Provisional text

JUDGMENT OF THE GENERAL COURT (Fifth Chamber)

7 March 2019 ([\*](#Footnote*))

(REACH — Commission Decision authorising the use of lead sulfochromate yellow and of lead chromate molybdate sulfate red –Article 60(4) and (5) of Regulation (EC) No 1907/2006 — Examination of the lack of availability of alternatives — Error of law)

In Case T‐837/16,

**Kingdom of Sweden,** represented initially by A. Falk and F. Bergius, and subsequently by A. Falk, C. Meyer-Seitz, H. Shev and J. Lundberg, acting as Agents,

applicant,

supported by

**Kingdom of Denmark,** represented initially by C. Thorning and M. Wolff, and subsequently by M. Wolff and J. Nymann-Lindegren, acting as Agents,

by

**Republic of Finland,** represented by S. Hartikainen, acting as Agent,

and by

**European Parliament,** represented by A. Neergaard and A. Tamás, acting as Agents,

interveners,

v

**European Commission,** represented by R. Lindenthal, K. Mifsud-Bonnici, K. Simonsson and G. Tolstoy, acting as Agents,

defendant,

supported by

**European Chemicals Agency (ECHA),** represented by M. Heikkilä, W. Broere and C. Schultheiss, acting as Agents,

intervener,

APPLICATION under Article 263 TFEU for the annulment of Commission Implementing Decision C(2016) 5644 final of 7 September 2016 granting an authorisation for some uses of lead sulfochromate yellow and of lead chromate molybdate sulfate red under Regulation (EC) No 1907/2006,

THE GENERAL COURT (Fifth Chamber),

composed of D. Gratsias, President, I. Labucka and A. Dittrich (Rapporteur), Judges,

Registrar: P. Cullen, Administrator,

having regard to the written part of the procedure and further to the hearing on 27 September 2018,

gives the following

**Judgment**

**Background to the dispute**

1        Lead sulfochromate yellow (C.I. Pigment Yellow 34; EC No 215-693-7, CAS No 1344-37-2) and lead chromate molybdate sulfate red, known as Pigment Red 104 (C.I. Pigment Red 104; EC No 235-759-9, CAS No 12656-85-8) (‘the pigments at issue in the present case’ or ‘the lead chromates at issue in the present case’ or ‘the substances at issue in the present case’) are mixtures of the elements lead and chromium VI.

2        Because of their durability, light colour and brightness, those pigments are used in varnishes and paints, for example for iron and steel bridges and constructions or in situations where the paint has a signalling function, for example on warning signs. Lead chromates are also used for yellow road markings.

3        Under index numbers 082-009-00-X and 082-010-00-5 in the harmonised classification and labelling list for dangerous substances, contained in Table 3.1 in Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1), the pigments at issue in the present case have been classified, in particular, as carcinogens and human reproductive toxicants.

4        In adopting Regulation (EU) No 125/2012 of 14 February 2012 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ 2012 L 41, p. 1), the European Commission included the pigments at issue in the present case, on account of their properties as carcinogens and as reproductive toxicants, in Annex XIV to 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), with an expiry date of 21 May 2015.

5        Eight undertakings registered lead chromates in accordance with the provisions of Title II of Regulation No 1907/2006, including DCC Maastricht BV, which is the representative within the European Union, for the purposes of Article 8 of Regulation No 1907/2006, of a Canadian manufacturer of such substances.

6        DCC Maastricht, which supplies, inter alia, the pigments at issue in the present case to approximately 100 downstream users in the European Union, was the only undertaking to have lodged, by 19 November 2013, an application for authorisation under Article 62 of Regulation No 1907/2006 to place on the market the pigments at issue in the present case. More specifically, authorisation was requested for the following uses, which are identical for both substances:

–        distribution and mixing of pigment powder in an industrial environment into solvent-based paints for non-consumer use;

–        industrial application of paints on metal surfaces (such as machines, vehicles, structures, signs, road furniture, coil coating, etc.);

–        professional, non-consumer application of paints on metal surfaces (such as machines, vehicles, structures, signs, road furniture, etc.) or as road marking;

–        distribution and mixing of pigment powder in an industrial environment into liquid or solid premix to colour plastic/plasticised articles for non-consumer use;

–        industrial use of solid or liquid colour premixes and pre-compounds containing pigment to colour plastic or plasticised articles for non-consumer use; and

–        professional use of solid or liquid colour premixes and pre-compounds containing pigment in the application of hot melt road marking.

7        The application for authorisation contains the following non-exhaustive examples of products covered by the uses referred to therein and which, according to the applicant for authorisation, require the technological performance provided by the pigments: boot covers for cars, warning signs, containers for pharmaceutical waste, tubing for the petrochemical industry, cranes, agricultural machinery, road equipment, steel bridges, steel vaults and steel containers.

8        In accordance with Article 64(2) of Regulation No 1907/2006, the European Chemicals Agency (ECHA) held a public consultation to provide interested third parties with the opportunity to submit information on alternative substances or techniques. In the context of that consultation, opinions were submitted by EU manufacturers, downstream users of the pigments at issue in the present case, sector organisations, Member States and some non-governmental organisations.

9        The downstream users who expressed a view during the consultations indicated that the substances which could be used in the place of the lead chromates at issue in the present case did not offer the same advantages and were more expensive in most cases. By contrast, the British Coatings Federation, which represents 90% of the United Kingdom coatings industry, stated, in essence, that it did not agree with the claim of the applicant for authorisation that lead chromates were irreplaceable. That organisation stated that, at that time, a significant number of alternatives, which contained no lead, were used in the paint sector. Similarly, A., a paint and coatings manufacturer, noted that suitable and safer alternatives to the lead chromates at issue in the present case have been available commercially throughout the world for many years and that they could be used to achieve the desired product characteristics and performance at reasonable cost. Finally, B., another producer of chemicals and paints, stated that most of its clients had successfully switched to lead-free alternatives or were ready to do so. The applicant for authorisation responded to the comments of B. and A. by stating that a number of small and medium-sized enterprises (SMEs), which had supported its application in the context of the consultations, needed the pigments at issue in the present case to manufacture specific products intended for certain ‘niche’ uses.

10      On 11 December 2014, the ECHA Committee for Risk Assessment and Committee for Socio-economic Analysis adopted 12 consolidated opinions relating to the application for authorisation to take into account the six uses applied for in respect of each of the two substances concerned.

11      In those opinions, the Committee for Risk Assessment concluded, as regards the pigments at issue in the present case, that it was not possible to determine a derived no-effect level in accordance with Section 6.4 of Annex I to Regulation No 1907/2006 either for the carcinogenic properties or for the properties toxic for reproduction.

