Guidance documents

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Guidance

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 there is compliance with what has been laid down by the Registrant.

This document includes links to the tools developed by the metal substances sector (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.

Framework for human health risk assessment to inform decision making (US EPA, 2014)

The purpose of this document is to describe a process for conducting human health risk assessments that are responsive to the decision-making needs of EPA. The Framework for Human Health Risk Assessment to Inform Decision Making (Framework) is further intended to facilitate implementation of existing and future EPA guidance for conducting human health risk assessments and improve the utility of risk assessment in the decision-making process. The Framework addresses recommendations on risk assessment design and utility described in the National Research Council’s (NRC) 2009 report, Science and Decisions: Advancing Risk Assessment, and those put forth in earlier NRC reports (e.g., NRC 1994). This Framework highlights the important roles of planning and scoping, as well as problem formulation, in designing a risk assessment that will serve a specific and documented purpose. In accordance with longstanding Agency policy, it also emphasizes the importance of scientific peer review, as well as public, stakeholder and community involvement.

Framework for Metals Risk Assessment (US EPA, 2007)

The 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.

Guidance on grouping chemicals (2014, Chapter 6.7: Metals and inorganics metal compounds) (OECD) pp100-101 (Grouping for human health 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 substances. In the category approach, not every substance 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. It includes some metal-specific examples

Guidance on the assessment of Occupational Exposure to Metals based on monitoring data (EBRC, EM, 2016)

The aim of this guidance is to address best practices on inhalation monitoring at the workplace.

The guidance covers five aspects:

sampling strategy
sampling equipment
documentation and reporting
data management
data analysis

Also included is further use as calibration data for exposure estimation tools, and a summary of further sources of information.

Guidance for Evaluating the Oral Bioavailability of Metals in Soils for Use in Human Health Risk Assessment (US EPA, 2007)

The purpose of this document is to provide guidance to Regional risk assessors on how to assess site-specific oral bioavailability of metal substances in soils for use in human health risk assessments. Specifically, this guidance document provides:

a recommended process for deciding when to collect site-specific information on the oral bioavailability of metal substances in soils for use in human health risk assessments;
a recommended process for documenting the data collection, analysis, and implementation of a validated method that would support site-specific estimates of oral bioavailability; and
general criteria that EPA normally will use to evaluate whether a specific bioavailability method has been validated for regulatory risk assessment purposes.

This guidance is focused on media-specific relative bioavailability and does not address adjustments to default absolute bioavailability values. Also, this guidance addresses human health risk assessment and may not be necessarily useful for evaluating ecological receptors. Finally, the guidance document provides information on methodologies for directly assessing bioavailability and does not pertain to indirect methods for predicting bioavailability (e.g., speciation).

Guidance on the classification of inorganic UVCB substances for human health hazards (EM, 2020)

This guidance document describes a tiered approach and its application to hazard classification of inorganic UVCB substances for human health hazards. The information necessary to conduct the assessment is identified at 3 levels: elemental composition, mineralogy / speciation, and information on bioaccessibility. This information is used to establish a hazard classification by treating the UVCB substance as if it were a mixture of its constituents.

Hazard assessment of ores and concentrates for marine transport (ICMM, 2014)

This guidance provides assistance to metals and mining companies to meet their needs regarding the new marine transports’ regulations (such as MARPOL, IMSBC, IMDG). The document is currently under revision and a new version will be available soon.

HERAG- Health Risk Assessment Guidance for Metals - Fact Sheets (2007)

HERAG is a Human Health risk assessment guidance targeting metal substances, therefore taking the metal specificities into account contrary to most of the other risk assessment guidance.

The critical concepts are presented in a series of eight independently reviewed HERAG fact sheets. These fact sheets were written to reflect the lessons learned from the metal substances risk assessment conducted under the previous EU legislation (2000-2008). It is hoped that these latest concepts will enable regulators and scientists to create new or adapt local, national or regional risk assessment systems accordingly.

Fact sheets:

Ores and concentrates guidance on EU Hazard Classification (ARCHE, ICMM)

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.

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.

