Provisional text

delivered on 8 May 2025 (1)

Case C‑315/24

Nestlé Sverige AB

Miljönämnden i Helsingborgs kommun

(Request for a preliminary ruling from the Högsta förvaltningsdomstolen (Supreme Administrative Court, Sweden)

( Reference for a preliminary ruling – Approximation of laws – Food safety – Food for special medical purposes – Information requirements – Additional mandatory particulars – Specific requirements relating to the mandatory nutrition declaration – Prohibition of the repetition on the labelling of information contained in that declaration )

This case presents the Court with an opportunity to interpret, for the first time, the provisions of EU law relating to the mandatory additional particulars that are required in the labelling of food for special medical purposes.

Regulation (EU) No 1169/2011

Recital 41 of Regulation (EU) No 1169/2011 (2) reads:

‘To appeal to the average consumer and to serve the informative purpose for which it is introduced, and given the current level of knowledge on the subject of nutrition, the nutrition information provided should be simple and easily understood. To have the nutrition information partly in the principal field of vision, commonly known as the “front of pack”, and partly on another side on the pack, for instance the “back of pack”, might confuse consumers. Therefore, the nutrition declaration should be in the same field of vision. In addition, on a voluntary basis, the most important elements of the nutrition information may be repeated in the principal field of vision, in order to help consumers to easily see the essential nutrition information when purchasing foods. A free choice as to the information that could be repeated might confuse consumers. Therefore, it is necessary to clarify which information may be repeated.’

Article 9 of the regulation, entitled ‘List of mandatory particulars’, provides, in paragraph 1 thereof, as follows:

‘In accordance with Articles 10 to 35 and subject to the exceptions contained in this chapter, indication of the following particulars shall be mandatory:

…

(l) a nutrition declaration.’

Article 30 of the regulation, which concerns the content of the nutrition declaration referred to in Article 9(1)(l), provides, in paragraphs 1 and 3 thereof:

‘1. The mandatory nutrition declaration shall include the following:

(a) energy value; and

(b) the amounts of fat, saturates, carbohydrate, sugars, protein and salt.

…

3. Where the labelling of a prepacked food provides the mandatory nutrition declaration referred to in paragraph 1, the following information may be repeated thereon:

(a) the energy value; or

(b) the energy value together with the amounts of fat, saturates, sugars, and salt.’

Article 32 of the regulation, entitled ‘Expression per 100 g or per 100 ml’, provides, in paragraph 2 thereof:

‘The energy value and the amount of nutrients referred to in Article 30(1) to (5) shall be expressed per 100 g or per 100 ml.’

Article 33(1), (2) and (4) of the regulation provides as follows:

‘1. In the following cases, the energy value and the amounts of nutrients referred to in Article 30(1) to (5) may be expressed per portion and/or per consumption unit, easily recognisable by the consumer, provided that the portion or the unit used is quantified on the label and that the number of portions or units contained in the package is stated:

(a) in addition to the form of expression per 100 g or per 100 ml referred to in Article 32(2);

…

When the amounts of nutrients are expressed on the basis of per portion or per consumption unit alone in accordance with the first subparagraph, the energy value shall be expressed per 100 g or per 100 ml and on the basis of per portion or per consumption unit.

…

4. The portion or unit used shall be indicated in close proximity to the nutrition declaration.’

Regulation (EU) No 609/2013

Recital 24 of Regulation (EU) No 609/2013 (3) reads as follows:

‘Regulation … No 1169/2011 lays down general labelling requirements. Those labelling requirements should, as a general rule, apply to the categories of food covered by this regulation. However, this regulation should also provide for additional requirements to, or derogations from, Regulation … No 1169/2011, where necessary, in order to meet the specific objectives of this regulation.’

Article 2(2)(g) of Regulation No 609/2013 provides:

‘The following definitions shall … apply:

(g) “food for special medical purposes” means food specially processed or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; it is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medically determined nutrient requirements, whose dietary management cannot be achieved by modification of the normal diet alone’.

Article 9(5) and (6) of that regulation provide:

‘5. The labelling, presentation and advertising of food referred to in Article 1(1) shall provide information for the appropriate use of such food, and shall not mislead, or attribute to such food the property of preventing, treating or curing a human disease, or imply such properties.

6. Paragraph 5 shall not prevent the dissemination of any useful information or recommendations exclusively intended for persons having qualifications in medicine, nutrition, pharmacy, or for other healthcare professionals responsible for maternal care and childcare.’

