Meeting

Final minutes of the 7th February 2023 COT Meeting

TOX/MIN/2023/08

Last updated: 27 October 2023

Meeting of the Committee at 10:00 on 7th February 2023 at  Broadway House, London and on Microsoft Teams

Present

Chair:

Prof Alan Boobis

 

COT Members:

Dr Phil Botham 

Dr Stella Cochrane  

Professor James Coulson  

Professor Gary Hutchison 

Professor Thorhallur Ingi Halldórsson                         

Dr Michael Routledge  

Dr Natalie Thatcher           

Dr Simon Wilkinson          

Professor Matthew Wright  

Professor Maged Younes 

Ms Jane Case 

Dr Gunter Kuhnle

Dr David Lovell

Professor Shirley Price

Dr Cheryl Scudamore

 
SACN Liaison Professor Paul Haggarty  
Science Council Liaison Professor John O’Brien  

Food Standards Agency (FSA)

Secretariat:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Ms Cath Mulholland 

Mr Michael Dickinson 

Dr David Gott 

Dr Alex Cooper 

Mr Barry Maycock 

Ms Claire Potter 

Dr Barbara Doerr 

Dr Olivia Osborne 

Dr Joseph Shavila 

Ms Emma French  

Ms Rhoda Aminu 

Ms Sabrina Thomas 

Dr Gail Drummond 

Ms Frederique Uy 

Ms Cleanncy Hoppie 

Ms Jocelyn Frimpong-Manso  

Ms Sophy Wells 

Dr Gaetana Spedalieri  

Mr Thomas Hornsby 

Dr Emily Hudson 

Dr David Kovacic 

Ms Kaitlyn Jukes 

Dr Aaron Bradshaw 

Dr Andrew McClure

Ms Jessica Cairo

Dr Lorcan Browne

Ms Natasha Adams

Ms Abigail Smith

 
UK Health Security Agency (HSA) Secretariat: Ms Britta Gadeberg UK HSA Scientific Secretary
Invited Experts and Contractors: Dr Sarah Bull Institute of Environment and Health (IEH) Consulting
  Dr Sibylle Ermler FSA FCMJEG
  Dr Gill Clare FSA FCMJEG
  Dr Emma Bradley FSA FCMJEG
Assessors:

Ms Valerie Swaine

Rachel Daniels 

Health and Safety Executive (HSE)
 

Ms Rachel Elsom

Ms Susannah Brown

Office for Health Improvement and Disparities, (OHID), DHSC
 

Ms Holly Alpren

Department for Environment, Food and Rural Affairs (DEFRA)
   Prof Tim Gant UK Health Security Agency (UKHSA)
  Mr Ian Martin Environment Agency (EA)
Observers

Dr Stephen Ruckman

Ms Izzy McKenna

Dr Lauren Hyde

TSG Consulting

Newcastle University

Newcastle University

FSA and other Officials:

Dr Amie Adkin

Mr Vincent Greenwood

Mr Tim Chandler

Ms Lisa Nelson

Mr Allan Shivembe

Ms Angela Goundry

Mr Vincent Greenwood

Mr Thomas Horgan

Mr Craig Jones

Food Standards Agency (FSA)

 

 

Ms Kerry Gribben

Mr Gareth Thompson

Ms Lindsey Henley-Dobbs

Mr Elliott Dews

Food Standards Agency Northern Ireland (FSA NI)
  Ms Debby Webb DHSC
  Mr Mark Cairns Civil Aviation Authority (CAA)
 

Dr Ovnair Sepai

UKHSA

Contents

Item                                                                                                          Paragraph

1

Apologies for absence

3

2

Draft minutes/reserved minutes of December 2022 meeting-

4

3

Matters arising –

JEGs Update

Working Groups Update

6

4

Discussion paper on existing health-based guidance values (HBGVs) for T2 and HT2 mycotoxins (TOX/2023/04)

20

5

First draft statement on the safety of green tea catechins (TOX/2023/05)

29

6

Opinion on the safety of 2-hydroxyethyl methacrylate as a monomer for use in the manufacture of plastic food contact materials and articles (RESERVED) (TOX/2023/01)

41

7

First draft statement on the review of the guidance levels for fortificants in the bread and flour regulations (BFR) (TOX/2023/03)

