欧盟重新评估聚乙烯吡咯烷酮（E1201）和聚乙烯聚吡咯烷酮（E1202）作为食品添加剂的安全性

 

　　经过评估，专家小组认为报告的聚乙烯吡咯烷酮（E1201）和聚乙烯聚吡咯烷酮（E1202）用作食品添加剂的用途和使用水平没有安全问题。在建议的最大允许水平和建议的消费水平下，预期的扩展使用范围不会对安全造成影响。部分原文报道如下：
 

　　The present opinion deals with the re‐evaluation of polyvinylpyrrolidone (E 1201, PVP ) and polyvinylpolypyrrolidone (E 1202, PVPP ) when used as food additives. One request for extension of use of PVP (E 1201) in foods for special medical purposes was also considered in this assessment. The Panel followed the conceptual framework under Commission Regulation (EU ) No 257/2010 and considered that: the exposure assessment was based on the reported use and use levels (one food category out of the two food categories in which PVP and PVPP are authorised); the 95th percentile of exposure to PVP and PVPP of maximally 23.7 and 25 mg/kg body weight (bw) per day in children, respectively, was overestimated, because it was assumed that 100% of the food supplements consumed contained PVP or PVPP at the maximum reported use levels; the extension of use of PVP (E 1201) to foods for special medical purposes (FC 13.2) would result in an exposure of PVP of 4.3 mg/kg bw per day for children; the absorption of PVP and PVPP is very low; sufficient toxicity data were available for PVP ; there is no concern with respect to the genotoxicity of PVP and PVPP ; no carcinogenic effects were reported in carcinogenicity studies in rats at a dose of 2,500 mg PVP /kg bw per day, the highest dose tested; there is no need for chronic toxicity/carcinogenicity data for PVPP for the safety assessment of PVPP given the chemical similarity between PVP and PVPP , and the lack of adverse effects in the available repeated dose toxicity studies. Therefore, the Panel concluded that there is no need for numerical acceptable daily intakes (ADI s) for PVP and PVPP , and that there is no safety concern for the reported uses and use levels of PVP and PVPP as food additives. The Panel further concluded that the proposed extension of use is not expected to be of safety concern at the proposed maximum permitted level (MPL ) and recommended consumption level.

 

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