Guidance

Technical Guidance for implementing Environmental Quality Standards (EQS) for metals: Consideration of metal bioavailability and natural background concentrations in assessing compliance (European Commission, 13 October 2021)

The European Commission published a guidance document titled “Technical Guidance for implementing Environmental Quality Standards (EQS) for metals: Consideration of metal bioavailability and natural background concentrations in assessing compliance” on 13 October 2021. The guidance was developed to support Member States to determine compliance with bioavailability-based Environmental Quality Standards (EQS) for metals and is Guidance Document No. 38 of the Common Implementation Strategy for the Water Framework Directive (2000/60/EC).

In general, it is a robust resource that should help the Member States in their compliance checking programs, which is key to determining whether or not metals represent a risk to aquatic ecosystems at the continental scale. Eurometaux was part of the Expert Group that prepared the guidance, along with Member State representatives (including AT, BE, DE, DK, FR, IE, IT, and NL). The expert group worked from 2017 through January 2019, and the publication of the final document was delayed due to the COVID 19 situation.

The centrepiece of the guidance is a tiered approach that takes bioavailability and natural background concentrations into account. In Tier 1, the dissolved metal concentration at the site of compliance is compared to the reference EQS value. If the dissolved concentrations of the metal substance are greater than the reference EQS, then Tier 2 calls for the use of site water chemistry to determine the bioavailability-based EQS, which is determined by the simplified bio-met tool. Failure at Tier 2 triggers Tier 3, where the full Biotic Ligand Model and natural background concentrations can be used to verify that an exceedance has occurred.

The guidance evaluates the performance of bio-met and shows that its performance is superior to that of the Dutch PNECPro model. Approaches to determine natural background concentrations are also included. This guidance should increase the implementation of bioavailability correction when determining compliance to bioavailable metal EQSs.

Assessment levels for Soil, Sediment and Water, Contaminated Sites Management Series (Department of Environment and Conservation, February 2010)

This updated version of the Assessment Levels for Soil, Sediment and Water guideline has been prepared by the Department of Environment and Conservation (DEC)1. It is designed to provide consultants, local government authorities, industry and other interested parties with information about the assessment levels used by accredited contaminated sites auditors and DEC to determine whether a site is potentially contaminated and whether further investigation is required.

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.

Framework for Metals Risk Assessment (US EPA, 2007)

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.

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 Harmonised 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 the substances 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 which may be toxic, or which may be organic and might 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.

Guidance on grouping chemicals (2014, Chapter 6.7: Metals and inorganics metal compounds) (OECD) p.101 (Grouping for environmental endpoints)

This guidance document is part of the OECD’s effort to provide guidance for assessing the hazards of chemical substances while gaining efficiency 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 on the Incorporation of Bioavailability concepts for assessing the Chemical Ecological Risk and/or environmental Threshold Values of Metals and Inorganic Metal Compounds (OECD, 2016)

Practical guidance for regulators, industry or other experts faced with assessing bioavailability for inorganic substances. This guidance provides a step by-step explanation that can be used to implement bioavailability for the water, sediment and soil compartments and describes the key scientific principles. As ecotoxicity data are a key component of setting safe thresholds for metals the guidance focuses on how bioavailability corrections can be applied for the purpose of using the normalised ecotoxicity data in a risk assessment framework.

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.

Hazard assessment of ores and concentrates for marine transport (ICMM, 2014)

MERAG-Metals Environmental Risk Assessment Guidance (Factsheets, 2016)

MERAG is an environmental risk assessment guidance targeting metal substances, therefore taking metal specificities into account contrary to most of the other risk assessment guidances. The critical concepts are presented in a series of nine independently reviewed MERAG fact sheets. It is hoped that these latest concepts will enable regulators and scientists to create new or adapt local, national or regional risk assessment systems accordingly.

Fact Sheets:

Ores and concentrates guidance on EU Hazard Classification (ARCHE, ICMM, 2020)

REACH Guidance Environmental risk assessment for metals and metal compounds (ECHA, 2008)

REACH Guidance on information requirement and chemical safety assessment targeting Environmental Risk Assessment for metals and metal compounds. This official document published on ECHA’s website has been based on the MERAG fact sheets. This document contains guidance on REACH explaining the REACH obligations and how to fulfil them.

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.

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