Further lycopene safety trials necessary, says EFSA

Lycopene, obtained from tomatoes, has been available for a number of years, though it is most commonly used in concentrated form as a food colour (E160d), falling under legislation for additives.

This restricts the amount that can be added to foods.

Most recently, EFSA's scientific panel on dietetic products, nutrition and allergies evaluated the use of oil suspensions of lycopene obtained from the fungus Blakeslea trispora for use as a novel food ingredient.

The panel found that proposed use levels of lycopene from the fungus B. trispora as a food colour may increase substantially the daily intake of lycopene compared to intakes solely from natural dietary sources.

While the toxicity data on lycopene from B. trispora and on lycopene from tomatoes did not give indications for concern, EFSA said that such data was limited and therefore did not allow the establishment of an Acceptable Daily Intake (ADI).

The EFSA panel also noted that the range for potential additional intake from the proposed use levels as a food colour exceeds the range for the mean intake from natural dietary sources by a considerable margin.

Food makers in Europe have already been given the go-ahead to use lycopene produced in tomatoes in amounts of 5mg per serving, thought to be the dose required to produce a health benefit. This carotenoid, found in red fruits and vegetables, has been shown to be a powerful antioxidant, with trials demonstrating protective effects against heart disease and prostate cancer.

Regular intakes of lycopene from natural dietary sources in different populations are, according to dietary surveys, estimated to be on average between 0.5 and 5 mg/day, with high intakes up to about 8 mg/day.

The EFSA panel suggested that high consumption of fruits and vegetables, especially tomato products, may result in occasional intakes of 20 mg lycopene/day or more.

Lycopene is biosynthesised by the fungus B. trispora through the same pathway as lycopene produced in the tomato. The predominant lycopene isomer in the material is all-trans lycopene.

The lycopene is formulated into a 20 per cent or 5 per cent sunflower oil suspension with a-tocopherol at 1 per cent of the lycopene level, and is also available as a a-tocopherol-containing 10 per cent and 20 per cent lycopene cold water dispersible (CWD) product.