--- title: "CosR — Cosmetics Regulation" description: "The Cosmetics Regulation requires every cosmetic product to have a responsible person in the Union, a safety assessment, a product information file, CPNP notification and compliant labelling within the substance rules of Annexes II to VI, binding manufacturers, importers and distributors. It has applied since 11 July 2013; Regulation (EU) 2026/909 applies from 1 January 2027." type: "guide" url: "https://www.conphora.com/regulations/cosr/" markdown: "https://www.conphora.com/regulations/cosr.md" locale: "en" language: "en" published: "2010-01-11" updated: "2026-09-11" author: "Conphora compliance team" publisher: "Conphora" reference: "Regulation (EC) No 1223/2009" celex: "32009R1223" source: "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009R1223" tags: ["CosR", "Food & Cosmetics"] license: "Free to quote with attribution and a link to the page" --- # CosR — Cosmetics Regulation The Cosmetics Regulation requires every cosmetic product to have a responsible person in the Union, a safety assessment, a product information file, CPNP notification and compliant labelling within the substance rules of Annexes II to VI, binding manufacturers, importers and distributors. It has applied since 11 July 2013; Regulation (EU) 2026/909 applies from 1 January 2027. ## Key facts - **Official title:** Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) - **Reference:** Regulation (EC) No 1223/2009 - **CELEX:** 32009R1223 - **Act type:** Regulation - **In force:** 2010-01-11 - **Applies from:** 2013-07-11 - **Enforced by:** The national competent authorities that each Member State designates under Article 34 monitor compliance through in-market controls of products and economic operators, including checks of the product information file and physical and laboratory checks, and the general market surveillance framework of Regulation (EU) 2019/1020 applies where the regulation has no specific provision, the regulation being listed in Annex I of that framework; in Denmark, Miljøstyrelsen is the competent authority and supervisory body under sections 4 and 5 of bekendtgørelse nr. 803 of 21 June 2013 om kosmetiske produkter, and its chemicals inspection, Kemikalieinspektionen, carries out the inspections. The toolkit is an order to the responsible person or distributor to take corrective action, withdraw or recall the product within a set time limit, a prohibition or restriction of the making available, withdrawal or recall by the authority itself where the operator fails to act or where a serious risk to human health requires immediate action, provisional measures under the safeguard clause, a request for the list of all products containing a substance in serious doubt, and national penalties that must be effective, proportionate and dissuasive. - **Category:** Food & Cosmetics ## Who it applies to **Covered by the act:** 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, exclusively or mainly to clean, perfume, change the appearance of, protect or keep in good condition those parts or to correct body odours; Skin creams and lotions, sunscreens, make-up, perfumes, deodorants, soaps and shower gels, shampoos and hair dyes, toothpastes and mouthwashes, nail products and professional salon products, whether for consumers or professional users; Cosmetic products made available on the Union market, including free samples, products sold online to EU end users and products packed at the point of sale; The economic operators in the chain: the responsible person established in the Union, manufacturers, importers and distributors; The substances used in cosmetic products through the Annex II ban list, the Annex III restrictions and the positive lists of colorants (Annex IV), preservatives (Annex V) and UV-filters (Annex VI), plus the rules on CMR substances, nanomaterials and traces **Derived and downstream products:** A 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; warnings do not exempt anyone from the other requirements (Art. 3); Cosmetic products carry no CE marking and need no notified body: compliance rests on the responsible person, the safety report, the product information file and the CPNP notification (Art. 4, Art. 10, Art. 11 and Art. 13); A distributor that sells under its own name or trade mark, or modifies a product already on the market in a way that may affect compliance, becomes the responsible person; translating the label is not such a modification (Art. 4(6)); Products containing nanomaterials must be notified six months before they are placed on the market, unless the nanomaterial is used as a colorant, preservative or UV-filter under Article 14 or complies with Annex III (Art. 16(2) and Art. 16(3)); Where a product could be a cosmetic or a medical device, the Commission may decide by implementing measure whether it falls within the definition of cosmetic product, a power added by the Medical Devices Regulation (Art. 2(4)); Claims in labelling, marketing and advertising must satisfy the six common criteria of Regulation (EU) No 655/2013: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making (Art. 20 and that regulation's Annex) **Roles under the act:** - **Responsible person** — The legal or natural person designated within the Union for a cosmetic product, who ensures compliance with the regulation for every product placed on the market; by default the manufacturer established in the Union, the importer for imported products, or the person a manufacturer or importer designates by written mandate, and a distributor that sells under its own name or modifies the product. - **Manufacturer (including brand owners)** — Any natural or legal person who manufactures a cosmetic product or has such a product designed or manufactured, and markets that cosmetic product under his name or trademark; a manufacturer established in the Union is the responsible person unless it mandates someone else, and a manufacturer outside the Union must designate one by written mandate. - **Importer** — Any natural or legal person established within the Community who places a cosmetic product from a third country on the Community market; each importer is the responsible person for the products it places on the market unless it designates a person established in the Union by written mandate. - **Distributor (wholesaler or retailer)** — Any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the Community market. ## Key dates - 2009-11-30: Regulation (EC) No 1223/2009 adopted by the European Parliament and the Council as a recast of Directive 76/768/EEC - 2010-01-11: Entry into force, the twentieth day after publication in OJ L 342 of 22 December 2009 - 2010-12-01: The CMR rules of Article 15(1) and (2) apply, together with Articles 14, 31 and 32 as far as needed to apply them; Article 4b of Directive 76/768/EEC repealed - 2012-01-11: A notification made under Article 13 counts as a notification under Article 7(3) and Article 7a(4) of Directive 76/768/EEC - 2013-01-11: Article 16(3), second subparagraph, applies: products containing nanomaterials already on the market had to be notified between 11 January and 11 July 2013 - 2013-03-11: End of the implementation period for the marketing ban on products and ingredients tested on animals for repeated-dose toxicity, reproductive toxicity and toxicokinetics - 2013-07-11: The regulation applies in full; Directive 76/768/EEC repealed; Member States had to notify their penalty rules; distributors translating labels must notify; Regulation (EU) No 655/2013 on common criteria for claims applies - 2014-01-11: Deadline for the Commission's catalogue of all nanomaterials used in cosmetic products on the market - 2016-07-11: Deadline for the Commission's report on the use of claims under the common criteria - 2017-05-25: Regulation (EU) 2017/745, the Medical Devices Regulation, enters into force; its Article 119 adds Article 2(4), letting the Commission decide whether a product or group of products is a cosmetic product, but the amendment only takes effect on the MDR's date of application, 26 May 2021 (Article 123(2), as postponed by Regulation (EU) 2020/561) - 2018-07-11: Deadline for the Commission's first review of the nanomaterial provisions - 2020-07-11: End of the duty to keep the information collected under Article 7(3), Article 7a(4) and