Transparency data

Draft minutes 19th May 2026 COT meeting

Published 6 July 2026

Minutes of the meeting of the Committee on Toxicity (COT) at 10:00am, Tuesday 19th May 2026 at Broadway House and via Microsoft Teams.

Present

Chair:	Reverend Professor Lesley Stanley
Deputy Chair:	Professor Shirley Price
COT Member:	Professor Gary Hutchison  Professor Thorhallur Ingi Halldórsson Dr David Lovell Dr Cheryl Scudamore Professor Mireille Toledano (From Item 4) Dr Steven Enoch Dr Simon Wilkinson Professor Philippe Wilson Professor Peter Barlow Dr Chris Morris Dr Meera Cush (Until Item 8) Mr Gordon Burton (From Item 4) Dr Andreas Kolb  Dr Alison Yeates (Until Item 9) Mr Nick Richardson Dr Bryony Ross Dr Michelle Bellingham Professor Martin Clift  Professor Mohammad Qasim Chaudhry Dr Tarek Abdelghany   Dr Antonio Peña Fernández (From Item 4)
Scientific Advisory Committee on Nutrition (SACN) Liaison:	Professor Susan Fairweather-Tait
Science Council Liaison:	Ms Jacqueline Healing (Until Item 7)
Secretariat Food Standards Agency (FSA):	Ms Cath Mulholland–FSA Scientific Secretary Ms Claire Potter Mr Barry Maycock Dr Olivia Osborne Ms Sabrina Thomas Dr Gail Drummond Ms Frederique Uy Ms Jocelyn Frimpong-Manso Ms Josephine Walker Ms Sophy Orphanos Dr Gaetana Spedalieri Dr Katie Schulz Ms Katie Wetherall Mr James Metcalfe Ms Polly Bevan Ms Alba Ureña Rusillo Mr Liam Blacklock Ms Chara Tsoulli Ms Yoana Petrova Mr Thomas Hornsby
Secretariat: UK Health Security Agency (UKHSA):	Ms Britta Gadeberg (Until Item 5) Ms Sanyukta Pallavi
UKHSA Contractor – Bibra:	Mr Chris Waine
Environment Agency (EA) Assessor:	Mr Ian Martin (From Item 4)
Health Improvement Global and Public Health Group Department of Health and Social Care (DHSC) official:	Ms Neeve Pearce (From Item 7)
Department for Business and Trade	Ms Frances Hill (From 11:00)
Invited Experts: (From Item 5 onwards)	Dr Alex Kalian - kings College London Dr Arthur de Carvalho e Silva - University of Birmingham
FSA Official:	Dr Andy Axon Ms Louise Darby Ms Priscilla Wanjiru
Food Standards Scotland (FSS) officials:	Ms Krystle Boss (Item 4 and Items 7-10) Mr Lorcan Browne (From Item 4)
Health and Safety Executive (HSE) officials:	Ms Charlotte Thorpe (From Item 4)
External Observer: (From Item 6 onwards)	Dr Stephen Ruckman – Principal Consultant, Sagentia Regulatory Dr Mukesh Summan – Global Director of Toxicology, AHN, Kerry Group Ms Michaela Kaler KlatIkova – Independent Consultant

Contents

Item	Title	Paragraph(s)
1	Apologies for absence	4
2	Draft minutes and reserved minutes of the meeting held on the Tuesday 31st March 2026 (TOX/MIN/2026/02)	5

3	Matters arising - JEG updates. - Subgroup and working group updates.	6-11
4	Second draft statement on ashwagandha (Reserved) (TOX/2026/17)	12-13
5	AI in Chemical Risk Assessment: SWOT Analysis (Reserved) (TOX/2026/18)	14-15
6	Annual updates from the PhD student and the FSA Fellow (TOX/2026/19)	16 – 24
7	Calcidiol in the maternal diet. - Draft position statement on calcidiol in the maternal diet (TOX/2026/20) - Draft Supplementary report on the effects of calcidiol in the maternal diet (TOX/2026/21)	25 – 37
8	Presentation on the work of the Partnership for the Assessment of the Risks from Chemicals (PARC)	38
9	Horizon scanning	39 – 41
10	Update on the work of other FSA Scientific Advisory Committees - for information (TOX/2026/22)	42
11	Any other business	43

Announcements

1. The Chair welcomed Members and other attendees to the meeting.

2. Dr Stephen Ruckman, Principal Consultant from Sagentia Regulatory, Dr Mukesh Summan, Global Director of Toxicology, AHN, Kerry Group and Ms Michaela Kaler KlatIkova, Independent Consultant were present as external consultants from Item 6 onwards.

