Draft Minutes of the 6th February 2024 COT Meeting
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Skip the menu of subheadings on this page.Meeting of the Committee at 10:00 on 6th February 2024 on Microsoft Teams
Present
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Chair: |
Professor Alan Boobis |
| COT Members: |
Dr Phil Botham Dr James Coulson Professor Gary Hutchison Professor Matthew Wright Dr Michael Routledge Dr Natalie Thatcher Ms Juliet Rix Dr Simon Wilkinson Professor Mireille Toledano Professor Philipe Wilson Ms Jane Case Dr Gunter Kuhnle Professor Shirley Price Dr Cheryl Scudamore Dr Stella Cochrane Dr David Lovell Professor Peter Barlow Dr Steven Enoch Dr Mac Provan Dr Sarah Judge |
| COT Associate Members: |
Professor Jeanette Rotchell Ms Eimear O'Rourke Dr Charlotte Mills Dr Tarek Abdelghany |
| Scientific Advisory Committee on Nutrition (SACN) Liaison | Professor Paul Haggarty |
|
Food Standards Agency (FSA) Secretariat:
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Ms Cath Mulholland - FSA Scientific Secretary Dr David Gott Dr Alex Cooper Ms Claire Potter Dr Barbara Doerr Dr Olivia Osborne Ms Sabrina Thomas Dr Gail Drummond Ms Cleanncy Hoppie Ms Jocelyn Frimpong-Manso Ms Sophy Orphanos Dr Gaetana Spedalieri Mr Thomas Hornsby Dr Emily Hudson Dr Aaron Bradshaw Ms Jessica Cairo Dr Lorcan Browne Ms Natasha Adams Dr Katie Schulz Mr Barry Maycock Ms Frederique Uy Dr Rachel Kerr Mr James Metcalfe |
| UK HSA Secretariat: | Ms Britta Gadeberg - UK HSA Scientific Secretary |
| Contractors: |
Dr Sarah Bull - Institute for Environmental Health (IEH) |
| Invited Experts: | Dr Arthur de Carvalho e Silva - University of Birmingham |
| Assessors: |
Dr Ovnair Sepai - UK Health Security Agency (UKHSA) Ms Frances Hill - Business, Energy and Industrial Strategy (BEIS) Ms Susannah Brown - Office of Health Improvement and Disparities (OHID) Mr Ian Smith - Environment Agency (EA) Ms Akosua Adjei - Medicines and Healthcare Products Regulatory (MHRA) |
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Observers: |
Mr Jason Aungst - Centre for Food Safety and Applied Nutrition (CFSAN) Ms Luisa Camacho - US Food and Drug Administration Mr Gordon Barrett - Health Canada |
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FSA and other Officials: |
Mr Allan Shivembe - FSA Dr Amie Adkin - FSA Dr Andy Axon - FSA Mr Vincent Greenwood - FSA Mr Tim Chandler - FSA Dr Joseph Shavila - FSA Ms Lucy Smythe - Food Standards Scotland (FSS) Ms Krystle Boss - FSS |
Contents
Item Paragraph
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1 |
Apologies for absence |
1 |
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2 |
Draft minutes of December meeting- TOX/MIN/2023/07 |
4 – 15 |
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3 |
Matters arising - Continuous improvement for the regulated product service – TOX/2024/10 (reserved) - Update on JEGs |
16 – 28 |
|
4 |
Second draft statement on the potential risks from ergot alkaloids in the maternal diet - TOX/2024/01 |
29 – 39 |
|
5 |
Third draft statement on the safety of Titanium Dioxide (E171) as a Food Additive. – TOX/2024/02 |
40 – 55 |
|
6 |
Benchmark dose modelling in a UK chemical risk assessment framework - TOX/2024/03 |
56 – 67 |
|
7 |
Advancing in silico methods for chemical risk assessment – update from the FSA fellow - TOX/2024/04 |
68 – 78
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|
8 |
Draft 2023 COT Annual Report - TOX/2024/05 |
79 |
|
9 |
Annual COT Horizon Scanning - TOX/2024/06 |
79 – 82 |
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10 |
Update on actions taken subsequent to the Committee’s advice - TOX/2024/07 |
83 |
|
11 |
Fourth draft interim position statement on bisphenol A - TOX/2024/08. |
84 – 96 |
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12 |
Update on the work of other FSA Scientific Advisory Committees - for information TOX/2024/09 |
97 |
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13 |
AOB |
98 |
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Date of the next meeting – Tuesday 26th March at Clive House, London and via Microsoft Teams |
99 |
Announcements
1. The Chair welcomed Members and other attendees.
Interests
2. The Chair reminded those attending the meeting to declare any commercial or other interests they might have in any of the agenda Items.
