Danone to resubmit bolstered article 13.5 dossiers

By Shane Starling

- Last updated on GMT

Related tags: Probiotic health claims, Probiotic

Danone will resubmit withdrawn article 13.5 European Union probiotic health claims by year’s end with additional trials added to the dossiers to strengthen their claims, according to a health claims expert working with the company.

Studies such as one published this month in the British Journal of Nutrition ​that showed gut health benefits among a healthy population of women would boost Danone’s claims, said Cédric Bourges-Sevenier, general manager of the French consultancy, Nutraveris.

“The three withdrawn claims will be resubmitted by year’s end,”​ Bourges-Sevenier told NutraIngredients.com in a discussion about health claims. “Danone has some new studies onboard and they will strengthen its case.”

Danone head of vice president of external affairs and head of EU regulatory affairs, Patrick O'Quin, last week said the company was on the brink of resubmitting claims but first wanted to see European Food Safety Authority (EFSA) guidance stemming from its June stakeholders meeting.

An EFSA spokesperson could only say that guidance would be published “soon”.

Danone was unavailable for comment at the time of publication.

Additional backing

The British Journal of Nutrition ​study should add to the strength of Danone’s gut health argument that is central to two of its three article 13.5 claims relating to its spoonable probiotic yoghurt, Activia.

It showed gastro-intestinal well-being was improved by about 70 per cent in about 200 women with mild intestinal discomfort when they consumed Activia fortified with Bifidobacterium lactis​ DN-173 010-containing .

To read NutraIngredients.com’s coverage of that study click here​.

Danone’s other withdrawal was an immunity claim for the drinking yoghurt, Actimel, for which Bourges-Sevenier said other studies were close to completion.

Generic opionions

Bourges-Sevenier said the probiotics industry was waiting for the publication of the first batch of article 13.1 generic claims, which was likely to include some of the 300 or 400 probiotic strains on the list, due by the end of September.

But he said many of the claims were being withdrawn because they were too specific to lie on the generic list and were to be resubmitted on the article 13.5 list, especially in the case of probiotic blends.

He said a similar situation was occurring in regard to a number of herbal products owned by clients of Nutraveris, which has advised on more than 20 health claim dossiers.

Danone’s US arm, Dannon, completed an out of court settlement yesterday in which it agreed to remove the word “immunity” ​from on-package marketing from its DanActive drinking yoghurt product.

It has also set up a fund to pay $35m to disgruntled consumers.

For more on that, click here​.

Related news

Show more

Related products

show more

Whitepaper: Optimizing immunity with vitamin D

Whitepaper: Optimizing immunity with vitamin D

DSM Nutritional Products | 16-Jun-2022 | Technical / White Paper

With vitamin D science evolving rapidly since the COVID-19 pandemic, our new whitepaper breaks down the latest research on the role of vitamin D in supporting...

Innovative colic solutions

Innovative colic solutions

Webinar

Colic is one of the most frequent reasons for visits to the pediatrician and can often lead to parental and infant exhaustion. As a functional gastrointestinal...

Register for free

Happier with indication-specific probiotics

Happier with indication-specific probiotics

Winclove Probiotics | 07-Jun-2022 | Product Brochure

From the very founding of Winclove Probiotics, our aim to help people, society, and the world has been an essential part of our business DNA.

Botanicals you can rely on, from ADM

Botanicals you can rely on, from ADM

ADM | 02-Jun-2022 | Product Brochure

Today more than ever, consumers are striving to support their overall well-being in a convenient way, with foods, beverages and dietary supplements that...

Related suppliers

Follow us

Products

View more

Webinars