Upcoming regulatory & policy changes with

IT impact

8th BPR IT User Group Meeting 14 November 2016, Brussels

Dr Alfonso Las Heras

European Commission

DG SANTE, Unit E.4

Table of contents

� Legal basis and implications

� Added value from R4BP:

� Tracking of procedures

� Statistics & monitoring of BPR implementation

� Dissemination & support to enforcement authorities

� Regulatory and policy issues with IT impact:

� Closer monitoring of delays in refMSs

� Improvement of the MR phase

� SA procedure

� SBP procedures

� Others

Legal basis and implications

• Article 71. Register for Biocidal Products

• 71(1) ECHA shall establish and maintain R4BP

• 71(2). R4BP shall be the only platform for the exchange of information.

• 71(3). Applicants shall use the R4BP to submit applications & data for all procedures in the BPR

• 71(6). (….) CAs/COM shall update the information in R4BP: terms & conditions; SPC & PAR

Added value from R4BP:

• Tracking of procedures

• Relevant for review programme and product authorisation procedures

• Allows follow-up of the different procedural steps ("where we are")

• Tracks back communication with applicants ("when was done what") and/or other CAs (e.g. Article 48 issues)

Added value from R4BP:

• Statistics

• Huge data base enabling the generation of detailed statistics (e.g. product authorisations by asset type, MS, PT, AS, etc..)

• Pre-requisite: information in R4BP has to be up to date and accurate

• � MSs to close finalised cases and create the

relevant assets

Added value from R4BP:

• Monitoring of BPR implementation (deadlines)

• Allows measuring compliance with the relevant deadlines in the BPR or implementing legislation for the different procedural steps

• Possibility of quantifying delays: % of cases closed under/above the legal deadlines, median of delays, class distribution (e.g. very low vs. significant delays)

• Pre-requisite: information in R4BP has to be up to date and accurate

• � Need to split MR-P in 3 steps (refMS+MR+NA)

Added value from R4BP:

• Dissemination & support to enforcement authorities

• Key tool to facilitate the dissemination of SPCs and ARs (transparency)

• Pre-requisite: SPCs in R4BP have to be in xml format and complete

• R4BP (& dissemination platform in future): reference tools for inspectors when carrying out checks (e.g. label compliant with SPC)

• New BPF concept (CA-Nov14-Doc.5.8 - Final.rev1)

• SBP Regulation (as amended by IR 2016/1802)

• Addressed in R4BP release end October 2016

Regulatory & policy issues with IT impact:

Regulatory & policy issues with IT impact:

• Closer monitoring of delays in refMSs (MR-P)

• As agreed at the 66th CA meeting (actions list against delays):

• Currently one single period, until the authorisation is granted in all MSs (365+90+30)

• Need to monitor the evaluation phase by the refMS(validation + 365 days, clock stop excluded)

� Essential to identify delays impacting on other MSs

(Art. 89(2) of the BPR)

Regulatory & policy issues with IT impact:

• Improvement of the MR phase

• Adaptation to the new steps under discussion in the CG (after a pilot phase), with clear communication tools.

• .. but there is a need to address some requirements in the BPR in any case as a priority:

• Submission of the draft SPC and PAR to CMSs (Art. 34(4) of the BPR � start of the 90-day MR phase

• Record in R4BP of the agreed SPC by the refMS (Art. 34(5) of the BPR) � start of the 30-day NA phase

Regulatory & policy issues with IT impact:

• SA procedure

• Notifications under Article 27(1) of the BPR for family members:

• Notification to one MS of one/severall/all family members in a single notification.

• Notification to more than one MSs of one or more products following the notification to the e-CA of a new family member in accordance with Article 17(6) of the BPR

Regulatory & policy issues with IT impact:

• SBP procedures

• Application for MR-S of same products:

• The "three checks" rule will block the last step of the application where the reference product has been mutually recognised in the same cMS(s)

• ECHA is working on a solution by Q2 2017 to remove this rule for this particular case, while ensuring that consistency and security in the whole system is maintained

Search functionalities

• Comparative assessment

• Key functionality enabling:

• Identification of eligible alternative products (at EU level) by the refMS � best use of resources

• Search by "use description" in the SPC (e.g. mice/indoor/general public) or by the individual elements combined in a given use (e.g. user category, target organism, application method, RMMs, etc..)

� Promising features in the dissemination platform

Search functionalities

• Other relevant searches

• Linked to Article 47 issues and/or enforcement actions: e.g. all products containing…

• … an AS being a candidate for substitution within a PT,

• … a specific source of an active substance,

• … a given SoC or coformulant,

• ….. manufactured by a manufacturer or at a specific manufacturing site.

Sustainable use

• To be defined and agreed first…..

• Reporting of sale/use volumes?

• Identification of products with the best profile for human health, animal health and the environment?

Thank you for your attention

For further information:

Commission website:http://ec.europa.eu/health/biocides/policy/index_en.htm

https://circabc.europa.eu/w/browse/e947a950-8032-4df9-a3f0-f61eefd3d81b

(Sante-Biocides@ec.europa.eu)

ECHA website & Helpdesk on Biocides: http://echa.europa.eu/regulations/biocidal-products-regulation

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