Exporting Cosmetics to Mexico: COFEPRIS, NOM-141 Labels and Import Duty

What counts as a cosmetic in Mexico, and why there is no product registration

Mexico's General Health Law (Ley General de Salud, LGS) has called these products "productos cosméticos" since a decree published in the Diario Oficial de la Federación (DOF) on 7 June 2011; older rules that say "productos de perfumería y belleza" (perfumery and beauty products) now refer to cosmetics. Article 269 defines a cosmetic as a substance or formulation placed on the outer parts of the body (skin, hair, nails, lips, external genitals) or on the teeth and mouth, mainly to clean, perfume, change the appearance, protect, keep in good condition or correct body odour. The Reglamento de Control Sanitario de Productos y Servicios (RCSPS), Article 187, lists the product types. They include antiperspirants and deodorants, perfumes, sunscreens (bloqueador solar, protector o filtro solar), bronzers and self-tanners, hair dyes, straighteners and perm products, depilatories, make-up, creams and lotions, toilet soap, shampoo, bath salts, shaving preparations and adhesives for false eyelashes and nails. So sunscreens and antiperspirants are cosmetics in Mexico, with extra label warnings.

Article 270 of the LGS forbids attributing medicinal actions to a cosmetic, such as curing a disease or being a definitive solution to it, regulating weight or fighting obesity, whether in the name, indications, instructions or advertising. A product sold with such claims is outside the cosmetics rules; check with COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) how it is regulated before you ship it.

The cosmetics chapter of the LGS (Articles 269 to 272) and the cosmetics title of the RCSPS set product rules, not an approval step: there is no registro sanitario and no product notification to COFEPRIS. Instead, the law places duties on manufacturers, importers and sellers, who must hold safety and efficacy studies and give them to the Secretaría de Salud when it asks (LGS Article 270). Keep these studies ready before the first sale.

The importer's duties: operating notice, GMP, safety studies and the animal-testing ban

The Mexican importer files COFEPRIS's operating notice for establishments of products and services (aviso de funcionamiento del establecimiento de productos y servicios, procedure COFEPRIS-05-018) online in COFEPRIS's DIGIPRiS platform, choosing its activity code from the SCIAN industry classification; changes or closure are reported with COFEPRIS-05-019. NOM-259-SSA1-2022, the official Mexican standard (Norma Oficial Mexicana, NOM) on good manufacturing practice (GMP) for cosmetics, was published in the DOF on 5 July 2022 and entered into force 60 calendar days after publication, with 180 calendar days from publication to set up the documentation system and 240 days to adapt facilities. It is mandatory for every establishment that processes and/or imports cosmetics sold in Mexico, so the importer needs its own documented GMP system covering the products it imports. Under clause 9.3.3, raw materials and packaging may be approved on a supplier's quality certificate only if the supplier is qualified by the company.

RCSPS Article 190 lists safety tests for perfumery and beauty products: a primary dermal irritation index, a sensitisation index and an eye irritation index, each for named product types. Article 191 requires products sold as hypoallergenic to pass prior dermal sensitisation tests, and Article 192 sets microbiological controls for skin, eye and children's products. Send the importer the results with the formula and specifications.

A decree published in the DOF on 14 October 2021 added Article 271 Bis to the LGS: cosmetics may not be made, imported or sold if the final formulation was tested on animals, or if they contain ingredients that are or were tested on animals. Safety studies may not include animal tests (Article 270), and labels may say that no animal tests were used (Article 272). The decree gave the federal government 180 days to issue implementing rules and manufacturers two years from those rules to replace animal tests; the ban does not apply to products and ingredients already tested and on sale. Check with COFEPRIS whether the implementing rules have been issued. The exceptions are:

• An ingredient must be safety tested and no validated alternative method exists.
• The animal data were generated for a purpose other than cosmetics.
• The safety of the ingredient is widely recognised from its historical use.
• The test is needed to meet another country's regulatory requirement, for export.

