Key takeaways:
The text describes the key differences between 2023/1230 and 2006/42/EC, and explains when a notified body is required and when Module A is sufficient. It also indicates selected dates on which certain provisions apply before 20 January 2027.
- On 14 June 2023, Regulation (EU) 2023/1230 on machinery was adopted, replacing the Machinery Directive 2006/42/EC.
- The aim is to improve machine safety on the EU market and simplify conformity assessment procedures.
- The Regulation takes into account the risks associated with digital technologies and AI, as well as more complex machinery.
- For high-risk machinery listed in Annex I, Part A, the involvement of a notified body is required (e.g. EU type-examination, quality audits)
- Technical documentation must be retained for at least 10 years from the date of placing on the market (digital form is permitted); CE is subject to more stringent rules
The new Machinery Regulation 2023/1230 is already nearly a year old! On 14 June 2023, the European Parliament and the Council of the European Union adopted Machinery Regulation 2023/1230, which replaces the Machinery Directive 2006/42/EC. The new rules are intended to improve the safety of machinery placed on the European Union market and simplify conformity assessment procedures. These changes reflect the experience gained from applying the previous directive, as well as the need to adapt the rules to a rapidly evolving technology market.
Key Changes Compared with the Machinery Directive 2006/42/EC
The table below presents the main changes introduced by Machinery Regulation 2023/1230:
| Area | Previous Rules | New Rules (2023/1230) |
|---|---|---|
| Scope of the Regulation | The Machinery Directive 2006/42/EC covered a broad range of machinery, but did not take advanced technologies such as AI into account. | Machinery Regulation 2023/1230 covers more complex machinery, including AI-based systems and new technologies. |
| Conformity Assessment Procedures | The procedures were less stringent, and the involvement of a notified body was not always required. | More stringent conformity assessment procedures, including the involvement of a notified body, are required for high-risk machinery. |
| Documentation Requirements | Technical documentation had to be retained for at least 10 years from the date the machine was manufactured. | Technical documentation must be retained for at least 10 years from the date the machine is placed on the market. It may also be stored in digital form. |
| CE Marking | CE marking was required, but the rules for affixing it were less restrictive. | The CE marking must be affixed in accordance with new, stricter rules, in a visible, legible, and indelible manner. |
| Digital Technologies | There were no explicit provisions covering digital technologies and AI. | Machinery Regulation 2023/1230 addresses risks associated with digital technologies and AI. |
| Transitional Provisions | The transitional provisions were less detailed. | Detailed transitional provisions have been introduced to ensure a smooth transition to the new rules. |
| Penalties for Non-Compliance | Penalties for non-compliance were less severe. | Stricter penalties for non-compliance have been introduced. |
| Role of Economic Operators | The role of economic operators was defined less precisely. | Clearly defined obligations now apply to all economic operators in the supply chain. |
Machinery Regulation 2023/1230: When Is a Notified Body Required?
Not all machinery will require conformity assessment involving a notified body under Machinery Regulation 2023/1230. The situations in which a notified body must be involved are outlined below:
- High-risk machinery: Machinery or related products listed in Annex I, Part A of Machinery Regulation 2023/1230 must undergo a more stringent conformity assessment procedure involving a notified body. Examples include:
- Detachable mechanical transmission devices, including guards.
- Portable cartridge-operated fixing and other impact machinery.
- Safety components with fully or partially self-evolving behaviour using machine learning.
- EU type-examination certificate: For certain types of machinery, the manufacturer must obtain an EU type-examination certificate from a notified body confirming that the machinery meets the relevant health and safety requirements.
- Quality system audit: Notified bodies will carry out periodic audits of manufacturers’ quality systems to ensure that production processes comply with the requirements of Machinery Regulation 2023/1230.
Machinery Regulation 2023/1230: Procedures Without a Notified Body
For machinery that is not listed as high-risk, the manufacturer may apply the internal production control procedure (Module A) under Machinery Regulation 2023/1230, which does not require the involvement of a notified body. Under this procedure, the manufacturer independently ensures and declares that the machinery meets the relevant requirements of the regulation, prepares the EU declaration of conformity, compiles the technical documentation, and affixes the CE marking.
Machinery Regulation 2023/1230: Implementation and Transitional Provisions
Some provisions of the new regulation will apply before 20 January 2027:
- From 14 October 2023: Penalties for breaches of Machinery Regulation 2023/1230.
- From 14 January 2024: Provisions on the notification of conformity assessment bodies.
- From 14 July 2024: Articles allowing the list of dangerous machines in Annex I to be amended or expanded without a full revision of the Regulation.
Machinery Regulation 2023/1230: CE Marking
CE marking under Machinery Regulation 2023/1230 will have to meet stricter requirements. The new rules cover:
- Precise placement of the CE mark: The marking must be affixed so that it is visible, legible, and indelible.
