EU Cosmetics Regulation (EC) No 1223/2009: the complete guide

• In force since 11 July 2013 (main application date); replaced Directive 76/768/EEC after it had been amended on numerous occasions.
• Requires a Responsible Person per product, CPNP notification before market placement, and a complete Product Information File — all verifiable through our CosIng database.
• Organises ingredient restrictions across six Annexes; only the preservatives, colorants, and UV filters listed in Annexes V, IV, and VI respectively may be used in those functions. Track changes with Regulatory Watch.

1. What is Regulation 1223/2009?

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) is the legal instrument that defines the conditions for EU market access for all cosmetic products. Its EUR-Lex reference is CELEX 32009R1223; the latest consolidated version is CELEX 02009R1223-20250901.

It was published in the Official Journal L 342 of 22 December 2009 (p. 59). It entered into force on 11 January 2010 and its main provisions have applied since 11 July 2013. On that date it repealed Directive 76/768/EEC under its Art. 38.

Why a Regulation rather than a Directive?

The distinction is fundamental. A Directive sets objectives and leaves each Member State to transpose it into national law. A Regulation is directly applicable in all 27 Member States without transposition. This means the rules are identical in Germany, Spain, France, or any other Member State from the first day of application.

Directive 76/768/EEC, its predecessor, was amended on numerous occasions over decades, producing divergences in application across countries. The Regulation removed that source of fragmentation and established a truly uniform internal market for cosmetics.

2. Definition of cosmetic product (Art. 2)

Art. 2(1)(a) of the Regulation defines a cosmetic product as:

"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 with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours."

The definition has three cumulative elements: the substance or mixture is applied to the external parts of the body or to teeth and oral mucosa; the purpose is exclusively or mainly one of the six listed functions (cleaning, perfuming, changing appearance, protecting, keeping in good condition, correcting body odours); and the route of application is contact, not ingestion or systemic pharmacological action.

Products that do not fit this definition — medicinal products (Dir. 2001/83/EC), biocidal products (Reg. (EU) 528/2012), medical devices (Reg. (EU) 2017/745) — fall outside the scope of Regulation 1223/2009. For a detailed analysis of borderline cases, see the post on the legal definition of cosmetic product.

3. Structure of the Regulation: chapters and key articles

The Regulation is organised into ten Chapters:

Chapters II, III, IV, V, and VI carry the greatest operational weight for Regulatory Affairs teams. Chapter II establishes accountability; Chapter III defines what documentation a product requires before market placement; Chapter IV limits which ingredients may be used; Chapter V protects consumers from animal testing; and Chapter VI determines what information must appear on packaging.

4. The six Annexes: the core of compliance

The Annexes contain the regulated substance lists. They are the destination for virtually every formulation question:

The architecture matters: Annex II operates as a negative list (what is listed is prohibited), while Annexes IV, V, and VI operate as positive lists (only what is listed may be used in that function).

For a detailed analysis of each Annex, the guide EU cosmetic regulation Annexes explained covers Annexes II, III, V, and VI with application examples. Specific entries are available in our database: Annex V: preservatives, Annex VI: UV filters, and the CosIng search tool.

5. The Responsible Person (Art. 4 and 5)

The Responsible Person (RP) is the linchpin of the Regulation's compliance system. Art. 4 requires that, for each cosmetic product, a natural or legal person established in the EU acts as RP.

Who is RP by default?

• The manufacturer who places the product on the EU market under their name or trademark (Art. 4(2)).
• The importer who brings the product from a third country into the EU (Art. 4(5)).
• Anyone who has received a written mandate from the manufacturer to take on the role (Art. 4(3)).

Art. 5 obligations:

Art. 5 lists the RP's obligations: ensuring compliance with Arts. 3, 8, 10–17, 18, 19–21; maintaining the PIF for 10 years; notifying the CPNP before market placement; taking corrective measures, withdrawals, or recalls when necessary; reporting serious undesirable effects to authorities; and cooperating with competent authority controls.

For the full analysis of Responsible Person obligations, the guide Responsible Person obligations covers each point in detail. For the compliance verification service, see the Responsible Person page.

