Mexico Cosmetic Regulations

Mexico is among top 10 global markets for cosmetic and personal care products. The leading categories of products include skin care, hair care (20% of market), fragrances (14% of market), color cosmetics and nails (15% of market).  

Cosmetic Market in Mexico (Figures in billions of USD)

2017201820192020(Estimated)
Total Local Production6.907.107.157.10
Total Exports2.552.672.652.62
Total Imports2.762.873.002.94
Imports from the U.S.0.890.900.920.90
Total Market Size*7.117.307.507.42
Exchange Rates18.9119.2319.2620.00

 

 

Regulatory Bodies in Mexico

The Federal Commission for Protection against Health Risks (COFEPRIS) is a decentralized body of the Ministry of Health, that has a technical, administrative and operational autonomy. COFEPRIS is responsible for protection of heath of population by regulating the pharmaceutical, cosmetics, nutrition and other health products.

mexico cosmetic regulations

Definition of Cosmetics in Mexico

A cosmetic is defined as “substances or formulations intended to be brought into contact with the superficial parts of the human body: epidermis, hair and capillary system, nails, lips and external genitalia, or with teeth and oral mucosa for the sole or primary purpose of cleaning, perfuming them , help modify their appearance, protect them, keep them in good condition or correct body odors or attenuate or prevent deficiencies or alterations in the functioning of healthy skin”.

 

Cosmetic Registration in Mexico

  • There is no  registration requirement for cosmetics in Mexico, however, manufacturers need to comply with Cofepris requirements
  • In order to commercialize cosmetic products in Mexico, manufacturers must obtain a business license.
  • Cosmetic products need not be registered or notified to Cofepris for commercialization and distribution in Mexico. However, manufacturers and distributors of cosmetic products must comply with the Cofepris guidelines regarding the cosmetic ingredients used, product claims and labelling requirements.
  • It is mandatory to register the advertisements for cosmetic with Cofepris and obtain approval

Cosmetic Products Categories in Mexico

Products of any origin, regardless of their physical state, intended to modify the natural smell of the human bodyProducts or preparations for external use intended to preserve or improve personal appearanceProducts or preparations intended for personal hygieneRepellents that are applied directly to the skin

 

Regulatory Process for Commercializing Cosmetics in Mexico

It is mandatory to have a legal representative in Mexico for foreign manufacturers in order to import and commercialize cosmetic products. This legal representative could be the distributor who will own the business license and import permit in Mexico. However, many cosmetic companies intend to protect their formulation and intellectual property and therefore seek a regulatory partner who could be the license holder for the company in Mexico while distributor focuses on the commercialization.

 

The regulatory process in Mexico includes,

  • Appointment of a Regulatory Partner as Local Representative: The local representative must have a sanitary license in Mexico and a foreign manufacturer needs to appoint a local representative to import cosmetics in Mexici.
  • Ingredient Assessment: Assessment of ingredients safety against the prescribed list from Cofepris. Articles 234 and 245 of the General Health Law defines the prohibited list of ingredients as well as restricted list of ingredients. Manufacturers must review their product ingredients and compositions.
  • Label review
    1. Manufacturers must comply with Mexico’s labelling guidelines n NOM-141-SSA/SCFI-2012
    2. The labelling content must be in Spanish (translated from original version)
    3. Content on the label: the label must include the following information,
      1. The content must be truthful and verifiable
      2. Generic and specific name of the product
  • Name and identification of the responsible person for the product
  1. Batch number
  2. Instructions for use
  3. Should not include any prohibited statements
  • Any commercial information must comply with provisions of NOM-008-SCFI-2002 General System of Measurement Units
  • Include registration details
  • Claims Assessment
    1. Manufacturers are prohibited to make therapeutic claims for cosmetic products, therefore the claims must be validated before marketing the products
  • Application for Import License
    1. In order to obtain the import license, a manufacturer must identify the applicable tariff code for the cosmetic product
    2. Enrol on the register of importers
    3. Request for an import permit through the Ministry of Economy’s website
    4. Obtain RFC with active status. The status of the RFC will be automatically verified with SAT by the SE.

 

  • Application for Advertisement Permit: An advertising permit is mandatory to promote a product in Mexico irrespective of manufacturer’s country of origin
    1. Manufacturers must fill the publicity form (Cofepris-020-002-D) available on Cofepris website
    2. Develop advertising material and send for third party review to obtain opinion. A third party is notified body designated by Cofepris to evaluate product conformity.
    3. Submit the publicity form along with third party opinion to Cofepris
    4. Cofepris will review the application
    5. Permit granted
    6. Manufacturer will enter into contract with agencies for publicity – print, TV
    7. Advertise the product

Timelines and Fee:

Advertising ApplicationTimelineFee
Advertising Application w/o third party opinion40 business daysNo fee
Advertising Application w/ third party opinion5 business daysFee depends on 3rd party

 

References:

Mexico Country Commercial Guide

NOM-141-SSA/SCFI-2012

 

Artixio is a global integrated compliance, commerce, creative and communication agency helping cosmetic companies identify new products, suppliers, assess new markets, pricing and help them with registration in global markets for product launch. For more details about Artixio’s services in Mexico, please write to us at info@artixio.com

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