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ACC GlobalChem Conference Panel on Chemicals Management Developments in the European Union Session Sponsor: Steptoe, LLP Panel Date: Wednesday, March 27, 2024, 11:30 am - 12:30 pm Moderator: Speakers: Dr. Sharon McGuinness, Executive Director, ECHA , , Steptoe & Johnson LLP Questions for Dr. Sharon McGuinness: 1. ECHA is the driving force among regulatory authorities in implementing the EU's chemicals legislation. Earlier this year, ECHA published its Strategy Statement 2024-2028, detailing the agency's goals and priorities over the next five years. Could you provide us with the highlights of the current and longer-term agency priorities? 2. How does the proposed "One Substance, One Assessment" approach streamline chemical assessments across EU legislation, and what impact will it have on ECHA's operations, if adopted? 3. How does ECHA plan to address the challenges posed by the increasing workload, including additional tasks and responsibilities? What is the status of ECHA's Basic/Governance Regulation? 4. In February 2023, five European countries proposed one of the broadest restrictions in the EU's history, focusing on the entire group of PFAS substances. The proposal generated 5600 comments, which are currently being reviewed by ECHA's Risk Assessment (RAC) and Socio-Economic Analysis Committees (SEAC). Can you please explain the role of these committees in the ECHA's ecosystem? How are the Committees approaching the review of comments received on PFAS, and what is the current timeline for completing the review and issuing recommendations? 5. ECHA's mandate is to minimize and whenever possible shift away from animal testing. Recently, ECHA contracted a consortium led by the Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM) to conduct scientific studies on the reliability and relevance of new approach methodologies (NAMs) as alternatives to animal studies and to promote the use of such methods in the future. Could you please provide insights into what ECHA is aiming to achieve through this collaboration? 6. The Chemicals Strategy for Sustainability called on the EU Commission to play a leading role globally by championing and promoting the EU's high chemical safety standards. To what extent does ECHA get involved and what role does it play in the global chemicals management policy discussions? How do you collaborate with international entities such as UNEP, BRS, and SAICM, OECD? 7. How does ECHA cooperate with other regulatory agencies, such as EPA? Is there a structure for information exchange? Does ECHA rely on information that may have been submitted by companies in the US - and is publicly available? Questions for : 1. The Chemicals Strategy for Sustainability, a key part of the European Green Deal, has been the guiding document for chemical management regulatory initiatives over the last three to four years. What are the potential implications of the upcoming European elections on the EU's Chemicals Strategy for Sustainability? What the CSS 2.0 might look like? 2. REACH revisions have been postponed at least until the end of 2024 or 2025. Can you offer any insights into what the Commission (DG Environment) is working on now as it prepares to turn the file to the new Commission after the elections? 3. CLP is another significant piece of legislation in the European Union concerning the classification and labeling of chemicals that went through revisions last year. Can you highlight the major changes and how they impact business? 4. The concepts of grouping and essentiality are becoming defining factors in the chemical management policies in the EU and play critical roles in risk assessment, authorization, and restriction processes. Can you talk about the impact of these concepts on future policies? 5. We are seeing increased regulatory actions on hazardous chemicals in sector-specific regulations, especially those focused on consumer products and consumer protection (cosmetics, toys). In January 2024, the European Parliament approved the Directive on Empowering Consumers for the Green Transition, which aims to curb greenwashing claims by businesses. In addition, the Parliament adopted its position on the Green Claims Directive, which it will take up after the elections. Can you provide more insights/significance of these developments?