Mung Bean Protein – Additional Information Discussion Paper

Committee Paper for Discussion - ACNFP/169/01

Advisory Committee For Novel Foods and Processes

Application for Authorisation as a Novel Food for Mung Bean Protein - Additional Information for Review.

Application Number RP32  

Issue

The Committee reviewed this application for the first time at April 2021 meeting, and again at four further ACNFP meetings. At the last meeting, members advised that further information should be requested in one area, allergenicity, to complete the assessment.

The Committee is invited to consider the response from the applicant. 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 content the data gap is adequately captured in the CAD and the impact this has on the assessment reflected accurately.

Background

1. The FSA received an application for mung bean protein as a novel food from Eat Just, Incorporated, in January 2021. Mung bean protein is manufactured by extraction, purification, and spray drying of the protein from mung bean (Vigna radiata) flour (≥ 84% w/w protein) and is intended to be used as a non-animal egg replacer.

2. The Committee first reviewed this dossier at the 147^th meeting, and subsequently at the 149^th, the 150^th, the 152^nd, and the 153^rd meetings. Following the discussion at the meeting in June 2022, the Secretariat sought further information from the applicant in the following area: 

• Allergenicity

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

4. The Secretariat has also drafted a Committee Advice Document for mung bean protein as a novel food considering the further information received which can be found in Annex C. This also includes details of the points considered by the Committee and resolved for this dossier at previous meetings. Members are asked whether this accurately reflects the assessment to date.

Applicant’s response to request for further information

Allergenicity

5. Previously, the applicant submitted sequence homology data which indicated the novel food could be allergenic. The Committee therefore requested that the applicant conduct the next tier of allergenicity testing, targeted serum screening, using IgE produced by legume allergic consumers.

6. In November 2022, the applicant provided a research proposal for a sensitisation study with a deadline of no later than 1^st September 2024. Feeback from the allergenicity experts on the ACNFP confirmed this was an appropriate study. 

7. The applicant informed the Secretariat in early 2024 that study had not been conducted. Instead, the applicant has provided a copy of a published paper by Calcinai et al., (2023) as an alternative source of data to replace their proposed study.

8. Members are asked whether the response provided is sufficient to address the original query (Annex B).

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 

November 2024

Annexes

Annex A – Request for Information.

Annex B – Applicant’s Response to RFI letter.

Annex C – Draft Committee Advice Document.