G/TBT/N/ECU/449  
27 May 2019 
(19-3640) 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 A lfonso 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 ; 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) : Tooth 
brushes, including dental -plate brushes (HS 960321)  
5. Title, number of pages and language(s) of the notified document : Proyecto de 
Primera Revisión del Reglamento Técnico Ecuatoriano PRTE INEN 210 (1R) "Cepillos 
Dentales"  (Draft first revision (1R) of Ecuadorian Technical Regulation PRTE INEN 210 
"Tooth brushes") (10 pages, in Spanish)  
6. Description of content : The notified Ecuadorian Technical Regulation establishes the 
requirements to be met by tooth brushes, prior to the marketing of domestic and imported 
products, with the aim of protecting human health and safety and preventing deceptive 
practices.  G/TBT/N/ECU/449  
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  It applies to  the following products:  
• Manual tooth brushes;  
• Manual brushes used to clean between the teeth;  
• Electric tooth brushes.  
The notified Technical Regulation does not apply to:  
• Electric brushes used to clean between the teeth;  
• Finger tooth brushes for babies.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Consumer information, labelling ; Prevention of deceptive practices and 
consumer protection ; Protection of human health or safety.  
8. Relevant documents:  
Normative references:  
1. ISO 1942:2009, Dentistry -- Vocabulary;  
2. 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;  
3. ISO 16409:2016, Dentistry -- Oral care products -- Manual interdental brushes;  
4. ISO/IEC 17025:2017, General requirements for the competence of testing and 
calibration laboratories;  
5. ISO/IEC 17050 -1:2004, Conformity assessment - Supplier's declaration of 
conformity - Part 1 : General requirements;  
6. ISO/IEC 17067:2013, Conformity assessment - Fundamentals of product 
certification and guidelines for product certification schemes;  
7. ISO 20126:2012, Dentistry -- Manual toothbrushes -- General requirements and 
test met hods;  
8. ISO 20127:2005, Dentistry -- Powered toothbrushes -- General requirements and 
test methods;  
9. IEC 60335 -1:2010+ADM1:2013+AMD2:2016 CSV, Household and similar 
electrical appliances - Safety - Part 1 : General requirements;  
10. IEC 60335 -2-52:2002+AMD1:2008+A MD2:2017 CSV, Household and similar 
electrical appliances - Safety - Part 2 -52: Particular requirements for oral hygiene 
appliances.  
Notification history:  
1. G/TBT/N/ECU/210  
2. G/TBT/N/ECU/210/Add.1  
9. Proposed date of adoption : 60 days from notification or thereafter  
Proposed date of entry into force : 180 days from the date of adoption  
10. Final date for comments : 60 days from notification  G/TBT/N/ECU/449  
- 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  (Under -Secretariat for Quality)  
Ministerio de Producción, Comercio Exterior, Inversiones y Pesca , MPCEIP (Ministry of 
Production, Fore ign 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 ; jsanchez@produccion.gob.ec  
http://www.normalizacion.gob.ec/  
https://members.wto.org/crnattachments/2019/TBT/ECU/19_3030_00_s.pdf