Since robots already feature safety functions and AGVs are equipped with safety scanners, can the two be integrated to allow for pallet delivery without stopping the machine?
For a given palletizer, should the emergency stop, prevention of unexpected startup, and protection against personnel entry all be designed to meet Performance Level d (PL d)?
The previous version specified 200 mm, while the new version specifies 100 mm—does this mean the required anti-fall distance has been halved across the board?
With the update of EN 415-4 from the 1997 version to the 2025 version, safety assessments—involving combinations of robots, grippers, pallets, conveyors, and human tasks—must now be tailored to specific machine models, functions, and actual interfaces.
I. Becoming a Harmonized Standard: Distinguishing Between Technical Replacement and Legal Citation
EN 415-4:2025 has been added to the list of harmonized standards under the Machinery Directive 2006/42/EC via Commission Implementing Decision (EU) 2026/2015 (specifically, item 14a, added to point 2 of Part III in the Annex). This decision was published and entered into force on September 7, 2026.
It is important to distinguish between four separate aspects:
CEN publishes a new version of a standard, which replaces the previous version within the technical standards framework.
The European Foreword mandates the withdrawal of conflicting national standards by June 2026 at the latest.
The EU publishes the citation of the harmonized standard in the Official Journal of the European Union (OJEU), which carries specific legal implications.
Harmonized citations under the new Machinery Regulation require separate confirmation in accordance with that regulation.
The withdrawal date for national standards cannot be equated to the termination date for the EU’s previous harmonized citation. Furthermore, the addition of EN 415-4:2025 does not imply that all existing projects automatically become non-compliant as of that date.
The "presumption of conformity" provided by a harmonized standard is limited to the Essential Health and Safety Requirements (EHSRs) actually covered by that standard; the use of the standard does not automatically signify that all regulatory requirements for the entire machine have been met. The specific scope of coverage should be determined by consulting Annex ZA of the standard, along with the relevant conditions for harmonized references.
Furthermore, Article 2 of Decision (EU) 2026/2015 stipulates that Decision (EU) 2023/1586—which concerns harmonized standards under the Machinery Directive—will be repealed effective January 20, 2027. Consequently, the mere fact that a standard is referenced under the current Machinery Directive does not automatically grant it a presumption of conformity under Regulation (EU) 2023/1230.
For more information on this transition, please refer to the article: "Can Existing EN Harmonized Standards Still Be Used After the Machinery Regulation Comes into Effect?"
Regarding the technical scope, the new Section 1 covers palletizers, depalletizers, associated auxiliary equipment, and conveyor systems that form an integral part of such equipment; however, it does not encompass all equipment within an entire production line. Conveyors connected to machinery outside the scope of this standard are excluded. Also explicitly excluded are risks related to potentially explosive atmospheres, as well as health, safety, or hygiene hazards posed by the products being handled (the "load"); note, however, that there are specific exceptions for cases where machine malfunctions lead to the spillage of hazardous substances.
II. Robotics and Multi-Station Systems Are Not New Concepts; Interface Requirements Have Become More Specific
Consider a robotic workstation serving two pallet positions simultaneously: one side receives empty pallets via an Automated Guided Vehicle (AGV), while the other side discharges fully loaded pallets.
It would be incorrect to interpret the foreword of the new edition as implying that "robotic palletizing only entered the safety standard framework in 2025." The 1997 edition (Section 1) already addressed industrial robots used in palletizing and depalletizing applications, with corresponding definitions provided in Section 3.1.4.12. Furthermore, Sections 3.1.4.6 and 3.1.4.8 of the older version already described multi-position palletizing and depalletizing operations.
