An article published on August 1, 2018, in the peer-reviewed journal Human and Ecological Risk Assessment, reported on the comparison between data required to be submitted under the European Regulation on the Registration, Authorisation and Restriction of Chemicals (REACH) and data needed to support classifications under the Classification, Labelling and Packaging (CLP) Regulation. Marjolijn Woutersen and colleagues from the National Instituut for Public Health and the Environment (RIVM), Centre for Safety of Substances and Products (VSP), Bilthoven, the Netherlands, compared REACH data requirements for mutagenicity and carcinogenicity with corresponding CLP classification criteria as well as “the studies used as key evidence by [the] Committee for Risk Assessment (RAC) in drafting its opinions on the appropriate classification.” The motivation behind this analysis was that “classification and labeling is essential in the communication of the hazardous properties of substances and mixtures and is amongst others an important first step in the identification of a substance as a Substance of Very High Concern (SVHC).”

The analysis “revealed that the REACH information requirements will not provide sufficient information to conclude a substance is a Cat 1B mutagen and/or carcinogen.” Furthermore, obtaining “such information via a substance evaluation under REACH requires a large investment from the Member States and takes years,” the authors explain. Therefore, they conclude that “REACH will hardly generate sufficient information for classification of substances as category 1B for mutagenicity and carcinogenicity,” possibly resulting in a situation where “indications of very severe hazards of substances are missed and health risks could occur.”

Woutersen and colleagues propose “various ways to deal with this problem,” but comment that “most of these require adaptation of regulations” and thus “will cost considerable time and political will.” Their study is “a first step to raise awareness for the problem and to start a discussion to search for a sustainable solution,” the authors emphasize.


Woutersen, M., et al. (2018). “Does REACH provide sufficient information to regulate mutagenic and carcinogenic substances?Human and Ecological Risk Assessment: An International Journal (published August 1, 2018).