Minutes of the 20th January 2023 meeting - SFWG

Joint Expert Group on Additives, Enzymes and other Regulated Products Smoke Flavouring Working Group (AEJEG SFWG) 

Meeting of the Committee at 10:00 on Friday 20th January 2023 via Microsoft Teams 

Contents 

Declaration of interest(s) 

1. Dr Gill Clare declared a personal non-specific interest for Labcorp Ltd., a contract research organisation, which was commissioned for genotoxicity testing by some of the Applicants. Whilst not directly involved in the study, Dr Clare’s role involves scoring slides; however, these are blinded. Members agreed Dr Clare could participate in the general discussions but would not be able to contribute to forming conclusions on applications where new testing was performed by Covance. 

2. No other interests were declared. 

Item 1: Welcome and apologies  

3. The Chair welcomed AEJEG SFWG Members and other attendees. Due to several new colleagues i.e., co-opted Experts joining the AEJEG for the Smoke Flavouring assessments, the Chair requested all existing Members and new Experts to introduce themselves and provide a brief summary of their background and expertise. The FSA Secretariat and other officials present also provided their introductions. 

Item 2: Introduction to Smoke Flavourings Q&A 

4. The purpose of this Item was to allow a Question-and-Answer discussion for all those present in the meeting to raise any questions regarding the safety and risk assessment of smoke flavourings.  

5. Members discussed the most appropriate strategy to ensure consistency and transparency of their approach in performing their assessments for the smoke flavouring applications.  

6. Members also requested a wider discussion on the approach for ‘Weight of Evidence’ to rank each data type e.g., in silico, in vitro and in vivo, and to discuss the prioritisation of results gained by each type. It was agreed that this discussion would be held in a later Smoke Flavourings meeting. 

7. Members concluded that the information available within the Applications was not sufficient to allow for conclusions to be drawn and that further questions would be posed to the Applicants. The questions for each application would be agreed upon consideration of the individual dossiers and questions relevant to all applications would be agreed upon evaluation of all the dossiers.   

Item 3: Application for the renewal of smoke flavouring primary product ‘Smoke concentrate 809045’ (RP1616) (Reserved) 

8. The Secretariat presented the Renewal for Authorisation of Smoke Concentrate 809045. The Applicant had provided information on the characterisation of the smoke flavouring, exposure, and safety of the product. For each of the volatile components in the mixture, the applicant had provided data from published studies, read-across data, analysis from in silico methods, or in vitro or in vivo studies for genotoxicity based on a tiered system of requirements. The entire mixture had also been tested with several in vitro and in vivo test methods.  

9. Members discussed that overall, the information provided at the time by the applicant was insufficient to allow for conclusions. The AEJEG considered that further, more in depth evaluation of the data would be required to fully assess the information. A number of areas were identified, where further information was needed. These were in particular with regards to the analytical information provided, information on stability, batch-to-batch variability, exposure and toxicity. 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 Request For Information letter to be sent to the Applicant. The item would be revisited upon receipt of the requested additional information. 

Item 4: Any other business 

10. Members were reminded that the next AEJEG meeting on Smoke Flavourings would take place online via Microsoft Teams on Monday 23rd January 2023 at 10:00AM.