“The documentation has already been updated to comply with the Regulation.”
What exactly does that mean? Was the number of the legal act changed, along with the references to the annexes and the date on the first page? And were the same responses left next to the requirements: “met,” “met,” “not applicable”?
If so, the file was updated. The analysis was not.
The list of essential requirements for machinery is not a new obligation.Directive 2006/42/EC already required the applicable requirements to be identified and the measures implemented to eliminate identified hazards or reduce risks to be described. The documentation had to demonstrate conformity, not merely state that the manufacturer had kept it in mind.
Regulation 2023/1230 retains the list but formulates the obligation to describe protective measures differently. These measures are intended to fulfil:
“each applicable essential health and safety requirement.”
Each one.
This is not a revolution whereby conformity previously did not have to be demonstrated. It is a clearer link between the description of protective measures and specific requirements. It is worth recognising this before the old list is given a new heading.
Consider the response: “guards and a safety-related control system were used.” It was entered under protection against moving parts, maintenance and isolation from energy sources.
It sounds professional. Until someone asks how those guards allow a jam to be cleared safely and what happens to the pressure remaining in the actuator.
That is when you need more than the ability to copy the response into the next row.
It is necessary to determine why the requirement applies to the machine, what solution satisfies it, and what evidence confirms its effectiveness. And if “not applicable” was entered, that decision must also be explained.
The legislation says “each.” Pasting “compliant” thirty times still does not provide a single explanation.
1. The list already existed in the Directive. So what does the Regulation change?
First, let us distinguish renumbering from a substantive change. Find and replace handles the former. The latter requires reading what is being replaced.
| Element | Directive 2006/42/EC | Regulation 2023/1230 |
|---|---|---|
| Essential requirements | Annex I | Annex III |
| Technical documentation for machinery | Annex VII, Part A | Annex IV, Part A |
| List of applicable requirements | Required in the risk assessment documentation | Still required in the risk assessment documentation |
| Description of measures implemented | Protective measures implemented to eliminate identified hazards or reduce risks | Measures implemented to comply with each applicable requirement |
The last row is the most important.
The Directive already required conformity to be demonstrated. Drawings, calculations, test results, and information enabling verification that the machine met the requirements were required. Where standards were applied, the essential requirements covered by them had to be identified.
It did not provide for a simplified procedure called “we have been making machines like this for twenty years.”
The list of requirements was part of the risk assessment documentation, not a standalone questionnaire that could be completed from memory after the project was finished.
The Regulation more explicitly links the description of protective measures to each applicable requirement. It does not create the obligation to ensure safety from scratch. It specifies more precisely what the documentation must demonstrate.
Everything is there. You just need to know whom to ask
Imagine the documentation for a packaging line.
The risk assessment describes the crushing hazard and the interlocked guard provided. In the checklist, the requirements are marked as fulfilled. The electrical schematic, guard drawings, and safety system verification report are attached.
At first glance, nothing is missing.
The problem emerges only when a specific requirement is examined:which solution fulfills it, and where was this verified?
Does the report cover opening the guard or activating the emergency stop? Does it cover all hazardous movements or only the conveyor drive? Which drawing shows the guard actually installed on this version of the machine?
“The design engineer will know.”
Probably. Provided they remember this particular line rather than three similar ones from the previous quarter.
The documentation is complete. You just need to include the design engineer.
This is precisely the dependency worth eliminating. For each requirement, it should be possible to determine how it was fulfilled and then locate the documents needed to verify it.
Requirement → solution → evidence.
Not: requirement → “fulfilled” → the phone number of someone who may still remember.
There is no need to produce a separate report for each item. The Regulation specifies the content of the documentation but does not prescribe a single form. The same drawing, description, or test record may demonstrate compliance with several requirements. A single requirement may also require several pieces of evidence.
The objective is to establish clear links, not to make the binder thicker.
Therefore, when transitioning from the Directive to the Regulation, it is not enough to check whether the list exists. You need to see where each “compliant” entry leads.
A shared binder does not yet establish a link between a requirement and the evidence. At this stage, it is merely a storage location.
2. Annex III: read everything first, then eliminate what does not apply
The most convenient approach would be to select “packaging machine” from a list, receive a set of requirements, and proceed to check compliance.
However, Annex III is not a commercial catalogue. The name of the machine does not determine which requirements apply to it.