Delegated Regulation (EU) 2016/128

Recitals 13, 14 and 15 of Delegated Regulation (EU) 2016/128 (4) read as follows:

‘(13) Food for special medical purposes has to comply with [Regulation No 1169/2011]. In order to take account of the specific nature of food for special medical purposes, this Regulation should lay down additions and exceptions to those general rules, where appropriate.

(14) Providing all information that is necessary to ensure the appropriate use of food for special medical purposes should be mandatory for this type of food. That information should include information on the properties and characteristics in relation to, among others, the special processing and formulation, nutritional composition and rationale of use of the product that make it useful for its specific intended purpose. Such information should not be considered as nutrition and health claims within the meaning of [Regulation No 1924/2006].

(15) The nutrition declaration for food for special medical purposes is essential in order to guarantee its appropriate use, both for patients consuming that food and for health care professionals who recommend its consumption. For that reason and in order to provide more complete information to patients and healthcare professionals, the nutrition declaration should include more particulars than those required by [Regulation No 1169/2011]. …’

Article 5 of that delegated regulation, entitled ‘Specific requirements on food information’, provides, in paragraph 1 and paragraph 2(g) thereof:

‘1. Unless otherwise provided in this regulation, food for special medical purposes shall comply with [Regulation No 1169/2011].

…

(g) 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’.

Article 6 of the regulation, entitled ‘Specific requirements on the nutrition declaration’, provides, in paragraph 2 thereof:

‘By way of derogation from Article 30(3) of [Regulation No 1169/2011], the information included in the mandatory nutrition declaration for food for special medical purposes shall not be repeated on the labelling.’

The facts of the dispute, the main proceedings, the questions referred for a preliminary ruling and the procedure before the Court

Nestlé Sverige AB (‘Nestlé’) is a food business that markets a variety of products as food for special medical purposes.

As is apparent from the request for a preliminary ruling, those products bear, on the front of the packaging, particulars of the energy value and the amounts of various nutrients, such as fat, protein and fibre, expressed not per 100 g or per 100 ml, but per portion or per consumption unit (‘the particulars at issue’).

The Miljönämnden i Helsingborgs kommun (Environmental Committee of the Municipality of Helsingborg, Sweden) required Nestlé to remove the particulars at issue on the ground that, in breach of Article 6(2) of Delegated Regulation 2016/128, they constituted a repetition of particulars included in the mandatory nutrition declaration in accordance with Article 30(1) of Regulation No 1169/2011, which must, under Article 32(2) of that regulation, be expressed per 100 g or per 100 ml.

After unsuccessfully attempting to have that decision reviewed, Nestlé brought an action before the Förvaltningsrätten i Malmö (Administrative Court, Malmö, Sweden) for its annulment. In that action, Nestlé argued that the particulars at issue were not a repetition of particulars included in the mandatory nutrition declaration, but should be regarded as particulars supplementing that declaration, in accordance with Article 5(2)(g) of Delegated Regulation 2016/128.

That action was dismissed on the ground that, even though the particulars at issue were expressed per portion or per consumption unit rather than per 100 g or per 100 ml, they nevertheless constituted a repetition of particulars in the mandatory nutrition declaration, prohibited by Article 6(2) of Delegated Regulation 2016/128.

After failing in its appeal before the Kammarrätten i Göteborg (Administrative Court of Appeal, Gothenburg, Sweden), which held that the particulars at issue did not fall within the scope of Article 5(2)(g) of Delegated Regulation 2016/128 but constituted a repetition of particulars included in the mandatory nutrition declaration, Nestlé brought an appeal on a point of law before the Högsta förvaltningsdomstolen (Supreme Administrative Court, Sweden), the referring court.

In order to establish whether the labelling of the products at issue is in conformity with Delegated Regulation 2016/128, the referring court questions, in essence, whether the particulars at issue constitute an additional description of the properties and characteristics of a product within the meaning of Article 5(2)(g) of that delegated regulation or whether they are merely a repetition of particulars included in the mandatory nutrition declaration, which is prohibited by Article 6(2) of that delegated regulation.

It is in those circumstances that the Högsta förvaltningsdomstolen (Supreme Administrative Court) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:

‘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 2016/128]?

The order for reference, dated 25 April 2024, was received at the Registry of the Court of Justice on 29 April 2024. Written observations were submitted by the appellant in the main proceedings, the Czech Government and the European Commission. The appellant, the Miljönämnden i Helsingborgs kommun (Environmental Committee of the Municipality of Helsingborg), the respondent in the main proceedings, as well as the Czech Government and the Commission, also attended the hearing, which was held on 12 February 2025.

