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Basics - harmonised standards, directives and laws in the EU

What is the relationship between standards, directives and laws?

Standards puzzle

The European Union is experiencing ever closer union. This leads to increasing harmonisation of laws, regulations and provisions in engineering. Initially, the EU formulates general safety objectives via directives. These safety objectives require precise specification. Specific regulation occurs via standards.

EU directives do not come into effect until countries within the EU incorporate them into domestic law. In each EU country, a law or provision refers to the relevant EU directive and thus elevates it to the status of domestic law.

Standard met, requirement met – harmonised standards

Standards alone have no legal relevance. They do not achieve legal relevance until they are published in the Official Journal of the EU or are referenced in domestic laws and provisions. Publication of these harmonised standards triggers "presumption of conformity". Users applying the standard can therefore assume that they are acting in compliance with the law and directives. The burden of proof has therefore been reversed in the event of a claim. If a harmonised standard refers to a standard that has not been harmonised, the latter can obtain a status comparable to that of harmonisation.

 

Standards, directives and laws in the EU

Where are harmonised standards published?

New procedure established for publishing harmonised standards in the Official Journal of the European Union

Procedure for publishing harmonised standards in the Official Journal of the European Union

On 18.3.2019, the EU Commission published the Implementing Decision (EU) 2019/436 in the EU Official Journal, outlining the changes to the list of harmonised standards for machines with regard to the Machinery Directive 2006/42/EC. It updated the list of standards whose application triggers presumption of conformity in accordance with the Machinery Directive 2006/42/EC. What is new is that this publication describes only modifications in comparison with the previous document and does not appear as a consolidated list.

In the past, harmonised standards were published in the Official Journal of the European Union, most recently on 9 March 2018. The publication was valid until the next complete catalogue was published. That changed this year.

The designated EU implementing decision 2019/436 includes 3 annexes:

Annex I: Newly published harmonised standards

Annex II: Harmonised standards that are published in addition to the previous publication with some restrictions

Annex III: Previously harmonised standards that are withdrawn from the Official Journal of the European Union

It is important for the user of the standards to read the implementing decisions in conjunction with the last valid consolidated list of harmonised standards (published in Official Journal 2018/C 92/1).

The EU Commission plans to publish consolidated lists on their home page. To date, the EU has not yet published a list. Pilz is always on the ball - we will keep you up to date.

 

Annex I - Newly published harmonised standards Annex III - Previously harmonised standards that were withdrawn from the Official Journal of the European Union on 19.03.2019 Notes

EN ISO 14118:2018 Safety of machinery — Prevention of unexpected start-up (ISO 14118:2017)) (type B standard)

EN 1037:1995+A1:2008
Safety of machinery — Prevention of unexpected start-up

EN ISO 14118:2018 supersedes EN ISO 1037 WITHOUT a transition period
EN 12013:2018 Plastics and rubber machines — Internal mixers — Safety requirements (type C standard) EN 12013:2000+A1:2008 Plastics and rubber machines — Internal mixers — Safety requirements EN 12013:2018 supersedes EN 12013:2000+A1:2008 WITHOUT a transition period
EN ISO 16092-1:2018 Machine tools safety — Presses — Part 1: General safety requirements (ISO 16092-1:2017) EN 692:2005+A1:2009 Machine tools — Mechanical presses — Safety EN ISO 16092-1:2018 supersedes EN 692:2005+A1:2009 WITHOUT a transition period
EN ISO 16092-3:2018 Machine tools safety — Presses — Part 3: Safety requirements for hydraulic presses (ISO 16092-3:2017) EN 693:2001+A2:2011 Machine tools — Safety — Hydraulic presses EN ISO 16092-3:2018 supersedes EN 693:2001+A2:2011 WITHOUT a transition period
  EN 13736:2003+A1:2009 Safety of machine tools — Pneumatic presses. Loses the presumption of conformity WITHOUT a transition period!
  EN 61496-1:2013 Safety of machinery – Electrosensitive protective equipment – Part 1: General requirements and tests.

Loses the presumption of conformity WITHOUT a transition period!

Reason: Previously, only EN 61496-1 was harmonised. Parts 2 and 3 were never harmonised. This generally means that a notified body has to be involved in the conformity assessment procedure when applied, and that a type examination certificate is stipulated!

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