How do EU and US cosmetic rules differ?
Direct answer
Both frameworks impose operator obligations through different procedures. The EU applies Regulation 1223/2009; in the US, MoCRA of 2022 expanded the FD&C Act. Registrations and notifications must not be confused with approval of each product. [1] [2] [3]
Regulatory status
EU: a responsible person established in the EU, prior assessment and safety report, product information file retained for ten years after the last batch is placed on the market, and CPNP notification before marketing. Articles 10, 11 and 13 specify these obligations. [1]
Restrictions and conditions of use
US: FDA describes facility registration renewed every two years, listing each marketed product and its ingredients with annual updates, and keeping records of adequate safety substantiation. Certain small businesses are exempt from registration and listing, with product-dependent exceptions. FDA does not prescribe a single test for every cosmetic. [2]
Fragrance allergens: the EU requires individual declarations specified in Annex III. MoCRA directs FDA to establish specific rules. The consulted 2026 federal agenda places the matter at the proposed-rule stage, with a proposal scheduled for November 2026. This future schedule is not a final rule in force on 31 October 2026. [1] [2] [5]
Database: California regulatory source, separate from federal law. [4]
Database: federal eCFR source, 21 CFR Part 700 and section 250.250, cosmetic ingredient rules. [4]
Database: Washington regulatory source, separate from federal law. [4]
Dated primary sources
[1] Règlement (CE) n° 1223/2009. Text : 2009-11-30. Consolidated version : 2026-05-18. Consulted : 2026-10-31. Articles 4, 10, 11, 13 et 19 ; débuts de paragraphes distincts..
The Regulation provides for a responsible person, assessment, file and pre-market notification.
Seuls les produits cosmétiques pour lesquels une personne physique ou morale est désignée dans la Communauté comme «personne responsable» sont mis sur le marché.
Avant la mise sur le marché du produit cosmétique, la personne responsable transmet à la Commission, par des moyens électroniques, les informations suivantes:[2] FDA, mise en œuvre de MoCRA. Text : not stated. Consulted : 2026-10-31. Rubriques Facility Registration, Product Listing, Safety Substantiation et Exemptions ; extraits distincts..
FDA describes biennial registration, annually updated product listing, documentation and exemptions.
renew their registration every two years.
provide any updates annually.
ensure and maintain records supporting adequate safety substantiation
MoCRA exempts certain small businesses[3] FDA, enregistrement des établissements et liste des produits. Text : not stated. Consulted : 2026-10-31. Paragraphe sur le sens des numéros attribués..
A registration or listing number is not FDA approval.
The assignment of a facility registration number or product listing number does not indicate FDA approval of the facility or its cosmetic products.FDA, enregistrement des établissements et liste des produits
[4] FDA, Cosmetics & U.S. Law. Text : not stated. Consulted : 2026-10-31. Introduction et rubrique Assuring Ingredient and Product Safety, phrases distinctes..
Legal categories differ, including sunscreens; FDA distinguishes cosmetics, drugs and colour additives.
Sunscreens are a case in point.
FDA does not pre-approve cosmetic products or ingredients, with the important exception of some color additives.[5] Agenda fédéral, RIN 0910-AI90, allergènes de parfum. Text : not stated. Consulted : 2026-10-31. Agenda identifié Publication ID 2026 ; stade et calendrier. Version officielle indexée lue ; accès direct en erreur temporaire..
The consulted agenda schedules a proposal for November 2026; it does not establish adoption of a final rule.
Agenda Stage of Rulemaking: Proposed Rule Stage
NPRM 11/00/2026Limits of the data
FDA notes that sunscreens or certain dual-use products also fall under drug rules in the US. Comparing ingredient lists without checking legal categories and state rules is insufficient. [4]
The US source inventory above describes database provenance; it is not a fresh verification of every California or Washington rule. These tables do not establish a comprehensive MoCRA register. [1] [2]
Last verification
2026-10-31