Preliminary observations

I shall first mention some specific characteristics of food for special medical purposes and their consequences for the legal framework which applies to their labelling, the comprehension of which is essential in order to provide useful answers to the questions referred to the Court in this case.

It is important to bear in mind that, in EU law, the labelling of foodstuffs is governed by Regulation No 1169/2011. That regulation lays down general food labelling requirements, in accordance with which certain mandatory information must be given. (5) It also provides for the possibility of providing voluntary information. (6) Given that foods for special medical purposes are, first and foremost, and despite their specific characteristics, foodstuffs, those general requirements apply to such food. (7)

As regards the specific characteristics of the foods concerned in this case, according to its legal definition, a food for special medical purposes is, first, a food specially processed or formulated for the dietary management of patients and which is to be used only under medical supervision. (8) Thus, food for special medical purposes is characterised by its nutritional function, in that it is ‘specially processed or formulated’ to meet the particular nutritional requirements of patients. (9)

Secondly, according to its legal definition, food for special medical purposes is intended for the exclusive or partial feeding of patients who have a particular disease, disorder or medical condition. (10) Thus, that food is, by its nature, intended to be ingested and used for consumption by patients whose capacity to take, digest, absorb, metabolise or excrete ordinary food or some of its ingredients or metabolites is limited, impaired or disturbed, or by patients whose medical condition gives rise to other medically determined nutrient requirements which cannot be satisfied by a modification of the normal diet alone. (11)

It follows from the foregoing that food for special medical purposes is different from ordinary food in two main respects. One is the population group for which it is intended and the other is the way in which it is used. Food for special medical purposes is intended for vulnerable population groups, consisting of patients affected by a disease, disorder or medical condition which requires them to have a specific diet. Ordinary food is intended for consumers in good health or, in other words, ordinary consumers.

These two types of food differ in the way in which they are used. While the use of ordinary food is not subject to any conditions, food for special medical purposes is to be used only under medical supervision. That medical supervision, which is a concomitant of ‘food for special medical purposes’, implies that the use of such food, which is special because it is adapted to the patient’s dietary management needs, must be recommended to the patient by a health care professional, in view of the patient’s dietary management needs. In that context, ‘medical supervision’ implies that a health care professional, as referred to in recitals 3 and 15 of Delegated Regulation 2016/128, ensures that the use of a food for special medical purposes is in line with the patient’s specific dietary management needs. (12)

Those specific characteristics are the reason for which the labelling of food for special medical purposes must comply not only with the requirements applicable to ordinary food, but also with specific requirements formulated for this special type of food. The labelling of this type of food is therefore subject to a dual regime. (13) Thus, Regulation No 609/2013 and Delegated Regulation 2016/128, which govern, in particular, the specific requirements that apply to food for special medical purposes, must be construed in the light of Regulation No 1169/2011, which establishes the general requirements applicable to all foodstuffs.

As regards those general requirements, Chapter IV of Regulation No 1169/2011, entitled ‘Mandatory food information’, provides, in particular, that a nutrition declaration must be provided. (14) That declaration must contain information on the food’s energy value and the amounts of fat, saturates, carbohydrate, sugars, protein and salt. Some of that information, either the energy value alone or the energy value together with the amounts of fat, saturates, sugars, and salt, may be repeated on the labelling of ordinary food when the labelling provides the mandatory nutrition declaration. (15)

However, in order to take account of the specific nature of food for special medical purposes, certain additions to and exceptions from those rules were considered by the EU legislature to be necessary. In particular, it was decided that, in order to ensure the appropriate use of such food, it should be mandatory to provide information on the properties and characteristics of such food and for the nutrition declaration for that same food to provide more complete information. (16)

Among the additional mandatory particulars that must be provided, along with those satisfying the general requirements applicable to all foodstuffs, is 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 special processing and formulation, the nutrients which have been increased, reduced, eliminated or otherwise modified and the rationale of the use of the product. (17)

As regards the specific requirements relating to the nutrition declaration for food for special medical purposes, by way of derogation from the general rule set out in Article 30(3) of Regulation No 1169/2011, the information included in the mandatory nutrition declaration for food for special medical purposes must not be repeated on the labelling. (18) However, Articles 31 to 35 of Regulation No 1169/2011 apply to all of the nutrients included in the nutrition declaration for food for special medical purposes. (19)

