Minutes of the 13th February 2023 meeting

Meeting of the Committee at 10:00 on Monday 13^th February 2023 via Microsoft Teams

Please note: These minutes have been redacted to remove any confidential information relating to the applications discussed.

Present

Contents

Item                                                                                                                                                             Paragraph

Announcements

1. The chair welcomes Members and other attendees.
2. The Members welcomed Ms Abigail Smith of the FSA Secretariat, who had recently joined the Secretariat Team for the AEJEG as an HSO.
3. The Members also welcomed Ms Angela Goundry a Risk Assessment Officer in the FSA’s Trade team who was observing this AEJEG meeting.

Interests

4. No conflicts of interest were declared.

Item 1: Apologies for absence

5. Apologies were received from AEJEG Member Dr Martin Rose, and Ms Claire Potter of the Secretariat.

Item 2: Minutes from the last meeting

6. Members requested Paragraphs 27, 35 of the confidential minutes to be restructured slightly.

7. The Secretariat agreed to check the notes on Paragraph 70 of the confidential minutes to ensure this was accurate and rephrase if appropriate.

8. The minutes of the last meeting were agreed as accurate record, subject to minor editorial changes and the changes described above.

Item 3: New application for authorisation of the substance glycolipids (E 246) (Nagardo, AM-1) for use as a new food additive (RP1457)

9. The AEJEG considered a new application for the authorisation of the substance Glycolipids (E 246) which is 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 10mg/l and a maximum proposed level of up to 50mg/l. As part of the Secretariat checks on the application a Request for information (RFI) was raised covering multiple aspects of the application, the original application, and the responses to this RFI were reviewed by the AEJEG.

10. Members praised the cover paper produced by the Secretariat.

11. Members highlighted EFSA has produced an opinion for this substance, and Members commented that although EFSA and the FSA are two separate organisations this would add value to the application and supports the safety of the material. In addition to the EFSA opinion Members acknowledged approval for this substance has also been granted by Health Canada, Australia New Zealand FSANZ and the product has US FDA GRAS Notice.

12. Members concluded that although the opinion of other authorities will be considered as part of the supporting information, the evidence provided by the applicant would still be reviewed by the AEJEG and Members will form their own conclusions based on the evidence provided as part of this application, not based on the evaluations of other authorities.

13. Members noted Health Canada has approved an ADI of 2.5mg/kg whereas EFSAs ADI is 10mg/kg. It was questioned if the same effect can be achieved with a lower dose of AM-1 such as what is approved in Canada, should the lowest dose be adopted.  It was agreed an RFI would be sent to the Applicant to explain how the ADI of 2.5mg/kg from Health Canada was established.

14. Overall, Members were mostly satisfied with the application for AM-1, and acknowledged the Application was thorough and covered almost every aspect the AEJEG would expect. Members agreed clarification was needed within the Specification section. More detail was required on how the lower approved ADI from Health Canada was established, and Members requested further details of the antimicrobial properties of AM-1. Although Members accepted the original study reports were not created by the Applicant but a third party, Members agreed that further clarification was needed on the reports provided.

15. Based on the above information, it was agreed that the Secretariat would prepare questions which would be circulated to the AEJEG, prior to being included in an RFI letter to be sent to the Applicant. This item would be revisited upon receipt of the requested additional information.

Item 4: Update on extension of use of phosphates (E 338–341, E 343, E 450–452) (RP40)

16. Members were last introduced to Regulated products application RP40 in March of 2022. This Application features a request by the Applicant ‘Eat Just’ to extend the use of phosphates to a new food category "egg analogues". Members were presented with previously assessed information, correspondence between the European Commission and the Applicant, and a response to a request for information.   The AEJEG had previously requested information regarding the composition of the egg analogue product including total concentrations of phosphate. The AEJEG also requested a reworked exposure assessment. The Applicant had also separately provided a second technical dossier, submitted to the European Commission. This was provided as Annex D for information.

17. Members concluded issues were still present within the original dossier, response to the request for information and the second paper provided by the Secretariat for information. They considered that pending review by the AEJEG through correspondence, a request for information would be submitted to the Applicant.

Item 5: New application for the authorisation of soy legume hemoglobin (shortened to soy leghemoglobin) derived from Pichia pastoris (P. pastoris) as a flavouring precursor for plant-based meat alternatives in the United Kingdom (UK) (RP733)

18. The AEJEG were presented with an initial dossier application for the approval of soy legume hemoglobin (soy leghemoglobin) derived from Pichia pastoris (P. pastoris) (RP733) as a flavouring precursor for plant-based meat alternatives in the United Kingdom (UK).

19. Members noted that the paper was well written and nicely presented.

20. Members discussed the background of use of the organism, specifications and proposed uses and exposure estimates submitted by the applicant. Members also considered the different uses of Soy leghemoglobin in the food industry.

21.The Secretariat provided a summary of meetings held with the Applicant. The Secretariat noted that the Applicant had also submitted an application to EFSA for their product, which was, at the time of the meeting, on hold. The Secretariat also noted the divergence between the UK and the EU on the classification of the product in that the EU sought to classify the product as a food additive. Furthermore, as the UK application was pending, the classification would not affect the UK’s categorisation of the product.

22. Some points of clarification noted with respect to the specifications of the final product and the exposure assessment. The Secretariat would request further information on exposure estimates and also to consider different scenarios, particularly for consumers consuming a mixed diet. This item would be revisited upon receipt of the requested additional information.

23. The AEJEG will continue review of the dossier in a future meeting.

Item 6: Any Other Business

24. There was no other business.

Date of next meeting

25. The next meeting of the AEJEG will be at 10:00 on 25^th April 2023 on Microsoft Teams.