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TRANSCRIPT
Experience with
Biocidal Product Family
as competent authority6th BPR Symposium
Brussels, Belgium
17 October 2017
Karima Azdad
Attaché Biocides – DG Environment
Content
I. General introduction
Biocidal Product Family concept
II. Experience handling BPF
as eCA
as cMS
III. Conclusion
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
CA-Nov14-Doc.5.8 - Final.rev3 - Implementing the new BPF concept
1st level: BPF
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.
2nd level: meta SPC
CA-Nov14-Doc.5.8 - Final.rev3 - Implementing the new BPF concept
3rd level: meta SPC
CA-Nov14-Doc.5.8 - Final.rev3 - Implementing the new BPF concept
CA-Nov14-Doc.5.8 - Final.rev3 - Implementing the new BPF concept
Content
I. General introduction
Biocidal Product Family concept
II. Experience handling BPF
as eCA
as cMS
III. Conclusion
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
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
https://echa.europa.eu/support/dossier-submission-tools/r4bp/supporting-documents
May 2017
BPF overview document
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
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
Content
I. General introduction
Biocidal Product Family concept
II. Experience handling BPF
as eCA
as cMS
III. Conclusion
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
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
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
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
Content
I. General introduction
Biocidal Product Family concept
II. Experience handling BPF
as eCA
as cMS
III. Conclusion
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
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