6. The Product Information File (Art. 11)

Art. 11 requires the RP to maintain a Product Information File (PIF) accessible to competent authorities. The PIF must contain the five elements of Art. 11(2):

1. A product description (enabling clear attribution of the PIF to the cosmetic product)
2. CPSR — Cosmetic Product Safety Report (Parts A and B of Annex I)
3. Description of the manufacturing method and GMP compliance declaration (Art. 8)
4. Proof of the claimed effect (where the nature or effect of the product justifies it)
5. Data on any animal testing carried out (manufacturer, agents, suppliers)

Retention: 10 years from the date the last batch was placed on the market (Art. 11(1)), at a single address within the EU.

The CPSR is the central element of the PIF. It contains the toxicological assessment of all ingredients, the safety evaluation of the finished product, and the sign-off of a qualified assessor (Art. 10(2)). For a dedicated guide to the PIF, see the post on the cosmetic PIF, and for the CPSR specifically, the post on the CPSR safety report.

7. CPNP notification (Art. 13)

Before placing any cosmetic on the EU market, the Responsible Person must notify it through the CPNP (Cosmetic Products Notification Portal), the Commission's free portal. Notification is single: one CPNP notification covers all Member States where the product is sold.

Art. 13(1) sets out the data to be notified: product category and identification; RP name and address; country of origin (for imports); target Member States; contact person details; nanomaterial information (where applicable); names of CMR substances and CAS/EC data (where applicable); and frame formulation (where applicable).

For a complete analysis of the notification process, including the special case of nanomaterials (Art. 16(3)) requiring notification 6 months before market placement, see the dedicated guide on CPNP notification.

8. Substance restrictions (Art. 14–17)

Chapter IV manages ingredient restrictions through four articles:

Art. 14 refers to Annexes II–VI as the restriction mechanism. No cosmetic may contain Annex II substances, or Annex III–VI substances outside their specified conditions.

Art. 15 governs CMR substances (carcinogenic, mutagenic, or toxic for reproduction). Substances classified as CMR 1A or 1B under the CLP Regulation (1272/2008) are presumptively prohibited; CMR category 2 substances require SCCS evaluation and may be exceptionally authorised if shown to be safe. The CMR mechanism is the primary route by which Annex II grows: ECHA classifies → Art. 15 triggers the prohibition presumption → the Commission formalises it in Annex II via an Omnibus Regulation. For the CMR mechanism analysis, see the post on CMR substances in cosmetics and the CMR substances page.

Art. 16 governs nanomaterials. Any cosmetic containing nanomaterials (other than those already covered by Annexes III–VI) requires notification 6 months before market placement and may be subject to Commission safety review.

Art. 17 governs traces. The non-intentional presence of small quantities of a prohibited substance is permitted when technically unavoidable under good manufacturing practice and the product remains safe under Art. 3. There is no fixed numerical threshold — the qualitative justification rests with the Responsible Person in the CPSR.

For Annex II ingredients, see the post on prohibited Annex II ingredients, the post on Annex III restricted substances, and the recently prohibited ingredients page.

9. The animal testing prohibition (Art. 18)

Art. 18 contains the animal testing ban, one of the Regulation's most recognised provisions. The prohibition covers both the finished product and its ingredients. Implementation was progressive:

The 2013 ban is the most operationally significant: since that date, no cosmetic may be sold in the EU if its ingredients or formulation were tested on animals, regardless of where the testing took place. The only exception is very narrow: where other legislation requires animal safety data for which no validated alternative exists.

10. Labelling (Art. 19) and claims (Art. 20)

Art. 19 sets out the mandatory labelling elements: the RP's name and address; nominal content; minimum durability date or period after opening; precautions for use; batch number; product function (unless evident); and ingredient list in INCI nomenclature in descending order by weight (headed "Ingredients:").

Art. 20 governs product claims: they must be true and verifiable. Regulation (EU) 655/2013 establishes the common criteria applicable to claims: substantiated, honest, fair, and not misleading. Decision (EU) 2025/1175, applicable from 30 July 2026, updates the Art. 33 common ingredient names glossary to 30,419 entries. For the updated glossary, the CosIng database is the reference resource.

