Call for EU working group to bring harmonisation to probiotic regulation

By Nikki Hancocks

- Last updated on GMT

Getty | Marian Vejcik
Getty | Marian Vejcik

Related tags European commission Probiotic Regulation Efsa

The European Commission has discussed the creation of an EU working group to bring some regulatory harmonisation over use of the term ‘probiotic’ across Member States.

The development came during a recent meeting of the EU Member States and the European Commission, in which Austria requested clarification from the French authorities on the recent permission​ given to the food supplement sector to use the term 'probiotics' on labels.

According to a news update from IADSA (International Alliance of Dietary Food Supplement Associations) concerns were raised that several Member States were allowing this term "while it is currently prohibited in Europe".

"The Commission reminded countries to take action to ensure conformity of their market with EU rules. Noting the divergent views in the room, a suggestion was made to address this topic in a working group," states IADSA's bulletin.

Responding to this update, David Pineda Ereño, Managing Director and Consultant on Strategy, Policy and Regulation at DPE International Consulting, says this could be a step forward in seeing acceptance of the term across the EU.

“The suggestion to address it in a Working Group discussion of the European Commission and the EU Member States would be a necessary step forward for the acceptance of the use of the term ‘probiotic’ as a class name in foods and food supplements within the EU.”

In the European Union (EU), probiotic strains have not received a positive opinion from the European Food Safety Authority (EFSA) and no health claim specific to probiotics has been authorised in the EU. As a result, since 2007, the European Commission considers the term 'probiotic' to be an unauthorised health claim that cannot be used in food labelling.

Most Member States initially followed the interpretation of the EC. However, Italy and the Czech Republic permitted use of the term and over the years more states have joined, including Spain, Denmark, the Netherlands, and mostly recently, France.

In fact, both Italy and France allow the use of the term in supplements, using a health claim indicating that 'it promotes or contributes to the balance of the intestinal flora’. 

Luca Bucchini, Managing Director at Hylobates Consulting Srl, says the idea to create a working group “would be great if the aim is to find a proportionate solution taking into consideration the science and the needs of the consumer.”

He explains: “It seems that the position of a growing number of Member States has irritated Austria and the Commission, which has launched an inquiry into Italy for allowing the term "probiotic", though it is unclear why it would be a priority for the Commission as opposed to the fragmentation of the internal market for botanicals.  As the 2007 document has no legal force, the statement 'the term is prohibited in the EU' is not accurate at all; it is a position of some Member States."

He explains that a growing number of Member States have “come to realise that with probiotic demand in constant growth, and with a number of legal arguments in favour of the term ‘probiotic’, the original interpretation of 2007 was not well founded, was based on assumptions on EFSA's decisions that did not come to pass, and was not serving consumers."

He adds: “I understand that consumers have a good appreciation of what probiotics do, which is what EFSA decided is not a health claim, and they are better served by regulating probiotics, without forcing euphemisms like bio-cultures, live cultures or similar.”

Whilst the update sounds promising, George Paraskevakos, Executive Director or the International Probiotics Association, says he has not received information about the working group yet so is currently looking into how the association can be involved.

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