One of the key success drivers for the adoption of Cellular Agriculture (Cell Ag) is the sector’s regulatory landscape. Although the concept dates back to 1912, the regulations for Cell Ag are still evolving. Like every other food product, the source and method of manufacturing are evaluated before it reaches the consumer. Plant-based protein alternative companies like Impossible Foods and Beyond are already commercially available but cell-based food has yet to reach that level of progress.
Singapore’s regulations in Cellular Agriculture
The governing body overseeing the manufacture and sale of food products in Singapore is the Singapore Food Agency (SFA). SFA’s extensive guidelines already cover traditionally grown food and animal products ranging from rice to meat to beverages.They have carefully evaluated criteria which companies follow in order to register their products for sale and consumption.
Cell-based foods fall under the category of ‘Novel Food’ for which a set of guidelines were introduced by SFA in 2019. The label applies to foods that do not have the history of safe use but are chemically similar to naturally-occuring substances albeit produced through different technologies. Interestingly, plant-based foods do not fall under the ‘Novel Food’ category in Singapore as they are made from protein extracts from plants that are commonly consumed such as wheat, pea, rice, etc.
For food with a history of safe use (history of safe use refers to food products and ingredients that have been consumed by a significant human population, for more than 20 years without reported adverse effects on human health), SFA evaluates a number of criteria such as an ingredient’s length of use, quantity of consumption, intention of use and any evidence of adverse effects to human health. These information are validated against available resources including scientific literature, publications, cookbooks, and patents.
One major component of this assessment is that of safety on human health. For novel food in Singapore, SFA has put down guidelines for evaluation such as structure of compounds being produced, manufacturing methods, and performing microbiological and toxicological studies. Singapore also takes into consideration safety assessments being conducted in accordance with different authorities across the globe such as the USA’s FDA, the European Union’s European Food Safety Authority (EFSA), and global bodies like the World Health Organization and Food and Agriculture Organization.
SFA evaluates the manufacturing process of the cultured meat, cell line characterization which includes the source of cells, screening process of selecting the cells, expansion methodologies, and the modification made to the cell lines. These modifications are then further studied to establish safety and eliminate any risk it might cause to consumers due to genetic instability. SFA also requests reports such as how well the food product can be digested, if there are any toxic effects from the food product, and if they cause any allergies upon ingestion, etc.
Once the cells have grown, SFA also recommends companies to produce evidence on whether or not the culture media they were grown in would be present in the final product. The final product also undergoes tests to check if there are any microbial contamination which could potentially cause harm to human health.
Regulations for cell-based milk
As for Cell-based milk, it could be a little different. Since it is a novel field even compared to cell-based meat, regulations are still evolving. Start-up companies in this space like TurtleTree play a key role in helping government agencies shape the guidelines for companies who wish to pursue this route further down the line.
In order to produce milk from cells, the cells would still be put in a cocktail of reagents mimicking the environment inside an animal to try and stimulate the cells to produce milk with a similar composition to mammal milk. Hence a majority of the tests done for cultured meat such as source testing the cells, assessing genetic stability, microbial testing, and cultured media testing would also be necessary. Cultured milk as a final product would not have cells in them.
A key difference is the genetic material present in the cells are not directly ingested by a consumer, so agencies may base the safety evaluation of the final product on bio-equivalence. For now, mammalian milk from the animal is the benchmark when evaluating the composition and concentration of different components like protein, fats, and carbohydrates.
It would be interesting to see which other nation would be next in line after Singapore to accept Cell Ag as one of the alternative sources to that of traditional agriculture and farming. This would also tell us how regulations evolve and change from nation to nation. For now, we wait, watch, and be in constant conversations with our regulators to see how we can keep driving the Cell Ag and cell-based milk industry forward!