Probiotics and prebiotics, Ministry’s green light


Probiotics and prebiotics. After years of intense debate in Brussels, the Italian Ministry of Health is finally paving the way for yogurt and similar products.

Milk enzymes in Italy have been used in the food supplement industry for at least 35 years. Subject to approval by the Ministry of Health, according to the regulations then in force.

The first approvals were for products containing Saccharomyces cerevisiae, Streptococcus thermophilus, and Lactobacillus bulgaricus.

On the research front, Italy has reached the second place at the planetary level (after the U.S., endowed with far more economic resources) for the number of scientific publications on probiotics and prebiotics. Preconceiving the essential role of the microbiota in human and animal health, decades ahead of the consensus reached by medical science in recent years.

The European regulation on
Nutrition & Health Claims
(1) has, however, introduced a serious obstacle to research on probiotics and prebiotics. Prescribing that the relevant health claims be substantiated by clinical studies on healthy individuals. Meaningless, if not impossible, measurements when it comes to estimating changes in ‘health status’ on parameters in the normal, i.e., non-pathological, range.

The Italian Ministry of Health, after years of mobilizing against the nonsense of Brussels’ determinations, has pursued the most logical interpretation of European rules. Affirming-in special guidelines (2)-the possibility of using the terms ‘probiotic‘ and ‘prebiotic,’ on the labels of yogurt and similar products that meet certain characteristics.

Promotes the balance of the intestinal flora is the claim allowed on plain yogurt, derived by fermentation with milk with strains of Streptococcus thermpophilus and Lactobacillus bulgaricus.

Available scientific evidence shows that the minimum amount sufficient to achieve temporary colonization of the intestine by a microbial strain is at least 10^9 live cells per day. The recommended daily ration-in the form of product servings-should therefore contain an amount equal to 10^9 live cells for at least one of the strains present.

Information about the presence of a probiotic/prebiotic for rebalancing gut flora-under the conditions stipulated in the guidelines under review-should not be qualified as a health claim. Rather, it is a statement regarding the presence of a substance, on par with an ingredient, in the individual food. Wording that is accompanied by an identifying attribute of the milk enzymes in question, with nods to their characteristics according to generally accepted science.

Microorganisms that can be used in foods and food supplements, in turn, must meet the following requirements:

(a) Be used traditionally to supplement human intestinal microflora (microbiota),

(b) be considered safe for use in humans. A useful reference for this purpose is the criteria defined by EFSA on ‘QPS’ (‘Qualified Presumption of Safety‘) status. In any case, microorganisms used for food production must not carry acquired and/or transmissible antibiotic resistance,

(c) be active in the intestine in such quantities as to multiply there (see section 1.3, Quantity of microorganisms).

Dario Dongo


(1) See reg. EC 1924/06, as amended, implemented through reg. EC 353/08 and reg. EU 432/12

(2) V.