G/TBT/N/ECU/327  
20 September 2016  
(16-4990) 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, Cont rol y Vigilancia Sanitario,  ARCSA (National Agency for 
Sanitary Regulation, Control and Surveillance)  
Ciudadela Samanes, Av . Francisco de Orellana y Av . Paseo del Parque , Bloque 5  
Guayaquil  
Fax: (+593 -4) 3727 440  
Tel.: (+593 -4) 3727 440  
Email: PuntocontactoOTCECU@mipro.gob.ec  
Website: http://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 la Calidad  (Under -Secretariat for Quality)  
Ministerio de Industrias y Productividad , MIPRO (Ministry  of Industry and Productivity)  
Yánez Pinzón N26 -12, entre Av . Colón y La Niña  
Quito, Ecuador  
Tel.: (+593 -2) 3948 760, Ext. 2358 or 2253  
Email: PuntocontactoOTCECU@mipro.gob.ec , mmartinez@mipro.gob.ec  
Website: http://www.industrias.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 applicabl e, otherwise national tariff 
heading . ICS numbers may be provided in addition, where applicable) : 
2106.90.71.00, 2106.90.72.0 0, 2106.90.73.00, 2106.90.74.00  and 2106.90.79.00.  
5. Title, number of pages and language(s) of the notified document : Proyecto de  
normativa técnica sanitaria para la obtención de la notificación sanitaria y control de 
suplementos alimenticios y de los establecimientos en donde se fabrican, almacenan, 
distribuyen, importan y comercializan (Draft Sanitary Technical Regulation on the issuance  
of sanitary certificates  and the control of food supplements  and establishments that 
manufacture, store, distribute , import  or market such products ) (21 pages, in Spanish)  
6. Description of content : The notified draft Technical Regulation covers t he following: 
Purpose and s cope; Definitions and abbreviations ; Sanitary certificate s; Renewal  of and 
changes  to sanitary certificate s; Certification  of good manufacturing  practices ; Criteria for 
the formulation  of food supplements ; Packaging and labelling ; Other authorizations ; 
Marketing and advertising; O perating permits for food supplement establishments ; 
Derogations ; General provisions ; Transitional provisions ; Amending provision ; and Final 
provision .  G/TBT/N/ECU/327  
- 2 - 
  7. Objective and rationale, including the nature o f urgent problems where 
applicable:  
The aim of the notified Sanitary Technical Regulation is to establish  the requirements 
governing the issuance of sanitary certificates for food supplements.   
It also establish es the requirements for  the production, proce ssing, formulation, labelling, 
quality , safety , advertising, control and monitoring of food supplements in establishments 
that manufacture, stor e, distribut e, import or market  such products .  
This Sanitary Technical Regulation is binding on  natural and leg al persons, whether 
Ecuadorean  or foreign, who are responsible for manufactur ing, importing, exporting, 
storing, distributing  or marketing food supplements throughout the national territory.   
8. Relevant documents:  
 Publication where notice appears: http://www.industrias.gob.ec/  and 
http://www.controlsanitario.gob.ec/ ; 
 Proposal and basic document : Proyecto de Normativa Técnica Sanitaria Ecuatoriana 
"Obtención de la notificación sanitaria y control de suplementos alimenticios y de los 
establecimientos en donde se fabrican, almacenan, distribuyen, importan y 
comercializan"  (Draft Ecuadorian Sanitary Technical Regulation  on the issuance of 
sanitary certificates  and t he control of food supplements  and establishments that 
manufacture, store, distribute , import  or market such products ); 
 Publication in which Technical Regulation will be published when adopted : Registro 
Oficial  (Official Journal) . 
9. Proposed date of adop tion: 90 days as from 1 2 September 2 016 
Proposed date of entry into force : 180 days after adoption  
10. Final date for comments : 11 December 2 016 
11. Texts available from : National enquiry point [X] or address, telephone and fax 
numbers and email and webs ite addresses, if available, of other body:  
Marlon Martínez  
Subsecretaría de la Calidad  
Ministeri o de Industrias y Productividad,  MIPRO  
Yánez Pinzón N26 -12, entre Av . Colón y La Niña  
Quito, Ecuador  
Tel.: (+593-2) 3948 760, Ext. 2358 or 2253  
Email: PuntocontactoOTCECU@mipro.gob.ec , mmartinez@mipro.gob.ec  
Website: http://www.industrias.gob.ec/