Registration of Agricultural Chemical Pesticides in Ecuador
PQUA
LEGAL FRAMEWORK
The registration of a Chemical Pesticide in Ecuador is governed by the Decision 804 of the Andean Community of Nations (CAN) and Resolution No. 2075 with its Andean Technical Manual for the Registration and Control of Chemical Pesticides for Agricultural Use. In order to comply with these provisions, the Plant and Zoosanitary Regulation and Control Agency – Agrocalidad, through Resolution 020 of March 30, 2021, issues the ‘Complementary Technical Manual to facilitate the application of Decision 804 of the Andean Community regarding the registration and control of chemical pesticides for agricultural use.’
Steps of the registration process
The registration process in Ecuador involves a series of steps, starting from obtaining the import permit for product samples to be registered, conducting efficacy trials, laboratory analysis, preparing a dossier to be evaluated by National Control Authorities (Agriculture, Health, and Environment), and ultimately obtaining registration.
1. PimPex:
Import permit for samples
2. Quality analysis
3. Protocol, Implementation, and Execution of Efficacy Trials
Efficacy Trials for Registration, Development, Use Extensions, Dose Changes, and Screening
4. Submission of dossier to local authorities:
Agriculture – Health – Environment.
Preparation of dossier under applicable regulations, handling of confidential information.
5. Approved – Registered Product
Delivery of the approved registration certificate along with comprehensive information that led to the registration approval.
Registration of Biological Pesticides for Agricultural Use
PBUA
LEGAL FRAMEWORK
In Ecuador, the regulation governing Biological Control Agents, plant extracts, mineral preparations, semiochemicals, and related products for agricultural use is Resolution 105 issued by Agrocalidad in June 2022.
Within the classification for the registration of biological inputs, the following categories are included:
1. Biological Control Agents (BCA): Natural enemies, antagonists, competitors, or other organisms used for pest control. Processed products, ready for application and/or release in the field for agricultural crop protection purposes, which are classified into:
a. Entomopathogenic agents (developed from fungi, bacteria, protozoa, and viruses); antagonists (developed from fungi and bacteria).
b. Parasitoids and predators.
c. Entomopathogenic nematodes.
d. Secondary metabolites from the production of microorganisms.
2. Vegetal extracts (VE) and others.
3. Semiochemicals (SC):
a. Feromones.
b. Allelochemicals (allomonas, kairomonas, sinomonas and antimonas)
c. Food attractants.
4. Mineral preparations (MP)
Other Regulatory Processes
- Labeling updates under the Harmonized Global System (GHS).
- Environmental compliance reports in accordance with the Environmental Management Plan.
- Annual declarations according to the Comprehensive Management Plan for hazardous and special waste.
- Registration of operators/companies with Agrocalidad.
- Modifications to the registry: Addition of manufacturers, formulators and country of origin, toxicological recategorization, Transfers of ownership, Tariff consultations before Customs (SENAE).
- Post-registration follow-up, quality control and administrative processes.
- Import permits for samples and commercial imports.
- Hazardous and Special Waste Generator Records.
- Training in accordance with the Environmental Management Plan and Comprehensive Management Plan.
- Design of final arts in accordance with current regulations for Pesticides, Fertilizers and Related Products (Corel Draw / Illustrator).
- Clones (Product registration to one already registered).
- Data update in Government Systems/Platforms (GUIA, Ecuapass).
- Labeling modification for Reentry Period (REI).