What is a cosmetic product: the EU legal definition under Regulation 1223/2009 and its boundaries

• The legal definition of cosmetic product is set out in Article 2(1)(a) of Regulation (EC) No 1223/2009: any substance or mixture, applied to external body parts (or the oral cavity), with a cosmetic purpose as its exclusive or main function.
• All three elements are cumulative: if any one is absent, the product is not a cosmetic and may fall under a different framework (medicinal products, biocides, or medical devices).
• Sunscreens are cosmetics under this Regulation — not biocides: Recital 7 lists them explicitly and UV filters are regulated under Annex VI.

1. The exact definition in Article 2(1)(a)

Article 2(1)(a) of Regulation (EC) No 1223/2009 sets the legal definition applicable throughout the European Union. The official English text (EUR-Lex consolidated version CELEX:02009R1223-20250901) reads:

'cosmetic product' means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.

This definition contains three cumulative elements. For a product to qualify as a cosmetic, all three must be satisfied simultaneously:

The phrase "exclusively or mainly" in the third element is decisive. A product may have a cosmetic function as its predominant purpose and still satisfy the criterion even if it has minor secondary effects of a different nature. What it cannot do is have a pharmacological, immunological or metabolic effect as its primary function — in that case it would fall within the scope of medicinal products.

Article 2(2) completes the definition by exclusion: "For the purposes of point (a) of paragraph 1, a substance or mixture intended to be ingested, inhaled, injected or implanted into the human body shall not be considered to be a cosmetic product." Dietary supplements, inhalers and injectables are thus outside the Regulation's scope regardless of any claimed effects on appearance.

2. What products does Regulation 1223/2009 cover?

Recital 7 of Regulation 1223/2009 provides an indicative, non-exhaustive list of product categories that may be cosmetics:

• Creams, emulsions, lotions, gels and oils for the skin
• Face masks, tinted bases (liquids, pastes, powders)
• Make-up powders, after-bath powders, hygienic powders
• Toilet soaps, deodorant soaps
• Perfumes, toilet waters and eau de Cologne
• Bath and shower preparations (salts, foams, oils, gels)
• Depilatories, deodorants and anti-perspirants
• Hair colorants; products for waving, straightening and fixing hair
• Hair-cleansing products (lotions, powders, shampoos); conditioning products
• Shaving products (creams, foams, lotions)
• Make-up and make-up removing products; products for the lips
• Products for care of the teeth and the mouth (toothpastes, mouthwashes)
• Products for nail care and make-up
• Products for external intimate hygiene
• Sunbathing products (sunscreens)
• Self-tanning products, skin-whitening products, anti-wrinkle products

This list is indicative: any product meeting all three elements of Article 2(1)(a) is a cosmetic, even if it does not appear in Recital 7. Conversely, appearing in Recital 7 does not automatically guarantee cosmetic classification if the product's claims or mechanism of action bring it closer to another regulatory framework.

3. What is not a cosmetic product?

Recital 6 of the Regulation states expressly: "This Regulation relates only to cosmetic products and not to medicinal products, medical devices or biocidal products."

The three frameworks that co-exist alongside Regulation 1223/2009 are:

Medicinal products (Directive 2001/83/EC): products that, by virtue of their pharmacological, immunological or metabolic properties, are intended to cure, prevent or diagnose disease, or to restore, correct or modify physiological functions.

Biocidal products (Regulation (EU) No 528/2012): products whose primary function is to destroy, neutralise, render harmless or prevent the action of harmful organisms. Hand sanitisers, antibacterial soaps and surface disinfectants are typical examples.

Medical devices (Regulation (EU) 2017/745): products for a medical purpose that achieve their intended effect through a physical or physiological mechanism in or on the human body, for diagnostic, therapeutic or relief purposes related to disease or disability.

Additionally, products ingested, inhaled, injected or implanted are explicitly excluded from the cosmetics scope by Article 2(2).

4. Borderline products: when classification is not obvious

A borderline product is one whose classification is not immediately clear because it may sit at the intersection of two or more regulatory frameworks. The final classification depends on the primary function, the claims, the mechanism of action and the reasonable perception of the average consumer.

The European Commission publishes the Borderline Products Manual through its Working Group on Cosmetic Products (Sub-Group on Borderline Products). The current version is 5.5 (June 2025), available on EC DocsRoom. This manual is non-binding practical guidance for national competent authorities and companies; definitive classification rests with the competent authorities of each Member State.

The five classification criteria are:

1. Primary function — what is the product intended for according to its instructions and presentation?
2. Mechanism of action — does it act superficially/physically (→ cosmetic) or pharmacologically/metabolically (→ medicinal)?
3. Claims and labelling — words such as "treats", "heals", "cures", "anti-inflammatory" point towards medicinal status; "soothes", "moisturises", "cleanses" are compatible with cosmetic classification.
4. Application site — must be one of the external parts listed in Article 2(1)(a); the internal nasal cavity, internal vaginal cavity and gastrointestinal tract fall outside the cosmetic scope.
5. Consumer perception — how a reasonably informed average consumer would perceive the product.