Annex III begins with definitions and general principles. These are followed by six chapters:
| Chapter | Scope |
|---|---|
| 1. General requirements | Among other matters, design, control systems, mechanical hazards, guards, maintenance, and information for users. |
| 2. Requirements for certain categories | Among other categories, machinery intended to come into contact with foodstuffs, cosmetics, or pharmaceutical products; portable hand-held or hand-guided machinery; woodworking machinery; and machinery for the application of plant protection products. |
| 3. Machinery mobility | Risks arising from the mobility of machinery, not simply from the movement of its parts. |
| 4. Lifting | Risks associated with lifting loads. |
| 5. Underground work | Additional requirements for machinery intended for such work. |
| 6. Lifting persons | Specific hazards associated with lifting persons. |
These are not six alternatives to choose from. The requirements in the subsequent chapters supplement the general requirements.
The entire annex must be analyzed to determine which points apply. Reading everything does not mean selecting everything. But neither does it mean stopping at the first chapter because the others were not included in the company template.
A packing machine that also lifts a pallet
Let us return to our packaging line. It has conveyors, perimeter guarding, pneumatic systems, and a lift that transfers a pallet to a higher level.
The list includes only the general requirements. The chapter on lifting has been omitted.
The justification?
“We do not manufacture lifting equipment. This is a packaging line.”
The pallet is being lifted. Calling the entire machine a packing machine does not stop it from lifting.
In such an example, the relevant lifting requirements must be considered alongside the general requirements, including those concerning strength, movement control, and the prevention of unexpected load descent.
Otherwise, the conveyor guards can be described very thoroughly while overlooking the question of what will hold the pallet in the event of a power failure.
The list will remain short. The list of problems encountered during commissioning may not be quite so concise.
Caution is also required in the opposite direction. The movement of a conveyor belt does not in itself mean that the machine is mobile and that the whole of chapter 3 must be assigned to it.The load moves, but the machine does not necessarily move.A similar word in the name of a hazard is no substitute for checking the scope of the requirement.
First the scope, then the individual points
In practice, we start with the intended use, functions, and limits of the machine. We check what it processes, what it moves, whether it lifts loads or people, where it operates, and what tasks people perform on it. On this basis, we determine the applicable scope and then analyze the individual requirements.
Merely assigning the machine to a chapter does not complete the work. Not every provision in that chapter will apply to every design.
Therefore, “each applicable requirement” means neither “everything for everyone” nor “whatever remains in our table.”
A requirement can be removed from a template with a single click. It does not thereby disappear from the manufacturer’s obligations.
3. “Not applicable because there is a guard.” In other words, two questions have been confused
The checklist for our packaging line gives the following answer for the requirement concerning moving parts:
“Not applicable—the moving parts are protected by a guard.”
A highly effective guard. It not only prevented access to the mechanism but also removed from the documentation the very requirement for which it had been installed.
Except that it does not work that way.
If moving parts create a risk and a guard is the means of protection against them, the requirement still applies. The safeguard used must be described as the means by which the requirement is met, not as a reason for deleting it.
“Applicable” and “met” answer two different questions.
The first is: does this obligation apply, given the machine's design, intended use, and foreseeable use scenarios?
The second: what has been done to meet it, and is that solution actually sufficient?
Reversing these answers produces excellent results in the table. The more safeguards we install, the fewer requirements will supposedly apply to us.
Eventually, it will turn out that a well-guarded machine is effectively subject to no requirements at all. The manufacturer can breathe a sigh of relief. The author of the provision presumably intended something else.
A guard does not cover every use scenario either
Suppose that access to the mechanism is effectively prevented during production. But when a jam occurs, the operator opens the door and removes the jammed package.
Has safe unblocking been provided for? Can hazardous movement continue after the door is opened? What about energy stored in the system?
The requirement concerning moving parts also covers the prevention of accidental blockages and appropriate means for safely clearing such blockages. Simply stating that “there is a guard” therefore fails to address even all the issues covered by this single requirement.
A guard is intended to protect people from the mechanism—not the author of the documentation from further questions.
When is “not applicable” the correct answer?
When it follows from the scope of the requirement and the machine's characteristics, rather than from the fact that a safeguard has been implemented.
Our line is used exclusively for packaging products. It is not intended for applying plant protection products. In this case, the non-applicability of the requirements in section 2.4 can be justified by the intended use of the equipment.
This is a specific determination. There is no need to write an essay. You need to know why a particular point is being omitted.
