Safety of packaging machines - Part 3: Form, fill and seal machines

This European standard establishes safety requirements for form, fill and seal packaging machines and the filling machines which are particularly associated with them. This group of machines is defined in detail in clause 3 of this standard, with diagrams illustrating examples of the principle of operation of each machine type.

Sicherheit von Verpackungsmaschinen - Teil 3: Form-, Füll- und Verschließmaschinen

Diese Europäische Norm stellt Sicherheitsanforderungen für Form-, Füll- und Verschließmaschinen und die speziell mit ihnen verbundenen Füllmaschinen auf. Diese Gruppe von Maschinen wird im einzelnen in Abschnitt 3 dieser Norm definiert und mit Schemazeichnungen versehen, die Beispiele der Arbeitsprinzipien jeder Maschinenart aufzeigen.

Sécurité des machines d'emballage - Partie 3: Machines d'emballage à former, remplir et sceller

La présente norme spécifie les prescriptions de sécurité pour les machines d'emballages à former, remplir et sceller et les machines de remplissage qui sont spécialement associées à elles. Ce groupe de machine est défini en détail dans l'article 3 de cette norme avec des schémas représentant le principe de fonctionnement de chaque type de machine.

Pakirne naprave - Varnost pakirnih naprav - 3. del: Oblikovalne, polnilne in zapiralne naprave

General Information

Status: Withdrawn
Publication Date: 07-Dec-1999
Withdrawal Date: 13-Oct-2009

ICS: 55.200 - Packaging machinery

Technical Committee: CEN/TC 146 - Packaging machines - Safety
Drafting Committee: CEN/TC 146/WG 2 - Form-fill and seal machines - Particular requirements for safety

Current Stage: 9960 - Withdrawal effective - Withdrawal
Start Date: 14-Oct-2009
Completion Date: 14-Oct-2009

Directive: 98/37/EC - Machinery

Mandate: M/BC/CEN/88/13 - Standardization request to CEN/CENELEC relating to machinery

Ref Project: SIST EN 415-3:2001 - Safety of packaging machines - Part 3: Form, fill and seal machines

Relations

Merged Into: EN 415-3:1999+A1:2009 - Safety of packaging machines - Part 3: Form, fill and seal machines
Effective Date: 18-Jan-2023

Referred By: EN 415-1:2000+A1:2009 - Packaging machines safety - Part 1: Terminology and classification of packaging machines and associated equipment
Effective Date: 28-Jan-2026

Standard

EN 415-3:2001

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88 pages

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Frequently Asked Questions

What is EN 415-3:1999?

EN 415-3:1999 is a standard published by the European Committee for Standardization (CEN). Its full title is "Safety of packaging machines - Part 3: Form, fill and seal machines". This standard covers: This European standard establishes safety requirements for form, fill and seal packaging machines and the filling machines which are particularly associated with them. This group of machines is defined in detail in clause 3 of this standard, with diagrams illustrating examples of the principle of operation of each machine type.

What is the scope of EN 415-3:1999?

What ICS categories does EN 415-3:1999 belong to?

EN 415-3:1999 is classified under the following ICS (International Classification for Standards) categories: 55.200 - Packaging machinery. The ICS classification helps identify the subject area and facilitates finding related standards.

What standards are related to EN 415-3:1999?

EN 415-3:1999 has the following relationships with other standards: It is inter standard links to EN 415-3:1999+A1:2009, EN 415-1:2000+A1:2009. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

Is EN 415-3:1999 a harmonized European standard?

EN 415-3:1999 is associated with the following European legislation: EU Directives/Regulations: 98/37/EC; Standardization Mandates: M/BC/CEN/88/13. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.

How can I access EN 415-3:1999?

EN 415-3:1999 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)

EN 415-3:2001

SLOVENSKI STANDARD
01-februar-2001
Pakirne naprave - Varnost pakirnih naprav - 3. del: Oblikovalne, polnilne in
zapiralne naprave
Safety of packaging machines - Part 3: Form, fill and seal machines
Sicherheit von Verpackungsmaschinen - Teil 3: Form-, Füll- und Verschließmaschinen
Sécurité des machines d'emballage - Part
...

