International Standards

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General Standards

Standards organizations

Standards in Ecuador are fixed by the Ecuadorian Standards Institute (INEN). The Institute is a member of the International Standards Organization, the Panamerican Technical Standards Commission, the Interamerican Metrology System and the Organisation Internationale de Metrologie Legale. INEN also ensures the contact with the Codex Alimentarius Commission.

The Agriculture Quality Assurance Agency (AGROCALIDAD) is responsible for supervising sanitary and phytosanitary controls. Ecuador is a member of the WTO and as a result must comply with the WTO Agreement on the Application of Sanitary and Phytosanitary Measures. In addition, AGROCALIDAD follows the “Andean Sanitary Standards” established under the Andean Community of Nations (CAN). Several standards applied to CAN members differ from those applied to third countries. The Andean Community of Nations is working to harmonize its regulations with those of the WTO, but there are cases when specific regulations apply to imports from third countries. For example, there are differences in the requirements for CAN and third countries for the importation of live animals, animal products, plants, and plant products.

Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) is the body responsible for sanitary control. In Ecuador, sanitary registrations are required for the following imported and locally produced products:

- Processed foods

- Natural products

- Cosmetics

- Personal care items

- Pesticides

- Pharmaceuticals

- Reagents

- Medical disposable supplies

- Other consumer goods

Conformity Assessment

The Ecuadorian Standards Institute is responsible for conformity assessment with support from the Ecuadorian Accreditation Organization (SAE).

For products subject to standards compliance it is mandatory to obtain the certificate of conformity INEN-1, prior to shipping the goods to the country. The certificate must presented to customs at the point of entry.

The Ecuadorian Accreditation Organization establishes the framework, mechanisms, and procedures, and qualifies laboratories or institutions that may issue conformity assessment certificates.

Product Certification

Products subject to technical standards must obtain the INEN-1 certificate. The following products require 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

- Christmas decorations

AGROCALIDAD requires certifications stating that the products comply with risk analysis and that the country of origin is free from plant or animal diseases.

Accreditation

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

Contacts

Servicio Ecuatoriano de Normalización (INEN)

Website: http://www.normalizacion.gob.ec/

Address: Baquerizo Moreno E8-29 y Diego de Almagro, Quito-Ecuador

Tel: (593-2) 250-1885 / 256-5626

AGROCALIDAD

Website: http://www.agrocalidad.gob.ec/

Address: Av.Eloy Alfaro y Av. Amazonas, Edif. MAGAP piso 9, EC170125, Quito – Ecuador

Tel: (593-2) 256-7232

Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA)

Website: http://www.controlsanitario.gob.ec/

Email: atencionalusuario@controlsanitario.gob.ec