ECLI:EU:C:2026:788

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OPINION OF ADVOCATE GENERAL

SZPUNAR

delivered on 24 September 2026 (1)

Case C‑122/25 P

BASF SE,

Nouryon Functional Chemicals BV

European Commission

( Appeal – Environment and protection of human health – Regulation (EC) No 1272/2008 – Classification, labelling and packaging of certain substances and mixtures – Delegated Regulation (EU) 2022/692 – Classification and labelling of the substance N-carboxymethyliminobis (ethylenenitrilo)tetra(acetic acid) and its pentasodium and pentapotassium salts (DTPA) – Criteria for classification of a substance as a reproductive toxicant – Intrinsic, specific property to produce an adverse effect on reproduction – Substance with the ability to bind metal ions – That property being liable to induce zinc deficiency in the maternal body, resulting in adverse effects on the development of the foetus )

Introduction

1. By their appeal, the appellants, BASF SE and Nouryon Functional Chemicals BV, seek to have set aside the judgment of the General Court of the European Union of 27 November 2024, BASF and Others v Commission (T‑453/22, ‘the judgment under appeal’, EU:T:2024:867), by which the General Court dismissed their action for annulment of Delegated Regulation (EU) 2022/692, (2) in so far as it concerns the harmonised classification and labelling of the substance N-carboxymethyliminobis (ethylenenitrilo)tetra(acetic acid) (‘DTPA-H5’), its pentasodium (‘DTPA-Na5’) and its pentapotassium salts (‘DTPA-K5’) in the hazard class ‘Reproductive toxicity’ in Category 1B.

2. In support of their claims, the appellants put forward four grounds of appeal. In accordance with the Court’s wishes, in this Opinion I shall focus on the first part of the first ground of appeal, concerning the interpretation of one of the criteria for classification of substances in the hazard class ‘Reproductive toxicity’. According to that criterion, a substance must, in order to be so classified, have, depending on the language version of Regulation (EC) No 1272/2008, (3) either an intrinsic, specific property to produce an adverse effect on reproduction or an intrinsic property to produce an adverse effect specifically on reproduction.

Legal context

3. Recitals 5, 6, 8, 10 and 12 of Regulation No 1272/2008, in the version applicable on the date of adoption of the regulation at issue, state:

‘(5) With a view to facilitating worldwide trade while protecting human health and the environment, harmonised criteria for classification and labelling have been carefully developed over a period of 12 years within the United Nations (UN) structure, resulting in the Globally Harmonised System of Classification and Labelling of Chemicals (hereinafter referred to as “the GHS”).

(6) This Regulation follows various declarations whereby the Community confirmed its intention to contribute to the global harmonisation of criteria for classification and labelling, not only at UN level, but also through the incorporation of the internationally agreed GHS criteria into Community law.

…

(8) Therefore[,] it is essential to harmonise the provisions and criteria for the classification and labelling of substances, mixtures and certain specific articles within the Community, taking into account the classification criteria and labelling rules of the GHS …

…

(10) The objective of this Regulation should be to determine which properties of substances and mixtures should lead to a classification as hazardous, in order for the hazards of substances and mixtures to be properly identified and communicated. …

…

(12) The terms and definitions used in this Regulation should be consistent with those set out in Regulation (EC) No 1907/2006 … ^[(4)^] with those set out in the rules governing transport and with the definitions specified at UN level in the GHS, in order to ensure maximum consistency in the application of chemicals legislation within the Community in the context of global trade. The hazard classes specified in the GHS should be set out in this Regulation for the same reason.’

4. Article 1(1) of that regulation provides:

‘The purpose of this Regulation is to ensure a high level of protection of human health and the environment as well as the free movement of substances, mixtures and articles as referred to in Article 4(8) by:

(a) harmonising the criteria for classification of substances and mixtures, and the rules on labelling and packaging for hazardous substances and mixtures;

…

(d) establishing a list of substances with their harmonised classifications and labelling elements at Community level in Part 3 of Annex VI;

…’

5. Article 3 of that regulation, entitled ‘Hazardous substances and mixtures and specification of hazard classes’, provides, in the first paragraph thereof:

‘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.’

6. Annex I to that regulation (‘Annex I’), entitled ‘Classification and labelling requirements for hazardous substances and mixtures’, includes, in Part 3 thereof, entitled ‘Health hazards’, a Section 3.7, entitled ‘Reproductive toxicity’.

7. Section 3.7.1 of that annex, entitled ‘Definitions and general considerations’, provides, in Section 3.7.1.1, thereof:

‘Reproductive toxicity means adverse effects on sexual function and fertility in adult males and females, as well as developmental toxicity in the offspring, occurring after exposure to a substance or mixture. The definitions presented below are adapted from those agreed as working definitions in IPCS/EHC Document No 225, Principles for Evaluating Health Risks to Reproduction Associated with Exposure to Chemicals. …

In this classification system, reproductive toxicity is subdivided into two main headings:

(a) adverse effects on sexual function and fertility;

(b) adverse effects on development of the offspring.

…’

8. Section 3.7.2 of that annex, entitled ‘Classification criteria for substances’ is divided into five sections entitled ‘Hazard categories’, ‘Basis of classification’, ‘Weight of evidence’, ‘Maternal toxicity’ and ‘Animal and experimental data’.

9. The section ‘Hazard categories’ contains Section 3.7.2.1.1, which is worded as follows:

‘For the purpose of classification for reproductive toxicity, substances are allocated to one of two categories. Within each category, effects on sexual function and fertility, and on development, are considered separately. In addition, effects on lactation are allocated to a separate hazard category.’

10. The two hazard categories for reproductive toxicants are defined in Table 3.7.1(a) of Annex I, (5) which provides:

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11. Section 3.7.2.2 of that annex, entitled ‘Basis of classification’, is worded as follows:

‘3.7.2.2.1. Classification is made on the basis of the appropriate criteria, outlined above, and an assessment of the total weight of evidence (see 1.1.1). Classification as a reproductive toxicant is intended to be used for substances which have an intrinsic, specific property to produce an adverse effect on reproduction and substances shall not be so classified if such an effect is produced solely as a non-specific secondary consequence of other toxic effects.

The classification of a substance is derived from the hazard categories in the following order of precedence: Category 1A, Category 1B, Category 2 and the additional Category for effects on or via lactation. If a substance meets the criteria for classification into both of the main categories (for example Category 1B for effects on sexual function and fertility and also Category 2 for development) then both hazard differentiations shall be communicated by the respective hazard statements. Classification in the additional category for effects on or via lactation will be considered irrespective of a classification into Category 1A, Category 1B or Category 2.

