Why does Presumption of Conformity Matter?

26 Aug 2026

Understanding how Harmonized Standards and the EU Official Journal Support Compliance with the new EU Machinery Regulation

As the clock keeps ticking down until 20 January 2027, I am hearing more questions from manufacturers about standards, presumption of conformity, and the EU Official Journal.

The EU Official Journal is where the list of harmonized standards is found and includes the specific standard with edition, the date it was added, and the date that the standard stops providing presumption of conformity (also known as cessation of presumption of conformity).

Harmonized Standards are a key element to the overall EU product regulatory framework. Currently we are waiting for the first publication of the EU Official Journal that will provide a list of the initial standards which will provide presumption of conformity to the Machinery Regulation.

What is Presumption of Conformity?

Presumption of conformity is a term that is used throughout the different EU product Directives and Regulations. It is the mechanism where products conform to harmonized EN standards (hEN standards), and through that conformance they are presumed to conform to the relevant essential health and safety requirements (EHSRs) found within the applicable EU Directives or Regulations.

The hEN standards that will be published in the Official Journal for the Machinery Regulation will each include a clear annex that identifies which EHSRs the standard covers. Most standards do not currently address Protection against corruption, EHSR 1.1.9. As such most standards will make it clear that conforming to the standard will not provide presumption of conformity for EHSR 1.1.9. To address this gap, EN 50742 is being developed to provide presumption of conformity to EHSR 1.1.9. Many manufacturers may need EN 50742, in conjunction with other standards, to provide full coverage of all the applicable EHSRs.

Why is Presumption of Conformity Important?

The importance of presumption of conformity is that it provides a lower risk path to demonstrating conformance with the EU product directives and regulations. If there are questions from market authorities or complainants who believe a product does not conform to the EHSRs, the manufacturer can point to the use of appropriate hEN standards and the associated presumption of conformity.

While the manufacturer still needs to maintain the technical file and comply with the other requirements of the Machinery Regulation, the general burden shifts away from the manufacturer and to the market authorities or complainants who need to prove that the product doesn’t comply with the EHSR requirements. If the hEN standards are properly applied, and the technical file is complete – this will be a greater burden.

For manufacturers who choose not to use hEN standards to demonstrate conformance with the applicable EHSRs, the manufacturer must be able to demonstrate that their product meets all applicable legal requirements.

Important Decisions for Manufacturers

As manufacturers prepare their declarations of conformity for the upcoming Machinery Regulation, there will be important decisions to make. Will you rely on hEN standards that will provide presumption of conformity, use other non-cited standards, or choose other means of demonstrating conformance with the EHSRs?

This is further complicated by not knowing what standards and editions will be cited in the EU Official Journal. While using hEN standards reduces regulatory risk, there may be situations where they are out of date and don’t adequately cover the scope of the machine. In these cases, manufacturers should consider other approaches that don’t include hEN standards, notably when newer versions of the standard exist, but are not currently cited in the EU Official Journal (such is the case currently with the Machinery Directive and ISO 10218-1).

Ultimately how to navigate the requirements regarding hEN standards, conformance to the EHSRs, and presumption of conformity are all strategic decisions that need to be made for any product entering the EU Market. Understanding the advantages and limitations of these concepts is going to be important as manufacturers transition to the Machinery Regulation and the updated requirements found therein.