The FDA approval allows Israeli firm LycoRed to market its natural lycopene Tomat-O-Red as a natural colorant for foods and beverages.
"This FDA approval is important for us since it opens an additional marketing channel in the US, and creates new business opportunities," said LycoRed chief executive Morris Zelkha.
"Thanks to its beneficial attributes, Tomat-O-Red has great potential and we anticipate significant share in the red food colorant market."
In Europe, Lycopene still falls under legislation for additives, and is known as food colour E160d. This restricts the amount that can be added to foods.
"Lycopene has been allowed as a colorant for a long time, and is a registered colorant," Joost Overeem, Lycopene Europe product manager, told FoodNavigator.
"We would obviously want to have official legislation recognising lycopene as a natural ingredient, but for the time being, there is no such legislation in place. This of course does not mean that it is not allowed.
"Such regulation would be our goal, but you can't always force the EU to make these decisions quickly."
LycoRed says that in contrast to other natural colorants available on the market, Tomat-O-Red is ready-to use, and highly stable under a wide range of temperatures and the colour does not shift with changes in pH. The product is available as a liquid dispersion or a cold-water dispersible powder.
It can be used to colour a variety of food and beverage products, including beverages, dairy products, confectionery products and baked goods.
The market for natural and synthetic food colourings together is estimated at $1 billion. LycoRed claims that the usage of synthetic colorants appears to be declining in favour of natural colorants.
The natural food colorant market is estimated at $250 million, with red accounting for $30 to $40 million. LycoRed's sales have shown strong growth in Japan, which approved lycopene formulations as food colorants several years ago.
Tomat-O-Red, derived from tomato lycopene, is claimed to provide health advantages along with its function as a colorant. It is thought to be a powerful antioxidant.
The product is produced with lycopene extracted from a proprietary variety of non-GMO, lycopene-rich tomatoes.
Strong demand from Japan for this colour helped boost sales growth over the last year. Parent company Makhteshim Agan reported recently that it had seen an increase of 17.6 per cent in sales of its non-agro products (LycoRed and a hydrogen peroxide and other business) to $151.7 million for the first nine months of the year. This growth"mainly stemmed from an increase in LycoRed's sales," it said.