SIST EN 415-2:2025
(Main)Safety of packaging machines - Part 2: Packaging machines for pre-formed rigid containers
Safety of packaging machines - Part 2: Packaging machines for pre-formed rigid containers
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.
Sicherheit von Verpackungsmaschinen - Teil 2: Verpackungsmaschinen für vorgefertigte formstabile Packmittel
Dieses Dokument ist anwendbar auf die folgenden Maschinen und auf Maschinen, die mehr als eine der unten aufgeführten Funktionen aufweisen. Das Dokument gilt auch für unvollständige Maschinen, soweit die Konformität mit bestimmten grundlegenden Sicherheits- und Gesundheitsschutzanforderungen geltend gemacht wird.
Dieses Dokument ist anwendbar auf die folgenden Maschinen, wenn sie formstabile Behälter handhaben:
- Vereinzelungs- und Aufrichtmaschinen;
- Verschlusskappen-Entfernungsmaschinen;
- Reinigungsmaschinen;
- Entkeimungsmaschinen;
- Füllmaschinen;
- Kappenaufsetz-, -Verschließ- und Versiegelungsmaschinen;
- Verschlusssicherungsmaschinen;
- Inspektionsmaschinen;
- Etikettiermaschinen;
- Dekoriermaschinen;
- Erhitzungs- und Kühlmaschinen für verpackte Produkte, die bei atmosphärischem Druck arbeiten;
- Sterilisiermaschinen (außer Maschinen, die mittels Wärmebehandlung sterilisieren);
mit einer oder mehreren der folgenden Funktionen: Reinigung, Entkeimung, Pasteurisieren, Füllen, Etikettieren, Verschließen, Versiegeln oder Kontrollieren und Handhaben vorgefertigter formstabiler Behälter einschließlich ihrer Verschlüsse.
Dieses Dokument ist auch anwendbar auf die folgenden Ausrüstungen, sofern sie Teil von einer der oben genannten Maschinen sind:
- Fördereinrichtungen;
- Vakuumtransferförderer;
- Magnetbandförderer;
- Verteil- oder Auswurfmechanismen (Pusher);
- Keg-Stoppeinrichtungen;
- Keg-Hebe- und -Wendemechanismen;
- Absaug- oder Lüftungseinrichtungen;
- Trichter;
- Rotationsmechanismen;
- Codier- und Markiereinrichtung, die in eine Verpackungsmaschine integriert ist:
- Heißfolien-Kodiereinrichtungen;
- Laserkodiereinrichtungen;
- Tintenstrahl-Kodiereinrichtungen;
- Prägekodiereinrichtungen.
Die einzelnen Maschinen im Anwendungsbereich dieses Dokuments sind in 3.2 beschrieben.
Dieses Dokument behandelt die Sicherheitsanforderungen und deren Verifizierung für die Konstruktion, den Bau von Maschinen einschließlich Informationen, die anwendbar sind für die Installation, die Inbetriebnahme, den Betrieb, die Einstellung, die Wartung, die Reinigung, die Entkeimung und die Demontage von Verpackungsmaschinen für vorgefertigte formstabile Behälter.
Der Umfang, in dem Gefährdungen, Gefährdungssituationen und Ereignisse abgedeckt sind, ist in Anhang B angegeben.
Dieses Dokument ist nicht anwendbar auf die folgenden Maschinen:
- Maschinen, die vor dem Datum der Veröffentlichung dieses Dokuments durch CEN hergestellt wurden;
- Maschinen für Becher und Schalen oder Kübel aus Kunststofffolie, Aluminium oder Papier im Anwendungsbereich von EN 415 3:2021;
- Aerosolabfüll- und Verschließmaschinen;
- Füllmaschinen für Gas;
- Autoklaven;
- Fördereinrichtungen, die Verpackungsmaschinen verbinden, aber nicht in Verpackungsmaschinen integriert oder Teil von Verpackungsmaschinen sind;
- Blasformmaschinen;
ANMERKUNG Siehe EN 422:2009.
- Maschinen zum Entfernen von Banderolen.
