G/TBT/N/ECU/ 329 
22 December 2016  
(16-7027) 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, Con trol 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  
Fax: (+593 -4) 3727 440  
Tel.: (+593 -4) 3727 440  
Email : PuntocontactoOTCECU@m ipro.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 commen ts 
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 applicable, otherwise national tariff 
heading . ICS numbers may be provided  in addition, where applicable) : 19011010 ; 
19011091 ; 19011099 ; 20051000 ; 20052000 ; 20054000 ; 20055100 ; 20055900 ; 
20056000 ; 20058000 ; and 21069080.  
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 
alimentos para regímenes especiales de los establecimientos en donde se fabrican, 
almacenan, distribuyen, importan y comercializan  (Draft Sanitary Technical Regulation on 
the issuance of sanitary certificates for foods for special dietary uses, and the control of 
establishments that manufacture, store, distribute, import or market such products) (24 
pages, in Spanish)  G/TBT/N/ECU/329  
- 2 - 
  6. Description of content : The notified draft Technical Regulation covers the f ollowing : 
Purpose and scope ; Definitions and abbreviations ; Sanitary certificates ; Renewal of and 
changes to sanitary certificates ; Certification of good manufacturing practices ; Criteria for 
the formulation of foods for special dietary uses ; Packaging and  labelling ; Other 
authorizations ; Marketing and advertising ; Operating permits for establishments concerned 
with foods for special dietary uses ; General provisions ; Transitional provisions ; Amending 
provision ; and Final provision.  
7. Objective and rationa le, including the nature of urgent problems where 
applicable : The notified Sanitary Technical Regulation seeks to establish the requirements 
governing the issuance of sanitary certificates for foods for special dietary uses.  
It also establishes parameters for manufacturing, production, formulation and labelling 
processes, quality and safety parameters, advertising criteria, and criteria for the control 
and monitoring of foods for special dietary uses in establishments that manufacture, store, 
distribute,  import or market such products . 
Scope : The notified Sanitary Technical Regulation is mandatory for natural and legal 
persons, whether domestic or foreign, that are responsible for manufacturing, importing, 
exporting, storing, distributing or marketing foods for special dietary uses in national 
territory.  
8. Relevant documents:  
1. Publication where notice appears:  
http://www.industrias.gob.ec/ ; 
http://www.controlsan itario.gob.ec/  
2. Proposal and basic document : Proyecto de Normativa Técnica Sanitaria para la 
obtención de la notificación sanitaria y control de alimentos para regímenes especiales de 
los establecimientos en donde se fabrican, almacenan, distribuyen, im portan y 
comercializan  (Draft Sanitary Technical Regulation on the issuance of sanitary certificates 
for foods for special dietary uses, and the control of establishments that manufacture, 
store, distribute, import or market such products) . 
3. Publication in which Technical Regulation will be published when adopted : Registro 
Oficial  (Official Journal).  
9. Proposed date of adoption : 90 days from 1 6 December 2 016. 
Proposed date of entry into force : Upon the signing thereof.  
10. Final date for comments : 16 March 2 017 
11. Texts available from : National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Marlon Martínez  
Subsecretaría de la Calidad  
Ministerio 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/