european-union business directive
ISO 12100 no longer a normative reference in Machine Directive
<h3>Introduction</h3>

<p>Within European industry, every machine manufacturer has to comply with <a href="https://osha.europa.eu/en/legislation/directives/directive-2006-42-ec-of-the-european-parliament-and-of-the-council" rel="nofollow noreferrer">Directive 2006/42/EC</a>, otherwise known as the Machine Directive (MD).</p>

<p>The MD is implemented by CENELEC's EN 60204 standard, sometimes known as IEC 60204. The most recent version came out in <a href="https://www.cencenelec.eu/news/brief_news/Pages/TN-2018-075.aspx" rel="nofollow noreferrer">2018</a>, the one before that in 2006 and the one before that 1997. It's been around for a while.</p>

<h3>Observation</h3>

<p>While comparing the 2018 version to the 2006 version, I noticed ISO 12100 (specifically parts 1 and 2, 12100-1:3004 and 12100-2:2003) is removed from the normative references (Annex ZA, but also chapter 2 of the standard). Considering ISO 12100 is or used to be one of the most important standards on risk assessment and safety integrity requirements (required for determining how 'safe' a complex system is), I'm confused by the MD simply dropping the reference from its normative list. It has now moved to the Bibliography, which doesn't hold the same value.</p>

<h3>Question</h3>

<p>Last I checked, everything 'normative' in these standards is basically law. Did the value of ISO 12100 change within the scope of the MD so far that compliance is no longer required? Relevant parts are now part of the 60204, but not even close to everything.</p>

<p>It's entirely possible I've misunderstood something here, but are we no longer required to comply with ISO 12100 like we used to?</p>

<p>I have not the slightest clue about this area of the law, so don't take this as an actual answer, rather as some sort of suggestion that doesn't fit into a comment:</p>

<p>As far as I can see, ISO 12100-1:2003 and ISO 12100-2:2003 (which you ask about) were revised and summarised in the new ISO 12100:2010 (Safety of machinery — General principles for design — Risk assessment and risk reduction). The ISO 12100:2010 standard was subsequently published in the Official Journal (<a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52011XC0408(03)" rel="nofollow noreferrer">2011/C 110/01</a>), where it is stated that it will supersede EN ISO 12100-1:2003 and EN ISO 12100-2:2003, giving 30 November 2013 as the "Date of cessation of presumption of conformity of superseded standard". So perhaps we should really talk about EN ISO 12100:2010 rather than EN ISO 12100-1:2003 and EN ISO 12100-2:2003?</p>

<p>Now, I'm writing this because the Commission's Implementing Decision 2019/436 of 18 March 2019 on the harmonised standards for machinery drafted in support of Directive 2006/42/EC of the European Parliament and of the Council, <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32019D0436" rel="nofollow noreferrer">C/2019/1932</a>, which provides for some necessary "clean up" in the wake of new CENELEC standards ("As the result of the work by CEN and Cenelec [...] several harmonised standards published in the Official Journal of the European Union have been replaced, revised or amended [...] It is therefore necessary to withdraw the references of those standards from the Official Journal of the European Union."), notes in recital 14 that</p>

<blockquote>
  <p>"Harmonised standards EN 786:1996+A2:2009; EN 61496-1:2013; EN ISO
  11200:2014 and <strong>EN ISO 12100:2010 should be withdrawn</strong> as they <strong>no longer
  satisfy the requirements which they aim to cover and which are set out
  in Directive 2006/42/EC</strong>." (Emphasis added.)</p>
</blockquote>

<p>Perhaps that is also the reason for your observation?</p>
