Notification Detail

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

Notification Number: 2016/615/B (Belgium)
Date received: 25/11/2016
End of Standstill: 27/02/2017 ( 29/05/2017)

Issue of comments by: Commission,Hungary
Issue of detailed opinion by: Commission
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fr
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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. Structured Information Line
MSG 002 IND 2016 0615 B EN 25-11-2016 B NOTIF


2. Member State
B


3. Department Responsible
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


3. Originating Department
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. Notification Number
2016/0615/B - C00A


5. Title
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. Products Concerned
Foodstuffs: fortified foods and food supplements


7. Notification Under Another Act
- 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. Main Content
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. Brief Statement of Grounds
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. Reference Documents - Basic Texts
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. Invocation of the Emergency Procedure
No


12. Grounds for the Emergency
-


13. Confidentiality
No


14. Fiscal measures
No


15. Impact assessment
-


16. TBT and SPS aspects
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

Stakeholders Contributions

The TRIS website makes it easy for you or your organization to contribute with your opinion on any given notification.
Due to the end of standstill we are currently not accepting any further contributions for this notification via the website.


en
  EHPM on 29-05-2017
Click to expand

 

Comments on draft Belgium Legislation on maximum levels for Vitamins and Minerals

 

Listed below are EHPM’s comments on TRIS Notification 2016/615/B (Belgium). EHPM was created in 1975 and represents approximately 1,750 health-product manufacturers in 14 European countries. Through our member associations, we aim to provide consumers with safe, science-based, high quality products as well as accurate and helpful information about their nutritional value and use. Over 90% of the companies that are members of EHPM through our national associations are SMEs.

 

Recent Jurisprudence & Proposed Levels

EHPM considers that the ECJ judgement[1] on Case C-672/15 (“Noria”) issued on 27 April 2017 has to be taken into account by not only the Belgian proposal to revise its maximum levels but also in all future regulatory activity by Member States in the area of maximum levels. The Belgian proposal was notified before the Noria judgement emerged so the Belgian authoritities would not have been in a position to factor the findings of this case into their drafting.

 

The key point from the Noria judgement from an EHPM perspective was that while it confirms that national governments are free to set levels in the absence of EU harmonisation, a clear scientific and robust basis that takes into account recent international scientific opinions  is needed to justify any levels established – see point 3 of the judement below:

 

“The provisions of Directive 2002/46 and those of the TFEU relating to the free movement of goods must be interpreted as precluding that the scientific assessment of the risks referred to in Article 5(1)(a) of that directive, prior to the establishment of upper safe limits which must in particular be taken into account in order to set the maximum amounts referred to in Article 5 thereof, be carried out solely on the basis of national scientific opinions, even though recent international scientific opinions concluding in favour of the possibility of setting higher limits are also available on the date of the adoption of the measure at issue.”

 

In this context, EHPM feels that adjustments are needed to some of the levels proposed in order for these levels to reflect recent scientific analysis and also levels applied widely in other EU Member States without any history of adverse effects. The table below looks at the levels proposed in the Belgian law, compares it with scientific opinions adopted by the European Food Safety Authority for example. The table shows a clear divergence between the levels proposed and leading scientific analysis on safety. A column with EHPM’s suggested level is also included.

 

Vitamin or Mineral

Proposed Level

EHPM

Suggestion

Justification

Niacin (nicotinamide) (mg) (vitamin B3)

54

820

The current proposal is an improvement of the original proposal of 10mg but is still excessively low particularly given that the Scientific Committee on Food approved an Upper Tolerable Level (UTL) of 900mg[2].

Niacin (nicotinic acid and inositol hexaniacinate ) (mg) (vitamin B3)

0

10

The proposal notified through TRIS would ban the use of nicotinic acid and inositol hexaniacinate despite its approval under the Food Supplements Directive.EHPM understand that the authorities are now considering setting a level of 10mg which when formally confirmed would be supported by EHPM.

 

Vitamin B6 (pyridoxine) (mg)

6

25

The proposal is inconsistent with the UTL set by EFSA of 25mg. It is unclear what the scientific basis for the low level proposed is and clarification should be provided on this.

 

Vitamin C (L-ascorbic acid) (mg)

1000

1750

EFSA has not established UTL  because of limited data but has confirmed that daily doses of vitamin C up to about 1000mg in addition to normal dietary intakes are not associated with adverse gastrointestinal effects, but that acute

gastrointestinal effects may occur at higher intakes (3-4 g/day)[3]. Internationally the US FNB have approved a dosage of 2000mg[4].

Vitamin E (alfa-tocopherol equivalents) (mg)

39

300

The proposal is inconsistent with the UTL set by EFSA of 300mg[5]. Furthermore, the SC considered that the current estimated intakes from food and supplements, including the 97.5th percentile, in the population

are generally well below the UL. It is unclear what the scientific basis for the low level proposed is and clarification should be provided on this.

 

Vitamin K (phytomenadione equivalents) (µg)

210

600

The UK expert Group on Vitamins and Minerals (EVM) indicates 1000µg as a maximum daily level for food supplements[6]. Qualitative assessment of SCF Opinions (and other authoritative reports) show

no adverse effects in healthy individuals associated with high intakes of vitamin K[7].

