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

polyvinylpyrrolidone, E 1201, polyvinylpolypyrrolidone, E 1202, food additives, foods for special medical purposes
First published in the EFSA Journal
10 Agosto 2020
Adopted
1 Julio 2020
Type
Scientific Opinion

Note: The full opinion will be published in accordance with Article 8 of Regulation (EU) No 257/2010 once the decision on confidentiality will be received from the European Commission.

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% 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 (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.

Substances
Polyvinylpyrrolidone
Cas: 9003-39-8
Polyvinylpyrrolidone
Cas: 9003-39-8

Panel members at the time of adoption

Gabriele Aquilina, Laurence Castle, Karl‐Heinz Engel, Paul Fowler, Maria Jose Frutos Fernandez, Peter Fürst, Rainer Gürtler, Ursula Gundert‐Remy, Trine Husøy, Melania Manco, Wim Mennes, Sabina Passamonti, Peter Moldeus, Romina Shah, Dina Hendrika Waalkens‐Berendsen, Detlef Wölfle, Matthew Wright and Maged Younes.
Panel on Food Additives and Flavourings
Contact
fip [at] efsa.europa.eu
doi
10.2903/j.efsa.2020.6215
EFSA Journal 2020;18(8):6215
On request from
European Commission