Document B80yJoY6L9eQGgX2LQd2JgoNE

Key topics for REACH 2.0 drafting and related policy discussions including the CRM Act version February 2022 Eurometaux continues to call "for a more action-oriented legislation focussing on what matters and is of real concern, whilst ensuring that all types of chemicals are treated equally, from a risk-based perspective". This will ensure a more focussed and effective REACH, with a better allocation of resources for all actors including key / strategic value chains. Overall, clarification of (and application of) concepts such as Essential Uses, Substances of Concern, Most Harmful Chemicals; working on the coherence between chemicals policy and other EU objectives (e.g., Green Deal twin transition, Industrial Policy, CRM Act) will be key to have a predictable, effective and implementable REACH 2.0. More specifically, Eurometaux recommends the following: 1. Start with a clear prioritisation system to facilitate data collection and predictability A prioritisation system will help select "what really matters from a societal perspective", integrating the activities of data collection and evaluation, and clarifying the need for risk management. It should start from the screening of substances for regulatory needs (e.g., via ECHA's IRS and the mapping of the chemicals universe) and subsequently apply defined and transparent criteria (based e.g. on hazard endpoints of concern, exposure potential, and also on the critical/strategic nature of a chemical) to confirm the inclusion of the substance on a `screening list' and prioritise it for action. The prioritisation should recommend a "fast-track" process for taking urgent risk management decisions e.g., for investments on critical/strategic raw materials required to be produced and used in the short to medium term. These criteria should be transparent to ensure a predictable system and should be reviewed on a regular basis by authorities, and communicated to stakeholders e.g., via PACT. The publication of this screening list on PACT - explaining the main risk-based concerns - should be associated with a notification obligation for the supply chain to: ensure the representativeness of information on uses and exposure/emissions and on alternatives; provide a strong signal to registrants to update dossiers to include information of relevance for the selection of the Risk Management option (e.g., feasible alternatives, industry RMO evidence, information on existing regulated uses via OSH, product legislation, recycling and end-of-life management, etc.)1 Based on the available information, regulatory needs could be reviewed, confirming relevance and helping to define the most appropriate regulatory action to be selected and launched. 1 This would require an adaptation of the REACH registration format 1 2. To be effective and target what matters, risk management in REACH should remain riskdriven and consider exposure potential in addition to hazard. While "hazard identification" is a key step in the process to identify `substances to be screened', it shall be complemented by a consideration of exposure potential to be able to confirm the concern and identify the most appropriate risk management measure(s). In practice, the "dynamic link" between the CLP and currently proposed risk management measures such as restrictions and the GRA shall be complemented by a mandatory step to assess the potential for exposure - and hence risk. This will allow where justified, derogations and or de-prioritisation (e.g., if an EU-wide unacceptable risk cannot be demonstrated for some uses under a restriction, if safe use for consumers - due to negligible exposure - can be demonstrated, etc.). 3. Avoid regrettable substitution by considering safer and more sustainable alternatives in a lifecycle approach Substitution should not create unwanted additional risks at other steps in the lifecycle - risks for workers and the environment nor for society - that would not have been considered in the use targeted by the RMO. Substitutes (alternative substances or techniques) should be "safer and more sustainable" ensuring a comparable technical function and efficiency, while not being in conflict with other key objectives like the twin transition, industrial policy, circularity and strategic autonomy/resilience. 4. Consider metal/inorganic specificities: refine the Mixture Assessment Factor (MAF) and confirm the non-application of PBT/PMT for inorganics A MAF by default, proposed to cover the potential hazards and risks for Unintentional Mixture effects, will impact the majority of metals and inorganics. Considering the specificities of inorganics, such as their natural occurrence and background concentrations, but also their use of monitoring data, we ask for the possibility to be exempted from the default or to be able to overrule it by refined science-based assessments as a basic concept under REACH 2.0. The ongoing MEED programme (more info here ) and its outcomes will provide the additional justification for this request. We also ask, still based on the knowledge of the properties of inorganics, for confirmation of the exemption from the PBT regime (Annex XIII) and the PMT definition for inorganic metal compounds. 5. Ensure transparency and predictability A well-functioning chemicals management system, combined with a prosperous and innovative EU industry, requires that chemicals management measures remain proportionate and focussed on what matters, and that all processes and steps - in hazard identification, data collection, identification of concerns and ensuing risk management decisions - are understandable and predictable. This necessitates transparent processes, clear criteria supporting decisions, and guidance on new concepts which will also allow the review and hence, the reproducibility of the assessments made by all actors. These elements exist for several aspects of the REACH regulation but not yet for some critical steps like 2 ECHA's ARNs and grouping approaches. Recently the BOA confirmed that ARNs cannot be challenged given that they are only recommendations, which leaves (if no interaction and refinement of this critical step is brought in) significant uncertainty and unpredictability. 6. Extend the low tonnage information requirement proportionately In line with the "focus on what matters" principle, the additional testing and information requirements for Low Volume substances should be related to their potential for exposure to workers, consumers, or the environment. Absence of such potential should therefore eliminate the relevance for such additional testing requirements. It may be further considered to extend this principle to the higher tonnage bands also, with respect to additional exposure and hazard information requirements (e.g., immuno- and neurotoxicity, etc.). 3