EU Cosmetics Regulation 1223/2009: What Sellers Need to Know

EU Cosmetics Regulation (EC) No 1223/2009 is the single piece of legislation that governs every cosmetic product placed on the EU market. It replaced the previous Cosmetics Directive in 2013 and applies directly in all 27 EU member states — no national transposition required. Whether you sell a single lip balm on Amazon.de or distribute 500 SKUs across every EU marketplace, this regulation applies to you.

For UK sellers, the regulation applies to products sold into the EU. The UK has its own parallel cosmetics regulation post-Brexit, but the EU regulation is what matters when your products cross the Channel. For sellers based in the US, Asia, or anywhere else outside the EU, the same rule holds — if you sell into the EU market, you comply with 1223/2009.

This guide focuses on the parts of the regulation that matter most to Amazon sellers and e-commerce brands. It is not an academic analysis of every article — it is a practical breakdown of what you need to do to sell cosmetics legally in the EU.

What Counts as a Cosmetic Product?

The regulation 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 to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition, or correcting body odours.

This definition is broader than many sellers expect. Skincare, haircare, makeup, fragrances, deodorants, toothpaste, soap, bath products, nail products, shaving products, sun protection products, and self-tanning products all fall under the cosmetics regulation. Products making therapeutic claims — treating eczema, curing acne, medicating scalp conditions — may fall under medicinal products regulation instead, which is an entirely different compliance framework.

The distinction between a cosmetic product and a medicinal product depends on the claims you make. A moisturiser that "hydrates skin" is a cosmetic. A cream that "treats dermatitis" is potentially a medicinal product. This is a critical distinction that affects your entire regulatory strategy.

The EU Responsible Person (Article 4)

Article 4 establishes that every cosmetic product placed on the EU market must have a designated Responsible Person established within the EU. This is not a recommendation — it is a legal requirement with no exceptions.

The EU Responsible Person is the entity that guarantees compliance with the regulation for each product they are responsible for. Their obligations include ensuring that the product safety assessment has been carried out, that the Product Information File is established and maintained, that CPNP notification has been submitted, that the labelling complies with Article 19, and that the product does not contain prohibited substances or exceed restriction limits.

For EU-based manufacturers, the manufacturer is automatically the Responsible Person unless they designate someone else. For products manufactured outside the EU, the importer is the Responsible Person. And for products where neither the manufacturer nor the importer is established in the EU, the Responsible Person is the person who places the product on the EU market — which, in practice, means you need to appoint someone.

If you are a UK-based seller, you are outside the EU and must appoint an EU Responsible Person. Eldris provides this through responsible.eldris.ai, with the EU RP details then feeding directly into the CPNP notification and labelling requirements.

The Product Information File (Article 11)

Article 11 requires that a Product Information File is maintained for every cosmetic product placed on the market. The PIF must be kept at the address of the EU Responsible Person and made readily accessible to competent authorities — in electronic or other format — at that address.

The PIF must contain a description of the cosmetic product, the Cosmetic Product Safety Report (Annex I), a description of the manufacturing method and a statement of compliance with GMP, proof of the effect claimed for the product (where justified by the nature of the claim), and data on animal testing.

The PIF must be kept for 10 years after the date on which the last batch of the product was placed on the market. This is a long-term obligation — even after you stop selling a product, the PIF must remain accessible for a decade.

The Cosmetic Product Safety Report (Annex I)

Annex I of the regulation sets out the requirements for the CPSR — the formal safety assessment that must be completed before any cosmetic product is placed on the market. The CPSR is the cornerstone document of EU cosmetics compliance.

Part A of the CPSR covers the Cosmetic Product Safety Information: the quantitative and qualitative composition, physical and chemical characteristics, stability, microbiological quality, impurities, packaging material, normal and reasonably foreseeable use, product exposure, substance exposure, toxicological profiles, undesirable effects, and other relevant information.

Part B covers the Cosmetic Product Safety Assessment itself — the qualified safety assessor's conclusion on whether the product is safe. The assessor must state the assessment reasoning, any warnings and conditions of use, and their final safety conclusion. Part B must be signed by a person with the requisite qualifications — pharmacy, toxicology, medicine, or an equivalent discipline.

For a detailed breakdown of CPSR costs and what to expect, see the dedicated pricing guide.

CPNP Notification (Article 13)

Article 13 requires electronic notification to the EU Cosmetic Products Notification Portal before a cosmetic product is placed on the market. The CPNP notification includes the product category, name, EU Responsible Person details, country of origin, member states where the product will be placed on the market, formulation information, the original label, and a product photograph.

