12

By application lodged at the Court Registry on 8 March 2019, the applicant brought the present action.

13

By document lodged at the Court Registry on 20 June 2019, the Kingdom of Sweden sought leave to intervene in the present proceedings in support of the form of order sought by the Commission. The Commission and the applicant expressed their consent to that application for leave to intervene on 9 and 17 July 2019 respectively. By decision of 25 July 2019 of the President of the First Chamber of the General Court, the Kingdom of Sweden’s application for leave to intervene was granted.

14

On 24 June 2019, the Commission lodged its defence at the Court Registry.

15

The reply and the rejoinder were lodged at the Court Registry on 21 August and 22 October 2019, respectively.

16

On 9 October 2019, the Kingdom of Sweden lodged its statement in intervention at the Court Registry.

17

The Commission and the applicant lodged their observations on the Kingdom of Sweden’s statement in intervention at the Court Registry on 5 and 7 November 2019, respectively.

18

By decision of the President of the General Court of 16 October 2019, the present case was assigned to a new Judge-Rapporteur, sitting in the Second Chamber.

19

In application of Article 106(2) of the Rules of Procedure of the General Court, the applicant submitted, on 3 December 2019, a reasoned request for a hearing.

20

By decision of 16 July 2020, the Court adopted a measure of organisation of procedure, on the basis of Articles 88 to 90 of the Rules of Procedure. The Commission replied to that measure of organisation within the prescribed time limit. The other parties did not respond to the invitation, which had been sent to them, to submit their observations on the Commission’s reply.

21

At the hearing of 6 October 2020, the parties presented oral arguments and answered the questions put to them by the Court.

22

By order of 11 March 2021, the Court decided to reopen the oral part of the procedure and, by decision of the same date, adopted a measure of organisation of procedure, on the basis of Articles 88 to 90 of the Rules of Procedure, asking the applicant to clarify its legal relationship with Brunswick Bowling & Billiards, referred to in recital 1 of the contested decision as the manufacturer of the products at issue.

23

In its reply of 26 March 2021, the applicant submitted explanations and evidence showing that the contested decision referred to the applicant using its former company name. By letter of 16 April 2021, the Commission stated that it had no observations to make regarding the applicant’s reply. The Kingdom of Sweden did not lodge any observations within the prescribed period.

24

The applicant claims that the Court should:

25

The Commission, supported by the Kingdom of Sweden, contends that the Court should:

42

Directive 2006/42 thus establishes a system of surveillance and regulation of the internal market, under which it is primarily the role of the competent national authorities to determine whether machinery is liable to compromise the health and safety of persons and, in the affirmative, to take the requisite withdrawal or prohibition measures. The safeguard clause provided for that purpose by Article 11 of Directive 2006/42 must itself be viewed in the light of Article 114(10) TFEU, which authorises Member States to take such measures for one or more of the non-economic reasons referred to in Article 36 TFEU, which include the protection of health and life of humans. It is clear from the case-law that such an exercise may entail complex technical and scientific assessments. The Commission, for its part, is to verify whether the measures adopted by the Member States under Directive 2006/42 are justified in law and in fact (see judgment of 3 May 2018, Grizzly Tools v Commission, T‑168/16, not published, EU:T:2018:246, paragraph 52 and the case-law cited).

43

In that context, the General Court has previously held that, first, in order to be able to effectively pursue the objective assigned to it, bearing in mind the complex technical assessments which it must undertake, the Commission must be recognised as enjoying a broad discretion as regards the assessment of the facts. Secondly, a judicial review of the merits of the legal grounds leading to the Commission’s finding that the national measures at issue were justified must be a complete review, since it concerns a question of law (see, to that effect, judgment of 15 July 2015, CSF v Commission, T‑337/13, EU:T:2015:502, paragraphs 48 and 80 and the case-law cited).

