EN 415-4:2025: safety requirements for palletisers and depalletisers

Why EN 415-4:2025 is important for packaging and end-of-line system

palletising is one of the most critical areas of the end of the line. The risks are obvious: often high masses, automatic movements, loads that can be unstable, high production speeds, gripping organs, lifts, layer training tables, rollers, chains, handling robots or organs that rotate at high speed; however the real risk often arises from the interactions: operator who enters the area protected by the photoelectric barrier, maintenance technician who is located in a non visible arc, access to machine carried out troubleshooting, damaged palletizer,

The new EN 415-4 addresses this complexity. The standard is not limited to saying that there must be guard and emergency stops. Enter the merit of zones, openings, loads, access, electrosensitive devices, reset sequences, separation of protected areas, blocks against unforeseen lowering, protection against falling products, traversing of conveyors, safety functions and performance levels required.

This is particularly important in food, pharmaceutical, cosmetic, beverage, tissue, secondary packaging, automated logistics and industrial automation. In these environments the palletizer is almost never an isolated machine: it is a system inserted in a line, often with high demands of productivity and frequent format changes. Technical compliance must therefore be defendable both in front of the customer and in front of a CE audit or HSE verification.

The scope of EN 415-4:2025 standard

EN 415-4:2025 standard applies to palletisers, depalletisers, auxiliary equipment incorporated or connected to their operations, to transport systems that are part of the palletizer or depalletizer and to combined machines where the palletising function relies on other parts of EN 415. series.

The perimeter is important because many errors arise right here, a manufacturer can consider its supply boundary limited to the main machine block, while the actual risk involves inlet tapes, output tapes, pallet warehouses, layer pads systems, grippers, checkers, pallet exchange systems, robotized cells and interfaces with AGV or forklifts. The standard pushes to read the palletizer as an integrated safety function in the line, not only as a mechanical structure.

EN 415-4 standard ratio with EN 415 series and EN 415-10

EN 415-4 is part of EN 415 series, dedicated to the safety of packaging machinery. The series includes terminology and classification standards, preformed rigid container machines, form-fill-seal, wrapping, pallet wrapping, group and secondary packaging, tearing, noise measurement and general requirements.

The 10, EN 415-10:2014, is particularly important because it contains general requirements for packaging machinery. The new EN 415-4:2025 has been rewritten in coherence with this general part. This means that the evaluation of a palletizer should not be done by reading only part 4: you must always connect the specific requirements of the machine with the general requirements of the series.

The practical consequence is clear: when designing or assessing an end-of-line system, the list of applied standards must be developed systematically. EN 415-4 provides type-C requirements for palletisers and depalletisers; EN 415-10 covers general packaging machinery requirements; EN ISO 12100 provides the methodology for risk assessment and risk reduction; EN ISO 13849-1 supports the design and validation of safety-related parts of control systems; EN 60204-1 covers electrical equipment; and EN ISO 13855 and EN ISO 13857 support safety distances, guard positioning and protective devices.

Main technical requirements of EN 415-4:2025

The standard organizes safety requirements starting from general requirements for machines in its scope and continuing with specific requirements for different configurations: semi-automatic palletisers, low-level and high-level automatics, pick and place, robot palletisers, case-packer palletisers, multi-station systems served by AGV, mechanical gripping organs, vacuum, magnetic or rug/rullo, pallet stacker/de changer

Repealing, interlocking, ESPE, AOPD and AOPDDR

When the hazards from mobile parts cannot be eliminated with inherently safe design, access must be prevented by guards or protective devices. In palletisers the delicate point is that the machine must however allow the passage of pallet load, products, layer pads and sometimes vehicles. That is why protection is not trivial.

The input and output openings must be designed so as not to become improper steps for the operator; the presence of ESPE does not solve the problem alone, especially when there is a risk of falling the load outside the protected area. In these cases physical measures, guards, barriers, distances, logic of muting, resets and consistent segregations are required.

