--- title: "Machinery Regulation Annex I high-risk categories" canonical_url: "https://www.sorena.io/artifacts/eu/machinery-regulation/annex-i-and-high-risk-machinery" source_url: "https://www.sorena.io/artifacts/eu/machinery-regulation/annex-i-and-high-risk-machinery" author: "Sorena AI" description: "Explain what Annex I does under Regulation (EU) 2023/1230, which listed machinery categories trigger special conformity routes, and what evidence to keep." published_at: "2026-05-09" updated_at: "2026-05-09" keywords: - "EU Machinery Regulation" - "Regulation (EU) 2023/1230" - "Annex I" - "high-risk machinery" - "conformity assessment" - "notified bodies" --- **[SORENA](https://www.sorena.io/)** - AI-Powered GRC Platform [Home](https://www.sorena.io/) | [Solutions](https://www.sorena.io/solutions) | [Artifacts](https://www.sorena.io/artifacts) | [About Us](https://www.sorena.io/about-us) | [Contact](https://www.sorena.io/contact) | [Portal](https://app.sorena.io) --- # Machinery Regulation Annex I high-risk categories Explain what Annex I does under Regulation (EU) 2023/1230, which listed machinery categories trigger special conformity routes, and what evidence to keep. *Artifact Guide* *EU* ## EU Machinery Regulation Annex I high-risk categories Annex I to Regulation (EU) 2023/1230 lists machinery and related product categories that receive a special conformity-assessment route because of their inherent potential risk. Use this page to distinguish Annex I Part A from Part B, identify the listed category, and keep the evidence that supports the selected conformity-assessment route. Annex I is not the Annex that contains the essential health and safety requirements under the Machinery Regulation. It is the list of machinery and related product categories that receive the Article 25 conformity-assessment procedures reserved for higher-risk categories. The essential health and safety requirements are in Annex III; the Annex I decision tells the manufacturer which assessment route must be used before CE marking and the EU declaration of conformity. ## What Annex I means under Regulation (EU) 2023/1230 Article 6 divides Annex I into Part A and Part B. Part A categories must use one of the Article 25(2) procedures. Part B categories use Article 25(3), where internal production control is available only when the product is designed and constructed in accordance with harmonised standards or common specifications specific to that category and covering all relevant essential health and safety requirements. The Regulation also explains how categories can be added, removed, or moved between parts. The Commission assesses the seriousness of inherent potential risk using probability of harm and severity of harm, with criteria such as hazard nature, persons affected, exposure, avoidability, safety-component failure consequences, accident data, close calls, market surveillance findings, and uncertainty in risk assessment methods for new technologies. - Do not treat every Annex III essential health and safety requirement as an Annex I high-risk category; Annex I is a category trigger for conformity assessment. - Use the exact Annex I item text, product configuration, intended use, and foreseeable misuse when classifying a product. - Keep the category decision separate from the technical design evidence that proves conformity with Annex III. Sources for this answer: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Article 6 and Annex I define the listed categories and link Part A and Part B to the Article 25 conformity-assessment routes. - [European Commission - Machinery sector page](https://single-market-economy.ec.europa.eu/sectors/mechanical-engineering/machinery_en?ref=sorena.io) - Commission context for the Regulation's treatment of machinery presenting a higher risk factor and its continued use of mandatory requirements plus voluntary harmonised standards. ## Part A categories and the mandatory third-party routes Annex I Part A contains a short list: removable mechanical transmission devices including their guards; guards for removable mechanical transmission devices; vehicle servicing lifts; portable cartridge-operated fixing and other impact machinery; safety components with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions; and machinery with embedded systems with such self-evolving behaviour ensuring safety functions, in respect only of those systems. For these Part A categories, Article 25(2) does not offer Module A internal production control. The manufacturer, or the person responsible for a substantial modification under Article 18, must use EU type-examination followed by conformity to type, full quality assurance, or unit verification. - Record whether the product is the listed machinery, a related product, an independently placed safety component, or an embedded safety-function system inside the machinery. - If Part A applies, identify the selected procedure as Module B plus Module C, Module H, or Module G. - If the classification depends on machine-learning self-evolving behaviour, document the safety function, whether the component is independently placed on the market, and the product boundary covered by the decision. Sources for this answer: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Annex I Part A lists the categories and Article 25(2) names the available procedures for those categories. - [Single Market Compliance Space - notified bodies by legislation](https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/by-legislation?ref=sorena.io) - Official EU search page showing Regulation (EU) 2023/1230 on machinery as active legislation for notified-body conformity assessment searches. ## Part B categories and when internal production control is enough Annex I Part B carries the longer list. It includes specified woodworking and meat-processing saws, hand-fed planing and tenoning machinery, thickeners, bandsaws, combined woodworking machinery, portable chainsaws, certain metalworking presses, injection or compression plastics and rubber moulding machinery with manual loading or unloading, specified underground-working machinery, manually loaded household refuse trucks with a compression mechanism, lifting devices for persons or persons and goods involving a vertical fall hazard of more than 3 m, protective devices detecting persons, certain power-operated interlocking movable guards, logic units for safety functions, ROPS, and FOPS. Part B does not automatically require a notified body in every case. Article 25(3) permits Module A internal production control only where harmonised standards or common specifications specific to the category cover all relevant essential health and safety requirements and have been applied for design and construction. If that full coverage and application cannot be shown, the route changes to Module B plus Module C, Module H, or Module G. - Quote the specific Part B item number and the words that match the product, such as manual loading or unloading, vertical fall hazard over 3 m, or safety-function logic unit. - For Module A, keep a standards coverage matrix showing the harmonised standards