RIVM conclude that current REACH information requirements are inadequate for nanomaterials
The National Institute for Public Health and the Environment (RIVM), Netherlands, last month published a new report – Nanomaterials under REACH – Nanosilver as a case study – which investigates whether the new EU REACH Regulation on chemicals is suitable for assessing the safe use of nanomaterials by means of a hypothetical registration of nanosilver, taking into account the on-going discussions within the REACH Competent Authorities and its Subgroup on Nanomaterials.
According to the report, the information on substances to be provided under REACH is not sufficient to determine the specific properties of nanomaterials, nor to assess how these properties affect their behaviour and effects in humans and the environment. RIVM therefore proposes an adapted set of minimum information requirements, to be applied to all nanomaterials to be registered under REACH, independent of their volume of production and import. These requirements, the authors say, will allow a proper risk assessment of nanomaterials to be undertaken.
Further conclusions of the report are that no definition of a nanomaterial is present, and that a relevant measure for expressing harmfulness and exposure is as yet not known. In addition, the standard information requirements are insufficient to assess hazard and exposure. They are also insufficient for a proper characterisation of the nanomaterial. Consequently, it cannot be determined to what extent the nanoform of a substance corresponds to the non-nanoform of the same substance, RIVM state. Furthermore, it was unclear whether current risk reduction measures and extrapolation methods in risk assessment, as established for non-nanomaterials, are applicable to nanomaterials.
The case study on nanosilver was conducted as a purely a scientific exercise, with the aim to generate recommendations for future policy guidance on how to deal with first generation nanomaterials under REACH. Given this, the authors stress that this report does not pretend to provide a complete overview of all available toxicity data on (nano)silver, and is as such not to be used for an actual registration under REACH.
The full-text report is available to download free from the RIVM website – click here for access.
Source: RIVM