In the EU market,Cosmetics regulations are known for their strictness,And the most controversial among them The easiest to step on lightning,exactly.  Boundary products  Borderline Products    Those between cosmetics and medicine medical device Biocidal agent food Waiting for products between other categories.

To assist enterprises in accurately determining product classification,The European Commission has released a very important document

Handbook on the Scope of Application of Cosmetics Regulations  Manual on the Scope of Application of the Cosmetics Regulation ,Commonly referred to in the industry as EU Borderline Products Manual.

As of 2025, the latest version has been updated to V5.5 (June 2025).

It is worth noting that,After Brexit, the UK will continue to use the same boundary product judgment logic as the EU,Therefore, this guide is also applicable to the UK market.

for example ·A certain product looks like cosmetics,But with anti-inflammatory repair heal Waiting for medical declaration

·A spray can be used for body cleaning,It also claims to be disinfectable and bactericidal

·Whether a self heating facial mask involves physics mechanism of action Mode of Action

These types of products often fall into regulatory gray areas

Is it cosmetics medicine medical device Or is it a biocide

And the classification of the product determines

· What efficacy can be claimed

· What tests are needed/clinical

· How to go public

· How to be enforced by regulatory authorities.

Two The EU's regulatory approach to border products

EU cosmetics are subject to  Cosmetics Regulations EC No 1223/2009  supervision.

But the regulations themselves cannot cover all practical cases,Therefore, the EU working group has developed this guideline,Providing services to member states and enterprises Actual cases and interpretations,Assist in determining whether a product belongs to the category of cosmetics.

It should be emphasized that

This guide is not a law,But rather the most important practical reference document in the industry.

The law enforcement agencies of each member state will make judgments based on this logic.

The latest version (V5.5, updated in June 2025) includes a large number of typical cases, which serve as an important basis for brands to make compliance judgments.

Three The core purpose of the guide

1. Clear classification

Assist companies in determining whether a product belongs to the category of cosmetics,So as to apply the correct regulations.

2. Ensure compliance with regulations

Different categories imply different security requirements Claiming restrictions and listing path.

3. Promote consistency among member states

Reduce market chaos caused by national differences.

4. Support law enforcement

When the product is misclassified,Regulatory agencies can take action based on this,Including bans and recalls.

Four 2023–2025 Important updates of the year

·  False nails/False eyelash adhesive 2023

·  Magnetic eyeliner liquid 2023

·  Ampoule Glass bottle small dose product 2024

·  Contour paste Self service concentrated tanning solution oral spray/gel 2025

·  Tattoo fading/Clear category products 2025

These categories often have controversies,Therefore, it has been included in the guidelines as a key focus.

Five How to judge Is my product a cosmetic  

1. Product intent Intended Use

Is it used for cleaning protect Maintain good condition Change the appearance and other cosmetic purposes

2. Mechanism of action Mode of Action

Cosmetics can only act on the surface layer,Shall not affect the physiological functions of the body.

If physiological functions are altered through chemical or biological processes,It is likely to be identified as a drug or medical device.

3. Declare Claims

Acceptable: Moisturizing, soothing, brightening, refreshing

Unacceptable: Treatment, anti-inflammatory, circulation-promoting, skin-repairing

4. Part used Application Site

Cosmetics are only suitable for the appearance of the body Oral mucosa and teeth.

For example cavidade nasal Vaginal products Never regarded as cosmetics.

Six Why is this important

·  The product has been found to be illegally listed

·  Regulatory authorities require recall

·  The product has been completely banned from sale

· Enterprises face legal responsibilities

·  Brand reputation damaged

Therefore,For products located in gray areas,Compliance assessment must be conducted before listing,Especially the formula Declaration and label design phase.

Seven Differences between the United States and the European Union Why pay more attention

Different from the European Union,The United States does not have a border product guide.

FDA main basis Declaration and purpose To decide whether it's cosmetics or OTC medicine.

Typical Differences

· Sunscreen for cosmetics in the European Union anti-dandruff shampoo,In the United States, however OTC medicine,Must meet drug grade requirements.

This means that international brands must adjust their compliance strategies according to local conditions,Cannot simply reuse the same set of claims and content.

Conclusion Boundary products are the most sensitive area for compliance

The release of the latest version in 2025 serves as a reminder to businesses:

Stay tuned understand Grey zone products Classification principle,It is a necessary condition for entering the EU market.

For enterprises,The earlier the product classification is judged The earlier you plan and declare your strategy,The more it can avoid listing risks,Enhance product compliance,Ensure smooth entry into the EU and UK markets.