Court of Justice of the European Communities (including Court of First Instance Decisions)

OPINION OF ADVOCATE GENERAL

KOKOTT

delivered on 20 April 2023 (1)

Case C‑558/21 P

Global Silicones Council and Others

v

European Commission

(Appeal – Regulation (EC) No 1907/2006 (REACH) – Amendment of Annex XVII to Regulation (EC) No 1907/2006 on restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles – Restriction on the use of octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5) – Persistent, bioaccumulative and toxic substances – Very persistent and very bioaccumulative substances – Unacceptable risks – Statement of reasons)

I.      Introduction

1.        The REACH Regulation (2) permits the Commission to restrict the manufacture, use or placing on the market of substances if those activities pose an unacceptable risk to human health or the environment.

2.        Substances which pose particular risks include those which are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB). (3) These substances are degraded only very slowly or not at all and therefore have the potential to accumulate in parts of the environment. The effects of this accumulation are unpredictable in the long term. Such accumulation is also difficult to reverse in practice, as cessation of emission of the substance will not necessarily result in a reduction in substance concentration in the environment. Furthermore, PBT or vPvB substances may contaminate remote areas that should be protected from further contamination by hazardous substances resulting from human activity. (4)

3.        By the contested regulation, (5) the Commission prohibits the use of the substances at issue, octamethylcyclotetrasiloxane (‘D4’) and decamethylcyclopentasiloxane (‘D5’), in wash-off cosmetic products on the ground that D4 is a PBT/vPvB substance and D5 is a vPvB substance.

4.        After the General Court dismissed the action brought against the contested regulation, the present appeal raises questions in particular as to whether the Commission itself should have determined that there are unacceptable risks arising from the substances at issue, how the notion of unacceptable risks is to be applied and whether there is a sufficient statement of reasons for the prohibition. In addition, it concerns the classification of the substances at issue as PBT/vPvB and vPvB, although I address this point only in the Opinion in the parallel pending proceedings in Case C‑559/21 P, Global Silicones v ECHA.

II.    Legal framework

5.        The REACH Regulation authorises the Commission to restrict the manufacturing, use or placing on the market of substances (Title VIII).

6.        Article 68(1) of the REACH Regulation forms the legal basis for the imposition of restrictions:

‘When there is an unacceptable risk to human health or the environment, arising from the manufacture, use or placing on the market of substances, which needs to be addressed on a Community-wide basis, Annex XVII shall be amended in accordance with the procedure referred to in Article 133(4) by adopting new restrictions, or amending current restrictions in Annex XVII, for the manufacture, use or placing on the market of substances on their own, in mixtures or in articles, pursuant to the procedure set out in Articles 69 to 73. Any such decision shall take into account the socio-economic impact of the restriction, including the availability of alternatives.

…’

7.        Article 69 of the REACH Regulation regulates the initiation of a procedure for imposing a restriction. Paragraph 4 concerns initiation by a Member State:

‘If a Member State considers that the manufacture, placing on the market or use of a substance on its own, in a M3 mixture or in an article poses a risk to human health or the environment that is not adequately controlled and needs to be addressed it shall notify the Agency that it proposes to prepare a dossier which conforms to the requirements of the relevant sections of Annex XV.’

8.        In addition, Article 69 of the REACH Regulation provides for public participation and under Articles 70 to 72 opinions are to be obtained from the Committee for Risk Assessment and the Committee for Socio-economic Analysis.

9.        Article 73(1) of the REACH Regulation lays down rules governing the adoption of the restriction:

‘If the conditions laid down in Article 68 are fulfilled, the Commission shall prepare a draft amendment to Annex XVII …

Where the draft amendment diverges from the original proposal or if it does not take the opinions from the Agency into account, the Commission shall annex a detailed explanation of the reasons for the differences.’

10.      The final decision is taken pursuant to Article 73(2) and Article 133 of the REACH Regulation using a comitology procedure with the participation of the Member States.

11.      Annex I to the REACH Regulation lays down the general requirements for assessing substances and chemical safety reports. Point 4.0.1 describes how to deal with PBT and vPvB substances:

‘The objective of the PBT and vPvB assessment shall be to determine if the substance fulfils the criteria given in Annex XIII and if so, to characterise the potential emissions of the substance. A hazard assessment in accordance with Sections 1 and 3 of this Annex addressing all the long-term effects and the estimation of the long-term exposure of humans and the environment as carried out in accordance with Section 5 (Exposure Assessment), step 2 (Exposure Estimation), cannot be carried out with sufficient reliability for substances satisfying the PBT and vPvB criteria in Annex XIII. Therefore, a separate PBT and vPvB assessment is required.’

12.      Point 6.5 of Annex I to the REACH Regulation regulates risk management for PBT/vPvB substances in particular:

‘…

For substances satisfying the PBT and vPvB criteria, the manufacturer or importer shall use the information as obtained in Section 5, Step 2 when implementing on its site, and recommending for downstream users, risk management measures which minimise exposures and emissions to humans and the environment, throughout the lifecycle of the substance that results from manufacture or identified uses.’

