The Regulation on Machinery 2023/1230 is already a year old! On June 14, 2023, the European Parliament and the Council of the European Union adopted the Regulation on Machinery 2023/1230, replacing the Machinery Directive 2006/42/EC. This new regulation aims to enhance the safety of machinery entering the EU market and streamline conformity assessment procedures. These changes stem from the experiences gained from the previous directive and the need to adapt regulations to the rapidly evolving technological market.
Table of Contents
Key Changes Compared to the Machinery Directive 2006/42/EC
The table below outlines the main changes introduced by the Regulation on Machinery 2023/1230:
| Area | Previous Regulations | New Regulations (2023/1230) |
|---|---|---|
| Scope of Regulation | The Machinery Directive 2006/42/EC covered a wide range of machinery but did not account for advanced technologies such as AI. | The Regulation on Machinery 2023/1230 includes more complex machines, including those based on AI and new technologies. |
| Conformity Assessment Procedures | Procedures were less stringent, and the involvement of a notified body was not always required. | More stringent conformity assessment procedures with the involvement of notified bodies are required for high-risk machinery. |
| Documentation Requirements | Technical documentation had to be kept for at least 10 years from the date of manufacture. | Technical documentation must be kept for at least 10 years from the date the machine is placed on the market and can be stored digitally. |
| CE Marking | CE marking was required, but the rules for its placement were less strict. | The CE mark must be placed according to new, stricter rules, in a visible, legible, and indelible manner. |
| Digital Technologies | No clear regulations regarding digital technologies and AI. | The Regulation on Machinery 2023/1230 accounts for risks associated with digital technologies and AI. |
| Transitional Provisions | Transitional provisions were less detailed. | Detailed transitional provisions aim for a smooth transition to the new regulations. |
| Penalties for Non-Compliance | Penalties for non-compliance were less severe. | Introduction of stricter penalties for non-compliance. |
| Role of Economic Operators | The role of economic operators was less precisely defined. | Precisely defined obligations for all economic operators in the supply chain. |
Regulation on Machinery 2023/1230: When is a Notified Body Required?
Not all machinery will require conformity assessment with the involvement of a notified body under the Regulation on Machinery 2023/1230. The following outlines when a notified body is necessary:
- High-Risk Machinery: Machines or related products listed in Annex I, Part A of the Regulation on Machinery 2023/1230 must undergo a more stringent conformity assessment procedure involving a notified body. Examples include:
- Detachable devices for mechanical power transmission with guards.
- Portable assembly machines and other impact machines operated with cartridges.
- Safety components with self-changing behavior 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 machine meets the relevant health and safety requirements.
- Quality System Audit: Notified bodies will conduct periodic audits of manufacturers’ quality systems to ensure that production processes comply with the requirements of the Regulation on Machinery 2023/1230.
Regulation on Machinery 2023/1230: Procedures Without a Notified Body
For machinery not listed as high-risk, manufacturers can apply the internal production control procedure (Module A) under the Regulation on Machinery 2023/1230, which does not require the involvement of a notified body. In this procedure, the manufacturer independently ensures and declares that the machine meets the regulation’s requirements, prepares technical documentation, and affixes the CE marking.
Regulation on Machinery 2023/1230: Implementation and Transitional Provisions
Some provisions of the new regulation come into effect before January 20, 2027:
- From October 14, 2023: Penalties for violating the Regulation on Machinery 2023/1230.
- From January 14, 2024: Provisions regarding the notification of conformity assessment bodies.
- From July 14, 2024: Articles enabling the amendment/extension of the list of dangerous machinery in Annex I without a full revision of the regulation.
Regulation on Machinery 2023/1230: CE Marking
CE marking under the Regulation on Machinery 2023/1230 will have to meet more stringent requirements. The new rules concern:
- Precise Placement of the CE Mark: The marking must be placed in a visible, legible, and indelible manner.
- Accompanying Information: The CE marking must be supported by detailed technical documentation confirming compliance with essential health and safety requirements.
- Digital Declaration of Conformity: The declaration of conformity can be provided in digital form, simplifying access to necessary information.
Violations During the Transitional Period According to the Regulation on Machinery 2023/1230
During the transitional period, violations of the Regulation on Machinery 2023/1230 can occur in several ways:
- Non-compliance with New Regulations: If a manufacturer does not adapt to the new requirements regarding conformity assessment, technical documentation, CE marking, or other obligations imposed by the Regulation on Machinery 2023/1230, they may face penalties from October 14, 2023.
- Failure to Update Production Processes: Manufacturers who do not update their production processes according to new safety requirements may encounter issues during inspections and audits conducted 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 deemed to be in violation of the Regulation on Machinery 2023/1230.
