In August 2025, the European Commission published version 5.5 of the Borderline Manual on the Scope of Application of the Cosmetics Regulation. This update introduces several new sections and amendments clarifying the classification of products under the Cosmetics Regulation.
The previous update occurred in January 2025.
New section: henna contouring paste
The Manual clarifies that henna contour pastes, which are applied on or around eyebrows or lips to create a barrier and prevent henna from running, qualify as cosmetic products. They meet the definition of cosmetic products by being applied to external body parts and serving a cosmetic function (protection from unintended coloration).
New section: self-tanning concentrates
The update introduces a new entry for self-tanning drops or concentrates. These products are intended to be mixed by the end-user with another cosmetic (e.g., facial cream, body lotion) before application to achieve a change in skin colour.
These products qualify as cosmetics whether applied directly to the skin or mixed with another cosmetic prior to application. For such products, the Manual specifies that the labelling should provide clear instructions for use.
New section: oral drops, sprays, or gels
The new version introduces clarifications on the classification of oral products claiming cosmetic functions, such as freshening breath or maintaining the oral mucosa in good condition. Products presented as drops, sprays, or gels can be considered cosmetics if:
- The primary function is clearly cosmetic,
- They are not intended to be partially or entirely swallowed, and the intent is demonstrated by clear warnings on the label,
- They are labelled with instructions to spit out or rinse out any excess product, and
- They are not designed to dissolve in saliva or be absorbed through the mucous membrane.
For each classification, national competent authorities retain responsibility for case-by-case assessments, considering product composition, presentation, mode of use, and instructions for use, as well as the indications published in the Borderline Manual.
Updated section: tattoo removal and fading products
The revised Manual expands the scope of tattoo removal products to also cover tattoo fading claims. In the previous version, it was specified that products injected into the dermis (via pens or devices) to remove or fade ink are not cosmetics. Nevertheless, the new version clarifies that products applied topically to the skin may be considered cosmetics if their claimed effect (e.g., via exfoliation or skin-whitening) does not involve pharmacological, immunological, or metabolic action.
As with other borderline cases, national authorities will need to assess classification individually, based on product characteristics.
To never miss a regulatory update, subscribe to COSlaw (free membership). For any questions on cosmetics compliance, contact COSlaw Team here or at coslaw@obelis.net.
References
European Commission. (2025). Manual of the Working Group on cosmetic products (sub-group on borderline products) on the scope of application of the Cosmetics Regulation (EC) no. 1223/2009 (Art.2(1)(a)). Retrieved on 2 September 2025.
EUR.lex (2009). Regulation (EC) No 1223/2009 of the European Parliament and of the Council on Cosmetic Products. Retrieved on 2 September 2025.
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