Enabling Market Expansion Through Streamlined Pesticide Registration in Latam

THARSA, a regional agrochemical company specializing in the development and distribution of crop protection solutions, is well-established in Ecuador. The company approached Battelle to support its expansion into new markets, specifically Costa Rica and Guatemala, by registering its banana-targeted pesticide products.  Bananas are not only a major export crop in both countries but also play a vital role in rural livelihoods and national economies. Their crop protection solutions are vital for agrochemical market expansion.

Each of THARSA’s products contains different combinations of active ingredients, requiring a tailored regulatory strategy to meet the distinct requirements of each target country.

Battelle’s regulatory specialists conducted a comprehensive review of THARSA’s proprietary data and performed a detailed Data Gap Analysis (DGA). The analysis identified the studies required to comply with pesticide registration regulations in:

• Costa Rica: Regulated by the Servicio Fitosanitario del Estado (SFE) under the Ministry of Agriculture and Livestock (MAG), Costa Rica enforces stringent environmental and toxicological standards, with a strong emphasis on ecological impact.
• Guatemala: Governed by the Ministerio de Agricultura, Ganadería y Alimentación (MAGA), Guatemala’s regulatory framework places greater focus on agricultural efficacy and product safety, with comparatively greater emphasis on toxicological, ecotoxicological and environmental standards.

To address these differences, Battelle’s team leveraged its deep expertise in Latin American regulatory frameworks to align THARSA’s data with local requirements and ensure a streamlined path to registration.
A key asset in this process was Battelle’s multilingual regulatory team, which includes native Spanish speakers based in South America. Their language fluency and regional familiarity enabled the team to:

• Translate and interpret regulatory documents with precision
• Clarify ambiguous or country-specific requirements
• Facilitate effective communication with officials from MAG and MAGA

This collaborative approach ensured smooth navigation of local regulatory landscapes and strengthened engagement with authorities in both Costa Rica and Guatemala.
The team’s DGA identified:

• Which existing studies could be leveraged across both jurisdictions
• Which new studies were required to meet country-specific data requirements
• How to align THARSA’s dossier with the latest regulatory expectations in both Costa Rica and Guatemala

Navigating the regulatory landscape for pesticide registration requires careful attention to regional differences. The European Union (EU) has the most demanding process globally, characterized by extensive data requirements, detailed risk assessments, and mandatory public consultations. In contrast, Costa Rica and Guatemala have less stringent risk assessment protocols but present their own unique challenges. Successfully registering pesticides in these countries requires a nuanced understanding of local guidelines and proactive engagement with regulatory authorities.

Battelle delivered a strategic report that included:

• A country-by-country breakdown of regulatory requirements
• A list of recommended studies to address identified data gaps
• Estimated costs and timelines for completing the required studies
• A roadmap for dossier preparation and submission

By leveraging Battelle’s regulatory expertise in the pesticide registration process across Latin America, THARSA was able to confidently advance its registration plans. This partnership ensured regulatory compliance, minimized delays, and avoided redundant testing.