Pojedinosti notifikacije

Regulation relating to amendment of regulation on food supplements

Broj notifikacije: 2016/9016/N (Norway)
Datum zaprimanja: 11/02/2016
Prestanak razdoblja mirovanja: 12/05/2016

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Message 901

Communication from the Commission - TRIS/(2016) 00509
Procedure for the provision of information EC - EFTA

Notificación - Oznámení - Notifikation - Notifizierung - Teavitamine - Γνωστοποίηση - Notification - Notification - Notifica - Pieteikums - Pranešimas - Bejelentés - Notifika - Kennisgeving - Zawiadomienie - Notificação - Hlásenie-Obvestilo - Ilmoitus - Anmälan - Нотификация : 2016/9016/N - Notificare.

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: 201600509.EN)

1. Strukturirana informacijska linija
MSG 901 IND 2016 9016 N EN 11-02-2016 N NOTIF


2. Država članica
N


3. Odgovorni odjel
ROYAL MINISTRY OF TRADE, INDUSTRY AND FISHERIES
Department for Trade Policy
P.O.BOX 8090 DEP
N-0032 OSLO
Norway


3. Pokretački odjel
The Norwegian Food Safety Authority
P.O. 383
N-2381 Brumunddal


4. Broj notifikacije
2016/9016/N - C80A


5. Naziv
Regulation relating to amendment of regulation on food supplements


6. Predmetni proizvodi
Food supplements


7. Notifikacija u sklopu drugog zakona
-


8. Osnovni sadržaj
National maximum limit for the amount of magnesium in food supplements, cf. directive 2002/46/EC art. 5. A specific national limit for the amount of folic acid in food supplements for women who are planning a pregnancy, or who might become pregnant, and accordingly a particular requirement for labelling of such products. National minimum limits for vitamin A, vitamin E, vitamin K, thiamin, riboflavin, niacin, folic acid, vitamin B6, pantothenic acid, vitamin B12, biotin, vitamin C, calcium, phosphorus, magnesium, iron, copper, iodine, zinc, manganese, selenium, chromium, molybdenum, potassium, fluoride and chloride.


9. Kratka izjava o razlozima
Norway implemented directive 2002/46/EC on food supplements in 2004. Existing national minimum- and maximum limits for vitamins and minerals were then continued.
The maximum limit for magnesium is proposed reduced to 250 mg per day, in line with the tolerable upper intake level (UL), etablished in the Opinion of the Scientific Committee on Food on the Tolerable Upper Intake Level of Magnesium (2001).
On the basis of a scientific opinion on folic acid by the Norwegian Scientific Committee for Food Safety from 2015, and a recommendation by the Norwegian Directorate of Health, it is proposed to establish a national limit specificly for the amount of folic acid in food supplements for women who are planning a pregnancy, or who might become pregnant, and accordingly a particular requirement for labelling of such products. The provisions on folic acid shall contribute to fulfilment of the public recommendation, and the specific labelling requirement shall ensure that the product reaches its target group, and that women are provided information that 400 μg folic acid per day reduces the risk of neural tube defects. The minimum limits of the vitamins and minerals mentioned under section 8, is proposed to be amended such that they are equal to 15 % of the reference intakes as indicated in annex XIII, part A in regulation (EU) No. 1169/2011 on food information to consumers.
Please see link to the scientific opinion on folic acid - Risk assessment of folic acid in food supplements. Opinion of the Panel on Nutrition, Dietetic Products, Novel Food and Allergy of the Norwegian Scientific Committee for Food Safety: http://www.vkm.no/dav/86f93d4c96.pdf


10. Referentni dokumenti - Temeljni tekstovi
References of the Basic Texts: Regulation of 20 May 2004 No 755 on food supplements (implementing Directive 2002/46/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to food supplements in Norway). See link: https://lovdata.no/dokument/SF/forskrift/2004-05-20-755?q=kosttilskudd
Basic Texts have been forwarded within the framework of a previous notification: 2003/9008/N


11. Pozivanje na hitni postupak
No


12. Razlozi za hitnost
-


13. Povjerljivost
No


14. Fiskalne mjere
No


15. Procjena utjecaja
The Norwegian national public hearing:http://www.mattilsynet.no/mat_og_vann/spesialmat_og_kosttilskudd/kosttilskudd/revisjon_av_nasjonal_maksimumsgrense_for_folsyre_i_kosttilskudd.16020.
Recommendation by the Norwegian Directorate of Health: https://helsedirektoratet.no/folkehelse/graviditet-fodsel-og-barsel/kosthold-for-gravide.


16. Sa stajališta TBT-a i SPS-a
TBT aspect

No - The draft has no significant impact on international trade

SPS aspect

No - The draft has no significant impact on international trade



**********
European Commission

Contact point Directive (EU) 2015/1535
Fax: +32 229 98043
email: grow-dir83-189-central@ec.europa.eu

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