- Accompanying information: CE marking must be supported by detailed technical documentation confirming compliance with the essential health and safety requirements.
- Digital declaration of conformity: The declaration of conformity may be provided in digital form, making the required information easier to access.
Breaches During the Transitional Period Under Machinery Regulation 2023/1230
During the transitional period, Machinery Regulation 2023/1230 may be breached in several ways:
- Failure to comply with the new rules: If a manufacturer does not adapt to the new requirements for conformity assessment, technical documentation, CE marking, or other obligations imposed by Machinery Regulation 2023/1230, it may be subject to penalties from 14 October 2023.
- Failure to adapt production processes: A manufacturer that does not update its production processes in line with the new safety requirements may encounter problems during inspections and audits carried out by notified bodies or market surveillance authorities.
- Lack of digital documentation: If technical documentation or declarations of conformity are not properly stored or made available in digital form, the manufacturer may be considered in breach of Machinery Regulation 2023/1230.
Implications for Businesses
The adoption of Machinery Regulation 2023/1230 means that many companies operating in industrial automation will need to make changes to their production and control processes. Companies must adapt their conformity assessment procedures and ensure that all new products meet the stricter safety requirements. In addition, the need to retain documentation and undergo regular safety audits may increase operating costs while also improving the safety and quality of the products offered.
Key Takeaways from Machinery Regulation 2023/1230
Machinery Regulation 2023/1230 is an important step towards improving the safety of machinery users in the European Union. By introducing new product categories, stricter conformity assessment procedures, and requirements for documentation and CE marking, the new rules are intended to ensure that all machinery placed on the EU market is safe and compliant with the highest standards. A broader overview of the key changes in the Machinery Regulation 2023/1230 helps put these obligations into context.
Machinery Regulation 2023/1230: Key Points
- Adapting machines to minimum requirements: All machines must be adapted to the minimum safety requirements set out in the regulation. The design office responsible for machine design must take these requirements into account at every stage of the process.
- CE certification of machinery: The CE certification process for machinery will be more stringent for high-risk machines. Companies must ensure that all relevant harmonised standards are followed.
- Strength calculations (FEA): For high-risk machines, strength calculations must be carried out accurately and documented properly. These analyses must be available during quality system audits.
- Engineering outsourcing: Companies may consider outsourcing engineers who specialise in CE certification and project management to ensure compliance with the new requirements.
- Project management: Effective project management is essential for adapting production processes and quality control to the new regulations.
Implementation of the Machinery Regulation 2023/1230
- From 14 October 2023: Manufacturers may face sanctions for non-compliance with the new rules.
- From 14 January 2024: Notified bodies must be ready to carry out audits in line with the new requirements.
- From 14 July 2024: The list of dangerous machines may be expanded without a full revision of the regulation.
CE marking under the Machinery Regulation 2023/1230
The CE marking must be affixed visibly, legibly, and indelibly. Under Machinery Regulation 2023/1230, it requires detailed technical documentation and may be supported by a digital declaration of conformity and updated CE nameplate requirements.
Violations During the Transitional Period
During the transitional period, manufacturers must comply with the new requirements of Machinery Regulation 2023/1230 to avoid sanctions:
- Failure to comply with the new regulations: Sanctions may be imposed from 14 October 2023.
- Failure to adapt production processes: Manufacturers must update their processes in line with the new requirements.
- Lack of digital documentation: Technical documentation and declarations of conformity must be available in digital form.
Summary
Machinery Regulation 2023/1230 is intended to improve the safety of machinery users in the EU through stricter requirements for conformity assessment, documentation, and CE marking. Companies must now focus on implementing these requirements in order to continue operating on the European market in compliance with the new rules. This is particularly relevant for manufacturers, importers, and businesses dealing with particularly hazardous machines or preparing machinery for placement on the market.
Sources:
- Regulation (EU) 2023/1230 of the European Parliament and of the Council “”
The Machinery Regulation 2023/1230 is now one year old
It replaces the Machinery Directive 2006/42/EC. It was adopted on 14 June 2023 by the European Parliament and the Council of the EU.
The Regulation takes into account, among other things, more complex machinery, including AI-based machinery, as well as the risks posed by digital technologies. It also tightens the rules for CE marking and clarifies the obligations of economic operators in the supply chain.
It is required for machines or related products listed in Annex I, Part A (high-risk machines). This may include obtaining an EU type-examination certificate and periodic audits of the quality system.
For machines not included on the high-risk list, the manufacturer may apply internal production control (Module A). The manufacturer itself ensures compliance, prepares the technical documentation, and affixes the CE marking.
Penalties for infringement of the Regulation have applied since 14 October 2023, and the provisions on the notification of conformity assessment bodies since 14 January 2024. From 14 July 2024, the articles allowing the list of high-risk machinery in Annex I to be amended/expanded have applied.