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The European Union has a guide for Borderline Cosmetic Products, that are products between Cosmetics and other product categories (often referred to simply as the EU Borderline Products Manual or Guideline for Borderline Products) is a practical document issued by the European Commission to help decide whether a product falls under the scope of the EU Cosmetics Regulation (EC) No 1223/2009 or another regulatory framework.
This also applies to UK cosmetic products, as the UK Cosmetic Regulation has the same approach and rules of the EU nowadays. As the definition of cosmetic products is the same, the guidelines can be used also to classify cosmetic products in the UK.
What is a Borderline Cosmetic Product?
The European cosmetics market is one of the most strictly regulated in the world, and this is especially true for borderline cosmetic products. A borderline product is one for which it is not immediately clear which EU legislation applies. For example, a product might appear to be a cosmetic but could also be regulated as a biocidal or medicinal product depending on its composition, intended use, or claims made by the manufacturer.
The product may fall into a grey area between cosmetics and other categories such as drugs, medical devices, biocides or even food. Determining whether a product qualifies as a cosmetic or not is crucial, because the applicable regulation dictates what claims can be made, what testing is required and how the product can be marketed.
The European Approach to Borderline Cosmetic Products
Cosmetics in the European Union are regulated under Regulation (EC) No 1223/2009. However, not all products are easy to classify. To ensure consistency, the Working Group on Cosmetic Products (Sub-Group on Borderline Products) published a Manual on the Scope of Application of the Cosmetics Regulation, the most recent version being 5.5 (June 2025).
This manual is not legally binding, but it provides practical guidance and examples to help national authorities and companies interpret the definition of a cosmetic product under Article 2(1)(a). Each case must still be assessed individually, but the manual is an essential tool for understanding the grey areas, as it contains case-by-case assessments of product types that may be difficult to classify.
Objective of the Guide
The main objectives of the EU Borderline Products Guide are:
- Clarify Classification: To assist in determining the correct legal framework for a product on a case-by-case basis, to ensure compliance with the different regulations. In this case, to ensure the product is correctly classified as a cosmetic product.
- Ensure Compliance: To ensure that products are regulated under the appropriate legislation, which affects safety requirements, marketing authorizations, and enforcement actions.
- Promote Harmonization: To encourage consistent classification decisions across EU Member States, reducing regulatory uncertainty and market fragmentation.
- Support Enforcement: To help authorities take appropriate action when products are misclassified, including removal from the market if necessary.
Recent Updates (2023–2025)
The last revisions of the Guideline have included new product types that often raise doubts, such as:
- Adhesives for false nails, false eyelashes or tooth jewelry (2023).
- Magnetic eyeliners (2023).
- Products in vials or ampoules (2024).
- Contouring paste, self-tanning concentrates, oral sprays or gels (2025).
- Tattoo removal and fading products (2025).
Key Criteria for Product Classification. Is My Product a Cosmetic Product?
When deciding whether a product qualifies as a cosmetic, regulators consider different aspects, such as:
- Intended use: cleaning, perfuming, protecting, keeping in good condition or changing appearance.
- Mode of action: does the product act only on the surface or does it restore/modify physiological functions?
- Presentation and claims: wording such as “refreshing” or “soothing” may be acceptable, while “healing”, “anti-inflammatory” or “circulatory” would point to medicinal claims.
- Application site: cosmetics apply only to external parts of the body (skin, hair, nails, lips, external genital organs) or to teeth and oral mucosa. Vaginal or nasal products, for example, are excluded.
Why It Matters
Misclassification can lead to enforcement actions, recalls or a complete ban on marketing. For companies, this means that borderline products must be carefully reviewed before launch, not only for formulation but also for claims and labelling.
The U.S. Approach to Borderline Cosmetic Products
In the U.S., the situation is different. There is no equivalent manual of borderline products. Instead, the FDA distinguishes cosmetics from OTC products mainly based on claims and intended use. For example, sunscreens and anti-dandruff shampoos are cosmetics in the EU but regulated as OTC products in the U.S.
This contrast shows how important it is for international brands to adapt their regulatory strategy to each market.
Conclusion
Borderline cosmetic products remain one of the most sensitive areas of cosmetic compliance in Europe. While the EU manual does not provide binding law, it reflects the collective practice of Member States and is updated frequently, most recently in 2025. For companies, keeping track of these updates and understanding how borderline products are assessed is essential to avoid compliance risks and ensure smooth market entry.
References
- Manual on the Scope of Application of the Cosmetics Regulation (EC) No 1223/2009, Version 5.5 (June 2025), Working Group on Cosmetic Products (Sub-Group on Borderline Products).
- Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products
- FDA Cosmetics Overview