44

8

Draft EFSA Opinion on the tolerable upper level for Vitamin B6 (TOX/2023/10)

51

9

Discussion paper on the effects of pica during pregnancy (TOX/2023/06)

66

10

Draft 2022 COT Annual report (TOX/2023/07)

73

11

Update on actions taken subsequent to the Committee’s advice (TOX/2023/08)

80

12

Annual COT horizon scanning (TOX/2023/09)

82

13

Update on the work of other FSA Scientific Advisory Committees – for information (TOX/2023/11)

91

14

AOB

92

 

Date of the next meeting

28th March 2023

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 Professor Mireille Toledano, Dr Sarah Judge, Ms Juliet Rix and Professor Phillippe Wilson. Apologies were also received from Ms Chara Tsoulli of the Secretariat.

Item 2: Draft Minutes from the meeting held on 14th of December 2022 (TOX/MIN/2022/08)

4.             On page 4 of the main minutes which covered the discussion of the Codex report on food allergen threshold levels and the proposal for the formation of a COT sub-group to review it, a personal non-specific interest should have been recorded for Dr Stella Cochrane as she works for the food industry where the proposed thresholds would be of interest.

5.             No further comments were made on the minutes or the reserved minutes which were accepted as an accurate record.

Item 3: Matters arising

JEGs Update

6.             Members were updated on the current work of the Joint Expert Groups.

AEJEG

7.             The Joint Expert Group for Additives, Enzymes and other Regulated Products (AEJEG) will be having their next two meetings on the 13th and 14th of February 2023. The meeting on the 13th February is a regular AEJEG meeting where the Secretariat would be presenting two new dossiers. The meeting on the 14th February would be solely concerned with smoke flavourings.  Members were informed that there have been four Smoke Flavouring AEJEG meetings since the 20th January and that Members have assessed 4 out of the 8 dossiers submitted. Due to the high workload, AEJEG members have requested 12 additional meetings and more time to assess the Smoke Flavouring dossiers.

FCMJEG

8.             The Food Contact Materials (FCM) JEG are considering a number of responses providing additional information for recycling process dossiers and one new plastic additive dossier. They will also be reviewing an opinion for a recycling dossier which will be presented to COT shortly; the COT will have to assess whether or not the recycling process is sufficiently effective in removing contaminants.

ACAF

9.             The Animal Feed and Feed Additives JEG has been superseded by the Advisory Committee on Animal Feedingstuffs (ACAF). The next meeting of ACAF will take place on the week commencing the 6th February. Four new dossiers will be discussed at this meeting along with responses to five requests for further information (RFI) from applicants for previously discussed applications. There will also be several draft opinions, a short presentation on nanoparticles and an update on feed-based research projects at the FSA. It was agreed that future updates on the work of ACAF should be provided in the “Update on the work of other scientific advisory committees”.

Working Groups Update

Plant based drinks

10.          The Working Group have started work on a draft statement for plant based drinks and it is expected to be presented to the COT in Spring/Summer.  

CBD

11.                Members were informed that the joint COT/ACNFP WG were continuing to review data on CBD arising from novel food authorisations. Their findings would be discussed with the two Committees in due course.

CODEX report on food allergens

12.               Members were informed that the first meeting of the Working Group is planned for March and members who had volunteered to join were thanked for assisting with this.

Oral nicotine pouches

13.                Members were informed that the draft statement for oral nicotine pouches had been updated and circulated to Members for final comment prior to Chair’s approval. The deadline for comments is Wednesday 8th Feb.

COT Workshop

14.          COT members were informed that the 2023 COT workshop would be taking place in London on Wednesday 17th May, with the COT meeting on Tuesday 16th May. Due to new finance rules effective from April 2023 the FSA would not be able to provide or pay for an evening meal (with the exception for Members staying overnight who would be able to claim towards it) so that the Workshop would not have the usual format. However, the FSA could help to organise bookings and the Secretariat would contact Members on possible options.  Members will be informed of the new finance rules shortly.

SAC recruitment

15.          Members were informed that recruitment for the FSA Scientific Advisory Committees (SACs) was now open and Members should have received information. It is hoped that two new Members can be recruited, with expertise in chemistry/QSAR and read across being of particular interest along with strengthening one or more of the areas of reproductive toxicology, pathology and immunotoxicology. Members were asked to let the Secretariat know if they had suggestions for suitable individuals who could be approached directly.