A significant change in the new edition is that these applications have been elaborated into more precise requirements for equipment and systems. The 2025 edition, in §4.6.1, stipulates that the robots and robotic equipment used must comply with EN ISO 10218-1:2025, while robotic palletizing or depalletizing systems must comply with EN ISO 10218-2:2025. Documentation for the robot unit itself cannot serve as a substitute for an integrated risk assessment that accounts for end-effectors (grippers), the loads being handled, peripheral equipment, and the tasks performed by personnel. Relevant boundaries can be determined by referring to the article: "EN ISO 10218-1/-2:2025 Added to the List of Harmonized Standards: What Has Changed in These Robot Safety Standards?"
Section §4.8 of the new edition specifically addresses multi-station palletizing systems serviced by AGVs (Automated Guided Vehicles).
Section §4.8.2 does permit the use of "muting" (temporary suspension of the safety function) for ESPE (Electro-Sensitive Protective Equipment) at entry/exit points under specified conditions, allowing a palletizer to remain operational while an AGV picks up or drops off a pallet. However, this is contingent upon a comprehensive set of safety requirements, including: personnel detection by the AGV itself, auxiliary detection zones, restrictions on the number of vehicles entering, verification of positioning and clearances, communication-based requests, continuous monitoring on both sides, and defined safety responses for anomalous situations.
The mere fact that an AGV is equipped with a scanner is only one of several conditions; it is not, by itself, sufficient to authorize entry into an active workstation.
For instance, if an AGV stops midway through an entry point, the conditions regarding controlled obstruction and personnel proximity may change. Therefore, it is not enough to verify only a standard, uninterrupted passage; one must also evaluate the system's response following an abnormal stop. Section §4.8.1 further specifies requirements for the location of external restart controls, visibility into the hazard zone, and the necessary conditions for resetting the system when multiple workstations are involved.
Furthermore, the provision for automatic resetting under the conditions defined in §4.8.2 cannot be interpreted as a blanket rule allowing the entire system to restart automatically simply because personnel have left the area.
III. The Required Performance Level (PLr) is determined based on individual safety functions; a single, uniform safety level cannot be assigned to the entire machine.
The previous edition already incorporated requirements based on "Categories." For example, §5.3.1 of the 1997 edition mandated a minimum of Category 2 for safety controls related to entry/exit protection and muting—demonstrating that the earlier version did, in fact, include performance requirements for safety control systems. In accordance with EN ISO 13849-1:2023, the new version specifies the PLr (Required Performance Level) for various machine types and safety functions.
Taking an automatic low-level palletizer or depalletizer as an example, the minimum requirements listed in §4.3.2 of the 2025 version are as follows:
This table specifies only the machine types and functions covered by the relevant provision; it cannot be applied to robotic palletizers or other structural configurations. The appropriate machine type for a robot must be determined by following the reference path provided in §4.6.2.
Furthermore, the legacy "Category 2" classification cannot be directly equated to the current "PL d" (Performance Level d). "Category" represents only one aspect of performance evaluation; other factors—such as component reliability (MTTFd), diagnostic coverage (DC), common-cause failures (CCF), and systematic measures—also influence the final achieved performance level. For further details, please refer to the article: *"What Exactly Is the Relationship Between PL, PLr, Architecture Category, MTTFd, DC_avg, and CCF?"*
For existing projects, a more valuable exercise is to re-verify the safety function list: identify what is being protected, define the hazardous movements, determine the required state following a trigger event, and confirm whether the actual configuration and verification evidence support the specified requirements. The fact that a safety PLC or a robot’s technical documentation specifies "PL d" does not satisfy the requirements for the entire safety function. For more information, see: *"From Safety PLC to a Complete Safety Function: What’s Missing?"*
IV. A Key Challenge in Goods Entry/Exit: Ensuring Personnel Remain Protected During Transit
Consider a scenario where a single conveyor opening accommodates both wide pallets and narrower loads. The absence of significant gaps when a wide load passes through does not guarantee that personnel cannot enter the area alongside a narrower load
The 1997 version of the standard (§5.3.1) already addressed the distinction between personnel and goods, as well as the concept of "muting." It also mandated intentional resetting (§5.3.3) and included provisions for protection against personnel becoming trapped (§5.3.4). The new version does not introduce these principles for the first time; rather, in sections §4.1.5–§4.1.6, it provides further clarification regarding area separation, reset logic, gap management, and the protective conditions required for loads of varying widths.
