ECLI:EU:C:2026:508

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OPINION OF ADVOCATE GENERAL

SZPUNAR

delivered on 18 June 2026 (1)

Case C‑395/25

Orkla Care AB

Kemikalieinspektionen

(Request for a preliminary ruling from the Svea hovrätt, Mark- och miljööverdomstolen (Svea Court of Appeal, Land and Environment Court of Appeal, Stockholm, Sweden))

( Reference for a preliminary ruling – Classification, packaging and labelling of substances and mixtures – Packaging having a similar presentation or design to that used for foodstuffs – Misleading for consumers – Packaging for liquid consumer laundry detergents – Packaging similar to packaging normally used for beverages )

I. Introduction

1. The present case concerns the interpretation of a provision of the CLP Regulation, (2) which lays down requirements relating to the packaging of substances or mixtures classified as hazardous. More particularly, the referring court is uncertain, first, as to the requirements aimed at preventing the marketing of hazardous substances and mixtures with packaging which might lead consumers into mistaking them for foodstuffs and, second, as to various aspects of the assessment which it must carry out in order to establish whether the products at issue comply with those requirements.

II. Legal framework

A. European Union law

1. The CLP Regulation

2. The first paragraph of Article 3 of the CLP Regulation provides that ‘a substance or a mixture fulfilling the criteria relating to physical hazards, health hazards or environmental hazards, laid down in Parts 2 to 5 of Annex I is hazardous and shall be classified in relation to the respective hazard classes provided for in that Annex’.

3. Article 4 of that regulation, entitled ‘General obligations to classify, label and package’, provides, in paragraphs 4 and 10 thereof:

‘4. Where a substance or mixture is classified as hazardous, suppliers shall ensure that the substance or mixture is labelled and packaged in accordance with Titles III and IV, before placing it on the market.

…

10. Substances and mixtures shall not be placed on the market unless they comply with this Regulation.’

4. Article 35 of that regulation, entitled ‘Packaging’, provides:

‘1. Packaging containing hazardous substances or mixtures shall satisfy the following requirements:

…

(c) the packaging and fastenings shall be strong and solid throughout to ensure that they will not loosen and will safely meet the normal stresses and strains of handling;

…

2. Packaging containing a hazardous substance or a mixture supplied to the general public shall not have either a shape or design likely to attract or arouse the active curiosity of children or to mislead consumers, or have a similar presentation or a design used for foodstuff or animal feeding stuff or medicinal or cosmetic products, which would mislead consumers.

…’

2. Regulation (EU) 2019/1020

5. Article 2(1) of Regulation (EU) 2019/1020 (3) provides:

‘This Regulation shall apply to products that are subject to the Union harmonisation legislation listed in Annex I (“Union harmonisation legislation”), in so far as there are no specific provisions with the same objective in the Union harmonisation legislation, which regulate in a more specific manner particular aspects of market surveillance and enforcement.’

6. The CLP Regulation is referred to in the annex to Regulation 2019/1020.

7. Article 11(1) and (9) of that regulation provides:

‘1. Market surveillance authorities shall conduct their activities in order to ensure the following:

(a) effective market surveillance within their territory of products made available online and offline with respect to products that are subject to Union harmonisation legislation;

…

9. Without prejudice to any Union safeguard procedure pursuant to the applicable Union harmonisation legislation, products that have been deemed to be non-compliant on the basis of a decision of a market surveillance authority in one Member State shall be presumed to be non-compliant by market surveillance authorities in other Member States, unless a relevant market surveillance authority in another Member State concluded the contrary on the basis of its own investigation, taking into account the input, if any, provided by an economic operator.’

B. Swedish law

8. The Kemikalieinspektionen, (Chemicals Inspectorate; ‘the Chemicals Inspectorate’), an administrative authority of the Kingdom of Sweden, is the authority which, under Article 43 of the CLP Regulation, is responsible for enforcement of the obligations set out in that regulation, as stated in Paragraph 32(5) of förordningen (2008:245) om kemiska produkter och biotekniska organismer (Chemical Products and Biotechnical Organisms Ordinance (2008:245)).

9. In addition, under Chapter 2, Paragraphs 19 and 21 of the miljötillsynsförordningen (2011:13) (Environmental Inspection Ordinance (2011:13)), the Chemicals Inspectorate is the market surveillance authority which, pursuant to Article 16 of Regulation 2019/1020, is to take appropriate measures if a product subject to European Union harmonisation legislation, when used in accordance with its intended purpose or under conditions which can be reasonably foreseen and when properly installed and maintained is liable to compromise the health or safety of users, or does not conform to applicable European Union harmonisation legislation. In such a case, the Chemicals Inspectorate is without delay to require the relevant economic operator to take appropriate and proportionate corrective action to bring the non-compliance to an end or to eliminate the risk within a period the Chemicals Inspectorate specifies.

10. The Chemicals Inspectorate has, pursuant to Chapter 26, Paragraph 9 of the miljöbalken (1998:808) (Environmental Code (1998:808)), the power to decide on the orders and prohibitions necessary to ensure compliance with Regulation 2019/1020.

III. The facts of the case in the main proceedings, the procedure before the Court and the questions referred for a preliminary ruling

11. Orkla Care AB, a company established under Swedish law, markets chemical products including liquid consumer laundry detergents. The packaging of the products at issue is in an oblong cardboard form with a square base and a folded top with a screw cap on one side of the fold.

12. Upon being informed by consumers that the packaging of Orkla Care’s products displayed similarities with that of foodstuffs and that those products could be confused with those foodstuffs, the Chemicals Inspectorate asked that company to comment in that regard and on the compliance of the packaging of those products with the requirements laid down in Article 35(2) of the CLP Regulation.

13. Orkla Care disputed that there were similarities between the packaging of its products and that of foodstuffs, maintaining that its products complied with the requirements laid down in that provision. It claimed, in that regard, (i) that the packaging does not have any images that could be confused with foodstuffs, but images of textiles; (ii) that a sealing label must be torn off before the product can be used and that the information on the packaging stating that the contents are not to be consumed provides a sufficient safeguard; (iii) that the products at issue are merely an eye irritant and are not hazardous when ingested; and (iv) that the choice of cardboard was based on ecological considerations.

14. The Chemicals Inspectorate considered, in the light of the presentation of the packaging at issue being in the form of an oblong cardboard packaging with a square base and a folded top with a screw cap on one side of the fold, combined with the colouring of the packaging and a label stating that the product is vegan, that both the shape and design of the packaging were likely to mislead consumers and result in them confusing those products with foodstuffs. The Chemicals Inspectorate therefore held that the packaging did not satisfy the requirements laid down in the first subparagraph of Article 35(2) of the CLP Regulation. Accordingly, the Chemicals Inspectorate decided to prohibit Orkla Care from putting the products at issue in packaging with the presentation and design concerned.

