Probiotic Approval in the EU

Navigate complex EU probiotic regulations with expert guidance to achieve market access and compliance.

What Is Probiotic Approval in the EU?

The European market for probiotics is rapidly expanding across foods, beverages, and dietary supplements—but regulatory approval remains complex and fragmented. Unlike the U.S., the EU does not have an officially harmonized framework for “probiotics.” Each member state applies its own national guidance on whether the term probiotic can appear on labels or marketing materials.

To be compliant, probiotic products must be safe, accurately characterized, and supported by scientific evidence for any health-related claims. In most cases, manufacturers must demonstrate:

Strain identification and safety through genomic and toxicological data.
Proof of viability throughout the product’s shelf life.
Compliance with EFSA and national labeling requirements.

While no health claims for probiotics are currently authorized at the EU level, several countries—including France, Italy, Spain, the Czech Republic, and Bulgaria—now permit limited use of the term probiotic when specific conditions are met.

When Is EU Probiotic Compliance Needed?

When introducing probiotic-containing foods, beverages, or supplements in any EU member state.
When your probiotic strains are not already on the EU’s Qualified Presumption of Safety (QPS) list.
When making structure–function or health-related claims, even general ones (e.g., “supports gut health”).
When adding probiotics to novel food matrices (e.g., water, snacks, infant formulas, fortified products).
When entering multiple EU markets and needing consistent regulatory and labeling strategies.
When preparing for potential EU harmonization that may require documented compliance.

Our EU Probiotic Regulatory Services

Regulatory Pathway Assessment: Evaluate your product’s regulatory status across EU markets—food supplement, novel food, or FSMP.
Strain Characterization & Safety Review: Confirm strain identity (genus, species, subspecies), viability, and safety through genomic sequencing and toxicology data.
Claims & Labeling Compliance: Review and adapt labels to meet EFSA and national authority rules on probiotic terminology and health claims.
Dossier Preparation & Submission: Compile scientific and technical dossiers for novel food or national submissions.
Stability & Viability Testing: Verify CFU counts, formulation compatibility, and survival under EU storage and distribution conditions.
Clinical Evidence Evaluation: Assess human study data or coordinate new RCTs to support strain-specific benefits.
Post-Market Surveillance: Support ongoing vigilance, reporting, and compliance updates as regulations evolve.

Why Choose dicentra?

Over 20 years of experience in global food and ingredient compliance.
Proven success helping clients navigate EFSA, FSA, and member state authorities.
Multi-disciplinary expertise across probiotics, prebiotics, and synbiotics.
Deep understanding of QPS and GRAS equivalencies to streamline cross-market approvals.
Comprehensive end-to-end support—from strain safety to health claim strategy.
Offices and experts across North America and Europe supporting global market entry.

Related Services

Novel Food Applications
Health Claim Substantiation
Prebiotic & Synbiotic Regulatory Support
GRAS Submissions (U.S.)

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