EU Regulation 1223/2009: The Complete Guide for Businesses
Regulation (EC) No 1223/2009 is the legal backbone of cosmetics safety in the European Union. Adopted in 2009 and fully applicable since 2013, it governs every cosmetic product placed on the EU market — from mass-market shampoos to luxury perfumes.
What It Covers
The Regulation defines a "cosmetic product" as any substance intended to be placed in contact with external parts of the human body (skin, hair, nails, lips, external genital organs) or teeth and mucous membranes of the oral cavity, with a view to cleaning, perfuming, changing appearance, protecting, or maintaining them.
Key Obligations
Safety Assessment (Article 10)
Every cosmetic product must undergo a safety assessment by a qualified person before being placed on the market. This includes toxicological profile, chemical structure, and exposure levels.
Product Information File (Article 11)
A comprehensive dossier must be maintained and available to authorities for 10 years after the last batch is placed on the market.
Notification (Article 13)
Products must be notified to the European Commission through CPNP before being placed on the market.
Labeling (Article 19)
10 mandatory labeling elements. See our complete labeling guide.
Claims (Article 20)
Product claims must be substantiated and comply with common criteria established by the Commission.
The Annexes — The Heart of the Regulation
| Annex | Content | Significance |
|---|---|---|
| Annex II | Prohibited substances | 1,600+ banned substances. Products containing these are illegal. |
| Annex III | Restricted substances | Substances allowed only with restrictions (concentration limits, conditions). |
| Annex IV | Colorants | Allowed colorants with conditions. |
| Annex V | Preservatives | Allowed preservatives with maximum concentrations. |
| Annex VI | UV filters | Allowed UV filters with maximum concentrations. |
BeautyGuard and Regulation 1223/2009
Our ingredient scoring system is built directly on this Regulation:
- Annex II substances → Banned (score: 0)
- Annex III-VI substances → Restricted (score: 60)
- Known allergens → Allergen (score: 50)
- CosIng registered ingredients → Known (score: 65-80)
Every score is traceable to a specific legal provision — not arbitrary opinions.