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

Maged Younes, Gabriele Aquilina, Laurence Castle, Karl-Heinz Engel, Paul Fowler, Peter Fürst, Rainer Gürtler, Ursula Gundert-Remy, Trine Husøy, Melania Manco, Wim Mennes, Peter Moldeus, Sabina Passamonti, Romina Shah, Dina Hendrika Waalkens-Berendsen, Detlef Wölfle, Matthew Wright, Polly Boon, Riccardo Crebelli, Alessandro Di DomenicoMetka Filipič, Alicja Mortensen, Ruud Woutersen, Henk Van Loveren, Alessandra Giarola, Federica Lodi, Ana Maria Rincon, Alexandra Tard, Maria Jose Frutos Fernandez, EFSA Panel on Food Additives and Flavourings (FAF)

Research output: Contribution to specialist publicationArticle

Abstract

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 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 (ADIs) 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.
Original languageEnglish
Pagese06215
Number of pages43
Volume18
No.8
Specialist publicationEFSA Journal
DOIs
Publication statusPublished - Aug 2020

Keywords

  • polyvinylpyrrolidone
  • E 1201
  • polyvinylpolypyrrolidone
  • E 1202
  • food additives
  • foods for special medical purposes

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