Second draft statement on the guidance levels for fortificants in the Bread and Flour Regulations (BFR)
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Skip the menu of subheadings on this page.This is a paper for discussion.
This does not represent the views of the Committee and should not be cited.
Introduction
1. In 2022, the Department for Environment, Food and Rural Affairs (Defra) held a consultation on the Bread and Flour Regulations (BFR) 1998 to increase the fortification level to allow harmonisation with EU retained Regulation (EU) No 1169/2011. Defra asked whether the consultees agreed with the proposal to raise the minimum levels of calcium carbonate, iron and niacin added to non-wholemeal flour to 15% of the nutrient reference values (NRV). The minimum amount of thiamin required to be present in non-wholemeal wheat flour would remain the same at 19% of the NRV. NRVs are established guidelines for the recommended daily energy and nutrient consumption.
2. The Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) have been asked by the Department of Health and Social Care (DHSC) to provide an assessment on the dietary exposure of calcium carbonate, iron, niacin and thiamin (Vitamin B1) at current and proposed fortification levels. The exposure assessment should provide a comparison to the UK Expert Group on Vitamins and Minerals (EVM) safe levels and upper levels (UL) and assess whether there is a potential risk to human health from the proposed increased fortification in non-wholemeal wheat flour.
3. A first draft statement (TOX/2023/03) was presented to the Committee in February 2023 and DHSC have requested that a statement be published with the conclusions of the Committee.
4. The Committee requested clearer wording in the discussion of the nutrient reference values of calcium and calcium carbonate. It was also asked that the dose of iron discussed in the toxicity section is noted to be in its elemental form and clarified that reports of iron poisoning in adults are related to free iron.
5. It was further requested that statement address more recent case reports on thiamin toxicity and reflect that the homozygous haemochromatosis genotype is predominantly a concern for the Caucasian population.
6. Finally, the Committee requested the conclusions to be revised to better address the risk of the proposed fortification levels for individuals with the homozygous genotype. As well as a clear statement on the influence on supplement usage on the overall risk from the proposed fortification levels of calcium, iron, thiamine and niacin.
7. The Committee are asked to consider the second draft statement (attached in Annex A) which includes further information on the above which has been highlighted in yellow.
Questions on which the views of the Committee are sought
Members are invited to consider the following questions:
i). Do the Members have any comments on the amendments of the second draft statement?
ii). Do Members have any further comments?
Secretariat
March 2023
TOX/2023/17 Annex A
Background
1. In 2022, the Department for Environment, Food and Rural Affairs (Defra) held a consultation on the Bread and Flour Regulations (BFRs) 1998 to increase the fortification level to allow harmonisation with EU retained Regulation (EU) No 1169/2011. Defra asked whether the consultees agreed with the proposal to raise the minimum levels of calcium as calcium carbonate, iron and niacin added to non-wholemeal flour to 15% of the nutrient reference values (NRV). The current minimum amounts of calcium, iron and niacin required to be present in non-wholemeal wheat flour are 11.75%, 12% and 10% respectively. However, the minimum amount of thiamin required to be present in non-wholemeal wheat flour would remain the same at 19% of the NRV. NRVs are established guidelines for the recommended daily energy and nutrient consumption.
2. The Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) have been asked by the Department of Health and Social Care (DHSC) to provide an assessment on the dietary exposure of calcium, iron, niacin (nicotinic acid) and thiamin (Vitamin B1) at current and proposed fortification levels. The exposure assessment provides a comparison to the UK Expert Group on Vitamins and Minerals (EVM) guidance levels and assess whether there is a potential risk to human health from the proposed increased fortification in non-wholemeal wheat flour.
Introduction
3. The BFR 1998 stipulates the levels of calcium as calcium carbonate, iron, thiamin (vitamin B1) and niacin (nicotinic acid) that are required to be present in all wheat flour other than wholemeal (i.e. non-wholemeal flour). Calcium is added in the form of calcium carbonate. Natural calcium found in food would not be present in the form of calcium carbonate. Therefore, exposure to calcium from fortified food can be distinguished from natural or supplementary sources when analysed. Niacin is added to flour using either nicotinic acid or nicotinamide.
4. The existing BFRs (1998) set a minimum fortification level for thiamin (vitamin B1) of 0.24 mg for thiamin hydrochloride, which is equivalent to 0.21 mg of thiamin or 19% of the NRV. The proposed minimum fortification levels of calcium, iron and niacin have been set at 15% of the nutrient reference value (NRV) as stated in Annex XIII of regulation EC No. 1169/2011 (in point 1 of Part A). In practise, foods are not currently fortified at these respective levels, but industry are looking to increase fortification to the set minimum levels. The daily NRVs for calcium, iron, niacin and thiamin (Vitamin B1) are 800 (or 2,000 as calcium carbonate), 14, 16 and 1.1 mg, respectively.
Toxicity
Calcium
5. High intakes of calcium carbonate of around 4,000 mg/day (equivalent to 1,600 mg calcium) can result in a condition called milk-alkali syndrome in people with underlying medical conditions such as peptic ulcers (EFSA, 2006). This condition is characterised by hypercalcaemia, alkalosis and renal impairment, which is associated with symptoms of hypertension, neurological problems, abdominal pain and tissue calcification (EVM, 2003).
6. Calcium supplements have been administered to people with colonic polyps or people who are at risk of colonic polyps. Gastrointestinal (GI) effects were reported in a small number of patients receiving 1,600 or 2,000 mg/day of calcium (EVM, 2003).
7. High calcium diets can affect the bioavailability of other minerals such as iron, zinc, magnesium and phosphorous by inhibiting the absorption of iron salts, haem-iron and zinc, reducing magnesium absorption and excretion, and the binding of calcium acetate and calcium carbonate to phosphate in the intestinal lumen (EFSA, 2006).
Iron
8. Iron toxicity is particularly hazardous in children and most poisoning cases are reported in children consuming iron supplements intended for adults. Symptoms in infants include gastrointestinal irritation at acute doses of around 20 mg/kg bw and systemic effects which occur at doses <60 mg/kg bw. The lethal dose in children is between 200-300 mg/kg bw (EVM, 2003).
9. In adults, gastrointestinal effects such as constipation, nausea, vomiting and diarrhoea have been reported at therapeutic doses of 50-220 mg/person/day (EFSA, 2006). Iron toxicity can lead to inflammation and perforation of the gastrointestinal tract and iron disrupts the cellular metabolism in the central nervous system, liver and heart. The free iron in the serum enters and concentrates in the mitochondria where it forms free radicals, which can impair energy metabolism and can eventually lead to cell death (Baranwal and Singhi, 2003; Yuen and Becker, 2022). However, iron poisoning (where iron is in its free form) in adults is rare, individual case reports suggest a lethal dose of 1,400 mg/kg bw (EVM, 2003).
Niacin (nicotinic acid/vitamin B3)
10. Symptoms of acute toxicity from niacin include flushing, itchy skin, nausea, vomiting and gastrointestinal issues (such as diarrhoea and constipation). Long term intakes of 3,000 mg/day of niacin have been reported to cause jaundice, hyperglycaemia and abdominal pain. In addition to elevated serum bilirubin, increased alkaline phosphatase and aminotransferase levels have been reported in a small number of cases. Anorexia, ophthalmological effects, skin hyperpigmentation and precipitation of incipient psychosis have also been reported as side effects of niacin therapy (EVM, 2003).
11. Patients with hypercholesterolaemia that have been treated with niacin at 3-9 g/day over a period of months to years showed symptoms of severe liver dysfunction which has the potential to be life threatening and may require liver transplantation (EFSA, 2006).
Thiamin (Vitamin B1)
12. Thiamin is considered to be of very low toxicity with symptoms such as headache, nausea, irritability, insomnia, rapid pulse and weakness being seen at high oral doses of ≥7,000 mg thiamin hydrochloride (EVM, 2003).
13. However, a small number of case reports have shown association with adverse effects such as muscle tremors, rapid pulse and nerve hyperirritability at low daily doses of 17 mg/day of thiamin hydrochloride. In one case, a patient consuming thiamin at 100 mg/day for a period of 15 days, 2 months prior to consumption of a single oral dose of thiamin of 100 mg, experienced an anaphylactic reaction followed by death. In another case, a patient experienced exacerbated eczema after receiving an oral dose of 200 mg of thiamin in an experimental provocation (EVM, 2003). A 2018 case report where patients with Parkinson’s disease were treated with 2-3 intramuscular doses of 100 mg of thiamin/week experienced adverse effects of discomfort, unrest and an overall worsening of symptoms of Parkinson’s disease, and a medium intensity migraine (Costantini and Fancellu 2018).
