“PROBIOTIC” in Italy: how can the word be used?

Italians are quite accustomed to the idea of consuming microorganisms to accomplish several beneficial goals. They have been doing it for years, either through fermented food or food supplements.
The first appearance of probiotics as supplements on the Italian market dates back to about 40 years ago, in products that contained live cultures of Streptococcus thermophilus, Lactobacillus bulgaricus, Saccharomyces cerevisiae, and vitamins.

Since then the background developed, with the enforcement of European directives and regulations on food supplements and on nutritional and health claims.

In 2013, the Italian ministry of health (Ministero della Salute) published national guidelines on probiotics and prebiotics to be used in food and food supplements (Linee guida su probiotici e prebiotici); an updated version of the guidelines was issued in 2018:

The peculiarity of Italian guidelines is that they allow the use of the words “probiotic” and “prebiotic” for products complying to given dispositions. And even further, they allow a specific claim on such products: “It promotes the intestinal flora balance”.

As specified in the guidelines, this phrasing does not indicate a direct benefit on human health and therefore does not constitute a health claim pursuant Reg (EC) 1924/2006, as “Increasing the number of any groups of bacteria” as well as “enhance levels of beneficial microflora” are not themselves “beneficial to human health …” (EFSA Journal 2009; 7(9) 1232).
If we consider that promoting the intestinal flora balance is indeed the action of a probiotic and/or a prebiotic, then the mentioning of these terms on the product label becomes logic and acceptable.

So, which are the specifications set out in the guidelines?

• Concerning probiotics, the document establishes the general characteristics of the products, the characterization of the microorganisms (the methods differ for bacteria and for yeasts), their quantity and, of course, their safety. In particular, the chosen microorganisms must be amongst those traditionally used to supplement gut microflora; moreover, they must be considered safe for human use (for more information) on this point, the guidelines refer to the QPS criteria established by EFSA, and state that the microorganisms must not carry antibiotic-resistance). As for the quantity of live cells, it must be sufficient to allow their temporary colonisation of the gut; the guidelines establish this at 10⁹ live cells per day for at least one strain, according to the latest scientific evidence.
• Concerning prebiotics, the guidelines refer to the FAO definition on the word; then they state that substances used as prebiotics must be safe for humans, and be in a sufficient quantity to achieve the desired effect.

Zooming out of Italy and talking about Europe, the regulatory situation of probiotic products continues to be quite diversified. At the moment, less than 10 European countries allow the terms “probiotic” or “prebiotic” to appear on the label. Meanwhile, the only health claim accorded by EFSA to a prebiotic substance (“chicory inulin contributes to normal bowel function by increasing stool frequency”) will presumably be increasingly showed on labels, as its use, restricted to the applicant until Jan 1^st 2021 due to protection of proprietary data, will be now allowed to all.

On this background, Italian guidelines make Italy a rare market in the EU, as products can benefit both from the words “probiotic” and “prebiotic”, and from the claim on intestinal flora balance.

To know more, you can consult the guidelines on probiotics and prebiotics (italian and english versions are available) on the website of the italian ministry of health.