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Registration of food supplements in Belgium. The list of nutrients is updated
The registration of food supplements in Belgium, increasingly operational.
As usual, Belgium remains one of the European countries that most worries about the importance of updating the legislation on food supplements and nutrients that can be added to them.
Those who work with food supplements, whether in their formulation, trade or legal advice, know that these products fit into a variant legal framework between different Member States. Many times nonexistent, but in any case being aware that periodic information updates are required, and in many cases, a review and modification of this.
For this reason, Belgium not only recently modified its Royal Decree of August 29, 1997 regarding the manufacture and trade of food products that are composed or contain plants or preparations thereof, by means of the publication of the new Royal Decree of January 24 of 2017. Currently, on September 19, 2017, he has published an update of the Royal Decree of March 3, 1992 regarding the placing on the market of nutrients and food products to which nutrients have been added. This new legal document has been applied since October 31, 2017, and represents a breakthrough in Belgian national legislation on food supplements.
Especially since the maximum permitted amounts of addition of vitamins and minerals in food products have been reviewed and updated, among which of course are food supplements. We say that it is a breakthrough because in many cases, it was very difficult to be able to notify products in Belgium because the maximum levels allowed for some vitamins and minerals were quite limiting, with values well below the maximum tolerable intake levels (UL) established by the EFSA.
This meant that many food supplements that in other countries were perfectly accepted, there was no possibility of their trade there, much less being able to notify these products in Spain by applying the principle of mutual recognition through a prior acceptance in Belgium. The novelty of this legislative amendment is that for the registration of food supplements in Belgium maximum levels allowed for Vitamin B1, Vitamin B2, Pantothenic Acid, Biotin and Vitamin B12 have been suppressed, which before this modification were limited to quite low.
Regarding minerals, no maximum allowed value has been suppressed except for Chloride, and many of them still have the same maximum allowed level established before the modification of this Royal Decree.
In the table below, we have made a comparison of the maximum levels allowed for vitamins and minerals before and after the modification of the legal text in question for the Registration of food supplements in Belgium:
| Before the modification of the Royal Decree of March 3, 1992 | After the modification of the Royal Decree of March 3, 1992 | |
| VITAMIN | MAXIMUM LEVEL ALLOWED | MAXIMUM LEVEL ALLOWED |
| Vitamin C | 180 mg | 1000 mg |
| Niacin | 54 mg NE (for both forms Ac. nicotinic and Nicotinamide) | 10 mg NE for Ac. nicotinic 54mg NE Nicotinamide |
| Vitamin B2 | 4.8 mg | – |
| Vitamin B1 | 4.2 mg | – |
| Vitamin B6 | 6 mg | 6 mg |
| Pantothenic acid | 18 mg | – |
| Vitamin A | 1200 µg | 1200 µg |
| Vitamin E | 30 mg α-TE | 39 mg α-TE |
| Vitamin D | 75 µg | 75 µg |
| Vitamin K | 135 µg | 210 µg |
| Folic acid | 400 µg | 500 µg |
| Biotin | 450 µg | – |
| B12 vitamin | 3 µg | – |
| MINERAL | MAXIMUM LEVEL ALLOWED | MAXIMUM LEVEL ALLOWED |
| Calcium | 1600 mg | 1600 mg |
| Chloride | 7000 mg | – |
| Chrome | 187.5 µg | 187.5 µg |
| Iodine | 225 µg | 225 µg |
| Copper | 1.65 mg | 2 mg |
| Magnesium | 450 mg | 450 mg |
| Manganese | 5.25 mg | 1 mg |
| Molybdenum | 225 µg | 225 µg |
| Potassium | 6000 mg | 6000 mg |
| Selenium | 105 µg | 105 µg |
| Iron | 28 mg | 45 mg |
| Match | 1600 mg | 1600 mg |
| Zinc | 22.5 mg | 22.5 mg |
With respect to the minimum required value of addition of vitamins and minerals, the level imposed by the European Union of 15% of the Nutrient Reference Value for vitamins and minerals (NRV), also established in Regulation (EU) 1169/2011 is maintained on food information provided to the consumer. In addition to having reviewed the maximum values for vitamins and minerals, this update introduces novelties in the form of 4 mandatory warnings in the case of products to which certain vitamins and minerals have been added for the registration of food supplements in Belgium.
Thus, in the case of adding in a product nicotinic acid or inositol hexanicotinate, or the association of both substances as a source of Niacin, it implies the obligation to advise against the consumption of the product to pregnant or nursing women by means of a warning inserted in its labeling.
Those products that contain or provide more than 25 µg of Vitamin K per recommended daily dose will include a warning against the consumption of the product in people treated with coumarin anticoagulants; or for example, limit the consumption of the product to only a few weeks or months before a contribution of more than 10 mg of Zinc per recommended daily dose of product. Finally, those products that provide at least 1,000 mg of Potassium will incorporate in their labeling a warning advising against the consumption of the product in elderly people, suffering from kidney disease, diabetes with insulin resistance or treated for hypertension.
The text provides a transitional period of two years for those products that were already on the market and complied with the provisions of the Royal Decree before this last modification in force, to give a reasonable period of time to the operators of the sector to adapt to these new requirements for the registration of food supplements in Belgium. From LegaleGo Nutrition consider that this modification is advantageous for companies in the sector of food supplements, by making more flexible the maximum doses allowed above all, vitamins in Belgium.
Thus, the registration of food supplements in Belgium will be more operational. Although the ideal as we always claim, it would be a harmonization at European level as far as food supplements legislation is concerned, to eliminate obstacles and differences between the different member states of the European Union. As a food safety consultancy, we notify and register food supplements especially in Belgium, France, Italy, Portugal and Ireland.
