Q.01

What does the EU cosmetics regulation require?

Regulation (EC) No 1223/2009 lets a cosmetic product onto the EU market only if four things are in place before launch. An EU-established responsible person must be designated. That person must have a safety assessment done, keep a product information file (PIF) and notify the product to the Commission. Once on the market, the product must also meet the ingredient lists in Annexes II-VI, the CMR ban, the labelling, claims and animal-testing rules, and the reporting of serious undesirable effects. This summary uses the current consolidated text (version of 18 May 2026).

Approach: I read the consolidated Official Journal text of Regulation 1223/2009, article by article, plus Annex I and the most recent amending Regulations. The substance-by-substance Annex entries and Commission guidance documents are not summarised here.

Scope and basic safety duty

  • What counts as a cosmetic (Art. 2): anything applied to the external parts of the body, the teeth or the mouth, mainly to clean, perfume, change appearance, protect, keep in good condition or correct body odours. Anything ingested, inhaled, injected or implanted is excluded [1][2].
  • Safety (Art. 3): the product must be safe under normal or reasonably foreseeable use. Presentation, labelling, instructions and other information count towards this, and adding warnings does not remove any other obligation [3].
  • Free movement (Art. 9): Member States may not block compliant products on grounds covered by the Regulation [4].

Who is responsible

  • Responsible person (Art. 4): only products with a responsible person designated in the EU may be placed on the market. Who that is depends on the route to market:
    • for EU-made products, the EU manufacturer;
    • for imported products, the importer;
    • in either case, another EU person appointed by written mandate and accepting in writing;
    • a distributor who sells under its own name or modifies a product in a way that may affect compliance. Translation alone is not a modification. [5]
  • What the responsible person must do (Art. 5):
    • ensure compliance with Arts. 3, 8, 10-18, 19(1), (2) and (5), 20, 21, 23 and 24;
    • correct, withdraw or recall non-compliant products;
    • tell the national authorities at once if a product presents a risk to human health [6].
  • Distributors (Art. 6): must act with due care and, before selling, check:
    • the responsible person's name and address, batch number and ingredient list on the label;
    • the language requirements;
    • that any minimum durability date has not passed. They must not sell products they believe are non-compliant [7].
  • Supply-chain traceability (Art. 7): on request, operators must identify who supplied them and whom they supplied, for 3 years after the batch reached the distributor [8].

Before placing on the market

  • Good manufacturing practice (Art. 8): manufacturing must follow GMP. Compliance is presumed when the harmonised standards published in the Official Journal are followed [9].
  • Safety assessment (Art. 10 and Annex I): a cosmetic product safety report (CPSR) must be drawn up and kept up to date.
    • It must take account of intended use and systemic exposure, using a weight-of-evidence approach.
    • Part B must be signed by an assessor with a university qualification in pharmacy, toxicology, medicine or a similar discipline.
    • Non-clinical studies carried out after 30 June 1988 must follow GLP [10].
    • Part A covers composition, stability, microbiological quality (including challenge test results), impurities and packaging, exposure, toxicological profile with a NOAEL-based margin of safety, and undesirable effects [11].
    • Part B gives the safety conclusion, the required warnings and the reasoning. It needs a specific assessment for products for children under three and for external intimate hygiene products [12].
  • Product information file (Art. 11):
    • contents: a product description, the CPSR, the manufacturing method and a GMP statement, proof of claimed effects where justified, and data on any animal testing (including testing done for non-EU markets);
    • it must be kept for 10 years after the last batch is placed on the market;
    • it must be readily accessible to the authority at the address on the label [13].
  • Notification (Art. 13): before launch, the responsible person notifies the Commission electronically. The notification gives:
    • the product category and name, and the responsible person's address;
    • the country of origin for imports, and the Member State of launch;
    • a contact person;
    • any nanomaterials;
    • any CMR 1A/1B substances;
    • the frame formulation. The original label and, where legible, a packaging photograph must also be notified [14]. Distributors who translate labels have their own notification duty, and all changes must be updated without delay [15].
  • Nanomaterials (Art. 16):
    • an extra notification is due 6 months before launch, with identity, specification, annual quantity, toxicological profile, safety data and exposure conditions;
    • this does not apply to nano colorants, UV filters or preservatives regulated under Art. 14, or to nanomaterials that meet Annex III requirements;
    • the Commission may refer a nanomaterial to the SCCS (the Commission's Scientific Committee on Consumer Safety) [16].

