KIND TO BIOME

Is "modulating the microbiome" even a cosmetic claim?

It’s the right question to ask, and the honest answer is: it depends on how you say it.

A cosmetic, by definition, acts on the surface of the body to keep skin clean, protected and in good condition. A product that sets out to restore, correct or modify a physiological function can instead fall under medicinal rules.[2][7] Because the skin microbiome lives on that surface, supporting it can sit within cosmetics, but the wording of a modulation claim can move it toward the medicinal borderline. “Helps maintain a balanced skin microbiome,” tied to healthy-looking skin, reads very differently from “corrects microbial dysbiosis” or any claim tied to treating a skin condition. Classification is assessed case by case, and it varies between markets.[8]

This is exactly why we separate the two claim tiers, and why we don’t treat “more ambitious” as automatically “better.” A non-modulating, microbiome-friendly claim, substantiated by our in-vitro + ex-vivo protocol, is a lower-risk, squarely-cosmetic default. A modulation claim can be powerful and differentiating, but it needs both the right evidence (in-vivo) and the right wording to stay a lawful cosmetic claim rather than drifting into medicinal territory.

The claim spectrumA horizontal axis from Cosmetic on the left to Medicinal borderline on the right. "Helps maintain a balanced skin microbiome" sits toward the cosmetic end; "Corrects microbial dysbiosis" sits toward the medicinal end. A marker in the middle reads "wording matters".“Helps maintain a balancedskin microbiome”“Corrects microbial dysbiosis”wording mattersCOSMETICMEDICINAL BORDERLINE
The claim spectrum: wording moves a microbiome claim along the line between cosmetic and the medicinal borderline.

“…the wording of a modulation claim can move it toward the medicinal borderline.”

Our role is to help you navigate that line: to design the study that substantiates a genuine, modulation-grade benefit, and to frame the resulting claim so it does the commercial work you want without inviting reclassification. We don’t make the legal determination, that rests with your regulatory team and the competent authority, but we make sure the science and the claim are built to survive the scrutiny.

References

These references are added to the certification page reference list.

  1. 1.Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use. Official Journal, 2001. (Art. 1(2): medicinal product by function = “restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action.” The test a microbiome-modulation claim must avoid triggering.)
  2. 2.European Commission. Manual on the Scope of Application of the Cosmetics Regulation (EC) No 1223/2009 (Art. 2(1)(a)) — “the Borderline Manual.” (Guidance on how borderline cosmetic/medicinal (and other) classifications are assessed case-by-case; useful precedent for the case-by-case principle.)