G/TBT/N/ECU/332  
22 March  2017 
(17-1585) 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 Sanitaria,  ARCSA (National Agency for 
Sanitary Regulation, Control and Surveillance)  
Francisco de Orellana y Av . Paseo del Parque  
Bloque 5 Guayaquil – Ecuador  
Fax: (+593 -2) 2567815  
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)  
Address : Yánez Pinzón N26 -12, entre Av . Colón y La Niña  
Quito, Ecuador  
Tel.: (+593 -2) 3948760, Ext. 2272 or 2253  
Email: PuntocontactoOTCECU@mipro.gob.ec , jcadena@mipr o.gob.ec , 
cyepez@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 cover ed (HS or CCCN where applicable, otherwise national tariff 
heading . ICS numbers may be provided in addition, where applicable) : 
3402.13.10.00  
5. Title, number of pages and language(s) of the notified document : Proyecto de la 
Normativa Técnica Sanitaria Ec uatoriana para productos higiénicos de uso industrial y 
productos de higiene grado alimenticio (Draft Ecuadorian Sanitary Technical Regulation on 
hygiene products for industrial use and food -grade hygiene products) (18 pages, in 
Spanish)  
6. Description of  content : The notified draft Ecuadorian Sanitary Technical Regulation 
covers the following : Purpose ; Scope; Definitions ; Mandatory sanitary certificates (NSO) ; 
Renewal of and amendments to sanitary certificates ; Packaging and labelling ; Operating 
permits ; Free sale certificates and export certificates ; Good manufacturing practices 
(GMP) ; GMP certification requirements and procedure ; Inspection service and GMP 
certification fees ; Notification of changes ; GMP certificate s; Monitoring and inspection.  G/TBT/N/ECU/332  
- 2 - 
  7. Objec tive and rationale, 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 hygiene products for industrial use and 
food-grade hygiene products . It also establishes the parameters for the operation, control 
and monitoring of establishments that manufacture, import, store and market hygiene 
products for industrial use and food -grade hygiene products.  
Its application is mandator y for natural and legal persons responsible for manufacturing, 
importing, exporting, storing, distributing or marketing hygiene products for industrial use 
and food -grade hygiene products.  
8. Relevant documents:  
 Publication where notice appears: http://www.controlsanitario.gob.ec/  
 Proposal and basic document : Proyecto de la Normativa Técnica Sanitaria 
Ecuatoriana para productos higiénicos de uso industrial y productos de higiene 
grado alimenticio (Draft Ec uadorian Sanitary Technical Regulation on hygiene 
products for industrial use and food -grade hygiene products)  
 Publication in which Technical Regulation will be published when adopted : Registro 
Oficial  (Official Journal)  
9. Proposed date of adoption : - 
Proposed date of entry into force : 180 days after publication in the Official Journal.  
10. Final date for comments : 17 April 2 017 
11. Texts available from : National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, i f available, of other body:  
Contact and/or National Enquiry Point:  
Juan Carlos Cadena  
Subsecretaría de la Calidad  
Ministerio de Industrias y Productividad - MIPRO  
Address : Yánez Pinzón N26 -12, entre Av . Colón y La Niña  
Quito, Ecuador  
Tel.: (+593-2) 3948760 , Ext. 2272 or 2219  
Email: PuntocontactoOTCECU@mipro.gob.ec , jcadena@mipro.gob.ec , 
cyepez@mipro.gob.ec  
Website: http://www.industrias.gob.ec/  
https://members.wto.org/crnattachments/2017/TBT/ECU/17_1397_00_s.pdf