G/TBT/N/ECU/374  
24 April 2019 
(19-2710) Page: 1/3 
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:  
Servicio Ecuatoriano de Normalización , INEN (Ecuadorian Standardization Service)  
Calle Baquerizo Moreno E8 -29 y Diego de Almagro  
Tel.: (+593 -2) 3825960 to 90  
Website: http://www.normalizacion.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 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  
puntocontactoOT CECU@gmail.com  
aramon@produccion.gob.ec  
cyepez@produccion.gob.ec  
jsanchez@produccion.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) : 701349 - 
Other ; (HS: 3924, 401490, 701399)  
5. Title, number of pages and language(s) of the notified document : Proyecto de 
Segunda Revisión del Reglamento Técnico Ecuatoriano PRTE INEN 065 (2R) "Chupetes y 
artículos de puericultura para la alimentación líquida de bebés y niños pequeños"  (Draft 
second revision (2R) of Ecuadorian Standardization Institute Technical Regulation (PRTE 
INEN) No. 065 "Dummies/pacifiers and childcare articles for the provision of liquid  food 
for babies and young children") (14 pages, in Spanish)  
6. Description of content : The notified Technical Regulation establishes the requirements 
to be met by dummies/pacifiers and childcare articles for the provision of liquid food for 
babies and yo ung children, prior to the marketing of domestic and imported products, 
with the aim of protecting human health and preventing misleading practices.  
The notified Technical Regulation applies to the following products:  
1. Rubber or plastic dummies/pacifiers  for babies and young children;  G/TBT/N/ECU/374  
- 2 - 
  2. Plastic, glass or rubber childcare articles for the provision of liquid food (such as 
straws, teats, bottles, cups for liquid food and other items defined as childcare articles for 
the provision of liquid food).  
The notif ied Technical Regulation does not apply to products designed for specialized 
medical applications or for use under medical supervision, for example those related to 
Pierre Robin syndrome or premature babies.  
7. Objective and rationale, including the natur e of urgent problems where 
applicable : Consumer information ; labelling ; prevention of misleading practices ; 
consumer protection ; protection of human health and safety.  
8. Relevant documents:  
Regulatory references:  
1. ISO 2859 -1:1999+Amd 1:2011, Sampling procedures for inspection by attributes 
- Part 1 : Sampling schemes indexed by acceptance quality limit (AQL) for lot -by-lot 
inspection;  
2. ISO/IEC 17025:2017, General requirements for the competence of testing and 
calibration la boratories;  
3. ISO/IEC 17050 -1:2004, Conformity assessment - Supplier's declaration of 
conformity - Part 1 : General requirements;  
4. ISO/IEC 17067:2013, Conformity assessment - Fundamentals of product 
certification and guidelines for product certification schemes;  
5. Spanish Standard UNE-EN 1400:2013 + A1 : 2014, Artículos de puericultura . 
Chupetes para bebés y niños pequeños . Requisitos de seguridad y métodos de ensayo ; 
6. Ecuadorian Technical Standard NTE INEN -EN 14350 -1:2011 + fe de erratas : 2011, 
Artículos de puericultura . Artículos para la alimentación líquida . Parte 1 : Requisitos 
generales y mecánicos y ensayos ; 
7. Ecuadorian Technical Standard NTE INEN -EN 14350 -2:2011, Artículos de 
puericultura . Artículos para la alimentación líquida . Parte 2 : Requisitos químicos y 
ensayos ; 
8. Sanitary Technical Regulation ARCSA -DE-026-2016-YMIH, Normativa técnica 
sanitaria sustitutiva para el registro sanitario y control de dispositivos médicos de uso 
humano, y de los establecimientos en donde se fabrican, impor tan, dispensan, expenden 
y comercializan . 
TRACEABILITY:  
1. G/TBT/N/ECU/81  
2. G/TBT/N/ECU/81/Add.1  
3. G/TBT/N/ECU/81/Add.2  
4. G/TBT/N/ECU/81/Add.3  
5. G/TBT/N/ECU/81/Add.4  
6. G/TBT/N/ECU/81/Add.5  
7. G/TBT/N/ECU/81/Add.6  
8. G/TBT/N/ECU/81/Add.7  
9. G/TBT/N/ECU/81/Rev.1  
10. G/TBT/N/ECU/81/Rev.1/Add.1  
11. G/TBT/N/ECU/81/Rev.1/Add.2  
12. G/TBT/N/ECU/81/Rev.1/Add.1  
13. G/TBT/N/ECU/81/Rev.1/Add.2  G/TBT/N/ECU/374  
- 3 - 
  9. Proposed date of adoption : 165 days from the date of notification  
Proposed date of entry into force : 180 days from date of adoption  
10. Final date for comments : 60 days from the date of 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  (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  
puntocontactoOTCECU@gmail.com  
aramon@produccion.gob.ec  
cyepez@produccion.gob.ec  
jsanche z@produccion.gob.ec  
https://members.wto.org/crnattachments/2019/TBT/ECU/19_2376_00_s.pdf