REACH and CLP: Dutch Study Uncovers Regulatory Gaps

The materials data required by REACH is insufficient for a correct assessment of the dangers that such chemicals pose and a valid classification according to the CLP regulation. That’s the finding of scientists at the Dutch National Institute for Public Health and the Environment (RIVM) developed as part of a study. Potential mutagens and carcinogens pose a particular problem.

In their article in Human and Ecological Risk Assessment: An International Journal, the authors criticize the current situation in which both regulations require different data because the clinical studies have different end points. In CLP for example, classification of a material as a 1B mutagen must be substantiated by somatic in vivo germ cell tests in mammals or humans. REACH, however, requires only in vitro studies. Only in exceptional cases does it ask registrants to consider germ cell tests, but such tests are not mandatory. The authors note that because the tests require a great deal of time and expense, it is unlikely that registrants will perform them voluntarily.

Theoretically, the data gaps can be closed within the REACH substance evaluation process (German only), and member states could make in vivo tests mandatory. Nevertheless, the entire process lasts up to seven years. The RIVM scientists therefore suggest three solutions:

  • Modifying REACH to require in vivo mutagen and carcinogen studies
  • Changing the CLP criteria to accept in vivo evidence for classification in Category 1B.
  • Lowering the REACH criteria for the classification of substances of very high concern (SVHC) to include carcinogens and mutagens of Category 2

The authors also state that all these measures require “considerable time and political will”. But they note that the primary goal of their study was not to find fixes, but to serve as a first step toward identifying the discrepancy between REACH and CLP and to trigger an overdue discussion of the matter.

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