Article 7a of Directive 76/768/EEC - 2021-07-16: Regulation (EU) 2019/1020 on market surveillance applies: the regulation is listed in its Annex I, and Articles 15 to 29 of Regulation (EC) No 765/2008, still cited in Article 25(7), are deleted and read as the corresponding provisions of Regulation (EU) 2019/1020 - 2023-08-09: Regulation (EU) 2023/1490 in force: CMR substances classified by Delegated Regulation (EU) 2022/692 added to Annex II, applying from 1 December 2023 - 2023-08-16: Regulation (EU) 2023/1545 in force: 56 additional fragrance allergens must be named in the ingredient list above 0,001 % in leave-on and 0,01 % in rinse-off products; non-compliant products may be placed on the market until 31 July 2026 and made available until 31 July 2028 - 2023-12-01: Regulation (EU) 2023/1490 applies, on the same date as the CLP classifications it implements - 2024-04-04: Regulation (EU) 2024/858 in force: twelve nanomaterials added to Annex II (entries 1725 to 1729) and Hydroxyapatite (nano) restricted in Annex III (entry 372) - 2024-04-24: Regulation (EU) 2024/996 in force: 4-Methylbenzylidene Camphor prohibited, Vitamin A, Alpha-Arbutin, Arbutin, Genistein, Daidzein and Kojic Acid restricted, Triclosan and Triclocarban conditions tightened - 2024-12-13: Regulation (EU) 2023/988, the General Product Safety Regulation, applies and repeals Directives 2001/95/EC and 87/357/EEC, which Articles 3, 25(7) and 27(2) still cite; the references are read as references to that regulation - 2024-12-31: Last day to place on the market toothpaste, mouthwash and other products with Triclosan or Triclocarban under the conditions that applied on 23 April 2024; such products already on the market may be made available until 31 October 2025 - 2025-02-01: Products containing the twelve Annex II nanomaterials, or Hydroxyapatite (nano) outside its conditions, and products with Genistein, Daidzein, Kojic Acid, Alpha-Arbutin or Arbutin outside the new limits may no longer be placed on the market - 2025-05-01: Products containing 4-Methylbenzylidene Camphor may no longer be placed on the market; point (4) of the Annex to Regulation (EU) 2024/996, removing the substance from the Annex VI UV-filter list, applies - 2025-06-02: Regulation (EU) 2025/877 in force: CMR substances classified by Delegated Regulation (EU) 2024/197 added to Annex II and Trimethylbenzoyl Diphenylphosphine Oxide removed from Annex III, applying from 1 September 2025 - 2025-09-01: Regulation (EU) 2025/877 applies, on the same date as the CLP classifications it implements - 2025-11-01: Products containing the twelve Annex II nanomaterials or non-compliant Hydroxyapatite (nano), Genistein, Daidzein, Kojic Acid, Alpha-Arbutin or Arbutin may no longer be made available; products with Retinol, Retinyl Acetate or Retinyl Palmitate outside the Vitamin A limits may no longer be placed on the market - 2026-02-02: Regulation (EU) 2026/78 in force: CMR substances classified by Delegated Regulation (EU) 2024/2564 added to Annex II, silver, Hexyl Salicylate and Sodium o-Phenylphenate given conditions in Annexes III, IV and V, applying from 1 May 2026 - 2026-05-01: Regulation (EU) 2026/78 applies; products containing 4-Methylbenzylidene Camphor may no longer be made available - 2026-05-18: Regulation (EU) 2026/909 in force: Triphenyl Phosphate prohibited, Benzyl Salicylate, aluminium-containing ingredients, water-soluble zinc salts, Acetylated Vetiver Oil and Citral restricted, three hair dyes and Hydroxypropyl-p-phenylenediamine allowed with limits, silver zinc zeolite allowed as a preservative and a 10 ppm DnHexP limit set for the UV-filter DHHB; the date of the consolidated text used for this guide - 2026-07-31: Last day to place on the market products whose fragrance allergen labelling does not follow Regulation (EU) 2023/1545 - 2027-01-01: Products containing Triphenyl Phosphate, or Benzyl Salicylate, aluminium-containing ingredients, water-soluble zinc salts, Acetylated Vetiver Oil, Citral or DHHB outside the new conditions, may no longer be placed on the market - 2027-05-01: Products with Retinol, Retinyl Acetate or Retinyl Palmitate outside the Vitamin A limits may no longer be made available - 2028-07-01: Products non-compliant with Regulation (EU) 2026/909 may no longer be made available; for the Citral isomers the date is 1 August 2028 - 2028-07-31: Last day to make available products whose fragrance allergen labelling does not follow Regulation (EU) 2023/1545 ## What you must do ### Responsible person - Ensure that every product you place on the market complies with the safety requirement, good manufacturing practice, the safety assessment, the product information file, sampling and analysis, notification, the substance rules, the animal-testing rules, labelling, claims, public access to information and the reporting of serious undesirable effects, and be established in the Union so that authorities have one accountable person. - Before placing the product on the market, have a safety assessment carried out by a person with a university qualification in pharmacy, toxicology, medicine or a similar discipline, taking into account the intended use and the systemic exposure to each ingredient, and draw up the cosmetic product safety report of Annex I, Part A (safety information) and Part B (assessment), and keep it up to date. - Keep a product information file for 10 years after the last batch was placed on the market, containing the product description, the safety report, the manufacturing method and GMP statement, proof of the claimed effect where justified and data on any animal testing, and make it readily accessible in electronic or other format at the address on the label, in a language the authority of that Member State easily understands. - Before placing the product on the market, draw up its product information file: the product description, the cosmetic product safety report, the manufacturing method and GMP statement, proof of the claimed effect where justified and data on any animal testing. - Keep the product information file for 10 years after the last batch was placed on the market, readily accessible in electronic or other format at the address on the label, in a language the competent authority of that Member State easily understands. - Notify the product electronically in the Cosmetic Products Notification Portal before placing it on the market with its category and name, your name and address, the country of origin for imports, the Member State of placing, a contact person, any nanomaterials, any CMR substances of category 1A or 1B and the frame formulation, then upload the original labelling and a photograph of the packaging, and update the notification without delay when anything changes; notify nanomaterials six months in advance under Article 16. - Before placing the product on the market, notify it in the Cosmetic Products Notification Portal with its category and name, your details, the country of origin for imports, the Member State of placing, a contact person, nanomaterials, CMR substances of category 1A or 1B and the frame formulation; upload the labelling and a packaging photograph, and update it without delay. - Notify cosmetic products containing nanomaterials electronically to the Commission six months before placing them on the market. - Keep the formulation within the annexes: no Annex II substance, Annex III substances only within their restrictions, only the colorants, preservatives and UV-filters of Annexes IV, V and VI under their conditions, no CMR substance unless exempted under Article 15, and traces of prohibited substances only where technically unavoidable in good manufacturing practice and still safe. - Label the container and packaging indelibly, legibly and visibly with your name and address (and the country of origin for imports), the nominal content, the date of minimum durability or the period-after-opening symbol for products lasting more than 30 months, precautions for use, the batch number, the function unless obvious, and the ingredient list headed ingredients in descending order of weight using the common ingredient names, with parfum or aroma plus the individually listed allergens and the word nano in brackets after nano ingredients; the language of the content, durability, precautions and function is set by the Member State of