Interests

3. 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

4. Apologies were received from COT Members Ms Christel Wake and Dr Arvind Veiraiah. Apologies were received from FSA colleagues Dr Barbara Doerr, Dr Emily Hudson, Dr Alex Cooper and Dr Ovnair Sepai.

Item 2: Draft minutes and reserved minutes of the Tuesday 31st March 2026 (TOX/MIN/2026/02)

5. The Committee reviewed the draft minutes, and reserved minutes of the meeting held on the 31st of March 2026.   The minutes were accepted as an accurate record.

Item 3: Matters arising

Joint Expert Group (JEG) updates

6. The Committee were provided with an update on the work of the JEGs.

Subgroups and Working Groups

Per- and Polyfluoroalkyl Substances (PFAS) working group

7. At the recent meeting of the Scientific Advisory Committee (SAC) Chairs, the topic of Per- and Polyfluoroalkyl Substances (PFAS) was discussed and the increasing media interest on the topic noted. COT Members requested timelines and milestones for the work of the PFAS Working Group to be presented to the COT at a future meeting.

COT Guidance Working Group

8.  No further updates were available on the work of the COT Guidance Working Group. Updates would be provided at the next COT meeting.

COT website

9.  COT Members were informed that the new COT website would be live at the end of June, however the Secretariat noted there would be a backlog of documents to be published.

Submissions to EFSA

10. At the March COT meeting, COT Members commented on a number of draft EFSA opinions including berberine, hydroxycitric acid, and, default values and uncertainty factors. The Secretariat confirmed that all Members’ comments on these draft EFSA opinions had been submitted to the respective consultations.

Annual workshop

11.  The Secretariat invited COT Members to suggest topics or speakers for the next COT Workshop; a number of suggestions were made and Members were asked to send any additional suggestions to the Secretariat. It was noted that the venue was yet to be confirmed.

Item 4: Second draft statement on ashwagandha (Reserved) (TOX/2026/17)

12. No interests were declared.

13. This item is currently being treated as reserved because it contains commercially confidential information. 

Item 5: AI in Chemical Risk Assessment: SWOT Analysis (Reserved) (TOX/2026/18)

14. No interests were declared.

15. This item is currently being treated as reserved because it contains unpublished information.

Item 6: Annual updates from the PhD student and the FSA Fellow (TOX/2026/19)

16.  No interests were declared.

17.  The FSA and COT have been reviewing New Approach Methodologies (NAMs) to scope out the best scientific methods available for use in the risk assessment of chemicals in foods and the environment and to understand how these can be incorporated and accepted within a regulatory context.

18.  In 2021, the FSA provided funding to support a three-year PhD Studentship at King’s College, London for Alexander Kalian (London Interdisciplinary Doctoral Program-LIDo-TOX AI) a 4-year computational toxicology postdoctoral fellowship at the University of Birmingham for Dr Arthur de Carvalho e Silva.

19.  Dr Kalian has now finished his PhD. In September 2025.  Dr de Carvalho e Silva transitioned to a 3-year follow-up fellowship on utilising in silico, in vitro and ‘omics” NAMS for priority-setting and safety assessment of tropane alkaloids and other plant toxins as potential food contaminants. At this meeting, both presented their progress to date to COT Members.

20.  Dr Kalian provided an overview of his postgraduate research. This involved the development of novel Quantitative Structure-Activity Relationship (QSAR) models using innovative Artificial Intelligence (AI) approaches. The aim of these models is to reliably predict the toxicological properties of molecules found in food and drink over a diverse range of endpoints of interest. Summaries of several thesis chapters were presented by Dr. Kalian, including: QSAR Modelling of Mutagenicity, Case Study on SARMs, Exploring Graph Neural Network (GNN) Architectures, along with general discussion, conclusions and future outlook. Dr. Kalian also presented other work, which was not included in his thesis, including: a case study on brominated flame retardants, systematic approaches to chemical space, generative AI experiments, and predicting molecular initiating events.

