Europe does not have a clear or harmonized regulatory framework on probiotics, and therefore decisions may be made on them by individual Member States. The general view by both European and National authorities is that the term “probiotic” is an implicit, non-authorized health claim, as consumers may automatically link this word with health benefits. Therefore, the very use of the name is not authorized in most countries.
The Spanish Agency now acknowledges the significant presence of products containing probiotics (citing food supplements and infant formulas) on the Spanish market. It also states that a disharmonized situation may go against the Mutual Recognition Principle, by which products legally manufactured or sold in one Member State should not be prevented from entering the market of all other EU members. Given that adjacent markets, like Italy, already allowed for the use of the term “probiotic”, the Agency considered that the position it held until now may be detrimental for the Spanish industry, market and consumers.
A lot remains to be decided around probiotics in Europe, and the decision by AESAN is firm yet provisional “until a uniform criterion is generated” at the EU level. This resolution does also not imply the authorization of any health claim for probiotics in Spain. However, the very capacity to use the term “probiotic” on product labels is certainly a small victory for the microbiome industry.
Source (in Spanish): https://www.aesan.gob.es/AECOSAN/web/seguridad_alimentaria/subdetalle/probioticos.htm?idU=1&utm_source=newsletter_1712&utm_medium=email&utm_campaign=importante-probioticos-etiquetado
Source: Sandwalk Bioventures
Sandwalk BioVentures is a specialty strategy, innovation, regulatory and management consulting firm focused on microbiome technologies servicing companies in the food and pharma sectors, as well as financial and strategic investors exploring to enter this field. The company has created the Microbiome Drug Database™, an online repository containing the most extensive and thorough analysis of biotechnology companies developing pharmaceuticals from or through the microbiome.