Key Facts · 2026-09-14
- EU: every product needs a Compliant Product Information File (PIF), a Responsible Person, and CPNP notification before sale.
- US: MoCRA requires facility registration, product listing, labelling (INCI, warnings) and adverse-event reporting — fully effective since 2024.
- UK: post-Brexit, UK Responsible Person + UK Notification (UKNAP) replace EU RP/CPNP for Great Britain.
- Budget $800-3,000+ per product for a safety assessment + notification, depending on complexity and market.
EU — Regulation 1223/2009 & CPNP
Before any EU sale you need: a Product Information File (PIF) (formula, safety report, manufacturing GMP, animal-testing declaration), a designated Responsible Person in the EU, and a CPNP notification. The PIF must be kept for 10 years after the last batch is sold. Microbiological and stability testing are expected for most products.
US — MoCRA
The Modernization of Cosmetics Regulation Act gives the FDA real authority. In practice you must: register the facility, list each product (with ingredients), meet labelling rules (INCI names, warnings, domestic contact), keep records of adverse events, and follow good manufacturing practice once the rule is finalised. 'Organic' and 'clean' claims remain FTC/AFP-adjacent and must be substantiated.
UK — UKCA / UKNAP
For Great Britain you need a UK Responsible Person and a UK product notification (via the UKNAP portal); Northern Ireland follows EU rules. The substantive safety duties mirror the EU regime.
Other markets at a glance
- GCC / Saudi (SFDA): GCC Cosmetic Regulation + halal certification for many categories; Arabic labelling required.
- ASEAN: mutual recognition of notification across member states; varies by country.
- Brazil (ANVISA): pre-market notification and strict labelling.
- China (NMPA): broader 'cosmetic' definition; registration/filing by category.
Checklist before you produce
- Lock the INCI formula and full ingredient specs.
- Commission a Certified Cosmetic Product Safety Report (EU/UK) or equivalent.
- Appoint a Responsible Person per market.
- File CPNP / UKNAP / MoCRA listing.
- Print compliant labels (INCI, warnings, RP contact, batch/PAO).
QuickOEM's partner factories work to ISO 22716 GMP and can supply the technical files your assessor needs.
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