Absorption and excretion
Because PVP/VA is a high-molecular-weight polymer, the gut does not absorb it to any significant extent. Animal studies show it is largely excreted intact in the faeces. This limited absorption is central to the regulatory assessment that dietary exposure from supplement use is very low.
PVP/VA copolymer is poorly absorbed orally and is largely excreted intact in the faeces in animal studies.
2010AnimalEFSA ANS Panel, Scientific Opinion on the safety of polyvinylpyrrolidone-vinyl acetate copolymer (EFSA Journal 2010;8(12):1948)
Animal toxicology
Long-term animal feeding studies in rats (24 months) and dogs (52 weeks) found no adverse effects at very high doses, well above any realistic human exposure from food supplement use. The studies established high no-observed-adverse-effect levels. The toxicological database was considered too limited for EFSA to set a formal numerical ADI, but a calculated margin of safety was assessed as acceptable.
Oral administration to rats for 24 months and to dogs for 52 weeks produced no-observed-adverse-effect levels of 2800 mg/kg body weight/day and 2500 mg/kg body weight/day respectively, at the highest doses tested.
2010AnimalEFSA ANS Panel, Scientific Opinion on the safety of polyvinylpyrrolidone-vinyl acetate copolymer (EFSA Journal 2010;8(12):1948)
The calculated margin of safety from realistic food supplement use ranged from approximately 43 to 120 for adults and 63 to 175 for children, which EFSA considered acceptable.
2010Regulatory reviewEFSA ANS Panel, Scientific Opinion on the safety of polyvinylpyrrolidone-vinyl acetate copolymer (EFSA Journal 2010;8(12):1948)
Hydrazine residue
The manufacturing process for PVP/VA can leave trace amounts of hydrazine, a genotoxic impurity. The EU approved the additive on the condition that hydrazine residue in the final food product does not exceed 1.0 mg/kg. EFSA assessed this limit as unlikely to present a concern given the small amounts used in supplement tablets and the infrequent intake typical of supplement users. However, the data package reviewed was limited, and the hydrazine specification is a condition of authorisation, not a clean bill of health.
Hydrazine, a genotoxic impurity from manufacture, was proposed at a maximum residue level of 1.0 mg/kg in the final product. EFSA concluded this was unlikely to present a safety concern at the proposed use levels.
2010Regulatory reviewEFSA ANS Panel, Scientific Opinion on the safety of polyvinylpyrrolidone-vinyl acetate copolymer (EFSA Journal 2010;8(12):1948)