16.          The SACs were also hoping to appoint associate Members to encourage younger applicants to gain a better understanding of SAC work and increase Committee diversity in the future.

Climate change action plan

17.          The FSA have been asked to contribute an annex to a cross-governmental Climate Change Action Plan by Defra; one of the key points is understanding how food safety risks might be affected by climate change.  This would include potential risks arising from mycotoxins so is of interest to both the microbiological and chemical teams. The FSA were planning to address this via a climate change section in the Advisory Committee on the Microbiological Safety of Food (ACMSF) horizon-scanning workshop this summer; COT members were asked to contact the Secretariat if they wished to be involved.

Single use plastics

18.          The FSA has a project underway looking at alternatives to single-use plastics. The consultants working on this are forming an expert panel of 5-10 people to conduct interviews for this project and to review findings from a literature review. COT members who wished to be involved should contact the Secretariat as soon as possible.

Lead in breast milk and related products

19.          The Secretariat thanked the Chair and Members who assisted with urgent advice in December following an incident involving lead in products derived from human breast milk.

Item 4: Discussion paper on existing health-based guidance values (HBGVs) for T2 and HT2 mycotoxins (TOX/2023/04)

20.          No interests were declared.

21.          The COT last assessed T2 and HT2 mycotoxins in 2018 when reviewing the diet of infants aged 0 to 12 months and young children aged 1 to 5 years. At the time, the COT agreed with the group Acute Reference Dose (ARfD) and group Tolerable Daily Intake (TDI) for T2 and HT2 established by the European Food Safety Authority (EFSA) in 2017.

22.          In 2021, the COT published a further statement on the potential risk(s) of combined exposure to mycotoxins, however it was unable to reach conclusions on this due mostly to a lack of UK occurrence data.  

23.          Commission Recommendation 2013/165/EU sets out indicative levels for T2/HT2 in a number of food commodities. However, the European Commission has now proposed replacing these current indicative values with legislative limits for T2/HT2 in the EU. These draft legislative limits are much lower that the pre-existing indicative values and may have an impact on UK industry, especially on cereals.  Currently there is no retained EU law covering T2 and/or HT2. However, the FSA has had extensive dialogue with industry, and has previously been involved in EU working groups on the development of appropriate maximum levels.

24.          The FSA intends to assess the level of risk arising from dietary exposure to T2/HT2 for UK consumers through a call for UK occurrence data.  The focus of the assessment is T2 and HT2; the FSA Policy team has not asked the Committee to consider the related mycotoxins neosolaniol (NEO) and 4,15-diacetoxyscirpenol (DAS) due to the limited data available for these compounds. Therefore, NEO and DAS have not been included in the discussion paper; however, as part of the full risk assessment that will be conducted later in the year, the Secretariat will review the scientific literature to assess whether any additional information has been published on these compounds.   

25.          The COT were asked to consider the existing HBGVs for T2/ HT2 published by EFSA and by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and to confirm an appropriate HBGV for FSA risk assessments.

26.          It was noted that in the last sentence of paragraph 17 of TOX/2023/04, ‘reactive processes’ should be changed to ‘regressive processes’. 

27.          The Committee noted that it was unclear why JECFA did not include an uncertainty factor to account for interspecies differences. The COT presumed that JECFA had considered emesis to be a direct effect rather than a central effect, and therefore no variability would be expected in the kinetics. The COT did not necessarily disagree, but clarification on this would be helpful when the full toxicological monograph was available.

28.          Overall, the Committee was content with the use of EFSA’s HBGVs for future risk assessments.

Item 5: Second draft statement on the safety of green tea catechins (TOX/2023/05)

29.          Professors Maged Younes and Matthew Wright declared a personal non-specific interest relating to flavanols as the Chair and a Member, respectively, of the EFSA ANS Panel that produced the original opinion on the safety of green tea catechins (GTCs). They were able to provide comment and clarification on the EFSA opinion but not to contribute to the conclusions.  Professor Gunter Kuhnle declared that he is currently involved in performing research on flavanols for industry, therefore although he was not precluded from the general discussions, he was not able to provide input for the conclusions. No additional interests were declared.  

