Limits are set at 1200 micrograms/ day (ug/d) of retinol equivalent (RE) of vitamin, 75 ug/d of vitamin D and 21 milligrams/ day (mg/d) of vitamin B6. The level on B6 is 4 mg/d lower than EFSA’s Upper Level, reflecting estimated intake from food. Specific warnings on lower limits for children are also included.
Under Dutch legislation (Article 10(1) of the Commodities Act Decree), beverages and foodstuffs may not contain vitamins unless they are naturally present in the same composition and quantity as in the beverages and foods themselves.
However, the regulations have previously granted exemptions on vitamin A and D content. The recent notification has enabled a new exemption order to be granted for vitamin B6.
The notification, originated by the Department of Nutrition, Health Protection and Prevention, Netherlands Ministry of Health, Welfare and Sport, replaces an earlier one, which has not been written into Dutch law.
After May 5th 2018, if the European Commission has no objections, at the end of the 90-day standstill period after receipt of the notification, the Netherlands may adopt the proposed legislation.
The action taken by the Netherlands is significant in two ways, suggested EU nutrition and law expert and managing director of Hylobates Consulting, Luca Bucchini.
“The first is that almost all Member States now think that maximum levels at least for some vitamins need to be written into law,” he told Nutraingredients.
“Moreover, Member States are taking action because they are losing hope with the Commission's efforts to set maximum levels. The EC has apparently given up, but this creates problems for the single market,” he added.
For example, the Netherlands applies EU law in terms of the scientific process on setting limits (which appear to be based on risk assessment). However, other Member States do not, Bucchini explained.
Variations between Member States
Limits on vitamin contents of supplements can vary, sometimes by an order of magnitude between Member States, elucidated Bucchini.
“For comparison, France has max levels of 800 ug of RE vitamin A in the form of retinoids per day, up to 2 mg of vitamin B6 per day, and up to 5 ug of vitamin D.
“Italy is closer to the proposed levels in the Netherlands with 1200 ug of RE vitamin A, 9.5 for B6, and 50 ug of vitamin D.”
The inconsistency between Member State limits also raises the question of whether food supplement businesses will be able to use mutual recognition for products that comply with Dutch law.
“In a strictly legal sense, the answer is generally yes because Dutch law is based on risk assessment. However, some Member States make mutual recognition difficult to apply,” suggests Bucchini.
It is however essential to pay close attention to the warning levels applied to maximum limits on children’s doses, he emphasised.