Re‐evaluation of polyvinylpyrrolidone (E 1201) and polyvinylpolypyrrolidone (E 1202) as food additives and extension of use of polyvinylpyrrolidone (E 1201)

摘要

The present opinion deals with the re‐evaluation of polyvinylpyrrolidone (E 1201, ) and polyvinylpolypyrrolidone (E 1202, ) when used as food additives. One request for extension of use of (E 1201) in foods for special medical purposes was also considered in this assessment. The Panel followed the conceptual framework under Commission Regulation ( ) 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 and are authorised); the 95th percentile of exposure to and 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 or at the maximum reported use levels; the extension of use of (E 1201) to foods for special medical purposes ( 13.2) would result in an exposure of of 4.3 mg/kg bw per day for children; the absorption of and is very low; sufficient toxicity data were available for ; there is no concern with respect to the genotoxicity of and ; no carcinogenic effects were reported in carcinogenicity studies in rats at a dose of 2,500 mg /kg bw per day, the highest dose tested; there is no need for chronic toxicity/carcinogenicity data for for the safety assessment of given the chemical similarity between and , 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 ( s) for and , and that there is no safety concern for the reported uses and use levels of and 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 ( ) and recommended consumption level.