Probiotics

Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. In human health applications, the term therefore refers to defined microbial strains whose beneficial effect has been demonstrated at a specified viable dose. It does not describe every microorganism present in food or the human gut.

Essential elements of the definition

• The microorganisms must be alive when administered and remain viable in the amount required to produce the claimed benefit.
• Their identity should be established at the genus, species and strain levels because effects can differ between strains.
• A probiotic designation requires a demonstrated health benefit, not merely evidence that the organism can survive or grow in the digestive tract.

Evidence and safety requirements

A microorganism is evaluated for its intended human use, dose and target population rather than being treated as universally beneficial.

• The claimed benefit should be supported by appropriate human studies using the particular strain or strain combination.
• Safety assessment should consider pathogenic potential, undesirable metabolic activity and transferable antimicrobial resistance.
• The effective viable quantity should be maintained during the product's stated shelf life and communicated through appropriate labelling.

What the term does not automatically include

• A fermented food is not necessarily probiotic unless it contains adequately characterized live microorganisms with a demonstrated benefit at the consumed dose.
• Probiotics are distinct from prebiotics, which are non-living dietary substrates used selectively by beneficial host microorganisms.
• Permanent colonisation of the gut is not part of the definition; a health benefit may occur while the organism is passing through the gastrointestinal tract.