In diesem Dokument werden die folgenden Gefährdungen nicht berücksichtigt:
- die Verwendung von Verpackungsmaschinen in explosionsgefährdeten Atmosphären, die nicht von der Maschine selbst erzeugt werden;
- Gefährdungen im Zusammenhang mit der Verpackung von Explosivstoffen;
- Gefährdungen, die von Hilfseinrichtungen ausgehen, die nicht Teil der Maschine sind, z. B. Einrichtungen zum Ableiten von Gasen, zur Kühlung oder zum Gefrieren, zur Dampf-, Energie- oder Produktversorgung.
Sécurité des machines d'emballage - Partie 2: Machines d'emballage pour contenants rigides préformés
Le présent document s'applique aux machines suivantes et aux machines qui comportent plus d’une fonction telles qu’indiquées ci-dessous. Le document s’applique également aux quasi machines dans la mesure où la conformité à certaines exigences essentielles de santé et de sécurité est réclamée.
Le présent document traite des machines suivantes manipulant des contenants rigides parmi lesquels :
- arrangeuses ;
- décapsuleuses ;
- machines de nettoyage ;
- machines de désinfection ;
- remplisseuses ;
- capsuleuses, fermeuses et scelleuses ;
- machines à sécuriser les fermetures ;
- machines de contrôle (vérificateurs) ;
- étiqueteuses ;
- décoreuses ;
- chauffeuses et refroidisseurs de produits emballés, fonctionnant à la pression atmosphérique ;
- machines de stérilisation (autres que par traitement thermique)
disposant d’une ou de plusieurs des fonctions suivantes : nettoyage, désinfection, pasteurisation, remplissage, fermeture, étanchéité ou contrôle et manipulation de contenants rigides préformés, y compris leurs fermetures.
Le présent document traitement également des équipements lorsque ceux-ci font partie d’une des machines citées ci-dessus :
- convoyeurs ;
- convoyeurs sous vide ou à bande magnétique ;
- dispositifs d’éjection ou d’élimination (poussoirs) ;
- dispositifs d'arrêt de fûts ;
- machines de levage et de retournement de fûts ;
- système d’extraction ou de ventilation ou souffleurs ;
- trémies ;
- mécanismes rotatifs ;
- équipement de codage et marquage incorporés dans une machine d’emballage ;
- codeuses de feuille à chaud ;
- codeuses à laser ;
- codeuses à jet d'encre ;
- codeuses en relief.
Chaque machine est décrite en 3.2.
Le présent document traite des prescriptions de sécurité et leur vérification pour la conception, la construction de machines et les informations applicables à l’installation, la mise en service, le fonctionnement, le réglage, la maintenance, le nettoyage, le démontage de machines d'emballage pour contenants rigides préformés.
L'étendue des phénomènes dangereux, situations et évènements dangereux couverts est indiquée en Annexe B.
NOTE Les phénomènes dangereux associés à une machine spécifique peuvent varier en fonction de son principe de travail ; le type, la taille et la masse du produit ; le matériau d’emballage ; l’équipement auxiliaire relié à la machine et l’environnement dans lequel la machine est utilisée. Si la machine présente des phénomènes dangereux non couverts par le présent document ou l’EN 415-10, le fabricant peut apprécier ces phénomènes dangereux et prendre des mesures à l’aide des principes détaillés dans l’EN ISO 12100:2010.
Exclusions
Le présent document ne s’applique pas aux machines suivantes :
- machines fabriquées avant la date de publication du présent document par le CEN ;
- machines fabricant des godets, des plateaux ou des tubes en feuille de plastique, d’aluminium ou de papier et soumises à l’EN 415-3 ;
- machines à remplir et à sceller les aérosols ;
- remplisseuses de gaz ;
- autoclaves ;
- convoyeurs qui relient les machines d’emballage mais ne sont pas intégrés aux machines d’emballage ou à une partie d’entre elles ;
- machines de soufflage ;
NOTE Voir l’EN 422-2009 :
- machines à retirer les manchons.
Le présent document ne prend pas en considération les phénomènes dangereux suivants :
- l'utilisation de machines d'emballage dans des atmosphères explosives non générées par la machine elle-même ;
- les phénomènes dangereux associés à l'emballage d'explosifs ;
- les phénomènes dangereux engendrés par les équipements auxiliaires, qui ne font pas partie de la machine, par exemple, les équipements pour l’évacuation des gaz, le refroidissement ou la réfrigération, l’alimentation en vapeur, en énergie ou en produit.
