G/TBT/N/ECU/331  
27 February  2017 
(17-1164) 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 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  
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 P roductivity)  
Yánez Pinzón N26 -12, entre Av . Colón y La Niña  
Quito, Ecuador  
Tel.: (+593 -2) 3948760, 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 nation al tariff 
heading . ICS numbers may be provided in addition, where applicable) : 
3305.10.00.00  
5. Title, number of pages and language(s) of the notified document : Proyecto de la 
Normativa Técnica Sanitaria Ecuatoriana para productos cosméticos, productos de  higiene 
doméstica, productos absorbentes de higiene personal  (Draft Ecuadorian Sanitary 
Technical Regulation on cosmetics, domestic hygiene products and absorbent personal 
hygiene products) (23 pages, in Spanish)  
6. Description of content : The notified draft Ecuadorian Sanitary Technical Regulation 
covers the following : Purpose ; Scope; Definitions ; General considerations ; Mandatory 
sanitary notification (NSO), procedure and amendments, recognition (mandatory sanitary 
notification procedure, amendments to  mandatory sanitary notification, recognition of 
mandatory sanitary notification code) ; Circulation of samples of no commercial value ; 
Certificate of free sale and export certificate ; Operating permit ; Donation of cosmetics, 
domestic hygiene products or ab sorbent personal hygiene products in the event of a health 
emergency ; Good manufacturing practices (GMP) ; GMP certification procedure ; Inspection 
service and GMP certification fees ; Notification of changes to GMP certificate ; GMP 
certificate ; and Monitorin g and inspection.  G/TBT/N/ECU/331  
- 2 - 
  7. Objective and rationale, including the nature of urgent problems where 
applicable : The aim of the notified Sanitary Technical Regulation is to establish the 
internal procedure for obtaining mandatory sanitary notification ; for volunt arily obtaining a 
certificate of good manufacturing practices ; for obtaining a certificate of free sale or export 
certificate, authorization for samples with no commercial purpose, and an operating 
permit ; and for donating cosmetics, domestic hygiene produ cts and absorbent personal 
hygiene products in emergency situations.  
The provisions contained in the present Technical Regulation apply to all national or foreign 
natural or legal persons located in national territory that manufacture, store, package, 
pack, arrange, assemble, sell, import, export, distribute or market cosmetics, domestic 
hygiene products and absorbent personal hygiene products.  
8. Relevant documents:  
1. Publication where notice appears: http:/ /www.controlsanitario.gob.ec/  
2. Proposal and basic document : Proyecto de la Normativa Técnica Sanitaria 
Ecuatoriana para productos cosméticos, productos de higiene doméstica, productos 
absorbentes de higiene personal  (Draft Ecuadorian Sanitary Technical Reg ulation on 
cosmetics, domestic hygiene products and absorbent personal hygiene products)  
3. Publication in which Technical Regulation will be published when adopted : Registro 
Oficial  (Official Journal).  
9. Proposed date of adoption : 30 days from 2 3 February 2017 
Proposed date of entry into force : 25 March 2 017 
10. Final date for comments : 25 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:  
Contact and/or National Enquiry Point:  
Eduardo Yépez  
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) 3948760, Ext. 2272 or 2219  
Email: PuntocontactoOTCECU@mipro.gob.ec , jcadena@mipro.gob.ec , 
cyepez@mipro.gob.ec  
Website: http:/ /www.industrias.gob.ec/