TABLE 1.

Comparison of European regulatory statuses applicable to finished products containing postbiotics: food ingredients, food supplements, medicinal products and medical devices.

	Food ingredients and supplements	Medicinal products	Medical devices
Targeted population	Healthy, general population	Patients suffering from a particular disease	Patients suffering from a particular disease
Intended use	Meet the nutritional needs of the general population	Prevent or treat a disease, alleviate symptoms, make a medical diagnosis	Diagnose, prevent, monitor, predict, prognose, treat, or alleviate disease
Mechanism of action	Nutritional or physiological	Pharmacological, immunological, or metabolic	Non- pharmacological, immunological, or metabolic means (i.e., physical)
Claims	Health claims	Disease claims	Disease claims
Requirements to reach the market	Historical safe consumption or demonstration of safety in the case of “novel food”	Demonstration of safety, quality, and efficacy à positive benefit/risk ratio in the targeted population	Demonstration of safety, quality, and efficacy à positive benefit/risk ratio in the targeted population
Production/quality requirements	HACCP; ISO 22000; FSSC 22000	pharma GMP	CE marking
European competent authority	EFSA	EMA	Notified bodies