Food, drink and supplement makers across the European Union’s 27-member states are free to make cholesterol-lowering health claims after an oat beta-glucan health claim passed into EU law books yesterday.
The final claim, based on a disease reduction, article 14, European Food Safety Authority (EFSA) positive health claim opinion, permits cholesterol reduction claims on foods containing 1g of beta glucans with 3g recommended per day to gain the benefit.
But claims for soy protein (cholesterol lowering) and a Danone probiotic strain (Lactobacillus casei DN-114 001) seeking to link a reduction in acute diarrhea are now officially rejected as health claims across the bloc.
The three finalised health claim verdicts can be found here.
The beta-glucan claim applicant, Swiss supplier CreaNutrition, welcomed the news, saying it “does make a difference” that the EFSA opinion was now law.
“An opinion is one thing but it needs to be written into the law,” managing director Ruedi Duss told NutraIngredients. “So this is the last part of a long process that began more than four years ago. It will be a very good and convincing tool in helping people understand what beta-glucans are and how they can help health.”
He said the ingredient now had the legal backing to compete with cholesterol-lowering, market leading plant stanols and strerols.
“It is very important to have a clear regulatory situation for our dealings with both multinationals and smaller companies.”
He said beta-glucans had received another boost in the summer when the European Society of Cardiology and European Arteriosclerosis Society recommended them as being beneficial to heart health and cholesterol levels.
The European Natural Soyfoods Manufacturers Association (ENSA) said there was nothing that significant in the rule-making as it had known in the summer via European Commission meetings that there was little change likely to occur to EFSA’s 2010 negative ruling for a cholesterol-lowering claim.
It has already resubmitted an article 14 claim which is yet to be ruled upon by EFSA’s health claims panel.
“We fully believe the claims are scientifically valid,” an ENSA spokesperson told NutraIngredients.
In the meantime it is advising its member base of 11 soy food manufacturers including European market leader Alpro, Finnish company Raisio as well as Hain Europe, that as of yesterday, all soy protein-cholesterol lowering claims are now against EU law.
There is no six-month transition period for article 14 and article 13.5 claims as there is for general function article 13.1 claims that are set to enter the law books in the first quarter of 2012.
In a statement made in the summer, ENSA said: “In the new application, the applicants have taken into account comments previously received from EFSA and provided a clearer charactersisation 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.”
The other joint-applicants for the soy claim are the Soya Protein Association (SPA) and the European Vegetable Protein Federation (EUVEPRO).