21.  Dr de Carvalho e Silva provided an overview of both fellowships and described how the aims for both were to scope the FSA’s problem space in chemical risk assessment, provide training on the use of computational NAMS, develop confidence in new hazard assessment workflow, and develop and deliver case studies. The summary of the first fellowship discussed the main case study which used perfluorooctanoic acid (PFOA) as the chemical of interest. It was subsequently published as a paper setting out a novel method to derive a human safety limit for PFOA by gene expression profiling and modelling.

22.  The second fellowship focuses more on plant alkaloids of three large classes: tropane alkaloids, pyrrolizidine alkaloids, and glycoalkaloids. The first objective of this case study is to support the UK FSA’s policy need to determine which tropane alkaloids are the most potent (neuro)toxicants to prioritise specific substances and inform decisions on the UK’s monitoring of these alkaloids in foods. The second objective is to derive a Health Based Guidance Value (HBGV) for human exposure to the most potent substance within the class of tropane alkaloids. This will use physiologically-based pharmacokinetic (PBPK) modelling and quantitative in vitro to in vivo extrapolation (QIVIVE). Current work includes the Tier 3 planning of the ‘Omics studies and Tier 4 PBPK modelling. Tiers 1 and 2 are currently being written up for publishing. Consideration of molecular docking would be the next step, as well as beginning the PBPK modelling.

23. COT Members appreciated the work carried out and were impressed by the varied outputs. Members also congratulated Dr Kalian on the award of his PhD and Dr de Carvalho e Silva on the completion of his first fellowship.

24.  COT Members thanked both presenters and wished them well in the next steps of their research.

Item 7: Draft position statement on calcidiol in the maternal diet (TOX/2026/20) and Draft Supplementary report on the effects of calcidiol in the maternal diet (TOX/2026/21)

25. Professor Peter Barlow declared a direct commercial interest. He is a named inventor on a patent covering a composition which may include Vitamin D for therapeutic use, which could be subject to future commercialisation by his employer through the Medicines and Healthcare products Regulatory Agency (MHRA). This was considered a specific, personal interest and it was agreed that he should not contribute to the discussion of this item. Dr Meera Cush and Rev Prof Lesley A. Stanley declared interests as they have both been involved in preparing CADs published by the Advisory Committee on Novel Foods and Processes (ACNFP) panel. However, it was agreed that they were able to contribute to discussions. No other interests were declared.

26.  In 2019, the Scientific Advisory Committee on Nutrition (SACN) agreed to conduct a risk assessment on nutrition and maternal health, focusing on maternal outcomes during pregnancy, childbirth and up to 24 months after delivery. SACN requested the COT review the risks of calcidiol supplementation in the maternal diet following publication of the 2022 Statement on the potential effects of excess vitamin D intake during preconception, pregnancy and lactation. This was on the basis that calcidiol is a more bioavailable form of vitamin D2 and D3 and its availability on the market is increasing.

27.  In May 2025 the Committee was presented with a discussion paper on calcidiol supplementation during preconception, pregnancy and lactation (TOX/2025/21). At that meeting, the COT concluded that there was no substantive difference between EFSA and the Advisory Committee on Novel Foods and Processes (ACNFP) advice, with both identifying a safe intake level of 10 µg/day, and ACNFP additionally proposing a conservative upper intake level of 40 µg/day to account for potential misuse. Members agreed that estimated intakes did not reach levels of concern and were therefore not considered a risk. However, a number of limitations were noted, including that women during preconception, pregnancy and lactation were underrepresented in the evidence base. Further clarification and revisions for inclusion of these underrepresented groups in the statement were requested.

28. In relation to the exposure assessment, Members had asked whether the assessment should include all forms of vitamin D to better reflect total intake. Following discussion with SACN, it was agreed that the COT should assess the risks of calcidiol when used as a supplement, rather than vitamin D exposure more broadly or calcidiol as a naturally-occurring metabolite of vitamin D.

