The Federal Commission for Protection against Health Risks (COFEPRIS)
Link for RA:
General Health Law
Who can register :
There is no registration requirement for cosmetics in Mexico. However, manufacturers and distributors need to comply with COFEPRIS requirements.
A legal representative from Mexico
Data to be communicated :
- Technical and scientific data demonstrating the product’s safety and efficacy;
- Laboratory tests, if applicable; detailed product description.
- The origin country’s Ministry of Health issued a Certificate of Free Sale;
- The Certificate of Sale must have current ISO 13485 certification, CE marking, or a Declaration of Conformity with US GMP.
- A list of accessories/components;
- Instruction manual and labelling (Spanish)
- Overview of the sterilising method/manufacturing process
- Clinical studies.
Appoint a Local Representative
- Before bringing a cosmetic product to the Mexican market, foreign corporations must appoint a local agent.
- The local agent must hold a sanitary licence to handle and sell cosmetic items in Mexico.
Check the Status of the Ingredients
- The company must ensure that the cosmetic product’s ingredients are not on the prohibited or restricted list of ingredients as defined in Articles 234 and 245 of the General Health Law, which prohibits the use of drugs, prepared drugs, and the following: preparation of perfume and beauty products.
Check on the compliance of the Claims.
- The manufacturer must ensure that no medicinal claims are stated on the cosmetic product’s labelling. Examine the Labeling’s Content
Request for an Importation License – The company must
- Register in the register of importers.
- Determine the cosmetic product’s tariff code.
- On the Ministry of Economy’s website, you can apply for an import permit.
- Have an active RFC. The SE will check the status of the RFC with the SAT electronically.
Timeframe and fees:
The COFEPRIS takes around from 4 to 12 months to manifest the registration request and charges registration fees by-product (which vary depending on the classification). In addition, the registration is valid for five years.
- Labelling for pre-packaged cosmetic products must follow the Mexican Official regulation NOM-141-SSA/SCFI-2012.
- All the labelling content should be in Spanish.
- The labelling for a cosmetic product should :
- Include truthful and verifiable information
- Include the product’s general and particular names.
- Include the name and contact information of the person in charge of the product.
- Include the batch number
- Include the Instructions or mode of use
- Not include prohibited property statements
- Comply with the commercial information as per the provisions of NOM-008-SCFI-2002 General System of Measurement Units
- Include the sanitary information