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 (presence or 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, September 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 EU 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 document RiCo for the remaining process steps. It has been developed to address the specific needs of an assessment of RiCo for metal intermediates.
Guidance
RMOa Guidance-Risk Management Option Analysis (EM, 2021)
This Industry-Risk Management Option Analysis (I-RMOa) guidance is intended to be used when:
- anticipating regulatory management assessments and preparing the collection of additional data for substances that meet the criteria of the SVHC Roadmap,
- developing a broad and open view on the selection of chemical management measures based on their expected efficiency and efficacy,
- aligning manufacturers and their supply chains on relevant data needs and the discussion of risk management options.
The I-RMOa guidance reflects the priorities set in the European Green Deal by proposing a method to integrate the circular economy and climate dimensions into the analysis.
The package also includes a role play that aims to “broaden the mindset”, offering the possibility to understand and explore the views to be expected from other players in the supply chain or stakeholders in society, on what could constitute a relevant risk management measure. It is suggested to conduct this role-play before starting the full RMOa exercise.
This guidance will soon be explained in detail in a dedicated section on the Reach Metal Gateway website.
ES for DU-mmies guidance (EM, 2011)
The Exposure Scenario (ES) Guidance for DU-mmies is designed to help the Downstream Users (DU) check whether they are covered by the ES received from the Registrant for their specific 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 'tips' and asking the reader questions at the end of most of the sections, allowing him/her to check whether there is compliance with what has been laid down by the Registrant.
This document includes links to the tools developed by the metal substance sectors (such as 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.3
The aim of this publication is to facilitate 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:
- General introduction
- Sources of Exposure to inorganic complex materials
- Mechanisms Underlying Toxicity of Complex Inorganic Materials
- Principles of Risk Assessment and Management of Complex Inorganic Materials
- Main characteristics of relevance for the assessment of complex inorganic materials
- Data needs, availability, sources and reliability
- Environmental Toxicity assessment of complex inorganic materials
- Human Health Toxicity assessment of complex inorganic materials
- Specific methodologies/tools to support assessment
- Hazard assessment of ores and concentrates
- Risk assessment of exposure to inorganic substances of UVCBs during manufacturing (recycling) of metals
- Risk assessment for manufacture and formulation of Inorganic Pigments (manufacturing and use)
- Risk assessment of alloys (manufacturing, use, end of life)
- Emerging tools in the assessment of metals: Current Applicability