Transcript FEA Presentation

The Biocidal Products Directive
Presentation to the European Aerosol Federation
28 September 2005
Athens Greece
Steve Smith, SC Johnson
Agenda
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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/EC
The 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
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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
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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
Annex 1 Inclusion Procedure
Active substance dossier
Incl. representative product
Review by RMS
Recommendation re Annex 1 listing
Annex 1
Inclusion
Denied
Standing
Committee
on Biocides
Annex 1
Inclusion
Restrictions, Limitations etc.
Additional
Data
Required
Dossier components
Complete Dossier
Summary Dossier
Doc. I
Overall
Summary
and Assessment1)
Evaluation
Report1)
Doc. II Risk Assessment
Doc. II Risk Assessment
Doc. II-C Risk
Characterisation
for Use of A.S. in B.P.(s)
Doc. II-C Risk
Characterisation
for Use of A.S. in B.P.(s)
Doc II-A
Effects and
Exposure3)
Assessment
Active
Substance2)
Document III-A
Study Summaries
Active Substance2)
1) To append:
CAs' Report
Doc II-B
Effects and
Exposure
Assess.
Biocidal
Prod.(s)2)
Doc II-A
Effects and
Exposure3)
Assessment
Active
Substance2)
Document III-B
Study Summaries
Biocidal Product(s)2)
List of end points 2) To append:
Reference lists
List of abbreviations
Check for completeness
Doc. IV-A: Test and
Study Reports a.s.
Doc. I
Doc. IV-B: Test and
Study Reports b.p.(s)
Document III-A
Study Summaries
Active Substance2)
1)
To include:
Doc II-B
Effects and
Exposure
Assess.
Biocidal Prod.(s)
2)
Document III-B
Study Summaries
Biocidal Product(s) 2)
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
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
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 Smith
[email protected]
+44(0) 1784 484 282