Varnost pakirnih strojev - 2. del: Pakirni stroji za vlaganje v predoblikovano trdo embalažo
Ta dokument se uporablja za naslednje stroje in stroje z več kot eno funkcijo, kot je navedeno v nadaljevanju. Uporablja se tudi za delno dokončane stroje, v kolikor se zahteva skladnost z nekaterimi bistvenimi zdravstvenimi in varnostnimi zahtevami. Ta dokument obravnava naslednje stroje za ravnanje s trdo embalažo: – stroji za razvrščanje plastenk/steklenic; – stroji za odstranjevanje zamaškov; – stroji za čiščenje; – stroji za razkuževanje; – stroji za polnjenje; – stroji za nameščanje in pritrjevanje zamaškov ter stroji za tesnjenje; – stroji za nameščenje varnostnih zapork; – stroji za nadzor; – stroji za etiketiranje; – stroji za dekoriranje; – stroji za ogrevanje in hlajenje pakiranih izdelkov, ki delujejo pri atmosferskem tlaku; – stroji za sterilizacijo (razen toplotne obdelave) z eno ali več naslednjimi funkcijami: čiščenje, razkuževanje, pasterizacija, polnjenje, etiketiranje, zapiranje, tesnjenje ali nadzor in ravnanje s predoblikovano trdo embalažo, vključno z zaporkami. Ta dokument obravnava tudi opremo, kadar je le-ta del zgoraj navedenega stroja: – transportni trakovi; – vakuumski ali magnetni transportni trakovi; – naprave za odstranjevanje ali izmet (potiskalnik); – stroji za ustavljanje sodčkov; – stroji za dvigovanje in obračanje sodčkov; – sistem za odsesavanje/prezračevanje ali puhala; – lijaki; – rotacijski mehanizmi; – oprema za kodiranje in označevanje, vgrajena v pakirni stroj; – kodirniki z vročo folijo; – laserski kodirniki; – brizgalni kodirniki; – kodirniki z vtiskovanjem. Posamezni stroji so opisani v točki 3.2. Ta dokument obravnava varnostne zahteve in njihovo preverjanje za projektiranje in izdelavo strojev ter informacije, ki se uporabljajo za nameščanje, začetek uporabe, delovanje, prilagajanje, vzdrževanje, čiščenje in razstavljanje pakirnih strojev za vlaganje v predoblikovano trdo embalažo. V dodatku B je naveden obseg, v katerem so zajete nevarnosti, nevarne situacije in dogodki. OPOMBA: Nevarnosti pri posameznem stroju se lahko razlikujejo glede na njegov način delovanja, vrsto, velikost in težo izdelka, embalažo, pomožno opremo, nameščeno na stroj, ter okolje, v katerem se stroj uporablja. Če stroj predstavlja nevarnosti, ki niso zajete v tem dokumentu ali standardu EN 415-10, jih lahko proizvajalec oceni in sprejme ukrepe na podlagi načel, podrobneje opisanih v standardu EN ISO 12100:2010. Izključitve Ta dokument se ne uporablja za naslednje stroje: – stroje, ki so bili izdelani, preden je CEN izdal ta dokument; – stroje za skodelice, pladnje ali posode iz folije iz plastike, aluminija ali papirja, ki so obravnavani v standardu EN 415-3; – stroje za polnjenje in zapiranje aerosolov; – stroje za polnjenje plina; – avtoklave; – transportne trakove, ki povezujejo pakirne stroje med seboj, vendar niso vgrajeni vanje oziroma del teh strojev; – pihalne stroje za oblikovanje; OPOMBA: glej standard EN 422:2009; – stroje za odstranjevanje etiket. V tem dokumentu niso obravnavane naslednje nevarnosti: – uporaba pakirnih strojev v potencialno eksplozivnih okoljih, ki jih ne ustvarja sam stroj; – nevarnosti, povezane s pakiranjem eksplozivov; – nevarnosti, ki izhajajo iz pomožne opreme, ki ni del stroja (npr. oprema za odvajanje plinov, za hlajenje ali zamrzovanje, za dovajanje pare, energije ali izdelkov).
