CosR - Regulation (EC) No 1223/2009

What CosR is and why it matters

The Cosmetics Regulation (CosR) — formally Regulation (EC) No 1223/2009 on cosmetic products — is the EU’s single, directly applicable framework governing the safety, composition, labelling and marketing of every cosmetic product placed on the European market. If you make, import or sell skin creams, perfumes, toothpaste, hair dye, make-up, deodorant, soap or any other product intended to be applied to the external parts of the body, the teeth or the mucous membranes of the mouth, CosR almost certainly applies to you. It replaced the patchwork of earlier directives with one rulebook that is identical across all Member States.

CosR matters because it is strict and product-specific in a way that general safety law is not. Unlike many product categories, cosmetics carry no CE marking. Instead, lawful sale depends on a defined chain of obligations: a designated Responsible Person established in the EU, a documented safety assessment, a Product Information File, electronic notification through a central portal before the product reaches the market, and compliance with extensive substance and labelling rules. Getting any one of these wrong can keep a product off the shelf or trigger a recall.

📄 Official text: Regulation (EC) No 1223/2009 on cosmetic products — on EUR-Lex →

Who CosR applies to

CosR assigns duties across the supply chain, but it centres responsibility on one named actor:

The Responsible Person — every cosmetic product placed on the EU market must have a Responsible Person established within the Union. This is the legal or natural person who guarantees compliance and is the point of accountability for authorities. For an EU manufacturer it is usually the manufacturer; for imported products it is by default the importer, unless a manufacturer or distributor is designated in writing.
Manufacturers — those who formulate and produce the product. They must work to Good Manufacturing Practice and supply the data the Responsible Person needs.
Importers — businesses bringing cosmetics from outside the EU into the Union; they typically take on the Responsible Person role for those products.
Distributors — wholesalers and retailers who make products available on the market. They must check that core labelling elements are present, that language requirements are met and that products are within any date of minimum durability, and must act when they believe a product is non-compliant.

The Regulation applies to finished cosmetic products intended for sale to consumers and for professional use alike.

Key obligations and structure

CosR builds its obligations around a small number of interlocking documents and processes rather than around dated transition deadlines.

The Regulation has applied across the EU since 2013, replacing the previous Cosmetics Directive 76/768/EEC, and is updated continuously through amending regulations that revise its technical annexes.
Its substance rules live in Annexes II to VI, which are kept current as scientific opinions are issued, so the lists of what is banned or restricted change over time and must be tracked.

Core requirements

The Responsible Person and the Product Information File

No cosmetic product may be placed on the market without a Responsible Person established in the EU whose name and address appear on the label. That person ensures the product meets every requirement of CosR and keeps, for ten years after the last batch is placed on the market, a Product Information File (PIF). The PIF is the dossier that proves compliance: it describes the product, contains the cosmetic product safety report, sets out the method of manufacture and a statement of compliance with Good Manufacturing Practice, and holds data on any animal testing and proof of claimed effects. It must be readily accessible in electronic or other format to the competent authority of the Member State where the file is kept.

Cosmetic product safety assessment

Before a product is placed on the market, the Responsible Person must ensure it has undergone a safety assessment and that a cosmetic product safety report has been drawn up. The report is in two parts: Part A gathers the safety information (composition, physico-chemical characteristics, microbiological quality, impurities, exposure to the product and its substances, the toxicological profile of each ingredient), and Part B is the safety assessor’s reasoned conclusion, warnings and instructions. The assessment must be carried out by a person holding a relevant qualification in pharmacy, toxicology, medicine or a similar discipline.

CPNP notification before placing on the market

The Responsible Person must notify each product electronically through the Cosmetic Products Notification Portal (CPNP) before it is placed on the market. The notification covers the product category and name, the Responsible Person’s details, the country of import where relevant, the presence of substances classified as carcinogenic, mutagenic or toxic for reproduction, and the frame formulation needed for poison-centre and medical treatment. Where the product contains nanomaterials, additional notification is required. Distributors who translate elements of a label may also have notification duties.

