The Biocidal Products Directive

Presentation to the European Aerosol Federation28 September 2005Athens GreeceSteve Smith, SC Johnson

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

The Biocidal Products Directive

98/8/ECThe BPD

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

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

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

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…

PT Examples

PT 18 PT 19

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

Review by RMSRecommendation re Annex 1 listing

Active substance dossierIncl. representative product

Standing Committee on Biocides

Annex 1InclusionDenied

Annex 1Inclusion

Restrictions, Limitations etc.

Additional Data

Required

Annex 1 Inclusion Procedure

Doc II-AEffects and Exposure3) Assessment

Active Substance2)

Doc II-BEffects 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

EvaluationReport1)

Document III-BStudy Summaries

Biocidal Product(s) 2)

Document III-AStudy SummariesActive Substance2)

1) To include: I.1 Subject Matter 2) To append: Reference listsI.2 Overall Summary and ConclusionsI.3 Proposal for Decision Re. Annex I, IA , IB InclusionAppendix: 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-AEffects and Exposure3)

AssessmentActive

Substance2)

Doc II-BEffects 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. IOverall

Summary and Assessment1)

Document III-BStudy Summaries

Biocidal Product(s)2)

Document III-AStudy SummariesActive Substance2)

1) To append: List of end points 2) To append: Reference lists

List of abbreviationsCheck for completeness

Summary Dossier

Complete Dossier

Dossier components

Product:Formulation, Data,

Use Pattern

Competent Authority

Dose ResponseHazard IdentificationExposure AssessmentEfficacy

Compare Hazard and Exposure for Relevant Human and Animal Populations And Environmental Compartments

Benefit

RiskEfficacy

Authorized Biocidal ProductFailed More Data Required

Biocidal Product Authorisation Procedure

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

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

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…

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

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

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

Questions?

Thank you for your time

Steve Smithsrsmith@scj.com

+44(0) 1784 484 282