14. The COT noted that alcohol consumption may be a confounding factor in some of the case reports. Most cases of thiamin deficiency were associated with chronic alcoholism where absorption and utilisation of thamin are impaired (EVM, 2003).
Health based guidance values
15. No tolerable upper levels (TUL) or safe upper levels (UL) have been established for calcium, iron, niacin (nicotinic acid) and thiamin by the EVM due to the lack of sufficient animal and human data (EVM, 2003).
16. However, the EVM stated that “1,500 mg/day of supplemental calcium would not be expected to result in any adverse effect, but that higher doses could result in adverse gastrointestinal symptoms in a few people” (EVM, 2003). The Scientific Committee on Food (SCF) established a TUL of 2,500 mg/day for calcium in 2003 (SCF, 2003). This TUL was based on long duration intervention studies of different time periods in which total daily calcium intakes of 2,500 mg from both diet and supplements were tolerated without adverse effects and was endorsed by EFSA in 2012 (EFSA, 2012).
17. The EVM proposed that a supplemental intake of 17 mg/day for iron would not be expected to produce adverse effects in the majority of individuals. However, this guidance value does not apply to individuals who have an increased susceptibility to iron overload, a condition which is associated with a homozygous haemochromatosis genotype (with an estimated prevalence of up to 0.4% in the Caucasian population). An UL for iron has not been established by EFSA. The National Institutes of Health Office of Dietary Supplements in the United States have advised safe ULs of 40 mg/day for individuals aged 0 months to 13 years and 45 mg/day for individuals aged 14 years and over (Institute of Medicine, 2001). However, moderate symptoms of iron toxicity have been reported from (20 mg/kg bw/day (Madiwale and Liebelt, 2006) or 1,572 mg/person/day for a 78.6kg adult (based on the average body weight in NDNS data) (Bates et al., 2014, 2016, 2020; Roberts et al., 2018)). However, Madiwale and Liebelt (2006) reported that ingestion <20 mg/kg is non-toxic and moderate symptoms of iron toxicity can occur between 20 to 60 mg/kg.
18. The EVM proposed that a guidance level of 17 mg/day for niacin (nicotinic acid) would not be expected to result in any adverse effects. However, it was noted by the EVM that this guidance level is for supplementation only, as adverse effects from niacin seem to be related to acute, bolus intakes. Adverse effects from long term exposure of niacin in food would be less likely as free niacin levels in food are low. Additionally, the EVM noted that the guidance level is based on intakes of conventional formulations of niacin. This would not be applicable to sustained release preparations and niacin contained in dietary supplements is not in the sustained release form (EVM, 2003). In 2002, the SCF set an UL of 10 mg/day for niacin based on flushing of skin (EFSA, 2014).
19. The EVM proposed a guidance level for supplemental thiamin of 100 mg/day which would not be expected to result in adverse effects. The EVM noted however that this guidance level was only applicable to the water-soluble forms of thamin. Furthermore, the study by Gokhale et al. (1999), used to derive the guidance level, was conducted in young women (EVM, 2003). An UL for thiamin was not established by the SCF as there were only limited data on adverse effects in humans and lack of dose-response studies (EFSA, 2016). Whilst there is a lack of evidence of toxicity from a high intake of thamin from food or supplements (Martel et al., 2021), symptoms such as headache, nausea, irritability, insomnia, rapid pulse and weakness have been seen at high oral doses of ≥7,000 mg/day thiamin hydrochloride (EVM, 2003).
Exposure assessment
20. Exposures to calcium, iron, niacin and thiamin were determined using consumption data from the Diet and Nutrition Survey of Infants and Young Children (DNSIYC) and the National Diet and Nutrition Survey (NDNS). Levels of these nutrients in the entire diet were obtained from the nutrient databank (Bates et al., 2014, 2016, 2020; Roberts et al., 2018). Levels of nutrients in non-wholemeal flour used in the exposure assessment were those currently in use by industry. Exposure to the nutrients based on the proposed increases were also determined, except for thiamin, where no increases have been proposed. Table 2 provides information about current and proposed fortification levels for each nutrient where applicable. Exposure to these nutrients were calculated in Crème Global, the software that the FSA uses to interrogate dietary data and calculate exposure. Exposure estimates were derived by multiplying food consumption amounts by the levels of the nutrients in the foods. Chronic exposure or intake of these nutrients are presented. Chronic intake is derived from the average amount of flour consumed over the survey days multiplied by the levels of nutrients. Chronic exposure or intake is calculated for each consumer. The mean and P97.5 are then computed.
Table1. Concentration data used to derive exposure to calcium, iron, niacin and thiamin.
|
Nutrient
|
Nutrient reference value (mg/person/day) |
Guidance level (mg/person/day) |
Current minimum levels (mg/100 g non-wholemeal flour) |
Level based on fortification at 15% (mg/100 g non-wholemeal flour) |
|
Calcium |
800 |
2,500 |
94 |
120 |
|
Iron |
14 |
17 (supplemental)** |
1.65 |
2.1 |
|
Niacin |
16 |
17 (supplemental)** |
1.6 |
2.4 |
|
Thiamin |
1.1 |
100 (supplemental)** |
0.24 |
NA* |
* A change in fortification level has not been proposed.
**Guidance level is for supplementation only.
Methodology for estimating current and proposed exposures from non-wholemeal flour
21. Exposures based on current and proposed levels were calculated from foods containing non-wholemeal flour. This by definition is wheat flour without whole grain wheat. The recipe database associated with the NDNS food groupings identified foods containing non-wholemeal flour (n=1835). A selection of food groups (foods with non-wholemeal flour), each containing more than 20 foods are shown in Table A1 in Annex A.
22. The fortification level for thiamin remains unchanged, therefore exposures at the proposed fortification levels were only calculated for calcium, iron, and niacin.
23. Exposures to these nutrients from supplements were also considered. Data for supplements were obtained from market sources (e.g., websites of major retailers). Concentrations of calcium supplements ranged from 200-1200 mg for adults and 80-450 mg for children. Whereas concentrations of iron supplements ranged from 14-28 mg in adults and 2.8-7.5 mg in children. Concentrations of niacin supplements ranged from 50-1000 mg in adults and 4.8-20 mg in children. Concentrations of thiamin supplements ranged from 100-500 mg for adults and 0.7-5 mg for children.
Exposures from the entire diet and from flour at the current and proposed fortification levels
24. Exposure to the nutrients from the entire diet was estimated using all food groups from NDNS years 1-11, which are presented in Table A2 of Annex B. All food groups including the foods containing non-wholemeal flour are detailed in paragraph 21. The levels of the nutrient for each of the foods included were derived from the nutrient databank from the NDNS.
25. 25. Exposure to calcium, iron, niacin and thiamin from the entire diet and from flour fortification at current and proposed levels are shown in Table 2-5.
26. For calcium, across all age groups (4 months to 65+ years), the maximum mean and maximum 97.5th percentile exposures at the current level of fortification were 68 and 140 mg/person/day, respectively. The maximum mean and 97.5th percentile exposures at the proposed level of fortification are 87 and 180 mg/person/day, respectively. The maximum exposures to calcium from the entire diet are 820 and 1,600 mg/person/day at mean and 97.5 the percentile levels respectively (Table 3).
27. For iron, across all age groups (4 months to 65+ years), the maximum mean and maximum 97.5th percentile exposures at the current level of fortification are 1.2 and 2.5 mg/person/day respectively. The maximum mean and 97.5th percentile exposures at the proposed level of fortification are 1.5 and 3.2 mg/person/day respectively. The maximum exposures to iron from the entire diet are 10 and 19 mg/person/day at mean and 97.5th percentile levels respectively (Table 4).
