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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

  1. 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.

  2. 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.

  3. 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