Responding to a proprietary dossier submitted by Spanish omega-3 specialist, Brudy Technology, in regard to its ingredient, Algatrium, EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) concluded causality between the ingredient and boosted antioxidant activity had not been demonstrated and so rejected the claim.
The NDA found only two of five submitted human trials used Algatrium as well as one of 13 in vitro trials, and took issue with the other studies it deemed relevant, all of which were unpublished.
The two clinical studies related to cyclists being administered Algatrium, but the NDA said the selected biomarkers (8-hydroxy-2'-deoxyguanosine), were not reliable indicators of DNA damage.
“The Panel also considers that the evidence provided does not establish that a reduction of 8-OHdG excretion indicates a beneficial change in function,” the NDA said.
It did not go into detail about why the in vitro study was rejected.
Brudy has spent eight years developing Algatrium, which won the bronze award for innovation at Health Ingredients Europe (HIE) in November.
The Barcelona-based company’s marketing manager, Francisco Gasso, told NutraIngredients.com the company disputed EFSA’s verdict and would be submitting further evidence in the 30-day window it has to respond.
He said the re-submission would highlight the opinion of oxidation experts and focus on correcting the NDA’s opinion that the biomarkers employed in some of Brudy’s submitted trials were irrelevant as a measure of in vivo antioxidant activity.
He highlighted the fact the ingredient was FOSHU (Foods for Special Health Uses) in Japan and GRAS-certified in the US.
“This decision is not correct,” Brasso said. “This is a political decision. We will submit further information to have this opinion changed.”
Brudy’s submitted claim stated: “Algatrium promotes your antioxidant response: a singular nutritional substance that has scientifically demonstrated in humans a stimulation of the own cells antioxidant defences”.
The claim targeted the general population and recommended consuming between 500mg and 1500mg per day for three months or more in healthy people in the form of food supplements. For shorter consumption periods, a maximum of 3500mg per day was recommended.
Algatrium contains 67 per cent docosahexaenoic acid (DHA) and 10 per cent eicosapentaenoic acid (EPA) as well as other long-chain fatty acids.
The European Union is attempting to formulate a centralised list under the nutrition and health claims regulation that is due for completion in January, 2010. To date EFSA has published around 50 opinions of a list containing more than 4000 claims.
Article 13.5 claims relate to proprietary science as opposed to article 13.1 claims which are more generic and article 14 claims which related to children’s and disease reduction. To date most of EFSA’s opinions have been drawn from the article 14 list.
To view the NDA’s opinion click here.