sale. - Label the container and packaging indelibly, legibly and visibly with your name and address as the responsible person, and the country of origin for imported products. - Label the container and packaging indelibly, legibly and visibly with the nominal content, the date of minimum durability or period-after-opening symbol, the batch number, the function unless obvious and the ingredient list in descending order of weight (common names, parfum or aroma plus listed allergens, nano in brackets), in the language the Member State of sale sets. - Label the container and packaging with the particular precautions for use, in the language the Member State of sale requires. - Use only claims, names, trade marks and images that do not imply characteristics or functions the product does not have, meeting the common criteria of Regulation (EU) No 655/2013 and matching the proof in the product information file, and claim that no animal tests were carried out only where neither you, the manufacturer nor the suppliers tested the product, its prototype or its ingredients on animals or used ingredients tested by others for new cosmetic products. - Notify all serious undesirable effects known to you, with the product name and the corrective measures taken, without delay to the competent authority of the Member State where the effect occurred; make the composition, the perfume composition identifiers and existing data on undesirable effects easily accessible to the public; and on request identify the distributors you supplied for three years after the batch was supplied. - Notify all serious undesirable effects known to you, with the product name and the corrective measures taken, without delay to the competent authority of the Member State where the effect occurred. - Make the qualitative and quantitative composition, the perfume composition identifiers and existing data on undesirable and serious undesirable effects easily accessible to the public. - On request of the competent authorities, identify the distributors you supplied, for three years after the batch was made available to them. - If you consider or have reason to believe that a product you placed on the market does not comply, immediately bring it into conformity, withdraw or recall it, inform the competent authorities of the Member States concerned and of the Member State where the file is kept if the product presents a risk to human health, cooperate with authorities on risk-elimination measures and provide conformity information and documentation on reasoned request in a language the authority easily understands. - If you believe a product you placed on the market does not comply, immediately bring it into conformity, withdraw or recall it, and where it presents a risk to human health inform the competent authorities of the Member States where you made it available and where the product information file is kept. - On a reasoned request from a competent national authority, provide all the information and documentation needed to demonstrate the product's conformity, in a language that authority easily understands, and cooperate with it on any action to eliminate the risks posed by products you made available. ### Manufacturer (including brand owners) - Act as the responsible person for products you manufacture in the Union and place on the market under your name or trade mark, unless you designate a person established in the Union by written mandate that the person accepts in writing; if you are established outside the Union, you must designate such a responsible person. - Manufacture in accordance with good manufacturing practice; compliance is presumed where manufacture follows the harmonised standards whose references are published in the Official Journal of the European Union. - Do not test finished cosmetic products on animals in the Union, do not test ingredients on animals once a validated alternative method is listed in Regulation (EC) No 440/2008 or Annex VIII, and do not place on the market products or ingredients tested on animals to meet the regulation after such alternatives exist; the marketing ban became complete on 11 March 2013 for repeated-dose toxicity, reproductive toxicity and toxicokinetics. - Supply the responsible person with what the product information file needs from you: the method of manufacturing and the statement of GMP compliance, data on any animal testing performed by you, your agents or suppliers, including tests done for third-country requirements, and the qualitative and quantitative composition with the identity of perfume composition suppliers for the safety report. - Use sampling and analysis methods that are reliable and reproducible, presumed where the method follows the relevant harmonised standards, and run non-clinical safety studies for the safety assessment under good laboratory practice or equivalent international standards. ### Importer - You are the responsible person for every product from a third country that you place on the market, with all the duties of Article 5, unless you designate a person established in the Union by written mandate that the person accepts in writing. - State the country of origin on the label of imported products next to the responsible person's name and address, and give the country of origin in the CPNP notification. - Before placing an imported product on the market, obtain the safety assessment and safety report, build the product information file with the manufacturer's data, including animal-testing data from the manufacturer and its suppliers and tests done for third-country requirements, and keep it accessible at your address for 10 years after the last batch. - Before placing an imported product on the market, make sure its safety assessment has been carried out and the cosmetic product safety report drawn up. - Build the product information file for the imported product with the manufacturer's data, including animal-testing data from the manufacturer and its suppliers and tests done for third-country requirements. - Keep the product information file readily accessible at your address for 10 years after the last batch was placed on the market. - Check that the imported product was not tested on animals to meet the regulation after alternative methods were validated, since the marketing ban applies regardless of where the testing took place. - If an imported product presents a risk to human health, immediately take corrective measures, withdraw or recall it and inform the competent authorities of the Member States where you made it available, and cooperate with them on any action to eliminate the risk. - If an imported product presents a risk to human health or does not comply, immediately take corrective measures, withdraw or recall it, and inform the competent authorities of the Member States where you made it available. - Cooperate with the competent authorities on any action to eliminate the risks posed by products you made available, and provide the information and documentation on conformity they request. ### Distributor (wholesaler or retailer) - Act with due care and, before making a product available, verify that the label shows the responsible person's name and address, the batch number and the ingredient list, that the information for small products and non-pre-packaged products is given as required, that the language requirements of the Member State of sale are met and that the date of minimum durability has not passed. - Do not make available a product you consider or have reason to believe is non-compliant until it has been brought into conformity, make sure corrective measures, withdrawal or recall are taken for products you have already made available, and where the product presents a risk to human health immediately inform the responsible person and the competent authorities of the Member States concerned. - Do not make available a product you consider or have reason to believe is non-compliant until it has been brought into conformity. - Make sure corrective measures, withdrawal or recall are taken for non-compliant products you have already made available, and where the product presents a risk to human health immediately inform the responsible person and the competent authorities of the Member States concerned. - Keep storage and transport conditions from jeopardising