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2025
Varnost pakirnih strojev - 2. del: Pakirni stroji za vlaganje v predoblikovano trdo
embalažo
Safety of packaging machines - Part 2: Packaging machines for pre-formed rigid
containers
Sicherheit von Verpackungsmaschinen - Teil 2: Verpackungsmaschinen für vorgefertigte
formstabile Packmittel
Sécurité des machines d'emballage - Partie 2: Machines d'emballage pour contenants
rigides préformés
Ta slovenski standard je istoveten z: EN 415-2:2025
ICS:
55.200 Pakirni stroji Packaging machinery
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 415-2
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2025
EUROPÄISCHE NORM
ICS 55.200 Supersedes EN 415-2:1999
English Version
Safety of packaging machines - Part 2: Packaging machines
for pre-formed rigid containers
Sécurité des machines d'emballage - Partie 2: Machines Sicherheit von Verpackungsmaschinen - Teil 2:
d'emballage pour contenants rigides préformés Verpackungsmaschinen für vorgefertigte formstabile
Behälter
This European Standard was approved by CEN on 21 April 2025.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 415-2:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 6
Introduction . 8
1 Scope . 9
2 Normative references .11
3 Terms and definitions .13
3.1 Definitions of terms .13
3.2 Description of machines in the scope of this document .16
4 Safety requirements and protective measures .19
4.1 General requirements .19
4.1.1 General .19
4.1.2 Inherently safe design .19
4.1.3 Safeguarding .19
4.1.4 Reduction of risks from packaging material .20
4.1.5 Reduction of slip, trip or fall risks .20
4.1.6 Reduction of risks from loss of stability .20
4.1.7 Reduction of risks from pneumatic or hydraulic equipment .20
4.1.8 Reduction of electrical risks .20
4.1.9 Reduction of thermal risks .20
4.1.10 Reduction of risks from noise .21
4.1.11 Reduction of risks from radiation .21
4.1.12 Reduction of chemical risks .23
4.1.13 Reduction of biological risks .26
4.1.14 Reduction of ergonomic risks .27
4.1.15 Prevention of unexpected start-up by another person .27
4.1.16 Requirements for safety related control functions .28
4.1.17 Devices for energy isolation .28
4.2 Risk reduction on equipment .29
4.2.1 General .29
4.2.2 Conveyors.29
4.2.3 Container diversion or ejection mechanism (pusher) .31
4.2.4 Keg stopping device .32
4.2.5 Keg lift and inverting machine .32
4.2.6 Extraction or ventilation system .33
4.2.7 Closure unscrambler .34
4.2.8 Carousel type machines .35
4.2.9 Coding and marking equipment incorporated in a packaging machine .36
4.3 Plastic bottle unscrambling machine.37
4.4 Machines for applying caps or removing packaging components or materials from
containers .38
4.4.1 Screw cap removing machine, screw capping machine, crown capping machine, roll-
on capping machine and plugging/corking machine .38
4.4.2 Crown cork removing machine .39
4.5 Cleaning machines .41
4.5.1 Bottle washing machines .41
4.5.2 Carousel type keg cleaning, filling and combined cleaning and filling machine .48
4.5.3 In-line keg cleaning, filling and combined cleaning and filling machine . 50
4.5.4 Semi-automatic keg cleaning, filling and combined cleaning and filling machine
(single head machine) . 50
4.5.5 Crate washing machine. 51
4.5.6 Closure sanitizing machine . 52
4.6 Filling machines . 52
4.6.1 Carousel type rinsing/sterilizing or filling machine . 52
4.6.2 In-line filling machine . 55
4.7 Sealing, seaming, crimping, flanging machine . 56
4.7.1 Foil sealing machine . 56
4.7.2 Can filling and seaming machine . 57
4.8 Closure securing machine / cork wiring machine . 57
4.9 Labelling and decorating machines . 57
4.9.1 Reduction of mechanical risks . 57
4.9.2 Reduction of electrical risks . 57
4.9.3 Reduction of thermal risks . 57
4.10 Heating or cooling machine for packed product working at atmospheric pressure
(pasteurizer) . 57
4.10.1 Reduction of chemical risks . 57
4.10.2 Reduction of biological risks . 57
4.10.3 Reduction of combined risks . 58
