扒哥吃瓜

Present

Chair:	Reverend Professor Lesley Stanley
Deputy Chair:	Professor Shirley Price
COT Member:	Professor Gary Hutchison聽(Item 5 onwards) Professor Thorhallur Ingi Halld贸rsson Dr David Lovell Dr Cheryl Scudamore Dr Steven Enoch Dr Simon Wilkinson Professor Philippe Wilson Professor Peter Barlow (Item 5 onwards) Dr Meera Cush聽 Mr Gordon Burton Dr Andreas Kolb Dr Alison Yeates Mr Nick Richardson Dr Bryony Ross Dr Michelle Bellingham Professor Martin Clift Dr Aravindan Veiraiah Professor Mohammad Qasim Chaudhry Dr Tarek Abdelghany聽 Ms Christel Wake Dr Antonio Pe帽a Fern谩ndez
Scientific Advisory Committee on Nutrition (SACN) Liaison:	Dr Susan Fairweather-Tait
Science Council Liaison:	Ms Jacqueline Healing
Secretariat Food Standards Agency (FSA):	Ms Cath Mulholland鈥� FSA Scientific Secretary Ms Claire Potter Dr Olivia Osborne Ms Sabrina Thomas Dr Gail Drummond Ms Sophy Orphanos Dr Gaetana Spedalieri Dr Katie Schulz Ms Katie Wetherall Mr James Metcalfe Ms Polly Bevan Ms Alba Ure帽a Rusillo Dr Barbara Doerr Dr Alex Cooper Mr Liam Blacklock Ms Chara Tsoulli Ms Yoana Petrova Dr Emily Hudson Mr Thomas Hornsby
Secretariat: UK Health Security Agency (UKHSA):	Ms Britta Gadeberg Ms Sanyukta Pallavi
UKHSA Contractor 鈥撀燘ibra:	Mr Richard Young
UK Health Security Agency (UKHSA) Assessor:	Dr Ovnair聽Sepai
UKHSA Official:	Ms Kerry Foxall (Item 5) Mr Stephen Robjohns (Item 8)
Environment Agency (EA) Assessor:	Mr Ian Martin
Health and Safety Executive (HSE) Assessor:	Ms聽Minako Allen
HSE Official:	Ms聽Beth Glennie聽 Ms Charlotte Thorpe
Health Improvement Global and Public Health Group Department of Health and Social Care (DHSC) Official:	Ms Neeve Pearce
Department鈥痜or鈥疊usiness鈥痑nd Trade (DBT) Assessor:	Ms Hannah Jones Ms Frances Hill
Medicines and Healthcare Products Regulatory Agency (MHRA) Assessor:	Ms Akosua Adjei
MHRA Official:	Ms Ruth Lloyd Williams聽(Item 8)
FSA Chief Scientific Advisor:	Professor Ian Young聽(until 11:30)
FSA Official:	Dr聽Andy Axon Ms Clare Mccartney-Collard (Item 6 onwards) Dr Tahmina Khan
Food Standards Scotland (FSS) Official:	Mr Lorcan Browne
External Observer item 6 onwards):	Dr Helen Crawley 鈥� Director, The Lizzie Vann Foundation Dr Stephen Ruckman 鈥� Principal Consultant,聽Sagentia聽Regulatory Dr聽Mukesh Summan 鈥� Global Director of Toxicology, AHN, Kerry Group Professor Erik鈥疢illstone 鈥� Science Policy Research Unit, University of Sussex

