The regulation of alternative proteins around the world: who’s holding the recipe to success?

Alternative proteins and their potential impact on the future of the global food industry have been in the spotlight recently. But why? Justyna Pałasińska and Ioannis Kartanos from Pen + Tec Consulting look at the regulatory landscape in the EU, the UK, Singapore and the USA for answers

Meat substitutes such as plant-based, insect proteins, fermentation-enabled proteins and cultured meat have undeniably caught the attention. However, the enthusiasm for alternative proteins is frequently tempered by legislation, which varies quite significantly among markets, and creates challenges for food business operators all over the world.

European Union

As per EU Regulation 2015/2283 on novel foods, food business operators are required to determine whether their food products have a history of consumption to a significant degree before 15 May 1997. Otherwise, the foods will be treated as ‘novel foods’ requiring premarket authorization.

Not all alternative protein products are considered ‘novel’. In the EU, this has produced a great deal of heated debate among member states with some being more flexible and others keeping a much more conservative and vigilant stance. An unequivocal way to reassure the non-novel status of a protein is through public consultation, whereby the member state in which the food is intended to be placed on the market evaluates evidence of the consumption of the product. For example, pea and soy protein hydrolysate and rice proteins have been proven to not be novel.

Nevertheless, it is common to see alternative protein sources derived from insects, microalgae and even jellyfish to be considered novel foods in the EU, which implies something in the region of a two-year-long authorization process. This struggle means that many food business operators – eager to launch their alternative proteins – are faced with lengthy and complicated safety assessments as dictated by the EU Novel Food Regulation.

The novel food authorization process includes a safety evaluation, which is carried out by the European Food Safety Authority (EFSA). According to EFSA’s risk-benefit assessment on shifting from traditional meat-based diets to alternative dietary patterns, the benefits of alternative proteins must outweigh any safety risks involved, such as the exposure to natural toxins found in plant-based foods.

The safety assessment will require the submission of detailed information on the identity, production process, composition, specifications, history of use, intended use, nutritional and toxicological profile of the novel food concerned as well as information related to absorption, distribution, metabolism excretion, and its allergenic potential. Although several alternative proteins have been authorized in the EU (mainly plant-based), we are yet to see a cell ag product go through the entire authorization process.

Responding to the great interest and demand for alternative proteins, the EC has released its flagship ‘Farm to Fork’ strategy, which targets the transformation of the European food market with emphasis on alternative food and feed-stuffs and focus on increasing the availability and sources of alternative proteins such as plant, microbial, marine, and insect-based meat substitutes. Many stakeholders, including the Good Food Institute, supported this new strategy, advocating that alternative proteins will lead the way to a more sustainable and healthy food industry.

United Kingdom

Although the UK has gained its regulatory freedom from the EU, at the moment, it still largely adheres to the novel food regulation of the EU. However, the Food Safety Authority (FSA) is reassessing the framework, and working on new, more tailored legislation to help the evaluation and authorization of alternative proteins. As reported by the FSA, “the UK’s priority is to design a regulation that will need to be a dynamic and proactive process, where the FSA interacts continuously with the industry to encourage innovation, while protecting long-term interests of consumers in terms of health and sustainability of the food system”.

The new legislation is expected to be implemented within the next three years, and continuously re-evaluated over time.

Singapore

Meanwhile, the authorization procedure in Singapore seems to have been more approachable, becoming the first market to authorize the actual commercialization of cell-based poultry for human consumption, and more recently allowing the first serum-free cultivated chicken on its market. This is thanks to the Singapore Food Agency (SFA), which continuously updates its guidelines on the requirements for the safety assessment of novel foods and novel food ingredients.

The includes specific requirements for the different types of alternative proteins, and the SFA also enables meetings with the applicants on demand, during which they advise on the data requirements specific to the novel food. The timeline for authorizations is nine to 12 months from the moment the full application is submitted.

Singapore is undeniably the leading country in the regulation of alternative proteins, moving faster than any other toward a more sustainable food industry. It relies greatly on the introduction and development of meat alternatives, including anything from lab-grown meat or cultivated fish to plant-based, insect-originated or fermentation-enabled proteins. Singapore has also vowed to produce more of its own food as part of a sustainability plan with a strict timeline – a shift to alternative proteins is in the epicenter of this agenda. Many companies have rushed to explore and develop innovative food ideas that will eventually deal with the ultimate challenge of upscaling and producing sustainable food alternatives.

The USA

The increasing appetite of consumers for meat alternatives could not remain unnoticed in the USA. In mid-November 2022, after a 13-month evaluation, the US Food and Drug Administration (FDA) shook the global food industry by declaring for the first time ever that a cell-based poultry product is safe for human consumption. The partially approved product from UPSIDE Foods is still pending a green light from the USDA before it can be officially placed on the market. Nevertheless, this is a strong signal of the beginning of a new era that could follow Singapore’s first steps to allow consumers to buy alternative protein products on the supermarket shelves in the very near future. And in late March 2023, GOOD Meat, the cultivated meat unit of Eat Just, also successfully completed FDA’s pre-market consultation.

Depending on the type of the product, the regulatory pathway may vary. For instance, foods may be ‘Generally Recognized as Safe’. A GRAS notice is based on the views of experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food, providing reasonable certainty that the substance is not harmful to humans consuming the food, under the conditions of its intended use.

As per FDA’s implementing regulations (21 Code of Federal Regulations 570 on Food Additives), the use of a food substance may be GRAS either (1) through scientific procedures or (2) in the case of a substance used in food prior to 1 January 1958, through experience based on common use in food. In case of demonstrating GRAS status through scientific procedure, food business operators must prepare an assessment supported by a substantial amount of published peer-reviewed data on safety, stability and homogeneity, which demonstrates the safety of the ingredient for the specific uses. This GRAS assessment can be notified to the FDA. Also, in the case of the US regulatory pathways, the FDA invites communication with applicants in respect to data requirements and interpretation of data, to facilitate a smoother process.

It comes as little surprise that the USDA appears to be on the same line as the FDA, recently investing heavily on the research and development of cultivated proteins, and approving a fund of US$10 million to Tufts University with the sole purpose of creating a new National Institute for Cellular Agriculture. This fund comes as part of a wider US$146 million investment on sustainable agriculture research projects, indicating a major turn to a more sustainable food industry future.

In the case of the US regulatory pathways, the FDA invites communication with applicants in respect to data requirements and interpretation of data, to facilitate a smoother process

Conclusion

The need for a clear regulatory framework that can accommodate the novelty of these new foods as well as the rapid pace of their market entry is evident. This new reality in the food industry has triggered changes in the food legislation among the key countries in the development and regulation of alternative proteins, such as the EU, the UK, Singapore and the USA, which bear the responsibility to safeguard the health and interests of consumers in this complex and rapidly changing environment, with some of them proven to be more flexible and adjustable than others, but all moving in the same direction.

Across the different legal systems, it is clear that food safety authorities in the USA and Singapore are open to communication with the applicants and provide guidance on specific data requirements. This supportive approach is already yielding results for food business operators to get to market as fast as possible, as can be seen with the first steps in the approval of cell cultured products. In the EU and the UK, however, cell-cultured products still face the most uncertain road to market.

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