12      As regards the technical feasibility of alternatives in general, with respect to the first and fourth uses applied for, as set out in paragraph 6 above, the Committee for Socio-economic Analysis stated in Section 7 of the respective consolidated opinions (Annexes E.1, E.4, E.7 and E.10 to the pleading of the Kingdom of Sweden of 21 August 2018) that the applicant for authorisation had not provided an analysis of alternatives. It is also apparent from those opinions that, at the ‘formulation stage’, the pigments at issue in the present case had no function and that, consequently, no valid analysis of alternatives could or should be carried out.

13      As regards the technical feasibility of alternatives in general for the second and fifth uses applied for, the Committee for Socio-economic Analysis essentially enumerated, in Section 7.2.1 of the respective opinions (Annexes E.2, E.5, E.8 and E.11 to the pleading of the Kingdom of Sweden of 21 August 2018), the views of the applicant for authorisation and of the other stakeholders heard during the public consultation. Those views were, in essence, contradictory.

14      As regards the technical feasibility of alternatives in general for the third use applied for, the Committee for Socio-economic Analysis stated by way of conclusion, in Section 7.2.1 of the respective opinions (Annex A.5 to the application and Annex E.3 to the pleading of the Kingdom of Sweden of 21 August 2018), that it ‘tended to concur with the view of the applicant for authorisation that there [we]re no alternatives’. However, in view of the contradictory views expressed during the public consultation, according to that committee, that issue necessitated a further examination as regards the road marking sector. In the opinion of that committee, the uncertainties concerning that matter had to be taken into account when setting the review period.

15      As regards the technical feasibility of alternatives in general for the sixth use set out in paragraph 6 above, the Committee for Socio-economic Analysis concluded in Section 7.2.1 of the respective consolidated opinions (Annexes E.6 and E.12 to the pleading of the Kingdom of Sweden of 21 August 2018) that, in the light of the opposing views expressed during the public consultation, that issue necessitated a further examination for the road marking sector. It also stated that ‘that uncertainty’ would be taken into account when setting the review period.

16      Finally, in the introductory part of each of the consolidated opinions of 11 December 2014 (see page 4 of Annex A.5 to the application and page 4 of Annexes E.1 to E.10 to the pleading of the Kingdom of Sweden of 21 August 2018), the Committee for Socio-economic Analysis noted that it ‘seemed’ to it that there were no alternatives which would be technically and economically suitable ‘for the applicant’.

17      The Commission received the 12 consolidated opinions on 2 January 2015.

18      On 7 and 8 July 2015, on 22 and 23 September 2015 and on 3 and 4 February 2016, the application for authorisation was also examined within the committee set up under Article 133 of Regulation No 1907/2006 (‘the REACH Committee’).

19      During the discussions on the application for authorisation within the REACH Committee, two Member States and the Kingdom of Norway stated that those lead chromates were not used as pigments in paints for yellow road markings within their national territories. In one of those Member States, the use of lead chromates for road markings was even prohibited 20 years ago. The Kingdom of Norway also stated that lead chromates are not used in the paints for oil rigs in the North Sea or for platforms owned by the oil company S.

20      The Commission submitted its draft decision to the vote of the members of the REACH Committee. Twenty-three Member States voted in favour of the draft, whereas three Member States, including the Kingdom of Sweden, voted against. Two Member States abstained.

21      On 7 September 2016, the Commission adopted Implementing Decision C(2016) 5644 final granting an authorisation for some uses of lead sulfochromate yellow and of lead chromate molybdate sulfate red under Regulation No 1907/2006 (‘the contested decision’).

22      In recital 6 of the contested decision, the Commission observed as follows:

‘The [ECHA Committee for Socio-economic Analysis] confirmed the applicant’s conclusion that the overall [socio-economic] benefits arising from the uses applied for, outweigh the risks to human health or the environment arising from those uses. It further confirmed that there are no suitable alternative substances or technologies in terms of their technical and economic feasibility for the applicant’s downstream users.’

23      It is apparent from recitals 8 and 9 of the contested decision that the ECHA Committee for Socio-economic Analysis had, in its opinions, recommended that the review period referred to in Article 60(9)(e) of Regulation No 1907/2006 be set at 12 years for four uses of the two substances applied for, namely for the uses referred to in the first, second, fourth and fifth indents of paragraph 6 above, and at 7 years for the remaining two uses of the two substances applied for, namely for the uses referred to in the third and sixth indents of paragraph 6 above.

24      As is apparent, in essence, from recitals 8 and 9 of the contested decision, those review periods recommended by the Committee for Socio-economic Analysis take into account, inter alia, the lack — in terms of technical feasibility — of suitable alternatives to replace the pigments at issue in the present case in the uses applied for; the particular importance of the technical suitability of alternatives when safety is required for some specific applications; and the very low risks arising from the uses of the two substances and also very low associated benefits to human health in case the substances are not authorised. As regards the uses referred to in the third and sixth indents of paragraph 6 above, the review period recommended by the Committee for Socio-economic Analysis also takes account of the uncertainties related to the claim of the applicant for authorisation regarding the lack of technical feasibility of alternatives for the road marking sector.

25      According to the same recitals, the Commission takes the view that, due to the difficulties in fully ascertaining the lack of technically feasible alternatives for the entire scope of those uses, the authorisation should be reviewed earlier than recommended by the Committee for Socio-economic Analysis. In particular, according to recital 9 of the contested decision, after further verification with Member States, it appeared that use of the pigments at issue in the present case in the road marking sector had been substituted or was prohibited in some Member States but not in others. According to the Commission, in the light of those factors, it was therefore appropriate to set the review period at 7 years for four uses of the two substances applied for, namely for the uses referred to in the first, second, fourth and fifth indents of paragraph 6 above, and at 4 years for the remaining two uses of the two substances applied for, namely for the uses referred to in the third and sixth indents of paragraph 6 above.

26      Moreover, in recital 12 of the contested decision, the Commission stated as follows:

‘Due to the difficulties in fully ascertaining the lack of technically feasible alternatives for the entire scope of the uses covered by the application, it is appropriate to further specify the authorised uses, in terms of the technically required performance characteristics of pigment premixes, paints and pre-compounds and of articles containing them, imparted by the two substances that cannot be achieved by any other suitable alternative substance or technology. The authorisation should therefore be subject to the condition that the authorisation holder submits a report on the status of the suitability and availability of alternatives for his downstream users and on that basis refines the description of the authorised uses. Furthermore, in the event that the review report referred to in Article 61(1) of Regulation No 1907/2006 is submitted, the authorisation holder should refine the description of the authorised uses, based on information on alternatives from downstream users within its supply chain.’