Ingredients: the Acuerdo on prohibited and restricted substances

LGS Article 269 says the Secretaría de Salud publishes the restricted and prohibited substances for cosmetics in acuerdos and lists. The Acuerdo "por el que se determinan las sustancias prohibidas y restringidas en la elaboración de productos de perfumería y belleza" was published in the DOF on 21 March 2007. RCSPS Article 189 also bans narcotics, psychotropics, drugs and pharmaceutical preparations in these products. Article 196 lets any interested party ask the Secretaría to change the lists, with data such as the substance name, function, acute toxicity, irritation and sensitisation results, analytical methods and proposed limits. No later amending Acuerdo appeared on the official pages checked for this note, so ask your importer or COFEPRIS whether newer criteria apply.

Check every ingredient against the Mexican lists by its International Nomenclature of Cosmetic Ingredients (INCI) name and concentration. A formula that meets EU, ASEAN or Korean rules can still conflict with a Mexican limit or condition of use. The Acuerdo is organised as follows:

• Definitions of colourants, preservatives, UV filters, salts and esters.
• Prohibited substances, plus substances prohibited only in fragrances.
• Restricted substances, with maximum concentrations and conditions of use.
• Permitted preservatives, with maximum concentrations.
• Permitted UV filters, with maximum concentrations.
• Permitted colourants by Colour Index (CI) number, with restrictions of use.

Labels in Spanish under NOM-141-SSA1/SCFI-2012

NOM-141-SSA1/SCFI-2012, "Etiquetado para productos cosméticos preenvasados. Etiquetado sanitario y comercial", was published in the DOF on 19 September 2012. It applies to everyone who makes or imports prepackaged cosmetics for the final consumer. The Secretaría de Economía's standards catalogue shows it in force; its systematic review of 8 February 2024 confirmed it without changes. RCSPS Article 196 Bis also requires the label in Spanish, except the ingredient list, which may use INCI names; precautionary legends must be in Spanish and name the ingredient. Under NOM-141, a label includes text printed on the pack and labels adhered or attached to it (clause 3.8), so a Spanish sticker is a valid label if it stays on until the product is bought and used (5.1.3). Main items:

• All mandatory information in Spanish; other languages are allowed, but the Spanish characters must be at least as large (5.1.1).
• Generic name of the product (denominación genérica), in Spanish except cosmetic forms, which may stay in the original language (5.1.5).
• Name or company name and full address of the party responsible for the product; for imported products these data may be added in Mexico after customs clearance and before sale (5.1.6.1). Country of origin, such as "Producto de ..." (5.1.6.2).
• Batch (lote), instructions for use, and net content in units of the general system of measurement (5.1.7, 5.1.8, 5.2).
• Ingredients headed "ingredientes" in descending order of quantity, by INCI or another accepted name; perfumes and fragrances are exempt (5.3.1 to 5.3.3).
• Expiry date (month and year) for products that last 24 months or less, with exceptions such as oils, solid soaps, perfumes, antiperspirants, hair dyes, shampoos and aerosols (5.3.6).
• Product-specific warnings (5.3.7), for example for deodorants and antiperspirants, hair dyes, straighteners, depilatories, aerosols and sunscreens. Sunscreens state the sun protection factor (SPF, FPS in Spanish) and UVB and UVA protection; Appendix A sets a minimum SPF of 6 and UVA protection of at least one third of it. No unverifiable claims and no medicinal actions (5.1.9).

At the border: importer registration, pedimento and NOM-141 checks

The importer must be in the SAT's Padrón de Importadores. The SAT lists the requirements as an active RFC (tax ID), a valid e.firma, tax obligations up to date, a fiscal address, a validated tax mailbox (buzón tributario) and a customs broker or authorised representative; online applications are answered within 6 working days. In practice, the importer is a company or person established in Mexico. Annex 10 of the Reglas Generales de Comercio Exterior (RGCE) for 2026, published on 14 January 2026, lists the 16 sectors that also need the Padrón de Importadores de Sectores Específicos, such as chemicals, chemical precursors, footwear, textiles, ethyl alcohol, steel and automotive goods; finished cosmetics in chapter 33 are not among its fractions.