3.7.2.2.2. In the evaluation of toxic effects on the developing offspring, it is important to consider the possible influence of maternal toxicity (see section 3.7.2.4).

3.7.2.2.3. For human evidence to provide the primary basis for a Category 1A classification there must be reliable evidence of an adverse effect on reproduction in humans. Evidence used for classification shall ideally be from well conducted epidemiological studies which include the use of appropriate controls, balanced assessment, and due consideration of bias or confounding factors. Less rigorous data from studies in humans shall be supplemented with adequate data from studies in experimental animals and classification in Category 1B shall be considered.’

12. Section 3.7.2.3 of that annex, entitled ‘Weight of evidence’, contains Sections 3.7.2.3.4 and 3.7.2.3.5, which provide:

‘3.7.2.3.4. Data from animal studies ideally shall provide clear evidence of specific reproductive toxicity in the absence of other systemic toxic effects. However, if developmental toxicity occurs together with other toxic effects in the dam, the potential influence of the generalised adverse effects shall be assessed to the extent possible. The preferred approach is to consider adverse effects in the embryo/foetus first, and then evaluate maternal toxicity, along with any other factors which are likely to have influenced these effects, as part of the weight of evidence. In general, developmental effects that are observed at maternally toxic doses shall not be automatically discounted. Discounting developmental effects that are observed at maternally toxic doses can only be done on a case-by-case basis when a causal relationship is established or refuted.

3.7.2.3.5. If appropriate information is available it is important to try to determine whether developmental toxicity is due to a specific maternally mediated mechanism or to a non-specific secondary mechanism, like maternal stress and the disruption of homeostasis. Generally, the presence of maternal toxicity shall not be used to negate findings of embryo/foetal effects, unless it can be clearly demonstrated that the effects are secondary non-specific effects. This is especially the case when the effects in the offspring are significant, e.g. irreversible effects such as structural malformations. In some situations it can be assumed that reproductive toxicity is due to a secondary consequence of maternal toxicity and discount the effects, if the substance is so toxic that dams fail to thrive and there is severe inanition, they are incapable of nursing pups; or they are prostrate or dying.’

13. Section 3.7.2.4 of Annex I, entitled ‘Maternal toxicity’, contains Sections 3.7.2.4.1 and 3.7.2.4.3, according to which:

‘3.7.2.4.1. Development of the offspring throughout gestation and during the early postnatal stages can be influenced by toxic effects in the mother either through non-specific mechanisms related to stress and the disruption of maternal homeostasis, or by specific maternally mediated mechanisms. In the interpretation of the developmental outcome to decide classification for developmental effects it is important to consider the possible influence of maternal toxicity. This is a complex issue because of uncertainties surrounding the relationship between maternal toxicity and developmental outcome. Expert judgement and a weight of evidence approach, using all available studies, shall be used to determine the degree of influence that shall be attributed to maternal toxicity when interpreting the criteria for classification for developmental effects. The adverse effects in the embryo/foetus shall be first considered, and then maternal toxicity, along with any other factors which are likely to have influenced these effects, as weight of evidence, to help reach a conclusion about classification.

…

3.7.2.4.3. Classification shall not automatically be discounted for substances that produce developmental toxicity only in association with maternal toxicity, even if a specific maternally mediated mechanism has been demonstrated. In such a case, classification in Category 2 may be considered more appropriate than Category 1. However, when a substance is so toxic that maternal death or severe inanition results, or the dams are prostrate and incapable of nursing the pups, it is reasonable to assume that developmental toxicity is produced solely as a secondary consequence of maternal toxicity and discount the developmental effects. Classification is not necessarily the outcome in the case of minor developmental changes, when there is only a small reduction in foetal/pup body weight or retardation of ossification when seen in association with maternal toxicity.’

The background to the dispute, the action before the General Court, the judgment under appeal, the procedure before the Court of Justice and the forms of order sought by the parties

Background to the dispute

14. The background to the dispute is set out in paragraphs 2 to 18 of the judgment under appeal. It may be summarised as follows.

15. The appellants are manufacturers, importers or suppliers in the EU market of the substances DTPA-H5, DTPA-Na5 and DTPA-K5 (together, ‘DTPA’).

16. DTPA is used as a chelating agent, in particular, in the pulp and paper industries and in the laundry detergents, cleaners, soaps and textiles industries. The function of a chelating agent is to bind metal ions and, by doing so, to form stable, water-soluble metal-chelate complexes. Among other things, chelating agents enable water hardness to be controlled by limiting the concentrations of calcium and magnesium ions and enable barium sulphate scale in oil processing plants to be removed.

17. On 21 November 2015, Dow Chemical Company Ltd submitted a proposal to the European Chemicals Agency (ECHA) for harmonised classification and labelling of DTPA-Na5, in particular, for the hazard class for reproductive toxicity, Category 2, with the hazard statement code ‘H361d (Oral)’ (suspected of damaging the unborn child). On 1 April 2016, Akzo Nobel Functional Chemicals BV, now Nouryon Functional Chemicals, submitted two proposals to ECHA for harmonised classification and labelling for DTPA-H5 and DTPA-K5 proposing the same hazard class, category and statement code as those referred to in Dow Chemical Company’s abovementioned proposal.

18. On 16 February 2022, on the basis of the opinions of ECHA’s Committee for Risk Assessment, the European Commission adopted the regulation at issue. By that regulation, the substances constituting DTPA were inserted into Annex VI, Part 3, Table 3, to Regulation No 1272/2008, with harmonised classification and labelling, inter alia, in the hazard class for reproductive toxicity, Category 1B (Presumed human reproductive toxicant), with the hazard statement code ‘H360D’ (may damage the unborn child) and a specific concentration limit of 3% (‘the contested classification’).

The action before the General Court and the judgment under appeal

19. On 21 July 2022, the appellants and Dow Europe GmbH brought an action before the General Court for annulment of the regulation at issue as regards the contested classification.