The design must therefore distinguish at least three scenarios: gates for the only passage of the pallet load, access intended for personnel and internal areas where the whole body can enter. This distinction must be visible in the layout and command logic, not only in the instructions for use.

Access to dangerous areas, reset personnel key

One of the most important themes of the new setting is access management. If a machine has multiple protected areas, such as pallet warehouse, layer pads area, palletizing area and conveyor area, these areas cannot be treated as a single indistinct volume. Zones must be separated and reset and restart logic must prevent a part of the machine from rebooting while a person is in another area not visible or uncontrolled.

The standard introduces strong attention to sequential resets, to the visibility of the area to be reset and to the use of personal keys when the operator enters areas with risk of complete access of the body. This point is very concrete: often accidents on automatic machines happen not because there is guard, but because someone resets and without having the full perception of who is inside the hazard zone.

For the designer, this means that the layout of the reset buttons, the position of the doors, the visibility through the guards, the choice of nets or transparent panels, the output sequence and the behaviour of the interlocks are an integral part of the safety design.

Openings for pallet load, muting and loads of variable width

Modern lines treat pallet load with very variable dimensions. The standard pays attention to the openings in the guards, to the minimum distance between protection devices and hazard zone, to the passage of loads on conveyors and to the possibility that a operator exploits a passage during the phase of muting.

When pallet loads have different widths, protection must prevent full body access even during loading transit. From here the use of additional vertical devices, AOPDDR or equivalent configurations. In cases where the automation of the muting is not applicable for the great variability of the load, the use of instructions for use muting must be treated as a critical function: maintained command, external position to the hazard zone, visibility, signaling the status of muting, controlled time and emergency stop near the device.

This is an important change of mindset. Muting is not a shortcut to pass the pallet. It is a safety function that allows the passage of the load without allowing the passage of the person.

Prevention of unforeseen downfall and mechanical blocks

In palletisers and depalletisers the masses raised are one of the main risks. The standard treats the resistance of the mechanical components that support a load, the coefficients to be applied, the behaviour in case of breakage, the devices against unforeseen lowering, the mechanical blocks and the measures for interventions under raised elements.

From the point of view of the technical file, this theme cannot be solved by a generic phrase. We need data: masses, coefficients, components, chains, belts, ropes, brakes, cylinders, retaining devices, functional tests and maintenance procedures. If access is provided under a raised organ, even for maintenance or failure removal, the design must demonstrate that the unforeseen fall or downfall is adequately considered and protected.

Access at altitude, conveyor crossings and product fall

The standard is also very concrete on high-level access: when the operator has to access high levels for cleaning, maintenance, troubleshooting or product management, the machine must be designed preferably to avoid high-level access. If it is not possible, you need means of access, protection against falling, any automatic mobile parapets, door blocks and, in the residual cases, PPE and correct anchor points.

Another subject often underestimated are the crossings of the pallet conveyors. If the operator has to cross a roller conveyor or chain, the project must manage surfaces, steps, handrails, controls on both sides, any ESPE, instructions for use stops, speed and prevention of transfer between load pallets and fixed parts. It is not acceptable to leave the operator an improvised passage over an active conveyor.

The product fall is equally critical; an unstabilised pallet load, a high load, an unsuitable pattern layer, high accelerations or a faulty pallet can generate impact and crushing risks. The standard also connects this aspect to the stability of the load and the quality of the pallets declared in the instructions for use. Reference

Safety functions and Performance Level required

One of the most important news of EN 415-4:2025 is the explicitation of PLr for many safety functions. This brings the standard much closer to the real practice of the electric designer and automation: it is not enough to say that an interlocked guard stops the machine, you have to design the function, calculate it and validate it.

Among the functions treated include, for example, stop at the occurrence of opening a guard or activation ESPE, prevention of unexpected start-up, stop of vertical movements, stop of push mechanisms, stop of gripping devices, activation of anti-duty mechanical devices, limitation of movement, functions for multi-station systems and functions connected to AGV.

