Anaelle Guez
Co-founder & CEO, Compliance
Cosmetic Regulation by Country: EU vs US vs Japan vs Brazil vs China
A cosmetic product sold globally must comply with completely different regulatory frameworks in each market. The EU bans over 1,600 ingredients; the US bans 11. Japan requires quasi-drug classification for anti-aging claims. China mandates animal testing for imported ordinary cosmetics. This guide maps the key differences.
The global cosmetic regulatory landscape
The global cosmetics market is worth $430 billion (2025) and growing at 6% annually. Yet there is no global harmonized standard for cosmetic safety. Each major market has its own regulatory authority, product classification system, ingredient restrictions, labeling rules, and pre-market requirements. A brand selling in 5 major markets must navigate 5 completely different compliance regimes.
Regulation comparison by market
| Criteria | EU | US | Japan | Brazil | China |
|---|---|---|---|---|---|
| Authority | EC + Member States | FDA | PMDA / MHLW | ANVISA | NMPA |
| Key law | EC 1223/2009 | FD&C Act + MoCRA | PMD Act | RDC 752/2022 | CSAR 2021 |
| Banned ingredients | 1,600+ | 11 | ~30 + negative list | Aligned w/ EU | 1,200+ |
| Pre-market approval | Notification (CPNP) | None (MoCRA: listing) | Quasi-drug: yes | Grade 2: yes | Registration required |
| Animal testing | Banned | Not required | Not required | Banned (2023) | Required for imports* |
| Labeling language | Local language(s) | English | Japanese | Portuguese | Simplified Chinese |
| Safety assessment | Mandatory (CPSR) | Voluntary (MoCRA: substantiation) | Manufacturer responsibility | Mandatory for Grade 2 | Mandatory (safety report) |
* China exempts certain imported ordinary cosmetics from animal testing since 2021 if safety data is available.
EU: The most restrictive market
The EU Cosmetics Regulation (EC 1223/2009) is the global gold standard. It bans over 1,600 substances (Annex II), restricts 300+ more (Annex III), and requires a Cosmetic Product Safety Report (CPSR) by a qualified assessor before any product can be notified on the CPNP portal. All products must have a Responsible Person established in the EU. Claims must comply with the Common Criteria (Regulation 655/2013). Labeling must include INCI ingredient list, PAO symbol, batch number, and function — in the official language(s) of each member state where the product is sold.
US: MoCRA changes everything
The US Modernization of Cosmetics Regulation Act (MoCRA, 2022) is the first major FDA cosmetics reform in 85 years. New requirements include: mandatory facility registration with FDA, product listing for every marketed cosmetic, adverse event reporting within 15 business days, safety substantiation records, and Good Manufacturing Practice (GMP) compliance. FDA can now mandate recalls — previously, all recalls were voluntary. MoCRA brings the US closer to EU-style regulation, but significant gaps remain: ingredient pre-approval is still not required, and the FDA banned list remains at just 11 substances.
How to manage cosmetic compliance across markets
With 5 major markets requiring 5 different regulatory approaches, cosmetic brands need a systematic way to track ingredient bans, labeling requirements, and regulatory changes. Cleo's AI-powered platform scans 3,700+ regulatory sources across 106 countries, automatically mapping which cosmetic regulations apply per product per market. When an ingredient gets added to a restricted list in any market, compliance teams get an instant alert with impact assessment on their product portfolio.
Frequently asked questions
How many ingredients are banned in cosmetics in the EU versus the US?
The EU bans 1,600+ substances under Annex II of Regulation 1223/2009. The US bans only 11. MoCRA (2022) introduced facility registration and product listing but does not require ingredient pre-approval.
Does China still require animal testing for imported cosmetics?
Since 2021, China exempts certain imported "ordinary" cosmetics from animal testing if safety substantiation data is available. "Special-use" cosmetics (sunscreen, hair dye, etc.) still require it.
Do I need a Responsible Person to sell cosmetics in the EU?
Yes. EU Cosmetics Regulation 1223/2009 requires every product to designate a Responsible Person established in the EU before it can be notified on the CPNP portal and placed on the market.
Related resources
Product Compliance · 2026-04-27
When a lipstick becomes a legal risk: what 2025's cosmetic recalls reveal about product compliance
Compliance · 2026-03-11
Multi-Market Product Compliance for Retail & Consumer Goods: The Definitive Guide
Product Compliance · 2026-03-12
Global Chemical Product Compliance: CAS Numbers, Formulations & Multi-Country Regulations
Try Cleo: free regulatory risk scan
See your regulatory landscape mapped in minutes. No signup, no credit card.
