Belgian Ministerial Order Could Signal Start of Higher Ingredient Level Across EU

The Belgian Order’s list currently only covers coenzyme Q10, choline and carnitine, all of which have undergone a rigorous safety assessment with levels set on the advice of Belgium’s Superior Health Council.

27/04/09 A recent Belgian Ministerial Order setting a 200mg maximum daily level for coenzyme Q10 (ubiquinone) in food supplements could signal the start of a trend towards higher levels for the ingredient in supplements and foods across the European Union (EU), international food policy consultancy EAS has said.

EAS Regulatory Adviser Pieter Lagae said that the agreed level for coenzyme Q10, which is higher than that accepted in a number of EU Member States, is a significant step as Belgium is well respected for its rigid notification system and its levels could be taken as a benchmark in other Member States setting their national rules for the use of bioactive and botanical substances.

The Belgian Order’s list currently only covers coenzyme Q10, choline and carnitine, all of which have undergone a rigorous safety assessment with levels set on the advice of Belgium’s Superior Health Council.

“Across the EU, where maximum levels have been established, they are often between 30mg and 100mg,” said Mr Lagae. “Belgium’s decision to set it at 200mg is a significant move. The level is based heavily on scientific evidence submitted, and it could play an important role in setting a maximum level for coenzyme Q10 in Europe. In Denmark too, for example, a daily maximum level of 180mg is being considered for coenzyme Q10.”

Mr Lagae also highlighted the new mutual recognition Regulation applicable from next month, which enables products lawfully marketed in one EU Member State to be permitted entry into another Member State’s market, even if those products are not strictly in compliance with that Member State’s national legislations.

With no plans underway for the setting of EU-wide levels or conditions for substances other than vitamins and minerals used in food supplements, the mutual recognition Regulation and others, such as those for food fortification and novel foods, will come into play in determining the future EU market for these ingredients.

Mr Lagae said: “Many companies consider mutual recognition to be an impractical tool, which is understandable because to date it has not been easy to implement. The new Regulation, however, sets down clear rules for both regulators and the sector on how the principle can be used. Therefore in theory, once a product has been accepted in one Member State, entering several other EU Member States via mutual recognition should be feasible.”