The CPNP notification serves two purposes. First, it enables market surveillance — authorities across all EU member states can see what products are on the market and who is responsible for them. Second, it provides information to poison centres — Article 13(4) specifically requires that certain information be made available to poison centres to enable prompt and appropriate medical treatment in cases of adverse reactions.

For Amazon sellers, the CPNP reference number issued upon successful notification is the critical output. Amazon requires this reference number when listing cosmetics on EU marketplaces, and its absence is one of the most common reasons for listing suppression.

Ingredient Restrictions (Annexes II–VI)

The regulation controls what can and cannot go into a cosmetic product through five annexes that every formulator and safety assessor must check.

Annex II lists prohibited substances — ingredients that must not be present in cosmetic products under any circumstances. This is an extensive list of over 1,600 substances.

Annex III lists restricted substances — ingredients that are permitted but only under specific conditions, such as maximum concentration limits, specific product types, or mandatory label warnings. The 26 allergenic substances with declaration thresholds sit in Annex III.

Annex IV lists permitted colourants with their allowed concentrations and conditions of use.

Annex V lists permitted preservatives with maximum concentration limits.

Annex VI lists permitted UV filters with maximum concentration limits.

The safety assessor checks your formulation against all five annexes during the CPSR process. If your product contains a prohibited substance, it cannot be placed on the market. If it contains a restricted substance above its permitted concentration, the formula must be adjusted. If it uses a colourant, preservative, or UV filter, these must appear in the relevant positive list at the concentration used.

Labelling Requirements (Article 19)

Article 19 specifies what must appear on cosmetics packaging. The mandatory elements include the EU Responsible Person name and address, country of origin for non-EU products, nominal content, date of minimum durability or period after opening, precautions for use, batch number, product function, and the full ingredient list in INCI format.

For a complete breakdown of each labelling element and how to get it right, see the EU cosmetics labelling requirements guide.

Claims (Article 20)

Article 20 establishes that claims made about cosmetic products must not mislead consumers. The European Commission has published Common Criteria for cosmetic claims, which require that claims be truthful, supported by evidence, honest, fair, and enable informed decisions. Claims must not attribute characteristics to a product that it does not possess, and they must not create the impression of a benefit that the product does not deliver.

For sellers, this means that any claim on your product — from "long-lasting hydration" to "reduces the appearance of fine lines" — must be supportable with evidence. The safety assessor may request claim substantiation data as part of the CPSR process, particularly for specific or quantified claims.

Enforcement and Consequences

EU Cosmetics Regulation is enforced by competent authorities in each member state. Enforcement actions can include product recall orders, market withdrawal, fines (which vary by member state), and in serious cases, criminal prosecution. The regulation also includes provisions for serious undesirable effect reporting — both by the EU Responsible Person and by end users through the competent authority.

For Amazon sellers, marketplace enforcement adds another layer. Amazon conducts its own compliance checks, and non-compliant products face listing suppression, inventory holds, and account restrictions. While Amazon's enforcement is separate from regulatory enforcement, the documentation requirements largely overlap — if you are compliant with the regulation, you have what Amazon needs.

UK vs EU: The Post-Brexit Split

Since 1 January 2021, the UK has operated its own cosmetics regulation separate from the EU. Products sold in Great Britain must comply with UK cosmetics regulation (which currently mirrors much of 1223/2009) and be notified through the UK's SCPN (Submit Cosmetic Product Notification) system rather than the CPNP.

Products sold in Northern Ireland follow EU rules under the Windsor Framework. Products sold in both the UK and the EU need dual compliance — UK SCPN notification and EU CPNP notification, with a UK Responsible Person for the GB market and an EU Responsible Person for the EU market.

This dual-compliance requirement catches many UK sellers off guard. Being compliant in the UK does not make you compliant in the EU. The documentation requirements are similar, but the notifications, responsible persons, and enforcement frameworks are separate.

Getting Compliant

The regulation covers a lot of ground, but for most sellers the compliance journey follows a clear path: appoint an EU Responsible Person, gather your product documentation, get your CPSR produced, compile the PIF, submit the CPNP notification, and ensure your labelling meets Article 19 requirements.

Eldris Cosmetics handles this complete chain as a done-for-you service. You provide the product information and raw documentation. Eldris delivers the CPSR, PIF, CPNP reference number, and packaging compliance guidance. Fixed pricing per product, no retainers, no hourly billing.

If you are ready to get started, view current pricing or learn more about what documents you need to provide.