Viviana Cervieri
Cervieri Monsuárez, Montevideo, Uruguay
vivianacervieri@cmlawyers.com.uy

Jesús Urbina
Cervieri Monsuárez, Montevideo, Uruguay
jurbina@cmlawyers.com.uy

Katherin Pérez
Cervieri Monsuárez, La Paz, Bolivia
kperez@cmlawyers.com.bo

Lucía Arimón
Cervieri Monsuarez, Asunción, Paraguay
larimon@cmlawyers.com.py

Introduction

In South America, food reflects history, through recipes and culinary practices that reflect centuries of adaptation, biodiversity, and culture. Today, however, this richness faces a new global landscape, where food innovation and international regulation define what can or cannot reach the table.

In this context, countries such as Bolivia, Paraguay and Uruguay illustrate two complementary paths, on one hand, the preservation and appreciation of traditional foods; on the other, openness to technological innovation and new regulatory paradigms. All share a common challenge ‘how to harmonise cultural identity and sustainable development with the technical demands of international markets’.

The rise of the Novel Foods concept, along with increasing demands for transparency, safety, and sustainability, is transforming the rules of the game. What for an Andean community is regarded as an everyday food, for a European authority, it may be considered a ‘new’ product that requires evidence of safety, traceability, and scientific validation. At the same time, the emergence of alternative proteins, advanced fermentations, and functional foods presents the region with the challenge of adapting regulations that often do not yet account for these categories.

Bolivia

Bolivia is a pluricultural and megadiverse country located in the heart of South America, where the Andes, the Altiplano, and the Amazon converge in a unique blend of biological and cultural richness. Over the centuries, Bolivian communities have preserved ancestral knowledge related to the cultivation, preparation, and consumption of foods that today form an essential part of their identity.

In a global context where food innovation is defined under the concept of Novel Foods, traditional Bolivian foods gain new relevance.

Products such as quinoa, cañahua, tarwi, maca, and coca leaves are a living legacy of Bolivia’s indigenous peoples. However, when these same foods cross borders, they often cease to be considered traditional and instead fall under the category of Novel Foods, meaning foods without a significant history of consumption in regions such as the European Union or the United States.

The contrast between what is traditional and what is novel reflects both cultural differences and complex regulatory challenges. The current situation is that the safety of a product is evaluated although it has been consumed for centuries yet is considered a ‘new’ product in another region.

Currently, several emblematic products illustrate this situation:

• Coca leaf (Erythroxylum coca): traditionally used in infusions and as a natural stimulant at high altitudes. Its commercialisation as a food product is prohibited outside Andean countries under the Single Convention on Narcotic Drugs (1961).
• Maca (Lepidium meyenii): recognised as a traditional food in the EU since 2002, although its concentrated extracts or capsules remain classified as Novel Foods.
• Cañahua (Chenopodium pallidicaule): a high-protein Andean grain, still without recognised consumption history in Europe.
• Tarwi or chocho (Lupinus mutabilis): a protein-rich legume whose European authorisation remains under review.
• Yacón (Smallanthus sonchifolius): its syrup was approved as a Novel Food in 2014, but the fresh root remains under evaluation.
• Achachairú (Garcinia humilis): received EU authorisation in 2022 after evidence of safe consumption.
• Llama meat/dried llama meat: traditionally consumed but lacking sufficient documented history for international markets.

Global innovation seen from Bolivia

Just as traditional foods may appear ‘new’ outside the country, Bolivia also faces the opposite challenge: new food technologies that still lack a local regulatory framework. Lab-grown foods, plant-based substitutes, and products containing functional microorganisms are examples of categories that have yet to be formally defined in national regulations.

This highlights the need to prepare the regulatory landscape for future innovations, while maintaining a cultural perspective and safeguarding food sovereignty.

Regulatory implications and opportunities

Recognising the nutritional and cultural value of traditional Bolivian foods can open doors to export opportunities, provided that international safety and traceability requirements are met.

Main challenges:

• documenting the history of consumption and traditional methods of preparation;
• conducting toxicological and compositional studies when necessary;
• aligning labelling and claims with the standards of the destination country;
• managing intellectual property and rights over traditional knowledge.

Opportunities:

• positioning Andean products as functional and sustainable ingredients;
• leveraging the rise of clean label and natural foods;
• promoting designations of origin and fair-trade certifications;
• strengthening cooperation among Bolivian institutions (SENASAG, INIAF, universities) and international agencies for the recognition of traditional foods.

In summary, traditional Bolivian foods represent a unique opportunity to unite identity, biodiversity, and regulatory innovation. The challenge lies in demonstrating to international bodies that these products, far from being ‘new’, are backed by centuries of safe and culturally validated consumption.

