ARCSA – Agencia Nacional de Regulación, Control y Vigilancia Sanitaria
Link for RA:
Decision No 833
Who can register :
Data to be communicated :
- Name of the Legal Representative or Proxy accompanied by the documents that prove their representation, according to current national regulations
- Name or business name and address of the manufacturer(s) and the holder of the NSO
- When applicable, the bottler and conditioner’s name or company name and address.
- 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.
- Commercial presentation
- Cosmetic Form
- Name of the technical person in charge (Pharmacist Chemist)
- Payment of the fee established by the Member Country
- The description of the product with an indication of its qualitative formula.
- International or generic nomenclature of ingredients (INCI)
- Organoleptic and physicochemical specifications of the finished product
- Microbiological specifications, when appropriate, according to the nature of the finished product and current Andean regulations
- 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
- 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
- Instructions for the use of the product, when applicable
- Primary and secondary packaging material, when appropriate
- Description of the production batch coding system. If there is more than one manufacturer of the product, each manufacturer must submit this information.
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 is in charge of 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.
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.