In Italy, probiotic cultures for human consumption are marketed as
pharmaceuticals and foods (fermented, supplement and novel foods).
The probiotic microorganisms used by the food industry that have
been traditionally recognised to be safe, do not require pre-marketing
health approval. Manufactures have to notify the health authorities, if
labelled probiotic food supplements display health benefits. In
addition, manufactures have to adhere to the Guidelines for Probiotics
and Prebiotics for humans, issued by the same health authorities
(Ministry of Health, 2005). This Italian document was based on the
Joint FAO/WHO Expert Meeting reports on probiotics (2002) and on
the European Food Safety Authority (EFSA) consultations regarding
the Qualified Presumption of Safety (QPS) approach (EFSA, 2007). The
Italian guidelines recommend: i) a minimum labelled concentration of 109 CFU of live microorganisms/daily dose, for each probiotic
species guaranteed up to the “use by” expiry date; ii) that each
labelled probiotic species nomenclature conforms to the International
Code of Nomenclature; iii) an absence of any pathogens.