Understanding the Regulation on Machinery 2023/1230/EU: Key Changes and Implications

The Regulation on Machinery 2023/1230/EU introduces significant changes, replacing the well-known Machinery Directive 2006/42/WE. This regulation brings new definitions and requirements, impacting manufacturers and users alike. It prompts a reevaluation of industry practices, focusing on safety, responsibility, and quality in machine creation and usage. The Regulation on Machinery 2023/1230/EU aims to enhance user safety through numerous changes.

Many wonder how these new regulations will affect daily practices. Will they truly enhance safety, or will they add complexity to an already intricate legal environment? Despite new regulations, market chaos and lack of uniform standards persist. Any manufacturer can theoretically issue a declaration of conformity for most industrial machines, and inadequate control over competence in regulations leads to concerning situations.

Do purchasing departments, not necessarily experts in machinery law, often prioritize cost over compliance? Are they aware that compliant manufacturers incur higher costs to ensure full conformity and safety? Does this lead to unfair competition and undermine the effectiveness of new regulations? These concerns raise questions about the industry’s future.

However, the introduction of the new regulation is a step in the right direction. The new rules aim to increase safety and standardize practices across the European Union. The issue lies not with the regulation itself but with the lack of clear methods in Poland to verify manufacturers’ competence before accidents occur. Without effective control mechanisms, even the best regulations may not yield the desired results.

We’d like to share our thoughts on the changes introduced by Regulation (EU) 2023/1230. Notably, we focus on new definitions like “significant modification”, “safety function”, and clarifications of “machines”, “assemblies of machines”, and “safety components”.

Join us in reflecting on how these changes impact our daily work, the challenges they pose, and how we can foster a more informed and responsible machinery industry. Through this, we may not only better understand the new regulations but also influence improvements in market practices, which often leave much to be desired.

Structural Changes

Scope

Upon reviewing the documents, the structural differences are apparent. The Machinery Directive spanned 63 pages, with annexes starting from page 12.

1. Essential health and safety requirements for the design and construction of machinery
2. Declarations (both EC for machinery and incorporation for incomplete machinery)
3. CE marking (template)
4. Categories of machinery subject to procedures specified in Article 12(3) and (4)
5. Indicative list of safety components
6. Assembly instructions for incomplete machinery
7. Technical documentation for machinery
8. Conformity assessment combined with internal control during manufacturing
9. EC type examination
10. Full quality assurance
11. Minimum criteria for notifying bodies
12. Correlation table

The Regulation 2023/1230/EU on Machinery presents differences in both volume (102 pages) and approach, which we find significantly improved. Definitions are consolidated in one place, with more definitions than before. Annexes start from page 40 and are reorganized:

1. Categories of machinery or related products subject to procedures specified in Article 25(2) and (3)
2. Indicative list of safety components
3. Essential health and safety requirements for the design and manufacture of machinery or related products
4. Technical documentation
5. EU declaration of conformity and EU declaration of incorporation
6. Internal production control (module A)
7. EU type examination (module B)
8. Conformity to type based on internal production control (module C)
9. Conformity based on full quality assurance (module H)
10. Conformity based on unit verification (module G)
11. Assembly instructions for incomplete machinery

At first glance, the order seems slightly altered, but the changes are significant. The annex with the CE mark template is “missing” (general rules for CE marking are established in Regulation (EC) No 765/2008). However, substantial changes occur within the annexes and conformity assessment procedures, discussed below.

New Definitions in the Regulation on Machinery 2023/1230/EU

One of the most critical aspects of the new regulation is introducing precise definitions to unify terminology and eliminate interpretative ambiguities. Let’s examine the most important ones and consider their impact on our daily work.

Significant Modification

The previous directive lacked a clear definition of “significant modification”. The term “major modification” was often used but not precisely defined, leading to varied interpretations and uncertainty about obligations arising from machine changes.

The Regulation on Machinery 2023/1230/EU introduces a new definition:

“Significant modification” means a change to a machine or related product made physically or digitally after it has been placed on the market or put into service, not foreseen or planned by the manufacturer, affecting the safety of the machine or related product, creating new hazards or increasing existing risks, requiring:

1. the addition of guards or protective devices to the machine or related product, requiring modification of the existing safety system; or
2. additional protective measures to ensure the stability or mechanical strength of the machine or related product;

This definition holds particular significance. Consider how often we’ve made changes to machines without realizing the potential legal consequences. Now, we know that any significant modification may require a new conformity assessment and may shift safety responsibility to the entity making the change. We now have a clear definition of when we become the manufacturer of a significant change (effectively the entire solution through which new risks arise). However, let’s emphasize that “being a manufacturer” should not be feared. The goal is to ensure that changes do not introduce new safety risks.

