Probiotics and prebiotics: health claim substantiation
Open accessAbstract
'Probiotics' and 'prebiotics' by definition should have health benefits. Health claims on microorganisms proposed as probiotics and probiotic stimulating agents (prebiotics) suggest that there is a relationship between the specific food and maintaining good health or that the food can reduce the risk of a disease. The Health Claim Regulation in European Union aims at a level consumer protection. Thereby, health claim assessment focuses on defining the probiotics and prebiotics, assessing the health relationship and evaluating studies with emphasis on controlled human intervention studies. The challenges include the focus of claims for healthy populations while most intervention studies with probiotics and prebiotics have been conducted in patients or subjects at risk of specific diseases. Another challenge is the risk reduction claim, which requires demonstrated changes in biomarkers that are generally accepted as indicators of disease risk. Existing assessment opinions from EFSA illustrate the need for further research for probiotics and prebiotics in the future.
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The majority of probiotic-related health claim applications submitted to EFSA have been rejected due to insufficient evidence of a cause-effect relationship between microorganism consumption and the claimed health benefit, as well as insufficient strain characterization and study design.
“The majority of probiotic-related health claim applications submitted to EFSA have been rejected due to insufficient evidence of a cause–effect relationship between microorganism consumption and the claimed health benefit, as well as insufficient strain characterization and study design [59].”
From Current Concepts in Probiotic Safety and Efficacy (2026) · cites this paper as [59]
The copy’s Abstract says several claims failed because of study-design flaws and identifies insufficient evidence that the strain studied matched the strain claimed. It also says claimed health relationships were often too general to assess or not considered beneficial by EFSA. It does not establish that a majority of probiotic-related applications were rejected, or attribute those rejections specifically to failure to show a cause–effect relationship between consumption and benefit. No page number is supplied in the indexed copy. (LLM, conf=0.85)
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Cites
Guidance on the scientific requirements for health claims related to gut and immune function
EFSA Panel on Dietetic Products, N. A. A. (. (2011) · EFSA Journal · doi:10.2903/j.efsa.2011.1984 · Cited by 99 · see citing works
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Research works printed but not linked: 5
- [1]van Loveren H Sanz Y Salminen S Health claims in Europe: probiotics and prebiotics as case examples Annu Rev Food Sci Technol 2012 3 247 61 22224554
- [7]FAO FAO Technical Meeting on Prebiotics 2008 Rome, Italy FAO 1 12 18685504
- [9]Ventura M Turroni F Zomer A Foroni E Giubellini V Bottacini F The Bifidobacterium dentium Bd1 genome sequence reflects its genetic adaptation to the human oral cavity PLoS Genet 2009 5 e1000785 20041198 PMC2788695
- [10]Verhagen H Vos E Francl S Heinonen M van Loveren H Status of nutrition and health claims in Europe Arch Biochem Biophys 2010 501 6 15 20417175
- [12]Sanders ME Kneifel W Salminen S Substantiating Health Benefit Claims for Probiotics in the United States Probiotics and health claims 2011 Chichester, United Kingdom Wiley-Blackwell 90 101
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Reappraisal of probiotics’ safety in human
Sotoudegan, F., Daniali, M., Hassani, S., Nikfar, S., & Abdollahi, M. (2019) · Food and Chemical Toxicology · doi:10.1016/j.fct.2019.04.032 · Cited by 154 · see citing works
Current Concepts in Probiotic Safety and Efficacy
Churin, A. A., Sokolyanskaya, L. O., Lukina, A. P., & Karnachuk, O. V. (2026) · Nutrients · doi:10.3390/nu18040696 · Cited by 31 · see citing works
- Authors
- Salminen, S., & van Loveren, H.
- Affiliations
- University of Turku (FI)
- Corresponding author
- Salminen, Seppo
- ORCID
- Salminen, Seppo
- Venue
- Microbial Ecology in Health & Disease
- Publisher
- Co-Action Publishing
- Published
- 2012-06-18
- Volume
- 23
- Issue
- 0
- ISSN
- 0891-060X (ISSN-L)
- 1651-2235
- PMC
- PMC3747744
- OpenAlex
- W2091175126
- Cited by
- 43
- References
- 1
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 3 · 2023: 2 · 2022: 3 · 2021: 1 · 2020: 2 · 2019: 5 · 2018: 4 · 2017: 5 · 2016: 4 · 2015: 3 · 2014: 3 · 2013: 5 · 2012: 1
- FWCI
- 5.90
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Licence
- cc-by
- Locations
- Microbial Ecology in Health and Disease (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Consumer Attitudes and Food Labeling
- Health Sciences › Nursing › Nutrition and Dietetics › Microbial Metabolites in Food Biotechnology
- Keywords
- probiotics, prebiotics, health claims, health claim substantiation, health claims regulation, biomarkers of disease risk, consumer protection, healthy population
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