“We cannot be sure but we’re confident,” spokesperson Raphael Wermurth told NutraIngredients this morning. “The dossier contains five clinical studies, some of which have not yet been published. We have been waiting for the outcome of some of these studies to see if they delivered positive outcomes and so we moved in the summer of 2011 to submit the claim.”
He said the company had not yet received any queries from EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) about the dossier under the nutrition and health claims regulation (NHCR).
The submission comes even as the NDA in October 2010 rejected an article 13.1 dossier linking cocoa flavanols and protection against oxidative damage and the maintenance of normal blood pressure. There the NDA was unimpressed by 10 randomised clinical trials backing the blood pressure claim, saying the data was, “inconsistent.”
That opinion can be found here.
Healthy blood flow
A posting on the EFSA website noted the proprietary and emerging science claim was for cocoa flavanols that could, “help maintain endothelium-dependant vasolidation which contributes to healthy blood flow”.
Dr Mark J Tallon, the managing director of UK-based consultancy and food law experts, Nutrisciences, said he expected the claim bid to be successful.
“It’s not surprising that previous attempts to get a positive opinion from EFSA of flavanols from cocoa has failed as very little evidence exists for blood pressure benefits,” Dr Tallon said.
“However, providing you limit studies based on the specific flavanol and polyphenol content and type (i.e. monomer units), dose, and subject characteristics - strong evidence for flow-mediated dilatation could make a credible submission under 13.5.”
EFSA’s to-date hardline on antioxidants played its part in the delay in Barry Callebaut submitting its claim as it carefully assessed the scientific literature, EFSA guidance and other opinions.
Initially it sought to focus on blood flow, but included ‘endothelium-dependant vasolidation’ because that was what the evidence specifically indicated.
Dr Tallon speculated that the difference between success and failure for the dossier could be the NDA view of some 30 other studies of varying types that provide supporting data to the claim area.
“our own human clinical studies”
Swiss-based Barry Callebaut actually announced its intention to lodge a claim in its 2011 annual report. There it stated: “For more than six years, we have been conducting our own human clinical studies to investigate the potential health benefits of cocoa.”
“Based on the positive results of five clinical studies, finalized last year, we submitted our first dossier in the EU requesting approval of a health claim for products high in cocoa flavanols. We are hopeful to receive approval for various claims to help our customers differentiate their offerings.”