20. In support of their action, they raised five pleas in law. Only the first, alleging infringement of the classification criteria laid down in Section 3.7.2.2.1 of Annex I, is relevant in the context of the present Opinion. The appellants claimed, in essence, that the criteria laid down in that section were not satisfied in the case of DTPA. In particular, in their view, Section 3.7.2.2.1 of Annex I provides that a substance may be classified as a reproductive toxicant only if (i) it has the intrinsic and specific property to (ii) produce a direct adverse effect on reproduction. By contrast, secondary, indirect effects resulting solely from extrinsic properties (excessive exposure) or other factors (maternal toxicity) should not be taken into account when classifying a substance in accordance with the criteria laid down in Regulation No 1272/2008. In the present case, DTPA has the ‘intrinsic and specific property’ of binding itself to metals – it cannot reach the foetus and is not capable of producing primary adverse effects on reproduction. It is only under extreme exposure conditions that DTPA could induce zinc deficiency, which is liable to trigger secondary, non-specific effects on the development of the foetus.

21. By the judgment under appeal, the General Court dismissed the action in its entirety.

22. As regards the first plea for annulment, the General Court considers that it follows, inter alia, from Section 3.7.2.2.1 of Annex I that classification in the hazard class at issue requires two cumulative classification criteria to be satisfied (paragraph 47 of the judgment under appeal), namely first, that the substance has an intrinsic property and that that property has the effect of specifically harming reproduction (‘the first classification criterion’) (paragraph 59 of the judgment under appeal) and, second, that that effect is not regarded as a ‘non-specific secondary consequence of other toxic effects’ (‘the second classification criterion’) (paragraph 62 of the judgment under appeal).

23. As regards the first classification criterion, the General Court notes, in paragraphs 48 and 50 of the judgment under appeal, that the wording of Section 3.7.2.2.1 of Annex I is not exactly the same in the various language versions of Regulation No 1272/2008. In that context, it rejects the appellants’ argument that Section 3.7.2.2.1 of Annex I requires the substance to have an ‘intrinsic and specific’ property of harming reproduction. It states, in that regard, in paragraph 56 of the judgment under appeal, that that interpretation, based on the English-language version of that section, is contradicted by the French-language version of the same section. It is clearly apparent from the latter version that the adverb ‘spécifiquement’ (specifically) is not linked to ‘substance’, but to ‘reproduction’, since the term ‘specific’ is linked to the type of health hazard referred to therein and, therefore, to the effects caused by the intrinsic property of the substance.

24. The General Court considers, in paragraph 57 of the judgment under appeal, that the latter interpretation is consistent with the general scheme and purpose of Regulation No 1272/2008 in so far as that regulation concerns the assessment of hazards linked not to the ‘intrinsic [and] specific properties’, but to the ‘intrinsic properties’ of a substance. It adds, in paragraph 58 of the judgment under appeal, that it is apparent, in particular, from Sections 3.7.1.1 and 3.7.2.3.4 of Annex I that the harmonised classification and labelling in the hazard class of reproductive toxicity are intended to identify toxic effects ‘touchant spécifiquement la reproduction’ (specifically affecting reproduction). Moreover, it notes that the second classification criterion laid down in Section 3.7.2.2.1 of Annex I requires that the adverse effect on reproduction should not be considered to be a ‘non-specific’ secondary consequence of other toxic effects. It follows that the term ‘specific’ is always linked to toxic effects.

Procedure before the Court of Justice and forms of order sought by the parties

25. On 5 February 2025, the appellants brought an appeal against the judgment under appeal. The European Commission, ECHA and the French Republic, granted leave to intervene in support of the form of order sought by the Commission in the case before the General Court, submitted their responses. By decision of the President of the Court, the parties were granted leave to submit a reply and a rejoinder.

26. By their appeal, the appellants claim that the Court should:

– set aside the judgment under appeal;

– annul the regulation at issue or refer the case back to the General Court for it to rule on the action for annulment; and

– order the Commission to pay the costs.

27. The Commission and ECHA contend that the Court should:

– dismiss the appeal; and

– order the appellants to pay the costs.

28. The French Republic contends that the Court should:

– dismiss the appeal.

29. The Court decided to give judgment without holding a hearing.

Analysis

30. The appellants put forward four grounds of appeal in support of their appeal. As I have stated and in accordance with the wishes of the Court, I shall focus my Opinion on the first part of the first ground of appeal.

Arguments of the parties

31. By the first part of the first ground of appeal, the appellants complain that, in paragraphs 49 to 60 of the judgment under appeal, the General Court erred in law in its interpretation of the first classification criterion and, consequently, erred in finding that that criterion is satisfied in the case of DTPA. They raise two complaints in that regard.

32. In the context of the first complaint, the appellants criticise, first of all, the literal interpretation of Section 3.7.2.2.1 of Annex I given by the General Court, according to which the property of a substance must ‘specifically’ harm reproduction. The General Court interpreted the terms used to describe the first classification criterion by relying on the French-language version of that section. However, it is apparent from other language versions of the same section, in particular, but not only, its English-language version, that the substance should have the ‘intrinsic [and] specific’ property to harm reproduction.

33. Next, the appellants dispute the General Court’s contextual interpretation of Section 3.7.2.2.1 of Annex I. They criticise the General Court’s observation that Regulation No 1272/2008 as such does not refer to the assessment of hazards linked to the intrinsic and specific properties of substances, but only to that linked to their intrinsic properties. They note, in that regard, that that regulation does not use the term ‘intrinsic’ in the definition of the classification criteria for all hazard classes, but only for some of them. They submit that the use, in Section 3.7.2.2.1 of Annex I, of the terms ‘intrinsic’ and ‘specific’ requires each of them to be interpreted in such a way as to give that section ‘an effective and distinctive meaning’. According to the appellants, the expression ‘intrinsic [and] specific property’ refers to the substance’s inherent, distinctive and characterising property and capacity to harm reproduction on its own; it designates the distinctive, characterising ability of the substance’s inherent chemistry to produce a harm particularly and distinctively to reproduction. They submit that that restriction on the classification of substances in that hazard class is justified by the particular context of reproductive toxicity, characterised, in principle, by maternally mediated processes. Thus, Section 3.7.2.2.1 of Annex I is intended to ensure that it is the substance itself that harms reproduction, and not external factors and circumstances.

34. Finally, the appellants submit that, in the light of their interpretation of Section 3.7.2.2.1 of Annex I, the first classification criterion is not satisfied in the case of DTPA, since DTPA does not have the capacity to harm reproduction ‘in and of itself’. (6) Whether or not a zinc deficiency effect occurs during pregnancy, preventing correct bone formation in the foetus, depends not on DTPA ‘on its own’, but on various external factors and circumstances, such as the overall quantity of zinc in the rat’s daily diet.

