Ecuador - Country Commercial Guide
Standards for Trade
Last published date:

Overview

National standards are set by the Ecuadorian Standards Institute (INEN), an affiliated institution of the Ministry of Production, Trade, Investment, and Fisheries.  INEN is a member of the International Standards Organization (ISO), the Pan-American Technical Standards Commission (COPANT), the Pacific Area Standards Congress (PASC), the International Bureau of Weights and Measures (BIPM), and the Organization Internationale de Metrologie Legale (OIML).  INEN is also affiliated to the International Electrotechnical Commission (IEC) and the Affiliate Conformity Assessment Status (ACAS) from IEC. 

Products subject to technical standards must obtain the INEN-1 certificate in order to clear customs. INEN-1 has a one-year validity.   

INEN has regulations (143) that are compulsory and norms (7,183) that are voluntary.  It is highly recommended that U.S. companies visit INEN’s website for an up-to-date list of products at https://www.normalizacion.gob.ec

A list of regulations can be found at: INEN regulations

Ecuador’s Agriculture Quality Assurance Agency (AGROCALIDAD) is an agency within the Ministry of Agriculture (MAG) responsible for administering Ecuador’s sanitary and phytosanitary (SPS) controls.  As a member country of the WTO, Ecuador must comply with the WTO Agreement on the Application of Sanitary and Phytosanitary Measures.

The National Agency of Sanitary Control and Vigilance (ARCSA) is the regulating body for sanitary control and is an agency under the Ministry of Public Health (MSP).  Sanitary registrations or notifications are required for imported and domestic products such as:  

 Processed foods: https://www.controlsanitario.gob.ec/alimentos-procesados/

Ecuador accepts the U.S. Certificate of Free Sale authorized by the U.S. Food and Drug Administration.  For cosmetics and personal care items, GMP (Good Manufacturing Practices) certificates can be issued by the PCPC (Personal Care Products Council) or any other independent association.  

Standards

As a member of the ISO, Ecuador in general uses the parameters of this organization for standards development.  Besides ISO, INEN also uses International Electrotechnical Commission (IEC) standards, as well as Codex Alimentarius Commission guidelines.  Most INEN regulations include an equivalence from other standards bodies such as ASTM or UL.  However, in the case the importer is required to file an equivalence for any given standard there is an accepted procedure to be followed. 

INEN welcomes for parties to participate in standards development and receives e-mails directly at: reglamentacion@normalizacion.gob.ec. 

Testing, Inspection and Certification

Created in 2007 and linked closely to INEN, the Ecuadorian Accreditation Service (SAE) qualifies laboratories or institutions that may issue conformity assessment certificates.   

A list of accredited and recognized SAE organisms can be found at: https://sisac.acreditacion.gob.ec/accreditations/scopes-public?tab=Nombre%20del%20Organismo%20o%20Raz%C3%B3n%20Social

Products that require INEN certification, therefore testing include: 

  • Vehicles
  • Refrigerators and kitchen appliances 
  • Stoves and ranges 
  • Tires 
  • Electric generators 
  • Textiles, apparel, footwear, and accessories 
  • Certain construction materials such as Portland cement, steel bars, tubing, and piping 
  • Certain automotive components such as security glass, spark plugs, and brake pads 
  • Automotive brake fluids and lubricants 
  • Ceramic tableware and kitchenware 
  • Food products 
  • Toys 
  • Cosmetics and personal care items 
  • Cleaning supplies 
  • Fans 
  • Washing machines and dryers 
  • Pipes and pipeline accessories 
  • Wires 
  • Valves 
  • Radios, televisions, and computers 
  • Jewelry and articles manufactured with pearls and precious metals 
  • Bags, briefcases, backpacks 

Fees related to accreditation for laboratories can be found at: https://www.acreditacion.gob.ec/tarifas-proceso-acreditacion/

Publication of Technical Regulations

INEN is in charge of informing the public of new and revised technical regulations and standards. These regulations are published in Ecuador’s Official Gazette (https://www.registroficial.gob.ec/).  

 For every regulation of modification issued, there is a comment period both at the WTO Technical Barriers to Trade (TBT) Committee or at the CAN level.  INEN also works with industry to receive feedback on regulations. 

Contact Information:

Servicio Ecuatoriano de Normalización, INEN 

Baquerizo Moreno E7-50, Quito 170143 

(593) 2-2382-5960 

 

Agencia Nacional de Regulación, Control y Vigilancia Sanitaria, ARCSA 

Ciudadela Samanes, y, Av. Paseo del Parque, Guayaquil 090112 

(593) 4-372-7440 

 

Agencia de Regulación y Control Fito y Zoosanitario, AGROCALIDAD 

Av. Eloy Alfaro N30-350 y Av. Amazonas esq. 

(593) 2-382-8860 

 

Servicio Nacional de Aduana del Ecuador, SENAE 

Malecón Simón Bolívar entre 9 de Octubre y P. Icaza, Guayaquil - Ecuador 

(593) 4-373-1030 

 

Servicio de Acreditación Ecuatoriano (SAE) 

Av. Amazonas N38-42 y Villalengua

(593) 2-245-4393 

Use ePing to review proposed technical regulations and conformity assessment procedures. 

The ePing SPS&TBT platform (https://epingalert.org/), or “ePing”, provides access to notifications made by World Trade Organization (WTO) Members under the Agreements on Sanitary and Phytosanitary Measures (SPS) and Technical Barriers to Trade (TBT), distributed by the WTO from January 16, 1995 to present.  ePing is available to all stakeholders free of charge and does not require registration unless the user wishes to receive customized e-mail alerts.  Use it to browse notifications on past as well as new draft and updated product regulations, food safety and animal and plant health standards and regulations, find information on trade concerns discussed in the WTO SPS and TBT Committees, locate information on SPS/TBT Enquiry Points and notification authorities, and to follow and review current and past notifications concerning regulatory actions on products, packaging, labeling, food safety and animal and plant health measures in markets of interest. 

Notify U.S., operated and maintained by the National Institute of Standards and Technology (NIST) since 2003 to distribute and provide access to notifications (and associated draft texts) made under the WTO TBT Agreement for U.S. stakeholders, has reached its end of life.  Per obligation under the TBT Agreement, each WTO Member operates a national TBT (and an SPS) Enquiry Point.  National TBT Enquiry Points are authorized to accept comments and official communications from other national TBT Enquiry Points, which are NOT part of the WTO or the WTO Secretariat.  All comment submissions from U.S. stakeholders, including businesses, trade associations, U.S domiciled standards development organizations and conformity assessment bodies, consumers, or U.S. government agencies on notifications to the WTO TBT Committee should be sent directly to the USA WTO TBT Inquiry Point.  Refer to the comment guidance at https://tsapps.nist.gov/notifyus/data/guidance/guidance.cfm for further information.