Quick Answer
Global cosmetic regulations are not one universal approval system. Beauty brands must confirm the legal route for each destination market: product classification, safety evidence, responsible local operator, label, notification or listing, and post-market duties.
Global cosmetic regulations: the B2B framework
A cosmetic that can be sold in one market may need different documentation, notification and label information elsewhere. Start with the market and intended claims, not with a generic “global certificate”. Claims can affect classification and therefore the applicable rules.
Five questions before launch
- Is the product regulated as a cosmetic in this destination?
- Who is the locally responsible party or importer?
- What safety file, formula and manufacturing evidence must be retained?
- Is notification, product listing or facility registration required—and when?
- What label, language and claims rules apply?
United States: regulation is not pre-market cosmetic approval
FDA explains that cosmetic products and ingredients, except color additives, generally do not require FDA approval before marketing. Under MoCRA, defined cosmetic facilities must register and the responsible person must list marketed cosmetic products, subject to statutory exemptions. FDA states that registration and listing are not an approval program and do not result in FDA certificates.
European Union: product file, safety assessment and CPNP
Regulation (EC) No 1223/2009 is the central EU legal framework. Before a product is made available, brands should identify the EU Responsible Person and confirm the Product Information File, Cosmetic Product Safety Report, label and claims obligations. The European Commission states that notification in the Cosmetic Products Notification Portal (CPNP) removes the need for further national notification within the EU.
Great Britain: Responsible Person and OPSS notification
For Great Britain, GOV.UK states that a UK-established Responsible Person is required and that the product must be notified to OPSS before it is made available to consumers. The Responsible Person must keep product information and address safety, label and serious-undesirable-effect duties. Great Britain and the EU should be assessed separately.
Canada: notification after first sale
Health Canada states that manufacturers and importers must notify within 10 days after first sale in Canada. The Cosmetic Notification Form is not an approval for sale; the notifier remains responsible for compliance with the Food and Drugs Act and Cosmetic Regulations.
What an OEM/ODM manufacturer can provide
| Manufacturer support | Brand or responsible party decision |
|---|---|
| INCI, formula and technical records | Target markets and compliant claims |
| COA, SDS, batch, stability or microbiological information where available | Responsible Person, importer and notification route |
| Packaging compatibility and manufacturing information | Final artwork, label and market entry confirmation |
Common mistakes
- Calling a notification or listing an approval.
- Assuming one market’s file satisfies every other market.
- Finalizing packaging before destination-market review.
- Using a voluntary certificate as a substitute for legal compliance.
FAQs
Is there a global cosmetics licence?
No. Compliance is market-specific and depends on the product, claims and supply chain.
Does ISO 22716 replace legal requirements?
No. It is a GMP guideline; destination-market duties still apply.
Who owns compliance?
Responsibilities vary, but the brand and legally designated responsible party must confirm market access. Manufacturers provide agreed technical support.
Sources
- FDA: Cosmetic facility registration and product listing
- EUR-Lex: Regulation (EC) No 1223/2009
- European Commission: CPNP
- GOV.UK: Cosmetics in Great Britain
- Health Canada: Notification of Cosmetics
Author: MOOYAM Editorial
Last Reviewed: September 8, 2026
MOOYAM provides cosmetic OEM/ODM manufacturing and technical documentation support for international beauty brands.
Regulatory requirements may change. Verify current requirements with the relevant authority or a qualified compliance professional before placing products on the market.