27      In Article 1(1) and (2) of the contested decision, the Commission authorised the uses of the lead chromates at issue in the present case, as set out in the application for authorisation (see paragraph 6 above), under the condition that the performance of the pigment premixes, paints and pre-compounds containing the substances concerned, or of finished articles containing them, in terms of shade functionality and chroma, opacity (hiding power), dispersibility, durability (light and weather fastness), heat stability or non-leaching behaviour, or a combination thereof, is technically achievable only by using that substance and that such performance is necessary for the intended use.

28      According to Article 1(3)(d) of the contested decision, authorisation for all the uses was subject to the condition that, essentially, the authorisation holder’s downstream users submit by no later than 30 June 2017 to ECHA information on the status of the suitability and availability of alternatives for their use or uses, providing a detailed justification of the need to use the substances at issue in the present case.

29      It also follows from Article 1(3)(e) of the contested decision that the authorisation is subject to the condition that, in essence, the authorisation holder must submit a report to the Commission on the elements referred to in Article 1(3)(d) of that decision by 31 December 2017. The authorisation holder is required to refine, in its report, the description of the authorised uses, based on information on alternatives provided by downstream users.

30      Finally, Article 1(4) of the contested decision provides, in essence, as regards uses for road marking, that the authorisation is not to apply in Member States where national legislation prohibits the use of lead chromates in road marking applications.

**Procedure and forms of order sought**

31      By application lodged at the Registry of the General Court on 28 November 2016, the Kingdom of Sweden brought the present action.

32      By documents lodged at the Court Registry on 10 February and 27 and 30 March 2017, respectively, the Kingdom of Denmark, the Republic of Finland and the European Parliament sought leave to intervene in the present proceedings in support of the form of order sought by the Kingdom of Sweden. By decisions of 24 March and 3 May 2017, the President of the Fifth Chamber of the Court granted them leave to intervene.

33      On 20 March 2017, ECHA sought leave to intervene in the present proceedings in support of the Commission. On the same day, ClientEarth, a non-profit, non-governmental organisation whose objective is the protection of the environment, also sought leave to intervene in the present proceedings in support of the Kingdom of Sweden.

34      By order of 20 July 2017, the President of the Fifth Chamber of the Court granted ECHA leave to intervene. By contrast, it dismissed ClientEarth’s application for leave to intervene by order of 13 October 2017, *Sweden* v *Commission* (T‐837/16, not published, EU:T:2017:740).

35      The defence was lodged on 7 March 2017.

36      The statements in intervention of the Kingdom of Denmark, the Parliament, ECHA and the Republic of Finland were lodged, respectively, on 10 May, 29 September, 4 October and 5 October 2017.

37      The reply and rejoinder were lodged, respectively, on 2 May 2017 by the Kingdom of Sweden and on 5 October 2017 by the Commission.

38      The Kingdom of Sweden and the Commission lodged their observations on the statements in intervention on 19 December 2017.

39      By letter of 18 July 2018, the Court, by way of a measure of organisation of procedure under Article 89(3)(c) and (d) of its Rules of Procedure, invited the Kingdom of Sweden to submit the consolidated opinions of 11 December 2014, other than the consolidated opinion relating to the third use applied for concerning lead sulfochromate yellow, as included in the Court’s file in Annex A.5 to the application. By the same letter, the Kingdom of Sweden was invited to provide information on a dossier which ECHA was preparing in order to ascertain whether it was appropriate to limit the use in products of lead chromates. That dossier had been referred to by the Kingdom of Sweden in its application. Finally, by the same letter, the Commission was requested to produce a copy of the report which the authorisation holder had to submit to the Commission by 31 December 2017 in accordance with Article 1(3)(e) of the contested decision.

40      The Kingdom of Sweden and the Commission complied with those requests within the period prescribed.

41      The Kingdom of Sweden claims that the Court should:

–        annul the contested decision;

–        order the Commission to pay the costs of the proceedings before the Court.

42      The Commission contends that the Court should:

–        dismiss the application;

–        order the Kingdom of Sweden to pay the costs of the proceedings;

–        maintain, in the event of annulment of the contested decision, the effects of that decision until the Commission is able, with the assistance of ECHA, to reconsider the application for authorisation.

43      The Kingdom of Denmark and the Parliament argue that the Court should annul the contested decision. The Republic of Finland asks the Court to annul the contested decision and order the Commission to pay the costs.

44      ECHA contends that the Court should dismiss the application and order the Kingdom of Sweden to pay the costs.

**Law**

45      In support of its action, the Kingdom of Sweden, supported by the Parliament, the Kingdom of Denmark and the Republic of Finland, puts forward three pleas in law.

46      By its first plea, the Kingdom of Sweden alleges, in essence, errors of law in the application of Article 60(4) of Regulation No 1907/2006 and an infringement of the principle of due care. The second plea alleges an infringement of the Commission’s obligation to state reasons under Article 296 TFEU and Article 130 of Regulation No 1907/2006 and an infringement of the principle of good administration. By its third plea, the Kingdom of Sweden alleges an infringement of Article 55 of Regulation No 1907/2006.

47      The first plea may be broken down into three parts. By the first part of that plea, the Kingdom of Sweden argues in essence that the Commission has not carried out its own independent assessment of the question whether the conditions for granting authorisation were fulfilled in accordance with Article 60(4) of Regulation No 1907/2006. On the contrary, the Commission entrusted the task of assessing the conditions set out in that provision solely to the ECHA committees, namely the Committee for Risk Assessment and the Committee for Socio-economic Analysis. By the second part of its first plea, the Kingdom of Sweden claims that the Commission infringed Article 60(4) of Regulation No 1907/2006 by granting the authorisation at issue in the present case without having duly established that there were no suitable alternative substances or technologies to replace lead chromates for the uses referred to by the application for authorisation. The mere fact that the Commission granted the authorisation without having duly verified that alternatives were unavailable supports the conclusion that it also failed in its duty of care. The third part alleges that, by attaching certain conditions and certain review periods to the authorisation, the Commission wrongly attempted to remedy the shortcomings contained in the analysis of alternatives submitted by DCC Maastricht, on the one hand, and the shortcomings of the analysis of alternatives which it had itself carried out under Article 60(4) of Regulation No 1907/2006, on the other hand, by attaching certain conditions and brief review periods to the authorisation, without being ‘permitted’ to act in that way.

48      The Court considers that it is appropriate to examine, first of all, the second part of the first plea.

**The second part of the first plea, concerning the existence of an error of law allegedly committed by the Commission when examining the lack of availability of alternatives and the duty of care**

49      The Kingdom of Sweden, supported by the Kingdom of Denmark, the Republic of Finland and the Parliament, argues that the Commission infringed Article 60(4) of Regulation No 1907/2006, by granting the authorisation at issue in the present case without it being duly established that there were no suitable alternative substances or technologies to replace lead chromates for the uses referred to by the application. The ‘basis for decision-making in the case’ failed to establish the lack of availability of suitable alternative substances or technologies which could be used in the place of lead chromates for the uses referred to by the contested decision.