Therefore, in the working checklist, it is worth distinguishing the applicability of a requirement from the status of its implementation. For a requirement that applies to the machinery, a solution, calculation, or verification result may still be missing.
“To be determined” is then an honest statement about the status of the work.
“Not applicable” is an attempt to resolve missing data by changing the answer.
Moreover, not all obligations can be excluded on the basis that a specific hazard is absent. For complete machinery, the general principles identify the principles of safety integration, marking, and instructions that apply in every case.
The non-applicability of a requirement must be distinguished from its effective fulfilment. Otherwise, the checklist will reward the designer for safeguards by removing any trace of why they were needed.
4. “A switch has been installed.” Good. What about the rest of the requirement?
For point 1.4.2.2, concerning interlocking movable guards, the checklist for our packaging line stated:
“Fulfilled. A safety switch has been installed.”
The entire point was checked off on the basis of a single device. The remaining paragraphs were apparently expected to fulfil themselves.
One item number in the list does not mean one obligation. This item covers requirements concerning guard design, prevention of start-up, initiation of a stop command, conditional use of guard locking, and behavior in the event of a missing or failed component.
The switch part number does not answer all these questions.
The test passed. But too little was checked
Suppose that opening the door of our production line initiates a stop command. This was checked during commissioning, and the result was recorded as satisfactory.
However, the door can be opened immediately, while the mechanism stops only after coasting down. The operator can reach the moving parts before they come to a stop.
The switch works.
The stop command is received.
The “compliant” status got ahead of the machine. The machine is still stopping.
This arrangement also requires guard locking: the guard must remain closed until the risk of injury has ceased, rather than merely informing the controller that it has just been opened.
This is not a minor addition to the description. It is the missing answer to one of the obligations contained in an item that has already been deemed compliant.
How should the requirement be broken down so that it is clear what must be checked?
Below is an example of a working breakdown of item 1.4.2.2. The solutions and documents indicated are intended to demonstrate the working method—they are not a ready-made design or a complete test plan.
| What must be demonstrated? | Solution in the example under consideration | Where should confirmation be sought? |
|---|---|---|
| As far as possible, the guard remains attached when open, and its adjustment requires deliberate action. | Hinged door; specified fastening and adjustment method. | Design drawing and verification of installation and adjustment. |
| Hazardous functions cannot be started when the guard is open. | Prevention of the start of movements accessible through this door. | Functional description, circuit diagram, and results of start-up tests with the guard open. |
| Opening the guard initiates a stop command. | The signal from the interlocking device initiates a specified response. | Circuit diagram, operating description, and results of response verification. |
| If access is possible before the risk has ceased, the guard remains closed and locked. Hazardous functions can only be started after it has been closed and locked. | In our example: guard locking and control of its release are missing. | Assessment of access possibility, stop-time measurements, and verification of guard locking and the conditions for its release. To be completed. |
| The absence or failure of a component prevents start-up or stops the hazardous functions. | A solution that takes the failures under consideration and the required responses into account. | Failure analysis and the relevant verification results. |
Only after setting it out in this way does it become clear what is actually complete. A successful switch test does not resolve the missing guard locking. Similarly, a correct circuit diagram does not yet confirm that the guard has been installed in accordance with the design.
It is not necessary to create a separate row for every sentence of the regulation. However, its content must be addressed, not merely its title.
The reference must lead to the answer
“See electrical documentation” is of little help when the documentation is three hundred pages long.
In practice, it is advisable to identify the specific drawing or circuit diagram, its revision, the relevant section of the functional description, and the test report entry containing the verification result. These documents do not need to be reproduced in the list. They must be easy to locate.
The same test report may confirm several obligations. However, the result of verifying the opening of the door does not also confirm safe isolation from all energy sources. For 1.6.3, a reference will be required to the appropriate isolation devices, the conditions for locking them, and the handling of energy remaining in the system.
One document may support several requirements. This does not make one result the answer to everything.
This is exactly how the word “every” should be translated into work with the checklist. Do not create more forms; instead, check whether the blanket statement “compliant” is hiding an obligation that no one has yet addressed.
“The switch was checked” may be a valid test result. “The entire item is compliant” requires a little more than feeling good after start-up.
5. The standard number has been entered. But what part of it was applied?
After “a switch was installed,” there is another way to close out a requirement quickly:
“Compliant with the standard.”
