What the Machinery Regulation Shift Means for Harmonized Standards and EHSR Compliance

16 Jun 2025

Understanding the evolving landscape of EU standardization is essential for navigating this transition effectively

As part of standardization in the EU, the development of standards is currently governed by EU Regulation 1025/2012, which came into force in 2012. Article 10(5) of this Regulation requires that the Commission together with the European standardization organisations shall assess the compliance of the documents. What this means practically is that all standards, developed for use in the Official Journals (EUOJ) need to be reviewed to ensure that they address the Essential Health and Safety Requirements (EHSRs) of the regulations for which they are to provide presumption of conformity.  

For example, the EHSRs of the Machinery Regulation (NMR) (2023/1230) and Machinery Directive (MD) (2006/42/EC) require in EHSR 1.7.4.1 that the instructions manufacturers provide with their machinery not only include information about the intended use of the machinery, but also any foreseeable misuse.  

If a standard is to both:  

1. be included in the Official Journal of the NMR or MD, and
2. provide presumption of conformity for EHSR 1.7.4.1,  

then the standard will need to require that the instructions include the information about the intended use and foreseeable misuses.  

HAS Assessment Process 

The Harmonized Standards (HAS) Assessment Process was updated in 2022. The goal of this process is to fulfill the requirements of Article 10(5) of Regulation 1025/2012 by having an independent review of a standard done to ensure that the documents are compliant with applicable regulations. 

If the review finds that the standard lacks compliance with the requirements, a detailed list of the deficiencies is provided to the technical committee and they need to address these issues before the standard is accepted to the appropriate EUOJ. 

HAS Assessments Impact on the Machinery Regulation 

With the significant differences in EHSRs between the MD and the NMR, approximately 60% of the harmonized EN (hEN) standards are impacted by the new or modified EHSRs in the NMR, and to be included in the EUOJ for the NMR they will require an update. 

According to the HAS Consultants report on activities, between March 2024 and March 2025 there were 243 HAS requests under the MD and NMR. Of those: 

• 31 were compliant assessments,
• 14 were conditional assessments, and
• 198 were lacking compliance. 

As a result of the standards lacking compliance with the HAS assessments, the standardization update program is slowing down. Because of this, it is expected that when the first EUOJ for the NMR is published, there will be standards currently within the MD EUOJ that will not be present. In those situations, manufacturers will be faced with difficult decisions on how to demonstrate compliance with the NMR EHSRs without the use of hEN standards within the NMR OJ. 

Conclusion: Harmonized Standards at the Core of a Complex Transition 

As the EU shifts from the Machinery Directive (MD) to the new Machinery Regulation (NMR), harmonized standards are proving to be both a cornerstone and a challenge in ensuring continued compliance. The HAS Assessment Process, now more rigorous and transparent, plays a critical role in validating whether these standards meet the EHSRs of the NMR. 

However, with a significant portion of standards currently failing to meet compliance, the pace of standardization is slowing leaving manufacturers in a difficult position. Until the first Official Journal under the NMR is published and populated with updated harmonized standards, companies will need to be ready to explore alternative routes to demonstrate conformity if the current standards used are not within this first published EUOJ. 

Understanding the evolving landscape of EU standardization, especially the role of HAS assessments, is essential for navigating this transition effectively. Staying informed and engaged with the standardization process will be key to maintaining compliance and market access in the years ahead.