…

54

Thus, in accordance with the case-law, the contested decision requires each of the Member States other than the Kingdom of Sweden to take appropriate measures in relation to placing the products at issue on their respective markets, or to retaining them on the market, and, in so doing, guarantees the proper and uniform application of Directive 2006/42, in the light of the measures adopted by the Swedish authorities, after they have been found to be justified by the Commission. The direct consequence of the contested decision is to trigger national procedures that have an impact on the right that the applicant had, until then, enjoyed within the whole of the European Union, to market machinery that benefited from the presumption of conformity under Article 7 of that directive, since it bore the ‘CE’ marking and was accompanied by the EC declaration of conformity (see, to that effect, judgment of 15 July 2015, CSF v Commission, T‑337/13, EU:T:2015:502, paragraph 28).

…

65

In the first place, as regards the applicant’s arguments alleging infringement of the principle of proportionality in so far as the Commission did not take account of its upgrade plan presented at the Gustavsberg bowling centre in 2016 or of the positive observations of the independent study in that regard, it must be noted, as submitted by the Commission, that the contested decision concerns the question as to whether or not the safeguard measures taken by the SWEA in 2013 were justified.

66

In that regard, it should be noted that Article 95(10) EC, which constitutes the legal basis of Directive 2006/42, provides that the harmonisation measures adopted on that basis are, in appropriate cases, to include a safeguard clause authorising Member States to take, for one or more of the non-economic reasons referred to in Article 36 TFEU, ‘provisional measures subject to a Union control procedure’. It follows, according to the case-law, that, although it is effectively for the Member States to correctly implement Directive 2006/42, in particular with regard to the principle of proportionality, and to ensure that machinery placed on the market or put into service in their territory complies with those provisions, if necessary by taking measures such as those envisaged in Article 11, it is still for the Commission to review whether those measures are justified, by, inter alia, ensuring that the legal and factual grounds for the adoption of the measures are valid and, in particular, proportionate. The result of that review determines definitively whether the national measure at issue may be retained, meaning that the Member State may only retain it if the Commission declares it to be justified and must remove it if that is not the case (see, to that effect, judgment of 3 May 2018, Grizzly Tools v Commission, T‑168/16, not published, EU:T:2018:246, paragraph 51 and the case-law cited).

67

It is apparent from the case-law cited in paragraph 66 above that, as part of the review which it carries out, the Commission is solely competent to verify whether or not the national safeguard measures, as adopted and subsequently notified by the Kingdom of Sweden pursuant to Article 11(1) and (2) of Directive 2006/42, are justified and, consequently, whether those measures may, following that review, be definitively maintained.

68

Moreover, given that, as is apparent from that case-law, it is for the Commission to review whether the safeguard measures concerned are justified, by ensuring, inter alia, that the legal and factual reasons for their adoption are well founded, it must be held that the review carried out by the Commission may be based only on circumstances which existed at the time of the adoption of the SWEA decision, and not on subsequent circumstances.

69

For the reasons set out in paragraphs 66 to 68 above, the circumstances relied on by the applicant which arose after the SWEA decision, such as the improvements to the products at issue at the Gustavsberg bowling centre in 2016, are not relevant for the purposes of assessing the merits of the contested decision. Similarly, it must be stated that the applicant’s arguments regarding the ‘positive observations’ in the independent study, as regards the goods at issue, relate to improvements to those products which were carried out after the adoption of the SWEA decision. Accordingly, they are also irrelevant.

70

In the second place, it is apparent from the applicant’s arguments that it complains that the Commission, first, failed to examine whether the deficiencies identified were so significant that the safeguard measures were justified and, secondly, confirmed safeguard measures that went beyond what was necessary to ensure the health and safety of persons.

71

In that regard, first, it must be borne in mind that it is apparent from Article 11(1) of Directive 2006/42 that, where the machinery referred to in that article, such as that in the present case, does not comply with the relevant EHSRs and may thus endanger the health or safety of persons, Member States are to take all appropriate measures to withdraw them from the market, to prohibit them from being placed on the market or put into service or to restrict their free movement. Therefore, a finding that machinery does not comply with the relevant EHSRs and may compromise the health and safety of persons justifies the adoption by the competent authorities of decisions to withdraw machinery from the market and prohibit them from being placed on the market.