30.          In 2017, following a series of reports of adverse effects on the liver following the consumption of green tea supplements, the European Commission requested EFSA to assess the available information on the safety of green tea catechins (principally - epigallocatechin-3-gallate (EGCG)) from all dietary sources including preparations such as food supplements and traditional infusions, with a focus on liver toxicity. At that time, and at the request of Department of Health and Social Care (DHSC), who have the policy lead for food supplements in England, the FSA Chemical Risk Assessment Unit team reviewed the EFSA opinion informally and agreed with its conclusions. 

31.          Following the adoption of the EFSA opinion, the EU Commission are proposing amendments to EU legislation to restrict or prohibit the use of green tea catechins to ensure that foods containing these substances are safe for human consumption. The proposed risk management measures could include prohibiting the substance, restricting the permitted dose, or placing it under Community scrutiny for a period of time under Article 8 of Regulation (EC) 1925/2006.

32.          Following a request to FSA from the Nutrition Labelling Composition and Standards (NLCS) Common Framework on behalf of the UK, COT have been asked to evaluate whether the conclusions of the 2018 EFSA opinion are still applicable, in view of any new data that have become available since its adoption, to enable them to consider the next steps. This evaluation of the 2018 EFSA opinion, as indeed the opinion itself, pertains to green tea catechins and the associated cases of probable idiosyncratic hepatotoxicity, rather than a safety assessment of either green tea catechins or green tea infusions and extracts more generally.

33.          A discussion paper was presented to the Committee in September 2021 followed by a draft statement in September 2022. 

34.          Following discussion of the Statement, Members requested the Secretariat to clarify the regulatory status of GTCs for use in food, since the proposals from the EU Commission to prohibit the use of GTCs (in food) were put in place for late 2022, and since the UK are no longer part of the European Union, the relevance of this policy to UK Legislation was unclear.

35.          Members also requested the Secretariat to add a specific reference to idiosyncratic hepatotoxicity and to clarify certain points related to the literature cited in the statement.

36.          A number of articles had been identified that had not been retrieved in the original literature search. These would be shared with the Secretariat. 

37.          Members noted that flavanols have been reported to cause epigenetic changes such as DNA methylation, which may be involved in their toxicity and should be considered further.

38.          The Committee considered that the statement required additional text to provide a more detailed description of the hepatotoxic effects of GTCs, which seem to result from idiosyncratic reactions.

39.          A number of minor editorial changes were also proposed.

40.          A revised draft of the statement would be presented to the Committee in due course.

Item 6: Opinion on the safety of 2-hydroxyethyl methacrylate phosphate as a monomer for use in the manufacture of plastic food contact materials and articles (RESERVED) (TOX/2023/01)

41.          No interests were declared.

42.          Members were asked to comment on the FCM JEG final opinion of 2-hydroxyethyl methacrylate phosphate (HEMAP) for use in the manufacture of kitchen countertops and sinks under the proposed conditions of use. The assessment was on HEMAP only, and not the final reaction mixture.

43.          The item was reserved, as the data are commercially confidential.

Item 7:  First draft statement on the review of the guidance levels for fortificants in the Bread and Flour Regulations (BFR) (TOX/2023/03)

44.          No interests were declared.

45.          In 2022, consultees of the Bread and Flour Regulations (BFR) 1998 review were asked whether they agree with the proposal to raise the minimum levels of calcium carbonate, iron and niacin to 15% of the Nutrient Reference Values (NRVs) supplied by 100 g of non-wholemeal flour, whilst keeping thiamin at the same fortification level of 19% of the NRV supplied by 100 g of non-wholemeal flour. Therefore, the Department of Health and Social Care (DHSC) requested the COT provide an assessment of the dietary exposure of calcium carbonate, iron, nicotinic acid and thiamin (Vitamin B1) at the current and/or proposed new minimum fortification levels and to assess whether there is a potential risk from fortification with thiamin (B1) and the proposed increased levels of the other fortificants in non-wholemeal wheat flour. This issue was initially discussed at the October 2022 COT meeting.

46.          The Committee discussed the first draft statement on the review of the guidance levels for fortificants in the BFR and made a number of comments. They asked for clarification on whether the NRV applied to calcium carbonate or elemental calcium.