Item 1: Apologies for absence
3. Apologies were received from COT Members Professors Maged Younes and Thorhallur Halldórsson and Dr Silvia Gratz. Apologies were also received from Associate Members Dr Ben Amies-Cull and Dr Sam Donellan, HSE assessor Ms Louise Dearsly, and Mr Michael Dickinson and Ms Abigail Smith of the COT Secretariat.
Item 2: Draft Minutes from the meeting held on 12th of December 2024 (TOX/MIN/2023/07)
4. The Committee reviewed the draft minutes and the reserved minutes of the 12th December 2023 meeting (TOX/MIN/2023/07).
5. A number of minor editorials were identified.
6. It was noted that ‘PTX’ and ‘PTXs’ were used interchangeably throughout the minutes. This would be standardised to ensure consistency.
7. Paragraph 55, second sentence was reworded to read “The Secretariat was also asked to address any potential interaction with anticoagulant drugs such as warfarin and any antihistamine effects directly related to ginger consumption and their implications in pregnancy”.
8. Paragraph 57 was amended to read “Members suggested the addition of a paragraph on the rate of spontaneous abortions observed in the in vivo toxicological studies and noted that not all of the increases in the incidence of spontaneous abortions were statistically significant…”
9. With respect to paragraph 59, Members stated that it was unclear what the animals were pretreated with. The paragraph was amended to read “Members also asked for data on studies where the animals had been pre-treated for example, with drugs to induce diabetes to be omitted to avoid difficulty with interpretation.
10. Members considered that paragraph 92 on RP1112 (steviol glycosides) read as though the minutes for this item would not be released. The Secretariat explained that confidentiality arrangements were still ongoing with the applicant, following which the minutes could be published. It was agreed to change the wording to reflect this.
11. The reserved minutes were reviewed.
12. It was agreed that paragraph 3 on Item 9 would be reworded to ensure that it was clear that it referred to the COT’s 2021 opinion.
13. Members requested that paragraph 28 was edited to clarify why the Threshold for Toxicological Concern (TTC) was used in the assessment of kaurenoic acid.
14. In paragraph 35 it was stated the Secretariat were to provide a timeline for the approval of RP1466. The Secretariat confirmed this had not yet been done. It was noted that this item will be returning to Members via correspondence.
15. The remaining draft minutes and reserved minutes were accepted as an accurate record.
Item 3: Matters arising from the meeting held on 12th of December 2023
Continuous improvement for the regulated product service -TOX/2024/10. (Reserved)
16. No interests were declared.
17. A paper on the continuous improvements being made to the regulated product service was presented. The item is currently being treated as reserved as it discusses developing policy.
Joint Expert Group (JEG) update
AEJEG
18. On the 24th of January the AEJEG presented a paper to the Advisory Committee on the Microbiological Safey of Food (ACMSF) on the potential antimicrobial resistance to nisin.
19. The final two of the “Deep Dive” round 2 meetings examining the smoke flavourings dossiers were scheduled for the 31st January and 15th February 2023.
20. On the 14th of February the AEJEG toxicology experts would be meeting for a deep dive of the RP507 application. The full AEGEG would be meeting on the 20th of February 2024.
COT/COM
21. An extraordinary meeting of the COT and COM is being planned to review the recent EFSA opinions on smoke flavourings. A date for this would be circulated shortly.
FCMJEG
22. The next FCMJEG meeting was at the end of February to discuss an updated statement on ocean bound plastics and a Request for Further Information (RFI) for a plastic additive. These would be presented to COT in due course.