72

It should also be pointed out that, according to the case-law, the objective of the protection of the health and life of humans ranks foremost among the assets or interests protected by Article 36 TFEU (see, to that effect, judgment of 23 December 2015, Scotch Whisky Association and Others, C‑333/14, EU:C:2015:845, paragraph 35), in the light of which the Member States may adopt the safeguards provided for in Directive 2006/42, as is clear from the case-law cited in paragraph 42 above.

73

In the present case, it is apparent from all the infringements of the EHSRs found by the Commission in recitals 9 to 13 of the contested decision that those infringements constitute risks to human health and safety, in particular the lack of overview of the danger zone, the risk of injury, the risk of falling in the machine, the risk arising from moving parts and the risk of misuse. The Commission was therefore right to find, in recital 14 of the contested decision, that the deficiencies identified were liable to compromise the health and safety of persons.

74

Consequently, since the machines in question do not comply with the EHSRs and present risks to human health and safety, it must be held that the Commission was justified, pursuant to Article 11 of Directive 2006/42 and without infringing the principle of proportionality, in concluding that the safeguard measures, namely the prohibition of placing on the market and the withdrawal from the market of the products at issue, adopted by the SWEA, were in themselves justified.

75

Secondly, as regards that withdrawal, it should be added that, as is apparent from recital 2 of the contested decision, a number of alternative solutions for implementation were envisaged, namely the possibility of correcting the defects relating to the operator’s working environment, taking back the products at issue and replacing them with other deficiency-free products of the same or corresponding kind or taking back the products at issue and paying compensation to the owner.

76

It should be noted that, in recital 5 of the contested decision, the Commission states that:

‘Regarding the measures adopted, the Swedish authorities explained that they respected the principle of proportionality, laid down in Article 18 of Regulation … No 765/2008 … Based on that principle, considering the severity of the risks and the costs of the withdrawal, some of the actions required to address the deficiencies for the [new products at issue], were not required in the case of the withdrawal of the [products at issue]. Namely, those concerning the fitting of three separate lights that indicate different modes in the control panel, the enlargement of the access points between the machines also used as work platforms and the overview of the danger zone.’

77

It must be held that, since the Commission has not called into question the explanations of the Kingdom of Sweden referred to in paragraph 76 above, it confirmed the finding that the SWEA approach was proportionate.

78

Thus, it is apparent from the contested decision that, in the light of the principle of proportionality, the seriousness of the risks was weighed against the cost of withdrawal. On that basis, products that were to be sold in the future were distinguished from the products at issue already on the market, in the case of the latter, by the application of a reduced list of deficiencies requiring withdrawal. In addition, the three alternative solutions for implementing the withdrawal of the products at issue, as explained in paragraph 75 above, contribute to respect of the principle of proportionality by the SWEA and, therefore, by the Commission.

79

In the third place, having regard to the above findings, the applicant’s arguments concerning a disproportionate financial burden resulting from the safeguard measures cannot be upheld. First, the risks which the applicant’s machines pose to the health and safety of humans, as referred to in paragraph 73 above, justify the need to prohibit the placing on the market and the withdrawal from the market of the products at issue, notwithstanding the cost that that might represent for the applicant. Secondly, the distinction between the safeguard measures for existing and new products, the three alternative solutions for withdrawing the products at issue and the fact that, under the first of those solutions, the number of deficiencies to be corrected in order to maintain those products on the market was reduced show, in that regard, that the approach adopted by the SWEA and the Commission was proportionate to the financial burden which the safeguard measures might impose on the applicant.

80

In the fourth place, it must be stated that, in view of both the precise references to the justifications provided by the Kingdom of Sweden and the detailed risk analysis of the use of the products at issue made by the Commission, the applicant’s arguments concerning the failure, in the contested decision, to state adequate reasons regarding the proportionality of the safeguard measures are unfounded.

