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

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

R4BP 3.11 and SPC editor 2.2

Compare SPC files

Compare meta SPC and member products

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

Preparing for dissemination

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

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

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.

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

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 (3.11 - May 2018)

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”.

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

Action needed!

Action needed!

biocides@echa.europa.eu Thank you!