Essential Health and Safety Requirements (Annex III): Every Section of the Machinery Regulation Explained

EHSR is the abbreviation used for them, and until 19 January 2027 the same term covers Annex I of Directive 2006/42/EC.

Annex III takes over from the Directive's Annex I without a parallel period. How Annex III fits into the EU Machinery Regulation as a whole is explained on the home page.

The sections below cover the structure of Annex III, chapter 1 section by section, chapters 2 to 6, the five new sections, the presumption of conformity under Article 20, the status as of 12 November 2026 and nine topic pages.

What Are the Essential Health and Safety Requirements?

The essential health and safety requirements are the obligations set out in Annex III of Regulation (EU) 2023/1230, titled "Essential health and safety requirements relating to the design and construction of machinery or related products", and they correspond to Annex I of Directive 2006/42/EC.

The annex text is published in the consolidated version of Regulation (EU) 2023/1230 on EUR-Lex.

The requirements govern how a product is designed and built, not how an employer uses it at the workplace.

Meeting them is one step of compliance, next to the technical documentation, the conformity assessment procedure, the EU declaration of conformity and the CE marking, and the full sequence of Machinery Regulation compliance steps is set out separately.

Annex I of the Regulation is a different list. It holds the high-risk categories, 6 in Part A and 19 in Part B, so the EHSR are never "Annex I of the Regulation"; only under the Directive does Annex I mean the essential health and safety requirements.

Legal Basis: Article 8 and Article 10(1) of the Regulation

Article 8 of Regulation (EU) 2023/1230 allows machinery and related products to be made available only if they meet the essential health and safety requirements of Annex III, and partly completed machinery only the relevant ones.

Article 10(1) of the Regulation places the design duty on the manufacturer, who ensures that the product is designed and constructed in accordance with the applicable requirements. The authorised representative cannot take this duty over: Article 12(1), second subparagraph, keeps the Article 10(1) obligations out of its mandate.

Annex III applies from 20 January 2027 under Article 54 as corrected. Whether a product is high-risk is a separate question, because the Annex I high-risk machinery categories decide the conformity route, not which requirements apply.

How Annex III Is Structured: Part A, Part B and Six Chapters

Annex III of Regulation (EU) 2023/1230 opens with Part A, nine definitions, and Part B, five general principles, and then sets out the requirements in six chapters, of which chapter 1 applies to every product and chapters 2 to 6 add requirements for certain machinery.

Chapter 1 holds the general requirements in sections 1.1 to 1.7, and chapters 2 to 6 supplement them for certain categories of machinery, mobility, lifting operations, underground work and the lifting of persons. Table 1 sets out each part with its content and scope.

Part A Definitions and Part B General Principles

Part A defines nine terms: hazard, danger zone, exposed person, operator, risk, guard, protective device, intended use and reasonably foreseeable misuse. A guard, for example, is "a part of machinery or a related product used specifically to provide protection by means of a physical barrier".

Part B sets five general principles. Point 1 makes "the manufacturer" ensure an iterative risk assessment in five steps, (a) to (e), from determining the limits of the product to eliminating hazards or reducing risks; the Directive named the "manufacturer of machinery or his authorised representative".

Point 3 keeps the requirements mandatory: where the state of the art prevents meeting them, the design approaches their objectives as far as possible.

Point 5 applies the general principles to the risk assessment of the manufacturer of partly completed machinery; the Directive had no such principle, though its Annex VII Part B already required risk-assessment documentation. The full wording of Annex III is on the Machinery Regulation legal text page.

Which Chapters Apply to Which Product

Part B point 2 makes each requirement apply only where the hazard it addresses exists for the product, while sections 1.1.2, 1.7.3 and 1.7.4 always apply. Those three sections cover the principles of safety integration, marking and the instructions for use.

Part B point 4 requires the manufacturer to examine the whole Annex: chapter 1 applies to every product, and chapters 2 to 6 apply according to the type of product.

The environmental protection requirements apply only to machinery covered by section 2.4. The Directive's general principle 4 spoke of "several parts"; the Regulation counts "six chapters".

Chapter 1: The General Requirements Section by Section

Chapter 1 of Annex III applies to every machine and related product and runs from section 1.1.1 on applicability to section 1.7.5 on sales literature, covering control systems, mechanical risks, guards and protective devices, energy, emission and radiation risks, maintenance, and information for users.

Table 2 lists the sections with their headings and the change against Annex I of Directive 2006/42/EC.

The contents list for instructions in section 1.7.4.2(1) now runs from (a) to (x), 24 points against 22 in the Directive, and point (v) on rescue information and point (x) on hazardous emissions are new.

The labels "Original instructions" and "Translation of the original instructions" no longer appear, and sales literature moves to its own section 1.7.5 (Directive section 1.7.4.3). Language, digital format and content of machinery instructions are explained on their own page.