In this connection, the Czech Government submits, in substance, that there is nothing in Delegated Regulation 2016/128 to prohibit nutrition information, expressed on a per portion basis or per consumption unit, from being mentioned on foods for special medical purposes in accordance with Article 33 of Regulation No 1169/2011, which governs how such information should be presented. The Czech Government maintains that Article 6(2) of Delegated Regulation 2016/128 lays down a derogation from Article 30 of Regulation No 1169/2011, but not from Article 33 of that regulation. In its view, only the second question referred for a preliminary ruling, which relates to Article 6(2) of Delegated Regulation 2016/128, needs to be analysed. (20)

It is therefore appropriate to consider, from that perspective, the relationship between the various provisions referred to by the Czech Government and whether that relationship has any consequences for the treatment of the questions referred to the Court for a preliminary ruling in this case.

Paragraphs 1 and 2 of Article 30 of Regulation No 1169/2011, entitled ‘Content’, essentially set out the requirements relating to the content of the nutrition declaration for foodstuffs, including both the mandatory information and optional additional information. Paragraph 3 of that article provides that certain information, covered by the nutrition declaration and expressly referred to in this paragraph, may, provided that the labelling of the prepacked food provides the nutrition declaration, be repeated on the labelling of that foodstuff. Such optional repetition is permitted, where it appears in the principal field of vision, that is, on the front of the packaging, in order to help consumers easily to see the essential nutrition information when purchasing food. (21)

The articles which follow that provision and, in particular, Articles 32 and 33, respectively entitled ‘Expression per 100 g or per 100 ml’ and ‘Expression on a per portion basis or per consumption unit’, lay down rules governing how the information that makes up the content of the nutrition declaration is to be expressed. While the main rule, set out in that Article 32, is that it must be expressed per 100 g or 100 ml, that Article 33 provides for additional cases in which that information may, in addition to its expression per 100 g or 100 ml, be expressed on a per portion basis and/or per consumption unit. (22)

The articles I have just mentioned all fall within Chapter IV (on ‘Mandatory food information’), Section 3 (entitled ‘Nutrition declaration’), of Regulation No 1169/2011.

To my mind, the considerations set out in points 35 to 37 of this Opinion warrant the construction of Article 30 of Regulation No 1169/2011 as a general provision that defines what mandatory nutrition information must be included in the nutrition declaration for foods. Article 30 also indicates what strictly circumscribed information in that declaration may be repeated on the labelling, which is to say, on the front of the food’s packaging. It is clear from Article 6(2) of Delegated Regulation 2016/128 that that provision establishes a derogation from precisely that rule, concerning the items of information that may be repeated on the labelling.

It seems to me that Articles 32 and 33 of Regulation No 1169/2011, on the other hand, focus more on specifying the formatting rules which apply to the presentation of the information referred to in Article 30. Article 32 establishes the ‘principal’ formatting rule, which may, where appropriate, be supplemented by that defined in that Article 33. These rules, set out in those two articles, apply to the nutrient information that is included in the nutrition declaration. It may be observed that these rules also apply to the nutrition declaration for foods for special medical purposes, in so far as that declaration must contain values expressed per 100 g or 100 ml and may be supplemented by values expressed on a per portion basis or per consumption unit. (23)

Therefore, the provisions of Articles 32 and 33 of Regulation No 1169/2011, which concern the expression of the information contained in the nutrition declaration by reference to the amounts per 100 g or 100 ml and, where appropriate, per portion and/or consumption unit, would be redundant if those items, and the amounts of each of them, did not have to be included in the nutrition declaration. Accordingly, the very existence of the rules set out in Articles 32 and 33 is dependent on Article 30, which is, in my view, the central provision of the section of Regulation No 1169/2011 dealing with the general requirements relating to the nutrition declaration on the labelling of foodstuffs.

Having clarified that, the position adopted by the Czech Government, referred to in point 33 of this Opinion and explained at the hearing, would, in my view, render meaningless the derogation established in Article 6(2) of Delegated Regulation 2016/128, which refers neither to Article 32 nor to Article 33 of Regulation No 1169/2011. The prohibition of the repetition of nutrition information, laid down in Article 6(2), does not expressly refer to the expression of that information either per 100 g or per 100 ml or on a per portion or per consumption unit basis. Consequently, the derogation in Article 6(2) of that delegated regulation must be understood as a general derogation that applies regardless of the form of expression of the energy value and amounts of nutrients in accordance with Article 32 or Article 33 of Regulation No 1169/2011.

