Maximum daily dose of vitamin B6 in dietary supplements has now been legally established in the Netherlands

18-10-2018

From October 1st, 2018, dietary supplements may not contain a daily dose of more than 21 milligram vitamin B6 in the Netherlands. A higher vitamin B6 intake can have a harmful effect on health.

High doses of vitamin B6 are associated with neuropathy. The Netherlands Pharmacovigilance Centre Lareb received over 100 reports of neuropathy related complaints after use of freely available dietary supplements containing vitamin B6. These reports have been sent to the Dutch Food and Consumer Product Safety Authority, who is responsible for the regulation of these products, with the recommendation to regulate the maximum daily dose of vitamin B6 in supplements that they regulate.

Based on the risk assessment, the Dutch Food and Consumer Product Safety Authority advised the minister of Public Health, Welfare and Sport to establish a national maximum daily dose for vitamin B6 in freely available dietary supplements. The minister adopted this advice.

From October 1st, 2018, the maximum daily dose of vitamin B6 in dietary supplements may not exceed 21 milligram. This maximum daily dose is based on the maximum safe upper limit for vitamin B6, taken into account that part of vitamin B6 intake comes from food. The maximum safe upper limit for vitamin B6 is lower for children compared to adults. For this reason, the maximum daily dose of vitamin B6 in dietary supplements for children is also lower:

Dosing vitamin B6 in supplements and warning on label:

  • Until 3 milligrams/day, with warning ‘not suitable for children under 1 year of age’
  • 3 milligrams/day and more, with warning ‘not suitable for children under 4 years of age’
  • 5 milligrams/day and more, with warning ‘not suitable for children under 11 years of age’
  • 7 milligrams/day and more, with warning ‘not suitable for children under 18 years of age’