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Analyses · 2026-10-03

Cosmetics: the gate is who is responsible, and whether it is registered

The earlier articles asked what standard a product has to pass. Cosmetics do not work that way. They ask first whether a local responsible person exists and whether a registration is in place, and only then whether the formula and testing hold up.

This category is shaped differently

Ask the earlier articles' question about cosmetics, which standard this face cream passed, and the answer comes back empty. In most markets cosmetics are not governed by a set of product standards but by two procedures: appoint a responsible person in that territory, and register or notify the formula and product information.

Testing is still required and restricted substance lists still apply, but these are not the first gate. The first gate is who is responsible for the product. That explains a familiar pattern: the same product sells in the EU and stalls in the US, and the obstacle is usually not the formula but whether anyone is willing to be the responsible entity.

EU: responsible person, safety assessment, notification

The EU basis is the Cosmetics Regulation (EC) No 1223/2009, which comes down to four concrete things. First, there must be a responsible person established in the EU, carrying responsibility for the product and its information. Second, there must be a safety assessment report and the product information file behind it. Third, the product must be notified through CPNP before being placed on the market. Fourth, manufacture follows good manufacturing practice for cosmetics.

Restricted substances sit in the annexes to the regulation, which are amended continuously. This is the same point as REACH Annex XVII in the textiles article: on whether a substance is allowed, the answer is a specific entry at a specific date, not a standard number.

Of the four, the one most often underestimated is the first. A responsible person is not a contact name; it means a legal entity inside the EU carrying liability.

US: MoCRA added the registration step

The Modernization of Cosmetics Regulation Act, passed at the end of 2022 as Division FF of Public Law 117-328, changed the position. Before it, the US had almost no federal registration requirement for cosmetics; after it, there is facility registration and product listing, along with a responsible person and serious adverse event reporting.

For an exporter the meaning is direct: the US market moved from barely any registration to a registration requirement, and registration runs separately by facility and by product. A factory or brand selling into the US has to work out who registers, and which entity is being registered.

China: registration and filing are two routes

China's basis is the Cosmetics Supervision and Administration Regulation, State Council Order No. 727, promulgated on 16 June 2020 and in force from 1 January 2021. It splits products into two routes: special cosmetics go through registration, ordinary cosmetics through filing, with a separate registration and filing scheme for new cosmetic ingredients. Manufacture requires a licence, and efficacy claims need substantiation.

Registration and filing are not the same thing, and the effort and timelines differ sharply. A buyer asking only whether a certificate exists cannot tell which one is in hand. The useful questions are which class the product falls into, which route it took, and what the number is.

Japan, Korea, Gulf, Brazil, Australia-NZ

Japan regulates under its pharmaceuticals and medical devices act: cosmetics need a manufacturing or import licence plus a notification, with ingredient restrictions set by ministerial standards. Korea works under its cosmetics act, with manufacturing and import registration, review for functional cosmetics and manufacturing standards. In the Gulf, taking Saudi Arabia as the example, cosmetics must be registered with the regulator. Brazil manages cosmetics through registration or notification with its health regulator. Australia and New Zealand require annual declarations for industrial chemicals in cosmetics, and a product claiming therapeutic action moves to therapeutic goods regulation instead.

For these markets we currently hold the regime described but no primary text, so the page states the regime and no document numbers.

Ten markets side by side

Pulling out the responsible person and the registration columns makes the structural difference clear:

The column that matters most here is the second. In most markets the first threshold for cosmetics is whether anyone locally is willing to carry the product, and until that is settled, the most thorough testing in the world does not help.

What to ask before you order

Ask four things about cosmetics: who the responsible person is in the target market, whether it is the factory, the brand or a local importer; which route the product takes, registration or filing, and what the number is; whether the formula and restricted substances have been checked against the annexes currently in force, and on what date, since the annexes change; and who issued the safety assessment and on what basis.

The first two cannot be delegated to a test report. Testing can be redone and a formula can be adjusted, but whether a local responsible entity exists tends to decide whether the product can be listed at all, rather than how well it is made. To work through these in order, start with the free verification checklist. The previous article in this series is food contact materials and kitchenware; the next, packaging, is a category where the constraint lands on design rather than the product. To see how registrations and certifications are recorded, look at a report sample, or get in touch.