Experience with Biocidal Product Family as competent authority 6 th 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
1 st level: BPF CA-Nov14-Doc.5.8 - Final.rev3 - Implementing the new BPF concept
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.
2 nd level: meta SPC CA-Nov14-Doc.5.8 - Final.rev3 - Implementing the new BPF concept
3 rd 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) Biocidal Product Family Applications NA-APP UA-APP 90 80 70 60 50 40 30 20 10 0 2013 2014 2015 2016 2017 Belgium: 4 applications introduced in 2015-2017
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
BPF overview document https://echa.europa.eu/support/dossier-submission-tools/r4bp/supporting-documents May 2017
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-authorization notification 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: cms BPF applications in R4BP-3 (figures R4BP 17/10/17) Biocidal Product Family Applications NA-MRP/S NA-BBS/P 450 400 350 300 250 200 150 100 50 0 2013 2014 2015 2016 2017
BPF: cms BPF applications in R4BP-3 (figures R4BP 17/10/17) EU Biocidal Product Family Applications BE Biocidal Product Family Applications NA-MRP/S NA-BBS/P NA-MRP/S NA-BBS/P 450 400 350 300 250 200 150 100 50 0 2013 2014 2015 2016 2017 20 18 16 14 12 10 8 6 4 2 0 2014 2015 2016 2017
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 BPF Defined conditions to be applied Reduces the costs for registration: one application for multiple products Flexibility Possibility to add new family products post-authorization 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