“We had to understand what EFSA was looking at and we have done a very close analysis of that in preparing this new dossier,” European Vegetable Protein Federation (EUVEPRO) secretary general Jean-Christophe Kremer told NutraIngredients this morning. “It is hard to read EFSA but we are confident about this submission.”
EFSA health claims panel last August rejected much of the evidence in the article 14 disease risk factor reduction dossier submitted by EUVEPRO along with the European Natural Soyfoods Manufacturers Association (ENSA) and the UK Soy Protein Association (SPA), because it said documented health benefits could be attributed to other soy components than protein, such as isoflavones.
With this in mind the new claim wording broadens beyond ‘soy protein’ to state: “Protein-rich soybean components have been shown to lower-reduce blood cholesterol; blood cholesterol lowering may reduce the rate of (coronary) heart disease.”
Hard to tell
The UK-based consultant behind the original and fresh submission, Janice Harland, Phd, from HarlandHall, said the new submission contained some of the same science as the old one, with the addition of one new meta-analysis, but it had been presented with the rejected learnings in mind and within the criteria and scope of the new claim wording.
“It is 2.5 years since the original submission so it is not absolutely the same,” she told this publication. “There have been different criteria to select the studies to support the claim. But I didn’t agree with the verdict of the Panel last time, I thought it was disingenuous, and so I wouldn’t like to predict the outcome here. And that does not just relate to the soy claim. A number of their article 13 opinions have not been consistent.”
"Previously they gave a very specific interpretation of what soy protein is that is out of step with authorities around the world. So we’ll see.”
EFSA’s Panel on Dietetic Products Nutrition and Allergies (NDA) has three months to assess the claims if no stop-the-clock procedures are employed.
In a statement ENSA said: “In the new application, the applicants have taken into account comments previously received from EFSA and provided a clearer characterisation of the food constituent on which the claim is made. ENSA hopes that this adapted characterisation will allow the Panel to review the entire scientific evidence of the application dossier and is confident that the NDA Panel will consider approval of the health claim in the framework of the new evaluation procedure.”
Soy-cholesterol lowering claims are approved in Japan, the US, the UK, South Africa, the Philippines, Brazil, Indonesia, Korea, Malaysia and Turkey.
The NDA’s initial article 14 opinion can be found here.