Section 1.7.3 keeps the marking requirement, but the minimum nameplate particulars now follow from Article 10(5) and (6) and Article 24 of the Regulation. Section 1.5.1 applies the safety objectives of the Low Voltage Directive to the electricity supply.

Chapters 2 to 6: Supplementary Requirements for Certain Machinery

Chapters 2 to 6 of Annex III add requirements on top of chapter 1 for food, cosmetic and pharmaceutical machinery, portable hand-held machinery, woodworking machinery and plant protection machinery (chapter 2), and for mobility (chapter 3), lifting (chapter 4), underground work (chapter 5) and the lifting of persons (chapter 6).

Table 3 lists each chapter or section with its scope and its main point of change.

Chapter 3 now defines three terms in section 3.1.1: autonomous mobile machinery, the supervisor and the supervisory function. Autonomous mobile machinery is "mobile machinery which has an autonomous mode, in which all the essential safety functions of the mobile machinery are ensured in its travel and working operations area without permanent interaction of an operator".

Chapter 4 keeps the Directive's test and working coefficients, and section 4.1.3 now assigns the tests at the place of use to the manufacturer, without the authorised representative. Chapter 6 doubles the working coefficients for machinery lifting persons (section 6.1.1).

Machinery for Applying Plant Protection Products (Section 2.4)

Section 2.4 applies to machinery specifically intended for applying plant protection products within the meaning of Article 2(1) of Regulation (EC) No 1107/2009, and it is the only part of Annex III with environmental protection requirements.

Sections 2.4.3 to 2.4.10 cover controls, filling and emptying, application rate and drift, tests, cleaning, inspections, nozzle marking and instructions in points (a) to (k). Point 2.4.10(i) makes the instructions indicate the possible national regular inspection under Directive 2009/128/EC.

The section entered Annex I of the Directive through Directive 2009/127/EC, and the Commission issued standardisation request M/471 on 29 June 2010 for it. As of 12 November 2026, EN ISO 4254-6:2020 with EN ISO 4254-6:2020/A11:2021 and EN ISO 16119-1:2013 are listed under the Directive.

Machinery for Underground Work (Chapter 5)

Chapter 5 covers machinery for underground work: stability of powered roof supports (5.1), unhindered movement (5.2), the accelerator, brake and enabling device of rail machinery (5.3, 5.4), fire risks with built-in extinguishers, non-sparking brakes and low-vaporising-pressure fuel (5.5), and exhaust not discharged upwards (5.6). The chapter is unchanged against Annex I of the Directive.

What Is New in Annex III Compared with Directive Annex I

Annex III of Regulation (EU) 2023/1230 adds five new sections to the Directive's requirements, 1.1.9 on protection against corruption, 2.2.1(e) on extraction connections, 3.2.4 on the supervisory function, 3.5.4 on live overhead power lines and 3.6.3.3 on instructions for autonomous mobile machinery, and rewrites others such as 1.1.6 on ergonomics and 1.2.1 on control systems. Table 4 sets each change against Annex I of the Directive.

Directive 2006/42/EC applies until 19 January 2027, Regulation (EU) 2023/1230 from 20 January 2027.

Section 1.2.1(a) adds "reasonably foreseeable malicious attempts from third parties leading to a hazardous situation" to the influences a control system withstands.

Section 1.2.1(f) requires a tracing log of interventions and of safety software uploaded after placing on the market, enabled for five years after such upload, and self-evolving safety systems retain their safety-related decision data for one year after collection.

Both records serve exclusively to demonstrate conformity on a reasoned request from a competent national authority. The article-by-article Machinery Directive to Machinery Regulation changes sit on their own page.

Section 1.1.6 on ergonomics now says that stress on the operator "shall be eliminated or reduced to the minimum possible", taking into account "at least" seven principles, (a) to (g), where the Directive said "must be reduced" and listed five indents "such as".

Points (b), on demanding postures and manual force, and (g), on responding to people, are new.

Safety Integration and Testable Safety Functions (Section 1.1.2)

Section 1.1.2 keeps the Directive's order of protective measures, first eliminating hazards or minimising risks by design, then protective measures, then information on residual risks, and adds point (e): where applicable, the user must be able to test the safety functions, and the manufacturer describes specific functional test procedures.

Because section 1.1.2 is one of the three sections that always apply under Part B point 2, the new testing point reaches every product within the scope of the Regulation.

Human-Machine Coexistence and Hazardous Emissions (Sections 1.3.7 and 1.5.13)

Section 1.3.7 extends the prevention of contact risks, including psychological stress, to humans and machines coexisting in a shared space without direct collaboration and to direct human-machine interaction. The Directive's section 1.3.7 named neither situation.

Section 1.5.13 on emissions of hazardous materials and substances is linked to the new instruction point 1.7.4.2(1)(x).

Where the design allows hazardous emissions, the instructions give the characteristics of a capture, filtration or discharge device that is not supplied with the product, and data on the flow rate, the concentration around the machine or the effectiveness of the device.

Section 1.6.2 on access adds cleaning and the emergency rescue of persons who enter machinery.