13.      Annex XV to the REACH Regulation sets out the requirements for a dossier proposing a restriction. In the introduction, reference is made to Annex I:

‘The relevant parts of Annex I shall be used for the methodology and format of any dossier according to this Annex.’

14.      A further reference to Annex I can be found in a subsection of point 3 of Annex XV to the REACH Regulation:

‘Information on hazard and risk

The risks to be addressed with the restriction shall be described based on an assessment of the hazard and risks according to the relevant parts of Annex I and shall be documented in the format set out in Part B of that Annex for the Chemical Safety Report.

Evidence shall be provided that implemented risk management measures (including those identified in registrations under Articles 10 to 14) are not sufficient.’

III. Facts and procedure

15.      On 17 April 2015, the United Kingdom submitted a dossier to the European Chemicals Agency (ECHA) pursuant to Annex XV to the REACH Regulation proposing a restriction on the use of the substances at issue in cosmetic products that are washed off with water in normal conditions of use. This was necessary to prevent the substances at issue being discharged into waste water.

16.      On 10 March 2016, the ECHA Committee for Risk Assessment adopted an opinion concluding that D4 meets the criteria for PBT and vPvB substances and that D5 fulfils the criteria for vPvB substances. The Committee confirmed the risks that arise when those substances are discharged in water. It also concluded that the proposed restriction was a targeted and appropriate EU-wide measure to minimise emissions of the substances at issue caused by wash-off products.

17.      On 9 June 2016, the ECHA Committee for Socio-economic Analysis adopted its opinion, indicating that the proposed restriction is the most appropriate measure for reducing the discharge of the substances at issue into waste water in terms of its socio-economic benefits and costs.

18.      By the contested regulation of 10 January 2018, the Commission amended Annex XVII to the REACH Regulation such that the substances at issue may not be placed on the market in wash-off cosmetic products in a concentration equal to or greater than 0.1% by weight of either substance after 31 January 2020. (6) It is clarified that ‘wash-off cosmetic products’ means products that, under normal conditions of use, are washed off with water after application.

19.      According to recital 8 of the contested regulation, this restriction on the use of the two substances is based on hazard properties as a PBT substance and a vPvB substance in the case of D4 and as a vPvB substance in the case of D5. Consequently, a risk to the environment arises from the presence of the substances at issue in certain cosmetic products that are washed off with water after application.

20.      Recital 9 clarifies the scope of the restriction:

‘… In cosmetic products that are intended to stay in prolonged contact with the skin, the hair or the mucous membranes, D4 and D5 evaporate over time after application and any residue is washed off in the course of normal ablutions. The Annex XV dossier did not cover those products, considering that they did not represent the major source of risk to the environment from D4 and D5, and consequently the risk which they may present to the environment has not yet been assessed by RAC [(Risk Assessment Committee)]. Therefore, the restriction should apply only to wash-off cosmetic products that, under normal condition of use, are removed with water shortly after application because in these circumstances D4 and D5 are emitted to the aquatic environment before evaporation.’

21.      The first appellant, Global Silicones Council, represents companies which manufacture and sell silicone products throughout the world. The other appellants, Wacker Chemie AG, Momentive Performance Materials GmbH, Shin-Etsu Silicones Europe BV and Elkem Silicones France SAS, are companies established in the European Union which manufacture, sell and supply silicone products, in particular D4 and D5.

22.      They brought an action against the contested regulation, which was dismissed by the General Court by the judgment under appeal of 30 June 2021, Global Silicones Council and Others v Commission (T‑226/18, not published, EU:T:2021:403).

23.      On 8 September 2021, the appellants lodged the present appeal. They claim that the Court should:

1.      set aside the judgment under appeal;

2.      annul the contested regulation or, in the alternative, refer the case back to the General Court; and

3.      order the Commission to pay the costs of the proceedings, including the costs of the proceedings before the General Court.

24.      American Chemicals Council (ACC) intervened in support of the appellants in the proceedings before the General Court and supports the forms of order sought by them.

25.      The European Commission opposes the appeal and contends that the Court should:

1.      dismiss the appeal; and

2.      order the appellants to pay the costs.

26.      Germany and ECHA intervened in support of the Commission in the proceedings before the General Court. They support the Commission and contend that the Court should order the appellants to pay the costs. The other interveners in support of the Commission before the General Court did not participate in the appeal proceedings.

27.      The parties submitted written observations. The Court did not consider it necessary to hold a hearing as it did not require any further information on the basis of the written procedure.

IV.    Legal assessment

28.      The appellants and ACC raise five grounds of appeal.

29.      The fourth and fifth grounds of appeal concern the determination of the bioaccumulative properties of D4 and D5. They are broadly similar to the grounds of appeal raised by the appellants and ACC in Case C‑559/21 P, Global Silicones Council v ECHA,  and must therefore be rejected on the basis of the considerations I set out in the Opinion of 20 April 2023 in that case. I will not therefore examine those grounds of appeal further in the present Opinion.

30.      The first three grounds of appeal in the present case, on the other hand, relate to confirmation by the General Court of the Commission’s view that the release of the substances at issue poses a risk justifying a restriction of the use of the substance concerned in wash-off cosmetics.