28. For nicacin, across all age groups (4 months to 65+ years), the maximum mean and maximum 97.5th percentile exposures at the current level of fortification are 1.2 and 2.4 mg/person/day respectively. The maximum mean and 97.5th percentile exposures at the proposed level of fortification are 1.7 and 3.6 mg/person/day respectively. The maximum exposure to niacin from the entire diet are 36 and 68 at the mean and 97.5th percentile, respectively (Table 5).
29. For thiamin, across all age groups (4 months to 65+ years), the maximum mean and maximum 97.5th percentile exposures at the current level of fortification are 0.17 and 0.36 mg/person/day. The maximum exposure to thiamin from the entire diet are 1.5 and 2.8 mg/person/day at the mean and 97.5th percentile, respectively (Table 6).
Table 2. Chronic exposures to calcium from the diet and from flour fortification at current and proposed levels (15% of the nutrient reference value supplied by 100 g flour) levels.
|
Age group |
Category |
Chronic exposure to calcium (mg/person/day) Mean |
97.5th Percentile |
|
Infants (4-18 months) |
Entire diet |
680 |
1200 |
|
Current |
Levels in flour |
15 |
48 |
|
Proposed |
Levels in flour |
19 |
61 |
|
1.5-3 years |
Entire diet |
740 |
1300 |
|
Current |
Levels in flour |
34 |
78 |
|
Proposed |
Levels in flour |
43 |
99 |
|
4 - 10 years |
Entire diet |
760 |
1400 |
|
Current |
Levels in flour |
55 |
110 |
|
Proposed |
Levels in flour |
71 |
140 |
|
11 – 18 years
|
Entire diet |
770 |
1500 |
|
Current |
Levels in flour |
68 |
140 |
|
Proposed |
Levels in flour |
87 |
180 |
|
19 – 64 years |
Entire diet |
810 |
1600 |
|
Current |
Levels in flour |
58 |
140 |
|
Proposed |
Levels in flour |
74 |
180 |
|
65 + years |
Entire diet |
820 |
1500 |
|
Current |
Levels in flour in flour |
49 |
120 |
|
Proposed |
Levels |
62 |
150 |
Table 3. Chronic exposures to iron from the diet and from flour fortification at current and proposed (15% of the nutrient reference value supplied by 100 g flour) levels.
|
Age group |
Category |
Chronic exposures to niacin (mg/person/day)* |
97.5th Percentile |
|
Infants (4-18 months) |
Entire diet |
14 |
25 |
|
Current |
Levels in flour |
0.26 |
0.81 |
|
Proposed |
Levels in flour |
0.39 |
1.2 |
|
1.5-3years |
Entire diet |
18 |
28 |
|
Current |
Levels in flour |
0.58 |
1.3 |
|
Proposed |
Levels in flour |
0.87 |
2 |
|
4 - 10 years |
Entire diet |
25 |
39 |
|
Current |
Levels in flour |
0.94 |
1.9 |
|
Proposed |
Levels in flour |
1.4 |
2.8 |
|
11 - 18years |
Entire diet |
31 |
55 |
|
Current |
Levels in flour |
1.2 |
2.4 |
|
Proposed |
Levels in flour |
1.7 |
3.6 |
|
19 - 64 years |
Entire diet |
36 |
68 |
|
Current |
Levels in flour |
0.98 |
2.4 |
|
Proposed |
Levels in flour |
1.5 |
3.6 |
|
65 + years |
Entire diet |
31 |
52 |
|
Current |
Levels in flour |
0.83 |
2 |
|
Proposed |
Levels in flour |
1.2 |
3 |
Table 4. Chronic exposures to niacin equivalents from the diet and from flour fortification at current and proposed (15% of the nutrient reference value supplied by 100 g flour) levels.
|
Age group |
Category |
Chronic intake of thiamine (mg/person/day)* Mean |
97.5th Percentile |
|
Infants (4-18 months) |
Entire diet |
0.81 |
1.3 |
|
Current |
Levels in flour |
0.039 |
0.12 |
|
1.5-3years |
Entire diet |
1 |
1.8 |
|
Current |
Levels in flour |
0.087 |
0.2 |
|
4 - 10 years |
Entire diet |
1.3 |
2.3 |
|
Current |
Levels in flour |
0.14 |
0.28 |
|
11 - 18years |
Entire diet |
1.4 |
2.8 |
|
Current |
Levels in flour |
0.17 |
0.36 |
|
19 - 64 years |
Entire diet |
1.5 |
2.8 |
|
Current |
Levels in flour |
0.15 |
0.36 |
|
65 + years |
Entire diet |
1.5 |
2.7 |
|
Current |
Levels in flour |
0.12 |
0.3 |
* Rounded to 2.s.f
Exposure from supplements
30. It should be noted that supplements data were derived from various online sources in Tables A5-A8 in Annex A[CP1] . The exact consumption by the population was unknown therefore exposures were calculated based on recommended serving sizes.
31. Across all age groups (4 months to 65+ years) the upper exposures of supplemental calcium were up to 1,200 mg/day. In adults aged over 18 years, this exposure is equivalent to 1.48- and 0.75-fold the mean and 97.5th percentile calcium exposures from the entire diet (which includes all food groups including non-wholemeal flour), respectively.
32. Across all age groups (4 months to 65+ years) the upper exposures of supplemental iron were up to 28 mg/day. In adults aged over 18 years, this exposure is equivalent to 3- and 1.6-fold the mean and 97.5th percentile calcium exposures from the entire diet, respectively.
33. Across all age groups (4 months to 65+ years) the upper exposures of supplemental niacin were up to 1,000 mg/day. In adults aged over 18 years this exposure is equivalent of up to 32- and 19-fold of the mean and 97.5th percentile niacin exposures from the entire diet, respectively.
34. Across all age groups (4 months to 65+ years) the upper exposures of supplemental thiamin were up to 500 mg/day. In adults aged over 18 years, this exposure is equivalent to 330- and 185-fold the mean and 97.5th percentile thamin exposures from the entire diet.
[CP1]This is currently Annex B, until we publish and don't have a cover paper attached.
Risk characterisation
Exposures from food
35. Chronic exposure of calcium from non-wholemeal wheat flour at the current and proposed fortification levels (Table 2) did not exceed the guidance levels of 1,500 mg/person/day (EVM, 2003) and 2,500 mg/day (EFSA, 2012) across all age groups. Exposures from the entire diet were up to 1,600 mg/person day which although it exceeds the EVM guidance level, marginally, is below the SCF TUL of 2,500 mg/day
36. Chronic exposures to iron from non-wholemeal wheat flour at the current and proposed fortification levels (Table 3) did not exceed the guidance levels of 17 mg/day (EVM, 2003) across all ages. However, it is important to note that the guidance level is based on supplemental intake. Exposures from the entire diet were up to 19 mg/person/day, which would result in marginal exceedance of the EVM guidance level but not the level reported to cause moderate symptoms of iron toxicity of 20 mg/kg bw per day (1572 mg per person/day for a 78.6 kg adult) (Madiwale and Liebelt, 2006). It is not anticipated that there would be a risk to health from iron exposures in the entire diet to most of the population. However, the EVM guidance value does not apply to individuals who have an increased susceptibility to iron overload, a condition which is associated with a homozygous haemochromatosis genotype. Such individuals would normally be under medical supervision to ensure their exposure to iron was appropriate.
37. Chronic exposures to niacin equivalents from non-wholemeal wheat flour (Table 4) at the current and proposed fortification levels did not exceed the guidance level for niacin of 17 mg/day (EVM, 2003) across all age groups. Exposures to niacin from the entire diet were up to 68 mg/person/day, which exceeds the EVM guidance level up to 4-fold. However, the EVM guidance level is for supplementation only, as adverse effects from niacin seem to be related to acute, bolus intakes. It is unlikely that there would be a risk of adverse health effects at these exposures although there is some uncertainty because of the data used to establish the EVM guidance level: that it is intended for supplements and is based on a bolus intake.
38. Chronic exposures to thiamin at the current fortification level (Table 5) did not exceed the current guidance level of 100 mg/day (EVM, 2003). Exposures to thiamin from the entire diet were up to 2.8 mg/person/day which were also well below the EVM guidance level and it is unlikely that there would be a risk of adverse health effects.
