The European Commission requested the EFSA to update the framework for Tolerable Upper Intake Level (UL) assessment and the current ULs for some vitamins and minerals. When it was not possible to establish an UL, the Commission requested the ESA to determine the safe level which is an indication on the highest level of intake for which there is a reasonable confidence on the absence of adverse effects. Consequently, the EFSA published until 2024 the guidance for establishing and applying tolerable upper intake levels for vitamins and essential minerals and the scientific opinions on the tolerable upper intake for preformed vitamin A and bêta-carotene, for vitamin E, for vitamin D, and some essential minerals such as iron, manganese, selenium
The EFSA shared the results and conclusions of its assessment during a webinar on November 14, 2023.
What is the Tolerable Upper Intake Level(UL) of a nutrient?
The Tolerable Upper Intake Level(UL) of a nutrient is defined as the maximum amount (from all dietary sources including foods, fortified foods and food supplements) of a nutrient that can be consumed safely over a long period of time. The maximum amount (MA) is the maximum amount of a nutrient that can be added to foods (fortified foods) or used in food supplements. MAs are legal values determined by the European Commission and the Member States who are the risk managers.
Backgound
In 2 000, the Scientific Committee on Food (SCF) published the guidelines for the development of ULs for vitamins and minerals. From 2000 to 2005, the ULs for vitamins and minerals were published. In 2012, the ULs for calcium and vitamin D were updated. In 2018 the UL for vitamin D in infants was set up by the NDA Panel. From 2020 to 2024, under the request from the Commission to review the evidence related to minerals and vitamins, the EFSA updated the guidance for establishing the ULs and reviewed the ULs related to vitamins B6, B9, to liposoluble vitamins A,D and E and to some essential minerals : iron, manganese, and selenium.
What are the changes made by the EFSA ?
- ULs newly set up for vitamin A for infants:
The ULs for vitamin A for infants aged from 4 to 6 months and from 7 to 11 months have been newly set up. They were not been determined before. They are of 600 µg of Retinol Equivalent (RE) /d. No other changes of ULs for vitamin A compared to SCF, 2002 for the other age ranges.
- No UL determined for beta-carotene:
For the beta carotene, available data are not sufficient and suitable to establish a UL. The EFSA considers that smokers should avoid supplements containing beta-carotene and that supplemental beta-carotene by the general population should be limited to the purpose of meeting vitamin A requirements.
No changes of ULs for vitamin D:
For the vitamin D, the EFSA did not change the ULs previously set up in 2012. The ULs are of 25 µg of vitamin D equivalent /d for infants from 4-6 months of age and of 35 µg of vitamin D equivalent/d for infants from 7- 11 months, and of 50 µg vitamin D equivalent/d for the children aged from 1 to 10 years and of 100 µg of vitamin D equivalent for subjects aged of 11 y and more. The notion of vitamin D equivalent newly introduced takes into account the different sources of vitamin D (ergocalciferol, the vitamin D2, and cholecalciferol, the vitamin D3) with different bio availabilities.
- ULS newly set up for vitamin E for infants
For the vitamin E, the EFSA set up new ULs of 50 mg/d for infants of 4-6 months of age and of 60 mg/d for infants of 7-11 months of age. The other ULs stated in 2003 did not change for the other age ranges..
- For vitamin B6, the EFSA set up new ULs for infants and decreased the ULs for the other age ranges compared with the ULs defined in 2 000.
ULs newly set up for the vitamin B6 for infants of 4-6 months of age of 2,2 mg/d and for infants of 7-11 months of 2,5 mg/d.
New levels of ULs for vitamin B6 for children: aged 1-3 years: 3,2 mg/d, aged 4-6 years: 4,5 mg/d, aged 7-10 years: 6,1 mg/d ; aged 11-14 years: 8,6 mg/d, aged 15-17 years: 10,7 mg/d; for adults of 18 years and more, and pregnant and lactating women: 12 mg/d.
- For vitamin B9 (folates), the EFSA set up new ULs for infants of 4-11 months of 200µg/d.
The ULs of the other age ranges did not change.
- For selenium, the EFSA increased the ULs for the young children and decreased the ULS from the age of 11 years and more compared with the ULS determined in 2000.
New levels of ULS for children aged 1 -3 years of 70 µg/d and for children aged 4-6 years of age of 95µg/d.
New levels of ULS for children aged 11-14 years of 180µg/d, for children aged 15-17 years of 230 µg/d ; for adults of 18 years and more, and pregnant and lactating women : 255 µg/d.
No changes of ULs for the other age ranges.
For iron, the EFSA could not determine ULs on the basis of the available data and newly set up safe levels.
The EFSA considers that a dietary intake (from all sources) of 40 mg/d is safe for the general population. The panel set up safe levels for infants aged 4-11 months of 5 mg/d, and for children aged 1-3 years of 10 mg/d, 4-6 years of 15 mg/d, 7-10 years of 20 mg/d, 11-14 years of 30 mg/d, 15-17 years: 35 mg/d and for adults of 18 years and more, and pregnant and lactating women of 40 mg/d.
- For manganese, the EFSA could not determine ULs on the basis of the available data and newly set up safe levels.
- Safe levels for :
- Infants aged 4-11 months: 2 mg/d
- Young children aged 1-2 years : 4 mg/d
- Children aged 3-6 years : 5 mg/d
- Children aged 7-13 years : 6 mg/d
- Children aged 14-17 years : 7 mg/d
- Adults aged 18 years and more, and pregnant and lactating women : 8 mg/d
Where can you find these data ?
The « DRV Finder » is an interactive tool that gives quick and easy access to EFSA’s Dietary reference values (DRVs) for nutrients on the EU. The ULs are also provided.
