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CE · Packaging and filling machines

CE conformity for Packaging and filling machines

For Packaging and filling machines, the applicable CE scope is determined from intended use, energy sources, safety architecture and target market. The risk assessment, technical file, testing and conformity route must be verified against the actual model.

CE conformity for Packaging and filling machines — Product-specific conformity guide
The machine familiesVertical form-fill-closing (FFS), horizontal flowpack, vacuum packing and liquid fill
Line entriesProduct characteristics, packaging material, type of container, speed of production, format and cleaning method
Critical searchDose unit, feed, conveyor, control equipment, closing and labelling
File focusProduct-based safety evidence of jaw, cutter, lid, nozzle and transfer movements
Direct response to the scope

CE conformity for Packaging and filling machines — Define the product boundary first

The packaging facility often consists of more than one machine with successive functions. The product preparation or dosing unit, packaging body, metal detector, control weight, labeling, conveyor, and coupling closure module can operate at a common prescription and production speed. The list of modules delivered when drawing the CE boundary is not sufficient; the material and signal flow, emergency stop zones, operator transitions, and line restarting power must be shown. Even a conveyor later added by the user is subject to interfacial evaluation if it changes the protective openness or access duration.

In a vertical form-fill-closing machine, film film filming belts, shaping shoulder, dosing input, hot jaws and cutter are assembled on the same vertical axis. In a bed flowpack machine, product pushers and long input feeding chain create a risk of capture and cutting along with rotating end adhesive jaws. In a vacuum packing machine, a heavy lid, closing bar, vacuum hazard and hot wire are promoted. In a fluid fill line, rotating stars, moving nostrils, container pressure, carrying products and cleaning chemicals are evaluated. These similar corrosion bodies; the motion, temperature and access of the evidence with the module are not accepted, each type of mode of operation is referred to by its own principle.

In machines that come into contact with food, cosmetics or pharmaceutical products, hygienic design is an integral part of safety. Parts that are removed for cleaning can pose a risk of sharp edges, heavy lifting, chemical exposure or unexpected movement. If a cleaning (CIP) system is in place, the fluid temperature, pressure, chemical concentration and false valve scenario are in the technical file. The declaration of material conforming to food law is a different group of evidence of CE compliance; the two are not used in place of each other.

The EU/EEA period for packaging and filling machines is selected by first supply to the market or first service. If the packaging machine is subject to the first event, including 19 hob 2027, 2006/42/EC; if the filling machine is subject to the first event, starting from 20 hob 2027, (EU) 2023/1230 is applied.

Product boundaries

How do you sort out the right product line in this category?

Name similarity alone is not sufficient; the energy source, intended use, and safety architecture are read together.

Product or limitThe distinguishing featureThe relevance of the results
Single packaging machineThe limits of a machine ready to take the product dose and remove the closed packaging are determined by the feed and exit connections specified by the manufacturer.
Full packing lineIf the modules are running at common speed and control, the compression transitions, common positioning and restart are evaluated over the entire line.
External dosing systemThe mechanical and electrical interface between the packaging body of the separate CE marked dosing unit and the product flow shall not create any new hazard.
Multiple formatsIf the film width, package length, volume of container and parts of change produce different protective openings, the safety is confirmed in the most negative variant.
Slip cleanThe cleaning instructions for washing pressure, water access to electrical equipment, slippery floor and removable parts must be in accordance with IP class.
Full product burnerIf solvent or alcohol vapor can form, the explosive atmosphere, ventilation and ignition source analysis are carried out separately from the normal fluid filling.
Risk architecture

The main dangers to be addressed in the file

The protective, control and verification approach shall be based on the actual product cycle.

01

The patch faces

The forward or reverse jaws combine the danger of crushing, cutting and hot surface at the same point; protection must remain active throughout the cycle.

02

Feeding of films and products

The belt, chain, ladder and pushers form long grip zones; the method of handling product trapping is defined safely.

03

Vacuum cap and treasure

Heavy cap fall, finger sticking and treasure breakdown; support, lock and pressure differential management are treated.

04

Full noodles

A moving nozzle, a rotating vessel carrier, and a jumping hot or chemical product can create mechanical and process exposure at the same station.

05

Unexpected line start

Once a sub-module is deactivated, the central prescription should be prevented from automatically starting the line; a visible and controlled restart approval is required.

06

Clean and change format

Tasks requiring routine access to a cutter, hot bar or propulsion unit provide a method of energy allocation and ergonomic transport.

The conditional law matrix

When will the regulation take effect?

A single product name doesn't give the same answer for all models.

