If you are manufacturing cosmetics for American or European brands, you need to understand two very different regulatory systems. The US is governed by the FDA under MoCRA, while the EU requires CPNP notification and an EU Responsible Person. Here is a practical overview.
United States – FDA and MoCRA
The US FDA does not pre-approve cosmetics before they go on the market, with the exception of most color additives. However, the Modernization of Cosmetics Regulation Act (MoCRA) of 2022 introduced mandatory facility registration and product listing requirements, enforced since July 2024.
Key obligations for the brand (Responsible Person):
- Register each manufacturing or processing facility with the FDA
- Submit a product listing for every cosmetic product marketed in the US
- Report serious adverse events within 15 business days
- Maintain safety substantiation records
For foreign manufacturers: A US Agent must be designated for FDA communications and inspections.
Labeling: Ingredients must be listed by their common English names in descending order. Terms like “Aqua” or “Parfum” are not accepted as substitutes, though they may appear in parentheses.
Important note on claims: The word “whitening” can trigger drug classification in the US. Use “brightening appearance” or “improves the look of dull skin” instead.
European Union – CPNP and Responsible Person
The EU Cosmetics Regulation (EC) 1223/2009 is stricter than the US framework. Every product must have an EU-established Responsible Person (RP) before it can be placed on the market.
Key obligations:
- Appoint an EU-based Responsible Person
- Maintain a Product Information File (PIF) with safety assessment
- Submit a notification via the CPNP portal before market placement
- Comply with labeling in the local language(s) of each member state
For non-EU manufacturers: You cannot register directly. The RP handles CPNP notification, safety documentation, and regulatory correspondence on your behalf .
Ingredient restrictions: The EU bans over 1,600 substances, compared to just 11 in the US
What We Provide as Your OEM Partner
We manufacture to GMP standards and provide the documentation your brand needs for both markets: formula disclosure, GMP certificate, stability data, and COA. We can also support your US Agent or EU RP with the technical files they require.
Tell us your target market — we will confirm the specific documents we can supply.
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