There are three major and complementary ways of safely delivering the essential vitamins and minerals for human health and well-being:

  1. by promoting the consumption of nutrient-dense foods;
  2. by increasing the availability and intake of foods with added nutrients (fortified foods);
  3. and by appropriate use of food (dietary) supplements.

Regulatory authorities around the world need to ensure that levels of micronutrients in the total diet are safe, and that the cumulative intake from all sources does not lead to excessive intakes and any adverse effects in the population, including sensitive groups such as children, the elderly and women during pregnancy and lactation.

Risk analysis for nutrients differs from other substances in foods because vitamins and minerals are essential for life, and consequently adverse effects can result from suboptimal intakes and deficiencies as well as from excessive intakes.

Risk analysis comprises three distinct but closely linked components: risk assessment, risk management and risk communication. The primary objectives are not only to protect the health of consumers but also to take into account other legitimate factors including the facilitation of consumer choice and avoidance of barriers to international trade.

The key regulatory criteria to be taken into account for setting maximum amounts of vitamins and minerals in fortified foods and food supplements are:

  • The upper safe levels of each vitamin and mineral established by scientific risk assessment based on generally accepted scientific data, taking into account, as appropriate, the varying degrees of sensitivity of different consumer groups
  • The intake of vitamins and minerals from all dietary sources
  • Reference intakes of vitamins and minerals for the population
Principles for scientific risk assessment: problem formulation

STEP #1 Nutrient Hazard Identification

Review literature to identify potential health problems (e.g. deficiency and excess endpoints)

STEP #2 Nutrient Hazard Characterisation/Quantitative Evaluation of Critical Effects

Identify, where possible, level at which a nutrient causes adverse effects (e.g. dose–response, clinical, epidemiological, metabolic data, case reports).

Set acceptable range of oral intake (AROI) or tolerable upper intake level (UL) or safe upper limit (SUL).

STEP #3 Dietary Intake Assessment

Evaluation of the average intake of various population groups from food, water, supplements. Assess variability of the magnitude of intake using intake percentiles.

STEP #4 Nutrient Risk Characterisation

Integrate intake information and AROI, UL, SUL data.

Evaluate strength and weakness of each step and identify group of greatest concern.

Nutritional risk analysis identifies the proportion of the population or subpopulation likely to exceed the tolerable upper intake level (UL). ULs represent an intake that can be consumed daily over a lifetime without any significant risk to health, on the basis of the available evidence.

Scientific risk analysis and the setting of ULs have become internationally accepted ways to evaluate the safety of the essential nutrients and to underpin regulatory approaches to setting maximum levels of vitamins and minerals where appropriate in food supplements and fortified foods.

A comparison of the upper safe levels for total daily intake from the Scientific Committee on Food (SCF) and the European Food Safety Authority (EFSA), the US Institute of Medicine (IOM), and the daily levels for supplementation proposed by the UK Food Standards Agency Expert Group on Vitamins and Minerals (EVM)

Nutrient Unit SCF/EFSA total intake (UL) IOM total intake (UL) EVM for long-term supplementation (SUL) a
Vitamin A µg 3000 3000 1500 (G, T)
Beta-carotene mg Below 15 Not set 7 (not for smokers)
Vitamin D b µg 50→100 50→100 25 (G)
Vitamin E c mg 300 1000 540 (800 IU)
Vitamin K µg Not set Not set 1000 (G)
Thiamin (B1) mg Not set Not set 100 (G)
Riboflavin (B2) mg Not set Not set 40 (G) (43T)
Nicotinamide mg 900 35 d 500 (G) (560T)
Nicotinic acid mg 10 17
Pantothenic acid mg Not set Not set 200 (G) (210T)
Pyridoxine (B6) mg 25 100 200 (short term) e
10 (long term)
Folic acid µg 1000 (+dietary folate) 1000 supp. (+200 diet) 1000 (G) (1500T)
Vitamin B12 µg Not set Not set 2000 (G)
Biotin µg Not set Not set 900 (G) S (970T)
Vitamin C mg Not set 2000 1000 (G)
Calcium mg 2500 2500 1500 (G)
Magnesium mg 250 as supplement 350 as supplement+ diet 400 (G)
Iron mg Not set 45 17 (G)
Copper mg 5 10 1 (10T)
Iodine µg 600 1100 500 (G) (940T)
Zinc mg 25 40 25 (42T)
Manganese mg Not set 11 4 (G) (9–12T)
0.5 (G) for older people
Potassium mg Not set Not set 3700 (G)
Selenium µg 300 400 350 (450T)
Chromium (trivalent) f mg Not set Not set 10 (G, T)
Molybdenum µg 600 2000 Not set
Fluoride mg Not set 10 Outside terms of reference
Phosphorus mg Not set 4000 250 (G) (2400T)

G, guidance level; T, total intake; IU, International Unit.
a All EVM amounts relate to 60 kg bodyweight adult and figures in parentheses are total (T) amounts from all dietary sources.
b The UL for adults established by SCF in 2003 was 50 µg/day, the same as that from IOM. In 2010, IOM, and in 2012, EFSA, published their reassessments and the ULs were increased to 100 µg/day for adults, including pregnant and lactating women.
c d-α-tocopherol equivalents/day.
d This UL is applied to the total of all forms of niacin resultant on the IOM’s decision to establish a lowest-observed-adverse-effect level(LOAEL) based on skin flushing by nicotinic acid. In the EU niacin supplements and niacin fortification are generally in the form of nicotinamide.
e Implied in text of report.
f Picolinates are excluded.

Current levels of nutrients used in food supplements and in food fortification practices for over three decades have been shown to be safe and effective. However, because of the increased interest in, and availability of, fortified foods and food supplements, it is important to continue to undertake appropriate nutritional risk analysis measures to ensure consumer protection. The nutrition information provided on all labels of food supplement products and directions for use help facilitate informed choice.

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