35. In the second complaint, the appellants submit that, even if the General Court’s interpretation of Section 3.7.2.2.1 of Annex I were correct, the General Court erred in law by concluding that DTPA satisfies the condition of having the intrinsic property of ‘specifically’ harming reproduction. The intrinsic property of a substance specifically to harm reproduction must be a characteristic property of the substance to cause harm ‘precisely’ or ‘particularly’ to reproduction alone, and not to something else. It is therefore not a property consisting in causing a deficiency, which might subsequently harm reproduction depending on a number of external factors and circumstances.

36. The Commission, supported by ECHA and the French Republic, contends that the first part of the first ground of appeal should be rejected. The Commission submits that the appellants’ interpretation of Section 3.7.2.2.1 of Annex I, according to which the substance must produce an effect ‘on its own’, such that its effect on reproduction must be direct, thereby excluding any indirect effect via a chain of events linked by a causal relationship, is untenable. In view of the property of DTPA to bind metal ions, even if it were considered that that section provides that the property of a substance must be ‘intrinsic [and] specific’, the mere fact that the properties of DTPA trigger a chain of events ultimately leading to adverse effects on foetus development cannot mean that the adverse effects on the developing offspring are not specific to DTPA.

37. The French Republic adds that the objective of Regulation No 1272/2008 is to ensure a high level of protection of human health and the environment and that it would be contrary to that objective to interpret restrictively the criteria for classification of a substance in the hazard class for reproductive toxicity by requiring, as the appellants maintain, that such a substance has not only an intrinsic, but also a specific property of harming reproduction.

38. In the reply, the appellants state that, in their view, the term ‘specific’ defines how the classified substance must produce effects. Irrespective of the language version of Section 3.7.2.2.1 of Annex I, that is the direct causal relationship between an inherent property of the substance and the harm, which must not result from external events. However, the General Court merely ‘deleted’ that term by not seeking to give it a distinctive meaning.

Assessment

Whether the first part of the first ground of appeal is ineffective

39. While the first part of the first ground of appeal consists of two separate complaints, (7) I am nonetheless of the opinion that it is appropriate to examine them together. Both of those complaints are based on a language version of Section 3.7.2.2.1 of Annex I: the first on the English-language version (8) and the second on the French-language version. However, the normative content of that section cannot be different depending on the language version. All the arguments raised, based on two different language versions, must therefore be assessed together. Moreover, it is apparent from the reply that the appellants themselves consider that each of the two language versions allows the same conclusion to be drawn as regards the interpretation of the terms ‘specific’ and ‘specifically’.

40. Thus, by the first part of the first ground of appeal, the appellants seek, in essence, to challenge the General Court’s finding that the first classification criterion is satisfied in the case of DTPA. In order to arrive at that result, they criticise the interpretation given to that criterion in the judgment under appeal and submit, in essence, that its correct interpretation precludes the classification of DTPA as a reproductive toxicant, since the occurrence of adverse effects on the development of the foetus, identified following exposure to that substance, depends not on DTPA ‘on its own’, but on a number of external factors and circumstances, such as zinc deficiency.

41. I take the view that that part of the ground of appeal is ineffective. The finding that the occurrence of adverse effects depends on a number of external factors and circumstances is in no way apparent from the judgment under appeal. On the contrary, the General Court expressly rejected such assertions. After summarising the appellants’ arguments, (9) the General Court held that the contested classification is based on the mode of action of the toxicity of DTPA found by ECHA’s Committee for Risk Assessment. According to the latter, first of all, DTPA binds itself to zinc. Next, that binding effect of DTPA limits the absorption of zinc into the body, thereby causing zinc deficiency, which triggers mechanisms in the maternal body which seek to reserve all the available zinc for that body and to restrict the supply of zinc to the foetus. Finally, the insufficient zinc supply to the foetus causes a number of adverse effects on it, in particular malformations and skeletal variations. (10) Thus, according to the General Court, it is the binding property of DTPA which triggers a chain of events which has an adverse effect on the development of the offspring. (11)

42. It follows from the foregoing that the General Court did not rely on the fact that the effects observed depend on the amount of zinc in the body or expelled from it and that it thus rejected the argument put forward by the appellants in the action for annulment and reiterated in the first part of the first ground of appeal, (12) according to which the adverse effects on the development of the foetus stem from a number of external factors and circumstances. That part is therefore based on a different assessment of the facts from that carried out in the judgment under appeal by the General Court. (13)

43. I would point out in that regard that the appraisal of the facts by the General Court does not constitute, save where the clear sense of the evidence produced before it is distorted, a question of law which is subject, as such, to review by the Court of Justice. (14) While the appellants once again claim that the occurrence of adverse effects on development depends in fact on zinc deficiency, they do not raise grounds of appeal by which they criticise the General Court for distorting the evidence as regards DTPA’s mode of action.

44. In those circumstances, I take the view that the first part of the first ground of appeal should be rejected as ineffective. Even if the Court were to accept the interpretation according to which the first classification criterion precludes the classification of a substance as a reproductive toxicant where the occurrence of adverse effects on development depends on a number of external factors and circumstances, such a finding would not, however, lead to the judgment under appeal being set aside, since that judgment is not based on such a finding.

45. Nevertheless, on an alternative reading of the first part of the first ground of appeal, the expression ‘a number of external factors and circumstances’ could be read as also referring to the mode of action set out in the judgment under appeal. Thus, it is necessary to examine the first part of the first ground of appeal in so far as the appellants criticise the General Court’s interpretation of the first classification criterion to the extent that it follows that that criterion does not preclude the classification of a substance as a reproductive toxicant where the adverse effects on the development of the foetus are caused not as a result of the substance’s direct action on the foetus, but as a result of a chain of events triggered by it. That is, moreover, how the Commission understands the first part of the first ground of appeal. The appellants therefore dispute the possibility of classifying a substance as a reproductive toxicant in the event of adverse effects produced by a maternally mediated mechanism or process.

46. The problem with that reading is that the appellants do not deny the relevance, for the purposes of classifying a product as a reproductive toxicant, of maternally mediated effects as such. In their reply, they expressly state that the adverse effects of DTPA may be produced by a maternally mediated mechanism or process, whereas the relevant question is whether the maternally mediated mechanism is specific to DTPA. As is apparent from their reply, the appellants submit that the term ‘specific’ defines how the classified substance must produce effects, which was not examined by the General Court.

