Enzymotec achieves GRAS for PS in foods

Following the green light, the company today announced that it plans to publish results of three human clinical trials made on PS in the next few months.

PS (phosphatidylserine) is a phospholipid that occurs naturally in the organs such as brain, liver and kidneys.

It plays an important role in regulating the functionality of key proteins in cell membranes, and has been shown to have a role in slowing or even reversing some forms of age-related cognitive deteriorations - such as short term memory and the capacity to learn new tasks.

So far, Enzymotec's Sharp-PS product has been used as a supplement for the last 20 years to improve memory, concentration and other cognitive capabilities, especially for the aged population.

"We believe that PS can expand into functional foods in the near future and a GRAS determination was the first step to enable that," said Enzymotec's Iris Meiri-Benedek, Enzymotec regulatory affairs manager.

"What makes this product unique is the fact that it is GRAS for use in its active dosages that will allow functional food manufacturers to introduce an efficacious level of PS in their finished products, thus extending their flexibility and the message they will eventually be able to make for their products."

The company said it has already tested the ingredient in chocolate and dairy applications, and has achieved positive taste and texture results.

According to Enzymotec, there are fears that the modern diet, in particular low fat and vegetarian choices, lead to low PS consumption and may lead to worse-than-normal brain function in old age.

The firm believes there is currently a strong market for the cognitive category, especially among older consumers, but with room to grow into niches affecting other age groups.

In US market for cognitive supplements alone is estimated to be worth around $350m. Last year, the firm's SharpPS gold, a PS-DHA conjugate, entered a US supplement for the first time with the reformulation of Cognitex from Life Extension.

Cognitex is a supplement marketed as providing 'advanced brain protection'.

Since its original launch in 2000 the product has been reformulated several times to take advantage of the latest developments in ingredients for cognitive function Initially PS was sourced from bovine brains, but fears over 'mad cow disease' led the industry to prefer soy lecithin-derived PS.

Although it has a different fatty acid composition, the effect on cognition has been shown to be similar.