50      First, according to the Kingdom of Sweden, the applicant for the authorisation at issue in the present case has not established that there were no alternatives. Secondly, the Commission’s own analysis of the alternatives in the present case was insufficient. Indeed, in the view of the Kingdom of Sweden, certain information revealed during the authorisation procedure demonstrated that there were — at least in part, for example for road marking — suitable alternatives to the lead chromates at issue in the present case. According to the Kingdom of Sweden, that was the conclusion which the Commission would have had to draw if it had duly examined the information from third parties such as the British Coatings Federation, A. and B. (see paragraph 9 above) and the information submitted by some Member States and the Kingdom of Norway. In any event, and thirdly, because of the existence of contradictory information, the Commission should have examined the condition relating to the lack of availability of suitable alternatives in greater depth. According to the Kingdom of Sweden, in the light of the information contradicting the conclusion of the Committee for Socio-economic Analysis, it would appear that the Commission quite simply had not examined the case sufficiently for it to be able to grant the authorisation in question.

51      The Commission, supported by ECHA, disputes those arguments.

52      According to the Commission, first, the Committee for Socio-economic Analysis took into account all the contributions submitted during the public consultation. In analysing and approving the opinions of the ECHA committees, the Commission also took into account the information provided by third parties. As is apparent from the minutes of the REACH Committee meetings, the Commission also took into account all third-party contributions received after the opinions of the ECHA committees and examined whether those contributions contained additional or new information. It submits that they did not.

53      Secondly, following questions put by certain Member States within the REACH Committee, the Commission claims that it carried out additional analyses to examine whether there were alternatives for the uses referred to. It invited the applicant for authorisation to provide clarification as to the uses covered by the application for authorisation, and the applicant provided information concerning the decisive technical and economic factors justifying the selection of the substance by the downstream users. That additional information was recorded and communicated to Member States within the REACH Committee (Annex B.3 to the defence). Member States were also consulted by the Commission concerning any national obligations or prohibitions applicable to lead pigments used for road marking. The supplementary information received supported the conclusions of the Committee for Socio-economic Analysis in its opinions, according to which there were no alternatives that were technically and economically suitable for the intended uses.

54      Thirdly, at the end of its assessment of the conditions laid down in Article 60(4) of Regulation No 1907/2006, the Commission argues that it did indeed consider that the applicant for authorisation had not definitively established that there were no technically and economically suitable alternatives for all the possible uses falling within the description of the uses. However, it was of the view that such alternatives were lacking only for certain uses falling within the description contained in the application for authorisation.

55      In spite of the difficulties associated with the finding that alternatives were unavailable, the Commission did not consider that it was necessary to refuse authorisation. According to the Commission, it would be disproportionate to refuse an authorisation in order to take into account certain concerns, where those concerns may be taken into account in a less restrictive manner, for example by limiting the definition of authorised uses, and where all the relevant information is already included in the documentation.

56      Therefore, according to the Commission, the only consequence of the difficulties noted in the examination of the lack of alternatives was to limit the authorisation solely to the uses for which it had been established that alternatives were unavailable. To that end, a series of restrictions applicable to the applicant for authorisation and to its downstream users covered by the authorisation under Article 56(2) of Regulation No 1907/2006 were set out in the first sentence of paragraphs 1 and 2 of Article 1 of the contested decision, namely that the performance of the pigment premixes, paints and pre-compounds containing the substances concerned, or of finished articles containing them, is necessary for the intended use (see paragraph 27 above).

57      As a preliminary point, it should be pointed out that the arguments put forward by the Kingdom of Sweden in the context of the second part of the first plea require explanations of several elements, without which those arguments cannot be convincingly addressed. Those elements relate, in the first place, to the legal framework on the basis of which an authorisation to use a substance of very high concern can be granted (see paragraphs 58 to 62 below). In that context, it must be determined whether the Commission correctly chose Article 60(4) of Regulation No 1907/2006 as the legal basis for the contested decision (see paragraph 63 below). In the second place, a number of clarifications must be made concerning the allocation of tasks between the actors involved, in the context of the authorisation procedure referred to in Article 60(4) of Regulation No 1907/2006, that is to say the Commission, on the one hand, and the ECHA committees, on the other hand (see paragraphs 64 to 69 below). In the third place, it is necessary to make some preliminary points of clarification as to the concept of ‘alternatives’, as referred to in Regulation No 1907/2006 (see paragraphs 70 to 76 below). In the fourth place, in response to the Kingdom of Sweden’s arguments, it is necessary to provide a number of clarifications as regards the burden of proof, as provided for in Article 60(4) of Regulation No 1907/2006, read in conjunction with recital 69 of that regulation (see paragraphs 77 to 79 below). In the fifth place, it is useful to add some comments concerning the manner of allocating the burden of proof as provided for by those two provisions (see paragraphs 80 to 83 below).

58      In the first place, it should be noted that an authorisation to use a substance may be granted under what is commonly known as an ‘adequate control procedure’, such as that referred to in Article 60(2) of Regulation No 1907/2006, or, alternatively, under a ‘socio-economic’ procedure, such as that referred to in Article 60(4) of Regulation No 1907/2006.

59      According to Article 60(2) of Regulation No 1907/2006, an authorisation is to be granted if the risk to human health or the environment from the use of a substance arising from its intrinsic properties, such as those specified in Annex XIV to that regulation, is adequately controlled as shown by the risk assessment provided for in Section 6 of Annex I to Regulation No 1907/2006.

60      If authorisation cannot be granted under Article 60(2) of Regulation No 1907/2006 or for substances listed in Article 60(3) of that regulation, Article 60(4) of Regulation No 1907/2006 provides that authorisation may only be granted if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies.

61      In particular, according to the second sentence of Article 60(4) of Regulation No 1907/2006, such a decision is to be taken having regard to the opinions of the ECHA Committee for Risk Assessment and the ECHA Committee for Socio-economic Analysis and after consideration of all the elements referred to in Article 60(4)(a) to (d) of that regulation. Those elements include, in particular, the socio-economic benefits arising from the use of the substance and the socio-economic implications of a refusal to authorise (Article 60(4)(b) of Regulation No 1907/2006), as well as an analysis of the alternatives submitted by the applicant for authorisation under Article 62(4)(e) of Regulation No 1907/2006 (Article 60(4)(c) of Regulation No 1907/2006).

