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. 2023 Dec;97(12):3075-3083.
doi: 10.1007/s00204-023-03601-5. Epub 2023 Sep 27.

Analysis of health concerns not addressed by REACH for low tonnage chemicals and opportunities for new approach methodology

Philip Botham  1 , Mark T D Cronin  2 , Richard Currie  1 , John Doe  3 , Dorothee Funk-Weyer  4 , Timothy W Gant  5   6 , Marcel Leist  7 , Sue Marty  8 , Bennard van Ravenzwaay  9 , Carl Westmoreland  10
Affiliations

Analysis of health concerns not addressed by REACH for low tonnage chemicals and opportunities for new approach methodology

Philip Botham et al. Arch Toxicol. 2023 Dec.

Abstract

In Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) the criterion for deciding the studies that must be performed is the annual tonnage of the chemical manufactured or imported into the EU. The annual tonnage may be considered as a surrogate for levels of human exposure but this does not take into account the physico-chemical properties and use patterns that determine exposure. Chemicals are classified using data from REACH under areas of health concern covering effects on the skin and eye; sensitisation; acute, repeated and prolonged systemic exposure; effects on genetic material; carcinogenicity; and reproduction and development. We analysed the mandated study lists under REACH for each annual tonnage band in terms of the information they provide on each of the areas of health concern. Using the European Chemicals Agency (ECHA) REACH Registration data base of over 20,000 registered substances, we found that only 19% of registered substances have datasets on all areas of health concern. Information limited to acute exposure, sensitisation and genotoxicity was found for 62%. The analysis highlighted the shortfall of information mandated for substances in the lower tonnage bands. Deploying New Approach Methodologies (NAMs) at this lower tonnage band to assess health concerns which are currently not covered by REACH, such as repeat and extended exposure and carcinogenicity, would provide additional information and would be a way for registrants and regulators to gain experience in the use of NAMs. There are currently projects in Europe aiming to develop NAM-based assessment frameworks and they could find their first use in assessing low tonnage chemicals once confidence has been gained by their evaluation with data rich chemicals.

Keywords: New Approach Methodologies; REACH; Risk Assessment; low tonnage chemicals.

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Conflict of interest statement

The authors’ affiliations are as shown on the cover page. The authors had sole responsibility for the writing and content of the paper. The views and opinions expressed in the paper are those of the authors, and do not necessarily reflect the views or policies of the authors’ current or former employers.

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