Thursday, 11 December 2025
Following the recent ruling made on 09 October 2025 by the Court of Justice of the European Union (CJEU), from Case C-315/24 Nestlé Sverige AB v Miljönämnden i Helsingborgs kommun, the Food Safety Authority of Ireland (FSAI) is informing food businesses that the repetition of nutrition information is not permitted on the label of Foods for Special Medical Purposes (FSMPs).
FSMPs are foods designed to meet the dietary needs of patients with special nutritional requirements for use under medical supervision. These foods are defined by Regulation (EU) No 609/2013 and their specific labelling, composition and information requirements are set down in Commission Delegated Regulation (EU) 2016/128. Article 6(2) of the delegated regulation states “mandatory nutrition declaration for food for special medical purposes shall not be repeated on the labelling”. Despite this, food businesses have repeated nutrition information on the labels of FSMPs across the European market. Prior to the ruling, industry maintained the repeated nutrition information was fulfilling the food information requirement set down in Article 5(2)(g) of the delegated regulation. Article 5(2)(g) requires FSMP labels to contain “a description of the properties and/or characteristics that make the product useful in relation to the disease, disorder or medical condition for the dietary management of which the product is intended, in particular, as the case may be, relating to the special processing and formulation, the nutrients which have been increased, reduced, eliminated or otherwise modified and the rationale of the use of the product.” The differing opinion gave rise to the recent court case. In this case, two questions were referred to the Court of Justice for a preliminary ruling in relation to industry’s interpretation of Article 5(2)(g):
Question 1: Can information regarding a product’s energy value and the amounts of different nutrients it contains, which is provided elsewhere than in the nutrition declaration, constitute an additional description of the product’s properties and characteristics, as referred to in Article 5(2)(g) of [Delegated Regulation (EU) 2016/128]?
Question 2: If the answer to Question 1 is in the affirmative, does Article 6(2) [of that delegated regulation], which prohibits the repetition on the labelling of the information included in the mandatory nutrition declaration, preclude the indication, in a description under Article 5(2)(g) [of that delegated regulation], of information on the energy value and the amounts of different nutrients, if that information is expressed in a way other than per 100 g or per 100 ml?
The Court ruled
“Article 5(2)(g) and Article 6(2) of Commission Delegated Regulation (EU) 2016/128 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes must be interpreted as meaning that the indication of the energy value and the amount of various nutrients, expressed per portion or per consumption unit, on the front of the packaging of food for special medical purposes, whereas the mandatory nutrition declaration on the back of that packaging contains a statement of those same elements per 100 g or per 100 ml, does not constitute a ‘description of the properties and/or characteristics’ of a product, within the meaning of Article 5(2)(g) of that delegated regulation, but is a repetition of the information in that mandatory nutrition declaration, which is prohibited by Article 6(2) of that delegated regulation.”
The above ruling makes it clear that the repetition of nutrition information on FSMPs is not permitted in any form. This includes, but is not limited to, the use of front-of-pack style nutrition circles, expressing nutrient values in different formats, and any other similar nutrition labelling.
The prohibition of the repetition of nutrition information expands to the use of nutrition claims whereby Article 7 (Nutrition and Health Claims) of Delegated Regulation (EU) 2016/128 states “Nutrition and health claims shall not be made on food for special medical purposes” while in national legislation, Regulation 16 of S.I. No. 425 of 2019 states “A food business operator who makes a nutrition or health claim on a food referred to in Regulation 3(3), is guilty of an offence.”
Conclusion
The repetition of nutrition information, of any kind, is not permitted on the label of FSMPs and should only appear in the mandatory nutrition declaration on the label. Repetition of nutrition information does not meet the requirements set out in Article 5(2)(g) of Commission Delegated Regulation (EU) 2016/128, also set down in national legislation under Regulation 15(1)(d) of S.I. No. 425 of 2019.
The following resources are available to assist food businesses comply with the FSMP legislation:
- Commission Notice on the classification of Food for Special Medical Purposes
- FSAI Guidance for Foods governed under Regulation (EU) No 609/2013 Foods for Specific Groups
- Foods for Specific Groups
- Foods for Special Medical Purposes
- Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control Commission Delegated Regulation (EU) 2016/128
- S.I. No. 425/2019 - European Union (Food Intended For Infants And Young Children, Food For Special Medical Purposes, And Total Diet Replacement For Weight Control) Regulations 2019
Links to the case, opinion and ruling:
- Case C-315/24, Nestlé Sverige: Request for a preliminary ruling from the Högsta förvaltningsdomstolen (Sweden) lodged on 29 April 2024 – Nestlé Sverige AB v Miljönämnden i Helsingborgs kommun
- Opinion of Case C315/24 Nestlé Sverige AB v Miljönämnden i Helsingborgs kommun of the Court of Justice of the European Union (CJEU)
- Ruling: CURIA - Documents