G/TBT/N/ECU/519  
30 August  2023 
(23-5818) 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, Control 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  
Tel.: (+593 -4) 3727 440  
Website: https://www.controlsanitario.gob.ec  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or a uthority 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 or 2272  
Email:  
puntocontactoOTCECU@produccion.gob.ec ; 
puntocontactoECU@gmail.com ; 
jmarino@produccion.gob.ec ; 
cyepez@produccion.gob.ec ; 
Website : www.produccion.gob.ec  
3. Notifi ed under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], 
other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading . ICS numbers may be provided in addition, where applicable) : The 
notified regulation s are the Draft Sanitary Technical Regulations for the process of issuing 
the toxicology evaluation report, amending the toxicology report and aligning the labelling 
of chemical pesticides for agricultural use with the Globally Harmonized System.  
The purpo se of the Draft Regulations is to set out the procedure for obtaining the 
toxicology evaluation report for chemical pesticides for agricultural use, in accordance 
with the provisions of Andean Community Decision No. 804 and Resolution No. 2075, or 
those am ending or replacing them . The Draft Regulations lay down the legal and technical 
requirements for obtaining and amending the toxicology evaluation report, and for 
aligning the labelling of chemical pesticides for agricultural use with the Globally 
Harmonized System.  G/TBT/N/ECU/519  
- 2 - 
  5. Title, number of pages and language(s) of the notified document : Proyecto de 
Normativa Técnica Sanitaria para el proceso de emisión del informe de evaluación 
toxicológica, modificaciones de informe toxicológico y adaptación de etiquetas al sistema 
globalmente armonizado de los Plaguicidas Químicos de uso Agrícola (PQUA) (Draft 
Sanitary Technical Regulations for the process of issuing the toxicology evaluation report, 
amending the toxicology report and aligning the labelling of c hemical pesticides for 
agricultural use with the Globally Harmonized System) (15 page(s), in Spanish)  
6. Description of content : The purpose of the Draft Regulations is to set out the procedure 
for obtaining the toxicology evaluation report for chemical p esticides for agricultural use, 
in accordance with the provisions of Andean Community Decision No. 804 and Resolution 
No. 2075, or those amending or replacing them . The Draft Regulations lay down the legal 
and technical requirements for obtaining and amend ing the toxicology evaluation report, 
and for aligning the labelling of chemical pesticides for agricultural use with the Globally 
Harmonized System.  
The notified Sanitary Draft Regulations are applicable to and binding on all natural and 
legal persons, wh ether domestic or foreign, governed by public or private law, that 
request the toxicology evaluation for chemical pesticides for agricultural use, as well as 
amendments to the toxicology evaluation report issued by National Agency for Sanitary 
Regulation, Control and Surveillance (ARCSA) prior to the issuance of the Certificate of 
Registration granted by the Agency for Phytosanitary and Animal Health Regulation and 
Control (AGROCALIDAD), and the alignment of the labelling for chemical pesticides for 
agricul tural use with the Globally Harmonized System.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Prevention of deceptive practices and consumer protection ; Protection of 
human health or safety ; Protection of animal or p lant life or health ; Protection of the 
environment.  
8. Relevant documents : - 
9. Proposed date of adoption : To be determined  
Proposed date of entry into force : Six months after adoption  
10. Final date for comments : 60 days from notification  
11. Texts available from : National enquiry point [ ] 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 or 2272  
Email:  
puntocontactoOTCECU@produccion.gob.ec ; 
puntocontactoECU@gmail.com ; 
jmarino@produccion.gob.ec ; 
cyepez@produccion.gob.ec ; 
www.controlsanitario.gob.ec  
https://members.wto.org/crnattachments/2023/TBT/ECU/23_12073_ 00_s.pdf