EU Cosmetics Regulation (EC 1223/2009)
The primary European Union law governing cosmetic products, establishing requirements for safety assessment, CPNP notification, responsible person designation, ingredient restrictions (Annexes II-VI), labeling, and post-market surveillance across all EU/EEA member states.
Regulation (EC) No 1223/2009 of the European Parliament and of the Council entered into force on January 11, 2010 and has been fully applicable since July 11, 2013. It replaced the previous Cosmetics Directive 76/768/EEC and is directly applicable in all EU member states without requiring national transposition.
The regulation requires that every cosmetic product placed on the EU market has a designated Responsible Person established within the EU, who must maintain a Product Information File (PIF) containing the Cosmetic Product Safety Report (CPSR), and submit a notification to the Cosmetic Products Notification Portal (CPNP) before the product is placed on the market.
EC 1223/2009 maintains six annexes governing ingredient safety: Annex II lists over 1,600 prohibited substances, Annex III lists restricted substances with specific conditions, Annex IV lists permitted colorants, Annex V lists permitted preservatives, and Annex VI lists permitted UV filters. The Scientific Committee on Consumer Safety (SCCS) provides scientific opinions that inform amendments to these annexes.
The regulation also prohibits animal testing for cosmetic purposes, requires reporting of serious undesirable effects to competent authorities, and mandates specific labeling including INCI ingredient lists, PAO symbols, and responsible person details.
Related Terms
Cosmetic Products Notification Portal (CPNP)
The European Commission's online portal where responsible persons must notify cosmetic products before placing them on the EU market, as required by Article 13 of EC 1223/2009. Notifications include product details, ingredient composition, and labeling information.
DocumentProduct Information File (PIF)
A mandatory dossier required under EC 1223/2009 (Article 11) that the Responsible Person must maintain for each cosmetic product on the EU market. It contains the CPSR, product description, manufacturing method, GMP evidence, and claims substantiation.
DocumentCosmetic Product Safety Report (CPSR)
A two-part safety assessment document required within the PIF under EC 1223/2009 (Annex I). Part A compiles safety data for each ingredient; Part B is a qualified safety assessor's conclusion on whether the product is safe for human health.
ProcessResponsible Person
An entity established within the EU (or UK for the GB market) who is legally responsible for ensuring a cosmetic product complies with the Cosmetics Regulation. The Responsible Person maintains the PIF, submits CPNP/SCPN notifications, and reports serious undesirable effects.
OrganizationScientific Committee on Consumer Safety (SCCS)
An independent scientific committee that advises the European Commission on health and safety risks of non-food consumer products, including cosmetic ingredients. SCCS opinions form the scientific basis for EU ingredient restrictions in the Cosmetics Regulation annexes.
IngredientAnnex II — EU Prohibited Substances List
The list of over 1,600 substances prohibited from use in cosmetic products under the EU Cosmetics Regulation (EC 1223/2009). Annex II substances may not be used as cosmetic ingredients under any conditions, regardless of concentration.
IngredientAnnex III — EU Restricted Substances List
The list of substances restricted to specific conditions of use in cosmetic products under EC 1223/2009. Annex III specifies maximum concentrations, product types, warnings, and other conditions under which listed substances may be used.
ProcessInternational Nomenclature of Cosmetic Ingredients (INCI)
A standardized system of ingredient naming developed by the Personal Care Products Council (formerly CTFA), used worldwide for cosmetic ingredient labeling. INCI names are required on product labels in the EU, US, Canada, and most other regulated markets.
IngredientPeriod After Opening (PAO)
The period of time after a cosmetic product is first opened by the consumer during which the product remains safe and effective. PAO is indicated on EU/UK cosmetic labels by an open jar symbol with a number and 'M' (e.g., '12M' means 12 months after opening).
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