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Human equivalent lactoferrin α discussion paper

Updated 25 June 2026

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This publication is available at https://www.gov.uk/government/publications/23-april-2026-acnfp-meeting/human-equivalent-lactoferrin-discussion-paper

Committee Paper for Discussion - ACNFP/176/02

Advisory Committee For Novel Foods and Processes

Application for the authorisation as a novel food for human equivalent lactoferrin α

Application Number - RP2296

Issue

An application has been received under the authorisation process (assimilated Regulation 2015/2283) for human-equivalent lactoferrin α (heqLα). 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 February 2025, the FSA received a notification under the novel food authorisation process from Heliana Inc. for human-equivalent lactoferrin α (heqLFα).

  2. This new application is for a protein with the same primary amino acid sequence, and equivalent secondary and tertiary structure as human-milk lactoferrin α. It is produced by fermentation using a genetically modified strain of the yeast Komagataella phaffii (formerly Pichia pastoris), followed by purification via filtration and ion exchange chromatography. The novel food is intended for use as an ingredient in conventional food and beverages, infant formulas, follow-on formulas, food for infants and young children, foods for special medical purposes, diet replacement for weight control, and food supplements.

  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) and the applicant’s response to the RFI are included as Annexes D and E, respectively. Annex E also contains confidential information.

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

April 2026

Annexes

ACNFP-176-02-Annex A – Draft Committee Advice Document 

ACNFP-176-02-Annex B – Dossier and References [Confidential]

ACNFP-176-02-Annex C – Annexes [Confidential]

ACNFP-176-02-Annex D – FSA Request for Further Information

ACNFP-176-02-Annex E – Response to Request for Further Information

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