47. In those circumstances, it is therefore necessary to examine whether the General Court erred in its interpretation of the first classification criterion by finding that Section 3.7.2.2.1 of Annex I does not require the substance to have an intrinsic and specific property which is harmful to reproduction on its own. That part of the plea could succeed if it were established that the property of DTPA to bind metal ions, identified by the General Court in the judgment under appeal as responsible for the occurrence of adverse effects on the development of the foetus, does not fall within the concept of ‘intrinsic [and] specific property’ because of the absence of a direct link between it and adverse effects such as malformations and skeletal variations in the foetus.

The literal interpretation of the first classification criterion

48. A literal interpretation of Section 3.7.2.2.1 of Annex I, in so far as it relates to the first classification criterion, does not lead to a conclusive result as regards its normative content.

49. In the first place, according to the language versions of Section 3.7.2.2.1 of Annex I, in order to be classified as a reproductive toxicant, a substance must, in some versions, have an intrinsic, specific property to produce an adverse effect on reproduction (English-language version), while in others it must have an intrinsic property specifically to produce an adverse effect on reproduction (French-language version). The English-language version thus appears to emphasise the specific nature of the intrinsic properties of the substance, while the French-language version focuses on the specificity of the adverse effects it produces.

50. There is no reason to consider that one of those language versions takes precedence over the other, since all the language versions of a provision of EU law must, in principle, be recognised as having the same weight. (15) Moreover, no argument in favour of the primacy of one of those two versions of Section 3.7.2.2.1 of Annex I can be derived from the GHS, which Regulation No 1272/2008 seeks to incorporate into EU law. (16) Each of the language versions of Section 3.7.2.2.1 of Annex I reproduces almost word for word the wording of paragraph 3.7.2.2.1 of the GHS in its corresponding language version. Thus, that paragraph of the GHS provides that substances which are classified as a reproductive toxicant, according to the English-language version, those which have the ‘intrinsic, specific property to produce an adverse effect on reproduction’ and, according to its French-language version, those which possess the ‘intrinsic property specifically to produce an adverse effect on reproduction’. Hence, when incorporating the GHS into EU law, the legislature relied on those two language versions in order to ensure that those language versions of the EU legislation remain faithful to the integrated text. (17)

51. In the second place, no particular argument can be derived from the use, in Section 3.7.2.2.1 of Annex I, of the concept of ‘intrinsic property’ (of the substance).

52. In that regard, as I have just pointed out, Regulation No 1272/2008 seeks to incorporate into EU law a system established at United Nations level, namely the GHS. (18) The level of that integration is such that the content of Annex I, at issue in the present case, is modelled on the text of the corresponding parts of the GHS. Thus, the definitions of hazard classes and the principles for classifying substances in those classes, as laid down in Annex I to Regulation No 1272/2008, correspond to those set out in the GHS.

53. In that context, paragraph 1.3.2.2.1 of the GHS, which is part of paragraph 1.3.2.2 thereof, entitled ‘Concept of “classification”’, states that ‘the GHS uses the term “hazard classification” to indicate that only the intrinsic hazardous properties of substances or mixtures are considered’. Moreover, paragraph 1.1.2.6.2.1 of the GHS, which clarifies the relationship between the concepts of ‘hazard’ and ‘risk’, states that ‘the degree of [a chemical’s] capacity to harm depends on its intrinsic properties, i.e. its capacity to interfere with normal biological processes, and its capacity to burn, explode, corrode etc.’.

54. That requirement that the relevant hazard depends on the intrinsic properties of the substance or mixture reflects one of the principles underlying the GHS, set out in paragraph 1.1.1.6(b) thereof, according to which ‘the hazard classification process [should principally refer to] the hazards arising from the intrinsic properties of substances and mixtures, whether natural or synthetic’. (19)

55. It follows that the hazards covered by the hazard classes laid down in the GHS, and subsequently by Regulation No 1272/2008, are in principle linked to the intrinsic properties of the substances. (20) It is only exceptionally that they may be linked to other properties.

56. It follows that the use of the words ‘intrinsic … property’ in Section 3.7.2.2.1 of Annex I cannot be interpreted as seeking to limit the scope of classification in the hazard class ‘Reproductive toxicity’ in a particular way in comparison with other hazard classes. Such a limitation (to the intrinsic properties of the substances) in principle characterises the entire scheme established by the GHS and Regulation No 1272/2008. Only if other properties of a substance gave rise to the adverse effects found would it be necessary to ascertain whether that circumstance precludes the classification of the substance.

57. The appellants emphasise that, in the classification criteria, reference is made to the intrinsic properties of substances only for certain hazard classes. (21)

58. In that regard, it might, admittedly, be possible to question why the legislature (22) opted to refer to the intrinsic property of the substances only in certain sections of Annex I. As interesting as that may appear, that analysis does not, however, have any bearing on the fate of the first part of the first ground of appeal. In the present case, the adverse effects on reproduction caused by DTPA are the result of DTPA’s ability to bind metal ions. (23) There is no doubt that that ability is a property of that substance which is its own, and is therefore an intrinsic property of it. (24) Accordingly, even though Section 3.7.2.2.1 of Annex I limits the scope of classification in the hazard class ‘Reproductive toxicity’ to substances with intrinsic properties that harm reproduction, it is indeed such a property that formed the basis of DTPA’s classification.

59. In the third and last place, as the appellants themselves note, the term ‘specific’ is used, in Regulation No 1272/2008, in different contexts and has several meanings. The concept of ‘specific property’ appears only in Section 3.7.2.2.1 of Annex I to the English-language version. As regards the interpretation of that concept proposed by the appellants, it must be observed that it is not supported by arguments based on the wording of Regulation No 1272/2008, in which that concept is not defined and the meaning of which, unlike the concept of ‘intrinsic property’, cannot be inferred from the system as a whole. Since the term ‘specific’ is particularly broad and ambiguous, it lends itself to many literal interpretations. The same is true of the term ‘specifically’ used in the French-language version of Section 3.7.2.2.1 of Annex I. In those circumstances, it is not possible to give those terms a precise and concrete interpretation solely on the basis of the customary definitions of those terms.

60. Admittedly, it is undeniable, and I agree here with the view expressed by the appellants, that it is not by chance that the legislature used the term ‘specific’ in the presentation of the classification criteria. That term clearly reflects a requirement that there be a particular link between the substance (or its intrinsic properties) and the occurrence of adverse effects on reproduction. On the other hand, since it is an ambiguous and general term, its meaning cannot be determined solely on the basis of a literal interpretation.