31.      In this respect, the appellants object formally that the Commission itself did not determine that the restriction was necessary to counter an unacceptable risk, but relied largely on assessments made in the course of the preliminary procedure (see B). Substantively, they object to details in the assessment of that risk (see C). In discussing these grounds of appeal, I will first describe the legal standard to which regard must be had in applying the relevant provision, Article 68(1) of the REACH Regulation (see A).

A.      Legal standard

32.      Under Article 68(1) of the REACH Regulation, the Commission is to impose restrictions when there is an unacceptable risk to human health or the environment arising from the manufacture, use or placing on the market of substances.

33.      In assessing whether a risk is unacceptable, the Commission must apply the principle of proportionality. It thereby ensures that the restriction respects fundamental rights. Protective measures like the contested restriction may be carried out only if they are necessary and meet objectives of general interest recognised by the European Union or the need to protect the rights and freedoms of others. When there is a choice between several (equally (7)) appropriate measures, recourse must be had to the least onerous, and the disadvantages caused must not be disproportionate to the aims pursued. (8)

34.      Article 68(1) of the REACH Regulation pursues the specific aim of reducing or preventing risks arising from the manufacture, use or placing on the market of substances. A restriction adopted pursuant to that provision must, first, be appropriate for achieving that aim and, second, be necessary for that purpose, that is to say, it must constitute the least onerous means.

35.      Third, the disadvantages caused by the restriction must not be disproportionate to the desired reduction or prevention of the risk concerned.

36.      The legislature specified this proportional relationship more precisely in Article 68(1) of the REACH Regulation with the notion of ‘unacceptable risks’. For the risk to be ‘unacceptable’ and to justify a restriction, it must be substantial. ‘Acceptable’ risks which may not be countered by means of a restriction are also conceivable. It is nevertheless clear from Articles 35 and 37 of the Charter of Fundamental Rights of the European Union, Article 114(3) TFEU and Article 1(1) and recital 1 of the REACH Regulation that the aim of a high level of protection of human health and the environment is to be pursued. This must also be borne in mind in taking the decision on restrictions.

37.      It is for the institutions that are responsible for making political choices to determine specifically the level of risk considered acceptable to society. The acceptable risk is determined not only on the basis of strictly scientific considerations but also taking account of social factors. (9) Article 68(1) of the REACH Regulation confers this task in connection with the adoption of a restriction on the Commission, which carries it out using a comitology procedure with the participation of the Member States.

38.      Because the assessment whether a risk is unacceptable involves a scientifically and technically highly complex question, which also requires political consideration, the Commission enjoys a broad discretion. The EU judicature may review such measures only to verify whether manifest errors of appraisal have been committed or the limits of discretion have been manifestly exceeded. In such a context, the EU judicature cannot substitute its assessment of scientific and technical facts for that of the authorities on whom alone the legislature has placed that task. (10)

39.      However, where the EU institutions have such discretion, respect for the rights guaranteed by the EU legal order in administrative procedures is of even more fundamental importance. Those guarantees include, in particular, the right to have an adequately reasoned decision. Only in this way can the Court verify whether the factual and legal elements upon which the exercise of the discretion depends were present. (11)

B.      The formal ‘distinction argument’

40.      By the first part of the first ground of appeal and the second ground of appeal, the appellants and ACC raise more formal objections.

41.      In the statement of reasons for the contested regulation, the Commission did not explain that it itself considers that an unacceptable risk arises from the contested use of the substances at issue and why that is so. Instead, it merely stated in recital 8 of the contested regulation that a risk to the environment arises from the presence of the substances at issue in certain cosmetic products that are washed off with water after application. That risk arises because D4 is a PBT substance and a vPvB substance and D5 is a vPvB substance.

42.      Fuller assessments and statements are contained in the opinions submitted by the United Kingdom and the ECHA Committees for Risk Assessment and Socio-economic Analysis in the preliminary procedure, but the appellants and ACC argue that these should not be accepted. This plea can be summarised as the ‘distinction argument’.

43.      I will begin below by refuting this distinction argument and then examine the statement of reasons for the contested regulation.

1.      First part of the first ground of appeal – consideration of the preliminary procedure

44.      By the first part of the first ground of appeal, the appellants and ACC challenge findings made by the General Court in paragraphs 192 and 217 of the judgment under appeal which state, in essence, that the Commission may implicitly appropriate the assessments and statements made in the preliminary procedure, as it did in the present case.

45.      According to the appellants and ACC, the results of the preliminary procedure should be strictly distinguished from the assessment to be carried out by the Commission where it imposes a restriction. Article 68(1) of the REACH Regulation only empowers the Commission to impose a restriction, which is the most severe intervention provided for by the regulation. Furthermore, the term ‘unacceptable risks’ is used only in that provision, while it does not appear in the provisions governing the preliminary procedure.

46.      This argument is unconvincing, however, as the General Court’s findings are consistent with the second subparagraph of Article 73(1) of the REACH Regulation. Under that provision, the Commission must present a detailed explanation of the reasons if its draft restriction diverges from the original proposal (by the Member State or ECHA) or it does not take the opinions from ECHA into account. It follows a contrario that the Commission does not need to present a detailed explanation if the restriction is consistent with the original proposal and the opinions. The General Court rightly relies on that provision in paragraph 213 of the judgment under appeal.

