---
title: "EU Machinery Regulation Safety Components"
canonical_url: "https://www.sorena.io/artifacts/eu/machinery-regulation/safety-components"
source_url: "https://www.sorena.io/artifacts/eu/machinery-regulation/safety-components"
author: "Sorena AI"
description: "Definition, scope, conformity assessment, technical documentation, declaration, CE marking, and grounded examples for safety components under Regulation (EU) 2023/1230."
published_at: "2026-05-09"
updated_at: "2026-05-09"
keywords:
  - "EU Machinery Regulation"
  - "Regulation (EU) 2023/1230"
  - "safety components"
  - "related products"
  - "CE marking"
  - "conformity assessment"
---
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# EU Machinery Regulation Safety Components

Definition, scope, conformity assessment, technical documentation, declaration, CE marking, and grounded examples for safety components under Regulation (EU) 2023/1230.

*Artifact Guide* *EU*

## Machinery Regulation safety components

Regulation (EU) 2023/1230 treats safety components as related products when they are independently placed on the Union market and meet the regulation's safety-function definition.

Use this page to classify a component, choose the conformity assessment route, and collect the technical-file, declaration, and CE-marking evidence needed before placing it on the market.

A safety component is not just any part that helps a machine operate safely. Under Regulation (EU) 2023/1230, it is a physical or digital component, including software, designed or intended to fulfil a safety function, independently placed on the market, whose failure or malfunction endangers persons, and that is not necessary for the product to function or can be replaced by a normal component.

## When a component is in scope

Article 2 lists safety components as related products within the Machinery Regulation's scope. That matters because a safety component placed on the market as its own product follows the machinery-and-related-product obligations, not the partly completed machinery declaration route.

Use the Article 3 definition as a gating test. The component must be physical or digital, may include software, must be designed or intended for a safety function, must be independently placed on the market, and its failure or malfunction must endanger the safety of persons. The definition also excludes components that are necessary for the product to function unless a normal component may be substituted for that function.

- Record the safety function and the protective measure it supports.
- Confirm whether the component is independently placed on the Union market rather than only supplied inside finished machinery.
- Do not classify an identical replacement safety component supplied by the original manufacturer as in-scope when Article 2(2)(a) excludes that spare-part case.
- Treat software and digital components as candidates where they perform the safety function and meet the independent-market condition.

Sources for this answer:

- [Consolidated Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A02023R1230-20230629&ref=sorena.io) - Supports the scope rule that safety components are related products, the spare-part exclusion, and the Article 3 definition of a safety component.

## EHSR and risk assessment record

A safety component that is a related product may be made available or put into service only if it meets the applicable essential health and safety requirements in Annex III when properly installed, maintained, and used as intended or under reasonably foreseeable conditions.

The technical file should therefore start with a risk-assessment record, not with a label. Annex IV, Part A requires documentation of the risk-assessment procedure, the applicable EHSRs, protective measures for each applicable requirement, and residual risks where relevant.

- Identify the hazardous situation the safety function is meant to eliminate or reduce.
- Map each applicable Annex III EHSR to design measures, tests, inspections, calculations, or other verification evidence.
- List any harmonised standards or common specifications applied, and identify any partial application or alternative technical specifications.
- For safety-related software, keep enough source-code or programming-logic evidence to support authority checks when a competent national authority makes a reasoned request.

Sources for this answer:

- [Consolidated Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A02023R1230-20230629&ref=sorena.io) - Supports the Annex III EHSR obligation and Annex IV, Part A technical-documentation elements for machinery and related products.
- [ISO 12100:2010 safety of machinery](https://www.iso.org/obp/ui/en/?ref=sorena.io#!iso:std:51528:en) - Grounding source for machinery risk-assessment and risk-reduction methodology used to structure safety-component evidence.

## Conformity assessment route

Article 25 chooses the conformity assessment route by Annex I status. If the safety component is in Annex I, Part A, the manufacturer must use one of the Article 25(2) procedures: EU type-examination with conformity to type, full quality assurance, or unit verification.