4.11 Inspection equipment . 58
4.11.1 Reduction of radiation risks . 58
4.11.2 Requirements for safety related functions . 58
5 Verification of safety requirements and measures . 59
5.1 General . 59
5.2 Visual inspections with the machine stopped . 59
5.2.1 Mechanical parts . 59
5.2.2 Pneumatic systems. 59
5.2.3 Hydraulic systems . 59
5.2.4 Electrical systems . 59
5.2.5 Safeguards . 59
5.2.6 Design requirements . 59
5.2.7 Marking and warning signs . 59
5.3 Measurements with the machine stopped. 59
5.3.1 Safeguards . 59
5.3.2 Electrical testing . 59
5.4 Visual inspections with the machine running . 60
5.4.1 Safeguards . 60
5.4.2 Interlocking devices . 60
5.4.3 Dissipation of stored energy . 60
5.5 Measurements with the machine running . 60
5.5.1 Electrical testing . 60
5.5.2 Measurement and declaration of noise emission . 60
5.5.3 Temperature . 60
5.5.4 Radiation . 60
5.6 Verification procedures . 60
6 Information for use . 63
6.1 General . 63
6.2 Marking . 63
6.3 Signals and warning signs . 63
6.4 Instructions . 65
6.4.1 General .65
6.4.2 Ergonomic hazards .65
6.4.3 Radiation hazards .65
6.4.4 Chemical hazards .65
6.4.5 Fire or explosion hazards .66
6.4.6 Additional information for specific machines .66
Annex A (normative) Noise test code .67
A.1 General .67
A.2 Terms and definitions .67
A.3 Determination of emission sound pressure level at the workstation .67
A.4 Determination of the sound power level .70
A.5 Alternative method for very large machines .70
A.6 Operating conditions .70
A.7 Measurement .70
A.8 Measurement uncertainty .71
A.9 Information to be recorded .71
A.10 Information to be reported .71
A.11 Declaration and verification of the noise emission values .72
Annex B (informative) List of significant hazards .73
B.1 General .73
B.2 Hazards that occur on most machines in the scope of this document .74
B.3 Components and equipment .77
B.3.1 General .77
B.3.2 Conveyors.77
B.3.3 Container diversion or ejection mechanism (pusher) .83
B.3.4 Keg stopping device .85
B.3.5 Keg lift and inverting machine .86
B.3.6 Extraction or ventilation system .87
B.3.7 Closure unscrambler .88
B.3.8 In-line mechanisms .90
B.3.9 Carousel type mechanisms .90
B.3.10 Coding and marking equipment incorporated in a packaging machine .92
B.4 Plastic bottle unscrambling machine.94
B.5 Machines for applying caps or removing packaging components or materials from
containers .95
B.5.1 Screw cap removing machine, screw capping machine, crown capping machine, roll-
on capping machine and plugging/corking machine .95
B.5.2 Crown cork removing machine .96
B.6 Cleaning machines. 98
B.6.1 Cleaning machine for bottles and jars (bottle washing machine) . 98
B.6.2 Carousel type keg cleaning, filling or combined cleaning and filling machine . 103
B.6.3 In-line keg cleaning, filling and combined cleaning and filling machine . 104
B.6.4 Semi-automatic keg cleaning, filling and combined cleaning and filling machine
(single head machine) . 107
B.6.5 Crate washing machine. 110
B.6.6 Closure sanitizing machines . 113
B.7 Filling machines . 115
B.7.1 Carousel type rinsing/sterilizing or filling machine . 115
B.7.2 In-line filling machine . 117
B.8 Sealing, seaming, crimping, flanging machine . 119
B.8.1 Foil sealing machine . 119
B.8.2 Can filling and seaming machine . 120
B.8.3 Closure securing machine / cork wiring machine . 121
B.9 Labelling and decorating machines . 122
B.10 Heating or cooling machine for packed product working at atmospheric pressure
(Pasteurizer) . 124
B.11 Inspection machines . 126
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 2006/42/EC . 128
Bibliography . 132
European foreword
This document (EN 415-2:2025) has been prepared by Technical Committee CEN/TC 146 “Safety of
packaging machines”, the secretariat of which is held by UNI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by December 2025, and conflicting national standards shall
be withdrawn at the latest by December 2025.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 415-2:1999.