Exposure from supplements
39. Daily exposure to calcium supplements did not exceed the EVM guidance level of 1,500 mg/day (EVM, 2003) or the SCF guidance level of 2,500 mg/day in adults and children (SCF, 2003). Exposure to higher dosage iron supplements (i.e., 28 mg/day) can exceed the guidance level of 17 mg/day (EVM, 2003) by up to 1.6-fold in adults. Daily exposure to niacin supplements could result in exceedances of the guidance level of 17 mg/day (EVM, 2003), by between 3- and 60-fold. For thiamin supplements, daily exposure could lead to up to a 5-fold exceedance of the guidance level of 100 mg/day (EVM, 2003).
Exposure from supplements and food
40. Mean calcium exposures from food (the entire diet and flour at the current and proposed fortification levels) and supplements (Table A3) were up to 2,000 mg/person/day, respectively and below either the EVM guidance level and/or the SCF TUL, with the exception of 65+ years, in whom there was a 30% exceedance of the guidance level. Exposures associated with 97.5th percentile consumption were between 1,700 and 2,800 mg/person/day. For population groups below 19 years of age, the exposures are below the SCF TUL and it is unlikely that there would be a risk of adverse health effects. Population groups for 18 years and over marginally exceeded the SCF TUL and it is unlikely that there would be a risk of adverse health effects in humans at these exposures.
41. Mean and 97.5th percentile iron exposures from food and supplements were up to 25 mg/person/day which were either below or a minor exceedance of the guidance level of 17 mg/day (EVM, 2003) in those aged up to 18 years. There is unlikely to be a risk of adverse health effects in these populations due to exposures from iron. However, in the 19-64 and 65+ years age groups, mean and 97.5th percentile iron exposures were up to 38 and 47 mg/person/day which were exceedances of up to 2.2-fold and 2.8-fold, respectively. It is unlikely that there is a risk of adverse health effects. The EVM guidance value does not apply to individuals who have an increased susceptibility to iron overload, a condition which is associated with a homozygous haemochromatosis genotype, and who should be advised appropriately by a medical practitioner.
42. Mean and 97.5th percentile niacin exposure from food (entire diet) and supplements exceeded the guidance level of 17 mg/day (EVM, 2003) across all age groups. In those aged up to 18 years exceedances of the 17 mg/day guidance level were up to 3- and 4.4-fold for mean and 97.5th percentile consumption, respectively. In individuals aged up to 3 years the exceedances were approximately half of these (up to 2.2- and .8-fold for mean and 97.5th percentile consumers, respectively). In those aged over 18 years the exceedances of the 17 mg/day guidance level were up to 59- and 65-fold for mean and 97.5th percentile consumers, respectively. Most of this exceedance comes from the consumption of supplements containing niacin at 1,000 mg.
43. As noted previously, the EVM guidance level is for supplementation only, as adverse effects from niacin seem to be related to acute, bolus intakes. Adverse effects from long term exposure to niacin in food would be less likely. Exposures from consumption of supplements containing high levels of niacin e.g,. 1,000 mg could result in increased risk of adverse health effects, especially when consumed consistently at these high doses over a prolonged period of time.
44. Exposures to thiamin for all age groups below 18 years of age are below the guidance level of 100 mg/day (EVM, 2003). Mean and 97.5th percentile intakes from food and supplements only exceeded the guidance level for thiamin of 100 mg/day (EVM, 2003) in the 19-64 years and 65+ years age groups. In these age groups both exceeded the guidance level by 5-fold. This was predominantly from consumption of supplements which may contain up to 500 mg. It is unlikely that these exposures would cause adverse health effects.
Conclusion
45. Chronic exposures of calcium (as calcium carbonate), iron, niacin and thiamin (for which no change was proposed) from non-wholemeal wheat flour at the current and proposed fortification levels did not exceed their respective guidance levels. For each of the nutrients, the difference in exposure between current and proposed levels of fortification is at most 4%, when compared to exposures form the entire diet and even less when compared with combined exposure from the diet and supplements. Therefore, the change to the proposed levels of fortification would not result in any material increase in risk of adverse health effects particularly when considering the entire diet and consumption of supplements.
46. Independent of the proposed increase in the level of fortification, calcium exposure from food and supplements exceeded the EFSA TUL of 2,500 mg/day, however the exceedance was marginal and only in high (97.5th percentile) consumers in those aged over 18 years. There is unlikely to be a risk of adverse health effects based on these exposures.
47. Iron exposures from food and supplements exceeded the guidance levels of 17 mg/day in some age groups, up to a maximum of 2.8-fold, independent of the proposed increase in the level of fortification. There is unlikely to be a risk of adverse health effects based on these exposures. However, the EVM guidance value does not apply to individuals who have an increased susceptibility to iron overload, a condition which is associated with a homozygous haemochromatosis genotype. For these individuals medical advice would be necessary on the appropriate level of iron intake.
48. In those aged <18 years niacin exposure from food and supplements exceeded the guidance level of 17 mg/day (EVM, 2003), up to 3- and 4.4-fold for mean and 97.5th percentile consumption, respectively. In those aged over 18 years the exceedances of the 17 mg/day guidance level were up to 59- and 65-fold for mean and 97.5th percentile consumers, respectively. These exceedances were independent of the proposed increase in the level of fortification. Most of the exceedances are due to consumption of supplements containing niacin at 1,000 mg. Adverse effects from long term exposure to niacin in food would be less likely. However, there is some uncertainty because of the data used to establish the EVM guidance level. It is intended for supplements and is more relevant for a bolus intake. Exposures from consumption of supplements containing high levels of niacin e.g., 1,000 mg could lead to increased risk of adverse health effects, especially when consumed consistently over a prolonged period of time.
49. No change in the fortification level of thiamin was proposed. Current exposures to thiamin from food and supplements for all age groups below 18 years of age are below the guidance level of 100 mg/day (EVM, 2003). Mean and 97.5th percentile intakes from food and supplements exceeded the guidance level for thiamin only in consumers aged over 18, by a maximum of up to 5-fold. This was predominantly from consumption of supplements which may contain up to 500 mg. It is unlikely that these exposures would cause adverse health effects.
50. Although not impacted by the level of fortification of non-wholemeal wheat, it was noted that intakes of calcium from supplements alone did not exceed the guidance level for this mineral. However, consumption of higher dosage iron, niacin and thiamin supplements may result in exceedances of the respective guidance levels.
51. The COT, overall concluded, that an increase in the minimum fortification level of calcium (as calcium carbonate), iron and niacin to 15% of the NRV would not result in any material increase in risk when compared to current fortification levels.
Secretariat
March 2023
List of Abbreviations and Technical terms
|
BFR |
Bread and Flour Regulations |
|
COT |
Committee on Toxicity Chemicals in Food, Consumer Products and the Environment. |
|
DHSC |
Department of Health and Social Care |
|
SCF |
Scientific Committee on Food |
|
TUL |
Tolerable Upper Level |
|
NRV |
Nutrient reference Value |
References
Bates B, Lennox A, Prentice A, Bates C, Page P, Nicholson S, Swan G (2014). National Diet and Nutrition Survey Results from Years 1, 2, 3 and 4 (combined) of the Rolling Programme (2008/2009 – 2011/2012): Main heading (publishing.service.gov.uk).
Bates, B.; Cox, L.; Nicholson, S.; Page, P.; Prentice, A.; Steer, T.; Swan, G. (2016) National Diet and Nutrition Survey Results from Years 5 and 6 (combined) of the Rolling Programme (2012/2013 – 2013/2014): Main heading (publishing.service.gov.uk).
Bates, B.; Collins, D.; Jones, K.; Page, P.; Roberts, C.; Steer, T.; Swan, G.(2020) National Diet and Nutrition Survey Results from years 9, 10 and 11 (combined) of the Rolling Programme (2016/2017 to 2018/2019) Available at: National Diet and Nutrition Survey (publishing.service.gov.uk).
Baranwal, A.K. and Singhi, S.C. (2003) ‘Acute iron poisoning: management guidelines’, Indian Pediatrics, 40(6), pp. 534–540.
DH (2013). Diet and Nutrition Survey of Infants and Young Children (DNSIYC), 2011. Available at: Diet and nutrition survey of infants and young children, 2011 - GOV.UK (www.gov.uk).
EFSA (2006). Tolerable Upper Intake Levels for Vitamins and Minerals. Scientific Committee on Food: complet_chapitres.indd (europa.eu).