A number appears next to it, sometimes even with the year of publication. It looks more convincing than “compliant” on its own. Especially if the list is long and contains several abbreviations that the person accepting the documentation will not want to decipher in front of witnesses.
The point is that citing a standard and applying it are two different activities. The first requires knowing the number. The second requires knowing the content and verifying your own solution.
The presumption of conformity has a defined scope
Harmonised standards have legal significance. Conformity with the relevant standard or part thereof, the reference to which has been published in the Official Journal of the EU, gives rise to a presumption of conformity with the essential requirements covered by it.
Not with every requirement that happens to be included in the checklist.
It is therefore necessary to determine whether the standard covers the issue under consideration, what conditions it imposes, and whether our machine actually meets them. When transitioning from the directive to the regulation, it is also necessary to verify for which legal act the reference to the relevant edition of the standard was published. The “EN” designation alone does not resolve this issue.
A standard may be technically useful without providing a presumption of conformity with the legal act referenced in the documentation.
This is an important distinction. Otherwise, updating the list ends with the assumption that if the standard number matched the previous declaration, it will also adapt to the new one.
Only part of the standard applied? Specify which part
The Regulation explicitly states that where harmonised standards or common specifications are applied only in part, the documentation must identify the parts applied. If they have not been applied at all or have been applied only in part, the other technical specifications used to meet the relevant requirements must be described.
Partial application of a standard does not permit partial compliance with the law.
Suppose that specific provisions of a standard were used when designing the guard for our line. For the remaining issues, a proprietary solution was adopted, and its effectiveness was demonstrated through calculations and tests.
There is no need to pretend that the entire guard was manufactured in accordance with all relevant provisions of that standard. The documentation must clearly show where the standard was applied, where another solution was used, and on what basis that solution was considered sufficient.
The problem begins when “partially applied” actually means:
“We read up to the point where our design stopped matching the standard.”
A proprietary solution requires technical justification. The shipping deadline is not such a justification.
The standard specifies the criterion. The verification result applies to our machine
It is therefore worth separating three pieces of information in the list:
Essential requirement—what the manufacturer must ensure.
Standard or other technical specification—the rules according to which the solution was designed and assessed.
Evidence—what confirms that the specific implementation meets the adopted criteria.
This is a proposed way of organising information, not another mandatory form.
If a standard specifies the conditions for implementing a safeguard, citing its number alone does not confirm that those conditions have been met. This may be confirmed by appropriate drawings, calculations, measurements or test results. The Regulation lists such materials alongside references to standards, not as substitutes for them.
Applying a standard does not mean having to prove the validity of each of its provisions from the beginning. It must be demonstrated that they have been applied correctly to this machine.
The presumption of conformity does not mean presuming that someone has applied the standard.
6. The same clause number does not mean the same requirement
A new clause is easy to notice. It is harder to identify new obligations under a number we have known by heart for years.
“1.6.2—access to operating positions and servicing points. We already have that.”
The list uses the same number. The designer recognises the title. The old “met” status is carried over to the new documentation without further questions.
But the questions are precisely what has changed.
A worker entered the mixer. What if they cannot get out unaided?
The Directive required safe access to areas where intervention is necessary during operation, adjustment and maintenance. The Regulation also lists cleaning and adds a specific obligation: where people enter the machinery to perform these activities, the access points must have suitable dimensions and be suitable for the use of rescue equipment.
Suppose a worker enters the mixer to remove product residue. The access hatch is large enough for them to pass through sideways, turning their torso and lifting one leg. Access was checked during acceptance testing.
“A person can fit through.”
Yes—if they are conscious, able-bodied and actively assisting their own passage.
But what about someone who has lost consciousness? Can they be extracted through the same opening using the intended equipment? Could the pipework or a drive component located above the access hatch obstruct the rescue?
The entry test was successful. A rescue test was not even planned.
This does not mean that the safety of a person inside the machinery could be ignored under the Directive. Requirements already existed for preventing entrapment and enabling a person to call for help. The Regulation, however, adds an explicit criterion concerning rescue access itself.
In our example, a photograph of the open access hatch alone is therefore insufficient justification. It is advisable to show its dimensions and surroundings, the intended rescue method, and verification that the appropriate equipment can be used. This is a way to demonstrate compliance with the requirement—not a statutory obligation to conduct one specific type of test.
An emergency call button solves the notification problem. It does not make the access hatch larger.
