Updated EFSA guidelines set to streamline EU novel foods approval process

The European Food Safety Authority (EFSA) has released an updated document providing guidance on novel foods. The document takes into consideration over 700 comments received during a public consultation and from stakeholders. It presents the latest advice applicants need to know to meet the new requirements.

“The European Commission (EC) tasked EFSA with updating the guidance on how to prepare and submit applications to market novel foods in the EU. This update consists of two key documents,” Ermolaos Ververis, a scientific officer in EFSA’s Nutrition and Food Innovation Unit, comments on the recent updates to the guidance for novel food applications.

The authority defines novel foods as foodstuff and food ingredients that were not used for human consumption to a “significant degree” within the EU before 15 May 1997.

“First, the scientific guidance outlines the scientific information applicants must provide. Second, the administrative guidance clarifies the process for applying, which is handled by our front-desk support team.”

The new updates concern all novel food applications submitted to the EC starting February next year. These include guidance on the scientific requirements for a notification and application for authorization of traditional foods from third countries, for an application for authorization of a novel food and on scientific principles and data requirements for the safety and relative bioavailability assessment of new micronutrient sources.

Expectations for applicants 

Ververis explains that the new updates to the EU legal framework for novel foods and the guidelines for producers and suppliers aim to reflect the changes taking place in this rapidly evolving industry. 

“We’ve seen a growing variety of novel food applications, and the update takes this into account. We’ve also learned a lot from assessing novel food applications since the 2018 novel food regulation came into effect.”

The EC has asked EFSA to update its guidance on the preparation and submission of applications to market novel foods in the EU.As part of this process, EFSA has clarified definitions and data requirements, aiming to facilitate applicants’ ability to submit higher-quality applications and a more efficient risk assessment process.

The new guidance provides more details on scientific requirements, where Ververis says that some gaps have been previously noted. It now explains how applicants should describe and identify the novel food, and how they should detail the production process, composition, specifications and proposed uses. 

“Applicants also need to provide information on the food’s expected consumption, history of use and safety data, including how the body processes the food, toxicology, nutrition and potential allergens,” Ververis writes.

“The administrative guidance complements this by outlining the practical steps for preparing and submitting an application.”

The guidance is applicable to all novel food applications, with cell culture-derived foods and food ingredients being highlighted as relevant as well. 

Application assessment 

The update of the guidelines aims to help streamline the application process by making requirements clearer and making the likelihood of missing information lower. 

EFSA has a nine-month deadline to complete the risk assessment for each novel food. “That said, thoroughness always comes first,” says Ververis.

“Consumer safety is our top priority, and the time needed for the assessment depends on the complexity and quality of the data submitted. The EC and the EU national authorities handle the final approval and marketing rules.”

He asserts that the EU has some of the highest food safety standards in the world. “EFSA’s role is to ensure any novel food is safe to eat under its proposed uses. Once our assessment is complete, it’s up to the EC and the EU national authorities to make decisions on approval and marketing, including labeling requirements.”

“Our goal is to ensure all novel foods on the market are safe and not nutritionally disadvantageous.” 

Stakeholder review

EFSA aimed to involve a wide range of relevant stakeholders in creating the guidelines, including academia, consumer groups, industry, NGOs and the public. All feedback, along with EFSA’s responses, is publicly available as an annex to the guidance document.

EFSA defines novel foods as foodstuff and food ingredients that were not used for human consumption to a “significant degree” within the EU before 15 May 1997.“We also hosted a scientific colloquium in May 2023 to discuss current trends in food research and ensure our risk assessment methods remain effective. Now that the guidance is published, we’ll be presenting it at workshops, conferences and other events,” Ververis details.

The document further aims to contribute to the minimization of animal testing in line with the EU’s broader strategy to phase it out. EFSA recommends that applicants use validated alternative methods when possible. 

When the study on animals is necessary, the applicants must comply with EU standards. They must first conduct a thorough literature review before proceeding with any in vivo studies. 

Examples of novel food products and ingredients that have recently been recognized as safe by EFSA include dsm-firmenich’s GlyCare 3-FL and LNFP-I/2'-FL HMOs, Kyowa Hakko’s 2’-FL HMO, Kemin’s algae-derived beta-glucan ingredient and Sabinsa’s Curcumin C3 Reduct.

Earlier this year, the EC also requested that EFSA revise its standards on fortified foods to reflect the latest vitamin A and β-carotene research findings, and EFSA launched its intake model aiming to assess Europeans’ chronic dietary exposure to food enzymes.

Nutrition Insight spoke to the EFSA about its up-to-date guidance on dietary supplements for consumers, suppliers and producers.