This requires consistent electrical schematics, safety functions definition, component parameters, architecture, MTTFd, DCavg, CCF, category, PL achieved, validation according to EN ISO 13849-2 and consistency with the actual behaviour of the machine.

Teleservice, remote control and software responsibility

The standard also treats remote control or teleservice when it can affect the operation or machine safety. It is a very current theme, because many packaging lines are connected to diagnostics, remote assistance, parameters update, supervision or data collection.

If the remote connection can affect the function or safety, the user must have access control and awareness; the machine must be uniquely identified when it is permanently connected and access must be authorized and recognized by the user at the machine with a suitable procedure.

This does not transform EN 415-4 into a cybersecurity rule but makes it clear that teleservice is no longer an auxiliary service, it is a function to design, limit, describe and document. With Machinery Regulation, CRA, NIS2 and EN 50742:2025, this point will become increasingly important for connected machines. Reference

The latest 2025 version compared to EN 415-4:1997

The tracked-changes version compares BS EN 415-4:2025 with BS EN 415-4:1998, which adopted the historic EN 415-4:1997. The standard has been updated to reflect the state of the art in modern packaging lines.

1. Robot palletisers and palletisers

The first strong novelty is the explicit entry of robots into the scope. The standard recalls the requirements of robotic applications and robotic cells. This is essential because many modern end lines do not use more traditional palletisers to push or layer, but anthropomorphic robots, gantry, multifunction grippers and compact cells with reduced access.

For the manufacturer, the question is not only to choose a compliant robot. Check the cell: robot zone, outlet organ, product, pallet, conveyor, maintenance access, reset, unexpected start prevention, product fall, format change and interface with other machines.

2. Multi-station systems served by AGV

The second strategic novelty concerns multi-station systems and AGV access. This theme is new because it represents the end current industrial line: automation does not end to the palletizer, but continues with automatic vehicles, shuttles, warehouses and logistic systems.

The standard enters the detail of the gates, loading/unloading areas, people detection, vehicle position, horizontal or vertical barriers, timing, sequences and reset. This requires a much tighter coordination between palletizer manufacturer, AGV supplier, line integrator and end user.

3. Updating regulatory references

The historical standard was born in a very different regulatory framework. Today the safety of the machines is built on more mature references: EN ISO 12100 for risk methodology, EN ISO 13849-1:2023 for safety-related control system parts, EN ISO 13855:2024 for protection device positioning, EN ISO 13857:2019 for distances, EN 60204-1:2018 for electrical equipment, EN ISO 10218 for robots and robotic cells.

This update has a practical effect linked to the standards recalled in the technical documentation of the machine, the latter must be consistent with the design edition used and with the state of the art at the time of placing on the market.

4. Performance Level required

The new version specifies the PLr for many functions, so you have to switch from risk to safety function, from function to circuit, from circuit to calculation, from calculation to validation.

In particular, guard functions, ESPE, vertical movements, unexpected start-up prevention, anti-duty devices, AGV and conveyor must be designed with a consistent performance level. This affects components, architectures, diagnostics, fault masking, serial interlocking connection and software/parameter validation.

5. More attention to real accidents

The annex on significant hazards recalls typical situations that have led to serious or deadly accidents: entry through a photoelectric barrier, reset by a second operator without visibility, defective devices, access to living machine for faulty research, transit with pallets or layer pads that is interpreted as load to change, unseparated internal zones, unexpected start.

The safety of the palletizer is designed taking into account the reasonably foreseeable behaviour, not only the ideal use. If a door is uncomfortable, the operator will use the pallet lane. If the reset is far away, someone will find a shortcut. If the fault finding requires you to enter with a live machine, sooner or later it will happen. The standard requires design against these scenarios, not to write them as generic prohibitions in the instructions for use.

Impact on manufacturers, supplements and users

For palletisers and palletisers manufacturers, EN 415-4:2025 standard requires a review of standard designs. You will need to check layouts, access, guards, ESPE, safety functions, vertical movements, gripping organs, admitted pallet quality, instructions for use, maintenance procedures and verification matrices.

