EN ISO 12100: The Type-A Standard for Risk Assessment and Risk Reduction Explained

It is the basis for type-B and type-C machinery standards, and its method serves the step in which a manufacturer identifies a machine's hazards and reduces its risks.

As of 12 November 2026, EN ISO 12100:2010 is the only type-A standard in the Official Journal list under Directive 2006/42/EC, which applies until 19 January 2027.

Regulation (EU) 2023/1230 applies from 20 January 2027 and requires a risk assessment in Annex III, Part B, point 1, so the method of the standard keeps its purpose under the EU Machinery Regulation, whatever the citation status of the standard itself.

The sections below cover what the standard is, which edition applies with which Official Journal status, which legal requirements it supports, how it organises the work, how it enters the conformity file and which documents accompany it. The table gives nine key data points of EN ISO 12100 as of 12 November 2026.

What Is ISO 12100?

ISO 12100 is the ISO standard "Safety of machinery, General principles for design, Risk assessment and risk reduction", prepared by ISO/TC 199 and adopted in Europe as EN ISO 12100:2010. The same text carries both designations: ISO publishes it at international level, and CEN adopts it as a European standard.

ISO 12100:2010 is the first edition of the single-document standard, runs to 77 pages, sits in ICS group 13.110 and is published in English, French and Russian, according to the ISO catalogue. As of 12 November 2026, ISO lists it at stage 90.92, "to be revised".

Applying it is voluntary: Article 3(24) of Regulation (EU) 2023/1230 defines a harmonised standard by reference to Article 2, point 1, point (c) of Regulation (EU) No 1025/2012, and a harmonised standard gives a presumption of conformity, never an obligation. EN ISO 12100 is the basic tier of the harmonised standards for machinery.

Scope: Safety in Design and What the Standard Leaves Out

ISO 12100 specifies basic terminology, principles and a methodology for achieving safety in the design of machinery, covering risk assessment, risk reduction, and the documentation and verification of both. The ISO abstract ties the standard to safety in design, so it addresses the decisions taken while a machine is designed and constructed.

ISO 12100 is also the basis for type-B and type-C safety standards, so type-B standards, such as EN ISO 13849-1 for control systems, and type-C standards for individual machine families build on it.

The scope has a stated limit. ISO 12100 does not deal with risk or damage to domestic animals, property or the environment, so a design question on those subjects needs another source than this standard.

The Type-A Position of ISO 12100 in the Standards Hierarchy

ISO 12100 defines the standards hierarchy used for machinery: type-A basic safety standards, type-B generic safety standards and type-C machine safety standards.

The Commission uses the same split. Implementing Decision (EU) 2023/1586, the Official Journal list under Directive 2006/42/EC, sorts its Annex I into Part One (type A), Part Two (type B) and Part Three (type C).

The hierarchy itself is a term of the standards world and not of Regulation (EU) 2023/1230, which speaks only of harmonised standards.

The three tiers also settle conflicts between documents. The note to Annex I, Part Three of Implementing Decision (EU) 2023/1586 states that where a type-C standard deviates from a type-A or type-B standard, the type-C specifications take precedence.

Which Edition of EN ISO 12100 Applies?

As of 12 November 2026, EN ISO 12100:2010, the first edition of the single-document standard, is the only type-A standard listed in Annex I, Part One of Implementing Decision (EU) 2023/1586 under Directive 2006/42/EC, with no restriction.

Article 2 of Implementing Decision (EU) 2026/2015 repeals Implementing Decision (EU) 2023/1586 with effect from 20 January 2027, so 19 January 2027 is the last day on which EN ISO 12100:2010 gives presumption of conformity under the Directive list.

That is also the last day on which the Machinery Directive 2006/42/EC applies. The table and the timeline set out each dated step.

Status as of 12 November 2026; the listing carries no restriction.

EN ISO 12100:2010 in the OJ List under Directive 2006/42/EC

EN ISO 12100:2010 was first published in the Official Journal under Directive 2006/42/EC on 8 April 2011, as Communication 2018/C 092/01 (OJ C 92, 9.3.2018, p. 1) records. That Communication lists the standard with the references it superseded and the date on which their presumption ended.

The superseded references were EN ISO 12100-1:2003, EN ISO 12100-2:2003 and EN ISO 14121-1:2007, and their presumption of conformity ceased on 30 November 2013.

Presumption under the Directive rests on Article 7(2) of Directive 2006/42/EC: machinery manufactured in conformity with a harmonised standard whose reference is published in the Official Journal is presumed to comply with the essential health and safety requirements that the standard covers.

