About
Polyvinylpyrrolidone (PVP) is a synthetic, water-soluble polymer used in food as a clarifying agent (e.g., in beer and wine), a tablet binder in food supplements and special medical foods, and a stabiliser. It is poorly absorbed from the gastrointestinal tract and is largely excreted unchanged in faeces.
Safety summary
EFSA's 2020 re-evaluation concluded there is no safety concern at reported use levels and no numerical ADI is required, given very low gastrointestinal absorption and the absence of genotoxic or carcinogenic effects up to 2,500 mg/kg bw/day in animal studies. The small absorbed fraction is primarily eliminated via the kidneys, warranting caution in individuals with severe renal impairment. No broad sensitive-population warnings have been issued by major regulatory bodies.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | Authorised under Regulation (EC) No 1333/2008 (Annex II) in food supplements and, from Commission Regulation (EU) 2022/1038, also in foods for special medical purposes (FC 13.2) as a tablet binder/stabiliser. No numerical ADI established; EFSA 2020 found no safety concern at reported use levels. Lead limits in EU specifications recommended to be lowered; data on potential nanoparticles also requested.source |
| FDA (Food and Drug Administration) (United States) | Approved | Permitted as a clarifying agent under 21 CFR 173.55 and listed as an indirect food additive/food contact substance under 21 CFR parts 175–178. No numerical ADI set by FDA.source |
Who should approach with care
Research citations
- 1WHO. WHO/FAO JECFA Combined Compendium of Food Additive Specifications – Polyvinylpyrrolidone. apps.who.int
- 2FDA. 21 CFR 173.55 – Secondary Direct Food Additives Permitted in Food for Human Consumption: Clarifying Agents. accessdata.fda.gov
- 3other. Commission Regulation (EU) 2022/1038 of 29 June 2022 amending Annex II to Regulation (EC) No 1333/2008 as regards the use of polyvinylpyrrolidone (E 1201) in food for special medical purposes, 2022. eur-lex.europa.eu
- 4EFSA. Re-evaluation of polyvinylpyrrolidone (E 1201) and polyvinylpolypyrrolidone (E 1202) as food additives and extension of use of polyvinylpyrrolidone (E 1201), 2020. efsa.europa.eu
- 5PubMed. Re-evaluation of polyvinylpyrrolidone (E 1201) and polyvinylpolypyrrolidone (E 1202) as food additives and extension of use of polyvinylpyrrolidone (E 1201), 2020. pubmed.ncbi.nlm.nih.gov