Folic acid hypersensitivity
23. COT’s comments on folic acid hypersensitivity were provided to the FSA policy team and a summary of the risk management advice taking this into account was available on the risk analysis register on the FSA/FSS website. It was concluded that the risk was tolerable as adverse reactions, if they do occur, are very rare and moderate in nature.
Subgroups
Plant-based drinks
24. The joint COT/SACN working group on plant-based drinks would be meeting on the 14th of February to discuss comments on the first draft of their report. A second draft will then be prepared and presented to the two committees in March. A public consultation will take place later in the Spring.
Cannabidiol (CBD)
25. The joint subgroup of COT/ACNFP on CBD had its first face to face meeting in early February. This group has now reviewed the group A ‘pure’ compounds and established an ADI for CBD. It is considering the less pure group B compounds. An acceptable level of tetrahydrocannabidol (THC) contamination, taking into account the legal limit set by the Home Office, was an additional topic of discussion.
Aircraft cabin air
26. The Statement on aircraft cabin air has now been finalised and signed off by the Chair, including a lay summary. UKHSA is arranging with the Department for Transport (DfT) and the Civil Aviation Authority (CAA) when this would be published.
Publications
27. The Committee position paper on chitosan in biologically based food contact materials has now been published on the FSA website. The lay summary of the cow’s milk risk assessment and the risk assessment on vitamin D have been cleared by chair’s action and would be published shortly.
SAC Recruitment
28. COT has recruited several new Members who will be inducted in March, prior to their first official meeting in May. Professors Shirley Price, Mireille Toledano and Thorhallur Halldórsson and Dr Simon Wilkinson have also been appointed to the Committee for additional terms. Efforts are ongoing to recruit a new Chair and a clinical toxicologist, but Professor Boobis and Dr James Coulson have agreed to serve an additional one year term, respectively.
29. A declaration of interest was made by Dr David Lovell as a member of the 91st JECFA in 2021 cited in the paper. This did not preclude him taking part in the discussion. No other interests were declared.
30. The paper on ergot alkaloids is part of the ongoing programme of work assessing the maternal diet being conducted by the Scientific Advisory Committee on Nutrition (SACN) to which the COT are contributing. It was agreed that ergot alkaloids were among the priority chemicals for consideration.
31. Ergot alkaloids (EA) are secondary metabolites produced by the fungal families Clavicipitaceae and Trichocomaceae, with Claviceps purpurea being the most widespread EA-producing species in Europe. EAs affect more than 400 plant species, including some economically important cereal grains such as rye, wheat, triticale, barley, millet and oats.
32. Due to their structural similarities, EAs are agonists or antagonists of noradrenaline, dopamine and serotonin neurotransmitters and produce effects such as uterotonic action or vasoconstriction and central nervous system (CNS) effects such as induction of hypothermia and emesis.
33. The Committee discussed the potential risk from EAs in the maternal diet (TOX/2022/36) at the COT meeting in July 2022. The Committee agreed that a statement setting out their views should be prepared based on the information provided. The draft statement (TOX/2023/29) was discussed at the COT meeting in July 2023. During this discussion, the Committee asked for historical context to be added to the introduction, and for more specificity in the risk characterisation section. The requested information has been included in the second draft of the statement presented in TOX/2024/01, which Members reviewed in detail.
34. Although the terms ‘direct’ and ‘indirect’ peripheral effects had come from the EFSA opinion, Members recommended using the more general term “peripheral effects”.
35. Members considered there was a lack of evidence of immunotoxicity and suggested that the role of prolactin in immunity should be separated, and an additional paragraph on alkaloids in the immune system included.
36. It was agreed that a paragraph on overall exposure should be added to the exposure section of the paper.
37. The COT agreed to align with the JECFA Acute Reference dose (ARfD) of 0.4 μg/kg bw, rather than the value established by EFSA, noting this was both the more conservative value and from a more recent evaluation, which was based on human endpoints. It was agreed that an explanation of why the COT aligned with the JECFA value would be added to the statement.