61. In the light of the foregoing, the General Court, although referring to it, was right not to confine itself in fact to the literal interpretation of Section 3.7.2.2.1 of Annex I, based on its French-language version, in rejecting the appellants’ argument based on the English-language version thereof. Thus, like the General Court, and in accordance with settled case-law, it is necessary to interpret Section 3.7.2.2.1 of Annex I taking account of the context in which it occurs and the objectives pursued by the rules of which it forms part. (25)

Contextual interpretation of the first classification criterion

62. It is not possible to interpret the first classification criterion correctly without taking into account its context. That is thus all the more true given that that criterion is not a rule in its own right. On the contrary, it forms but a part of Section 3.7.2.2.1 of Annex I, which is itself part of one of the subdivisions of the section ‘Classification criteria for substances’ concerning the hazard class ‘Reproductive toxicity’. In that context, I would point out that the first paragraph of Article 3 of Regulation No 1272/2008 provides that a substance fulfilling the criteria laid down in Parts 2 to 5 of Annex I is to be classified in a hazard class provided for in that annex. In interpreting the first classification criterion, account must therefore be taken of all the criteria for classification in the hazard class at issue.

63. In that context, I note that the hazard class ‘Reproductive toxicity’ is characterised by a high degree of complexity on account of the complexity of the biological process which it covers. As stated in Section 3.7.1.1 of Annex I, ‘reproductive toxicity means adverse effects on sexual function and fertility in adult males and females, as well as developmental toxicity in the offspring, occurring after exposure to a substance’. As regards developmental toxicity in the offspring, at issue in the present case, that is defined in detail in Section 3.7.1.4 of Annex I. It is clear from that section, inter alia, that ‘for pragmatic purposes of classification, developmental toxicity essentially means adverse effects induced during pregnancy, or as a result of parental exposure. These effects can be manifested at any point in the life span of the organism. The major manifestations of developmental toxicity include (1) death of the developing organism, (2) structural abnormality, (3) altered growth, and (4) functional deficiency.’

64. In view of the diversity of modes of action and the adverse effects relevant from the point of view of classification in the hazard class ‘Reproductive toxicity’, it is hardly surprising that the criteria for classifying substances in that hazard class are highly elaborate. All of them appear in Section 3.7.2 of Annex I, which is divided into five sections entitled ‘Hazard categories’, ‘Basis of classification’, ‘Weight of evidence’, ‘Maternal toxicity’ and ‘Animal and experimental data’. (26) As is apparent from their headings, those sections cover different topics, and the points they contain are themselves varied: in some cases they define the hazard categories, while in others they provide guidance, in essence, on how to determine whether the adverse effects on reproduction are to be regarded as attributable to the classified substance and whether the data from animal studies may be transposed to humans.

65. Section 3.7.2.2.1 of Annex I, referred to in the first part of the first ground of appeal, appears in Section 3.7.2.2 entitled ‘Basis of classification’. I note that no other hazard class contains a section thus named, which supports the observations on the complexity of the classification in the hazard class at issue.

66. The section ‘Basis of classification’ is composed of three points. The first, divided into two paragraphs, sets out some general classification principles, the second emphasises the importance of taking account of maternal toxicity when assessing toxic effects on the developing offspring, and the third lays down the requirements as to the type of data allowing classification of a substance in Category 1A. Since the issue of maternal toxicity is the subject of a separate section and other sections relate to specific issues such as the assessment of the total weight of evidence or the use of animal and experimental data, I take the view that the section ‘Basis of classification’ should be regarded as constituting the general part of the section ‘Classification criteria for substances’. First, it applies to different types of adverse effects, whether on sexual function and fertility or on development, and, second, some of its points merely refer to other sections.

67. Section 3.7.2.2.1 of Annex I in that section is composed of two paragraphs. The first sentence of the first paragraph lays down a general rule that ‘classification [of substances as reproductive toxicants] is made on the basis of the appropriate criteria, outlined above, ^[(27)^] and an assessment of the total weight of evidence (see 1.1.1)’. That first sentence is followed by two sentences in the French-language version, but by only one in the English-language version. The second sentence of the French-language version (which corresponds to the first part of the second sentence of the English-language version) sets out the principle that the classification ‘s’applique aux substances qui possèdent la propriété intrinsèque de nuire spécifiquement à la reproduction’ (applies to substances which have an intrinsic property specifically to produce an adverse effect on reproduction) (in the English-language version ‘is intended to be used for substances which have an intrinsic, specific property to produce an adverse effect on reproduction’). The third sentence in French-language version (which corresponds to the second part of the second sentence in English-language version) states that ‘substances qui ne produisent cet effet que comme conséquence secondaire et non spécifique d’autres effets toxiques ne sont pas classées dans cette catégorie’ (substances shall not be so classified if such an effect is produced solely as a non-specific secondary consequence of other toxic effects). (28)

68. In view of the context, in particular its location in the part which acts as a general part of the classification criteria, I am of the view that Section 3.7.2.2.1 of Annex I sets out a general concept on which the classification of substances in the hazard class ‘Reproductive toxicity’ is based. The expression described as the first classification criterion is then part of the introductory sentence setting out that concept.

69. As I have already observed, (29) the use of the term ‘specific’ or ‘specifically’ clearly reflects the legislature’s intention to restrict the scope of the classification, that is to say to exclude certain substances from it despite a finding of the occurrence of adverse effects on reproduction following exposure to them. Nevertheless, given that that restriction is set out in the context of the general concept of classification and expressed using an ambiguous and general term, it seems clear to me that its exact scope should follow from the particular criteria set out in the section ‘Classification criteria for substances’. Otherwise, the classification would be carried out in accordance with a vague and imprecise rule, which would undermine the principle of legal certainty, which requires that legislation be clear and precise and that its application be foreseeable for all interested parties. (30)

70. While a reading of all the classification criteria does indeed suggest that the scope of the classification should be restricted to substances for which it is possible to establish a close causal link between the occurrence of adverse effects on reproduction and the intrinsic properties of the classified substance, the fact remains that the closeness of that link is not established by any definition of the ‘specificity’ of the intrinsic properties of substances required for the purposes of classification, but in the light of the specific nature of the adverse effects identified. In addition, it is rather the case that the particular criteria determine the circumstances excluding classification despite the finding of adverse effects on reproduction.