Section §4.1.6.3 of the 2025 version addresses the passage of loads with different widths through larger openings, specifying the configuration requirements for vertical AOPDs (Active Optoelectronic Protective Devices) or AOPDDRs (Active Optoelectronic Protective Devices responsive to diffuse reflection—for example, safety laser scanners). The focus of inspections should expand beyond "whether goods can pass through smoothly" to "whether sufficient space remains for personnel to enter while goods are in transit."
Manual muting is not a general-purpose bypass to be used whenever an unintended stop occurs. Section 4.1.6.3.2 defines the specific scenarios where it is applicable and mandates requirements such as continuous-operation control via a key-operated switch, installation positioning, permitted conveyor movement during activation, visual/audible indicators, and termination conditions.
For multi-zone systems, additional factors must be considered: Where do personnel go after leaving a zone? Can the person performing the reset see the hazardous area being restored? Have personnel carried their access keys (or "personnel keys") into the area? These questions determine whether adjacent zones can safely resume operation; one cannot rely solely on the fact that an "outer light curtain is no longer obstructed." For background information on safety gates and personnel keys, please refer to the article: "What Are the Key Changes to Safety Gate Interlocks in the New EN ISO 14119?"
Another figure frequently misused is 800 mm/s. The new Section 4.1.6.1 applies exclusively to specific scenarios where personnel approach a conveyor from above. Furthermore, it requires the relevant chain, belt, or roller conveyor to meet specific structural and geometric criteria before a reduced walking-approach speed can be used for safety distance calculations. It is not a universal "K-factor" for calculating safety distances for light curtains.
For a foundational understanding of safety distance assessments, you may consult: "What Has Changed Regarding Safety Distances for Light Curtains and Protective Devices in EN ISO 13855:2024?"
V. Lifting Mechanisms and Gripping Devices: What Happens to the Load After Motion Stops?
Consider a scenario where a robot has come to a stop, but a vacuum gripper is still holding a carton, or a lifting platform has received a safety-stop command while personnel prepare to enter the space beneath it to clear an obstruction.
In such cases, it is necessary to evaluate several factors: Has motion truly ceased? Can the load be securely maintained? What would happen in the event of a loss of power or a mechanical failure? And what protective measures are in place when personnel intervene? A stop command alone does not address all these concerns.
The previous version of the standard already addressed the risks of load instability or ejection (Section 5.5) and the potential for items held by vacuum grippers to fall in the event of a power loss (Section 5.7). The new version—sections §4.9 through §4.12—addresses mechanical, vacuum, magnetic, and roller-curtain gripping devices, respectively. Furthermore, mechanical and vacuum gripping devices are linked to the corresponding requirements of EN 415-10:2014 via §4.1.15. This does not represent the creation of a new, previously non-existent responsibility regarding the prevention of load drops.
It is also important to note a significant limitation introduced in §4.1.3: when there is a risk of a load falling outside the safeguarded area, relying solely on an ESPE (Electro-Sensitive Protective Equipment) for protection is not permitted. The detection of personnel entry and the prevention of load drops cannot be simply equated as the same type of protective function.
In particular, figures related to lifting mechanisms must not be evaluated in isolation from the conditions under which they apply:
Since the mechanisms, triggering conditions, and measurement starting points for these three scenarios differ, it is inaccurate to simply state that "the new version changes the fall-arrest distance from 200 mm to 100 mm."
Section §4.1.7.3.1 of the new version distinguishes between situations where a person is expected to enter the space beneath a lifting mechanism and situations where such entry is merely possible. Furthermore, §4.1.7.3.5 addresses the locking measures required for maintenance or prolonged intervention. Evaluating the point of entry, the reason for entry, and the duration of stay is far more critical than merely comparing two numerical values.