38. Members suggested several minor editorial changes to be included in the updated statement.
39. The revised statement will be circulated via correspondence before being cleared by Chairs action.
Item 5: Third draft statement on the safety of Titanium Dioxide (E171) as a Food Additive (TOX/2024/02)
40. Professor Alan Boobis declared an interest that dated back to 2019. He is a member on the External Advisory Committee of the Centre for Research on (Food) Ingredient Safety at Michigan State University. One of their research groups had undertaken research on titanium dioxide, published in 2019, which was partly funded by industry. This is not a direct interest and would not preclude Professor Boobis from contributing to the discussions, but the item was chaired by the Deputy Chair, Dr Sarah Judge.
41. Professor Matthew Wright was a Member of the EFSA Scientific Panel that reviewed the safety of titanium dioxide for the 2021 Opinion. He was available to answer COT Members’ questions and offer clarifications on the EFSA Opinion, but not participate in the COT’s discussion or conclusions. Professor Shirley Price declared an interest as she is a member of the JECFA group on titanium dioxide and will be attending the next JECFA meeting in October 2024 to discuss it. Dr Stella Cochrane and Dr Natalie Thatcher declared non-personal specific interests as their employers may use titanium dioxide in their products. These interests did not preclude these Members from contributing to the discussion of this item. No other interests were declared.
42. Titanium dioxide (TiO2) was an authorised Food Additive (E171) in the EU and currently remains authorised in the UK, under Retained EU Regulation No. 1333/2008 and Retained EU Regulation No. 231/2012. It is used in food as a colour to make food more visually appealing, to give colour to food that would otherwise be colourless, or to restore the original appearance of food. It is commonly used in products such as bakery products, soups, broths, sauces, salad dressings, savoury based sandwich spreads, processed nuts, confectionary, chewing gum, food supplements and cake icing.
43. Titanium dioxide has been the subject of multiple safety evaluations. The most recent EFSA Opinion was published in 2021, the EFSA Food Additives and Flavourings (FAF) Panel considered that some findings regarding immunotoxicity, inflammation and neurotoxicity with respect to TiO2 nanoparticles may be indicative of adverse effects. On the basis of the currently available evidence and the uncertainties, in particular a concern regarding genotoxicity, which could not be resolved, the EFSA Panel concluded that E171 can no longer be considered as safe when used as a food additive.
44. In 2021 the COT published an interim position on titanium dioxide (COT 2021). Members had been asked to evaluate the EFSA Opinion and comment on whether they agreed with EFSA’s conclusions and provide further guidance on the next steps that should be taken; it was agreed to produce an opinion paper following a review of the new EFSA opinion and the extended one generation reproductive toxicity (EOGRT) study data by both the COT and COM (Committee on Mutagenicity).
45. A previous draft of the statement (TOX/2023/56) had been discussed at the October 2023 meeting and amendments were requested.
46. Paper TOX/2024/02 was an updated version of the statement, which covered the COT conclusions to date on the following topics and endpoints: Absorption, Distribution, Metabolism, Excretion (ADME), Aberrant Crypt Foci, Reproductive and Developmental Toxicity and the establishment of a potential Health-Based Guidance Value, dependent on the outcomes of the review by COM. It also included the subsequent sub-group work on the additional endpoints reviewed in the EFSA 2021 opinion. The draft also included the titanium dioxide exposure assessment for the UK population.
47. It was noted that the aim was to finalise the statement as soon as possible after the Committees reached their conclusions. In addition to minor editorial suggestions, the Committee made a number of comments on the structure and content of the draft. It was agreed that the conclusions reached by Food Standards Australia New Zealand (FSANZ), Health Canada and other regulatory bodies on the safety of titanium dioxide in food would be included in the next draft statement, under each endpoint in a clear structured manner with specific titles for each section.
48. It was noted that the COM had also examined reviews undertaken by other regulatory bodies and COT members stated that these reviews should be included in the statement paper where relevant as was being done for the COT statement.
49. The COT discussed the summary table (Annex B) and were content with the layout and structure.
50. A number of minor revisions and editorials were requested for the Kreyling et al 2017, Nanotoxicology, 11(4), pp.434-442, Hendrickson et al, 2016 Current Nanoscience, 12, 228–236 and Heringa et al 2018, Particle and fibre toxicology, 15(1), p.15 studies, as well as the EFSA Review and conclusion section and that the reference list be updated. It was requested that an introductory paragraph on exposure be added to the exposure section of the paper.
