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Ecuador Cosmetic Product Registration

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Ecuador Cosmetic Product Registration

COSMETIC REGISTRATION IN ECUADOR

Regulatory Authority

ARCSA – Agencia Nacional de Regulación, Control y Vigilancia Sanitaria

Link for Regulatory Authority

https://www.controlsanitario.gob.ec/

Local Regulation

Decision No 833 

Who can Register?

Importer 

Data to be Communicated

  1.  Name of the Legal Representative or Proxy accompanied by the documents that prove their representation, according to current national regulations.
  2.  Name or business name and address of the manufacturer(s) and the holder of the NSO
  3.  When applicable, the bottler and conditioner’s name or company name and address.
  4.  Name of the product, its generic denomination that allows its identification, and when applicable, the name of the cosmetic group and the brand or brands of the product. These must be consistent with the function and characteristics of the product and not mislead or confuse with other types of products.
  5.  Commercial presentation
  6.  Cosmetic Form
  7.  Name of the technical person in charge (Pharmacist Chemist)
  8.  Payment of the fee established by the Member Country
  9.  The description of the product with an indication of its qualitative formula.
  10. International or generic nomenclature of ingredients (INCI)
  11.  Organoleptic and physicochemical specifications of the finished product
  12. Microbiological specifications, when appropriate, according to the nature of the finished product and current Andean regulations
  13. Technical, experimental, and scientific studies, among others that justify the benefits, proclamations, and effects of a cosmetic nature attributable to the finished product, whose inaccuracy may represent a health problem.
  14. Label or labelling, or art project of the label or labelling. If only the label art project is presented, the holder of the NSO must deliver the label to the Competent National Authority immediately after its commercialization has begun. The delivery of the label will be part of the initial file.
  15. Instructions for the use of the product, when applicable
  16. Primary and secondary packaging material, when appropriate
  17. Description of the production batch coding system. If there is more than one manufacturer of the product, each manufacturer must submit this information.

Process to Register Cosmetic Product

For all cosmetic products introduced into the CAN market, a Mandatory Sanitary Notification (NSO – Notificación Sanitaria Obligatoria) is required. The natural or legal person who notifies, alters, renews, or asks recognition of the NSO from the Competent National Authority is the NSO’s owner. 

This person must be based in the Member Country of notice or recognition and oversees the cosmetic product’s regulatory compliance.  Cosmetic products produced in the Member States or sold on the Community market must follow Good Manufacturing Practices (GMP). Furthermore, cosmetics must adhere to the Andean Technical Regulation on Microbiological Technical Specifications of Cosmetic Products, which establishes microbiological content restrictions. 

Timeframe and Fees

In ECUAPASS-vue system, the form is: “REQUEST FOR COMPULSORY SANITARY NOTIFICATION (NSO) OF COSMETIC PRODUCTS”. The regulation applies in all the countries of the Andean Community (CAN) -Decision 516- so, a single NSO lets to sell in Ecuador, Venezuela, Colombia and Perú. To register Foreign Cosmetics the COST of ARCSA is $ 904.34 usd and, for Ecuadorian Cosmetics is 565.21 usd.    

Additional Information

Cosmetics intended for the Andean Community market must adhere to international lists of ingredients that may or may not be added to goods and their associated functions and restrictions on use circumstances. These are the lists: 

  • Lists and dispositions issued by the U.S. Food and Drug Administration (FDA).
  • The Personal Care Products Council Cosmetic Ingredient List.
  • Directives and Regulations of the European Union refer to cosmetic ingredients.
  • Ingredients lists of Cosmetics Europe – The Personal Care Association.

Decision 833/2018 outlines the criteria and standardizes the processes necessary for the production, storage, importation, and commercialization of cosmetic products within the CAN. It also establishes guidelines for quality control and health monitoring. Resolution 2206/2121 details the Good Manufacturing Practices (GMP) prerequisites that companies involved in cosmetic products must adhere to secure health authorization for operations and obtain a GMP certification.

However, within the CAN, each member state operates under its own regulatory framework. In Ecuador, the National Agency for Health Regulation, Control, and Surveillance (ARCSA) serves as the technical authority responsible for overseeing the regulation, control, and health monitoring of cosmetic products. 

The marketing of cosmetics in Ecuador is governed by Resolution ARCSA-DE-006-2017-CFMR, available exclusively in Spanish on the websites of ARCSA and Procosméticos. Moreover, for marketing within the CAN region, cosmetic products necessitate mandatory health notification (Notificación Sanitaria Obligatoria – NSO). 

Chapter III of Decision 833/2018 outlines all the requirements for NSO application.Currently, the Ecuadorian government does not have national legislation prohibiting animal testing for cosmetic products, although this remains a subject of ongoing discussion. The permitted ingredients for cosmetic products are outlined in Articles 3, 4, and 5 of Decision 833. Regardless, all cosmetic products marketed must adhere to international ingredient lists. 

The restriction or prohibition of specific ingredients is determined by the national competent authority, the General Secretariat of the Andean Community (SGCAN), based on technical assessments from reference organizations or scientific studies demonstrating potential health impacts.

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