Modified specifications of the new food based on vitamin D2 in mushroom powder
European Union
Oct 18, 2024
With implementing Regulation (EU) 2024/2682 of 16 October 2024, the Commission amending Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food vitamin D2 mushroom powder.
On 29 March 2024, the company MBio, Monaghan Mushrooms (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 for a change of the specifications of the novel food vitamin D2 mushroom powder. The applicant requested to extend the authorised range of vitamin D2 concentrations in vitamin D2 mushroom powder to include lower concentrations and to revise the authorised levels of carbohydrates, to delete the different maximum levels for ‘carbohydrates’ and ‘total dietary fibre’ and set out a single maximum level for total carbohydrates.
The applicant justified the request for this revision by indicating that current authorised levels of vitamin D2 content (580-595 μg/g mushroom powder) are very narrow. As a result of subsequent commercial experience and understanding of customer requirements, it became clear that less concentrated formulations are needed in practice as they allow for easier inclusion in final product applications. The requested range of vitamin D2 to 137,5-595 μg/g dry weight will facilitate reliable addition to a variety of foods and achieve more accurate addition of vitamin D at required final concentrations.
The Commission considers that the requested update of the Union list concerning the change of the specifications of vitamin D2 mushroom powder proposed by the applicant, is not liable to have an effect on human health and that a safety evaluation by the European Food Safety Authority (‘the Authority’) in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary. The requested change of the specifications concerns lower levels of vitamin D2 content than previously assessed by the Authority as safe and which supported the authorisation of vitamin D2 mushroom powder by Regulation (EU) 2021/2079. Furthermore, changes in the production process do not affect safety of the novel food. Moreover, the requested change consisting in setting a single limit for total carbohydrates only combines two of the currently authorised parameters and therefore it does not affect the safety of the novel food.
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