Therefore, the wording and, in particular, the context of the provisions contained in Articles 30, 32 and 33 of Regulation No 1169/2011 and in Article 6(2) of Delegated Regulation 2016/128 are at odds with the position adopted by the Czech Government, which would exclude from the present analysis the first question referred by the national court. It is therefore necessary to address that question, as follows.

The first question

To recap, by its first question, the referring court asks, in essence, whether the energy value of the product and the amounts of the various nutrients, stated elsewhere than in the nutrition declaration, can constitute an additional description of the product’s properties and characteristics within the meaning of Article 5(2)(g) of Delegated Regulation 2016/128.

Under Article 5(2)(g) of Delegated Regulation 2016/128, ‘in addition to the mandatory particulars listed in Article 9(1) of [Regulation No 1169/2011], the following shall be additional mandatory particulars for food for special medical purposes: … a description of the properties and/or characteristics that make the product useful in relation to [(24)] 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’.

In order to answer the first question referred, I think it necessary to interpret the meaning of ‘a description of the properties and/or characteristics’ of the product for the purposes of Article 5(2)(g) of Delegated Regulation 2016/128. It is also necessary, in order to provide a useful answer to the first question, to interpret the concept of ‘additional mandatory particulars’, which Article 5 of Delegated Regulation 2016/128 introduces, since the description under point (g) is one of those additional mandatory particulars. (25)

It must be borne in mind that the interpretation of Article 5(2)(g) of Delegated Regulation 2016/128 must take into account not only the wording of that provision but also its context and the objective pursued by the legislation in question. (26)

As regards, in the first place, the wording of Article 5(2)(g) of that delegated regulation , it should be observed that neither that wording nor the delegated regulation generally defines the concept of 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 that regard, it is necessary to go on to interpret the terms ‘properties’ and ‘characteristics’ in the particular context of food for special medical purposes. Those terms must be understood as referring to qualities and all the recognisable attributes which distinguish, (27) in this case, special medical foods, in so far as concerns their ability to satisfy dietary management needs or nutritional requirements – or which render them particularly useful – (28) in relation to the disease, disorder or medical condition for the dietary management of which they are intended.

That literal interpretation of the terms ‘properties’ and ‘characteristics’ is corroborated by the examples given in Article 5(2)(g) of Delegated Regulation 2016/128, which include any special processing and formulation of the product, any alterations of nutrients, whether increased, reduced, eliminated or otherwise modified, and the rationale of the use of the product. (29)

That said, it must be observed that the drafting of Article 5(2)(g) of Delegated Regulation 2016/128, concerning the provision of mandatory information for specific foodstuffs, namely foods for special medical purposes, differs from the drafting of Article 9(1) of Regulation No 1169/2011 and Article 30(1) of that regulation, which concern the provision of mandatory information for all foodstuffs.

Indeed, the general requirements relating to the labelling of ordinary food, resulting from Article 9 and Article 30 of Regulation No 1169/2011, refer to ‘ingredients’ (30) or set out a list preceded by the words ‘the following’, and thus designate substances of which the product is composed and, more generally, refer to its content. The terms used in Article 5(2)(g) of Delegated Regulation 2016/128, by contrast, refer to the qualities or the special characteristics which determine a product’s proper use and which make it suited to nutritional requirements or the dietary management associated with a particular disease, disorder or medical condition. (31) The difference in the terms used in the drafting of these provisions therefore seems to me to be the result of the EU legislature’s intention to introduce a special rule for the description of the inherent qualities of foods for special medical purposes, as opposed to the general rule regarding the statement of the composition of foodstuffs in general.

Furthermore, it is clear from the wording of Article 5(2)(g) of Delegated Regulation 2016/128 that that provision concerns the disclosure of information other than the information referred to in Article 9(1) of Regulation No 1169/2011. That disclosure seems to me to be of particular importance in the present case, in order to conclude that the terms in which it is worded preclude the product’s energy value and the amounts of the various nutrients from being able to fall under the description of additional properties and characteristics of the product, over and above those which must be stated for all foodstuffs.

That conclusion seems all the more necessary given that the information referred to in Article 5(2)(g) of Delegated Regulation 2016/128 is characterised as ‘mandatory’, meaning that it must appear on all foods for special medical purposes.

In the second place, that literal interpretation is corroborated by the context in which Article 5(2)(g) of Delegated Regulation 2016/128 appears and by the objectives of that delegated regulation.

