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ECHA communications

Update on ECHA Dissemination actions and outcomes of the Active Substance Workshop focusing on AS approval improvement. Discusses resources, incomplete dossiers, complexity, pragmatic solutions, and next steps. Opportunities for ECHA to support MSAs and optimize resources.

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ECHA communications

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  1. ECHA communications 82nd CA meeting AP 7.1 14 March 2019 Hugues Kenigswald Biocidal Products Unit European Chemicals Agency

  2. Dissemination - update

  3. On 27 November 2018 the new dissemination portal became available Some issues regarding the availability of confidential data in on-confidential documents were reported. On 28 November as a precaution all documents related to product authorisations were removed. Dissemination

  4. Actions decided • Ask MSCAs to check and amend as necessary all product authorisations by end January • Publish only latest SPC • Expired and cancelled assets: no document disseminated • Publication of documents for product authorisations • End of March • No amendment of product authorisations in last week of March (25 March – 31 March) • Updating cycle: max 48 hours • To report issues contact ECHA Helpdesk Dissemination

  5. Active substance workshop 12 – 13 February 2019 Report and Follow-up

  6. Active substance workshop Aim Discuss how to improve the AS approval process Special focus on Review Programme Programme defined with Organising Committee (FR, DE, ES, SE, NL) Plenary sessions and break out groups Presentations available on S-CIRCABC

  7. Participants On site:44 participants Representatives of • MSCAs 39, from 23 MSs • ASOs 4 • COM 1 Remotely: 17 participants Representatives of • MSCAs 9, from 6 MSs • IND 6 • COM 2 ECHA staff

  8. Main Highlights POSITIVE ASPECTS: A lot of progress has been made since previous WS in 2015 (guidance, templates, WGs’ working methods,…) Resources in authorities have increased Overall, support and coordinationby ECHA is appreciated

  9. Whataretherootcauses for thecurrentlack of progress? There is not only one problem that could be solved by a “silver bullet” – there is a plethora of issues and factors explaining the situation • WS identified and addressedthemostimportantones We also need a variety of solutions, from principal to practical, from mindset change to instructions

  10. Whyshouldwecare? Because we are not achieving the expected high level of safety for human health and environment: • Old ASs are not assessed and decisions are not taken on their approval • Possible unacceptable risks are not managed • Thousands of biocidal products not being evaluated remain on the market Because we are not ensuring a level playing field • Companies’ situationvarieshugelydepending on the status of their AS undertheReviewProgramme Because authorities’ future resources are dependent on the progress on ASs and subsequent fee income at product authorisation phase

  11. Main topics discussed RESOURCES and PRIORITY Resources in MSCAshaveincreased – butsohas the work Expertresourcesavailabledo not match the needs (for example for ED assessment) • Work sharing, training and capacitybuilding, expertsupport from other MSs and ECHA etc. INCOMPLETE DOSSIERS Dialogue with Applicants Need to becometougher Harmonisation of approach among eCAs: common set of rules (and templates)

  12. Main topics discussed COMPLEXITY: how to reduce it? At every stage of the process, step back and ask – “does it matter for the outcome” Consider the ”systemimpacts”, not only single cases Groupingof similarsubstances and/or PTCooperation on ”coredossiers” e.g. for in-situs Avoidingdelays Numberof realistic, representative uses that need to be assessed at AS phase • Furtheralignment of viewsneeded Provideclearmap to the”guidancejungle”

  13. Main topics discussed FINDING PRAGMATIC SOLUTIONS withinthe legalframework ED assessment • Aiming at fit for purposeassessment (not more) • Providepracticalguidelines / instructions for industry Dissemination and confidentialinformation • Furtherinstructionsneeded on how to dealwithconfidentialityclaims and blanking of confidential data in CARs/CLH reports

  14. Proposals: How can ECHA best help with its (limited) resources? Coordination UsetheDossierManagers and ECHA dedicatedMS contactpoints Create a list of contact points / experts for specific areas/issues (ECHA and MSCAs) Develop common prioritisation principles for processing dossiers Identifytheprioritydossiers for support

  15. Proposals: How can ECHA best help with its (limited) resources? Support: Help to clarify the interface between legislations (REACH, CLP,…) Take over certain tasks for certain dossiers Support grouping (and coordinate among eCAs) Provide direct support during both evaluation and peer review Identify recurring issues and suggest solutions Develop rules how to deal with unresponsive applicants Support capacity building in MSs (e.g. trainings, WebstreamWG-meetings)

  16. Next stepsafterthe Workshop Firstconcrete action: ECHA will contact the eCAs to discuss supporton prioritiseddossiers Follow-upactions and concreteproposals at May CA meeting Summaryreport of the Workshop will be published ECHA will keepyouinformed on the follow-upactionsplanned / takenthroughWGs, BPC, CA-meeting

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

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