Absorption and gut fate
Studies show that high-molecular-weight polyvinyl alcohol is very poorly absorbed from the gut. The bulk passes through and is excreted. Animal studies found no accumulation in tissues at food-relevant doses. EFSA's ANS panel reviewed the available toxicological data and concluded the substance raised no safety concern at the levels used as a film coating on supplements.
EFSA's Panel on Food Additives and Nutrient Sources (ANS) evaluated polyvinyl alcohol as a food additive for use on food supplements and found no safety concern at the authorised use level of 18,000 mg/kg in the coated product.
2005Regulatory reviewEFSA ANS Panel Scientific Opinion on the safety in use of polyvinyl alcohol as a food additive (E 1203)
A 2014 EFSA statement on a proposed modification to PVA's ethanol-solubility specification concluded the change would not alter the safety assessment already in place.
2014RegulatoryEFSA Journal, Statement on modification of specification on solubility of E 1203 in ethanol
Long-term and repeat-dose toxicology
Animal feeding studies with polyvinyl alcohol have not produced evidence of carcinogenicity, reproductive toxicity, or organ damage at doses far exceeding those from normal supplement use. Because dietary exposure from a tablet coating is extremely small, the margin between the no-observed-adverse-effect level in animals and human intake is very large.
Repeat-dose animal studies included in the original EFSA dossier showed no systemic toxicity, carcinogenicity, or reproductive effects at doses used in food-additive assessment.
2005AnimalEFSA ANS Panel, original safety assessment for E 1203