Contents

Item	Title	Paragraph(s)
1	Apologies for absence	5
2	Draft minutes and reserved minutes of the Tuesday 3rd February 2026 (TOX/MIN/2026/01)	6
3	Matters arising: JEG Updates, Subgroups, Working groups, Horizon scanning 鈥� example of new format (TOX/2026/07)	7 鈥� 26
4	AI State of the Science (Reserved) (TOX/2026/08)	27-28
5	Review of guidance on irritant sprays and their formulations (Reserved) (TOX/2026/09)	29-30
6	Maternal diet Annex (TOX/2026/10)	31 鈥� 40
7	Echinacea in the maternal diet - second draft statement (TOX/2026/11)	41鈥� 49
8	Potential health risks from fluoride at UK exposure levels 鈥� Introductory paper (TOX/2026/12)	50 鈥� 58
9	Draft guidance on default values and uncertainty factors to be used by the EFSA Scientific Committee, Scientific Panels and Units in the absence of actual measured data (TOX/2026/13)	59 鈥� 71
10	Draft EFSA Scientific Opinion on the safety of plant preparations containing berberine (TOX/2026/14)	72 - 81
11	Draft EFSA Scientific Opinion on the safety of hydroxycitric acid and plant preparations containing hydroxycitric acid (TOX/2026/15)	82 鈥� 93
12	Update on the work of other FSA Scientific Advisory Committees for information (TOX/2026/16)	94
13	Any other business	95

Announcements

1. Professor Ian Young, the new FSA Chief Scientific Advisor, attended the meeting and introduced himself to the Committee. COT Members welcomed Professor Young and looked forward to working with him.

2. The Chair welcomed Dr Liam Blacklock as a new member of the COT Secretariat. COT Members were also informed that Dr Abigail Smith of the Secretariat has moved to a new position within the FSA.

3. Dr Helen Crawley of the Lizzie Vann Foundation, Dr Stephen Ruckman of Sagentia Regulatory, Dr Mukesh Summan of Kerry Group and Professor Erik鈥疢illstone of the Science Policy Research Unit, University of Sussex were present as external observers for the unreserved part of the meeting.

Interests

4.聽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

5.聽Apologies were received from COT Member Professor Mireille Toledano, FCMJEG colleague Dr Emma Bradley and Mr Barry Maycock of the Secretariat.

Item 2: Draft minutes and reserved minutes of the Tuesday 3rd February 2026 (TOX/MIN/2026/01)

6.聽The Committee reviewed the draft minutes of the meeting held on the 3rd of February 2026.聽聽 The minutes were accepted as an accurate record.

Post meeting note: As a result of an administrative oversight, the reserved minutes were not reviewed at the March COT meeting but were subsequently reviewed and accepted by correspondence.

Item 3: Matters arising

Joint Expert Group (JEG) updates

7.聽The Committee were asked to note that there has been only one meeting of the Additives and Enzymes JEG (AEJEG) since the last COT meeting which was held on the 12th of February 2026.聽聽 The Food Contact Materials JEG (FCMJEG) had not met since the previous COT meeting. COT Members were provided with an update on the timetable of future JEG meetings.

8.听COT Members requested that formal thanks be recorded to all members of AEJEG and FCMJEG for their considerable contributions, and also expressed appreciation to the Secretariat, and all JEG members for their sustained commitment.

Subgroups and Working Groups

Per- and Polyfluoroalkyl Substances (PFAS) working group

9.听罢丑别 PFAS Working Group (WG) reported that Bibra continues to collate the reproductive and developmental toxicity papers and the next WG meeting planned for later in the year.

COT Guidance Working Group

10.聽The Guidance Working Group met in March and continued its work on developing a comprehensive guidance document. WG Members had discussed the purpose, scope and structure of COT guidance, including ways of working, transparency, intended audiences and how best to integrate input from other Scientific Advisory Committees (SACs) such as the Committee on Mutagenicity of Chemicals in Food, Consumer Products and the Environment (COM) and the Committee on Carcinogenicity of Chemicals in Food, Consumer Products and the Environment (COC). The WG also considered how to incorporate emerging technologies, including New Approach Methodologies (NAMs), Quantitative Structure-Activity Relationship (QSAR) approaches, benchmark dose modelling (BMD) and artificial intelligence, as well as guidance needs for specific subject areas such as polymers, particles and exposure routes.