“We have no internet.” The service technician has just connected a laptop
The second example concerns the new point 1.1.9 — “Protection against corruption”.
It was added to the checklist for our packaging line with the following response:
“Not applicable — the machine is not connected to the internet.”
However, the local service port can be used to change safety-related configuration. Suppose this concerns the permissible speed in setup mode or the guard-locking release settings.
The machine is offline. The potential to interfere with its operation remains very much present.
Point 1.1.9 is not limited to the internet. Among other things, it covers the security of connections to other devices, the identification and protection of software and data critical to compliance, the identification of installed software necessary for safe operation, and the logging of interventions.
Including authorised interventions. Not only unauthorised ones.
There is therefore no need for an intrusion from the other side of the world. In our example, all it takes is a service technician with the right cable and the wrong configuration file.
The Directive already required that defects in the hardware and software of the control system must not lead to hazardous situations. The Regulation therefore does not newly establish that software can affect safety. It defines more explicitly the additional obligations concerning its protection, identification and intervention.
The checklist must therefore determine which obligations apply to the solution in question and then specify how they are fulfilled. Practical verification may cover access through the service port, protection of critical configuration, the ability to identify the software, and the operation of intervention logging.
“Service access only” is information about the user.
Not proof that the user will never make a mistake.
We update the answers, not just the list of questions
These two examples illustrate different pitfalls. In the first case, the content of a familiar item has changed. In the second, a new item has appeared that may be hastily ruled out on the basis of a single sentence.
Therefore, when transitioning from a directive to a regulation, finding the new item numbers is not enough. Requirements that have long been marked “met” must also be reread to verify whether the existing justification reflects their current wording.
An old “met” status is not a vested right. It must still fit the new question.
7. Partly completed machinery: “the integrator will handle it” also requires specifics
The documentation for the supplied module contains the following statement:
“Safeguards to be provided by the integrator.”
Brief. Broad. With a little goodwill, it can replace several pages of analysis.
But the integrator still does not know what has actually been supplied: a solution prepared for safe incorporation, or a list of problems the supplier preferred not to elaborate on before issuing the invoice.
Partly completed machinery is subject to separate conformity documentation rules. However, it is not machinery for which the essential requirements can simply be transferred as a whole to the next contractor.
More than the annex number changes in the list
The Directive required the risk assessment documentation for partly completed machinery to include a list of requirements applied and fulfilled. At this point, the Regulation refers to a list of requirements that apply to the partly completed machinery.
This is an important distinction. The starting point is to determine the scope of the obligations applicable to the product being supplied, rather than merely listing what the manufacturer intends to declare as fulfilled.
At the same time, the Regulation expressly excludes from this scope requirements that can be fulfilled only when the partly completed machinery is incorporated. However, the principles of safety integration remain applicable in all cases.
The word “only” matters here.
This concerns requirements that depend on incorporation, not work that could not be completed before shipment.
“Can only be fulfilled after incorporation” and “we did not finish in time before acceptance” are not two versions of the same exception.
Guarding the connection is one thing. Supplying the assembly safely is another
Suppose that a drive unit, correctly classified as partly completed machinery, is supplied for our packaging line. The final guarding of its connection to the mechanism it drives depends on the design of the final machinery and is to be installed during integration.
Such a division of work may be technically justified.
However, it does not explain how to handle the supplied assembly safely, what mounting conditions have been assumed, or what loads are permissible. This information will not materialize merely by bolting the equipment to the frame.
The assembly instructions should enable the integrator to determine what must be provided during incorporation and under what assumptions the supplier’s solution will operate safely.
In our example, this means specific information about the area requiring guarding, interface conditions, fastening, and the limitations of the assembly. There is no need to dictate every detail of the integrator’s design. The data and conditions required for correct incorporation must be provided.
“Use appropriate protective measures” sounds reasonable.
However, it still leaves the recipient to determine what the author considered appropriate.
Three documents, three different purposes
The list in the technical documentation should not be confused with the declaration of incorporation or the assembly instructions.
The manufacturer’s technical documentation must cover the applicable requirements and include materials that demonstrate compliance to the relevant extent.
The EU declaration of incorporation still identifies the requirements applied and fulfilled. It does not replace the analysis on which the manufacturer bases this declaration.
The assembly instructions specify the conditions for safe incorporation. The Regulation expands on their content, requiring, where applicable, information on the essential health and safety requirements applicable to the partly completed machinery, the method of fastening, stability, and safe interventions.