11. How the Regulation is amended

Art. 31 grants the European Commission the power to amend Annexes II–VI through delegated and implementing acts. The three main amendment routes are:

1. CMR-Omnibus route (Art. 15): when ECHA reclassifies a substance as CMR 1A/1B under the CLP Regulation, the prohibition in cosmetics is activated automatically under Art. 15. The Commission formalises the Annex II update via an Omnibus Regulation, published periodically in the Official Journal.

2. SCCS route (Art. 31(1)): the Commission mandates the Scientific Committee on Consumer Safety (SCCS) to evaluate an ingredient. If the opinion is unfavourable or conditional, the Commission amends Annexes II or III accordingly.

3. Nanomaterial route (Art. 16): the authorisation procedure for new cosmetic nanomaterials may result in new Annex entries.

Verified recent amendments:

• Reg. (EU) 2023/1545 — fragrance allergens; expanded labelling obligations to around 80 substances, with compliance deadlines of 31 July 2026 and 31 July 2028. See the full analysis in the post on Regulation 2023/1545 and fragrance allergens.
• Reg. (EU) 2025/877 (Omnibus VII) — CMR substances; applicable from 1 September 2025.
• Reg. (EU) 2026/78 (Omnibus VIII) — CMR substances; applicable from 1 May 2026.
• Decision (EU) 2025/1175 — INCI glossary updated to 30,419 entries; applicable from 30 July 2026.
• COM(2025)531 — Omnibus VI — a legislative proposal for simplification and clarification; still in the legislative process as of June 2026 (not yet adopted law).

To track these changes without manual review, the Regulatory Watch service and the guide on how to monitor EU cosmetic regulatory changes provide the tracking mechanisms.

12. Frequently asked questions

What is Regulation (EC) 1223/2009? Regulation (EC) 1223/2009 is the legal framework governing all cosmetic products placed on the European Union market. It was adopted on 30 November 2009 and has applied in full since 11 July 2013. It sets safety standards, Responsible Person obligations, Product Information File requirements, CPNP notification rules, ingredient restrictions through six Annexes, and the animal testing ban.

When did Regulation 1223/2009 enter into force and when does it apply? The Regulation entered into force on 11 January 2010 (20 days after publication in the Official Journal on 22 December 2009). Its main provisions have applied since 11 July 2013. Rules on CMR substances (Art. 15) applied from 1 December 2010, and nanomaterial notifications (Art. 16(3)) from 11 January 2013.

What is the difference between Regulation 1223/2009 and the old Directive 76/768/EEC? Directive 76/768/EEC required national transposition and was amended on numerous occasions, producing application differences across Member States. As a Regulation, 1223/2009 applies directly in all 27 Member States without transposition, ensuring uniform rules across the internal market. It also introduced the CPNP (single EU-level notification), the structured Annex I CPSR, and the full animal testing ban from 2013.

Who is the Responsible Person under Regulation 1223/2009? The Responsible Person is a natural or legal person established in the EU designated for each cosmetic product, responsible for ensuring compliance with the Regulation. By default, the manufacturer who places the product on the market under their name acts as Responsible Person. Importers are the Responsible Person for products they bring from third countries. Another person may be designated via written mandate (Art. 4(3)). Obligations are detailed in Art. 5.

What must be in the Product Information File (PIF)? Art. 11 of Regulation 1223/2009 requires the PIF to contain: a product description, the CPSR (Parts A and B under Annex I), a manufacturing method description with GMP compliance declaration, proof of claimed effect (where applicable), and animal testing data. It must be retained for 10 years after the last batch was placed on the market.

Is animal testing banned for cosmetics in the EU? Yes. Art. 18 of Regulation 1223/2009 prohibits placing on the market cosmetics whose formulations or ingredients were tested on animals where a validated alternative exists. The full marketing ban — including products tested outside the EU — has been in force since 11 March 2013. A very narrow exception exists only for safety data required by other legislation for which no validated alternative exists.