EFSA approves food supplement coating agent

The European Food Safety Authority (EFSA) was 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 polymerisation of vinyl acetate, followed by a controlled hydrolysis of acetate moieties. EFSA found that the physico-chemical properties of PVA vary depending on the degree of polymerisation and hydrolysis.

The food supplements sector has enjoyed rapid growth in recent years. Consumers now have a far greater understanding of nutrition and disease prevention, and are increasingly willing to self-medicate.

The European supplements market was estimated to be worth 5.2 billion in 2005, with growth rate expected to peak at 4.4 percent over this year before dropping to a steady 4.1 percent for the subsequent five years. By 2011, the market is predicted to be worth around 6.6 billion.

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 per cent w/w of the coating of the capsule.

Potential human exposures to PVA under intended conditions of use are expected to be low. 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 at its intended use level is not of safety concern.