MICROBIOME AND COSMETIC PRODUCTS: KEY CONCEPTS AND REGULATION
MICROBIOME AND COSMETIC PRODUCTS KEY CONCEPTS AND REGULATION

Our skin harbors a microbiome, in fact it harbors many different microbiomes, and skin problems are always related to an imbalanced skin microbiome. It is therefore not surprising that the skin microbiome is a hot topic in personal care.

However, what is the microbiome? What do claims of the microbiome as probiotic, prebiotic, postbiotic, etc. mean? How can a cosmetic firm justify these claims? And above all, how are these products regulated according to their safety and quality standards?

In simple terms, the microbiome is the genetic content of all microbes (including bacteria, fungi and viruses) living in a specific habitat. Therefore, the human microbiome is the genetic content of all microbes living on and in the human body. It can be found not only in our gut, i.e. the intestinal microbiome, but also in our lungs, reproductive organs, skin and scalp.

Although the microbiome is an evolving topic, both from a science and innovation standpoint, the regulatory landscape for cosmetics in various regions is designed to accommodate a variety of possible formulations and key principles such as safety, quality and efficacy leave room for scientific innovation.

Microbiome-focused cosmetics already meet robust standards to ensure safety, quality and efficacy. However, for companies to claim microbiome-focused effects based on their prebiotic, probiotic and postbiotic nature, more robust data is required to demonstrate safety and efficacy; which brings us to the starting point of the current debate.

The International Cooperation on Cosmetic Regulation (ICCR), has been evaluating the safety, quality and regulation of cosmetic products targeting the human skin microbiome, and discussions are currently ongoing.

In 2018, at the 12th annual International Cooperation on Cosmetics Regulation (ICCR) meeting, the topic of cosmetics and the microbiome was discussed, and it was agreed to create a new Joint Working Group (JWG) on the topic of “The microbiome in relation to cosmetics”.
In early 2021, the ICCR JWG published a summary document, “Microbiome and cosmetics: a survey of products, ingredients, terminologies and regulatory approaches”, which is a survey of product and ingredient terminologies and regulatory approaches.
According to it, probiotics are “live or dormant microorganisms (e.g., Lactobacillus casei, Lactobacillus acidophillus, Nitrosomonas eutropha, etc.)” and prebiotics are “nutrients for probiotics or the skin’s natural microbiota (e.g., oligosaccharides, natural oils, etc.).”

Postbiotics are defined as “soluble factors (metabolic products or by-products) secreted by living bacteria or released after bacterial lysis (e.g., bifida ferment lysate, Lactococcus ferment lysate, Bacillus coagulans ferment, etc.)”.

If a product is “microbiome friendly” or “microbiota-friendly”, it means that it does not interfere with the skin microbiome.

But can probiotics, prebiotics and postbiotics be considered cosmetic ingredients? Will they interfere with the microbiological limits set by regulators? Do cosmetics containing these ingredients fall under the definition of the EU Cosmetics Regulation or should they be considered bordeline products? Many questions remain to be answered and a case-by-case assessment is generally recommended.

Currently, there are no specific global regulations or requirements governing cosmetic products or ingredients intended to work specifically with the skin microbiome. In the meantime, companies seeking to commercialize microbiome-focused cosmetics follow the current local regulatory landscape for standard cosmetics; that is, continuing to ensure that products are safe and provide the claimed benefit.

Ivan Parra Guerra
Commercial Director at Dr. Goya Análisis

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