Dried Biomass of Paecilomyces Variotii discussion paper
Updated 4 September 2026
Committee Paper for Discussion - ACNFP/178/01
Advisory Committee For Novel Foods and Processes
Application for the authorisation as a novel food for dried Biomass of Paecilomyces Variotii
Application Number - RP2305
Issue
An application has been received under the novel food authorisation process (assimilated Regulation 2015/2283) for dried biomass of Paecilomyces variotii KCL-24. The Committee is asked to advise on whether the available data provides an adequate basis for a risk assessment, and whether the novel food is safe and not nutritionally disadvantageous under the proposed use and use levels.
A draft Committee Advice Document (CAD) has been prepared to support the review of this novel food application. Members are asked to consider the CAD and provide comments.
Background
-
In April 2025, the FSA received an application under the novel food authorisation process from EniferBio Oy for dry biomass of Paecilomyces variotii KCL-24.
-
This new application is for dried Paecilomyces variotii KCL-24 biomass manufactured under controlled conditions in submerged, aseptic, continuous fermentation, using glucose or dairy side streams as the carbon source. The novel food is intended for use as a protein-rich ingredient in a range of foods, including bakery wares, cereals and cereal bars, snacks, dairy products and analogues, meat and fish products, and meat and fish imitates.
-
The draft CAD is attached as Annex A. The application dossier and the annexes to the dossier are attached as Annexes B and C, respectively. These contain confidential information. The FSA’s request for further information (RFI) at the validation stage and the applicant’s response to the RFI are included as Annexes D and E, respectively.
Committee action required
● The Committee is asked whether the available data provide a satisfactory basis for evaluating the safety of the novel food under the proposed uses.
● If so, the Committee is asked whether it is content to recommend approval of the novel food as an ingredient to be added to the range of foods specified.
● If not, the Committee is asked to indicate what additional data would be required.
ACNFP Secretariat
September 2026
Annexes
Annex A – RP2305-Draft Committee Advice Document
Annex B – Technical dossier updated RFI_2
Annex C – RP2305 annexes to the dossier
Annex D – RP2305 RFI_1 Applicant response
Annex E – RP2035 RFI_2 Applicant response