Machinery CE Marking: Directive 2006/42/EC and Regulation (EU) 2023/1230

The Machinery Directive (2006/42/EC) sets the safety requirements a machine must meet, from design to placing on the market. Manufacturers, importers and authorised representatives must carry out a risk assessment, compile a technical file, draw up a Declaration of Conformity and affix the CE marking. The new Machinery Regulation (EU) 2023/1230 replaces the Directive from 20 January 2027. CE Danışmanı (CE Consultant) supports machine builders in Turkey, and buyers and importers of machinery made in Turkey, through this process.

What counts as machinery?

An assembly of linked parts, at least one of which moves, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, and joined together for a specific application. The Directive covers:

• Machinery
• Partly completed machinery
• Interchangeable equipment
• Safety components
• Lifting accessories
• Chains, ropes and webbing
• Removable mechanical transmission devices

Typical examples: CNC machine tools, presses, welding machines, wood- and metalworking machines, food processing and packaging machines, construction equipment, agricultural machinery, plastic injection machines, robots and automation lines.

Outside the scope

• Safety components supplied by the original manufacturer as spare parts for identical components
• Equipment for fairgrounds and amusement parks
• Weapons, including firearms
• Machinery for nuclear purposes which could emit radioactivity in the event of failure
• Certain means of transport, mine winding gear, and machinery designed for military or police purposes
• Lifts (2014/33/EU), tractors, ships and aircraft, which have their own legislation

What the manufacturer must do

1. Ensure the machine satisfies the essential health and safety requirements
2. Provide the necessary information, such as instructions
3. Compile the technical file
4. Carry out the applicable conformity assessment procedure
5. Draw up the EC Declaration of Conformity
6. Affix the CE marking visibly, legibly and indelibly

No marking, sign or inscription that could be confused with the CE marking may be affixed to the machine.

Risk assessment

Risk assessment is the core of machinery conformity. It follows EN ISO 12100:

1. Limits of the machinery. Intended use and reasonably foreseeable misuse.
2. Hazard identification. Mechanical, electrical, thermal, noise, vibration and ergonomic hazards over the whole life of the machine.
3. Risk estimation. Severity of harm and probability of occurrence: exposure, likelihood of the hazardous event and possibility of avoidance.
4. Risk evaluation. Deciding whether risk reduction is needed.
5. Risk reduction. Inherently safe design first, then safeguarding, then information for use.

Safety-related parts of control systems are assessed with EN ISO 13849-1 (Performance Level) or EN IEC 62061 (SIL).

Is a notified body required?

For most machines the manufacturer’s own declaration is sufficient. For the high-risk categories listed in Annex IV of the Directive, a notified body must be involved if harmonised standards have not been applied in full. Examples: circular saws, woodworking machines, presses, manually loaded plastic injection machines, vehicle servicing lifts, devices for lifting persons and logic units for safety functions. For these machines either EC type-examination or full quality assurance applies.

How long does it take?

• Machine outside Annex IV (self-declaration): 4–8 weeks, covering risk assessment, electrical safety and EMC tests, technical file and Declaration of Conformity
• Annex IV machine with a notified body: 3–6 months
• Complex automation line (integrated machines): 6–12 months

Other legislation that applies to machines

• Electrical safety. Electrical hazards are assessed under Annex I, section 1.5.1 of the Machinery Directive. The safety objectives of the Low Voltage Directive apply, but the LVD is not listed separately on the declaration.
• EMC (2014/30/EU). Required for machines with electrical or electronic control, such as PLCs, sensors, motor drives and HMIs.
• RoHS (2011/65/EU). Applies to the electrical and electronic control components. Large-scale stationary industrial tools are excluded.
• ATEX (2014/34/EU) for machines used in explosive atmospheres and PED for pressure-bearing components, where relevant.

The Declaration of Conformity must list all the legislation applied.

The new Machinery Regulation (EU) 2023/1230

The Regulation entered into force on 19 July 2023 and applies from 20 January 2027. There is no parallel transition period. The main changes:

• Scope: it explicitly addresses AI-supported systems, cybersecurity and machinery with self-evolving behaviour.
• Risk assessment: mandatory provisions for cybersecurity and software-update risks.
• Third-party assessment: for the six high-risk categories in Annex I, Part A, the involvement of a notified body becomes mandatory.

Machinery and Turkey

Turkey applies the Directive through its Machinery Safety Regulation (2006/42/AT), published in the Official Gazette of 3 March 2009, No. 27158, in force since 29 December 2009. A machine that is correctly CE marked can be placed on both the EU and the Turkish market.

When machinery is imported into Turkey, the CE marking and the technical documents are checked through the TAREKS import inspection system. For products selected for physical inspection, the test reports, the Declaration of Conformity and the match between product and brand are examined.

For exports to the Eurasian Economic Union (Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan), machinery needs EAC certification under TR CU 010/2011.

How CE Danışmanı helps

• Defining the safety concept and carrying out the machinery risk assessment
• Safety design review and validation
• Technical file and Declaration of Conformity
• Coordinating tests and, for Annex IV machines, the notified body process with accredited bodies
• Workplace machinery safety: inspection, evaluation of safeguards, lockout–tagout