Updated EFSA Guidance Scientific Reguirements for Novel Foods
The European Food Safety Authority (EFSA) recently published a series of updated guidance documents. What are the key aspects of these highly anticipated updates? We have summarised the new novel food scientific and administrative guidance here.
Key Takeaways: Novel Food Scientific and Administrative Guidance
EFSA recently ublished four documents :
Administrative guidance for the preparation of novel food applications - Link
Guidance on the scientific requirements for an application for authorisation of a novel food - Link
Guidance on the scientific requirements for a notification and application for authorisation of traditional foods - Link
Guidance on scientific principles and data requirements for the safety and relative bioavailability assessment of new micronutrient sources - Link
A summary of the key takeaways from the novel food scientific and administrative guidance:
The guidance has been updated to reflect technological advances in novel foods.
Overall, the guidance is more comprehensive and has closed some of the critical grey areas that were an issue with the previous version of the guidance.
EFSA has drawn from recent risk assessments and has used these learnings to inform this update. They refer to several of their risk assessments throughout the guidance to help applicants.
Both the admin and scientific guidance will apply from 1 February 2025, but in the case of the administrative guidance, EFSA encourages applicants to start using this guidance immediately.
An Overview: Administrative Guidance
Key highlights from the administrative guidance:
The guidance document consists of three chapters and three appendices.
Chapter 1 covers the background and terms of reference of the guidance.
Chapter 2 covers the procedure, the timelines and the documentation to be provided for a novel food application or for the modification of an existing authorisation.
Chapter 3 covers interactions with EFSA staff at different points during the life-cycle of the application, including pre-submission activities.
Appendix A is 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.
An Overview: Scientific Guidance
In terms of scientific guidance, the main highlights include the following:
Production process: Appendix B outlines the information that applicants need to provide on all inputs used in the production process.
Cultivated meat: there are no specific requirements for cultivated meat and seafood in terms of the source and identity of the cells.
Growth factors and other media inputs of microbial origin should follow the requirements outlined in Appendix A.
Appendix A helps to clarify the requirements for novel foods derived from or consisting of microorganisms.
Genetically modified microorganisms (GMMs): EFSA states that only Category 1 and 2 GMMs (e.g. no viable cells and host strain DNA removed) are in the scope of the novel food regulation! It is surprising to see this in a guidance document. The regulatory criterion for determining whether a food produced with a GMM falls in the scope of the GM food/feed regulation should be the presence of viable cells!
Analytical data supporting the nutritional composition and impurities of the novel food should be generated from at least five independent batches that are independently produced (ideally with independent batches of raw materials).
For the methods of analysis, the LOD and/or LOQ should be provided.
It is expected that the regulatory batches are produced either at an industrial production scale or at one representative of it. Representativeness shall be justified!
If the application includes different forms of the novel food (e.g. dried, frozen, powder), all analyses must be conducted on at least five representative batches of each form.
Details on the sampling practice employed should be described.
Applicants need to perform a risk assessment on the presence of nanoparticles. This would be a requirement for simple and complex substances if the production process may lead to the presence of small particles.
The Absorption, Digestion, Metabolism and Excretion (ADME) section has been expanded and describes a tiered approach. 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. In vitro methods are mentioned, but the technique must be justified.
The toxicology section has been expanded. Now, it includes a nice figure to help illustrate the tiered approach. Clarification is provided for genotoxicity testing for microorganisms. If the applicant needs to perform genotox, 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).
Expanded section on nutritional information and introduces considerations for novel protein sources. EFSA again mentions in vitro digestibility and says that methods are not validated, so they need to be fully justified. Moreover, EFSA wishes to see the digestible indispensable amino acid score (DIAAS).
New requirements for protein quality: The protein quality of the novel food must be investigated if the highest mean consumption of the novel food under the proposed conditions of use could substantially contribute to the average requirement (AR) for protein for one or more population groups. A substantial contribution is defined as at least 15% of the population-specific AR for protein (Appendix C). EFSA accepts in vitro models for this analysis and acknowledges that the in vitro models that have been developed so far are not validated. EFSA will assess their suitability on a case-by-case basis.
The allergenicity section has been expanded and a more comprehensive decision tree is provided.
Stakeholder Feedback
Public consultations are held on draft scientific outputs to gather feedback from the scientific community and stakeholders. Regarding the consultation on the draft guidance for the scientific requirements for novel foods, the public consultation ran from February 15 to April 14, 2024, via the Open EFSA platform, where stakeholders could submit comments electronically. A total of 715 comments were received from 47 interested parties.
A summary of the public consultation can be found here.
Building a Stronger Dossier
At ATOVA, we welcome these updates and believe the expanded requirements and clarifications will help the applicant build a more comprehensive dossier.
However, there are still grey areas, especially when it comes to which analyses to perform and which methods to use. At the end of the day, the guidelines cannot be fully prescriptive. In our opinion, some grey areas are not necessarily a bad thing as this leaves a certain amount of flexibility for the applicant to justify their own approach.
Get in touch to learn more about what these updates might mean for your company and how ATOVA’s regulatory specialists can support/guide you.
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