Experience with Biocidal Product Family as competent authority€¦ · Biocidal Product Family as...
Transcript of Experience with Biocidal Product Family as competent authority€¦ · Biocidal Product Family as...
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Experience with
Biocidal Product Family
as competent authority6th BPR Symposium
Brussels, Belgium
17 October 2017
Karima Azdad
Attaché Biocides – DG Environment
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Content
I. General introduction
Biocidal Product Family concept
II. Experience handling BPF
as eCA
as cMS
III. Conclusion
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Biocidal Product Family
Implementing the new BPF concept - CA-Nov14-Doc.5.8 - Final.rev3
3 levels of implementation
A family consists of products with:
Same actives substances (content ≠0)
Similar composition within specified variation
Similar uses
Similar levels of risks
Similar levels of efficacy
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CA-Nov14-Doc.5.8 - Final.rev3 - Implementing the new BPF concept
1st level: BPF
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Biocidal Product Family
New meta SPCs concept: grouping of products
Well structured SPC to define a group of BPs having: :
Similar composition within specified variation
Similar uses (common set of RMM)
Same hasard and precautionnary statements
Common first aid instructions, disposal, storage and shelf life.
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2nd level: meta SPC
CA-Nov14-Doc.5.8 - Final.rev3 - Implementing the new BPF concept
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3rd level: meta SPC
CA-Nov14-Doc.5.8 - Final.rev3 - Implementing the new BPF concept
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CA-Nov14-Doc.5.8 - Final.rev3 - Implementing the new BPF concept
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Content
I. General introduction
Biocidal Product Family concept
II. Experience handling BPF
as eCA
as cMS
III. Conclusion
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BPF applications in R4BP-3 (figures R4BP 17/10/17)
Belgium: 4 applications introduced in 2015-2017
0
10
20
30
40
50
60
70
80
90
2013 2014 2015 2016 2017
Biocidal Product Family Applications
NA-APP UA-APP
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BPF: eCA
New experience (learning process)
Contact your authority (early as possible)
Pre-submission meeting
Well structure family: logical and easy to follow
BPF overview (supporting document)
Transparent collaboration and in close contact
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https://echa.europa.eu/support/dossier-submission-tools/r4bp/supporting-documents
May 2017
BPF overview document
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BPF: eCA
meta SPC subdivision:
Composition
Uses
Maximum risk/minimum efficacy parameters
Critical points:
Efficacy testing
Representative products:
lowest/highest concentration of AS
Worst case scenario
Consider future perspectives: post-authorizationnotification
BPR deadlines
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BPF Working Party
Further clarification of the concept of similarity applicable to:
1. composition
2.uses
3. levels of risk and efficacy
Definition of limits for setting meta-SPC ranges
Possible limitation on the inclusion of different formulation types in BPF
Grouping of co-formulants
Definition of a BPF/meta-SPC range for physico-chemical parameters
Clarification whether the assessment of BPFs should be based on the BPF or meta-SPC level
Establishment of clear rules for identification of the worst case scenario (maximum risk/minimum efficacy)
Application of paragraph 77 of Annex VI to the BPR in relation to BPFs
Revision of the Q&A section and assess whether any points can be integrated in the general guidance
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Content
I. General introduction
Biocidal Product Family concept
II. Experience handling BPF
as eCA
as cMS
III. Conclusion
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BPF applications in R4BP-3 (figures R4BP 17/10/17)
0
50
100
150
200
250
300
350
400
450
2013 2014 2015 2016 2017
Biocidal Product Family Applications
NA-MRP/S NA-BBS/P
BPF: cMS
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BPF applications in R4BP-3 (figures R4BP 17/10/17)
BPF: cMS
050
100150200250300350400450
2013 2014 2015 2016 2017
EUBiocidal Product Family Applications
NA-MRP/S NA-BBS/P
0
2
4
6
8
10
12
14
16
18
20
2014 2015 2016 2017
BEBiocidal Product Family Applications
NA-MRP/S NA-BBS/P
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BPF: cMS
Mutual recognition process:
Authorisation under the same terms and conditions
(art.32(2))
Family members identical to the reference dossier
Transitional period: identification of products on the
national market
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BPF: cMS
Same biocidal products:
SBP regulation No 414/2013: article 2 (content of application)
Identification of the proposed differences
Evidence that the products are identical on all other aspects
BPF overview (supporting document)
Transitional period: identification of products on the national
market
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Content
I. General introduction
Biocidal Product Family concept
II. Experience handling BPF
as eCA
as cMS
III. Conclusion
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Conclusions
New concept
Defined conditions to be applied
Reduces the costs for registration: one application for multiple
products
Flexibility
Possibility to add new family products post-authorization
BPF
Complexity determined by BPF structure
Keep it simple: logical and easy to follow
Limited experience on MR procedure (art. 35)
No experience on UA peer review
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Thank you for your attention
?For further information
Belgian Biocides website
www.biocide.be
ECHA website
https://echa.europa.eu/regulations/biocidal-products-regulation/understanding-bpr
Commission website
https://ec.europa.eu/health/biocides/policy_en