71. First, the second classification criterion provides that substances which produce an adverse effect on reproduction are not to be classified if such an effect is produced solely as a non-specific secondary consequence of other toxic effects. That rule is then confirmed and clarified in Table 3.7.1(a) of Annex I, in the definitions of the hazard categories. In particular, in the definition of Category 1B, it is stated that the data ‘shall provide clear evidence of an adverse effect … on development in the absence of other toxic effects, or if occurring together with other toxic effects the adverse effect on reproduction is considered not to be a secondary non-specific consequence of other toxic effects’. Similarly, in the definition of Category 2, it is stated that adverse effects on reproduction ‘shall have been observed in the absence of other toxic effects, or if occurring together with other toxic effects the adverse effect on reproduction is considered not to be a secondary non-specific consequence of the other toxic effects’.

72. Second, the points contained in the sections ‘Weight of evidence’ and ‘Maternal toxicity’ are devised around the effects and the assessment of their secondary and non-specific nature. It is clear from the above that the adverse effects on development can be influenced by toxic effects in the mother either through non-specific mechanisms related to stress and the disruption of maternal homeostasis, or by specific maternally mediated mechanisms (Section 3.7.2.4.1), and that it is important to try to determine whether developmental toxicity is due to one of those mechanisms (Section 3.7.2.3.5). In any event, classification is not automatically to be discounted for substances that produce developmental toxicity only in association with maternal toxicity, even if a specific maternally mediated mechanism has been demonstrated (Section 3.7.2.4.3).

73. By contrast, the section ‘Classification criteria for substances’ does not contain other elements capable of clarifying the meaning of the terms ‘specific’ and ‘specifically’ used in the context of the first classification criterion. It must be stated above all that the particular criteria applicable to classification in the hazard class ‘Reproductive toxicity’ do not support the argument put forward by the appellants that the term ‘specific’ should be read as referring to the intrinsic property of the substance, in the sense that classification would be possible only if it were shown that the intrinsic property of the classified substance is, by its very nature, harmful to reproduction. I note that the particular criteria make no reference to the term ‘intrinsic property’ and, consequently, do not contain any information as to how to assess whether particular intrinsic properties of classified substances are sufficiently specific to form the basis for classification.

74. In those circumstances, there is only one way of interpreting the terms ‘intrinsic, specific property’ used in Section 3.7.2.2.1 of Annex I in its English-language version and the term ‘spécifiquement’ (specifically) used in the French-language version. In my view, they should be interpreted as meaning that the intrinsic property of a substance is specific and therefore justifies the classification of the substance as a reproductive toxicant where the adverse effects on reproduction are attributable to the substance. Such an element depends on an assessment of the causal link between the occurrence of the adverse effects and exposure to the classified substance, carried out in accordance with the specific criteria contained in the subsection ‘Classification criteria for substances’. The required link is lacking where the adverse effects on reproduction occur in combination with other toxic effects and are a secondary non-specific consequence of those other toxic effects.

75. The answer to the question as to whether adverse effects on reproduction are a secondary non-specific consequence of other toxic effects depends on the results of the assessment of the total weight of evidence, in particular the analysis of the mechanisms which led to the occurrence of the adverse effects identified, carried out in accordance with the specific criteria set out in the section ‘Weight of evidence’ and, as regards adverse developmental effects, in the section ‘Maternal toxicity’. (31) However, it is not provided for that classification should depend solely on the existence of a direct link between an intrinsic property of the classified substance and the occurrence of adverse effects on reproduction, including on development.

76. It follows from the foregoing that the first classification criterion must be read in the light of the second classification criterion, since those two ‘criteria’ are in fact two sides of the same coin. Indeed, it does not appear that they are two separate criteria, but only one, of which the positive side is initially presented (the first classification criterion) and subsequently the negative side (the second classification criterion). The wording of Section 3.7.2.2.1 of Annex I in the English-language version, in which, I would point out, the first and second classification criteria are set out in a single sentence, and not in two separate sentences, supports that interpretation.

77. That conclusion does not entirely correspond to the General Court’s finding that the term ‘specific’ used in Section 3.7.2.2.1 of Annex I concerns only the type of health hazard referred to therein. However, those two interpretations lead to the same result as regards the first part of the first ground of appeal. It is clear from my analysis that the General Court did not err in holding that it was not necessary to assess whether there is a direct link between the property of DTPA to bind metal ions and the adverse developmental effects that have been identified, such as malformations and skeletal variations in the foetus.

Teleological interpretation of the first classification criterion

78. The results of the contextual interpretation are supported by a teleological interpretation of that section.

79. In the first place, it is apparent, first, from recital 1 and Article 1 of Regulation No 1272/2008, adopted on the basis of Article 95 EC, now Article 114 TFEU, that that regulation seeks, inter alia, to ensure a high level of protection of health and the environment as well as the free movement of chemical substances, mixtures and certain specific articles, while enhancing competitiveness and innovation. Second, the objective of that regulation, according to recital 10 thereof, is to determine which properties of substances should lead to a classification as hazardous, in order for the hazards of substances to be properly identified and communicated.

80. It follows that the main purpose of Regulation No 1272/2008 is to ensure a high level of protection of health and the environment and that that aim is achieved, first, by the identification of substances which present a hazard to health and the environment and, second, by the communication of information on those hazards. That purpose opposes a restrictive interpretation of the criteria for classification of substances in the hazard classes established by that regulation. On the contrary, it supports the classification of a substance in a hazard class where there are data which make it possible to establish that exposure to that substance presents a hazard covered by one of the classes provided for. In the light of that purpose, it seems to me that restrictions on the classification of substances presenting a hazard should be clear or easily inferred from all the rules of the classification system established.

81. In the present case, those restrictions are clear from the particular criteria set out above. By contrast, no actual restriction may be inferred from the mere use of the word ‘specific’ in Section 3.7.2.2.1 of Annex I.

82. In any event, I would point out that Regulation No 1272/2008 is not intended to establish a list of substances presenting the greatest health hazard or with the main characteristic of presenting a particular hazard, but to determine whether or not a chemical substance presents a hazard covered by one or more hazard classes.

83. In the second place, that interpretation corresponds to the interpretation, in the scientific literature, of the criteria for classifying substances as reproductive toxicants laid down by the GHS. (32) It is considered that the purpose of the classification is to identify substances that cause specific effects on reproduction and not secondary and non-specific responses to general systemic or maternal toxicity. (33) The emphasis is thus placed not on the analysis of the specific nature of the intrinsic properties, but on the specific nature of the adverse effects which have been identified, which depends on the results of the analysis of other toxic effects which have been found.

