‘We’ve had enough of EFSA’, says fed-up global probiotics group

By Shane Starling

- Last updated on GMT

Related tags: European union

After months of silence the director general of the International Probiotics Association (IPA) has delivered a scathing attack on the European Food Safety Authority’s “flawed” health claim assessment methods.

Ioannis Misopoulos told NutraIngredients.com this morning that EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) had “made up its mind”​ about probiotics, a perception that has prompted the IPA into a strategic meeting with other trade groups in Brussels next week.

The meeting comes in the wake of the NDA last week issuing negative opinions for 94 article 13.1 probiotic strain submissions to go with 191 article 13.1 rejections in October.

The NDA is yet to issue a probiotic-based positive opinion, although all but a handful of the rejections have been a result of the NDA deeming the strains uncharacterised.

Therefore, in those cases it did not scrutinise the gut health, immunity and other health benefit data contained in the dossiers.


Misopoulos said the NDA preference for human intervention studies on healthy populations was flawed, and that these preferences had been defined too late.

“It can take three years to get these kinds of human studies together but in the meantime the claims are going to be wiped away,” ​he said. “The regulation is killing this industry and the job losses are already being felt. We’ve had enough of EFSA’s process as it stands and so are considering our options.”

An EFSA spokesperson said its methods were transparent and well-publicised, including the appointment of NPA panel members who each serve three year terms and declared all conflicts of interest at the point of consideration.

The NDA panel sought external, expert advice if they felt it necessary and had done so in the area of probiotics, she said.

Learning experience


Meanwhile, Carine Lambert, the director of ​the Yoghurt and Live Fermented Milks Association (YLFA) – which has Danone, Yakult, Yoplait, Lactalis-Nestlé, Danisco and Chr Hansen as members – issued a statement emphasising the “learning process”​ everybody was engaged in, while pointing to EU member states and the European Commission for claims moderation.

She said incongruence between EFSA’s scientific standards and those of member state agencies such as France’s, needed to be addressed.

“YLFA pleads for some adjustment between EFSA and member states’ agencies requirements for dossier evaluation,”​ she said. “Neither the consumer nor the industry would benefit from a two-tier system.”

Noting the characterisation problem many dossiers had encountered, she said the group was, “not too concerned” ​and that the next batch would be more important, along with article 13.5 opinions for Danone and Yakult submissions.

She warned of the confusion that could spread to consumers who may think dossiers were being rejected on the data they contained, when that data had not even been analysed.

No one should rush to judgement and conclude that there isn’t a causal relationship between the consumption of probiotics and their claimed effect.”

“YLFA's members, confident that the process will allow the beneficial effects of probiotics to be recognised, continue to work closely with EFSA in order to provide the expected data for the successful outcome of these dossiers.”

The NDA opinion containing the latest collection of non-characterised strains can be found here​.

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EFSA wants industry to reinvent the wheel

Posted by Food Doctor,

The beneficial health effects of probiotics and live cultures are known centuries and even mentioned in Bible. Pharmaceutical-sided EFSA will most likely not approve any of the structure/function claims soon unless EFSA members are selected from independent scientists.

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EFSA is unprofessional

Posted by Doctor Alex,

EFSA is unprofessional because it protects interests of pharmaceutical companies. Probiotics are proven to be beneficial for immunity and health. As a doctor I cured many of my patients using probiotics.What EFSA is doing is unacceptable.

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EFSA and Probiotics

Posted by Muriel Toffoli,

EFSA members are a bunch of morons, in the pay of the big pharmaceutical companies. My friends and I have used them for many years, particularly for gut problems, including a sufferer for 20 years from diverticulitis. He is cured, and is fine as long as he continues to use probiotics. Great for candida as well. EFSA has NO credibility.

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