United States - FDA MoCRA Compliance
The Modernization of Cosmetics Regulation Act (MoCRA) of 2022 transformed US cosmetic regulation. Key requirements include: biennial facility registration (renewed every two years), product listing for each cosmetic product, adverse event reporting within 15 business days of serious incidents, and safety substantiation documentation for all products. Importantly, the FDA does not pre-approve cosmetics or issue certificates - compliance is post-market surveillance based [1].
European Union - Regulation 1223/2009
EU cosmetic compliance requires: Cosmetic Product Safety Report (CPSR) prepared by qualified safety assessor, Product Information File (PIF) maintained for 10 years, Responsible Person established within EU, and CPNP notification before products enter the market. The critical 2026 update: fragrance allergen labelling becomes mandatory July 31, 2026, requiring disclosure of 80+ potential allergens on product labels [2][4].
ISO 22716 - International GMP Standard
ISO 22716:2007 provides guidelines for Good Manufacturing Practices specific to cosmetics. It covers production, control, storage, and shipment processes. While not legally mandatory in most jurisdictions, ISO 22716 certification demonstrates manufacturing excellence and is increasingly required by major retailers and B2B buyers. The standard was confirmed valid in 2022 and remains the global benchmark for cosmetic GMP [6].
Southeast Asia - Halal & ASEAN Cosmetic Directive
For Southeast Asian markets, two frameworks apply: The ASEAN Cosmetic Directive harmonizes regulations across 10 member states (Singapore, Malaysia, Thailand, Indonesia, Philippines, Vietnam, Cambodia, Laos, Myanmar, Brunei), requiring product notification before supply and GMP compliance. Halal certification becomes mandatory in Indonesia October 18, 2026 - all cosmetics must bear halal logo to be sold. Malaysia (JAKIM), Singapore (Muis), Thailand (CICOT), and Philippines (NCMF) have voluntary but commercially important Halal programs [5][7].