47.      In practical terms too, the strict distinction between the Commission’s assessment and the preliminary procedure seems unrealistic. The Commission takes its decision using a comitology procedure with the participation of the Member States. At the same time, under Article 85 of the REACH Regulation, the Member States are closely involved in the composition and work of the committees which comment in the preliminary procedure.

48.      Furthermore, as the General Court states in paragraph 188 et seq. of the judgment under appeal, the aim of the opinions in the preliminary procedure is to identify (or refute) an unacceptable risk. The applicable provisions merely describe that risk in other words.

49.      Thus, the initiation of the procedure by a Member State under Article 69(4) of the REACH Regulation is dependent on whether the Member State considers that the manufacture, placing on the market or use of the substance poses a risk that is not adequately controlled and needs to be addressed. As long as this is the case, the risk is unacceptable. Once it is adequately controlled, it is acceptable.

50.      The General Court states in paragraph 199 of the judgment under appeal that an unacceptable risk is not synonymous with a risk that is not adequately controlled and needs to be addressed. Contrary to the view taken by the appellants, however, this is not in contradiction with paragraphs 192 and 217, where the General Court holds that, in assessing whether a risk is unacceptable, the Commission may adopt the findings made in the preliminary procedure. In the context of paragraphs 198 and 199, that statement in paragraph 199 indicates, above all, that the risk assessment is further developed in the course of the procedure, particularly by the ECHA committees, as Germany corroborates by reference to the provision’s drafting history.

51.      This can also be seen from a closer examination of the preliminary procedure.

52.      In the dossier which is first to be prepared, under point 3 of Section II of Annex XV to the REACH Regulation, the Member State must provide evidence that implemented risk management measures are not sufficient and justify the proposed restriction, in particular with regard to whether action is required on an EU-wide basis. In addition, it must provide justification that the restriction is capable of reducing the risks to an acceptable level within a reasonable period of time and that it is proportional to the risk. This necessarily means that the dossier must be based on a risk which is unacceptable at least to date.

53.      After the Member State has provided evidence of all this, the Committee for Risk Assessment (Article 70 of the REACH Regulation) and the Committee for Socio-economic Analysis (Article 71) formulate an opinion on the proposal and its statement of reasons, taking account of public participation. In doing so, they carry out, within the scope of their respective competence, a comprehensive assessment of the risk, on the one hand, and the socio-economic impacts of the proposed restrictions, on the other.

54.      In paragraph 217 of the judgment under appeal, the General Court therefore merely indicates that there is no need for the Commission itself expressly to identify an unacceptable risk again when it adopts the restriction and, in doing so, appropriates the assessments made in the preliminary procedure which already demonstrate that risk. The Commission has expressly confirmed in the judicial proceedings that this is the approach underlying the contested regulation.

55.      Because of this link between the preliminary procedure and the Commission’s decision, the argument that the assessment of an unacceptable risk cannot be based on Annex I to the REACH Regulation must also be rejected. This submission is likewise founded on the purported distinction between the preliminary procedure and the assessment by the Commission. It is not disputed that Annex I is applicable in the preliminary procedure.

56.      The distinction argument advanced by the appellants and ACC in the first part of the first ground of appeal must therefore be rejected. Rather, account must be taken of the results of the preliminary procedure, both in examining whether the statement of reasons for the contested regulation is comprehensive, and in assessing that statement of reasons where, as in the present case, it is adopted by the Commission.

2.      Second ground of appeal – inadequate statement of reasons for the contested regulation

57.      Building on the distinction argument, by the second ground of appeal the appellants and ACC object that in paragraph 337 of the judgment under appeal, the General Court wrongly accepted the statement of reasons for the contested regulation as sufficient.

58.      The statement of reasons for a measure is, however, apparent not only from its wording but also from its context and all the legal rules governing the matter in question. (12) In the present case, the opinions from the preliminary procedure which are appropriated by the Commission contribute in particular to the statement of reasons. The appellants were aware of these; they were even able to comment on them during the preliminary procedure. Consequently, this ground of appeal also cannot be upheld.

59.      It is true that it would be desirable if the reasons for the contested regulation were apparent wholly or at least substantially from the recitals. Not only would the Commission in this way facilitate review of the regulation, but it would also avoid the risk of misunderstandings. Nevertheless, it is possible to reconstruct the statement of reasons for the contested regulation in the light of the opinions in the preliminary procedure.

60.      The contested regulation does not fully restrict the manufacture, use and placing on the market of the substances at issue. Instead, it prohibits the placing on the market of those substances in cosmetic products that, under normal conditions of use, are washed off with water after application.

61.      It is clear from recital 9 in particular that the immediate aim of that restriction is to reduce the release of the substances at issue into the aquatic environment. This represents the major source of risk to the environment arising from those substances. The opinion of the Committee for Risk Assessment reaches the same conclusion. (13)

62.      In their opinions, the Committee for Risk Assessment and the Committee for Socio-economic Analysis discuss whether the prohibition of the contested use is capable of achieving that aim and explain that other measures would be less effective.

