Is the EU going to make Harmonised Standards compulsory?

Last edit: 01/08/2023

Since their incorporation, the Harmonized Standards have been technical directives of optional application, which can be used by manufacturers to certify their products. However, recent judicial developments could change the legal value of the Standards and the whole European process of creating standards.


To circulate on the European Market, a product must be provided with CE certification. The European Community specifies what EHSR (Essential Health and Safety Requirements) a product must achieve to be certified but does not provide a mandatory method for achieving them; however, it is stated that the presumption of conformity is legitimate in the event of adherence to the Harmonised Standards. Harmonised Standards are a set of standards produced by private bodies (but ratified by the European Commission) which state the technical criteria to be met to achieve the required safety requirements. ATTENTION, the use of Harmonized Standards is not mandatory: a manufacturer can produce goods even without complying with the indications of the Standard, taking responsibility for showing adherence of its products to the EHSR.
To sum up: the European Union provides mandatory safety requirements in the various fields but does not impose a method to achieve them (New Approach); it states that adherence to officially recognized third-party standards, the Harmonised Standards, ensures compliance with EHSR. If, therefore, Harmonised Standards are not a mandatory method of complying with EHSR, they are practically the only recognized method to reach safety thresholds.

Currently the creation of Harmonised Standards follows this procedure: the Directorate-General for Internal Market, Industry, Entrepreneurship and  SMEs  (DG GROW) is the European body responsible for commissioning to third parties the creation of standard to be certified as Harmonised. The standards are commissioned through a group of consultants, the HAS (HArmonised Standard) Consultants (contract taken by Ernst & Young Global Limited), who communicates with private standardization bodies to verify that their work complies to the European regulation. The third parties responsible for drafting the standards are the European Standardization Organizations (ESO); the standard, once completed, is analyzed by both the HAS Consultants and the DG GROW. If approved, the standard is included in the list of Harmonised Standard and is published in the Official Journal of the European Union.


The legal soundness of Harmonised Standards has been called into question in recent years by different court cases.
James Elliott Construction Limited v Irish Asphalt Limited (C613/14): Elliot Construction charges a supplier who allegedly delivered concrete which did not comply with relative Harmonised Standard; the accused replies by stating that following the Standard is not compulsory. The case, which was brought before the Northern Ireland court, is entrusted to the European Court of Justice, which is therefore faced with the question: “can the Court of Public Justice base its judgments on the interpretation of voluntary standards created up by private bodies?” The answer is Yes.

[40] “ […] 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.” 
[43] “It must, moreover, be noted that while the development of such a harmonised standard is indeed entrusted to an organisation governed by private law, it is nevertheless a necessary implementation measure which is strictly governed by the essential requirements defined by that directive, initiated, managed and monitored by the Commission, and its legal effects are subject to prior publication by the Commission of its references in the ‘C’ series of the Official Journal of the European Union.”

While recognizing the private origin of the standard, the Court of Justice acknowledges its legislative validity, as it is directly ratified by the European Commission and published in the European Journal in the same way as the remaining legislative body. The standards are also recognized as NECESSARY for the achievement of safety requirements.

Global garden product v European Commission (ECLI:EU:T:2017:36): Global Garden, a manufacturer of gardening equipment, disputes the European Commission decision of removing one of its lawnmower models from the European market. The choice of the Commission is the consequence of the report of a Member State (Latvia), which detected non-compliance with the Standard EN 60335-2-77:2010 (in particular, the distance between the blades and the rear cover was not adequate). Global Garden disputes the Commission position, stating that the lawnmowers were produced and put on the market when the reference standard was EN 60335-2-77:2006, to which the product complies. In this case, therefore, the Harmonised Standards legal value is not the subject of the dispute. Nevertheless, in his judgment the European Court states that Harmonised Standards, even if not mandatory, are the easiest means of obtaining a declaration of conformity, and that publication in the European Journal gives them legal value.

[60] “[…] the publication by the Commission of the reference of a harmonised standard in the Official Journal which confers on it legal force […]”


The critical issues raised by these judgments can be summarized in two points:
1.    Harmonised Standards, if not yet mandatory, are still recognized as the necessary and easiest means of obtaining the declaration of conformity.
2.    The Commission’s control over their writing, and their publication in the European Journal gives the standards real legal value.
The certified legal value of the Standards would have a fundamental first consequence: they should be free available to manufacturers and control bodies, such as the rest European legal body. For an insight on this issues please refer to this article.

Merging Harmonised Standards with European legislation could lead to important developments for all operators related to the machine safety, developments that are in some cases, already taking place.

•    European Commission: conferring to the Harmonized Standards the status of law, the European Community increases its responsibilities on their content, and to protect itself at the juridical level it has already moved, hiring a number of HAS Consultants, who have been monitoring the content of the standard in approval status for some years, so as to exclude the possibility of any deficiencies. This is generating a slowdown in the approval of the new standard (the impact is seen in particular in type C standards), a slowdown already underway in several sectors such as for construction materials, where the Construction Product Regulation (CPR) has imposed the use of Harmonized Standards as an obligation for years.
•    Regulatory bodies: for the reasons I have just given, regulatory bodies would see a rise in the amount of time taken to approve the standards they produce; ESOs are therefore already changing their strategy, aiming to retire their EN ISO standards (we are talking about type C standards, each one concerning a single type of machinery) from the Standardized Standards. Regulatory bodies will draft and publish their type C standards without submitting them to the Commission to include them in the Harmonized Standards.

•    Machinery manufacturers: in the current scenario, manufacturers are without a Harmonised Standard for the production of their products. They will therefore be responsible for the safety of their machinery in the certification act, no longer being able to make use of the presumption of conformity given by compliance with the Harmonized Standards. The official recognition of standards as European laws would therefore not necessarily be a positive development, especially for manufacturers.

These and other judicial developments are forcing the European Union to clarify the value of the Harmonized Standards, knowing that any change in the current status quo would bring major changes for all players in the world of machine safety.

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