Prohibited and restricted substances (Annexes II–VI)

CosR controls what a cosmetic may contain through five working annexes. Annex II lists substances prohibited in cosmetics; Annex III lists substances restricted to defined conditions and concentrations. Annexes IV, V and VI are the positive lists of the only colorants, preservatives and UV-filters permitted, each with its own limits and conditions of use. A product is non-compliant if it contains a banned substance, exceeds a restriction, or uses a colorant, preservative or UV-filter not on the relevant list. Because these annexes are amended regularly in response to scientific assessment, ongoing monitoring is essential.

Labelling and the ingredient (INCI) list

Cosmetic labelling is prescriptive. The container and packaging must show, in indelible, easily legible and visible lettering: the name and address of the Responsible Person; the nominal content; a date of minimum durability or the period-after-opening symbol; particular precautions for use; the batch number or identifier; the product function where not obvious; and a list of ingredients headed “Ingredients”. Ingredients are listed in descending order of weight using INCI (International Nomenclature of Cosmetic Ingredients) names, with fragrance and flavour compositions named as “parfum” or “aroma” and certain allergens declared separately. Specific labelling requirements apply to nanomaterials, whose names must be followed by “(nano)” in the ingredient list.

Animal testing ban, GMP and undesirable-effect reporting

CosR enforces a ban on animal testing: testing finished cosmetics and their ingredients on animals for the purposes of the Regulation is prohibited, as is marketing products tested on animals to meet its requirements. Manufacture must follow Good Manufacturing Practice, with compliance presumed when the harmonised standard ISO 22716 is applied. The Responsible Person and distributors must also notify the competent authority of any serious undesirable effects — adverse reactions resulting in serious consequences — and make that information available.

Obligations by role

Responsible Person — hold the PIF, ensure the safety assessment, notify via CPNP, guarantee labelling and substance compliance, and report serious undesirable effects.
Manufacturers — apply Good Manufacturing Practice and provide the data underpinning the safety report.
Importers — usually act as the Responsible Person for imported products and carry its full duties.
Distributors — verify labelling, language and durability requirements, act on non-compliance, and pass on undesirable-effect information.

Enforcement

Each Member State designates competent authorities for market surveillance of cosmetics. In Denmark, the Danish Environmental Protection Agency (Miljøstyrelsen) is the competent authority for cosmetic products, working alongside other authorities on specific aspects. Authorities can require access to the Product Information File, demand corrective action, restrict or prohibit a product, and order withdrawals or recalls where a product presents a risk to human health.

Information on dangerous non-food products, including non-compliant cosmetics, is shared EU-wide through the Safety Gate rapid alert system, so an issue identified in one country can prompt action across the Union. Penalties for non-compliance are set at national level and can include sales bans, mandatory recalls, fines and reputational damage from public alerts.

Getting compliant

Designate a Responsible Person established in the EU and place their name and address on the label.
Build a Product Information File for each product and keep it accessible for ten years after the last batch.
Commission a cosmetic product safety assessment and safety report from a qualified assessor.
Check the full formula against Annexes II–VI for prohibited, restricted, colorant, preservative and UV-filter rules.
Notify each product through the CPNP before placing it on the market, with extra steps for nanomaterials and CMR substances.
Apply compliant labelling, including the INCI ingredient list, durability or period-after-opening, warnings and “(nano)” where relevant.
Manufacture to Good Manufacturing Practice, applying ISO 22716, and avoid prohibited animal testing.
Set up a process to record and report serious undesirable effects.

How Conphora helps

Conphora monitors CosR and maps your cosmetic products against its requirements, flagging gaps in the Responsible Person, the Product Information File, the safety assessment, CPNP notification and labelling before they become enforcement problems. The platform tracks changes to Annexes II–VI so you know when a substance becomes banned or restricted, helps you generate and keep the right documentation, and alerts you when obligations change so your compliance stays current.

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Sources and further reading

This guide is for general information and is not legal advice.

Last updated: 12 June 2026