Let’s talk, Yakult tells EFSA after negative opinion

By Jess Halliday

- Last updated on GMT

Related tags Upper respiratory tract Immune system Respiratory system

Yakult Europe has signalled its desire to talk to EFSA about the evaluation process and scientific criteria that led to the negative outcome of its proposed health claim on upper respiratory tract health, but pledges to take the decision into account for new dossier submissions.

EFSA’s Panel on Dietetic Products, Nutrition and Allergies has judged that no cause and effect relationship has been established between the consumption of Yakult’s Lactobacillus casei probiotic strain, Shirota, and maintenance of the upper respiratory tract defence against pathogens by maintaining immune defences.

Yakult had submitted a total of 12 study references to support the article 13.5 claim submission, including nine human intervention studies and three animal studies, that it considered pertinent for either the scientific substantiation of the claim or as supporting evidence for an effect of LcS on the immune system that could relate to the defence of the upper respiratory tract against pathogens.

The full opinion is available at http://www.efsa.europa.eu/en/scdocs/scdoc/1860.htm

Responding to the opinion, Yakult Europe said the health claim in question was in a specific health claim in a limited area, and is just one aspect of the research and claim evidence it has been working on.

“The claim was supported by well-designed double-blind placebo-controlled human studies,”​ it said, adding that “the company wishes to discuss the evaluation process, scientific criteria and this outcome with EFSA”.

The outcome of the submission will be taken into consideration by Yakult as it prepares to submit more health claim dossiers.

Asked about the aim of dialogue with EFSA, Jan-Albert Blaauw, manager corporate communications at Yakult Europe, told NutraIngredients.com: “Depending on the room EFSA would leave within a possible further dialogue, we would expect this to be especially with the aim to come to a positive opinion with future submissions..”

He added: “This is a learning process for all parties involved, both the industry and EFSA.”

Yakult also expects that future submissions will be benefit from new guidelines on scientific requirements for dossiers, which are being drafted, and which are due for discussion at the EFSA stakeholder meeting on 2 December.

“With the benefit of this further guidance, the company anticipates a positive EFSA opinion in due course.”

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