Directive Annex I Until 19 January 2027 and the Switch to Annex III

Annex I of Directive 2006/42/EC remains the set of essential health and safety requirements for machinery placed on the market until 19 January 2027, applied through the national transpositions, and Annex III of Regulation (EU) 2023/1230 takes over for products placed on the market or put into service from 20 January 2027.

No parallel period exists. Products placed on the market in conformity with the Directive before the switch may still be made available afterwards (Article 52(1) of the Regulation), and what else ends with Machinery Directive 2006/42/EC is covered on its own page.

Annex XII of the Regulation, the correlation table, maps three annexes of the Directive, listed below.

• Directive Annex I (essential health and safety requirements): becomes Regulation Annex III.
• Directive Annex IV (high-risk categories): becomes Regulation Annex I.
• Directive Annex VII (technical file): becomes Regulation Annex IV.

Section 1.1.1, which held the Directive's definitions, is now "Applicability", and the definitions sit in Part A.

How Conformity with Annex III Is Shown

A product that conforms to harmonised standards whose references are published in the Official Journal of the European Union is presumed to conform to the Annex III requirements those standards cover (Article 20(1) of Regulation (EU) 2023/1230), as it was under Article 7(2) of Directive 2006/42/EC.

Applying harmonised standards is voluntary. Where adequate standards are missing, the Commission may adopt common specifications by implementing act under Article 20(3), only when a requested standard was not accepted, not delivered on time or not compliant with the request, and no reference is published or expected within a reasonable period.

Type A, B and C harmonised standards for machinery are compared on the standards page.

Article 20(9) adds a second route for two sections. Products certified, or covered by a statement of conformity, under a cybersecurity certification scheme adopted under Regulation (EU) 2019/881 whose references are published in the Official Journal are presumed to meet sections 1.1.9 and 1.2.1, insofar as the scheme covers them.

Among the Directive's standards, EN ISO 12100:2010 has been the only type-A standard in the list since Implementing Decision (EU) 2024/1329, and type-A standards alone do "not give a full presumption of conformity".

Where Annex III Stands on 2026-11-12

As of 12 November 2026, Annex III of Regulation (EU) 2023/1230 is unamended and applies from 20 January 2027, no harmonised standard is cited in the Official Journal under Regulation (EU) 2023/1230, and the Directive's list of harmonised standards is repealed with effect from 20 January 2027.

The Directive list, Implementing Decision (EU) 2023/1586 (OJ L 194, 2.8.2023, p. 45), was last amended by Implementing Decision (EU) 2026/2015 of 4 September 2026, whose Article 2 repeals it.

Regulation (EU) 2024/2748 and Article 3 of Regulation (EU) 2026/1744 amend other provisions of the Regulation, not Annex III. Every date of the Machinery Regulation timeline is listed in one place.

Article 8 of the Regulation now has a third and a fourth paragraph, inserted by Regulation (EU) 2026/1744 and in force since 27 July 2026: Commission delegated acts adding health and safety requirements for high-risk AI systems to Annex III "shall apply by 2 August 2028", and none has been adopted as of 12 November 2026.

As of 12 November 2026, the Commission's guide to the Regulation exists only as a temporary and partial edition, whose sections include Annex III sections 1.1.9, 1.2.1(a) and (f) and the vibration sections 1.5.9, 2.2.1.1 and 3.6.3.1.

Annex III Topic Pages: Nine Requirement Areas

Nine pages take one requirement area of Annex III each, from the risk assessment of Part B point 1 to ergonomics in section 1.1.6. Table 5 names each page with the Annex III provision it covers and the question it answers.

What Annex III Does Not Decide

Annex III sets design and construction requirements for the manufacturer; it does not set the conformity procedure, which follows from Annex I and Article 25, and it does not govern how employers use machinery at work.

Section 1.5.1 brings in the safety objectives of Directive 2014/35/EU while conformity assessment stays under the Regulation, as explained for the Low Voltage Directive and machinery.

Workplace exposure values for noise and vibration under Directives 2003/10/EC and 2002/44/EC are user-side values, not the emission values declared under Annex III, as covered with the Work Equipment Directive.

AI systems acting as safety components are also high-risk under Regulation (EU) 2024/1689. Machinery with digital elements may additionally fall under the horizontal Cyber Resilience Act, Regulation (EU) 2024/2847.

Frequently Asked Questions

Do the essential health and safety requirements apply to partly completed machinery?

Yes, insofar as relevant: section 1.1.1 of Annex III applies the requirements to partly completed machinery as far as they are relevant, section 1.1.2 always, and Part B point 5 applies the general principles to its risk assessment. The duties for partly completed machinery are set out on their own page.

Is there an EHSR checklist?

Annex IV, Part A, point (b) of Regulation (EU) 2023/1230 requires the technical documentation to include the risk-assessment documentation with a list of the applicable essential health and safety requirements and a description of the protective measures taken and the residual risks. That list is kept as part of the machinery technical file.