51. Members noted that in a couple of papers, all of the standard deviations reported were exactly the same percentage of the means. It was considered that this was extremely unlikely to have occurred through biological variation and called into question the reliability of these papers.
52. Members suggested the summary of the extended one generation reproductive toxicity study be condensed.
53. The Committee discussed their overall conclusions. It was noted that the titanium dioxide COT subgroup would complete the uncertainty section, including toxicity uncertainties, and highlighted that while the EOGRT study was a well conducted OECD compliant study, it was still the only study available for certain endpoints. It was also requested that paragraph 331 be updated to reflect that it was the exposure to TiO2 that would need to be revisited by the FSA, not the regulatory levels.
54. Overall, the Committee were content with the layout and structure of the draft statement.
Item 6: Benchmark dose modelling in a UK chemical risk assessment framework (TOX/2024/03)
55. Professor Matthew Wright declared an interest as one of the co-authors of the 2022 EFSA Benchmark dose (BMD) modelling guidance document (Guidance on the use of the benchmark dose approach in risk assessment (wiley.com). Professor Alan Boobis declared an interest as he was co-author on a paper cited in the discussion paper (Haber et al., 2017). No other interests were declared.
56. The FSA and the COT were considering the use and practice of BMD modelling as part of its ongoing evaluation of New Approach Methodologies (NAMs) in chemical risk assessment, within a UK food safety context, for the safety of UK consumers.
57. The discussion paper set out the theory and practice of BMD modelling. The paper drew on previous evaluations by regulatory bodies and authorities. It also included a discussion of the areas of consensus and divergence between organisations and expert groups. The paper included a case study from the FSA Computational Fellow (see also Item 7 on the agenda; Advancing in silico methods for chemical risk assessment – update from the FSA fellow – TOX -2024- 04 Presentation from Tox Fellow pdf (food.gov.uk)
58. Members thanked the Secretariat for the work presented, they considered it provided a thorough and understandable overview of the subject matter. Note was made of the rapidly developing nature of the BMD guidance, the development of new approaches - such as Bayesian approaches - and the recent proliferation of new BMD software but noted that it was still uncertain if or what important divergences existed between these developments.
59. Members noted that there was debate about the role of benchmark dose modelling in other areas, such as genotoxicity testing, and recommended the COT also consider the views on BMD modelling by other UK Scientific Advisory Committees notably the COC and COM. Members noted that BMD modelling was already being used by some expert groups, such as the UK Expert Committee on Pesticides and it would be useful to capture their experience.
60. Members acknowledged that BMD modelling represented a useful tool in toxicology but emphasised that the No-observed-adverse-effect level (NOAEL) approach remained valid and, in many cases, was the only option (e.g. effects observed only at the highest dose). Members noted that the requirement for deeper knowledge of the statistical and computational basis of the BMD approach may represent a barrier for further adoption in traditional toxicology. It was agreed that applying the BMD approach to toxicology data was a more complex undertaking than the traditional NOAEL approach. Some areas where BMD modelling may provide advantages over the traditional NOAEL approach were identified including potency comparison, establishing toxicological equivalency factors (TEFs) and for situations where a reference point needed to be identified in the absence of a NOAEL.
61. Members also noted that transparency of the underlying algorithms was essential when considering whether the model and its outputs were reliable. To elucidate this and provide confidence in the model output, it was suggested that a series of case studies could be performed on the different models and their effects on the various outputs investigated.
62. The development of new BMD software was discussed. The Committee noted that these new pieces of software had their own capabilities, which allowed them to be tailored for specific scenarios and tasks. However, there was some concern this might lead to further divergence rather than convergence of BMD approaches. Members highlighted the recent development of Bayesian BMD software as part of EFSA’s modelling suite. Members raised concerns around how the Bayesian BMD modelling is used in practice, specifically with the selection of priors and whether this would introduce subjectivity into the analysis. The Committee also discussed some uncertainties expressed in the literature about the EPA Bayesian modelling software.
