EFSA health claim opinion

Clasado ‘surprised and disappointed’ by latest EFSA prebiotic rejection; promises action

By Shane STARLING contact

- Last updated on GMT

Related tags: Nutrition, Amino acid, Insulin

Clasado prebiotic claims rebuffed again. Firm continues to fight
Clasado prebiotic claims rebuffed again. Firm continues to fight
UK prebiotic specialist Clasado will contest the latest rejection of its gut health prebiotic science by the European Food Safety Authority (EFSA).

The firm was “surprised and disappointed” ​by the latest scientific rebuff, which came after dialogue with the agency during stop-the-clock procedures in the assessment process.

The company will respond with, "a number of areas of concern regarding the EFSA assessment itself”, ​Clasado said.

PR Neil Hunter told us “eyebrows had been raised” and the company would respond in the 30-day period for comments afforded to applicants after EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA)  hands down its verdicts.

Clasado believed it had a strong chance to win the EU’s forst prebiotic health claim due to the presence of a new, unpublished intervention trial involving more than 400 subjects across four European nations.

Too subjective?

But theNDA said the gut health assessment methods were too subjective.

“…a combined measure of efficacy which would indicate whether the intervention provided adequate relief of symptoms of gastro-intestinal discomfort, was not assessed, and that measures of individual gastro-intestinal symptoms through validated questionnaires may only be used as supportive evidence for the scientific substantiation of health claims on the reduction of gastro-intestinal discomfort,”​ the panel said.

Bimuno is Clasado’s trademarked transgalactooligosaccharide.

The opinion can be found here​.

White kidney bean & weight loss


Also rejected by EFSA this week was a submission from InQpharm Europe in the UK linking white kidney bean (Phaseolus vulgaris ​L.) and weight loss. Four human intervention trials did not sway the NDA which concluded of the key study that while it showed a weight loss effect, it was, “at risk of bias.”

It added a supporting study, “suffered from methodological limitations and that no evidence was provided for a mechanism by which the standardised aqueous extract from white kidney bean could exert the claimed effect.”

That opinion is here​.


Swedish firm DoubleBad was also rejected for a submission for a insulin response influencing formulation containing L-threonine, L-valine, L-leucine, L-isoleucine, L-lysine and chromium picolinate.

Double Bad said the blend could stimulate, “insulin release via the insulinogenic properties of the amino acids in the food”.

The NDA said, “the evidence provided by the applicant does not establish that a reduction in post-prandial glycaemic responses achieved by an increase in insulin secretion is a beneficial physiological effect for the target population in the context of this application.”

The opinion is here​.

Related news

Show more

Related products

show more

Going Organic: a new chapter in supplements

Going Organic: a new chapter in supplements

INNOBIO Corporation Limited | 21-Sep-2020 | Data Sheet

"Organic" is more of a healthy lifestyle. Rising consumer awareness of organic products and widening availability are two major drivers of global...

Time to rethink your probiotics for infant use

Time to rethink your probiotics for infant use

Morinaga Milk Industry Co., Ltd. | 17-Sep-2020 | Technical / White Paper

Undoubtedly, probiotics-fortified infant nutrition products have hit the mainstream, and a baby-friendly concept is on the consumer radar. Morinaga's...

Loading up on carb science

Loading up on carb science

FrieslandCampina Ingredients | 17-Sep-2020 | Technical / White Paper

In a world where everyone seems to be telling consumers to cut back on carbs, from a food industry point of view, there is an education job to be done...

Related suppliers

Follow us


View more