Metals Sector Risk Management Support Programme A vision on CHEMICALS MANAGEMENT-RMM by the metals sector Introduction More than 5 years of experience with Risk Management Options Analysis (RMOA), selection of the best REACH Risk management regime, Restrictions, Candidate Listing (CL), prioritisation and Authorisation applications; learnings and issues from each of these steps arise for metals and inorganics challenging the efficiency and efficacy of the choices made. This experience demonstrated a clear need for each of the steps of the risk management scheme to be reviewed to determine areas whereby the situation for metals can be improved, aiming for more relevancy and efficiency. Alternatively, the assessment confirmed that the metals sector can much better anticipate and prepare for the different steps. Main aim: The identification of the most logical potentials for improvement and anticipation so as to maximize the relevancy of the RMOa and its efficiency, are the mail goal of this project. The assessment and proposed measures are documented in a thought starter paper Means and steps: 1. A mapping of experiences and learning lessons on metals RMMs under REACH so far 2. Objectives for improving the Risk Management selection system 3. Potential areas for improvement of the existing system 4. Next steps RESULTS of the REVIEW of existing cases 1. Mapping of Experience and learning lessons from the last 5 years The metals review of experience started with a review of 7 metal REACH-RMM cases whereby the different stages of the RMM process were assessed on their relevancy and efficiency and suggestions for areas for improvements and anticipation were determined. The cases and main learning experience covered: 1. 2. 3. 4. 5. 6. 7. 2. Borates: the lack of an RMO not allowing to check efficiency of the Authorisation tool Arsenic oxides: low efficacy of the RMO selection and a negative environmental balance in the end Cr6+ compounds: a significant underestimation of the cost for society Cobalt salts: overlooking the value of the Public consultation and existing RMMs Pb compounds: lack of RMO prior to CL listing and lack of effectiveness of Authorisation due to overlap with other more effective existing RMOs CdS: RMO referred to existing Cd compound RMO without considering specificities RCFs: conflicting prioritisation and conflicts with other EU policy targets Objectives for improving the Risk Management Measures system REACH-RMM implementation is certainly gradually improving but the assessment of the cases demonstrated that the EU Risk Management Policy under REACH has so far not created “the expected added value for the protection of workers, professionals and consumers”. The RMM strategy of the metals sector aims for promoting and contributing to a more relevant and effective RMO identification and RMM follow-up scheme in the EU. The sector promotes in this respect a Risk Management System along the following main principles: 1. 2. 3. 4. 5. 6. Transparency: need for a clear and transparent system to identify Risk Management needs and identification of the most effective risk management options. Ensuring relevant stakeholder input is a critical issue in this respect Efficiency: A Risk based RMM system is required whereby a cradle to grave approach (manufacturing, use, product life and recovery) is used to assess the risks Efficacy: RMMs need to focus on the areas of potential for risks (e.g. exposure control of workers), thereby minimizing “collateral damage” by considering what should be out of scope Balance: the need to balance RMMs under REACH with other EHS objectives (e.g. climate change and energy objectives, resources policy, recycling objectives, waste and disposal objectives …) preventing REACH-RMMs would cause a unwanted impact on other EU policy areas. Pragmatic: A realistic implementation scheme that recognizes the time and resources needed to develop relevant RMMs (restrictions, OELs, Authorisation LAD, …) Equality: A non-discriminatory system treating all similar hazards/risks equally Industry is of the opinion that a more streamlined, integrated and transparent Risk Management strategy can be more cost and resource effective. Potential areas for improvement of the existing system Based on these 6 principles, all steps of the risk management chain were reviewed and recommendations for potential improvements from a metals industry perspective suggested. 1. Identification of hazards A) CMR self-classifications should be screened, checking the potential for consumer and workers exposure B) The Commission and ECHA created Task Forces to identify and review substances that fit these criteria, which is a positive step. Industry requests that this process be open and transparent and should include inputs from industry experts. C) A properly done and transparent Substance Evaluation (SE), can be used to validate the outcome of the TFs proposals and help the RMO assessment. Moreover this process allows MSs to request for additional information that is critical to identify the potential hazard or risk. D) Hazard identification and RMM selection should be sequential and not overlap to ensure a streamlined, objective and non-pre-empting system. 2. Identification of potential for risk and its scope E) A Substance Evaluation developed through a transparent and fact based process can provide this information in case not fully extractable from the CSR/registration dossier. F) In case of potential substance releases from articles, the risk can/should be considered preferably by a Restriction based on risk-based reduction/restriction measures. G) While a risk assessment is not in scope of an RMO analysis, it may in certain cases be relevant to determine the potential for risk on a qualitative basis as to define options for risk management. H) A materials flow assessment can indicate the relative part of the volume that could be evaluated for consideration under an Authorisation or a restriction scheme. 3. Selection of Relevant and effective RMMs I) RMOa should be based on the potential type of risk, scope and a holistic assessment of the most effective risk management option selection. A good RMM measure is cost effective and maximizes the efficiency in a targeted way without causing an impact on other areas or on other EU policy areas J) In principle all relevant potential SVHC substances should undergo RMO assessment. K) Substances without Registration, or all uses being outside the scope of Authorisation should not be placed on the Candidate List but alternative and appropriate RMOs be searched for. 4. Prioritisation L) Correct the scoring for volume by a factor reflecting density and potential exposure form M) Scoring should be conducted on the real amount falling under the Authorisation scheme based on evidence from the Registration dossiers 5. Implementation N) Differentiation of Authorisation application requirements (simplification for substances under the form of lighter regimes for spare parts, low volumes, recycled materials, substances with high societal value) O) Make LADs related to the application needs (complexity of the supply chain, n° of applicants, …) P) Make the SSD flexible as a function of the needs for ECHA to review the applications Proposed work-areas, projects and next actions for industry The economic consequences of a non-effective RMM decision can be very extensive. An anticipative investment can therefore, besides being an improvement in chemicals safety, also deliver an effective return on investment. The last part of the thought starter therefore proposes steps and actions on how companies/consortia can anticipate the RMM more effectively. The proposed actions are rated for their effectiveness for the RMOa screening and RMM implementation. - The RMO phase: Anticipative RMO data gathering by industry using a template form that complements the data of the REACH registration file (highly effective) - Substitution planning: Anticipative substitution planning by companies needs continuous encouragement (highly effective) - Improving the prioritisation scoring: Anticipative data gathering on factors relevant for the priority scoring (low effectiveness) - SEA and SIA data gathering: Promote anticipative SEA-SIA data gathering (medium effectiveness) - Communication and engagement of the supply chain: Communication with and engagement of the DU sectors may help in developing relevant data for the different steps of the RMM process but also limit its potential impact (high effectiveness) Suggestions for Discussion with ECHA Eurometaux would be most pleased to inform ECHA on: The outcome of the RMM learning lessons on metals so far The generic recommendations to improve the RMOa from a metals sector perspective Actions for the sector to anticipate the different RMM steps. Reference material for the Metals Sector Risk Management Support Programme: - Eurometaux’s thought starter on an assessment to improve chemicals Management RMM in the EU : http://www.reach-metals.eu/index.php?option=com_content&task=view&id=203&Itemid=310
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