Cosmetic Regulations in Mexico: A Comprehensive Guide

1. Governing Body:

• COFEPRIS (Federal Commission for the Protection against Sanitary Risk):
  • COFEPRIS is the regulatory body overseeing cosmetics in Mexico.
  • It operates under the Ministry of Health and is responsible for ensuring the safety, efficacy, and quality of cosmetic products.

2. Regulatory Framework:

• General Health Law:
  • The General Health Law and its regulations serve as the primary legal framework for cosmetics.
  • The law outlines the definitions, requirements, and standards for cosmetic products.

3. Definition of Cosmetics:

• In Mexico, cosmetics are defined as substances or mixtures intended to be placed in contact with the external parts of the human body, teeth, and mucous membranes for the purpose of cleaning them, perfuming them, altering their appearance, and/or correcting body odors.

4. Registration and Notification:

• Sanitary Registration:
  • Certain cosmetic products require sanitary registration with COFEPRIS before being marketed.
  • Others can be marketed without registration but must comply with the applicable regulations and standards.

5. Labeling and Ingredient Disclosure:

• Labeling Requirements:
  • Labels must be in Spanish and include information such as the product's name, net content, country of origin, instructions for use, precautions, and manufacturer details.
• Ingredient Listing:
  • Ingredients must be listed in descending order of predominance.
  • The INCI nomenclature is used for ingredient naming.

6. Prohibited and Restricted Ingredients:

• COFEPRIS maintains a list of substances that are prohibited or restricted in cosmetic products.
• It is crucial for manufacturers to regularly check this list and ensure product compliance.

7. Good Manufacturing Practices (GMP):

• Cosmetics must be manufactured according to Good Manufacturing Practices to ensure product quality and safety.
• COFEPRIS can inspect manufacturing facilities to verify compliance with GMP.

8. Adverse Event Reporting:

• Manufacturers, importers, and marketers are required to report any adverse events or reactions associated with the use of cosmetic products to COFEPRIS.

9. Imported Cosmetics:

• Imported cosmetic products must comply with Mexican regulations and standards.
• They may be subject to inspection by COFEPRIS upon entry into the country.

10. Organic and Natural Claims:

• There are no specific regulations for "organic" or "natural" claims for cosmetics, but such claims must be truthful and substantiated.

11. Animal Testing:

• In 2020, Mexico banned the use of animal testing for cosmetic products and ingredients.
• The law also prohibits the manufacture, import, or marketing of cosmetics tested on animals.

Additional Resources:

• COFEPRIS Website - The official website of COFEPRIS provides resources and guidelines related to cosmetic regulations.