14 February 2006 - SUMMARY: The EFSA has been asked to evaluate polyvinyl alcohol (PVA) as a food additive used as film coating agent for food supplements. Polyvinyl alcohol is a synthetic polymer prepared by the polymerization of vinyl acetate, followed by a controlled hydrolysis of acetate moieties.The physico-chemical properties of PVA vary depending on the degree of polymerization and hydrolysis. The PVA evaluated by the Panel requested by the petitioner is a partially hydrolysed polymer, with an average molecular mass in the range of 26,000 to 30,000 Dalton.
PVA is only minimally absorbed following oral administration and possesses a low order of acute oral toxicity. The safety of PVA is documented by a number of dietarytoxicity studies, including a 90-day oral toxicity study and a 2-generation reproductive toxicity study in the rat and in vitro and in vivo genotoxicity assays, which have been performed with PVA meeting the proposed specifications. There was no evidence of toxicity in either the 90-day or 2-generation studies at the highest dose levels tested of 5000mg/kg bw/day. PVA is neither mutagenic nor genotoxic. There is no evidence to indicate that PVA has carcinogenic activity.
Controlled human studies are limited, but there is a history of use of PVA for several different applications. In particular, PVA is commonly used in film coating formulations for pharmaceutical tablets and capsules in Europe, Japan, and the United States. There is no evidence that such use has resulted in any adverse effects in humans. Generally, the petitioner intends to use PVA for coating of food supplement products in the same way as it is currently used in the pharmaceutical industry. PVA in a typical coating would constitute 1.8% w/w of the coating of the capsule.
Potential human exposures to PVA under intended conditions of use are expected to be low. The highest assumed intake in the range of 1.8 mg/kg bw/day is more than 2,780-fold below the No-Observed-Adverse-Effect-Level (NOAEL) in experimental animals. Considering the potential for additional exposure from pharmaceutical products, for which PVA has already been approved as a coating agent, the combined intake is estimated to be in the range of 4.8 mg/kg bw, this is approximately 1,040-fold below the established NOAEL. These estimates of intake are gross over-estimates as it is extremely unlikely that all food supplements and pharmaceutical products consumed on a daily basis will be coated with PVA-containing film in actual practice. Therefore, the Panel concluded that the consumption of the PVA as specified by the petitioner, through use as a coating agent for food supplement tablets and/or capsules at its intended use level is not of safety concern.