15. Orkla Care brought an appeal against the decision with the Mark- och miljödomstolen i Nacka (Land and Environment Court, Nacka, Sweden). That court varied the Chemical Inspectorate’s decision only by holding that the prohibition would take effect three months from the date on which the judgment of the court became final and upheld the decision as to the remainder. It found that, on the basis of the design, size and closure mechanism of the packaging at issue, combined with the colouring and layout, that the packaging was likely to be confused with food packaging used, for example, for milk, yoghurt, fruit juice and other liquid foodstuffs, and as such could attract and arouse the curiosity of children. It also held that the Chemical Inspectorate’s prohibition was proportionate and did not go beyond what was necessary. Moreover, it did refuse Orkla Care’s request for a preliminary ruling to be made to the Court of Justice.

16. Orkla Care has lodged an appeal against that judgment with the Svea hovrätt, Mark- och miljööverdomstolen (Svea Court of Appeal, Land and Environment Court of Appeal, Stockholm, Sweden), the referring court. That court harbours doubts as to whether the packaging of the products at issue, which contain mixtures classified as hazardous under the CLP Regulation, satisfies the requirements imposed on packaging under Article 35(2) of that regulation.

17. It is in those circumstances that the Svea hovrätt, Mark- och miljööverdomstolen (Svea Court of Appeal, Land and Environment Court of Appeal, Stockholm), by decision of 11 June 2025, received at the Court on 13 June 2025, decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:

‘(1) On the basis of which detailed criteria must the assessment under Article 35(2) of the CLP Regulation be made as to whether packaging has a similar presentation or design to that used, for example, for foodstuffs? Must measures to distinguish packaging from, for example, food packaging, be permanent throughout the life cycle of the packaging or may they be designed to be torn off?

(2) Must the assessment of whether packaging has a similar presentation or design to that, for example, for foodstuffs, be made on the basis of the food packaging on the market on which the product is placed or the market on which it is supplied to the public, and must the assessment then be made solely on the basis of the national market, the entire EU market, or parts thereof?

(3) How should the term “consumer” be interpreted and applied in Article 35(2) of the CLP Regulation? Does it relate to the average consumer or must vulnerable or disadvantaged consumer groups, such as visually impaired persons, persons with other disabilities and children, also be included in the notion of consumer? If so, how must their specific needs be taken into account?

(4) What must be the level of likelihood of the consumer being misled into believing that the packaging contains foodstuff? Is it sufficient for there to be a theoretical or insignificant likelihood or must the likelihood be real? Is it relevant to take into account in that assessment whether confusion with foodstuffs has actually occurred, where such information is available?

(5) Must the hazard category and the specific risk of the substance or mixture be taken into account when applying Article 35(2) of the CLP Regulation? Must that article be interpreted as applying to packaging containing a hazardous substance or mixture and having a similar presentation or a design used for foodstuffs, where, as in this case, the contents of the packaging are not hazardous to ingest but are hazardous only in the case of other types of exposure, such as the mixture being capable of causing reversible eye irritation?’

18. Written observations have been submitted by Orkla Care, the French and German Governments and the European Commission. No hearing has been held.

IV. Analysis

A. Preliminary remarks

1. The questions for a preliminary ruling

19. The referring court asks the Court five questions for a preliminary ruling relating to the first subparagraph of Article 35(2) of the CLP Regulation. That provision, read in conjunction with the first paragraph of Article 3 of that regulation, lays down certain requirements which must be fulfilled by packaging containing a substance or mixture classified in one of the hazard classes provided for in Annex I to that regulation and supplied to the general public. According to Article 4(4) of that regulation, suppliers must ensure that the substance or mixture classified as hazardous is, before being placed on the market, labelled and packaged in accordance with Titles III and IV, to which Article 35(2) of that regulation belongs.

20. The referring court starts from the premiss that the packaging at issue contains a mixture meeting the health hazard criteria set out in Annex I to that regulation and, more specifically, the criteria set out in point 3.3 of that annex, namely ‘serious eye damage/eye irritation’, and that that mixture is classified in hazard category 2 ‘eye irritation’.

21. The first subparagraph of Article 35(2) of that regulation envisages two situations: one where the shape or design of the packaging is likely to attract or arouse the active curiosity of children or to mislead consumers and one where the presentation or design of the packaging is similar to that of other products, in particular foodstuffs, and where that similarity could mislead consumers. Since the wording of the questions referred suggests that the referring court is concerned with the second situation, my analysis will focus on that.

2. The CLP Regulation

22. Before embarking upon the analysis of the questions referred, I wish to make an observation concerning the place of the CLP Regulation within the broader framework of product safety legislation and the objectives of that regulation.

23. Although that regulation uses the term ‘consumer’, in particular in the first subparagraph of Article 35(2) thereof, that regulation does not fall within the broader category of consumer law, which principally aims to strike a balance between two contracting parties, the trader and the party in a weaker contractual position. However, that regulation pursues two main objectives: on the one hand, the protection of human health and the environment, and, on the other, the facilitation of trade in chemical substances, mixtures and certain specific articles within the internal market and beyond. (4)

24. Consequently, the obligations imposed on suppliers under the CLP Regulation have been introduced not only in the interest of purchasers of hazardous substances or mixtures, but also in the interest of the public as a whole. The first subparagraph of Article 35(2) of that regulation cannot therefore be interpreted in the light of the corpus of consumer protection directives in the strict sense of the term. However, I observe that that provision aims to protect all individuals likely to use a given substance or mixture, or even any person able to have access to it.

B. The first question referred – the assessment criteria

25. The first question referred consists of two parts. By the first part of that question, the referring court seeks to determine the criteria for assessing the similarity between the presentation or design of packaging containing a hazardous substance or mixture supplied to the general public and the presentation or design of packaging containing a foodstuff used by the EU legislature in the first subparagraph of Article 35(2) of the CLP Regulation. By the second part of that question, that court asks, in essence, whether, during that assessment, it is necessary to take into account a safety device affixed to the former packaging designed to distinguish that packaging from packaging containing a foodstuff, where that device does not remain intact throughout the life cycle of the packaging.

1. The first part – the criteria for assessing the similarity of the packaging

26. Although the first subparagraph of Article 35(2) of the CLP Regulation does not specify the criteria for assessing the similarity of the packaging, they can be inferred from the scheme and objectives of that regulation.

27. As regards the objectives of that regulation, it is intended, inter alia, to ensure the efficient functioning of the internal market for substances, mixtures and certain specific articles, while enhancing competitiveness and innovation. (5) In the light of that objective, first, the first subparagraph of Article 35(2) of that regulation cannot be interpreted as aimed at prohibiting the marketing of a vast range of products. It should, however, be borne in mind that that provision is intended to prevent the marketing of hazardous substances and mixtures which have packaging that does not satisfy the requirements laid down by that provision. The assessment as to whether a given packaging satisfies those requirements must be carried out on a case-by-case basis.

28. Second, the criteria for assessing the similarity of the packaging must be uniform throughout the territory of the European Union. Therefore, they must not be defined by the Member States but must be sought in the CLP Regulation.

