For machinery exported to the European Union, CE marking is a legally mandatory requirement. Within the CE technical documentation, there is a frequently overlooked report that directly determines the completeness of technical files and the validity of the CE Declaration of Conformity — the ISO/EN 12100 risk assessment report.
The EU Machinery Directive 2006/42/EC explicitly mandates that manufacturers shall carry out risk assessment for machinery and design and manufacture machinery based on assessment results. As a Category A basic safety standard, EN ISO 12100 defines the methodological framework for risk assessment and risk reduction.
Without a risk assessment report developed in accordance with ISO/EN 12100, the technical file will be incomplete, and the CE Declaration of Conformity will lack a solid foundation. Products may face detention at EU customs, removal from the market, or even legal liabilities during market surveillance.
01 What is ISO/EN 12100?
Standard Positioning: The Top-Tier Document in the Machinery Safety Standard Hierarchy
Machinery safety standards are classified into three tiers:
Category A (Basic Safety Standards): Specify fundamental concepts and design principles applicable to all machinery
Category B (Generic Safety Standards): Address a specific safety aspect or protective devices
Category C (Machine-Specific Safety Standards): Provide detailed safety requirements for particular types of machinery
ISO/EN 12100 falls under Category A, serving as the "constitution" for the entire machinery safety standard system. Both Category B and Category C standards are formulated based on it.
History & Revision
The 2010 edition of EN ISO 12100 consolidated three previous standards: ISO 12100-1 (basic terminology and methodology), ISO 12100-2 (technical principles), and ISO 14121-1 (risk assessment). A 2025 revision draft is in progress, incorporating new clauses on hygiene and cybersecurity, while retaining the core methodology.
Core Content: Three-Step Iterative Risk Process
The standard defines a cyclic and iterative workflow:
Define machinery limits → Hazard identification → Risk estimation and evaluation → Risk reduction (in a priority order: inherently safe design, safety guards, information for use) → Verification.
The report shall fully document evidence of this entire workflow.
02 Key Clarifications Before Application
Question 1: Self-Declaration or Third-Party Certification?
This depends on whether the machinery belongs to high-risk categories listed in Annex IV of the Machinery Directive.
Annex IV machinery (e.g., certain presses, injection moulding machines, woodworking machinery): Mandatory intervention by an EU Notified Body for CE type examination; the risk assessment report is subject to review.
Non-Annex IV machinery: Self-declaration route is permitted. Manufacturers may complete risk assessment and sign the Declaration of Conformity on their own.
However, "self-declaration" does not mean arbitrary declaration. The technical documentation must remain complete and traceable for inspection.
Question 2: Relationship Between Report and Certificate
The ISO/EN 12100 report itself is not a certificate. It is a core component of technical documentation. Reports issued by Notified Bodies or third-party test laboratories demonstrate that the machinery’s risk assessment process complies with the methodology specified in EN ISO 12100.
For Annex IV machinery: The Notified Body issues the CE type examination certificate based on this report and other technical documents.
For non-Annex IV machinery: The report serves as factual evidence supporting the manufacturer’s self-declaration.
Question 3: How to Verify a Notified Body
The primary verification tool is the EU NANDO database. A valid Notified Body with assessment competence under the Machinery Directive has a four-digit NB number, and its scope of designation must explicitly cover Machinery Directive 2006/42/EC.
Possession of ISO 9001 or ISO/IEC 17025 accreditation alone does not confer Notified Body status.
03 Application Process & Required Documents
Workflow Overview
Confirm applicability of the Machinery Directive and machinery classification: Verify whether the product falls within the scope of the Machinery Directive per Annex I, then check Annex IV to determine if Notified Body involvement is required.
Prepare draft technical documentation: This is the most time-consuming step and the core subject for laboratory review.
Conduct risk assessment: Complete hazard identification, risk estimation & evaluation, and risk mitigation plan documentation following the iterative workflow of EN ISO 12100 to generate the risk assessment report.
Submit for review and obtain the report: The third-party laboratory audits the methodological compliance of risk assessment and completeness of technical files. On-site inspection or physical testing may be performed when necessary. A formal report will be issued upon approval.
Required Document Checklist
Product description: Function, intended use, technical parameters, and variant analysis for different models
Design documents: General assembly drawings, component drawings, electrical/pneumatic schematics, description of safety devices
Risk assessment report: Prepared under the EN ISO 12100 framework, including hazard list, risk estimation, mitigation measures and residual risk statement
List of safety-related components: CE certificates or declarations of conformity for safety components such as emergency stop buttons, safety light curtains and interlock devices
Information for use: Operation manual, maintenance instructions, warning labels and nameplate drawings
Draft Declaration of Conformity: To be signed by the manufacturer
Per Annex VII of the Machinery Directive, technical documentation must enable assessment of the machinery’s compliance with directive requirements and shall be retained for at least 10 years after the machinery is placed on the market.
04 Common Misconceptions & Practical Tips
Misconception 1: "A CE certificate is everything."
A certificate issued by a Notified Body proves compliance at the time of certification. Market surveillance authorities may request full technical files at any time. If the risk assessment report contains methodological defects, the certificate may still be challenged.
Misconception 2: "One-time risk assessment is sufficient."
EN ISO 12100 mandates an iterative assessment. Design changes, newly identified hazards or incident feedback can trigger reassessment. For product series, coverage analysis must be documented for any model variation.
Practical Tips
Technical documentation shall be kept for a minimum of 10 years after machinery launch.
An English version of the report is recommended for review by EU regulators.
For first-time applicants, pre-review consultation with the testing laboratory at the draft technical documentation stage is recommended to avoid repeated revisions caused by non-compliant document frameworks for EN ISO 12100.
05 Our Services
As an accredited third-party testing and certification laboratory, we provide professional support for ISO/EN 12100 report preparation:
Accreditation: CMA, CNAS and IAS recognition
Full-cycle service: Machinery Directive applicability confirmation, technical document review and risk assessment report issuance
Expert team: Well-versed in EU Machinery Directive and EN ISO 12100 methodology
One-stop support: Assistance with CE Declaration of Conformity and technical documentation preparation
