North America · Mexico

What does it take to sell cosmetics in Mexico? Entry route, responsibility, labeling

No product registration or notification — the manufacturer or importer files an Aviso de …; Responsible person: No formal RP; Labeling: Spanish labelling per NOM-141-SSA1/SCFI-2012 (pro….

Latest change 2025-07-11 — COFEPRIS published in the DOF an Acuerdo de simplificación merging, eliminating and fully digitising sanitary procedures (including notices) via its digital single window, effective 20–30 business days after publication; NOM-259-SSA1-2022 GMP became mandatory 2023-03-02 and the prohibited/restricted-substances Acuerdo (DOF 2010-05-21) was last amended 2014-03-11. Source

Factory-side digest; the official text prevails; not legal advice.

Authority: Federal Commission for Protection against Sanitary Risks (COFEPRIS), Secretaría de Salud
Main regulation: Ley General de Salud Arts. 269–272 and 271 Bis; Reglamento de Control Sanitario de Productos y Servicios; NOM-141-SSA1/SCFI-2012 · General Health Law (Ley General de Salud) and the Regulation on Sanitary Control of Products and Services, with NOM-141-SSA1/SCFI-2012 (labelling) and NOM-259-SSA1-2022 (GMP)
In force: 1984-07-01
Market entry: No product registration or notification — the manufacturer or importer files an Aviso de Funcionamiento (establishment operating notice) with COFEPRIS and compliant products can be sold; an Aviso de Publicidad is required for advertising.
Responsible person: No formal RP; the Mexican manufacturer or importer that files the Aviso de Funcionamiento is legally accountable and must appear on the label.
Safety file: No mandatory PIF — the manufacturer/importer must hold evidence of safety and of compliance with the substances Acuerdo and GMP (NOM-259) available to COFEPRIS on inspection.
Labeling: Spanish labelling per NOM-141-SSA1/SCFI-2012 (product name, INCI ingredient list, net content, responsible party, lot, warnings); no fragrance-allergen disclosure requirement.
Animal testing: Banned since 2021-10-15 — Art. 271 Bis of the General Health Law prohibits manufacturing, importing or marketing cosmetics tested on animals (decree DOF 2021-10-14).
Ingredient lists: Acuerdo por el que se determinan las sustancias prohibidas y restringidas en la elaboración de productos cosméticos (DOF 2010-05-21, amended 2014-03-11).
Notes: The DOF page for the 2025 simplification Acuerdo could not be fetched, so its cosmetic-specific effects are summarised from CIRS/Greenberg Traurig.
Official text: https://www.gob.mx/cofepris/acciones-y-programas/productos-cosmeticos-404020

FAQ

Does Mexico require notification or registration before sale?

No product registration or notification — the manufacturer or importer files an Aviso de Funcionamiento (establishment operating notice) with COFEPRIS and compliant products can be sold; an Aviso de Publicidad is required for advertising.

Is a local responsible person mandatory in Mexico?

No formal RP; the Mexican manufacturer or importer that files the Aviso de Funcionamiento is legally accountable and must appear on the label.

What are the labeling requirements in Mexico?

Spanish labelling per NOM-141-SSA1/SCFI-2012 (product name, INCI ingredient list, net content, responsible party, lot, warnings); no fragrance-allergen disclosure requirement.

What changed recently in Mexico cosmetic regulation?

2025-07-11 COFEPRIS published in the DOF an Acuerdo de simplificación merging, eliminating and fully digitising sanitary procedures (including notices) via its digital single window, effective 20–30 business days after publication; NOM-259-SSA1-2022 GMP became mandatory 2023-03-02 and the prohibited/restricted-substances Acuerdo (DOF 2010-05-21) was last amended 2014-03-11.

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What does it take to sell cosmetics in Mexico? Entry route, responsibility, labeling

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