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Selling cosmetics and beauty products in Mexico

In Mexico, cosmetics are defined and controlled under the General Health Law, with COFEPRIS acting for the Secretaría de Salud. Makers, importers and sellers hold safety and efficacy studies, products tested on animals may not be made, imported or sold, and labels follow NOM-141-SSA1/SCFI-2012 in Spanish, with INCI names allowed.

Updated · Each section links to the official source it comes from

Definition
Article 269, General Health Law
Labelling
NOM-141-SSA1/SCFI-2012
Safety evidence
Studies held and given to the Secretaría on request
Animal testing
Banned for cosmetics, with listed exceptions (Article 271 Bis)
Ingredient names
INCI, the common chemical name, or the Agreement's names
Advertising
Notice to the Secretaría, by brand (Article 270)

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Is it a cosmetic, or does a claimed effect make it a medicine? Read more
  2. 2Is each ingredient allowed, and within its restrictions? Read more
  3. 3Are the safety and efficacy studies on file, without animal testing? Read more
  4. 4What has to be on the label, in Spanish, including precautionary legends? Read more
  5. 5Who answers for it, and how does it come into Mexico? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

Advertising notice

Cosmetics advertising needs a notice, not a permit.

  • COFEPRIS lists cosmetics, by brand, among the products for which an advertising notice (Aviso de Publicidad, COFEPRIS-02-002) is enough.
  • The notice is filed online through DIGIPRiS, is free, and needs no reply from COFEPRIS.

How we help: Compliant Always keeps the advertising notice with the brand it covers, dated, beside the advertising it relates to. Ask about this

What counts as a cosmetic

The legal definition, and the claims that turn a product into a medicine.

  • Cosmetic products are substances or formulations put in contact with the surface of the body, teeth or oral mucosa with the sole or main aim of cleaning, perfuming, helping change their appearance, protecting them, keeping them in good condition, correcting body odours, or easing or preventing deficiencies in healthy skin (Article 269, General Health Law).
  • A substance or mixture meant to be ingested, inhaled, injected or implanted is not a cosmetic (Article 269).
  • Cosmetics may not be credited with actions proper to medicines, such as curing disease, regulating weight or fighting obesity, in their name, directions or advertising (Article 270).
  • Products for slimming or reshaping the body, or containing hormones, vitamins or substances credited with therapeutic action, are treated as medicines (Article 271).

How we help: Compliant Always keeps the classification reasoning and the claims each product makes with the product, so the file shows why it is sold as a cosmetic. Ask about this

Safety studies and the animal testing ban

The evidence a cosmetic needs, and how it may not be produced.

  • Manufacturers, importers and sellers of cosmetics hold safety and efficacy studies and other studies required by the applicable rules, and give them to the Secretaría when asked (Article 270).
  • Cosmetics may not be made, imported or sold where the final formulation, or any ingredient or combination, has been tested on animals (Article 271 Bis), with exceptions such as data generated for a non-cosmetic purpose or to meet another country's rules for export.
  • Manufacturers are responsible for the sanitary quality of what they make (Article 188 of the Regulation).
  • The Regulation lists products that need a primary dermal irritation test, such as creams, deodorants, shampoos, sunscreens and lip products, and those that need microbiological controls in manufacture, such as eye-area and children's products (Articles 190 and 192).
  • Products sold as hypoallergenic first undergo dermal sensitisation tests (Article 191).

How we help: Compliant Always keeps the safety studies and test reports with each product, dated, so the file is ready when COFEPRIS asks for it. Ask about this

Prohibited and restricted substances

What may go into a cosmetic.

  • The Secretaría publishes, by agreement or list, the substances restricted or prohibited in cosmetics; substances it has evaluated and accepted may be used at once, before they join the list (Article 269).
  • The Agreement on prohibited and restricted substances in perfumery and beauty products (Acuerdo por el que se determinan las sustancias prohibidas y restringidas en la elaboración de productos de perfumería y belleza), signed on 6 May 2010, sets those lists.
  • Narcotics, psychotropics, drugs and pharmaceutical preparations, and substances on the corresponding lists, may not be used (Article 189 of the Regulation).
  • Anyone may ask the Secretaría to change the lists by providing the substance's identity, function, toxicology and analytical methods (Article 196).

How we help: Compliant Always reads your formula against the prohibited and restricted lists, so a restricted ingredient shows up against the products that use it. Ask about this

Labelling under NOM-141

The sanitary and commercial information on a prepackaged cosmetic.

