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Beta-Lactoglobulin further information 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/beta-lactoglobulin-further-information-paper

Committee Paper for Discussion - ACNFP/176/01

Advisory Committee For Novel Foods and Processes

Application for the authorisation as a novel food for Beta-Lactoglobulin. Further information received from applicants to inform the assessment.

Application Number - RP1571

Issue

The Committee is invited to consider the response from the applicant providing further information to support the assessment. Members are asked whether the response is sufficient to conclude the safety assessment and form the basis of a positive Committee Advice Document (CAD). Alternatively, if the information provided is not sufficient, the Committee is asked whether the data gap is adequately captured in the CAD and the impact this has on the assessment is reflected accurately.

Background

  1. In April 2022, the FSA received the submission from Perfect Day Foods for beta-lactoglobulin. The novel food is manufactured by microbial fermentation using a genetically modified strain of the fungus, Trichoderma reesei. No recombinant DNA remains in the purified bet-lactoglobulin, so the food is not considered a GM and is subject to review under the novel food regulation.

  2. The novel food is intended to be used in the following food categories: dairy products and analogues, edible ices, confectionary, bakery wares, salts, spices, soups, sauces, salads and protein products, food intended for total diet replacement for weight control as defined in assimilated Commission Regulation (EC) No. 609/2013, beverages, ready-to-eat savouries and snacks, and desserts.

  3. The Committee first reviewed this dossier at the 172nd meeting and again at the 174th meeting. Following the discussion at the November 2025 meeting, further information was sought from the applicant in the following areas:

● Identity

● Production Process

● Compositional information

● Proposed uses

● Allergenicity

4.    The Committee is asked whether the applicant’s response addresses the outstanding questions from their request for information. To inform the discussion, development and finalisation of a CAD, the FSA’s requested further information (Annex A) and the applicant’s response (Annex B) are provided.

5.    The Secretariat has also drafted a Committee Advice Document for beta-lactoglobulin as a novel food considering the further information received which can be found in Annex C. Members are asked whether this accurately reflects the assessment to date.

Committee Action Required

● The Committee is asked whether the response from the applicant is sufficient to address the data gaps identified and conclude that the novel food is safe under the proposed conditions of use.

● If the applicant’s response is not sufficient, the Committee is asked how this should influence the outcome of the assessment for this novel food.  

ACNFP Secretariat

April 2026

Annexes

Annex A – Request for Information

Annex B – Applicant’s Response to RFI letter

Annex C – Draft Committee Advice Document

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