Two German institutions charged with chemical risk assessment suggested lowering the production volume for nanomaterials at which registration under the European Registration, Evaluation, Authorisation and Restriction of Chemical substances (REACH) regulation is required in a paper published January 23, 2013.
The Ministry of Occupational Safety and Health, together with the German Federal Institute for Risk Assessment (BfR), published a background paper on how the safety of nanomaterials can be effectively controlled under REACH. They argue that due to nanomaterials’ special physical properties, including their effectiveness at lower levels and higher water solubility, a simplified registration with the European Chemical Agency (ECHA) should already be required at a production volume of only 100 kg/year. Currently the notification limit is 10 tonnes/year. Further, they contend that different toxicological data is needed for nanomaterials than for bulk materials in order to effectively assess a substance’s safety.
Earlier last year the European Commission had concluded that REACH was adequate in regulating nanomaterials. However, nanomaterial specific additions and modifications in the annexes of REACH were deemed necessary. The concept published now by the German ministry and the BfR presents a clear recommendation.