62      In the present case, it is clear from the file, and in particular from the opinion of the ECHA Committee for Risk Assessment, that, as regards the lead chromates at issue in the present case, it was not possible to determine a derived no-effect level in accordance with Section 6.4 of Annex I to Regulation No 1907/2006 either for carcinogenic properties or for properties toxic for reproduction, both for the purposes of Article 60(3)(a) of that regulation.

63      The Commission is therefore right to start from the premiss that the only legal basis capable of permitting the adoption of the contested decision was Article 60(4) of Regulation No 1907/2006.

64      In the second place, as regards the allocation of tasks between the actors involved in the authorisation procedure referred to in Article 60(4) of Regulation No 1907/2006, it must be noted from the outset that it is for the Commission alone to verify whether the conditions provided for in that provision are fulfilled. In that context, the Commission has an obligation to consider on its own initiative the relevant information, since it does not act as an arbitrator whose remit is limited to making an award solely on the basis of the information and the evidence provided by the actors involved in the authorisation procedure (see, by analogy, judgment of 22 March 2012, *GLS*, C‐338/10, EU:C:2012:158, paragraph 32). In accordance with the obligation to carry out an *ex officio* examination of the conditions laid down in Article 60(4) of Regulation No 1907/2006, the Commission must, in the context of good administration and taking into account its duty of care, play its part, using the means available to it, in ascertaining the relevant facts and circumstances (see, by analogy, judgment of 13 July 1966, *Consten and Grundig* v *Commission*, 56/64 and 58/64, EU:C:1966:41, page 347).

65      As regards, in particular, the technical and economic assessments necessary for carrying out a socio-economic analysis or an analysis of suitable alternatives in a particular case, the Commission is required to take into account the opinions of the ECHA committees referred to in Article 64(1) of Regulation No 1907/2006. More specifically, the assessment of the risk associated with the uses of the substance and the assessment of information on the risks to human health or the environment of any alternative substances or technologies are responsibilities entrusted to the Committee for Risk Assessment under Article 64(4)(a) of Regulation No 1907/2006. Similarly, the assessment of the socio-economic benefits arising from use of the substance and the socio-economic implications of a refusal of authorisation, evidence of which must be adduced by the applicant for authorisation or other interested parties, and the analysis of the alternatives or of a substitution plan and of any third-party contributions submitted during the public consultation held by ECHA are tasks entrusted to the Committee for Socio-economic Analysis under Article 64(4)(b) of that regulation.

66      The opinions of the Committee for Risk Assessment and of the Committee for Socio-economic Analysis have the status of scientific opinions. Such an interpretation is supported by recital 102 of Regulation No 1907/2006, according to which, in essence, ECHA has the same role as any scientific committee attached to the Commission. According to the second sentence of recital 81 of Regulation No 1907/2006, those opinions ‘should’ be taken into account by the Commission when considering whether or not to grant an authorisation. It follows from the word ‘should’ that the Commission is not bound by such opinions.

67      However, the Commission is not prevented from partially or wholly adopting the assessments set out in an opinion of one of the ECHA committees, but nor is it required to reproduce those assessments or to replace them on each occasion with its own reasoning. Where there is no information which seriously casts doubt on the opinions of those ECHA committees, the scientific analysis contained in such an opinion may, in principle, be sufficient to enable the Commission to grant or refuse an authorisation in accordance with Article 60(4) of Regulation No 1907/2006, without there even being any need for additional scientific assessments by the Commission.

68      Where the Commission endorses the opinion of one of those ECHA committees in order to justify an authorisation decision, it must ensure that the reasoning in the opinion is full, consistent and relevant (see, by analogy, judgment of 11 September 2002, *Pfizer Animal Health* v *Council*, T‐13/99, EU:T:2002:209, paragraph 198). If the opinion concerned is not full or not consistent, or if the reasoning is not relevant, the Commission is to address to the committee questions intended to remedy any shortcomings found.

69      In spite the fact that it is not bound by the opinions of the Committee for Risk Assessment and the Committee for Socio-economic Analysis, in the event that the Commission opts substantially to disregard an opinion or to substitute, in relation to technical or economic points, its opinion for the opinion issued by one of those ECHA committees, it must provide specific reasons for its findings by comparison with those made in the ECHA opinion and its statement of reasons must explain why it is disregarding the latter. The statement of reasons must be of a scientific level at least commensurate with that of the opinion in question. In such a case, the institution may take as its basis either a supplementary opinion from the same committee or other evidence, whose probative value is at least commensurate with that of the opinion concerned. In the event that the Community institution disregards only partially, but still substantially, the opinion, it may also avail itself of those parts of the scientific reasoning which it does not dispute (see, by analogy, judgment of 11 September 2002, *Pfizer Animal Health* v *Council*, T‐13/99, EU:T:2002:209, paragraph 199).

70      In the third place, as regards the term ‘alternatives’, Regulation No 1907/2006 states inter alia in Article 55 that one of its objectives is the progressive replacement of substances of very high concern. It follows from Article 64(4), Article 60(5) and recital 69 of Regulation No 1907/2006 that an ‘alternative’ constitutes an ‘alternative substance’ or ‘technology’, which are relevant for the purposes of the authorisation procedure laid down in Regulation No 1907/2006 only to the extent that they are ‘suitable’. The latter term is used in both Article 55 and Article 60(4) of Regulation No 1907/2006.

71      In the interests of further refining the elements referred to in paragraph 58 above, the ‘ECHA Guidance on the preparation of an application for authorisation’ (OJ 2011 C 28, p. 1), drawn up and distributed to the public pursuant to recital 31 and Article 77(2)(g) of Regulation No 1907/2006, with the aim of providing guidance on the analysis of the alternatives, the substitution plan and the possibilities of third-party contributions to the authorisation procedure in that regard, states as follows in Section 3.2 thereof:

‘An alternative is a possible replacement for the Annex XIV [to Regulation No 1907/2006] substance. It should be able to replace the function that the Annex XIV substance performs. The alternative could be another substance or it could be a technique (e.g. a process, procedure, device, or modification in end product) or a combination of technical and substance alternatives. For example, a technical alternative could be a physical means of achieving the same function of the Annex XIV substance or perhaps changes in production, process or product that removes the need for the Annex XIV substance function altogether.’

72      As regards the term ‘suitable’, as referred to in paragraph 70 above, it should be noted that it aims to limit the number of relevant alternatives to the number of ‘safer’ alternatives as referred to in recital 73 of the regulation, that is to say substances or technologies whose use entails a lower risk as compared to the risk of using the relevant substance of very high concern. Moreover, that term means that such an alternative must be ‘economically and technically viable’ within the meaning of Article 55 of the regulation.

