G/TBT/N/ECU/374/Rev.1  
3 June 2020 
(20-3958) Page: 1/3 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  NOTIFICATION  
Revision  
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: 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  
puntocontactoOTCECU@gmail.com  
cyepez@produccion.gob.ec  
jsanchezc@produccion.gob.ec  
Website: www.produccion.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 ; Tableware, other household articles and hygienic or toilet articles, of plastics (HS 
3924) ; - Other (HS 401490) ; Household equipment for children ( ICS 97 .190)  
5. Title, number of pages and languag e(s) of the notified document : Proyecto de 
Segunda Revisión del Reglamento Técnico Ecuatoriano PRTE I NEN 065  (2R) "Chupetes y 
artículos de puericultura para la alimentación líquida de bebés y niños pequeños"  (Draft 
second revision (2R) of Ecuadorian 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)  G/TBT/N/ECU/374/Rev.1  
- 2 - 
  6. Description of content : The notified Technical Regulation establishes the requirements to 
be met by dummies/pacifiers for babies and young children and childcare articles for the 
provision of liqu id food, prior to the marketing of domestic and imported products, with the 
aim of protecting human health and preventing deceptive practices.  
It applies to the following products:  
• Rubber or plastic dummies/pacifiers for babies and young children;  
• 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).  
It 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 nature of urgent problems where 
applicable : Consumer information, labe lling; Prevention of deceptive practices and 
consumer protection ; Protection of human health or safety.  
8. Relevant documents : Normative 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 laboratories;  
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 certif ication schemes;  
5. Spanish Standard UNE -EN 1400:2013 + A2 : 2019, 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 , Artículos de 
puericultura . Artículos para la alimentación líquida . Parte 1 : Requisitos general es y 
mecánicos y  ensayos ; 
7. Ecuadorian Technical Standard NTE INEN -EN 14350 -2:2011 + corrigendum : 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, importan , dispensan, 
expenden y comercializan . 
Notification history:  
G/TBT/N/ECU/374  
9. Proposed date of adoption : 30 days from notification  
Proposed date of entry into force : Six months from the date of adoption  
10. Final date for comments : 30 days from notification  G/TBT/N/ECU/374/Rev.1  
- 3 - 
  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  
Ministerio de Producción, Comercio Exterior, Inversiones y Pesca  (MPCEIP)  
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  
cyepez@produccion.gob.ec  
jsanchezc@produccion.gob.ec  
www.normalizacion.gob.ec  
www.normalizacion.gob.ec  
https://members.wto.org/crnattachments/2020/TBT/ECU/20_3547_00_s.pdf