The level proposed here is significantly lower and it is not clear what risk this low level is intended to mitigate.  

Manganese (mg)

1

5.5

A level of 5.5mg has been in place in Belgium for 25 years with no adverse effects report. It is therefore unclear what the basis is for the proposed reductions. In Italy, for example there is a longstanding maximum level of 10mg in place.

Selenium (µg)

105

200

The proposal is inconsistent with the UTL set by EFSA of 300µg for adults[8]. This value covers selenium intake from all sources of

food, including supplements. It is unclear what the scientific basis for the low level proposed is and clarification should be provided on this.

Zinc (mg)

22.5

25

The current proposal is an improvement of the original proposal 10mg but EHPM would still suggest a level consistent with the UTL of 25mg recommended by EFSA[9].

 

 

EHPM Suggested Changes to Warning Statements

Article 6 of the draft Royal Decree proposes warning statements in the label for specific nutrients and specific dosages. EHPM questions whether these warnings are based on sufficient scientific evidence and whether they are necessary for safe supplemental use, specifically:

 

·       Vitamin K: The draft Royal Decree proposed warning states: “foodstuffs containing a daily dose of vitamin K exceeding 25 μg should display the following warning: ‘Not suitable for people taking coumarin anticoagulants.’” EHPM considers that this warning is only relevant for vitamin K2, at all dosages. Research suggests that coumarin inhibits the K2-dependent MGP protein system that keeps calcium out of arterial walls. Thus, vitamin K and coumarin interaction may actually encourage cardiovascular calcification as an adverse side effect. However, the combination of vitamin K2 with coumarin anticoagulants is not always a problem[10] so, the best approach would be to simply suggest ‘People taking coumarin anticoagulants should consult a health professional before taking the supplement’.

·       Potassium: The draft Royal Decree proposed warning states: “foodstuffs containing a daily dose of potassium of at least 1000 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’”. It is not clear what the scientific basis for suggesting this warning is and this should be clarified with the Belgian authorities particularly given that EFSA consider that a potassium intake of 3500mg can have a beneficial effect[11].  

·       Zinc: The draft Royal Decree proposed warning states “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 EFSA SCF noted in its document “Tolerable Upper Intake Levels for Vitamins and Minerals”[12]  an absence of any adverse effects on a wide range of indicators of copper status at an intake of 50 mg/day (NOAEL) and recommended a UL of 25 mg/day (*see page 199 of the EFSA SCF document). It should also be noted that there is a long history of supplements being sold at a dosage of 15mg/day in countries like Italy for example. It is not clear what the scientific basis for the proposal warning is and this should be clarified with the Belgian authorities.

 

 

General Comments

EHPM would like to emphasise that all the nutrients covered in the draft proposal have authorized health claims in Regulation (EU) No 432/2012[13] without specific restrictions of use and/or additional statements or warnings.

 

EHPM acknowledges that the proposal is a significant improvement on the current levels permitted in Belgium and our Belgian federation NAREDI has supported the work of the authorities in bringing forward this proposal as it would significantly  improve the current situation for Belgian companies. On the whole, EHPM’s membership feels that it is nevertheless important to request that changes be made to the proposal to ensure the level established are consistent with leading scientific consensus and ECJ case law.

 

For Further Information

Patrick Ahern

EHPM Director General

Email: p.ahern@ehpm.org

Tel: +32 721 64 95

 

 


[6] UK Expert Group on Vitamins and Minerals (EVM), “a daily supplementary intake of 1 mg/day would be unlikely to result in adverse effects” page 160-161

https://cot.food.gov.uk/sites/default/files/vitmin2003.pdf.


en
  European Specialist Sports Nutrition Alliance on 23-02-2017
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ESSNA would like to voice its concern on two points included in this draft decree.

 

 

The Decree specifies “Nicotinic acid and inositol hexanicotinate (inositol hexaniacinate) as a source of niacin”. Sources of vitamins are harmonised at the EU level (Annex II of Regulation 1925/2006, and Commission Regulations (EU) No 119/2014, No 1161/2011 and No 1170/2009). As such, we believe that national legislation on this matter is not appropriate.

In addition, the Decree seeks to impose limits on the Mutual Recognition principle, by failing to specify that proof of lawful marketing shall be "readily available information" (as set out in article 4 of Reg. (EC) No 764/2008), not setting out a specific timeline and conditions for response to a notification of denial by the relevant authorities (as set out in article 6 of Reg. (EC) No 764/2008) and not setting out notification procedures to the European Commission in case of refusal (as set out in article 6.2 of Reg. (EC) No 764/2008). We believe this constitutes a potential threat to the free movement of goods and a weakening of the Mutual Recognition principle.


fr
  Pharmanager Development on 23-12-2016
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L'article 9 de ce projet prévoit d'interdire des formes de vitamine B3 pourtant autorisées par la directive 2002/46 concernant les compléments alimentaires (acide nicotinique et hexanicotinate d'inositol) et par le réglement 1925/2005 concernant l'adjonction de vitamines, de minéraux et de certaines autres substances aux denrées alimentaires (acide nicotinique)

Cette position belge me semble contredire les textes européens (directive 2002/46 et réglement 1925/2006), sauf si une modification de ces derniers est prévue.