29. COT Members had also asked whether exposure scenarios could consider NHS dietary advice for pregnant women. While this suggestion was considered, it was not taken forward because many of the NHS recommendations – for example, cooking practices, portion limits or product-specific distinctions – are not reflected in the available NDNS data. Furthermore, altering food groups could introduce bias and uncertainty without significantly affecting exposure estimates, particularly given that supplements rather than the diet are responsible for the majority of the exposure to calcidiol. Any such refinements were considered unlikely to change the overall conclusions.

30.  Following an auxiliary meeting between the COT Chair, Secretariat and rapporteurs, it was agreed that a position statement, supported by a supplementary report, should be developed. These documents would summarise the Committee’s conclusions and provide a clear account of the evidence base and key data gaps. These papers are presented as TOX/2026/20 and TOX/2026/21.

31.  The draft position statement sets out the Committee’s overall conclusions on calcidiol and vitamin D in the maternal diet, drawing on previous COT outputs and the 2024 ACNFP assessment. It is intended to provide a concise, standalone summary of the Committee’s current position on the effects of calcidiol and vitamin D, including key considerations on risk, exposure and data gaps.

32. The supplementary report supports the position statement by setting out the underlying evidence on calcidiol. It provides a more detailed assessment of toxicology, exposure and risk characterisation, including human and animal data, derivation of health-based guidance values, and a summary of uncertainties.

33. COT Members were asked to consider both documents together. In particular, views were sought on whether the position statement accurately reflected the Committee’s conclusions, and whether the supplementary report provided sufficient supporting detail.

34. Regarding paragraph 19 of the supplementary report, it was noted that the study in a group of 18 females (7 premenopausal and 11 postmenopausal: age range 24-72 years) (Russo, et al, 2011; Calcified tissue international, 89, pp.252-257) may include individuals with lower starting levels of vitamin D. Therefore, the lack of harmful effects seen in this group may not apply to people with normal vitamin D levels, and that there was limited data for these populations.

35. COT Members discussed how polymorphic variation in the cytochrome P450 gene CYP24A1 might affect individuals’ responses to calcidiol supplementation. It was noted that individuals with two copies of a mutation (homozygotes) may be at greater risk of harmful effects, although such cases were rare. Individuals with one copy (heterozygotes) were more common; it is unclear whether they were also at increased risk of adverse effects from vitamin D. It was suggested that the literature on this topic be reviewed to understand the available evidence; a Member offered to assist with this.

36.  COT Members were content with the structure and quality of both the position statement and the supplementary report.  COT Members made a number of editorial comments and noted that they would send any further editorial suggestions to the Secretariat after the meeting.

37. Subject to minor corrections and further review on the CYP24A1 topic, COT Members agreed that both documents could be finalised by Chair’s action.

Item 8: Presentation on the work of the Partnership for the Assessment of the Risks from Chemicals (PARC)

38. This item was deferred to a future meeting due to a change in the presenter’s availability.

Item 9: Horizon scanning

39. Following the discussion at the March meeting, two additional tables had been introduced to the draft horizon scanning document: one to capture emerging issues and another to provide links to other regulatory authorities and risk assessment bodies.

40.  Due to time constraints, COT Members were invited to provide any initial comments on the revised format during the meeting and to send any further thoughts to the Secretariat following the meeting. No comments were received on the proposed revision during the meeting.

41.  It was noted that horizon scanning discussions could be expanded where necessary to allow for more detailed consideration of specific issues. Horizon scanning was an ongoing process and COT Members were encouraged to submit any future suggestions or additions via the COT mailbox.

Item 10: Update on the work of other FSA Scientific Advisory Committees - for information (TOX/2026/22)

42.  This paper was largely for information, but COT Members were invited to contact the Secretariat if they had any questions.

Item 11: Any other business

43.  There was no other business.

Date of next meeting

44.  The next meeting of the Committee will be at 10:00 on Tuesday 14th July 2026 via Microsoft Teams.

Secretariat

May 2026