As regards, first of all, context, it is important to bear in mind the context in which the rule on the labelling of food for special medical purposes laid down in Article 5(2)(g) is set out. That rule is in fact supplemental to all the rules which already apply to all foodstuffs, as is confirmed by the heading of Article 5: ‘Specific requirements on food information’.

Next, all of the particulars mentioned in Article 5 of Delegated Regulation 2016/128, and notably those relating to the use of foods for special medical purposes under medical supervision, (32) the specific age group for which such food is intended, (33) and adequate precautions and contra-indications, (34) go beyond the nutritional content of a foodstuff and are intended to be supplemental to that information.

Lastly, it is particularly useful to note at this juncture that Article 6(2) of Delegated Regulation 2016/128 lays down a specific prohibition on the repetition on the labelling of food for special medical purposes of information included in the nutrition declaration. (35) In this connection, it must be noted that the particulars at issue are, because of their very substance, items of information that must be provided in the nutrition declaration in accordance with Article 30(1) of Regulation No 1169/2011. Like the Commission, I take the view that the energy value and the amounts of nutrients remain information of the same nature, regardless of the way in which that information is expressed.

The prohibition, set out in Article 6(2) of Delegated Regulation 2016/128, and the obligation, under Article 5(2)(g) thereof, respectively to provide certain particulars on the labelling of food for special medical purposes cannot change depending on the various ways in which the same information is expressed, because it does not change, as a result of being expressed differently, as to its substance, which alone is relevant for the application of the abovementioned provisions. (36) To admit the contrary, as Nestlé essentially advocates, would, in my view, result in the circumvention of the prohibition contained in the abovementioned Article 6(2) of Delegated Regulation 2016/128.

For those reasons, the context in which Article 5(2)(g) appears in Delegated Regulation 2016/128 precludes, to my mind, the particulars at issue from being additional mandatory particulars required solely for food for special medical purposes. A fortiori, they cannot constitute a ‘description of the properties and/or characteristics’ as referred to in Article 5(2)(g) of Delegated Regulation 2016/128.

Second of all, the foregoing conclusion seems to me the most consistent with the objectives pursued by Delegated Regulation 2016/128.

In this connection, it must be remembered that Delegated Regulation 2016/128 supplements Regulation No 609/2013 by defining specific compositional and information requirements that apply to food for special medical purposes. These supplement the general requirements that apply, under Regulation No 1169/2011, to all foodstuffs and, therefore, equally to the specific foods concerned in this case.

Delegated Regulation 2016/128 seeks, by laying down specific requirements that take account of the specific nature of food for special medical purposes, (37) to ensure that such food is safe, beneficial and effective for the persons for whom it is intended. (38) Thus, by laying down specific labelling requirements for certain foods, the EU legislature sought to establish a high level of protection for vulnerable consumers, in order to ensure that they can accurately identify products that will constitute a partial source or the sole source of their nourishment. (39)

62.First of all, to interpret Article 5(2)(g) of Delegated Regulation 2016/128 as imposing an obligation to state on the labelling of food for special medical purposes, as additional information, mandatory particulars applicable to all foodstuffs, like those at issue in this case, would be contrary to the objective of establishing specific labelling requirements.

63.Next, the protection of vulnerable consumers, by means of ensuring that products that will constitute a partial source or the sole source of their nourishment can be accurately identified, could also be undermined by that interpretation. Indeed, to make it compulsory merely to state certain nutrition information on the front of the packaging could disorient such consumers or even mislead them. (40)

64.Lastly, contrary to Nestlé’s allegation, I am not convinced that, to justify its interpretation, one can speak of the essential information (41) concerning foods for special medical purposes as one can in the case of ordinary food, (42) in particular because of their special nature, to which I alluded in my preliminary observations. Indeed, the composition of foods for special medical purposes may vary significantly, depending on, inter alia, the particular disease, disorder or medical condition that gives rise to the nutritional requirements the food meets, the age of the patients and the place where they receive health care, as well as the intended use of the food. (43)

65.Thus, an interpretation of Article 5(2)(g) of Delegated Regulation 2016/128 according to which the energy value of the product and the amounts of various nutrients may be stated elsewhere than in the nutrition declaration and can constitute an additional description of the properties and characteristics of food intended for special medical purposes does not secure the objective of Delegated Regulation 2016/128 relating to a high level of protection of vulnerable consumers. Indeed, to my mind, that objective requires that both health care professionals who medically supervise the use of such food and vulnerable consumers should be able to make an informed choice on the basis of all the nutrition information.

