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

2. 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

3. 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)

4. 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.

5. 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.

6. 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)

7. 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.

8. 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.

9. 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

10. 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.

11. 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).

12. 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 Q

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

14. 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

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

16. 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

17. Thank you! biocides@echa.Europa.eu
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