Ingredient rules

  • Annexes II-VI (Art. 14):
    • Annex II: prohibited substances;
    • Annex III: substances allowed only within its restrictions;
    • Annex IV (colorants), V (preservatives) and VI (UV filters): positive lists, so only the listed substances may be used for those functions, and only under the listed conditions [17].
  • CMR substances (Art. 15): these are substances with a harmonised CLP Annex VI classification as carcinogenic, mutagenic or toxic for reproduction.
    • Category 2: banned unless the SCCS has found the substance safe.
    • Categories 1A/1B: banned, with an exception only if all four conditions are met: compliance with food-safety requirements, no suitable alternatives, a specific use with known exposure, and an SCCS finding of safety.
    • The Commission must amend the Annexes within 15 months of the CLP listing [18].
  • Traces (Art. 17): technically unavoidable traces of a prohibited substance are tolerated if the product is still safe under Art. 3 [19].

Animal testing, labelling and claims

  • Animal testing ban (Art. 18): two prohibitions apply.

    • Marketing ban: no placing on the market of products, or products with ingredients, tested on animals to meet the Regulation once validated alternatives exist. The cut-off dates were 11 March 2009, and 11 March 2013 for repeated-dose toxicity, reproductive toxicity and toxicokinetics.
    • Testing ban: no testing of finished products in the EU [20].

  • Labelling (Art. 19): the label must show, in indelible and legible lettering:

    • the responsible person's name and address (and country of origin for imports);
    • nominal content;
    • a date of minimum durability, or a period-after-opening symbol where durability exceeds 30 months;
    • precautions, including those required by Annexes III-VI;
    • a batch number;
    • the product's function;
    • an "ingredients" list [21].

    The ingredient list follows these rules:

    • descending order of weight, with ingredients under 1% in any order;
    • nanomaterials marked "(nano)";
    • common ingredient (glossary) names;
    • the language is set by the Member State where the product is sold [22].

  • Claims (Art. 20): labels and advertising must not imply characteristics or functions the product does not have. A "not tested on animals" claim is allowed only if neither the manufacturer nor its suppliers tested the product or any ingredient [23].

  • Public information (Art. 21): the composition (quantities only for hazardous substances) and data on undesirable effects must be easily accessible to the public [24].

After launch

  • Serious undesirable effects (Art. 23): responsible persons and distributors must report them without delay to the authority of the Member State where they occurred, with any corrective measures [25].
  • Information on substances (Art. 24): where there is serious doubt about a substance's safety, an authority may require a list of all the responsible person's products containing it, with concentrations [26].
  • Enforcement:
    • Member States run in-market controls through PIF, physical and lab checks, and review their surveillance at least every 4 years (Art. 22) [27].
    • Authorities can order corrective action, withdrawal or recall (Arts. 25-27) [28][29].
    • Penalties are set nationally and must be "effective, proportionate and dissuasive" (Art. 37) [30].
  • Application date: the Regulation has applied since 11 July 2013, and Art. 15 since 1 December 2010 [31].

Recent amendments to the Annexes

The ingredient Annexes change often: 53 amending acts are on record.

  • Regulation (EU) 2025/877: amends Annexes II and III to follow CMR classifications; applies from 1 September 2025 [32][33].
  • Regulation (EU) 2026/78: amends Annexes II, III, IV and V under Art. 15; applies from 1 May 2026 [34][35].
  • Regulation (EU) 2026/909: amends Annexes II, III, V and VI; its recitals open with benzyl salicylate (Annex III entry 75) [36][37]. The text I read does not show its application date.

I can next look up a specific ingredient's Annex II-VI status, or set out the detailed changes made by the 2025-2026 amending acts.

Q.02

Who needs to be the responsible person?

The responsible person must be a natural or legal person established in the EU. No cosmetic product may be placed on the market without one. Article 4 of Regulation (EC) No 1223/2009 decides who it is by default, based on how the product reaches the EU market [5].

Approach: I read Article 4 and the Article 2 definitions in the current consolidated text of the EU Cosmetics Regulation (version of 18 May 2026).

Route to marketWho is the responsible person by defaultCan it be handed to someone else?
Made in the EU by an EU-established manufacturer (and not exported and re-imported)The manufacturer (Art. 4(3))Yes. The manufacturer may appoint another EU-established person by written mandate, and that person must accept in writing.
Made in the EU by a manufacturer established outside the EUNobody by default. The manufacturer must appoint an EU-established person by written mandate, accepted in writing (Art. 4(4)).Appointment is mandatory
Imported from a non-EU countryEach importer, for the specific product it places on the market (Art. 4(5))Yes. The importer may appoint another EU-established person by written mandate, accepted in writing.
A distributor puts the product on the market under its own name or trademark, or modifies a product already on the market in a way that may affect complianceThe distributor (Art. 4(6))The Article does not provide for this

[5]

Points that often decide the answer in practice:

  • Translation is not a modification. A distributor that only translates information on a product already on the market does not become the responsible person [5].
  • "Importer" means an EU-established person that places a product from a third country on the EU market [1]. A non-EU brand owner therefore cannot itself be the responsible person. It relies on its EU importer or on an EU-established person it appoints by mandate, which is the usual third-party responsible person service.
  • "Manufacturer" includes anyone who has a product designed or manufactured and markets it under its own name or trademark [1]. A brand owner that uses a contract manufacturer is therefore the manufacturer.
  • "Placing on the market" means the first making available of the product on the EU market [1]. That first EU supply is the point at which a responsible person must be in place.

