G/TBT/N/ECU/520  
30 August  2023 
(23-5811) 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 abov e: 
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 or 2272  
Email:  
puntocontactoOTCECU@produccion.gob.ec  
puntocontactoecu@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 [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, whe re applicable) : The 
purpose of the Draft Substitute Sanitary Technical Regulations for the control of products 
for human use and consumption subject to sanitary control and surveillance and 
considered to be counterfeit or substandard is to ensure the sanit ary control and 
surveillance of products for human use and consumption that are regulated by the 
National Agency for Sanitary Regulation, Control and Surveillance (ARCSA, Doctor 
Leopoldo Izquieta Pérez) and could be considered counterfeit or substandard pr oducts.  
5. Title, number of pages and language(s) of the notified document : Proyecto de 
Normativa Técnica Sanitaria Sustitutiva para el control de productos de uso y consumo 
humano sujetos a control y vigilancia sanitaria considerados falsificados o de calidad 
subestándar  (Draft Substitute Sanitary Technical Regulations for the control of products G/TBT/N/ECU/520  
- 2 - 
  for human use and consumption subject to sanitary control and surveillance and 
considered to be counterfeit or substandard) (16 page(s), in S panish)  
6. Description of content : The purpose of the notified Sanitary Technical Regulations is to 
ensure the sanitary control and surveillance of products for human use and consumption 
that are regulated by the National Agency for Sanitary Regulation, C ontrol and 
Surveillance (ARCSA, Doctor Leopoldo Izquieta Pérez) and could be considered counterfeit 
or substandard products.  
The provisions of the Regulations are applicable to all natural and legal persons, whether 
domestic or foreign, that process, manuf acture, package, store, export, import, donate, 
distribute, transport, market, sell or dispense, throughout the national territory, products 
for human use and consumption subject to ARCSA control and surveillance.  
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 : The notified Sanitary Technical Regulations will enter int o 
force upon their publication in the Official Journal, once the international guidelines have 
been followed.  
Proposed date of entry into force : To be determined . The notified Sanitary Technical 
Regulations will enter into force on the date of publication in the Official Journal.  
10. Final date for comments : 60 days from notification  
11. Texts available from : National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
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 or 2272  
Email:  
puntocontacto -otcecu@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_12074_00_s.pdf