The classification query submitted to the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is a crucial step in regulating cosmetic products and dietary supplements.
Through this procedure, companies can ensure compliance with the applicable health regulations for these types of products in Mexico, as it verifies that their formulation and labeling correspond to a cosmetic or a dietary supplement, and therefore that their commercialization under these product categories is viable.
COFEPRIS, as the regulatory agency in Mexico, aims to ensure the safety, quality, and efficacy of products marketed within the national territory. For this reason, it is essential to understand the classification of a product, as it determines the specific requirements for its manufacturing, labeling, and commercialization.
The classification query proves to be a valuable resource, but this procedure is not a sanitary authorization; however, it provides an official technical opinion from COFEPRIS regarding the product’s category and its regulatory compliance.
To submit a classification query to the sanitary authority, the following information must be provided for each product intended for commercialization:
Product description: product name, designation, and intended use.
Quali-quantitative formula: list of ingredients and their concentrations.
Instructions for use.
Label sample and commercial information: original labeling and, where applicable, labeling from the country of origin.
COFEPRIS will review the submitted information and issue the corresponding technical opinion within approximately 90 business days, indicating whether or not the product qualifies as a cosmetic or a dietary supplement. In some cases, the authority may request additional information before issuing a response.
An incorrect product classification may result in significant delays in commercialization, additional costs due to reformulation or relabeling, and regulatory non-compliance, which could lead to fines or even product withdrawal from the market. Therefore, it is strongly recommended to carry out this procedure in the early stages of product development.
For more information on the regulation and general considerations for cosmetics and dietary supplements, you can consult our previously published articles:
Written By:
Mariel Antonio
Tania Ramírez
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We offer comprehensive advisory services to:
Prepare and submit your classification query request.
Ensure that your product complies with all applicable regulations.
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