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ECHA communications 80th CA meeting AP 7.1 28 September 2018
Hugues Kenigswald Biocides Assessment Unit European Chemicals Agency
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Preparing for dissemination
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Dissemination In November 2018 the new dissemination portal will be available R4BP 3 will become “transparent” and any information foreseen to be disseminated and not identified as confidential will be available. ATD requests are foreseen to increase in relation to unavailable information (e.g. missing PARs) or information inappropriately identified as confidential (e.g. PARs too much blackened out). => need for MSCAs to assess correctly the confidentiality claims => increased workload for MSCAS and ECHA
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Dissemination MSCA & COM using - built-in R4BP 3 corrections
NA-AAT to change asset validity or SPC content NA-CAT to terminate assets SA-AAT SA-CAT UA-AAT UA-CAT ECHA- Data correction Standard data correction Non-standard data correction
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Conclusions & Actions In the next 6 months there will be an increase of activities related to Brexit and Dissemination, in particular on communication and data changes in the biocides database R4BP 3 All the involved actors should prepare resources for the needed data evaluation or data changes
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Review programme slow down:
Identifying issues
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Rationale to start the survey
The review programme is not progressing as expected and has significantly slowed down in the last semester Several dossiers under peer review were stuck for various reasons Overall number of stuck dossiers unknown
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The survey and follow-up (1/3)
Phase 1: The BPC was informed about the survey All eCAs for active substance were contacted to provide information on the progress of all dossiers We are currently in the process of finalising the last surveys
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The survey and follow-up (2/3)
Phase 2: Prepare an overview of the issues blocking progress of the active substance dossiers Determine how ECHA can help the eCAs solve the issues blocking the progress Prioritise the actions Support the eCAs
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The survey and follow-up (3/3)
Future expectations Speed up the finalisation of dossiers in the review programme Member states will have more knowledge so that they can solve issues themselves Stronger ties between MSs and ECHA will enable more pro-active communication from MSs to ECHA for help to solve issues
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Results so far 14/17 MSs have provided the feedback for all their dossiers Main reasons for dossiers being stuck: Requested data not provided by applicant (or significantly delayed) Insufficient data to perform ED assessment Insufficient resources (experts) Delay originating from CLH dossier Missing guidance
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Future actions Identify the issues regarding ED assessment and support eCAs Identify what can be done when applicants are not willing to complete their dossier Support on individual dossiers
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Thank you!
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