The regulatory landscape for cosmetic products underwent significant transformation with the Modernization of Cosmetics Regulation Act (MoCRA) of 2022, representing the most substantial expansion of FDA authority over cosmetics since 1938. For 2026, several key provisions affect B2B suppliers selling to the US market.
FDA MoCRA 2026 Key Requirements:
Facility Registration: Cosmetic manufacturing facilities must register with FDA and renew registration every two years. The first renewal cycle begins in early 2026. Any changes to registration information must be reported within 60 days. This applies to both domestic and foreign facilities exporting to the US market [1].
Product Listing: All cosmetic products must be listed with FDA, with annual updates required. Product listings must include ingredient information and facility registration numbers. This creates traceability from raw material to finished product.
Safety Substantiation: Manufacturers must maintain adequate safety substantiation for all products. This includes documentation of ingredient safety assessments, stability testing, and microbiological testing records. FDA can request this documentation during inspections.
Adverse Event Reporting: Serious adverse events must be reported to FDA within 15 business days. Manufacturers must maintain records of all adverse event reports for six years. This post-market surveillance requirement holds suppliers accountable for product safety throughout the product lifecycle [1].
MoCRA represents the most significant expansion of FDA's authority over cosmetics since the Federal Food, Drug, and Cosmetic Act of 1938. Facility registration is mandatory and must be renewed every two years. [1]
EU Cosmetic Regulation 2026 Updates:
European Union cosmetic regulations continue evolving with 2026 updates focusing on ingredient restrictions and transparency requirements. Key changes include expanded fragrance allergen labeling (expected proposal May 2026), PFAS (per- and polyfluoroalkyl substances) phase-outs across cosmetic categories, and updated REACH SVHC (Substances of Very High Concern) restrictions affecting packaging materials [2].
For Alibaba.com sellers targeting European buyers, compliance with EU Regulation 1223/2009 remains mandatory. This includes maintaining a Product Information File (PIF), completing a Cosmetic Product Safety Report (CPSR), and registering products via the Cosmetic Products Notification Portal (CPNP) before market placement.
ISO 22716 GMP Certification: While not legally mandatory in most markets, ISO 22716 (Good Manufacturing Practices for Cosmetics) has become a de facto requirement for B2B buyers, particularly in Western markets. This certification demonstrates that a facility follows internationally recognized hygiene and quality control standards throughout the manufacturing process [3].