The Belgian government has changed the maximum nutrient content permitted in supplements and fortified foods for numerous vitamins and minerals.
Changes to the decree (originally introduced in 1992) apply from 10th November 2017. However, a two-year transitional period applies to products already on the market which comply with previous legislation, but fall outside the new limits.
Mandatory warnings must also be included on the labelling of supplements containing above threshold levels of niacin (nicotinic acid and inositol hexanicotinate forms), vitamin K, potassium and zinc.
Although the legislation is technically new, the changes have effectively already been in place for a while, explained Joris Geelen, partner at Food Compliance International, Brussels, and a leading expert in the area of European regulatory policy on food, supplements and botanicals.
“The new levels were, in practice, already applied by the Belgian government because they were based on advice from this superior health council,” commented Geelen.
The new rules also simplify notification requirements on fortified foods. Only details of the added nutrient itself are now required (in terms of type and amount per recommended daily intake) rather than provision of a total ingredient list.
Finally, the amendments include a clause on mutual recognition, enabling firms to submit documentation to Belgian authorities to prove that the product has been marketed legally in other EU countries.
Principal changes in limits
Removal of upper limits on a number of B vitamins: B1 (thiamine), B2 (riboflavin), B5 (pantothenic acid), B7 (biotin) and B12. The upper limit is also abolished on chloride within supplements.
Relaxation of upper limits for vitamin A (1200 ug), vitamin B6 (6 mg), vitamin C (1000 milligrams (mg), vitamin D (75 micrograms (ug) / (3000 IU), vitamin E (39 mg) / (43 IU synthetic form), folic acid (500 ug), iron (45 mg) and copper (2 mg).
A reduced limit on two forms of niacin (vitamin B3) – nicotinic acid and inositol hexanicotinate, dereased to 10 mg. The maximum manganese content is also lower from 5.25 mg to 1 mg.
Introduction of upper limits on boron (3 mg) and fluoride (1.7 mg).
Need for EU-wide harmonisation
Experts welcomed the fact that Belgium was taking a science-based initiative on nutrient levels, but this appeared to be overshadowed by the continuing lack of EU harmonisation on the issue.
“The changes are significant, especially given that the notification process, and detailed legislation, of Belgium give some degree of regulatory leadership in terms of food supplements in the EU,” commented Luca Bucchini, Managing Director of Rome based food consultant Hylobates, while Joris Geelen acknowledged “it is good to see that Member States are applying science-based policies.”
However, Geelen also argued that in paying to too much attention to the changes in the Belgian decree, it was possible to lose focus on more important matters.
“The most important thing is to take a look at the big picture there is no real harmonisation at the European level,” he explained.
“Member states still set their own maximum levels and they are based on their own scientific evaluation they don't take new scientific developments into account. If firms want to put a product on the market at European level then they have to change all their product and labels for each country that they go to.
“This is a major hurdle for free movement of goods,” Geelen concluded.