CosR in plain terms
The Cosmetics Regulation (CosR), formally Regulation (EC) No 1223/2009, is the EU’s single rulebook for cosmetic products. It establishes the rules that any cosmetic product made available on the market must comply with, to ensure the functioning of the internal market and a high level of protection of human health (Art. 1). A cosmetic product is any substance or mixture intended to be placed in contact with the external parts of the human body, the teeth or the mucous membranes of the mouth, exclusively or mainly to clean, perfume, change the appearance of, protect or keep in good condition those parts or to correct body odours (Art. 2(1)(a)). Creams, sunscreens, make-up, perfumes, deodorants, soaps, shampoos, hair dyes, toothpastes and nail products all qualify.
CosR is a regulation, so it applies directly in every Member State without transposition. It was adopted on 30 November 2009, entered into force on 11 January 2010 and has applied in full since 11 July 2013, when it repealed Directive 76/768/EEC (Art. 38 and Art. 40). Unlike most product law it works without CE marking or notified bodies: lawful sale rests on a responsible person established in the Union, a documented safety assessment, a product information file, an electronic notification before the product reaches the market, and compliance with the substance annexes and the labelling rules. The annexes are amended several times a year, most recently by Regulation (EU) 2026/909 of 27 April 2026.
Official text Read the regulation on EUR-Lex: Regulation (EC) No 1223/2009 (CELEX 32009R1223), or the consolidated text of 18 May 2026 that incorporates the 54 amending acts listed in its header.
Scope
The definition turns on two things: contact with the external parts of the body (epidermis, hair system, nails, lips and external genital organs), the teeth or the mucous membranes of the oral cavity, and an exclusive or main cosmetic purpose (Art. 2(1)(a)). A substance or mixture intended to be ingested, inhaled, injected or implanted into the human body is not a cosmetic product (Art. 2(2)), so food supplements, tattoo inks and injectable fillers fall outside. Where a product could equally be a medicinal product, a medical device or a biocide, the purpose decides; since the Medical Devices Regulation added Article 2(4), the Commission may, at a Member State’s request or on its own initiative, determine whether a specific product or group of products falls within the definition (Art. 2(4), inserted by Art. 119 of Regulation (EU) 2017/745).
The end user may be a consumer or a professional (Art. 2(1)(f)), so salon and professional-use products are covered, with their own precautionary labelling (Art. 19(1)(d)). Making available and placing on the market are the trigger events (Art. 2(1)(g) and (h)). Compliant products move freely: Member States may not refuse, prohibit or restrict them for reasons related to the regulation’s requirements (Art. 9).
The duties fall on the responsible person, the manufacturer, the importer and the distributor. A manufacturer makes a cosmetic product or has it designed or manufactured and markets it under its own name or trade mark (Art. 2(1)(d)); an importer places a product from a third country on the Union market (Art. 2(1)(i)); a distributor is anyone else in the supply chain who makes a product available (Art. 2(1)(e)). Only products for which a responsible person is designated within the Union may be placed on the market (Art. 4(1)).
What you must do
The responsible person
For each product placed on the market the responsible person ensures compliance with the regulation (Art. 4(2) and Art. 5(1)). For a product manufactured in the Union that is the manufacturer established there, for an imported product it is the importer, and either may designate a person established in the Union by written mandate that the person accepts in writing; a manufacturer outside the Union must do so (Art. 4(3) to (5)). A distributor becomes the responsible person when it places a product on the market under its own name or trade mark or modifies a product already on the market in a way that may affect compliance, but translating the label is not such a modification (Art. 4(6)). The responsible person who believes a product does not comply must immediately correct, withdraw or recall it, inform the competent authorities where it presents a risk to human health, cooperate with them and provide conformity documentation on reasoned request (Art. 5(2) and (3)). On request it must identify the distributors it supplied for three years after the batch was supplied (Art. 7).
Safety assessment and the product information file
A cosmetic product must be safe for human health under normal or reasonably foreseeable use, taking into account its presentation, labelling, instructions for use and disposal and any other information from the responsible person (Art. 3). To demonstrate that, the responsible person has a safety assessment carried out before the product is placed on the market and a cosmetic product safety report drawn up under Annex I: Part A collects the safety information, from the quantitative and qualitative composition, physico-chemical characteristics and stability, microbiological quality, impurities and packaging to exposure and the toxicological profile of each substance, and Part B is the assessor’s reasoned conclusion, warnings and instructions (Art. 10(1) and Annex I). The assessor must hold a university qualification in pharmacy, toxicology, medicine or a similar discipline (Art. 10(2)), and the report is kept up to date after placing on the market (Art. 10(1)(c)).
