April 14. 2024. 6:14

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Probiotics sector ferments amid push to tweak outdated EU framework


Latest developments on the ‘probiotics’ term saga suggest that the time is ripe for overcoming the current regulatory framework which, for more than 15 years, has hindered the EU probiotics sector from flourishing as well as restricting consumer information.

Probiotics are live microorganisms thought to provide beneficial effects when consumed, generally by improving or restoring the gut microbiome and the bacterial flora and reinforcing the immune system.

The widely used definition of probiotics comes from an expert consultation group set up in 2001 by the World Health Organisation (WHO), and the Food and Agriculture Organisation (FAO) which described them as “live microorganisms that, when administered in adequate amounts, confer a health benefit on the host”.

Much has been made of the potential of probiotics in human health recently, resulting in a boom in probiotic yoghurt and fermented drinks – including today’s popular beverage, kombucha – as well as probiotic food supplements.

Only in Europe, the retail value of the probiotic market (which includes sour milk products, probiotic yoghurts, and probiotic supplements) went from €8.6 billion in 2018 to €9.4 billion in 2021 – with the highest increase recorded in online sales for probiotic supplements worthy €190 million.

However, probiotics suffer from a certain degree of uncertainty at the EU level linked to a restrictive regulatory approach to using the term ‘probiotics’ itself.

This led to the peculiar situation in which probiotics cannot be advertised as such on food labels in the EU market, whereas the term is broadly used worldwide are with no restrictions.

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A regulatory bottleneck

Food business operators in the EU have to refer to the so-called ‘Claims regulation‘ if they want to highlight particular beneficial effects or just nutritional facts of their products – for instance, on the product label or in its advertising.

This regulatory framework provides that nutritional and health claims may only be made on foods if they are authorised on a case-by-case basis, following a scientific assessment by the European Food Safety Authority (EFSA).

Problems for probiotics started in 2006 with the Commission’s guidance on implementing this regulation. In these non-binding guidelines, the EU executive noted that marketing a product by saying it ‘contains probiotics/prebiotics’ should be considered a health claim ‘per se’.

However, all the applications submitted for the authorisation of the term probiotic as a health claim have not received a favourable opinion by EFSA “due to the lack of established scientific evidence as to the effects on human health,” explained a Commission official to EURACTIV.

“It is therefore prohibited, for the time being, to use health claims on probiotics in the EU market, as none have been authorised,” the official said.

The main consequence of this regulatory bottleneck is the impossibility of just informing about the probiotics content of a certain food on labels, even without an actual health claim, such as an additional remark on the benefits for human health.

The only authorised health claim that indicates the presence of probiotics so far is ‘live cultures of yoghurt improve lactose digestion’, ,which is how most probiotic yoghurts are currently marketed.

“New applications could be introduced in the future, with updated scientific grounds, for further consideration by EFSA,” added the Commission official, maintaining the strong stance from the 2006 guidance.

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‘What’s in a name?’

However, things are slowly changing as pushes to tweak the current obsolete regulatory framework are piling up.

The latest development on the ‘probiotic’ term saga comes from the Fit for Future (F4F) platform, an advisor body of the European Commission consisting of representatives from member states, other EU institutions, and stakeholders which delivers opinions for simplification, burden reduction, and modernisation of existing EU laws.

In a set of suggestions to the EU executive released last December, the platform called on the Commission to “consider appropriate actions to provide for a harmonised implementation and enforcement of the rule guiding industry stakeholders to uniformly
implement EU rules related to probiotics content of food products.”

According to the advisory body, “both consumers and industry will benefit from a harmonised approach,” as different national interpretations of the term ‘probiotics’ might put the internal market at risk of fragmentation.

Since 2018 some EU member states, such as Italy, Czechia, Spain, and most recently France, have, in the meantime, adopted national guidelines developing certain requirements for qualifying specific strains as probiotics as factual information.

“These member states are taking a different position opening a small door to probiotics by distinguishing ‘probiotics’ as just a category from a real health claim,” Katia Merten-Lentz, a lawyer at the Brussels and Paris Bars and expert on the matter, told EURACTIV.

According to the expert, the 2006 Commission guidance is no longer acceptable, particularly compared to the regulatory approaches adopted outside the EU.

In several third countries, like the US and Brazil, probiotics are already considered food or as ingredients, while Canadian authorities even allow the use of health claims about microorganisms represented as ‘probiotics’ on food labels and in advertising.

Likewise, third countries like India, Argentina, and Thailand have adopted specific probiotic regulations and definitions for probiotics.

What consumer wants

In its suggestions, the Fit for Future (F4F) platform suggests kicking off a comprehensive dialogue about using the word ‘probiotic’ as it “would ensure better legal certainty and better information to consumers about the products they are interested in.”

In a recent survey of 8,000 consumers in eight different European countries conducted by the International Probiotics Association (IPA), 57% of those surveyed do not feel informed that a product contains probiotics.

Likewise, 79% of the respondents would like to be informed whether a product contains probiotics through food labels, either in the list of ingredients or on the packaging.

“We need, at least, to inform consumers as they would like to know that they are buying probiotics,” concluded Merten-Lentz.

Contacted by EURACTIV, a Commission official said that the EU executive is aware that one of the suggestions made in the opinion of the F4F platform concerns probiotics are but did not comment further.

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