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EU - Novel foods authorised in the European Union: analysis and assessment of their specifications

European Union

Feb 29, 2024

In the European Union, the term novel food refers to foods that have not been used for human con- sumption to a significant degree within the Union before 15 May 1997. These novel foods require prior authorisation for placing on the market, based on an assessment of their safety for consumption. The authorisations for each novel food include, among other matters, the establishment of specifications with the main parameters characterising it and the limits to be respected.
This paper reviews and analyses the specifications established until 31 May 2023 for the novel foods included in the Union List, published in the Annex to Implementing Regulation (EU) 2017/2470. The specifications relate to compositional parameters, contaminants, microbiological criteria or the absence of genetically modified organisms.
The review and analysis carried out revealed a certain lack of uniformity in the criteria used to establish the specifications, both for novel foods authorised under the general procedure and for those authorised under the existing procedure for traditional foods from third countries. In some cases, the specifications do not include any parameter or do not specify the purity of some extracts.
Although the establishment of methods for the analysis of contaminants may be useful for the competent authorities when carrying out official controls and for operators, it would be more appro- priate to refer to the criteria or conditions that these methods should meet rather than to the specific methods of analysis, since the progress in analytical techniques means that the specific methods established may become obsolete over time. It is to be expected that, as the safety assessment has become a more centralised procedure through Regulation (EU) 2015/2283, with the European Food Safety Authority (EFSA) as the assessment authority, uniform criteria will be adopted for the establishment of specifications.


Author(s):   López Sánchez de León, Lydia., Cámara Hurtado, M, Calderón Pascual, V  & López Rodríguez, R.

Published in: Revista del de la AESAN Comité Científico Nº 38



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