1. BPR AS Review Programme
76th CA meeting
17-19 January 2018 1

2. Current situation : need for improvement
Review programme set in 2013 for progressive implementation and spread of the workload
1st list : deadline 31/12/2015
9 reports still missing : dCAR by 2018?
2nd list : deadline 31/12/2016
Around 33 reports still missing : dCAR by ?
BPC : 30 opinions on the review programme in 2017
To be noted also for new AS : delays in particular for applications submitted under BPD 2

3. Current situation : need for improvement
Over the CA meetings of 2017, discussions with Member States and ECHA on possible actions for improvements
Many various possible reasons for delays from applicants, Member States, ECHA, Commission
Number of possible actions identified for all parties 3

4. Overall Summary of key actions identified
Applicants / Stakeholder associations
Applicants: Respect procedures and duties set in the BPR, both during the eCA evaluation and during the BPC review BPC
These are clearly set in:
- the BPR, in particular Articles 6 to 8, Article 90(2)
- the Review Regulation (EU) No 1062/2014
- CA meetings clarifications : in particular, CA-Sept13-Doc.3.0 – Final, CA-March14- Doc.4.1 – Final, CA-Nov14-Doc.4.5 – Final, CA-May15-Doc.6.1 – Final
- the operating procedures agreed by the BPC for the peer review : BPC document "Introducing new information during the peer review process of active substance approval", Agreed at BPC 13, 20 January 2016
Applicants: Keep the eCA informed about the progress in the realisation and submission of missing data requested by the eCA
Applicants: for substances subject to exclusion, anticipate and prepare the justifications for a possible derogation to exclusion, and submit them in due time (CA-Nov14-Doc Final - Processus Art 5(1)&(2))
Applicants/Stakeholder associations: identify if there are key missing technical guidance, and contact ECHA on the matter
Stakeholder associations: remind their affiliates about BPR rules and procedures 4

5. Overall Summary of key actions identified
Key reminders to applicants about BPR rules and processes:
All needed data should be present at the submission of its application
The eCA has the responsibility to decide if additional data are needed/requested to carry out the evaluation, not the applicant.
 To do so, the eCA may consult the ECHA's BPC Working Groups to ensure more harmonisation and advise on difficult cases
The eCA has no obligation to accept additional data that it has not requested (ie. the request for data are only foreseen in the BPR at the initiative of the eCA, not the applicant)
The failure to submit the requested data in the requested timeframe may lead the eCA to conclude that the applicant has withdrawn its application (Article 11(d) of Regulation No 1062/2014)
Commenting periods are foreseen in the procedures to submit written comments, not new data or plans to submit new data (ex: in Article 8(1) of the BPR when the eCA sends its draft report to the applicant prior to submitting it to ECHA). 5

6. If required, data must submitted within 10 days after the WG
For the peer review at ECHA's BPC level (Article 8(4) of the BPR, BPC13 document) :
No submission of additional data is foreseen in the BPR during this phase, the BPC should normally conclude on the basis of the data already available in the application and the evaluation report from the eCA.
Therefore, additional data may be considered only in limited and exceptional cases :
The decision on the need or acceptance of new data already generated/available that the applicant may want to submit is in the remit of the relevant BPC WG.
If required, data must submitted within 10 days after the WG
Exceptionally and in duly justified cases, additional data may generated during the peer review process if agreed/requested by the relevant BPC WG.
This should, a priori, only concern the evaluation under the new ED criteria (see Article 90(2) of the BPR, document CA-March14-Doc.4.1 – Final, document CA-Jan18-Doc.7.3b) 6

7. Overall Summary of key actions identified
Member States :
Have a higher commitment to apply agreements, procedures, and priority lists
Remind applicants about the rules in the BPR, the Review Regulation, and the procedures in the ECHA's BPC
Improve the management of suspensions in accordance with Article 6(5) of the Review Regulation (or Article 8(2) of the BPR for applications outside the review programme), and use the provisions of Article 11(1)(d) of the Review Regulation where necessary (de-facto withdrawal of an applicant in absence of submission of requested data)
Consult the BPC WGs during evaluation on difficult issues
Inform ECHA of difficulties as early as possible, and provide frequent updates to ECHA
Make pro-active checks of exclusion/substitution criteria, specifications of active substances, limit the quest for finding safe uses
Do not postpone dossiers in WG/BPC meetings when the evaluations can be concluded
Show more consistency in commenting on draft CARs from other MS with their own evaluations 7

8. Overall Summary of key actions identified
ECHA
Anticipate, identify missing guidance and emerging technical issues, consult the BPC (and the CA meeting when needed) on priorities
Improve the coordination (in particular on late dossiers, complex cases like in situ, CLH / PBT process when needed), monitor the stop of the clocks
Improve the management of BPC WGs in decision-taking and expert judgement
Commission
Continue to monitor progresses and delays
On late dossiers, initiate/continue trilateral discussions with ECHA and MS on appropriate actions
Consider sending letters to Member States, and more formal actions where necessary 8