Regulating right: hybrid alternative proteins and the role of regulatory sandboxes

Published on September 30th, 2025

A new generation of alternative proteins

The introduction of new foods relies on acceptance from consumers, industry players, and public authorities.

In recent years, alternative proteins have been in the spotlight due to their potential to reduce the environmental impact of food production and help fight nutritional deficiencies (1). Insects and plant-based, cultured, and fermentation-derived proteins have achieved significant progress in areas such as nutritional value, consumer perception, and economic feasibility. Yet, none of these solutions seem to fully deliver in all areas. For example, while plant-based alternatives may succeed in scalability, cultured meat continues to face substantial hurdles in becoming commercially available. Additionally, most alternative proteins are perceived by consumers to be unnatural or overly processed (2,3), and their sustainability claims are voided by their limited adoption and diffusion.

One promising path forward may lie in hybrid products, which refer to the combinations of two or more protein sources, such as meat, plants, cultured cells, or mycelium-fermented ingredients (4). However, as Kaplan and McClements highlight in their Frontiers in Science lead article (5), hybrid products also encounter considerable challenges, particularly regarding their cost-effectiveness, sustainability, consumer acceptance, and regulatory authorization.

The state of the art of regulation for hybrid alternative proteins

The regulation of alternative proteins is a complex and multifaceted matter, which reflects the diversity of technologies and production methods. For some alternative proteins, regulatory challenges are largely linked to their labeling, particularly concerning the use of terminology traditionally associated with meat and dairy. For instance, in the European Union, there is a longstanding public debate about whether alternative proteins should be allowed to bear terms such as “milk”, “cheese”, or “burger” in their commercial and legal names and how these terms influence consumer perception and market competition (6). Plant-based proteins and traditional fermentation products are typically challenged by these labeling requirements.

For other products, the principal obstacle is not terminology but pre-market authorization. For cultured meat, insects, or precision-fermented ingredients, regulatory authorities require extensive evidence to demonstrate that the food is safe for human consumption before it can be commercialized. This process is often lengthy, resource-intensive, and highly dependent on jurisdiction-specific requirements (7). While some countries, such as Singapore, Israel, or the United States, are often described as innovation-friendly pioneers, other regulatory frameworks, such as the ones in force in the European Union, are less welcomed by innovators (8, 9).

The emergence of hybrid alternatives introduces an additional layer of complexity. Combining multiple protein sources, such as plant-based proteins with cultured cells, can result in a product that is subject to overlapping regulatory requirements. For example, a hybrid burger containing both plant-based and cultured ingredients would likely be treated by regulators as a food requiring full pre-market authorization, similar to a product composed entirely of cultured cells. At the same time, hybrid formulations raise new questions regarding product classification and labeling. For example, what proportion of cultured material would qualify a “cell-based product” and how should such information be communicated to ensure consumers are not misled?

New products, new regulatory strategies: regulatory sandboxes  

Businesses and public authorities must thus strike a balance between the risks and benefits of alternative proteins and hybrid products. Effective regulation should be rational, ensuring that rules are well-suited to achieving their intended goals; consistent, so that different legal frameworks complement rather than contradict each other; predictive, providing clarity and stability so that businesses and other stakeholders can plan in the long term; and adaptive, capable of responding to rapid technological, economic, and social change (10). Building such a framework also requires the institutional capacity to implement and enforce it in a transparent way. 

As Kaplan and McClements (5) highlight, collaboration between stakeholders is critical in this regard. Food scientists, industries, investors, consumer representatives, and regulatory bodies should all work together to make meaningful innovations available, authorized, and accepted by consumers and society as a whole. To practically implement this suggestion, spaces where all interests and concerns are represented are needed (11). Regulatory sandboxes could provide such a space. 

Regulatory sandboxes are spaces, either physical or virtual, set up by regulators to allow companies operating with new technologies to test innovative products, services, or business models in a real-world environment under controlled regulatory requirements (12). They create a flexible environment where rules can be temporarily eased or adapted to test different approaches. Their use has been proposed in several innovative sectors, including food innovations such as novel foods and genetically modified organisms (12, 13).  

Their primary purpose is to enable collective learning while reducing exposure to risk (14). For regulators, sandboxes provide a chance to deepen their understanding of emerging technologies, anticipate potential problems, and discuss issues with stakeholders. For businesses, they offer an early glimpse into market viability while allowing them to demonstrate the benefits of their innovations to both authorities and society. Consumers, in turn, gain the opportunity to become familiar with new technologies in a safe and controlled setting. 

Regulatory sandboxes for hybrid products could be designed in two ways. One model could aim at labeling and tasting experimentations, allowing the tasting of not-yet-approved innovations, much like in the case of the Dutch government’s initiative regulating the tasting of cultured-cell products for marketing and industrial purposes (15). At the same time, the sandboxes could be used to test names and marketing materials to study consumer perception of hybrid products and the necessary formulations to prevent consumers from being misled.  

The second model for a regulatory sandbox could focus on pre-market authorization. This does not mean that the sandbox should substitute the authorization or be established with the main purpose of generating data instrumental for it. Rather, the sandbox could be used to discuss with innovators the particulars of their products, for example, concerning the appropriate design of scientific studies and the type of evidence that must be produced to demonstrate product safety (12). One example is the recently established cultured foods sandbox in the United Kingdom, which aims to develop guidelines, procedures, and methods for the safety assessment of cell-based products and technologies (15). Well-designed regulatory sandboxes enable innovation and could prevent short- and long-term risks in a proportionate manner, especially in regions with weaker oversight where vulnerable populations could be exposed to harm. 

Conclusion 

Hybrid products represent the next frontier for alternative proteins. Their regulation demands not only the alignment of existing instruments but also the development of innovative approaches that enable mutual learning and dialogue between stakeholders. Only by combining traditional and new techniques can policymakers provide a framework that is both robust and adaptive to rapid technological change.

Copyright statement 

Copyright: © 2024 [author(s)]. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in Frontiers Policy Labs is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. 

Generative AI statement 

The author declared that no generative AI was used in the creation of this article.

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