EU Machinery Regulation 2023/1230 will progressively replace Machinery Directive 2006/42/EC by 2027. For those buying or manufacturing packaging machines, it is important to understand what changes and how to prepare.
Machinery Directive 2006/42/EC: basics and requirements
Currently in force, Directive 2006/42/EC requires the manufacturer to ensure every machine is safe, with CE marking, declaration of conformity and technical file. For food machines, hygiene requirements of Annex I, section 2.1 are added: no accumulation zones, inert materials, ease of cleaning.
- CE marking: mandatory for EU market placement
- CE declaration of conformity: legal document signed by manufacturer
- Technical file: drawings, risk analysis, instructions — kept 10 years
- Operating manual in destination country language: mandatory
- Risk analysis: according to EN ISO 12100
New EU Machinery Regulation 2023/1230
EU Regulation 2023/1230 entered into force on 19 July 2023 with a transitional period until 20 January 2027. Main innovations concern software and control system safety, cybersecurity of connected machines and extension of scope to new product categories.
- Mandatory application date: 20 January 2027
- New: cybersecurity requirements for network-connected machines
- New: embedded software safety (IEC 62443)
- New: extension to partly completed machinery (line subsystems)
- Transitional period: Dir. 2006/42/EC still valid until 2027
Practical implications for machine buyers
Those buying a machine today must verify compliance with Dir. 2006/42/EC and plan that by 2027 all machines in operation comply with the new Regulation — which may require software or hardware updates. It is advisable to purchase machines already designed for Reg. 2023/1230 compliance.
- Immediate check: CE marking + Dir. 2006/42/EC declaration of conformity
- 2027 planning: update to Reg. 2023/1230 for connected machines
- Ask your supplier: compliance roadmap for the new regulation
- EMA Pack machines: designed for long-term compliance
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