Artikel | 20 november 2025
EU Court clarifies front‑of‑pack nutrition labelling for foods for special medical purposes: per‑portion figures included in such labelling constitute a prohibited repetition
The European Court of Justice clarifies front‑of‑pack nutrition labelling requirements for foods for special medical purposes – here are the main takeaways.
Brief background
On 9 October 2025, the Court of Justice of the European Union (CJEU) delivered its judgment in Case C‑315/24, in proceedings between Nestlé Sverige AB and the Environmental Board of Helsingborg Municipality. The dispute concerned the labelling of foods for special medical purposes (FSMPs). On the front of certain FSMP packages, Nestlé displayed the energy value and quantities of nutrients per portion or consumption unit, while the mandatory nutrition declaration per 100 g/ml appeared elsewhere on the pack. The Swedish authorities ordered removal of the front‑of‑pack per‑portion figures, on the basis that they constitute a prohibited repetition under Article 6(2) of Commission Delegated Regulation (EU) 2016/128. The case went through the court system, and Sweden’s Supreme Administrative Court sought a preliminary ruling on whether such per‑portion front‑of‑pack information could qualify as the “description of properties/characteristics” required by Article 5(2)(g) of Regulation 2016/128, and, if so, whether Article 6(2) nevertheless barred it.
The CJEU held that per‑portion front‑of‑pack energy and nutrient information, where the same parameters are already provided per 100 g/ml in the mandatory nutrition declaration, does not constitute a descriptive product characteristic under Article 5(2)(g) but rather a prohibited repetition within the meaning of Article 6(2). The judgment tightens the labelling framework for FSMPs, underscoring the stricter consumer‑protection rationale and the medical‑supervision context of these products.
Legal framework
FSMPs fall under Regulation (EU) No 609/2013, supplemented by rules on composition and information under Delegated Regulation (EU) 2016/128. In parallel, the horizontal food information regime of Regulation (EU) No 1169/2011 applies unless specific lex specialis rules declare otherwise.
- Under Regulation 1169/2011, a mandatory nutrition declaration must be expressed per 100 g/ml, with certain elements permitted to be repeated on the “front of pack” for general foods. The regulation also allows, in defined circumstances, per‑portion expression as an addition to, or sometimes instead of, the per‑100 g/ml values for general foods.
- Delegated Regulation 2016/128, recognising the clinical use of FSMPs, both supplements and derogates from the general regime. Two provisions were central to the case:
- Article 5(2)(g) requires additional FSMP‑specific information: a description of the properties and/or characteristics that make the product particularly useful in relation to the disease or condition, for example due to special processing or the increase, reduction, removal or alteration of specific nutrients, and the rationale for the product’s use.
- Article 6(2) imposes a lex specialis prohibition: “by way of derogation from Article 30(3) of Regulation (EU) No 1169/2011”, the information contained in the mandatory nutrition declaration for FSMPs may not be repeated in the labelling.
This framework reflects the objectives of preventing consumer deception, ensuring appropriate use under medical supervision and avoiding marketing that might target vulnerable patients with simplified or promotional messages.
Questions put to the Court
The referring court asked whether:
- Energy and nutrient information presented outside the nutrition declaration could qualify as additional, descriptive information required by Article 5(2)(g) of Delegated Regulation 2016/128; and
- If so, whether Article 6(2)’s ban on repeating nutrition‑declaration information in FSMP labelling would nevertheless preclude such per‑portion front‑of‑pack information where it is expressed differently from the per‑100 g/ml format.
The Court’s reasoning
The Court approached Articles 5(2)(g) and 6(2) contextually, against the backdrop of Regulations 1169/2011 and 609/2013, and the particular characteristics of FSMPs.
