EFSA novel food application summary
- EFSA requires detailed scientific evidence proving novel foods are consistently safe
- Early regulator engagement helps applicants understand requirements and reduce delays
- Submitting incomplete data leads to repeated EFSA questions and slower assessments
- Applicants must provide robust shelf life stability data to pass initial checks
- Demonstrating absence of nanoparticles is essential for successful EFSA submission
The EU is world famous for its stringent novel food approval process. On the plus side, the process provides Europe’s consumers with confidence that products they consume are as safe as they can be. However, it also means that getting such products approved can be time-consuming.
Long and unpredictable timelines for novel food approval have dissuaded investors and made some nascent food sectors, such as cultivated meat, less attractive for capital.
The EU’s European Food Safety Authority (EFSA) is aiming to make the process easier for start-ups. But it’s a two-way street, and there is a lot that start-ups themselves can do to make the process go more smoothly.
What do they need to know before submitting an application?
1. An application must demonstrate safety
The novel food approval process is all about ensuring the food is safe for consumers.
Therefore, a successful application for novel food is one that demonstrates safety within the proposed conditions of use, explains Océane Albert, team leader of product safety for novel foods at EFSA.
EFSA looks into a wide range of elements to ascertain the product’s safety, including the identity of the novel food, the production process, composition, nutritional aspects, toxicity, and allergenicity. The application should be sufficiently detailed for experts to carry out a full risk assessment, as well as being scientifically robust and transparent.
Applicants should carefully follow the existing guidance, ensuring that they have everything they need before applying.
2. Speak to the regulators before submission
Applicants should have as much dialogue with regulators as possible before submission, explains EFSA’s Albert.
“I would recommend for applicants, and especially SMEs and first-time applicants, to get engaged with EFSA early on and ask for pre-submission advice.”
This would allow them to understand the EFSA requirements that they need to fulfil right from the beginning of the process.
The upcoming Biotech Act could provide EFSA with more scope to interact with applicants at the early stages, says Albert. It would enable EFSA to engage earlier and provide more tailored pre-submission advice.
This could shorten the application process, increase the quality of the dossier, and improve the predictability of its outcome, says Albert. Whether these changes will come into play is currently uncertain.
EFSA has already increased pre-submission talks by 47%, according to EFSA’s executive director Dr Nikolaus Kriz.
3. Don’t submit too early
One of the major mistakes that start-ups often make is the submission of incomplete data. EFSA often must ask questions about information that is already a required part of the dossier.
Many applicants also submit too early, with not enough data. This can happen if the product is still at the lab developmental scale and the production process is not definitive, or if toxicological data is not available at all or is not done on the product as intended to be put on the market.
All of this will trigger questions, slowing down the process. “If the data is too premature to be consistent, the questions will boomerang back to the applicant during the risk assessment process”.
4. Demonstrate stability over shelf life
Stability data is often lacking, explains Albert, demonstrating that a novel food can be stable over its proposed shelf life.
For example, if an applicant says that a novel food can be shelf-stable for two years but are unable to demonstrate this, the question will come back to them.
The lack of stability data could even prevent applicants from getting past the suitability check, preventing the application from even reaching EFSA and leaving it in a limbo for years.
5. Address the presence of nanoparticles
EFSA provides guidance about addressing the presence of nanoparticles within food. Albert suggests that applicants should ensure this is addressed before applying.
There are a number of processing aids that are linked to the presence of nanoparticles. They can also be present for other reasons.
The absence of nanoparticles needs to be demonstrated by applicants, stresses Albert.
While EFSA continues to work to make the process easier for applicants, it remains important for applicants themselves to ensure their dossier is comprehensive, detailed and leaves nothing important out.
