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ComplianceApril 22, 202512 min read

Comparativo: ANVISA vs FDA vs EU Cosmetics Regulation

Differences between Brazil ANVISA, US FDA, and EU cosmetics regulations for cross-border sellers.

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Why regulatory differences matter for cross-border sellers

If you're selling cosmetics across multiple markets, understanding the differences between regulatory frameworks is crucial. A product compliant with FDA rules may not pass ANVISA inspection.

Key differences: ANVISA vs FDA vs EU

AspectANVISA (Brazil)FDA (USA)EU Regulation
Pre-market approvalRequired for importsNot requiredNotification via CPNP
Ingredient listsPortuguês obrigatórioEnglish requiredAny EU language
Prohibited substancesRDC 665/202221 CFR 700EU Regulation 1223/2009
Testing requirementsANVISA-approved labsNo specific lab requirementGLP compliant labs

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Comparativo: ANVISA vs FDA vs EU Cosmetics Regulation | CosmetCheck