or common specifications, publication references, applied parts, and the Annex III requirements they cover. - Where standards are absent, partial, not applied, or not category-specific, document why a notified-body route is being used instead of Module A. Sources for this answer: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Annex I Part B lists the categories, and Article 25(3) sets the condition for using internal production control. - [European Commission - Machinery sector page](https://single-market-economy.ec.europa.eu/sectors/mechanical-engineering/machinery_en?ref=sorena.io) - Commission context for harmonised standards and notified bodies under EU machinery legislation. ## How to document the category decision A usable Annex I record should let a reviewer reproduce the classification without knowing the project history. Start with the product boundary, model or configuration, intended use, foreseeable misuse, market role, and whether the item is machinery, a related product, a safety component, or partly completed machinery. Then attach the Annex I item analysis, the Article 25 route, and the evidence behind that route. For a Part B Module A route, the key evidence is the standards or common specifications coverage. For notified-body routes, keep the application, technical documentation, certificates, reports, quality-system decisions, and any changes or certificate reviews that affect the approval. - Store the Annex I item number, quoted category text, matching product facts, exclusions considered, and final route. - Keep risk assessment documentation, Annex III EHSR mapping, drawings and schemes, applied standards or other specifications, design calculations, tests, inspections, examinations, instructions for use, declarations, and production-control evidence. - For safety-related software, sensor-fed, remotely driven, or autonomous machinery, retain the source-code or programming-logic response basis and the system characteristics, capabilities, limitations, development, testing, and validation records described in Annex IV where applicable. - For legacy Machinery Directive files, preserve the old Annex IV classification and conformity-assessment evidence separately from the Regulation Annex I decision so transition reviews do not mix the two lists. Sources for this answer: - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Annex IV describes the technical documentation elements for machinery, related products, and partly completed machinery. - [Guide to application of the Machinery Directive 2006/42/EC](https://ec.europa.eu/docsroom/documents/60145?ref=sorena.io) - Commission guide for legacy Directive 2006/42/EC context, including Annex IV machinery and conformity-assessment interpretation under the predecessor regime. - [ISO 12100:2010 - Safety of machinery](https://www.iso.org/obp/ui/en/?ref=sorena.io#!iso:std:51528:en) - ISO source for machinery risk assessment and risk-reduction methodology used as engineering context for classification evidence. *Recommended next step* *Placement: after implementation section* ## Document the Annex I route before release Turn the Annex I category decision into a reusable classification record with the product facts, Article 25 route, standards coverage, notified-body evidence where needed, and technical-file references. - [Open Research Copilot](/solutions/research-copilot.md): Answer Machinery Regulation scope, category, and source questions with cited outputs. - [Talk through implementation](/contact.md): Review your Annex I category logic, conformity route, technical-file evidence, and release controls. ## Common classification mistakes The main error is using a broad label such as high-risk machinery without tying it to an Annex I item and an Article 25 route. The Regulation's list is category-specific. A category decision should be based on the listed product type and its characteristics, not on a general view that the machine is dangerous. Another recurring problem is confusing the Regulation's Annex I with the Machinery Directive's Annex IV. The legacy guide is still useful for understanding Directive classifications, but Regulation (EU) 2023/1230 moved the listed high-risk categories into Annex I and changed the legal route references. - Do not use a voluntary certificate from a body outside its notified scope as proof of conformity. - Do not select Module A for a Part B product unless the standards or common specifications are specific to that category and cover all relevant Annex III requirements. - Do not treat a safety component, an embedded safety-function system, and complete machinery as interchangeable classifications. - Do not bury the category analysis inside a generic risk assessment; the Annex I item and Article 25 route should be explicit. Sources for this answer: - [European Commission - Machinery sector page](https://single-market-economy.ec.europa.eu/sectors/mechanical-engineering/machinery_en?ref=sorena.io) - Commission warning that voluntary or additional certificates are not a recognised means to prove compliance under EU harmonisation checks. - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Article 46 identifies formal non-compliance issues such as missing CE marking, incorrect declarations, and incomplete technical documentation. ## Primary sources - [Regulation (EU) 2023/1230 on machinery](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Primary legal source for Annex I category lists, Article 6 risk-listing logic, Article 25 conformity-assessment routes, Annex IV technical documentation, and Annex V declaration content. - Quote: "Categories of machinery and related products listed in Annex I" - [European Commission - Machinery sector page](https://single-market-economy.ec.europa.eu/sectors/mechanical-engineering/machinery_en?ref=sorena.io) - Commission source for Regulation implementation context, harmonised standards, notified bodies, higher-risk conformity assessment, and the warning on voluntary certificates. - Quote: "addresses the conformity assessment of machinery presenting a higher risk factor" - [Single Market Compliance Space - notified bodies by legislation](https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/by-legislation?ref=sorena.io) - Official EU notified-body search entry confirming Regulation (EU) 2023/1230 on machinery appears as active legislation for conformity-assessment body searches. - Quote: "Regulation (EU) 2023/1230 on machinery" - [Guide to application of the Machinery Directive 2006/42/EC](https://ec.europa.eu/docsroom/documents/60145?ref=sorena.io) - Commission guide used only for legacy Machinery Directive context, especially Annex IV machinery and predecessor conformity-assessment terminology. - Quote: "Annex IV machinery" - [ISO 12100:2010 - Safety of machinery](https://www.iso.org/obp/ui/en/?ref=sorena.io#!iso:std:51528:en) - Machinery-safety standard source for risk-assessment and risk-reduction methodology used to structure category evidence. - Quote: "Risk assessment and risk reduction" ## 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. - 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