Consultant: Walnut positive health claim opinion is “astonishing”

Friday’s fourth batch of article 13 general function health claims highlighted inconsistencies in the European Food Safety Authority (EFSA) approach, according to Joerg Gruenwald, PhD, the president of German health claims consultancy and CRO, Analyze + Realize.

Gruenwald said the opinion that walnuts could help endothelium-mediated vasodilation (improved blood vessel function), showed “astonishing” reasoning.

This was due to low-powered trials and inconsistent dosages, he said.

Astonishing

“It’s quite astonishing that three clinicals trials conducted on rather small subjects numbers (12-24 particiants) with healthy, type-2-diabetes and hypercholestaeriemic volunteers were accepted for substantiation of the claim,” he observed.

“While 40-65g walnuts per day were consumed during the trials, only 30g of walnuts per day were suggested by EFSA as conditions-of-use for the claim.”

The walnut opinion can be found here. Both walnuts and almonds were shown to maintain normal LDL cholesterol levels though not beyond what could be expected from their fatty acid composition.

Botanical treatment

Gruenwald told NutraIngredients the fact there were opinions at all for the likes of walnuts and pine nut oil (negative), olive oil (negative) and olive polyphenols (positive) meant the agency’s treatment of botanicals remained ambiguous.

“Surprisingly, plant based ingredients like pine nut oil or walnuts have been evaluated although the botanicals were supposed to be put aside for now,” he said in reference to the 2010 EC decision to remove botanicals from the health claims process until a more suitable scientific approach could be found.

“This leaves the industry in a dim light as to what EFSA considers to be a botanical,” Gruenwald reflected.

Race to article 13.4

Nigel Baldwin from Cantox International said the high number of rejections in Friday’s batch would begin a “race” to resubmit reworked dossiers and data under article 13.4 of the nutrition and health claims regulation (NHCR).

“I think the race is on now to decide which of those will be eligible for the list of claims which get a second chance under Article 13.4,” he said.

“The main thing is this list really does mean that full dossiers have to be done, not second rate ones, so I suspect even some of those claims on the second chance list will not have dossiers submitted. We assume that completeness checks are done correctly this time then EFSA’s time will not be wasted on two-page dossiers like they were for food supplements when they were derogated.”

Correction: This article has been amended to reflect the fact the positive walnut claim related to the improved function of blood vessels, not LDL cholesterol levels.