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As the name suggests, borderline products are products that cannot be clearly classified solely as cosmetics and may fall under more than one regulatory framework. Within the EU, such classification is determined through a holistic assessment of multiple factors, including the product’s composition, presentation, marketing claims, and intended use.
The “Borderline Manual”, published and regularly updated by the European Commission, provides practical, example-based guidance on which regulation a product should fall under. Although this document is not legally binding, it serves as a key reference for Member States and national authorities and remains a frequently updated resource as of 2025.
The European Union cosmetic market is governed by strict and detailed regulations aimed at protecting consumer health. Under these rules, some products may initially appear to be cosmetics but, due to their composition, intended purpose, or marketing claims, may fall under a different regulatory regime. Such products are defined as Borderline Cosmetic Products.
Correct classification of borderline cosmetic products is critical to ensure legal compliance and to prevent regulatory and market-entry risks.
According to the EU Cosmetics Regulation (EC) No 1223/2009, for a product to be considered a cosmetic, it must:
Be applied to the external parts of the human body
Have the primary purpose of cleaning, perfuming, changing appearance, protecting, or keeping the body in good condition
However, some products partially meet this definition but may also be assessed as medicinal products, medical devices, or biocidal products due to:
Claims of therapeutic or physiological effects
An intention to affect body functions
Specific modes of use or dosage forms
Whether a product qualifies as a cosmetic is assessed based on the criteria defined in Regulation (EC) No 1223/2009. The intended function of the product must be to:
Clean
Perfume
Change appearance
Protect
Keep in good condition
These functions apply only to products intended for use on external body surfaces, as well as teeth and the oral mucosa. However, when a product goes beyond cosmetic effects and claims to treat, modify biological functions, or control microorganisms, it may fall under another regulatory framework.
Classification is assessed based on the following criteria:
Intended use of the product
Product presentation and marketing language
Modus operandi (mechanism of action)
Product packaging and dosage form
Nature and wording of product claims
These factors must be evaluated collectively, and the final decision is made on a case-by-case basis.
The Borderline Products Manual published by the European Commission is the primary reference document for correct classification. The guide includes:
Current regulatory interpretations
Product-specific examples
Previous classification decisions
and is updated on a regular basis.
Recent updates have highlighted several product categories that frequently raise classification questions in the cosmetic sector.
Some examples of product categories listed in the current version of the EU Borderline Manual that may raise classification concerns include:
False nail / eyelash adhesives
Magnetic eyeliners
Products presented in ampoules or vials
Tanning concentrates and contour pastes
Tattoo removal or fading products
Self-tanning concentrates
Oral spray or gel formulations
When products are presented in ampoule or vial formats, classification uncertainty may increase, requiring detailed regulatory analysis.
These examples represent product types that may fall under both cosmetic and non-cosmetic regulatory frameworks, highlighting the need for thorough, product-specific assessment to ensure correct classification.
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