G/TBT/N/ECU/508  
25 August  2021 
(21-6411) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English/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 n otification 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, 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  
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 [.], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading . ICS numbers may be provided in addition, whe re applicable) : Draft 
Sanitary Technical Regulation for obtaining the certificate indicating whether or not the 
sanitary notification for processed foods and pesticides or the mandatory sanitary 
notification for cosmetics and hygiene products is required, and the certificate indicating 
whether or not sanitary registration for medicines, natural products, medical devices and 
biochemical reagents is required . The notified draft Sanitary Technical Regulation also 
establishes the procedure for obtaining these c ertificate s. 
5. Title, number of pages and language(s) of the notified document : Proyecto de 
"Normativa Técnica Sanitaria para la obtención del certificado de requerimiento o no de 
la notificación sanitaria de alimentos procesados, plaguicidas o notificación sanitaria 
obligatoria de cosméticos y productos higiénicos, y certificado de requerimiento o no de 
registro sanitario de medicamentos, productos naturales, dispositivos médicos y reactivos 
bioquímicos"  (Draft Sanitary Technical Regulation for obtaining the certificate indicating G/TBT/N/ECU/508  
- 2 - 
  whether or not the sanitary notification for processed foods and pesticides or the 
mandatory sanitary notification for cosmetics and hygiene products is required, and the 
certificate indicating whether or not sanitary r egistration for medicines, natural products, 
medical devices and biochemical reagents is required) (13 pages, in Spanish)  
6. Description of content : The notified Sanitary Technical Regulation lays down the 
procedure for obtaining the certificate indicatin g whether or not the sanitary notification 
for processed foods and pesticides or the mandatory sanitary notification for cosmetics 
and hygiene products is required, and the certificate indicating whether or not sanitary 
registration for medicines, natural products, medical devices and biochemical reagents is 
required, with a view to establishing whether the above -mentioned certificates should be 
obtained for the product . It applies to all national or foreign natural or legal persons 
involved or engaged in t he relevant processes.  
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 adopt ion: 60 days from notification or thereafter  
Proposed date of entry into force : 180 days from the date of adoption  
10. Final date for comments : 60 days from notification  
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  
Ministerio de Producción, Comercio Exterior, Inversiones y Pesca (MPCEIP)  
Address : Av. Amazonas entre Unión Nacional d e Periodistas y Alfonso Pereira, Piso 8, 
Bloque amarillo  
Tel.: (+593 2) 3948760, Ext. 2254 - 2272 
Email:  
puntocontacto -otcecu@produccion.gob.ec  
puntocontactoecu@gmail.com  
jmarino@produccion.gob.ec  
cyepez@produccion.gob.ec  
jsanchezc@produccion.gob.ec  
www.controlsanitario.gob.ec  
https://member s.wto.org/crnattachments/2021/TBT/ECU/21_5369_00_s.pdf