Technical article

EN ISO 12100 is being revised

Standard on risk assessment and risk reduction

The new EN ISO 12100 - what's changing?

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The most important standard for risk assessment, (EN) ISO 12100, is currently being revised! You can find out the relevant facts below to stay on the ball.

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What is the current status?

On 1 December 2023, ISO, the International Organisation for Standardisation, assigned the current edition of the 2010 standard the stage code "International Standard to be revised". As a result, a new follow-up project ISO/AWI 12100 was launched, which currently has the status "New project accepted".

When is the new standard (EN) ISO 12100 coming?

There are several stages in the ISO standardisation process (known as ISO Stages). The new standard is currently still in phase 1 (proposal phase). It will therefore be some time before the document reaches phase 6 (publication phase).

By way of comparison, the last revision of the standard in 2008 took just under 2.5 years from the proposal phase to the publication phase. If the current revision follows a similar cycle, users can expect a new edition of the standard in mid-2026 at the earliest.

This publication process only reflects the international version. CEN, the European standardisation organisation, has also launched a new standardisation project named prEN ISO 12100 rev. It can be assumed that the ISO and CEN committees will work closely together, as they did for the 2010 edition of the standard. Publication at European and then national level usually takes place a few months after publication of the international edition.

Is there a transition period?

When it comes to the question of a possible transition period, a distinction must be made between the various publishers:

  • International: ISO is expected to withdraw the predecessor document immediately upon publication of the successor, i.e. there will be no transition period.
  • Europe: CEN/CENELEC only communicate the date of withdrawal indirectly: In the date of the new standard, the DOW, the so-called "date-of-withdrawal", communicates the latest date by which national implementations of the standard that contradict the current edition must be withdrawn. This date is on average 2-3 years after a new publication.
  • European Union: A special case in Europe is also the indirect publisher status of the European Commission, which publishes the new standard as a harmonised standard in the EU Official Journal in accordance with the Machinery Directive (in future the Machinery Regulation). With the listing in the EU Official Journal, the predecessor standard EN ISO 12100:2010 is expected to be granted a transitional period of 2.5 years for the presumption of conformity, during which both editions may be used.
  • National level: National standardisation organisations such as DIN or Austrian Standards generally withdraw national predecessor standards immediately, but there are exceptions here too.

When does the new ISO 12100 standard have to be applied?

This question is not easy for manufacturers to answer, as they find themselves in a field of tension, especially in Europe.

On the one hand, the listing of the predecessor standard EN ISO 12100:2010 in the EU Official Journal in accordance with the Machinery Directive provides a certain degree of legal certainty, i.e. the presumption of conformity, while on the other hand the EU directives in particular require compliance with the state of the art. It could be argued here that the new edition of (EN) ISO 12100 better reflects this state of the art from the time of publication than the previous standard due to its up-to-dateness.

For more information - also from a legal perspective - on this topic, please refer to our technical article Standards topicality vs. presumption of conformity.

What will change in terms of content?

The official documents or draft standards that can be publicly commented on by users are not yet available. However, as soon as new information is available, we will communicate the details promptly.

In the work programme of the European standardisation organisations CEN/CENELEC for 2024, the revision of the standard was specified as one of the main tasks of Technical Committee 114 (Safety of machinery). The main objective of the revision is therefore to review some definitions, to adapt the content to the Machinery Regulation (EU) 2023/1230 and to introduce links to the committee's latest horizontal documents.1

When will Safexpert - the risk assessment software - be adapted to the new requirements?

As soon as we have the first details of the content in the form of draft standards, we will start the preparatory work as soon as possible in order to enable our customers to perform risk assessments in accordance with the new standard as soon as possible after the final edition of the standard is published.

Of course, we will only be able to finalise the functions once the official documents are available. The implementation of the new requirements in Safexpert has the highest priority.

Posted on: 2024-02-29


Daniel Zacek-Gebele, MSc
Seit 2020 Community Manager bei IBF für die Standards Experts Community (SECOM) und Produktmanager für Safexpert Zusatzprodukte am Safexpert Live Server. Studium der Wirtschaftswissenschaften in Passau (BSc) und Stuttgart (MSc) im Schwerpunkt International Business and Economics.

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