EFSA says ‘no’ to probiotic health claims guidance

The current lack of regulatory definitions and standards for probiotics has resulted in the term being misused both commercially and scientifically, producing an inconsistent and often unfair market for the products.

During a question-answer session at EFSA’s recent health claims summit, the agency was asked if it was planning to produce guidance for probiotics along the lines of a similar effort recently made by the Canadian regulatory authority.

According to a number of attendees at the meeting, EFSA responded that this was not in the agency’s plans. It said it was unaware of the Canadian guidance and would look into it, but said no similar commitment could be made in Europe at this time.

Probiotics in the health claims process​

The meeting with EFSA, which took place on June 15, saw around 120 industry representatives gather in Brussels for a much anticipated stakeholders’ dialogue on health claims.

The invite-only and heavily over-subscribed event was the first chance industry had to meet face-to-face with EFSA and the European Commission since the new health claims regulation came into force about three years ago.

Questions and concerns from industry members related to EFSA’s scientific health claim dossier assessment process, which has churned out a string of negative opinions since August last year. So far, the agency has issued eight opinions on probiotics, all of them negative.

Some of the main concerns EFSA has expressed in its opinions on probiotic dossiers have been that strains were not adequately characterized, and that some of the science referenced in dossiers referred to different strains to those present in the foods for which the claims were being made.

No more guidance​

EFSA has not issued health claims guidance on any food groups, and confirmed in the question-answer session that it has no plans to do so.

Despite the fact that probiotics are live cultures and therefore different from other ‘food groups’, and may consequently be considered a special category requiring specific guidance, EFSA also confirmed that it does not plan to issue probiotic health claim guidance.

The agency told NutraIngredients.com this morning that it will publish an ‘overview’ – but not a detailed and exhaustive list – of questions and answers from the meeting. This will come as part of EFSA’s report on the meeting, due to be published this autumn. In addition, the agency will publish an overview of written comments received during the consultation period prior to the meeting.

“These sets of documents should clarify EFSA’s point of view on many aspects,”​ said an EFSA spokesperson.

Canadian guidance​

On the other side of the Atlantic, Health Canada recently released a guidance document for the use of probiotics in food, and the use of health claims associated with these products.

The document also provides guidance on the safety, quality (stability) and labeling aspects of food products containing probiotic microorganisms.

To access the document – entitled Guidance Document - The Use of Probiotic Microorganisms in Food – ​click here​ .