Safety Function

The previous directive lacked a direct definition of “safety function” – this concept was primarily defined in harmonized standards such as EN ISO 13849-1 and EN 62061. Regulation (EU) 2023/1230 introduces a precise definition:

“‘Safety function’ means a function of a protective measure designed to eliminate hazards or, if not possible, reduce risk, and whose faulty performance may increase that risk;”

This definition highlights several issues:

• Function of a protective measure: The safety function is integrally linked to the machine’s protective measures, such as guards, interlocking devices, or safety control systems.
• Purpose of hazard elimination or risk reduction: The safety function aims to minimize risks associated with machine use. If hazard elimination is not possible, this function should reduce risk to an acceptable level.
• Impact of faulty performance: If the safety function does not work correctly, risk may increase, potentially leading to accidents or incidents.

Significance of this definition for engineering practice:

• Design with safety in mind: Manufacturers must consider safety functions as a key element of the machine during the design phase.
• Risk analysis: A thorough risk analysis is necessary to identify potential hazards and determine appropriate safety functions.
• Reliability of safety functions: These functions must be designed and implemented to ensure reliability appropriate to the level of risk. Faulty performance can have serious consequences.

Practical implications:

• Technical documentation: The manufacturer must detail safety functions in the technical documentation, including how they are implemented and tested. (This obligation was not previously explicitly stated in the Machinery Directive; harmonized standard EN ISO 13849 specified the need to inform about the achieved PL level, e.g., PLd, how and according to which standard.)
• Maintenance and service: Users must ensure regular maintenance and checking of safety functions to ensure their continuous proper operation (very important due to MTTFd defined by the safety controller manufacturer or other device in the machine safety system).
• Training: Personnel operating machines should be adequately trained in safety functions to understand their significance and operation.

Comparison with previous legal status:

• Lack of definition in the directive: In Directive 2006/42/WE, the safety function was not directly defined, which could lead to differences in interpretation and application.
• Introducing a definition in the regulation: We now have a clear and precise definition, facilitating uniform application of regulations across the European Union.

Reflection

Introducing a precise definition of “safety function” in the Regulation on Machinery 2023/1230/EU is crucial for enhancing machine safety. It underscores the need for careful design, implementation, and maintenance of safety functions, which is vital for protecting users’ health and lives.

It’s worth considering whether we pay enough attention to safety functions in our daily practice. Are we confident they are properly designed and implemented? Do we regularly test and maintain them? The new regulations prompt deeper reflection on these issues.

Definition of “Machine”

The regulation also clarifies the concept of “machine”. While the definition may initially seem similar to the previous one, subtle differences warrant attention:

Directive 2006/42/WE

In Article 2(a) of the directive, “machine” is defined as:

“‘Machine’ means:

a) an assembly fitted or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application;

b) an assembly referred to in point (a) lacking only components to connect it to its place of use or to sources of energy and motion;

c) an assembly referred to in point (a) or (b) ready for installation and capable of functioning only after being mounted on a means of transport or installed in a building or structure;

d) assemblies of machines referred to in points (a), (b), or (c) which, to achieve the same result, are arranged and controlled so that they function as an integral whole;

e) a set of interconnected parts or components, at least one of which moves, joined together to lift loads and powered directly by human effort.”

Regulation on Machinery 2023/1230/EU

In Article 3(1) of the regulation, the definition of “machine” is expanded:

“‘Machine’ means:

a) an assembly fitted or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application;

b) an assembly referred to in point (a) lacking only components to connect it to its place of use or to sources of energy and motion;

c) an assembly referred to in point (a) or (b) ready for installation and capable of functioning only after being mounted on a means of transport or installed in a building or structure;

d) assemblies of machines referred to in points (a), (b), or (c) which, to achieve a common goal, are arranged and controlled so that they function as an integral whole;

e) a set of interconnected parts or components, at least one of which moves, joined together to lift loads and powered directly by human effort;

f) an assembly referred to in points (a)–(d) which requires only the installation of software developed by the manufacturer or under their responsibility to function.”

Analysis of Changes

• Addition of point f):
  • New point f) in the regulation is a key change in the definition of “machine”.
  • Content of point f):“an assembly referred to in points (a)–(d) which requires only the installation of software developed by the manufacturer or under their responsibility to function.”
  • Significance of this change:
    • Recognition of software’s importance: Modern machines increasingly rely on software for control and operation.
    • Extension of definition: Machines that are physically complete but require software installation are now explicitly recognized as “machines” under the regulation.
    • Manufacturer’s responsibility: The manufacturer is responsible for software necessary for the machine’s operation, even if not installed at delivery.
• Terminology change from “elements” to “components”:
  • In points a) and e), “elements” is replaced with “components” to unify terminology and reflect the growing importance of both mechanical and electronic parts in machines.
• Change in wording in point d):
  • In the directive: “to achieve the same result”
  • In the regulation: “to achieve a common goal”
  • This subtle change may indicate a broader understanding of machine integration into complex production systems.

