Chile has positioned itself as a leader in agricultural biotechnology and gene editing, thanks to a flexible, science-based regulatory framework that encourages innovation in crops.

Genomic editing, through techniques such as CRISPR-Cas9 and TALENs, allows precise modifications in plant genomes, improving pest resistance, climate tolerance, productivity, and nutritional quality. 

A recent study by Dr. Miguel Ángel Sánchez, CEO of ChileBio, highlights that Chile implemented in 2017 a pioneering regulatory framework in Latin America for new breeding techniques (NBTs), becoming the second country worldwide, after Argentina, to establish clear rules for plant gene editing.

This approach has promoted innovation and attracted applications from both local and international developers. 

The Agricultural and Livestock Service (SAG) regulates these practices in Chile, evaluating case by case whether a plant product is a genetically modified organism (GMO) or not. The process, which takes about 20 working days, has been praised for its simplicity, speed, and predictability.

Between 2017 and November 2024, of 57 applications received, 52 were classified as non-GMO and five as GMO. CRISPR-Cas9 is the most frequently used technique, with maize and soybeans being the most common crops. 

Dr. Sánchez notes that some applications included over 100 lines, reflecting a trend toward multiplexing, where several genes are edited simultaneously to generate complex traits, such as climate resilience and yield improvement. This capability strengthens Chile’s leadership in advanced agricultural biotechnology. 

Latin America against the international backdrop

Internationally, regulatory frameworks vary significantly. The U.S. applies a product-based approach, while Canada evaluates novelty. Latin American countries such as Argentina, Brazil, and Colombia assess NBT-derived crops case by case.

In Asia, Japan and the Philippines treat gene-edited plants without foreign DNA as conventional varieties, while China regulates these plants under GMO rules, albeit with a faster process than for traditional transgenics. 

The study identifies challenges for Chile, including pre-commercial and regulatory barriers, unnecessary post-commercial requirements, international regulatory differences, adaptation to complex genetic modifications, and market acceptance.

Public perception and distrust toward gene-edited products could limit export and adoption of these innovations. 

Despite these challenges, Chile’s product-based regulatory approach provides functionality, flexibility, and predictability, allowing multiple lines from a single gene-editing process under one application. This strategy encourages field trials and local seed multiplication, consolidating Chile as a biotechnology leader in Latin America. 

Dr. Sánchez concludes that Chile must proactively adapt its regulatory framework to maintain its leadership, balancing innovation, safety, and market demands while fostering international collaboration and public transparency.