Absorption and what the body does with it
Studies using radiolabelled PVP showed that around 97% of what is swallowed is recovered unchanged in faeces, with very little entering the bloodstream. Because so little is absorbed, systemic exposure from normal food and supplement use is very low. This low absorption is central to the regulatory conclusion that no numerical daily intake limit needs to be set.
Approximately 97% of orally administered radiolabelled PVP was recovered in faeces, indicating very low gastrointestinal absorption.
2020Regulatory reviewEFSA Panel on Food Additives and Flavourings (FAF), Re-evaluation of E 1201 and E 1202
Genotoxicity and carcinogenicity
EFSA reviewed the available laboratory and animal studies and found no evidence of genotoxic or carcinogenic effects. Rat carcinogenicity studies run at the highest dose tested (2500mg per kg body weight per day) produced no tumours attributable to PVP. The panel concluded there was no genotoxicity concern based on in vitro and in vivo data.
No carcinogenic effects were reported in rat carcinogenicity studies at 2500mg PVP per kg body weight per day, the highest dose tested.
2020AnimalEFSA Panel on Food Additives and Flavourings (FAF), Re-evaluation of E 1201 and E 1202
In vitro and in vivo genotoxicity data gave no concern with respect to the genotoxicity of PVP.
2020Lab + animalEFSA Panel on Food Additives and Flavourings (FAF), Re-evaluation of E 1201 and E 1202
Nanoparticle uncertainty flagged by EFSA
EFSA noted it could not rule out the presence of nano-sized particles in some commercial PVP grades, and asked manufacturers to provide characterisation data. Nano-sized particles can behave differently in the body from bulk material, so the panel flagged this as an open specification question rather than a confirmed harm. This is a data gap rather than a demonstrated safety problem.
EFSA could not exclude the presence of nano-sized particles in tested PVP materials and requested appropriate characterisation data from industry.
2020Regulatory reviewEFSA Panel on Food Additives and Flavourings (FAF), Re-evaluation of E 1201 and E 1202
Specification impurities
EFSA recommended tightening the chemical specifications for PVP to set limits on impurities including 2-pyrrolidone, peroxides, formic acid, and several heavy metals. The panel also recommended lowering the existing lead limit. These are manufacturing quality controls, not signals from consumer exposure data.
EFSA recommended adding specification limits for 2-pyrrolidone, peroxide content, formic acid, triethanolamine formate, and heavy metals including arsenic, cadmium, mercury, and lead in PVP used as a food additive.
2020RegulatoryEFSA Panel on Food Additives and Flavourings (FAF), Re-evaluation of E 1201 and E 1202