81

In the light of all the foregoing considerations, it must be concluded that the Commission did not infringe the principle of proportionality in finding that the safeguard measures at issue were justified.

82

In the fifth place, as regards the applicant’s arguments concerning infringement of the principle of proportionality in so far as all other Member States are required to take measures following the contested decision, first of all, it must be noted that, according to the case-law, the decision taken by the Commission within the meaning of Article 11 of Directive 2006/42 is addressed to all the Member States of the European Union in a manner consistent with the communication and information obligations imposed on the Commission by Article 11(3) and (6) of Directive 2006/42. The contested decision is therefore binding in its entirety on all Member States, pursuant to Article 288 TFEU (see, to that effect, judgment of 15 July 2015, CSF v Commission, T‑337/13, EU:T:2015:502, paragraph 24).

83

Thus, the consequences claimed by the applicant are inherent in the Commission’s procedure for examining the justification of safeguard measures, as provided for in Article 11 of Directive 2006/42. As recalled in paragraph 54 above, it follows from all the provisions of Directive 2006/42, as interpreted by the case-law, that the contested decision requires the Member States to take appropriate measures relating to the placing or retaining of the products at issue on their market. That is an essential element of the safeguard clause procedure laid down in Article 11 of Directive 2006/42, which is intended to ensure uniform application.

84

Next, it is clear from the provisions of Article 11 of Directive 2006/42 that the Commission was obliged to act following the SWEA’s notification of the safeguard measures taken in respect of the products at issue and to take a decision as to whether or not those measures were justified. Accordingly, the applicant’s arguments in that regard cannot succeed.

85

Furthermore, it must be observed that the conclusions set out in paragraphs 82 to 84 above cannot be refuted by the content of Article 9 of Directive 2006/42, to which the applicant referred during the hearing in support of its argument that the Commission had discretion as regards the consequences resulting from the contested decision in the Member States.

86

Article 9 of Directive 2006/42, which introduces ‘specific measures to deal with potentially hazardous machinery’, provides, inter alia, that when, in accordance with the procedure referred to in Article 11 of the directive, the Commission considers that a measure taken by a Member State is justified, it may take measures requiring Member States to prohibit or restrict the placing on the market of machinery presenting the same risk as that covered by national measures by virtue of its technical characteristics or to make such machinery subject to special conditions. Moreover, recital 13 of that directive states that such measures, adopted at EU level, are not directly applicable to economic operators and must be implemented by Member States (judgment of 15 July 2015, CSF v Commission, T‑337/13, EU:T:2015:502, paragraph 33).

87

In that regard, it must be stated that, in accordance with settled case-law, even though Member States must ensure the proper and uniform application of Directive 2006/42 by drawing the conclusions from a national safeguard measure taken in relation to a certain machine and found to be justified by the Commission, and they do not have any margin of discretion as to the result to be achieved, they clearly cannot step beyond the procedural and material framework provided for by Article 11(1) by unilaterally choosing to extend the scope of that measure to other machines on the ground that they too present the same risk, as to do so would constitute a breach of the principle of free movement set out in Article 6(1) of that directive and of the presumption of conformity provided for by Article 7 thereof. That is why the EU legislature made such an extension conditional on a specific procedure being followed, as laid down in Article 9 of Directive 2006/42, involving the adoption of both an express decision to that effect by the Commission and national measures implementing that decision. However, such steps are neither provided for, nor are they necessary, for the purposes of Article 11 of the directive at issue, bearing in mind the scope of that article (see judgment of 15 July 2015, CSF v Commission, T‑337/13, EU:T:2015:502, paragraph 34 and the case-law cited).

88

It must be concluded that, having regard to the case-law referred to in paragraphs 86 and 87 above, in the circumstances of the present case, which relate solely to the examination of the safeguard measure at issue, the provisions of Article 9 of Directive 2006/42 are not applicable to the present case.