First, the Court interpreted Article 5(2)(g) as calling for additional information that is distinct from and supplementary to the mandatory particulars listed in Regulation 1169/2011. The “description of properties/characteristics” aims to inform about what makes the FSMP suitable for its intended medical purpose. This includes, where applicable, the processing, specific nutrient modifications and the rationale underpinning use in particular conditions. By its wording and purpose, the provision does not re‑authorise the restatement of items that fall within the mandatory nutrition declaration. Information about energy and nutrient amounts is already within the scope of the nutrition declaration; simply re‑expressing those data per portion or unit on the package front does not convert them into a descriptive characteristic within the meaning of Article 5(2)(g).
Second, the Court interpreted Article 6(2) as a clear derogation from the general allowability under Regulation 1169/2011 to repeat certain nutrition items on front of pack. In the case of FSMPs, an express prohibition applies to repeating the mandatory nutrition declaration in the labelling, regardless of format. The substance of the data determines: whether the information is of the same nature as that in the mandatory declaration (energy and specified nutrients), placing equivalent content elsewhere amounts to repetition. The form of expression (per 100 g/ml vs per portion or unit) does not save it.
This interpretation is consistent with the regulatory context and aims. FSMP consumers are patients, and these products are to be used under medical supervision. Allowing selective front‑of‑pack restatement of nutrition data poses the risk of presenting a partial picture and could mislead. The general policy in Regulation 1169/2011 of enabling front‑of‑pack repetition to aid quick consumer assessment is not transposable to FSMPs. Further, nutrition and health claims are barred for FSMPs, reflecting an overarching intent to avoid promotional labelling. In that light, the FSMP regime is stricter and purpose‑built: labelling should enable correct use and clear identification, not consumer marketing through highlighted nutrition cues.
Accordingly, the Court held that front‑of‑pack per‑portion energy and nutrient figures that duplicate the subject matter of the mandatory nutrition declaration are not a permissible “description” under Article 5(2)(g) but are a prohibited repetition under Article 6(2).
Practical implications for industry, and enforcement
The judgment has immediate implications for FSMP manufacturers, importers and distributors in the EU, as well as for national enforcement authorities.
The commercial interests of Nestlé and others to highlight certain key elements is of course understandable and fair as such but found to be prohibited from a regulatory perspective.
For businesses, any front‑of‑pack display of energy or nutrient amounts that accord with the parameters of the mandatory nutrition declaration, whether expressed per 100 g/ml, per portion, or per consumption unit must be removed unless forming part of the single, mandatory nutrition declaration itself. The distinction between repetition and permissible descriptive content cannot be bridged by changing the reference base or unit. Attempts to position per‑portion panels as clinical guidance or consumer assistance will not qualify under Article 5(2)(g) unless they genuinely describe properties or characteristics that render the product suitable for the specified medical condition, such as the nature and rationale of nutrient modification or special processing steps, and do not restate the nutrition declaration’s quantitative items.
For authorities, the ruling provides a bright‑line standard, and simplifies oversight. Where front‑of‑pack information mirrors the energy and nutrient fields contained in the mandatory declaration—even in a different expression or format—enforcement action is supported by Article 6(2). At the same time, inspectors should recognise that Article 5(2)(g) demands the presence of additional FSMP‑specific descriptive content, which must go beyond numeric restatements and must address the product’s medical suitability and use rationale.
For healthcare professionals and patients, the decision reinforces the centrality of the comprehensive nutrition declaration and the FSMP‑specific description, rather than fragmenting key information across multiple panels. This aligns with the supervised‑use paradigm and seeks to minimise confusion.
Main takeaways
The CJEU’s judgment draws a clear boundary around FSMP labelling. Front‑of‑pack per‑portion or per‑unit energy and nutrient figures that duplicate the contents of the mandatory nutrition declaration are prohibited. Article 5(2)(g) does not provide a backdoor for such repetition; it requires additional, qualitative, FSMP‑specific descriptive content addressing why the product’s properties make it suitable for the designated medical condition. The FSMP regime is intentionally stricter than the general food labelling rules to protect vulnerable consumers and preserve the supervised nature of use. Manufacturers should audit labels promptly, remove quantitative front‑of‑pack repetitions, and strengthen the Article 5(2)(g) description to meet the informational needs of healthcare‑directed dietary management without drifting into promotional territory.