Interim conclusion

84. In the light of the foregoing, I am of the view that the General Court did not err in law when it concluded that the general scheme and purpose of Regulation No 1272/2008 support the interpretation that it is not apparent from the use in Section 3.7.2.2.1 of Annex I of the term ‘specific’ that the substance may be classified as a reproductive toxicant only where there is a direct link between its intrinsic property and the adverse effects on development, that is to say, in the present case, between the property of DTPA to bind metal ions and malformations or skeletal variations in the foetus.

85. In that regard, the question as to whether the adverse effects identified as a result of exposure to a substance must be regarded as secondary and non-specific in relation to other toxic effects is decisive for the classification of that substance in the hazard class at issue. That issue is covered by the second part of the first ground of appeal, the analysis of which is not the subject of this Opinion.

Costs

86. Since this Opinion is limited to the analysis of one part of a ground of appeal, I shall make no proposal as to costs, since the solution in that regard depends on the outcome of the other complaints, in accordance with Article 138 of the Rules of Procedure of the Court of Justice.

Conclusion

87. In the light of all the foregoing considerations, I propose that the Court reject the first part of the first ground of appeal.

1 Original language: French.

2 Commission Delegated Regulation of 16 February 2022 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 2022 L 129, p. 1; ‘the regulation at issue’).

3 Regulation 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), as amended by Commission Delegated Regulation (EU) 2021/1962 of 12 August 2021 (OJ 2021 L 400, p. 16) (‘Regulation No 1272/2008’).

4 Regulation 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).

5 Table 3.7.1(b) sets out the hazard category for effects on or via lactation.

6 The appellants refer to the definition of the concept of ‘intrinsic property’ adopted by the General Court in the judgment of 23 November 2022, CWS Powder Coatings and Others v Commission (T‑279/20, T‑283/20 and T‑288/20, EU:T:2022:725, paragraph 138).

7 See points 32 to 35 of the present Opinion.

8 The appellants also refer to a number of other language versions of the regulation (namely the German-, Bulgarian-, Greek-, Spanish-, Italian-, Dutch-, Polish- and Portuguese-language versions), the wording of which corresponds to that of the English-language version. In my Opinion, my references to the latter version should be read as also referring to the language versions consistent with the English-language version.

9 See paragraph 71 of the judgment under appeal, according to which the appellants had argued, inter alia, that the effects observed depended exclusively on the amount of zinc in the body or expelled from it, and not on the amount of DTPA to which the pregnant mother has been exposed. In other words, other circumstances, and not DTPA, led to the effects in question, which are all related to zinc deficiency.

10 See paragraphs 72 to 74 and 79 of the judgment under appeal.

11 See paragraph 80 of the judgment under appeal.

12 See also paragraph 86 of the judgment under appeal.

13 The Commission raises the same argument in its response (paragraphs 32 to 34), but in the part concerning the second part of the first ground of appeal.

14 Judgment of 12 December 2024, DD v FRA (C‑680/22 P, EU:C:2024:1019, paragraph 34 and the case-law cited).

15 See judgment of 21 May 2026, FZ AR and SX (Freezing of assets in trust) (C‑428/24 and C‑476/24, EU:C:2026:409, paragraph 89 and the case-law cited).

16 See recital 6 of Regulation No 1272/2008.

17 Similarly, the Spanish-language version of Section 3.7.2.2.1 of Annex I is modelled on the Spanish-language version of the GHS. In the Spanish-language version, the first paragraph of that section of Annex I consists of three sentences, like the French-language version, but uses, in the second sentence, terms closer to those used in the English-language version. In particular, according to that language version, the classification at issue applies ‘a las sustancias que tienen la propiedad intrínseca y específica de producir efectos adversos sobre la reproducción’ (‘to substances which possess the intrinsic and specific property to produce adverse effects on reproduction’).

18 See point 50 of this Opinion.

19 As stated in footnote 1 to the GHS, account will exceptionally also be taken of hazards arising from other properties, whether the physical state of the substance or mixture (for example, pressure and temperature) or properties of substances produced by chemical reactions (for example, flammability of gases produced by contact with water).

20 The same applies to mixtures. In view of the subject matter of the case, which does not concern the classification of mixtures, in the following part of my Opinion I shall refer only to the classification of substances.

21 That applies to carcinogenic, mutagenic and reprotoxic (CMR) hazards, as well as to the identification of substances hazardous to the aquatic environment, referred to in Sections 3.5, 3.6, 3.7 and 4.1 of Annex I.

22 I shall use that concept as also encompassing the authors of the GHS.

23 See point 41 of this Opinion.

24 I refer here to the definition of the concept of ‘intrinsic property’ adopted by the General Court and relied on by the appellants. See point 34 of this Opinion.

25 See judgment of 15 January 2026, AVR-Afvalverwerking (C‑692/23, EU:C:2026:4, paragraph 37 and the case-law cited).

26 Section 3.7.2 of Annex I, entitled ‘Classification criteria for substances’, occupies almost seven pages in the version of Regulation No 1272/2008 published in the Official Journal.

27 That is to say, in Section 3.7.2.1, entitled ‘Hazard categories’.

28 In the English-language version, the two parts of the second sentence are joined by the conjunction ‘and’, which gives the following sentence: ‘Classification as a reproductive toxicant is intended to be used for substances which have an intrinsic, specific property to produce an adverse effect on reproduction and substances shall not be so classified if such an effect is produced solely as a non-specific secondary consequence of other toxic effects’.

29 See point 60 of this Opinion.

30 See, to that effect, judgment of 5 March 2015, Europäisch-Iranische Handelsbank v Council (C‑585/13 P, EU:C:2015:145, paragraph 93 and the case-law cited).

31 See point 72 of this Opinion.

32 See Moore, N.P., Boogaard, P.J., Bremer, S., Buesen, R., Edwards, J., Fraysse, B., Hallmark, N., Hemming, H., Langrand-Lerche, C., McKee, R.H., Meisters, M.-L., Parsons, P., Politano, V., Reader, S., Ridgway, P. and Hennes, C., ‘Guidance on classification for reproductive toxicity under the globally harmonized system of classification and labelling of chemicals (GHS)’, Critical Reviews in Toxicology, Vol. 43, No 10, 2013, pp. 850 to 891; available at: https://doi.org/10.3109/10408444.2013.854734.

33 Ibid., p. 853.

Opinion of Advocate General Szpunar delivered on 24 September 2026.###

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