1

Registration of Cosmetics in Mexico

Esperanza Olivares Lopez

2

Table of ContentsOverview 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

Overview of Cosmetics Regulations in Mexico

Cofepris

CAS

CCAyAC

CGJC

SG

CIS

CEMAR

CGSFS

COS

• Cosmetics do not need to be registered ornotified to Cofepris prior tocommercialization.

• Manufacturers are required to obtain abusiness license prior selling cosmetics inMexico.

• Manufacturers must comply with Cofeprisregulation regarding list of ingredients,products’ claims on packaging and labelingrequirements.

• Manufacturers must register with Cofepristhe advertisements for cosmetic.

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.

PresenterPresentation Notes*AbbreviationCFS- Comisión de Fomento Sanitario.COS- Comisión de Operación SanitariaCCAyAC- Comisión de Control Analítico y Ampliación de CoberturaCAS- Comisión de Autorización SanitariaCEMAR- Comisión de Evidencia y Manejo de RiesgoCGSFS- Coordinación General del Sistema Federal SanitarioCGJC- Coordinación General Jurídica y ConsultivaCIS-Centro Integral de Servicios

4

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”.

Definition of Cosmetics in Mexico

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 orimprove personal appareance

Products or preparations intended for personal hygiene

Repellents that are applied directly to the skin

Different Categories of Cosmetics

Introduction of Cosmetics in Mexico

Step 1• Appoint a Local Representative

Step 2 • Check on the Status of the Ingredients

Step 3• Check on the Compliance of the Claims

Step 4 • Check on the Content of the Labelling

Step 5• Request for an Importation License

Step 6• Request an Advertising permit

7

Introduction of Cosmetics in MexicoStep 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.

Introduction of Cosmetics in MexicoStep 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 useNot include prohibited property statementsComply wit the commercial information as per the provisions of NOM-008-SCFI-2002 General

System of Measurement Units Include the sanitary information

9

Introduction of Cosmetics in MexicoStep 5: Request for an Importation LicenseThe company must :

Register in the register of importers.

Identify the Tariff code for the cosmetic product Example: 3303 Perfumes and toilet

waters,

Request for the importation permit in the Ministry of Economy website:

Have RFC with active status. The SE will electronically verify the status of the RFC

with the SAT.

10

Step 6 : Request for an Advertising Permit

1 • Complete “Publicity Form" available on COFEPRIS web page - COFEPRIS-02-002-D

2• Create advertising Project and send to third party for evaluation• Obtain opinion from third party

4 • Submit Third Party review & Plubicity Form to Cofepris

3 • Cofepris Reviews Request

4 • Obtain permit and make a contract with a company (TV, newspaper, etc)

5 • Publicise the product

To advertise a cosmetic, regardless of the origin of the manufacturer, he must have an advertising permit issued by COFEPRIS

Introduction of Cosmetics in Mexico

Advertising Permit Fees & Timelines

*3rd Party known as "notified bodies can review the advertising project before request to COFEPRIS. A notified body is an organization designated by Cofepris to assess the conformity of certain products before being placed on the

market. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation.

12

References• Health Secretary NOM-141-SSA/SCFI-2012, Labeling for prepackaged cosmetic products. Sanitary and commercial

labeling. Published January 17th 2012. Consulted May 19th 2020. Available at http://www.dof.gob.mx/nota_detalle.php%3Fcodigo%3D5269348%26fecha%3D19/09/2012

• Health Secretary PROY-NOM-259-SSA1-2014, Products and services. Good manufacturing practices in cosmetic products. Published January 20th 2015. Consulted April 29th 2020. Available at http://www.dof.gob.mx/nota_detalle.php?codigo=5378954&fecha=20/01/2015

• Health Secretary NOM-008-SCFI-2002 General System of Measurement Units. Published October 24th 2002. Consulted May 19th 2020. Available at http://dof.gob.mx/nota_detalle.php?codigo=718870&fecha=27/11/2002

• Ley General de Salud. Diario Oficial de la Federacion. Mexico

• Official Journal of the Federation. AGREEMENT BY WHICH PROHIBITED AND RESTRICTED SUBSTANCES ARE DETERMINED IN THEPREPARATION OF PERFUMERY AND BEAUTY PRODUCTS. Available at: http://dof.gob.mx/nota_detalle.php?codigo=5143790&fecha=21/05/2010

• Oficial Jorunal of the Federation. AGREEMENT AMENDING THE MISCELLANEOUS BY WHICH THE PROHIBITED AND RESTRICTED SUBSTANCES IN THE PRODUCTION OF PERFUMERY AND BEAUTY PRODUCTS ARE DETERMINED. Available at https://www.dof.gob.mx/nota_detalle.php?codigo=5335505&fecha=11/03/2014

• Reglamento de la Ley General de Salud en Materia de Investigacion para la Salud. Diario Oficial de la Federacion. Mexico.

http://www.dof.gob.mx/nota_detalle.php%3Fcodigo%3D5269348%26fecha%3D19/09/2012http://www.dof.gob.mx/nota_detalle.php?codigo=5378954&fecha=20/01/2015http://dof.gob.mx/nota_detalle.php?codigo=718870&fecha=27/11/2002http://dof.gob.mx/nota_detalle.php?codigo=5143790&fecha=21/05/2010https://www.dof.gob.mx/nota_detalle.php?codigo=5335505&fecha=11/03/2014

13

Thank You

Esperanza Olivares Lopez(USA) +1 781-672-4200( MX)+52 557373-4841

info@globalregulatorypartners.com

Global Regulatory Partners

Gracias

Slide Number 1Table of ContentsOverview of Cosmetics Regulations in MexicoDefinition of Cosmetics in MexicoDifferent Categories of CosmeticsIntroduction of Cosmetics in MexicoIntroduction of Cosmetics in Mexico�Introduction of Cosmetics in MexicoIntroduction of Cosmetics in MexicoStep 6 : Request for an Advertising PermitAdvertising Permit Fees & TimelinesReferencesThank You