G/TBT/N/ECU/516  
10 January  2023 
(23-0282) Page: 1/3 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6.  
 
1. Notifying Member : ECUADOR  
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible:  
Agencia  Nacional de Regulacion, Control y Vigilancia Sanitaria,  ARCSA (National Agency 
for Sanitary Regulation, Control and Surveillance)  
Ciudadela Samanes, Av . Francisco de Orellana y Av . Paseo del Parque . Bloque 5, 
Guayaquil - Ecuador  
Tel.: (+593 -4) 3727 440  
Website: https://www.controlsanitario.gob.ec  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:  
Subsecretaría de Calidad  (Under -Secretariat for Quality)  
Ministerio de Producción, Comercio Exterior, Inversiones y Pesca , MPCEIP (Ministry of 
Production, Foreign Trade, Invest ment and Fisheries)  
Address : Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira, Piso 8, 
Bloque amarillo  
Tel.: (+593 -2) 3948760, Ext. 2254 or 2272  
Email:  
puntocontactoOTCECU@produccion.gob.ec ; 
puntocontactoECU@gmail.com ; 
jmarino@produccion.gob.ec ; 
cyepez@produccion.gob.ec ; 
Website : www.produccion.gob.ec  
3. Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], 
other:  
4. Products covered (HS or CCCN  where applicable, otherwise national tariff 
heading . ICS numbers may be provided in addition, where applicable) : The 
Republic of Ecuador notifies and publishes the Substitute Technical Sanitary Regulations 
to grant the Sanitary Operating Permit to Establi shments subject to Sanitary Control and 
Surveillance, with the exception of Health Services' Establishments . The regulations have 
been issued pursuant to Resolution No. A RCSA -DE-2022-013-AKRG of 29  December  
2022, by the National Agency for Sanitary Regulat ion, Control and Surveillance (ARCSA, 
Doctor Leopoldo Izquieta Pérez) . This notification concerns national establishments and 
therefore does not affect trade . It has been submitted for transparency purposes.  
The notified Sanitary Technical Regulations will  enter into force on the date of publication 
in the Official Journal.  
The purpose is to categorize, codify and establish the requirements that establishments 
subject to sanitary control and surveillance must satisfy, prior to the issuance of the 
sanitary o perating permit by the National Health Authority, through the National Agency G/TBT/N/ECU/516  
- 2 - 
  for Sanitary Regulation, Control and Surveillance (ARCSA, Doctor Leopoldo Izquieta 
Pérez) ; without prejudice to the other requirements laid down in the rules governing each 
type of product or service provided by establishments subject to sanitary control and 
surveillance, which are within the Agency's remit.  
5. Title, number of pages and language(s) of the notified document : Normativa 
Técnica Sanitaria Sustitutiva para otorgar el Permiso de Funcionamiento Sanitario a los 
Establecimientos sujetos a Control y Vigilancia Sanitaria, con excepción de los 
Establecimientos de Servicios de Salud  (Substitute Sanitary Technical Regulations to 
grant the Sanitary Operating Permit to  Establishments subject to Sanitary Control and 
Surveillance, with the exception of Health Services' Establishments) (50 pages, in 
Spanish)  
6. Description of content : The purpose of the notified Sanitary Technical Regulations is to 
categorize, codify and establish the requirements that establishments under sanitary 
control and surveillance must satisfy, prior to the issuance of the sanitary operating 
permit by the National Health Authority, through the National Agency for Sanitary 
Regulation, Control and S urveillance (ARCSA, Doctor Leopoldo Izquieta Pérez) ; without 
prejudice to the other requirements laid down in the rules governing each type of product 
or service provided by establishments subject to sanitary control and surveillance, which 
are within the Agency's remit.  
 
The provisions of these sanitary technical regulations will be mandatory at the national 
level for all natural or legal persons owning or legal representatives of public or private 
establishments subject to sanitary control and surveillanc e, engaged in the production, 
storage, packaging, distribution, marketing, dispensation, sale, import or export of 
products for human use and consumption, and other activities within the Agency's remit ; 
with the exception of public and private health servi ces' establishments.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Prevention of deceptive practices and consumer protection ; Protection of 
human health or safety.  
8. Relevant documents:  
- 
9. Proposed date of adoption : 29 January 2 023 
Proposed date of entry into force : 29 January 2 023. The notified Sanitary Technical 
Regulation will enter into force on the date of its publication in the Official Journal.  
10. Final date for comments : Not applicable . This notification concerns national 
establishments and therefore does not affect trade . It has been submitted for 
transparency purposes.  G/TBT/N/ECU/516  
- 3 - 
  11. Texts available from : National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses,  if available, of other body:  
Contact and/or national enquiry point:  
Subsecretaría de Calidad  
Ministerio de Producción, Comercio Exterior, Inversiones y Pesca , MPCEIP  
Address : Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira, Piso 8, 
Bloque amarillo  
Tel.: (+593 -2) 3948760, Ext. 2254 or 2272  
Email:  
puntocontactoOTCECU@produccion.gob.ec  
puntocontactoECU@gmail.com  
jmarino@produccion.gob.ec  
cyepez@produccion.gob.ec  
www.controlsanitario.gob.ec  
https://members.wto.org/crnattachments/2023/TBT/ECU/23_0308_00_s.pdf