Navigating the EU’s Machinery Regulation: The Role of HAS Assessments in a Changing Standards Landscape

As the European Union transitions from the Machinery Directive (2006/42/EC) to the new Machinery Regulation (2023/1230), understanding the evolving standardization framework is critical for manufacturers aiming to maintain compliance and market access.

At the heart of this transition is EU Regulation 1025/2012, which mandates that harmonized standards must align with the Essential Health and Safety Requirements (EHSRs) of the applicable legislation. This alignment is verified through the Harmonized Standards (HAS) Assessment Process, which was updated in 2022 to ensure greater rigor and transparency.

Key insights from our latest blog include:

• Why HAS Assessments Matter: Standards must now explicitly address EHSRs—such as the requirement to include both intended use and foreseeable misuse in machinery instructions—to be listed in the Official Journal (EUOJ) and provide presumption of conformity.
• The Compliance Challenge: Between March 2024 and March 2025, only 31 of 243 HAS assessments under the MD and NMR were fully compliant. This bottleneck is slowing the publication of harmonized standards under the NMR.
• What It Means for Manufacturers: Many existing standards may not appear in the first EUOJ under the NMR, leaving manufacturers to explore alternative conformity routes.

Read the full article to understand how these regulatory shifts could impact your compliance strategy and what steps you can take to stay ahead:
Understanding the Evolving Landscape of EU Standardization

Learn more about how Intertek supports industrial manufacturers in navigating global compliance challenges: www.intertek.com/industrial