compliance while the product is under your responsibility, and cooperate with the authorities on risk-elimination measures, providing on reasoned request the information and documentation showing conformity with the points you must verify. - While a product is under your responsibility, keep its storage and transport conditions from jeopardising its compliance. - Cooperate with the competent authorities on any action to eliminate risks, and on a reasoned request provide the information and documentation showing conformity with the points you must verify. - On request, identify the distributor or responsible person who supplied you and the distributors you supplied, for three years after the batch was made available to you. - If you make available in one Member State a product already placed on the market in another and translate any element of its labelling on your own initiative, notify the Commission electronically of the product category and names, the Member State, your name and address and the responsible person's details; if you introduce a product placed on the market before 11 July 2013 that is no longer sold, tell the responsible person so it can notify. - Notify serious undesirable effects known to you, with the product name and any corrective measures, without delay to the competent authority of the Member State where the effect occurred. - If you place a product on the market under your own name or trade mark, or modify a product already on the market in a way that may affect compliance, you become its responsible person with all the duties of Article 5; translating information is not such a modification. ## Requirements Each duty above as an identified requirement (38); ids are permanent and shared with the compliance engine. ### evidence - `cosr-oth-draw-product-information-file` (Responsible person, product, before-market) — Before placing the product on the market, draw up its product information file: the product description, the cosmetic product safety report, the manufacturing method and GMP statement, proof of the claimed effect where justified and data on any animal testing. [Art. 11(1) and Art. 11(2)] - `cosr-oth-keep-formulation-annexes` (Responsible person, product, before-market) — Keep the formulation within the annexes: no Annex II substance, Annex III substances only within their restrictions, only the colorants, preservatives and UV-filters of Annexes IV, V and VI under their conditions, no CMR substance unless exempted under Article 15, and traces of prohibited substances only where technically unavoidable in good manufacturing practice and still safe. [Art. 14, Art. 15 and Art. 17] - `cosr-oth-use-claims-names` (Responsible person, product, before-market) — Use only claims, names, trade marks and images that do not imply characteristics or functions the product does not have, meeting the common criteria of Regulation (EU) No 655/2013 and matching the proof in the product information file, and claim that no animal tests were carried out only where neither you, the manufacturer nor the suppliers tested the product, its prototype or its ingredients on animals or used ingredients tested by others for new cosmetic products. [Art. 20; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32013R0655 · Art. 2 and Annex] - `cosr-mfr-test-finished-cosmetic` (Manufacturer (including brand owners), product, before-market) — Do not test finished cosmetic products on animals in the Union, do not test ingredients on animals once a validated alternative method is listed in Regulation (EC) No 440/2008 or Annex VIII, and do not place on the market products or ingredients tested on animals to meet the regulation after such alternatives exist; the marketing ban became complete on 11 March 2013 for repeated-dose toxicity, reproductive toxicity and toxicokinetics. [Art. 18(1) and Art. 18(2)] - `cosr-imp-build-product-information-file` (Importer, product, before-market) — Build the product information file for the imported product with the manufacturer's data, including animal-testing data from the manufacturer and its suppliers and tests done for third-country requirements. [Art. 11(1) and Art. 11(2)] ### data - `cosr-oth-publish-product-information` (Responsible person, product, ongoing) — Make the qualitative and quantitative composition, the perfume composition identifiers and existing data on undesirable and serious undesirable effects easily accessible to the public. [Art. 21] - `cosr-mfr-supply-responsible-person` (Manufacturer (including brand owners), product, before-market) — Supply the responsible person with what the product information file needs from you: the method of manufacturing and the statement of GMP compliance, data on any animal testing performed by you, your agents or suppliers, including tests done for third-country requirements, and the qualitative and quantitative composition with the identity of perfume composition suppliers for the safety report. [Art. 11(2) and Annex I, Part A, point 1] ### mark - `cosr-oth-label-name-address` (Responsible person, product, before-market) — Label the container and packaging indelibly, legibly and visibly with your name and address as the responsible person, and the country of origin for imported products. [Art. 19(1), point (a)] - `cosr-oth-label-product-particulars` (Responsible person, product-market, before-market) — Label the container and packaging indelibly, legibly and visibly with the nominal content, the date of minimum durability or period-after-opening symbol, the batch number, the function unless obvious and the ingredient list in descending order of weight (common names, parfum or aroma plus listed allergens, nano in brackets), in the language the Member State of sale sets. [Art. 19(1), points (b), (c), (e), (f) and (g), Art. 19(5) and Art. 19(6)] - `cosr-oth-label-precautions-use` (Responsible person, product-market, before-market) — Label the container and packaging with the particular precautions for use, in the language the Member State of sale requires. [Art. 19(1), point (d), and Art. 19(5)] - `cosr-imp-state-country-origin` (Importer, product, before-market) — State the country of origin on the label of imported products next to the responsible person's name and address, and give the country of origin in the CPNP notification. [Art. 19(1), point (a), and Art. 13(1), point (c)] ### decision - `cosr-dist-hold-non-compliant` (Distributor (wholesaler or retailer), product, on-event) — Do not make available a product you consider or have reason to believe is non-compliant until it has been brought into conformity. [Art. 6(3)] ### procedure - `cosr-oth-have-safety-assessment` (Responsible person, product, before-market) — Before placing the product on the market, have a safety assessment carried out by a person with a university qualification in pharmacy, toxicology, medicine or a similar discipline, taking into account the intended use and the systemic exposure to each ingredient, and draw up the cosmetic product safety report of Annex I, Part A (safety information) and Part B (assessment), and keep it up to date. [Art. 10 and Annex I] - `cosr-mfr-use-sampling-analysis` (Manufacturer (including brand owners), product, before-market) — Use sampling and analysis methods that are reliable and reproducible, presumed where the method follows the relevant harmonised standards, and run non-clinical safety studies for the safety assessment under good laboratory practice or equivalent international standards. [Art. 12 and Art. 10(3)] - `cosr-imp-obtain-safety-report` (Importer, product, before-market) — Before placing an imported product on the market, make sure its safety assessment has been carried out and the cosmetic product safety report drawn up. [Art. 10] ### submission - `cosr-oth-notify-cpnp` (Responsible person, product, before-market) — Before placing the product on the market, notify it in the Cosmetic Products Notification Portal with its category and name, your details, the country of origin for imports, the Member State of placing, a contact person, nanomaterials, CMR substances of category 1A or 1B and the frame formulation; upload the labelling and a packaging photograph, and update it without delay. [Art. 13(1), Art. 13(2) and Art. 13(7)] - `cosr-oth-notify-nanomaterials` (Responsible person, product, before-market) — Notify cosmetic