The following table covers the most common borderline cases:

Sunscreens are not biocides in the EU

A persistent error in non-official sources is to classify sunscreens as biocidal products in the EU context. This classification is incorrect. Recital 7 of Regulation 1223/2009 explicitly lists "sunbathing products" in the indicative catalogue of cosmetics. UV filters — the active ingredients in sunscreens — are regulated under Annex VI of the Regulation as a positive list of authorised UV filter substances for use in cosmetics. For the full list of authorised UV filters, see our guide to Annex VI.

Biocidal products under Regulation (EU) No 528/2012 are defined by their primary function: destroying, neutralising or preventing the action of harmful organisms. A sunscreen does not act by destroying micro-organisms: it acts by absorbing or reflecting UV radiation to protect the skin — which is a cosmetic protective function under Article 2(1)(a).

Anti-dandruff shampoo classification is claim-dependent

Anti-dandruff shampoo is the canonical example of a cosmetic-medicinal borderline product. The same formula can be classified differently depending on the claims: if the labelling and marketing present the product as a hair-cleansing and conditioning agent, it is a cosmetic. If it claims to treat or prevent a dermatological condition through a pharmacologically active ingredient, it becomes a medicinal product. There is no categorical answer independent of the claims.

5. The consequences of classification

The classification of a product entirely determines the applicable regulatory framework and the operator's obligations. Incorrect classification is not a minor error: it means operating under the wrong legislation, with incorrect authorisation, safety and labelling requirements.

For cosmetics under Regulation 1223/2009, the main obligations include:

• Appointing a Responsible Person established in the EU (Arts. 4–5)
• Notifying the product on the CPNP portal before placing it on the market (Art. 13)
• Maintaining a Product Information File (PIF) for 10 years (Art. 11)
• Having a Cosmetic Product Safety Report (CPSR) signed by a qualified assessor (Art. 10)
• Verifying that all ingredients comply with the restrictions in the Regulation's Annexes (Arts. 14–17)

6. How to verify whether your ingredients comply with the 1223/2009 framework

Once it is established that a product is a cosmetic under Article 2(1)(a), the next step is to verify that each ingredient complies with the Regulation's restrictions. This means checking:

• That no ingredient appears on Annex II (prohibited substances)
• That Annex III substances (conditional restrictions) are used within the established limits and conditions
• That preservatives come only from Annex V, colorants only from Annex IV, and UV filters only from Annex VI
• The status of CMR substances under the categories and concentrations set in Art. 15

The European Commission's CosIng database compiles all cosmetic ingredients with their regulatory status. Our ingredient database provides direct access to the current status of each ingredient against the Annexes of the EU Cosmetics Regulation (EC) No 1223/2009. Contact us if you need a product classification or compliance assessment.

7. Frequently asked questions

What is a cosmetic product under EU law?

Under Article 2(1)(a) of Regulation (EC) No 1223/2009, a cosmetic product means "any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours." Three cumulative elements must all be satisfied: the product must be a substance or mixture, applied to listed external body parts or the oral cavity, and have a cosmetic purpose as its exclusive or main function.

What is the legal definition of a cosmetic product in Europe?

The legal definition is set out in Article 2(1)(a) of Regulation (EC) No 1223/2009. It requires the product to be: (1) a substance or mixture, (2) intended to be placed in contact with the external parts of the human body or with the teeth and oral mucous membranes, and (3) with a view exclusively or mainly to cleaning, perfuming, changing appearance, protecting, keeping in good condition, or correcting body odours. If any of the three elements is absent, the product is not a cosmetic under the Regulation.

What is the difference between a cosmetic and a medicine in the EU?

The key difference lies in the purpose and mechanism of action. A cosmetic acts on the external body for the purposes listed in Article 2(1)(a): cleaning, perfuming, changing appearance, protecting or correcting odours. A medicinal product, governed by Directive 2001/83/EC, produces a therapeutic or prophylactic effect through pharmacological, immunological or metabolic action. The same product can be classified as cosmetic or medicinal depending on the claims made and the effect attributed to the active ingredient.

Is anti-dandruff shampoo a cosmetic or a drug in the EU?

It depends entirely on the claims made about the product. If the shampoo is presented as a hair-cleansing or conditioning product, it is a cosmetic under Regulation 1223/2009. If it claims to treat or prevent a scalp condition through pharmacological action, it falls under Directive 2001/83/EC as a medicinal product. There is no categorical answer: classification is always case-by-case, determined by the product claims and the reasonable perception of the average consumer.

Are sunscreens cosmetics or biocides in the EU?

Sunscreens are cosmetics in the EU. Recital 7 of Regulation 1223/2009 explicitly lists "sunbathing products" in its indicative catalogue of cosmetics. UV filters are regulated under Annex VI of the Regulation as a positive list of authorised UV filter substances. Classifying sunscreens as biocides in the EU context is incorrect: biocidal products are governed by Regulation (EU) No 528/2012 and have as their primary function the destruction or neutralisation of harmful organisms.

What are borderline cosmetic products?

Borderline products are those whose classification is not immediately obvious because they may sit at the intersection of two or more regulatory frameworks — cosmetic, medicinal, biocidal, or medical device. The European Commission Working Group on Cosmetic Products publishes the Borderline Products Manual (version 5.5, June 2025) as non-binding practical guidance. Classification is always case-by-case and ultimately decided by the competent authorities of each Member State.