63. It was asked whether it was known how many datasets (such as from OECD guideline studies) were, in practice, suitable for modelling, and by extension, how many data sets were not and were consequently omitted from analysis. It was suggested that selecting only the subset of the total number of available data sets that were suitable for modelling using the BMD approach may risk biasing outcomes.
64. Member discussed toxicological study design and the potential limitations of OECD guidelines in this regard. It was agreed that it was important that experiments should aim at generating biologically relevant data and not just statistically relevant data. The design of toxicology studies should also be considered in light of the developments in NAMs.
65. There was general agreement that BMD modelling should be viewed as a step towards a larger goal of more realistic, toxicodynamic systems approaches. This may become more feasible with the further development of models based on in silico and in vitro approaches.
66. The potential impact of BMD modelling on FSA resources was also briefly discussed. If new and potentially varied methodologies were implemented and expected to be used in assessments, how much capacity did FSA colleagues have to use the various BMD approaches. The impact of BMD modelling should also be taken into consideration when updating COT guidelines.
Item 7: TOX/2024/04 Advancing in silico methods for chemical risk assessment – update from the FSA fellow.
67. No interests were declared.
68. The FSA and COT have been considering New Approach Methodologies (NAMs) to understand the best scientific methodologies available for use in the risk assessment of chemicals, and to consider how these can be incorporated and accepted in a regulatory context.
69. In 2021, the FSA started funding a computational toxicology postdoctoral Fellow at the University of Birmingham and a PhD Student at King’s College London as part of their Interdisciplinary Doctoral Program (LIDo-TOX AI).
70. The fellow and PhD student have been working alongside other Government Departments to understand how NAMs will improve indicative levels of safety in chemical risk assessment.
71. In addition, these new partnerships have helped with networking, research collaboration, training opportunities and other activities. The Fellowship and studentship also complement the work set out in the COT FSA UK Roadmap towards using new approach methodologies in chemical risk assessment.
72. The fellow had prepared a yearly review and presented his progress to date to COT Members.
73. A workflow to generate a human-health based point of departure for risk assessment utilising multiple NAM approaches was presented. The NAMs used included: NAMs in relation to the type of testing platform using in vitro hepatic microtissues; NAMs in relation to the type of data/read-outs using transcriptomics data, which provide an untargeted measurement of extensive gene expression; NAMs in relation to data analysis using PBPK modelling.
74. To date, two case studies had been conducted. The first case study focused on the plasticiser di-2-ethylhexyl terephthalate (DEHTP). The main objective was to derive a health-based guidance value. Concentration-response data obtained from ToxCast, via the Chemicals Dashboard (US EPA), were used. The second case study had as the chemical of choice, a perfluorinated substance, perfluorooctanoic acid (PFOA). The main objective was to integrate an in-silico workflow with transcriptomics data to derive a health-based guidance value for PFOA that could be compared with that previously published by EFSA. Transcriptomics data published by Health Canada (Rowen-Carrol et al., 2021) from in vitro exposures of human liver microtissues to PFOA were used as a data source.
75. The FSA Fellow also presented some preliminary work on the third case study, which is on tropane alkaloids.
76. The COT Members were impressed with the progress to date and gave feedback to the postdoctoral fellow.
Item 8: Draft 2023 COT Annual Report (TOX/2024/05)
77. It was agreed that this item would be postponed to the March COT meeting due to time constraints.
Item 9: Annual COT Horizon Scanning (TOX/2024/06)
78. Paper TOX/2024/06 introduced the annual COT horizon scanning session, reviewing all work anticipated for the year; this included both new and ongoing topics.
79. It was noted that COM and COC had held a day of horizon scanning where they focussed on the methodology of horizon scanning, which might be of interest. It was also suggested that the last few years of horizon scanning discussions should be reviewed as to whether any topics remained outstanding or had increased in priority. In addition, the topic for the annual workshop had not yet been finalised and Members were asked for suggestions for suitable topics.
80. Members proposed potential workshop or single paper topics including potential regulatory changes on chemicals in the environment, the microbiome, including the effects of chemicals other than antimicrobials, the presence of novel contaminants in the oceans that could enter the food chain, vegan/vegetarian foods and their ultra-processed replacements (where these were in the COT remit), non-EATS (estrogen, androgen, thyroid and steroidogenesis) mechanisms for endocrine disruption, and obesogens.
