G/TBT/N/ECU/366  
16 April 2019 
(19-2529) 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:  
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 and 2272  
Email: puntocontactoOTCECU@produccion.gob.ec ; puntocontactoOTCECU@gmail.com ; 
aramon@produccion.gob.ec ; cyepez@produccion.gob.ec ; jsanchez@produccion.gob.ec  
Website: http://www.in dustrias.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) : Condoms 
(HS 401410) ; (ICS: 11.200)  
5. Title, number of pages and language(s) of the notified document : Proyecto de 
Segunda Revisión del Reglamento Técnico Ecuatoriano PRTE INEN 049 (2R) "Condones 
(preservativos) masculinos de látex de caucho natural"  (Draft second revision (2R) of 
Ecuadorian Standardization Institute Technical Regulation (PRTE INEN) No. 049 "Natural 
rubber latex male condoms") (11 pages, in Spanish)  
6. Description of content : The notified Technical Regulation establishes the requirements  
to be met by natural rubber latex male condoms, prior to the marketing of domestic and 
imported products, with the aim of protecting human safety and health, and preventing 
misleading practices.  
The notified Technical Regulation applies to the following p roducts : Natural rubber latex 
male condoms.  
The notified Technical Regulation does not apply to : Female condoms.  G/TBT/N/ECU/366  
- 2 - 
  7. Objective and rationale, including the nature 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 acceptanc e quality limit (AQL) for lot -by-lot 
inspection;  
2. ISO 4074:2015, Natural rubber latex male condoms -- Requirements and test 
methods;  
3. ISO/IEC 17025:2017, General requirements for the competence of testing and 
calibration laboratories;  
4. ISO/IEC 17050 -1:2004, Conformity assessment - Supplier's declaration of 
conformity - Part 1 : General requirements;  
5. ISO/IEC 17067:2013, Conformity assessment - Fundamentals of product 
certification and guidelines for product certification schemes;  
6. ASTM D3492 -16, Standard Specification for Rubber Contraceptives (Male 
Condoms);  
7. 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 estableci mientos en donde se fabrican, importan, dispensan, expenden 
y comercializan  (published i n Official Journal No. 921 of 1 2 January 2 017);  
8. Sanitary Technical Regulation ARCSA -DE-033-2017-FMRH, Reforma a la 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  (published i n Official Journal No. 156 of 9 January 2 018).  
TRACEABILITY:  
1. G/TBT/N/ECU/70  
2. G/TBT/N/ECU/70/Add.1  
3. G/TBT/N/ECU/70/Add.2  
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 and 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_2206_00_s.pdf