Case T‑337/13

CSF Srl

v

European Commission

‛Approximation of laws — Directive 2006/42/EC — Machinery bearing the ‘CE’ marking — Essential safety requirements — Risks to the safety of persons — Safeguard clause — Commission decision declaring a national measure prohibiting the placing on the market to be justified — Conditions governing the implementation of the safeguard clause — Manifest error of assessment — Equal treatment’

Summary — Judgment of the General Court (Third Chamber), 15 July 2015

Approximation of laws — Machines — Directive 2006/42 — Marketing — Compliance with the health and safety requirements in Annex I — Requirement concerning the existence of a structure giving appropriate protection against the falling of objects or materials — Interpretation in the light of the priority objective of eliminating or reducing risks — Consequences for machines with different uses

Actions for annulment — Natural or legal persons — Measures of direct and individual concern to them — Whether directly concerned — Criteria — Commission decision finding justified national measures prohibiting the placing on the market of a machine not complying with the requirements of Directive 2006/42 — Manufacturer directly affected — No margin of discretion of other Member States capable of affecting the situation of the manufacturer

A natural or legal person is directly concerned within the meaning of the fourth paragraph of Article 263 TFEU by an act that directly affects the legal situation of that person and that leaves no discretion to its addressees, its implementation being purely automatic and resulting from EU rules without the application of other intermediate rules. Concerning an action directed against a Commission decision finding justification for measures adopted by national authorities, based on Article 11(3) of Directive 2006/42 on machinery, in relation to the conditions under which a machine is placed on the national market, and addressed to the Member States, that decision directly produces, on the legal situation of the manufacturer of the said machine, effects other than those flowing from the said national measures. In the first place, such a decision obliges each of the Member States other than the State which adopted the measures in question to take appropriate measures in relation to placing the machine in question on their respective markets, or to retaining it on the market, and, in so doing, to guarantee the proper and uniform application of Directive 2006/42, in the light of the measures adopted by the authorities of the Member State concerned and found to be justified by the Commission. To that extent, 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. In second place, a decision based on Article 11(3) of Directive 2006/42 leaves no discretion to its addressees as to the result to be achieved, its implementation being entirely automatic and resulting from EU rules without the need for the application of other intermediate rules. It is certainly true that, in order to determine whether the manufacturer has placed or intends to place specimens of its machine into circulation in their territories, and whether any of those specimens presents the same risk as that addressed by the national measures adopted by the Member State concerned, the competent national authorities must first carry out review measures. Nevertheless, if that does turn out to be the case, those authorities must conclude that the safety of persons is liable to be compromised and must take appropriate measures to address that risk, ensuring the proper and uniform application of Directive 2006/42, in the light of the Commission decision and the national measures found to be justified by that decision, and ordering the prohibition, withdrawal or modification of the machine at issue or adopting equivalent measures. It is therefore the Commission’s decision finding the measures adopted by the national authorities to be justified that determines the result that the other national authorities must achieve, those authorities having no margin of discretion in the matter. (see paras 17, 23, 28, 30, 31)

Even though Member States must ensure the proper and uniform application of Directive 2006/42 by drawing the conclusions from a national 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 grounds 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 the directive and of the presumption of conformity provided for by Article 7 of that directive. That is why the EU legislature made such an extension conditional on a specific procedure being followed, 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 Directive 2006/42, bearing in mind the scope of that article. (see para. 34)

Even though it is effectively down to the Member States to correctly implement Directive 2006/42 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 satisfying itself in particular of the merits of the legal and factual grounds for the adoption of the measures. 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. It follows that any person entitled to apply for the annulment of a decision finding such measures to be justified is entitled to assert, in support of its pleadings, that the decision is based on a misinterpretation of the provisions of Directive 2006/42, even if such an interpretation, which must be duly taken into account by all Member States was first made by the competent national authorities and then upheld by the Commission. In such a case, the error of law capable of invalidating the decision in which the Commission found the national measures at issue to be justified must be capable of being challenged before the EU courts, so as not to restrict the scope of Article 263 TFEU and the principle of effective legal protection. In addition, 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 paras 46-48)