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CEN

EN 415-4:2025(Main)

Safety of packaging machines - Part 4: Palletizers and depalletizers and associated equipment

SIST EN 415-4:2026

This document is applicable to the following groups of machines, auxiliary equipment and their combinations:
-   palletizers;
-   depalletizers;
-   auxiliary equipment incorporated in or linked to the operations of palletizers and depalletizers;
-   conveying systems which are part of palletizers or depalletizers;
-   palletizers combined with functions of machines which are covered by other parts of EN 415, but detailed requirements are only provided for palletizing functions.
The individual machines are described in 3.2. Auxiliary equipment is described in 3.3.
This document deals with safety requirements for machine design, transport, installation, commissioning, operation, adjustment, maintenance and cleaning of palletizers, depalletizers, auxiliary equipment and conveying systems which are part of palletizer or depalletizer. The extent to which hazards, hazardous situations and events are covered is indicated in Annex A.
Exclusions:
This document is not applicable to the following machines:
-   machines that were manufactured before the date of publication of this document by CEN;
-   conveyors that connect palletizers and depalletizers with machines that are not in the scope of this document.
Conveyors in the scope of this document also fall in the scope of EN 619:2022, however, this document describes the additional or specific hazards for conveyors fitted into palletizers and depalletizers and so the requirements of this document take precedence over the requirements of EN 619:2022.
This document does not consider the following hazards:
—   the use of palletizers and depalletizers in a potentially explosive atmosphere;
—   the health, safety or hygiene hazards associated with the products that are contained in the unit load handled by palletizers and depalletizers except for the spillage of hazardous substances caused by the malfunction of a machine.

Standard
94 pages
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CEN

EN 415-2:2025(Main)

Safety of packaging machines - Part 2: Packaging machines for pre-formed rigid containers

SIST EN 415-2:2025

This document applies to the following machines and to machines which incorporate more than one function as listed below. The document also applies to partly completed machinery as far as conformity is claimed for certain essential health and safety requirements.
This document deals with the following machines handling rigid containers including:
-   unscrambling machines;
-   cap removing machines;
-   cleaning machines;
-   sanitizing machines;
-   filling machines;
-   capping, closing and sealing machines;
-   closure securing machines;
-   inspection machines;
-   labelling machines;
-   decorating machines;
-   heating- and cooling machines for packed product, working at atmospheric pressure;
-   sterilizing machines (others than heat treatment)
with one or more of the following functions: cleaning, sanitizing, pasteurizing, filling, labelling, closing, sealing or inspecting and handling pre-formed rigid containers including their closures.
This document also deals with equipment when it is part of a machine listed above:
-   conveyors;
-   vacuum or magnetic transfer conveyors;
-   dispose or eject devices (pushers);
-   keg stopping devices;
-   keg lift and inverting machines;
-   extraction or ventilation system or blowers;
-   hoppers;
-   rotary mechanisms;
-   coding and marking equipment incorporated in a packaging machine;
-   hot foil coders;
-   laser coders;
-   ink jet coders;
-   emboss coders.
The individual machines are described in 3.2.
This document deals with safety requirements and their verification for machine design, construction and information applicable to installation, commissioning, operation, adjustment, maintenance, cleaning, dismantling of packaging machines for pre-formed rigid containers.
The extent to which hazards, hazardous situations and events are covered is indicated in Annex B.
NOTE   The hazards on a specific machine can vary depending on its working principle; the type, size and mass of the product; the packaging material; auxiliary equipment attached to the machine and the environment in which the machine is used. If the machine presents hazards that are not covered by this document or EN 415-10, the manufacturer can assess these hazards and take measures by using the principles detailed in EN ISO 12100:2010.
Exclusions
This document is not applicable to the following machines:
-   machines that were manufactured before the date of publication of this document by CEN;
-   machines for cups or trays or tubs made of a foil of plastic, aluminium or paper, which are the subject of EN 415-3;
-   aerosol filling and sealing machines;
-   filling machines for gas;
-   autoclaves;
-   conveyors which link packaging machines but are not integrated in packaging machines or part of packaging machines;
-   blow moulding machines;
NOTE   See EN 422:2009:
-   sleeve label removing machines.
This document does not consider the following hazards:
-   the use of packaging machines in potentially explosive atmospheres not generated by the machine itself;
-   hazards associated with packing explosives;
-   hazards arising from ancillary equipment, which is not part of the machine, e.g. equipment for evacuating gases, for cooling or refrigeration, for the supply of steam, energy or product.

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EN 415-8:2025(Main)

Safety of packaging machines - Part 8: Strapping machines

SIST EN 415-8:2025

This document is applicable to the following groups of machines:
-   powered hand strapping tools;
-   semi-automatic strapping machines;
-   automatic strapping machines.
This document does not apply to:
-   strapping tools, where the strap tension is only applied by manual effort;
-   machines, intended for use with paper strap;
-   hand-held motor-operated electric strapping tools.
NOTE   For hand-held motor-operated electric strapping tools see EN 60745-2-18:2009 and EN 62841-1:2015.
This document deals with safety requirements for machine design, transport, installation, commissioning, operation, adjustment, maintenance and cleaning. The extent to which hazards, hazardous situations and events are covered is indicated in Annex A.
This document does not consider the following hazards:
-   the use of strapping machines in potentially explosive atmosphere;
-   the health, safety or hygiene hazards associated with the products that may be handled by the machines, but does include general advice on this subject;
-   hazards that are associated with decommissioning strapping machines.
Hazards associated with decommissioning of strapping machines are not considered and therefore excluded but are generally part of the instruction manual (see Clause 6), together with suited measures, if necessary.