81. Members were reminded that they could send any suggestions for subjects that could be considered to the Secretariat at any time.
82. Members were content with the current skills balance of the Committee.
Item 10: Update on actions taken subsequent to the Committee’s advice (TOX/2024/07)
83. Paper TOX/2024/07 provided Members with an update on how their advice has been used over the year. It was circulated largely for information and Members were asked to send in any questions or comments to the Secretariat.
Item 11: Fourth draft interim position statement on bisphenol A (TOX/2024/08)
84. Dr David Gott of the Secretariat was a Member of the EFSA CEP panel and BPA Working Group. He was able to answer questions and provide clarification but could not take part in the discussion. Professor Matthew Wright is an EFSA panel Member but was not involved in the BPA evaluation and was able to take part. Dr Stella Cochrane and Dr Natalie Thatcher declared non-personal specific interests, as their employers would have an interest in the use of BPA in packaging. No other interests were declared.
85. In April 2023, the EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) established a new tolerable daily intake (TDI) of 0.2 ng BPA/kg bw per day. Following their diverging view from EFSA the Bundesinstitut fuer Risikobewertung (BfR) published a full assessment of BPA in 2023, establishing a TDI of 0.2 µg/kg bw per day (equivalent to 200 ng/kg bw per day).
86. Following the COT’s discussions of the EFSA opinion, a draft interim position statement was presented to the Committee in May and following discussion, again at the September and October 2023 meetings. Following the publication and discussions of the BfR assessment at the December meeting the draft interim statement was updated to reflect these, and to include the Committee’s consideration of the BfR assessment.
87. FSA policy colleagues have advised that the need for a UK TDI remains for risk management purposes. Given the extensive work and timelines of a full review of BPA and in light of the recent assessment by the BfR, with a critical endpoint previously used by the COT, the question arose whether the Committee would be willing, in principle, to fully adopt the BfR TDI and if so, what further information would they require to do so. An amended draft interim position statement was circulated to Members shortly before the meeting with suggested changes to reflect this possibility.
88. The Committee agreed that it was feasible to consider adopting assessments and health-based guidance values (HBGVs) established by other authorities, rather than undertaking a (full) review themselves, where Members agreed with the approach and the scientific assessment of the database.
89. In the case of BPA, the Committee had previously assessed the EFSA opinion, the diverging opinions by the BfR and the European Medical Agency (EMA) and then the full assessment by the BfR. While Members had significant reservations regarding the approach taken by EFSA and their subsequent derivation of the HBGV, Members agreed with the BfR approach and considered it, while conservative, scientifically robust and more reasonable. The Committee therefore agreed to adopt the BfR TDI.
90. However, Members noted that while they were content with the current draft interim statement subject to minor amendments, they would require a detailed supplementary statement to be published at a later date. This statement should provide a more detailed summary of how the Committee reached its conclusion to adapt the BfR TDI, summarising Members concerns regarding the EFSA TDI and focusing on the Committee’s review of the studies and the approaches taken by the BfR, including the modelling and studies selected to establish the HBGV. The supplementary statement should clearly and transparently demonstrate how the Committee reached its conclusion to adopt the BfR TDI.
91. Member suggested that it would be worth performing a short literature search from the BfR cut-off to ensure no additional relevant information had been published since the BfR assessment that would require consideration.
92. The Committee reiterated that establishing a UK TDI was only part of the assessment of BPA. As EFSA and the BfR had noted in their respective assessments, the current level of BPA exposure in consumers was unknown, as the exposure data dated from 2015. Members agreed that to fully assess whether there was a risk to the UK population from BPA, an up-to-date exposure assessment using UK data was required.
Item 12: Update on the work of other FSA Scientific Advisory Committees - for information (TOX/2024/09)
93. This paper was circulated for information. Members were asked to send in any questions or comments on the document to the Secretariat.
Item 13: Any other business
94. There was no other business.
Date of next meeting
95. The next meeting of the Committee will be at 10:00 on the 26th of March 2024 at Clive House, London and via Microsoft Teams.