Beta Lactoglobulin (BLG) Discussion Paper

Committee Paper for Discussion - ACNFP/172/02

Advisory Committee For Novel Foods and Processes

Application for authorisation as a novel food for Beta Lactoglobulin (BLG)

Application Number - RP1571

Issue

An application has been received under the novel food authorisation process (assimilated Regulation 2015/2283) for beta-lactoglobulin (BLG). 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. On the 19^th April 2022, the FSA received the submission for beta-lactoglobulin (BLG), from Perfect Day Foods, USA.
2. The novel food is a highly purified extract comprised of ≥ 88% protein, of which > 95% is BLG. BLG is one of the main proteins in milk and in this application BLG is produced via microbial fermentation using a genetically modified microorganism. The novel food, BLG, is intended to be used as an ingredient in the following food categories: nutritional products, dairy and dairy alternative products, sugar-based products and snack food, and dressings.
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

June 2025

Annexes

ACNFP-172-0X-Annex A – Draft Committee Advice Document 

ACNFP-172-0X-Annex B – Dossier and References [Confidential]

ACNFP-172-0X-Annex C – Annexes [Confidential]

ACNFP-172-0X-Annex D – Request for Information

ACNFP-172-0X-Annex E – Response to Request for Information