The novel food evaluation process delays access to food innovation in the European Union
- PMID: 40593922
- PMCID: PMC12219162
- DOI: 10.1038/s41538-025-00492-x
The novel food evaluation process delays access to food innovation in the European Union
Abstract
This article analyzes the timelines of 292 novel food (NF) applications submitted to EFSA between 2018 and 2024 under Regulation (EU) 2015/2283. The average duration from submission to publication was 2.56 ± 1.19 years, with significant variability, and delays due to suitability checks and additional data requests. Improved guidelines and pre-submission support could streamline the process, fostering innovation and timely market access for NFs.
© 2025. The Author(s).
Conflict of interest statement
Competing interests: All authors are employed of FoodChain ID, a consulting company managing new ingredient authorization in Europe and in the U.S. on behalf of its clients.
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References
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- European Commission. Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (Text with EEA relevance)Text with EEA relevance [Internet]. Mar 27, 2021. Available from: http://data.europa.eu/eli/reg/2015/2283/2021-03-27/eng.
-
- Ververis, E. et al. Novel foods in the European Union: Scientific requirements and challenges of the risk assessment process by the European Food Safety Authority. Food Res Int Ott. Ont.137, 109515 (2020). - PubMed
-
- Le Bloch, J., Rouault, M., Iriantsoa, V. & Michelet, O. Polyphenols in human nutrition: European regulations and potential classification as a novel food or food additive. J. Agric Food Chem.72, 26936–26942 (2024). - PubMed
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