products containing nanomaterials electronically to the Commission six months before placing them on the market. [Art. 16(3)] - `cosr-oth-notify-serious-effects` (Responsible person, product-market, on-event) — Notify all serious undesirable effects known to you, with the product name and the corrective measures taken, without delay to the competent authority of the Member State where the effect occurred. [Art. 23(1)] - `cosr-oth-correct-withdraw-recall` (Responsible person, product, on-event) — If you believe a product you placed on the market does not comply, immediately bring it into conformity, withdraw or recall it, and where it presents a risk to human health inform the competent authorities of the Member States where you made it available and where the product information file is kept. [Art. 5(2)] - `cosr-imp-correct-withdraw-recall` (Importer, product, on-event) — If an imported product presents a risk to human health or does not comply, immediately take corrective measures, withdraw or recall it, and inform the competent authorities of the Member States where you made it available. [Art. 5(2)] - `cosr-dist-make-sure-corrective` (Distributor (wholesaler or retailer), product, on-event) — Make sure corrective measures, withdrawal or recall are taken for non-compliant products you have already made available, and where the product presents a risk to human health immediately inform the responsible person and the competent authorities of the Member States concerned. [Art. 6(3)] - `cosr-dist-notify-commission-electronically` (Distributor (wholesaler or retailer), product-market, before-market) — If you make available in one Member State a product already placed on the market in another and translate any element of its labelling on your own initiative, notify the Commission electronically of the product category and names, the Member State, your name and address and the responsible person's details; if you introduce a product placed on the market before 11 July 2013 that is no longer sold, tell the responsible person so it can notify. [Art. 13(3) and Art. 13(4)] - `cosr-dist-notify-serious-undesirable` (Distributor (wholesaler or retailer), product-market, on-event) — Notify serious undesirable effects known to you, with the product name and any corrective measures, without delay to the competent authority of the Member State where the effect occurred. [Art. 23(1)] ### verification - `cosr-imp-check-imported-product` (Importer, product, before-market) — Check that the imported product was not tested on animals to meet the regulation after alternative methods were validated, since the marketing ban applies regardless of where the testing took place. [Art. 18(1), points (a) and (b)] - `cosr-dist-act-due-care` (Distributor (wholesaler or retailer), product-market, before-market) — Act with due care and, before making a product available, verify that the label shows the responsible person's name and address, the batch number and the ingredient list, that the information for small products and non-pre-packaged products is given as required, that the language requirements of the Member State of sale are met and that the date of minimum durability has not passed. [Art. 6(1) and Art. 6(2)] ### standing - `cosr-oth-keep-product-information-file` (Responsible person, product, ongoing) — Keep the product information file for 10 years after the last batch was placed on the market, readily accessible in electronic or other format at the address on the label, in a language the competent authority of that Member State easily understands. [Art. 11(1) and Art. 11(3)] - `cosr-oth-identify-distributors` (Responsible person, company, ongoing) — On request of the competent authorities, identify the distributors you supplied, for three years after the batch was made available to them. [Art. 7] - `cosr-oth-provide-information-request` (Responsible person, company, ongoing) — On a reasoned request from a competent national authority, provide all the information and documentation needed to demonstrate the product's conformity, in a language that authority easily understands, and cooperate with it on any action to eliminate the risks posed by products you made available. [Art. 5(3) and Art. 24] - `cosr-mfr-manufacture-accordance-good` (Manufacturer (including brand owners), company, ongoing) — Manufacture in accordance with good manufacturing practice; compliance is presumed where manufacture follows the harmonised standards whose references are published in the Official Journal of the European Union. [Art. 8] - `cosr-imp-keep-product-information-file` (Importer, product, ongoing) — Keep the product information file readily accessible at your address for 10 years after the last batch was placed on the market. [Art. 11(1) and Art. 11(3)] - `cosr-imp-provide-information-request` (Importer, company, ongoing) — Cooperate with the competent authorities on any action to eliminate the risks posed by products you made available, and provide the information and documentation on conformity they request. [Art. 5(3)] - `cosr-dist-keep-storage-conditions` (Distributor (wholesaler or retailer), company, ongoing) — While a product is under your responsibility, keep its storage and transport conditions from jeopardising its compliance. [Art. 6(4)] - `cosr-dist-provide-information-request` (Distributor (wholesaler or retailer), company, ongoing) — Cooperate with the competent authorities on any action to eliminate risks, and on a reasoned request provide the information and documentation showing conformity with the points you must verify. [Art. 6(5)] - `cosr-dist-identify-distributor-responsible` (Distributor (wholesaler or retailer), company, ongoing) — On request, identify the distributor or responsible person who supplied you and the distributors you supplied, for three years after the batch was made available to you. [Art. 7] ## Penalties Member States lay down the penalties for infringing the regulation, which must be effective, proportionate and dissuasive, and had to notify them to the Commission by 11 July 2013. Where the responsible person breaches good manufacturing practice, the safety assessment, the product information file, sampling and analysis, notification, the substance restrictions, the animal-testing rules, labelling, claims, public access to 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; if the operator does not act, or where a serious risk to human health requires immediate action, the authority itself prohibits or restricts the making available, withdraws or recalls the product and informs the Commission and the other Member States, using the rapid alert system of Article 12 of Directive 2001/95/EC (read as Regulation (EU) 2023/988 since 13 December 2024) and Article 23 of Regulation (EC) No 765/2008 (read as Regulation (EU) 2019/1020 since 16 July 2021). Distributors are ordered to correct breaches of their Article 6 duties, and under the safeguard clause even compliant products that present a serious risk can be withdrawn, recalled or restricted provisionally. Every decision states its grounds and the remedies, and the operator may put forward its viewpoint first unless immediate action is needed. In Denmark, Miljøstyrelsen supervises compliance and takes the decisions under Articles 25 to 27, which cannot be appealed to another administrative authority; under section 6 of bekendtgørelse nr. 803 of 21 June 2013 a breach of the Danish labelling and language rules is 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. 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). ## Checklist 1. Confirm the product is a cosmetic under Article 2(1)(a): intended for the skin, hair, nails, lips, external genital organs, teeth or mouth, exclusively or mainly to clean, perfume, change appearance, protect, keep in condition or correct body odour, and not ingested, inhaled, injected or implanted (Article 2(2)). 2. Designate the responsible person established in the Union: the EU manufacturer, the importer, a mandated person who accepts in writing, or yourself if you sell under your own brand or modify the product (Article 4). 3. Commission the safety assessment from a qualified assessor and draw up the Annex I safety report, Part A and Part B, before placing the product on the market (Article 10). 