Annex I, Part A expressly includes safety components with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions. If a safety component is not listed in Annex I, Article 25(4) points to internal production control.

- Check Annex I before selecting Module A because some safety components require a notified-body route.
- Use Article 25(2) for Annex I, Part A safety components, including qualifying machine-learning safety components.
- Use Article 25(4) internal production control only where the safety component is not in Annex I.
- Keep the conformity-route decision in the technical documentation with the Annex I classification rationale.

Sources for this answer:

- [Consolidated Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A02023R1230-20230629&ref=sorena.io) - Supports Article 25 conformity-assessment routes and Annex I, Part A treatment of machine-learning safety components.
- [Single Market Compliance Space notified bodies listing](https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/by-legislation?ref=sorena.io) - Grounding source for the EU notified-body search context used when a safety component follows a notified-body conformity-assessment route.

*Recommended next step*

*Placement: after conformity section*

## Classify safety components before release

Turn the safety-function definition, Annex I route, Annex IV file contents, declaration, and CE marking checks into a release review for components placed independently on the Union market.

- [Open Research Copilot](/solutions/research-copilot.md): Answer Machinery Regulation scope and conformity questions with cited outputs.
- [Talk through implementation](/contact.md): Review your safety-component classification, technical-file evidence, and conformity route.

## Technical documentation, declaration, and CE marking

Before placing a safety component on the market, the manufacturer must draw up Annex IV, Part A technical documentation and carry out, or have carried out, the relevant Article 25 conformity assessment procedure. Once compliance is demonstrated, the manufacturer draws up the EU declaration of conformity and affixes the CE marking.

The EU declaration of conformity must state that the applicable EHSRs have been demonstrated, follow the Annex V, Part A model structure, stay updated, and be translated into the required Member State language or languages. The CE marking must be visible, legible, indelible, and affixed before the related product is placed on the market or put into service.

- Keep technical documentation and the EU declaration of conformity available for market surveillance authorities for at least 10 years after placing on the market or putting into service.
- Include the EU declaration with the safety component or provide the internet address or machine-readable code where it can be accessed through the instructions and Annex III information.
- Add the notified body's identification number after the CE marking where the selected Article 25 procedure requires notified-body involvement.
- Ensure importer and distributor checks align with the manufacturer's CE marking, required documents, and instructions package.

Sources for this answer:

- [Consolidated Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A02023R1230-20230629&ref=sorena.io) - Supports manufacturer duties for technical documentation, EU declaration of conformity, CE marking, document availability, and declaration access.

## Examples grounded in Annex II

Annex II is an indicative list, so a component can still need analysis even if it is not named there. Use the list as a practical check against the definition and the market-placement facts.

Examples named in Annex II include protective devices designed to detect the presence of persons, logic units to ensure safety functions, emergency stop devices, two-hand control devices, valves with additional means for failure detection for dangerous movements, extraction systems for machinery emissions, and roll-over or falling-object protective structures.

- Do not stop at the example name; confirm independent placing on the market and the safety-function failure consequence.
- For guards, protective devices, logic units, and emergency stops, document whether the component is supplied as its own related product or only as part of finished machinery.
- For software-driven or machine-learning safety functions, check both the Article 3 definition and the Annex I classification before choosing the conformity procedure.

Sources for this answer:

- [Consolidated Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A02023R1230-20230629&ref=sorena.io) - Supports the Annex II indicative safety-component examples and the Annex I classification point for machine-learning safety components.

