G/TBT/N/ECU/449/Rev.1  
30 October  2019 
(19-7272) 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  
aramon@produccion.gob.ec  
cyepez@produccion.gob.ec  
jsanchez@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) : Tooth 
brushes, including dental -plate brushes (HS 960321) ; Body care equipment ( ICS 97 .170)  
5. Title, number of pages and language(s) of the notified document : Proyecto de 
Primera Revisión del Reglamento Técnico Ecuatoriano PRTE I NEN 210  (1R) "Cepillos 
Dentales"  (Draft first revision (1R) of Ecuadorian Technical Regulation PRTE INEN No. 210 
"Tooth brushes") (10 pages, in Spanish)  
6. Description of content : The notified Ecuadorian Technical Regulation establishes the 
requirements to be met by toothbrushes, prior to the marketing of domestic and imported 
products, with the aim of protecting human safety and preventing decep tive practices.  
It applies to the following products:  G/TBT/N/ECU/449/Rev.1  
- 2 - 
  • Manual toothbrushes;  
• Manual interdental brushes;  
• Powered toothbrushes.  
It does not apply to:  
• Powered interdental brushes;  
• Finger toothbrushes 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 - Vocabular y; 
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+ADM1:2018, Dentistry - Manual toothbrushes - General 
requirements and test methods;  
8.  ISO 20127 :2005, Dentistry - Powered toothbrushes - General requirements 
and test methods;  
9.  IEC 60335 -1:2010+ADM1:2013+AMD2:2016, Household and similar 
electrical appliances - Safety - Part 1 : General requirements;  
10. IEC 60335 -2-52:2002+AMD1:2008+AMD2:2017, Household and similar electrical 
appliances - Safety - Part 2 -52: Particular requirements for oral hygiene 
appliances.  
Notification history:  
G/TBT/N/ECU/449  
9. Proposed date of adoption : 30 days from notification or thereafter  
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/449/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, P iso 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  
www.normalizacion.gob.ec  
https://members.wto.org/crnattachments/2019/TBT/E CU/19_6078_00_s.pdf