EU Regulation 1223/2009 — what it governs and why every consumer should know it

When you buy a cream, shampoo or lipstick in any shop within the European Union, the safety of that product rests on a single piece of legislation: Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. It applies directly in all 27 Member States — including Poland — without the need to be transposed into national law. It is the foundation on which the entire European cosmetics safety system is built.

What is a cosmetic product under the Regulation?

Article 2(1)(a) defines a cosmetic product as “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 is crucial because it draws the line between a cosmetic and a medicinal product. A moisturising cream is a cosmetic. A cream containing an active substance that treats eczema is a medicine, governed by different rules (Directive 2001/83/EC). Manufacturers who cross this line in their formulation or marketing claims are breaking the law.

Annex II — more than 1,600 banned substances

Annex II of the Regulation is the list of substances that must not be used in cosmetic products under any circumstances. As of 2025 it contains more than 1,600 entries. Among them you will find:

• Formaldehyde as a deliberate ingredient (permitted only as an impurity up to 0.001% in certain categories).
• Hydroquinone — a powerful lightening agent, allowed only in professional artificial nail systems.
• Mercury compounds — still found in illegal lightening creams imported from outside the EU.
• CMR substances (carcinogenic, mutagenic or toxic to reproduction) of categories 1A and 1B — an absolute ban, subject to the exceptions set out in Article 15.

It is worth stressing that the presence of a substance on the banned list does not mean it was ever in widespread use. Many entries were added as a precaution on the basis of toxicological data. Check specific ingredients in the PurScore ingredient database to see their regulatory status.

Annex III — restricted substances

Annex III is an intermediate category: substances that are permitted, but subject to specific restrictions on concentration, product type or conditions of use. Examples include:

• Salicylic acid — a maximum of 2% in skincare preparations (not in products for children under 3 years of age).
• Hydrogen peroxide — a maximum of 6% in tooth-whitening products, available for professional sale only above 0.1%.
• 26 fragrance allergens — must be declared on the label above thresholds of 0.001% (leave-on products) and 0.01% (rinse-off products).

These restrictions are updated regularly by the European Commission on the basis of opinions from the Scientific Committee on Consumer Safety (SCCS). If you want to understand the composition of a specific product, use our guide to reading the INCI list.

Annexes IV, V and VI — colorants, preservatives, UV filters

These three annexes work on the principle of positive lists: only substances explicitly named may be used for the relevant function.

• Annex IV (colorants) — around 150 permitted colorants, divided into those allowed in all products, only in leave-on products, or only in products that do not come into contact with mucous membranes.
• Annex V (preservatives) — 59 permitted preservatives with defined maximum concentrations. This is why the popular phenoxyethanol is limited to 1%.
• Annex VI (UV filters) — 29 permitted sunscreen filters. Every new filter must pass an SCCS assessment, which is why far fewer UV filters are available in the EU than in, for example, Japan or South Korea.

The responsible person and the safety assessment

Article 4 of the Regulation introduces the role of the responsible person — a legal entity established in the EU that takes full responsibility for the product's compliance with the rules. For products manufactured in the EU this is usually the manufacturer; for imports from outside the EU it is the importer.

Before a product is placed on the market, the responsible person must ensure that a safety assessment is carried out (Article 10). The assessment is prepared by a qualified person holding a degree in pharmacy, toxicology, medicine or a related discipline. The safety report consists of two parts:

1. Part A — quantitative and qualitative information: composition, physicochemical properties, toxicological data on the individual ingredients, and exposure.
2. Part B — the conclusions and the signature of the assessor, together with the reasoning that the product is safe under normal and reasonably foreseeable use.

CPNP notification — a requirement before placing on the market

Article 13 requires every cosmetic product to be notified through the CPNP portal (Cosmetic Products Notification Portal) before being placed on the EU market. The notification includes, among other things, the frame formulation, the product category, the details of the responsible person and a photograph of the label. The portal is managed by the European Commission and is accessible to market surveillance authorities and poison control centres in all Member States.

A missing CPNP notification is a breach of the law — regardless of whether the product is safe. In Poland, the cosmetics market is supervised by the Chief Sanitary Inspector through the regional sanitary and epidemiological stations.

What does this mean for the consumer?

Regulation 1223/2009 ensures that every cosmetic on the shelf in a Polish shop has undergone a safety assessment, has been notified in the central EU system and contains no banned substances. This does not eliminate the risk of allergies or irritation (which is an individual matter), but it guarantees a minimum safety standard that markets outside Europe do not offer.

It is worth knowing these rules so you can tell reliable information from marketing tricks. Search for a product in the PurScore database to see how its composition measures up against EU regulations.