On December 3, 2025, the Plenary of the Foreign Trade Committee issued Resolution No. 017-2025 (the “Resolution”), which amends Article 4 of COMEXI Resolution No. 376-2007 with respect to the use of Sanitary Registrations and Sanitary Notifications as prior control documents in importation processes.
Below is a summary of the most relevant aspects for importers and holders of Sanitary Registrations and Sanitary Notifications:
1. Partial Amendment
Resolution No. 017-2025 amends Article 4 of COMEXI Resolution No. 376-2007, approved on January 10, 2007 by the Extended Executive Commission of the former Foreign Trade and Investment Council (“COMEXI”).
Under the previous regulation, the importation of products subject to the presentation of a Sanitary Registration as a prior control document could be carried out by persons other than the holder of the Registration, provided that the holder had expressly authorized the importer.
With the amendment, Article 4 now provides, in essence, that:
In the case of imports of products subject to the presentation of Sanitary Registrations and Sanitary Notifications as prior control documents, the control authorities will only accept their use when the National Agency for Regulation, Control and Sanitary Surveillance (“ARCSA”), or its successor, has expressly authorized the use or modification of such Registrations and Notifications in favor of the importer, in accordance with the procedure established by said authority.
Any form of endorsement, assignment, or transfer of Sanitary Registrations and Sanitary Notifications that has not been processed and authorized by ARCSA, or its successor, in accordance with the applicable sanitary regulations, is expressly prohibited.
In summary, the authorization of the Sanitary Registration holder is no longer sufficient. As of the entry into force of this Resolution, ARCSA is granted exclusive authority to regulate this procedure, and its express authorization is required for an importer to use the corresponding Sanitary Registration or Sanitary Notification.
2. Regulations and Guidelines for Implementation
The Resolution provides that the National Customs Service of Ecuador (“SENAE”) and ARCSA, within the scope of their respective powers, must coordinate the implementation, dissemination, and actions necessary for the proper application of the amendment.
In this regard, the Resolution includes two relevant transitional provisions:
- A period of thirty (30) calendar days, counted from the entry into force of the Resolution—i.e., until January 8, 2026—is granted for SENAE and ARCSA to coordinate the operational and regulatory actions necessary for the implementation of the amendment.
- A period of one hundred twenty (120) calendar days, counted from the entry into force of the Resolution—i.e., until April 8, 2026—is granted for foreign trade operators that are using Sanitary Registrations or Sanitary Notifications belonging to persons other than the holder, even if they have the holder’s express authorization or consent, to carry out the corresponding process before ARCSA in order to obtain express authorization in their favor.
Once this period has elapsed, the control authorities will not accept the use of Sanitary Registrations or Sanitary Notifications that do not have ARCSA’s express authorization in favor of the importer, in accordance with the applicable regulations.
3. Entry into Force
The Resolution was adopted at the session held on December 3, 2025, and entered into force on December 9, 2025, without prejudice to its publication in the Official Gazette.
4. SENAE Bulletin No.130.2025
Pursuant to the Resolution, SENAE, through Bulletin No. 130-2025, informed the general public that, as of December 9, 2025, the screen called “Endorsement of Supporting or Accompanying Documents” was disabled in the Ecuadorian Single Window (“VUE”).
This measure was adopted in compliance with the Resolution and urges persons who are currently using Sanitary Registrations or Sanitary Notifications belonging to different holders, and who are previously registered in the VUE, to carry out the procedures established by ARCSA to regularize the corresponding authorizations of use. In accordance with the Resolution itself, ARCSA has a period of thirty (30) days from its entry into force—i.e., until January 8, 2026—to carry out the necessary operational and regulatory actions for this purpose.
We will be pleased to provide further information on this matter. For additional information, please contact us at the following email addresses:
María Rosa Fabara Vera: mrfabara@bustamantefabara.com
Andrés Becdach Fierro: abecdach@bustamantefabara.com
Luis Rivadeneira Pinargote: lrivadeneira@bustamantefabara.com
Tomás Bonilla Sevilla: tbonilla@bustamantefabara.com