The cosmetics industry in Mexico is subject to a robust regulatory framework enforced by the Federal Commission for Protection against Health Risks (COFEPRIS). This oversight aims to safeguard consumer health and ensure product safety and quality. Given the growing popularity of cosmetics, understanding these regulations is crucial for businesses operating within this sector.
Cosmetic products in Mexico are regulated by the Federal Commission for Protection against Health Risks (COFEPRIS, by its acronym in Spanish). This agency is responsible for controlling and monitoring the marketing of these products and developing the necessary applicable regulations.
Given the surge in cosmetics marketing, these products have garnered heightened attention in Mexico. Therefore, distributors and manufacturers seeking to market these products must be well-versed in and adhere to the requirements to avoid potential sanctions or fines from the authority.
According to the General Health Law, cosmetics are products that are applied directly to the external parts of the human body like skin, lips, nails, teeth, external genital organs, and buccal mucosa. These products aim to modify the body´s natural odor, preserve or enhance personal appearance, or contribute to personal hygiene. It's important to consider only applying it to healthy skin.
Do not include products that are ingested, injected, or inhaled; not those that are indicated to cure any disease nor regulate weight.
The applicable regulations for cosmetics products in Mexico:
1. General Health Law
2. Regulation on the Sanitary Control of Products and Services
3. Mexican Official Standard NOM-259-SSA1-2022, Products and Services. Good Manufacturing Practices in Cosmetics Products
4. Mexican Official Standard NOM-141-SSA1/SCFI-2012. Labeling for Prepackaged Cosmetic Products. Sanitary and Commercial Labeling Requirements.
5. Agreement determining Prohibited and Restricted Substances in the Elaboration of Perfumery and Beauty Products.
A list of cosmetic products is described in the Regulation on the Sanitary Control of Products and Services. For example, we find the next type of products:
Deodorants, hair dyes, conditioners, sunscreens, creams, makeup removers, shampoo, gels, nail care products, eyelash and nail adhesives, and more.
To market cosmetics in Mexico, it is necessary to have the following requirements:
Distributor established in Mexico
Classification query
Operating license
Advertising notice by brand
Finally, it is important to note that cosmetic products do not require sanitary registration and only need to submit a notice of advertising by brand. However, advertising for these products should be considered a crucial aspect of their regulation, as it is monitored by the health authority. An ingredient, word, description, or claim that is included in their labeling or advertising may influence and modify the perception of the product, changing it from a cosmetic to a product that requires sanitary registration, which leads to the application of a different regulatory framework to that of this type of product.
Written By:
about ips
In IPS, our regulatory affairs consulting services specialize in guiding you through the intricate regulatory landscape governing cosmetic products. Contact us today to discover how our regulatory affairs consulting services can benefit your cosmetic product endeavors in Mexico: info@insumosparasalud.com