Transparency data

Human equivalent lactoferrin α

Updated 5 November 2026

Committee Paper for Discussion - ACNFP/179/03

Advisory Committee For Novel Foods and Processes

Application for the authorisation as a novel food for Human equivalent lactoferrin α.

Application Number - RP2296

Issue

At the June meeting, the Committee reviewed an application for human-equivalent lactoferrin α (heqLFα) as a novel food under (assimilated Regulation 2015/2283). The Committee compiled an extensive Request for Further Information that was sent onto the applicant. Their response was received in Jully 2026. The Committee is asked to continue its review and advise on whether the additional data (and the original dossier) 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.

The draft Committee Advice Document (CAD) has been updated with the latest RFI responses 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). 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.

2. Following an initial review of the application at the June 2026 meeting, data gaps were raised on several areas of the application (see below). The applicant provided their responses, along with additional data and revised Annexes.

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. As part of the RFI response, the applicant uploaded amended versions of some Annexes. These have replaced any previous versions, so all Annexes contain the most up-to-date information.

Applicant’s latest RFI responses and outstanding considerations for this application

Identity of the novel food

1.  More information was requested on the iron binding characteristics and on the differences in glycosylation. The Committee is asked to comment on whether the information provided by the applicant is adequate to determine whether the protein is equivalent to hmLF.

2.  Clarification was sought over the gene sequences inserted.

Production process

3.  More information was requested on viable cell and DNA sampling during the production process. The Committee is asked on comment on whether the applicant’s response is sufficient.

Composition

4.  Clarification was sought on which form of arsenic was tested for in the heavy metal analyses.

5.  Clarification was sought on the methods used to quantify E. coli and S. aureus in the microbiological tests. The applicant provided the ISO methods used.

6.  The applicant clarified some parameters within the compositional data that pertained to lactoferrin content. This also impacts the Specification of the novel food (see point 8).

Stability

7.  The applicant was asked to explain the high value for aerobic plate count observed in the stability study. The applicant also stated the next time point in the stability study is expected in January 2027 (24-month time point). The Committee is asked if the available information is enough to determine the stability of the novel food.

Specification

8.  The applicant was asked to consider amending the Specification to more closely reflect the composition of the novel food. The Committee is asked to comment on the response from the applicant and the changes made to the Specification.

9.  The applicant was asked to explain why ash levels were so high. The applicant provided additional analysis of the ash content which has been included in the CAD.

10.  The applicant was asked to express iron content as a wt/wt calculation. They have updated their composition tables to reflect this.

11.  The applicant was asked to explain why in-house methods were used for some parameters in the Specification. The applicant provided a reference for the method, along with its formal validation. The Committee is asked to determine whether this method is acceptable.

Proposed uses and anticipated intakes

12.  The applicant was asked to provide a summary of the literature on human lactoferrin and its role as an auto-immune antigen. The Committee is asked whether the applicant’s response addresses the question.

13.  The applicant was asked to compare the levels of heqLFα in the novel food to levels of lactoferrin in human breast milk. The applicant provided estimates of exposure to lactoferrin from human breast milk and compared this to exposure estimates of heqLFα from three scenarios. The applicant also provided a wt/wt calculation of iron intake from heqLFα. The Committee is asked to comment on this additional information and whether it addresses the questions asked.

Toxicity Information

14.  The applicant was requested to provide historical control data in the context of the OECD408 toxicity study. The applicant provided this in a spreadsheet. The Committee is asked whether the information supplied addresses the question.

15.  The applicant was asked to interpret the adverse effects observed in human studies. The Committee is asked to comment on the applicant’s response.

Immunogenicity

16.  The applicant was asked to provide a rationale for doing immunogenicity studies. The applicant was asked to consider the effect in individuals with auto-immune responses to lactoferrin. The Committee is asked to comment on the applicant’s response.

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

November 2026

Annexes

ACNFP-179-03-Annex A – Draft Committee Advice Document 

ACNFP-179-03-Annex B – Dossier [Confidential]

ACNFP-179-03-Annex C – Annexes [Confidential]