73      As may be inferred from the phrase ‘economically and technically viable’, the meaning of the word ‘suitable’ is not limited to the existence of an alternative *in abstracto* or in laboratory conditions or under conditions which are only of an exceptional nature. The word ‘suitable’ relates to the ‘availability’ of alternative substances and technologies which are technically and economically feasible in the European Union, thereby implying in particular that the analysis concerning them must be carried out from the perspective of the production capacities for those substances and the feasibility of those technologies, as well as in the light of the legal and factual requirements for putting them into circulation.

74      Finally, in the context of the socio-economic procedure, it is also necessary, according to Article 60(5)(b) of Regulation No 1907/2006, to determine whether the alternatives established during the authorisation procedure are technically and economically feasible ‘for the applicant’ for authorisation.

75      Where the analysis required by Article 62(4)(e) of Regulation No 1907/2006 or the information gathered by the ECHA Committee for Socio-economic Analysis or by the Commission, for example information from third parties obtained in the course of a public consultation such as that referred to in Article 64(2) of that regulation, or even the actual analyses of the Committee for Socio-economic Analysis or the Commission, suggest that suitable alternatives are available in general, but that those alternatives are not technically or economically feasible for the applicant for authorisation, this does not necessarily mean that authorisation under Article 60(4) of the regulation must be refused.

76      In fact, if that is the case and if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance, that is to say if the analysis provided for in Article 60(4) of Regulation No 1907/2006 is carried out, authorisation may be granted if the applicant for authorisation submits, in accordance with Article 62(4)(f) of that regulation, a substitution plan within the meaning of Article 60(4)(c) of that regulation. Moreover, the subjective criterion provided for in Article 60(5)(b) of Regulation No 1907/2006, that is to say the criterion relating to the absence, on the date of adoption of the authorisation decision, of technically or economically feasible alternatives for the applicant for authorisation, is one of the elements which must be taken into account when establishing a substitution plan. The latter includes, in particular, a timetable for proposed actions by the applicant for authorisation pursuant to Article 62(4)(f) of the regulation containing, in particular, information on any research and development the applicant for authorisation is undertaking or intends to undertake to support the aim of eventual replacement of substances of very high concern by suitable alternative substances or technologies (recital 72 of Regulation No 1907/2006).

77      In the fourth place, with regard to the burden of proof, as relied on by the Kingdom of Sweden in support of the second part of the first plea, it must be pointed out that, as follows from the Article 60(4) of Regulation No 1907/2006, read in conjunction with recital 69 thereof, during the authorisation procedure, it indeed falls to the applicant for authorisation to show that no alternative is available.

78      However, it should be recalled that, in the context of the examination of the conditions provided for in Article 60(4) and (5) of Regulation No 1907/2006, it is for the Commission to establish whether all the relevant facts and the technical and economic assessments relating to them support the conclusion that the conditions provided for in that provision are indeed fulfilled (see paragraph 64 above).

79      In view of that assessment obligation on the part of the Commission, the burden of proof under Article 60(4) of Regulation No 1907/2006, read in conjunction with recital 69 thereof, means that the applicant for authorisation bears the risk of any impossibility of establishing whether it must be concluded that alternatives are unavailable. Therefore, where, in spite of the submission of evidence by the various stakeholders involved in the authorisation procedure, including evidence which the Commission has collected by its own efforts, there remain uncertainties as regards the condition relating to the lack of availability of alternatives, it must be concluded that the applicant for authorisation has not discharged the burden of proof and, therefore, that he cannot be granted authorisation. In that context, it is also worth noting that none of the stakeholders involved in the authorisation procedure or, moreover, ECHA or the Commission is required to prove the opposite of the condition relating to the absence of alternatives, that is to say that alternatives do exist.

80      In the fifth place, it is necessary to examine the issue of the interplay, coordinated by the Commission, between the burden of proof incumbent on the applicant for authorisation, on the one hand, and the manner in which that institution carries out its own examination of the condition relating to the lack of availability of alternatives, on the other hand.

81      First, the Commission cannot adopt an authorisation decision on the basis of mere hypotheses, which were neither confirmed nor rebutted by the information at its disposal (see, to that effect and by analogy, judgment of 17 September 2009, C*ommission* v *MTU Friedrichshafen*, C‐520/07 P, EU:C:2009:557, paragraphs 51 and 52). If, after the examination concerning the lack of availability of alternatives, there exist only hypotheses, it must be concluded that the specific conditions provided for in Article 60(4) of Regulation No 1907/2006 are not fulfilled and that the Commission is therefore not entitled to grant an authorisation, even one which is conditional.

82      In that regard, and at the risk of responding to an argument which was put forward not in the specific context of the second part of the first plea, but only in the context of the third part of the first plea (see paragraph 47 above), while nonetheless bearing in mind that those two parts are closely linked, it should be emphasised that, in principle, irrespective of their content, the conditions imposed in accordance with Article 60(8) and (9)(d) and (e) of Regulation No 1907/2006 cannot purport to remedy any shortcomings in an application for authorisation or in the analysis of alternatives submitted by an applicant for authorisation or any deficiencies in the Commission’s examination of the conditions provided for in Article 60(4) of Regulation No 1907/2006.

83      In other words, the possibility of attaching certain conditions to an authorisation, as provided for in Article 60(8) and (9)(d) of Regulation No 1907/2006, cannot be interpreted as allowing the Commission to leave open the question of whether the conditions of Article 60 of Regulation No 1907/2006 have been met and to respond to that situation by attaching to that authorisation conditions purporting to remedy any deficiencies or gaps in the assessment incumbent on it under that latter provision.

84      Secondly, as the Kingdom of Sweden has rightly pointed out, if the evidence provided by the applicant for authorisation in its analysis of alternatives is contradicted by the evidence submitted by third parties or Member States, it is for the Commission, in accordance with its duty of care, to examine the condition concerning the lack of availability of alternatives in greater depth.

85      If, following examination of the condition relating to the lack of availability of alternatives, as provided for in Article 60(4) of Regulation No 1907/2006, there remain uncertainties relating to the scientific assessment which it was possible to dispel neither with the evidence adduced by the applicant for authorisation, at the request of either the Commission or one of the ECHA committees, nor with the information gathered by the Commission or those committees or even by third parties or Member States, it must be concluded, as has been pointed out in paragraph 81 above, that in principle that condition is not fulfilled and that the Commission is therefore not entitled to grant an authorisation, even one which is conditional.