The current list is Implementing Decision (EU) 2023/1586 of 26 July 2023 (C/2023/4914), OJ L 194, 2.8.2023, p. 45, in force since 2 August 2023. The Commission has amended it seven times, from Implementing Decision (EU) 2024/1256 to Implementing Decision (EU) 2026/2015, and the consolidated text dates from 7 September 2026.

One amendment changed the type-A part: since 15 May 2024, when Implementing Decision (EU) 2024/1329 entered into force, EN ISO 12100:2010 has been the sole type-A reference, because EN 1127-2:2014 had been listed as type A in error and moved to the type-B part.

ISO 12100 Status under the Machinery Regulation from 20 January 2027

From 20 January 2027 a harmonised standard gives presumption of conformity with the Annex III requirements it covers only once its reference is published in the Official Journal under Article 20(1) of Regulation (EU) 2023/1230. The Machinery Regulation timeline places that switch on 20 January 2027, the day the Regulation applies.

A reference published under Article 20(1) also changes the EU declaration of conformity, which must name the date on which the reference of each harmonised standard applied was published in the Official Journal, as the conformity-file section below explains.

As of 12 November 2026, no harmonised standard is cited in the Official Journal under Regulation (EU) 2023/1230, and that includes EN ISO 12100:2010. The Directive list, Implementing Decision (EU) 2023/1586, was last amended by Implementing Decision (EU) 2026/2015 of 4 September 2026 (C/2026/6163), which also repeals it with effect from 20 January 2027.

The Draft Revision ISO/DIS 12100.3

ISO 12100 is being revised at ISO: as of 12 November 2026, the revision is a draft, ISO/DIS 12100.3 (ISO project 88578), at ISO stage 40.60, the close of the DIS vote. The draft is a second edition and runs to 94 pages, against 77 pages for the 2010 edition.

ISO Open Data lists the draft as replacing three documents: ISO 12100:2010, ISO/TR 22100-1:2021 and ISO/TR 22100-2:2013. A draft gives no presumption of conformity and has no publication date, so EN ISO 12100:2010 stays the reference for designers until a new edition is published and its reference appears in the Official Journal.

Which Machinery Requirements Does ISO 12100 Support?

ISO 12100 supports the general principles of Annex III, Part B of Regulation (EU) 2023/1230, the essential health and safety requirements annex, which continues the general principles of Annex I of Directive 2006/42/EC.

The annex number changes between the two acts: Annex III of the Regulation holds the requirements that Annex I of the Directive held, while Annex I of the Regulation lists the high-risk categories. Part B opens the essential health and safety requirements that every machinery product meets where the hazard exists.

The method of ISO 12100 serves four provisions of Regulation (EU) 2023/1230: the risk assessment duty, the order of protective measures, the risk-assessment record and the EU declaration of conformity. The table sets each provision against its Directive counterpart and against the part of the standard's method that serves it.

Annex III, Part B, Point 1 and the Standard's Risk Assessment Method

Annex III, Part B, point 1 of Regulation (EU) 2023/1230 requires the manufacturer to ensure that a risk assessment is carried out to determine which essential health and safety requirements apply, in five iterative steps from (a) the limits of the product to (e) eliminating hazards or reducing risks.

Step (a) covers the limits of the machinery or related product, including the intended use and any reasonably foreseeable misuse.

The three middle steps follow the same logic as the method of ISO 12100: (b) identify the hazards and the associated hazardous situations, (c) estimate the risks by the severity of the possible injury or damage to health and the probability of its occurrence, and (d) evaluate whether risk reduction is required.

Annex I, general principle 1 of Directive 2006/42/EC placed the duty on "the manufacturer of machinery or his authorised representative", while the Regulation names the manufacturer of machinery or a related product. The full duty and its five steps are explained on the page on machinery risk assessment.

The Regulation adds two subjects to the risk assessment. It must include hazards that can be foreseen at placing on the market as an intended evolution of fully or partially self-evolving behaviour or logic, for machinery designed to operate with varying levels of autonomy, and risks from interactions between machinery arranged and controlled to function as an integral whole under Article 3, point (1)(d) of Regulation (EU) 2023/1230. Neither subject has an equivalent in the general principles of Directive 2006/42/EC.

Clause 6 and the Order of Protective Measures in Section 1.1.2(b)

Section 1.1.2(b) of Annex III of Regulation (EU) 2023/1230 sets the order of protective measures that step (e) of the risk assessment follows, and EN ISO 12100:2010 describes this method in its clause 6. The order is binding law; the standard describes how to apply it.