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EN 415-11:2021(Main)

Safety of packaging machines - Part 11: Determination of efficiency and availability

SIST EN 415-11:2021

This document is applicable to packaging machines falling within the scope of EN 415 1, referred to in the following as “machine systems”. This document can also be applied by analogy to other related processing machines. This document specifies
—   a time model,
—   an output model derived from this time model,
—   general key figures,
—   technical key figures, and
—   a methodology for system acceptance
for describing the operating behaviour of packaging machines and packaging lines.
This document does not contain safety requirements.

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19-Oct-2021
29-Apr-2022
55.200
CEN/TC 146

CEN

EN 415-3:2021(Main)

Safety of packaging machines - Part 3: Form, fill and seal machines; fill and seal machines

SIST EN 415-3:2021

This document establishes safety requirements for the main types of form, fill and seal machines, fill and seal machines and the filling machines which are frequently fitted to these machines.
Form fill and seal machines within the scope of this document are:
-   flow wrapping machine;
-   vertical form, fill and seal machine;
-   horizontal sachet form, fill and seal machine;
-   thermoform, fill and seal machine;
-   tubular bag form, fill and seal machine;
-   mandrel form, fill and seal machine.
Fill and seal machines within the scope of this document are:
-   pre-made bag, erect, fill and seal machine;
-   cup or tub fill and seal machine;
-   sack fill and seal machine.
Filling machines commonly fitted to form, fill and seal machines and fill and seal machines within the scope of this document are:
-   auger filler;
-   volumetric cup filler;
-   nett weigher;
-   multi-head weigher.
Other types of form, fill and seal machine which are described in 3.3 have similar hazards to these machines and Clause 4 indicates which clauses of this document are applicable to these machines.
This document covers the safety requirements for machine design, construction and all phases of life of the machines including installation, commissioning, operation, adjustment, maintenance and cleaning.
This document applies to machines manufactured after the date of publication of this document.
This document does not apply to:
-   blow mould fill and seal machines;
-   bulk container fill and seal machines;
-   cartoning machines;
-   food depositors, including volumetric piston depositors in the scope of EN 15180;
-   thermoforming machines in the scope of EN 12409.
This document does not consider:
-   hazards due to the products packed in these machines, but does consider the hazards caused by dusts, modified atmosphere gases, and flammable products;
-   hazards resulting from the operation of the machines in a potentially explosive atmosphere.

Standard
127 pages
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12-Oct-2021
29-Apr-2022
55.200
2006/42/EC
M/396
CEN/TC 146

CEN

EN 415-1:2014(Main)

Safety of packaging machines - Part 1: Terminology and classification of packaging machines and associated equipment

SIST EN 415-1:2014

This European Standard defines the field of packaging machines. The machines defined fall within the following general groups:
—   filling machines;
—   closing machines;
—   labelling, decorating and coding machines;
—   cleaning, sterilizing, cooling and drying machines;
—   fill and seal machines;
—   inspection machines;
—   container and packaging component handling machines;
—   form, fill and seal machines;
—   carton erecting, carton closing and cartoning machines;
—   wrapping machines;
—   group or secondary packaging machines;
—   palletizers, depalletizers and ancillary equipment;
—   pallet wrapping machines;
—   strapping machines.
This part of EN 415 indicates the relevant machine specific part of EN 415, or another relevant standard, where safety requirements for dealing with the hazards associated with these machines can be found.

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EN 415-10:2014(Main)

Safety of packaging machines - Part 10: General Requirements

SIST EN 415-10:2014

This European Standard gives general requirements for packaging machines which are defined in the scope of EN 415 1 or are in the scope of another relevant machine specific part of EN 415. When used together with a relevant machine specific part of EN 415, it gives the requirements for that specific type of machine.
This document deals with safety requirements and their verification for design, construction, installation, commissioning, operation, adjustment, maintenance and cleaning of packaging machines when used as intended and under the conditions of misuse foreseeable by a manufacturer.
The extent to which hazards, hazardous situations and events are covered is indicated in Clause 4.
The hazards on a specific machine can vary depending on its working principle; the type, size and mass of the product; the packaging material; auxiliary equipment attached to the machine and the environment in which the machine is used. If the machine presents hazards that are not dealt with in this standard, the manufacturer should assess these hazards by using the principles detailed in EN ISO 12100:2010. Such deviations or additions are outside the scope of this standard.
Exclusions
This European Standard is not applicable to the following:
-   machines that were manufactured before the date of publication of this document by CEN.
This standard does not consider the following:
-   the risk resulting from the use of machines in public accessed areas.
NOTE   For machines used in public accessed areas different or additional requirements can apply. It is the responsibility of the manufacturer to identify such additional risks, which are outside the scope of this standard or such deviating risks which arise from this specific use, and provide suitable protective measures in accordance with EN ISO 12100.
-   the use of packaging machines in potentially explosive atmospheres;
-   specific health, safety or hygiene hazards associated with the products that may be handled by the machines, but does include general advice on this subject;
-   hazards that may be associated with decommissioning packaging machines.

