NEW BELGIAN DECREE ON NUTRIENTS PUBLISHED

The decree removes maximum levels for several vitamin B sources, increases the maximum level of Vitamin C to 1 gram and introduces new mandatory warnings.

What will change?

The maximum levels are mainly based on the advice of the Superior Health Council of June 2015.[1]

The decree introduces the following changes: 

• removal of the existing maximum levels for: vitamin B1 (thiamin), vitamin B2 (riboflavin), vitamin B12, pantothenic acid, biotin and chloride;

• new maximum levels for boron (3 mg) and fluoride (1.7 mg);

• increased maximum levels for the following nutrients: vitamin C (1000 mg), vitamin D (75 µg), vitamin E (39 mg), vitamin K (210 µg), folic acid (500 µg), iron (45 mg) and copper (2 mg); and

• decreased maximum levels for manganese, from 5.25 to 1 mg and for nicotinic acid and inositol hexanicotinate (vitamin B3) the level is reduced from 54 to 10 mg

To ensure safe use, the following warnings will become mandatory in the labeling of foodstuffs containing (a daily dose that exceeds) the following levels of nutrients: 

• 25 μg vitamin K: “Not suitable for people taking coumarin anticoagulants.”;

• 1000 mg potassium: “Not suitable for elderly people or people with a renal disorder, insulin-resistant diabetes or people with arterial hypertension.”;

• 10 mg zinc: “The intake of zinc should be limited to a period of a few weeks/months.”; and

• Nicotinic acid or inositol hexanicotinate: “Not suitable for pregnant or lactating women”.

Other changes?

Furthermore, the decree simplifies the existing notification requirement for fortified foods. The notification procedure no longer requires a full list of ingredients of the fortified food product. 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.

Lastly, the decree adds an additional provisions on mutual recognition. A written application can be submitted to the Belgian authorities with evidence showing that the product has been legally marketed in another Member State. Under the previous decree, firms could submit requests for derogation from the maximum levels to the Superior Health Council. 

When will it be applicable?

The decree was published on October 31, 2017. As a transitional measure, foodstuffs already placed on the market that do not comply with the provisions of the decree, but do comply with the provisions of the previous decree, can still be placed on the market until November 10, 2019. 

What about the other EU countries and the Commission?

Besides Belgium, most EU Member States have adopted maximum levels for vitamins and minerals.

Italy[2] and France[3] have set legally binding maximum levels for all vitamins and most minerals.  

Recently the Netherlands, one of the most liberal EU countries regarding the addition of nutrients or other substances, announced their intention to set a maximum level for vitamin B6. The levels, based on a report of the Dutch Food Safety Authority (NVWA), would be 21 mg for adults and 3-13 mg per day for children, depending on the age. The former would be lower than the upper level of 25 mg published by EFSA, and significantly higher than the low levels in Belgium (6 mg) and Italy (9.5 mg).

Germany is currently working on new maximum levels for vitamins and minerals.

Comments

As long as there are no EU-wide maximum levels set for vitamins and minerals, EU countries still have the right to set their own maximum levels in national regulation. This is often done based on a risk assessment of their local scientific bodies, and not by directly applying the tolerable upper intake levels for vitamins and minerals set by EFSA.

Although it is good to see that Member States are applying science-based policies, it is clear that, as long as the European Commission does not cut the Gordian knot and finally adopt EU-wide maximum levels, EU countries will each set their own levels based on their interpretation of the science. As a result, the mutual recognition principle does not always ensure EU wide acceptance when it comes to maximum levels of vitamins and minerals.

Recently though, in the case C-672/15, the Court found that, whilst France could maintain its own maximum levels, the absence of a procedure for authorizing food supplements marketed in other EU countries with levels above those limits made the legislation contrary to the principle of mutual recognition.

In its judgement the court also confirmed that maximum limits should be based on the most reliable scientific data available and the most recent results of international research. They may not be based merely on national scientific opinions, if recent international scientific opinions concluding in favor of the possibility of setting higher limits are also available on the date of the adoption of the measure at issue.

[1]        Opinion No° 9285 of the Superior Health Council 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)

[2]        Apporti giornalieri di vitamine e minerali ammessi negli integratori alimentari (http://www.salute.gov.it/imgs/C_17_pagineAree_1268_listaFile_itemName_5_file.pdf)

[3]      Arrêté du 9 mai 2006 relatif aux nutriments pouvant être employés dans la fabrication des compléments alimentaires.