How the EU cosmetics regulation applies to nail polish

A bottle of polish on a European shelf has passed through a legal process most buyers never see. Someone in the EU has put their name to it, an assessor has signed off its formula, a database in Brussels knows what is in it, and the label follows a fixed list. All of that comes from one regulation.

Regulation (EC) No 1223/2009 works by lists: what may not be used, what may be used with limits, and which colourants are allowed at all. For nail polish, three of its rules matter most, and two amendments since 2020 have changed what a gel polish may contain.

What is Regulation (EC) No 1223/2009?

Regulation (EC) No 1223/2009 is the European Union law on cosmetic products that sets the safety, composition, labelling and notification rules for every cosmetic placed on the EU market. It was adopted on 30 November 2009 and has applied in full since 11 July 2013¹.

Its first principle, in Article 3, is that a cosmetic product must be safe for human health under normal or reasonably foreseeable conditions of use. Everything else exists to make that principle checkable¹. Nail polish, base and top coats, gel polish and cuticle oil are all cosmetics under its definition.

What do the annexes do?

The regulation controls substances through six annexes, listed in Article 14. Three of them decide what can be in a polish¹.

Article 15 adds a rule above the lists: any substance classified as carcinogenic, mutagenic or toxic to reproduction (CMR) in category 1A or 1B under the EU classification, labelling and packaging (CLP) Regulation is prohibited in cosmetics, with narrow exceptions. When a new classification takes effect, the Commission adds the substance to Annex II, which is how TPO was removed from gel polish in 2025³.

Who is the responsible person?

The responsible person is a person or company established in the EU who guarantees that a specific cosmetic product complies with the regulation, under Article 4. For a product made in the EU it is usually the manufacturer; for an imported product, the importer¹. Its name and address must be printed on the label.

The responsible person keeps three things. First, a cosmetic product safety report under Article 10, written by a qualified safety assessor on the exact formula, before the product is sold. Second, a product information file under Article 11, kept for ten years after the last batch and open to inspectors. Third, the CPNP notification. These duties fall on any brand that sells polish under its own name in the EU, whether it makes the polish itself or has it made.

What is the CPNP?

The Cosmetic Products Notification Portal (CPNP) is the European Commission's online database on which every cosmetic product must be notified before it is placed on the EU market, under Article 13². The responsible person enters the product name, category, formulation, label images and country of first sale.

The CPNP is not an approval and not a review of safety. Its purpose is that authorities and poison centres can identify a product and its formula at once if a problem is reported. Consumers cannot search it; the responsible person's EU address on the label is the visible sign that a notification exists.

What must a nail polish label show?

Article 19 sets the label. A nail polish sold in the EU must carry¹:

• The name and address of the responsible person, and the country of origin if imported.
• The nominal content by volume, such as 12 ml, for anything above 5 ml.
• A date of minimum durability if the product keeps for 30 months or less, or the open-jar symbol with a period after opening, such as 12M or 24M, if it keeps longer.
• Any precautions of use required by the annexes, such as the two warnings that accompany toluene, or For professional use only and Can cause an allergic reaction on HEMA-containing gel.
• A batch number.
• The list of ingredients, headed Ingredients, in descending order of weight down to 1%, with those below 1% in any order and colourants listed by CI number after the rest.

Where a range of shades shares one formula, colourants may be listed with the sign +/- so one list covers the range. Claims on the front are governed by Article 20 and by the six common criteria in Regulation (EU) No 655/2013⁶.

What changed for gel polish in 2021 and 2025?

Two amendments apply to gel polish, which cures under a lamp. Commission Regulation (EU) 2020/1682 of 12 November 2020 added hydroxyethyl methacrylate (HEMA) and di-HEMA trimethylhexyl dicarbamate to Annex III as entries 313 and 314, restricted to professional use only, with the label warnings For professional use only and Can cause an allergic reaction. Non-compliant products could not be placed on the market from 3 June 2021 or made available from 3 September 2021⁴.

Commission Regulation (EU) 2025/877 of 12 May 2025 added trimethylbenzoyl diphenylphosphine oxide (TPO), the photoinitiator that makes gel cure fast under UV or LED light, to Annex II as entry 1731, applicable from 1 September 2025. The trigger was its classification as toxic to reproduction category 1B under Commission Delegated Regulation (EU) 2024/197³. The Commission's guidance states that from that date all placing on the market and making available in the course of commercial activity must stop, even for products already in stock⁵.

Solvent polish is outside both rules, because it dries by evaporation and contains no methacrylate monomer and no photoinitiator. An India Anaïs lacquer, for example, needs no lamp and neither warning.

What does banned in the EU mean in practice?

The regulation distinguishes two acts. Placing on the market is the first supply of a product in the EU. Making available is any later supply, including a salon selling a bottle or using it on a client for payment. A prohibition under Annex II stops both, and for CMR substances there is no sell-through or use-up provision, so stock bought before the date cannot be sold or used professionally after it⁵.

A ban does not reach into a private bathroom. The regulation governs commercial activity, and a consumer who uses a gel bought before the ban is not breaking the law. The ban follows from the classification rule in Article 15, not from a new finding of harm; earlier safety opinions found the amounts in nail products far below any level of concern⁷.

Dates diverge outside the EU. Great Britain's Office for Product Safety and Standards set later deadlines: TPO products may not be placed on the GB market after 15 August 2026 and may not be made available after 14 February 2027⁸. The United States has no equivalent restriction.

How to check that a polish is compliant

You will need: the bottle, its outer packaging or leaflet, and a minute.

1. Find the responsible person. An EU name and address on the pack means someone in the EU is accountable and a CPNP notification should exist. A pack with only a non-EU address is a warning sign.
2. Find the ingredient list under the heading Ingredients. A missing list means a non-compliant product.
3. Check for prohibited names. Formaldehyde and Dibutyl Phthalate should not appear on any polish; Trimethylbenzoyl Diphenylphosphine Oxide should not appear on any gel sold after 1 September 2025.
4. Check the warnings match the ingredients. Toluene requires Keep out of reach of children and To be used by adults only. HEMA in gel requires For professional use only and Can cause an allergic reaction, and such a gel may not be sold to consumers.
5. Check for a batch number and a best-before date or open-jar symbol.

A product that fails these checks can be reported to the national authority, in the Netherlands the NVWA.

Written and fact-checked by the India Anaïs editorial team. Every number and rule is linked to its source. How the guides are made.