66.In conclusion, it is clear from the foregoing considerations that, in my view, the answer to the first question referred by the national court for a preliminary ruling should be that Article 5(2)(g) of Delegated Regulation 2016/128 must be interpreted as meaning that the particulars at issue cannot constitute an additional description of a product’s properties and characteristics within the meaning of that article.

The second question

67.This question is raised in the event that the first question is answered in the affirmative. If the Court interprets Article 5(2)(g) of Delegated Regulation 2016/128 as I suggest in point 66 of this Opinion, there is no need to answer it.

68.In any event, if the prohibition referred to in Article 6(2) of Delegated Regulation 2016/128 is not to be rendered meaningless, the particulars at issue cannot escape that prohibition simply on account of the form in which they are expressed. That form in no way changes the content, which, in my view, remains the sole criterion relevant to the application of that prohibition. (44)

Conclusion

69.Having regard to all of the foregoing considerations, I suggest that the Court answer the question referred by the Högsta förvaltningsdomstolen (Supreme Administrative Court, Sweden) for a preliminary ruling as follows:

Article 5(2)(g) 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 information concerning the energy value of the product and the amounts of various nutrients provided elsewhere than in the nutrition declaration cannot constitute an additional description of the product’s properties and characteristics.

—

1Original language: French.

2Regulation of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ 2011 L 304, p. 18).

3Regulation 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 and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ 2013 L 181, p. 35).

4Commission Delegated Regulation 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 (OJ 2016 L 25, p. 30).

5Article 2(2)(c) of Regulation No 1169/2011.

6Recital 47 and Articles 36 and 37 of Regulation No 1169/2011.

7Recital 24 and Article 6 of Regulation No 609/2013.

8See Article 2(2(g) of Regulation No 609/2013.

9Judgment of 2 March 2023, Kwizda Pharma (C‑760/21, EU:C:2023:143, paragraph 39).

10See Article 2(2(g) of Regulation No 609/2013.

11See, to that effect, judgment of 27 October 2022, Orthomol (C‑418/21, EU:C:2022:831, paragraphs 26, 31 and 32).

12See judgment of 2 March 2023, Kwizda Pharma (C‑760/21, EU:C:2023:143, paragraphs 71 and 74).

13Recital 24 of Regulation No 609/2013.

14Article 9(1)(l) of Regulation No 1169/2011.

15See Article 30 of Regulation No 1169/2011.

16Recitals 13 to 15 of Delegated Regulation 2016/128.

17Article 5(2)(g) of Delegated Regulation 2016/128.

18Article 6(2) of Delegated Regulation 2016/128.

19Article 6(4) of Delegated Regulation 2016/128.

20See point 20 of this Opinion.

21See recital 41 of Regulation No 1169/2011. On this point, I think it useful to emphasise, first, that such repetition is permitted solely with regard to the information expressly mentioned in Article 30(3) of that regulation, to the exclusion of all other information, and that this is the case for foodstuffs generally. Secondly, Article 30(3) of that regulation addresses a very specific case of repetition – on the labelling of prepacked food, elsewhere than in the nutrition declaration, and so, in practice, on the front of the packaging – of information which, as a principle, must be included in the nutrition declaration.

22It is clear from recital 35 of Regulation No 1169/2011 that the decision to require nutrition declarations to refer to 100 g or 100 ml values, while allowing additional portion-based values, where appropriate, was made in order to facilitate the comparison of products in different package sizes.

23Article 6(4) of Delegated Regulation 2016/128. It should be noted that this optional additional information, which may be shown in close proximity to the nutrition declaration, should not, under any circumstances, be confused with the repetition of such information on the labelling itself, which is expressly prohibited by Article 6(2) of Delegated Regulation 2016/128.

24This formulation varies in some language versions of the provision. As Nestlé points out, while the French version has ‘une description des propriétés et des caractéristiques qui permettent au produit de répondre aux’, in the Swedish version, as in the English version, the accent is placed on the usefulness of the product in such cases (‘en beskrivning av de egenskaper och/eller kännetecken som gör produkten särskilt användbar i relation till’. The same is true of the Spanish version (‘una descripción de las propiedades o características que expliquen la utilidad del producto en el manejo dietético’) and the Lithuanian version (‘produkto savybių ir (arba) ypatumų, dėl kurių jis yra naudingas’).

25As is apparent from the referring court’s wording of the first question, from which it is clear that interpretation is sought of the concept of ‘additional description’.