Paraguay

Paraguay combines a strong food tradition with a regulatory framework that is still evolving, seeking to adapt to current international trade requirements. Its cuisine, based primarily on ingredients such as cassava, maize, beans, and peanuts, gives rise to emblematic foods like chipa, mbejú, and sopa paraguaya, which reflect a culinary identity deeply rooted in the country’s history and local customs.

From a regulatory perspective, Paraguay has made progress toward a more structured and efficient system for food safety control. Law No 6788/2021, together with its recent amendments, assigns the National Directorate of Health Surveillance (DINAVISA) a central role in the registration, control, and inspection of food, beverages, and related products. In addition, resolutions issued in 2025 introduced updated criteria for the sanitary registration of products and establishments according to their risk levels, representing a significant step toward alignment with international standards on food safety and traceability.

However, Paraguay does not yet have a specific regulation covering so-called ‘novel foods’, understood as foods containing new ingredients or ingredients without a well-documented history of consumption. In practice, these products are evaluated on a case-by-case basis within the general sanitary registration system. Applicants are required to submit detailed technical information on composition, conditions of use, proposed labelling, and, where applicable, evidence supporting product safety.

The absence of a specific regulatory framework means that food innovation is managed individually, requiring the health authority to apply interpretative criteria based on existing regulations. This is particularly relevant for products incorporating emerging ingredients, such as alternative proteins or uncommon functional components, where balancing the promotion of innovation with public health protection and compliance with international standards is essential.

At the same time, specific regulatory developments can be observed that reflect a more restrictive approach to certain types of innovation. In particular, in Paraguay a bill has been introduced that provides for the prohibition of the production, importation, and commercialisation of animal-derived proteins obtained in laboratories, or cultivated meat. This approach highlights the existing tension between the promotion of new technologies and the preservation of traditional food systems, as well as the need to establish clear criteria in response to these developments.

In this context, Paraguay faces challenges similar to those of other countries in the region: preserving and promoting its traditional food heritage, while also creating conditions for the safe and competitive introduction of innovations, both in the domestic market and for international trade.

Uruguay

Uruguay is undergoing a transformation in how it produces and consumes food. In a country that is historically proud of its livestock tradition, new trends are emerging driven by technology, research, and, more recently, by growing cultural diversity.

Innovation is driven by the need to add value, respond to new consumer preferences, and comply with increasingly demanding regulations on safety, traceability, and labelling.

Institutions such as the National Institute of Agricultural Research (INIA), the Technological Laboratory of Uruguay (LATU), and the National Agency for Research and Innovation (ANII) are leading projects that connect science, sustainability, and productive development. A growing foodtech ecosystem is also taking shape, integrating traditional ingredients with modern techniques such as controlled fermentations, alternative proteins, and biodegradable packaging.

These initiatives do not seek to replace tradition but to complement it. The main challenge is not technological but cultural: in a country where food is deeply tied to identity, innovation can generate resistance. Replacing meat with plant-based proteins, lab-produced elements, or reformulating traditional recipes sparks debates about authenticity and modernisation.

Food diversity and migration

Over the past decade, Uruguay has received more than 100,000 migrants, mainly from Venezuela, Cuba, the Dominican Republic, Peru, and Argentina, transforming not only its demographics but also its food culture. New ingredients, recipes, and culinary practices are enriching the country’s gastronomy and expanding the range of products seeking formal entry into the market.

However, many of these ventures begin informally, producing food at home or in unlicensed facilities. The transition toward formalisation requires compliance with the standards set by the Registro Único Nacional de Alimentos y Envases (RUNAEV, National Unified Registry of Foods and Packaging) and the Directorate of Bromatology, as well as meeting food safety and labelling requirements.

In response, some municipalities and national agencies offer training and technical support programs designed to help micro-entrepreneurs enter the formal market, ensuring food safety while promoting social inclusion.

Evaluation of innovative foods

Uruguay has taken a key step by creating the Ateneo Técnico, a formal and systematic body for evaluating Novel Foods before their authorisation. This interdisciplinary group – comprising experts in nutrition, toxicology, microbiology, and pharmacology – reviews the composition, labelling, and safety evidence submitted by applicants seeking product registration.

The objective is clear: to ensure that innovation reaches the market without compromising public health, while keeping the country aligned with international standards.

Conclusion

Bolivia, Paraguay and Uruguay show that food regulation is not only a technical matter, but also a tool to protect cultural heritage and support its development over time. In Bolivia, the challenge is to demonstrate that traditional foods are as safe as they are valuable. In Paraguay, the main issue is how to manage innovation within a regulatory framework that is still developing, allowing new products and ingredients to enter the market without compromising food safety or traditional food identity. In Uruguay, the focus is on incorporating innovation within a regulatory system that maintains consumer trust and preserves the authenticity of its food culture.