Practical Implications for Manufacturers and Users

• Manufacturers:
  • Software as an integral part of the machine: They must include software in the conformity assessment process, even if installed later.
  • Technical documentation: Should include information on software necessary for machine operation.
  • Responsibility for safety: The manufacturer is responsible for ensuring both hardware and software meet safety requirements.
• Users:
  • Awareness of software requirements: Users must install software provided by the manufacturer or under their responsibility to ensure proper and safe machine operation.
  • Software updates and modifications: Changes to software may affect the machine’s compliance with the regulation.

Impact on Conformity Assessment

Increased scope of manufacturer’s responsibility: The manufacturer must ensure that software does not introduce new hazards and complies with essential health and safety requirements.

Conformity assessment must cover both hardware and software: This process should include all elements necessary for the machine’s operation.

Assemblies of Machines

The new Regulation (EU) 2023/1230 refines and expands the definition of “assemblies of machines” compared to the previous Machinery Directive 2006/42/WE.

In Directive 2006/42/WE, “machine” includes:

• Key point d) on “assemblies of machines”:“Assemblies of machines referred to in points (a), (b), or (c) which, to achieve the same result, are arranged and controlled so that they function as an integral whole.”

• Application: Point d) means that machines connected and controlled as one system, if their joint operation is necessary to achieve a result, are considered one “assembly of machines.”

Changes in the Definition of “Machine” in the Regulation on Machinery 2023/1230/EU

The regulation adds point f) and modifies points d) and e):

• Point d):“Assemblies of machines referred to in points (a), (b), or (c) which, to achieve a common goal, are arranged and controlled so that they function as an integral whole.”
• New point f):“An assembly referred to in points (a)–(d) which requires only the installation of software developed by the manufacturer or under their responsibility to function.”

What Does This Change?

• Assemblies of machines: The change to “common goal” allows for more flexible interpretation of “assemblies of machines” as a single system, even if machines do not necessarily achieve “the same result.” This clarification is especially important when integrating production lines, where different machines perform separate tasks but must operate as a whole.
• Inclusion of software: Point f) extends the manufacturer’s responsibility to software. This requires a full analysis and compliance of software with safety requirements, potentially affecting the cost and time of machine implementation.

In the Machinery Directive 2006/42/WE, assemblies of machines were described in the context of requirements for stopping elements:

“In the case of machines or parts of machines designed to operate together, the machine must be designed and constructed so that stopping controls, including emergency stop devices, can stop not only the machine itself but also all related devices if further operation of those devices may be hazardous.”

Regulation (EU) 2023/1230 introduces a more detailed definition of assemblies of machines and adds the concept of “related products”:

“In the case of a machine or related product or part of a machine or related product designed to operate together, the machine or related product must be designed and manufactured so that stopping controls, including emergency stop devices, can stop not only the machine or related product itself but also all related devices if further operation of those devices may be hazardous.”

Differences

1. Scope of definition: Directive 2006/42/WE focuses solely on machines and their parts, while Regulation 2023/1230 expands this definition to “related products.” This means that safety requirements now also apply to devices that may not be machines but are integrated with machines in one system.
2. Function of stopping elements: Both the directive and regulation emphasize that emergency stop devices must enable simultaneous stopping of all related devices if further operation could pose a hazard. The new regulation, however, introduces a more comprehensive approach to stopping the entire system of devices, which is crucial in modern industrial environments.

Applying standard PN-EN ISO 11161 is not required but can significantly facilitate demonstrating compliance with the regulation and ensure a high level of safety in complex production systems, where managing safety for the entire integrated production line is crucial.

Safety Components

The definition of “safety components” has been refined, though its essence remains similar:

In Directive 2006/42/WE:

**“‘Safety component’ means a component:

— serving to fulfill a safety function,

— placed on the market independently,

— whose failure or malfunction endangers the safety of persons,

— not necessary for the machine’s functioning or can be replaced by normal components to allow the machine’s functioning.”**

Regulation on Machinery 2023/1230/EU:

**“‘Safety component’ means a component:

— placed on the market independently,

— fulfilling a safety function,

— whose failure or malfunction endangers the safety of persons,

— not necessary for the machine’s functioning or can be replaced by ordinary components to allow the machine’s functioning.”**

Note the change from “element” to “component” and minor differences in wording. Do we always correctly identify such components in our machines?

Conformity Assessment Process – Changes Introduced by the Regulation on Machinery 2023/1230/EU

The new Regulation on Machinery 2023/1230/EU introduces significant changes in the conformity assessment process, especially for machines and products considered high-risk. One of the most important changes is the expanded requirement for involving a notified body in the conformity assessment of machines listed in Annex I, Part A of the regulation.

