Document aBd51abxr1do8bM1pYDagRL3y

Procedure in SEAC and involvement of relevant stakeholders FPP4EU Collaboration Platform Workshop 12 December 2022 Michael Gmeinder European Chemicals Agency ECHA Overview 2 REACH restriction process Opinion-making in SEAC Input of stakeholders REACH restriction Protects our health and the environment from chemical risks Addresses a risk that is not adequately controlled Where action is required at EU wide level Safety net for other REACH and EU processes Usually limits or bans manufacture, placing on the market or use of a substance (also in a mixture/article) Can set out specific conditions such as technical measures or labelling requirements Dossier Submitter can be Member State(s) or ECHA 3 Restriction proposal Restriction report (Annex XV report) includes: Information on hazards, exposures and risk Justification for action at EU wide level Available information on alternatives Report has to show that a restriction is the most appropriate measure to address identified risk Restriction report may also include socio-economic analysis Net benefits (human health, environment) Net costs (industry, consumers, social and wider implications) Usually included Inform decision maker for final decision (with opinions) 4 After submission Expected for `universal' PFAS: 13 January 2023 Restriction report publicly available after submission (prepublication, not for consultation) Early February 2023 Opinion-making process (typically 14 months) Conformity check: RAC and SEAC March 2023 meetings Six-month consultation on restriction report 22 March 2023 Evaluations of RAC and SEAC documented as `opinions' 60-day consultation on SEAC draft opinion Comments submitted in consultation (and responses) published with updated proposal (Background Document) After adoption, opinions published and sent to Commission Scrutiny by EU Council and European Parliament 5 Restriction process 6 echa.europa.eu/restriction-process Objectives of opinion-making Client is the decision maker (Commission and Member States) Based on the proposal and RAC/SEAC opinions they need to: Decide that there is an unacceptable risk to human health or the environment, arising from the manufacture, use or placing on the market of substances Decide that the risk needs to be addressed on a EU wide basis Take into account the socio-economic impacts of the proposal, including the availability of alternatives RAC/SEAC evaluation focuses on 'justification for a restriction' Assessment by the Dossier Submitter in restriction report Comments by interested parties in the consultations 7 Objectives of opinion-making - SEAC Formulate an opinion on the proposed restriction and the related socio-economic impacts, taking into account consultation comments What are the impacts of the proposed restriction? Costs Reliability, representativeness and appropriateness of Benefits Uncertainties data/assumptions/methodology; impact of uncertainties on conclusions; can be qualitative or quantitative Is the proposed restriction the most appropriate means to address the identified risk (Annex XV criteria)? Effectiveness (to address the risk) Practicality (including enforceability) Monitorability Proportionality to address the identified risk; can the measure be enforced (not necessarily by analytical means); is risk reduction monitorable over time? 8 Input of stakeholders - When? e9cha.europa.eu/restriction-process Input of stakeholders - When? Consultation on the restriction report Make use of the early submission deadline if possible Multiple submissions can be made RAC and SEAC meetings Ensure that relevant stakeholders are registered to follow the discussions Further info on committees' procedures: echa.europa.eu/about-us/who-we-are/committee-for-risk-assessment echa.europa.eu/about-us/who-we-are/committee-for-socio-economic-analysis Consider the indicative evaluation schedule 10 Indicative evaluation schedule Committee plenary meeting Committee for Risk Assessment Verify scope (of risk assessment) 2.5 months after C onclude evaluation of hazard assessment consultation starts Initial evaluation of exposure and risk 5.5 months after consultation starts C onclude evaluation of exposure and risk and that action is required on an EU-wide basis Initial evaluation that the proposed restriction is the most appropriate EU-wide measure (effectiveness, practicality and monitorability; all assessed restriction options and RMOs to be evaluated) 8.5 months after consultation starts Address comments from the Annex XV report consultation C onclude evaluation that the proposed restriction is the most appropriate EU-wide measure Summarise, evaluate and conclude on uncertainties Adopt opinion Not relevant 11 Committee for Socio-Economic Analysis Verify scope (of impact assessment) C onclude that action is required on an EU-wide basis C onclude on appropriateness of other regulatory RMOs Initial evaluation of AoA Initial evaluation of costs and benefits Initial evaluation of practicality and monitorability C onclude evaluation of AoA C onclude evaluation of costs and benefits Initial evaluation of proportionality Address comments from the Annex XV report consultation C onclude evaluation that the proposed restriction is the most appropriate EU-wide measure (costs, benefits, proportionality, practicality and monitorability) Summarise, evaluate and conclude on uncertainties Agree draft opinion C onclude on issues raised during SEAC draft opinion consultation Adopt opinion Input of stakeholders - How? Consultations Detailed information should be submitted through consultations Use of alternative routes is discouraged - response will be to submit the information through the consultations Non-confidential submissions will be published RAC/SEAC members also have access to confidential submissions All consultation submissions analysed in detail by Rapporteurs - responses to (non-confidential) submissions published RAC/SEAC meetings Input during meetings should be brief scientific/technical points to aid discussions Keep in mind the remit of each Committee 12 Input of stakeholders - What? Information typically relevant for SEAC Alternatives and their performance/suitability Impacts of proposed restriction Uses affected by the proposal missing from the assessment Make impactful consultation submissions Structure submissions clearly - provide a summary section, use bullet points for key issues, prioritise issues, avoid jargon Answer specific questions that have been asked Provide supporting information and evidence - if documents are attached be clear why these are important Requests for derogations or longer transition periods must demonstrate that the impacts of the proposal would be disproportionate - be realistic 13 Conclusions 14 REACH restriction is a flexible tool - it addresses chemical risks that cannot be addressed otherwise Opinion-making is about facilitating informed decision-making - SEAC's focus is on socio-economic impacts Stakeholder inputs are important throughout the process - clear submissions to consultations are key Thank you echa.europa.eu/contact echa.europa.eu/subscribe Connect with us echa.europa.eu/podcasts @EU_ECHA European Chemicals Agency @EUECHA @one_healthenv_eu EUchemicals