11.听罢丑别 WG minutes would be circulated to COT Members and a shorter public鈥慺acing version prepared for publication. A more detailed outline of the guidance document was expected by late summer.

Publications

12.聽Members were informed that the COT website would be migrating to 扒哥吃瓜 later in the year. The new website would look different to the current website and would be consistent with the COC and COM websites.

13.听罢丑别 COT 鈥淏enchmark Dose Modelling report in a UK Chemical Risk Assessment framework 鈥� Science and special topics report鈥� has now been published. The Secretariat has been asked to present this publication at the upcoming Health and Environmental Sciences Institute (HESI) workshop on BMD modelling, thus highlighting the Committee鈥檚 work on an international stage.

14.聽The statement on the assessment of the mycotoxins T2 and HT2 has also been published and the Chair thanked Members and the Secretariat for their efforts.

15.聽It was noted that the British Toxicology Society (BTS) would be interested in signposting COT publications to their audience as it is keen to provide statements relating to issues in toxicology. The BTS would be pleased to promote COT publications through the monthly NewsFeed and also as a link on the BTS Website. It was suggested that short summaries of relevant COT published papers could be provided for inclusion on the BTS website, along with links to public statements, and COT Members agreed that the Deputy Chair should draft text for the Secretariat to review.

Horizon scanning 鈥� example of new format (TOX/2026/07)

16.聽No interests were declared.

17.聽At the February meeting, COT Members had agreed to trial a rolling approach to horizon scanning, broadly following the model currently used by the COC. The aim would be to provide brief updates at each meeting, supplemented by an in depth annual discussion.

18.听A draft horizon scanning table was presented for review. COT Members were broadly supportive of the proposed structure but noted that the document would evolve over time as new issues emerged and priorities shifted. COT Members considered that some entries required clearer separation between the 鈥渢opic鈥� and 鈥渃omment鈥� columns. The Secretariat agreed to revise the table based on the feedback.

19.听COT Members discussed the mechanisms for feeding topics into the horizon scanning process. It was agreed that if COT Members identified relevant items, these could be submitted via the COT inbox. Options for capturing links to the work of other advisory bodies were also discussed, such as a column indicating where topics fell under the remit of other Committees. It was, however, noted that some information was already captured in the regular SAC update paper.

20.聽There was agreement on the importance of tracking how topics moved over time, for example, items evolving from watching briefs to areas for progression or vice versa, and topics being revisited when new evidence became available.

21.听COT Members also suggested including a section for emerging issues where Committee responsibility may be unclear, such as injectable peptides. These could potentially be listed under 鈥渢opics not progressed.鈥�

22.聽The possible implications of the potential Sanitary and Phytosanitary (SPS) agreement were discussed. COT Members noted that there were some uncertainties around the Committee鈥檚 future role, though UK specific assessments such as ongoing work on the maternal diet were expected to remain a priority. It was agreed that the SPS issue could not be meaningfully reflected in the horizon scanning table at this time.

23.聽The degree to which the horizon scanning document should be made publicly accessible was discussed. COT Members recognised the potential benefits, including increased transparency and highlighting coordination across the SACs; lay explanations could also be added to priority items. However, concerns were raised regarding the risk of creating external expectations that might not be met. Overall Members preferred to keep the document as an internal working tool, with high level updates being shared publicly via the minutes. However, further input, particularly from lay Members, would be sought before a final approach was agreed.

24.聽While supportive of including additional information, Members acknowledged that significantly expanding the table would increase the Secretariat鈥檚 workload.聽 It was agreed that horizon scanning would continue as a standing agenda item, with updates captured, refined, and incorporated into the evolving document.

Phytoestrogens

25.听COT Members were reminded that one of the planned topics for consideration in the maternal diet work was phytoestrogens. Given the complexity of the assessment due to the number of potential compounds involved, COT Members discussed potential approaches to the structuring of the literature search. A Member offered to help optimise the search terms for this exercise.

COT workshop

26.聽A number of possible options for the topic of the annual COT workshop were presented to COT Members. After some discussion, it was agreed that the workshop would cover weight of evidence and context of use.

