Resources/Cosmetic GMP
Cosmetic GMP: EU's settled standard vs. the US's still-pending rule
Disclaimer: The information provided in this guide is for educational and regulatory context purposes only and does not constitute formal legal advice. Compliance requirements can vary based on formulation, regional authority updates, and specific product claims. Consult a certified regulatory affairs professional or specialized legal counsel for official filings. The US GMP status on this page changes as FDA.gov moves — verify before relying on it.
EU: ISO 22716 under Article 8
Regulation (EC) No 1223/2009, Article 8 requires cosmetic manufacturing to follow Good Manufacturing Practice. The Regulation doesn't write its own GMP checklist — it points to ISO 22716 as the harmonized reference standard, and compliance with ISO 22716 creates a legal presumption of compliance with Article 8. ISO certification itself isn't mandated by the Regulation; manufacturers can instead issue a declaration that products are made in accordance with ISO 22716, though many pursue formal certification for commercial reasons (retailer/contract requirements).
ISO 22716 covers personnel, premises, equipment, raw materials and packaging, production, quality control, finished-product storage/shipping, deviation handling, and documentation — organizational and technical controls, not a residue/impurity limit list.
US: MoCRA's GMP rule is still pending
MoCRA directed FDA to issue a proposed GMP rule by December 29, 2024 and a final rule by December 29, 2025. Both statutory deadlines have passed — FDA has not issued a proposed rule, and as of this writing the rulemaking sits on FDA's Long-Term Actions list, meaning it isn't expected within the next 12 months. There is currently no binding US cosmetic GMP regulation — check FDA.gov before relying on any specific timeline you find elsewhere, including on this page.
When FDA does finalize a rule, it's expected to draw heavily on ISO 22716 (management responsibility, personnel training, production/process controls, environmental monitoring, lab controls, corrective and preventive actions, documentation) — which is why manufacturers already selling into the EU, or supplying contract customers that require it, are often ISO 22716-aligned regardless of the US rule's status.
Aligning manufacturing practice is one half of compliance — the other is the formula itself. Run a free INCI compliance scan, or sign in to check a full formulation across US, EU, and other markets at once.
Related: FDA facility registration & product listing, CPSR & PIF safety documentation.