Scientific Opinion on the safety of polyvinylpyrrolidone‐vinyl acetate copolymer for the proposed uses as a food additive

Abstract

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion on the use of polyvinylpyrrolidone-vinyl acetate (PVP/VA) copolymer in food supplements. PVP/VA copolymer is poorly absorbed orally and largely excreted intact in the faeces. No genotoxicity data are available. Both a 28-day and a 90-day feeding study with PVP/VA copolymer in the rat, revealed a NOAEL of 1000 mg/kg bw/day (highest dose tested). Oral administration of PVP/VA copolymer to male/female rats for 24 months and to male/female dogs for 52 weeks revealed NOAELs of 2800 mg/kg bw/day and 2500 mg/kg bw/day respectively (highest doses tested). No reproductive or developmental toxicity data are available. The exposure to PVP/VA copolymer from its use in food supplements and in pharmaceuticals is 23.4 mg/kg bw/day (adult high consumers) and 16 mg/kg bw/day (child high consumers). The toxicological database was too limited to derive an ADI. From the given range of NOAELs and the intake of PVP/VA copolymer, a Margin of Safety (MOS) varying from 43 to 120 for adults and from 63 to 175 for children can be calculated. These MOS are considered sufficient given the lack of absorption of PVP/VA, the fact that the NOAELs were the highest doses tested and that exposure estimates are based on worst case assumptions. From the maximum residual levels of VA, Margins of Exposure (MOE) of > 10 6 were calculated. The MOE for hydrazine were above 10000. The Panel concluded that the residual levels of hydrazine (up to a maximum of 1.0 mg/kg in the final product) are unlikely to be of safety concern, but considered it would be prudent to lower the level of hydrazine as far as reasonably achievable. The Panel concluded that the use of PVP/VA copolymer in solid food supplements as a binding/coating agent is unlikely to be of safety concern at the proposed uses. © European Food Safety Authority, 2010 KEY WORDSPolyvinylpyrrolidone-vinyl acetate copolymer, CAS Registry Number 25086-89-9, vinyl acetate; polyvinylpyrrolidone; copolyvidon; copovidone; 1-vinyl-2-pyrrolidone-vinyl acetate copolymer; 2-pyrrolidinone, 1-ethenyl-, polymer with ethenyl acetate. SUMMARYFollowing a request from the European Commission, the Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion on polyvinylpyrrolidone-vinyl acetate (PVP/VA) copolymer when used as a food additive.The present opinion deals with the safety of PVP/VA copolymer for use in food supplements in tablet form as a binding/coating agent in an amount of up to 10% of weight per tablet, for a tablet weight of 1000 mg.PVP/VA copolymer is a copolymer produced by polymerisation of the monomers N-vinyl-2-pyrrolidone (NVP) and vinyl acetate (VA). The substance will be used in food supplement tablets as a binding agent and as a coating agent.No absorption, distribution, metabolism and excretion (ADME) studies were provided by the petitioner. It is reported in literature that PVP/VA copolymer, given its high weight average molecular weight of about ...

Impact of Polyvinylpyrrolidone-Vinyl Acetate Copolymer and Sodium Starch Glycolate Excipients on Phenolic Extraction from Red Clover: Enhancing Biological Activity and Antioxidant Potential

“…PVP/VAC is a commonly used excipient in the pharmaceutical industry. It is soluble in both water and alcohol and is valued for its ability to improve the solubility of poorly soluble compounds by reducing particle size and increasing surface area for dissolution [ 22 ]. The copolymer can serve as a carrier or stabilizer for drug molecules, averting aggregation and maintaining an amorphous state that is conducive to dissolution and absorption in the body [ 23 ].…”

“…The copolymer can serve as a carrier or stabilizer for drug molecules, averting aggregation and maintaining an amorphous state that is conducive to dissolution and absorption in the body [ 23 ]. Daily dosage recommendations stand at 100 mg per tablet (10% in a 1000 mg tablet) for high consumers, with anticipated exposures of 200 mg PVP/VAC/day for children and 700 mg PVP/VAC for adults [ 22 ]. Comprising 1-vinyl-2-pyrrolidone and vinyl acetate in a 6:4 mass ratio, the current literature on PVP/VAC indicates solid dispersion preparation as a predominant approach to enhance the solubility and bioavailability of water-insoluble drugs [ 24 , 25 , 26 ].…”