Update: proposal for new legal maximum vitamin B6 in food supplements
On 1 February 2018 a draft proposal was sent to the European Commission by The Netherlands, announcing a new maximum level and several mandatory warning for vitamin B6 in food supplements. Levels of vitamins and minerals in food supplements are not yet harmonized on a European level, which is why the rules on maximum levels differ per member state. A challenge to those active in more countries.
Vitamin B6: background
Since a few years we have a national discussion regarding vitamin B6 in food supplements. As the food authority (NVWA) received multiple notifications of consumers experiencing health effects after consuming food supplements with high amounts of vitamin B6, it decided to instruct the national risk assessment organization (BuRo) to start investigating vitamin B6 in food supplements. End of 2016 these results were presented: a safe daily upper limit for adults would be 21 mg vitamin B6 (EFSA’s 25 mg advice minus the average intake from food). Last year, this result was incorporated in a draft proposal to change the law.
Draft proposal
The draft proposal is still only available in Dutch. It proposes a maximum level for B6 (max 21 mg vitamin B6 per daily amount of the product as stated on the label) and introduces several warning statements to be placed on the package (age warnings depending on the level of vitamin B6 in the product).
Warning statements (to be placed on the label in Dutch):
Max 3 mg vitamin B6 per daily amount of the product: “this food supplement is not suitable for children <1 year old.”
More than 3 mg vitamin B6 per daily amount of the product: “this food supplement is not suitable for children up to and including 3 years old.”
More than 5 mg vitamin B6 per daily amount of the product “this food supplement is not suitable for children up to and including 10 years old.”
More than 7 mg vitamin B6 per daily amount of the product “this food supplement is not suitable for children up to and including 17 years old.”
Status of the law
In the current proposal is stated that the new law will come into force per 1 October 2018. Products that were on the market before the first of October 2018 can still be sold until stock lasts. In order to comply with these changes once they will come into effect, it is advisory to already assess which products in the food supplements portfolio contain vitamin B6 and prepare for changes in the formula and label if necessary. Never a dull moment in the food industry!
Sarah Arayess