, then it and all products containing it must be withdrawn from the EU market for use in that PT.
     
  The deadline for this withdrawal will be given in the second Review Regulation, but is likely to be before the end of 2003.
    
  If an active substance has been identified in a disinfectant PT but it is not notified then all biocidal products containing it must be withdrawn from the EU market for use in that PT. The deadline for this withdrawal (currently expected to be no later than mid-2006) will be given in the second Review Regulation.
    
  If an active substance has been notified for use in a disinfectant PT then biocidal products containing it will be able to stay on the market in the notified product types until the active substance has been reviewed for Annex 1, etc., listing. The Directive gives 10 years for all existing active substances to be reviewed.
    
  If, following review, the active substance is included on Annex 1, etc. of Biocidal Products Directive, then authorisation of individual products containing that active substance can occur under Biocidal Products Directive. If inclusion in Annex 1, etc. is not possible then products containing that active substance will have to be withdrawn from the EU market.
     
  NB: the BPR applies immediately to active substances new to the EU market since 14 May 2000, and the biocidal products based on them.

What is the difference between notification and identification

• There are many, possibly more than 2000, substances that are claimed to be active substances for use in biocides. The first Review Regulation introduces two procedures by which industry can either:
    
  i) Identify those active substances already used in biocidal products, but which they do not intend to support in the review programme. This is a relatively simple procedure in which essential information on the identity, uses etc of the active substance are sent to the ECB; or
    
  ii) Notify those active substances that they intend to support during the review programme. A Notification will require submission of summary data on the essential hazards and will be used to prioritise active substances for review. Making a Notification does commit you to supporting the active substance during the next phase of the review programme. In this next phase you will be required to provide a full dossier of all the data and other information needed for the evaluation of the active substance for possible inclusion on Annex I. If you do not provide the full dossier at the appropriate time, without good reason, then it is likely that the active substance will have to be withdrawn from the EU market within a short time period.

Where can I find the list of existing substances

• The non-exhuastive indicative list of existing substances referred to in Article 3.3 of the 1st Review Regulation can be found at the ECB website – http://ecb.jrc.it/biocides/. But the (legally) important list of active substances identified and notified will be part of the 2nd Review Regulation.

What is a letter of access?

• A letter of access is a letter granting a Regulatory Authority (this will be HSE in the UK) access to another company’s data on your behalf. It is a commercial arrangement between a data holder and a company seeking access to their data in order to gain an authorisation.

I supply ink cartridges for inkjet and laser printers. The ink contains a biocide solely to preserve it; do I have any responsibilities under the BPR?

• In GB, authorisation for the placing on the market of biocidal products is done under the BPR. If your company does not intend that the ink itself will have any biocidal effects, then you are not placing a biocidal product on the market. Therefore you do not have responsibilities under the BPR. But the company that supplies the biocide you put into the ink will have responsibilities under the BPR.

I am a manufacturer of powder coatings used to coat for example hospital beds; if I add a biocide to the powder coating do I have any responsibilities under the BPR?

• If your company intends that the coating has a biocidal effect, and you wish to place it on the market, then you will have responsibilities under the BPR.
    
  If the biocide is added solely to preserve the powder coating, then (as in the example above for ink) you will not have responsibilities under the BPR; but the company supplying the biocide to you will have such responsibilties.

HSE Biocides contacts

For general information on the Directive, progress with implementation or to register your interest in Biocides please contact us on:

Biocides & Pesticides Assessment Unit General information number:

Tel: 0151 951 3535
Fax. 0151 951 3317
biocides@hse.gsi.gov.uk

Our address:
Biocides & Pesticides Assessment Unit
Health and Safety Executive
Magdalen House
Bootle
Merseyside L20 3QZ

HSE Books:
Tel: 01787 881165
Fax: 01787 313995

• Booking form for Biocides Roadshows in 2002 [link removed]