29. In that regard, in the first place, Article 2(36) of that regulation defines the term ‘packaging’ as ‘one or more receptacles and any other components or materials necessary for the receptacles to perform their containment and other safety functions’. Packaging, within the meaning of that regulation, therefore appears to designate any element of a product necessary for its distribution to the general public, in accordance with the rules applicable to it and taking into account the practical needs of logistics and commerce.

30. In the second place, the use, in the second situation provided for in the first subparagraph of Article 35(2) of that regulation, of the concepts of ‘presentation’ and ‘design’ linked by the conjunction ‘or’ implies that the EU legislature envisaged for all of the perceptible characteristics of the packaging of a product concerned to be taken into account during the assessment carried out under that provision. Thus, concerning the presentation and design of the packaging of a product potentially similar to that of a foodstuff, characteristics of the packaging are elements such as the shape, size, the volume of the product, the materials used, the design, labelling, colour and smell. Those are characteristics which enable the general public to identify foodstuffs and can create an undesired resemblance between the packaging of such products and packaging containing hazardous substances or mixtures.

31. In the third place, that interpretation is corroborated by an analysis of the EU’s other product safety legislation.

32. Regulation (EU) 2023/988 (6) lays down essential rules on the safety of consumer products placed or made available on the market. (7) Although that regulation is not applicable in the present case, (8) it constitutes the general framework for consumer product safety, having replaced (9) Directive 87/357/EEC, (10) which covered consumer products resembling foodstuffs. That regulation therefore provides relevant information on the elements which are, according to the EU legislature, likely to mislead consumers as to whether a given product is a foodstuff. Accordingly, in the interest of the consistency of EU law, those elements might be used as a basis for confirming my interpretation of the CLP Regulation set out in point 30 of this Opinion.

33. In that regard, the relevant assessment criteria are, according to the EU legislature, laid down in Article 6(1)(f) of Regulation 2023/988. According to that provision, when assessing whether a product is a safe product, that is to say, whether it presents any risk or only minimum risks under normal or reasonably foreseeable conditions, account must be taken, inter alia, of the appearance of the product where it is likely to lead consumers to use the product in a way different to what it was designed for, and, in particular, where a product, although not foodstuff, resembles foodstuff and is likely to be confused with foodstuff due to its form, odour, colour, appearance, packaging, labelling, volume, size or other characteristics and might therefore be placed in the mouth, sucked or ingested by consumers, especially by children.

34. Moreover, Directive 87/357, which was repealed and replaced by Regulation 2023/988, contained a list of criteria almost identical to those in Article 1(2) of that regulation. (11) That list is recalled in recital 10 of Regulation (EC) No 1223/2009, (12) which raises the same concern about the risk of confusion with foodstuffs and states that ‘the presentation of a cosmetic product and in particular its form, odour, colour, appearance, packaging, labelling, volume or size should not endanger health and safety of consumers due to confusion with foodstuffs, in accordance with [Directive 87/357]’.

35. In the light of the foregoing, the answer to the first part of the first question for a preliminary ruling should be that, when assessing the similarity of the packaging under the first subparagraph of Article 35(2) of the CLP Regulation, the characteristics of the packaging such as the form, size, volume, materials used, design, labelling, colour and odour must be taken into account.

2. The second part – the assessment criteria and the life cycle of the packaging

36. This part also concerns the criteria for assessing the similarity of packaging adopted in the first subparagraph of Article 35(2) of the CLP Regulation. However, this second part, unlike the first part, which takes an abstract approach to those criteria, focuses on a specific aspect of the case in the main proceedings.

37. It is apparent from the wording of the question referred that the packaging in question has a safety device designed to distinguish that packaging from packaging containing a foodstuff which is torn off when that product is first used. That description reflects the statements made by Orkla Care before the national authorities and in its written observations indicating that the packaging at issue contains a sealing label covering the cap which must be torn off before the product is used.

38. I therefore understand the second part as meaning that the referring court seeks to ascertain whether, when assessing the similarity of the packaging under Article 35(2) of the CLP Regulation, account must also be taken of an element of the presentation and design of packaging designed to distinguish it from packaging for foodstuffs where that element does not remain intact throughout the life cycle of the product.

39. In that regard, first, packaging containing a hazardous substance or mixture may possess elements which neutralise its similarity with foodstuff packaging. The question whether the addition of safety devices to rule out any likelihood of confusion on the part of consumers alters the presentation and design of packaging or the overall impression given by it must be assessed on a case-by-case basis. (13)

40. Second, the presentation of packaging may change during the life cycle of the product concerned. Certain elements of the packaging may disappear after the product is first used, as in the case of various types of lead seals or safety devices for the transport of goods. Such devices are elements of the presentation of packaging, in view of the broad definition of the concept of ‘packaging’ in Article 2(36) of the CLP Regulation, which covers ‘one or more receptacles and any other components or materials necessary for the receptacles to perform their containment and other safety functions’. (14) Although the wording of the first subparagraph of Article 35(2) of that regulation does not provide any useful guidance in that regard, I take the view that the elements of packaging which are not intended to remain intact throughout the life of the product should not, in principle, be taken into account when assessing the similarity of packaging under that provision.

41. In the first place, the first subparagraph of Article 35(2) of that regulation must be read in the light of the general considerations relating to the role of that regulation in the EU legal order. As I explained in point 24 of this Opinion, the CLP Regulation aims to protect not only the purchaser of a substance or mixture when deciding to purchase a product or upon its acquisition, but also any potential user of such a substance or mixture, throughout the life cycle of the product.

42. In the second place, Article 35(1)(c) of that regulation provides that packaging containing hazardous substances or mixtures must satisfy, inter alia, the requirement that the elements of the packaging and fastenings will be strong and solid throughout ‘to ensure that they will not loosen’ and will safely meet the normal stresses and strains of handling. The interpretation of the first subparagraph of Article 35(2) of that regulation must follow the same logic.

43. In the third place, another contextual point which may be taken into account is that indicated in point 3.3.2 of Annex II to that regulation (15) relating to outer packaging, even though that point concerns liquid consumer laundry detergents packaged in soluble packaging intended for single use. It indicates that outer packaging must maintain its functionality when being repeatedly opened and closed ‘throughout the life of the outer packaging’. The same requirement must apply to liquid detergents such as those at issue in the main proceedings, which are packaged in packaging which is not for single use.

44. I therefore propose that the answer to the second part of the first question referred should be that, when assessing the similarity of packaging, an element of the packaging of a hazardous substance or mixture designed to distinguish it from packaging for foodstuffs should not, in principle, be taken into account where it does not remain intact throughout the life cycle of the product.

45. In the light of the considerations set out in points 35 and 44 of this Opinion, the answer to the first question referred should be that, when assessing the similarity of the packaging under the first subparagraph of Article 35(2) of the CLP Regulation, the characteristics of the packaging such as the shape, size, volume of the product, materials used, design, labelling, colour and smell must be taken into account. However, an element of the packaging designed to distinguish it from packaging for foodstuffs should not, in principle, be taken into account in that assessment where it does not remain intact throughout the life cycle of the product.

