As of 2025, navigating the complex landscape of novel foods in Europe requires a thorough understanding of the European Union's regulatory framework. Novel foods, defined as those not consumed in the EU before May 15, 1997, must undergo a rigorous approval process before entering the market. This involves submitting a detailed dossier to the European Commission, which is then evaluated by the European Food Safety Authority (EFSA) for scientific validity.

Since the implementation of the Novel Food Regulations in 2018, EFSA has continuously refined its guidance to assist applicants. The most recent update, effective from February 2025, reflects the latest changes in EU legislation and advancements in food science, offering clearer data requirements for novel food applications.

Administrative Guidance: A Closer Look

The revised administrative guidance outlines the procedural necessities for submitting applications. It is structured into three chapters and includes three appendices:

• Chapter 1: Provides the background and scope of the guidance.
• Chapter 2: Details the procedure, timelines, and necessary documentation for applications.
• Chapter 3: Describes interactions with EFSA staff throughout the application process.

The appendices offer a suitability checklist, criteria for new nutrient sources, and conditions for submitting results from 90-day studies.

Scientific Guidance: Key Updates

Applicants are required to submit comprehensive information regarding the novel food's identification, production, composition, intended uses, historical consumption, and safety data. Notable updates include:

1. Microorganism-related Novel Foods

New definitions for microorganism types have been introduced, with Appendix A providing clarity on requirements for foods derived from microorganisms. The regulation now encompasses Category 1 and 2 genetically modified microorganisms (GMMs).

2. Production Process

Appendix B specifies the information needed on inputs used in production, with detailed process descriptions required for certain food categories.

3. Composition Data

Applicants must provide detailed analyte information, including production scale and sampling principles. Analyses should be conducted on five batches of each food form.

4. Stability

Shelf life must be established through stability testing, with scientific evidence required for extrapolating results from accelerated conditions. The impact of further processing on the novel food must also be assessed.

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

The ADME section now employs a tiered approach. Protein digestibility studies are mandated if there are concerns regarding the novel food's protein content.

6. Toxicological Information

A tiered approach is outlined for toxicological assessments. Genotoxicity testing for microorganisms now includes both the supernatant and cell lysate.

7. Nutritional Information

The requirements for nutritional information have been expanded. New assessments are necessary for micronutrient and protein sources, including the digestible indispensable amino acid score (DIAAS).

8. Allergenicity

The allergenicity section now features a comprehensive decision tree for evaluating cross-allergenicity of proteins.

With the updated administrative and scientific guidance now in effect, the application process for novel foods has been refined to ensure higher standards for scientific rigor and completeness. In an era of heightened industry interest, accurately interpreting regulations and efficiently preparing dossiers are essential for overcoming compliance challenges and expediting market entry.