The product information file holds the product description, the safety report, the manufacturing method and a statement of compliance with good manufacturing practice, proof of the claimed effect where justified, and data on any animal testing by the manufacturer, its agents or suppliers, including tests done for third-country requirements (Art. 11(2)). It is kept for 10 years after the last batch was placed on the market and made readily accessible, in electronic or other format, at the address on the label to the competent authority of the Member State where it is kept, in a language that authority easily understands (Art. 11(1) and (3)). Manufacture must follow good manufacturing practice, presumed where the harmonised standards published in the Official Journal are applied (Art. 8).
Notification in the CPNP
Before placing a product on the market the responsible person submits electronically to the Commission the product category and name, its own name and address, the country of origin for imports, the Member State of placing, a contact person, the presence and exposure conditions of nanomaterials, the name and CAS or EC number of any CMR substance of category 1A or 1B, and the frame formulation for poison centres; when the product is placed on the market it adds the original labelling and a photograph of the packaging, and updates the notification when anything changes (Art. 13(1), (2) and (7)). A distributor that translates any element of the labelling on its own initiative to sell in another Member State notifies too (Art. 13(3)). Products containing nanomaterials are notified six months before placing on the market with the nanomaterial’s identification, specification, annual quantity, toxicological profile, safety data and exposure conditions, unless the nanomaterial is a colorant, preservative or UV-filter regulated under Article 14 or complies with Annex III (Art. 16(2) and (3)). The Commission’s Cosmetic Products Notification Portal is free of charge, and a product notified there needs no further national notification.
Substances: Annexes II to VI, CMR substances and nanomaterials
A product may not contain the substances listed in Annex II, may contain Annex III substances only within their restrictions, and may use only the colorants, preservatives and UV-filters listed in Annexes IV, V and VI under the conditions set there (Art. 14(1)). Substances classified as carcinogenic, mutagenic or toxic for reproduction under Part 3 of Annex VI to the CLP Regulation are prohibited: category 2 substances unless the SCCS has found them safe, and category 1A or 1B substances unless they meet the food-safety requirements, no alternative exists, the application concerns a particular use with known exposure and the SCCS has found them safe; for category 1A and 1B substances the Commission must amend the annexes within 15 months of the CLP classification (Art. 15 and Art. 15(2)). That is the mechanism behind the Omnibus regulations: after every adaptation of the CLP Regulation the Commission adds the newly classified substances to Annex II and moves any exempted ones to the positive lists, each act applying on the date its classifications apply, most recently Regulations (EU) 2023/1490 (from 1 December 2023), 2025/877 (from 1 September 2025) and 2026/78 (from 1 May 2026). The unintended presence of a small quantity of a prohibited substance is tolerated only where it is technically unavoidable in good manufacturing practice and the product remains safe (Art. 17).
For every product containing nanomaterials a high level of protection of human health must be ensured, and where the Commission has safety concerns it asks the SCCS for an opinion and may amend Annexes II and III (Art. 16(1), (4) and (6)); Regulation (EU) 2024/858 used that route to ban twelve nanomaterials and restrict Hydroxyapatite (nano). The Commission also amends the annexes after SCCS opinions on individual ingredients where there is a potential risk to human health (Art. 31(1)): Regulation (EU) 2023/1545 added 56 fragrance allergens to the individual labelling requirement, Regulation (EU) 2024/996 prohibited 4-Methylbenzylidene Camphor and restricted Vitamin A, the Arbutins, Genistein, Daidzein, Kojic Acid, Triclosan and Triclocarban, and Regulation (EU) 2026/909 prohibited Triphenyl Phosphate and restricted Benzyl Salicylate, aluminium-containing ingredients, water-soluble zinc salts, Acetylated Vetiver Oil and Citral, with transition periods for placing on the market and for making available that the key dates above set out.
