Non-legally binding guidance documents are released with updated testing recommendations and a major decision about regulating nano-forms.
Chemicals that are manufactured or imported into Europe in volumes over 1 tonne per year are required to be registered under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The European Chemicals Agency (ECHA) has developed Guidance on Information Requirements and Chemical Safety Assessment (IR & CSA) on how to complete the registration requirements. Registrants must submit dossiers that include identity, manufacturing, guidance on safe use, exposure information (e.g. uses and potential routes of exposure), and human health and environmental assessments.
In 2012, ECHA published nanomaterial-specific appendices to guide data development on nanoforms of REACH substances. In early 2017, these appendices were updated with best practices and detailed guidance on appropriate tests forphysicochemical, human health, ecotoxicity and fate endpoints. In addition, two new appendices are going through review: Recommendations for Nanomaterials Applicable to the Guidance on Registration and the Guidance on QSARs and Grouping of Nanomaterials. The appendices are going through consultation with member states, and have tentative final publication dates in May 2017.
The updates state that these changes will affect all those going through REACH by the 31 May 2018 registration deadline. However – recent legal cases reminds us that these are guidance notes and should be considered advice on current best practices, not strict legal requirements.
In March 2017, ECHA’s Board of Appeals (BoA) ruled in favor of industry, who had contested a Decision made by ECHA; in 2014, ECHA had done a compliance check of a TiO2 registration dossier and had issued a Decision requesting more information on the crystal phases, nanoforms, and surface treatment of nanoforms, to be added to their registration. The BoA ruled that the REACH regulations do not explicitly require these types of information, and therefore no additional information is needed to be submitted. This decision comes after a similar decision by the BoA in October 2016, where the BoA overturned another request by ECHA to get more information of nanoforms of silicic acid for a registration dossier.
These decisions may inspire future amendments to REACH regarding nanomaterials. We encourage anyone doing physicochemical or safety testing to refer to these guidance documents, as they provide up-to-date advice on nanomaterial-specific testing.