Implications of not detecting non-genotoxic carcinogens in the absence of carcinogenicity tests under REACH guidelines
De gevolgen van de invoering van REACH op de identificatie van niet-genotoxische kankerverwekkende stoffen
26 May 2012, PDF |
49 pages |
Hernandez LG, van Benthem J, Luijten M, van Steeg H
RIVM Report 340700003
Research performed by the RIVM has demonstrated that the European legislation does not comply with a specific small group of carcinogens, the so-called non-genotoxic carcinogens, which induce cancer via a mechanism other than the introduction of DNA damage. In view of these findings, several recommendations for alternative test methods are given including the use of innovative genomics techniques for the detection of these compounds. REACH, which stands for Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), was implemented on July 2008. The policy forces companies to collect, assess and distribute information on qualities and risks of chemicals among users to safely manage these compounds. Under REACH test batteries for carcinogenicity of a chemical are in vitro and in vivo genotoxicity assays. Carcinogenicity tests are only performed for compounds with production volumes greater than 1000 tonnes per annum and/or positive in the previously mentioned genotoxicity tests. Given that non-genotoxic carcinogens are negative for genotoxicity, they will not be detected under REACH. Ten to twenty % of the known, probable or possible human carcinogens appear to be non-genotoxic carcinogens. For one third of these compounds, exposure is high enough that an increased risk for cancer can not be excluded. Nevertheless, the expected number of non-genotoxic carcinogens among newly registered compounds is assumed to be very low. Moreover, REACH requires data on carcinogenicity for compounds with a high production volume and a probable higher human exposure.