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EU Clears 34 Probiotic Strains From Novel Food Authorisation

An updated EU Novel Food Catalogue treats 34 probiotic strains as not novel, removing an 18 to 24 month authorization step for affected supplements.

Key Takeaways

►34 probiotic strains now cleared as not novel

►Saves an 18 to 24 month authorization step

►Verify your specific strains against the list

►EFSA rules on fennel, berberine, HCA in 2026

The European Commission has updated its Novel Food Catalogue to classify 34 probiotic strains as not novel when used in food or food supplements. The practical consequence is significant: brands with supplement products containing any of those 34 strains no longer require a Novel Food authorization to sell those products in the EU. For US supplement brands, this removes one of the most time-consuming and costly regulatory barriers on the path to EU market entry for probiotic products.

34probiotic strains classified as not novel in the updated EU Novel Food Catalogue, removing the authorization requirement for these strains in food supplements and potentially cutting 18 to 24 months from EU market entry timelines for affected probiotic products

The EU Novel Food Regulation (EU) 2015/2283 requires that food ingredients without a significant history of consumption within the EU before May 15, 1997 obtain Novel Food authorization before being placed on the EU market. Novel Food applications are detailed dossiers reviewed by EFSA, typically taking 18 to 24 months and significant investment. The updated Catalogue classification for these 34 probiotic strains means brands selling products containing them no longer need to complete that application, because the strain is treated as a conventional food ingredient. The update specifically covers strains when used in food and food supplements, not all applications.

The Commission's update also signals the direction of further regulatory activity in 2026. Separate Novel Food applications for fennel, berberine and hydroxycitric acid are currently under EFSA review, with final decisions expected during 2026. For supplement brands with products containing any of these ingredients, the EFSA timeline matters, because a positive decision could open EU market access for those ingredients in the same way the probiotic Catalogue update has for the 34 strains, while a negative decision would close it. Both outcomes should be built into EU product range planning now rather than addressed reactively.

34 probiotic strains classified as not novel in the updated EU Novel Food Catalogue, with no Novel Food authorization required for these strains in food and food supplement applications
Novel Food applications typically take 18 to 24 months and significant investment, and the Catalogue reclassification removes this burden for the 34 affected strains
US supplement brands should verify whether any probiotic ingredients in their range match the updated Catalogue list, and obtain written confirmation from their EU safety advisor before relying on the classification
EFSA is expected to issue decisions on fennel, berberine and hydroxycitric acid Novel Food applications in 2026, which will materially affect EU market access for products containing these ingredients
The Novel Food Catalogue is advisory. The legally binding reference is the Novel Food authorization list, so confirm classification status with a qualified regulatory advisor before market entry

For US supplement brands with probiotic products, the Catalogue update is a meaningful market access development, but it requires verification against the specific strains in your formulation. Not all probiotics are on the list. Expandly includes EU supplement regulatory mapping as part of market entry onboarding, covering Novel Food Catalogue status, health claim restrictions under Regulation (EC) 1924/2006, and EFSA authorization requirements for specific ingredients.

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The bigger picture

What the Catalogue update signals for EU supplement access

The Novel Food Regulation was introduced to protect consumers from ingredients with unknown safety profiles, and in its early years it was applied broadly, treating any ingredient without documented pre-1997 EU consumption as novel by default. This Catalogue update reflects a more mature approach, where a well-characterized probiotic strain with established safety is reclassified as not novel, removing a process burden that no longer serves a protective purpose. For a US supplement brand, the EU probiotic market, one of the fastest-growing supplement categories in Europe, is now more accessible for well-documented formulations. Expandly's compliance-first onboarding begins with formulation and label review against EU maximum levels, then maps Novel Food Catalogue status, health claim permissions and any member state restrictions, so brands confirm the legal position of their specific strains before committing rather than after.

The pending EFSA decisions on berberine and hydroxycitric acid are high-profile, since both are widely used in US weight management formulations, and EU access depends on the assessment
Even where Novel Food authorization is not required, EU entry still needs compliance with health claims rules under Regulation (EC) 1924/2006, which is separate from the Novel Food question
Expandly maps EU supplement ingredient status, covering Catalogue classification, health claim permissions and member state restrictions, as part of market entry onboarding

Novel Food Authorization Timeline

A Novel Food authorization application under Regulation (EU) 2015/2283 involves a full safety dossier to EFSA, a risk assessment typically taking 18 to 24 months, and Commission adoption of the decision. For US supplement brands, the Catalogue reclassification of 34 probiotic strains removes that entire process for those specific ingredients.

18-24 mo

typical EFSA review timeline for a Novel Food authorization application, removed for the 34 reclassified probiotic strains

Supplement demand

Regular supplement use is mainstream rather than niche, which is what makes a strain reclassification commercially significant. A cleared strain can go straight into a product aimed at a large and habitual audience.

43%

of global consumers use supplements at least weekly, in a consumer health and nutrition survey

Compliance-First Onboarding

For supplement brands, Expandly begins with formulation and label review against EU maximum levels. From there, VAT registration, marketplace setup and EU-local fulfilment follow in the right order.

2,000+

brands expanded with Expandly

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EU Clears 34 Probiotic Strains From Novel Food Authorisation

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Key Takeaways

The bigger picture

What the Catalogue update signals for EU supplement access

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