Safety assessment of the substance benzophenone‐3,3′,4,4′‐tetracarboxylic dianhydride, for use in food contact materials
Competing interests: R. Franz declared that Fraunhofer institute at which he was employed provides advisory services to private business operators active in the sector on food contact materials. In line with EFSA's Policy on Independence (http://www.efsa.europa.eu/sites/default/files/corporate_publications/files/policy_independence.pdf) and the Decision of the Executive Director on Competing Interest Management (http://www.efsa.europa.eu/sites/default/files/corporate_publications/files/competing_interest_management_17.pdf), a waiver was granted to R. Franz regarding his participation to the EFSA's Working Group on Food Contact Materials (FCM WG) in accordance with Article 21 of the Decision of the Executive Director on Competing Interest Management. Pursuant to Article 21(6) of the above‐mentioned Decision, the involvement of R. Franz is authorised as member in the FCM WG, allowing him to take part in the discussions and in the drafting phase of the scientific output, but he is not allowed to be, or act as, a chairman, a vice‐chairman or rapporteur of the working group.
The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of benzophenone‐3,3′,4,4′‐tetracarboxylic dianhydride (BTDA), FCM substance No 1083, as co‐monomer for the production of polyimides used in repeated use materials and articles that are in contact with acidic and fatty foods at temperatures up to 250°C. Migration of BTDA from a polyimide containing 43% BTDA, into olive oil was below the limit of quantification of about 3 μg/kg food, and in 3% acetic acid it decreased from 30.3 μg/kg in the first test to 22.1 μg/kg in the third test (2 h/100°C). In a semi‐quantitative screening using acetonitrile and acetonitrile/water to extract the polymer powder, linear and cyclic oligomers were detected at levels below 1 mg/kg material. In thermal desorption of the polymer powder at 250°C, phenol, tentatively identified were found, but the modelled migrations of these were far below a level of potential concern. The substance did not induce gene mutations in bacterial and mammalian cells. In an in vitro chromosomal aberration test, the substance was found to be directly clastogenic in the absence of metabolic activation. In an in vivo follow‐up, the substance did not induce the formation of micronuclei in experimental conditions associated with evidence of systemic exposure and therefore the Panel considered that the substance does not raise concern for genotoxicity. The CEP Panel concluded that the use of the substance BTDA is not of safety concern for the consumer if it is applied at up to 43% as a co‐monomer in the production of polyimides for repeated use contact with acidic or fatty foods at temperatures up to 250°C. In addition, the migration of BTDA should not exceed 50 μg/kg.