Describes the country's standards landscape, identifies the national standards and accreditation bodies, and lists the main national testing organization(s) and conformity assessment bodies.

Standards

National standards are set by the Ecuadorian Standards Institute (INEN). INEN is a member of the International Standards Organization (ISO), the Panamerican Technical Standards Commission (COPANT), the Interamerican Metrology System (SIM), the Organisation Internationale de Metrologie Legale (OIML), and is the point of contact for the Codex Alimentarius Commission.

Products subject to technical standards must obtain the INEN-1 certificate in order to clear customs. It is highly recommended that U.S. firms visit INEN’s website for an up-to-date list of products.

The Servicio de Acreditación Ecuatoriano (SAE) establishes the framework, mechanisms, and procedures, and qualifies laboratories or institutions that may issue conformity assessment certificates.

Ecuador’s Agriculture Quality Assurance Agency (AGROCALIDAD) is an agency within the Ministry of Agriculture (MAGAP). It is 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. In most cases, the SPS certificate may be obtained quickly and access is granted hassle-free so long as the proper documentation is submitted. However, denials of SPS certification have been used in a discriminatory fashion to block the import of U.S. products that could compete with Ecuadorian production, e.g., poultry, and dairy products. The ability to import some products, such as rice, corn, soybeans, and soybean meal, is at the discretion of the MAGAP due to government programs aimed at supporting local agricultural production. The government has established import quotas for these and other items based on domestic consumption patterns using an opaque methodology.

AGROCALIDAD follows the “Andean Sanitary Standards” established under the Andean Community of Nations (CAN). Some standards applied to third countries are different from those applied to CAN members. Although CAN is working to harmonize its regulations with those of the WTO, there are cases when specific regulations apply to imports from third countries, some of which do not comply with WTO standards. There are, for example, differences in the requirements for CAN and third countries for the importation of live animals, animal products, plants, and plant by-products.
AGROCALIDAD also requires certifications for each product stating that the product complies with risk analysis and that the country of origin or the area of production is free from certain exotic plant or animal diseases. According to the guidelines of the International Plant Protection Council (IPPC), importing countries are free to develop a pest risk assessment (PRA) and implement mitigation measures to reduce the risk of introduction of exotic diseases or pests. There have been instances when it appeared that PRAs and mitigation measures have been used as trade barriers to protect domestic producers.

ARCSA (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria) is the regulating body for sanitary control. Sanitary registrations or notifications are required for imported and domestic products such as:

  • Processed foods,
  • Natural products,
  • Cosmetics,
  • Personal care items,
  • Pesticides,
  • Pharmaceuticals,
  • Reagents,
  • Medical disposable supplies, and
  • Certain other consumer goods.

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.

Specific sanitary controls regulations can be found at: http://www.controlsanitario.gob.ec/servicios/.

Conformity Assessment

INEN is also in charge of conformity assessment with support from the SAE (Ecuadorian Accreditation Organization). All products subject to standards compliance must obtain the certificate of conformity (INEN-1) prior to shipping the products to Ecuador and must present it at the port of entry to clear Customs.

In December 2013, Ecuador enacted COMEX Resolution 116 requiring conformity assessment certificates on around 300 tariff lines. The certificates were very difficult or impossible to obtain and thus restricted the import of these products. 

Product Certification

INEN requires the following products to have special certification:

  • 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,
  • Contraceptives,
  • 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, and
  • Christmas decorations.

Accreditation

The Ecuadorian Accreditation Organization (SAE) is the official accreditation body in Ecuador. The SAE certifies and recognizes accredited laboratories and accredited standards organizations. Certificates of conformity submitted to INEN must be validated and approved by the SAE.

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/).
 

Contact Information

Servicio Ecuatoriano de Normalización (INEN)
Baquerizo Moreno E8-29 y Diego de Almagro
Quito-Ecuador
Phone number: (593-2) 250-1885 / 256-5626
 
AGROCALIDAD
Av.Eloy Alfaro y Av. Amazonas
Edif. MAGAP piso 9, EC170125
Quito – Ecuador
Phone number: (593-2) 256-7232
 
Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA)
La Razón 280 y El Comercio,
Edificio San Francisco.
Quito – Ecuador
Phone number: (593-2) 382-4230
atencionalusuario@controlsanitario.gob.ec
 
Servicio de Acreditación Ecuatoriano (SAE)
Av. América N37-204 y Juan José Villalengua
Quito-Ecuador
Phone number: (593-2) 331-6610
 
Servicio Nacional de Aduana del Ecuador (SENAE)
Av. 25 de Julio, Km. 4.5, Vía Puerto Marítimo
Guayaquil-Ecuador, Tel: (593-4) 500-6060

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