G/TBT/N/ECU/333  
22 March  2017 
(17-1587) 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:  
Agencia Nacional de Regulacion, Con trol y Vigilancia Sanitaria,  ARCSA (National Agency for 
Sanitary Regulation, Control and Surveillance)  
Ciudadela Samanes, Av . Francisco de Orellana y Av . Paseo del Parque, Bloque 5 Guayaquil 
- Ecuador  
Fax: (+593 -2) 2567815  
Email: PuntocontactoOTCECU@mipro.gob.ec  
Website: http://www.controlsanitario.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 la Calidad (Under -Secretariat for Quality)  
Ministerio de Industrias y Productividad , MIPRO (Ministry of Industry an d Productivity)  
Address : Yánez Pinzón N26 -12, entre Av . Colón y La Niña  
Quito, Ecuador  
Tel.: (+593 -2) 3948760, Ext. 2272 or 2253  
Email: PuntocontactoOTCECU@mipro.gob.ec , jcadena@mipro.gob.ec , 
cyepez@mipro.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) : 
0406.10.00.00  
5. Title, number of pages and language(s) of the notified document : Proyecto de la 
Normati va Técnica Sanitaria Ecuatoriana sustitutiva para alimentos procesados, plantas 
procesadoras de alimentos, establecimientos de distribución, comercialización, transporte 
de alimentos y establecimientos de alimentación colectiva  (Draft Substitute Ecuadorian  
Sanitary Technical Regulation on processed foods, food processing plants, establishments 
for the distribution, marketing and transportation of food, and mass catering 
establishments) (89 pages, in Spanish)  
6. Description of content : The notified draft Ec uadorian Sanitary Technical Regulation 
covers the following : Purpose ; Scope; Definitions ; Processed foods ; General 
considerations ; Sanitary certificates ; Procedure for obtaining sanitary certificates  according 
to risk profile ; Requirements for the issuance  of sanitary certificates for processed foods ; 
Domestic processed foods ; Foreign processed foods ; Administration of sanitary certificates ; 
Amendments to sanitary certificates ; Renewal of sanitary certificates ; Processed foods 
manufactured on production lin es certified for good manufacturing practices ; Technical 
representatives of food processing plants ; Authorizations ; Exportation of processed foods ; 
Batch guarantee certificate s; Free sale certificate s; Sanitary export certificate s; G/TBT/N/ECU/333  
- 2 - 
  Importation of processed  foods ; Food processing plants ; Operating permits ; Good 
manufacturing practices (GMP) ; Installations and requirements for good manufacturing 
practices ; Equipment and utensils ; Hygiene requirements during the manufacturing 
process ; Raw materials and ingredi ents; Production operations ; Packaging, labelling and 
packing ; Storage, distribution, transport and marketing ; Quality assurance and control ; 
GMP certification procedure ; Procedure for the registration of GMP certificates ; Procedure 
for the approval of GMP  certificates or for highly stringent certification ; Notification of 
changes to GMP certificates ; GMP certificates ; Transportation ; Mass catering 
establishments ; Sanitary conditions ; Hygiene conditions for staff ; Hygiene conditions for 
the handling of food ; Cleaning practices and pest control ; Restrictions ; Monitoring and 
control ; Monitoring and control of processed foods ; Monitoring and control of 
establishme nts that manufacture and market  foods ; Inspections of monitoring and control 
activities in food pro cessing plants certified for good manufacturing practices ; Monitoring 
and control of mass catering establishments ; Penalties.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : The notified Sanitary Technical Regulation establishes the hygiene and 
sanitary conditions and requirements to be met during the processes of manufacturing, 
production,  processing,  preparation, packaging, packing, transportation and marketing of 
foods for human consumption, and the requirements for  obtaining sanitary certificates for 
domestic and foreign processed foods , based on the risk profiling system, with the aim of 
protecting the health of the population and ensuring a healthy and safe food supply.  
It applies to all national or foreign natura l or legal persons involved or engaged in the 
processes referred to in the above paragraph of the notified Sanitary Technical Regulation, 
and to the establishments and the means of transport, distribution and marketing used for 
such purposes.  
8. Relevant documents:  
 Publication where notice appears: http://www.controlsanitario.gob.ec/  
 Proposal and basic document : Proyecto de la Normativa Técnica Sanitaria 
Ecuatoriana sustitutiva para alimentos procesados, p lantas procesadoras de 
alimentos, establecimientos de distribución, comercialización, transporte de 
alimentos y establecimientos de alimentación colectiva  (Draft Substitute 
Ecuadorian Sanitary Technical Regulation on processed foods, food processing 
plants , establishments for the distribution, marketing and transportation of food, 
and mass catering establishments)  
 Publication in which Technical Regulation will be published when adopted : Registro 
Oficial  (Official Journal)  
9. Proposed date of adoption : - 
Proposed date of entry into force : 180 days after publication in the Official Journal.  
10. Final date for comments : 17 April 2 017 
11. Texts available from : National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, i f available, of other body:  
Contact and/or National Enquiry Point:  
 
Juan Carlos Cadena  
Subsecretaría de la Calidad  
Ministerio de Industrias y Productividad - MIPRO  
Address : Yánez Pinzón N26 -12, entre Av . Colón y La Niña  
Quito, Ecuador  
Tel.: (593-2) 3948760 , Ext. 2272 or 2219  
Email: PuntocontactoOTCECU@mipro.gob.ec , jcadena@mipro.gob.ec , 
cyepez@mipro.gob.ec  
Website: http://www.industrias.gob.ec/  
https://members.wto.org/crnattachments/2017/TBT/ECU/17_1399_00_s.pdf