G/TBT/N/ECU/411  
13 May 2019  
(19-3263) 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) : 392410 : 
Other; Carboys, bottles, flasks and similar articles (HS 392330) ; Stoppers, lids, caps and 
other closures (HS 392350) ; Other (HS 392390) ; Other (HS 392490)  
5. Title, number of pages and langua ge(s) of the notified document : Proyecto de 
Primera Revisión del Reglamento Técnico Ecuatoriano PRTE INEN 100 (1R) "Materiales y 
artículos plásticos destinados a estar en contacto con los alimentos"  (Draft first revision 
(1R) of Ecuadorian Technical Regulation PRTE INEN No. 100 "Plastic materials and articles 
intended  to come into contact with food") (12 pages, in Spanish)  
6. Description of content : The notified Ecuadorian Technical Regulation establishes the 
requirements to be met by plastic materials and articles that are to come into  contact 
with food, prior to the marketing of domestic and imported products, with a view to 
protecting human health a nd preventing deceptive practices.  
It applies to the following products:  
• Plastic materials and articles that are to come into contact with food  
It does not apply to:  G/TBT/N/ECU/411  
- 2 - 
  • Articles made of silicone  
• Articles made of rubber  
• Flexible plastic containers for the comm ercial sterilization of food  
• Plastic feeding bottles  
• Drinking straws, teats, sippy cup spouts, training spoons , and cups for liquid food.  
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 472:2013, Plastics - Vocabulary.  
2. ISO 1382:2012, Rubber - Vocabulary.  
3. 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.  
4. ISO 16103:2005, Packaging - Transport packaging for dangerous goods -
Recycled plastics mater ial. 
5. ISO/IEC 17025:2017, General requirements for the competence of testing and 
calibration laboratories.  
6. ISO/IEC 17050 -1:2004, Conformity assessment - Supplier's declaration of 
conformity - Part 1 : General requirements.  
7. ISO/IEC 17067:2013, Conformity asse ssment - Fundamentals of product 
certification and guidelines for product certification schemes.  
8. 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 migrat ion. 
9. EN 1186 -2: 2002, Materials and articles in contact with foodstuffs - Plastics - Part 
2: Test methods for overall migration into olive oil by total immersion.  
10. EN 1186 -3:2002, Materials and articles in contact with foodstuffs - Plastics - Part 
3: Test m ethods for overall migration into aqueous food simulants by total 
immersion.  
11. EN 1186 -4:2002, Materials and articles in contact with foodstuffs - Plastics - Part 
4: Test methods for overall migration into olive oil by cell.  
12. EN 1186 -5:2002, Materials and articles in contact with foodstuffs - Plastics - Part 
5: Test methods for overall migration into aqueous food simulants by cell.  
13. EN 1186 -6:2002, Materials and articles in contact with foodstuffs - Plastics - Part 
6: Test methods for overall migration into olive oil using a pouch.  
14. EN 1186 -7:2002, Materials and articles in contact with foodstuffs - Plastics - Part 
7: Test methods for overall migration into aqueous food simulants using a pouch.  
15. EN 1186 -8:2002, Materials and articles in c ontact with foodstuffs - Plastics - Part 
8: Test methods for overall migration into olive oil by article filling.  
16. EN 1186 -9:2002, Materials and articles in contact with foodstuffs - Plastics - Part 
9: Test methods for overall migration into aqueous food si mulants by article 
filling.  
17. EN 1186 -10:2003, Materials and articles in contact with foodstuffs - Plastics - Part 
10: Test methods for overall migration into olive oil (modified method for use in 
cases where incomplete extraction of olive oil occurs).  G/TBT/N/ECU/411  
- 3 - 
  18. EN 11 86-11:2003, Materials and articles in contact with foodstuffs - Plastics - Part 
11: Test methods for overall migration into mixtures of C -labelled synthetic 
triglycerides.  
19. EN 1186 -12:2002, Materials and articles in contact with foodstuffs - Plastics - Part 
12: Test methods for overall migration at low temperatures.  
20. EN 1186 -13:2003, Materials and articles in contact with foodstuffs - Plastics - Part 
13: Test methods for overall migration at high temperatures.  
21. EN 1186 -14:2003, Materials and articles in contac t with foodstuffs - Plastics - Part 
14: Test methods for "sub stitute tests" for overall migration from plastics 
intended to come into contact with fatty foodstuffs using test media iso -octane 
and 95% ethanol.  
22. EN 1186 -15:2003, Materials and articles in contact with foodstuffs - Plastics - Part 
15: Alternative test methods to migration into fatty food simulants by rapid 
extraction into iso -octane and/or 95% ethanol.  
23. Commission Regulation (EU) No. 10/2011, Plastic materia ls and articles intended 
to come into contact with food.  
Notification history:  
1. G/TBT/N/ECU/105  
2. G/TBT/N/ECU/105/Add.1  
9. Proposed date of adoption : 60 days from the date of 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)  
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  
https://members.wto.org/crnattachments/2019/TBT/ECU/19_2771_00_s.pdf