EU Cosmetic Products Regulation
The EU regulation governing cosmetic products placed on the EU market. It requires a designated Responsible Person, a Product Information File with a Cosmetic Product Safety Report, notification via the CPNP portal, GMP compliance (aligned to ISO 22716), ingredient restrictions, and cosmetovigilance for undesirable effects.
What this does not cover
stated in the document's own scope- Covers cosmetic products as defined by the regulation; medicinal products and medical devices fall under the medicines legislation and the Medical Device Regulation respectively.
- Sets the framework and safety-file requirements, with the detailed GMP supplied by ISO 22716 rather than the regulation text itself.
- Governs products placed on the EU market; equivalent access to other markets follows those jurisdictions’ own cosmetics rules.
- Addresses cosmetic safety and market access, not the general chemicals regime under REACH, which applies to substances more broadly.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
Regulation (EC) No 1223/2009 governs cosmetic products placed on the EU market and is widely regarded as the global reference regime for cosmetics regulation. It requires every product to have a designated Responsible Person established in the EU, a complete Product Information File including a Cosmetic Product Safety Report signed by a qualified safety assessor, and notification through the Cosmetic Products Notification Portal (CPNP) before the product is placed on the market. It sets manufacturing good-practice expectations, controls ingredients through positive and negative lists, mandates labelling rules, and establishes cosmetovigilance for reporting serious undesirable effects.
Scope & applicability
Cosmetic products on the EU market — safety assessment, GMP, ingredient control, labelling, and post-market cosmetovigilance.
Legal basis & how it acquires force
This is a Regulation, so it applies directly and uniformly across the EU/EEA without national transposition, having recast and replaced the earlier Cosmetics Directive 76/768/EEC to remove divergent national rules. It became fully applicable on 11 July 2013. It is updated frequently through Commission amending regulations that revise its annexes — the lists of prohibited, restricted and permitted colorants, preservatives and UV filters — so the substance controls evolve while the framework articles remain stable.
Document structure
| Part | Covers |
|---|---|
| Responsible Person and safety | The designated Responsible Person and the general safety obligation for products |
| Product Information File and safety report | The PIF and the two-part Cosmetic Product Safety Report signed by a qualified assessor |
| Notification | Pre-market notification through the Cosmetic Products Notification Portal (CPNP) |
| Substance restrictions (Annexes II–VI) | Prohibited and restricted substances and lists of permitted colorants, preservatives and UV filters |
| Good manufacturing practice and claims | GMP compliance, labelling requirements, and rules on product claims |
| Cosmetovigilance and market surveillance | Reporting of serious undesirable effects and Member-State market surveillance |
Key requirements
- Designate a Responsible Person and maintain the Product Information File
- Hold a Cosmetic Product Safety Report by a qualified assessor
- Comply with GMP (ISO 22716) and notify products via CPNP
- Respect ingredient Annexes and operate cosmetovigilance
Implementation tips
- Keep the Product Information File inspection-ready — authorities can request it at short notice
- Track the substance Annexes; restrictions change and force reformulation
- Use ISO 22716 as the shared GMP basis for EU and (incoming) US requirements
Revision notes
Applying since July 2013 (replacing Directive 76/768/EEC); amended regularly via its Annexes as substance assessments evolve.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
The regulation’s good-manufacturing-practice requirement is met by compliance with ISO 22716, the international GMP standard for cosmetics, which it recognises as the harmonised reference. Its structure — a Responsible Person, a safety dossier and pre-market notification — has become the template that many non-EU jurisdictions have modelled their own cosmetics rules on, which is why it functions as a de facto international benchmark.
Regulation (EC) No 1223/2009: frequently asked questions
Quick answers to common questions about Regulation (EC) No 1223/2009.
Who is the Responsible Person under the EU Cosmetic Products Regulation?
The Responsible Person is a natural or legal person established in the EU that each cosmetic product must have designated. They ensure the product meets the regulation — including holding the Product Information File, notifying the product, and being the point of contact for authorities.
What is the Cosmetic Product Safety Report?
It is the safety assessment that forms part of the Product Information File. It has two parts — safety information on the product and the safety assessment itself — and must be signed by a qualified safety assessor before the product is placed on the market.
How does the regulation relate to ISO 22716?
The regulation requires cosmetic products to be manufactured in compliance with good manufacturing practice, and it recognises ISO 22716 as the harmonised GMP standard, so following ISO 22716 is the accepted route to meeting the GMP obligation.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.