Minutes of the AEJEG 16th April 2024 meeting

Meeting of the Committee at 09:30 on Tuesday 16^th April 2024 via Microsoft Teams 

Contents

Announcements  

1. Members were informed that Prof Shirley Price had joined the AEJEG.

2. It was announced that Chris Rundle of the FSA would be joining for the second item to provide an update for a new process being implemented in Regulated Products.

Interests  

3. No conflicts of interest were declared.  

Item 1: Welcomes and Apologies for absence  

4. Apologies were received from Dr Claude Lambré, Carol Beevers and Prof Shirley Price. Apologies were also received from Dr Martin Rose, who would be joining in the afternoon.

Item 2: Matters arising: Update on the new process in Regulated Products

5. Chris Rundle, Head of Regulated Products Risk Assessment at the FSA, was introduced to the AEJEG and presented a paper outlining proposed regulated products process reforms. Members were invited to offer any suggestions or ask questions.

Matters Arising – RP1245

6. The AEJEG was presented with and asked to consider questions posed by the Applicant in connection with the Application RP1245. This Application consists of a request to change the Steviol Glycoside specification in the United Kingdom to include a new manufacturing method for Steviol Glycosides including Rebaudioside D. The Applicant had asked for clarification on questions asked in the RFI issued after the 20^th February 2024 AEJEG meeting.

7. Members reviewed the requested clarifications from the Applicant and provided clarity on the information they required. The Secretariat confirmed that the clarifications would be provided to the Applicant following the meeting.

Item 3: RP507 Opinion paper on Application for Authorisation of Blue Microalgae Extract (Blue Galdieria Extract) for Use as a New Food Additive in the ‘Colour’ Functional Class (RP 507) (Reserved) Opinion Paper AEJEG/2023/26 AEJEG/2023/23 

8. The AEJEG was presented with a first draft of the Safety Advice Document for this Application related to the authorisation of blue microalgae or blue Galdieria extract for use as a new food additive. The AEJEG initially reviewed the Application in February 2022. The AEJEG further reviewed the Application in the July 2022, October 2022, April 2023, July 2023, September 2023, and February 2024 meetings. A subgroup of the AEJEG also met in January 2024 for a focused discussion of the toxicology data and requests for further information (RFI) had been drafted.

9. In conclusion, the AEJEG completed a review the first draft Safety Advice Document for RP507. They provided minor editorial adjustments and requested further information regarding the exposure assessment. The Secretariat agreed to send another RFI to the Applicant and for the response to be presented to the AEJEG alongside the second draft of the Safety Advice Document at a later meeting.

Item 4: RP1457 Update on Application for Authorisation of the substance RP1457 Update on Application for Authorisation of the substance glycolipids (E 246) (Nagardo, AM-1) for use as a new food additive (RP1457) (Reserved) Update Paper AEJEG/2024/01 

10. The AEJEG was presented and asked to evaluate the most recent request for further information (RFI) response provided for Regulated Products Application RP1457. This application is for the authorisation of the substance Glycolipids (E 246) also known as Nagardo and AM-1, for use as a new food additive. The substance has antimicrobial effects and therefore is proposed for use in beverages with a normal use level of 10 mg/l and a maximum proposed level of up to 50 mg/l.

11. Glycolipids (E 246) had previously been presented at the 13^th February 2023 meeting in which a RFI was raised, the responses to this RFI were presented to the AEJEG at the meeting on 20^th July 2023, and a further RFI was raised on the 10^th August 2023. The AEJEG met to discuss the Toxicological studies submitted for RP1457 on its meeting on 8^th September 2023, due to the nature of some of the studies received, a Member of the Committee on Toxicity of Chemicals in Food, Consumer Products, and the Environment (COT) attended the meeting to assist the AEJEG in these discussions. During the September meeting the AEJEG agreed that no conclusions could be drawn on this data until further data on the antimicrobial properties of Glycolipids (E 246) had been received from the Applicant. A further RFI had been sent to the Applicant on Wednesday 8th November 2023 and a response was received on the 29^th February 2024, this response was discussed in the April 2024 meeting.

12. It was agreed that RP1457 would return to the AEJEG as an updated cover paper with inclusion of all the received RFI information to allow the AEJEG to review the entire dossier in its totality.

Item 5: RP733 Update on the application for the authorisation of soy leghemoglobin derived from Pichia pastoris as a flavouring precursor for plant-based meat alternatives in the United Kingdom. (RP733) 

13. The AEJEG was presented with and asked to evaluate the Applicant’s response to a request for further information (RFI) for Application RP733 received on the 15^th of February 2024. Members were last presented with this Application for the authorisation of soy legume haemoglobin (shortened to soy leghemoglobin) derived from Pichia pastoris as a flavouring precursor for plant-based meat alternatives in the United Kingdom (RP733) at the February 2023 meeting. Members had further reviewed the Application during meetings in June, October, and December 2023. The RFI had been sent following the October 2023 AEJEG meeting. 

14. Members agreed that an RFI should be issued to the Applicant requesting that more detailed statistical analysis be conducted. The Secretariat agreed they would prepare the question and circulate it to the AEJEG, prior to being sent to the Applicant. This item would be revisited upon receipt of the requested additional information.  

Item 6: Minutes from the last meeting - AEJEG/2024/04 

15. Due to time constraints, the Chair stated that minutes of the previous meeting would be considered and approved via correspondence.

16. It was agreed the Secretariat would resend the hyperlink to the minutes document to Members.

Item 7: Any other business

17. Members were reminded that the draft RFI questions for RP41 had been circulated and were encouraged to provide feedback as quickly as possible.

18. Members were informed that the next meeting for AEJEG would occur on the 4^th of June 2024.