47.          Members considered the statement should be clear that the dose of iron discussed in the toxicity section was elemental and that reports of iron poisoning in adults related to free iron.

48.          The Committee asked for the statement to reflect that the homozygous haemochromatosis genotype was most common in Caucasians, especially the Celtic population, but was less common in other ethnicities. Members also requested that the conclusions be revised to better address the risk of the proposed fortification levels for individuals with the homozygous haemochromatosis genotype.

49.          Members highlighted that the case reports for thiamin toxicity dated back to 2003 and it would be useful to check for and include more recent case reports, if available. Additionally, Members noted that consumption of alcohol may be a confounding factor in these case reports.

50.          The Committee also asked for a clearer statement on the influence of supplement usage on the overall risk from the proposed fortification levels of calcium, iron, thiamin and niacin.

Item 8: Draft EFSA opinion on the Tolerable Upper Level for vitamin B6 (TOX/2023/10)

51.          Professor Gunter Kuhnle declared an interest as he had applied for a grant using vitamin B6 supplementation; this did not prevent him taking part in the discussion.  No other interests were declared.

52.          EFSA are holding a public consultation on their draft opinion on a proposed tolerable upper intake level (TUL) of vitamin B6. The consultation will be closing on the 10th February 2023. The COT were asked to provide comments on the draft opinion to be fed back to EFSA. The discussion paper provided a summary of the draft EFSA opinion; however, it did not include a review of the dietary exposure assessment due to the short timelines.

53.          The TUL was based on the observation of peripheral neuropathy in a study in women being treated for premenstrual syndrome. Members agreed that the most relevant toxicological endpoint was peripheral neuropathy as this had been observed in both humans and animals. Members considered that the Lowest Observed Adverse Effect Level (LOAEL) used to derive the TUL and the rationale for the accompanying uncertainty factors needed clarification as there were concerns that they might not reflect the full variability of the human pharmacokinetics. 

54.          Members considered that additional discussion of the suitability of the TUL for pregnant women would be useful.

55.          Regarding the ADME section, Members were of the opinion that further clarification of this section was needed, as it suggested binding was to the lysine residues of albumin in some sections, but noted binding to lysine residues in other proteins as well as albumin elsewhere.  

56.          The Committee discussed biomarkers of vitamin B6 intake and status, and stated it would provide greater context if commentary on the implications of genetic variability, for example in alkaline phosphatase activity, were provided. A Member noted a recently published paper by Jarett at al which showed an interaction between vitamin B6 and genotype which affected the dose-response. It was agreed that this literature should be brought to the attention of EFSA for their consideration.

57.          Members noted that the study by Chaudry and Cornblath (2013) was retrospective not prospective.

58.          The Committee queried whether there might be some potential confusion when using the abbreviation PMS (for pre-menstrual syndrome) and post-menstrual syndrome.

59.          Members commented on the case reports reviewed by EFSA. Members queried the accuracy of the summary for the Dalton and Dalton (1987) study. Members were of the opinion that the participant was not positively re-challenged but rather symptoms recurred when consumption of the vitamin was resumed.

60.          The recommended range of the health-based guidance value for vitamin B6 was wide; 10-100 mg for adults. This reflected variability, but also choices in the selection of LOAELs and UFs.  The COT was of the opinion that a paragraph to introduce or provide explanation on the broad HBGV range would prove beneficial for context setting and transparency.

61.          In addition, Members were of the opinion that further detail on the reason behind EFSA’s selection of 50 mg/day as the threshold at which peripheral neuropathy occurs was needed, given that the nutrivigilance data indicted effects at lower doses of vitamin B6.

62.          Members raised concern regarding interpretation of the LOAEL identified in the dog studies outlined in the animal data section. Members stated that while pathological changes had been observed , there was uncertainty around measurements of neurological endpoints and it was questioned how sensitive these clinical signs would be.

63.          A Member further highlighted that there seems to be a mismatch between human and animal data and the comparability of reproductive toxicity endpoints since the available human data related to effects on women rather than their offspring.

64.          Members supported the proposed recommendations for further research made by EFSA, in particular for further studies on toxicogenetics.

