Regulatory Challenges for Genetically Modified Organisms (GMOs) in Latin America

Genetically Modified Organisms (GMOs) play a significant role in the agri-food and industrial sectors, offering innovative solutions to global problems such as food security and climate change. However, the regulatory complexity across Latin American countries presents significant challenges for companies seeking to operate in this region.

Regulatory Fragmentation

Each Latin American country has its own regulatory framework for GMOs, with marked differences in definition and approval requirements. For example:

In Argentina, regulation is conducted by several entities, such as SENASA and the National Biotechnology Commission (CONABIA), with a relatively well-structured process.

In Brazil, CTNBio leads the GMO evaluation process, focusing on food and environmental safety aspects.

Countries such as Bolivia and Peru, on the other hand, still do not have robust or clear regulations, making predictability difficult for companies.

This lack of harmonization between regulatory systems increases compliance costs, as companies need to adjust their strategies to meet different local requirements.

Lack of Consistent Definitions

One of the biggest challenges faced by companies is the variability in the definitions of GMOs. While countries such as Brazil have a clear definition (“organism whose genetic material has been modified in an unnatural way”), others, such as Chile, do not yet have a formalized definition. This inconsistency can generate uncertainty about which products qualify as GMOs and which do not, impacting the planning and execution of business strategies.

Bureaucratic and Lengthy Processes

Even in countries with more established regulations, the processes for GMO approval can be lengthy and bureaucratic. Companies often face:

A lack of clear deadlines for completing the assessment.

Excessive demands for technical documentation, especially in countries such as Colombia and Ecuador.

Regular changes in regulations, which can render processes already initiated obsolete.

These factors delay the entry of new products into the market, affecting competitiveness.

Public Perception and Restrictive Policies

Public opinion plays an important role in shaping regulatory policies. In countries such as Peru and Venezuela, popular resistance to GMOs has led to the implementation of more restrictive regulations or even bans on genetically modified crops. Companies need to invest in communication and education to reduce the impact of negative perceptions about GMOs.

Lack of Infrastructure and Technical Capacity

Some countries lack the infrastructure and skilled human resources to conduct the necessary assessments. This includes laboratories equipped for food or environmental safety testing and staff trained in biotechnology. Without these resources, analyses may be outsourced or performed internationally, increasing the cost and time for approval.

Conclusion

For companies operating with GMOs in Latin America, it is essential to take a proactive approach to navigating regulatory challenges. This includes:

Constantly monitoring regulatory changes in each country.

Collaboration with local authorities to promote harmonization of standards.

Engagement with the public to increase social acceptance of GMOs.

While the challenges are significant, the region also offers substantial opportunities due to the growing demand for innovative solutions in agriculture and food. With a well-structured strategy, it is possible to overcome the barriers and capture the potential of this expanding market.

In many Latin American countries, regulations require that products containing GMOs be declared when the percentage of genetically modified material exceeds a specific threshold. For example, in Brazil, labeling is mandatory for foods with more than 1% GMOs in their composition, as is the case in Uruguay. Other countries, such as Bolivia and Ecuador, follow similar percentages, 0.9%, while in some nations, such as Chile, labeling legislation is still poorly defined.

GMO Requirements - Latin America
Argentina	Decreto del Poder Ejecutivo N°206/2001
Brazil	Decreto nº 4680/2003 Lei 11.105/2005 Portaria nº 2658/2003 IN Nº 1/2004
Bolivia	Decreto Supremo 2452 de 2015 Decreto Supremo 2735 de 2016
Chile	Decreto Supremo Nº 977/96
Colombia	Decreto 4254 de 2011
Ecuador	NTE INEN 1334-1 RTE 022-2008
Mexico	Ley de Bioseguridad de los Organismos Genéticamente Modificados y Ley General de Salud
Paraguay	-
Peru	Not regulated
Uruguay	Res 4178/14
Venezuela	Not regulated