The subjectThe situationProduct-based evaluation
The Commission shall adopt implementing acts in accordance with Article 21 of Regulation (EC) No 2006/42/EC and Turkey's 2006/42/AT.YES, YESThe Directive period begins with the first supply or first service in the EU/EEA for packaging and filling machines.
(EU) 2023/1230IT 'S A MESS .For the EU/EEA, the Regulation period starts when packaging and filling machines are first supplied or first put into service. Packaging and filling machines are covered during this period (EU) 2023/1230; production dates are not determinative.
The following information is provided for in Article 2 (1) of Regulation (EU) No 575/2014:IT 'S A MESS .The electromagnetic conformity of the servo, heater switching, weighing electronics and communication equipment is considered.
2014/35/EU LVDNO , NOT AT ALL .The LVD is not applied separately for packaging and filling machines. Electrical hazards are assessed in accordance with Appendix I 1.5.1 to the Packaging and Filing Machines file 2006/42/AT; the encoder, weighing device or electrical module presented alone is examined in its own supply status.
2014/68/EU PEDIT 'S A MESS .The feasibility is assessed according to the technical class of the vacuum tank, pressure product tank or arrangement.
The following information is provided:IT 'S A MESS .The filling process, which contains the combustion liquid vapor or dust, is determined by the design of the atmosphere and equipment.

Standard and verification approach

  • EN ISO 12100: It establishes a risk-reduction order by identifying hazards at all stages of packaging and product flow.
  • EN 415-3: The current pressure on the safety of form-fill-closing and fill-closing machines is controlled.
  • EN 415-2: Provides for the type of product concerned in pre-formed rigid container packaging machines.
  • EN 415-10: It provides general provisions for common security headers on packaging machines; it does not replace the special section.
  • EN 60204-1: The machine is used for the protection, control, marking and verification of electrical equipment according to product design.
  • EN ISO 13849-1/-2: It supports performance and verification of security functions such as door lock, jaw position, and line restart.
  • EN ISO 14159: It helps to structure decisions between cleanliness and safety in machine design where hygiene is at risk.
The relevant management systems

Corporate links separate from the product's CE work

— Supports hygiene and food safety management in food and beverage applications; does not replace the CE conformity of the machine.

The compliance work plan

In what order will the technical preparation proceed?

Product and package not defined

The product, packaging, speed, format, temperature, pressure and cleaning conditions for VFFS, flowpack, vacuum and filling systems are set separately.

Combine the boundaries of the module

The dosage, input feed, conveyor, tank, pump, labelling and output equipment are displayed in physical interfaces with the common control.

Secure the intervention tasks

Safe modes are designed for filming, prescription switching, lid opening, nozzle cleaning, compression removal and CIP operations.

Function and process tests

The brake, cutter, lid, nozzle, restart of the line, temperature, electricity, EMC and conditioned PED-ATEX requirements are confirmed.

Do not close the line document

Product-format-cleanness limits are transferred to user instructions; the final system label and compliance statement are published according to the delivery scope.

Product records to search for in the technical file

  • Packaging and product configuration matrix
  • Product-film-cap flow and module settings
  • Machine and process-based risk assessments
  • Electrical, pneumatic, product, vacuum and CIP schemes
  • Confirmation of the door, jaw, cutter, lid and nozzle
  • Standing, temperature, pressure, electricity and EMC reports
  • Instructions on format, hygiene, cleaning, operation and maintenance
  • The EU Statement of Compliance is prepared for packaging and filling machines during the period of the Directive.

They 're the entries for a healthy offer .

  • Packaging or filling machine types
  • Product, packaging, container and format characteristics
  • Maximum production speed and prescription number
  • Interface of dosage, feed, tank, pump and conveyor
  • Hygiene, temperature, pressure and combustion data
  • Existing schematics, risk analysis and test records
  • Target market planned supply date

Line length or body material is not a pricing measure alone. Product hazard, formats, integration, hygiene, conditional PED-ATEX coverage and current test level are assessed with separate pens.

Frequently Asked Questions

CE conformity for Packaging and filling machines — Technical answers about

Does the C-sign on the dosing machine cover the packaging line?

No, evidence of the dosage unit is hidden, but the drop-off mouth, common command, cleaning access and restart of the line are evaluated in the final system.

Can the flowpack be displayed in the same technical file as VFFS?

Joint company procedures may be used; product risk analyses should be kept separate as the working direction, jaw movement, feeding and access are different.

Does the food contact certificate replace the CE certificate?

Material and hygiene evidence is directed to the product subject; mechanical, electrical and control safety are also addressed in the CE compliance file.

Is there a PED on the vacuum packaging machine?

The pressure conditions, design and, if any, pressure relief equipment of the treasure are compared to PED thresholds.

Can you remove the protector when you change the format?

If the installation is required, the manufacturer defines safe energy separation, part-holding and reassembly control; production without a protector cannot be a normal mode of operation.

How do you sort the restart zones on the packing line?

The area that the operator can see, the intermodal product flow and the common control are taken into account; the warning, permit and conscious restart behavior are confirmed for each region.

Technical scope and offer

CE conformity for Packaging and filling machines — Let us clarify your technical file together.

Share the model of the machine or device, the location of use and the basic technical data. The Kayra Patent explains the path to be followed for scope analysis, technical preparation, test plan and, where necessary, approved organization coordination.

Ask for expert opinion and suggestions

Final inspection of content and technical scope: 20 August 2026The official bases: European Commission Machinery · EUR-Lex — EU 2023/1230
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