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EU cosmetics regulation for importers and distributors

Journal · Regulation · 7 min read

EU cosmetics regulation for importers and distributors

Who carries which obligation when cosmetics are imported or sold in the EU: an overview of Regulation (EC) No 1223/2009, with article references and official sources.

In brief

Every cosmetic product needs a Responsible Person established in the EU; for imports, this is normally the importer.

Before placing a product on the market: safety report, Product Information File and CPNP notification.

Distributors check labelling, language and durability, and act if a product does not comply.

Which law governs cosmetics in the EU?

The core rules are set by Regulation (EC) No 1223/2009, which has applied directly in all EU member states since 11 July 2013. Claims are additionally governed by Regulation (EU) No 655/2013.

As a regulation, 1223/2009 does not need to be transposed into national law; the same requirements apply in Spain, Germany or France. Member states add national rules on enforcement, penalties and, in some cases, registration of manufacturing or import activities. In Spain the competent authority is the AEMPS; in Germany, enforcement lies with the federal states.

The annexes of the regulation list banned and restricted substances and the permitted colourants, preservatives and UV filters. They are amended regularly, so always check the consolidated version.

Sources: Regulation (EC) No 1223/2009 (EUR-Lex) · Regulation (EU) No 655/2013 (EUR-Lex).

Please note: this guide is a general overview, not legal advice. For a specific product or business model, consult a specialised lawyer or regulatory consultant.

Who is the Responsible Person, and when does an importer become one?

Only products for which a Responsible Person established in the EU has been designated may be placed on the EU market (Article 4). For a product imported from outside the EU, the importer is the Responsible Person, unless they designate another person by written mandate.

For products manufactured in the EU, the manufacturer is the Responsible Person, unless it designates someone else in writing. A distributor becomes the Responsible Person if it places a product on the market under its own name or trademark, or modifies it in a way that may affect compliance.

Under Article 5, the Responsible Person ensures that the product meets the regulation’s requirements: safety, good manufacturing practice, safety assessment, Product Information File, notification, labelling and claims. If a product does not comply, it must take corrective action and cooperate with the authorities.

Who carries this role in a private label project is explained in our private label guide.

What belongs in the Product Information File (PIF)?

Under Article 11, the Responsible Person keeps a Product Information File for each cosmetic product. It must be kept for ten years after the last batch was placed on the market and be readily accessible to the authorities at the address on the label.

The file contains:

a description of the product that clearly links the file to it
the Cosmetic Product Safety Report
a description of the manufacturing method and a statement of compliance with good manufacturing practice (often EN ISO 22716)
proof of the effect claimed, where justified by the nature or effect of the product
data on any animal testing related to the product or its ingredients

The file must be in a language the authorities of the member state where it is kept can readily understand. Source: Article 11 of Regulation (EC) No 1223/2009 (EUR-Lex).

What is a Cosmetic Product Safety Report (CPSR)?

The CPSR shows that a product is safe for human health under normal or reasonably foreseeable use (Article 10). It consists of Part A with the safety information and Part B with the assessment by a qualified safety assessor.

Part A, as set out in Annex I, covers among other things the composition, physical and chemical characteristics and stability, microbiological quality, impurities, packaging material, intended use, exposure and the toxicological profile of the substances. Part B contains the assessor’s conclusion, any warnings and instructions for use, and the reasoning.

The assessment must be carried out by a person with a diploma in pharmacy, toxicology, medicine or a similar discipline. If the formula changes, the report must be reviewed. As an importer or retailer, you do not need to see the report itself, but you should be able to rely on the Responsible Person having one. The ingredient names it uses are explained in our INCI guide.

How does CPNP notification work?

Before a product is placed on the market, the Responsible Person notifies it electronically in the Cosmetic Products Notification Portal (CPNP) under Article 13. One notification covers the whole EU.

The notification includes, among other things, the product category and name, the Responsible Person, the country of origin for imported products, the member state where the product is first placed on the market, the presence of nanomaterials or substances classified as CMR, the frame formulation and the original label with a photograph of the packaging.

Distributors have their own notification duty in one case: if they make a product available in another member state and translate elements of the labelling on their own initiative to comply with national law (Article 13(3)). The CPNP is free of charge and run by the European Commission: Cosmetic Products Notification Portal (CPNP).

What must the label show, and which claims are allowed?

Article 19 lists the mandatory information, from the Responsible Person and nominal content to batch number and ingredient list. Claims must meet the six common criteria of Regulation (EU) No 655/2013.

For imported products, the country of origin must also appear on the label. The language of certain information is set by the law of the member state where the product is sold. Our wholesale buyer’s guide lists the label elements in detail.

The six criteria for claims are: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making. In practice:

No claim may suggest a medical effect such as treating a skin condition.
Claims such as ‘moisturising’ need suitable evidence.
‘Free from’ claims for substances that are banned anyway are not allowed.

Source: Regulation (EU) No 655/2013 (EUR-Lex).

What obligations do distributors and retailers have?

Under Article 6, distributors act with due care. Before making a product available, they check that the mandatory label information is present, that the language requirements are met and that the date of minimum durability has not passed.

A distributor is anyone in the supply chain other than the manufacturer or importer who makes a product available, including wholesalers, shops and online retailers. Their duties in brief:

check the Responsible Person, batch number and ingredient list on the label
store and transport products so that compliance is not affected
if a product does not comply, do not sell it, or take corrective action, and inform the Responsible Person
if there is a risk to health, inform the authorities as well
name their suppliers and customers to the authorities on request (Article 7)

Anyone building a distribution business will find more in our distributor guide.

Last updated: October 2026This page provides general information on cosmetics and trade practice. It is not legal, tax or medical advice.

FAQ

Frequently asked questions

Does an importer from outside the EU automatically become the Responsible Person?

Yes. For each product it places on the EU market, the importer is the Responsible Person, unless it designates another person established in the EU by written mandate and that person accepts it in writing (Article 4).

When does a retailer become the Responsible Person?

When it places a product on the market under its own name or trademark, or modifies it in a way that may affect compliance. Translating labelling information alone does not count as such a modification (Article 4(6)).

Do I need a new notification to sell in another EU country?

No, one CPNP notification covers the entire EU. Only if you translate the labelling on your own initiative do you, as distributor, submit the information listed in Article 13(3).

What applies when exporting cosmetics outside the EU?

The law of the destination country applies. Many countries require their own local responsible person, a notification or registration, and labels in the local language; in the United Kingdom, for example, a UK Responsible Person and notification via the UK government’s SCPN service are required. Importers often ask for a certificate of free sale.

Which customs tariff headings apply to cosmetics?

Skin care products usually fall under heading 3304, hair care products such as shampoo under 3305, and soap and liquid skin-cleansing products under 3401. The exact code depends on the product; check it in the TARIC database or with your customs broker.

Do undesirable effects have to be reported?

Yes. Serious undesirable effects must be reported to the competent authority without delay by the Responsible Person and by distributors (Article 23). Customers with skin problems should be referred to a doctor.

Is this guide legal advice?

No. It summarises the EU rules in general terms and does not replace advice from a lawyer or regulatory expert. For product documents or questions about our range, please use the contact form.

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