Item 4: AI State of the Science (Reserved) (TOX/2026/08)

27.聽No interests were declared.

28.听This item is currently being treated as reserved as it is being finalised ahead of publication.

Item 5: Review of guidance on irritant sprays and their formulations (Reserved) (TOX/2026/09)

29.聽No interests were declared.

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

Item 6: Maternal diet Annex (TOX/2026/10)

31.聽No interests were declared.

32.聽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 agreed that, where appropriate, other expert committees would be consulted and asked to complete relevant risk assessments. In 2020, a scoping paper was presented to the COT to define the scope of the work on this project from a toxicological safety perspective and request their input on the selection of candidate chemicals or chemical classes that could be added or removed.

33.聽In December 2024, the COT requested clarification on the scope of SACN鈥檚 nutrition and maternal health project and recommended preparing an overarching Annex to define the reproductive and developmental life stages relevant to the project, identify the endpoints for assessment, and establish the list of chemicals of interest. This Annex, incorporating initial COT discussions, was presented to the Committee in December 2025.听聽 On review, the COT advised that the schematic describing reproductive and developmental life stages would be clearer if presented in a linear rather than circular format, better reflecting the structure and scope of the SACN project. The schematic had therefore been revised to a linear 鈥渕aternal life history stages鈥� format, as recommended by COT Members, to emphasise the maternal centred focus of the assessment.

34.聽The Committee also discussed the endpoints to be assessed within the maternal health project and sought clarification on whether these should be limited to outcomes secondary to maternal toxicity or also include effects occurring via maternal exposure. Following discussions between the COT Secretariat and the SACN Secretariat, the endpoints have now been confirmed and grouped into pregnancy related outcomes and broader maternal health outcomes. In line with suggestions from COT Members, placental health has been added as a pregnancy related outcome.

35.听SACN has further confirmed that the work should focus on maternal outcomes arising during pregnancy, childbirth and up to 24 months postpartum. While the 24鈥憁onth period applies specifically to maternal outcomes, neonatal effects may be relevant in some cases. Effects on offspring mediated through lactation were out of scope, as these had already been addressed in SACN鈥檚 previous work on the infant diet; however, effects on lactation itself remain within scope.

36.聽The second draft of the Annex outlining the scope of the SACN maternal health and nutrition project was presented in the paper TOX/2026/10.聽聽 This second draft incorporated revisions to the first draft of the Annex () including the presentation of the revised schematic and clarification of the endpoints considered within the project.

37.听COT Members were content with the revised linear 鈥渕aternal life history stages鈥� schematic and agreed that the scope of the maternal health project was now sufficiently defined for the purpose of the COT鈥檚 work.

38.听However, the Committee requested a clarification on the precise definition of the neonatal period, currently described in the Annex as 鈥渁 few days after birth鈥�. It was agreed that the Secretariat would liaise with the SACN Secretariat to refine this definition. COT Members noted the importance of considering species differences in the timing of developmental events when defining the neonatal window for interpretation of animal studies. A Member agreed to provide a reference slide comparing neonatal developmental stages across species for use as needed, although it was not required for the Annex.

39.聽It was noted that the list of chemicals in the Annex needed some minor updating. The Secretariat would resolve this.

40.聽Members had no further comments on the revised Annex. It was agreed that it could be signed off by Chair鈥檚 action, incorporating the minor amendments noted.

Item 7: Echinacea in the maternal diet - second draft statement (TOX/2026/11)

41.聽No interests were declared.

42.聽As part of the programme of work on the potential risks of components and contaminants in the maternal diet, the COT reviewed a scoping paper on commonly used herbal supplements during pregnancy. Echinacea, marketed for immune support and for the prevention or treatment of cold and flu鈥憀ike symptoms, was among the supplements identified for review.