  • NOM-141-SSA1/SCFI-2012 (Etiquetado para productos cosméticos preenvasados. Etiquetado sanitario y comercial) applies to prepackaged cosmetics of any size for the final consumer, and binds those who process or import them.
  • The generic name is given in Spanish, except cosmetic forms, which may be given in their original language (5.1.5.2).
  • The label gives the name and address of the party responsible (which, for imports, may be added in Mexico after customs and before sale), the country of origin, and a lot code (5.1.6 and 5.1.7).
  • Ingredients follow the word "ingredientes" in decreasing order, or with those at 1% or less in any order; perfumes and fragrances are exempt, and INCI names may be used (5.3.1 to 5.3.3).
  • Products lasting 24 months or less show the date until which they are safe, with at least month and year (5.3.6).
  • Precautionary legends are set by product type, for example for deodorants, hair dyes and permanents, and sunscreens give directions such as applying before sun exposure; a modification of the NOM added Appendix A on sunscreens.

How we help: Compliant Always sets your label beside the clauses of NOM-141, including the legends for the product type. Ask about this

Advertising, import and enforcement

Who notifies what, and how cosmetics come into Mexico.

  • Those responsible for advertising cosmetics give the Secretaría a notice, by brand, with the manufacturer, importer and distributor, the brand, and the RFC of those responsible for the product and the advertising (Article 270).
  • Cosmetics are under sanitary control for processing, import and export; the importer must be domiciled in Mexico, and the Secretary of Health may require prior import authorisation for products named by agreement (Articles 194, 285 and 286).
  • Products imported without a required prior import permit are treated as illegally imported (Article 235 of the Regulation).
  • Cosmetics advertised as medicines, or tested on animals, may be seized, including stock held by distributors and retailers (Article 414 Bis).

How we help: Compliant Always keeps the advertising notice, import documents and safety studies together for each product. Ask about this

Who answers for what

WhoWhat they answer forHow we help
BrandFormula, label, claims and the advertising notice.Formula and label checked against the lists and NOM-141.
ManufacturerSanitary quality, tests and microbiological controls.Test reports kept by product and batch.
ImporterBeing domiciled in Mexico, safety studies on request, and its details on the label.Supplier documents read and dated before the goods arrive.
SellerHolding the safety studies on request, and selling only products that meet the rules.The documents each product needs, shown when a retailer asks.

Federal rules and the states

Product rules in Mexico are federal: the General Health Law, the Federal Consumer Protection Law and the Normas Oficiales Mexicanas apply across the national territory.

Health surveillance is shared. Under the General Health Law, a notice of operation (aviso de funcionamiento) goes to the Secretaría de Salud or to the government of the state (entidad federativa), and several sanitary NOMs are enforced by COFEPRIS and the state governments together.

Questions businesses ask

Do cosmetics need a sanitary registration in Mexico?
The General Health Law's list of products needing sanitary registration does not include cosmetics. Makers, importers and sellers hold safety and efficacy studies and give them to the Secretaría when asked (Articles 270 and 376).
Is animal testing of cosmetics banned in Mexico?
Yes. Cosmetics may not be made, imported or sold where the formulation or its ingredients were tested on animals, with listed exceptions such as data for non-cosmetic purposes or for another country's export requirements (Article 271 Bis).
Which NOM sets cosmetic labelling in Mexico?
NOM-141-SSA1/SCFI-2012, for prepackaged cosmetics of any size sold to the final consumer, binding on those who process or import them.
Must cosmetic labels be in Spanish?
Yes, with an exception: cosmetic forms may be given in their original language (NOM-141, 5.1.5.2).
Can INCI names be used on Mexican cosmetic labels?
Yes. Ingredients may be named using the Agreement's names, the most common chemical name, or the International Nomenclature of Cosmetic Ingredients (NOM-141, 5.3.3).
Do perfumes need an ingredients list?
Perfumes and fragrances are exempt from declaring ingredient names (NOM-141, 5.3.2).
Do cosmetics need an expiry date in Mexico?
Products lasting 24 months or less show the date until which they remain safe, with at least the month and year (NOM-141, 5.3.6).
Can a cosmetic claim to treat a condition?
No. Cosmetics may not be credited with actions proper to medicines, such as curing disease, regulating weight or fighting obesity (Article 270).
Is a notice needed to advertise cosmetics?
Yes. Those responsible for advertising give the Secretaría a notice by brand, with the manufacturer, importer, distributor and the RFC of those responsible (Article 270).
Where are banned cosmetic ingredients listed?
In the Agreement on prohibited and restricted substances in perfumery and beauty products, signed on 6 May 2010, and in the lists the Secretaría publishes under Article 269.
Do I need a permit to advertise cosmetics in Mexico?
No permit is needed. COFEPRIS says an advertising notice (COFEPRIS-02-002) is enough for cosmetics, by brand. It is filed online through DIGIPRiS, is free, and needs no reply.
How does Compliant Always help with selling in Mexico?
Our team reads the rules for the markets you sell in, including the Normas Oficiales Mexicanas and COFEPRIS requirements. Compliant Always shows which apply to your product, keeps the documents behind each one ready, and watches the sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

Tell us what you make, and we will show you the rules for it.

Name the product and the markets you sell in. We will come back to you with what applies in Mexico and what your paperwork needs to show.

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