ZeroPM removal workshop: Regulating Persistent and Mobile substances in Europe: Lessons learned from case processing under CLP, science-policy synergies and stakeholders' engagement

Regulating Persistent and Mobile substances in Europe: Lessons learned from case processing under CLP, science-policy synergies and stakeholders’ engagement Konstantinos Prevedouros European Chemicals Agency ©ECHA ZeroPM’s 3rd International Workshop: Removal through Technical Solutions 7-8 October 2025, Mytilene, Lesvos, Greece Outline →Recent regulatory developments and ECHA’s engagement in ZeroPM →ECHA update since last ZeroPM workshop and case processing →ECHA activities on science-policy interactions →ECHA activities on Stakeholder engagement 2 Refresher on ECHA’s involvement in ZeroPM Project →Following Project almost from the beginning →11/2022: Motivational chat with Project students →02/2023: Gothenburg/ Sweden Workshop on Prevention Drafting of new CLP Guidance on PM substances, ECHA’s expectations from Stakeholders, etc. →06/2024: Online Science-Policy Webinar Regulation evolution, ECHA’s role under CLP, regulatory processes, criteria, etc. →09/2024: Dessau-Roßlau/ Germany Workshop on Prioritisation ECHA mandate and vision, mapping of different Regulations managed by ECHA and related synergies, regulatory research needs and challenges, etc. →10/2025: Mytilene, Lesvos/ Greece Workshop on Removal 3 Refresher on relevant CLP regulatory developments →Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP) →10/2020 EU COM Chemicals Strategy for Sustainability (CSS) - towards a toxic-free environment One substance one assessment (1S1A) identifying regulatory need to manage new concern types, including substance with PBT/PMT properties →Commission Delegated Regulation (EU) 2023/707 New hazard classes for PBT/vPvB, PMT/vPvM and ED (ENV and HH) properties CLP Annex I update, followed by 2024 CLP update →Proposals for harmonised classification (CLH) submitted to ECHA since April 2023 →Updated CLP Guidance published in November 2024 4 What has happened since 09/2024 →11/2024: Publishing of amended CLP Guidance on the application of the CLP criteria (Parts 4 and 5) →11/2024: Online webinar to introduce the updated CLP Guidance on PBT and PMT hazards →Spring 2025: Workshops with Member State Competent Authorities →05/2025: Stakeholder Event including Industry, NGOs, etc. →2024 - present day: P and M discussions under UN GHS and OECD technical groups →By 10/2025: 8 PBT and PMT CLH proposals submitted to ECHA First case (vPvB) to be discussed in December 75 RAC cycle Several additional registered intentions 5 First PMT/vPvM CLH cases (N=5) 6 # Name Proposal P/vP M/vM T 1 Trifluoroacetic acid PMT/vPvM OECD TG 307 (no degrataion in 120d) Water: non-standard lab and field Sediment: non-standard lab study OECD 301D; 302A [monitoring] 4 OECD 106 studies OECD TG 312 2 QSARs [monitoring] Repr. 1B 2 [1] sodium trifluoroacetate; [2] and other inorganic salts of trifluoroacetic PMT/vPvM As above As above As above 3 Benzotriazole [1]; Sodium 1Hbenzotriazolide [2]; Potassium 1H-benzotriazolide [3] and inorganic salts [4]; PMT/vPvM Simulation studies Ready and inherent biodegradability tests Hydrolysis study OECD TG 106 Literature study QSARs Repr. 2 ED ENV 1 4 Methyl-1H-benzotriazole [1]; Sodium 4(or 5)-methyl-1Hbenzotriazolide [2]; 4(or 5)- methyl-1H-benzotriazole, potassium salt [3]and inorganic salts [4] PMT/vPvM Simulation studies Ready and inherent biodegradability tests Hydrolysis study OECD TG 106 Literature study QSARs Repr. 2 51,3,5-triazine-2,4,6-triamine [Melamine] PMT/vPvM Simulation studies Ready and inherent biodegradability tests Hydrolysis study Several OECD TG 106 Several QSARs [monitoring] STOT RE 2 Repr. 2 →Early notification of Member State intention to start working on a proposal beneficial →Identification of related work and/or conclusions in other regulatory programmes on same or related substance(s) →Early engagement with relevant experts (e.g. ECHA Secretariat, PBT EG, MSs, Industry, other data holders) →Acquaintance with the CLH process and CLP Guidance before submission →Ensuring information generation has been completed before submission; after that, new information can be provided/ used only during the consultation →Use the ECHA template for the recording of all reliable and relevant information; conclude, within a Weight-of-evidence (WoE) determination 7 Lessons learned from processing of first PMT CLH proposals ECHA activities promoting science-policy synergies →Transparent and proactive communication of ECHA’s scientific work (“ECHA Science”) How acquired data and knowledge on chemicals meet EU legal and policy goals →Publication of annual reports on key areas of regulatory challenge (needs) Protection against harmful chemicals, addressing chemical pollution, shift away from animal testing, improve availability of chemical data, promote circularity →Publication of ECHA strategy statement 2024-2028 Be a trusted chemicals agency, respond to emerging challenges, communicate & engage, lead on chemical knowledge and expertise, invest in organisational excellence →Building and sharing scientific expertise also by use of Framework contracts (calls for tender) For more details, please consult the “Business opportunities” section of the ECHA website 8 ECHA activities relating to science-policy synergies →Webinars, trainings, staff visits & exchanges, speaker requests, scientific conferences (e.g. SETAC) and missions →Publication of key work findings in peer-reviewed journals →Encouragement of scientific activities developing models, methodologies and generating chemicals’ data Screening, identification and prioritisation of most relevant substances →Engagement in integrated projects PARC (Partnership for the Assessment of Risks from Chemicals) ZeroPM 9