EFSA (2012). Scientific opinion on the tolerable upper intake level of calcium. EFSA Journal, 10(7), p.2814: Scientific Opinion on the Tolerable Upper Intake Level of calcium (wiley.com).
EFSA (2014). Scientific opinion on dietary reference values for niacin. EFSA Journal 2014;12(7):3759: Scientific Opinion on Dietary Reference Values for niacin (wiley.com).
EFSA (2016). Dietary reference values for thiamin. EFSA Journal, 14(12), p.e04653: Dietary reference values for thiamin (wiley.com).
Expert Group on Vitamins and Minerals (2003). Safe Upper Levels for Vitamins and Minerals. vitmin2003.pdf (food.gov.uk)
Gokhale, LB (1996). Curative treatment of primary (spasmodic) dysmenorrhea. Indian Journal of Medical Research 103, 227-231.
Institute of Medicine: Food and Nutrition Board. (2001) Dietary Reference intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc: a Report of the Panel on Micronutrients.
Madiwale, T. and Liebelt, E. (2006). Iron: not a benign therapeutic drug. Current opinion in pediatrics, 18(2), pp.174-179.
Martel, J.L., Kerndt, C.C., Doshi, H. and Franklin, D.S.(2021). Vitamin B1 (thiamine). In StatPearls [Internet]. StatPearls Publishing.
Roberts, C.; Steer, T.; Maplethorpe, N.; Cox, L.; Meadows, S.; Page, P.; Nicholson, S.; Swan, G. (2018) National Diet and Nutrition Survey Results from Years 7 and 8 (combined) of the Rolling Programme (2014/2015 – 2015/2016) Available at: NDNS: results from years 7 and 8 (combined) - GOV.UK (www.gov.uk).
Scientific Committee on Food (2003). SCF (Scientific Committee on Food), 2003. Opinion on the Tolerable Upper Intake Level of Calcium. CF/CS/NUT/UPPLEV/64 Final, 39 pp.
Yuen, H.-W. and Becker, W. (2022) ‘Iron Toxicity’, in StatPearls. Treasure Island (FL): StatPearls Publishing. Available at: Iron Toxicity - StatPearls - NCBI Bookshelf (nih.gov) (Accessed: 30 August 2022).
Secretariat
March 2023
TOX/2023/17 Annex B
Table A1: A selection of food groups containing foods with non-wholemeal flour.
|
Food group |
Number of foods assessed in the group |
|
Biscuits (manufactured/retail) |
105 |
|
Brown, granary and wheatgerm bread |
25 |
|
Buns cakes and pastries (homemade) |
118 |
|
Buns cakes and pastries (manufactured) |
103 |
|
Burgers and kebabs purchased |
24 |
|
Fruit pies (homemade) |
20 |
|
Manufactured coated chicken/turkey products |
34 |
|
Meat pies and pastries (homemade) |
39 |
|
Meat pies and pastries (manufactured) |
38 |
|
Other breakfast cereals (not high fibre) |
24 |
|
Other cereal-based puddings (homemade) |
40 |
|
Other cereals |
41 |
|
Other manufactured vegetable products (including ready meals) |
21 |
|
Other sausages (including homemade dishes) |
30 |
|
Pasta (manufactured products and ready meals) |
26 |
|
Savoury sauces pickles gravies & condiments |
31 |
|
White bread (not high fibre, not multiseed bread) |
56 |
|
White fish coated or fried |
112 |
Table A2: All food groups from the NDNS used to estimate the intake of nutrients from the entire diet.
|
Food group |
Number of foods assessed in the group |
|
1% Milk (60R) |
5 |
|
Alcoholic soft drinks (Alcopops) (49E) |
4 |
|
Apples and pears not canned (40A) |
27 |
|
Artificial sweeteners (55R) |
11 |
|
Baked beans (37C) |
8 |
|
Bananas (40C) |
5 |
|
Beans and pulses (including ready meal & homemade dishes) (37I) |
72 |
|
Beers and lagers (49A) |
29 |
|
Beverages dry weight (50A) |
44 |
|
Biscuits (homemade) (7B) |
15 |
|
Biscuits (manufactured/retail) (7A) |
153 |
|
Block margarine (20A) |
2 |
|
Bottled water still or carbonated (51D) |
11 |
|
Brown, granary and wheatgerm bread (59R) |
42 |
|
Buns cakes and pastries (homemade) (8E) |
132 |
|
Buns cakes and pastries (manufactured) (8D) |
113 |
|
Burgers and kebabs purchased (29R) |
31 |
|
Butter (17R) |
6 |
|
Calcium only or with vitamin D (54F) |
17 |
|
Canned fruit in juice (40D) |
24 |
|
Canned fruit in syrup (40E) |
41 |
|
Carrots (raw) (36A) |
4 |
|
Carrots not raw (37E) |
11 |
|
Cereal based milk puddings (homemade) (9D) |
26 |
|
Cereal based milk puddings (manufactured) (9C) |
40 |
|
Cheddar cheese (14B) |
9 |
|
Chips purchased including takeaway (38A) |
42 |
|
Chocolate confectionery (44R) |
53 |
|
Cider and perry (49C) |
7 |
|
Citrus fruit not canned (40B) |
12 |
|
Cod liver oil and other fish oils (54A) |
1 |
|
Cod liver oil and other fish oils (including with vitamins A,D,E) (54N) |
47 |
|
Coffee (made up weight) (51A) |
25 |
|
Commercial toddlers drinks (52A) |
9 |
|
Commercial toddlers foods (52R) |
131 |
|
Cottage cheese (14A) |
5 |
|
Cream (including imitation cream) (13B) |
41 |
|
Crisps and savoury snacks (42R) |
43 |
|
Dairy desserts (homemade) (15D) |
11 |
|
Evening primrose oil and other plant oils (54B) |
18 |
|
Folic acid (54D) |
2 |
|
Fortified wine (48B) |
10 |
|
Fromage frais and other dairy desserts (manufactured) (15C) |
51 |
|
Fruit juice (45R) |
45 |
|
Fruit pies (homemade) (8C) |
24 |
|
Fruit pies (manufactured) (8B) |
7 |
|
Green beans not raw (37B) |
8 |
|
Herbal tea (made up) (51C) |
3 |
|
High fibre breakfast cereals (5R) |
128 |
|
Ice cream (53R) |
40 |
|
Infant formula (13A) |
82 |
|
Iron only or with vitamin C (54E) |
11 |
|
Leafy green vegetables not raw (37D) |
28 |
|
Liqueurs (47A) |
9 |
|
Liver and dishes (28R) |
36 |
|
Low alcohol & alcohol-free beer & lager (49B) |
9 |
|
Low alcohol & alcohol-free cider & perry (49D) |
3 |
|
Low alcohol and alcohol-free wine (48C) |
4 |
|
Low fat spread not polyunsaturated (19R) |
7 |
|
Manufactured beef products (including ready meals) (23A) |
49 |
|
Manufactured canned tuna products (including ready meals) (34G) |
8 |
|
Manufactured chicken products (including ready meals) (27A) - 79 foods. |
79 |
|
Manufactured coated chicken/turkey products (26A) |
34 |
|
Manufactured egg products including ready meals (16C) |
18 |
|
Manufactured lamb products (including ready meals) (24A) |
11 |
|
Manufactured oily fish products (including ready meals) (35A) |
45 |
|
Manufactured pork products (including ready meals) (25A) |
9 |
|
Manufactured shellfish products (including ready meals) (34E) |
17 |
|
Manufactured white fish products (including ready meals) (34C) |
8 |
|
Meat alternatives (including ready meals and homemade dishes) (37K) |
41 |
|
Meat pies and pastries (homemade) (31B) |
39 |
|
Meat pies and pastries (manufactured) (31A) |
38 |
|
Minerals (two or more including multiminerals) no vitamins (54H) |
4 |
|
Multivitamins and/or minerals with omega (54P) |
30 |
|
Non-nutrient supplements (including herbal) (54J) |
46 |
|
Nutrition powders and drinks (50E) |