86      In the sixth and last place, in order to respond to the arguments put forward by the parties in the second part of the first plea, it must be pointed out that, on the date of the adoption of the contested decision, there was no evidence to establish the lack of availability of suitable alternative substances or technologies which could be used in the place of the lead chromates at issue in the present case for the uses referred to by the contested decision. At the time of the adoption of that decision, the Commission had in its possession both information supporting and information refuting the absence of technically viable alternatives for all the uses referred to by the application and no clear conclusion could yet be drawn in that regard. Therefore, at that date, the Commission’s examination of the condition relating to the lack of availability of alternatives in general, as provided for in Article 60(4) of Regulation No 1907/2006, had not been duly completed. In fact, the Commission granted the authorisation without having first verified a sufficient number of items of significant and reliable information to be able to conclude either that alternatives were indeed lacking for all the uses applied for or that the uncertainties still remaining in that regard on the date of adoption of the contested decision could be regarded as negligible. In the absence of a more in-depth examination of that condition laid down in Article 60(4) of Regulation No 1907/2006, the authorisation at issue in the present case could not be granted.

87      That finding follows, first, from a large number of documents which have been put before the Court by the parties.

88      It is true that, in its analysis of alternatives, the applicant for authorisation had compared the properties of more than 30 substances with the characteristics of the lead chromates at issue in the present case. Substances other than those chromates were indicated by means of their chemical names and diagrams. DCC Maastricht had stated, in essence, that none of those substances shared the technical properties of the pigments at issue in the present case. In particular, the latter are, in essence, characterised, according to the applicant for authorisation, by a high technical performance and ‘unique functionalities’ which were not matched by any of the alternatives. The body of scientific, technical and economic evidence which the applicant for authorisation had submitted in support of its application for authorisation was therefore substantial and conclusive in itself.

89      However, some of the views of the third parties and Member States heard during the authorisation procedure cast serious doubts on the analysis presented by the applicant for authorisation. In fact, on the date of the adoption of the contested decision, those views also cast serious doubts on the assessments of the Committee for Socio-economic Analysis, as contained in the 12 consolidated opinions of 11 December 2014.

90      Unlike the documents submitted by British Coatings and A. during the public consultation procedure, which, in so far as this may be inferred from the evidence put before the Court (see Annexes A.11 and A.12 to the application), were indeed lacking in detail, or even in substance, the document submitted by B. (see Annex A.13 to the application) contained an analysis similar to that prepared by DCC Maastricht. In particular, as regards the technical feasibility of the alternatives for plastic articles, B. had drawn a distinction between four levels of performance. Next, that undertaking had indicated which pigments could, in its view, replace the substances at issue in the present case. Those alternatives concerned various organic or inorganic substances. As regards the economic feasibility of those alternatives, in B.’s opinion, if downstream users accepted certain compromises as to colouration or opacity, the costs associated with the use of alternatives could be reduced significantly. According to B., under certain conditions, such as a downstream user’s willingness to sacrifice a certain level of colour performance and functionality, it could be concluded that alternatives existed on the EU market for all the uses referred to by DCC Maastricht in its application for authorisation.

91      Moreover, in the present case, the hypothesis of the applicant for authorisation that there were no alternatives was difficult to reconcile with the fact that the Kingdom of Norway and several Member States, including the Kingdom of Sweden, had manifestly given up using the pigments at issue in the present case in certain sectors, such as the road marking sector.

92      It was in the light of those views expressed by the applicant for authorisation and by third parties that the Committee for Socio-economic Analysis had reached its conclusions as to the technical feasibility of the alternatives for the uses at issue in the present case, as referred to in paragraphs 12 to 15 above. However, those assessments of the Committee for Socio-economic Analysis are not persuasive.

93      First of all, as regards the technical feasibility of alternatives for the second and fifth uses, the comments of the Committee for Socio-economic Analysis in that regard are limited to a simple enumeration of the views expressed by the applicant for authorisation and by the other stakeholders heard during the public consultation. Despite the fact that those views were essentially contradictory, the committee did not draw a specific conclusion with regard to them. The assessment made by that committee in the introductory part of the consolidated opinions, according to which it ‘seemed’ to it that there were no technically and economically suitable alternatives for the applicant for authorisation, in no way alters that finding. Quite apart from the fact that the assessment indicates that the Committee still had significant reservations which warranted mention, that assessment also refers to the feasibility of alternatives ‘for the applicant’, as referred to in Article 60(5) of Regulation No 1907/2006, and not to their general feasibility (see paragraph 86 above).

94      Next, as regards the technical feasibility of alternatives in general for the third and sixth uses applied for, the Committee expressly stated that the question whether alternatives were lacking necessitated a further examination for the road marking sector. In fact, in the light of the contributions by third parties, such as B., that conclusion was also inevitable for sectors other than the road marking sector, all the more so since the uses applied for had been described by the applicant for authorisation in a non-restrictive way.

95      Finally, as regards the first and fourth uses applied for, the analysis of alternatives made by the Committee for Socio-economic Analysis is not persuasive. It is true that the assertion that an analysis of alternatives could not or should not be made in relation to the first and fourth uses (see paragraph 12 above) may, initially, be accepted as the logical consequence of the fact that the pigments at issue in the present case have no function at the formulation stage of the paints covered by those uses, but have a function only at the stage of their actual use, for example, at the stage of manufacturing the metal surfaces and plastic or plasticised articles referred to by the other uses applied for. Subsequently, however, it is necessary to take into account in that regard that, in the present case, there existed a functional interdependence between the first and fourth uses, on the one hand, and the other uses applied for, on the other hand. Indeed, the specific function of the pigments at issue in the present case, that is to make it possible to produce a contrast effect, which is certainly not yet relevant at the stage of the distribution or mixing of pigment powder in an industrial environment into solvent-based paints or into liquid or solid premix (see the first and fourth uses), will manifest itself at the latest at the stage of the manufacture of metal surfaces and plastic or plasticised articles (see the other uses). Having regard to that interdependence and given the very broad scope of the description of the first and fourth uses, in the absence of any further explanation it must be held in the present case that any error vitiating the analysis of the alternatives for the uses other than the first and fourth uses at the same time vitiates the analysis of the alternatives for the latter uses.

96      Secondly, the assessment made in paragraph 86 above follows from a reading of recitals 8, 9 and 12 of the contested decision. It is apparent, in essence, from those recitals that, on the date of the adoption of the contested decision, the Commission itself still had doubts as to the lack of availability of technically feasible alternatives for all the uses covered by the application.

97      Thirdly, the consideration set out in paragraph 86 above is supported by a reading of the condition set out by the Commission in the first sentence of paragraphs 1 and 2 of Article 1 of the contested decision, which it describes as a ‘restriction’ (see paragraph 56 above). Indeed, the statement that use of the lead chromates at issue in the present case is limited solely to those cases in which the performance of the compositions of substances containing those chromates is really necessary amounts to a declaration that a downstream user, whenever he identifies an alternative, should refrain from using the lead chromates at issue in the present case. However, such a declaration is a strong indication that, at the time of the adoption of the contested decision, the Commission itself did not consider that the examination of the condition relating to the lack of availability of alternatives had been completed.

