The Biocidal Products Directive

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 19 PT 18

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

11. Complete Dossier Summary Dossier CAs' Report Doc. IOverall Summary and Assessment1) Doc. IEvaluationReport1) Doc. II Risk Assessment Doc. II Risk Assessment Doc. II-C Risk Characterisationfor Use of A.S. in B.P.(s) Doc. II-C Risk Characterisationfor Use of A.S. in B.P.(s) Doc II-BEffects and Exposure Assess.Biocidal Prod.(s) 2) Doc II-AEffects and Exposure3)AssessmentActive Substance2) Doc II-AEffects and Exposure3)AssessmentActive Substance2) Document III-BStudy SummariesBiocidal Product(s) 2) Document III-AStudy SummariesActive Substance2) Document III-AStudy SummariesActive Substance2) 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 1) To append: List of end points 2) To append: Reference lists List of abbreviations Check for completeness Doc. IV-B: Test and Study Reports b.p.(s) Doc. IV-A: Test and Study Reports a.s. Initial check for completeness of dossiers 3) This should address in particular cumulative exposure & exposure during manufacture Document III-BStudy SummariesBiocidal Product(s)2) Doc II-BEffects and Exposure Assess.Biocidal Prod.(s)2) Dossier components

12. Biocidal Product Authorisation Procedure Product: Formulation, Data, Use Pattern Competent Authority Efficacy Exposure Assessment Hazard Identification Dose Response Compare Hazard and Exposure for Relevant Human and Animal Populations And Environmental Compartments Efficacy Risk Benefit Failed Authorized Biocidal Product More Data Required

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