As marketing professionals in the food ingredients sector, we have often had to develop special expertise to overcome the regulatory hurdles associated with probiotics. This article takes an in-depth look at the restrictions still imposed by EFSA and suggests strategic approaches for communicating effectively while complying with the European legal framework.
The reasons behind EFSA's regulatory blockages about probiotics
European Regulation (EC) No 1924/2006 on nutrition and health claims has profoundly transformed the landscape of communication on probiotics. EFSA, which is responsible for the scientific evaluation of these claims, has systematically rejected applications concerning probiotics for three fundamental reasons:
1. Inadequate characterisation of micro-organisms
EFSA requires precise and exhaustive identification of probiotic strains. Dossiers simply mentioning «probiotics» or «lactic ferments» without detailed genomic characterisation are automatically rejected. This taxonomic rigour is justified by the principle that thehe beneficial effects are specific to each strain and cannot be generalised.
2. Insufficient scientific evidence
EFSA's assessment criteria are among the strictest in the world. The studies submitted must :
- Be randomised controlled clinical trials on human populations
- Demonstrate a direct causal link rather than a simple correlation
- Use scientifically recognised biomarkers
- Present an irreproachable and reproducible methodology
- Be published in peer-reviewed scientific journals
The majority of cases fail to meet all of these cumulative criteria.
3. Imprecise wording of allegations
EFSA systematically rejects claims considered too general or ambiguous. Terms such as «supports immunity» or «promotes intestinal balance» are deemed insufficiently precise to be scientifically verifiable.
Europe's regulatory mosaic on probiotics
Application of the European regulation varies considerably between Member States, creating a fragmented commercial environment:
| Country | Status of the term «probiotic» | Regulatory approach |
| Italy | Authorised | Considered as nutritional information |
| Spain | Authorised | Tolerated under certain conditions |
| Denmark | Authorised with restrictions | Requires scientific documentation |
| France | Not permitted | Considered an unauthorised health claim |
| Germany | Generally prohibited | Tolerated in certain specific contexts |
| United Kingdom (post-Brexit) | Under development | Trend towards greater flexibility |
This disparity poses considerable challenges for pan-European marketing strategies and requires approaches tailored to each market.
Communication strategies to meet regulatory constraints
What can you do about it? Certainly, you can't give up! You can always communicate effectively about probiotics by adopting certain tactics:
1. Factual, science-based communication
Communication should focus on verifiable factual information:
- Precise taxonomic nomenclature of strains (genus, species, designation)
- Concentration in CFU (Colony Forming Units)
- Optimum storage conditions
2. Differentiated educational approach
Develop layered educational content:
- Content for the general public : Popularising the role of the microbiota in human physiology
- Professional content : Detailed scientific documentation for healthcare professionals
- Digital content Webinars and online resources to learn more without making direct allegations
3. Strategic partnerships with the scientific community
Collaborate with :
- Independent research institutes for clinical studies
- Learned societies to disseminate scientific information
- Key Opinion Leaders to share their expertise
4. Alternative lexical formulation
Develop a precise and consistent vocabulary:
- «Contains the strain Lactobacillus rhamnosus GG» rather than «probiotic»
- «Specifically selected living micro-organisms»
- «Active ferments traditionally used in food».»
Or, as many are already doing today, link the bacteria to a micronutrient, such as vitamin D or vitamin C, which would allow greater freedom when it comes to making claims on packaging...
5. Differentiation through transparency
Turn regulatory constraints into opportunities for differentiation:
- Complete traceability of strains
- QR codes leading to detailed scientific dossiers
- Communications on production and quality control processes
Towards the necessary regulatory changes
However, current discussions at European level are (finally!) pointing to potential developments:
- Recognition of the term «probiotic» as a category descriptor, like Italy and Spain
- Establishment of a positive list of strains that have demonstrated certain benefits
- Harmonisation of national practices to avoid market distortions
Conclusion: Excellence and innovation in a constrained context
The regulatory restrictions, although restrictive, have paradoxically led to higher standards of quality and innovation in the probiotics sector in Europe. Companies capable of investing in rigorous scientific research and adopting sophisticated, regulatory-compliant communication approaches will establish a sustainable competitive advantage.
As marketing professionals, our challenge is to transform these constraints into opportunities, by combining scientific rigour, creative communication and proactive regulatory monitoring. It is through this integrated approach that we will be able to continue to develop the probiotics market in Europe, while respecting the existing regulatory framework and anticipating future developments.
Source:
Why the EU still restricts ‘probiotics’ claimsOpens in new window
Accessed on 24 March 2025
