BioCell collagen gains GRAS

28-Oct-2010 - Last updated on 29-Oct-2010 at 14:23 GMT

BioCell Technology’s collagen ingredient for joints and skin has received generally recognised as safe status from an independent panel following assessment on safety and toxicology and also good manufacturing practices (GMPs).

The patented ingredient, known as Biocell Collagen II, comes from articular cartilage. The three main constituents, collagen type II, chondroitin sulfate, and hyaluronic acid, are reduced to highly-bioavailable, very low molecular weight forms through a hydrolysis process.

This matrix is said to be similar to that in human articular cartilage, and the ingredient is used in value-added products to promote healthy joints and youthful-looking skin.

The independent expert panel concluded that BioCell Collagen II is safe when added into conventional foods and beverages and is therefore exempt from premarket approval under the Food, Drug and Cosmetics Act.

Suhail Ishaq, president of BioCell, told NutraIngredients.com that licensees of the ingredient can use it in a wide range of food products including juices, sports beverages, syrups, breakfast cereals, baked foods, canned foods, soups, food bars, yogurts, and sauces.

He added that the stability profile is “excellent”,and did not note any issues in formulation such as taste and texture.

GRAS affirmation by an expert panel is regarded as a step further than self-affirmed GRAS. Ishaq said the company is prepared to file for FDA GRAS if a particular company requires it.

Results

The latest scientific results on the ingredient were communicated in September, when the company said daily supplementation was seen to be effective in improving measures of joint health in people with osteoarthritis, in a multi-center, double-blind, placebo-controlled trial.

It was associated with significant improvements in measures of joint health, by improving various physical activities, as measured by VAS and WOMAC scores.

"I am particularly excited about these findings because they confirm earlier studies and offers further support that BioCell Collagen II is a safe and effective alternative to prescription drug products,” said Joosang Park, VP of scientific affairs for BioCell. “Qualitative and quantitative outcomes from this study indicate improvement in pain, stiffness, mobility, and overall improvement in quality of life.”