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Danone awaits EFSA guidance on probiotic health claims

By Shane Starling , 20-Apr-2009

French dairy giant Danone has withdrawn claims from the controversial EU nutrition and health claim process because it is waiting for procedural guidance from the claims assessment agency, the European Food safety Authority (EFSA).

Danone issued a statement to that effect on Friday evening after NutraIngredients.com revealed it had pulled from the process two article 13.5 gut health claims for its spoonable probiotic yoghurt, Activia, and one 13.5 immunity claim for its drinkable yoghurt, Actimel.

Still learning

Danone said companies were still in a “learning stage” about the “new and complex procedure” and that, while it remained confident about the strength of its claims, it decided it was better to remove the claims from the process until further guidance was issued by EFSA, due by mid-May.

Groupe Danone corporate communications director in health, nature and external communication, Agnès Berthet-d'Anthonay, said the regulation was not clear in its demands on companies and that it was, “better to know the rules before playing the game”.

She said once this clarification occurred the company would resubmit its dossiers, with potential changes occurring in claim wording.

“We will not change the studies that are in the dossiers but it may be that the way the information is presented needs to be changed and the wording may have to be modified,” Berthet-d'Anthonay told NutraIngredients.com this morning.

“It is a difficult thing to find the correct wording and that has contributed to the fact no article 13.5 claims have as yet been accepted by EFSA. But we are very confident about the strength of our science.”

The three withdrawn claims are:

· Improves digestive comfort (Activia)

· Improves slow transit (Activia)

· Helps to strengthen the body’s natural defences (Actimel)

These claims are already employed on its products so to have this communication tool stripped from it would be a massive body blow for Danone, not to mention the bad publicity that could follow any EFSA negative opinion.

Danone said its dossiers contained 24 scientific publications for Actimel, and 16 for Activia, published in “highly reputed scientific journals”.

Further guidance from EFSA

EFSA is holding a health claims summit in Brussels on June 15 and is in the process of publishing a FAQ (Frequently Asked Questions) document, but when contacted by NutraIngredients.com this morning would not reveal any detail about the kind of clarification that would be forthcoming in both the FAQ and the Brussels meeting.

In a statement on its website, EFSA said: “In the light of the experience gained with the evaluation of health claims applications, EFSA will provide further guidance to applicants for the preparation and presentation of applications for Article 14 and 13.5 claims in the form of a document outlining answers to FAQ.”

That statement can be viewed here .

“EFSA has recently decided to call a meeting in order to provide further guidance to applicants for the preparation and presentation of applications for Article 14 and 13.5 claims,” Danone said in Friday’s statement.

“In this context, Groupe Danone has - like several other industry players - decided to withdraw three applications... We welcome the new process and remain committed to working with EFSA.”

Danone is not the first major food or ingredients supplier to pull out of the European claims process. In the article 14 disease reduction and children’s claims list, something like 10 claims have been withdrawn from the likes of Nestle, Unilever and Valio as well as the Irish Dairy Council and the France-based Association of the Food Industries for Particular Nutritional Uses of the European Union (IDACE).

The 2006 nutrition and health claims regulation aims to formulate a centralised health claims list under the nutrition and health claims regulation that is due for completion in January, 2010.

Activia and Actimel, and versions of them that sell under different names in different markets, are some of the most successful functional foods in the world, with sales in the billions of euros.

US 'misleading' claims case

Meanwhile, last week it emerged that Dannon, the US arm of Danone, is settling class actions mounted against it for making misleading probiotic health claims.

Dannon spokesperson, Michael Neuwirth told NutraIngredients-USA.com that “we stand by our claims and will continue to defend them” but refused to deny that Dannon was settling out-of-court in class actions that sought at least $300m.

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