Navigating Novel Foods to Europe in 2025: Insights into the Latest EFSA Guidance

Background for Novel Food Application

In the European Union (EU), a novel food is defined as a food, food ingredient, or manufacturing process that has not been consumed or used in the EU before May 15, 1997. All novel foods must be approved before being placed on the market.

To obtain approval, the applicant is required to submit a novel food dossier built in compliance with the latest guidance documents to the European Commission. The dossier will be scientifically assessed by the European Food Safety Authority (EFSA).

Since the implementation of the Novel Food Regulations in 2018, EFSA has issued several guidance documents to facilitate applicants in their application activities.

In September 2024, EFSA updated its guidance concerning the scientific and administrative requirements for novel food applications, specifically:

• Administrative guidance for the preparation of novel food applications: Guidance clarifying the practical steps involved in preparing and submitting a novel food application.
• Guidance on the scientific requirements for an application for authorization of a novel food: Guidance outlining the scientific information that applicants must provide to support their application.

FIGURE 1 Updated guidance for Novel Food application

This update will apply to all novel food applications submitted starting in February 2025.

The updated guidance reflects changes in the EU legal framework for novel foods and recent advances in food research and innovation. Compared with the previous version, the new guidance has been improved in terms of comprehensiveness and clarity, serving to provide more specific and clear data requirements.

We have summarized the key points of the updated guidance here for the reference of enterprises.

Overview: Administrative Guidance

The updated administrative guidance further detailed the application's procedural requirements.

The guidance consists of three chapters and three appendices.

• Chapter 1: covers the background and scope of the guidance.
• Chapter 2: covers the procedure, the timelines, and the documentation to be provided for a novel food application. 
• Chapter 3: covers interactions with EFSA staff at different points during the life-cycle of the application, including pre-submission activities.
• Appendix A: the suitability checklist for applicants to help them verify that all information required for the application is included in the dossier, or its omission is justified. 
• Appendix B: must be completed when the novel food is also suggested as a new nutrient source. 
• Appendix C: must be submitted when the results of the 90-day study show (i) a statistically significant difference, and/or (ii) a trend in dose-dependent effect. 

Overview: Scientific Guidance

Generally, the applicant is required to provide information to identify the novel food, its production process, composition, specifications, proposed uses, expected consumption, history of use, and safety data, including how the body processes the food, toxicology, nutrition, and potential allergens. 

The highlights of this update are summarized as follows:

1. Microorganism-related novel food: 

• Definitions of the types of microorganisms involved in food are newly added.
• Appendix A is added to clarify the requirements for novel foods derived from or consisting of microorganisms.
• It is clarified that Category 1 and 2 GMMs (e.g. no viable cells and host strain DNA removed) are in the scope of the novel food regulation.

Please find further details on Novel Food Applications for Synthetic Biology-Derived Products Under the New EU Regulations here.

2. Production process

• Appendix B is added to outline the information that applicants need to provide on all inputs used in the production process.
• Clarify some specific process description requirements in terms of specific processes and food types.

3. Composition data

• Detailed information for analytes is required, including production scale, testing batch, and sampling principle.
• If the application pertains to various forms of the novel food (e.g. dried, frozen, powder), all analyses must be conducted on at least five representative batches of each form, produced independently.

4. Stability

• Shelf life should be determined by stability testing. In cases where results from accelerated conditions are extrapolated to predict results under the intended storage conditions, scientific evidence must be provided to justify the validity of this extrapolation.
• If the novel food is used as an ingredient added to other foods the manufacture of which requires further processing (e.g. heating), the impact on the novel food of this processing is to be investigated.

5. Absorption, Digestion, Metabolism and Excretion (ADME)

• The ADME section has been expanded and describes a tiered approach.

FIGURE 2 Overview of the tiered approach for assessing the ADME characteristics

• Where there is a potential concern about the protein in the novel food, appropriate protein digestibility studies should be performed as part of the weight of evidence approach for the assessment of the nutritional, toxicological, and allergenic properties.

6. Toxicological information

• A figure is included to help illustrate the tiered approach.

FIGURE 3 Tiered approach for ADME & toxicological assessment of novel foods

• Genotoxicity testing for microorganisms: the recommended approach is to test both the supernatant (from at least three independently produced batches of the novel food pooled together) and the cell lysate (from at least one batch of the novel food). 

7. Nutritional information

• Nutritional information is expanded.

FIGURE 4 Flowchart for investigating a potential detrimental nutritional impact of the novel food under the proposed conditions of use.

• New requirements for considerations of different types of novel food. E.g., for new sources of micronutrients (i.e. vitamins and minerals), applicants are required to conduct safety and relative bioavailability assessments; for novel protein sources, EFSA wishes to see the digestible indispensable amino acid score (DIAAS).

8. Allergenicity

• The allergenicity section has been expanded.
• A more comprehensive decision tree has been provided.

FIGURE 5 Tiered approach to investigate potential cross-allergenicity of single proteins and simple protein mixtures.

Conclusion

The administrative and scientific guidance for novel food applications in the EU is now in effect. The administrative guidelines further refine the application process, while the scientific guidelines provide clearer data requirements and set higher standards for the scientificity and completeness of application dossiers.

In the current climate of high industry interest in novel food applications, accurate interpretation of regulations and efficient dossier preparation are critical factors for enterprises to overcome international compliance barriers and shorten product time-to-market.

About CIRS

Established in 2012, the Food Business Division of CIRS Group has helped over 1,000 food companies globally in achieving one-stop compliance solutions. CIRS offers a full range of regulatory services covering novel food applications, synthetic biology-derived foods, US GRAS notification, EU novel food application, health food registration, and food for special medical purposes (FSMP).

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.