Global probiotics leader Danone continues to prepare for the worst under the European Union’s uber-strict health claims regime that may this year deliver a barren, claimless landscape to the world’s biggest-selling functional food category, an official said today.
Speaking at a Probiotics Summit in Brussels, Danone general food law counsel, Pierre-Hubert Cuijpers, said it was possible that the multi-billion euro, “probiotics category could disappear” as many probiotic strain claim rejections were likely to enter EU lawbooks this year under the article 13 general list.
With the probiotic moniker itself – and potentially individual strains – set to be deemed implied health claims, Cuijpers suggested the whole category may be in search of a new identity, even as he affirmed that Danone remained a supporter of the EU nutrition and health claims regulation (NHCR).
Cuijpers acknowledged that if EU legislative schedules were met, it was possible that this year the use of the term probiotic may only be possible, “after approval by an express authorisation according to the [European] Commission Guidance”.
He affirmed the company stance that the term ‘probiotic’ should not, “necessarily fall within the definition of a health claim” but said either way, “industry will have to adapt its communication following the publication of the final list”.
In the meantime probiotic claim-making could continue depending on existing approvals in individual member states, a fact that hasn’t stopped Danone voluntarily softening much of its own claim-making.
Danone notches more than €4bn in sales for probiotic spoonable yoghurt Activia and drinkable yoghurt Actimel – about a quarter of its overall revenue – sales which have remained steady in European markets even as the EU claims situation has evolved and fed much negative category press including the largest French and international newspapers.
It has twice removed applications around immunity (Actimel) and gut health (Activia) from the EU health claims system, crying foul over a lack of clarity in dossier guidelines and requirements and slammed the European Food Safety Authority for stunted or non- communication tendencies.
Cuijpers said the guidelines remained blurred and the company was prepared to play a waiting game rather than face a high-profile rejection as occurred to probiotic rival, Yakult.
Speaking at the same conference, Professor Ger Rijkers, head of science at the Department of Roosevelt Academy in the Netherlands, criticised EFSA for setting the scientific bar so high, that essentially there was not even a bar.
And that such a methodology stood in complete opposition to standards established in respected, peer-review journals.
“If it was an Olympic Games it would not occur because there would no one who would qualify,” he told the conference. “This is like roulette but you can’t win because every number is zero.”
But other presenters pointed the finger at poorly constructed dossiers and defended EFSA’s right to reject them.
Christine Alexander senior consultant from German consultancy, analyze&realize, observed EFSA, “is very fair and doing a good job and it is the quality of the applications that is the problem.”
Dr Dirk Haller, chair of Biofunctioinality of Food in the departments of Food, Nutrition and Medicine at the Technical University in Munich, Germany, added that, “there have been considerable holes in the dossiers” resulting in, “trust going lower and lower”.
About 70 probiotic dossiers have just re-arrived at EFSA for re-assessment after many of them suffered from strain characterisation issues in their first entry into the system. But most spoken to today in Brussels did not express confidence that any of those dossiers would possess the data power to force a change of heart about probiotics at the scientific agency’s Parma, Italy base.