65.          Members were asked to send any additional comments to the Secretariat by the 9th February.

Item 9: Discussion paper on the effects of pica during pregnancy (TOX/2023/06)

66.          No interests were declared.

67.          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; this would include the effects of chemical contaminants and excess nutrients in the diet.

68.          SACN agreed that, where appropriate, other expert Committees would be consulted and asked to complete relevant risk assessments e.g., in the area of food safety advice.  Following a discussion at the COT meeting in September 2020, a list of components was agreed, including heavy metals, that would be reviewed by the Committee.  At the COT meeting in May 2022, as part of the discussions regarding the contribution of soil and dust to lead exposure in the maternal diet, the Committee requested further information on the practice of pica: this information was incorporated into the second draft statement of the effects of lead on maternal health. At the September 2022 COT meeting, Members discussed the additions and determined that there it would be helpful to expand upon the theme of pica more generally, and that the effects of pica during pregnancy should be considered in a stand-alone paper.

69.          Members considered the paper had provided much useful information particularly explaining the differences between cravings in pregnancy and genuine pica behaviour, and the incidence in the population.  It was added that while it appeared that the main concern was specifically geophagia (i.e. consumption of earth, soil or clay), primarily of soil of ancestral origin, there may be additional concerns regarding the gastrointestinal effects of physical obstruction that were not mentioned in the paper.

70.          Members noted that geophagia and pica more generally , were not practices uniformly distributed across the population and the cultural differences in consumption of soil would mean that there could be a large disparity in exposure.  Furthermore, exposure would be difficult to determine, as background levels of heavy metals in UK soils would not be appropriate for exposure estimations as the soils consumed as part of geophagia are often imported from around the world. 

71.          It was concluded that the risks of pica behaviour could not be quantified, however Members discussed whether or not pica behaviour should be discouraged on health grounds.  Although anecdotally, anaemia had been associated with pica, the relevance of this was difficult to interpret as anaemia was almost ubiquitous in pregnancy and that it may be necessary to stratify by socioeconomic status before being able to understand the nature and the direction of the relationship between pica and anaemia.

72.          The Committee indicated that the chemicals of concern from pica were predominantly heavy metals and that these had largely been covered elsewhere in papers for the maternal diet.  Therefore, it was concluded that, given the limited data set, it would be more appropriate to include a general consideration of pica in the overarching statement for the maternal diet.

Item 10: Draft 2022 COT Annual report (TOX/2023/07)

73.          Members were invited to comment on the draft text of the COT section of the 2022 Annual report. A small change to the format had been made with an additional section added to include Presentations, Joint Expert Groups and other Committee activities to cover items that did not fit easily in the usual sections.

74.          Members suggested a number of editorial changes to the report including the use of references and abbreviations.

75.          Members were asked to send their updated job information and interests, and to send other relevant and personal interests to the Secretariat.

76.          Members were reminded that potential conflicts of interest, which Chairs and members should declare, include private financial or non-financial interests (or those of their close family members) which conflict or may be perceived to conflict with their SAC’s duties. Clarification was sought on whether all interests had to be declared, for example shareholdings in banks, or just directly relevant ones; The Secretariat agreed to check.

77.          Members were asked to consider the extent to which COT evaluations have complied with the Good Practice Agreement for Scientific Advisory Committees to consider how the COT has performed during 2022 against the Good Practice Guidelines for committees advising the FSA.  Members agreed that, in general, the Committee abided by the Good Practice Agreement. Members stated they were happy with the validation process for assessments, and the approach to declaring levels and types of uncertainty.

78.          The Committee were content with proposed new text for the code of practice which covered communication and collaboration, assurance of FSA risk assessment, urgent advice and relationships with the JEGs.

79.          Members were invited to send any other editorial comments to the Secretariat to finalise the annual report.

Item 11: Update on actions taken subsequent to the Committee’s advice (TOX/2023/08)

80.          This paper was circulated largely for information but Members were asked whether they had any comments or questions.

81.          Members agreed that it was useful to have feedback from the FSA and UKHSA with respect to the use of their advice.

Item 12: Annual COT horizon scanning (TOX/2023/09)

82.          Members were reminded that the annual horizon scanning paper reviewed the work anticipated for the coming year; this included ongoing topics, the workshop, working groups and the skills balance of the Committee.