C. The second question referred – the reference market

46. By its second question, the referring court seeks to ascertain whether the first subparagraph of Article 35(2) of the CLP Regulation must be interpreted as meaning that the similarity between the packaging of a hazardous substance or mixture and that of a foodstuff must be assessed on the basis of the national market alone, the entire EU market, or certain parts thereof.

47. The referring court states that the Chemicals Inspectorate has no power to carry out market surveillance other than in relation to packaging placed on the Swedish market. According to that court, the extent of that power may indicate that the similarity of the packaging within the meaning of the first subparagraph of Article 35(2) of that regulation should be assessed on the basis of Swedish consumers as a whole and in relation to packaging placed on the Swedish market. However, that regulation does not provide any clarity as to the reference market.

48. In that regard, nothing in the wording of the first subparagraph of Article 35(2) of that regulation makes it possible to resolve the legal issue raised by the second question referred. The answer to that question must therefore be sought by carrying out a systemic and teleological interpretation of the CLP Regulation and in consideration of the principles on which the structure of the EU legal order is based.

49. Under the traditional approach adopted in public law, or even that under public international law, the powers of a national supervisory authority are, in accordance with the principle of territorial sovereignty, confined to the territory of the Member State which established that authority and conferred powers on it. Although, as I have observed in another context, EU law does not necessarily have to adopt the same approach. (16) There is, however, nothing to suggest that the EU legislature has decided to abandon that basic approach in respect of the implementation by the national authorities of the Member States of the first subparagraph of Article 35(2) of that regulation.

50. In fact, under the first subparagraph of Article 43 of that regulation, ‘Member States shall appoint the competent authority or competent authorities responsible for proposals for harmonised classification and labelling and the authorities responsible for the enforcement of the obligations set out in this Regulation’. According to Article 46 of that regulation, Member States must take all necessary measures to ensure that substances and mixtures are not placed on the market, unless they have been classified, labelled, notified and packaged in accordance with the CLP Regulation. Pursuant to the second subparagraph of Article 43 of that regulation, national authorities ‘shall cooperate with each other in the performance of their tasks under this Regulation and shall give the corresponding authorities of other Member States all necessary and useful support to this end’.

51. The fact that all Member States must therefore designate at least one authority responsible for implementing that regulation, including in order to prohibit the placing on the market of products with packaging which does not fulfil the requirements laid down in that regulation, and that all national authorities are supposed to cooperate with each other in the performance of their tasks is an indicator that a responsible authority of a Member State must, above all, ensure that the CLP Regulation is complied with in the territory of that Member State.

52. The fact that the Member State’s market is the reference market does not call into question the uniform interpretation and application of the first subparagraph of Article 35(2) of that regulation. As is clear from my analysis of the first question referred, the criteria for assessing the similarity of the packaging are identical for all the Member States.

53. Nonetheless, national specificities and consumer habits may vary from one Member State to another. For example, in some Central and Eastern European Member States, (17) milk and cream are still packaged in plastic bags. That practice emanated from the desire to optimise foodstuff production costs. Today, it is more attributable to consumer habit. For a consumer originating from one of those Member States, that practice increases the similarity between foodstuffs and non-foodstuff products sold in plastic sachets. On the other hand, the use of such packaging is less widespread in other Member States, which reduces the similarity between those two groups of products for the consumers concerned of those Member States and the likelihood of them confusing a non-foodstuff product with a foodstuff.

54. Moreover, national specificities and consumer habits are taken into account in the approach adopted by the EU legislature with regard to the legal effects of decisions adopted by national authorities when implementing the first subparagraph of Article 35(2) of the CLP Regulation.

55. Regulation 2019/1020 establishes a basic regime (‘in so far as there [is none] … in the Union harmonisation legislation’, to use the words of Article 2(1) thereof), for the exercise by the market surveillance authorities of their activities. That regulation applies, in particular, to products subject to the CLP Regulation. (18)

56. It is apparent from Article 11(9) of Regulation 2019/1020 that, in the absence of special legislation in the matter, ‘products that have been deemed to be non-compliant on the basis of a decision of a market surveillance authority in one Member State shall be presumed to be non-compliant by market surveillance authorities in other Member States, unless a relevant market surveillance authority in another Member State concluded the contrary on the basis of its own investigation, taking into account the input, if any, provided by an economic operator’. In view of the fact that the CLP Regulation does not contain any rules concerning that issue, the solution provided for in Article 11(9) of Regulation 2019/1020 would appear to apply to national decisions adopted in the case of non-compliance with the first subparagraph of Article 35(2) of the CLP Regulation.

57. That solution does not constitute a mutual recognition mechanism for decisions delivered by national authorities. Rather, it appears to be based on the logic that the decision of a national authority of a Member State constitutes a precedent for the national authorities in the other Member States. However, the presumption of non-compliance attached to that decision can be refuted by those other national authorities in proceedings conducted by those other authorities.

58. Accordingly, it may be inferred from the modus operandi of that solution that the decisions of national supervisory authorities have primarily national scope. The presumption of non-compliance facilitates the task of national authorities and contributes to the uniformity of decisions within the European Union, without, however, requiring absolute consistency of the results of assessment of the similarity of packaging in the light of the first subparagraph of Article 35(2) of the CLP Regulation.

59. The interpretation of that provision according to which the national market constitutes the reference market is not contrary to the objective of that regulation to facilitate trade in chemical substances, mixtures and certain specific articles within the internal market.

60. In that regard, Directive 87/357 was aimed at, inter alia, prohibiting the marketing of products which, because they can be confused with foodstuffs, endanger the safety or health of consumers. It pursued a twofold objective: to provide adequate (and equivalent) protection of consumers in all the Member States and eliminate obstacles to the operation of the internal market. However, the Court has held that that directive applied to an indefinite number of products with certain characteristics and for which it is necessary to determine, on a case-by-case basis and ‘on the basis of each Member State’, whether they may entail the risks referred to in that directive. (19) In so far as that regulation pursues similar objectives to that directive, the interpretation of the first subparagraph of Article 35(2) of that regulation must follow the same logic.

61. To conclude, in the light of the fact that, textually, Article 35(2) of that regulation does not state which reference market is to be used for the assessment which must be carried out to establish non-compliance with the requirements laid down in that provision and taking into account the territorial scope of the activities performed by an authority responsible for implementing the CLP Regulation, I take the view that the decisions of those authorities produce their effects principally in the Member State of the responsible authority concerned. Consequently, those decisions must be based on facts relating to the market of that Member State.

62. I therefore propose that the answer to the second question referred should be that the first subparagraph of Article 35(2) of that regulation must be interpreted as meaning that the similarity between the packaging of a hazardous substance or mixture and the packaging of a foodstuff must be assessed solely on the basis of the market of the Member State which designated the national authority concerned as responsible for implementing that provision.

D. The third question referred – the average consumer

63. By its third question, the referring court seeks to ascertain, in essence, whether the concept of ‘consumer’ within the meaning of the first subparagraph of Article 35(2) of the CLP Regulation relates only to the average consumer or whether it also includes vulnerable consumer groups such as visually impaired persons, persons with other disabilities and children and, if so, how the specific needs of those groups are to be taken into account. I will analyse that question in four stages.

