Esterified Propoxylated Glycerol (EPG) Discussion Paper

Committee Paper for Discussion - ACNFP/171/02

Advisory Committee For Novel Foods and Processes

Application for authorisation as a novel food for Esterified Propoxylated Glycerol (EPG) - Additional information from applicant for review.

Application Number - RP1363

Issue

The Committee reviewed this application for the first time at the September 2024 meeting. Members advised further information was needed to support the assessment of the novel food. The Committee are invited to consider the response from the applicant and whether this addresses the requests for information satisfactorily. If further information is required, the Committee’s advice is sought to clarify the data gaps in the applicant’s response.

Background

1. On the 3^rd December 2021, the FSA received the submission for esterified propoxylated glycerol (EPG) from Epogee, LLC. The novel food is made by the chemical reaction of propoxylated glycerol with food grade fatty acids. The applicant proposes to use the novel food as a fat replacer with limited digestion in a range of food products.

2. The Committee conducted a review of the application for the first time at the September 2024 meeting.

3. The Committee advised further data to be sought to support the progression of the review of this full novel food application. The applicant has provided additional information in the following areas:

• Identity.
• Compositional information.
• Specification.
• Proposed use and anticipated intake.
• Absorption. Distribution, metabolism and excretion.
• Toxicological information.

4. The FSA’s request for further information and the applicant’s response are included as Annexes B and C, respectively.

5. The Secretariat notes that following discussion with the applicant they have focused their effort on addressing the points raised on the identity and ADME with the aim of understanding what further information to support the assessment might be needed. Specific questions where the Secretariat would welcome members views are provided in the relevant sections.

Committee Action Required

• The Committee is asked whether the response from the applicant is sufficient to address the issues raised by the Committee at the last meeting.
• If not, the Committee is asked to indicate what further data is required and the feedback that should be given to the applicant.

ACNFP Secretariat

April 2025

Annexes

Annex A – Committee Paper for Discussion

Annex B – RFI Letter

Annex C – Applicant’s Response to RFI Letter