EU REGULATION ON COSMETIC CLAIMS

As addressed in one of our previous posts, when making available a cosmetic product in the EU market, the product must comply with the definition of cosmetic product according to the European Regulation (EC) No 1223/2009. Moreover, every single claim made or implied by the product has to be compliant with the Commission Regulation (EU) No 655/2013, which lays down common criteria for the justification of claims in cosmetic products. This applies to all cosmetic product claims, irrespective of the medium or type of marketing tool used, the product’s claimed functions or its the target audience.

In order to help companies to comply with the Commission Regulation No 655/2013, in 2017, the European Commission has published a technical document. Besides providing a detailed description of the common criteria, this document also lays down the best practices to be followed in regard to the type of evidential support used for the justification of cosmetic claims, as well as for the application of the common criteria to “free from” and “hypoallergenic” claims.

Claims can be made in the form of texts, names, trademarks, pictures and figurative or other signs that convey, explicitly or implicitly, product characteristic or functions in the labelling, marketing and advertising media.

MICROBIOME RELATED TERMS AND DEFINITIONS

In 2018, at the 12^th annual meeting of International Cooperation on Cosmetics Regulation (ICCR), the topic of cosmetics and the microbiome was discussed. Given that “technologies exploring the relationship between the human microbiome and healthy skin was an area of increasing interest”, the ICCR Steering Committee agreed to create a new Joint Working Group (JWG) on the topic “Microbiome as it relates to Cosmetics”. Early this year, the ICCR has published a report entitled “Microbiome and Cosmetics: Survey of Products, Ingredients, Terminologies and Regulatory Approaches”.

According to the ICCR, Probiotics are “live or dormant micro-organisms (e.g. Lactobacillus casei, Lactobacillus acidophillus, Nitrosomonas eutropha, etc.)” and Prebiotics are “nutrients for probiotics or natural skin microbiota (e.g. niacinamide, minerals, thermal water, vitamins, oligosaccharides, natural oils, etc.)”. Postbiotics are defined as “soluble factors (products or metabolic by-products) secreted by live 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.

MICROBIOME CLAIMS IN COSMETIC PRODUCTS

Presently, there are no international guidelines on definitions or terminologies applicable to microbiome claims in cosmetic products.

The U.S. Food and Drug Administration (FDA) has expressed some concerns related with this type of cosmetics, specifically with the efficacy, safety and quality of these products. There are still some outstanding questions raised by the FDA, like whether probiotics are still alive in cosmetics in the presence of preservatives or if they affect product quality and safety.

The definition of cosmetic product and the substance/mixture it contains does not make any reference to the terms ‘viable’ or ‘non-viable’, so it is not clear if prebiotics, probiotics and other fall into this definition. There is a regulatory uncertainty, as these ‘ingredients’ are neither explicitly banned or allowed.

In the European Union, the safety of a cosmetic product must be demonstrated and data on microbiological quality must be included in the Cosmetic Product Safety Report (CPSR), which is part of the Product Information File (PIF). The total count of aerobic mesophilic microorganisms (bacteria, yeasts and moulds) and the absence of specific microorganisms (Candida albicans, Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli) should be included. Other regulated markets can establish different cosmetic requirements which may differ when it comes to the product’s microbiological quality standards.

For example, in South Korea, the use of live microorganisms in cosmetic products is usually not permitted. In Japan, “ingredients of cosmetics, including any impurities contained therein, shall not contain anything that may cause infection or that otherwise makes the use of the cosmetic a potential health hazard“. In Canada and USA, cosmetic products must comply with imposed microbiological limits. Depending on where the product shall be made available, the use of probiotics may not be a choice (as they are considered ‘live or dormant’ microrganisms) or it must comply with regional microbiological limits.

On another perspective, if a cosmetic product mentions it has pharmaceutical or medicinal-type activities, it will fall outside the cosmetic product definition set by the European Cosmetic Regulation. Claims like ‘microbiome-friendly’ usually fall under this definition. Therapeutic claims (e.g. preventing or treating diseases) are not permitted in cosmetics.

All cosmetic and personal care product must be proved as safe for the consumer, under normal and foreseeable conditions of use, and cosmetic claims must be supported and properly substantiated. However, some claims might be difficult or too complex to verify or substantiate (e.g., efficacy claims on the skin microflora).

In sum, can probiotics, prebiotics and postbiotics be considered cosmetic ingredients? Will they interfere with the microbiological limits set by regulators? Cosmetics containing these ‘ingredients’ fall under the definition of the EU Cosmetics Regulation or should be considered borderline products? There are still many questions to be answered and a case-by-case evaluation is usually advisable. CRITICAL CATALYST is here to help you! If you need further information or advice on which claims and type of substantiation can be made for your cosmetic products, feel free to contact us at info@criticalcatalyst.com.

References:

1. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
2. Commission Regulation (EU) No 655/2013 of 10 July 22013 laying down common criteria for the justification of claims used in relation to cosmetic products.
3. Technical document on cosmetic claims. Agreed by the Sub-Working Group on Claims. 2017. European Commission.
4. Microbiome and Cosmetics: Survey of Products, Ingredients, Terminologies and Regulatory Approaches. International Cooperation on Cosmetics Regulation (ICCR). 2021.