Analysis of the draft EFSA novel food guidance: impact for cultivated meat and seafood

On 15 February 2024, the European Food Safety Authority (EFSA) released a much-anticipated draft update of its novel food guidance, aimed specifically at addressing the advancements in food innovation, including cultivated meat and seafood. This update is crucial as it brings clarity and direction for companies in the cultivated meat/seafood sector on how to proceed with novel food applications in the European Union (EU).

Section 1.1.5 outlines specific requirements for the identity of novel foods derived from cell or tissue cultures from animals such as species verification, health status of the source animal, and showing absence of viruses or other zoonotic agents. Section 2.2 on the production process requires detailed information on whether primary cells or established cell lines are used, including their source, sterility, subculturing and banking. Any modifications must be documented, along with their implications for the production of potentially concerning substances. Detailed descriptions of the processes for isolating, screening, and selecting cell lines or tissues are essential, including the use of all chemicals and biological materials, and any resulting impurities. The genetic stability of the cells, morphological changes, and other phenotypic alterations from start to end of the production process must be demonstrated. Compliance with Good Cell Culture Practices and relevant standards – such as those in the EMA Guidance on cell substrate derivation and characterization – is mandatory.

Annex B, introduced in the draft, requires detailed information on all inputs used in production, including all materials that come into contact with the food. You must now provide details on the function of each, their regulatory status in the EU, and details on the specification/quality of the raw materials.

Applicants must provide compositional data from at least five independent batches, with the definition of independent batches meaning that new batches of raw materials must be used for each run! There are no specific requirements on compositional and impurity analyses, and it is up to the applicant to decide based on the specific cell type, production process, and cell culture media composition. However, EFSA wants specific details on each method, including that it has been validated for the specific food matrix.

The draft guidance related to cultivated meat and seafood marks a significant step forward. However, there are still gray areas that provide regulatory uncertainty

There have been significant updates made to the requirements on nutritional information focusing on whether the novel food would be nutritionally disadvantageous with regards to an excess intake of nutrients. There is also a relevant section on novel protein sources.

The guidance does not explicitly mention toxicological studies for cultivated meat/seafood. Therefore, applicants must follow the tiered approach detailed within the guidance document. In theory, if the cell line and production process (including all inputs) are thoroughly characterized – and the novel food itself is fully characterized – and no safety concerns emerge, it might not be necessary to conduct extensive in vivo toxicological studies.

While this updated draft guidance provides much-needed clarity, there are areas of contention, such as the mandatory compliance with EMA guidance, which is not entirely appropriate for food production! At the end of the day, we are producing food, not injectable drugs! Also, the requirement to provide data from at least five independent batches poses a significant challenge for startups that are in the early stages of production scaling.

The draft guidance related to cultivated meat and seafood marks a significant step forward. However, there are still gray areas that provide regulatory uncertainty. This
is where pre-submission advice with EFSA to discuss the regulatory strategy and proposed data package would bridge this gap. Ultimately, we need a balanced approach that considers the unique aspects of cultivated meat/seafood (and all novel foods) and innovation, while ensuring safety as this will be crucial for the continued development and acceptance of cultivated meat and seafood within the EU.

In terms of next steps, after the public consultation, EFSA will review the feedback and prepare an updated guidance document that is scheduled for adoption in June 2024.

Dr Hannah Lester is the CEO of Atova Regulatory Consulting and also Head of Regulatory Strategy at Gourmey. This article is republished from the Q2 2024 edition of Protein Production Technology International, the industry's leading resource for alternative proteins. To subscribe to all future editions, please click here