Probiotics industry unites over EFSA claims treatment

By Shane Starling

- Last updated on GMT

Related tags: Efsa’s panel, European union, European commission

Could pre-health claim submission meetings actually save resources?
Could pre-health claim submission meetings actually save resources?
Four groups with an interest in pre- and probiotics will today send a letter to the European Commission and European Food Safety Authority spelling out their ongoing concerns with the European Union health claims system that, to date, has unanimously rejected their science.

Joined by two academics – Dr Ger Rijkers and Professor Lorenzo Morelli, PhD – the groups praised EFSA’s health claims unit for being more communicative with stakeholders as demonstrated by the recent gut/immune function meeting in Amsterdam, but called for further process clarity and reform.

As occurred quite a few times by parties such as Danone at that Amsterdam meeting, the groups emphasised the need for pre-submission meetings with EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA), to allow for additional dialogue before an expensive dossier has been formally submitted.

NDA chief Professor Albert Flynn and some of his panel members did not dismiss the idea in Amsterdam, but said it was not feasible at this point in time due to a lack of resources.

Recognising this resourcing reality, the groups wrote: “Such consultations would not only benefit the quality of future applications but may also improve the efficiency of the process. Moreover, these consultations could – in the long run lower the cost to EFSA, as the majority of the applications would improve and be properly presented and structured.”

Speaking to NutraIngredients, Yoghurt and Live Fermented Milk Association (YLFA) spokesperson, Carine Lambert, said there were member state examples where industry even paid fees to have consultations, although this had not been raised by the four groups.


Of the Amsterdam workshop the groups – the YLFA, International Probiotics Association, the Lactic Acid Bacteria Industrial Platform and the European Food & Feed Cultures Association – said, “Some advances were made.”

But, “EFSA did not totally meet the expectations of the participants: many procedural and scientific aspects remained unanswered. In addition, the workshop revealed numerous discrepancies in the way the scientific community and the Panel are evaluating evidence.

”Further clarifications are needed on very basic elements such as, among others, recognised risk factors and beneficial physiological effects, ranking of different immune parameters, best study models and target populations to be used for claim substantiation for food and food supplements."

The letter goes on to call for the publication of scientific community feedback to the immune/gut health guidance issued by EFSA in September this year.

Deeply disconcerting

Given not a single pre- or probiotic claim submission has yet won a positive opinion from the NDA, the groups’ sense of urgency has increased.

“The impact of EFSA’s negative opinions is deeply disconcerting for the industry, both in terms of the time and money invested in clinical trials, but also in terms of the damage of the industry’s credibility and the impact on public opinion,”​ they wrote.

“Therefore, we plead to the European Commission to understand that an improvement of the functioning of the claims approval process is necessary.”

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