Cosmetic Regulatory Compliance FAQ: FDA, EU, ASEAN

What does FDA require for cosmetics in the US?

The FDA regulates cosmetics under MoCRA (Modernization of Cosmetics Regulation Act, 2022), which requires facility registration, product listing, safety substantiation, and good manufacturing practices. Cosmetics don't need pre-approval, but they must be safe and properly labeled, and adverse events must be reported.

What is the EU CPNP and do I need it?

The CPNP (Cosmetic Products Notification Portal) is the EU's mandatory notification system. Before a cosmetic can be sold in the EU, a Responsible Person must notify it in the CPNP, keep a Product Information File (PIF) with a safety assessment, and ensure labeling meets the Cosmetics Regulation (EC 1223/2009).

What are the ASEAN cosmetics requirements?

ASEAN follows the ASEAN Cosmetic Directive (ACD), which harmonizes rules across member states. Brands must notify each product to the national authority (like Singapore's HSA or Malaysia's NPRA) before marketing, and comply with the ACD's ingredient annexes — restricted, prohibited, and permitted substances.

Do I need a Responsible Person for compliance?

In the EU, yes — a legal entity based in the EU must be the Responsible Person, holding the PIF and handling the CPNP notification. Many OEM manufacturers provide a regulatory support service or partner to act as the Responsible Person, which is often the simplest path for non-EU brands.

What labeling is required on cosmetic products?

Labels must show the product name, net quantity, ingredient list (INCI names, descending order), batch number, expiry or PAO (period after opening), warnings, and the responsible party's name and address. Specific markets add requirements — for example, halal certification claims in parts of ASEAN and the Middle East.