89

In the light of all the foregoing considerations, the second part of the first plea in law, relating to infringement of the principle of proportionality and, consequently, the first plea in its entirety, must be rejected as unfounded.

…

108

As a preliminary point, it should be noted that Article 7(1) and (2) of Directive 2006/42 provides, inter alia, that Member States are to consider machinery bearing the CE marking and accompanied by the EC declaration of conformity to comply with the provisions of that directive and that machinery manufactured in accordance with a harmonised standard, the references to which have been published in the Official Journal of the European Union, is to be presumed to comply with the EHSRs covered by that harmonised standard. In other words, compliance with a harmonised standard makes it possible to presume that machinery complies with the respective EHSRs. Similarly, under Article 2(l) of Directive 2006/42, a harmonised standard is a technical specification adopted by a standardisation body on the basis of a remit issued by the Commission and is non-binding. It is apparent from those provisions that the technical solutions proposed by a harmonised standard are not mandatory, but that their application confers on the product at issue the benefit of the presumption of conformity with the provisions of Directive 2006/42.

109

However, while remaining free to choose the methods for assessing the conformity of their products with the EHSRs, the manufacturer or its authorised representative is obliged not only to ensure such conformity, but also to demonstrate it in the technical file, as provided for in Annex VII to Directive 2006/42. The choice not to apply harmonised standards means that the presumption of conformity mentioned above cannot be applied either and, therefore, that the conformity of products must be demonstrated by other means.

110

It should be pointed out that, in the light of the applicant’s arguments, the third plea relates to recital 10 of the contested decision, in which the Commission confirmed that the EHSRs set out in points 1.1.6, 1.6.1 and 1.6.2 of Annex I to Directive 2006/42, according to which the machinery must be designed and constructed in a manner which eases the work of an operator, allowing him or her to work in a comfortable and safe way, outside danger zones, had not been complied with as regards the machines at issue. More specifically, the Commission, on the basis of the SWEA decision, took the view that there was a risk of injury when accessing the machines at issue due to the narrow walkway of 190 mm between the machinery or to an abrupt end of the front of the machine of 1000 mm.

111

It should be noted that, as regards the 190 mm width of the walkway, the applicant’s arguments concern in particular the findings of the Commission, or even directly of the SWEA. In essence, first, the applicant claims that they failed to take account of the principle of the state of art given that there was no reference to that principle in their respective decisions. Secondly, according to the applicant, its technical solution in question corresponded to the state of the art at the time of the inspection, whereas the requirement laid down by harmonised standard EN ISO 14122‑2:2001 went beyond the state of the art.

112

Primarily, first of all, it must be borne in mind that it is common ground that, in the EC declaration of conformity, the applicant relied, inter alia, on harmonised standard EN ISO 14122‑2:2001. In other words, the applicant chose freely to apply that harmonised standard in order to establish that the products at issue complied with the EHSRs set out in points 1.1.6, 1.6.1 and 1.6.2 of Annex I to Directive 2006/42.

113

In addition, harmonised standard EN ISO 14122‑2:2001 lays down safety technical requirements for permanent means of access to machinery and specifically for machinery working platforms and walkways. Although the standard in question provides for a width of 500 mm, it is common ground that the walkways installed on the machines at issue had a width of 190 mm. Thus, it must be held, as the Commission submits, that, although the applicant chose to apply harmonised standard EN ISO 14122‑2:2001, it did not comply with it.

114

Lastly, as regards the conditions for the application of the EHSRs, recital 14 of Directive 2006/42 states that EHSRs should be applied with discernment to take account of the state of the art at the time of construction and of technical and economic requirements. In addition, point 3 of the first title, entitled ‘General Principles’, of Annex I to that directive provides that, although the EHSRs set out in that annex are mandatory, it cannot be excluded that it may not be possible to meet the objectives set by them. It states that, in that event, the machinery must, as far as possible, be designed and constructed with the purpose of approaching these objectives.