64. In the first place, I will examine the concept of ‘consumer’ within the meaning of the second situation provided for in the first subparagraph of Article 35(2) of that regulation in order to determine whether it covers not only the average consumer but also other persons. In the second place, I will address the referring court’s doubts as to whether the first situation provided for in the first subparagraph of Article 35(2) of that regulation refers both to consumers and to children, which, in its view, would suggest that the needs of children are not taken into account in respect of the second situation, which mentions only consumers. In the third place, I will consider the effect of other provisions of EU law and the case-law cited by Orkla Care on my interpretation of the concept of ‘consumer’. In the fourth place, I will explain how the specific needs of vulnerable persons are to be taken into account.

1. The concept of ‘consumer’

65. Although Article 35(2) of the CLP Regulation does not define the concept of ‘consumer’, it provides some indications in that regard.

66. In the first place, as I have already stated in point 24 of this Opinion, that provision aims to protect all individuals likely to use the products concerned, or even any person able to have access to them. Vulnerable persons cannot be excluded from that protection, as the role of a civilised society is to take care, by its actions and its laws, of the most vulnerable.

67. In the second place, the wording of the first subparagraph of Article 35(2) of the CLP Regulation refers to packaging containing a hazardous substance or a mixture supplied ‘to the general public’. Although that regulation does not clarify that wording, it is apparent from the guidance of the European Chemicals Agency (ECHA) on labelling and packaging in accordance with that regulation (20) (‘the ECHA Guidance’), that products are intended ‘for the general public’ if they are, for example, products on sale/offer at a retailer’s or an outlet where the general public have open access to them, or if they are sold through a website. Although that guidance is not legally binding, it may provide useful information for the interpretation of the relevant provisions of EU law and therefore contribute to ensuring that those provisions are applied uniformly. (21) Moreover, it is symptomatic that the definition of that wording is contained in the part of that guidance devoted inter alia to products which may be accessible to children. In any event, the products concerned are hazardous substances and mixtures marketed – that is to say, ‘supplied to the general public’ – in circumstances where persons may be exposed to substances or mixtures which are not intended for them.

68. In that connection, in the third place, useful information may be obtained from the requirements laid down in that regulation concerning the obligations imposed on suppliers of liquid consumer laundry detergents contained in soluble packaging for single use. In fact, that guidance (22) states that, ‘beside [the specific rules applicable to such laundry detergents], the supplier is responsible, according to [Article 35(2) of the CLP Regulation], for taking all necessary steps to make sure that the design of the packaging is not attractive to children, so that, for instance, it cannot be mistaken for foodstuff or toys’.

69. In the fourth place, the interpretation that the concept of ‘consumer’, within the meaning of the first subparagraph of Article 35(2) of that regulation, also covers vulnerable persons is corroborated by information obtained from other instruments of EU law relating to product safety.

70. In that respect, as regards Directive 87/357, the Court has already stated that the competent authorities’ assessment of the confusion for consumers resulting from the similarity of a non-foodstuff product and a foodstuff ‘must take into account the vulnerability associated with the categories of persons and consumers likely to be faced with products with the appearance of foodstuffs, including in particular children’. (23)

71. Furthermore, the EU legislature was more explicit in the instrument which succeeded that directive. According to recital 5 of Regulation 2023/988, all consumers, including the most vulnerable, such as ‘children, older persons or persons with disabilities’, have the right to safe products. Moreover, Article 6(1)(e) of that regulation provides that, when assessing whether a product is a safe product, account should be taken, inter alia, of the category of consumers using the product, in particular by assessing the risk for ‘vulnerable consumers such as children, older people and persons with disabilities’, as well as the impact of gender differences on health and safety.

72. In so far as the references to those two instruments of EU law have proved to be relevant in the context of the analysis of the first question, (24) they can also be considered to be relevant in the context of the third question.

73. It follows from the foregoing considerations that the concept of ‘consumer’, within the meaning of the first subparagraph of Article 35(2) of the CLP Regulation, covers all individuals likely to use the hazardous substances or mixtures concerned, or even any person able to have access to them, including vulnerable persons.

2. Are children consumers?

74. The referring court asks whether children must also be regarded as consumers within the meaning of the second situation provided for in Article 35(2) of the CLP Regulation, in so far as that provision provides, in particular, that the packaging must not attract or arouse the active curiosity of children.

75. In that regard, it is true that the first situation provided for in Article 35(2) of that regulation, relating to the shape or design of packaging, refers not only to consumers but also to children. However, it cannot be inferred from this that children are not consumers within the meaning of that provision. I understand that specific reference to children as the expression of the EU legislature’s desire to stress the importance of children’s interests and not to deprive them of the protection accorded to consumers as such.

76. Some of the information which I have already set out supports that interpretation. As I have stated, (25) the ECHA Guidance alludes to Article 35(2) of that regulation and to a child’s confusion of a substance or mixture with a foodstuff. Moreover, children are mentioned among those consumers protected in Directive 87/357 and Regulation 2023/988, (26) and there is no reason to consider that the EU legislature did not wish to protect them in the context of the CLP Regulation.

77. In conclusion, it follows from the foregoing that although children are mentioned alongside consumers in the first situation in Article 35(2) of that regulation, they are not excluded from the concept of ‘consumer’ in the second situation. It remains to be determined whether my interpretation of that concept is not called into question by the fact that certain legal instruments of EU law refer to the ‘average consumer’.

3. The concept of ‘average consumer’ in other legal instruments of EU law

78. When interpreting the concept of ‘consumer’ within the meaning of the second situation in Article 35(2) of the CLP Regulation, the EU legislature’s choice not to limit the scope of that concept to the average consumer cannot be ignored. That choice is informed by the nature of the products falling within the scope of that provision, namely substances and mixtures classified as hazardous.

79. Moreover, the concept of ‘average consumer’ is used in EU law by directives aimed at restoring the contractual balance between the contracting parties. However, in the light of the clarifications made in point 24 of this Opinion, those directives are not relevant in the present case.

80. Next, it is true that the Court has used the concept of ‘average consumer’ in its judgments concerning other legal instruments of EU law relating to product safety. Orkla Care cites, in that regard, the judgments concerning Regulation (EC) No 110/2008 (27) and No 1223/2009 and Directive 2000/13/EC. (28) However, those judgments are not relevant in the present case.

81. In the first place, as regards Regulation No 110/2008, it concerns the protection of geographical indications of spirit drinks. It aims to promote market transparency and fair competition in order to prevent the geographical origin of a product from being ‘monopolised’ by economic agents, as that origin may influence a consumer’s decision to buy a product. (29) The regulation is therefore concerned not only with protecting the health of persons who consume the products in question, but above all with the influence of the geographical indication on the consumer’s perception of the products. That is why the judgment in Viiniverla, (30) in which the central issue concerned Regulation No 110/2008, is not relevant in the present case.