4. Build the product information file with the product description, safety report, manufacturing method and GMP statement, proof of claims and animal-testing data, keep it 10 years after the last batch and make it accessible at the label address (Article 11). 5. Screen the formulation against Annex II, the Annex III restrictions including the fragrance allergen thresholds, the positive lists in Annexes IV to VI, the CMR ban of Article 15 and the trace rule of Article 17, and set up a watch on the annex amendments, which arrive several times a year (Articles 14 to 17, Article 31). 6. Notify the product in the CPNP before placing it on the market, including nanomaterials, CMR substances and the frame formulation, upload the label and packaging photo, and notify nanomaterials six months in advance (Articles 13 and 16). 7. Design the label with the responsible person and country of origin, nominal content, durability or period-after-opening symbol, precautions, batch number, function and the ingredient list with allergens and nano indications, in the language the Member State of sale requires, which in Denmark is Danish for content, durability, precautions and function (Article 19; bekendtgørelse nr. 803 of 21 June 2013, section 3). 8. Check every claim against the common criteria of Regulation (EU) No 655/2013 and the evidence in the product information file, and use a no-animal-testing claim only where Article 20(3) allows it (Article 20). 9. Set up the procedures for reporting serious undesirable effects to the authority of the Member State where they occur, for public access to composition and undesirable-effect data, for three-year supply-chain traceability and for corrective action, withdrawal or recall (Articles 5, 7, 21 and 23). ## Questions ### When did the Cosmetics Regulation start to apply? Regulation (EC) No 1223/2009 was adopted on 30 November 2009, published in the Official Journal on 22 December 2009 and entered into force on 11 January 2010. It applies from 11 July 2013, when Directive 76/768/EEC was repealed, with two earlier dates: the CMR rules of Article 15(1) and (2) applied from 1 December 2010 and the notification of nano products already on the market ran from 11 January 2013. Products complying with the regulation could be placed on the market before 11 July 2013 by way of derogation from the directive. ### Who is the responsible person and does every company need one? Only cosmetic products for which a legal or natural person established in the Union is designated as responsible person may be placed on the market, and that person ensures compliance with the regulation for each product. For a product manufactured in the Union it is the manufacturer, for an imported product it is the importer, and either may designate another person established in the Union by written mandate accepted in writing; a manufacturer outside the Union must do so. A distributor becomes the responsible person when it sells under its own name or trade mark or modifies the product in a way that may affect compliance, but translating the label does not count. ### What must the product information file contain and how long do I keep it? The responsible person keeps a product information file for 10 years after the last batch of the product was placed on the market. It contains a description of the product, the cosmetic product safety report drawn up under Annex I, a description of the manufacturing method and a statement of compliance with good manufacturing practice, proof of the effect claimed where the nature or effect of the product justifies it, and data on any animal testing by the manufacturer, its agents or suppliers, including tests done to meet third-country rules. The file must be readily accessible in electronic or other format at the address on the label, in a language the competent authority of that Member State easily understands. ### Do I have to notify my product before selling it in the EU? Yes. Before placing a product on the market the responsible person submits electronically, through the Commission's Cosmetic Products Notification Portal, the product category and name, its own name and address, the country of origin for imports, the Member State of placing, a contact person, any nanomaterials with their exposure conditions, 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. Products containing nanomaterials are notified six months before placing on the market. The portal is free of charge, and a product notified there needs no further national notification. A distributor that translates the label on its own initiative when selling in another Member State must also notify. ### What must be on the label, and does it have to be in Danish? The container and packaging must show, indelibly, legibly and visibly, the responsible person's name and address and the country of origin for imports, the nominal content, the date of minimum durability preceded by the hourglass symbol or the words best used before the end of, or for products lasting 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 in descending order of weight using the common ingredient names, with parfum or aroma, the individually listed fragrance allergens and the word nano in brackets after nano ingredients. The language of the content, durability, precautions and function is set by the Member State where the product is sold; in Denmark bekendtgørelse nr. 803 of 21 June 2013 requires those elements to be in Danish. ### Which substances are banned or restricted, and how do the Omnibus regulations work? A cosmetic product may not contain the substances in Annex II, may use 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 their conditions. Substances classified as carcinogenic, mutagenic or toxic for reproduction under the CLP Regulation are prohibited unless the SCCS has found them safe under the conditions of Article 15, and, for category 1A and 1B substances, the Commission must amend the annexes within 15 months of each classification. That is what the Omnibus regulations do: after every CLP adaptation the Commission adds the newly classified substances to Annex II and moves any exempted ones to Annexes III to VI, most recently by Regulations (EU) 2023/1490, 2025/877 and 2026/78, each applying on the date its CLP classifications apply. The Commission also amends the annexes after SCCS opinions on individual ingredients, as Regulations (EU) 2024/858, 2024/996 and 2026/909 did for nanomaterials, Vitamin A and endocrine-related substances, and Benzyl Salicylate, aluminium and other ingredients. ### Do the new fragrance allergen labelling rules apply to products already on sale? Regulation (EU) 2023/1545 requires 56 additional fragrance allergens to be named individually in the ingredient list when they exceed 0,001 % in leave-on and 0,01 % in rinse-off products, on top of the 24 allergens already listed in Annex III. It entered into force on 16 August 2023, but products that do not comply with the new requirements may still be placed on the market until 31 July 2026 and made available until 31 July 2028, provided they comply with the restrictions that applied on 15 August 2023. ### Is animal testing of cosmetics banned in the EU? Yes. It is prohibited to test finished cosmetic products on animals in the Union, to test ingredients on animals once a validated alternative method is listed in Regulation (EC) No 440/2008 or Annex VIII, and to place on the market products or ingredients tested on animals to meet the regulation after such alternatives were validated. 