## Primary sources

- [Consolidated Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A02023R1230-20230629&ref=sorena.io) - Primary source for safety-component scope, definition, related-product status, EHSRs, conformity assessment, technical documentation, EU declaration of conformity, CE marking, and Annex II examples.
  - Quote: "safety component"
- [ISO 12100:2010 safety of machinery](https://www.iso.org/obp/ui/en/?ref=sorena.io#!iso:std:51528:en) - Risk-assessment and risk-reduction source used only for the risk-assessment evidence framing.
  - Quote: "Risk assessment and risk reduction"
- [Single Market Compliance Space notified bodies listing](https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/by-legislation?ref=sorena.io) - EU notified-body search source used only for conformity-assessment routes that require notified-body involvement.
  - Quote: "conformity assessments"

## Related Topic Guides

- [Declaration of Conformity vs Declaration of Incorporation | Machinery Regulation FAQ](/artifacts/eu/machinery-regulation/faq/doc-and-doi.md): FAQ on when machinery needs an EU Declaration of Conformity and when partly completed machinery needs an EU Declaration of Incorporation under Regulation (EU) 2023/1230.
- [Directive 2006/42/EC to Machinery Regulation transition](/artifacts/eu/machinery-regulation/transition-from-directive-2006-42-ec.md): Transition guide for moving EU machinery files from Directive 2006/42/EC to Regulation (EU) 2023/1230, focused on the 20 January 2027 changeover, pipeline products, declarations, standards, technical documentation, software, cybersecurity, and digital instructions.
- [EU Machinery Regulation Applicability Test](/artifacts/eu/machinery-regulation/applicability-test.md): Test whether a product is machinery, a related product, partly completed machinery, a safety component, substantially modified, excluded, or covered by overlapping EU product laws.
- [EU Machinery Regulation compliance](/artifacts/eu/machinery-regulation/compliance.md): Machinery Regulation compliance checklist covering scope, EHSR risk assessment, technical documentation, instructions, conformity assessment, EU declarations, CE marking, software, transition, and market surveillance.
- [EU Machinery Regulation compliance checklist](/artifacts/eu/machinery-regulation/checklist.md): Checklist for Regulation (EU) 2023/1230 covering scope, EHSR risk assessment, technical documentation, instructions, conformity assessment, EU declarations, CE marking, digital duties, transition, and market surveillance.
- [EU Machinery Regulation deadlines and compliance calendar](/artifacts/eu/machinery-regulation/deadlines-and-compliance-calendar.md): Calendar for Regulation (EU) 2023/1230 dates, Directive 2006/42/EC transition, release documentation gates, standards monitoring, and substantial-modification reviews.
- [EU Machinery Regulation FAQ](/artifacts/eu/machinery-regulation/faq.md): Answers to Machinery Regulation questions on scope, partly completed machinery, Annex I categories, Article 25 conformity assessment, digital instructions, software, cybersecurity, transition, CE files, and overlap with other EU product laws.
- [EU Machinery Regulation Partly Completed Machinery](/artifacts/eu/machinery-regulation/partly-completed-machinery.md): What counts as partly completed machinery under Regulation (EU) 2023/1230, what documents travel with it, and where the final assembler takes over.
- [EU Machinery Regulation requirements](/artifacts/eu/machinery-regulation/requirements.md): Requirements under Regulation (EU) 2023/1230: machinery scope, EHSR risk assessment, technical documentation, instructions, conformity assessment, EU declaration, CE marking, software evidence, transition, and surveillance.
- [EU Machinery Regulation scope and machine categories](/artifacts/eu/machinery-regulation/scope-and-machine-categories.md): Scope guide for Regulation (EU) 2023/1230 covering machinery, related products, partly completed machinery, Annex I categories, exclusions, substantial modification, and category evidence.
- [EU Machinery Regulation substantial modification decision workflow](/artifacts/eu/machinery-regulation/substantial-modification-workflow.md): Workflow for assessing substantial modification under Regulation (EU) 2023/1230: change facts, hazard and risk impact, manufacturer obligations, conformity assessment, CE marking, and evidence.