63.      As far as the proportionality of the aim of the prohibition and the disadvantages caused are concerned, the statements made in the preliminary procedure on the significance of the risks to the environment are inconsistent. However, those inconsistencies do not have any bearing on the content of the contested regulation.

64.      The starting point is the statement that the effects of PBT/vPvB substances in the environment, and ultimately also on humans, are unpredictable because those substances may continue to accumulate. (14)

65.      In its dossier justifying the proposal for a restriction, the United Kingdom thus considered, on the one hand, that any release of the substances at issue was an indication of an ‘unacceptable risk’ (15) but, on the other hand, regarded release into the atmosphere as harmless since it was to be assumed that the substances would stay there until they were degraded. (16)

66.      The Committee for Risk Assessment also demands in principle that any release of the substances at issue be minimised (17) and even objects to atmospheric releases being regarded as harmless. Rather, a more recent study indicated that an atmospheric release poses a risk of deposition in water or soil. (18)

67.      Despite their more comprehensive statements regarding the risks of the substances at issue, both the United Kingdom and the Committee for Risk Assessment only proposed the prohibition imposed in the contested regulation, which is intended to prevent releases into the aquatic environment alone. The Committee simply stressed that the risk of atmospheric release should be further explored in the future review of the restriction. (19)

68.      The proposal for the prohibition by the United Kingdom and the approval by the Committee for Risk Assessment can therefore be explained only by the fact that the substances at issue are not expected to degrade completely when released into the aquatic environment but, at least in part, to accumulate in the environment.

69.      The United Kingdom and the Committee for Socio-economic Analysis examined, lastly, the proportionality of the advantages and the disadvantages of the proposed restriction. That Committee did not concur with all the assessments made by the United Kingdom either, in particular regarding the monetary valuation of the advantages of the restriction, but, like that former Member State, still concluded that the advantages far outweigh the disadvantages.

70.      Because by the contested regulation the Commission followed the proposal made by the United Kingdom and confirmed by the committees, it must be assumed that it specifically concluded from the comparison of the advantages and disadvantages of the prohibition that the risk to be countered is unacceptable. That is, moreover, how I understand the statement made by the General Court in paragraph 187 of the judgment under appeal.

3.      Interim conclusion

71.      The formal objections to the way in which the General Court addressed the statement of reasons for the contested regulation are thus unfounded.

C.      Substantive objections to the contested regulation

72.      The second part of the first ground of appeal and the third ground of appeal concern substantive objections to the contested regulation. They relate in essence to the first step of the proportionality test required by Article 68(1) of the REACH Regulation, namely the risk assessment. They are, however, based on excessive legal requirements and a misunderstanding of the judgment under appeal and the contested regulation.

1.      Second part of the first ground of appeal – threshold for unacceptable risk

73.      By the second part of the first ground of appeal, the appellants object that, in paragraph 202 of the judgment under appeal, the General Court wrongly accepted that the Commission and the opinions from the preliminary procedure had not defined a critical probability threshold for adverse effects which are not acceptable for society. In other words, the Commission failed to specify the threshold between an acceptable and an unacceptable risk.

74.      The Commission was not, however, obliged to make a finding in this regard.

75.      Because the risks of the substances at issue stem from their PBT/vPvB properties, it is clear from point 4.0.1 of Annex I to the REACH Regulation that there is no need to define an acceptable risk, as the General Court explains in paragraphs 190, 191 and 202 of the judgment under appeal.

76.      Point 4.0.1 of Annex I to the REACH Regulation states that a hazard assessment for humans and the environment and the estimation of the long-term exposure cannot be carried out with sufficient reliability for PBT/vPvB substances. For the chemical safety assessment and the chemical safety report, it is therefore examined only using the criteria laid down in Annex XIII whether the substances are PBT/vPvB substances and the release of those substances is then described.

77.      The reason for that provision is that such substances have the potential to accumulate. Consequently, it is also impossible to base the definition of an acceptable risk for PBT/vPvB substances on specific release thresholds.

78.      In so far as the appellants rely in this regard on the method applied by a scientific organisation to quantify the risks of PBT/vPvB substances, that method may be scientifically sound. However, it has no basis in the applicable rules of the REACH Regulation, which reflect the fact that the risk of accumulation of those substances makes it impossible to determine a quantity that can be safely released.

79.      Furthermore, the appellants and ACC base the obligation to define an acceptable risk on the General Court’s judgment in Pfizer, according to which precautionary measures require the determination of the level of protection which the competent authorities deem appropriate for society. It is by reference to that level of protection that those authorities must then determine the level of risk which in their judgment is no longer acceptable for society and above which it is necessary to take preventive measures despite any existing scientific uncertainty. The level of risk is the critical probability threshold for adverse effects and for the seriousness of those possible effects. (20)

80.      The judgment of the Court of Justice in Toolex, which was cited by the General Court in the judgment in Pfizer, shows, however, that it is not necessary in every case to determine precisely the threshold between acceptable and unacceptable risks. In that judgment, the Court of Justice had recognised that, taking account of the difficulty of establishing the critical threshold for a serious risk, a general prohibition on the use of the substance in question was justified. (21)

81.      It therefore follows from the Court’s settled case-law on the precautionary principle only that precautionary measures presuppose, first, identification of the potentially negative consequences and, second, a comprehensive assessment of that risk based on the most reliable scientific data available and the most recent results of international research. (22) On the other hand, a precise determination of the threshold for still acceptable risk is not required by the Court.

