Last edit: 01/08/2023
As we know, the compliance to the Harmonized Standards guarantees the presumption of conformity with the EHSR (Essential Health and Safety Requirements), compliance which is necessary and mandatory to obtain the CE marking of the products and the resulting free movement on the market. The application of Harmonised Standards is not an obligation, it is only a possible method to ensure the safety of products; in practice, Harmonised Standards are the main route (presumption of conformity), followed by each manufacturer, to obtain CE certification. For further information on the subject, please refer to the following article.
Referring to the formal non-mandatory nature of the Standards, the regulatory bodies (CEN, CENELEC and ETSI at European level) claim intellectual property on them: manufacturers have to pay for access to the rules, and both virtual and material copies cannot be reproduced after purchase.
ARE HARMONISED STANDARDS LAWS?
The concept of harmonized Standards was born precisely in order to eliminate technical specifications from the European legislative body and to standardize the laws of the Member States: instead of aligning the technical requirements of each Member State (Old Approach, a method that is expensive and complex to apply), only the general safety requirements are unified, pointing to private external standard as a possible way of achieving them (New Approach – 1985).
However, the Harmonized Standards are not simple private documents: their creation takes place at the explicit request of the European Commission, which then deals with approving their content. Once approved, the standard becomes a Harmonised Standard, its inclusion in this group of standards is officialized in the European Official Journal, in the same way as the laws issued by the European Parliament.
Recent court cases have questioned the official value of Harmonised Standards: in both James Elliott Construction Limited v Irish Asphalt Limited (C 613/14) and Global garden product v European commission (ECLI:EU:T:2017:36), the European Court found itself judging the value of the standard, and in both cases their legal value comparable to European law was recognized.
 “ […] It follows from the above that a harmonised standard such as that at issue in the main proceedings, adopted on the basis of Directive 89/106 and the references to which have been published in the Official Journal of the European Union, forms part of EU law, since it is by reference to the provisions of such a standard that it is established whether or not the presumption laid down in Article 4(2) of Directive 89/106 applies to a given product.”
More information about the legal developments of these cases can be found in this in-depth analysis.
IF THE STANDARDS ARE PART OF EUROPEAN LAW, SHOULD THEY BE ACCESSIBLE FREE OF CHARGE?
According to these developments, Harmonised Standards are indeed part of the European legislative body. If that were the case, the immediate consequence would be the obligation to provide them to the public free of charge, such as the other laws.
A first attempt to make access to the rules free of charge has already taken place in Germany, with a negative outcome. In 2014, German government agencies provided few partial standards on their sites (EN 1400-1 Annexes K9; K10, EN 1400-2 Annex K11; K12, EN 1481 Annex K7, EN 1482 Annex K8), concerning, among other things, safety requirements for infant objects. The Deutsches Institut fur Normung (DIN), the German regulator body, filed a complaint for copyright infringement, demanding the immediate elimination of the standards from the sites where they had been published free of charge. Both the Regional Court and the National Court of Hamburg ruled in favor of the DIN, recognizing the intellectual property of the standard.
The developments in the Elliott case could, however, provide new basis for judgment on this issue, an issue that could be clarified in early 2021 by the Commission itself, in response to the official question by Carl Malamud. Carl Malamud is a US civil activist known for his political fight for free online circulation of legislative codes, and since 2015 he has started a campaign to make access to toy safety standard free of charge (UNI EN 71:2018); Malamund claims the right of parents to have access to regulations regarding their children's toys and has published on its website the previous version of the legislation making it accessible free of charge. After two petitions to the British government (2015 and 2019), Malamund addressed the European Court, obtaining a horal earing in November 2020: relying on the Elliott judgment, he asks for free access to Harmonised Standards for all citizens of the European Union. The answer is expected by May 2021 and should provide a clear conclusion to the matter.
There is therefore a possibility that Harmonised Standards will become freely accessible to all market players, such as manufacturers and consultants. On the other hand, regulatory bodies would lose a large part of their incomes (these institutions receive also substantial European contributions for each standard requested by the Commission).
A recent change in the process of creating standards could in any case change this scenario. For some years now, the Commission has not interfaced directly with regulatory bodies, but has been using consultants, the HAS Consultants (HArmonised Standard Consultants), as intermediaries in development, to verify the compliance of the standard to the EHSR . This change is causing major delays in the publication of the standard, which face long waiting periods between their final drafting and approval. For this reason, the regulatory bodies seem intent on no longer submit their standards to the Commission (we are talking about type C standards, concerning specific models of machinery) , and indeed would like the ones already accepted to be excluded from the group of the Harmonized Standards. The exclusion of these standards from Harmonised Standards would further distance them from European legislation, excluding any possibility of making them free of charge.
If, therefore, the Elliott case has created the possibility of free access to the Harmonised Standard, there are still many obstacles along this road and this scenario may not come true.