- [EU Machinery Regulation vs LVD](/artifacts/eu/machinery-regulation/machinery-vs-lvd.md): Compare the EU Machinery Regulation and Low Voltage Directive boundary for machinery EHSRs, electrical risks, excluded electrical products, CE documentation, and evidence reuse.
- [EU Machinery Regulation vs Market Surveillance Regulation: compliance comparison](/artifacts/eu/machinery-regulation/machinery-vs-msr.md): Compare Machinery Regulation product compliance duties with EU MSR market surveillance duties, authority requests, online sales, corrective action and evidence records.
- [EU Machinery Regulation: autonomous mobile and collaborative machinery](/artifacts/eu/machinery-regulation/autonomous-mobile-and-collaborative-machinery.md): Grounded guide to Regulation (EU) 2023/1230 requirements for autonomous mobile machinery, human-machine interaction, controls, software, cybersecurity, risk assessment, technical documentation, and conformity routes.
- [EU Machinery Regulation: when does a modification constitute substantial modification?](/artifacts/eu/machinery-regulation/substantial-modification.md): Guide to substantial modification under Regulation (EU) 2023/1230: change triggers, risk assessment, EHSRs, technical documentation, conformity assessment, CE marking, and records.
- [EU Machinery Risk Assessment Method](/artifacts/eu/machinery-regulation/risk-assessment-method.md): How to document an EU Machinery Regulation risk assessment: ISO 12100 hazard identification, EHSR mapping, risk reduction, residual risk, software, cybersecurity, and technical-file evidence.
- [How to map Annex III EHSRs under the EU Machinery Regulation | Machinery Regulation FAQ](/artifacts/eu/machinery-regulation/faq/annex-iii-ehsr.md): FAQ on mapping Annex III essential health and safety requirements to hazards, risk reduction, software controls, technical documentation, and Annex I classification under Regulation (EU) 2023/1230.
- [Machinery CE documentation template for Regulation (EU) 2023/1230](/artifacts/eu/machinery-regulation/machinery-ce-documentation-template.md): Template fields for Machinery Regulation CE documentation: product identity, scope, EHSR risk assessment, standards, tests, instructions, EU declaration, CE marking, notified body route, software, cyber, and substantial modification checks.
- [Machinery Regulation and EU AI Act overlap for AI-enabled safety functions](/artifacts/eu/machinery-regulation/faq/ai-act-overlap.md): FAQ on Machinery Regulation overlap with the EU AI Act for self-evolving or machine-learning safety functions, Annex I categories, standards work, and technical documentation boundaries.
- [Machinery Regulation Annex I conformity route workflow](/artifacts/eu/machinery-regulation/annex-i-route-workflow.md): Classify machinery against Annex I Part A and Part B, choose the Article 25 conformity assessment route, and assemble the technical evidence file.
- [Machinery Regulation Annex I high-risk categories](/artifacts/eu/machinery-regulation/annex-i-and-high-risk-machinery.md): Explain what Annex I does under Regulation (EU) 2023/1230, which listed machinery categories trigger special conformity routes, and what evidence to keep.
- [Machinery Regulation category and scope checks](/artifacts/eu/machinery-regulation/category-and-scope-workflow.md): Check whether a product is machinery, a related product, partly completed machinery, a safety component, excluded from scope, or listed in Annex I under Regulation (EU) 2023/1230.
- [Machinery Regulation conformity assessment and CE marking](/artifacts/eu/machinery-regulation/conformity-assessment-and-ce.md): EU Machinery Regulation guide to Article 25 conformity assessment routes, Annex I machinery categories, technical documentation, EU declarations, CE marking, and instructions.
- [Machinery Regulation cybersecurity evidence FAQ](/artifacts/eu/machinery-regulation/faq/cybersecurity.md): What cybersecurity evidence connected or software-enabled machinery should keep for protection against corruption, safety-related control systems, and machinery risk assessment.
- [Machinery Regulation digital instructions](/artifacts/eu/machinery-regulation/digital-instructions.md): EU Machinery Regulation guide to digital instructions for use: access marking, print and download access, paper copies, non-professional safety information, languages, and records.
- [Machinery Regulation penalties and enforcement](/artifacts/eu/machinery-regulation/penalties-and-fines.md): EU Machinery Regulation enforcement guide covering Member State penalty rules, corrective action, market surveillance powers, and cross-border authority cooperation.