62 |
|
Nuts and seeds (56R) |
53 |
|
Other bacon and ham (including homemade dishes) (22B) |
66 |
|
Other beef & veal (including homemade recipe dishes) (23B) |
135 |
|
Other bread (4R) |
17 |
|
Other breakfast cereals (not high fibre) (6R) |
70 |
|
Other canned tuna (including homemade dishes) (34H) |
7 |
|
Other cereal-based puddings (homemade) (9H) |
58 |
|
Other cereal-based puddings (manufactured) (9G) |
23 |
|
Other cereals (1R) |
106 |
|
Other cheese (14R) |
80 |
|
Other chicken/turkey (including homemade recipe dishes) (27B) |
146 |
|
Other cooking fats and oils not polyunsaturated (20C |
28 |
|
Other eggs and egg dishes including homemade (16D) - |
98 |
|
Other fried/roast potatoes (including homemade dishes) (38D) - |
55 |
|
Other fruit not canned (40R) |
193 |
|
Other lamb (including homemade recipe dishes) (24B) |
80 |
|
Other manufactured potato products fried/baked (38C) |
20 |
|
Other manufactured vegetable products (including ready meals) (37L) |
49 |
|
Other meat (including homemade recipe dishes) (32B) |
66 |
|
Other meat products (manufactured including ready meals) (32A) |
34 |
|
Other milk (13R) |
72 |
|
Other nutrient supplements (54K) |
55 |
|
Other oily fish (including homemade dishes) (35B) - 71 foods. |
71 |
|
Other pork (including homemade recipe dishes) (25B) |
69 |
|
Other potato products and dishes (manufactured) (39A) |
20 |
|
Other potatoes (including homemade dishes) (39B) |
50 |
|
Other sausages (including homemade dishes) (30B) |
46 |
|
Other shellfish (including homemade dishes) (34F) |
45 |
|
Other vegetables (including homemade dishes) (37M) |
217 |
|
Other white fish (including homemade dishes) (34D) |
83 |
|
Pasta (manufactured products and ready meals) (1D) |
39 |
|
Pasta (other, including homemade dishes) (1E) |
36 |
|
Peas not raw (37A) |
20 |
|
Pizza (1C) |
12 |
|
Polyunsaturated low fat spread (19A) |
10 |
|
Polyunsaturated margarine (18A) |
1 |
|
Polyunsaturated oils (18B) |
7 |
|
Preserves (41B) |
22 |
|
Ready meals based on sausages (30A) |
2 |
|
Ready meals/meal centres based on bacon and ham (22A) |
3 |
|
Reduced fat spread (not polyunsaturated) (21B) |
16 |
|
Reduced fat spread (polyunsaturated) (21A) |
9 |
|
Rice (manufactured products and ready meals) (1F) |
9 |
|
ice (other, including homemade dishes) (1G) |
53 |
|
Salad and other raw vegetables (36B) |
93 |
|
Savoury sauces pickles gravies & condiments (50R) |
203 |
|
Semi-skimmed milk (11R) |
9 |
|
Single vitamins/minerals not Folic acid, iron, calcium or vitamin C (54M) |
61 |
|
Skimmed milk (12R) |
11 |
|
Smoothies (61R) |
10 |
|
Soft drinks low calorie carbonated (58B) |
24 |
|
Soft drinks low calorie concentrated (58A) |
13 |
|
Soft drinks low calorie, ready to drink, still (58C) |
26 |
|
Soft drinks not low calorie carbonated (57B) |
39 |
|
Soft drinks not low calorie concentrated (57A) |
23 |
|
Soft drinks not low calorie, ready to drink, still (57C) |
43 |
|
Soft margarine not polyunsaturated (20B) |
3 |
|
Soup (homemade) (50D) |
39 |
|
Soup (manufactured/retail) (50C) |
48 |
|
Spirits (47B) |
1 |
|
Sponge puddings (homemade) (9F) |
10 |
|
Sponge puddings (manufactured) (9E) |
9 |
|
Sugar (41A) |
15 |
|
Sugar confectionery (43R) |
54 |
|
Sweet spreads fillings and icing (41R) |
23 |
|
Tap water only (51R) - |
2 |
|
Tea (made up) (51B) - |
9 |
|
Tomatoes not raw (37F |
14 |
|
Tomatoes raw (36C) |
3 |
|
White bread (not high fibre, not multiseed bread) (2R) |
58 |
|
White fish coated or fried (33R) |
139 |
|
Whole milk (10R) |
11 |
|
Wholemeal bread (3R) |
31 |
|
Wine (48A) |
16 |
|
Yogurt (15B) |
82 |
Table A3: Calcium exposure from foods and supplements.
|
Age group |
Category |
Chronic exposure of calcium from food (mg/person/day)* Mean |
97.5th Percentile |
Calcium exposure from supplements, upper range (mg/person/day) |
Calcium exposure from supplements and diet (mean) (mg/person/day) |
Calcium exposure from supplements and diet (97.5th percentile) (mg/person/day) |
|
Infants (4-18 months) |
Entire diet |
680 |
1200 |
450 |
1100 |
1700 |
|
Current |
Levels in flour |
15 |
48 |
450 |
470 |
500 |
|
Proposed |
Levels in flour |
19 |
61 |
450 |
470 |
500 |
|
1.5-3years |
Entire diet |
740 |
1300 |
450 |
1200 |
1800 |
|
Current |
Levels in flour |
34 |
78 |
450 |
490 |
530 |
|
Proposed |
Levels in flour |
43 |
99 |
450 |
490 |
550 |
|
4 - 10 years |
Entire diet |
760 |
1400 |
450 |
1200 |
1900 |
|
Current |
Levels in flour |
55 |
110 |
450 |
510 |
560 |
|
Proposed |
Levels in flour |
71 |
140 |
450 |
520 |
590 |
|
11 - 18years |
Entire diet |
770 |
1500 |
450 |
1200 |
2000 |
|
Current |
Levels in flour |
68 |
140 |
450 |
520 |
590 |
|
Proposed |
Levels in flour |
87 |
180 |
450 |
540 |
630 |
|
19 - 64 years |
Entire diet |
810 |
1600 |
1200 |
2000 |
2800 |
|
Current |
Levels in flour |
58 |
140 |
1200 |
1300 |
1300 |
|
Proposed |
Levels in flour |
74 |
180 |
1200 |
1300 |
1400 |
|
65 + years |
Entire diet |
820 |
1500 |
1200 |
2000 |
2700 |
|
Current |
Levels in flour |
49 |
120 |
1200 |
1200 |
1300 |
|
Proposed |
Levels in flour |
62 |
150 |
1200 |
1300 |
1400 |
Table A4: Iron exposure from food and supplements.
|
Category |
Chronic exposure to iron (mg/person/day)* Mean |
97.5th Percentile |
Iron exposure from supplements, upper range (mg/person/day) |
Iron exposure from supplements and diet (mean) (mg/person/day) |
Iron exposure from supplements and diet (97.5th percentile) (mg/person/day) |
|
|
Infants (4-18 months) |
Entire diet |
6.8 |
12 |
7.5 |
14.0 |
20 |
|
Current |
Levels in flour |
0.27 |
0.84 |
7.5 |
7.8 |
8.3 |
|
Proposed |
Levels in flour |
0.34 |
1.1 |
7.5 |
7.8 |
8.6 |
|
1.5-3years |
Entire diet |
6 |
10 |
7.5 |
14 |
18 |
|
Current |
Levels in flour |
0.6 |
1.4 |
7.5 |
8.1 |
8.9 |
|
Proposed |
Levels |
0.76 |
1.7 |
7.5 |
8.3 |
9.2 |
|
4 - 10 years |
Entire diet |
8.1 |
14 |
7.5 |
16 |
22 |
|
Current |
Levels in flour |
0.97 |
1.9 |
7.5 |
8.5 |
9.4 |
|
Proposed |
Levels in flour |
1.2 |
2.4 |
7.5 |
8.7 |
9.9 |
|
11 - 18years |
Entire diet |
9.3 |
17 |
7.5 |
17 |
25 |
|
Current |
Levels in flour |
1.2 |
2.5 |
7.5 |
8.7 |
10 |
|
Proposed |
Levels in flour |
1.5 |
3.2 |
7.5 |
9 |
11 |
|
19 - 64 years |
Entire diet |
10 |
19 |
28 |
38 |
47 |
|
Current |
Levels in flour |
1 |
2.4 |
28 |
29 |
30 |
|
Proposed |
Levels in flour |
1.3 |
3.1 |
28 |
29 |
31 |
|
65 + years |
Entire diet |
9.7 |
17 |
28 |
38 |
45 |
|
Current |
Levels in flour |
0.85 |
2.1 |
28 |
29 |
30 |
|
Proposed |
Levels in flour |
1.1 |
2.6 |
28 |
29 |
31 |
Table A5: Exposure to niacin from food and supplements.
