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Risk Management

Today’s regulatory regimes are rightly aimed at ensuring the safe use of chemicals for environment and human health. The risk assessment described in previous chapters gives the assessor a good impression of the (absence of) risks of a chemical. If safe use can be undoubtedly shown, then the assessment can stop. If safe use cannot be shown, or if there are remaining doubts, additional risk management measures need to be implemented. These measures are mostly targeted to eliminate or at least reduce exposure, are easy to monitor and report, and have a direct effect on risk reduction if applied correctly. The safe threshold values, on the other hand are less flexible. They can be refined, for instance, by performing additional testing to reduce the uncertainty associated with the safe threshold value. However, testing and consequently increasing the safe threshold value is generally not the option preferred by authorities and risk assessors, and this approach needs to be well considered for reasons of responsible care.

Risk Management of Complex Inorganic Materials, Violaine Verougstraete, 2018

Models

RiCoG (EBRC, 2012).

This tool is intended to provide guidance to registrants of isolated intermediates on how rigorous containment (RiCo) of their intermediates could be assessed and documented according to the stipulations of REACH.

In an integrated assessment of strictly controlled conditions (SCC) for an entire process, RiCoG can be used to prioritise process steps requiring such higher tier assessments and provides an easy and structured way to assess and to document RiCo for the remaining process steps. It has been developed to address specific needs of an assessment of RiCo for metal intermediates.

Guidance

RMOa Guidance - Risk Management Option Analysis (EM, 2016-2017).

This Risk Management Option Analysis (RMOa) guidance and template helps to:

  • anticipate RMOa assessments for substances that meet the criteria of the SVHC Roadmap,
  • develop a broad and open view on RMOa selection based on potential efficiency and efficacy of the RMM,
  • anticipate additional data needs beyond information in the registration dossier that could help define the best RMOa option,
  • help align manufacturers and their supply chains on relevant RMOa needs, information required and implementation.

The package also includes a role play that aims to “broaden the mindset” towards potential different views   arising from other players in the supply chain or society, on the need for possible relevant Risk Management Measures. It is suggested to conduct this role play before starting the full RMOa exercise.

This guidance is currently being updated and will be available soon on the Reach Metal Gateway website.

ES for DU-mmies guidance (EM).

The Exposure Scenario (ES) Guidance for DU-mmies is designed to help the Downstream Users (DU) to check whether he is covered by the ES received from the Registrant from his substance.The guidance takes the reader through an exposure scenario step by step, section by section, explaining the reasoning, where the information comes from, giving him 'tips' and asking him questions at the end of most of the sections, allowing him to check his compliance with what has been laid down by the Registrant.

This document includes links to the tools developed by the metals sector, such as the MEASE and DU Scaling tools, as well as 'scaling tips' aimed at highlighting consequences, requirements and limitations for scaling. It also includes a glossary of terms and a blank template, which may be used to contact the registrant.

Publications

Risk Management of Complex Inorganic Materials: A practical Guide (Violaine Verougstraete, 2018, Chp. 4.5, 13.6).

The aim of this publication is to facilitate the hazard identification as part of risk assessment and management of complex inorganic materials around the world by providing accessible and specific guidance on their assessment. This book explains the main characteristics of inorganic complex materials affecting their hazard and risk assessment and management, including their source and main uses, also covering hazard and exposure assessment, risk characterisation and risk management.

It is an essential reference for regulators involved in risk assessment and risk management, industry experts charged with compliance of chemicals management programme requirements, consultants preparing chemicals management files for companies and regulators, and academics involved in research on complex inorganic materials.

Table of Contents:

  1. General introduction
  2. Sources of Exposure to inorganic complex materials
  3. Mechanisms Underlying Toxicity of Complex Inorganic Materials
  4. Principles of risk Assessment and Management of Complex Inorganic Materials
  5. Main characteristics of relevance for the assessment of complex inorganic materials
  6. Data needs, availability, sources and reliability
  7. Environmental Toxicity assessment of complex inorganic materials
  8. Human Health Toxicity assessment of complex inorganic materials
  9. Specific methodologies/tools to support assessment
  10. Hazard assessment of ores and concentrates
  11. Risk assessment of exposure to inorganic substances of UVCBs during manufacturing (recycling) of metals
  12. Risk assessment for manufacture and formulation of Inorganic Pigments (manufacturing and use)
  13. Risk assessment of alloys (manufacturing, use, end of life)
  14. Emerging tools in the assessment of metals: Current Applicability

Last page update: 2 September 2020