Your EU Responsible Person for cosmetics under Regulation (EC) No 1223/2009

Selling US cosmetics in the EU

A product that complies with US rules is not automatically compliant in the EU. Regulation (EC) No 1223/2009 requires a documented pre-market safety assessment, an EU-established Responsible Person and a notification before the first sale.

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EU Responsible Person required Pre-market safety assessment Animal testing ban Different product boundaries

Key differences from the US system

Topic	United States	European Union
Who is accountable	Manufacturer, packer or distributor on the label; MoCRA facility registration and product listing with FDA	A Responsible Person established in the EU (Article 4)
Safety evidence	Safety substantiation kept by the responsible person under MoCRA	A Cosmetic Product Safety Report prepared by a qualified assessor, per Annex I, before placing on the market
Notification	Product listing with FDA	CPNP notification before placing on the market
Ingredient restrictions	A short list of prohibited and restricted ingredients	Long lists of prohibited (Annex II) and restricted (Annex III) substances, plus positive lists for colorants, preservatives and UV filters
Animal testing	Not banned federally	Testing and marketing bans for cosmetics and their ingredients (Article 18)

Products that change category

Sunscreens and antiperspirants are over-the-counter drugs in the US but cosmetics in the EU. In the EU they may only use UV filters listed in Annex VI, and sun protection claims follow Commission Recommendation 2006/647/EC. Conversely, a product sold as a cosmetic in the US may be a medicinal product in the EU if it makes therapeutic claims.

Label changes US brands usually need

EU Responsible Person name and address, and country of origin
Period after opening (PAO) symbol or "best before" date as applicable
Batch number on the pack
Warnings required by Annexes III to VI and by the safety assessor
Mandatory text in the languages of each Member State where you sell

Where to start

Run your formulas against the EU annexes first - a single non-compliant preservative or colorant means reformulating before anything else. Then prepare the CPSR and PIF, appoint your Responsible Person and notify in CPNP.

Frequently asked questions

Does MoCRA compliance mean my product can be sold in the EU?

No. MoCRA is US law. The EU requires a Responsible Person established in the EU, a CPSR under Annex I, a PIF and a CPNP notification.

Is my US sunscreen a cosmetic in the EU?

Yes, sunscreens are cosmetic products in the EU. They may only contain UV filters listed in Annex VI and need an EU safety assessment and CPNP notification.

Can my US company be the Responsible Person?

No. The Responsible Person must be a legal or natural person established in the EU. For imported products this is the EU importer, unless a person established in the EU is designated by written mandate to take on the role (Article 4(5)).

Check whether you need an EU Responsible Person

Tell us your product category and where your company is established. Before you sign a mandate, we tell you what the next step is.

Free eligibility check