The three ranks of section 1.1.2(b) are fixed in the Regulation. First, (i) eliminate hazards or, if that is not possible, minimise risks by inherently safe design and construction. Second, (ii) take the necessary protective measures for risks that cannot be eliminated.

Third, (iii) inform users of the residual risks, of any training needed and of any personal protective equipment required. Section 1.1.2(b) carries the same number in Annex I of Directive 2006/42/EC, the predecessor annex of essential health and safety requirements.

Why ISO 12100 Alone Gives No Full Presumption of Conformity

Implementing Decision (EU) 2023/1586 states that the application of type-A standards alone "does not give a full presumption of conformity", so EN ISO 12100:2010 is used with type-B and type-C standards or with other technical solutions.

The note sits in Annex I, Part One, point 1 of that Decision, the part that lists EN ISO 12100:2010.

Type-B standards work the other way round. The note in Annex I, Part Two, point 1 of the Decision states that type-B standards confer presumption when a type-C standard or the manufacturer's risk assessment shows that the type-B solution is adequate.

The Commission's Guide to application of the Machinery Directive 2006/42/EC, Edition 2.3 (April 2024), adds that applying type-C harmonised standards does not entirely dispense the manufacturer from the risk assessment, and hazards a standard does not cover need a full risk assessment. Presumption therefore shapes the route only together with the conformity assessment modules.

These notes belong to the Directive list and apply with it until 19 January 2027. For a product under Regulation (EU) 2023/1230, the manufacturer's own risk assessment remains the document that shows which requirements apply.

How Does ISO 12100 Organise Risk Assessment and Risk Reduction?

EN ISO 12100:2010 organises risk assessment and risk reduction as one design method in seven numbered clauses and four annexes, ZA, A, B and C, according to a CEN-CENELEC presentation of May 2019.

The standard's own title pairs the two activities, and Annex III, Part B, point 1 of Regulation (EU) 2023/1230, like Annex I, general principle 1 of Directive 2006/42/EC, describes them as one iterative process.

The table sets out what public sources record about the standard's organisation, in this page's own layout. The content of the clauses and annexes is part of the standard's sold text and is not described here, apart from clause 6, which describes the method behind the order of protective measures.

The iteration has a practical meaning for the designer. The Commission's Guide to application of the Machinery Directive 2006/42/EC, Edition 2.3 (April 2024), explains that the process is iterative because each risk reduction measure must be evaluated for its adequacy and for new hazards it creates, and that the risk assessment runs in parallel with the design process.

ISO 12100 Terms and the Definitions in Annex III, Part A

EN ISO 12100:2010 sets the basic terminology of machinery safety, while Regulation (EU) 2023/1230 sets nine definitions of its own in Annex III, Part A, moved out of section 1.1.1 of Annex I of Directive 2006/42/EC.

The nine terms are hazard, danger zone, exposed person, operator, risk, guard, protective device, intended use and reasonably foreseeable misuse.

Two of them carry the risk assessment. "Hazard" means "a potential source of injury or damage to health", and "risk" means "a combination of the probability and the degree of an injury or damage to health that can arise in a hazardous situation".

An "exposed person" means "any person wholly or partially in a danger zone", and a "guard" means "a part of machinery or a related product used specifically to provide protection by means of a physical barrier".

In a conformity file, the Regulation's definitions decide what the law requires, and the standard's terms describe how the method is applied.

Documenting the ISO 12100 Risk Assessment

The ISO 12100 risk assessment is documented as part of the technical documentation, because Annex IV, Part A, point (b) of Regulation (EU) 2023/1230 makes the risk-assessment record one of its 15 points, (a) to (o). The ISO abstract lists the documentation of risk assessment and risk reduction among the subjects of the standard.

Point (b) asks for the documentation on risk assessment demonstrating the procedure carried out, including (i) a list of the essential health and safety requirements that are applicable to the product, and (ii) the description of the protective measures implemented to meet each applicable requirement and, when appropriate, the indication of the residual risks.

Article 10(3) of Regulation (EU) 2023/1230 requires the manufacturer to keep the technical documentation for at least 10 years after the machinery or related product has been placed on the market or put into service, and the record forms part of the machinery technical file.

How Is ISO 12100 Applied in a Conformity File?

A manufacturer uses ISO 12100 in five steps, from the limits of the product to the EU declaration of conformity, and keeps the record in the technical documentation for at least 10 years. The five steps below follow the order of the documents of Regulation (EU) 2023/1230, and each step names the provision it serves.