Labelling, claims and public information
The container and packaging must show, in indelible, easily legible and visible lettering, the responsible person’s name and address with the country of origin for imports, the nominal content, the date of minimum durability preceded by the Annex VII symbol or the words best used before the end of, or for products with a durability of more than 30 months the period-after-opening symbol, the precautions for use, the batch number, the function unless obvious, and the list of ingredients headed ingredients (Art. 19(1)). Ingredients are listed in descending order of weight using the common ingredient names of the Article 33 glossary, perfume and aromatic compositions as parfum or aroma with the individually listed allergens of Annex III added, nano ingredients followed by the word nano in brackets, and colorants with their Colour Index numbers (Art. 19(1)(g) and Art. 19(6)). Where the precautions or the ingredient list cannot fit, they go on a leaflet, label, tape, tag or card referred to by the Annex VII symbol, and for soap, bath balls and other small products on a notice next to the display (Art. 19(2) and (3)). The language of the content, durability, precautions and function is determined by the Member State where the product is made available to the end user (Art. 19(5)); in Denmark, section 3 of bekendtgørelse nr. 803 of 21 June 2013 requires those elements in Danish.
Text, names, trade marks, pictures and other signs may not imply characteristics or functions the product does not have (Art. 20(1)). The common criteria adopted under Article 20(2) are in Regulation (EU) No 655/2013, which applies from 11 July 2013 to every claim regardless of medium: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making, and the responsible person must keep the wording consistent with the evidence in the product information file. A no-animal-testing claim is allowed only where neither the manufacturer nor its suppliers tested the finished product, its prototype or its ingredients on animals, or used ingredients tested by others for new cosmetic products (Art. 20(3)). The responsible person must also make the qualitative and quantitative composition, the perfume composition identifiers and existing data on undesirable effects easily accessible to the public, the quantitative information being limited to hazardous substances (Art. 21).
Animal testing
It is prohibited to place on the market products whose final formulation, ingredients or combinations of ingredients were tested on animals to meet the regulation after a validated alternative method was adopted at Union level, to test finished products on animals in the Union, and to test ingredients on animals once a validated alternative is listed in Regulation (EC) No 440/2008 or Annex VIII (Art. 18(1)). The implementation period ended on 11 March 2009 and, for repeated-dose toxicity, reproductive toxicity and toxicokinetics, on 11 March 2013; a Member State may ask the Commission for a derogation only where serious safety concerns arise about an ingredient in wide use that cannot be replaced (Art. 18(2)).
Obligations by role
The responsible person carries the compliance, safety report, product information file, notification, substance, labelling, claims, public-information, serious-undesirable-effect and corrective-action duties (Art. 5, Art. 10, Art. 11, Art. 13 to Art. 21 and Art. 23). Manufacturers apply good manufacturing practice, respect the animal-testing bans and supply the manufacturing, testing and composition data for the file (Art. 8, Art. 11(2) and Art. 18). Importers are the responsible person for what they import unless they mandate someone else, and put the country of origin on the label and in the notification (Art. 4(5), Art. 13(1)(c) and Art. 19(1)(a)). Distributors act with due care, verify the responsible person, batch number, ingredient list, language and durability before making a product available, hold back or correct non-compliant products, inform the responsible person and the authorities of risks, protect the product in storage and transport, keep three-year traceability, notify translations and report serious undesirable effects (Art. 6, Art. 7, Art. 13(3) and Art. 23).
Enforcement and penalties
Member States monitor compliance through in-market controls of products and economic operators, using the product information file and, where appropriate, physical and laboratory checks, and review their surveillance at least every four years (Art. 22). Where the responsible person breaches good manufacturing practice, the safety assessment, the product information file, sampling and analysis, notification, the substance rules, the animal-testing rules, labelling, claims, public information, the reporting of serious undesirable effects or the duty to inform on substances, the competent authority orders corrective action, withdrawal or recall within a time limit commensurate with the risk, and where the operator fails to act or a serious risk to human health requires immediate action it prohibits or restricts the making available, withdraws or recalls the product itself and informs the Commission and the other Member States (Art. 25). Distributors are ordered to correct breaches of their Article 6 duties (Art. 26), the safeguard clause lets an authority provisionally withdraw, recall or restrict even compliant products that present a serious risk (Art. 27), and every decision states its grounds and remedies after the operator has been heard unless immediate action is needed (Art. 28). Article 25(7) still cites the rapid alert system of Directive 2001/95/EC and Article 23 of Regulation (EC) No 765/2008; those are read as Regulation (EU) 2023/988, which repealed the directive from 13 December 2024, and Regulation (EU) 2019/1020, which deleted Articles 15 to 29 of Regulation (EC) No 765/2008 from 16 July 2021 and lists the Cosmetics Regulation in its Annex I. Serious undesirable effects reported by the responsible person, distributors, end users or health professionals are shared between the competent authorities (Art. 23).
