On November 27, 2025, the European Food Safety Authority (EFSA) updated a series of administrative guidance regarding novel food, food improvement agents (including food additives, food enzymes, and food spices), and feed additives. This update was not only a streamlining of application procedures, but a signal that the EU is raising regulatory requirements.
The EU’s administrative guidance is intended to provide clear procedural instructions and workflow guidance for various types of applications, covering the specific requirements of each application stage, competent authorities, and dossier composition. The core objective for this update is to improve dossier quality and enhance processing efficiency. This indicates that, beyond technical requirements, the EU is also attempting to filter out low-quality submitted dossiers through administrative measures. CIRS has analyzed and extracted the key points on this update to support companies in their compliance and application strategies.
Three Major Common Changes
1. Admissibility check
If the dossier submitted by an applicant contains substantial missing information and no relevant justification is provided, making it impossible to proceed with the risk assessment, the EU will no longer issue a request for additional information. Instead, the application will be declared non-admissible and will not be accepted.
CIRS reminder:
Under the principle of transparent submissions, the EU will publicly record and disclose each key step of an application on its official website, including decisions of non-admissibility. Companies are therefore advised to submit only when their dossiers are fully prepared, so as to avoid the publication of unfavorable information.
2. Limits on extensions for data supplementation
During the data supplementation phase, EFSA will accept no more than two requests for extension, except in very exceptional circumstances.
CIRS reminder:
Previously, the EU did not set a limit on the number of extension requests, and the rules were relatively flexible. This update makes the EFSA review timeline more predictable, but it also places greater pressure on companies in terms of testing and project planning. Companies are advised to complete time-critical studies, such as toxicological tests, in advance and to strictly control key project milestones.
3. Qualification of toxicology laboratories
All toxicological studies submitted must be conducted in GLP laboratories located in OECD member countries or in laboratories operating under the Mutual Acceptance of Data system.
CIRS reminder:
This update further clarifies the EU’s requirements on the eligibility of laboratories conducting toxicological studies. Companies planning EU submissions should pay close attention to whether their toxicology laboratories meet these qualification criteria.
Key Changes on Novel Food
Attachment requirements
A new Excel template has been introduced. Applicants are required to complete the template with the characterisation data of the substance to be submitted, provide the relevant supporting information, and submit it together with the dossier.
CIRS reminder:
This template standardises the way in which compositional analysis and stability data are submitted, and requires applicants to specify, for each test item, the laboratory qualification, analytical method, and the limit of detection (LOD) and limit of quantification (LOQ). For any test item performed by a laboratory without the required accreditation, a method suitability confirmation (method validation) document must be provided.
Conclusion
With all the updated guidance being now in force and the EU continuing to reduce regulatory tolerance for deficiencies in applications, applicants are facing the challenge of submitting higher-quality dossiers to the EU in a shorter limited time. To meet these regulatory expectations, companies must cope with the following three points:
1. Thorough self-checks
To ensure the completeness of technical dossiers and to support EFSA’s efficient processing, EFSA has issued checklists of required data for different categories of substances. Companies should review their dossiers against these checklists before submission to identify and fill any gaps.
2. Selection of qualified laboratories
For compositional analysis and stability studies, the qualification of laboratories for each test item must be confirmed, and method validation must be carried out for any test performed by non-accredited laboratories. Toxicological studies should be commissioned at OECD-compliant GLP laboratories.
3. Earlier test preparation
Time-critical studies that may be required during the application process (such as shelf-life studies and toxicological tests) should be initiated in advance, in order to avoid application failure due to insufficient time for data supplementation.
Note: For the purpose of transparency, the EU requires all studies involved in an application to be pre-notified to the authorities before they are initiated. Failure to pre-notify, or delayed pre-notification, may result in an administrative suspension of up to six months during which EFSA will not assess the application.
About CIRS
The Food Business Division of CIRS Group, established in 2012, has successfully assisted over 1,000 food and feed companies globally in achieving "one-stop" regulatory compliance. Leveraging our extensive expertise and resources across multiple jurisdictions, we provide comprehensive compliance solutions, including:
- China – “Three New” Food Registration: new food material, new food additives, and new food contact materials (including synthetic biology-derived products)
- China – New Feed and New Feed Additive Application
- U.S. – FDA GRAS Notice
- U.S. – Animal Food GRAS Conclusions
- EU – Novel Food Application
- EU – Food Enzyme (Food Enzyme Preparation) Application
- EU – Food Additive Application
- EU – Feed Additive Application
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