1. Determine the limits, hazards and risks of the product with the method of ISO 12100, as the risk assessment under Annex III, Part B, point 1 of Regulation (EU) 2023/1230 requires.
2. Reduce the risks in the order of Annex III, section 1.1.2(b): inherently safe design and construction first, protective measures second, information on residual risks third.
3. Apply type-B and type-C standards where they fit the product, for example a type-C standard for the machine family or a type-B standard for its control system.
4. Record the list of applicable requirements, the protective measures and the residual risks under Annex IV, Part A, point (b) of Regulation (EU) 2023/1230.
5. List each harmonised standard applied in the EU declaration of conformity for machinery, with the date of publication of its reference in the Official Journal, as Annex V, Part A, point 7 of Regulation (EU) 2023/1230 requires.

Under Directive 2006/42/EC, until 19 January 2027, the same record supports the essential health and safety requirements of Annex I of that Directive and the technical file of its Annex VII. Only the legal references in the file change with the act.

Which Documents Work Alongside ISO 12100?

ISO 12100 is read with four groups of documents: its withdrawn predecessors, the ISO/TR 14121-2 guidance, the ISO/TR 22100 series that relates it to other standards, and type-B standards such as EN ISO 13849-1 for safety-related parts of control systems. The four groups are listed below with the role each one plays.

• Withdrawn predecessors: ISO 12100-1:2003, ISO 12100-2:2003 and ISO 14121-1:2007, replaced by the 2010 edition.
• ISO/TR 14121-2:2012: practical guidance on conducting risk assessment in accordance with ISO 12100.
• ISO/TR 22100 series: technical reports that explain how ISO 12100 relates to other machinery standards.
• Type-B standards: EN ISO 13849-1 safety-related control systems and the ergonomics standards for machinery, such as EN 547, EN 614-1, EN 894, EN 1005 and EN ISO 14738.

Withdrawn Predecessors: ISO 12100-1, ISO 12100-2 and ISO 14121-1

ISO 12100:2010 replaced ISO 12100-1:2003 and ISO 12100-2:2003 with their 2009 amendments and ISO 14121-1:2007, and ISO lists all of them as withdrawn, at stage 95.99. ISO 14121-1:2007 was "Risk assessment, Part 1: Principles", and the 2010 edition replaced it and the two parts of ISO 12100 with edition 1 of a single-document standard.

In the Official Journal under Directive 2006/42/EC, the presumption of the superseded European references ended on 30 November 2013, so none of them supports a conformity file today.

ISO/TR 14121-2 and the ISO/TR 22100 Series

ISO/TR 14121-2:2012 gives practical guidance on conducting risk assessment in accordance with ISO 12100, with methods and tools for each step and examples of risk reduction measures. ISO published it on 31 May 2012 as edition 2, 38 pages long and at stage 60.60, published.

The ISO/TR 22100 series relates ISO 12100 to other documents in four parts: ISO/TR 22100-1:2021 to type-B and type-C standards, ISO/TR 22100-2:2013 to ISO 13849-1, ISO/TR 22100-3:2016 to the implementation of ergonomic principles in safety standards, and ISO/TR 22100-5:2021 to the implications of artificial intelligence machine learning.

These documents are technical reports, not harmonised standards, so none of them gives presumption of conformity.

ISO 12100 Questions

Four questions recur about ISO 12100: whether it is mandatory, whether it is itself a risk assessment, whether an official checklist exists and where the official text is published.

Is ISO 12100 mandatory under the Machinery Regulation?

No: harmonised standards are voluntary, and Regulation (EU) 2023/1230 requires the risk assessment itself, not a particular standard for it. As of 12 November 2026, EN ISO 12100:2010 is cited in the Official Journal only under Directive 2006/42/EC, until 19 January 2027, and no harmonised standard is cited under Regulation (EU) 2023/1230.

Is ISO 12100 itself a risk assessment?

No: ISO 12100 is the standard that describes how to carry out a risk assessment and risk reduction, while the risk assessment is the manufacturer's own documented work for one product. Annex IV, Part A, point (b) of Regulation (EU) 2023/1230 sets what that record contains: a list of the applicable essential health and safety requirements, and the description of the protective measures implemented to meet each of them with, when appropriate, the indication of the residual risks.

Is there an official ISO 12100 checklist?

The Commission's Guide to application of the Machinery Directive 2006/42/EC, Edition 2.3 (April 2024), says the risk-assessment information can be drawn up as a checklist of the applicable essential health and safety requirements and the protective measures taken. Templates and examples belong with the risk assessment record itself.

Where is the official text of ISO 12100 published?

ISO publishes ISO 12100:2010, CEN adopts it as EN ISO 12100:2010, and national standards bodies publish national adoptions such as BS EN ISO 12100 and DIN EN ISO 12100. The standard's text is sold by these bodies and is not reproduced here.