G/TBT/N/ECU/463  
5 June 2019 
(19-3867) 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)  
Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pe reira, 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 nat ional tariff 
heading . ICS numbers may be provided in addition, where applicable) : Of other 
plastics (HS 392329)  
5. Title, number of pages and language(s) of the notified document : Proyecto de 
Segunda Revisión del Reglamento Técnico Ecuatoriano  PRTE INEN 253 (2R) "Envases 
flexibles para esterilización comercial de alimentos" (Draft second revision (2R) of 
Ecuadorian Technical Regulation PRTE INEN 253 : "Flexible packaging for the commercial 
sterilization of food") (10 pages, in Spanish)  
6. Description of content : The notified Ecuadorian Technical Regulation establishes the 
requirements to be met by flexible packaging for the commercial sterilization of 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 that are manufactured in, imported into or marketed 
in Ecuador:  
• Flexible packaging for sterilization, pre -formed, flat ("pouch" type) and 
rectangula r in shape , made of l aminated materials comprising three or more 
layers and with three seals applied by the manufacturer, empty and resistant to G/TBT/N/ECU/463  
- 2 - 
  commercial heat sterilization conditions, and used for the packaging of food that 
undergoes a heat sterilization process.  
It does no t apply to:  
• Packaging comprising three or more laminated layers that includes a side spout.  
• Packaging comprising three or more laminated layers that includes a centre spout.  
• Flat-bottom stand -up packaging with three seals comprising three or more 
laminated  layers.  
• Stand -up or "Doypack" packaging with caps or valves and resealing or zipper 
systems, comprising three or more laminated layers (for liquid or soft foods).  
• Stand -up or "Deltapack" packaging with caps or valves and resealing or zipper 
systems, compr ising three or more laminated layers (for solid foods).  
• Packaging comprising three or more laminated layers with a front degassing 
valve.  
• Other packaging used in the food industry comprising three or more laminated 
layers that does not meet the requirement s for resistance to commercial heat 
sterilization.  
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 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 12048:1994, Packaging - Complete, filled transport packages - Compression 
and stacking tests using a compression tester.  
3. ISO/IEC 17025:2017, General requirements for the competence of testing and 
calibration laboratories.  
4. ISO/IEC 17050 -1:2004, Conformi ty 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. EN 1186 -1:2002, Materials and articles in contact with foodstuffs - Plastics - Part 
1: Guide to the selection of conditions and test methods for overall migration.  
7. EN 13130 -1:2005, Materials and articles in contact with foodstuffs - Plastics 
substances subject to limitation - Part 1 : Guide to t est methods for the specific 
migration of substances from plastics to foods and food simulants and the 
determination of substances in plastics and the selection of conditions of 
exposure.  
8. EN 13130 -2:2005, Materials and articles in contact with foodstuffs - Plastics 
substances subject to limitation - Part 2 : Determination of terephthalic acid in 
food simulants.  
9. EN 13130 -7:2005, Materials and articles in contact with foodstuffs - Plastics 
substances subject to limitation - Part 7 : Determination of monoethylen e glycol 
and diethylene glycol in food simulants.  
10. ASTM F88/F88M -15, Standard test method for seal strength of flexible barrier 
materials.  
Notification history:  G/TBT/N/ECU/463  
- 3 - 
  1. G/TBT/N/ECU/284  
2. G/TBT/N/ECU/284/Add.1  
3. G/TBT/N/ECU/284/Add.2  
4. G/TBT/N/ECU/284/Add.3  
5. G/TBT/N/ECU/284/Add.4  
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  
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)  
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_3207_00_s.pdf