Similarly, technical documentation for a gripping device must be evaluated within the context of its actual application. Changes in packaging materials, the center of gravity of the load, or acceleration/deceleration profiles can alter the conditions under which the original retention and anti-drop measures remain effective. Analyzing such variables requires specific engineering judgment; one cannot assume an entire application is safe solely based on a compliance document for the gripper itself.
VI. Noise and Verification Requirements: Potential Changes to Delivered Documentation
The 1997 version (§1) explicitly excluded noise-related hazards from its scope. In contrast, the 2025 version (§4.1.13 and normative Annex B) introduces specific noise requirements and testing protocols. This does not imply that the previous Machinery Directive imposed no obligations regarding noise; rather, the scope of this particular "Type C" standard has evolved.
Annex B.5 stipulates that if the A-weighted emission sound pressure level at a workstation—measured in accordance with B.4—exceeds 80 dB(A), the A-weighted sound power level must be determined pursuant to EN 415-9:2009. Note that the threshold here is 80 dB(A), not 85 dB(A).
Measurements must also account for the operating conditions, measurement points, and declaration criteria specified in B.2 through B.4. If normal production involves impacts (such as with pallets), gripper actuation, or noise from conveying systems, a test report that fails to specify the operating conditions and measurement points is insufficient to determine whether these requirements have been adequately addressed.
Verification is not a new concept; the previous version (Chapter 6) already included visual inspections, measurements, installation verification, and safety function testing. The new version (Chapter 5, Table 1) further clarifies the correspondence between specific safety requirements and the methods used to verify them—namely visual inspection, functional testing, measurement, and calculation. The new version of §5.1 explicitly requires that every machine undergo the tests specified in items a, b, c, and h of EN 60204-1:2018, §18.1. This should not be interpreted as a requirement to perform *all* test items listed in §18.1; conversely, safety verification for an entire piece of equipment cannot be satisfied solely by providing reports on insulation and withstand voltage (dielectric) testing.
For manufacturers and integrators, this means that design documentation, calculations, commissioning records, and on-site verification must collectively address a consistent set of questions: What are the applicable requirements? What measures have been implemented? And what evidence exists to prove their effectiveness?
VII. Type-C standards are more specific, but they do not replace the need for a risk assessment of the entire line.
EN 415-4:2025 is a Type-C standard. According to its introduction, the complete requirements for machines within its scope must be considered in conjunction with the relevant provisions of EN 415-10:2014. If the requirements for a machine designed and manufactured under this Type-C standard differ from those in Type-A or Type-B standards, the specific requirements of the Type-C standard take precedence.
This does not mean that other standards can be disregarded. For conveyors falling within the scope of this standard, §1 indicates that EN 619:2022 also applies; however, EN 415-4 takes precedence regarding additional or specific hazard requirements for conveyors integrated into palletizing or depalletizing equipment. For connecting conveyors that fall outside this scope, one cannot use this principle of precedence to automatically bring them under the purview of EN 415-4.
Similar boundaries apply to combined case-packing and palletizing equipment: §4.7 directs users to the applicable requirements for both the case-packing and palletizing mechanisms. When different risks coexist within the same hazard zone, protective measures must be appropriate for the highest level of risk present and must address all types of hazards involved.
It is also essential to distinguish the nature of the annexes: Annex B is normative, while Annexes C, D, and E are informative—providing guidance on load stability, multi-station systems served by AGVs, and integrated systems, respectively. While informative annexes offer valuable engineering reference, their contents should not be construed as independent, mandatory requirements. Furthermore, one cannot infer from Annex E that "all integrators are required to obtain a specific certification." Regarding this version update, it is recommended that equipment manufacturers prioritize reviewing three areas: whether the boundaries of the equipment and its interfaces are fully defined; whether safety functions and protection conditions align with actual operational requirements; and whether the verification evidence covers the measures implemented.
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