The Member States may only introduce national rules on fortification of food by nutrients if the rules comply with the general requirements for risk analyses of the EU food legislation, the ruling by the Court of Justice of the European Union states. The German fortification rules prohibited the addition of amino acids to foods. However, the German authorities could grant an exemption if the food business operator filed a reasoned application for exemption prior to the marketing of the food product containing amino acids.

A German business operator applied for an exemption to produce and market a food supplement containing amino acids and iron. The authorities assessed that the amino acids used could imply a health risk, and therefore, they rejected the application for exemption. The German business operator commenced proceedings before a German court and, during the proceedings, the business operator was granted an exemption from the prohibition to the effect that it was allowed to produce and market the product for a period of three years.

The German business operator maintained its action at the German court, and the national Constitutional Court had to decide the matter.

The German Constitutional Court asked the Court of Justice of the European Union to decide whether the German system prohibiting the use of the amino acid, L-histidine, in food supplements was in compliance with EU law, regardless of whether there was reasonable suspicion that a health risk existed. The Court of Justice also had to consider whether it was legal to grant an exemption of limited duration.

Ruling by the Court of Justice of the European Union Based on a statement by Advocate-General M. Bobek, the Court of Justice of the European Union made its ruling in the proceedings (C-282/15) on 19 January 2017.

The Court of Justice concluded that Member States must at all times comply with the general Community law principles, including the principles of necessity, precaution and risk analysis, as laid down in Articles 6 and 7 of the Food Regulation (no. 178/2002).

The Court of Justice assessed that the national German food authority had not produced the documentation required to determine that the mere addition of amino acids to foods constituted a health risk.

Consequently, the system violated the precautionary principle laying down that the marketing or production of food products must be restricted only if the authorities can prove, by way of specific risk analyses, that the product poses a health hazard or if scientific uncertainty exists as to whether the product is hazardous to health.

At the same time, the Court of Justice stated that the system violated the principles of necessity and proportionality as all amino acids were subject to the prohibition – not only amino acids which the authorities, based on specific risk analyses, could not rule out as constituting an actual risk to public health.

Finally, the Court of Justice laid down that the exemption of limited duration granted in relation to the food supplement (which, in addition, could not be proved to be hazardous to health) was not necessary and was also disproportionate. Consequently, in the opinion of the Court of Justice, the exemption of limited duration violated the principles of necessity and proportionality.

Against this background, the Court of Justice reached the conclusion that the German system prohibiting food supplements containing amino acids violated EU food legislation rules on risk assessment and the precautionary principle.

Comments by Bech-Bruun With its ruling, the Court of Justice lays down that Member States must at all times observe the requirements of EU law as to specific risk assessments. This also applies if Member States consider introducing national rules restricting the marketing of food products, including rules on fortification.

In this specific case, the Court of Justice referred to the EC court case against Denmark from 2003 (C-192/01) and stated that the principles of that judgment could be applied. In those proceedings, the Court of Justice had to consider a Danish practice where the authorities only allowed fortification of food if a nutritional need for such existed among the citizens. The Court of Justice set aside the Danish practice concerning fortification of food and, already at that time, the Court of Justice laid down that national authorities must allow fortification of food, unless the addition, based on a specific risk assessment, is deemed to be irresponsible in terms of health.

Thus, this new judgment against Germany lays down once more that national authorities cannot prohibit the addition of specific substances to food on the basis of a more or less discretionary assessment.

National rules restricting the addition and marketing of food products must be based on specific, scientific risk assessments. Consequently, the authorities are subject to the same requirements that they define for food businesses to document that their products are safe for consumers to ingest. It will be interesting to see whether the Danish competent authorities, based on the most recent judgment, will find it relevant to re-assess the Danish fortification rules.

Read the judgment by the Court of Justice of the European Union.