No COFEPRIS import permit or notice for finished cosmetics was found on official pages. COFEPRIS's sanitary import notice (aviso sanitario de importación de productos, COFEPRIS-01-006) covers non-alcoholic drinks, ceramics and glazed pottery, toys and school supplies, not cosmetics. The Acuerdo listing goods whose import and export are regulated by the Secretaría de Salud, in force since 28 December 2020 and amended since, requires prior import permits for goods such as food for human consumption; no chapter 33 cosmetics fraction was found in the parts checked. Confirm your 8-digit fraction and its NICO (número de identificación comercial) with the customs broker, because medicines and some chemicals are regulated.

Under Article 36-A of the Ley Aduanera, last amended by a decree published in the DOF on 19 November 2025, the pedimento (import declaration) is transmitted with electronic copies of: the value and commercial data in the CFDI or equivalent document (for a foreign seller, the commercial invoice); the transport documents, such as the bill of lading, packing list or air waybill; proof of compliance with non-tariff regulations, including NOMs; origin documents when a trade agreement preference is claimed; and a guarantee when the declared value is below the estimated price. Customs checks NOM-141 at entry: Annex 26 of the RGCE for 2026 lists NOM-141, chapter 5 except clause 5.1.6.1, among the label data of commercial-information NOMs. Under rule 3.7.20, as published in the Second Resolution of Modifications to the RGCE for 2026 (DOF 22 September 2026), if compliance with a NOM in numeral 3 of Annex 2.4.1 is not shown at inspection and the problem is omitted or inaccurate label data listed in Annex 26, the importer may prove compliance within 30 days after the inspection record (acta) is notified and pay the fine under Article 185, section XIII. Apply the full Spanish label before shipping; the Economía standards catalogue links to the database of approved conformity assessment bodies, such as verification units (unidades de verificación), for NOM-141.

Import duty, IVA and trade agreements

Mexico classifies goods by an 8-digit tariff fraction of the Tarifa of the Ley de los Impuestos Generales de Importación y de Exportación (LIGIE), plus a 2-digit NICO. A decree published in the DOF on 29 December 2025 changed the general import duty (impuesto general de importación, IGI) on many lines; on most cosmetics lines it is now 25% of the customs value: 3303.00.01 (toilet waters), 3304.20.01 (eye make-up), 3304.30.01 (manicure preparations), 3304.91.01 (powders), 3304.99.01 (skin milks), 3304.99.99 (other beauty and skin care preparations), 3305.10.01 (shampoos), 3305.90.99 (other hair preparations) and 3307.30.01 (bath preparations). Lip make-up (3304.10.01) is 36% and toothpaste (3306.10.01) is 30%. Not every chapter 33 line was changed, so check your exact fraction in the current tariff with your broker. Triplicate's landed cost calculator gives a first estimate.

IVA (value added tax) on imports is 16%, charged on the customs value plus the IGI and the other charges paid on import (Ley del IVA, Articles 1 and 27). The broker calculates the amounts due in the pedimento.

The general IGI applies unless the goods originate in a country with which Mexico has a trade agreement and the importer claims the preference in the pedimento with the proof of origin that agreement requires. The Mexican government's list of agreements includes the USMCA (T-MEC) with the United States and Canada, the EU, EFTA, the Japan Economic Partnership Agreement, the CPTPP, the Pacific Alliance and agreements with Colombia, Chile, Peru, Uruguay, Central America, Panama and Israel. Korea and China are not on that list, so their cosmetics pay the general rate whatever the certificate of origin says; still show the true origin on the invoice. The EU and Mexico signed a modernised agreement and an interim trade agreement on 22 May 2026; until the interim agreement enters into force, EU goods use the agreement in force since 2000. Check the preferential rate for your fraction before you quote a delivered price.