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Probiotics – Regulatory Hurdles in the EU Commercial aspirations vs. regulatory realities in the EU food chain


Pen & Tec Consulting S.L.U., Barcelona, Spain


The global probiotics market is rapidly growing, and the EU is lagging behind this global trend, mainly due to implications of the current EU regulatory framework. Ongoing probiotics research is paving the way to the development of new and innovative products, not only in the area of gut health but also in depression, cardiac health, liver function, allergies, migraines, weight loss, etc. Getting health claims approved by EFSA for these types of products would, however, be extremely challenging: EFSA has rejected every strain specific health claim to date, so what can companies do?

Probiotics are defined by World Health Organisation (WHO) as live microorganisms that, when administered in adequate amounts, confer a health benefit on the host (1). Probiotics can generally help improve, restore and maintain the gut microbiota as the gut microbiota change throughout our lifespan, caused by age, diet, pregnancy and environment. They may also help the gut microbiota resist the growth of harmful microorganisms (2). Different genera of bacteria have been identified as beneficial for human health, including various strains of Bifidobacterium, Bacillus , and the genus previously classified under the old nomenclature of Lactobacillus, as well as the yeast Saccharomyces cerevisiae var. boulardii, among others. The beneficial effects of these microorganisms can be strain specific (3).

Research on probiotics has skyrocketed over the past years: over 12,000 articles have been published on PubMed over the past five years alone. Research on probiotics positively affecting several gut conditions such as lactose intolerance, irritable bowel syndrome, and inflammatory bowel, is booming. Thanks to the recent development in th ...

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