Whoever takes the role carries, for each product, the duty to ensure it complies with the relevant obligations of the Regulation (Art. 4(2)) [5]. In practice those are the Article 5 duties from my previous answer: the safety report, the product information file, notification, labelling, and corrective action.

I can also compare this with the GB responsible person rule under the UK Cosmetics Regulation, which requires a UK-established person.

Q.03

What has to go on the label?

Under Article 19 of Regulation (EC) No 1223/2009, seven items must appear on both the container and the outer packaging. They must be in indelible, easily legible and visible lettering. The seven are the responsible person's name and address, the nominal content, the durability marking, precautions for use, the batch number, the product's function and the ingredient list. There are set exceptions for small items, unpackaged products and multi-shade ranges [21].

Approach: I read Article 19 in full in the current consolidated text of the EU Cosmetics Regulation (version of 18 May 2026). The Annex VII symbols it refers to and the Article 33 ingredient glossary are cited by the Article but I did not reproduce them here.

The mandatory particulars (Art. 19(1))

ItemWhat is requiredWhere it can go
(a) Responsible personName or registered name and address. Abbreviations are allowed if the person and address can still be identified. If several addresses appear, highlight the one where the product information file is kept. Imported products must also state the country of origin.Container and packaging
(b) Nominal contentWeight or volume at the time of packaging. Not needed for packs under 5 g or 5 ml, free samples or single-application packs. Multi-item packs may give the number of items instead. That is also not needed if the number is visible from outside or the product is normally sold singly.Container and packaging
(c) DurabilityA date of minimum durability (month and year, or day, month and year), preceded by the Annex VII point 3 symbol or "best used before the end of". Add storage conditions if necessary. If durability is more than 30 months, the date may be left off. A period-after-opening must then be given using the Annex VII point 2 symbol plus months and/or years, unless durability after opening is not relevant.Container and packaging
(d) PrecautionsParticular precautions for use, and at least those required by Annexes III-VI. Products for professional use also need any special precautionary information.Container and packaging
(e) Batch numberThe manufacturing batch number or another reference that identifies the productPackaging only, if the container is too small
(f) FunctionThe product's function, unless it is clear from its presentationContainer and packaging
(g) IngredientsA list headed "ingredients"May be on the packaging alone

[21]

Ingredient list rules

  • What counts as an ingredient: any substance or mixture intentionally used during manufacture. Impurities in the raw materials and processing aids not present in the final product are excluded [21].
  • Fragrance and flavour: declared as "parfum" or "aroma". Any substance that Annex III requires to be named (its "Other" column) must also be listed separately, for example the labelled fragrance allergens [21].
  • Order: descending order of weight at the time each ingredient is added. Ingredients below 1% may follow in any order [22].
  • Nanomaterials: the name must be followed by "(nano)" [22].
  • Colorants (except hair colorants):
    • they may be listed in any order after the other ingredients;
    • for shade ranges, every colorant used across the range may be listed with "may contain" or "+/-";
    • Colour Index (CI) names must be used where applicable. [22]
  • Names: use the common ingredient name from the Article 33 glossary. If there is none, use a generally accepted nomenclature (Art. 19(6)) [22].

Exceptions and practical cases

  • Precautions or ingredients won't fit (Art. 19(2)): put them on an enclosed or attached leaflet, label, tape, tag or card. Unless that is impracticable, refer to it on pack with abbreviated information or the Annex VII point 1 symbol. For precautions the reference goes on the container or packaging; for ingredients it goes on the packaging [22].
  • Soap, bath balls and other small products (Art. 19(3)): if even a tag or leaflet is impossible, the ingredient list may go on a notice right next to the display container [22].
  • Not pre-packaged, packed at the customer's request, or pre-packed for immediate sale (Art. 19(4)): each Member State sets its own detailed labelling rules [22].

Language (Art. 19(5))

The Member State where the product reaches the end user decides the language for the following:

  • nominal content, durability, precautions and function;
  • the leaflet, tag and notice information under paragraphs 2-4.

The ingredient list is not in that list, because it uses the glossary names (INCI) [22].

The label is also subject to the Article 20 rule that labelling must not imply characteristics or functions the product does not have [23]. I can next look up the Annex III warnings and labelled-substance conditions for a specific ingredient, or pull the Annex VII symbols.

Q.04