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Navigating Novel Food Regulations and Challenges

Good news has recently come from the Alternative Protein industry as GOOD Meat received the FDA approval for its cultivated chicken to be consumed in the United States. This marks another significant milestone for the industry as the FDA gives its regulatory approval for the cultivated meat product. However, despite this success, the industry still faces a number of regulatory challenges that must be navigated in order to continue its growth and development.

The Food Technology and Alternative Protein space has been growing rapidly in recent years, driven by various factors (i.e., concerns around sustainability, health, and ethical implications of animal agriculture). The wide range of innovations and alternative protein sources, along with growing consumer interest in such products, have led to major hurdles for companies to overcome before bringing their products to market. The regulatory environment can be complex, depending on the type of product and the country or region in which they are distributed.

One major challenge faced by the industry is the lack of clear regulatory frameworks – there is no official legal definition that encompasses all alternative protein products (APPs) where criteria for APPs are provided but not expressly defined. This can be tricky for companies to know exactly the standards to meet in order to gain approval for their products. Nonetheless, countries are making the effort to improve this process by referencing and analysing other existing regulatory frameworks for novel foods.

In the U.S., the FDA regulates human food made from cultured cells of livestock and poultry jointly with USDA-FSIS, following the formal agreement established in March 2019. Under this agreement, the FDA oversees cell collection, cell banks, and cell growth and differentiation. The FDA is closely coordinating with the United States Department of Agriculture’s Food Safety and Inspection Service (USDA-FSIS), which shares jurisdiction over these human food products for certain animal species to ensure that they are safe and accurately labelled. Both agencies are working with manufacturers to ensure these products meet all applicable FDA and USDA-FSIS requirements.

Singapore, which has already established itself as a global leader by being the first country to approve the sale of cultivated meat, has adopted a flexible regulatory approach. The Singapore Food Agency (SFA) has updated its guidance on novel food four times since December 2020 to provide more transparency and clarity on the requirements of bringing products to market. For example, a recommended list of information comprising of the standards of novel food ingredients and safety assessments criteria is provided. Since the pre-market approval is granted on a case-by-case basis, the transparency of the process allows for feedback and information from the market, thereby revising guidance where necessary. Similarly, countries like Australia, New Zealand and Canada are also equipped with their own existing regulatory framework for novel foods evaluation.

On the other hand, South Korea is looking to develop food standards to govern the alternative protein products sector, proposing specific requirements to ensure food safety and quality management during manufacturing. Recently, the Ministry of Food and Drug Safety announced that it would be launching a public consultation to gather public opinions from industry players and consumers towards crafting these standards. In furtherance of this goal, the Korean National Assembly passed a number of regulatory "sandbox" laws late last year that are designed to exempt businesses from certain regulations, enabling them to more quickly adopt and commercialize new technologies and business models in Korea.

Meanwhile, the Japanese government has announced that it is assembling a team of experts to analyse the safety of cultivated meat. The move is seen as a precursor to implementing a regulatory framework for future commercial product approvals. The Japanese team will be curated by the Health, Labour, and Welfare Ministry. Its endeavours will focus on establishing whether there are any risks to human health from consuming cultivated meat products. The entire cultivation process will be analysed ahead of the anticipated industrialization of cell-based meat production.

At present, cultivated meat products are not marketed in the EU. Such products require pre-market authorization before they can be placed on the EU market, and depending on the techniques used, this authorization may need to be made via either the GMO legislation or the novel food regulation. Once an application for the authorization of these products is submitted to the Commission, the European Food Safety Authority (EFSA) will carry out the safety evaluation of these products, including whether they are nutritionally disadvantageous for consumers.

Frameworks from other countries, where cultivated meat is making meaningful progress, will be taken into consideration. This will necessarily include Singapore and U.S. which remains the only two countries to approve cultivated meat products for commercial sale. They are expected to be used as reference points alongside, as both have burgeoning cultivated sectors and multiple players within the niche vying for regulatory approval.

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