What are the regulatory challenges regarding microbiome in cosmetics?


Regulatory Affairs Managers, COSMED, France


Due to the possible cosmetic benefit of microbiota to keep skin in good health, microbiome-related cosmetic products are a growing trend. As per the novelty of the concept dedicated reflection was needed for cosmetics and International Cooperation on Cosmetic Regulation (ICCR) was a real opportunity to harmonize related terms and definition. Last meeting in June 2022 have led to the publication of specific definitions for cosmetics.
Some challenges remain: for R&D and analytic a key question is the control of the stability and distinction between intentionally and unintentionally added microorganism. Communication towards consumers should be also clearer to explain the mode of action of these products.

Microbiome-related cosmetic products represent a fast-growing market, particularly strong in Asia. If North America is currently a large market, global growth forecasts are between 6 and 7% over the next 5 years.
Driven by consumers’ desire for natural and effective products, cosmetic market has seen an increasing number of products referring to the skin microbiome and covering all cosmetic types and application sites. Nevertheless, for most consumers, the words probiotics, prebiotics, postbiotics, microbiome still have a very obscure connotation.
Cosmed has gathered information to clarify the meaning of these terms, their potential use in cosmetics and the associated regulation.


As soon as 2001, a joint report of World Health Organization and Food and Agriculture Organization (WHO/FAO) defined probiotics as “live microorganisms which when administered in adequate amounts confer a health benefit on the host” (1).
A few years later, prebiotics were defined by FAO as “a nonviable food component that confers a health benefit on the host as ...