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Nordic comments on the Health Risk Assessment Guidance for Metals

HERAG Fact Sheets

image of Nordic comments on the Health Risk Assessment Guidance for Metals

The HERAG (Health Risk Assessment Guidance Project) was initiated and financed by metal industry associations, represented by the International Council on Mining & Metals (ICMM), the European Confederation of Iron and Steel Industries (Eurofer) and the European Association of Metals (Eurometaux). The HERAG project consisted of exposure assessment, effects assessment and risk characterisation. From these a set of key-topics were selected for which Fact sheets (FSs) were developed for metals and inorganic metal compounds. The fact sheets focus on the applicability of the current Technical Guidance Document (TGD, 2003) on risk assessment of chemicals under the EU Existing Substances Regulation (793/93/EC). The fact sheets have been critically reviewed by a Nordic expert group. The opinions of the Nordic experts are compiled in the present report. The report concludes that the guidance presented in most of the fact sheets is at a very general level and might be applicable to all substances, not only for metals. The experience from the implementation of the Existing substances regulation (793/93/EC) risk assessments, which are done according to the TGD methodology, is that TGD allows deviations when required, as long as they are justified and done in a transparent way. Therefore, there is no reason to believe that special aspects of metal toxicology could not be considered under RIP (REACH Implementation Projects) projects. The present review has revealed a number of flaws and shortcomings in the proposed fact sheets, which further support the inclusion of metals health risk assessment under the general risk assessment RIP, corresponding to TGD (2003).

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Specific comments on: FS 9, Carcinogenicity

This document is well written and highlights many problems associated with risk assessment of carcinogens in general and emphasizes obstacles complicating risk assessments of carcinogenic metals in particular. A general comment is that many issues are common to all carcinogenic chemicals and that these problems are discussed in a way that might give the impression that they are specific for carcinogenic metals. Thus, chapter 5 (Recommendations, page 18) lists a number of critical issues that are important for carcinogen risk assessment in general. It is not hard to agree that these issues are critical and that lack of comprehensive knowledge can be an obstacle. Controversies or interpretation problems may arise in the risk assessment of single metals, as well as in risk assessment of other chemicals. For example, caution is always prudent when extrapolating from animals to humans.

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