G/TBT/N/ECU/499  
15 January  2021 
(21-0495) Page: 1/2 
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: 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 Ex terior, Inversiones y Pesca , MPCEIP (Ministry of 
Production, Foreign Trade, Investment and Fisheries)  
Address : Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira, Piso 8, 
Bloque amarillo  
Tel.: (+593 -2) 3948760, Ext. 2254 - 2272 
Email:  
puntocontactoOTCECU@produccion.gob.ec  
puntocontactoOTCECU@gmail.com  
jmarino@produccion.gob.ec  
cyepez@produccion.gob.ec  
jsanchezc@produccion.gob.ec  
Website: www.produccion.gob.ec  
3. Notified under Article 2.9.2 [ ], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other [X] : Substitute 
Technical Regulation for the issuing of regulatory administrative acts provided for in the 
competencies of the National Agency for Sanitary Regulation, Control and Surveillance 
(ARCSA), Doctor Leopoldo Izquieta Pérez.  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading . ICS numbers may be provided in addition, where applicable) : This 
Regulation is binding on all those responsible for the preparation, issuing and approval of 
regulatory administrative acts provided for in the functions of the National Agency for 
Sanitary Regulation, Control and Surveillance (ARCSA), Doctor Leopoldo Izq uieta Pérez, 
and establishes regulations governing natural and legal persons, whether domestic or 
foreign, concerned with products for human use and consumption and establishments 
subject to sanitary monitoring and control, in accordance with the functions  and 
competencies established in the applicable laws and regulations.  G/TBT/N/ECU/499  
- 2 - 
  5. Title, number of pages and language(s) of the notified document : NORMATIVA 
TÉCNICA SUSTITUTIVA PARA LA EMISIÓN DE ACTOS ADMINISTRATIVOS NORMATIVOS 
CONTEMPLADOS EN LAS ATRIBUCIONES DE LA AGENCIA NACIONAL DE REGULACIÓN, 
CONTROL Y VIGILANCIA SANITARIA - ARCSA, DOCTOR LEOPOLDO IZQUIETA PÉREZ  
(Substitute Technical Regulation for the issuing of regulatory administrative acts provided 
for in the functions of the National Agency for Sanitary Regulation, Control and 
Surveillance (ARCSA), Doctor Leopoldo Izquieta Pérez) (16 pages, in Spanish)  
6. Description of content : The purpose  of this Regulation is to establish the procedure for 
the issuing, creation or revision of regulatory administrative acts provided for in the 
functions of the National Agency for Sanitary Regulation, Control and Surveillance 
(ARCSA), Doctor Leopoldo Izquie ta Pérez).  
This Regulation is binding on all those responsible for the preparation, issuing and 
approval of regulatory administrative acts provided for in the functions of the National 
Agency for Sanitary Regulation, Control and Surveillance (ARCSA), Docto r Leopoldo 
Izquieta Pérez, and establishes regulations governing natural and legal persons, whether 
domestic or foreign, concerned with products for human use and consumption and 
establishments subject to sanitary monitoring and control, in accordance with  the 
functions and competencies established in the applicable laws and regulations.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Protection of human health or safety  
8. Relevant documents : - 
9. Proposed date of adoption : 17 December 2 020; entry into force on the date of its 
signature, without prejudice to its publication in the Official Journal.  
Proposed date of entry into force : 17 December 2 020; entry into force on the date of 
its signature, without prejudice t o its publication in the Official Journal.  
10. Final date for comments : The Substitute Technical Regulation for the issuing of 
regulatory administrative acts provided for in the functions of the National Agency for 
Sanitary Regulation, Control and Surveil lance (ARCSA), Doctor Leopoldo Izquieta Pérez, 
has been issued pursuant to Resolution No. A RCSA -DE-038-2020-MAFG of 1 7 December 
2020 by the National Agency for Sanitary Regulation, Control and Surveillance (ARCSA) . 
The Regulation will enter into force on the date of its signature, without prejudice to its 
publication in the Official Journal . The authority responsible for this Regulation is the 
National Agency for Sanitary Regulation, Control and Surveillance (ARCSA).  
11. Texts available from : National enquiry point [X] 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  (Under -Secretariat for Quality)  
Ministerio de Producción, Comercio  Exterior, Inversiones y Pesca , MPCEIP (Ministry of 
Production, Foreign Trade, Investment and Fisheries)  
Address : Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira, Piso 8, 
Bloque amarillo  
Tel.: (+593 -2) 3948760, Ext. 2254 - 2272 
Email:  
puntocontactoOTCECU@produccion.gob.ec  
puntocontactoOTCECU@gmail.com  
jmarino@produccion.gob.ec  
cyepez@produccion.gob.ec  
jsanchezc@produccion.gob.ec  
www.controlsanitario.gob.ec  
https://members.wto.org/crnattachments/2021/TBT/ECU/21_0338_00_s.pdf