MoCRA responsible person vs EU responsible person: two roles, two laws
They are different roles under different laws, and one does not stand in for the other. Under MoCRA, FDA defines the responsible person by whose name is on the label; under Regulation (EC) 1223/2009, the EU responsible person must be designated within the Union (Art. 4(1)). A US brand's MoCRA responsible person does not cover an EU launch.
On the US side, this page says nothing in its own words. Every statement about MoCRA is quoted from FDA, with the page it comes from.
The two definitions
United States. FDA defines the responsible person as:
the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act — FDA, Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
European Union.
Only cosmetic products for which a legal or natural person is designated within the Community as 'responsible person' shall be placed on the market. — Art. 4(1), Reg. (EC) 1223/2009
The EU responsible person holds the product information file (Art. 11), submits the CPNP notification (Art. 13(1)), is named on the pack (Art. 19(1)(a)), and is the address an authority writes to. The duties sit in Art. 5. How the EU role works →
What each role does
| MoCRA — in FDA's words | EU — Reg. (EC) 1223/2009 | |
|---|---|---|
| Registering the product | "A responsible person must list each marketed cosmetic product with the FDA, including product ingredients, and provide any updates annually" | A CPNP notification before the product is placed on the market (Art. 13(1)) |
| A file kept for the product | — | A product information file, kept at the responsible person's address for ten years after the last batch (Art. 11) |
| A safety report | — | A cosmetic product safety report, signed by a qualified safety assessor (Art. 10) |
| Small businesses | "MoCRA exempts certain small businesses from facility registration and product listing requirements", with exceptions FDA lists | We could not find a small-business exemption in Regulation (EC) 1223/2009 |
A dash means FDA's pages cited here do not describe an equivalent; it is not a statement about US law. The listing and small-business quotes are from FDA, Registration & Listing of Cosmetic Product Facilities and Products.
Check my product — free
Paste the product's public listing URL. We check which of the eight obligations are visibly met — free, while you wait — a screen of the public words, not a safety assessment.
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Can the MoCRA responsible person also be the EU one?
Only if it is designated within the Union (Art. 4(1)), which in practice means an establishment in the EU. A company established only in the United States cannot hold the EU role. We can be appointed as your EU Responsible Person, by written mandate. For US brands →
Questions people ask
Does my FDA product listing count as an EU notification?
No. CPNP is a separate submission, made by the EU responsible person (Art. 13(1)). How CPNP works →
Is there a small-business exemption in the EU like MoCRA's?
We could not find one in Regulation (EC) 1223/2009. The obligations attach to the product, not to the size of the business.
Where do I read MoCRA itself?
On FDA's MoCRA page. We do not paraphrase US law.
Tell us the product, the variants and the markets — a fixed quote in writing.