Document 82K8dyBZmz4mRZ02dDevvKr8B

MECHA REACH Restriction process EPEE APPLIA Regulating refrigerants:-a-sustainable route towards Green Deal objectives 09 March 2022 Restriction Process Coordinator FNS Ee echa.europa.eu/restriction-process REACH restriction Restriction is a tool for protecting our health and the environment from the risks posed by chemicals Address a risk that is not adequately controlled Where action is required at Union level Safety net for other REACH and EU processes Restrictions usually limit or ban manufacture, placing on the market or use of a substance (also in a mixture/article) A restriction can also set out specific conditions such as technical measures or labelling requirements Dossier submitter can be a Member State or ECHA Evaluated by ECHA's committees for risk and socio- economic analysis Decision making by COM with Member States Scrutiny by Council of the EU and European Parliament 2 echa.europa.eu/restriction-process Restriction process ( ) ( ) ( ) 3 Starting the process If Member States, Commission or ECHA have a concern that a substance poses a risk to our health or the environment, preparatory work starts to investigate the problem through risk management option analysis (RMOA) If they conclude that a restriction is the best way forward a notification is made Registry of intentions 12 months prior to submission Enables interested parties (citizens, organisations, companies and authorities) to plan for how they will contribute the restriction process echa.europa.eu/registry-of-restriction-intentions 4 Restriction proposal Annex XV report Annex XV report should contain: Information on hazards, exposures and risk Justification for action at EU-wide level Available information on alternatives Proposal has to show that a restriction is the most appropriate risk management measure to address identified risk Multiple restriction options can be assessed Proposal would typically also include socio-economic impact analysis 5 Evaluation (~12 months) After submission by ECHA Risk Assessment Committee (RAC) Socio-Economic Analysis Committee (SEAC) opinions Effectiveness, practicality and monitorability of the proposed restriction(s) An appropriate restriction must be: Targeted to effects or exposures resulting in the risk Capable of reducing these risks within a reasonable time period proportionate to the risk Socio-economic analysis Net benefits to society (human heath and environment) Net costs to society (manufacturers, importers, consumers) 6 Consultations and stakeholder input Proposed restrictions subject to a 6 month consultation Draft SEAC opinion consultation for 60 days RAC-related information Annex XV will use best available information Could be `default' values or reasonable assumptions Stakeholders could have information to refine the risk assessment e.g. Effectiveness of risk management measures Closed systems and minimisation Exposure/releases throughout the life cycle Manufacture Service life End of life Claims must be substantiated with argumentation or data ECHA guidance Always best to provide information early 8 SEAC-related information Availability and performance of alternatives Impacts of the proposed restriction Costs and benefits for affected actors Other impacts (e.g. climate impacts) Analysis demonstrating that the conditions of the proposed restriction would be disproportionate AKA derogation requests Relevant elements of impact assessment detailed in Annex XVI of REACH ECHA guidance Always best to provide information early 9 Summary Restriction is a flexible risk management tool to address risks for chemicals A dossier contains a risk assessment Justification that the proposed restriction is effective, practical and monitorable Impact assessment for restriction opinion(s) 6 month consultation Information on risk assessment Impacts of the proposal (positive and negative) Decision making takes into account RAC/SEAC opinions 10 Thank you! Subscribe to our news at echa.europa.eu/subscribe Follow us on Twitter @EU_ECHA Follow us on Facebook Facebook.com/EUECHA x "