82. In the second place, as regards Regulation No 1223/2009, it concerns, as is apparent from Article 1 thereof, cosmetic products and is intended to ensure the functioning of the internal market and a high level of protection of human health. However, the emphasis of that regulation is placed on the safety of the persons for whom the products concerned are intended. Article 3 of that regulation concerns the safety of the cosmetic products when used under normal or reasonably foreseeable conditions of use. (31)

83. In the same vein, the judgment in Estée Lauder, (32) cited by Orkla Care, concerns the instrument which preceded Regulation No 1223/2009, namely Directive 76/768/EEC, (33) and relates to the provisions on the advertising of cosmetic products, as it may influence consumer practice when purchasing the products.

84. Furthermore, it is true that, regarding the judgment in A.M. (Labelling of cosmetic products) (34) also cited by Orkla Care, the Court held that the information relating to the function of a cosmetic product required in Article 19(1)(f) of Regulation No 1223/2009 must ‘clearly [inform] an average consumer who is reasonably well informed and reasonably observant and circumspect of the function of the product concerned, so that that consumer will not be misled as regards its use and how it is to be used, and will use the product in a way that is not harmful to his or her health’. However, those clarifications provided by the Court are also guided by the desire to protect not the health of the general public but the health of the person for whom the product is intended.

85. In the third place, as regards Directive 2000/13, it concerned the labelling and advertising of foodstuffs. The judgments cited by Orkla Care in that regard concern the information on the composition, origin or provenance of foodstuffs, or their therapeutic properties, (35) which may prompt consumers to acquire and consume a given product or deter them from doing so. (36)

86. Broadly speaking, the case-law cited by Orkla Care concerns the concept of ‘average consumer’ not in the context of protecting the general public against error and from unknowingly consuming a hazardous substance or mixture, but in that of preventing that public from being deceived in respect of the properties of a product and its purchase and consumption. That case-law cannot, therefore, call into question my interpretation of the concept of ‘consumer’ within the meaning of Article 35(2) of the CLP Regulation.

4. The taking into account of specific needs

87. The third question referred also concerns the matter of how to take into account the specific needs of vulnerable persons likely to come into contact with a hazardous substance or mixture.

88. Orkla Care claims, in that regard, that, although visually impaired persons are regarded as falling within the concept of ‘consumer’ within the meaning of the second situation in Article 35(2) of the CLP Regulation, account should be taken of the fact that, in practice, such persons have methods for distinguishing the content of packaging and are assisted where necessary.

89. In my view, the taking into account of the fact that the concept of ‘consumer’, within the meaning of that provision, covers all individuals likely to use the substances or mixtures concerned, or even any person able to have access to them, including vulnerable persons, must be reflected in a specific approach to assessing the similarity between the packaging of such products and the packaging of foodstuffs.

90. When carrying out that assessment, account should be taken of the cognitive capacities of the persons whose senses or capacities of association are not those of a reasonably well-informed and reasonably observant and circumspect consumer. The issue is therefore not whether a person wishing to buy a foodstuff of being misled because of the similarity between the packaging of a hazardous substance or mixture and the packaging of a foodstuff, but the possibility for a visually impaired person or child of confusing those two types of packaging. The packaging of hazardous substances or mixtures must not therefore make any allusion that might risk it being taken for that of foodstuffs, as that may cause confusion with the packaging of foodstuffs.

91. I am aware that that interpretation of Article 35(2) of the CLP Regulation limits the possibility for economic operators freely to choose the packaging of their products. However, considerations related to the gaining of entry to markets and acquisition of customers by differentiating products from those of competitors must, in the light of the choices made by the EU legislature, give way to the protection of the general public from risks related to the consumption of substances and mixtures classified as hazardous.

92. Having regard to the considerations set out in points 73, 77, 85 and 90 of this Opinion, the answer to the third question for a preliminary ruling should be that the concept of ‘consumer’ within the meaning of the first subparagraph of Article 35(2) of that regulation covers all individuals likely to use the hazardous substances or mixtures concerned, or even any person able to have access to them, including vulnerable persons, and in particular children. When assessing the similarity between the packaging of such products and the packaging of foodstuffs, account should be taken of the cognitive capacities of vulnerable persons whose senses or capacities of association are not those of a reasonably well-informed and reasonably observant and circumspect consumer.

E. The fourth question referred – the level of likelihood of confusion

93. By its fourth question for a preliminary ruling, the referring court asks, in essence, whether Article 35(2) of the CLP Regulation must be interpreted as meaning that the likelihood of the consumer being misled, within the meaning of that provision, must be high or whether a theoretical or insignificant likelihood is sufficient. It also asks whether the fact that confusion has actually occurred is relevant.

94. Those doubts seem to originate in Orkla Care’s allegation claiming – by referring to certain language versions of the first subparagraph of Article 35(2) of that regulation (37) – that the requirement relating to confusion laid down in the first situation in that provision is lower than that laid down in the second situation.

95. In that vein, the referring court highlights the disparities, regarding the degree of likelihood required, between some language versions of Article 35(2) of that regulation. Thus, in its view, certain language versions of that provision suggest that the condition for the first situation is fulfilled where there is a potential likelihood of misleading customers (a given packaging is likely to mislead), whereas the wording relating to the second situation is more categorical and requires the existence of a higher likelihood.

96. However, first, I am not convinced that all the language versions of Article 35(2) of that regulation mentioned by Orkla Care suggest that the second situation in Article 35(2) of the CLP Regulation requires a higher likelihood than that required by the first situation. (38) Second, contrary to the referring court, I do not see any difference between the first and second situations in that provision in any of the language versions. (39) Consequently, in the light of that disparity between its various language versions, that provision must be interpreted as taking into account the general scheme and purpose of the legislation of which it forms a part.

97. In that regard, the purpose of that regulation is to ensure a high level of protection of human health. (40)

98. According to the second situation in Article 35(2) of that regulation, as worded at least in most language versions of that regulation, the misleading of a consumer is not an inevitable consequence of an intrinsic characteristic of the packaging, but a potential consequence, that is to say a risk.

99. That situation is focused on the similarity of the presentation and design of the packaging which would mislead consumers. Where such a similarity is established, and in the absence of elements which neutralise it, a not insignificant likelihood of misleading consumers, which goes beyond a theoretical likelihood, is sufficient to consider that the requirements laid down in Article 35(2) of the CLP Regulation have not been fulfilled.

100. Therefore, regarding the referring court’s questions as to the relevance, in assessing the likelihood of confusion with foodstuffs, of the fact that such confusion has actually occurred, I consider that it cannot be required that actual evidence of consumers being misled should be provided. The Court has already held, as regards Directive 87/357, that the competent national authorities are not required to demonstrate by objective and substantiated data that consumers will confuse the products with foodstuffs and that the risks of confusion have been established. (41) That interpretation can be applied to that regulation. I would add that, in order to remove the theoretical nature of the likelihood, a national authority responsible for implementing Article 35(2) of that regulation may take into account the information that such a confusion has occurred, where it is available.

