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EBRC
Consulting GmbH

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D-30659 Hannover
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HERAG

HERAG - Health Risk Assessment Guidance for Metals

Sponsors:

Eurometaux, The European Association of Metals:
www.eurometaux.org

ICMM, The International Council of Mining and Metals:
www.icmm.com

Eurofer, The European Confederation of Iron and Steel Industries:
www.eurofer.be

With its extensive background in metals risk assessments, EBRC Consulting GmbH was contracted in 2005 by the European Metals Industry* to compile a guidance document for the human health risk assessment of metals and inorganic metal compounds. The HERAG project was conducted from 2005 through 2007.

The principal purpose of this Health Risk Assessment Guidance for Metals (HERAG) is to provide the worldwide regulatory and scientific community with an overview of most recent developments of several aspects of risk assessment methodology specific to metals and inorganic metal compounds, with the aim to reduce uncertainty of future risk assessments.

The guidance and concepts presented in HERAG have mainly been built on experience gained with previous or ongoing risk assessments for metals under the EU Existing Substances Regulation (ESR, Council Regulation EEC 793/93) and of voluntary risk assessments conducted in the EU in accordance with this legislation. Cross-reference is also been made to other national or international institutions (e.g. US EPA, WHO, OECD).

To allow for an adaptation of this guidance and the underlying concepts to worldwide legislative contexts and to the recently amended EU legislation (REACH), HERAG follows a “building block” approach, addressing various aspects of risk assessment and assuring that the presented methodologies may also be of use to other applications, such as chemicals management and occupational exposure monitoring. Finally, a series of 12 HERAG topics was established, and a “fact sheet” was developed for each topic.

HERAG Summary Document

This document summarizes the key guidance elements for metals risk assessent and give the purpose, the intented use, the scope and the organization of the HERAG Project as background information.
Download (PDF, 0.5 MB)

Detailed Guidance - Final HERAG Fact Sheets:

Fact sheets related to Exposure Assessment

01	Assessment of occupational dermal exposure and dermal absorption for metals and inorganic metal compounds	Download (PDF, 875 kB)
02	Assessment of occupational inhalation exposure and systemic inhalation absorption	Download (PDF, 495 kB)
03	Indirect exposure via the environment and consumer exposure	Download (PDF, 1.1 MB)

Fact sheets related to Effects Assessment

04	Gastrointestinal uptake and absorption, and catalogue of toxicokinetic models	Download (PDF, 669 kB)
05	Mutagenicity	Download (PDF, 283 kB)
06	Quality screening procedures for health effects literature	Download (PDF, 1.0 MB)

Fact sheets related to Risk Characterisation

07	Essentiality	Download (PDF, 569 kB)
08	Choice of assessment factors in health risk assessment for metals	Download (PDF, 185 kB)

Several of these fact sheets have identified the need for further research and model development particular to the characteristics of inorganic compounds, some of which are already under consideration. In view of this and considering that the science of metals continues to be investigated, it is clearly anticipated that several recommendations presented in this document and the corresponding fact sheets may in the course of time require modifications or updating.

During the course of the project some of the initially identified 12 topics were considered not to warrant the publication of a full fact sheet at the time of conclusion of the project in late 2007, because they were either judged not intrinsically metal-specific or the status of development based on available knowledge was insufficient:

09	Classification, read-across and derogation criteria (overlap with REACH RIP efforts)
10	Carcinogenicity (issues of inert particles/overload, inflammation and secondary mechanisms, dosimetry insufficiently developed to date)
11	Reproductive toxicity (lack of examples of candidate metals)
12	Sensitisation (lack of examples of candidate metals)

Further development of these fact sheets is foreseen in the future. Working documents of these 4 fact sheets are not publicly available (only available to the HERAG Project Team and the sponsors).

* represented by the major industry associations EuroMetaux (The European Association of Metals), ICMM (The International Council of Mining and Metals) and Eurofer (The European Confederation of Iron and Steel Industries).