Foodstuffs: fortified foods and food supplements
Royal Decree amending the Royal Decree of 3 March 1992 concerning the placing on the market of nutrients and foodstuffs to which nutrients have been added
This draft decree amends the existing Royal Decree of 3 March 1992 concerning the placing on the market of nutrients and foodstuffs to which nutrients have been added.
The draft decree establishes maximum levels for vitamins, minerals and trace minerals in food supplements and fortified foods (Annex 1) which may not exceed the stated recommended daily intake/quantity of the nutrient equivalent to the average daily nutrient intake (defined in Annex 2).
The draft decree contains the following changes to the existing decree:
- no changes to the maximum levels for the following nutrients: vitamin A, niacin, vitamin B6, calcium, chromium, phosphorus, iodine, potassium, magnesium, molybdenum, selenium, silicon, zinc;
- removal of the existing maximum levels for the following nutrients: thiamin, riboflavin, pantothenic acid, vitamin B12, biotin, chloride, sodium, silicon;
- increased maximum levels for the following nutrients: vitamin C, vitamin D, vitamin E, vitamin K, folic acid, boron, fluoride, iron, and
- reduced maximum levels for: manganese.
An overview of the maximum levels laid down in this draft decree: vitamin A: 1 200 µg, niacin: 54 mg, vitamin B6: 6 mg, vitamin C: 1 000 mg, vitamin D: 75 µg, vitamin E: 39 mg, vitamin K: 210 µg, folic acid: 500 µg, boron: 3 mg, calcium: 1 600 mg, chromium 187.5 µg, fluoride 1.7 mg, phosphorus: 1 600 mg, iron: 45 mg, iodine: 225 µg, potassium: 6 000 mg, copper: 2 mg, magnesium: 450 mg, manganese: 1 mg, molybdenum: 225 µg, selenium: 105 µg, zinc: 22.5 mg.
The maximum levels for various nutrients have either been increased or removed. To ensure safe use, in respect of three nutrients mandatory warnings will be required in the labelling of products containing a particular level of the nutrient in question:
- foodstuffs containing a daily dose of vitamin K exceeding 25 μg should display the following warning: ‘Not suitable for people taking coumarin anticoagulants.’;
- foodstuffs containing a daily dose of potassium of at least 1 000 mg should display the following warning: ‘Not suitable for elderly people or people with a renal disorder, insulin-resistant diabetes or people with arterial hypertension.’ and
- foodstuffs containing a daily dose of zinc exceeding 10 mg should display the following warning: ‘The intake of zinc should be limited to a period of a few weeks/months.’.
The draft decree provides for requests for derogation from the maximum levels. Derogation requests must be duly substantiated.
The draft decree also establishes that the only vitamin formulation of niacin that is permitted to be added to food supplements and fortified foods, is nicotinamide.
The decree furthermore contains a proposal to simplify the existing notification requirement for fortified foods. The notification procedure no longer requires a full list of ingredients of the fortified food product since information on the added nutrients (type and amount) per recommended daily intake or quantity of the nutrient equivalent to the average daily nutrient intake, now suffices.
The draft decree brings the terminology of the existing decree in line with Regulation (EU) No 1169/2011 on the provision of food information to consumers: the names of the nutrients have been adapted and the word ‘reference intake’ is used (instead of ‘recommended daily allowance’).
Lastly this draft decree adds an additional article to the existing decree relating to provisions on mutual recognition.
As a transitional measure, foodstuffs that do not comply with the provisions of the draft, but do comply with the provisions of the existing decree, can still be placed on the market up to a maximum of two years from the date of entry into force of this draft decree.