The article 13.5 proprietary claim links the Lactobacillus casei-containing product and a reworked, tightly worded, immune health claim, and joins its Activia spoonable yoghurt gut health claim on the European Food Safety Authority’s list of article 13.5 claims to be processed.
Danone vice president of external affairs and head of EU regulatory affairs, Patrick O’Quin, told NutraIngredients.com the dossier contained no new science but had been reconfigured in a similar way to the Activia resubmission.
That meant ordering the information to more closely meet EFSA criteria that had become apparent during the second half of 2009.
“The redrafted dossier reflects all that we have learned especially in regard to focusing on the formula and ensuring the claim wording very accurately matches the science,” he said. “The major change is in the wording.”
The wording has shifted from the broad immunity claim Danone originally submitted and which appears on its Actimel products in many countries, to something altogether more scientific.
It states: “Fermented milk that contains the probiotic Lactobacillus casei DN 114001 / CNCM I-1518 Actimel, helps to maintain [contributes to] the intestinal defence function.”
The dossier contains about 20 studies that demonstrated the benefits of Actimel.
O’Quin said his company had not had any direct dialogue with EFSA scientists in preparing the resubmission, rather it had reordered the submission in counsel with EFSA-produced guidance documents and learnings taken from other opinions that had come through the system.
Danone in April, 2009, withdrew the two article 13.5 digestive health claims for Activia and one article 13.5 immunity claim for Actimel. In August, it resubmitted an article 14 disease reduction claim for Actimel centred on diarrhoea.
The waiting game
It now awaits opinions to be delivered by EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA), and after, how those might be interpreted by the European Commission and members states before they pass into the EU legislature.
O’Quinn said it was too early to speculate on how the rather technical wording Danone has submitted for Actimel may be modified or otherwise at EC committee level at some point in the future.
But a precedent for that to occur had been established by the consumer-friendly modification UK start-up, Provexis, received for its article 13.5, tomato extract-blood circulation claim.
EFSA says no
The NDA last week published a negative opinion for an article 14 claim linking consumption of Danone’s Immunofortis prebiotic formula and a claim to, “naturally strengthen the baby’s immune system”.
The opinion for babies up to 12 months of age found Danone’s 30-trial strong dossier wanting for containing limited, inconsistent and irrelevant trial data.
Danone Baby Nutrition criticized EFSA for failing to engage in scientific dialogue with applicants before publishing its opinion, and said it would be utilising the 30-day response period to challenge the NDA opinion.
“There clearly remains a discrepancy between the dossier submission requirements and EFSA assessment,” saidDanone Baby Nutrition vice president of global quality and public affairs, Phillip Pratt.
“As previously highlighted by stakeholders, this again focuses attention on the urgent need for direct scientific dialogue, which is currently lacking in the process between EFSA and applicants.”
Danone said even though the opinion was yet to be mandated at EC level, the company had begun considering the marketing implications for products such as Aptamel and Nutrilon in the 14 European Union countries in which it sells follow-on formulas.
“There are packaging implications so we will sit down and look at what we have to do,” he said.