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Regulatory Framework for Pesticides Registration in Andean Countries
Aug. 30, 2016
Knoell Germany GmbH
GermanyFollow
Germany-
-
Rosa Maria Criollo Cueva de Staal
Global Registration Manager
Back in 2000, the registration of pesticides was manageable but definitely not easy. It required a file containing completed forms, a copy of labels, information on intended uses, and efficacy information, along with the corresponding fee in these countries was all what was needed. Above all, only the National Authority was involved in the process. The Andean Community changed this significantly.
The Andean Law on the registration and control of chemical pesticides for agricultural use, – “PQUA” 1 , approved by Decision 436 in June 1998, was the result of several years of negotiation between the member countries of the Andean Community, which at the time included Bolivia, Colombia, Ecuador, Peru, and Venezuela. The FAO provided technical assistance.
The law changed the number of technical requirements from around 40 to over 200. To enforce this law, Resolution 630/2002 was published in 2002 as the Andean Technical Manual, listing all the data requirements and approved guidelines.
In Colombia, Law 101 of 1993 and Resolution ICA 3759 were drafted, and the Andean norm was applied in 2003. In Ecuador, the application of the law started in June 2005 through the national authority AGROCALIDAD. In 2000, Peru began enforcing Decision 436, with the SENASA operating as the national authority for this procedure.
The evaluation process is shared among three authorities (Health, Environment and Agronomy), and the technical dossier was allowed to be submitted on paper or electronically. The competent authority in each country is the Ministry of Agriculture or the delegated authority, such as Agrocalidad-Ecuador, ICA-Colombia, and SENASA-Peru. The Andean law in the cooperating countries can be compared with the European EC Regulation 1107/2009. The Andean Technical Manual is equivalent to the data requirements under EU Regulations No. 283/2013 and No. 284/2013.
The dossier(s) for the active substance and/or formulated product(s) are evaluated in parallel. Information sources for fulfilling the data requirement can either be already registered substances, where only a summary report is needed, or new molecules, which requires the entire report. The technical sections of the dossier include the following details:
• Basic information about the company and product;
• Physical and chemical properties;
• Analytical methods;
• Toxicology;
• Residues and Metabolism;
• Environmental fate;
• Ecotoxicology;
• Efficacy;
• MSDS, classification & labeling; Containers;
• Environmental Risk Assessment; and
• The environmental management plan
For risk assessment and technical guidelines, the American hazard approach is used.
The Andean countries are currently working on an update of the Andean Law. In April 2015, Decision 804, which completely modified Decision 436, was approved. Also, a working group was requested to review and update the Andean Technical Manual (Resolution 630), and this work has been implemented to date.
Companies have to honor these stricter and more demanding requirements if they want to place their products on the market. Even stricter and more challenging regulatory hurdles are planned, just as they are in other parts of the world.
1 In the Andean Law: Plaguicidas Quimicos de Uso Agrícola
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