What’s new?
In August 2025, the European Commission published version 5.5 of the 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.
The latest version introduces four significant additions addressing cosmetic product categories that have created regulatory uncertainty for manufacturers and national authorities. These updates reflect evolving market trends including specialized beauty application tools, customizable self-tanning products, oral care cosmetics, and expanded tattoo aftercare products.
This non-legally binding guidance document continues to serve as the primary reference tool for manufacturers, importers, distributors, and national competent authorities in determining whether products fall within the scope of EU Cosmetics Regulation (EC) No 1223/2009 or require classification under alternative regulatory frameworks.
New Product Categories
The manual establishes that Henna contour pastes qualify as cosmetic products when they:
- Are applied on or around eyebrows or lips to create protective barriers
- Serve the cosmetic function of protection from unintended henna coloration
- Meet the fundamental criteria of application to external body parts with cosmetic purpose
Self-tanning drops or concentrates are now explicitly classified as cosmetics regardless of application method:
- Products intended for direct skin application qualify as cosmetics
- Products designed for mixing with other cosmetics (facial creams, body lotions) before application also qualify as cosmetics
- Clear labeling with usage instructions is required for mixed-application products
- The end-user mixing process does not affect cosmetic classification
Oral drops, sprays, or gels can qualify as cosmetics under specific conditions:
- Primary function must be clearly cosmetic (breath freshening, maintaining oral mucosa condition)
- Products must not be intended for partial or complete swallowing
- Labels must include clear warnings against swallowing
- Instructions must specify to spit out or rinse out excess product
- Products must not be designed to dissolve in saliva or absorb through mucous membranes
The section on Tattoo removal products was expanded beyond removal to include fading claims:
- Topically applied products may qualify as cosmetics if effects occur through exfoliation or skin-whitening
- Classification requires that claimed effects do not involve pharmacological, immunological, or metabolic action
- Products injected into the dermis remain excluded from cosmetic classification
- Individual assessment required based on specific product characteristics and mechanisms of action