Mr Viral
The cellular ingredient being a highly innovative product, food business operators are reluctant to submit their dossier before the European Food Safety Authority (EFSA).
Actually, the perception – and consequently the assessment of this category of Novel Food[1] – is highly fragmented and Europe is reputed to fall behind the other authorities in the world.
Regarding cell meat, for instance, it could be of interest to overcome the ‘a priori’ and to use fruitfully the experience of Singapore/Hong Kong, the US or even the UK (in feed), which are the first countries to authorise the production and consumption of such products.
Undoubtedly, Europe shows a rising interest in food innovation.
Cellular ingredient, also referred to as cultivated-cell ingredient, is a type of ingredient that is produced by in vitro cell culture. The concept of cellular ingredient has gained growing attention in recent years due to concerns for animal welfare, the environment and food shortages.
However, the only legal avenue to allow its placement on the European market is the novel food procedure which is reputed to be highly rigorous, making its future somewhat uncertain for the companies considering a launch on this market.
But several arguments are very encouraging for all alternative production methods in general.
First of all, if for years, EFSA has not yet given the green light for any cell-cultured meat, it is only because no company has even submitted an application for authorisation. But, EFSA already delivered (May 2023) a positive opinion for the release of a cell-cultivated fruit biomass in use in food supplements[2].
Second, it is not really true that the length of the European procedure is longer than the one in other regions of the world: once the first dossier is submitted, the EFSA assessment will run over two years, which is not so different from the other authorities (actually they do not have a clear timeline but the procedure can last at least 12 to 18 months).
Third, it is very important to prevent questions and related stop-the clock delays from EFSA, by submitting a dossier as complete and justified as possible. Despite the novelty and the sensitivity of cell culture manufacturing, common and particular aspects must be anticipated in preparing a cell cultivated ingredient application as novel food in the EU: proper – and on time – notifications of the underlying studies, analyses from accredited laboratories, meticulous traceability of the whole history of the basal cells (encompassing safety assessment of the raw material of origin, passaging history, contact with any intrants along the development and their proper safety assessment), demonstration of the stability and safety of the cell line, etc.
Lastly, some national ethical and philosophical concerns have worried the FBOs, but they forget that it is primarily up to EFSA and the European Commission to reach a conclusion on novel food applications for cell ingredients and that they will base their conclusion on technical, scientific and regulatory criteria only.
[1] Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients
[2] EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens),Turck D, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A,Pelaez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Cubadda F, Frenzel T, Heinonen M,Marchelli R, Neuh€auser-Berthold M, Poulsen M, Sanz Y, Schlatter JR, van Loveren H, Gelbmann W andKnutsen HK, 2023. Scientific Opinion on the safety of apple fruit cell culture biomass as a novel foodpursuant to Regulation (EU) 2015/2283. EFSA Journal 2023;21(7):8065, 12 pp. https://doi.org/10.2903/j.efsa.2023.8065. https://www.efsa.europa.eu/en/efsajournal/pub/8065
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