Minutes of the AEJEG 4th December 2024

Meeting of the Committee at 09:30 on Wednesday 4th of December 2024 via Microsoft Teams

Contents

Announcements    

1. None 

Interests 

2. Carol Bevers declared a conflict of interest due to being a study director of one of the Genotoxicity studies submitted by the Applicant of RP1765 (Item 7). In addition to being the study director, she was also an employee at the time that the company undertook a further 5 Genotoxicity tests for this Application. It was agreed that Carol would not be present for discussion on this item and would leave the AEJEG meeting once the discussion on RP507 had concluded.  

Item 1: Welcome and apologies 

3. Apologies were received from Professor Qasim Chaudhry and Dr Claude Lambré 

Item 2: Matters Arising 

4. Members were informed that the Applications, RP42 and RP1457, have been cleared by ACMSF AMR Members. These Applications are being presented at the Committee on Toxicity (COT) meeting on the 10th of December. 

5. Following and RFI, additional references for the RP507 Application have been received. Members were satisfied by the additional information provided. 

Item 3: RP507 - 90-day study discussion for the Application for Authorisation of Blue Microalgae Extract (Blue Galdieria Extract) for Use as a New Food Additive in the ‘Colour’ Functional Class (RP507) 

6. The AEJEG was presented with and asked to evaluate the two most recent requests for information (RFI) responses for RP507. This Application is for 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, February 2024, April 2024, October 2024, and December 2024 meetings. A toxicology subgroup of the AEJEG also met in January 2024 for a focused discussion of the toxicology data. A sixth RFI had been sent to the Applicant on the 5th of April 2024 and a response was received on the 25th of June 2024. A seventh RFI had been sent to the Applicant on the 27th of June 2024 and a response had been received on the 17th of July 2024. These responses were presented to the AEJEG. 

7. The AEJEG was not satisfied with their review the RFI response or with the overall statistical analyses of the 90-day sub-chronic toxicity study and its outcomes. They provided comments and discussion points that would be added and viewed in the fourth draft CAD at a future AEJEG meeting. 

Item 4 RP507 CAD paper on Application for Authorisation of Blue Microalgae Extract (Blue Galdieria Extract) for Use as a New Food Additive in the ‘Colour’ Functional Class (RP507) - AEJEG/2024/017 

8. The AEJEG was presented with the third draft Committee Advice Document for RP507. This Application is for 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, February 2024, April 2024, October 2024, and December 2024 meetings. A toxicology subgroup of the AEJEG also met in January 2024 for a focused discussion of the toxicology data. 

9. The AEJEG completed a review the third draft Committee Advice Document for RP507. They provided minor editorial adjustments and stated that the final edits and conclusions would be viewed in the fourth draft CAD at a future AEJEG meeting. 

Item 5: New application for the authorisation 2,4-Dimethyl-5-vinylthiazole [FL-no: 15.005], 4-Methyl-5-vinylthiazole [FL-no: 15.018] and 4,5-Dimethyl-2-isobutyl-3-thiazoline [FL-no: 15.032] for their use as a food flavourings. 

10. Due to a direct conflict of interest, Dr Carol Beevers was not present for the discussion of this item.  

11. The AEJEG considered a new application for the authorisation of 2,4-Dimethyl-5-vinylthiazole [FL-no: 15.005], 4-Methyl-5-vinylthiazole [FL-no: 15.018] and 4,5-Dimethyl-2-isobutyl-3-thiazoline [FL-no: 15.032] for their use as a food flavourings under Assimilated Regulation (EC) No 1331/2008.  

12. As part of the Secretariat checks on the application a Request for Information (RFI) was raised covering multiple aspects of the application, the Secretariat combined the original application, and the responses to this RFI into the cover paper which was reviewed by the AEJEG.    

13. The AEJEG acknowledged that the flavourings in the application were ‘flavouring substances under evaluation’ in which the risk assessment process had not been finished by EFSA when the UK left the EU due to concerns with genotoxicity, as such RP1765 was an application to complete the process. It was also acknowledged that these flavourings had their application for authorisation assessed by the European Food Safety Authority (EFSA) which was published in 2023.  

14. The AEJEG agreed that a request for information (RFI) would be raised to cover all questions raised during the meeting, and this application would return to the AEJEG as an update paper.  

15. Footnote: since the AEJEG meeting, the Secretariat were informed by Policy colleagues that many of the requested RFI questions fell outside the AEJEGs remit, due to this being footnoted flavourings, where certain aspects of the Application had already been deemed acceptable by EFSA whilst the UK was part of the EU.  

16. It was agreed that the AEJEG would be informed of this via email, and only those RFIs requested which fell within the AEJEG’s remit for footnoted flavourings would be sent to the Applicant.  

Item 6: Minutes of the last meeting 

17. Members accepted the minutes of the October AEJEG meeting as an accurate reflection of the discussions held. 

Item 7 - AOB 

18. The next AEJEG meeting is to be held virtually on the 11th of February 2025.