The following significant changes have been made:
— Machines for secondary packing and unpacking have been removed from the Scope
— Description of hazards has been extended and the order of their presentation is hazard-based
— Safety requirements have been rewritten so that they are in line with EN 415-10:2014
— Noise test code has been rewritten to be in line with EN 415-9:2009
— Normative references have been changed to reflect the many changes that have been made to B1 and
B2 standards.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
EN 415, Safety of packaging machines consists of the following parts:
— Part 1: Terminology and classification of packaging machines and associated equipment
— Part 2: Packaging machines for pre-formed rigid containers
— Part 4: Palletizers and depalletizers
— Part 5: Wrapping machines
— Part 6: Pallet wrapping machines
— Part 7: Group and secondary packaging machines
— Part 8: Strapping machines
— Part 9: Noise measurement methods for packaging machines, packaging lines and auxiliary equipment,
grade of accuracy 2 and 3;
— Part 10: General requirements
EN 415-7:2006+A1:2008 is currently being revised with a new title: “Cartoning and Case-packing machines”.
— Part 11: Determination of efficiency and availability.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website. According to the CEN-CENELEC
Internal Regulations, the national standards organisations of the following countries are bound to
implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania,
Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the United Kingdom.
Introduction
This document is of relevance, in particular, for the following stakeholder groups representing the market
players with regard to machinery safety:
— machine manufacturers (small, medium and large enterprises)
— health and safety bodies (regulators, accident prevention organizations, market surveillance, etc.).
Others can be affected by the level of machinery safety achieved with the means of the document by the
abovementioned stakeholder groups:
— machine users/employers (small, medium and large enterprises)
— machine users/employees (e.g. trade unions, organizations for people with special needs)
— service providers, e.g. for maintenance (small, medium and large enterprises).
The above-mentioned stakeholder groups have been given the possibility to participate at the drafting
process of this document.
This document is a type-C standard as stated in EN ISO 12100:2010.
The machinery concerned and the extent to which hazards, hazardous situations or hazardous events are
covered are indicated in the scope of this document.
When requirements of this type-C standard are different from those which are stated in type-A or type-B
standards, the requirements of this type-C standard take precedence over the requirements of the other
standards for machines that have been designed and built according to the requirements of this type-C
standard.
The full set of requirements for machines in the scope of this document is composed by those given in
this document in conjunction with the relevant requirements of EN 415-10:2014.
Annex ZA of this document only lists Essential Health and Safety Requirements that are relevant for
machines in the scope of this standard.
When an assembly of machinery or partly completed machinery (multi-functional machine) contains a
function which is covered by another standard, the risk assessment and measures for that function should
comply with the relevant standard. In addition, the risks presented by the combination of functions or
mechanisms – which is not covered by one of the standards - should be considered.
NOTE EN ISO 11161:2007 and its A1:2010 provides guidance for combinations of machines.
1 Scope
This document is applicable 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 applies to the following machines when they handle rigid containers:
— 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 (excluding machines that sterilize using 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 is also applicable to the following equipment if it is part of one of the machines listed
above:
— conveyors
— vacuum transfer conveyors
— magnetic belt conveyors
— dispose or reject mechanisms (pushers)
— keg stopping devices
— keg lifting and inverting mechanisms
— extraction or ventilation systems
— hoppers
— rotary mechanisms
— coding and marking equipment incorporated in a packaging machine:
• hot foil coding equipment
• laser coding equipment
• ink jet coding equipment
• emboss coding equipment.
The individual machines in the scope of this document 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,
sanitizing and 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.
This document does not apply to the following machines:
— machines that were manufactured before the date of publication of this document by CEN;
— machines for cups and trays or tubs made of a foil of plastic, aluminium or paper, which are in the
scope of EN 415-3:2021;
— 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.