Penalties are set nationally and must be effective, proportionate and dissuasive; Member States had to notify them by 11 July 2013 (Art. 37). In Denmark, bekendtgørelse nr. 803 of 21 June 2013 om kosmetiske produkter, issued under lov om kemikalier, makes Miljøstyrelsen the competent authority under Article 34 and the supervisory body, and gives it the decisions under Articles 25 to 27, which cannot be appealed to another administrative authority (§§ 4 and 5); its Kemikalieinspektion carries out the inspections. Breaches of the Danish labelling and language rules are punished with a fine, rising to imprisonment of up to two years where the breach was intentional or grossly negligent and caused or risked harm to human health or the environment or gained an economic advantage, and companies can be held criminally liable (§ 6). Breaches of the regulation itself, such as placing a product on the market without a responsible person, a safety report or a CPNP notification, are punished under section 59(1)(1) of lov om kemikalier (lovbekendtgørelse nr. 1200 of 25 September 2025) with a fine, rising to imprisonment of up to two years under the same aggravating circumstances (section 59(2)), and companies can be held criminally liable (section 60).
How Conphora helps
Conphora monitors CosR and its annex amendments and maps your cosmetic products against the requirements, flagging gaps in the responsible person, the safety report, the product information file, the CPNP notification, the label and the claims before they become enforcement problems. The platform tracks each Omnibus and ingredient regulation with its placing-on-the-market and making-available dates, so you know when a substance becomes banned or restricted and how long existing stock may still be sold, and keeps your documentation current as the annexes change.
See how Conphora works · See plans and pricing
Sources
- Regulation (EC) No 1223/2009 on cosmetic products, consolidated text of 18 May 2026 (EUR-Lex)
- Regulation (EC) No 1223/2009 as published in OJ L 342, 22 December 2009 (EUR-Lex)
- Document information, dates and relationships for CELEX 32009R1223 (EUR-Lex)
- Commission Regulation (EU) 2023/1490 on CMR substances, Omnibus (EUR-Lex)
- Commission Regulation (EU) 2023/1545 on the labelling of fragrance allergens (EUR-Lex)
- Commission Regulation (EU) 2024/858 on nanomaterials (EUR-Lex)
- Commission Regulation (EU) 2024/996 on Vitamin A, Alpha-Arbutin, Arbutin and substances with potential endocrine-disrupting properties (EUR-Lex)
- Commission Regulation (EU) 2025/877 on CMR substances, Omnibus (EUR-Lex)
- Commission Regulation (EU) 2026/78 on CMR substances, Omnibus (EUR-Lex)
- Commission Regulation (EU) 2026/909 on Benzyl Salicylate, Triphenyl Phosphate, aluminium, zinc salts, Citral, hair dyes and DHHB (EUR-Lex)
- Commission Regulation (EU) No 655/2013 laying down common criteria for the justification of claims (EUR-Lex)
- Regulation (EU) 2017/745 on medical devices, Article 119 amending Regulation (EC) No 1223/2009 (EUR-Lex)
- Regulation (EU) 2019/1020 on market surveillance and compliance of products (EUR-Lex)
- Regulation (EU) 2023/988 on general product safety, repealing Directives 2001/95/EC and 87/357/EEC (EUR-Lex)
- Cosmetics legislation (European Commission, DG GROW)
- Cosmetic Products Notification Portal, CPNP (European Commission, DG GROW)
- Market surveillance of cosmetics and serious undesirable effects (European Commission, DG GROW)
- Kosmetiske produkter (Miljøstyrelsen)
- Lovgivning om kosmetiske produkter (Miljøstyrelsen)
- Faktaark: Mærkning af kosmetik (Miljøstyrelsen)
- Bekendtgørelse nr. 803 af 21. juni 2013 om kosmetiske produkter (Retsinformation)
- Lovbekendtgørelse nr. 1200 af 25. september 2025 af lov om kemikalier (Retsinformation)
This guide is for general information and is not legal advice.