115

In the present case, in the first place, the applicant claims that the Commission and the SWEA infringed the procedural rules laid down in Annex I to Directive 2006/42, on the ground that no reference was made to the principle of the state of the art in either the contested decision or in the SWEA decision. First, it should be noted that the applicant does not specify in any way which procedural rules it claims have been infringed, but cites the provisions requiring compliance with the principle of the state of the art in the application of the EHSRs. It is clear that, although, recital 14 of Directive 2006/42 and point 3 of the first title of Annex I to that directive, as referred to in the preceding paragraph, provide that account should be taken of the state of the art for the purposes of the application of the EHSRs, the directive does not lay down any procedural rule requiring the provision, in the decision of a competent national authority or in the Commission decision adopted in the context of the safeguard clause procedure, of an analysis of the application of that principle. Secondly, the fact that an analysis of the application of the principle of the state of the art was not provided in the contested decision or in the SWEA decision does not in itself imply an infringement of that principle. For those reasons, the applicant’s arguments concerning the absence of any reference to that principle in the decisions at issue cannot succeed.

116

Secondly, it is important to point out that, under Article 11(2)(b) of Directive 2006/42, the reasons for the non-conformity of machinery which a Member State must communicate to the Commission and to the other Member States on account of the safeguard measure that it has decided to adopt include the incorrect application of the harmonised standards. In other words, even if the harmonised standards are not obligatory, the choice to apply them and to rely on them in the EC declaration of conformity requires that they be properly applied. Where such standards are applied incorrectly, the competent national authority is entitled to declare the non-compliance of the products in measures taken under the safeguard clause procedure within the meaning of Article 11 of Directive 2006/42. For those reasons, the Commission was right to find, in recital 10 of the contested decision, with regard to the safeguard measure adopted by the SWEA, that, with regard to the machines at issue, the EHSRs set out in points 1.1.6, 1.6.1 and 1.6.2 of Annex I to Directive 2006/42 had not been complied with, due to the incorrect application of the harmonised standard.

117

As the Commission rightly submits, since the applicant had chosen to refer to a harmonised standard in the EC declaration of conformity, it should have complied fully with that standard. If, as in the present case, the standard had not been complied with as regards the width of the walkways of the machines at issue, the applicant should have presented another technical solution ensuring the same level of safety and should have shown that the products at issue complied with the respective EHSRs, something which it did not do.

118

In the third place, as regards the application of the principle of the state of the art as regards the requirement of a width of 500 mm for the walkways of the machines at issue, three points should be noted.

119

First, it should be made clear that a harmonised standard, the references to which have been published in the Official Journal of the European Union, forms part of EU law (see, by analogy, judgment of 27 October 2016, James Elliott Construction, C‑613/14, EU:C:2016:821, paragraph 40).

120

Secondly, the Commission rightly submits that, although harmonised standards are not mandatory, they reflect the required level of safety and take account of the state of the art.

121

In that regard, it is important to note that paragraph 162 of the Guide to application of the ‘Machinery’ Directive 2006/42, published by the Commission in June 2010, now states, inter alia, that harmonised standards provide a good indication of the state of the art at the time of their adoption. In addition, according to the same document, developments in the state of the art are reflected in subsequent amendments or revisions to the harmonised standards.

122

Thirdly, it should be added that the applicant refers to the findings of the independent study in order to support its arguments that there was no better option. In that regard, it must be stated that those conclusions, which relate to the possibility of correcting defects in machines already installed and not to the state of the art in general at the date of the SWEA decision, relate to the situation at the Gustavsberg bowling centre, after the modifications made to the products at issue following the adoption of the SWEA decision. However, as has already been stated in paragraph 69 above, those conclusions are not relevant in the present case.

123

It follows from the foregoing that the applicant’s argument that the requirement concerning the width of the walkways of the machines at issue went beyond the state of the art must be rejected as unfounded.

124

In the light of the foregoing considerations, the third plea in law must be rejected as unfounded.

…

On those grounds,

THE GENERAL COURT (Second Chamber)

hereby: