S.L. 449.36 Art. 13ferrous ferric ferrous ferrous ferric ferric elemental ferrous cupric cupric citrate cupric cupric copper sodium sodium potassium potassium zinc acetate zinc chloride zinc citrate zinc zinc lactate zinc oxide zinc zinc sulphate manganese manganese manganese manganese manganese manganese sodium sodiu

VITAMIN C

(a) L-ascorbic acid

(b) sodium-L-ascorbate

(c) calcium-L-ascorbate

(d) potassium-L-ascorbate

(e) L-ascorbyl 6-palmitate B. Minerals calcium carbonate calcium chloride calcium salts of citric acid calcium gluconate calcium glycerophosphate calcium lactate calcium salts of orthophosphoric acid calcium hydroxide calcium oxide magnesium acetate magnesium carbonate magnesium chloride magnesium salts of citric acid magnesium gluconate magnesium glycerophosphate magnesium salts of orthophosphoric acid magnesium lactate magnesium hydroxide magnesium oxide magnesium sulphate ferrous carbonate ferrous citrate ferric ammonium citrate ferrous gluconate fumarate sodium diphosphate lactate sulphate diphosphate (ferric pyrophosphate)

saccharate iron (carbonyl+electrolytic+hydrogen reduced) bisglycinate carbonate gluconate sulphate lysine complex iodide iodate iodide iodate gluconate carbonate carbonate chloride citrate gluconate glycerophosphate sulphate bicarbonate carbonate chloride citrate gluconate lactate sodium hydroxide sodium salts of orthophosphoric acid potassium bicarbonate potassium carbonate potassium chloride potassium citrate potassium gluconate potassium glycerophosphate potassium lactate potassium hydroxide potassium salts of orthophosphoric acid sodium selenate sodium hydrogen selenite sodium selenite chromium (III) chloride chromium (III) sulphate ammonium molybdate (molybdenum (VI))

sodium molybdate (molybdenum (VI)) potassium fluoride sodium fluoride THIRD SCHEDULE Permitted Levels and Guidance Levels for Vitamins and Minerals

Nutrient Maximum Guidance Vulnerable Groups Additional Notes Upper Level Level (per (per day) on day) on the the basis of a basis of a 60 60 kg adult kg adult

(b) (c) (d) (e) (f)

Biotin - 0.9 mg - -Folic Acid - 1.0 mg Individuals at risk of vitamin B12 deficiency, in whom folic acid supplementation may mask the haematological signs and symptoms of this deficiency, allowing the associated myeloneuropathy to develop. Patients treated with drugs which interfere with folate metabolism, and in whom folic acid supplementation may be associated with reduced effectiveness of the therapy or increased incidence of side effects. Nicotinic - 17.0 mg Individuals with This guidance acid hepatic dysfunciton level is based on or a history of liver intakes of disease, diabetes conventional mellitus, active formulations of peptic ulcer disease, nicotinic acid. gout, cardiac Sustained release arrhythmias, forms may not be migraine headaches used in food and alcoholism may supplements. be particularly susceptible to nicotinic acid. Nicotina- - 500 mg - There is a lack of mide data on the safety of nicotinamide in pregnancy, and there are no relevant animal data. Therefore, this level does not apply to pregnant women. Pantothenic - 200 mg - -acid Reference Nutrient Maximum Guidance Vulnerable Groups Additional Number Upper Level Level (per (per day) on day) on the the basis of a basis of a 60 60 kg adult kg adult

(a) (b) (c) (d) (e) 5 Riboflavin - 100 mg There is a theoretical (Vitamin possibility that B2) neonates undergoing phototherapy for hyperbilirubinaemia may be at risk at this time from photo-activation of riboflavin. 6 Thiamin - 100 mg No potential This (Vitamin vulnerable groups applicable B1) have been identified; w however, the clinical forms trials indicate that only. there is a possibility that a very small number of people may be particularly sensitive (allergic) to thiamin. 7 Vitamin B6 10 mg - -(Pyrido-xine) 8 Vitamin - 1mg -B12 (Cobala-min) 9 Vitamin C - 1000 mg Individuals unable to regulate iron absorption due to haemochromatosis or thalassaemia may be vulnerable to the enhanced iron absorption caused by vitamin C. Nutrient Maximum Guidance Vulnerable Groups Additional Notes Upper Level Level (per (per day) on day) on the the basis of a basis of a 60 60 kg adult kg adult

(b) (c) (d) (e) (f) Vitamin A - 1500µg Retinol may 1µg Retinol (Retinol) represent a Equivalent = 1µg teratogenic risk, retinol = 1.78 µg particularly within retinyl palmitate = the first trimester of 6 µg β-carotene = pregnancy. 12 µg other carotenoids with Women who are provitamin A pregnant or who activity = 3.33 IU wish to become vitamin A activity pregnant should not from retinol take dietary supplements containing vitamin A except on medical advice. Other groups potentially vulnerable to vitamin A toxicity include the young; older people; those suffering from osteoporosis, chronic renal failure, diabetes mellitus or under-nutrition; haemodialysis patients and individuals with compromised liver function. An apparent vitamin A intolerance has been observed on some children. β-carotene 7 mg - Groups vulnerable to -β-carotene toxicity include current smokers, individuals with previous high-level exposure to asbestos, those with high alcohol intakes, and/or a history of myocardial infarction. Reference Nutrient Maximum Guidance Vulnerable Groups Additional Number Upper Level Level (per (per day) on day) on the the basis of a basis of a 60 60 kg adult kg adult

