Action Plan following the Active substance workshop Update to 83rd CA meeting 16-17 May 2019 Hugues Kenigswald European Chemicals Agency

Causes for lack of progresses discussed at the WS Insufficient Resources Unclear Priorities Incomplete dossiers Complexity Absence of Pragmatic approaches Causes for lack of progresses discussed at the WS

Insufficient Resources in MSs Prioritisation of dossiers and support Issue to be solved Insufficient Resources in MSs Unclear priorities Actions Define the priorities: backlog and Review programme dossiers ECHA National Contact Point (NCP) identified cases for support among the priority dossiers which are blocked by one specific issue (and where solving this issue would enable the eCA to finalise the dossier)

Prioritisation of dossiers and support Actions NCP contact the eCA contact point: Clarify the priorities: Dossiers proposed by ECHA for support, Possible other dossiers suggested by the eCA Clarify the issues, support needed and the timelines; 4. Phone call(s) to discuss the proposals: until Mid-May.

Prioritisation of dossiers and support Actions Next steps: Analyse the needs, expertise required to address the identified issue(s) and timelines against ECHA resources; Select the dossiers for direct support; Agree with the eCAs; Implement the support. Timelines to be defined ad hoc.

Insufficient Resources in MSs Support Issue to be solved Insufficient Resources in MSs Actions Direct support from ECHA: Cases selected on the basis of the information collected in the Grip of the RP survey: Diamine PT8: HH exposure and risk assessment is ongoing. Discussion foreseen in Nov. WG Next steps: Identification of other needs (updated information from eCAs is crucial)

Insufficient Resources in MSs Support for ED assessment Issue to be solved Insufficient Resources in MSs Actions Guidance to support the Applicants and the eCAs in preparing the ED assessment. Finalisation foreseen by end of June. Specific support for ED assessment: ECHA contacted two eCAs offering support. The possibility of outsourcing the support is under investigation. Next steps: Identification of other substances for support.

Support Issue to be solved Actions Complexity Actions Possible groups of active substances based on chemical similarity have been identified Next steps: Identification of further grouping possibilities Identification of cases in the priority dossiers that could benefit from grouping Constantly ongoing: internal activities in ECHA to include biocides in the ECHA concept of chemical universe.

Support for relationship with applicants Issue to be solved Incomplete dossiers Actions ECHA drafted: 1. a procedural guidance for eCAs requesting additional information and dealing with applicant not submitting the requested information. 2. corresponding letter templates for the eCAs Consultation of BPC in June

Streamline the peer review Issue to be solved Complexity Actions Several documents have been drafted with aim to ease the peer review: New RCOM template: includes the indication of the impact of the comment and a justification. RCOM already in use. Early WGs: document listing items always to be discussed at early WGs. Ready for distribution to eCAs. Ad hoc follow up: document clarifying the triggering. Ready for distribution to eCAs. Reopening agreements: rules for reopening TM/WG agreements have been drafted. Discussion expected at Sept WG.

Streamline the peer review Issue to be solved Complexity Actions New approach in the WG practice: Break out groups during the WG meetings to unblock stuck discussions; Next steps: At May WGs: the proposed changes will be discussed together with other points raised at the WS (e.g. more pragmatic solutions adopted at the WG; increased and more explicit use of expert judgement and reporting of the uncertainties in the evaluation).

Making information clearer and easier to find Issue to be solved Complexity Actions Mapping and clarification of quasi guidance documents: the aim is to collect all the relevant documents currently spread in the web in one single document Project on TAB: all WG agreements will be included in the TAB facilitate the identification of applicability dates TAB will be converted in a new format to allow easy searching and filtering. Expected finalisation by Q4 2019.

Making information clearer and easier to find Issue to be solved Complexity Actions Improvement of the ECHA webpages

Insufficient Resources in MSs Interface CLP-BPR Issue to be solved Complexity Insufficient Resources in MSs Actions Improve the CAR-CLH template: Include in the template instructions on the level of details needed for RAC to conclude; Improved template sent to CLH-Biocides task force for comments Finalisation by Mid-June. Revitalise the Task Force for CLH and biocides CAs: ECHA will ask for topics to discuss

Harmonised assessment of confidentiality claims Issue to be solved Complexity Actions Next steps: Recommendations for assessing confidentiality claims for CARs is under preparation.

Other actions under consideration Creation of a list of contact points per MSCA Worksharing and co-rapporteurship Concept of “one safe use” for AS approval Ensuring more widespread information to MSs and Applicants

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