1. The Biocidal Products Directive Presentation to the European Aerosol Federation 28 September 2005 Athens Greece Steve Smith, SC Johnson

2. Agenda The Biocidal Products Directive Goals and Key Features Applicability and Product Types Process Active Substances involved and Milestones Impact on Formulators Resources; documents, websites Questions

3. The Biocidal Products Directive 98/8/EC The BPD

4. Primary Goals of the BPD Create/support a harmonized EC market Improve protection for man & environment Ensure scientific risk assessment Ensure fair competition via enforcement

5. Features of the BPD 10 year transition period Targeted review timelines Positive list of active substances (Annex 1) Requires pre-market authorization Fee for service Comparative hazard assessment Mutual Recognition

6. Applicability Biocides are active substances, preparations (as supplied to users) intended to destroy, deter, render harmless, prevent the action of or otherwise exert a controlling effect on harmful organisms by chemical or biological means Products not subject to other directives

7. 23 Product Types (PTs) in 4 Groups Disinfectants and general biocidal products –For surfaces, air, water, food/feed areas … Preservatives –In-can, film, wood, metal working fluids… Pest Control –Insecticides, repellents, attractants, rodenticides… Other biocidal products –Antifoulants, preservatives for food, embalming fluids…

8. PT Examples PT 18 PT 19

9. Overview of BPD Process Identification Notification Submission of active substance dossier Review by Rapporteur Member State Annex 1 listing of active substance Product submission to 1 Member State Application for Mutual Recognition

10. Review by RMS Recommendation re Annex 1 listing Active substance dossier Incl. representative product Standing Committee on Biocides Annex 1 Inclusion Denied Annex 1 Inclusion Restrictions, Limitations etc. Additional Data Required Annex 1 Inclusion Procedure

11. Doc II-A Effects and Exposure 3) Assessment Active Substance 2) Doc II-B Effects and Exposure Assess. Biocidal Prod.(s) 2) Doc. II-C Risk Characterisation for Use of A.S. in B.P.(s) Doc. II Risk Assessment Doc. I Evaluation Report 1) Document III-B Study Summaries Biocidal Product(s) 2) Document III-A Study Summaries Active Substance 2) 1) To include:I.1 Subject Matter 2) To append:Reference lists I.2 Overall Summary and Conclusions I.3 Proposal for Decision Re. Annex I, IA, IB Inclusion Appendix: List of end points.; Appendix: List of abbreviations Initial check for completeness of dossiers CAs' Report 3) This should address in particular cumulative exposure & exposure during manufacture Doc. IV-B: Test and Study Reports b.p.(s) Doc. IV-A: Test and Study Reports a.s. Doc II-A Effects and Exposure 3) Assessment Active Substance 2) Doc II-B Effects and Exposure Assess. Biocidal Prod.(s) 2) Doc. II-C Risk Characterisation for Use of A.S. in B.P.(s) Doc. II Risk Assessment Doc. I Overall Summary and Assessment 1) Document III-B Study Summaries Biocidal Product(s) 2) Document III-A Study Summaries Active Substance 2) 1) To append: List of end points 2) To append: Reference lists List of abbreviations Check for completeness Summary Dossier Complete Dossier Dossier components

12. Product: Formulation, Data, Use Pattern Competent Authority Dose ResponseHazard IdentificationExposure Assessment Efficacy Compare Hazard and Exposure for Relevant Human and Animal Populations And Environmental Compartments Benefit RiskEfficacy Authorized Biocidal ProductFailedMore Data Required Biocidal Product Authorisation Procedure

13. Active substances 2,700 identifications for 955 substances 570 notifications for 370 substances List A: 51 of 98 actives were submitted –drop out rate of > 50% –On top of programme attrition rate of > 60% It is not too late to notify an identified substance –Full dossiers due March 2006

14. Milestones Active substances submitted in 4 groups by product type: –March 2004 – PT 8 and 14 –April 2005 – PT 16, 18, 19 and 21 –July 2007 – PT 1, 2, 3, 4, 5, 6, and 13 –October 2008 – PT 7, 9-12, 15, 17, 20, 22, 23 NB: Products containing identified only active substances may not be placed on the market after 1 September 2006

15. Impact of BPD on formulators Fewer active substance alternatives Higher active substance costs ($$$ data) Significant costs for product dossiers – Data, study summaries, risk assessments, dossier assembly But there is the promise of Mutual Recognition…

16. Formulator’s Role Formulators are responsible for their products –Identify products subject to BPD –Confirm active substances are notified –Contact supplier (and stay in contact!) –Review product data requirements –Seek clarification from authorities –Consider joining a trade association

17. Regulations and Guidance 98/8/EC The Biocidal Products Directive EC 1896/2000 - First Review Regulation EC 2032/2003 – The Second Review Regulation EC 1048/2005 - The Third Review Regulation The Manual of Decisions Borderline documents Technical Notes for Guidance Technical Guidance Documents

18. Useful Websites DG Environment: –http://europa.eu.int/comm/environment/ biocides European Chemicals Bureau: –http://ecb.jrc.it/biocides OECD Biocides : –http://www.oecd.org/ehs/biocides UK Health Safety Executive –www.hse.gov.uk/biocides

19. Questions? Thank you for your time Steve Smith srsmith@scj.com +44(0) 1784 484 282