- [Machinery Regulation related products scope guide](/artifacts/eu/machinery-regulation/related-products.md): Classify EU Machinery Regulation related products, including interchangeable equipment, safety components, lifting accessories, lifting chains, ropes, webbing, and removable transmission devices.
- [Machinery Regulation software and cybersecurity considerations](/artifacts/eu/machinery-regulation/software-and-cybersecurity-considerations.md): How Regulation (EU) 2023/1230 treats safety-related software, control systems, corruption protection, technical documentation, and cyber-safety risk evidence.
- [Machinery Regulation Technical Documentation and Technical File](/artifacts/eu/machinery-regulation/technical-documentation-and-technical-file.md): What to keep in the EU Machinery Regulation technical file: product identification, risk assessment, EHSR mapping, standards, tests, instructions, declarations, software evidence, retention, and notified-body records.
- [Machinery Regulation technical file acceptance workflow](/artifacts/eu/machinery-regulation/technical-file-acceptance-workflow.md): Release-gate workflow for accepting an EU Machinery Regulation technical file: scope, EHSR risk evidence, standards, tests, declarations, notified-body records, software, cyber, and signoff.
- [Machinery Regulation Timeline and Transition: practical guide](/artifacts/eu/machinery-regulation/timeline-and-transition.md): EU Machinery Regulation guide to Timeline and Transition with scope decisions, owner actions, evidence records, source-linked citations, and practical next steps.
- [Machinery Regulation vs EMC Directive](/artifacts/eu/machinery-regulation/machinery-vs-emc.md): Compare EU machinery safety duties with EMC duties for equipment, CE documentation, harmonised standards, declarations, and combined technical files.
- [Machinery Regulation vs EU AI Act: machinery safety overlap](/artifacts/eu/machinery-regulation/machinery-regulation-vs-eu-ai-act.md): A grounded comparison of the EU Machinery Regulation and EU AI Act for machinery with AI-enabled safety functions, software, cyber-safety and technical documentation overlap.
- [Machinery Regulation vs Machinery Directive](/artifacts/eu/machinery-regulation/machinery-regulation-vs-machinery-directive.md): Grounded comparison of Regulation (EU) 2023/1230 and Directive 2006/42/EC across legal form, timing, scope, digital instructions, cybersecurity, conformity assessment, documentation, and CE marking.
- [Machinery vs RED comparison](/artifacts/eu/machinery-regulation/machinery-vs-red.md): Compare EU Machinery Regulation and Radio Equipment Directive boundaries for machinery safety, radio equipment scope, CE documentation, and shared evidence.
- [What counts as machinery under Regulation (EU) 2023/1230?](/artifacts/eu/machinery-regulation/faq/machinery-definition.md): FAQ on the Machinery Regulation definition of machinery, including assemblies, drive systems, missing components, software, related products, partly completed machinery, safety components, and exclusions.
- [When can a software update affect Machinery Regulation compliance?](/artifacts/eu/machinery-regulation/faq/software-updates.md): FAQ on when machinery software updates can trigger Machinery Regulation review, including safety functions, substantial modification, corruption protection, instructions, and CE technical-file evidence.
- [When does used or modified machinery need a new conformity assessment? | Machinery Regulation FAQ](/artifacts/eu/machinery-regulation/faq/used-and-modified-machinery.md): FAQ on used and modified machinery under Regulation (EU) 2023/1230, including substantial modification, first EU use, technical documentation, and market surveillance evidence.
- [When is a notified body needed under the EU Machinery Regulation?](/artifacts/eu/machinery-regulation/faq/notified-bodies.md): FAQ on when Machinery Regulation Annex I products need a notified body, how to find designated bodies, and what manufacturers still own.
- [Which Article 25 conformity assessment module applies? | EU Machinery Regulation FAQ](/artifacts/eu/machinery-regulation/faq/article-25-modules.md): FAQ on Article 25 of Regulation (EU) 2023/1230: Module A, Module B plus C, Module H, Module G, Annex I triggers, notified body involvement, and technical file evidence.


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