Belgium drafts supplement guidance for four nutrients … but is it right?


Industry should fight amendments to a Belgian decree setting out minimum and maximum levels for caffeine, lutein, lycopene and red yeast rice, because some proposed levels fall well below established EFSA safety data, an expert claims.

A draft of proposed maximum and minimum levels for four nutrients in food supplements in Belgium has been ridiculed for failing to take recent EFSA safety data into account when setting levels.

In addition to setting maximum and minimum levels the draft amendment, which appears on the European Commission website, also proposes compulsory warnings that must appear on dietary supplement product labels containing caffeine and/or red yeast rice in a bid to ensure safety.

The new draft decree follows a similar draft in December 2016, which proposed new maximum levels for a number of vitamins and trace minerals.

What are the proposals?

Currently, there are no legal limits for caffeine, lutein, lycopene and red yeast rice in food supplements in Belgium. As such the draft document amends an existing decree to include the nutrients on the basis of scientific opinion.

It defines minimum and/or maximum values for the four substances to be consumed per day from food supplements as: 

  • caffeine: maximum 80 mg/day
  • lutein: between 2 and 10 mg/day
  • lycopene: between 2.5 and 15 mg/day
  • red yeast rice or any other source of monacolin K: maximum 10 mg/day of monacolin K

The draft document states that these proposed limits are based on current scientific opinions including Advisory report No 8689 on the use of caffeine in foodstuffs, Advisory report No 8592 for recommendations concerning lycopene and lutein, and guidelines concerning red yeast rice published in December 2016.

In addition to setting out maximum and minimum intake values for the four nutrients in food supplements on sale in Belgium, the draft amendment will also see compulsory warnings introduced for caffeine and red yeast rice.

For caffeine the proposed warning will be: ‘Unsuitable for children or pregnant or lactating women.’ 

For red yeast rice the proposed warning will be: ‘This product is unsuitable for pregnant or lactating women, children and adolescents, those over 70 years of age, those with liver, kidney or muscular problems, those taking medicinal products liable to interact (e.g.: cholesterol-lowering drugs) or those intolerant to statins. If in doubt, please seek advice from your doctor or pharmacist.’

Positives vs negatives

Speaking to NutraIngredients, Luca Bucchini, managing director of Hylobates Consulting said the draft decree brings a combination of positives and negatives. On the positive side, he commended Belgium for recognising the use of monacolin K from red yeast rice at levels foreseen by authorised health claims – noting that some Member States object to these levels, and consider them medicinal. In contrast, he said that proposed levels for caffeine are ‘very low’ compared to levels already set by France and Italy.

“This is unsurprising as the scientific advice underpinning the decree dates back to 2012, and therefore ignores EFSA's opinion on the safety of caffeine which considered safe levels of 200 mg per single dose, and 400 mg per day,” Bucchini added.

“It should be noted that with this decree all the pending health claims for caffeine at 3 mg/kg bw (those related to endurance) are automatically banned in Belgium.”

The European food law expert also warned that since the ECJ has recently reiterated in its stance on maximum levels for vitamins, national regulations cannot ignore recent international studies such as those of EFSA.

“Belgium is proposing to do exactly that, and a decision by the EC or by a court would be past due to correct the recurring problem of outdated or very peculiar scientific advice from Belgium's Conseil supérieur d’hygiène (Scientific Health Council),” he said.

Mutual recognition

Bucchini also said the draft decree is a fresh example of how inaction by the European Commission on levels for vitamins, minerals and other nutrients leads to fragmentation of the single European market.

“Belgium is proposing to set rules on substances which EFSA has assessed under various provisions, and that should be harmonised at EU level, and includes - as usual for Belgium - a set of provisions that slap EU law in the face,” he said – noting that Belgium is ‘a serial offender’ when it comes to mutual recognition.

“If the EC does not object to this proposed measure, companies from other countries should expect a tough fight in court to protect their products in the Belgian market if they comply with EU law, but not with these peculiar Belgian initiatives.”

Bucchini said concerned companies should tell the EC very clearly that Belgium need to correct its decree to bring it in line with science and EU law, while keeping the good bits, using the online ‘contributions’ tab on the TRIS database.

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