Ecuador – ARCSA announces a reform of the Technical Health Regulation for the analysis of post-registration or post-notification quality control of products intended for human use and consumption that are subject to health control and surveillance

The National Agency for Regulation, Control, and Sanitary Surveillance (ARCSA in Spanish) has made public the draft of the Partial Reform to Resolution ARCSA-DE-2021-015-AKRG, through which the “Technical Sanitary Norm for the analysis of quality control post-registration or post-notification of products for human use and consumption subject to sanitary control and surveillance” was published in the Official Register No. 574 on November 10, 2021.

Products for human use and consumption subject to sanitary control and surveillance are those products that the Agency regulates, controls, and monitors, including: processed foods, food additives, processed water, general medications, biological products, processed natural products for medicinal use, homeopathic products, medical devices for human use, cosmetics, domestic hygiene products, personal hygiene absorbent products, industrial hygiene products, hospital-use disinfectant hygiene products, food-grade disinfectants, and pesticides for domestic, industrial, and public health use.

Article 5.- Replace Articles 7 and 8 of CHAPTER IV “ON POST-REGISTRATION OR POST-NOTIFICATION QUALITY CONTROL ANALYSES” with the following:
“Article 7.- The post-registration or post-notification quality control analyses aim to verify that products for human use and consumption maintain the conditions that allowed for the obtaining of the sanitary registration, mandatory sanitary notification, sanitary notification, or the unique BPM code, as applicable, and that the water for human consumption meets the applicable quality standards and criteria.

Public consultation:
From 12/08/2025 to 10/09/2025

Ecuador: Special Regime Food Reclassification Project

The National Agency for Regulation, Control and Sanitary Surveillance (ARCSA in Spanish) published a draft of external instructions on reclassification to Foods for Special Dietary Uses.
The purpose of the instructions is to establish the technical criteria for the reclassification of a product to the category of food for special diets, to define the guidelines for obtaining the sanitary notification or online GMP certified registration, and the steps to follow to request the depletion of stocks.
Consultation valid until August 22, 2022.

The Americas – Ecuador: ARCSA publishes the draft regulations for the granting of sanitary operating authorizations to establishments subject to sanitary surveillance and control

The provisions of the present technical sanitary regulations shall be of mandatory application at the national level for all natural or legal persons who are owners or legal representatives of establishments subject to sanitary surveillance and control, public or private, where the following activities are carried out activities of production, storage, conditioning, distribution, commercialization, dispensation, sale, importation or exportation of products for human use and consumption; with the exception of public and private health service establishments.

Ecuador: Buscan controlar la venta de alimentos con cannabinoide en el país

Denuncias ciudadanas recibidas por la Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (Arcsa), reportaron la comercialización, en una farmacia de Guayaquil, de un producto alimenticio que contiene Cannabidiol (CBD), uno de los dos componentes cannabinoides más importantes de la planta de cáñamo, y que en su etiquetado aseguraban “aliviar el dolor y prevenir múltiples enfermedades como el COVID-19” (Fuente).

canabis

Ecuador: Planta de embutidos fue clausurada por falsificar etiquetado

La Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (Arcsa) clausuró una planta procesadora de carnes y embutidos de Quito, debido a que se detectaron varias irregularidades sanitarias en sus procedimientos (Fuente).