Novel Food Regulations: Required Analytical Data for Dossier Submissions
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Novel food regulations define the pathway for bringing new and emerging food products to market, including innovations like cell-cultivated products and those derived through precision fermentation. As part of the process, they must undergo rigorous assessments to ensure they are safe, nutritionally appropriate, and properly labelled.
In this article, we explain how novel food regulations apply to cell-cultivated products and why robust analytical data are essential for regulatory approval. As a novel food testing laboratory, we further highlight how manufacturers can leverage our accredited and validated testing methods to produce the data needed for dossier submissions in the UK and internationally.
What are Novel Foods?
Novel foods are classed as foods that were not widely consumed in the UK, or Europe, before May 1997 and therefore require safety assessment before being approved for sale. The category covers a wide range of products that arise from new ingredients, production methods, or technologies that have not previously been part of the traditional food system.
Recent advances in food science and biotechnology have brought significant attention to innovations such as cell cultivated and precision fermentation products. “Lab-grown” foods are produced by growing animal cells in controlled environments to create products such as meat or dairy without the need to raise and slaughter animals. Precision fermentation uses microorganisms like yeast or bacteria that are programmed to produce specific proteins or nutrients, enabling the creation of ingredients such as dairy proteins without relying on livestock.
These technologies are expanding the definition of how food can be produced and are increasingly discussed for their potential to improve sustainability, reduce pressure on agricultural systems, and support the development of new types of food products.
Novel Food Regulations: Ensuring Safety and Nutritional Adequacy
Novel food regulations are designed to ensure that new foods placed on the market are safe and nutritionally appropriate. Because these foods have not been widely consumed before, they require rigorous scientific evaluation prior to approval.
Under Regulation (EU) 2015/2283, novel foods may only be authorised if they are demonstrated to be safe for human consumption, based on a comprehensive scientific assessment by European Food Safety Agency (EFSA). In addition, EFSA’s 2016 guidance specifies that a novel food intended to replace an existing product should not be nutritionally inferior, ensuring that its normal consumption does not compromise consumer nutrition.
The regulatory framework also addresses potential risks such as allergens, toxic compounds, or unintended effects linked to new products and production methods. As food technologies continue to advance, particularly with developments in cell cultivated production and precision fermentation, these regulations play an important role in maintaining transparency, supporting evidence-based decision making, and building consumer trust as the food industry continues to innovate.
Key Regulatory Considerations for Cell-Cultivated Products
When preparing a regulatory dossier for a cell-cultivated product, companies must provide detailed evidence of its nutritional composition and quality, estimates of anticipated consumption under proposed use, as well as potential allergenicity.
Both macro and micronutrients must be assessed, with special attention to those important for public health, such as essential amino acids. The novel food must be compared with a conventional counterpart to ensure it is not nutritionally disadvantageous. Factors such as nutrient stability during storage and cooking, batch consistency during production, and ADME (Absorption, Distribution, Metabolism and Excretion) profile to determine protein quality and digestibility, must also be evaluated.
Any proteins or ingredients with the potential to cause allergic reactions must be carefully examined to ensure consumer safety. This includes known allergens, such as those arising from fish or crustacean derived cell lines, as well as proteins from mammalian cell lines that may carry galactose-α-1,3-galactose (α-Gal), which can trigger IgE-mediated reactions. Protein digestibility is also an important consideration, as slowly digested proteins are more likely to remain partially intact and may increase the likelihood of immune responses. Therefore, it is essential to assess both the digestibility and the levels of specific allergens, such as α-Gal, relative to appropriate comparators to better understand and manage potential allergenicity.
Taken together, these evaluations ensure that cell-cultivated products are both nutritionally adequate and safe for consumers before they enter the market.
Validated Methods for FSA Novel Food Dossier Submissions
At AltaBioscience, our laboratory provides analytical testing for novel foods, including cell cultivated and precision fermentation products to support the preparation of robust regulatory dossiers in the UK and internationally. Our services include:
Amino Acid Analysis for Protein Composition Analysis
Our amino acid analysis service is performed using ISO 17025 accredited, fully validated methods to provide precise and reliable protein quantitation and amino acid composition profiling. Our testing supports the required five batch analyses, demonstrating consistent protein composition across multiple production runs. The analysis also quantifies critical nutrients, including essential amino acids (EAAs), which regulators focus on when evaluating whether a novel food is nutritionally comparable to its conventional counterpart.
For instance, in a recent case study with Meatly, our results confirmed that the amino acid profile of their cultivated chicken meat closely matched that of traditional chicken breast, providing strong evidence of nutritional suitability for their regulatory dossier.
Meatly Case study:
Comparing cultivated meat to traditional chicken through amino acid analysis
We also supported Those Vegan Cowboys in validating their in-house method by providing precise protein quantification of the casein standards produced through precision fermentation.
Those Vegan Cowboys Caste Study:
Enabling Quality Control in Precision Fermentation: Protein Quantification of Recombinant Casein
In vitro Protein Digestibility Studies for Nutritional Quality Assessment
Our in vitro protein digestibility service simulates how a protein is broken down in the human digestive system to assess its nutritional quality. During testing, the protein is exposed to enzymes and conditions that mimic stomach and intestinal conditions, allowing us to track how efficiently it is digested into amino acids. Amino acids are quantified accurately using our ISO 17025 accredited amino acid quantitation service. From these results, Digestible Indispensable Amino Acid Score (DIAAS) can be calculated, providing a measure of the protein quality and ability to meet human dietary amino acid requirements. This information is critical for regulatory submissions because it demonstrates whether a novel food’s protein is nutritionally adequate compared to conventional sources.
Protein Sequencing and Mass Spectrometry for Protein Identification Analysis.
As highlighted in the FSA guidance, comparing protein sequences with and without post-translational modifications (PTMs) is essential for demonstrating nutritional comparability to conventional foods. Our mass spectrometry service, combined with N-terminal protein sequencing, provides detailed insights into protein composition and modifications. For example, during Edman degradation sequencing, the process stops at a modified amino acid, directly indicating the presence of a PTM. This approach allows manufacturers to detect modifications that may influence protein function, digestibility or allergenicity, ensuring that the protein’s structure and composition are thoroughly documented.
Conclusion
Novel foods are transforming the future of food, but bringing them to market requires careful attention to safety, nutritional quality, and regulatory compliance. For cell-cultivated and novel food products, detailed analyses such amino acid profiling, in vitro protein digestibility with DIAAS, and protein sequencing with PTM assessment, are critical components of a successful regulatory dossier.
At Altabioscience, our ISO 17025 accredited and validated testing services provide manufacturers with reliable, reproducible data to demonstrate nutritional comparability, protein quality, and safety.
To find out more, contact us at info@altabioscience.com.
