经过评估,专家小组得出结论,当BTDA物质作为共聚单体以高达43%的比例用于生产聚酰亚胺,且在高达250℃的高温下与酸性或高脂肪食品反复接触时,该物质的使用不会对消费者造成安全隐患。此外,BTDA的迁移量不应超过50μg/ kg。部分原文报道如下:
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.
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