The EU Cosmetics Regulation (EC) No 1223/2009 governs every skincare, haircare, and personal care product sold in the European Union. Unlike supplements, cosmetics have no pre-market approval — but the safety, documentation, and notification requirements are extensive. Getting this right opens access to 450 million consumers across 27 countries.
Every cosmetic product placed on the EU market must comply with EC 1223/2009. Key obligations: the product must be safe for human health under reasonably foreseeable conditions of use; a Cosmetic Product Safety Report (CPSR) must be completed by a qualified safety assessor; a Product Information File (PIF) must be maintained; and the product must be notified via the CPNP portal before it is placed on the market.
The Cosmetic Products Notification Portal (CPNP) is the EU's online notification system. Before placing a cosmetic on the EU market, the Responsible Person (RP) must submit: product name and category, the frame formulation or full formulation, a photo of the label, and toxicology data for certain substances. Notification is free and can be completed in a few days once your CPSR and PIF are ready. The RP must be established in the EU — if you're a non-EU brand, you need an EU-based RP.
The CPSR must be completed by a qualified safety assessor (typically a toxicologist or cosmetic chemist). It covers: physico-chemical characteristics, microbiological quality, impurities, packaging interaction, normal and foreseeable use, exposure assessment, and a safety conclusion. Expect to pay €500–€2,000 per product for a thorough CPSR, depending on formulation complexity.
Annex II of the EU Cosmetics Regulation lists over 1,300 substances prohibited in cosmetics. Annex III lists substances that are permitted only under specific conditions. Common ingredients banned in the EU but used elsewhere: formaldehyde above 0.1%, parabens (some restricted), certain UV filters not yet approved under EU law, hydroquinone (restricted), and several colorants. The EU is also progressively restricting per- and polyfluoroalkyl substances (PFAS) — relevant for waterproof and long-wear products.
EU cosmetic labels must include: name and address of the RP, country of origin (for non-EU manufactured products), nominal content by weight or volume, date of minimum durability (or PAO symbol for products with >30 months shelf life), precautions for use, batch number, product function, full ingredient list in INCI nomenclature in descending order, and any required warnings. Language must be in the official language(s) of the country of sale.
EU Regulation 655/2013 establishes common criteria for cosmetic claims. Claims must be: legal, truthful, evidenced, honest, fair, and informed. Banned claim types: medical claims (implying drug action), claims for internal effects, claims based on virtual results only, claims suggesting a product is equivalent to a medicine. The EU has published specific guidance on claims like 'hypoallergenic', 'dermatologically tested', 'naturally derived', and 'microbiome-friendly' — all require substantiation.
Every EU cosmetic must have a Responsible Person (RP) established within the EU. The RP is legally responsible for compliance. For non-EU brands, options include: appointing your EU distributor as RP (common), working with a specialist RP service (€300–€1,500/year per product), or establishing a legal entity in an EU member state. The RP's name and address must appear on every product label.
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