How to classify a cosmetic product in Mexico: a regulatory case study
One of the most common mistakes when introducing a cosmetic product into the Mexican market is assuming that its regulatory classification depends solely on its formulation. In reality, health authorities evaluate multiple factors before determining whether a product can be marketed as a cosmetic.
In addition to its ingredients, aspects such as the product's intended use, claimed benefits, labeling, and even advertising may significantly influence its regulatory classification.
Making an incorrect decision at the outset may lead to commercialization delays, labeling redesign costs, revisions to marketing campaigns, or even the need to comply with an entirely different regulatory framework.
In this article, we analyze a case study that reflects a common situation faced by international manufacturers seeking to introduce cosmetic products into the Mexican market.
Case Study
An international company specializing in hair care products intends to commercialize a botanical anti-dandruff shampoo in Mexico. The product is currently marketed in several countries.
Its formulation includes ingredients commonly used for scalp care, including:
Salicylic Acid
Tea Tree Oil
Rosemary Extract
Panthenol
Niacinamide
At first glance, the product appears to fit within the cosmetic category.
However, a review of its promotional materials and labeling used in other markets reveals claims such as:
Eliminates dandruff.
Treats scalp disorders.
Controls fungal growth.
Restores scalp health.
Prevents dandruff recurrence.
Can this product be marketed as a cosmetic in Mexico, or does it require a different regulatory classification?
What will we evaluate?
Regulatory classification is not limited to determining whether an ingredient is permitted or prohibited.
Instead, the assessment integrates several factors that, taken together, determine the appropriate regulatory framework applicable to the product.
Among the main aspects evaluated are:
The formulation.
The function of each ingredient.
Ingredient concentrations.
The intended use of the product.
Directions for use.
Labeling.
Advertising materials.
The benefits communicated to consumers.
It is the combination of these elements that ultimately determines the product's regulatory classification.
The Formulation
The first step is to conduct a detailed review of the product's composition.
Identifying the ingredients alone is not sufficient. It is also necessary to understand the technological and cosmetic function of each ingredient within the formulation.
In this case, ingredients such as panthenol and niacinamide are widely used to improve the appearance and conditioning of the hair.
Botanical extracts, including tea tree oil and rosemary extract, may also be incorporated into cosmetic products provided their intended purpose remains consistent with cosmetic use.
However, salicylic acid requires a more careful evaluation.
Although it may be used in certain cosmetic products under specific conditions, its concentration, intended purpose, and the way it is communicated to consumers are determining factors when assessing regulatory risk.
At this stage, there is no sufficient basis to rule out cosmetic classification.
The product's intended use
One of the most important questions during a regulatory evaluation is: What is the product actually intended to do?
Mexican legislation establishes that a cosmetic is intended to be applied to the external parts of the human body for purposes such as:
Cleansing.
Perfuming.
Changing appearance.
Keeping the skin or hair in good condition.
Protecting.
Correcting body odors.
When a product is intended to modify physiological functions, prevent diseases, or treat medical conditions, it no longer falls within the cosmetic category.
In this case study, if the shampoo is intended solely to cleanse the scalp and reduce the visible appearance of dandruff, it may remain within the cosmetic category.
However, if its stated purpose is to eliminate infections, control microorganisms, or treat dermatological conditions, the regulatory assessment changes significantly.
Claims
In many cases, the greatest regulatory risk does not lie in the formulation itself, but rather in how the product is presented to consumers.
During the review of the original labeling, the following statements were identified:
Treats scalp disorders.
Controls fungal growth.
Prevents dandruff recurrence.
Restores scalp health.
From a regulatory perspective, these statements attribute therapeutic properties to the product.
Such claims may lead the health authority to determine that the product serves a purpose beyond that of a cosmetic.
By contrast, statements such as the following are generally more consistent with cosmetic products:
Helps reduce the visible appearance of dandruff.
Deeply cleanses the scalp.
Provides a refreshing sensation.
Helps maintain healthy-looking hair.
Contributes to the cosmetic care of the scalp.
Although the distinction may seem subtle from a commercial standpoint, it represents a significant regulatory difference.
Labeling
Once the formulation and claims have been evaluated, the next step is to assess label compliance.
Among other elements, the following should be verified:
Product name.
Ingredient list using INCI nomenclature.
Manufacturer or responsible party information.
Net content.
Directions for use.
Applicable warnings.
Mandatory information in Spanish.
It is important to remember that even a technically compliant label may become problematic if it includes claims that exceed the scope of cosmetic products.
Identified Risks
Following the comprehensive assessment, several regulatory risks are identified, including:
Product reclassification due to therapeutic claims.
Observations during import procedures.
The need to modify labels.
Changes to advertising campaigns.
Commercialization delays.
Increased regulatory costs.
In most cases, these risks can be prevented through a technical regulatory assessment before entering the Mexican market.
Recommended regulatory strategy
Based on the analysis, the recommended approach is to develop a comprehensive regulatory strategy that includes:
Technical review of the formulation.
Evaluation of each ingredient and its function.
Verification of compliance with applicable regulations.
Assessment of ingredient concentrations where restrictions may apply.
Review and adjustment of product claims.
Label validation.
Evaluation of advertising and promotional materials.
When uncertainty regarding the regulatory classification remains, it may also be advisable to request a Classification Query from the health authority to obtain greater regulatory certainty before commercialization.
Conclusions
This case demonstrates that properly classifying a cosmetic product involves much more than reviewing a list of ingredients.
A regulatory assessment requires a comprehensive analysis of the product, taking into account its composition, intended use, labeling, advertising, and commercial positioning.
The same shampoo may receive different regulatory classifications depending on how it is presented to consumers and the benefits it claims to provide.
For this reason, conducting a regulatory assessment early in the product development or market entry process allows companies to identify potential risks, optimize commercialization timelines, and reduce costs associated with subsequent modifications.
In an increasingly demanding regulatory environment, product classification should not be viewed as a mere administrative step, but rather as a strategic decision that directly impacts market access and regulatory compliance.
FAQ
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Yes. Claims suggesting that a product prevents, treats, or cures diseases—or modifies physiological functions—may lead authorities to determine that the product no longer falls within the cosmetic category. Ensuring that claims are consistent with the product's intended cosmetic purpose is an essential part of regulatory compliance.
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No. A product's regulatory classification may vary from one country to another. Even if a product is marketed as a cosmetic in jurisdictions such as the European Union or other international markets, it must still be evaluated under the Mexican regulatory framework to confirm that its formulation, intended use, labeling, and advertising claims comply with local requirements.
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A Classification Query may be advisable when there is uncertainty regarding the regulatory category of a product under the Mexican regulatory framework. This may occur when a product's formulation, intended use, or advertising claims place it near the boundary between two regulated categories.
Obtaining a classification opinion from COFEPRIS before commercialization can provide greater regulatory certainty and help companies define the appropriate compliance strategy, reducing the risk of delays, regulatory observations, or unexpected changes during market entry.
Written by:
Mariel Antonio
Regulatory affairs specialist with extensive technical expertise in the sanitary authorization and surveillance of advertising in digital platforms and traditional media. She provides strategic guidance to dietary supplement, cosmetic, and medical device companies to ensure strict compliance with current regulations.
About IPS
If your company is planning to commercialize cosmetic products in Mexico, IPS provides comprehensive regulatory support to help you navigate the Mexican regulatory framework with confidence. Our specialists assist manufacturers, importers, and distributors with product classification, formulation assessments, labeling reviews, advertising, and regulatory compliance strategies tailored to the Mexican market.
Contact us at info@insumosparasalud.com to learn more about our specialized regulatory services for cosmetic products.