101. I therefore propose that the answer to the fourth question referred should be that Article 35(2) of that regulation must be interpreted as meaning that the existence of a not insignificant likelihood of consumers being misled, which goes beyond a theoretical likelihood, is sufficient to consider that the requirements laid down in that provision have not been fulfilled. The information that confusion with foodstuffs has actually occurred may constitute evidence of the existence of such a likelihood.

F. The fifth question referred – the taking into account of the hazard or specific risk

1. The question referred and exposition of the problem

102. By its fifth question, the referring court asks, in essence, whether the first subparagraph of Article 35(2) of the CLP Regulation must be interpreted as meaning that the hazard category and the specific risk associated with a substance or mixture are decisive for the purpose of assessing the compliance of a hazardous substance or mixture with that provision and whether that provision is applicable to packaging containing a hazardous substance or mixture and having a similar presentation or design to that used for foodstuffs, where that content is not hazardous to ingest.

103. That question is rooted in the argument of the appeal brought by Orkla Care and reproduced in its written observations lodged with the Court. According to that company, in the first place, if the danger to health of a substance or mixture is at a lower level, the likelihood of consumers being mistaken or misled must be higher for that provision to apply, and vice versa.

104. In the second place, the misleading of consumers should only refer to confusions which increase the likelihood of harm to the consumer, since misleading packaging with non-hazardous content is subject to other consumer protection rules. In that regard, Orkla Care claims that the existence of a likelihood of confusion does not necessarily mean that the consumer is exposed to the hazard associated with a certain substance. In the present case, the hazard is transient eye irritation. Since the packaging at issue bears no similarity to that of any product intended to be placed in the eyes, any confusion with food products is irrelevant as to whether the consumer is likely to be exposed to transient eye irritation.

2. Assessment

105. As regards the applicability of the first subparagraph of Article 35(2) of the CLP Regulation to hazardous substances and mixtures which are not hazardous to ingest, I note that the requirements laid down in that provision are applicable to any substance or mixture supplied to the general public and classified as hazardous. (42) Those requirements therefore also apply to substances and mixtures posing a risk limited to eye irritation.

106. Moreover, when assessing whether a given packaging satisfies the requirements laid down in that provision, it is not apparent from the wording of the first subparagraph of Article 35(2) of that regulation that account must be taken of the hazard class and category in which the hazardous substance or mixture at issue is classified, or of the specific risk associated with that hazardous substance or mixture.

107. Next, the criteria for assessing the similarity of the presentation and design of packaging and the criterion for the likelihood of being misled, as provided for in the first subparagraph of Article 35(2) of that regulation, are the same irrespective of the hazard profile of the substance or mixture in question. In fact, that provision covers not only cases where a specific risk, under specific conditions of use, to human health may be established, but aims to prevent any confusion due to the similarity of packaging containing a hazardous substance or mixture to that of a foodstuff. In accordance with that aim, that provision is based on a binary logic: either a substance or mixture is classified as hazardous and its packaging must satisfy the requirements laid down in that provision, or that is not the case and only other consumer protection rules are applicable to it. That choice of the EU legislature reflects the desire to ensure a high level of health protection. (43)

108. Moreover, as the German Government stated, that interpretation accords with the fact that that regulation is based not on the assessment of risks (44) but on the assessment of hazards.

109. In its case-law referring to the instrument which preceded the CLP Regulation, namely Directive 67/548/EEC, (45) the Court stated that the assessment of hazards constitutes the first stage of the process of risk assessment, which is a more specific concept. Thus, an assessment of the hazards linked to the substances’ intrinsic properties must not be limited in light of specific circumstances of use, as in the case of a risk assessment, and may be properly carried out regardless of the place where the substance is used, the route by which contact with the substance might arise (by ingestion, by inhalation or by dermal penetration) and the possible levels of exposure to the substance. (46)

110. The distinction between the assessment of hazards and the assessment of risks remains relevant under that regulation. Recital 15 of that regulation states that that regulation should maintain the overall current level of protection of human health and the environment provided by Directive 67/548. Moreover, as the Court has stated, the distinction between hazards and risks was maintained in that regulation and in Regulation No 1907/2006. (47)

111. However, under the CLP Regulation, the hazard class and category affect the elements of labelling required by Article 17 of that regulation, read in conjunction, in particular, with point 3.3.4 (‘Hazard Communication’) of Annex I thereto. The principle of proportionality is therefore taken into account in the mechanism established by that regulation, in that the requirements for hazard communication vary depending on the hazard class and category.

112. I therefore propose that the answer to the fifth question referred should be that, when assessing whether a given packaging satisfies the requirements laid down in the first subparagraph of Article 35(2) of that regulation, neither the hazard class nor category in which the hazardous substance or mixture at issue is classified nor the specific risk associated with that hazardous substance or mixture are taken into account.

V. Conclusion

113. In the light of the foregoing considerations, I propose that the Court reply to the questions referred for a preliminary ruling by the Svea hovrätt, Mark- och miljööverdomstolen (Svea Court of Appeal, Land and Environment Court of Appeal, Stockholm, Sweden) as follows:

(1) When assessing the similarity of the packaging under the first subparagraph of Article 35(2) of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, the characteristics of the packaging such as the shape, size, volume of the product, materials used, design, labelling, colour and smell must be taken into account. However, an element of the packaging designed to distinguish it from packaging for foodstuffs should not, in principle, be taken into account in that assessment where it does not remain intact throughout the life cycle of the product.

(2) The first subparagraph of Article 35(2) of Regulation No 1272/2008

must be interpreted as meaning that the similarity between the packaging of a hazardous substance or mixture and the packaging of a foodstuff must be assessed solely on the basis of the market of the Member State which designated the national authority concerned as responsible for implementing that provision.

(3) The concept of ‘consumer’ within the meaning of the first subparagraph of Article 35(2) of Regulation No 1272/2008 covers all individuals likely to use the hazardous substances or mixtures concerned, or even any person able to have access to them, including vulnerable persons, and in particular children. When assessing the similarity between the packaging of such products and the packaging of foodstuffs, account should be taken of the cognitive capacities of vulnerable persons whose senses or capacities of association are not those of a reasonably well-informed and reasonably observant and circumspect consumer.

(4) Article 35(2) of Regulation No 1272/2008

must be interpreted as meaning that the existence of a not insignificant likelihood of consumers being misled, which goes beyond a theoretical likelihood, is sufficient to consider that the requirements laid down in that provision have not been fulfilled. The information that confusion with foodstuffs has actually occurred may constitute evidence of the existence of such a likelihood.

(5) When assessing whether a given packaging satisfies the requirements laid down in the first subparagraph of Article 35(2) of Regulation No 1272/2008, neither the hazard class nor the category in which the hazardous substance or mixture at issue is classified, nor the specific risk associated with that hazardous substance or mixture are taken into account.

1 Original language: French.

2 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1; the ‘CLP Regulation’).

3 Regulation of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ 2019 L 169, p. 1).

4 See, respectively, recitals 1 to 3 and recitals 4 and 5 of the CLP Regulation, which state that the trade in substances and mixtures is an issue relating not only to the internal market, but also to the global market. The regulation takes account of that with a view to facilitating worldwide trade.

