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The Biocidal Products Directive. Presentation to the European Aerosol Federation 28 September 2005 Athens Greece Steve Smith, SC Johnson. Agenda. The Biocidal Products Directive Goals and Key Features Applicability and Product Types Process Active Substances involved and Milestones - PowerPoint PPT Presentation
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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
