Cosmetics certification

Four things under Regulation (EC) No 1223/2009. A responsible person established in the Union (Article 4), who is named on the label and answers to the authorities. A product information file (Article 11) held at that person's address for ten years after the last batch. A cosmetic product safety report to Annex I, the cosmetic safety assessment, signed by an assessor with a degree in pharmacy, toxicology, medicine or a similar discipline. And a notification in the Cosmetic Products Notification Portal (Article 13) before the product is placed on the market. Notification is the visible step. The safety report is the work.

The report draws on toxicological data for every ingredient at its use concentration, checked against Annex II (prohibited substances), Annex III (restricted), and the positive lists of colourants, preservatives and UV filters in Annexes IV to VI. The annexes are amended several times a year, so a formulation cleared three years ago needs a fresh check before a new market.

The United Kingdom copied the regulation into Schedule 34 of the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019. It keeps the same structure, with a UK responsible person and a separate notification in the Submit Cosmetic Product Notifications service (SCPN); an EU notification has no effect in Great Britain.

The Modernization of Cosmetics Regulation Act of 2022 gave the FDA its first mandatory cosmetics registry. Every facility that manufactures or processes cosmetics for the US market registers with the FDA, and the responsible person lists each product with its ingredients through the Cosmetics Direct portal; the FDA began enforcing both on 1 July 2024. A foreign facility names a US agent. Registration renews every two years and listings are updated annually.

MoCRA also requires adverse-event records, serious adverse-event reporting within 15 business days, and a file substantiating the product's safety. There is no pre-market approval; the obligation is to be registered and listed before sale, with the safety file ready when the FDA asks.

TR CU 009/2011, the customs union regulation on perfumery and cosmetics, covers 40 product positions. For 19 of them the manufacturer or importer registers a declaration of conformity in the unified register on its own test reports. The other 21 need a state registration certificate (SGR) from a member state's health authority before sale, and the SGR is valid across the whole EAEU.

The SGR list is defined by product function: cosmetics for children, tanning products, skin-whitening products, tattoo cosmetics, intimate hygiene products, products protecting the skin from occupational hazards, chemical peels, hair dyes and permanent-wave products, and fluoride toothpastes above 0.15 per cent. A serum that adds a whitening claim moves from the declaration column to the SGR column on that claim alone.

Brazil splits cosmetics into two grades under ANVISA's RDC 907/2024, which replaced RDC 752/2022. Grade 1 products are notified electronically and can ship on filing; grade 2 products, those with a specific claim or a restricted ingredient, are registered after technical review. The holder must be a Brazilian company with an ANVISA operating authorisation. In the Gulf, the UAE assesses cosmetics under ECAS against UAE.S GSO 1943, and Saudi Arabia registers them with the SFDA; halal certification is added where animal derivatives are present. China registers or files cosmetics with the NMPA under the Cosmetics Supervision and Administration Regulation in force since 1 January 2021.

None of these accepts another market's notification: cosmetic product registration is made again in the local holder's name, market by market.

The safety assessment and its supporting toxicological data are the reusable part. Each notification or registration is made again per market and never transfers.