The Board of Appeal of the European Chemicals Agency (ECHA) has released two decision annulling a 2015 ECHA decision requiring additional information and data on Syntetic Amorphous Silica (SAS). The original decision was based on substance evaluation performed by The Netherlands Competent Authority where a number of requests were made.
The contested decision was adopted by ECHA in March 2015 . Two appeals were launched by two industry consortia of composed of 2 and 37 industries respectively.
The BoA annuls the request in the 2015 decision related to information on seven physicochemical properties of each individual SAS ‘form’ that is manufactured, imported and/or placed on the market. The request on information on the uses of each individual ‘form’ of SAS that is manufactured, imported and/or placed on the market is also dismissed. Other requests on information on eight physicochemical properties of each individual surface-treated SAS ‘form’ that is manufactured, imported and/or placed on the market as well as all toxicological information on surface-treated SAS as manufactured, imported and/or placed on the market as available to the Registrant(s) of SAS were also dismissed.
However, one request is still upheld, and industry will have to provide a sub-chronic toxicity study (90-day; OECD 413), in rats via the inhalation route with four pyrogenic SAS ‘forms’. This information shall be provided by 9 July 2019.
Please follow this link to read the full ECHA Board of Appeals decision.
NIA will work with members for a full analysis of the ruling from ECHA, in the short term for dossier content and longer term for ramifications for the REACH development.