For supplements the theme is even more delicate, the standard in fact defines the role of the supplement as a subject that designs, provides, realizes or assembles an integrated system and which is responsible for the safety strategy, including protective measures, command interfaces and interconnections of the control system. This means that integration cannot be treated as a simple mechanical and electrical connection between CE machines. When functions interact, the risks also interact.

For end users, however, the standard is useful in the phase of capitulation, FAT, SAT, audit and modification of existing lines. A company that acquires a fine line can ask for precise evidence: analysis of the specific risks for palletising, scheme of protected areas, list of safety functions, PL calculations, stop testing, access and reset procedure, instructions for pallets allowed, verification of the interface with AGV or muletti. Reference

Evidence to be included in the technical file

What evidence do you need in the technical file? The answer depends on the machine, but some elements are almost always necessary.

Attention to the state of harmonization

EN 415-4:2025 contains a ZA Annex that relates the standard to the essential requirements of 2006/42/CE.

The principle is clear: the presumption of conformity derives from the publication of references to the standard in the Official Journal of the European Union, according to the mechanism of implementing decisions of the Commission. The Commission's summary lists are useful for verification, but they have informational value and do not produce independent legal effects.

For the publication of the Waves article, the correct formula is prudent: EN 415-4:2025 is the new European standard of reference for palletisers and depalletisers; before using it as a harmonised standard for the purposes of the presumption of conformity, it is necessary to verify the last list GUUE and the possible national transposition applicable.

13. Does FAT/SAT tests include functional tests, measurements, calculations and verification registration?

14. Have the state of harmonisation and national transposition of the standard been verified before the declaration?

How Waves Engineering supports manufacturers

Waves Engineering supports manufacturers, integrators and companies using machinery in the technical evaluation of palletisers, depalletisers and end-of-line system systems according to EN 415-4:2025, EN 415-10, EN ISO 12100, EN ISO 13849-1 and EN 60204-1.

Support may include risk analysis, layout review, guard verification, opening study, safety functions definition, performance level calculation, verification of electrical schematics and tires, reset logic control, robot and AGV evaluation, document audit, technical file editing and instructions for use instruction update.

The aim is to prevent an end-of-line system from being sold, installed or modified with weaknesses that emerge only during FAT, SAT, a customer audit or, worse, after an accident. EN 415-4:2025 provides a strong technical reference and should be applied with regulatory expertise and practical knowledge of packaging machinery.

FAQ

What is EN 415-4:2025?

It is the European standard dedicated to safety requirements for palletisers, palletisers and associated equipment in the packaging machine industry. 2025 version deeply updates the previous EN 415-4:1997.

Does EN 415-4:2025 also concern palletizing robots?

Yes. One of the main innovations is the inclusion of palletisers and depalletisers that incorporate industrial robots. The evaluation must also consider the requirements applicable to robotic cells and robotic applications.

Does the standard also concern AGV and multi-station systems?

Yes. 2025 review processes multi-station systems and AGV access conditions, with requirements on protection devices, people detection, vehicle location, muting, resets and safety crashes.

What are the main innovations regarding EN 415-4:1997?

The main novelties are: extension of robot brooms and multi-station systems, rewriting requirements according to EN 415-10, updating of regulatory references B1 and B2 and specification of PLr according to EN ISO 13849-1:2023.

Is EN 415-4:2025 enough to mark CE a palletizer?

No. The standard is an important vertical reference, but it must be integrated with risk assessment under EN ISO 12100, applicable general and support standards, safety functions verification, technical file, instructions for use and evaluation of the updated harmonisation status.

What should a manufacturer check on an existing line?

It must check layout, access, guards, ESPE, muting, reset, vertical movements, safety functions, PL, instructions for use, pallet quality, maintenance and interfaces with other systems. Important changes or integrations may require a new risk assessment.

Does EN 415-4:2025 apply to the machines already built?

The standard is not applicable to machines manufactured before the date of publication of the standard by CEN. However, it can be a useful reference to assess the state of the art, especially in case of changes, revamping, integrations or safety audits.