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, and a no-animal-testing claim may be used only where neither the manufacturer nor its suppliers tested the product, its prototype or its ingredients on animals. ## What changed - 2028-07-31 (applies): **End of the sell-through period for the old fragrance allergen labelling** — From this date products whose ingredient list does not name the 56 additional fragrance allergens of Regulation (EU) 2023/1545 above the thresholds may no longer be made available on the market. - 2028-07-01 (applies): **End of the sell-through period under Regulation (EU) 2026/909** — Products containing Triphenyl Phosphate, or Benzyl Salicylate, aluminium-containing ingredients, water-soluble zinc salts, Acetylated Vetiver Oil or DHHB outside the new conditions, may no longer be made available; for the Citral isomers the date is 1 August 2028. - 2027-05-01 (applies): **End of the sell-through period for Vitamin A products** — Products containing Retinol, Retinyl Acetate or Retinyl Palmitate above 0,05 % retinol equivalent in body lotion or 0,3 % in other products, or without the warning, may no longer be made available. - 2027-01-01 (applies): **Regulation (EU) 2026/909 restrictions apply to placing on the market** — From this date products containing Triphenyl Phosphate, or Benzyl Salicylate, aluminium-containing ingredients, water-soluble zinc salts, Acetylated Vetiver Oil, Citral or the UV-filter DHHB outside their new conditions, may no longer be placed on the market. - 2026-07-31 (applies): **Last day to place products with the old fragrance allergen labelling on the market** — Products that do not follow the allergen labelling of Regulation (EU) 2023/1545 may be placed on the market until this date, provided they comply with the restrictions applicable on 15 August 2023, and made available until 31 July 2028. - 2026-05-18 (amendment): **Regulation (EU) 2026/909 in force: Benzyl Salicylate, Triphenyl Phosphate, aluminium, zinc, Citral, hair dyes, silver zinc zeolite and DHHB** — The Commission regulation of 27 April 2026 prohibits Triphenyl Phosphate, restricts Benzyl Salicylate, aluminium-containing ingredients, water-soluble zinc salts in oral products, Acetylated Vetiver Oil and Citral, allows HC Blue No 18, HC Yellow No 16, HC Red No 18 and Hydroxypropyl-p-phenylenediamine as hair dyes, moves silver zinc zeolite to the Annex V preservative list and caps di-n-hexyl phthalate in DHHB at 10 ppm; hair dye and preservative entries apply at once, the rest from 1 January 2027 for placing and 1 July 2028 for making available. - 2026-05-01 (applies): **Regulation (EU) 2026/78 applies; 4-Methylbenzylidene Camphor sell-through ends** — The CMR classifications of Delegated Regulation (EU) 2024/2564 take effect in Annexes II to V, and products containing 4-Methylbenzylidene Camphor may no longer be made available. - 2026-02-02 (amendment): **Regulation (EU) 2026/78 in force: Omnibus on CMR substances, silver, Hexyl Salicylate and o-Phenylphenol** — The Commission regulation of 12 January 2026 adds the CMR substances of Delegated Regulation (EU) 2024/2564 to Annex II, merges the perborate entries, prohibits silver massive and silver nano while keeping micron-sized silver powder as a colorant under conditions, restricts Hexyl Salicylate in Annex III and adds Sodium o-Phenylphenate to the Annex V preservative entry 7; it applies from 1 May 2026. - 2025-11-01 (applies): **Nanomaterial and Arbutin sell-through ends; Vitamin A limits apply to placing on the market** — Products containing the twelve nanomaterials added to Annex II by Regulation (EU) 2024/858, Hydroxyapatite (nano) outside its conditions, or Genistein, Daidzein, Kojic Acid, Alpha-Arbutin or Arbutin outside the limits of Regulation (EU) 2024/996 may no longer be made available, and products with Retinol, Retinyl Acetate or Retinyl Palmitate outside the Vitamin A limits may no longer be placed on the market. - 2025-09-01 (applies): **Regulation (EU) 2025/877 applies: TPO and other CMR substances prohibited** — The CMR classifications of Delegated Regulation (EU) 2024/197 take effect in the annexes: Trimethylbenzoyl Diphenylphosphine Oxide loses its Annex III entry 311 for professional nail systems and the other newly classified substances join Annex II. - 2025-06-02 (amendment): **Regulation (EU) 2025/877 in force: Omnibus on CMR substances** — The Commission regulation of 12 May 2025 amends Annexes II and III to implement the CMR classifications of Delegated Regulation (EU) 2024/197, applying from 1 September 2025. - 2025-05-01 (applies): **4-Methylbenzylidene Camphor prohibited for placing on the market** — Products containing the former UV-filter 4-Methylbenzylidene Camphor may no longer be placed on the market, and point (4) of the Annex to Regulation (EU) 2024/996 removes its Annex VI entry; such products may be made available until 1 May 2026. - 2025-02-01 (applies): **Nanomaterial bans and Arbutin, Genistein, Daidzein and Kojic Acid limits apply to placing on the market** — Products containing the twelve nanomaterials of Regulation (EU) 2024/858 or Hydroxyapatite (nano) outside its conditions, and products with Genistein, Daidzein, Kojic Acid, Alpha-Arbutin or Arbutin outside the limits of Regulation (EU) 2024/996, may no longer be placed on the market. - 2024-12-13 (applies): **General Product Safety Regulation replaces Directive 2001/95/EC** — Regulation (EU) 2023/988 applies and repeals Directives 2001/95/EC and 87/357/EEC; the references to them in Articles 3, 25(7) and 27(2) of the Cosmetics Regulation are read as references to the new regulation. Triclosan and Triclocarban products under the old conditions may be placed on the market until 31 December 2024 and made available until 31 October 2025. - 2024-04-24 (amendment): **Regulation (EU) 2024/996 in force: Vitamin A, Arbutins and endocrine-related substances** — The Commission regulation of 3 April 2024 prohibits 4-Methylbenzylidene Camphor, restricts Retinol, Retinyl Acetate, Retinyl Palmitate, Alpha-Arbutin, Arbutin, Genistein, Daidzein and Kojic Acid, and tightens the conditions for Triclosan and Triclocarban, with transition periods running to 1 May 2027. - 2024-04-04 (amendment): **Regulation (EU) 2024/858 in force: twelve nanomaterials banned, Hydroxyapatite (nano) restricted** — The Commission regulation of 14 March 2024 adds Styrene/Acrylates copolymer, Sodium Styrene/Acrylates copolymer, Copper, Colloidal Copper, Colloidal Silver, Gold, Colloidal Gold, Gold Thioethylamino Hyaluronic Acid, Acetyl heptapeptide-9 Colloidal gold, Platinum, Colloidal Platinum and Acetyl tetrapeptide-17 Colloidal Platinum in nano form to Annex II and restricts Hydroxyapatite (nano) to 10 % in toothpaste and 0,465 % in mouthwash, with placing on the market prohibited from 1 February 2025 and making available from 1 November 2025. - 2023-12-01 (applies): **Regulation (EU) 2023/1490 applies** — The substances classified as CMR by Delegated Regulation (EU) 2022/692 are prohibited in cosmetic products through Annex II from the date their CLP classifications apply. - 2023-08-16 (amendment): **Regulation (EU) 2023/1545 in force: 56 more fragrance allergens to be labelled** — The Commission regulation of 26 July 2023 amends Annex III so that 56 additional fragrance allergens must be named in the ingredient list above 0,001 % in leave-on and 0,01 % in rinse-off products, with a transition until 31 July 2026 for placing on the market and 31 July 2028 for making available. - 2023-08-09 (amendment): **Regulation (EU) 2023/1490 in force: Omnibus on CMR substances** — The Commission regulation of 19 July 2023 adds the substances classified as CMR by Delegated Regulation (EU) 2022/692 to Annex II, applying from 1 December 2023. - 2022-12-01 (amendment): **Annex updates 2013 to 2022, consolidated in the text** — Between Commission Regulation (EU) No 344/2013 of 4 April 2013 and Commission Regulation (EU) 2022/2195 of 10 November 2022, in force on 1 December 2022, 45 Commission regulations amended Annexes II to VI to add prohibited substances, adjust restrictions and update the lists of colorants, preservatives and UV-filters, including the Omnibus regulations on CMR substances such as Regulations (EU) 2019/831, 2021/850 and 2021/1902; they are marked M1 to M47 in the consolidated text, alongside the Medical Devices Regulation and its postponement, and are all incorporated in the consolidated text of 18 May 2026. - 2021-07-16 (applies): **Regulation (EU) 2019/1020 on market surveillance applies** — The Cosmetics Regulation is listed in Annex I of the market surveillance regulation, whose framework applies where the Cosmetics Regulation has no specific provision; Chapter III of Regulation (EC) No 765/2008, Articles 15 to 29, is deleted and references to it, such as the one in Article 25(7), are read as references to Regulation (EU) 2019/1020. - 2017-05-25 (amendment): **Medical Devices Regulation adds Article 2(4) on borderline decisions** — Regulation (EU) 2017/745, the Medical Devices Regulation, enters into force; its Article 119 adds Article 2(4), letting the Commission decide whether a product or group of products is a cosmetic