2 Normative references
The following documents are referred to in the text in such a way that some or all their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
EN 415-1:2014, Safety of packaging machines - Part 1: Terminology and classification of packaging
machines and associated equipment
EN 415-9:2009, Safety of packaging machines - Part 9: Noise measurement methods for packaging
machines, packaging lines and associated equipment, grade of accuracy 2 and 3
EN 415-10:2014, Safety of packaging machines - Part 10: General Requirements
EN 1005-2:2003+A1:2008, Safety of machinery - Human physical performance - Part 2: Manual handling
of machinery and component parts of machinery
EN 1672-2:2020, Food processing machinery - Basic concepts - Part 2: Hygiene and cleanability
requirements
EN 12198-1:2000+A1:2008, Safety of machinery - Assessment and reduction of risks arising from radiation
emitted by machinery - Part 1: General principles
EN 60204-1:2018, Safety of machinery - Electrical equipment of machines - Part 1: General requirements
(IEC 60204-1:2016)
EN 60825-1:2014, Safety of laser products - Part 1: Equipment classification and requirements (IEC 60825-
1:2014)
EN 60825-4:2006, Safety of laser products - Part 4: Laser guards (IEC 60825-4:2006)
EN 61310-3:2008, Safety of machinery - Indication, marking and actuation - Part 3: Requirements for the
location and operation of actuators (IEC 61310-3:2007)
EN ISO 3740:2019, Acoustics - Determination of sound power levels of noise sources - Guidelines for the use
of basic standards (ISO 3740:2019)
EN ISO 3744:2010, Acoustics - Determination of sound power levels and sound energy levels of noise sources
using sound pressure - Engineering methods for an essentially free field over a reflecting plane (ISO
3744:2010)
EN ISO 3746:2010, Acoustics - Determination of sound power levels and sound energy levels of noise sources
using sound pressure - Survey method using an enveloping measurement surface over a reflecting plane (ISO
3746:2010)
EN ISO 4413:2010, Hydraulic fluid power - General rules and safety requirements for systems and their
components (ISO 4413:2010)
EN ISO 4414:2010, Pneumatic fluid power - General rules and safety requirements for systems and their
components (ISO 4414:2010)
Document impacted by A1:2008 and A2:2011.
EN ISO 4871:2009, Acoustics - Declaration and verification of noise emission values of machinery and
equipment (ISO 4871:1996)
EN ISO 7010:2020, Graphical symbols - Safety colours and safety signs - Registered safety signs (ISO
7010:2019, Corrected version 2020-06)
EN ISO 11200:2014, Acoustics — Noise emitted by machinery and equipment — Guidelines for the use of
basic standards for the determination of emission sound pressure levels at a workstation and at other
specified positions (ISO 11200:2014)
EN ISO 11201:2010, Acoustics - Noise emitted by machinery and equipment - Determination of emission
sound pressure levels at a work station and at other specified positions in an essentially free field over a
reflecting plane with negligible environmental corrections (ISO 11201:2010)
EN ISO 11202:2010, Acoustics — Noise emitted by machinery and equipment — Determination of
emission sound pressure levels at a work station and at other specified positions applying approximate
environmental corrections (ISO 11202:2010)
EN ISO 11203:2009, Acoustics — Noise emitted by machinery and equipment — Determination of
emission sound pressure levels at a work station and at other specified positions from the sound power level
(ISO 11203:1995)
EN ISO 11204:2010, Acoustics - Noise emitted by machinery and equipment - Determination of emission
sound pressure levels at a work station and at other specified positions applying accurate environmental
corrections (ISO 11204:2010)
EN ISO 11553-1:2020, Safety of machinery - Laser processing machines - Part 1: Laser safety requirements
(ISO 11553-1:2020)
EN ISO 12001:2009, Acoustics - Noise emitted by machinery and equipment - Rules for the drafting and
presentation of a noise test code (ISO 12001:1996)
EN ISO 12100:2010, Safety of machinery - General principles for design - Risk assessment and risk reduction
(ISO 12100:2010)
EN ISO 13732-1:2008, Ergonomics of the thermal environment - Methods for the assessment of human
responses to contact with surfaces - Part 1: Hot surfaces (ISO 13732-1:2006)
EN ISO 13732-3:2008, Ergonomics of the thermal environment - Methods for the assessment of human
responses to contact with surfaces - Part 3: Cold surfaces (ISO 13732-3:2005)
EN ISO 13849-1:2023, Safety of machinery - Safety-related parts of control systems - Part 1: General
principles for design (ISO 13849-1:2023)
Document impacted by A1:2020.
Document impacted by A1:2021.
Document impacted by A1:2020.
Document impacted by A11:2020.