In practice, this information must be consistent. If the list makes fulfillment of a requirement conditional on specific installation conditions, those conditions cannot be omitted from the information provided to the integrator. If the declaration confirms fulfillment of a requirement, the documentation must provide a basis for that confirmation.
Division of responsibilities is permitted. Guessing how responsibilities are divided is not a sound method of ensuring safety.
The machinery may be partly completed. The information on what must be done when incorporating it should not be.
8. Modified machine. Evidence predating the modifications
The customer ordered another variant of our packaging line. The lift is to handle heavier pallets—now 1200 kg instead of 750 kg. The drive and its operating parameters have been changed.
The list of requirements was copied from the previous project. So were the references to calculations and test reports.
The machine received a more powerful drive. The documentation—a new date.
The problem is not the reuse of previous materials. It is reusing them without checking whether they still correspond to what we are manufacturing.
A higher lifting capacity may change more than just the calculation result
In our example, the lift has a mechanical drive. After increasing its lifting capacity, its strength, the behavior of the load after a power failure, and the effect of the changed parameters on stopping must all be reassessed.
But that is not all.
The modification may also trigger a requirement that did not previously apply. Section 4.2.2 on loading control covers lifting machinery powered other than by human effort whose maximum working load is at least 1000 kg or whose overturning moment is at least 40 000 Nm. It requires devices that warn the operator and prevent dangerous movements in specified overload situations.
If “not applicable” was correctly entered for the previous variant, that answer cannot simply be carried over when the lifting capacity is 1200 kg.
Reserve drive power does not provide a reserve of compliance with the requirements.
This is an important distinction: after a change, we verify both the scope of the requirements and how they are met. Not just whether the machine still completes its cycle.
The old test report does not become invalid. It may simply no longer be sufficient
Suppose the previous stopping test was performed with a specific mass, speed, and drive configuration. The result was valid and properly documented.
There is no reason to discard it. There is, however, a reason to check whether it also covers the new variant.
The previous calculations may have covered a wider range of loads. Some solutions may remain unchanged, and the existing evidence may still be sufficient. Alternatively, new calculations, measurements, or tests may be required.
This must follow from an assessment of the impact of the change, not from the similarity of file names.
The test report may be entirely valid—just not necessarily for the machine we are about to ship.
The Regulation requires procedures to ensure that series production remains in conformity. Changes to the production process, product design, and product characteristics must be duly taken into account, as must changes to the standards and specifications by reference to which conformity is declared.
Documentation should therefore not be reviewed only when a new regulation is introduced. The in-house engineering department can also provide reasons for an update.
We review the list from two directions
In practice, it is advisable to perform the review from both directions.
From requirement to evidence: for every “met,” is there still a solution and supporting evidence relating to the correct variant and operating conditions?
From change to requirements: have a new load capacity, a different drive, modified access, or a different cleaning method invalidated previous conclusions—including those marked “not applicable”?
The review record should identify what was changed, which requirements were rechecked, what evidence was retained and why, and what still needs to be added. This is a suggested way of organizing the work, not an additional form imposed by legislation.
There is no need to repeat the entire assessment without considering what is relevant. However, it is essential to ensure that information about the change reaches beyond the purchasing department and the workshop.
If the designer changes the assumptions and the person maintaining the requirements list learns about it while issuing the declaration, the update procedure has already been defeated by the flow of information.
The approval date indicates when the document was signed. It does not indicate whether the document describes the current machine.
9. “Met.” Good. Show me where.
The Directive already required a list of the applicable requirements and documentation enabling conformity to be verified. The Regulation explicitly links the description of protective measures to meeting each applicable requirement.
Therefore, the transition to the new legislation should not end with asking whether the number of the legal act has been updated in the documents. It is necessary to check whether the existing answers still correspond to the wording of the requirements, the machine as built, and its conditions of use.
If the documentation already demonstrated these links, there is no need to pretend that everything must start again from scratch. It must be updated thoroughly.
If, however, entire chapters were marked with a single “complied with in accordance with the standards,” the problem did not arise with the regulation. It simply received a new legal basis number.
The list should show determinations, not reassure the author
“Applicable” should result from analyzing the machine and the substance of the obligation. “Not applicable”—from a justified lack of applicability, not a lack of data. “Met”—from the solution and its verification, not from the fact that the field could not be left blank before submission.