|
Age Group |
Category |
Chronic exposure to niacin (mg/person/day)* Mean |
97.5th Percentile |
Niacin exposure from supplements, upper range (mg/person/dy) |
Niacin exposure from supplements and diet (mean) (mg/person/day) |
Nacin exposure from supplements and diet (97.5th percentile) (mg/person/day) |
|
Infants (4-18 months) |
Entire diet |
14 |
25 |
20 |
34 |
45 |
|
Current |
Levels in flour |
0.26 |
0.81 |
20 |
20 |
21 |
|
Proposed |
Levels in flour |
0.39 |
1.2 |
20 |
20 |
21 |
|
1.5-3 years |
Entire diet |
18 |
28 |
20 |
38 |
48 |
|
Current |
Levels in flour |
0.58 |
1.3 |
20 |
21 |
21 |
|
Proposed |
Levels in flour |
0.87 |
2 |
20 |
21 |
22 |
|
4 - 10 years |
Entire diet |
25 |
39 |
20 |
45 |
59 |
|
Current |
Levels in flour |
0.94 |
1.9 |
20 |
21 |
22 |
|
Proposed |
Levels in flour |
1.4 |
2.8 |
20 |
21 |
23 |
|
11 - 18 years |
Entire diet |
31 |
55 |
20 |
51 |
75 |
|
Current |
Levels in flour |
1.2 |
2.4 |
20 |
21 |
22 |
|
Proposed |
Levels in flour |
1.7 |
3.6 |
20 |
22 |
24 |
|
19 - 64 years |
Entire diet |
36 |
68 |
1000 |
1000 |
1100 |
|
Current |
Levels in flour |
0.98 |
2.4 |
1000 |
1000 |
1000 |
|
Proposed |
Levels in flour |
1.5 |
3.6 |
1000 |
1000 |
1000 |
|
65 + years |
Entire diet |
31 |
52 |
1000 |
1000 |
1100 |
|
Current |
Levels in flour |
0.83 |
2 |
1000 |
1000 |
1000 |
|
Proposed |
Levels in flour |
1.2 |
3 |
1000 |
1000 |
1000 |
Table A6: Exposure to thiamin from food and supplements.
|
Age group |
Category |
Chronic exposure to thiamin (mg/person/day)* Mean |
97.5th Percentile |
Exposure of thiamin from supplements, upper range (mg/person/day) |
Thiamin expsoure from supplements and diet (mean) (mg/person/day) |
Thiamin exosure from supplements and diet (97.5th percentile) (mg/person/day) |
|
Infants (4-18 months) |
Entire diet |
0.81 |
1.3 |
5 |
5.9 |
6.3 |
|
Current |
Levels in flour |
0.039 |
0.12 |
5 |
5.0 |
5.1 |
|
1.5-3years |
Entire diet |
1 |
1.8 |
5 |
6 |
6.8 |
|
Current |
Levels in flour |
0.087 |
0.2 |
5 |
5.1 |
5.2 |
|
4 - 10 years |
Entire diet |
1.3 |
2.3 |
5 |
6.3 |
7.3 |
|
Current |
Levels in flour |
0.14 |
0.28 |
5 |
5.1 |
5.3 |
|
11 - 18years |
Entire diet |
1.4 |
2.8 |
5 |
6.4 |
7.8 |
|
Current |
Levels in flour |
0.17 |
0.36 |
5 |
5.2 |
5.4 |
|
19 - 64 years |
Entire diet |
1.5 |
2.8 |
500 |
500 |
500 |
|
Current |
Levels in flour |
0.15 |
0.36 |
500 |
500 |
500 |
|
65 + years |
Entire diet |
1.5 |
2.7 |
500 |
500 |
500 |
|
Current |
Levels in flour |
0.12 |
0.3 |
500 |
500 |
500 |
Table A5. Online sources for iron supplement data.
|
Supplement |
Iron dosage per day (mg) |
Link |
Notes |
|
Sainsbury's Health Multivitamins & Iron Tablets 1 a Day x60 |
14 |
Sainsbury's Health Multivitamins & Iron Tablets 1 a Day x60 | Sainsbury's (sainsburys.co.uk) |
1 tablet per day |
|
Feroglobin Capsules |
17 |
Iron (as fumerate) 1 tablet per day |
|
|
Ultra Iron |
14 |
1 tablet per day |
|
|
Holland & Barrett Gentle Iron 20mg 90 Capsules |
20 |
Holland & Barrett Gentle Iron 20mg 90 Capsules : Amazon.co.uk: Health & Personal Care |
1 tablet per day |
|
Iron Complex 90 Capsules |
14 |
1 tablet per day |
|
|
Iron & Folic Acid Tablets |
14 |
1 tablet per day |
|
|
Nature's Bounty Gentle Iron Complex with Vitamins B12 and C Capsules x100 |
17 |
Iron (as Ferrous Bisglycinate) 1 tablet per day |
|
|
Solgar® Gentle Iron (Iron Bisglycinate) 20 mg Vegetable Capsules - Pack of 90 |
20 |
1 tablet per day |
|
|
Iron 14mg |
28 |
1-2 tablet per day |
|
|
Iron (Ferrous Bisglycinate) Capsules (K-Pure® ) 20mg |
20 |
1 tablet per day |
|
|
Nature's Bounty, Gentle Iron, 28 mg, 90 Capsules |
28 |
Nature's Bounty, Gentle Iron, 28 mg, 90 Capsules (iherb.com) |
1 tablet per day |
|
Range |
14-28 |
n/a |
n/a |
|
Supplement |
Iron dosage per day (mg) |
Link |
Notes |
|
Holland and Barrett Kids Multivits & Iron Tablets | Holland & Barrett |
7.5 |
Holland and Barrett Kids Multivits & Iron Tablets | Holland & Barrett |
n/a |
|
Tasty Chews, A Chewable Multivitamin and Mineral For Children 4-14 years |
2.8 |
Children's Chewable Multivitamins | Nature's Best (naturesbest.co.uk) |
n/a |
|
Wellkid Smart Chewable |
7 |
1 tablet per day children aged 4-12 years |
|
|
Solgar Kangavites Tropical Vitamins for Children - 120 Chewables |
5 |
Solgar Kangavites Tropical Vitamins for Children - 120 Chewables | bodykind |
Children 3-5 years 1 tablet per day children 6+ years 2 per day |
Table A6. Online sources for calcium supplement data.