82.      This is logical because that threshold is often one of the areas of scientific uncertainty which precautionary measures seek to counter. Furthermore, there may be several substances posing identical risks which offer advantages with different degrees of significance. In such cases, it is conceivable for the same risk to be regarded as acceptable for a very advantageous substance, but not for a less advantageous substance.

83.      Consequently, the Commission was also not required on the basis of general considerations to define precisely the extent to which the risk of the substances at issue being released could be acceptable.

84.      The second part of the first ground of appeal is also therefore unfounded.

2.      Third ground of appeal – emissions as an indication of a risk

85.      By the third ground of appeal, the appellants and ACC object in particular to paragraph 196 of the judgment under appeal, which states that the United Kingdom, in its dossier prepared pursuant to Annex XV, and the Committee for Risk Assessment concluded that the risks posed by the substances at issue could not be reliably quantified but their emissions could be regarded as an indication of a risk. The General Court does not consider this to be a manifest error of assessment, such as to call into question the contested regulation.

86.      The appellants and ACC, on the other hand, take the view that Article 68(1) in conjunction with Annexes XV and I to the REACH Regulation do not permit any release of PBT/vPvB substances to be regarded as an unacceptable risk. It is contrary to the General Court’s earlier case-law to base precautionary measures on the exclusion of any risk (‘zero risk’). (23) Furthermore, in dealing with risks it is not sufficient simply to identify a risk, but rather the authorities with political responsibility should determine, in a second step, what level of protection should be achieved, that is to say, what risk is still acceptable.

(a)    Level of protection

87.      With regard to the argument concerning the determination of the level of protection, reference should be made to the examination of the second part of the first ground of appeal immediately above, according to which it is not necessary in every case to determine the threshold between acceptable and unacceptable risks. Rather, the Commission may consider a certain risk to be unacceptable without determining the extent to which the release of the substance concerned would constitute an acceptable risk.

(b)    Release as an indication of a risk

88.      It is true that on a superficial examination the opinion of the Committee for Risk Assessment and the dossier submitted by the United Kingdom pursuant to Annex XV to the REACH Regulation give the impression that the sole reason for the restriction is that the release of PBT/vPvB substances should be prevented.

89.      The REACH Regulation does not, however, require that any release of such substances be prevented. In particular, point 6.5 of Annex I provides that manufacturers and importers of PBT/vPvB substances are to implement risk management measures which are intended merely to minimise a release, but do not have to prevent it.

90.      Furthermore, it is conceivable that the advantages of certain uses of PBT/vPvB substances are so significant that they clearly outweigh the risks of a release and a restriction is therefore not justified. This can be expected in particular if the substances presenting a risk cannot be replaced for important uses by substances with less risk.

91.      The appellants’ arguments on this point are, however, based on a misunderstanding of the judgment under appeal and the contested regulation. The regulatory content of the contested regulation and the reconstruction of its statement of reasons presented above show that it is not based on the idea that any release of PBT/vPvB substances requires a restriction. The reason for the restriction is, instead, that the substances at issue should be prevented from being released into the aquatic environment as a result of their use in wash-off cosmetics. This is also mentioned by the General Court in paragraphs 194 and 195 of the judgment under appeal, without the appellants and ACC raising an objection.

(c)    ‘Zero risk’

92.      Consequently, the argument put forward by the appellants and ACC that the Commission wishes to exclude any risk or requires evidence that no risk exists is also ineffective. The contested regulation instead addresses a specific risk, namely the risk of the substances at issue being released into the aquatic environment.

93.      Furthermore, the reference to the General Court’s earlier case-law on zero risk is also based on a misunderstanding. According to the General Court, the adoption of a preventive measure, or, conversely, its withdrawal or relaxation, cannot be made subject to proof of the lack of any risk. Such proof is generally impossible to give in scientific terms since ‘zero risk’ does not exist in practice. (24)

94.      Contrary to the view taken by the appellants and ACC, however, this does not mean that the complete exclusion of a specific risk would be prohibited. Rather, the implication is that a risk cannot justify preventive measures simply because it has not been completely excluded from a scientific point of view. Accordingly, the Court of Justice has consistently held that, in the application of the precautionary principle, the risk assessment cannot be based on purely hypothetical considerations. (25) This means mere assumptions which have not yet been scientifically verified. (26) On the other hand, scientifically based concerns satisfy the requirements under that principle even where there is still some scientific uncertainty. (27)

95.      The risk of accumulation of PBT/vPvB substances is not hypothetical, however, but is scientifically recognised.

96.      The third ground of appeal must also therefore be rejected.

3.      Interim conclusion

97.      Consequently, the substantive objections raised by the appellants and ACC likewise cannot be accepted.

D.      Final remark – unacceptability of the risk

98.      All the objections discussed above may be based on the conviction held by the appellants and ACC that the General Court wrongly accepted, in paragraphs 204 and 205 of the judgment under appeal in particular, that the Commission concluded on the basis of the preliminary procedure that the risk of the substances at issue being released into the aquatic environment arising from the use of wash-off cosmetics is unacceptable.