This does not require a separate binder for each item. It requires the documentation to show what was done about each requirement.
Finally, it is worth performing a simple test: select one item marked as met and ask someone who did not prepare the list to locate the solution and evidence of its effectiveness.
Without calling the designer. Without guessing which version the report applies to. Without explaining that “everyone knows how it works.”
If the answer can be reconstructed, the list serves its purpose. If it has to be supplied from memory, “met” is, for now, merely the opinion of the person who entered it.
The regulation says “each.” This does not mean adding more text to every item. It means not leaving any requirement without a specific answer.
For “met,” just ask one question: show me where.
Not where it was checked off. Where it was demonstrated.
Sources and footnotes
The legal basis consists of the texts of Directive 2006/42/EC and Regulation (EU) 2023/1230 available on EUR-Lex. The specific provisions, rather than merely the numbers of the legal acts, are identified below. References to other articles provide further information on the topics; they do not replace the legal basis.
The obligations discussed here arising from Regulation (EU) 2023/1230 generally apply from 20 January 2027.
The examples involving a packaging line, mixer, drive assembly and change in load capacity are illustrative. The proposed tables, statuses and method of linking requirements to evidence are the author's organisational solutions, not forms prescribed by law.
[1] List and documentation under the Directive. Directive 2006/42/EC, Annex VII, Part A, point 1(a) — risk assessment documentation, a list of applicable requirements, a description of preventive measures, standards and materials enabling conformity to be verified.
[2] Linking measures to each requirement. Regulation (EU) 2023/1230, Annex IV, Part A, point (b)(i)–(ii), points (c)–(d) and (g) — a list, a description of protective measures, drawings, explanations and verification results.
[3] Scope of Annex III. Regulation (EU) 2023/1230, Annex III, Part B, points 1–4, Chapters 1–6, in particular sections 3.1.1 and 4.1.1. Part B, point 2 identifies the requirements that apply in all cases to machinery and related products.
[4] Moving parts and non-applicability of the requirement. Regulation (EU) 2023/1230, Annex III, Part B, points 1–2 and sections 1.3.7 and 2.4.1 — hazards arising from moving parts, safe clearing of blockages and the scope of requirements concerning the application of plant protection products.
[5] Interlocking guards, guard locking and energy. Regulation (EU) 2023/1230, Annex III, sections 1.4.2.2 and 1.6.3; Annex IV, Part A, points (c)–(d) and (g). The table in Part 4 of the article is the author's example of how to organise evidence, not a ready-made safeguarding design.
[6] Standards, scope of the presumption of conformity and partial application. Regulation (EU) 2023/1230, Article 20(1) and (6) and Annex IV, Part A, points (e)–(g). For comparison: Directive 2006/42/EC, Article 7(2) and Annex VII, Part A, point 1(a).
[7] Access to the interior and rescue of a person. Directive 2006/42/EC, Annex I, sections 1.5.14 and 1.6.2; Regulation (EU) 2023/1230, Annex III, section 1.6.2, in particular the second paragraph concerning rescue equipment.
[8] Connections, software and interventions. Directive 2006/42/EC, Annex I, section 1.2.1; Regulation (EU) 2023/1230, Annex III, sections 1.1.9 and 1.2.1. Section 1.1.9 also covers evidence of authorised interventions.
[9] Partly completed machinery.Directive 2006/42/EC, Annex VII, Part B, point (a); Regulation (EU) 2023/1230, Article 11, Annex III, sections 1.1.1–1.1.2, Annex IV, Part B, point (b)(i), Annex V, Part B, point 5, and Annex XI, points 1–2.
[10] Load capacity and load control.Regulation (EU) 2023/1230, Annex III, sections 4.1.2.3, 4.1.2.6 and 4.2.2. The example 750 → 1200 kg concerns a change to the machinery variant, not a new legal threshold: the 1000 kg threshold already appeared in Annex I, section 4.2.2 of Directive 2006/42/EC.
[11] Maintaining conformity in series production.Regulation (EU) 2023/1230, Article 10(4) and Annex IV, Part A, points (g)–(h) and (l) — taking account of changes and documenting the conformity of the variant produced.
[12] Main date of application.Regulation (EU) 2023/1230 — text incorporating the corrigendum, Article 51(2), Article 52 and Article 54. The corrigendum was published in OJ L 169, 4 July 2023, p. 35.