98      Fourthly and finally, the finding made in paragraph 86 above is confirmed by Article 1(3)(d) and (e) of the contested decision (see paragraphs 28 to 29 above). The conditions under which, on the one hand, the authorisation holder’s downstream users had to supply information concerning suitable and available alternatives that provided a detailed justification of the need to use the lead chromates at issue in the present case and under which, on the other hand, the authorisation holder had to present a report in which it was to refine the description of the authorised uses, based on the alternatives provided by its downstream users, are evidence, in particular, that the Commission’s assessment of the lack of availability of alternatives had not yet been completed.

99      In the seventh place, the Commission’s other arguments are not such as to call into question the assessment made in paragraph 86 above.

100    On the one hand, the Commission’s argument that it carried out further analyses in order to examine the lack of availability of alternatives (see paragraph 53 above) cannot succeed.

101    It is true that, in principle, carrying out additional analyses in order to examine the lack of availability of alternatives is an appropriate way to proceed. However, in so far as this may be inferred from the evidence put before the Court, the additional analyses which the Commission carried out consisted essentially in requesting information from the applicant for authorisation. However, the additional information submitted by the applicant for authorisation did not provide any clarification as to the uses for which there were no alternatives to the lead chromates at issue in the present case. It is true that the list presented by the Commission as Annex B.3 to the defence contains examples of specific applications covered by the application for authorisation. However, that list does not explain why the alternatives which, according to the Kingdom of Sweden, existed on the market could not be used in the place of those lead chromates for the applications referred to in the list.

102    On the other hand, it is true that, when adopting authorisation decisions, the Commission is also required to respect the principle of proportionality. However, where the conditions laid down by one of the provisions of Regulation No 1907/2006 are not fulfilled, the question of proportionality is irrelevant.

103    In the eighth place and lastly, in the light of the foregoing assessments, there is no longer any need to respond to the Kingdom of Sweden’s argument that the Commission failed in its duty of care (see paragraph 46 above).

104    That argument is not a free-standing one in the context of the present action, but supplements the line of argument alleging infringement of Article 60(4) of Regulation No 1907/2006 as a result of an inadequate examination of the conditions laid down in that provision (see paragraphs 86 to 102 above).

105    It follows from all the foregoing that the second part of the first plea in law must be upheld.

106    It follows that, without it being necessary to examine the first and third parts of the first plea, or the other pleas raised in the context of the action, the contested decision must be annulled.

**Maintenance of the effects of the contested decision until it is replaced by a new decision**

107    The Commission requested that, in the event of annulment of the contested decision, the effects of the contested decision be maintained until it is able, with the assistance of ECHA, to reconsider the application for authorisation.

108    That request must be rejected, however.

109    Under the second paragraph of Article 264 TFEU, the Court may, if it considers this necessary, state which of the effects of an act which it has declared void are to be considered as definitive. The power conferred by that provision may be used in order to maintain duties imposed by a contested act until the competent institutions adopt appropriate measures (see, to that effect and by analogy, judgment of 20 March 1985, *Timex* v *Council and Commission*, 264/82, EU:C:1985:119, paragraph 32).

110    According to settled case-law, the EU judicature must exercise the power conferred on it by the second paragraph of Article 264 TFEU and maintain the effects of a contested measure which has been declared void in a judgment where this is consistent with the principle of legal certainty (judgment of 22 October 2013, *Commission* v *Council*, C‐137/12, EU:C:2013:675, paragraph 81), as interpreted in the light of another interest of the European Union (see, to that effect, judgments of 22 October 2013, *Commission* v *Council*, C‐137/12, EU:C:2013:675, paragraph 81; of 24 June 2014, *Parliament* v *Council*, C‐658/11, EU:C:2014:2025, paragraphs 90 and 91; and of 6 September 2012, *Parliament* v *Council*, C‐490/10, EU:C:2012:525, paragraph 91) or an interest of a Member State (see, to that effect, judgment of 18 October 2007, *Commission* v *Parliament and Council*, C‐299/05, EU:C:2007:608, paragraph 74).

111    The power provided for in the second paragraph of Article 264 TFEU may also be exercised in the interests of an individual (see, to that effect, judgment of 7 September 2016, *Germany* v *Parliament and Council*, C‐113/14, EU:C:2016:635, paragraph 83). On grounds of legal certainty, the effects of an act which the Court has declared void may be maintained, in particular where the immediate effects of its annulment would give rise to serious negative consequences for the persons concerned and where the lawfulness of the act in question is contested, not because of its aim or content, but on grounds of lack of competence or infringement of an essential procedural requirement (see judgment of 7 September 2016, *Germany* v *Parliament and Council*, C‐113/14, EU:C:2016:635, paragraph 81 and the case-law cited).

112    In the present case, the annulment with immediate effect of the contested decision is indeed likely to give rise to serious negative consequences for DCC Maastricht. That undertaking will no longer be in a position to market the pigments at issue in the present case. However, the annulment of the contested decision is based on grounds relating to the substantive legality of the contested decision. Moreover, it should be recalled that, according to Article 1(1) of Regulation No 1907/2006, the purpose of that regulation is to ensure a high level of protection of human health. In the light of the foregoing observations, the maintenance of the effects of the contested decision cannot be compatible with that objective.

**Costs**

113    Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. As the Commission has been unsuccessful, it must be ordered to bear its own costs and also to pay those incurred by the Kingdom of Sweden.

114    Under Article 138(1) of the Rules of Procedure, the Member States and institutions which intervene in the proceedings are to bear their own costs. It follows that the Kingdom of Denmark, the Republic of Finland and the Parliament are to bear their own costs.

On those grounds,

THE GENERAL COURT (Fifth Chamber)

hereby:

1.      **Annuls Commission Implementing Decision C(2016) 5644 final of 7 September 2016 granting an authorisation for some uses of lead sulfochromate yellow and of lead chromate molybdate sulfate red under Regulation (EC) No 1907/2006;**

2.      **Refuses the Commission’s request that, in the event of annulment of Implementing Decision C(2016) 5644 final of 7 September 2016, the effects of that decision be maintained until it is able to reconsider the application for authorisation;**

3.      **Orders the Commission to bear its own costs and those incurred by the Kingdom of Sweden;**

4.      **Orders the Kingdom of Denmark, the Republic of Finland and the European Parliament to bear their own costs.**

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| Gratsias | Labucka | Dittrich |

Delivered in open court in Luxembourg on 7 March 2019.

[Signatures]

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[\*](#Footref*)      Language of the case: Swedish.