Next steps:
The EFSA recently finished the updates of ULs for vitamins A, E and D, B6 and B9 and for some essential minerals: iron, manganese and selenium according to the mandate from the European Commissions. We are expecting for the maximal amounts reviewed by the European Commission and the Member States for fortifying foods and for use in food supplements.
Orchidali can provide support for fortifying in vitamins and minerals.
Français
Update of the upper tolerable levels (ULs) of vitamins and minerals in the EU
The European Commission requested the EFSA to update the framework for Tolerable Upper Intake Level (UL) assessment and the current ULs for some vitamins and minerals. When it was not possible to establish an UL, the Commission requested the ESA to determine the safe level which is an indication on the highest level of intake for which there is a reasonable confidence on the absence of adverse effects. Consequently, the EFSA published until 2024 the guidance for establishing and applying tolerable upper intake levels for vitamins and essential minerals and the scientific opinions on the tolerable upper intake for preformed vitamin A and bêta-carotene, for vitamin E, for vitamin D, and some essential minerals such as iron, manganese, selenium
The EFSA shared the results and conclusions of its assessment during a webinar on November 14, 2023.
What is the Tolerable Upper Intake Level(UL) of a nutrient?
The Tolerable Upper Intake Level(UL) of a nutrient is defined as the maximum amount (from all dietary sources including foods, fortified foods and food supplements) of a nutrient that can be consumed safely over a long period of time. The maximum amount (MA) is the maximum amount of a nutrient that can be added to foods (fortified foods) or used in food supplements. MAs are legal values determined by the European Commission and the Member States who are the risk managers.
Backgound
In 2 000, the Scientific Committee on Food (SCF) published the guidelines for the development of ULs for vitamins and minerals. From 2000 to 2005, the ULs for vitamins and minerals were published. In 2012, the ULs for calcium and vitamin D were updated. In 2018 the UL for vitamin D in infants was set up by the NDA Panel. From 2020 to 2024, under the request from the Commission to review the evidence related to minerals and vitamins, the EFSA updated the guidance for establishing the ULs and reviewed the ULs related to vitamins B6, B9, to liposoluble vitamins A,D and E and to some essential minerals : iron, manganese, and selenium.
What are the changes made by the EFSA ?
The ULs for vitamin A for infants aged from 4 to 6 months and from 7 to 11 months have been newly set up. They were not been determined before. They are of 600 µg of Retinol Equivalent (RE) /d. No other changes of ULs for vitamin A compared to SCF, 2002 for the other age ranges.
For the beta carotene, available data are not sufficient and suitable to establish a UL. The EFSA considers that smokers should avoid supplements containing beta-carotene and that supplemental beta-carotene by the general population should be limited to the purpose of meeting vitamin A requirements.
No changes of ULs for vitamin D:
For the vitamin D, the EFSA did not change the ULs previously set up in 2012. The ULs are of 25 µg of vitamin D equivalent /d for infants from 4-6 months of age and of 35 µg of vitamin D equivalent/d for infants from 7- 11 months, and of 50 µg vitamin D equivalent/d for the children aged from 1 to 10 years and of 100 µg of vitamin D equivalent for subjects aged of 11 y and more. The notion of vitamin D equivalent newly introduced takes into account the different sources of vitamin D (ergocalciferol, the vitamin D2, and cholecalciferol, the vitamin D3) with different bio availabilities.
For the vitamin E, the EFSA set up new ULs of 50 mg/d for infants of 4-6 months of age and of 60 mg/d for infants of 7-11 months of age. The other ULs stated in 2003 did not change for the other age ranges..
ULs newly set up for the vitamin B6 for infants of 4-6 months of age of 2,2 mg/d and for infants of 7-11 months of 2,5 mg/d.
New levels of ULs for vitamin B6 for children: aged 1-3 years: 3,2 mg/d, aged 4-6 years: 4,5 mg/d, aged 7-10 years: 6,1 mg/d ; aged 11-14 years: 8,6 mg/d, aged 15-17 years: 10,7 mg/d; for adults of 18 years and more, and pregnant and lactating women: 12 mg/d.
The ULs of the other age ranges did not change.
New levels of ULS for children aged 1 -3 years of 70 µg/d and for children aged 4-6 years of age of 95µg/d.
New levels of ULS for children aged 11-14 years of 180µg/d, for children aged 15-17 years of 230 µg/d ; for adults of 18 years and more, and pregnant and lactating women : 255 µg/d.
No changes of ULs for the other age ranges.
For iron, the EFSA could not determine ULs on the basis of the available data and newly set up safe levels.
The EFSA considers that a dietary intake (from all sources) of 40 mg/d is safe for the general population. The panel set up safe levels for infants aged 4-11 months of 5 mg/d, and for children aged 1-3 years of 10 mg/d, 4-6 years of 15 mg/d, 7-10 years of 20 mg/d, 11-14 years of 30 mg/d, 15-17 years: 35 mg/d and for adults of 18 years and more, and pregnant and lactating women of 40 mg/d.
Where can you find these data ?
The « DRV Finder » is an interactive tool that gives quick and easy access to EFSA’s Dietary reference values (DRVs) for nutrients on the EU. The ULs are also provided.
Next steps:
The EFSA recently finished the updates of ULs for vitamins A, E and D, B6 and B9 and for some essential minerals: iron, manganese and selenium according to the mandate from the European Commissions. We are expecting for the maximal amounts reviewed by the European Commission and the Member States for fortifying foods and for use in food supplements.
Orchidali can provide support for fortifying in vitamins and minerals.
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