The Swedish Supreme Administrative Court seeks guidance from the CJEU on the interpretation of the provisions of EU law on the labelling of food for special medical purposes

The Swedish Supreme Administrative Court has recently decided to request a preliminary ruling from the Court of Justice of the European Union (CJEU) on the interpretation of the EU rules governing the labelling of food for special medical purposes. By way of requesting a preliminary ruling, the Supreme Administrative Court is seeking clarification as to whether information concerning energy value and nutrients on the front of the packaging constitutes prohibited repetitions or, on the contrary, if it constitutes necessary information on the properties and characteristics of the product.

The relevant provisions

Both food in general and food for special medical purposes in particular are subject to regulatory frameworks. This applies specifically to information requirements on the labelling of the packaging.  Regulation (EU) 1169/2011 lays down specific requirements on the labelling of food, including the requirement to include a nutrition declaration. The nutrition declaration is required to inform the reader on the energy value and the quantity of nutrients declared per 100 g or per 100 ml.

With regard to food for special medical purposes, Regulation (EU) 1169/2011 is complemented by the Delegated Regulation (EU) 2016/128. The Delegated Regulation contains specific requirements as to the information on the packaging of such foods. Among other things, a description of the properties and characteristics making the food particularly useful in relation to the specific medical purpose is required. However, Regulation (EU) 1169/2011 also prohibits the repetition of information from the mandatory nutrition declaration in the labelling of food for special medical purposes. The regulation does not specify what may constitute a necessary repetition, leaving room for interpretation and potential conflict.

The national dispute

The potential conflict of rules was brought to a head in the national dispute leading up to the request for a preliminary ruling. The dispute originated between a food industry company and a municipal board acting in a supervisory role. The municipal board had issued an order against the company to remove information about the energy value and the actual nutrient content from the front of the packaging of certain foods for special medical purposes. The municipal board claimed that this information violated Delegated Regulation (EU) 2016/128, as it constituted unauthorised repetitions of the information contained in the nutrition declaration. The contested information presented the energy value and nutrient content in a way other than per 100 g or 100 ml.

For its part, the food company argued that the information contained on the front of the packaging complemented the mandatory nutrition declaration, rather than constituted an unauthorised repetition. It was held that the information was required in accordance with Delegated Regulation (EU) 2016/128, as the characteristics relevant to the clinical use of the food must be clearly labelled to instruct the user as to the proper use of the food. The company submitted that the aim of the provision concerned is to provide, in a reasonable way, the best possible conditions for the medical personnel handling the food. Information such as that presented on the front of the packaging enabled a quick overview of the specific characteristics of the food, minimising the risk of mistakes with major negative consequences. In addition, the information on the front of the packaging was not the same as that in the nutrition declaration, as it was not declared per 100 g or 100 ml.

The request for a preliminary ruling

The Supreme Administrative Court has noted that it is possible to fulfil the obligation to provide information regarding the characteristics of the product without indicating actual nutrient and energy content. While this possibility remains, it is not clear whether that is the only way to go. The wording of the relevant provisions does not provide for a clear answer. By way of requesting a preliminary ruling, the Supreme Administrative Court wishes to clarify if information on the nutrient contents and energy value can constitute mandatory characteristics information when declared differently to that in the nutrition declaration. It is against this background that the Supreme Administrative Court has requested that the CJEU take a position on the following questions:

1. Can information on the energy value and the quantity of nutrients of the product, which is declared elsewhere than in the nutrition declaration, constitute an additional description of the product’s properties and characteristics within the meaning of Delegated Regulation (EU) 2016/128?
2. If the answer to Question 1 is affirmative, does the ban on the repetition of the information contained in the mandatory nutrition declaration preclude the inclusion of information on energy value and the quantity of nutrients, if the information is expressed otherwise than per 100 g or per 100 ml?

The case is expected to have significant implications to the food industry for special medical purposes in the EU, as it will clarify the scope and limits of the EU regulations on the labelling of such foods. While a date for the preliminary ruling is yet to be set, such proceedings take on average between 15 and 18 months. It remains to be seen which way the CJEU will choose to go with regards to the requirement or indeed allowability of additional information.

Setterwalls is following developments in the case.