New Version of the EU Borderline Manual on Cosmetic Products
Topic: EU Borderline Manual on Cosmetic Products.

Date of publication: August 2025

The European Commission has published version 5.5 of the Borderline Manual for Cosmetic Products, introducing four new sections and expanding existing guidance to clarify the classification of henna contouring products, self-tanning concentrates, oral cosmetic products, and tattoo fading treatments.

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

References

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)), Version 5.5 (June 2025)

Linkedin Instagram Facebook

other REGULATORY UPDATES

SCCS Revision of the Scientific Opinion on Vitamin A

Ingredients: RETINOL, RETINYL PALMITATE, RETINYL ACETATE, RETINYL LINOLEATE, RETINAL

Date of publication: 25/10/2022

The Scientific Committee on Consumer Safety has issued a final version of the Scientific Opinion on Vitamin A, concluding that exposure to Vitamin A derived from cosmetics can be a concern for higher exposure consumers, and since cosmetics alone do not exceed the upper limit the SCCS cannot suggest maximum concentration limits that take into account contributions from other sources.

Read More »
Any REGULATORY QUESTION?
E-mail

French Anti-Waste Law – Impact in Cosmetics Packaging and Labelling

PACKAGING WASTE MANAGEMENT

Date of application: 01/01/2023, with a transition period until 09/03/2023 for packaging produced or imported before 09/09/2022.

The Loi relative à la lute contre le gaspillage et a l’économie circulaire (Anti-Waste for a circular economy) has come officially into force in France in 2020. From January 2023 the requirements of the law became mandatory, including specific symbols on the packaging or labelling of cosmetic products.

Read More »

SCCS Final Opinion on the Safety of Triclocarban and Triclosan

Ingredients: TRICLOCARBAN and TRICLOSAN

Date of publication: 25/10/2022

During the plenary meeting on 24-25 October 2022, the Scientific Committee on Consumer Safety (SCCS) presented its final opinion on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products.

Read More »