Mathilde Do Chi is the CEO of Vegan Food Law, a food law and regulatory consultancy in global alternative protein regulations. She is an
In this fifth installment of her special series, Mathilde explains how Novel Food, defined by EU Regulation 2015/2283 as any food not significantly consumed before May 15, 1997, requires pre-market approval from the European Food Safety Authority (EFSA), which provides guidance but not detailed study design advice, with upcoming procedural updates expected by 2025.
Feeling left in the dark with your EU novel food dossier preparation? EFSA is here to help
By Mathilde Do Chi
Defined as any food that has not been consumed to a significant degree before the 15th of May 1997 within the territory of the European Union by the EU Regulation 2015/2283, novel food is a concept that impacts a wide variety of food innovations ranging from microbial proteins, cellular products to plant-based derived ingredients and many more.
To sell them, companies must first obtain pre-market regulatory approval, a tedious and time-consuming process.
However, the European Food Safety Authority, hereafter referred to as EFSA, can help applicants in putting together a dossier to some extent.
Note that, EFSA is only responsible for the risk assessment of the novel food, not its risk management handled by the European Commission through the Standing Committee of Plants, Animals, Food and Feed, the so-called PAFF Committee.
Therefore, if an applicant seeks guidance for their dossier, they should consult EFSA and not the European Commission.
Before reaching out to EFSA, applicants can make use of publicly available EFSA guidance to help them to write a novel food dossier such as Guidance on the preparation and submission of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283 (Revision 1).
However, if they desire to engage with EFSA directly, they can do so via Connect EFSA, a platform dedicated to facilitating communication with the Authority.
The applicant must first request a pre-application identification (ID) required for any pre-submission activity, meaning before the submission of a novel food dossier.
Then, they can receive general pre-submission advice (GPSA) from the authority on specific matters such as the applicable regulations and requirements for their food ingredient. Note that GPSA is purely optional and should be asked at least 6 months before the submission of the novel food dossier. This advice remains general and abstractly transposable to all potential applications who plan to submit an application for the same regulated product under the same regulated product area.
Thus, EFSA cannot advise on the design of studies, specific requests on how to develop and manage a study, hypotheses to be tested, comment on any proposed design, or validate any protocol.
However, considering the complexity of putting a novel food dossier together and choosing the right testing methods to demonstrate the food safety of the ingredients, EFSA held a scientific colloquium in May 2023 pledging to update the aforementioned guidance, the base of the GPSA.
Among the proposed changes, EFSA is set to add the following elements: additional Identity qualifiers for specific novel food categories, specific production process requirements for specific novel food cases, enhanced instructions for fit-for-purpose compositional data, tools and methodological approaches for exposure assessment, further insights on nutrition-relevant testing requirements, including the area of novel proteins, updated tiered toxicity and Absorption, Distribution, Metabolism and Excretion (ADME) approach, and allergenicity testing requirements for specific novel food case.
The novel food approval system may be overwhelming to navigate but the EFSA remains committed to making the procedure smoother and implementing the said changes in 2025.
So far, in the cellular agriculture space, the German company, The Cultivated B., which is a cultivated meat subsidiary of Germany’s second-largest animal-based sausage manufacturer Infamily Foods, remains the only known company that requested GPSA for their ingredient.
Visit Mathilde’s website here for more information on food law.