5 See recitals 1 and 2 of the CLP Regulation.

6 Regulation of the European Parliament and of the Council of 10 May 2023 on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council and Directive (EU) 2020/1828 of the European Parliament and the Council, and repealing Directive 2001/95/EC of the European Parliament and of the Council and Council Directive 87/357/EEC (OJ 2023 L 135, p. 1).

7 See Article 1(2) of Regulation 2023/988.

8 Regulation 2023/988 provides, in Article 2(1) thereof, that it applies in so far as there are no specific provisions with the same objective under Union law which regulate the safety of the products concerned. The first subparagraph of Article 35(2) of the CLP Regulation is such a specific provision.

9 See recital 104 of Regulation 2023/988.

10 Council Directive of 25 June 1987 on the approximation of the laws of the Member States concerning products which, appearing to be other than they are, endanger the health or safety of consumers (OJ 1987 L 192, p. 49).

11 Article 1(1) and (2) of Directive 87/357 referred to products appearing to be other than they are, although not foodstuffs, possess a form, odour, colour, appearance, packaging, labelling, volume or size, such that it is likely that consumers, especially children, will confuse them with foodstuffs and in consequence place them in their mouths, or suck or ingest them, which might be dangerous and cause, for example, suffocation, poisoning, or the perforation or obstruction of the digestive tract.

12 Regulation of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ 2009 L 342, p. 59).

13 See point 27 of this Opinion.

14 See point 29 of this Opinion.

15 As amended by Commission Regulation No 1297/2014 of 5 December 2014 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (OJ 2014 L 350, p. 1).

16 See my Opinion in Irish Ferries (C‑570/19, EU:C:2021:177, point 194).

17 By way of illustration, see ‘Bagged Milk Still Popular in Slovakia’, https://www.esmmagazine.com/packaging-design/bagged-milk-still-popular-in-slovakia-7589.

18 See point 6 of this Opinion.

19 See judgment of 2 June 2022, Get Fresh Cosmetics (C‑122/21, EU:C:2022:421, paragraph 39).

20 ‘Guidance on labelling and packaging in accordance with Regulation (EC) No 1272/2008’ of 2 March 2021, https://echa.europa.eu/documents/10162/2324906/clp_labelling_en.pdf/89628d94-573a-4024-86cc-0b4052a74d65, point 3.4.1, p. 18.

21 See p. 2 of the ECHA Guidance. See also, to that effect, concerning another similar document, judgment of 13 March 2025, Cassella-med and MCM Klosterfrau (C‑589/23, EU:C:2025:173, paragraph 40).

22 ECHA Guidance, point 3.4.2, p. 21. Emphasis added.

23 See judgment of 2 June 2022, Get Fresh Cosmetics (C‑122/21, EU:C:2022:421, paragraph 43).

24 See points 33 and 34 of this Opinion.

25 See point 68 of this Opinion.

26 See points 33 and 34 of this Opinion.

27 Regulation of the European Parliament and of the Council of 15 January 2008 on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/89 (OJ 2008 L 39, p. 16).

28 Directive of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (OJ 2000 L 109, p. 29).

29 See recitals 2 and 7 to 9 of Regulation No 110/2008.

30 Judgment of 21 January 2016 (C‑75/15, EU:C:2016:35, paragraph 25).

31 To avoid any confusion and for the sake of completeness, I should point out that the references to Regulation No 1223/2009, in point 34 of this Opinion, were made not in order to draw on the solutions adopted in that regulation, but in order to refer to those adopted in Directive 87/357 – to which that regulation refers – concerning products which, appearing to be other than they are, endanger the health or safety of consumers.

32 Judgment of 13 January 2000 (C‑220/98, EU:C:2000:8, paragraph 30).

33 Council Directive of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (OJ 1976 L 262, p. 169), as amended by Council Directive 88/667/EEC of 21 December 1988 (OJ 1988 L 382, p. 46).

34 Judgment of 17 December 2020 (C‑667/19, EU:C:2020:1039, paragraph 36).

35 See judgments of 15 July 2004, Douwe Egberts (C‑239/02, EU:C:2004:445, paragraph 46); of 10 September 2009, Severi (C‑446/07, EU:C:2009:530, paragraph 61); and of 4 June 2015, Bundesverband der Verbraucherzentralen und Verbraucherverbände (C‑195/14, EU:C:2015:361, paragraph 36).

36 Judgment of 15 July 2004, Douwe Egberts (C‑239/02, EU:C:2004:445, paragraph 45).

37 In that regard, Orkla Care refers to the English-language version (‘likely … to mislead consumers, or have a similar presentation or a design used for foodstuff …, which would mislead consumers’), French-language version (‘susceptible … d’induire les consommateurs en erreur, ni une présentation ou une esthétique similaire à celles qui sont utilisées pour les denrées alimentaires, … qui tromperait les consommateurs’), and Swedish-language version (‘förpackningar … får varken ha en form eller formgivning som kan … vilseleda konsumenterna eller ha ett utförande eller en formgivning … som skulle vilseleda konsumenterna’). Emphasis added.

38 In the English-language version, the expression ‘likely … to mislead’ (first situation in the first subparagraph of Article 35(2) of the CLP Regulation) may refer to an objective and intrinsic characteristic of a given packaging, whereas the expression ‘which would mislead’ (second situation in that provision) may be interpreted as being fulfilled by hypothetical, or even potential, causality.

39 By way of illustration, the difference in question does not appear to be easily discernible, in particular, in the Danish-language version (‘eller vildlede forbrugerne, eller have en lignende fremtoning eller et design, … som vil vildlede forbrugerne’) and Italian-language version (‘o sia tale da indurre i consumatori in errore, né hanno una presentazione o un disegno …, atti a indurre i consumatori in errore’), which use the same expression for both situations. Emphasis added.

40 See Article 1(1) and recitals 1, 3 and 54 of the CLP Regulation.

41 See judgment of 2 June 2022, Get Fresh Cosmetics (C‑122/21, EU:C:2022:421, paragraph 44).

42 See point 19 of this Opinion.

43 See point 97 of this Opinion.

44 On the other hand, Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1, and corrigendum OJ 2007 L 136, p. 3) concerns that type of assessment.

45 Council Directive of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ 1967 196, p. 1), as amended by Commission Directive 2001/59/EC of 6 August 2001 (OJ 2001 L 225, p. 1) and by Commission Directive 2008/58/EC of 21 August 2008 (OJ, English Special Edition (I), p. 234) (‘Directive 67/548’).

46 See, to that effect, judgments of 21 July 2011, Nickel Institute (C‑14/10, EU:C:2011:503, paragraphs 81 and 82), and Etimine (C‑15/10, EU:C:2011:504, paragraphs 74 and 75).

47 See, to that effect, judgments of 21 July 2011, Nickel Institute (C-14/10, EU:C:2011:503, paragraph 81), and Etimine (C-15/10, EU:C:2011:504, paragraph 74).

Opinion of Advocate General Szpunar delivered on 18 June 2026.###

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