By Joerg Gruenwald, analyze & realize GmbH03.24.23
While the permitted micronutrients and their possible compounds for use in food and dietary/food supplements is harmonized across the EU, setting daily reference values (DRVs) and Tolerable Upper Intake Levels (ULs) for those micronutrients throughout the EU has been an unresolved issue, at least in part.
The European Food Safety Authority (EFSA) is currently in the process of setting values for ULs, but it is a lengthy process. The process for setting DRVs was completed in 2019. For 10 years, EFSA evaluated/updated the values for macronutrients such as proteins and carbohydrates, as well as 14 vitamins and 13 minerals. EFSA’s last scientific opinion about dietary reference values (DRVs) was published in September 2019, setting the DRVs for sodium and chloride.
DRV is an umbrella term for science-based nutrient reference values for the daily intake of healthy populations. These values include population reference intakes (PRIs), the average requirements (ARs), adequate intakes (AIs), and reference intake (RIs) ranges for macronutrients. These values indicate the amount of a nutrient which must be consumed on a regular basis to maintain health in an otherwise healthy individual (or population).
Following a request from the European Commission, the Scientific Committee on Food (SCF), which was the predecessor of EFSA, started off in the year 2000 by giving scientific advice in relation to ULs for vitamins and minerals. The task was then taken over by EFSA when it became operational. The first result of EFSA's deliberations was published in September 2018.
In the course of this process, EFSA's recent draft scientific opinion lowers the UL for vitamin B6 from 25 mg/day to 12 mg/day. This has triggered intense discussion and much criticism in the industry. The previous level was already much lower than that set by other scientific bodies. The World Health Organization (WHO) has set the UL for vitamin B6 at 100 mg/day, which is also the value referenced by authorities in the U.S. By further reducing the UL to 12 mg/day, the value is now eight times lower than that used in other parts of the world.
The assessment by EFSA is based at least in part on a very old study from 1987 in which neurological adverse effects from high pyridoxine intake were observed. This study is much criticized and regarded by the main international bodies as unreliable for setting a UL. Still, EFSA cites safety concerns with higher levels of vitamin B6 as the reason for its opinion.
Again, this refers to the UL, not the DRV, which would by inference be even lower than 12 mg/day.
Needless to say, if this opinion is adopted by the EU Commission, this will pose a bit of a problem for manufacturers wishing to market their products in the EU.
Vitamin B6 is not the only nutrient whose UL is being reduced. The UL of selenium for adults, including pregnant and lactating women, was reduced from 300 µg/day to 255 µg/day—not quite so drastic a reduction, but a reduction nonetheless.
Also, regulatory bodies may now regard these EFSA opinions as binding and make efforts to have products that overstep the new ULs removed from the market, especially in countries that have so far not set any legally binding national ULs.
In any case, marketing food supplements that contain vitamin B6 in the EU has just become a little more challenging. Fortunately, experienced consultancies such as analyze & realize GmbH are keeping an eye on developments and stand ready to assist.
About the Author: Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100, Fax: +49-30-40008500; e-mail: jgruenwald@a-r.com, www.analyze-realize.com.
The European Food Safety Authority (EFSA) is currently in the process of setting values for ULs, but it is a lengthy process. The process for setting DRVs was completed in 2019. For 10 years, EFSA evaluated/updated the values for macronutrients such as proteins and carbohydrates, as well as 14 vitamins and 13 minerals. EFSA’s last scientific opinion about dietary reference values (DRVs) was published in September 2019, setting the DRVs for sodium and chloride.
DRV is an umbrella term for science-based nutrient reference values for the daily intake of healthy populations. These values include population reference intakes (PRIs), the average requirements (ARs), adequate intakes (AIs), and reference intake (RIs) ranges for macronutrients. These values indicate the amount of a nutrient which must be consumed on a regular basis to maintain health in an otherwise healthy individual (or population).
Upper Intake Levels
On the other hand, the tolerable Upper Intake Level (UL) is the maximum level of total chronic intake of a nutrient from all sources that is judged to be unlikely to pose a risk of adverse health effects in humans. While the contents of a food supplement may be higher than the DRV without legal consequences, the UL should not be exceeded, since this might result in a safety issue, especially with fat-soluble nutrients that accumulate in the body.Following a request from the European Commission, the Scientific Committee on Food (SCF), which was the predecessor of EFSA, started off in the year 2000 by giving scientific advice in relation to ULs for vitamins and minerals. The task was then taken over by EFSA when it became operational. The first result of EFSA's deliberations was published in September 2018.
'EFSA's recent draft scientific opinion lowers the UL for vitamin B6 from 25 mg/day to 12 mg/day. This has triggered intense discussion and much criticism in the industry.'
Revisions and Reactions
EFSA is now in the process of revising the safety limits for certain vitamins and minerals. The authority has reviewed the existing risk assessment and is taking into account the latest scientific evidence and developments.In the course of this process, EFSA's recent draft scientific opinion lowers the UL for vitamin B6 from 25 mg/day to 12 mg/day. This has triggered intense discussion and much criticism in the industry. The previous level was already much lower than that set by other scientific bodies. The World Health Organization (WHO) has set the UL for vitamin B6 at 100 mg/day, which is also the value referenced by authorities in the U.S. By further reducing the UL to 12 mg/day, the value is now eight times lower than that used in other parts of the world.
The assessment by EFSA is based at least in part on a very old study from 1987 in which neurological adverse effects from high pyridoxine intake were observed. This study is much criticized and regarded by the main international bodies as unreliable for setting a UL. Still, EFSA cites safety concerns with higher levels of vitamin B6 as the reason for its opinion.
Again, this refers to the UL, not the DRV, which would by inference be even lower than 12 mg/day.
Needless to say, if this opinion is adopted by the EU Commission, this will pose a bit of a problem for manufacturers wishing to market their products in the EU.
Vitamin B6 is not the only nutrient whose UL is being reduced. The UL of selenium for adults, including pregnant and lactating women, was reduced from 300 µg/day to 255 µg/day—not quite so drastic a reduction, but a reduction nonetheless.
Potential Impact
It is currently unclear what the industry impact of this draft opinion will be, provided that it is adopted by the EU Commission. So far, many individual EU member states have set their own maximum intake levels for micronutrients, some of which are legally binding for products in the respective country, and some of which are not, like in Germany. How will these national ULs be affected?Also, regulatory bodies may now regard these EFSA opinions as binding and make efforts to have products that overstep the new ULs removed from the market, especially in countries that have so far not set any legally binding national ULs.
In any case, marketing food supplements that contain vitamin B6 in the EU has just become a little more challenging. Fortunately, experienced consultancies such as analyze & realize GmbH are keeping an eye on developments and stand ready to assist.
About the Author: Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100, Fax: +49-30-40008500; e-mail: jgruenwald@a-r.com, www.analyze-realize.com.