Requirement for Involving a Notified Body

Unlike previous Directive 2006/42/WE provisions, where self-conducted conformity assessments by manufacturers were often possible (if specific harmonized standards for Annex IV products were applied), Regulation on Machinery 2023/1230/EU mandates the use of notified bodies for high-risk machines and products specified in Annex I, Part A. This means:

• The manufacturer cannot conduct the conformity assessment alone for machines listed in Part A of Annex I.
• A notified body must be involved at every stage of the conformity assessment process to ensure the machine meets all essential health and safety requirements.

Highlighted elements previously in Annex IV to the Machinery Directive, now always requiring a notified body’s involvement:

• Detachable transmission devices with guards.
• Guards for detachable transmission devices.
• Vehicle servicing lifts.
• Portable cartridge-operated fixing and other impact machines.

and entirely new categories

• Safety components with fully or partially self-changing behavior using machine learning, providing safety functions.
• Machines with built-in systems with fully or partially self-changing behavior using machine learning, providing safety functions, not marketed independently, solely concerning these systems.

Significance of Change for Manufacturers

For manufacturers, this means adapting production and conformity verification processes to new requirements, especially if their products qualify as high-risk machines. Collaboration with notified bodies affects certification time and cost but also increases safety and compliance with legal requirements.

Regulation on Machinery 2023/1230/EU: Cybersecurity

Regulation 2023/1230 introduces the requirement to treat internet access-related threats as real threats to user safety and health. Thus, it mandates that cybersecurity be an integral part of machine conformity assessment, meaning machines must be designed and manufactured to withstand cyber threats. This obligation is particularly important for machines and systems with remote monitoring and control functions, as well as machines operating in complex industrial environments exposed to cyberattacks.

The manufacturer is responsible for assessing cyber threat risks during the design and production of the machine. This assessment should consider specific threats related to network connectivity and interaction with other systems. Manufacturers should, in particular:

• Identify and assess potential threats related to network connections and remote control.
• Ensure an appropriate level of security for software and hardware, tailored to the type of machine and its working environment.
• Conduct security tests of machines to identify and eliminate system vulnerabilities.

Support from Harmonized Standards

While regulation provisions require protection against cyber threats, detailed guidelines cannot yet be drawn from harmonized standards. In cybersecurity, standards like IEC 62443 play an increasingly important role, providing detailed guidelines on the security of industrial automation and control systems, including network security and protection methods against attacks. We may soon see detailed guidelines in this area.

EC Declaration of Conformity is Now EU Declaration of Conformity

In the new Regulation 2023/1230, the EC declaration of conformity is replaced by the EU declaration of conformity. Similarly, the previous declaration of incorporation for incomplete machinery (so-called incorporation declaration) now functions as the EU declaration of conformity for incomplete machinery.

Main Changes in Declarations of Conformity:

1. EU Declaration of Conformity (for completed machines) must now include an additional manufacturer statement explicitly confirming that the machine meets all essential safety and health requirements specified in the regulation.
2. EU declaration of conformity for incomplete machinery requires a similar statement, but it relates to partial compliance with the regulation, to the extent that the incomplete machine is designed to meet the target system’s requirements.

New Statement to Add to Both Declarations:

In both cases (for completed and incomplete machines), the regulation introduces an additional statement that the manufacturer is obliged to include in the declaration:

“We hereby declare that the machine (or incomplete machine) meets all applicable requirements of Regulation 2023/1230/EU concerning machinery and related products.”

This statement clearly confirms the manufacturer’s responsibility for the machine’s compliance with regulations and assures supervisory authorities that both finished machines and incomplete machines have been designed and manufactured according to applicable safety standards.

Summary of Changes:

• EC Declaration of Conformity replaced by EU Declaration of Conformity – introduction of a clear statement of compliance with regulation provisions.
• Declaration of incorporation for incomplete machinery replaced by EU declaration of conformity for incomplete machinery – addition of a manufacturer statement regarding machine safety in the target system.

These changes aim to strengthen manufacturers’ responsibility for product compliance with safety requirements specified in the regulation.

Regulation on Machinery 2023/1230/EU: Reflection

Introducing these definitions aims to unify terminology and eliminate ambiguities that could lead to errors and hazards. However, the mere existence of precise definitions does not guarantee improved market practices. In Poland, there is still a lack of clear methods for verifying manufacturers’ competence before an accident occurs. Will the new regulations change this situation? Are we ready for these changes? Do we have sufficient knowledge and resources to implement them effectively?

We encourage reflection on these issues. Perhaps through this, we can not only better understand the new regulations but also influence improvements in market practices and increase safety in our industry.

*- previously, Directives required transposition into national laws, while (EU) Regulations are applied immediately in each member state.

FAQ: Regulation 2023/1230/EU on Machinery