1. ECHA communications 78th CA meeting 29 May 2018 Hugues Kenigswald
CA-May18-Doc.7.1
29 May 2018
Hugues Kenigswald
Biocides Assessment Unit
European Chemicals Agency

2. Overview R4BP 3.11 and SPC editor 2.2 – brief glance:
Improved SPC comparison tool
Communication improvements
Preparing for dissemination
Now you can transfer only assets

3. R4BP 3.11 and SPC editor 2.2

4. Compare SPC files

5. Compare meta SPC and member products

6. e-mail notifications for authorities +
Can be made by Authority user
Allows to create/edit/delete the contact
will be sent to concerned CA and to evaluating Authority (eCA or ECHA)

7. Preparing for dissemination

8. What will be disseminated
In November 2018, improved biocides dissemination pages will be launched
NA, SA/SN and UA assets
From each authorisation granted the following documents will be disseminated:
SPC finalised or updated after 1/1/16
PAR
Authorisations/Decisions
For UA the BPC opinion will also be disseminated

9. Dissemination webpages Authorisation details
These are only mockups, the actual final implementation might not entirely correspond to what is shown on the slides.

10. Assessment History (only the SPC will be disseminated)
These are only mockups, the actual final implementation might not entirely correspond to what is shown on the slides.

11. Considerations on confidentiality
ECHA has received a large number of requests for PARs via the access to documents process
The above implies a high workload for ECHA, the MSCAs and the applicants in order to reach consensus on the amount and type of data which is non-confidential
Based on this experience, at the end of the evaluation process, MSCAs should ensure that the PARs (and other documents to be disseminated) are not excessively redacted and include all data which should be publicly available as per Article 67 of the BPR

12. Reviewing documents
MSCAs should review all the relevant documents in the assets and in the ongoing cases
For ongoing cases you can modify the access level of previously uploaded documents by using the new functionality made available in the latest R4BP 3 release ( May 2018)

13. Document types and access levels
UA, NA, SA, SN assets
 Document type
Terms and conditions of the authorisation (as per article 67(2)(a) i.e. a decision given by the CA at national authorisation level or Commission regulation at Union authorisation level)
Authorisation or Decision
Assessment report (as per article 67(4)(b))
Final assessment
(or CA report, PAR)*
BPC opinion (UA assets)
Opinion
For intermediate steps it would be preferable to use the document types listed in brackets and keep them tagged as “Restricted” or “Restricted-authority” until they are finalised and ready for publication.
N.B. Irrespective of the above-mentioned document type used, if the document access level is set to “Public” in the final step of the process, the document will be published on the ECHA website.
The intermediate steps - e. g. “CA report” metadata should be used by the eCA when completing EVL task, while ECHA would use “Final assessment” metadata for the assessment report finalised in the OPI task. As such “CA report” uploaded in the EVL task should be tagged as “Restricted” or “Restricted-authority”.

14. MSCAs action requested in R4BP 3
By 30 September 2018
Ensure that product authorisation assets contain non confidential PARs, authorisations/decisions and adequately filled SPCs which are fit for publication
Ensure that all documents in the asset have the correct type/access level combination
Be consistent in naming the PAR and authorisation documents and use meaningful filenames as they will be disseminated under that name

15. Action needed!

16. Action needed!

17.
Thank you!