43.聽The first draft statement (TOX/2025/45) on the effects on echinacea in the maternal diet was presented to the COT in December 2025.听聽 Members were broadly satisfied with the content of the statement, but requested some revisions to the conclusion, overall structure, the table summarising reproductive and developmental studies, and a clarification regarding OECD and GLP compliance of the toxicity studies.聽 A second draft statement incorporating the suggested revisions was presented in TOX/2026/11.聽聽

44.听COT Members鈥� views on the final conclusion were specifically requested, noting that regulatory authorities such as the European Medicines Agency (EMA) and the Medicines & Healthcare products Regulatory Agency (MHRA) advised against the use of medicinal echinacea products during pregnancy or lactation due to insufficient data being available. There was concern that the current wording could be misinterpreted as implying that echinacea supplements were safe during pregnancy, whereas in fact, there were few data available to draw conclusions as to their safety.

45.聽Members noted that medicinal echinacea products undergo regulatory assessment under the Traditional Herbal Registration (THR) whereas food supplements are regulated under general food law. Hence food supplements may not have defined purity or composition specifications and may differ considerably in their composition.聽 COT Members further noted that the manufacturers of food supplements are not required to demonstrate that their products have health benefits. Given the limited data on effects during pregnancy and the uncertainty around product composition, a precautionary approach was recommended.

46.聽It was agreed that the conclusion should accurately reflect the evidence assessed, without giving the impression of endorsing the use of Echinacea-containing supplements during pregnancy. Members advised against consumption of echinacea products during pregnancy unless recommended by an appropriately qualified health professional and emphasised the importance of distinguishing between insufficient data versus evidence of safety, highlighting the importance of avoiding language that could be misinterpreted. It was also noted that the conclusion should be balanced and avoid causing undue concern among women who may have already consumed such supplements.

47.听COT Members proposed restructuring the concluding paragraphs to reflect that no significant cause for concern had been identified based on available data, while clearly outlining the limitations and uncertainties, the very limited data on echinacea use in pregnant women, and precautionary advice regarding supplement use during pregnancy.

48.听It was suggested that standardised wording for herbal supplement assessments within the maternal diet project could be developed to reflect the limited availability of data on supplement use in pregnancy, the lack of robust information for risk assessment and the need for pregnant women to seek advice from a qualified health professional before using supplements.

49.聽Members also suggested that wording should be included early in the statement to clarify that, unless explicitly stated for each study, the studies discussed were not compliant with Good Laboratory Practice (GLP) or conducted according to Organisation for Economic Co-operation and Development (OECD) test guidelines.

50.聽A number of minor editorial comments were also suggested, and COT Members were asked to send anything additional to the Secretariat.聽

51.听COT Members agreed that the statement could be finalised by Chair鈥檚 action.

Item 8: Potential health risks from fluoride at UK exposure levels 鈥� Introductory paper (TOX/2026/12)

52.聽Professor Thorhallur Ingi Halld贸rsson declared that he had chaired the European Food Safety Authority (EFSA) working group on fluoride. This declaration was noted and it was agreed that Professor Halld贸rsson could participate in the discussion of this topic. No other interests were declared.

53.听罢丑别 COT has been requested by a number of Government Departments and Agencies to review toxicity information with respect to fluoride in relation to neurotoxicity, effects on bone and the thyroid, and to consider the potential risks in the context of UK exposure levels through dental products, drinking water, and other exposure sources. The introductory paper presented an overview of the regulatory frameworks covering public exposure to fluoride, the reason for use of fluoride in relation to dental health, the health outcomes associated with fluoride exposure from recent reviews, and the proposed approach to presenting information to the Committee. In addition, the proposed search approach for the toxicity reviews and results of preliminary investigations into the potential search strategy for the fluoridation review were presented to the Committee. This involved an initial assessment of relevant authoritative reviews (e.g., EFSA and the National Toxicology Program (NTP)), followed by preliminary screening of the recent literature.

54.聽The Committee welcomed the introductory paper as a background to the context of fluoride exposure in the UK but noted that beneficial effects are outside the Committee鈥檚 remit.