26See judgment of 16 July 2020, AFMB and Others (C‑610/18, EU:C:2020:565, paragraph 50 and the case-law cited).

27For a definition of the French terms ‘propriétés’ and ‘caractéristiques’, see Le Petit Robert de la langue française, Paris, Le Robert.

28Depending on the language version. It should be recalled that, according to the settled case-law of the Court of Justice, the need for uniform application and uniform interpretation of an act of EU law makes it impossible to consider one language version of the text in isolation, but requires the measure to be interpreted on the basis of both the real intention of its author and the aim that the latter seeks to achieve, in the light, in particular, of the versions in all the languages (judgment of 3 April 2014, 4finance, C‑515/12, EU:C:2014:211, paragraph 19 and the case-law cited).

29My emphasis. Moreover, the properties and characteristics could vary, depending on the case, and so it must be understood that the list of examples is not exhaustive.

30For the definition of an ‘ingredient’, see Article 2(2)(f) of Regulation No 1169/2011: ‘any substance or product, including flavourings, food additives and food enzymes, and any constituent of a compound ingredient, used in the manufacture or preparation of a food and still present in the finished product, even if in an altered form; residues shall not be considered as “ingredients”’.

31It must be borne in mind that, in so far as Article 5 of Delegated Regulation 2016/128 provides, as an example of particular characteristics, nutrients that have been increased, decreased, eliminated or otherwise modified, the alteration of the nutrient in question must be understood as being one that characterises the special nature of a food for special medical purposes by reason of the change in the level of the nutrients in the composition of the food. Like the referring court, I also note that it would be possible to satisfy that specific requirement under Article 5(2)(g) of Delegated Regulation 2016/128 without stating specific quantities.

32Article 5(2)(a) of Delegated Regulation 2016/128.

33Article 5(2)(c) of Delegated Regulation 2016/128.

34Article 5(2)(f) of Delegated Regulation 2016/128.

35In accordance with Article 30(1) of Regulation No 1169/2011, the energy value and information about actual nutrient content (including the amounts of fat and protein) are mandatory items of information that must be provided in the nutrition declaration for a food. Although paragraph 3 of Article 30 permits the repetition of some of the information included in the mandatory nutrition declaration for an ordinary foodstuff, information about protein may not be repeated. In any event, the repetition of the information referred to in Article 30(3) of Regulation No 1169/2011 on the labelling of food for special medical purposes is expressly prohibited by Article 6(2) of Delegated Regulation 2016/128.

36This seems to me to be confirmed also by Article 6(4) of Delegated Regulation 2016/128, in accordance with which the provisions relating to the form of expression of the nutrients included in the nutrition declaration, set out in Articles 32 and 33 of Regulation No 1169/2011, apply to all the nutrients included in the nutrition declaration.

37Recitals 13 and, to that effect, 15 of Delegated Regulation 2016/128.

38Recital 5 of Delegated Regulation 2016/128.

39See, on this point, recital 13 of Delegated Regulation 2016/128, read in conjunction with recitals 15 and 26 of Regulation No 609/2013.

40The fact, alleged by Nestlé at the hearing, that that company markets foods for special medical purposes mostly to health care professionals and not directly to consumers does not invalidate that conclusion, since the target public is one of the commercial choices made by an undertaking, which are by nature subjective and can in no way affect the interpretation of the objectives of Delegated Regulation 2016/128.

41In its observations, Nestlé argued that this essential information concerns the energy value and the amounts of various nutrients.

42Indeed, on what basis could it be said that, in the case of an individual affected by a particular disease, disorder or medical condition for whom, because of that situation, food for special medical purposes constitutes the sole source of his or her nourishment, it is more important to provide certain nutrition information than other nutrition information? While, in the case of individuals for whom such food constitutes a partial source of their nourishment, that might be plausible, how would it even be possible to require operators in the sector to ensure that, for the specific requirements in each case involving a vulnerable patient, the nutrition information they choose to state on the front of the packaging actually constitutes, from a medical viewpoint, the essential information or, in other words, information that is more important than other information? To my mind, the objectives of Delegated Regulation 2016/128 do not lend themselves to such a case-by-case approach, which probably would not ensure legal certainty in the area or, most importantly, ensure the protection of vulnerable consumers.

43See judgment of 2 March 2023, Kwizda Pharma (C‑760/21, EU:C:2023:143, paragraph 77).

44See points 33 to 42, 56 and 57 of the present Opinion.