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Cosmetics

Cosmetics Regulation: US, EU, and UK Compared

Cosmetics regulation in the United States, the European Union, and the United Kingdom operates on three different legal frameworks — and a cosmetic product sold in all three markets needs three different safety assessments, three different product notifications, and potentially three different labels. The US system under MoCRA emphasizes manufacturer self-declaration of safety. The EU system requires a formal Cosmetic Product Safety Report by a qualified safety assessor. The UK system, post-Brexit, mirrors the EU structure but with separate notification, separate responsible person requirements, and the UK's own scientific advisory function.

This guide compares cosmetics compliance across all three markets and shows how to build multi-market compliance from the same toxicological data and the same product formulation.

Not sure which cosmetics regulations apply in which market? Use the Sustalium Global Compliance Map — select Cosmetics and switch between the US, EU, and UK to see MoCRA, CPSR, and UK notification requirements side by side.

US Cosmetics Brand: What Most Founders Overlook

The gap between making a great lipstick in your kitchen and selling it legally in the United States is wider than most founders expect. Since MoCRA was signed into law in 2022, cosmetic regulation in the US changed fundamentally — facility registration is now mandatory, product listing is mandatory, safety substantiation is mandatory, and adverse event reporting is mandatory. And if you also sell in Europe, you need a separate EU Cosmetic Product Safety Report (CPSR) before your product reaches the market.

This guide walks through launching a cosmetics brand with the regulatory steps at each stage — so you are not discovering MoCRA requirements the week your product is supposed to ship.

On the Sustalium platform, the pattern we see with cosmetics brands is consistent: the founder handles formulation, packaging, branding, and website — then discovers MoCRA product listing and safety substantiation exist when Amazon requests the documentation. The compliance obligation has been in place for two years. The brand simply did not know it applied to them.

Not sure which regulations govern your cosmetics brand? Use the Sustalium Global Compliance Map — select Cosmetics and your target market, and see every framework from FDA MoCRA to the EU CPSR and UK SCPN notification.

FDA MoCRA: Cosmetic Compliance & Registration

Before the Modernization of Cosmetics Regulation Act (MoCRA) was signed into law in December 2022, cosmetic manufacturers could legally sell products in the US without ever registering with the FDA or listing a single product ingredient. The FDA had no authority to recall unsafe cosmetics, no mandatory adverse event reporting system for cosmetics, and no requirement that manufacturers substantiate product safety. MoCRA changed all of that in a single legislative package — the most significant overhaul of US cosmetic regulation since the Federal Food, Drug, and Cosmetic Act of 1938.

MoCRA imposes mandatory facility registration, product listing, safety substantiation, adverse event reporting, and — for the first time — gives the FDA mandatory recall authority over cosmetics. On the Sustalium platform, the MoCRA-related compliance activity we see most is cosmetic brands and contract manufacturers reconciling their ingredient lists with the FDA's product listing format — because the FDA's electronic submission portal requires structured ingredient data, and most brands' internal records are not yet structured to match.

Selling Cosmetics in the US and EU: MoCRA vs. CPSR

A cosmetic brand selling in both the United States and the European Union must comply with two regulatory frameworks that are structurally similar but operationally distinct — and neither framework accepts the other's documentation. The US system, modernized in 2022 by MoCRA, emphasizes manufacturer self-declaration of safety. The EU system, established under the Cosmetic Products Regulation (EC) 1223/2009, requires a qualified safety assessor to prepare a formal Cosmetic Product Safety Report (CPSR) and mandates notification to the EU's Cosmetic Product Notification Portal (CPNP) before the product reaches the market.

For brands selling in both markets, the compliance cost is additive — you need both a MoCRA safety substantiation and an EU CPSR. But the ingredient data and toxicological assessments that support one can inform the other, and building both in parallel from the same product data is significantly more efficient than treating them as separate compliance projects.