99.      However, this conviction could be attributed to the fact that the appellants and ACC consider only certain reasons for the contested regulation, but ignore the overall context.

100. It should be reiterated in this regard that the contested regulation concerns only one specific risk arising from the use of the substances at issue, namely the risk of release into the aquatic environment.

101. Uses which do not cause a release, by contrast, were not the subject of the procedure at all. Use in cosmetics that are not intended to be washed off within a short period of time was discussed, but is not covered by the contested regulation. According to current knowledge, such use results primarily in atmospheric release and only to a small degree in release into the aquatic environment.

102. As can be inferred from recital 9 of the contested regulation, the Commission considered the release into the aquatic environment to be the ‘major source of risk to the environment’ and thus implicitly regarded those risks as unacceptable. The reason for this assessment is that, when released into the aquatic environment, the substances at issue have the potential to accumulate in the environment, which is why they were classified as very bioaccumulative.

103. The appellants and ACC challenge this classification as very bioaccumulative in the fourth and fifth grounds of appeal. For the reasons which I explain in my Opinion of 20 April 2023 in Case C‑559/21 P, Global Silicones Council v ECHA, I consider those grounds of appeal to be unfounded.

104. However, this ignores the question whether the assessment that the risk of accumulation in the environment is unacceptable stems from a manifest error. Because the appellants do not raise any specific objections in this regard, only two points should be recalled.

105. First, in assessing this question the Commission enjoys a broad discretion which the EU judicature may review only to verify whether manifest errors have been committed. (28)

106. Second, the proportionality of the measure was examined very closely in the preliminary procedure. In particular, the Committee for Socio-economic Analysis found that the advantages of the prohibition far outweigh its disadvantages, (29) without this being challenged by the appellants or ACC.

107. A manifest error of assessment is not therefore evident. Consequently, the appeal would also have to be dismissed if it were interpreted as including the possible criticism addressed in the present section.

V.      Costs

108. Under Article 184(2) of the Rules of Procedure, where the appeal is unfounded, the Court is to make a decision as to the costs.

109. Under Article 138(1) of the Rules of Procedure, which is applicable to appeal proceedings by virtue of Article 184(1) thereof, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.

110. Since the appellants have been unsuccessful and the Commission has applied for costs, the appellants must be ordered to pay those costs.

111. Germany and ECHA, interveners at first instance, must bear their own costs pursuant to Article 140(1) of the Rules of Procedure. (30)

112. Furthermore, under Article 184(4) of the Rules of Procedure, where the appeal has not been brought by an intervener at first instance, but it participated in the written or oral part of the proceedings before the Court of Justice, the Court may decide that it is to bear its own costs. Since ACC took part in the proceedings and has been unsuccessful, it should be ordered to bear its own costs. (31)

VI.    Conclusion

113. I therefore propose that the Court should:

(1)      Dismiss the appeal;

(2)      Order Global Silicones Council and the other appellants to bear their own costs and to pay the costs incurred by the European Commission in connection with the appeal;

(3)      Order the Federal Republic of Germany, the European Chemicals Agency and American Chemistry Council, Inc. (ACC) to bear their own costs.

1      Original language: German.

2      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); the relevant version is as amended by Commission Regulation (EU) 2017/1510 of 30 August 2017 (OJ 2017 L 224, p. 110) (‘the REACH Regulation’).

3      Recital 3 of Commission Regulation (EU) No 253/2011 of 15 March 2011 amending Regulation (EC) No 1907/2006 as regards Annex XIII (OJ 2011 L 69, p. 7).

4      European Chemicals Agency, Guidance on Information Requirements and Chemical Safety Assessment, PBT Assessment (Chapter R.11) (28/06/2017), p. 11.

5      Commission Regulation (EU) 2018/35 of 10 January 2018 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards octamethylcyclotetrasiloxane (‘D4’) and decamethylcyclopentasiloxane (‘D5’) (OJ 2018 L 6, p. 45).

6      By Commission Regulation (EU) 2019/831 of 22 May 2019 amending Annexes II, III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (OJ 2019 L 137, p. 29), the use of D4 in cosmetics was prohibited entirely.

7      See judgments of 23 December 2015, Scotch Whisky Association and Others (C‑333/14, EU:C:2015:845, paragraph 49); of 26 September 2018, Van Gennip and Others (C‑137/17, EU:C:2018:771, paragraph 64); and of 26 April 2022, Poland v Parliament and Council (Uploadfilter) (C‑401/19, EU:C:2022:297, paragraph 83).

