RP1642 Assessment of Wax, Rice Bran, Oxidized and Saponified as a Component of Plastic Materials and Articles Intended to Come into Contact with Food

An application has been submitted to the Food Standards Agency (FSA) and Food Standards
Scotland (FSS) requesting the authorisation of wax, rice bran, oxidized (CAS 1883583-80-9) and
wax, rice bran, saponified (CAS 1850357-57-1) as a component of plastic materials and articles
intended to come into contact with food.
The applicant stated that due to the high decomposition points of the substances no thermal
decomposition is expected during manufacture or use of the food contact articles containing the
additive. However, non-intentionally added substances (NIAS) testing should also assess
impurities and reaction products and not just decomposition products. Therefore, additional data
was requested on NIAS testing in order to assess compliance with the relevant safety criteria in
accordance with assimilated Regulation 10/2011 on plastic materials and articles intended to
come into contact with food. Evidence was requested on the presence or absence of organic
impurities/matter in the additives as well as data on the presence or absence of other substances
of potential concern, e.g. minor oxidation products.
The applicant was requested to provide this additional information in March 2023 and reminded in
November 2023, however this was not provided and there has been no further communication.
As such, due to deficiencies in the data, the assessment of the additive has stopped and the FSA/
FSS could not conclude on the safety of the additive under its proposed conditions of use.