It is in relation to specific machinery or interchangeable equipment, intended for one or more specified purposes, that a Member State is able to invoke the safeguard clause in Article 11 of Directive 2006/42 and must, in that context, assess the risk to the health and safety of persons governing the implementation of such a clause. The ensuing assessment and national measure must therefore be justified in relation to that machinery as it was marketed and, where applicable, the interchangeable equipment with which it was equipped at the time it was placed on the market or put into service. Otherwise, it would be possible for a Member State to impair the principle of free movement without there being an existence of an actual risk to the health and safety of persons to justify that. In that regard, in the light of the actual wording of section 1.1.2(a) of Annex I to Directive 2006/42, it must be held that ‘any risk’ connected with the installation, maintenance or operation of the machinery in question, whether through the intended use or any reasonably foreseeable misuse, could justify invoking the safeguard clause under Article 11 of the directive. However, that article requires that the risk in question is ‘ascertained’ and therefore that the Member State relying on it proves to the requisite legal standard that such a risk is real. If that cannot be shown, impairment of the principle of free movement caused by the national measure adopted pursuant to the safeguard clause contained in that provision cannot be considered as ‘justified’ for the purposes of that clause. Moreover, it must be noted that the existence of a risk to the health and safety of persons for the purposes of Article 11(1) of Directive 2006/42 can be assessed, among other criteria, in the light of the essential health and safety requirements imposed on machinery manufacturers by Article 5(1)(a) of and Annex I to that directive. Compliance with the requirements, the aim of which is to ensure that the design and construction of the machinery takes into account the associated risks, is a precondition for the machinery being placed on the market. Meanwhile, non-compliance can be used to justify a withdrawal or prohibition measure. (see paras 54, 57, 58)

The scope of the specific health and safety requirement under Section 3.4.4 of Annex I to Directive 2006/42 on machinery, concerning falling objects, must be interpreted in the light of the general requirements under Directive 2006/42, and in particular point 1 of the ‘General principles’ appearing at the start of Annex I and the ‘Principles of safety integration’ set out in section 1.1.2 of the same annex. It clearly follows from those provisions, first, that the design and construction of machinery intended to be placed on the market in the European Union must ensure that the machinery can function ‘without putting persons at risk … under the conditions foreseen but also taking into account any reasonably foreseeable misuse thereof’ and, more broadly, ‘prevent abnormal use if such use would engender a risk’. The aim of measures taken to that effect ‘must be to eliminate any risk’. Finally, in order to fulfil such an obligation, the manufacturer, whilst having the possibility of choosing the most appropriate solutions, must still follow an order of priority, the highest priority being to ‘eliminate or reduce risks as far as possible. Bearing in mind the priority given to the aim to ‘eliminate or reduce … as far as possible’ the risks associated with the ‘intended use’ or any ‘reasonably foreseeable misuse’, from the time of ‘machinery design and construction’ onwards, to ‘prevent abnormal use’ and ‘take the necessary protective measures in relation to risks that cannot be eliminated’, it must be held that when machinery is intended to serve many different purposes, owing to the various interchangeable equipment that can be joined to it, it must be fitted with an appropriate protective structure before being placed on the market or put into service, when it is ascertained that, even if the intended use to which the buyer wishes to put it in a given case does not in itself give rise to a risk of falling objects or materials, one of the other reasonably foreseeable uses to which it could be put does entail such a risk. Such a measure falls under measures taken to ‘eliminate or reduce risks as far as possible’ by means of ‘inherently safe machinery design and construction’. Moreover, compliance with the requirement under Sections 1.7.4.1 and 1.7.4.2 of Annex I to the directive that machinery be accompanied by instructions describing its intended use does not call into question the overriding obligation on manufacturers of machinery to integrate safety into its design and construction, by eliminating or reducing as far as possible the risks associated with its intended use or any reasonably foreseeable misuse, as is clear from section 1.7.4.2 (l) of Annex I to Directive 2006/42. In other words, the directive does not merely impose an obligation on manufacturers to warn their customers against the risks associated with reasonably foreseeable misuse of the machinery that they are selling. It also obliges them to eliminate or reduce those risks as far as possible at the time of design and construction of the machinery. (see paras 64, 65, 69, 70)

It is clear from the general scheme of the Directive 2006/42 that that presumption of conformity which a machine enjoys by virtue of Article 7(1) of that directive is subject always to the recognised ability of the Member States to invoke the safeguard clause in Article 11 of the directive when the relevant conditions set out in that article are met. (see para. 72)

Directive 2006/42 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. Such an exercise may entail complex technical and scientific assessments. Meanwhile, the Commission is bound, within the context of that framework, to determine whether or not the measures adopted by the Member States are justified, in law and in fact. 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. The courts have also recognised that the Commission has such a power when it is called upon to review measures taken by a Member State in the context not of a directive containing a safeguard clause within the meaning of Article 114(10) TFEU, as in the present case, but in the context of the framework provided under Article 114(4) to Article 114(6) TFEU. The EU judicature must verify whether, on the basis of the pleas in law before it, the relevant procedural rules have been complied with, whether the facts admitted by the Commission have been accurately stated and whether there has been a manifest error of appraisal or a misuse of powers. In particular, it must establish whether, in the light of the arguments put forward by the parties, the evidence adduced in support of the contested act is factually accurate, reliable and consistent and must determine whether that evidence contains all the relevant data that must be taken into consideration in appraising a complex situation and whether it is capable of substantiating the conclusions drawn from it. (see paras 79-82)

