Cosmetic Definition: What Counts as a Cosmetic Product

You have a formulation, a draft label and a target launch date for the European market. Before anything else, one question decides which rulebook applies to you: is your product a cosmetic? The answer does not depend on what you call the product or which shelf you want it on. It depends on how the law defines a cosmetic product, and on how authorities read your product against that definition.

This guide walks through the cosmetic definition as the EU applies it. It covers the product types that fall inside it, the ones that fall outside, and the obligations that start the moment your product is in scope.

The short answer: what the EU treats as a cosmetic

The European Commission describes cosmetics as a range running from everyday hygiene products such as soap, shampoo, deodorant and toothpaste to luxury beauty items including perfumes and makeup [1]. These products are regulated at European level to ensure consumer safety and to secure an internal market for cosmetics [1].

The legal source is Regulation (EC) No 1223/2009, the main regulatory framework for finished cosmetic products placed on the EU market [2]. It replaced Directive 76/768/EC, which was adopted in 1976 and had been substantially revised on numerous occasions [2].

The regulation’s detailed definition of cosmetic products refers both to their areas of application and to the purposes of their use [3][5]. In practice, you need to look at where the product is applied and what it is meant to do. The marketing name alone does not settle it.

Products that commonly fall inside the definition

The recitals of the regulation give an illustrative list of what cosmetic products may include. The wording is “may include”, so treat the list as a guide, not a closed catalogue [3]. It names, among others:

creams, emulsions, lotions, gels and oils for the skin [3]
face masks and make-up powders [3]
toilet soaps and deodorant soaps [3]
perfumes and toilet waters [3]
bath and shower preparations [3]
hair colorants, shampoos and hair-conditioning products [3]
sunbathing products and products for tanning without sun [3]
skin-whitening products and anti-wrinkle products [3]

If your product resembles items on this list, you are probably working under the cosmetics framework. “Probably” is deliberate, as the next sections explain.

Products that sit outside the definition

The regulation relates only to cosmetic products and not to medicinal products, medical devices or biocidal products [3][5]. The delimitation follows from the detailed definition of cosmetic products, which refers to their areas of application and the purposes of their use [3][5].

For a brand, this boundary is where most classification problems begin. A product can look like a cosmetic and sit in a cosmetic-style package, yet be pushed toward another regime by what it is intended to do. The Commission’s cosmetics page lists “borderline products” as a specific topic, which tells you that regulators treat these cases as a recurring issue and not as a rare exception [1].

Two practical points follow:

Review the intended purpose of the product, not only its ingredient list. The definition turns on areas of application and purposes of use [3][5].
Do not assume that a product outside the cosmetics framework escapes regulation. It simply moves to a different set of rules.

Why classification is a case-by-case decision

The regulation states that the assessment of whether a product is a cosmetic product has to be made on the basis of a case-by-case assessment, taking into account all characteristics of the product [3]. A product category alone will not give you a reliable yes or no.

Where doubt remains, the regulation provides a route to resolve it. The Commission may, at the request of a Member State or on its own initiative, adopt the necessary measures to determine whether or not a specific product or group of products falls within the definition of “cosmetic product” [4].

Even when a product is a cosmetic, it can raise other questions. The Commission’s Q&A on TPO in nail products, for example, clarifies frequently misunderstood points, including the treatment of professional use, the role of CLP classification data, and the difference between the Cosmetics Regulation and REACH [1]. The Commission also notes that additional requirements under other EU legislation might apply to cosmetics. Examples include chemicals restrictions, aerosol dispensers, nominal quantities for prepackaged products, and packaging waste [2].

If your product could plausibly sit on either side of the line, document your reasoning early. Ask a qualified EU regulatory expert to review it before you commit to labels and packaging, because requirements and interpretations can vary by Member State.

Who the definition makes responsible

Once a product is a cosmetic, the regulation attaches duties to specific people. Three roles matter most.

The manufacturer

The regulation defines a manufacturer as any natural or legal person who manufactures a cosmetic product or has such a product designed or manufactured, and markets it under their own name or trademark [4]. The Commission also states that the manufacturer is responsible for the safety of their products [1]. That includes making sure the product undergoes an expert scientific safety assessment before it is sold [1].

The responsible person

Only cosmetic products for which a legal or natural person is designated within the EU as a “responsible person” can be placed on the market [2]. The regulation allows that person to be precisely identified and sets out their obligations [2].

The importer

For an imported cosmetic product, each importer is the responsible person for the specific cosmetic product they place on the market [3][4]. If you manufacture outside the EU, work out early who in your supply chain holds this role, and confirm that the person understands what it involves.

What the definition triggers once you are in scope

Classifying your product as a cosmetic is not a formality. It starts a set of obligations, and several of them must be complete before the first sale.

Safety assessment and report. Before placing a cosmetic product on the market, the responsible person must ensure it has undergone a safety assessment and that a cosmetic product safety report is set up in accordance with Annex I [3][4]. The regulation also says the product information should include a cosmetic product safety report documenting that a safety assessment has been conducted [3].
Notification. All products to be marketed in the EU must be registered in the cosmetic products notification portal (CPNP) before being placed on the market [1]. Manufacturers notify their products once, centrally, through this portal [2].
Serious undesirable effects. A responsible person has an obligation to notify serious undesirable effects to national authorities [2].
Restricted substances. The use in cosmetic products of substances classified as CMR substances of category 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 is prohibited [4]. A category 2 substance may be used where the SCCS has evaluated it and found it safe for use in cosmetic products [4]. The CosIng database gives access to data on cosmetic substances and ingredients, including legal requirements and restrictions [1].
Nanomaterials. Nanomaterials must be labelled in the list of ingredients with the word “nano” in brackets after the name of the substance, for example “titanium dioxide (nano)” [2].
Animal testing. EU cosmetics legislation ensures a ban on animal testing for cosmetic purposes [1]. A “no animal tests” statement on packaging or accompanying documents is allowed only if the manufacturer and its suppliers have not carried out or commissioned animal tests on the finished product, its prototype or any of its ingredients, and have not used ingredients tested on animals by others for the purpose of developing new cosmetic products [4].
Durability information. The regulation’s recitals explain that consumers should be told the date of minimum durability. Where the minimum durability is more than 30 months, they should also be told how long after opening the product may be used without harm [5].

Authorities can also ask questions after launch. If there is serious doubt about the safety of a substance, the competent authority of a Member State may by reasoned request require the responsible person to submit a list of all cosmetic products they are responsible for that contain that substance, with the concentration of the substance in each product [4].

A practical checklist for your next product

Use these steps before you commit to a launch plan:

Write down the intended area of application and purpose of use for the product. These are the two elements the definition refers to [3][5].
Compare the product with the illustrative list of cosmetic products in the recitals, and note where it differs [3].
Check whether any characteristic could push the product toward a medicinal product, a medical device or a biocidal product, which the cosmetics regulation does not cover [3][5].
If the answer is unclear, treat classification as a case-by-case question and get qualified EU regulatory advice before you finalise the label [3].
Identify your responsible person, or your importer if you ship from outside the EU [2][3][4].
Plan the safety assessment and the cosmetic product safety report, and schedule them before the first sale [3][4].
Prepare your CPNP notification so it is ready before the product reaches the market [1].
Check your ingredient list against CosIng and the CMR rules, and review any nanomaterial or animal-testing statements on the pack [1][2][4].

Sources

[1] Cosmetics (single-market-economy.ec.europa.eu, accessed 2026-11-02)
[2] Legislation (single-market-economy.ec.europa.eu, accessed 2026-11-02)
[3] Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (health.ec.europa.eu, accessed 2026-11-02)
[4] Consolidated TEXT: 32009R1223 — EN — 01.09.2025 (eur-lex.europa.eu, accessed 2026-11-02)
[5] L_2009342EN.01005901.xml (eur-lex.europa.eu, accessed 2026-11-02)

Written by Nour Abochama, Quality & Regulatory Advisor, Care Europe | VP Operations, Qalitex. Learn more about our team

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Cosmetic Definition: What Counts as a Cosmetic Product in the EU