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The regulatory landscape of alternative proteins: plant-based, fermentation and cell-based.

Celia Martin, Director Global Regulatory Affairs, Lallemand

The regulatory landscape of alternative proteins: plant-based, fermentation and cell-based.Celia Martin, Director Global Regulatory Affairs, Lallemand

The global food needs are expected to increase for the next decades. With the worldwide population growing to around 10 billion by 2050 and the consumption patterns evolving, the overall protein consumption is predicted to grow significantly and nearly double by 2025.

The consumption of animal-derived products poses serious health issues– World Health Organization having classified processed meat and read meat as carcinogenic – and that is one of the motivations driving consumers to seek for plant-based meat alternatives. Moreover, the animal agriculture negatively impacts the environment through greenhouse gas emissions, land take, water requirements and pollution. There is a clear need for more sustainable options to meet the growing demand for high quality protein-rich diets. Reducing the consumption of animal-derived proteins and shifting to other sources of protein is a way to address the environment and climate crisis as well as to contribute to more healthy and balanced diets.

Until recently, plant-based proteins have been the most conventional alternatives to animal proteins, and they are still gaining traction, as seen from the booming plant-based foods market in recent years. However, other proteins from insects, algae, fermentation-based (e.g., from bacteria, yeast, fungi) or cell-based proteins (e.g., cultivated meat, seafood, dairy) are progressively emerging as new options in the alternative protein market. To have a full success in the marketplace, including consumers’ acceptance, alternative proteins must overcome some challenges from the regulatory standpoint, including safety, nomenclature and labelling. 

The safety assessment is a key pillar of any innovative food to access the market. For alternative proteins, this is generally achieved through scientific procedures, such as the US Food and Drugs’ Administration’s food Generally Recognized As Safe (GRAS) or the European Food Safety Agency’s Qualified Presumption of Safety (QPS) and Novel Food assessment. Other agencies have specific evaluation systems based on the same scientific and risk-based principles. The approvals are generally granted on a product-by-product basis and there is not one single and harmonized system in the world. A novel protein must undergo toxicity, allergenicity and exposure assessments to be determined safe to the consumers. The complexity of the safety assessment may vary depending on different factors.

In some cases, like cultivated meat - growing animal cells in a bioreactor- it is the novelty of the technology what makes the regulatory pathway to market is not clear in many countries or the existing procedures, like GRAS, not fully adapted. In the EU, cultivated animal proteins fall under the Novel Food regulation although no product has been approved yet. In November 2020, the Singapore Food Agency granted the first regulatory approval to a cultured chicken product, which was a milestone in the cell-based sector.

In other cases, the reason triggering a full evaluation process is the process which alters the composition of the original products (hence improving functionality, texture or digestibility) in a way that the relative concentration of its components results in a new product which has not been of common use in food as such. This is the case of the mung bean protein isolate classified as a Novel Food, whereas the mung bean itself didn’t, or the isolated pea protein GRAS notice, where pea has been on the food chain for centuries.

In other instances, it can be the microorganism where the protein originates from that triggers the Novel Food classification and thus requires a complete taxonomic strain characterization by fully assembled whole-genome sequence analysis. Examples for this is a fungal protein-fiber rich biomass originating from a filamentous fungus for which the QPS had not been established yet.

The more straight forward examples are yeast proteins obtained from traditional strains used in food through cconventional physical and enzymatic methods. Those are normally consumed through yeast and yeast extracts present in the food chain and thesafety is well established without the need of any further pre-market assessment.

As regards denomination and claims, different terms are used to describe the protein ingredient. Hydrolysateextractor isolate are used for plant-derived proteins (pea, soy, mushroom, mung); terms such as fungal proteinsingle-cell biomass, dried biomass, my coprotein are seen for fermentation-based proteins; for cellular-based proteins, cultured or cultivated meat (or egg or fish) is the most accepted nomenclature. Outside the terms used in the authorization dossiers, there is no standard terminology to identify the alternative proteins names in the product ingredient list and the claims associated to them are not regulated in most jurisdictions. In the EU, the terms “burger” “sausage” and “steak” can be used for plant-based products, following a vote of the European Parliament. For the plant-based dairy, the EU policymakers have rejected in April 2021 a proposal that would have set up unprecedented restrictions preventing the use of words such as “creamy”, “buttery” “alternative to dairy milk” or “lactose-free”. In the US, some States have passed laws restricting the use of names like buttersausages or meat on products not made by animals, some of them being the object of lawsuits. Many questions remain unanswered and that creates challenges for regulators and confusion to the consumers.

As the alternative protein industry continues to expand, food standards and laws must also evolve to reflect the marketplace, giving room to these new and highly demanded food products. Different stakeholders including regulatory agencies, governmental bodies, industry and consumers associations, would discuss in order to shape the appropriate regulatory framework for this new generation of proteins. Dialogue has or is taking place in some jurisdictions through workshops or calls for comments and is the key to drive the transition to more sustainable, safe, nutritious and healthier food systems.

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