Message 002
Communication from the Commission - TRIS/(2016) 03589
Directive (EU) 2015/1535
Translation of the message 001
Notification: 2016/0615/B
No abre el plazo - Nezahajuje odklady - Fristerne indledes ikke - Kein Fristbeginn - Viivituste perioodi ei avata - Καμμία έναρξη προθεσμίας - Does not open the delays - N'ouvre pas de délais - Non fa decorrere la mora - Neietekmē atlikšanu - Atidėjimai nepradedami - Nem nyitja meg a késéseket - Ma’ jiftaħx il-perijodi ta’ dawmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Neotvorí oneskorenia - Ne uvaja zamud - Määräaika ei ala tästä - Inleder ingen frist - Не се предвижда период на прекъсване - Nu deschide perioadele de stagnare - Nu deschide perioadele de stagnare.
(MSG: 201603589.EN)
1. MSG 002 IND 2016 0615 B EN 25-11-2016 B NOTIF
2. B
3A. FOD Economie, KMO, Middenstand en Energie
Algemene Directie Kwaliteit en Veiligheid - Dienst Normalisatie en Competitiviteit - BELNotif
NG III – 5de verdieping
Koning Albert II-laan, 16
B - 1000 Brussel
Tel: 02/277.93.71
3B. Federale Overheidsdienst Volksgezondheid, Veiligheid Voedselketen en Leefmilieu
Directoraat-generaal Dier, Plant en Voeding
Dienst Voedingsmiddelen, Dierenvoeders en Andere Consumptieproducten
Eurostation, Victor Hortaplein 40/10, 1060 Sint-Gillis, België
tel.: 02 524 73 85
katrien.depauw@gezondheid.belgie.be
4. 2016/0615/B - C00A
5. 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
6. Foodstuffs: fortified foods and food supplements
7. - Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods
- Directive 2000/13/EC relating to the labelling, presentation and advertising of foodstuffs
- Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements
8. 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.
9. The current maximum levels for vitamins, minerals and trace minerals established in the existing decree, date back to 1992. The draft decree is adopting modified maximum levels based on recent scientific data.
The maximum levels in this draft decree are furthermore presented in a more accessible format: the maximum levels are conveniently displayed in Annex 1, whereas in the existing decree the maximum levels need to be calculated.
The maximum levels proposed in the draft decree are based on opinion No 9285 of the Superior Health Council (SHC) in respect of the dietary recommendations for Belgium, issued on 7 September 2016 (http://www.health.belgium.be/nl/advies-9285-voedingsaanbevelingen-voor-belgie-2016, available in Dutch and French). The most recent data resulting from the Food Consumption Survey 2014 on the intake of vitamins, minerals and trace minerals (https://fcs.wiv-isp.be/SitePages/Home.aspx) were also used.
The maximum levels for virtually all nutrients have increased or remain unchanged. The only exception is the trace mineral manganese the maximum level of which has been reduced from 5.25 mg to 1 mg due to its neurotoxicity as a result of manganese accumulation (SHC, 2016).
In order to avoid the risk of side effects related to nicotinic acid (SHC, 2016), vitamin formulations nicotinic acid and inositol hexanicotinate are not permitted to be added to food supplements and fortified foods, whereas nicotinamide is.
The warnings introduced in the draft decree for three nutrients in products containing a particular level of these nutrients, is intended to ensure the safety of certain vulnerable target groups. These warnings, too, are based on opinion No 9285 of the SHC in respect of the dietary recommendations for Belgium, issued on 7 September 2016.
10. Restriction of the trade or use of a substance, preparation or chemical product.
Numbers or titles of the basic texts: Royal Decree of 3 March 1992 concerning the placing on the market of nutrients and foodstuffs to which nutrients have been added.
11. No
12. -
13. No
14. No
15. -
16. TBT aspect
No - the draft has no significant impact on international trade.
SPS aspect
No - the draft has no significant impact on international trade.
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European Commission
Contact point Directive (EU) 2015/1535
Fax: +32 229 98043
email: grow-dir83-189-central@ec.europa.eu
