The calculation model was published and presented to the Commission in December 2021.
Our previous article described on the reopening of the European Commission’s work on the subject of harmonized values of vitamins and minerals in fortified foods and food supplements, and the suggestions that the Commission received from the EHPM and from the country of Germany. In these lines, we will focus on the model and the values proposed by the EHPM, that concern the food supplement category.
- The maximum quantity of micronutrients in food supplements: calculation
The formula proposed by the EHPM to calculate the maximum dose is, for each micronutrient:
Maximum amount = UL (Tolerable Upper Intake Level) – intake observed at the 95° percentile
The “raw” result will then be rounded and subjected to further evaluation if necessary.
Some micronutrients may be accompanied by additional consumer information, which may:
- Warn about possible mild undesirable effects that may occur among particularly sensitive people (such as “may cause skin flushes in sensitive people” for vitamin B3),
- Highlight the importance of a short-term intake (as in the case with iron),
- Represent additional warnings aimed at specific population subgroups (such as “not to be taken by heavy smokers” for beta-carotene).
- The maximum quantity of micronutrients in food supplements: proposed values
After providing a conceptual methodology for establishing maximum doses, the EHPM goes further by applying it in practice and proposing maximum and minimum values for vitamins and minerals.
- As UL values, the model used those established by EFSA over the past several years; when these were not available, as for iron or manganese, those established by the American Institute of Medicine (IoM) were used.
- The intakes considered are an average of those from the latest dietary surveys from the Netherlands (covering the 2012-2016 period) and Ireland (surveys published between 2008 and 2019), countries thought to have a “mature market” concerning food supplements and fortified foods. In the case of manganese and other nutrients, values were missing and calculations were based on EFSA dietary reference values (DRVs).
For the eight micronutrients that were the subject of the Commission’s request to EFSA (retinol, beta-carotene, vitamin D, E, B6, folic acid/folate, iron, and manganese) (see our previous article), Orchidali compared the maximum values proposed by EHPM with those currently set by France, Germany and Italy.
The results are interesting: for each of the eight compounds considered, the EHPM maximum values were found to be higher than in France, where the values are in turn higher than in Germany. Compared to Italy, all considered vitamins show higher maximum doses in the EHPM model. Iron and manganese, on the other hand, have lower maximum doses.
- The minimum quantity of micronutrients in food supplements
The EHPM proposal also concerns minimum doses, and suggests:
- 15% of the nutrient reference value (NRV) for supplements consisting of a single micronutrient (so as to ensure a useful quantity),
- 6% of the NRV for calcium and magnesium, when present, in supplements containing multiple nutrients (this recommendation has been driven by technological considerations),
- A minimum dose of boron (which does not have an NRV) of 0.23 mg.
Although the methodology of the EHPM proposal may have some limitations, such as the choice of the two countries that are sources of dietary intake data and their representativeness of the whole EU, the model has the merit of presenting a clear, evidence-based, and easily applicable and replicable proposal to the issue of establishing maximum and minimum doses of vitamins and minerals in supplements. It is worthy of note that the EHPM model does not suggest any value concerning fortified food.
Orchidali accompanies you in formulating food supplements in line with European regulations.
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Focus on the EHPM model for setting maximum and minimum amounts of vitamins and minerals in food supplements
The calculation model was published and presented to the Commission in December 2021.
Our previous article described on the reopening of the European Commission’s work on the subject of harmonized values of vitamins and minerals in fortified foods and food supplements, and the suggestions that the Commission received from the EHPM and from the country of Germany. In these lines, we will focus on the model and the values proposed by the EHPM, that concern the food supplement category.
The formula proposed by the EHPM to calculate the maximum dose is, for each micronutrient:
Maximum amount = UL (Tolerable Upper Intake Level) – intake observed at the 95° percentile
The “raw” result will then be rounded and subjected to further evaluation if necessary.
Some micronutrients may be accompanied by additional consumer information, which may:
After providing a conceptual methodology for establishing maximum doses, the EHPM goes further by applying it in practice and proposing maximum and minimum values for vitamins and minerals.
For the eight micronutrients that were the subject of the Commission’s request to EFSA (retinol, beta-carotene, vitamin D, E, B6, folic acid/folate, iron, and manganese) (see our previous article), Orchidali compared the maximum values proposed by EHPM with those currently set by France, Germany and Italy.
The results are interesting: for each of the eight compounds considered, the EHPM maximum values were found to be higher than in France, where the values are in turn higher than in Germany. Compared to Italy, all considered vitamins show higher maximum doses in the EHPM model. Iron and manganese, on the other hand, have lower maximum doses.
The EHPM proposal also concerns minimum doses, and suggests:
Although the methodology of the EHPM proposal may have some limitations, such as the choice of the two countries that are sources of dietary intake data and their representativeness of the whole EU, the model has the merit of presenting a clear, evidence-based, and easily applicable and replicable proposal to the issue of establishing maximum and minimum doses of vitamins and minerals in supplements. It is worthy of note that the EHPM model does not suggest any value concerning fortified food.
Orchidali accompanies you in formulating food supplements in line with European regulations.
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