Polivinilpirolidon (PVP)

Detailed information

What it is & how it is made

A linear homopolymer of the N-vinyl-2-pyrrolidone monomer (polyvinylpyrrolidone, PVP); its chemical formula is (C6H9NO)n and EFSA reports a minimum molecular weight of 25,000 g/mol. It is soluble in water and ethanol. It is produced by free-radical polymerisation in high-purity water with hydrogen peroxide, ammonium hydroxide and copper catalysts.

Where it is used

Used as a binder, stabiliser and tablet coating agent. Under EU Regulation (EC) No 1333/2008 it is authorised at quantum satis in solid food supplements (tablets and coated tablets only) and in table-top sweeteners in tablet form.

Health note

In its 2020 re-evaluation (EFSA Journal 2020;18(8):6215) EFSA concluded that there was no need for numerical acceptable daily intakes (ADIs) for PVP (E 1201) and PVPP (E 1202) and identified no safety concern for the reported uses, citing very low absorption, no concern for genotoxicity and no adverse effects at the highest dose tested for PVP (2,500 mg/kg body weight per day). The Panel also recorded data gaps: the presence of nanoparticles could not be excluded, chronic toxicity and carcinogenicity studies were absent for PVPP, and reproductive toxicity studies were absent for both additives. The Panel recommended lowering the lead limit and adding limits for arsenic, cadmium, mercury, chromium, cobalt, copper and nickel in the EU specification.

Halal assessment

It is an entirely synthetic polymer; its monomer is N-vinyl-2-pyrrolidone and no animal input is reported in the EFSA opinion. Consult the manufacturer's halal certificate for a definitive answer.