The new claim submitted to the European Food Safety Authority (EFSA) is centred on an independent, clinical trial published in June, 2007, in the British Medical Journal (BMJ), part-funded by Danone, that employed Actimel and demonstrated diarrhoea benefits.
To see NutraIngredients.com coverage of that study click here.
Danone vice president of external affairs and head of EU regulatory affairs, Patrick O'Quin, said Danone decided to pursue the diarrhoea claim because of the strength of the BMJ study, whose conclusions could only be pursued along the article 14 disease reduction path.
“We have already had a positive opinion an article 14, disease reduction claim accepted, so we feel very confident about this claim,” O’Quin told NutraIngredients.com this morning. “The article 14 opinions have been much clearer about why dossiers have been accepted or rejected”
That claim was for plant sterol-based , cholesterol-lowering Danacol one-shot drinks. Danone also had an article 14 children’s claim accepted for bone health and dairy consumption.
Danone’s submission, lodged yesterday, makes the rather technical claim: “Fermented milk that contains the probiotic Lactobacillus casei, reduces the presence of Clostridium difficile toxins in the gut, associated with the incidence of acute diarrhoea.”
O’Quin said the submission reflected guidance it had taken from EFSA about the need for claim wording to tightly match available science, but admitted it was unlikely to ever see the light of day in on-shelf marketing in its current form.
It would be down to the European Commission and the member states to draw up a more user-friendly wording, as appears is going to happen with a tomato extract, blood circulation claim currently being looked at by an EC standing committee.
But even in such a scenario, how an EU-approved, user-friendly, probiotic diarrhoea claim will be used by Danone is not clear. O’Quin admitted the company was as keen to see if the claim could make it through the process as it was to actually employ it on its products.
“If the claim is approved it won’t be the same as the claim we might use on the products but we want the science to be recognised,” he said.
Given existing marketing for Actimel is based around immunity (spoonable yoghurt Activia makes digestive health claims), it is interesting to see how a diarrhoea claim could be incorporated, if indeed those other claims are eventually resubmitted and approved under the process.
The withdrawn Actimel article 13.5 immunity claim and two Activia 13.5 digestive health claims have not yet been resubmitted as O’Quin affirmed, “we are waiting for further article 13.5 guidance due at the end of the month”.
But O’Quin said there are ongoing probiotic studies that may bolster the dossiers and noted the nutrition and health claims regulation will not conclude next year, when the initial batch of claims was due to be processed.
“It is an open-ended process,” he said.
EFSA’s claims assessment group, the Panel on Dietetic Products, Nutrition and Allergies (NDA), has five months to process the claim although clock-stop procedures to tackle claim queries may extend that timeframe.
To date, there have been 16 peer-reviewed studies published about Actimel and 24 about Activia.
It is estimated global sales for the two products are worth in excess of €5bn - more than 30 per cent of Danone’s turnover.
"If Danone would not be able to substantiate claims through the trials they've done, I think the shares would be vulnerable," ING analyst, Marco Gulpers, told the Wall Street Journal earlier this year.