Mexican Cosmetic Regulation

Mexico is one of the most dynamic beauty markets in Latin America. Market entry requires a solid understanding of the country’s regulatory framework. Cosmetics in Mexico are regulated by the Federal Commission for Protection against Health Risks (COFEPRIS) under the General Health Law and a series of Norma Oficial Mexicana (NOM) standards. Enterprises must comply with detailed requirements covering ingredient use, labeling, and permissible claims.

PART 1 Regulatory Framework and Competent Authority

1.1 Main Cosmetic Regulations in Mexico

In Mexico, the regulatory framework for health-related products, including cosmetics, is primarily established under the General Health Law.

A NOM is a mandatory technical regulation that sets out requirements for products, processes, and services that may pose risks to human health or safety. NOMs are issued and published in the Official Gazette of the Federation (Diario Oficial de la Federación, DOF) and generally enter into force the day following publication. In practice, NOMs serve to protect public health by defining technical and operational standards across a wide range of health-related areas, including medical care, disease prevention, healthcare infrastructure, and consumer products such as cosmetics.

1.2 Competent Authority

The Federal Commission for Protection against Health Risks (COFEPRIS) is a decentralized body under the Ministry of Health, with technical, administrative, and operational autonomy. Its mandate is to safeguard public health through the regulation and oversight of pharmaceuticals, cosmetics, food, medical devices, and other health-related products.

Within the cosmetics sector, COFEPRIS is responsible for issuing regulatory guidance on cosmetic ingredients, labeling, and claims; receiving notices of operation and advertising notifications; and conducting supervision and enforcement activities across the market.

PART 2 Cosmetic Products

2.1 Definition of Cosmetics

Under the Mexican law, cosmetic products are defined as substances or formulations intended to be applied to the superficial parts of the human body—such as the epidermis, hair and capillary system, nails, lips, external genitalia—or to the teeth and oral mucosa. Their sole or primary purpose must be to clean, perfume, modify appearance, protect, maintain in good condition, correct body odors, or attenuate or prevent deficiencies or alterations in the functioning of healthy skin. Notably, unlike many other jurisdictions, insect repellents applied directly to the skin are regulated as cosmetic products in Mexico.

By contrast, any substance or mixture intended to be ingested, inhaled, injected, or implanted into the human body is not considered a cosmetic. Products intended to slim or enlarge parts of the body, alter body proportions, or that contain hormones, vitamins, or other substances with a therapeutic effect—or to which therapeutic effects are attributed—are classified as medicines. Such products are subject to additional regulatory approvals, supporting data requirements, and more extensive regulatory review.

2.2 Notice of Operation

Cosmetic manufacturers and distributors are required to submit a Notice of Operation to COFEPRIS. This process can be completed online via the DIGIPRIS platform following the below steps.

1. Appointment of a Local Representative (LR)

For foreign cosmetic enterprises, the first step toward market entry is the designation of a local representative in Mexico. The LR must be a Mexican natural or legal person, such as a local subsidiary, distributor, or qualified third-party service provider. The LR is responsible for all regulatory communications with COFEPRIS and assumes legal responsibility for compliance.

2. Account Registration

Once the LR has been appointed, an account must be created on the DIGIPRIS platform.

3. Submission and Receipt of the Notice of Operation

Following account registration, the LR must submit an application for a Notice of Operation. Receipt of this notice confirms that the entity represented by the LR is recognized by COFEPRIS and authorized to carry out specific cosmetic-related activities in Mexico, including manufacturing, importing, storage, distribution, and marketing.

At this stage, enterprises must ensure that product formulations, labeling (including language and content), and marketing claims fully comply with applicable Mexican regulations and standards.

If you are interested in regulatory frameworks or regulatory alert reports for specific countries, please feel free to contact us at [email protected]. Our team would be happy to provide tailored regulatory support and related services.

2.3 Ingredients

Mexico issued the Agreement by Which the Prohibited and Restricted Substances Are Determined in the Manufacture of Perfumery and Beauty Products in 2010, with amendments adopted in 2014. This Agreement establishes the ingredient framework applicable to cosmetic products, including:

• List of Prohibited Ingredients;

• List of Ingredients Subject to Conditions of Use and Maximum Allowable Concentrations;

• List of Permitted Preservatives;

• List of Permitted UV Filters;

• List of Permitted Colorants; and

• List of Ingredients Permitted for Use in Insect Repellents.

