Technical standards are a form of soft law which has long played a fundamental role in the regulation of the internal market of the EU. The three distinctive characteristics of technical standards are their technical content, their establishment by private organisations, and their voluntary application. Specifically these last two characteristics were stressed when traditionally arguing that technical standards have nothing to do with the realm of binding legal provisions and, more generally, with law. However, the peculiar role they acquired in the harmonisation of the internal market under the New Approach, especially after important recent developments in EU legislation, in institutional practice and in the case law, questioned this assumption. According to many scholars, we witness a progressive ‘“juridification’” of the particular category of technical standards defined as harmonised standards, to the extent that the Court of Justice today defines them as “part of EU law” (James Elliott).
The implications of this evolution have been extensively debated in literature, especially with regard to the possibility of judicial review and the application of general principles of EU law to the standardisation process. However, less attention has been paid to the legal effects of harmonised standards and to the potential changes brought by this ‘juridification’ process in this regard. In the chapter included in the book The Legal Effects of EU Soft Law edited by Petra L. Láncos, Napoleon Xanthoulis and Luis Arroyo Jiménez, I discuss the precise effects of harmonised standards in terms of legal positions vis-à-vis different actors, within and outside the standardisation system. I argue that we can distinguish at least three different legal effects deriving from harmonised standards.
(i) Obligations vis-à-vis the National Standardisation Organisations
The adoption of a harmonised standard at the European level affects the freedom of national standardisation organisation (NSOs) in pursuing their activities. Even before the publication of the reference to a harmonised standard in the Official Journal, NSOs have a standstill obligation: as soon as a standardisation request is made, they shall not take any action which could prejudice the harmonisation intended. Following publication, NSOs are obliged to withdraw all conflicting national standards, thus eliminating potential obstacles to free movement in the internal market.
Moreover, pursuant to the internal regulations of CEN-CENELEC, NSOs must implement European standards (including harmonised standards) by giving them the status of national standards, either through publishing an identical text or by endorsement. In fact, being covered by copyright, harmonised standards are available to the public only by purchase from the NSOs. Remarkably, in the past, the need of national transposition was mentioned also in EU legislation, casting doubts on the actual existence of harmonised standards in their own right. Since the Court and Regulation 1025/2012 actually remained silent on the point, the value of harmonised standards for economic operators in the absence of national transposition remains unclear.
(ii) An Onus vis-à-vis Economic Operators
The adoption of a harmonised standard under the New Approach entails the establishment of a presumption of conformity of the relevant products with the legislative act. Although voluntary, compliance with the prescriptions contained in this instrument elaborated by private European standardisation bodies constitutes a privileged means to demonstrate the fulfilment of the binding essential requirements of the legislative acts. As such, the presumption of conformity constitutes a fictio iuris which links the compliance with legislative requirements with compliance to the standard, generally (and easily) proven through certification.
The presumption of conformity modifies the legal position of economic operators vis-à-vis national public authorities in the sense of shifting the burden of proof in administrative and judicial procedures on those public authorities. The violation of the rule of conduct established in the standard does not entail a sanction, but only the failure to benefit from this specific more favourable position in the procedure. The possibility to prove compliance in a different way means that compliance with the harmonised standard cannot be qualified as a legal obligation. I argue instead that compliance with the harmonised standard constitutes an onus, i.e. the specific legal position whereby individuals must perform a particular conduct in their own interest in order to enjoy a particular positive legal effect. Admittedly, this particular legal position is remarkably controversial within current legal theories, not only for its uncertain qualification as a positive or negative legal position, but also as an autonomous concept in law. It is, for instance, unaccounted for in the Hohfeldian approach predominant in EU law and, more in general, in the traditional imperativist theories of law. Yet, it arguably captures the peculiar legal effects produced by harmonised standards and the modification in the legal sphere that the mechanism of the presumption of conformity determines.
(iii) A De Facto Obligation vis-à-vis Economic Operators
In certain cases, the mechanism of the presumption of conformity and the particular circumstances of a market may determine that the technical standard has more incisive effects than the ones of an onus (which are still legal, but not binding). The seminal judgment in this context is Fra.bo. Here the CJEU analysed the legislative and regulatory context in which the standard-setting bodies operated, and on the practical impossibility to otherwise prove compliance in the case, to establish that national standards can ultimately be considered to have de facto binding effects on manufacturers. When compliance with the harmonised standard is not merely a particularly preferential means to demonstrate compliance with the essential requirements, but actually the only way to prove observance of the binding legal framework, the rule of conduct contained in the standard can be perceived as a hard, binding obligation by economic operators. This evolving perception of the legal effects of harmonised standards, which would represent the most remarkable result of the described process of progressive ‘juridification’, can be recognised also in the obiter dicta of the CJEU on harmonised standards and in the recent shift in the publication practice of the Commission.
As of yet, however, the Court did not have the opportunity to decidedly pronounce on the bindingness of the legal effects of harmonised standards by admitting an action for annulment under 263 TFEU against a harmonised standard. After the forward momentum of James Elliott, the Court of Justice appears to now follow the path of the ‘juridification’ of harmonised standards half-heartedly, adopting a rather restrictive approach on the recognition of the position of harmonised standards within the hierarchy of EU norms and on their interplay with some EU fundamental principles, such as legal certainly and transparency (see Public.Resource.Org). Arguably, striking the correct balance on transparency and accountability of standardisation organisations without losing the benefits of flexibility and involvement of industry that motivated the adoption of the New Approach in the first place, will depend also on the clarification and broader conceptualisation of the legal effects of harmonised standards and, in general, of soft law instruments.
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Posted by Annalisa Volpato, assistant professor at Università degli Studi di Padova.
Suggested citation: Annalisa Volpato, “The Legal Effects of Harmonised Standards in EU law”, REALaw.blog, available at https://realaw.blog/?p=2879
