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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

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