EN ISO 13851:2019, Safety of machinery - Two-hand control devices - Principles for design and selection
(ISO 13851:2019)
EN ISO 13854:2019, Safety of machinery - Minimum gaps to avoid crushing of parts of the human body (ISO
13854:2017)
EN ISO 13855:2024, Safety of machinery - Positioning of safeguards with respect to the approach speeds of
parts of the human body (ISO 13855:2024)
EN ISO 14119:2013, Safety of machinery - Interlocking devices associated with guards - Principles for
design and selection (ISO 14119:2013)
EN ISO 14120:2015, Safety of machinery - Guards - General requirements for the design and construction
of fixed and movable guards (ISO 14120:2015)
EN ISO 14122-2:2016, Safety of machinery - Permanent means of access to machinery - Part 2: Working
platforms and walkways (ISO 14122-2:2016)
EN ISO 14122-3:2016, Safety of machinery - Permanent means of access to machinery - Part 3: Stairs,
stepladders and guard-rails (ISO 14122-3:2016)
EN ISO 20607:2019, Safety of machinery - Instruction handbook - General drafting principles (ISO
20607:2019)
ISO/TS 15066:2016, Robots and robotic devices — Collaborative robots
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 12100:2010, EN 415-
1:2014, EN 415-10:2014 and the following apply.
NOTE Where definitions of this document differ from those in the standards listed above, the definitions of this
document have precedence over the definitions of those listed in the standards above for purposes of this document.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at https://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp
3.1 Definitions of terms
3.1.1
pre-formed rigid container
rigid container that had been formed to its final shape before it is handled by the packaging machine
Note 1 to entry: Examples of preformed rigid containers are: bottles, cans, jars, pots, ampoules, vials or kegs,
made of e.g. glass, metal, plastics, fibreboard, wood, ceramic material or composite materials.
3.1.2
carousel
rotating machine element which locates and transports containers through one or more processes in a
packaging machine
3.1.3
keg
rigid container typically with a capacity between 5 l and 60 l, equipped with a self-closing fitting through
which it can be filled, cleaned and emptied
3.1.4
cleaning
removal of soils
Note 1 to entry: See EN 1672-2:2020.
3.1.5
soil
any matter which can make food unsafe; including but not limited to product residues, micro-organisms,
residual detergent, chemicals or disinfecting agents, except substances migrating (or released metallic
ions) from food contact materials into the food
Note 1 to entry: See EN 1672-2:2020.
3.1.6
sanitizing
physical or chemical germ reduction procedure to reduce germs on product, containers, closures or other
packaging means to specified levels
Note 1 to entry: This germ reduction typically is performed with:
— liquid agents, e.g. peracetic acid or
— gaseous agents, e.g. H O or
2 2
— radiation, e.g. ultraviolet rays or
— heat or
— a combination of some of these methods.
EXAMPLES:
— immersion bath in the sterilizing agent with drying by means of germ-reduced hot air and/or UV light.
— dry germ reduction procedure and dilution of the sterilizing agent with germ-reduced water.
Note 2 to entry: These germ reduction procedures can be used for:
— packaging materials (bottles, cans, kegs, containers, closures).
— machine surfaces in the food industry, splash area.
— conveyor area of germ-reduced packaging.
3.1.6.1
disinfection
sanitizing process for inactivation of all pathogenic and product-damaging microbes to a level that
complies with the respective hygiene requirements
3.1.6.2
sterilization
sanitizing process for destruction of microorganisms, including bacterial spores present in products or
on the surfaces of materials and products
Note 1 to entry: In difference to disinfection, the target of the sterilization process is killing / deactivation of all
microorganisms and spores.
3.1.6.3
pasteurizing
sanitizing process of heat treatment of packaged product to reduce the quantity of product-damaging
microbes to an acceptable limit, in order to obtain a microbiological stable product within the chosen
minimum shelf life
3.1.7
aseptic filling
filling of a germ reduced product in a sanitized package and closing or sealing under germ reduced
conditions
3.1.8
star wheel
star shaped component with pockets fitting to the shape of containers for spacing them whilst they are
transported in a circular arc
3.1.9
air conveyor
machine or functional unit that conveys containers or components by the means of air flow along a guide
rail
3.1.10
neck gripper conveyor
machine or functional unit which transports containers, usually plastic bottles, by the means of gripping
devices fixed on a driven chain or belt
3.1.11
walking beam conveyor
machine or functional unit which transports containers step by step by a reciprocating motion of one or
more bars
Note 1 to entry: Commonly used on in-line keg cleaning or filling machines. See also Figure B.22.
3.1.12
gripper chain conveyor
machine or functional unit which transports containers or crates by friction applied laterally by parallel
running chains fitted with rubber grippers
Note 1 to entry: Gripper chain conveyors typically are used to convey containers or to invert containers
...
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