Additives and flavorings authorized for use in foods, beverages, and dietary supplements may also be used in cosmetics without restriction, unless otherwise specified in the Agreement. Similarly, food colorings permitted for use in foods but not expressly listed in the Agreement may be used in cosmetic products.

For insect repellents intended for human use that contain active ingredients not listed in the Agreement, manufacturers must conduct primary dermal irritation tests, sensitization tests, and toxicological studies to determine the acute oral and dermal LD50 values. Additional tests may be required by the Ministry of Health following a preliminary evaluation. Test results must be made available to the authorities upon request.

All cosmetic ingredients must comply with the specifications applicable to their respective industrial sectors to ensure that consumers are not exposed to physical, chemical, or microbiological contaminants. Ingredients used in products that may be ingested, such as lipsticks, must additionally comply with food additive specifications.

Cosmetic products must not contain narcotic, psychotropic, or pharmaceutical substances. Lists of substances classified as narcotic or psychotropic are set out in Articles 234 and 245 of the General Health Law.

2.4 Labeling

NOM-141-SSA1/SCFI-2012: Labeling for Prepackaged Cosmetic Products – Sanitary and Commercial Labeling sets out the mandatory labeling information for all prepackaged cosmetic products intended for end consumers, regardless of package size.

Language Requirements

Products marketed in Mexico must bear labeling in Spanish containing all information required under NOM-141-SSA1/SCFI-2012, with the exception of the ingredient list. Ingredient names may be declared following the nomenclature established in the Agreement, commonly used chemical names, or INCI names. Any precautionary statements related to ingredients that may pose health risks must be in Spanish and identify the relevant ingredients.

General Labeling Principles

All labeling information must be clear, legible, indelible, and presented in contrasting colors to ensure readability under normal conditions of purchase and use. Information provided to consumers must be truthful and verifiable.

Specifically, mandatory information must appear in a clearly visible location on the primary or secondary packaging. Where the nature of the product makes this impracticable, the label may be affixed to the packaging.

2.5 Claims

Cosmetic claims in Mexico are regulated to prevent consumer deception and ensure that products are marketed in a truthful, verifiable, and non-therapeutic manner. The following types of claims are prohibited:

• Claims that cannot be substantiated or verified;

• Medicinal or therapeutic claims, which shall not be attributed to cosmetic products;

• Misleading representations through labeling, advertising, names, trademarks, images, or any other figurative or non-figurative elements that imply characteristics or properties the product does not possess.

Additional restrictions apply to sunscreens. In particular:

• Claims such as “100% protection” or “total UV blocker” are prohibited;

• Claims such as “no need to reapply” or “all-day protection” are not permitted.

2.6 Advertising

General Requirements and Prohibitions

Cosmetic advertising in Mexico must comply with the following general principles:

• Advertising messages must be verifiable and must not mislead consumers regarding product quality, origin, purity, preservation, or intended use;

• Messages should include informative and educational content;

• Advertising elements must be consistent with the authorized characteristics and uses of the product.

Advertising must neither encourage behaviors or practices harmful to physical or mental health, nor may it threaten personal safety, integrity, or dignity, particularly with respect to women.

Advertising for cosmetic products must include slogans promoting hygiene and health, unless such concepts are already conveyed through images, text, scenes, or dialogue.

Advertising is prohibited where it:

• Attributes therapeutic, preventive, or rehabilitative properties to cosmetic products;

• Suggests changes to body proportions;

• Presents cosmetic products as indispensable to human life.

Products classified as cosmetic treatments must be advertised strictly in line with their authorized use.

Advertising Notification

Parties responsible for cosmetic advertising must submit a notification via the DIGIPRIS platform on a per-brand basis. At a minimum, the notification must include:

• Name and address of the manufacturer;

• Name and address of the importer and distributor;

• Brand name and Federal Taxpayer Registry information of the party responsible for the product and its advertising.

2.7 Post-Market Surveillance

Following market placement, cosmetic products are subject to post-market surveillance by COFEPRIS. Manufacturers, importers, and distributors must retain safety, efficacy, and other supporting studies required under applicable laws and standards, and must provide such documentation to the Ministry of Health upon request. Ongoing compliance is essential to mitigate enforcement risks and ensure continued market access.