CEN-TC146-WG2 N0050 EN 415-3 E August 2017

CEN/TC 146
Date: 2017-8
prEN 415-3 : 2017

CEN/TC 146
Secretariat: UNI
Safety of packaging machines — — Part 3: Form, fill and seal machines; fill
and seal machines
Sicherheit von Verpackungsmaschinen — — Teil 3: Form-, Füll- und Verschließmaschinen
Sécurité des Machines d'emballage — — Partie 3 : Machines d'emballage à former, remplir et sceller
ICS:
Descriptors:
Document type: European Standard

Document subtype:
Document stage: CEN Enquiry
Document language: E
C:\Users\Martin\Documents\Standards\WG 2\EN 415-3\EN_415-3_(E) August 2017.doc STD Version 2.5a

prEN 415-3:2015 (E)
Contents
Page
1 Scope ......................................................................................................................................................8
2 Normative references ............................................................................................................................9
3 Terms and definitions .........................................................................................................................11
3.1 Definition of terms ...............................................................................................................................11
3.2 Definitions of machines covered by this standard ..........................................................................14
3.2.1 Form, fill and seal machines...............................................................................................................14
3.2.2 Fill and seal machines .........................................................................................................................17
3.2.3 Filling machines ...................................................................................................................................18
3.3 Definition of machines which have similar hazards to those machines covered by this
standard ................................................................................................................................................19
4 Hazards .................................................................................................................................................21
4.1 Hazards which occur on all machines in the scope of this standard ............................................21
4.2 Hazards on a flow wrapping machine................................................................................................24
4.3 Hazards on a vertical form, fill and seal machine ............................................................................26
4.4 Hazards on typical horizontal sachet form, fill and seal machines ................................................28
4.5 Hazards on a thermoform, fill and seal machine ..............................................................................30
4.6 Hazards on a tubular bag form, fill and seal machine .....................................................................32
4.7 Hazards on a mandrel form, fill and seal machine ...........................................................................33
4.8 Hazards on a pre-made bag erect, fill and seal machine .................................................................36
4.9 Hazards on a cup or tub fill and seal machine .................................................................................37
4.10 Hazards on a sack fill and seal machine ...........................................................................................39
4.10.1 Hazards on an in-line sack fill and seal machine .............................................................................39
4.10.2 Hazards on a typical rotary sack fill and seal machine ...................................................................40
4.11 Hazards on an auger filler ...................................................................................................................41
4.12 Hazards on a volumetric cup filler .....................................................................................................42
4.13 Hazards on a nett weigher ..................................................................................................................43
4.14 Hazards on a multi-head weigher.......................................................................................................44
5 Safety requirements ............................................................................................................................46
5.1 General requirements ..........................................................................................................................46
5.1.1 Requirements to minimize mechanical risks ....................................................................................46
5.1.2 Electrical equipment ............................................................................................................................48
5.1.3 Thermal hazards ..................................................................................................................................48
5.1.4 Noise reduction ....................................................................................................................................48
5.1.5 Vibrating mechanisms ........................................................................................................................49
5.1.6 Radiation...............................................................................................................................................49
5.1.7 Products and substances used on machines which pose a risk ...................................................49
5.1.8 Ergonomic design................................................................................................................................52
5.1.9 Hygienic design requirements ...........................................................................................................53
5.2 Safety requirements for a flow-wrapping machine ..........................................................................53
5.2.1 General..................................................................................................................................................53
5.2.2 Product Feed ........................................................................................................................................54
5.2.3 Film reel unwind mechanism..............................................................................................................58
5.2.4 Longitudinal sealing mechanism .......................................................................................................60
5.2.5 Transverse sealing and cutting mechanisms ...................................................................................61
5.2.6 Discharge mechanism .........................................................................................................................61
5.2.7 Integrity of safety related control systems .......................................................................................62
5.3 Safety requirements for a vertical form, fill and seal machine .......................................................62
5.3.1 General..................................................................................................................................................62
5.3.2 Product feeding devices .....................................................................................................................63
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5.3.3 Packing material reel unwind mechanism ........................................................................................ 63

