The Borderline Manual of Cosmetics is a guidance document used to decide whether a product fits the legal definition of a cosmetic product or if it should fall under another regulatory framework. The latest version of the manual is dated June 2025. It helps determine if a product should instead be classified as medicinal products, biocides, or medical devices. The document provides criteria, examples, and interpretations based on EU and UK cosmetic regulations, including Regulation (EC) No 1223/2009 in the EU and the UK Cosmetics Regulation.
What the Borderline Manual of Cosmetics is
The Borderline Manual of Cosmetics is meant to help decide if a product actually qualifies as a cosmetic. If it does not, it may fall under another regulatory framework such as medicinal products, biocides, or medical devices. The manual includes criteria, examples, and interpretations drawn from EU and UK cosmetic regulations. These include Regulation (EC) No 1223/2009 in the European Union and the UK Cosmetics Regulation.
Definition of a cosmetic product
A product is considered a cosmetic if it is intended to be applied to external parts of the body, like the skin, hair, nails, or lips, or to the teeth and mucous membranes. The main purpose of the product must be cosmetic. That means it should clean, perfume, change appearance, protect, keep in good condition, or correct body odours.
Distinction from other product categories
The manual explains how cosmetics are different from other types of regulated products.
A product may be classified as a medicinal product if it has a therapeutic or preventive function. A biocide classification may apply if the product’s main action is antimicrobial or disinfectant, such as hand sanitizers. A product might instead be considered a medical device if it has a physical or physiological effect for a medical purpose.
Case studies and practical examples
The manual often uses real examples to show how authorities classify products. One example is anti-dandruff shampoo. It can be considered a cosmetic if its main function is cleansing and conditioning. If the product claims to treat a scalp condition, it may instead be classified as a medicine.
Who uses the Borderline Manual
Different groups rely on the Borderline Manual for guidance.
Regulatory authorities use it to assess compliance. Manufacturers and brands use it to check the correct classification before launching a product. Retailers and distributors rely on it to understand how products can be marketed legally.
The three key categories of product classification
Type of product: substance or mixture
A cosmetic product must be either a substance, like an essential oil, or a mixture, such as a lotion, cream, or shampoo. Devices, patches, or instruments are not considered cosmetics unless they only act as carriers for a cosmetic substance.
Application site
Cosmetics are defined as products applied to certain parts of the body. These include the skin, hair and scalp, nails, lips and external genital area, and the teeth and oral cavity. Products applied inside the body or that have a systemic effect are not considered cosmetics.
Intended cosmetic purpose
The intended purpose of the product plays a key role in classification. If a product makes claims that go beyond cosmetic effects, it may fall under pharmaceutical, biocidal, or medical device regulations.
How the manual affects cosmetic claims
The Borderline Manual has a strong influence on what claims cosmetic products can make. A product’s classification depends on its intended use, so claims used in marketing, labelling, and advertising must match the correct regulatory category.
Cosmetics classified under Regulation (EC) No 1223/2009 or the UK Cosmetics Regulation may make claims related to:
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Cleansing
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Protecting
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Maintaining good condition
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Perfuming
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Altering appearance
Claims suggesting medical or therapeutic effects may lead to the product being classified as a medicine instead.
Avoiding medicinal or therapeutic claims
A product that claims to prevent, treat, or cure a medical condition may be classified as a medicine. Examples of claims that could cause problems include statements like “Treats eczema” or “Cures acne.”
Claims such as “Soothes dry and sensitive skin” or “Reduces the appearance of blemishes” are considered acceptable cosmetic claims.
Evidence-based claims and compliance
Under Regulation (EU) No 655/2013, cosmetic claims must follow certain principles. Claims must be truthful, supported by evidence, honest about performance, and clear to consumers.
New updates in the 2025 version
In June 2025, the European Commission released version 5.5 of the Borderline Manual. The updated version added several new clarifications.
Contouring pastes with henna applied around or over the eyebrows or lips to prevent henna stains are considered cosmetics. These products are applied to external parts of the body and provide protection from unwanted colouring.
Nasal sprays are not considered cosmetics. The regulation does not include the nasal mucosa among the sites of application for cosmetic products.
Self-tanning drops or concentrates that consumers mix with another cosmetic before applying to the skin are still considered cosmetics. They can be cosmetics when used directly on the skin or when mixed with another cosmetic. Labels must give clear instructions for use. The safety assessment must consider the mixtures the user may create following those instructions.
The updated manual also clarifies the classification of sprays, drops, or gels used for the oral mucosa that claim cosmetic functions such as freshening breath or keeping the oral mucosa in good condition. These can be cosmetics if the main function is cosmetic, the product is not intended to be ingested, the label includes warnings, instructions say to rinse excess product, and the formulation is not designed to dissolve in saliva or be absorbed through the mucosa.
The revised version also addresses tattoo removal and fading products. Products injected into the dermis using pens or devices to remove or fade ink are not cosmetics. Products applied to the skin that claim fading effects through exfoliation or lightening may be considered cosmetics if they do not involve pharmacological, immunological, or metabolic action. National authorities still assess classification case by case based on the composition, presentation, methods, instructions for use, and the guidance in the Borderline Manual.
Ensuring regulatory compliance
Correct classification under the Borderline Manual is important to avoid legal risks. Cosmetic brands need to pay attention to claims, ingredients, and regulatory updates to remain compliant in different markets. Companies can seek assistance to confirm that a product is not incorrectly classified and to avoid fines or product seizures.