55.聽This introductory paper noted that the EFSA (2025) review was considered to provide a good basis, as it was recent and comprehensive in terms of the endpoints covered and the chemical, toxicity and species (human and laboratory animal) search terms included. The NTP (2024) review, focusing on neurotoxicity, incorporated a more extensive set of endpoint-specific search terms as well as unique chemical search terms, compared to the EFSA review. The Committee agreed with the proposal to use the EFSA review as a starting point for development of a search strategy, and to include PubMed as the primary data source and the Web of Science as a secondary one. Members also agreed to include the additional search terms utilised by the NTP (for neurotoxicity and chemicals) in the literature update, and to conduct retrospective searches on this basis, to check for potential omissions from the EFSA search. For the thyroid, the possibility of including the additional terms iodine and calcium as part of the endpoint search string, rather than the chemical, was suggested. It was also suggested that it would be useful to check on any new information published in response to the EFSA recommendations.

56.聽It was noted that there were differences between EFSA and ANSES in their views regarding the quality of literature on the effects of fluoride on the rodent thyroid; it was, therefore, considered important for the COT to undertake a robust review on this aspect. The Committee considered a number of aspects to be borne in mind when reviewing the effects on the thyroid, particularly the liver-thyroid axis and rodent-specific effects, consideration of indirect effects in humans with existing liver disease and effects in the parathyroid potentially affecting calcium, which may also in turn affect the brain. The potential for interaction between fluoride and iodide with respect to thyroid effects may link to work being undertaken by SACN in the context of iodine deficiency, which should also be considered.

57.聽The potential for effects in the thyroid has been linked to neurological effects so it was suggested that it would be more appropriate to consider effects on the thyroid and parathyroid in the initial toxicity review, other outcomes being considered subsequently.

58.听Overall, the Committee agreed the proposed search strategy, suggesting that toxicity endpoints should be considered in the following order: effects on the thyroid and/or parathyroid, neurotoxicity, then effects on bone. It was also recommended that exposure across the UK was considered when exposure was reviewed.

Item 9: Draft guidance on default values and uncertainty factors to be used by the EFSA Scientific Committee, Scientific Panels and Units in the absence of actual measured data (TOX/2026/13)

59.聽Professor Thorhallur Ingi Halld贸rsson declared an interest, as he is a Member of the EFSA Scientific Committee. Although the Scientific Committee would be reviewing the guidance, it was not involved in its drafting. This declaration was noted and it was agreed that Professor Halld贸rsson could participate in the discussion of this topic. No other interests were declared.

60.听EFSA has updated its 2012 guidance on the selected default values (DVs) and uncertainty factors (UFs) to be used by the EFSA Scientific Committee, Scientific Panels and Units in the absence of actual measured data. Comments were being sought on the draft guidance.

61.听COT Members agreed that the guidance was clearly structured and found it helpful, particularly in clarifying the distinction between DVs and UFs.

62.听COT Members queried how the aim of standardising the presentation of uncertainty in the guidance would be achieved, given that individual expert judgement plays a key role in the risk assessment process. The importance of setting out a clear and transparent rationale for each UF applied was highlighted, noting that this was where expert judgement was particularly important.

63.聽It was noted that the default UF for novel foods was currently 200; however, the draft guidance refers to a value of 100 to ensure alignment across EFSA Panels and Committees. It was presumed that the Novel Foods Panel applies an additional standard factor of 2 for extrapolation from subchronic to chronic exposure, resulting in an overall UF of 200.聽聽 Members agreed that this assumption would need to be confirmed in new guidance if consistency was to be achieved and this would be noted in the response to the consultation process.

64.听COT Members observed that EFSA has begun using human equivalent doses, which already incorporate an UF, in its risk assessments. An additional UF was then applied, which helped explain why some recently derived EFSA tolerable daily intakes (TDIs) were lower than those established by other organisations for the same chemical.