|
Supplement |
Calcium dosage per day (mg) |
Link |
Notes |
|
Calcium & Magnesium Tablets | MYPROTEIN™ |
800 |
3 tablets per day |
|
|
Osteocare Original |
800 |
2 tablets per day The UK’s No.1 calcium formula for women and men of all ages. |
|
|
Numark Chewable Calcium & Vitamin D - 30 x 400mg Tablets |
800 |
Numark Chewable Calcium & Vitamin D - 30 x 400mg Tablets | Chemist 4 U (chemist-4-u.com) |
1 tablet per day Numark Vitamin D and Calcium Tablets are not suitable for children under the age of 12. |
|
OsteoGuard®, High Strength Calcium and Magnesium Formula |
1000 |
Osteoguard® Calcium & Magnesium Tablets | Nature's Best (naturesbest.co.uk) |
1-2 tablets per day This product is suitable for all adults. |
|
Natures Aid Chewable Calcium with Vitamin D - 60 Tablets |
800 |
Natures Aid Chewable Calcium with Vitamin D - 60 Tablets | bodykind |
1-2 tablets per day |
|
Calcium + Vitamin D3 + Vitamin K1 Capsules 1000mg |
200 |
1 tablet per day |
|
|
Super Calcium |
780 |
1-3 tablets per day |
|
|
Nature's Bounty, Calcium Plus Vitamin D3, 600 mg, 220 Rapid Release Softgels |
1200 |
Nature's Bounty, Calcium Plus Vitamin D3, 600 mg, 220 Rapid Release Softgels (iherb.com) |
2 per day For adults, take two (2) softgels daily, preferably with meals. |
|
Alive! Calcium Gummies with Vitamin D3 | 60 Chewable Gummies | Specially Formulated for Adults and Children From 3 Years. |
500 |
2 soft gels per day 13+ years |
|
|
Range |
200-1200 |
n/a |
n/a |
|
Supplement |
Calcium dosage per day (mg) |
Link |
Notes |
|
Children's Chewable Multivitamins | Nature's Best (naturesbest.co.uk) |
80 |
Children's Chewable Multivitamins | Nature's Best (naturesbest.co.uk) |
|
|
CALCI-YUMMIES |
150 |
Children 2+ years take 1 gummy per day |
|
|
Lil Critters Calcium Gummy Bears with Vitamin D-200 Bears |
200 |
Lil Critters Calcium Gummy Bears with Vitamin D-200 Bears : Amazon.co.uk: Health & Personal Care |
children aged 3+ advised to take 2 gummies |
|
NaturesPlus Animal Parade Source of Life Calcium Children’s Chewable - Natural Vanilla Sundae Flavour - 90 Chewable Animal Shaped Tablets - Gluten Free - 90 Servings : Amazon.co.uk: Health & Personal Care |
250 |
2+ years 2 gummies per day |
|
|
Wellkid Calcium Liquid |
300-450 |
10ml (300mg) children aged 4-6 years and 15 ml (450 mg) for children aged 7-12 years |
|
|
Calcium and Vitamin D softies 30 |
280 |
Haliborange Kids Calcium and Vitamin D softies 30 : Amazon.co.uk: Health & Personal Care |
1-2 softies per day Recommended for children |
|
Alive! Calcium Gummies with Vitamin D3 | 60 Chewable Gummies | Specially Formulated for Adults and Children From 3 Years. |
250 |
1 soft gel per day for children aged 3-12 years |
|
|
Solgar Kangavites Tropical Vitamins for Children - 120 Chewables |
128 |
Solgar Kangavites Tropical Vitamins for Children - 120 Chewables | bodykind |
Children 3-5 years 1 tablet per day children 6+ years 2 per day |
Table A7. Online sources for Niacin supplement data.
|
Supplement |
Niacin dosage per day (mg) |
Link |
Notes |
|
Vitamin B3 Niacin/Nicotinic Acid (Flush Effect) 50mg, Magnesium Stearate Free & No Nasty Additives, Made in Wales … (180 Capsules) |
50 |
1 tablet per day |
|
|
NOW Foods, Niacin, 500 mg, 250 Tablets |
500 |
1 tablet per day |
|
|
Solgar Niacin (Vitamin B3) 500 Mg Vegetable Capsules - Pack Of 100 |
500 |
1 tablet per day |
|
|
Solgar Niacin 100mg Tablets 100 |
100 |
1 tablet per day |
|
|
Swanson Niacin, 100mg - 250 tablets |
100 |
Swanson Niacin, 100mg - 250 tablets (lifestylehealthstore.co.uk) |
1 tablet per day |
|
Niacin, 100 mg, 300 Tablet |
100 |
1 tablet per day |
|
|
Niacin, 1000 mg, 100 Quick Release Capsules, 2 Bottles |
1000 |
Niacin 1000 mg 2 x 100 Capsules | Niacin 1000 Tablets | PipingRock Health Products |
1 tablet per day |
|
Vitamin B3 250mg (Niacin), Contributes to the Normal Function Of The Nervous System |
250 |
Vitamin B3 & Niacin Tablets | Nature's Best (naturesbest.co.uk) |
1 tablet per day |
|
Source Naturals, Niacin, 100 mg, 250 Tablets |
100 |
1 tablet per day |
|
|
Nature's Way, Niacin, Vitamin B3, 100 mg, 100 Capsules |
100 |
Nature's Way, Niacin, Vitamin B3, 100 mg, 100 Capsules (iherb.com) |
1 tablet per day |
|
Range |
50-1000 |
n/a |
n/a |
|
Supplement |
Niacin dosage per day (mg) |
Link |
Notes |
|
Holland and Barrett Kids Multivits & Iron Tablets | Holland & Barrett |
13.5 |
Holland and Barrett Kids Multivits & Iron Tablets | Holland & Barrett |
1 tablet per day suitbale for 4+ years |
|
Children's Chewable Multivitamins | Nature's Best (naturesbest.co.uk) |
9 |
Children's Chewable Multivitamins | Nature's Best (naturesbest.co.uk) |
|
|
Wellkid Peppa Pig Multi-vits |
4.8 |
2 jellies per day children 3+ NE |
|
|
Wellkid Smart Chewable |
9 |
1 tablet per day children aged 4-12 years |
|
|
Kids Multivitamin Gummies |
8.2 |
1 gummy per day |
|
|
Solgar Kangavites Tropical Vitamins for Children - 120 Chewables |
20 |
Solgar Kangavites Tropical Vitamins for Children - 120 Chewables | bodykind |
Children 3-5 years 1 tablet per day children 6+ years 2 per day |
Table A8. Online sources for thiamin supplement data.
|
Supplement |
Thiamin dosage per day (mg) |
Link |
Notes |
|
Solgar Vitamin B1 (Thiamin) 500 mg Tablets - Pack of 100 - Supports Energy Metabolism and Nervous System - Vegan |
500 |
1 tablet per day |
|
|
Natures Aid Vitamin B1 Thiamin - 90 x 100mg Tablets |
100 |
Natures Aid Vitamin B1 Thiamin - 90 x 100mg Tablets | bodykind |
1 tablet per day |
|
Vitamed Thiamine 100mg 100 Tablets |
107 |
Vitamed Thiamine 100mg 100 Tablets : Amazon.co.uk: Health & Personal Care |
1 tablet per day |
|
Vitamin B1 100mg (Thiamin) 180 Tablets Suitable for Vegans and Vegetarians Made in UK by Futurevits 6 Month Supply, Premium Grade only. |
100 |
1 tablet per day |
|
|
B-1 (Thiamin), 100 mg, 250 Tablets | PipingRock Health Products |
100 |
B-1 (Thiamin), 100 mg, 250 Tablets | PipingRock Health Products |
1 tablet per day |
|
HealthAid Vitamin B1 (Thiamin) 100mg - Prolong Release - 90 Tablets |
100 |
1 tablet per day |
|
|
Source Naturals, B-1, Thiamin, 100 mg, 100 Tablets |
100 |
Source Naturals, B-1, Thiamin, 100 mg, 100 Tablets (iherb.com) |
1 tablet per day |
|
Holland & Barrett Vitamin B1 + Thiamine 100mg 120 Tablets |
100 |
1 tablet per day |
|
|
Lindens Vitamin B1 Thiamine Tablets - 100 Pack - for Heart, Immune and Psychological Function & Energy Release - UK Manufacturer, Letterbox Friendly |
100 |
1 tablet per day |
|
|
Vitamin B1 (Thiamin) 100mg 180 Vegan Tablets |
100 |
Vitamin B1 (Thiamin) 100mg 180 Vegan Tablets : Amazon.co.uk: Health & Personal Care |
1 tablet per day |
|
Range |
100-500 |
n/a |
n/a |
|
Supplement |
Thiamin dosage per day (mg) |
Link |
Notes |
|
Wellkid Peppa Pig Multi-vits |
0.7 |
2 jellies per day children 3+ |
|
|
Wellkid Smart Chewable |
0.9 |
1 tablet per day children aged 4-12 years |
|
|
Centrum Kids Multivitamins & Minerals, 30 Tablets |
0.5 |
Centrum Kids Multivitamins & Minerals, 30 Tablets : Amazon.co.uk: Health & Personal Care |
n/a |
|
[New] Creekside Naturals Mighty Eyes, Eye Vitamin and Mineral Supplement for Children with Lutein, Zeaxanthin, Thiamine, and Zinc, Vegan, Zero Sugar, 30 Soft Chewables |
5 |
1 tablet per day |
|
|
Solgar Kangavites Tropical Vitamins for Children - 120 Chewables |
1.5 |
Solgar Kangavites Tropical Vitamins for Children - 120 Chewables | bodykind |
Children 3-5 years 1 tablet per day children 6+ years 2 per day |