Significance for Enterprises
The adoption of the Regulation on Machinery 2023/1230 necessitates changes in production and control processes for many companies operating in the industrial automation sector. Companies must adapt their conformity assessment procedures and ensure that all new products meet stricter safety requirements. Additionally, the need to store documentation and conduct regular safety audits may increase operational costs but will also contribute to improved safety and quality of offered products.
Conclusions from the Regulation on Machinery 2023/1230
The Regulation on Machinery 2023/1230 represents a significant step towards enhancing the safety of machine users in the European Union. By introducing new product categories, more stringent conformity assessment procedures, and requirements for documentation and CE marking, the new regulations aim to ensure that all machinery entering the EU market is safe and meets the highest standards.
Regulation on Machinery 2023/1230: Key Points
- Adapting Machinery to Minimum Requirements: All machinery must be adapted to the minimum safety requirements specified in the regulation. Design offices responsible for machine design must consider these requirements at every stage of the process.
- CE Certification of Machinery: The CE certification process for high-risk machinery will be more stringent. Companies must ensure that all relevant harmonized standards are followed.
- Structural Calculations (FEM): For high-risk machinery, structural calculations must be thoroughly conducted and documented. These analyses must be available during quality system audits.
- Outsourcing Engineers: Companies may consider outsourcing engineers specializing in CE certification and project management to ensure compliance with new requirements.
- Project Management: Effective project management is crucial for adapting production processes and quality control to new regulations.
Implementation of the Regulation on Machinery 2023/1230
- From October 14, 2023: Manufacturers may face penalties for non-compliance with new regulations.
- From January 14, 2024: Notified bodies must be ready to conduct audits in accordance with new requirements.
- From July 14, 2024: The list of dangerous machinery can be expanded without a full revision of the regulation.
CE Marking According to the Regulation on Machinery 2023/1230
CE marking must be placed in a visible, legible, and indelible manner. CE marking according to the Regulation on Machinery 2023/1230 requires detailed technical documentation and can be supported by a digital declaration of conformity.
Violations During the Transitional Period
During the transitional period, manufacturers must adapt to the new requirements of the Regulation on Machinery 2023/1230 to avoid penalties:
- Non-compliance with New Regulations: Penalties may be imposed from October 14, 2023.
- Failure to Update Production Processes: Manufacturers must update their processes to comply with new requirements.
- Lack of Digital Documentation: Technical documentation and declarations of conformity must be available in digital form.
Summary
The Regulation on Machinery 2023/1230 aims to enhance the safety of machinery users in the EU by imposing stricter requirements for conformity assessment, documentation, and CE marking. Enterprises must now focus on implementing these requirements to continue operating in the European market in compliance with the new regulations.
FAQ: Regulation on Machinery 2023/1230
The Regulation on Machinery 2023/1230 is a new set of rules adopted by the European Parliament and the Council of the European Union on June 14, 2023, replacing the Machinery Directive 2006/42/EC. The regulation aims to improve the safety of machinery entering the EU market and simplify conformity assessment procedures.
The Regulation on Machinery 2023/1230 introduces more stringent conformity assessment procedures, detailed documentation requirements (including the possibility of storing documentation digitally), and new rules regarding CE marking. It also accounts for digital technologies and artificial intelligence.
The full implementation of the Regulation on Machinery 2023/1230 will occur on January 20, 2027. However, some provisions take effect earlier, such as penalties for violating the regulation from October 14, 2023, and provisions regarding the notification of conformity assessment bodies from January 14, 2024.
The regulation covers a wide range of machinery, including more complex machines based on artificial intelligence and modern technologies. It particularly focuses on high-risk machinery listed in Annex I, Part A.
According to the Regulation on Machinery 2023/1230, technical documentation must be kept for at least 10 years from the date the machine is placed on the market. A new feature is the possibility of storing and providing documentation in digital form.
Conformity assessment procedures are now more stringent for high-risk machinery. The involvement of a notified body is required to conduct conformity assessment and certification. For lower-risk machinery, the internal production control procedure can still be used.
The Regulation on Machinery 2023/1230 introduces stricter rules regarding CE marking. The CE mark must be placed in a visible, legible, and indelible manner. Additionally, the CE marking must be supported by detailed technical documentation.
From October 14, 2023, penalties will be imposed for violations of the Regulation on Machinery 2023/1230. Penalties may include financial fines and other administrative measures to ensure compliance with the regulations.
The Regulation on Machinery 2023/1230 accounts for risks associated with digital technologies and artificial intelligence. AI-based machines must meet additional safety and conformity assessment requirements to ensure their safe use.
Enterprises must adapt their conformity assessment procedures, ensure appropriate technical documentation, and ensure that all new products meet stringent safety requirements. Additionally, project management and outsourcing engineers may be crucial in the process of adapting to the new regulations.