(a) (b) (c) (d) (e) 11 Vitamin D - 0.025 mg Adults with disease states such as sarcoidosis, Mycobacterium infections and idiopathic hypercalciuria and hypercalcaemia are more vulnerable to hypercalcaemia resulting from moderate vitamin D intakes (>0.025mg/ day). Infants are most at risk of developing hypervitaminosis D; hypercalcaemia has been reported at vitamin D intakes of 0.050 mg/day and above. 12 Vitamin E 800 IU - -(727 mg) 13 Vitamin K - 1 mg Individuals with glucose-6-phosphate Vitamin K1 dehydrogenase (phyllo-deficiency are more quinone) susceptible to the development of methaemoglobanae mia, and this would include oxidative damage caused by menadione (vitamin K3). Infants are vulnerable to vitamin K3 toxicity. MINERALS 14 Chromium - 9 mg -(trivalent) 15 Copper - 2 mg Haemodialysis patients and subjects with chronic liver disease are potentially sensitive to copper excess. Children may be at increased risk of copper toxicity due to a combination of efficient uptake and immature biliary excretion. Nutrient Maximum Guidance Vulnerable Groups Additional Notes Upper Level Level (per (per day) on day) on the the basis of a basis of a 60 60 kg adult kg adult

(b) (c) (d) (e) (f) Iodine - 0.2 mg Pregnant and -lactating women, and neonates are considered to be vulnerable groups as iodine freely crosses the placenta and is expressed in breast milk, and goitre and hypothyroidism have been reported to occur in the offspring of mothers exposed to pharmacological doses of iodine and iodide. Manganese - 4 mg Anaemic individuals -(for the may be vulnerable to general the toxic effects of population) manganese due to the increased 0.5 mg absorption that (forproducts occurs in states of intended for iron deficiency. the older population) Groups with impaired biliary clearance, such as patients with liver disease or older people, may also be susceptible to manganese accumulation and toxicity. It has also been reported that ethanol and long-term use of anti-psychotic drugs increases the susceptibility of humans to manganese toxicity. Molybde- - 25µg - -num Selenium - 0.2 mg - -Zinc - 25 mg Zinc -supplementation may increase the levels of glycosylated haemoglobin in diabetics. Reference Nutrient Maximum Guidance Vulnerable Groups Additional Number Upper Level Level (per (per day) on day) on the the basis of a basis of a 60 60 kg adult kg adult

(a) (b) (c) (d) (e) 21 Calcium - 1500 mg Patients with renal failure are particularly susceptible to developing hypercalcaemia when taking calcium supplements. Individuals without renal failure taking diuretics may also be at increased risk. Patients with absorptive or renal hypercalcuria, primary hyperthyroidism and sarcoidosis may have a higher risk of renal stone formation following calcium supplementation. 22 Fluoride - 0.01 mg 8 year old children and younger have a much higher susceptibility to dental fluorosis. 23 Iron - 17 mg Individuals with pre-existing gastrointestinal tract disease or chronic hepatitis, have been shown to be vulnerable to the toxic effects of iron. 24 Magnesium - 400 mg -25 Phosphorus - 250 mg -Nutrient Maximum Guidance Vulnerable Groups Additional Notes Upper Level Level (per (per day) on day) on the the basis of a basis of a 60 60 kg adult kg adult

(b) (c) (d) (e) (f) Potassium - 3700 mg Older people may be -vulnerable to potassium toxicity due to reduced physiological resrve in renal function. Individuals with pre-existing renal disease, hyperkalaemia, adrenal insufficiency, acidosis or insulin deficiency are also vulnerable, as are those using certain drugs, such as potassium-sparing diuretics, β-adrenergic blockers, angiotensin-converting enzyme inhibitors, digitalis, non-steroidal anti-inflammatorydrugs, arginine hydrochloride and succinylcholine. Infants may be vulnerable to excessive potassium due to limited renal reserve and immature function. Sodium - - Salt-sensitive Because sodium chloride persons chloride may have effects at normal dietary intakes in suceptible individuals, it is not recommended for use in supplements. Levels of sodium shall be kept as low as possible unless the manufacturer is able to demonstrate a clear benefit to the consumer from a higher level. FOURTH SCHEDULE Illustrative List of Categories of Substances other than Nutrients which present in Food Supplements Herbs

Botanical products Other plant-derived substances Amino acids

Fatty acids Enzymes Organ tissues

Glandular tissues Constituents, concentrates, metabolites and extracts of plant or animal

FIFTH SCHEDULE

Guidance Body Weights per Age Bracket The following shall be taken as guidance body weights for the indicated, for the purposes of regulation 5.8. Age Group (years) Guidance Body Weight (kg) 1 – 3 12 4 – 6 18 7 – 10 24 11 – 14 36 15 – 17 48 18 + 60