The European Commission has instructed EFSA to update the Guidance on the scientific requirements for a notification and application for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283 .
This update consists of two key documents:
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The scientific guide outlines the scientific information that applicants must provide.
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The administrative guide clarifies the application process, which is managed by our support team at the reception.
These updates will apply to all novel food applications submitted to the European Commission from February 2025 onwards.
“ We have made these changes – explains Ermolaos Ververis, scientific officer of the “Nutrition and Food Innovation” Unit at EFSA in a note – to reflect the changes that have occurred in the EU legal framework for novel foods and recent progress in food research and innovation.
The novel food industry is evolving rapidly and it is important that our safety assessment processes keep pace. We have seen an increase in the variety of applications for novel food assessment and this update reflects this.
We have also learned a lot from assessing novel food applications since the 2018 Novel Food Regulation came into force.
This experience has helped us clarify definitions and data requirements , so that applicants can submit higher quality applications, which in turn should lead to a risk assessment process."
Overall, the new guidelines provide more detail, particularly on the scientific requirements where we have noticed gaps over the past six years.
The scientific guide explains:
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how to describe and identify the new food,
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details on the production process ,
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the composition ,
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the specifications,
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the proposed uses.
Applicants must also provide information on the intended consumption of the food , history of use and safety data, including how the body processes the food, toxicology, nutrition and potential allergens.
The Administrative Guidelines complement this aspect by outlining the practical steps for preparing and submitting an application.
The evaluation process
EFSA has a nine-month deadline to complete each risk assessment, but if it needs further information from the applicant, it suspends the process.
The updated guidance should help simplify the application process by clarifying requirements and reducing the chances of missing information.
EFSA's role is to ensure that any novel food is safe to eat within its proposed uses.
Once the evaluation is completed, it is up to the European Commission and the EU national authorities to take decisions on approval and marketing , including labelling requirements .
Animal testing
The guidance applies to all applications for the evaluation of novel foods, including those for foods and food ingredients derived from cell cultures.
“Our goal – explains Ververis – is to reduce animal testing to a minimum , in line with the broader EU strategy for their gradual elimination.
We recommend that applicants use validated alternative methods whenever possible .
If animal studies are required , these must comply with EU standards and applicants must conduct a careful review of the scientific literature before proceeding with any in vivo studies.” (Source: https://www.efsa.europa.eu /)