8      Judgments of 11 July 1989, Schräder HS Kraftfutter (265/87, EU:C:1989:303, paragraph 21); of 9 March 2010, ERG and Others (C‑379/08 and C‑380/08, EU:C:2010:127, paragraph 86); and of 4 June 2020, Hungary v Commission (C‑456/18 P, EU:C:2020:421, paragraph 41).

9      Judgment of 6 May 2021, Bayer CropScience and Bayer v Commission (C‑499/18 P, EU:C:2021:367, paragraph 155).

10      Judgments of 15 October 2009, Enviro Tech (Europe) (C‑425/08, EU:C:2009:635, paragraph 47); and of 21 July 2011, Etimine (C‑15/10, EU:C:2011:504, paragraph 60); and, specifically regarding the REACH Regulation, orders of 27 March 2014, Polyelectrolyte Producers Group and Others v Commission (C‑199/13 P, not published, EU:C:2014:205, paragraph 26); of 22 May 2014, Bilbaína de Alquitranes and Others v ECHA (C‑287/13 P, not published, EU:C:2014:599, paragraph 19); and of 4 September 2014, Rütgers Germany and Others v ECHA (C‑290/13 P, not published, EU:C:2014:2174, paragraph 25).

11      Judgments of 21 November 1991, Technische Universität München (C‑269/90, EU:C:1991:438, paragraph 14), and of 6 November 2008, Netherlands v Commission (C‑405/07 P, EU:C:2008:613, paragraph 56).

12      Judgments of 25 October 1984, Interfacultair Instituut Electronenmicroscopie der Rijksuniversiteit te Groningen (185/83, EU:C:1984:331, paragraph 39); of 12 July 2005, Alliance for Natural Health and Others (C‑154/04 and C‑155/04, EU:C:2005:449, paragraph 109); and of 29 September 2022, ABLV Bank v SRB (C‑202/21 P, EU:C:2022:734, paragraph 193).

13      Opinion of the Committee for Risk Assessment of 10 March 2016 (ECHA/RAC/RES-O-0000001412-86-97/D, p. 6).

14      Opinion of the Committee for Risk Assessment of 10 March 2016 (ECHA/RAC/RES-O-0000001412-86-97/D, p. 19).

15      Annex XV Restriction report of June 2015 (p. 16 et seq.).

16      Annex XV Restriction report of June 2015 (p. 20).

17      Opinion of the Committee for Risk Assessment of 10 March 2016 (ECHA/RAC/RES-O-0000001412-86-97/D, p. 6).

18      Opinion of the Committee for Risk Assessment of 10 March 2016 (ECHA/RAC/RES-O-0000001412-86-97/D, p. 9 and 10).

19      Opinion of the Committee for Risk Assessment of 10 March 2016 (ECHA/RAC/RES-O-0000001412-86-97/D, p. 26).

20      Judgment of the General Court of 11 September 2002, Pfizer Animal Health v Council (T‑13/99, EU:T:2002:209, paragraph 151).

21      Judgment of 11 July 2000, Toolex (C‑473/98, EU:C:2000:379, paragraph 45).

22      Judgments of 28 January 2010, Commission v France (C‑333/08, EU:C:2010:44, paragraph 92), and of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraph 46).

23      The appellants rely in particular on the judgments of the General Court of 11 September 2002, Pfizer Animal Health v Council (T‑13/99, EU:T:2002:209, paragraphs 145 and 152), and of 17 May 2018, Bayer CropScience and Others v Commission (T‑429/13 and T‑451/13, EU:T:2018:280, paragraph 116).

24      See, in particular, judgment of the General Court of 17 May 2018, Bayer CropScience and Others v Commission (T‑429/13 and T‑451/13, EU:T:2018:280, paragraph 116).

25      Judgments of 9 September 2003, Monsanto Agricoltura Italia and Others (C‑236/01, EU:C:2003:431, paragraph 106); of 28 January 2010, Commission v France (C‑333/08, EU:C:2010:44, paragraph 91); and of 19 January 2017, Queisser Pharma (C‑282/15, EU:C:2017:26, paragraph 60). See also judgment of the General Court of 11 September 2002, Pfizer Animal Health v Council (T‑13/99, EU:T:2002:209, paragraph 145).

26      Judgments of 9 September 2003, Monsanto Agricoltura Italia and Others (C‑236/01, EU:C:2003:431, paragraph 106); of 8 September 2011, Monsanto and Others (C‑58/10 to C‑68/10, EU:C:2011:553, paragraph 77); and of 13 September 2017, Fidenato and Others (C‑111/16, EU:C:2017:676, paragraph 51).

27      Judgment of 22 December 2010, Gowan Comércio Internacional e Serviços (C‑77/09, EU:C:2010:803, paragraphs 78 and 79).

28      See above, point 38.

29      See above, point 69.

30      See, with regard to Germany, judgment of 9 March 2023, PlasticsEurope v ECHA (C‑119/21 P, EU:C:2023:180, paragraph 155), and, with regard to ECHA, judgment of 13 July 2017, VECCO and Others v Commission (C‑651/15 P, EU:C:2017:543, paragraph 50).

31      Judgment of 6 May 2021, Bayer CropScience and Bayer v Commission (C‑499/18 P, EU:C:2021:367, paragraphs 182 and 183).

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