Concerning the risk assessment which the Member State concerned must undertake before resorting to the measures under Article 11 of Directive 2006/42, subject to review by the Commission, this must be carried out from the point of view of an average user who is reasonably attentive and well-informed. The power conferred by Article 11 on the national authorities amounts to a derogation from the principle of free movement set out in the directive and can only be justified where there is a risk associated with the ‘intended’ use or ‘reasonably foreseeable’ misuse of the machinery in question, this being defined in section 1.1.1 (i) of Annex I to the directive as a use ‘which may result from readily predictable human behaviour’. In that respect, the fact that the national authorities evaluate such a risk from the point of view of an average and reasonably diligent user, and not in an abstract way, helps to ensure that there is no unjustified impairment of the free movement of machinery, for the purposes of Article 11(1) of the directive. However, when the reality of such a risk is ascertained to the requisite legal standard, by reference to an average and reasonably diligent user, the fact that the user has received prior notice of the existence of the risk is in itself irrelevant, given both the hierarchy of the prevention and information requirements imposed on machinery manufacturers by Directive 2006/42 and the consequences attached to non-compliance with those obligations. (see paras 83, 84)

See the text of the decision. (see para. 94)

Article 11 of Directive 2006/42 does not oblige the Commission, specifically when examining whether or not the measures notified to it by Member States are justified, to determine in addition whether or not those measures comply with the principle of equal treatment. When such a measure is justified for the purposes of that article, the decision in which the Commission acknowledges that it is justified can therefore not be challenged on the ground that similar machines to that covered by the measure are present on the national market in question but have not been the subject of similar measures, in breach of the principle of equal treatment. In the first place, where a matter has been the subject of exhaustive harmonisation at EU level, any national measure relating to that matter must be assessed in the light of the provisions of the harmonising measure and not those of the Treaty. That applies, in particular, in a situation where the measure at issue is not one adopted by Member States by law or regulation but one affecting individuals. Thus, Directive 2006/42 having led to an exhaustive harmonisation at EU level of the rules relating not only to the essential safety requirements applicable to machinery and the certification of conformity of the machinery with the requirements, but also to the conduct that Member States must adopt with regard to machinery presumed to be compliant with those requirements, it is with regard to the provisions of Directive 2006/42 that it must be determined whether the Commission failed in its obligations by not verifying whether the national measures adopted by the competent authorities had been adopted in compliance with the principle of equal treatment, or whether it did not fall within the role of the Commission to carry out such a review. In the second place, the objective of Article 11 of Directive 2006/42 is not to entrust the Commission with the task of reviewing every aspect of the legality of the measures taken by the national authorities when they ascertain that machinery is liable to compromise the health and safety of persons. It is to the national courts that this review falls, under recital 25 and Article 20 of the directive. In the third place, although Article 11(3) of Directive 2006/42 provides only that the Commission shall consider whether or not the measures taken by the Member States are ‘justified’, the general scheme of Article 11 implies that that obligation should be understood in the light of the obligations already imposed on the national authorities by Article 11(1) and Article 11(2). In addition, Article 114(10) TFEU, which authorises the EU legislature to provide for safeguard clauses such as the one established by Article 11 of Directive 2006/42 and which refers to the reasons covered by the first sentence of Article 36 TFEU, does not refer to the second sentence of the latter, which provides that prohibitions or restrictions capable of being justified for such reasons may not constitute a means of arbitrary discrimination or a disguised restriction in trade between Member States. It therefore differs from Article 114(4) to 114(6) which concern the provisions that a Member State may introduce or maintain after adoption of a harmonisation measure under Article 114(1). (see paras 98-105)

All acts of the European Union must be interpreted in accordance with primary law as a whole, including the principle of equal treatment. In addition, in interpreting an EU act, it is necessary to consider not only the wording of its provisions but also its general scheme, the context in which it occurs and the objects of the rules of which it forms part. Concerning Directive 2006/42, it would be contrary not only to the principle of equal treatment but also to the objective of Directive 2006/42, which aims to harmonise the conditions under which machinery is placed on the internal market and moves freely on that market, whilst protecting the health and safety of persons from risks arising from use of that machinery, and indeed to the general scheme of the wording established to guarantee the proper and uniform application of the directive by the national authorities subject to review by the Commission, if a Member State were able to invoke the safeguard clause in Article 11 of the directive in relation to one machine liable to endanger the health and safety of persons, while failing to treat similar machines in a similar way, with no objective justification. (see paras 108, 109)