A "Hazard" is defined as the inherent capacity of a chemical or mixture to cause adverse effects in man or the environment under the conditions of exposure, and "hazard identification” as the identification of these adverse effects and the "estimation of the relationship between dose or level of exposure to a substance, and the incidence and severity of an effect" (Van Leeuwen and Vermeire,2007). When evaluating hazards, it is important to consider that:
- Some effects appear upon single ('acute’) exposure, whereas others require a long-term ('chronic') exposure; and
- The exposure routes (dermal, oral, inhalation) which may determine different toxic effects (only relevant for human health hazard identification).
Risk Management of Complex Inorganic Materials, Violaine Verougstraete, 2018
Assessing the hazard of ores and concentrates is essential in order to avoid potential environmental and health risks. There are several challenges to address for the assessment of ores and concentrates which includes the complexity and variation in their composition. This document helps companies to meet the demand in terms of new marine transport regulations (including MARPOL, IMSBC and IMDG). ICMM sets out approaches that mining and metals commodity associations together with scientific experts have developed.
This guidance is presently being updated and a new version will be released later this year.
Guidance document for the EU Hazard Classification of Ores and Concentrates (O&C) using the Global Harmonised System of classification and labelling of chemicals (GHS) criteria for both Human Health and environment classification.
Framework for Metals Risk Assessment (US EPA, 2007), Chp. 220.127.116.11 Characterization of effects/Hazard analysis; Chp. 3 Environmental Chemistry, transport and fate; Chp. 5.3 Aquatic ecological Risk assessment for metals - Characterization of effects (5; 14- 17); Chp. 6 Terrestrial Ecological Risk assessment for Metals - Characterization of effects
Framework for Metals Risk Assessment is a science-based document that addresses the special attributes and behaviours of metal substances and metal compounds to be considered when assessing their human health and ecological risks. The document describes basic principles to be considered in assessing risks posed by metal substances and is intended to foster consistency on how these principles are applied across the Agency’s programmes and regions when conducting these assessments.
Chp. 2. 2.3.3. Characterisation of Effects/Hazard Analysis (2-14)
Chp. 3. Environmental chemistry, transport and fate (1-29)
Introduction and terminology (3-1)
- Hard and Soft Acids and Bases: The Stability of Complexes (3-2)
- Transformations (3-3)
- Biotic Methylation Transformations (3-5)
- Abiotic Transformations (3-6)
- Aquatic Chemistry (3-7)
- Processes (3-7)
- Speciation and Complexes (3-7)
- Importance of pH and Redox Conditions (3-9)
- Ground Water and Metals Mobility (3-9)
- Application of Partition Coefficients to Metal Mobility in Ground Water (3-11)
- Sediment Chemistry (3-13)
- Metal Chemistry in Sediments (3-14)
- Estimating Metal Distribution in Sediments (3-16)
- Soil Chemistry (3-17)
- Key Parameters Affecting Metal Bioavailability in Soils (3-18)
- Adsorption Behaviour of the Metals of Concern (3-19)
- Aging of Metals in Soil (3-19)
- Dissolution and Transformation of Metals (3-20)
- Soil Metal Transfer to Plants (3-20)
- Atmospheric Behaviour/Chemistry (3-21)
- Metal fate and transport (3-23)
- Aquatic and Terrestrial Transport Pathways for Metals (3-24)
- Aquatic Transport Models (3-26)
- Terrestrial Fate and Transport (3-29)
- Atmospheric fate and transport (3-29)
Chp. 5. Aquatic ecological Risk assessment for metals
5.3 Characterisation of effects (5-14)
- Essentiality (5-14)
- Toxicokinetics/Toxicodynamics (Toxicity Issues) (5-14)
- Metal Mixtures (5-15)
- Critical Body Residues (5-17)
Chp. 6. Terrestrial Ecological Risk assessment for Metals
6.3.Characterisation of effects (6-11)
- Essentiality (6-11)
- Toxicity Tests (6-13)
- Metal Mixtures (6-14)
- Critical Body Residues (6-15)
- Plant and Soil Invertebrate Toxicity (6-16)
- Wildlife Toxicity (6-17)
Guidance on grouping chemicals (2014, Chap. 6.7: Metals and inorganics metal compounds) (OECD) p.101 (Grouping for environmental endpoints)
This guidance document is part of the OECD effort to provide guidance for assessing the hazards of chemical substances while gaining efficiencies and improving animal welfare. The approach described in this guidance document is to consider closely related chemicals as a group, or category, rather than as individual chemicals. In the category approach not every chemical needs to be tested for every endpoint. Instead, the overall data for that category should prove adequate to support a hazard assessment. The overall data set must enable an estimate of hazard for the untested endpoints. This chapter is intended to supplement the general guidance in the previous chapters with issues specific to metal substances and inorganic compounds. It includes some metal-specific examples.
Guidance document on transformation/dissolution of metals and metal compounds in aqueous media (OECD, series on testing and assessment, n° 29, 2001).
This test guidance is relevant for hazard identification in the environment. It is designed to determine the rate and extent to which metal substances and soluble metal substances can produce soluble available ionic and other metal-bearing species in aqueous media under a set of standard laboratory conditions representative of those generally occurring in the environment. This information can be used to evaluate the short term and long-term aquatic toxicity of the metal substance or sparingly soluble metal substances
- Metal Speciation
- Massive Classification
- Toxicity tests
- Unit World model
Developing an ecotoxicological soil screening standard for metals/metalloids (ICMM presentation at APEC, Philippines, 2015)
Risk Management of Complex Inorganic Materials: A practical Guide (Violaine Verougstraete, 2018, Chp. 4.2, 5.3, 7, 10.3, 13.4)
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:
- 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
Both the UN GHS and the EU CLP assign hazard classifications to substances based on observed ecotoxicity effects (hazard identification) for the aquatic compartment (e.g. acute toxicity or chronic toxicity). Metal specificities can affect these classifications and need to be considered when identifying hazard. Specific tests like the Transformation Dissolution protocol or criteria (e.g. to have split entries for different physical forms) need to be considered.
The MeClas tool allows to classify complex inorganic materials like ores and concentrates, complex intermediates, alloys or UVCBs, recognising the specific properties and assessment techniques for inorganics, using the most updated information on toxicity references and self-classifications available. The tool includes several tiers, aiming for a progressive refinement of the classification through recognition of speciation, specific mineral content and the availability of test data on the complex material in question.
Eurometaux has developed a Classification Mapping Tool, intended to support the identification of links between hazardous classifications, legislative provisions and industry impacts, as well as the evaluation of impacts associated to current, as well as potential future, hazardous (re)classifications. It contains information on approximately 60 EU directives/regulations covering: general measures, workers, consumers, environment and transport. It also provides indicative information on references associated to specific hazardous classifications, requirements, impacts on industry, derogations and legislative revisions.
In order to have access, please send an email to firstname.lastname@example.org
Globally Harmonized System of Classification and Labelling of Chemicals – GHS (United Nations, 6th Edition, 2015; Section A.9 pp.476-480)
A9.7 Classification of Metals and metal compounds.
The Harmonized system for classifying substances is a hazard-based system, and the basis of the identification of hazard is the aquatic toxicity of the substances, and information on the degradation and bioaccumulation behaviour (OECD 1998). Since this document deals only with the hazards associated with a given substance when this substance is dissolved in the water column, exposure from this source is limited by the solubility of the substance in water and bioavailability of the substance in species in the aquatic environment. Thus, the hazard classification schemes for metals and metal compounds are limited to the hazards posed by metals and metal compounds when they are available and do not take into account exposures to metals and metal compounds that are not dissolved in the water column but may still be bioavailable, such as metals in foods. This section does not take into account the non-metallic ion of metal compounds that may be toxic or organic and may pose bioaccumulation or persistence hazards. For such metal compounds the hazards of the non-metallic ions must also be considered.
Guidance on the Application of the CLP Criteria; ANNEX IV: METALS AND INORGANIC METAL COMPOUNDS (ECHA, Version 5.0, July 2017)
This document is the Guidance on the Application of the CLP Criteria. It is a comprehensive technical and scientific document on the application of Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures (CLP), which replaced the Dangerous Substances Directive 67/548/EEC (DSD) and the Dangerous Preparations Directive 1999/45/EC (DPD).CLP is based on the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) and implements the provisions of the GHS within the EU. The objective of this document is to provide detailed guidance on the application of the CLP criteria for physical, health and environmental hazards. The guidance is developed to primarily assist manufacturers, importers and downstream users in applying the classification and labelling criteria, and it also includes practical examples. Staged
MECLAS Tool for Complex Materials from the Metals Sector (ICMM presentation at APEC, Philippines, 2015)
- US. EPA (and U.S. States) regulatory approach as illustrative example
- Australia/New Zealand: similar approach
- European Union: similar approach
- Possible approaches for APEC economies for regulating metals
- Sources of metals in soils
- Development of ecological soil criteria
- How to handle biomagnification?
- Example frameworks- Australian National Environment Protection Measure
- Dealing with complex historically contaminated sites (after screening level assessment)