EFSA has acted on European Commission pressure to update not only scientific guidance for submitting novel food applications in the EU, but also the administrative guidance.
The two updates, carried out following stakeholder consultation, better clarify the complex processes food and drink manufacturers must endure to gain novel foods approval.
“First, the scientific guidance outlines the scientific information applications must provide,” says EFSA nutrition and food innovation unit scientific officer Ermolaos Ververis. “Second, the administrative guidance clarifies the process for applying, which is handled by our front-desk support team.”
Businesses, including cell culture-derived food companies, need apply the guidance update to applications from February 2025, only.
EFSA made the updates to better reflect the EU legal framework for novel foods, as well as recent food research and innovation advancements.
Novel foods safety assessment
“The novel food industry is evolving quickly, and it’s important that our safety assessment processes keep up,” continues Ververis.
“We’ve seen a growing variety of novel food applications, and the update takes this into account.”
Significant data had also been gathered since the novel food regulation’s initial implementation in 2018. As a result, EFSA had more experience in the process and built a better understanding of how to clarify definitions as well as the data requirements needed from applicants to submit higher-quality paperwork.
Read more: UK FSA pushes through speedier novel foods approval process
Updates to the scientific guidance outline how businesses should describe and identify the novel food, as well as processing, composition, specifications and proposed use details.
How consumers are expected to eat or drink the product should also be included, as well as any history of use, safety data – including toxicology, nutrition and allergic information.
“The administrative guidance complements this by outlining the practical steps for preparing and submitting an application,” continues Ververis.
EU animal testing for novel foods
EFSA has a nine-month deadline to complete risk assessments on novel food applications. Providing applicants with more detail in the initial stages could help to streamline the process, limiting the need for consultation between EFSA and applicants for additional information or clarification.
However, “thoroughness always comes first”, says Ververis. “Consumer safety is our top priority, and the time needed for assessment depends on the complexity and quality of the data submitted.”
Following EFSA approval, companies must seek advice and guidance on marketing and labelling requirements from the EC and national or local authorities.
Although, the new guidance would not reduce the necessity for animal testing in some novel food applications.
“Our goal is to minimise animal testing in line with the EU’s broader strategy to phase it out,” continues Ververis.
“We recommend applicants use validated alternative methods whenever possible. If animal studies are necessary, they must comply with EU standards, and applicants must first conduct a thorough literature review before proceeding with any in vivo studies.”
