Registration of Cosmetics in Mexico - Global Regulatory Partners, Inc.

Registration of Cosmetics in Mexico

Esperanza Olivares Lopez

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Table of Contents

Overview of Cosmetics' Regulations in Mexico Definition of Cosmetics in Mexico Different Categories of Cosmetics Introduction of Cosmetics in Mexico Advertising Permit Fees and Timelines References

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Overview of Cosmetics Regulations 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. Its purpose is to protect the health of the population.

COS

CAS

CCAyAC

CGSFS

Cofepris

CGJC

CEMAR

SG

CIS

? Cosmetics do not need to be registered or notified to Cofepris prior to commercialization.

? Manufacturers are required to obtain a business license prior selling cosmetics in Mexico.

? Manufacturers must comply with Cofepris regulation regarding list of ingredients, products' claims on packaging and labeling requirements.

? Manufacturers must register with Cofepris the advertisements for cosmetic.

Definition of Cosmetics in Mexico

Cofepris defines cosmetics 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".

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Different Categories of Cosmetics

Products of any origin, regardless of their physical state, intended to modify the natural smell of the human body Products or preparations for external use intended to preserve or

improve personal appareance Products or preparations intended for personal hygiene

Repellents that are applied directly to the skin

Introduction of Cosmetics in Mexico

? Appoint a Local Representative

Step 1

Step 2 ? Check on the Status of the Ingredients ? Check on the Compliance of the Claims

Step 3

Step 4 ? Check on the Content of the Labelling ? Request for an Importation License

Step 5

? Request an Advertising permit

Step 6

Introduction of Cosmetics in Mexico

Step 1: Appoint a Local Representative

Foreign companies must appoint a local representative in Mexico before introducing a cosmetic product to Mexican market.

The local representative in Mexico must have the sanitary license to handle and sell cosmetic products in Mexico.

Step 2: Check the Status of the Ingredients

The company must check that the ingredients included in the cosmetic product are not listed in the forbidden or restricted list of ingredients as defined in Articles 234 and 245 of the General Health Law, drugs, prepared drugs and the following may not be used in the preparation of perfume and beauty products.

Step 3 : Check on the compliance of the Claims

? The company must check that no therapeutic claims are made on the labelling of the cosmetic product.

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Introduction of Cosmetics in Mexico

Step 4: Check the Content of Labeling

Cosmetics must follow the Mexican Official regulation NOM-141-SSA/SCFI-2012, Labeling for prepackaged cosmetic products. ( similar to ISO/FDIS 22175:2005, for Cosmetics-Packaging and labeling)

All the labeling content should be in Spanish.

The labeling for a cosmetic product should : Include truthful and verifiable information Include generic and specific name of the product Include identification of the person responsible for the product. Include the batch number Include the Instructions or mode of use Not include prohibited property statements Comply wit the commercial information as per the provisions of NOM-008-SCFI-2002 General System of Measurement Units Include the sanitary information

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