65.聽It was noted that uncertainty related to chemical mixtures, and the potential need for an additional UF, was not addressed in the draft guidance, whereas some other regulators have begun to consider this issue. Substances were currently assessed individually, which was not realistic in real world exposure scenarios. However, it was noted that EFSA was considering the application of additional UFs in this area.

66.听COT Members questioned whether the adoption of these UFs would require revisions to previous opinions. It was confirmed that this would not be necessary.

67.聽Members also noted the importance of considering non-dietary exposure pathways, although it was acknowledged that EFSA鈥檚 remit was limited to exposure via food.

68.听The use of standard bodyweights was discussed. Members noted that the guidance specifies the use of 70 kg as the DV for body weight in the absence of measured data. The EFSA Opinion notes that the World Health Organisation (WHO) continues to use 60 kg as a global DV for body weight, although Members commented that this was not representative of some populations. It was highlighted that default bodyweights, as well as any other DV and/or UF were intended for use only when relevant data were not available.

69.听COT Members were advised that UK-specific bodyweight data can be provided for any age group and sex by the FSA Exposure Assessment Team, removing the need to rely on EFSA DVs. Bodyweight varies by age and stratified data can be requested from the EAT team. The importance of consistency in the use of bodyweight assumptions across different UK regulators was noted by COT Members

70.聽Members concluded that they were content with the proposed DVs and UFs outlined in the draft guidance because these were consistent with current scientific practice.

71.聽The closing date for comments was the 14th of May 2026.聽聽聽 COT Members were asked to send in any additional comments to the Secretariat by Friday 8th May, citing line and section number in the EFSA Draft Opinion where possible.

Item 10: EFSA draft scientific opinion on the safety of plant preparations containing berberine (TOX/2026/14)

72.聽No interests were declared.

73.听EFSA has published a draft scientific opinion on the safety for human consumption of preparations of selected plant species containing berberine. The Panel on Nutrition, Novel Foods and Food Allergens (NDA) assessed the safety of a range of species. The assessment considered evidence on adverse effects of berberine as a single substance; adverse effects of other alkaloids of the same family as berberine (protoberberine alkaloids), given their high structural similarity with berberine and their co-occurrence in plant species; adverse effects of the whole preparations of the respective plant species, and relevant parts thereof. The draft opinion outlines the methodology and evidence considered by EFSA in their assessment.

74.聽Overall, the NDA Panel was unable to conclude on the safety of berberine, outlining a number of concerns based on the data such as genotoxicity, herb-drug interactions and herb-liver induced injury.聽

75.听COT Members were asked to consider EFSA鈥檚 draft scientific opinion on the safety of plant preparations containing berberine.

76.听COT Members discussed the EFSA Panel鈥檚 assessment of genotoxicity. Members expressed concern that the available evidence indicated a potential genotoxic hazard and considered that the current evidence base was insufficient to exclude this risk with confidence. It was noted that berberine was structurally similar to other alkaloids that are known to be genotoxic, raising concerns about its safety. It was observed that potential mechanisms of genotoxicity, including DNA intercalation, did not appear to have been adequately considered in the EFSA draft opinion.

77.聽Significant limitations in the QSAR analysis were highlighted. Members noted that the assessment relied solely on VEGA tools and did not include a robust assessment such as the use of the Institute Superiore di Sanit脿 (ISS) profiler in the QSAR toolbox and consideration of the metabolic similarity between the compounds. Overall, the QSAR evidence was considered insufficiently robust to support conclusions on genotoxicity.

78.听COT Members also raised concerns regarding the exposure assessment. It was noted that exposure estimates appeared to be largely theoretical and not clearly underpinned by empirical data, reducing confidence in the risk characterisation.