Phosphate based flame retardants

83.          In 2019, the COT published a statement on phosphate-based flame retardants (PFRs) and the potential for neurodevelopmental toxicity. The Committee concluded that PFRs were very unlikely to share the neurodevelopmental effects of other OPs but could not exclude the possibility that PFRs could produce neurodevelopmental toxicity by some other mechanism.

84.          In 2021, the COT became aware of new data relating to PFRs and developmental neurotoxicity. A literature search was carried out to capture any additional data published between 2019 and 2021. The Committee also requested such searches be carried out in subsequent years to capture any new published data. 

85.          Members were asked if they wished to take this item forward and if so whether the paper should focus on neurodevelopmental toxicity or be widened to include adverse pregnancy outcomes.

86.          A Member requested clarification on why this issue was being raised at this time. The Secretariat explained to the Committee that following the publication of the 2019 statement, new studies were highlighted that had not been included in the original statement and the Committee had requested annual updates of the literature.

87.          The Committee considered that unless DHSC requested another review, there was insufficient new information to justify taking this further at this time. However, the literature should continue to be monitored,  though there was no need for an update every year, unless significant (in terms of toxicology or amount) new information became available.

General horizon scanning

88.          It was noted that the terms of reference for the Committee included advising on the request of many different government departments, on a wide variety of chemicals and routes of exposure, making them very broad, which might need to be considered. Particularly, as there was clear overlap with a number of other SACs. While the Committee’s work was mostly reactive, the terms of reference also include advising on important general principles and scientific discoveries in relation to toxic risks, which was more proactive. The Committee was constrained by a heavy workload. but it was important that the Committee was proactive where it could, taking a lead on advances in the application of novel science in the risk assessment of chemicals. The work on new approach methodologies and evidence integration are examples of this.

89.          Members noted that it was important the Committee is aware of emerging topics and a databank of potential areas of interest should be created. It was suggested that it would be useful to know whether there were topics being discussed elsewhere such as by EFSA and ECHA, that may be relevant to topics that should be addressed by the Committee.

90.          Members were informed that bisphenol A would be considered once the final EFSA opinion was published and that an opinion on nitrites may also be published by EFSA. The FSA would also be continuing work on the topic of PFAS.

91.          A Member asked whether there was any further work being undertaken by EFSA on acrylamide. It was noted that EFSA had reviewed the genotoxicity of acrylamide but did not have plans to look at other aspects. However, the FSA was considering commissioning a full review on the toxicity of acrylamide.

92.          The Secretariat stated that EFSA would be producing protocols for risk assessment and suggested that this could be incorporated into the COT workshop in May.

93.          A Member stated that EFSA had included the microbiome in their recent horizon scanning and considered that this should remain under consideration by the Committee.

94.          Members were asked if they had any suggestions for focussed topics for workshops or one-day meetings, although it was noted that the workshop on updating the COT guidance on toxicity testing and assessment was scheduled for May.

95.          The Committee did not consider there were any immediate areas where a working group might need to be established, although one might be needed following  the May workshop to help to develop draft guidance.

96.          Members were reminded that they were free to suggest topics for discussion throughout the year and indeed were encouraged to do so.

Item 13: Paper for information: Update on the work of other scientific advisory committees (TOX/2023/11)

97.          This paper was circulated for information but Members should contact the Secretariat if they have any questions.

Item 14: Any other business

98.          The Committee were advised that the Environmental Improvement Plan (EIP) 2023 for England was published at the end of January 2023 and was the first revision, building on the 25-year vision and setting out how DEFRA will work with landowners, communities and businesses to deliver the Government’s goals. The EIP makes a commitment to publish the UK strategy for the vision of chemicals up to 2040 this year. The Environmental Improvement Plan report will be available on the website and the link is included in these minutes.

99.          The Committee were reminded of the series of workshops that had been held by DEFRA over the summer months, which formed part of the evidence gathering exercise and the reports of the workshops are now available.

100.       Members were informed that the Science Advisory Council are looking at climate change and mycotoxins generally and the COT may be contacted with questions as the Committee have previously raised the topic.

Date of next meeting

101.       The next Committee Meeting will be at 10:00 on the 28th of March 2023 at Broadway House London and via Skype and Teams.