product, but the amendment only takes effect on the MDR's date of application, 26 May 2021 (Article 123(2), as postponed by Regulation (EU) 2020/561). This is the MDR's consequential amendment, not a change to the cosmetics rules themselves. - 2013-07-11 (applies): **The Cosmetics Regulation applies in full; Directive 76/768/EEC repealed** — The regulation applies in all Member States, the Cosmetics Directive is repealed, Member States had to notify their penalty rules, distributors translating labels must notify, and Regulation (EU) No 655/2013 on the common criteria for claims applies from the same day. - 2010-12-01 (applies): **CMR ban of Article 15(1) and (2) applies** — The prohibition of CMR substances of categories 1A, 1B and 2, with the exception routes through the SCCS, applies together with Articles 14, 31 and 32 as far as needed, and Article 4b of Directive 76/768/EEC is repealed. - 2010-01-11 (in-force): **Regulation (EC) No 1223/2009 enters into force** — Adopted on 30 November 2009 and published in OJ L 342 on 22 December 2009, the recast Cosmetics Regulation entered into force on the twentieth day after publication and applies from 11 July 2013. ## 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)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009R1223), or the [consolidated text of 18 May 2026](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518) 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](/how-it-works) · [See plans and pricing](/pricing) ## Sources - [Regulation (EC) No 1223/2009 on cosmetic products, consolidated text of 18 May 2026 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518) - [Regulation (EC) No 1223/2009 as published in OJ L 342, 22 December 2009 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009R1223) - [Document information, dates and relationships for CELEX 32009R1223 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32009R1223) - [Commission Regulation (EU) 2023/1490 on CMR substances, Omnibus (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R1490) - [Commission Regulation (EU) 2023/1545 on the labelling of fragrance allergens (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R1545) - [Commission Regulation (EU) 2024/858 on nanomaterials (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R0858) - [Commission Regulation (EU) 2024/996 on Vitamin A, Alpha-Arbutin, Arbutin and substances with potential endocrine-disrupting properties (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R0996) - [Commission Regulation (EU) 2025/877 on CMR substances, Omnibus (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025R0877) - [Commission Regulation (EU) 2026/78 on CMR substances, Omnibus (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R0078) - [Commission Regulation (EU) 2026/909 on Benzyl Salicylate, Triphenyl Phosphate, aluminium, zinc salts, Citral, hair dyes and DHHB (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R0909) - [Commission Regulation (EU) No 655/2013 laying down common criteria for the justification of claims (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32013R0655) - [Regulation (EU) 2017/745 on medical devices, Article 119 amending Regulation (EC) No 1223/2009 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745) - [Regulation (EU) 2019/1020 on market surveillance and compliance of products (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32019R1020) - [Regulation (EU) 2023/988 on general product safety, repealing Directives 2001/95/EC and 87/357/EEC (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R0988) - [Cosmetics legislation (European Commission, DG GROW)](https://single-market-economy.ec.europa.eu/sectors/cosmetics/legislation_en) - [Cosmetic Products Notification Portal, CPNP (European Commission, DG GROW)](https://single-market-economy.ec.europa.eu/sectors/cosmetics/cosmetic-product-notification-portal_en) - [Market surveillance of cosmetics and serious undesirable effects (European Commission, DG GROW)](https://single-market-economy.ec.europa.eu/sectors/cosmetics/market-surveillance_en) - [Kosmetiske produkter (Miljøstyrelsen)](https://mst.dk/erhverv/sikker-kemi/kemikalier/fokus-paa-saerlige-produkter/kosmetiske-produkter) - [Lovgivning om kosmetiske produkter (Miljøstyrelsen)](https://mst.dk/erhverv/sikker-kemi/kemikalier/fokus-paa-saerlige-produkter/kosmetiske-produkter/lovgivning-om-kosmetiske-produkter) - [Faktaark: Mærkning af kosmetik (Miljøstyrelsen)](https://mst.dk/erhverv/sikker-kemi/kemikalier/regler-og-handlingsplaner/faktaark-om-kemikaliereglerne/faktaark-maerkning-af-kosmetik) - [Bekendtgørelse nr. 803 af 21. juni 2013 om kosmetiske produkter (Retsinformation)](https://www.retsinformation.dk/eli/lta/2013/803) - [Lovbekendtgørelse nr. 1200 af 25. september 2025 af lov om kemikalier (Retsinformation)](https://www.retsinformation.dk/eli/lta/2025/1200) *This guide is for general information and is not legal advice.* ## Sources - [Regulation (EC) No 1223/2009 on cosmetic products, consolidated text of 18 May 2026 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518) - [Regulation (EC) No 1223/2009 as published in OJ L 342, 22 December 2009 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009R1223) - [Document information, dates and relationships for CELEX 32009R1223 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32009R1223) - [Commission Regulation (EU) 2023/1490 on CMR substances, Omnibus (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R1490) - [Commission Regulation (EU) 2023/1545 on the labelling of fragrance allergens (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R1545) - [Commission Regulation (EU) 2024/858 on nanomaterials (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R0858) - [Commission Regulation (EU) 2024/996 on Vitamin A, Alpha-Arbutin, Arbutin and substances with potential endocrine-disrupting properties (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R0996) - [Commission Regulation (EU) 2025/877 on CMR substances, Omnibus (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025R0877) - [Commission Regulation (EU) 2026/78 on CMR substances, Omnibus (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R0078) - [Commission Regulation (EU) 2026/909 on Benzyl Salicylate, Triphenyl Phosphate, aluminium, zinc salts, Citral, hair dyes and DHHB (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R0909) - [Commission Regulation (EU) No 655/2013 laying down common criteria for the justification of claims (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32013R0655) - [Regulation (EU) 2017/745 on medical devices, Article 119 amending Regulation (EC) No 1223/2009 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745) - [Regulation (EU) 2019/1020 on market surveillance and compliance of products (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32019R1020) - [Regulation (EU) 2023/988 on general product safety, repealing Directives 2001/95/EC and 87/357/EEC (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R0988) - [Cosmetics legislation (European Commission, DG GROW)](https://single-market-economy.ec.europa.eu/sectors/cosmetics/legislation_en) - [Cosmetic Products Notification Portal, CPNP (European Commission, DG GROW)](https://single-market-economy.ec.europa.eu/sectors/cosmetics/cosmetic-product-notification-portal_en) - [Market surveillance of cosmetics and serious undesirable effects (European Commission, DG GROW)](https://single-market-economy.ec.europa.eu/sectors/cosmetics/market-surveillance_en) - [Kosmetiske produkter (Miljøstyrelsen)](https://mst.dk/erhverv/sikker-kemi/kemikalier/fokus-paa-saerlige-produkter/kosmetiske-produkter) - [Lovgivning om kosmetiske produkter (Miljøstyrelsen)](https://mst.dk/erhverv/sikker-kemi/kemikalier/fokus-paa-saerlige-produkter/kosmetiske-produkter/lovgivning-om-kosmetiske-produkter) - [Faktaark: Mærkning af kosmetik (Miljøstyrelsen)](https://mst.dk/erhverv/sikker-kemi/kemikalier/regler-og-handlingsplaner/faktaark-om-kemikaliereglerne/faktaark-maerkning-af-kosmetik) - [Bekendtgørelse nr. 803 af 21. juni 2013 om kosmetiske produkter (Retsinformation)](https://www.retsinformation.dk/eli/lta/2013/803) - [Lovbekendtgørelse nr. 1200 af 25. september 2025 af lov om kemikalier (Retsinformation)](https://www.retsinformation.dk/eli/lta/2025/1200) _Reviewed 2026-09-24 by Conphora compliance team_