79.聽Uncertainties relating to toxicokinetics and metabolism were then discussed. The draft EFSA opinion identified glucuronidation as the primary Phase II metabolic pathway based largely on animal data; however, COT Members questioned the suitability of the rat as a model for human metabolism. It was noted that at least three structural analogues exhibited differing metabolic and toxicity profiles in humans, which may limit the validity of read-across approaches. COT Members further highlighted potential differences in thyroid-related glucuronidation and sulfation pathways, as well as the possible involvement of human-specific metabolic pathways which could result in the formation of more toxic metabolites. Variability in metabolic rates and clearance between species and between individuals was identified as an important uncertainty. In particular, evidence for CYP2D6-mediated metabolism raised a concern regarding potential toxicogenomic variability in susceptibility to the adverse effects of berberine and its analogues.

80.聽The Committee concluded that there were substantial data gaps and uncertainties in relation to genotoxicity, exposure estimation and toxicokinetics. Members agreed that these limitations reduced confidence in the conclusions of the draft EFSA opinion and considered that further clarification on how the assessment was supported by the current evidence base would be beneficial.

81.聽The closing date for comments was the 4th of May 2026.聽聽 Members were reminded to submit any remaining comments to the Secretariat by 17th April, giving the section and/or line number in the EFSA Draft Opinion where possible.

Item 11: Draft EFSA Scientific opinion on the safety of hydroxycitric acid and plant preparations containing hydroxycitric acid (TOX/2026/15)

82.聽No interests were declared.

83.听罢丑别 EFSA NDA Panel has published a draft scientific opinion on the safety for human consumption of some hydroxycitric acid (HCA) and HCA-containing plant preparations. The draft opinion outlined the methodology and evidence considered by EFSA in their assessment.

84.聽Overall, the NDA Panel concluded that the currently available data were insufficient to establish safe intake levels for (鈥�)-HCA, Garcinia gummi-gutta or G. indica aril or pericarp preparations, or for (+)-allo-HCA or Hibiscus sabdariffa calyx/petal preparations.

85.听COT Members considered that the available dataset was insufficient to allow firm conclusions to be drawn on genotoxicity.

86.聽It was highlighted that the QSAR fingerprint analysis was inadequate. COT Members noted that only the VEGA similarity measures were used to build the group and considered this approach to be limited because structural similarity alone was not sufficient to prove toxicological similarity. They considered that additional evidence was required to support the proposed approach and that other relevant factors should also be taken into account. For instance, information on metabolic similarity across the group would be useful, as would the use of profilers which allowed the identification of a molecular initiating event (MIE). The analysis should be carried out in accordance with existing guidance documents from the OECD and EFSA, ensuring best practice is followed.

87.听COT Members noted that no data on metabolism were available, meaning it was unclear how these preparations changed after entering the body. It was noted that this significantly undermined the interpretation of the safety data.

88.听With regard to reproductive toxicity, COT Members noted evidence of testicular toxicity in animals but highlighted the overall lack of data on reproductive and developmental endpoints.

89.听COT Members considered that the draft EFSA opinion did not provide sufficient evidence from the selected studies to justify its conclusions. They agreed that the opinion would benefit from greater transparency and detail to allow readers to understand how the conclusions were reached.

90.聽It was noted that the potential for drug-substance interactions was not addressed in the opinion.

91.听COT Members also agreed that some of the data gaps and uncertainties identified by EFSA were not those that the COT would have highlighted.

92.聽It was noted that the primary studies will be reviewed in detail for the upcoming COT statement on G. cambogia.

93.聽The closing date for comments was the 4th of May 2026.聽聽 Members were asked to send in any additional comments to the Secretariat by Friday 17th April, citing the line and section number in the EFSA Draft Opinion where possible.

Item 12: Update on the work of other FSA Scientific Advisory Committees for information (TOX/2026/16)

94.聽Members were presented a paper providing an update on the work of other FSA Scientific Advisory Committees. The paper was presented for information only, but Members were welcome to contact the Secretariat if they have any questions.

Item 13: Any other business

95.聽There was no other business.

Date of next meeting

96.聽The next meeting of the Committee will be at 10:00 on Tuesday 19th May 2026 in Broadway House London and via Microsoft Teams.

Secretariat

March 2026