Standard
94 pages
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21-Jan-2014
30-Jul-2014
55.200
2006/42/EC
M/396
CEN/TC 146

CEN

EN 415-6:2013(Main)

Safety of packaging machines - Part 6: Pallet wrapping machines

SIST EN 415-6:2013

This European Standard applies to the following groups of machines:
-   pallet banding machines;
-   stretch film pallet wrapping machines;
-   stretch film hood application machines;
-   mobile stretch film wrapping machines;
-   semi automatic self driving stretch film wrapping machines;
-   shrink film pallet wrapping machines;
-   shrink film hood application machines;
-   film removing machines;
-   shrinking systems;
-   sleeve wrapping machines for product greater than 400 mm in one direction;
-   product centralising machines.
The individual machines are described in 3.2.
This standard deals with safety requirements for machine design, construction, installation, commissioning, operation, adjustment, maintenance and cleaning of pallet wrapping machines.
The extents to which hazards, hazardous situations and events are covered are indicated in Clause 4.
Exclusions
This European Standard is not applicable to the following machines:
   machines that were manufactured before the date of publication of this document by CEN;
-   pallet strapping machines and destrapping machines. These machines are within the scope of
EN 415-8;
-   conveying systems that connect packaging machines with each other, but includes conveying systems that are part of the machines.
This standard does not consider the following hazards:
-   the use of pallet wrapping machines in potentially explosive atmospheres;
-   the health, safety or hygiene hazards associated with the products that may be handled by the machines, but does include general advice on this subject;
-   hazards that may be associated with electromagnetic emissions from pallet wrapping machines;
-   hazards that may be associated with decommissioning pallet wrapping machines.

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EN 415-5:2006+A1:2009(Main)

Safety of packaging machines - Part 5: Wrapping machines

SIST EN 415-5:2006+A1:2010

This European Standard applies to the following groups of machines:
-   wrapping machines which partially wrap products (see Figures 1-4)
-   wrapping machines which form a complete wrap without sealing (see Figures 5-7)
-   wrapping machines which form a complete wrap with sealing (see Figures 8-14)
-   shrinking equipment which is connected to wrapping machines covered by this standard (see Figures 15-16)
The individual machines are described in 3.2 of this standard.
This European Standard deals with safety requirements for machine design, construction, installation, commissioning, operation, adjustment, maintenance and cleaning of wrapping machines.
The extent to which hazards, hazardous situations and events are covered are indicated in Clause 4 of this document.
Exclusions:
This standard is not applicable to larger examples of wrapping machines designed to handle products higher than 400 mm and wider than 400 mm. These machines are covered by EN 415-6.
This document is not applicable to wrapping machines which are manufactured before the date of publication of this document by CEN.
This standard does not consider the following hazards:
-   Use of wrapping machines in potentially explosive atmospheres;
-   Health, safety or hygiene hazards associated with the products that may be handled by the machines but does include general advice on this subject;
-   Hazards that may be associated with electromagnetic emissions from wrapping machines;
-   Hazards that may be associated with decommissioning wrapping machines.

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EN 415-9:2009(Main)

Safety of packaging machines - Part 9: Noise measurement methods for packaging machines, packaging lines and associated equipment, grade of accuracy 2 and 3

SIST EN 415-9:2010

This standard specifies all the information necessary to carry out efficiently and under defined conditions the determination, information and verification of airborne noise emission from packaging machine covered by EN 415-1.
This measurement method specifies procedures for the determination of emission sound pressure levels at work station, at other specified positions and the sound power level on the basis of both the sound pressure level method and the sound intensity method. It also specifies installation and operating conditions.
This standard applies to machines covered by EN 415-1 as well as for any other packaging machine which are not covered by any other specific noise test code as well as for machines being part of packaging line. In such cases, all information relating to the assembly, installation and to the operating conditions as well as the arrangement of the work station shall be recorded and reported in the test report.
Noise emission characteristics include the following data:
- emission sound pressure level at work station and at other specified positions;
- sound power emitted by machine.
Both can be used:
- to determine the noise emitted by machine;
- to inform on the noise emitted by the machine;
- to verify the noise emitted by the machine.
Noise emission values permit comparison of packaging machines on the market.
The use of this standard ensures the reproducibility of the determination of the characteristic noise emissions values within specific limits which will be determined by the grade of accuracy of the noise emission measuring method used.

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