5.3.4 Longitudinal sealing mechanism....................................................................................................... 63
5.3.5 Packaging material transport mechanism ........................................................................................ 63
5.3.6 Transverse sealing and associated mechanisms ............................................................................ 63
5.3.7 Cutting and perforating mechanisms................................................................................................ 64
5.3.8 Product discharge opening ................................................................................................................ 64
5.3.9 Discharge conveyor ............................................................................................................................ 64
5.3.10 Discharge into bins ............................................................................................................................. 64
5.3.11 Provision for changing the forming tube .......................................................................................... 64
5.3.12 Integrity of safety related control systems ....................................................................................... 65
5.4 Safety requirements for a horizontal sachet form, fill and seal machine ...................................... 65
5.4.1 General ................................................................................................................................................. 65
5.4.2 Film reel unwind mechanism ............................................................................................................. 66
5.4.3 Vertical seal mechanism ..................................................................................................................... 66
5.4.4 Transport mechanism ......................................................................................................................... 66
5.4.5 Product feeding devices ..................................................................................................................... 66
5.4.6 Product settling mechanism .............................................................................................................. 66
5.4.7 Top sealing mechanism ...................................................................................................................... 66
5.4.8 Cutting mechanism ............................................................................................................................. 67
5.4.9 Discharge chute or conveyor ............................................................................................................. 67
5.5 Safety requirements for a thermoform, fill and seal machine ........................................................ 67
5.5.1 General ................................................................................................................................................. 67
5.5.2 Lower web reel unwind mechanism .................................................................................................. 68
5.5.3 Transport mechanism ......................................................................................................................... 68
5.5.4 Heating chamber ................................................................................................................................. 68
5.5.5 Forming die .......................................................................................................................................... 68
5.5.6 Packaging material apertures ............................................................................................................ 68
5.5.7 Automatic product feeding devices .................................................................................................. 73
5.5.8 Upper film reel unwind mechanism ................................................................................................... 73
5.5.9 Sealing die ............................................................................................................................................ 73
5.5.10 Cutting devices .................................................................................................................................... 73
5.5.11 Scrap reel ............................................................................................................................................. 73
5.5.12 Discharge mechanism ........................................................................................................................ 74
5.5.13 Pad or leaflet inserters ........................................................................................................................ 74
5.6 Safety requirements for a tubular bag form, fill and seal machine ................................................ 74
5.6.1 General ................................................................................................................................................. 74
5.6.2 Film reel unwind mechanism ............................................................................................................. 75
5.6.3 Transverse or corner sealing and cutting mechanism.................................................................... 75
5.6.4 Openings in guards ............................................................................................................................. 75
5.6.5 Cutting and perforating mechanisms................................................................................................ 75
5.6.6 Film draw and compensator ............................................................................................................... 75
5.6.7 Cooling mechanism ............................................................................................................................ 75
5.6.8 Filling station ....................................................................................................................................... 75
5.6.9 Bag opening mechanism .................................................................................................................... 75
5.6.10 Product settling mechanism .............................................................................................................. 76
5.6.11 Bag sealing mechanism...................................................................................................................... 76
5.6.12 Discharge conveyor ............................................................................................................................ 76
5.6.13 Conveyor height adjustment .............................................................................................................. 76
5.6.14 Bag transport mechanism .................................................................................................................. 76
5.7 Safety requirements for a mandrel form, fill and seal machine...................................................... 76
5.7.1 Packaging material reel unwind mechanism .................................................................................... 77
5.7.2 Cutting mechanism ............................................................................................................................. 77
5.7.3 Sealing mechanisms ........................................................................................................................... 77
5.7.4 Carton blank magazine ....................................................................................................................... 77
5.7.5 Mandrel former .................................................................................................................................... 79
5.7.6 Compression mechanism ................................................................................................................... 79
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5.7.7 Transfer mechanisms ..........................................................................................................................79

5.7.8 Transport section.................................................................................................................................79
5.7.9 Product feed .........................................................................................................................................79
5.7.10 Product settling devices .....................................................................................................................79
5.7.11 Sterilization section .............................................................................................................................79
5.7.12 Auxiliary media injection ....................................................................................................................79
5.7.13 Package closing mechanism ..............................................................................................................79
5.7.14 Vacuum sealing mechanism...............................................................................................................79
5.7.15 Discharge or compression conveyor ................................................................................................80
5.7.16 Pak reject mechanism .........................................................................................................................80
5.8 Safety requirements for a pre-made bag, erect, fill and close machine ........................................80
5.8.1 General..................................................................................................................................................80
5.8.2 Bag magazine .......................................................................................................................................81
5.8.3 Bag erecting mechanism ....................................................................................................................81
5.8.4 Transport mechanism .........................................................................................................................81
5.8.5 Product feed .........................................................................................................................................81
5.8.6 Product settling devices .....................................................................................................................81
5.8.7 Bag closing mechanism......................................................................................................................81
5.8.8 Discharge or compression conveyor ................................................................................................81
5.9 Safety requirements for a cup or tub fill and seal machine ............................................................82
5.9.1 General..................................................................................................................................................82
5.9.2 Cup magazine.......................................................................................................................................82
5.9.3 Cup dispensing mechanism ...............................................................................................................83
5.9.4 Transport mechanism .........................................................................................................................84
5.9.5 Product feed devices ...........................................................................................................................84
5.9.6 Manual product loading ......................................................................................................................84
5.9.7 Foil and lid magazines ........................................................................................................................84
5.9.8 Reel unwind mechanisms ...................................................................................................................84
5.9.9 Foil sealing mechanisms ....................................................................................................................84
5.9.10 Scrap reels............................................................................................................................................84
5.9.11 Lid placing mechanism .......................................................................................................................84
5.9.12 Discharge mechanism and conveyor ................................................................................................84
5.10 Safety requirements for a sack fill and seal machine ......................................................................85
5.10.1 Safety requirements for an in-line sack fill and seal machine ........................................................85
5.10.2 Safety requirements for a rotary sack fill and seal machine ...........................................................88
5.11 Safety requirements for an auger filler ..............................................................................................91
5.11.1 General..................................................................................................................................................91
5.11.2 Auger, stirrers and hopper .................................................................................................................91
5.11.3 Screw feeder.........................................................................................................................................91
5.11.4 Auger discharge and cut off devices .................................................................................................91
5.11.5 Power supplies.....................................................................................................................................92
5.11.6 Ergonomic design requirements........................................................................................................92
5.11.7 High level access .................................................................................................................................92
5.11.8 Dusty products.....................................................................................................................................92
5.12 Safety requirements for a volumetric cup filler ................................................................................93
5.12.1 General..................................................................................................................................................93
5.12.2 Hopper ..................................................................................................................................................93
5.12.3 Cup plates.............................................................................................................................................93
5.12.4 Discharge hopper ................................................................................................................................94
5.12.5 Ergonomic design requirements........................................................................................................94
5.12.6 High level access .................................................................................................................................94
5.12.7 Dusty products.....................................................................................................................................94
5.13 Safety requirements for a nett weigher .............................................................................................95
5.13.1 General..................................................................................................................................................95
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5.13.2 Product feed ......................................................................................................................................... 95

5.13.3 Vibratory feeders ................................................................................................................................. 95
5.13.4 Weigh hopper ....................................................................................................................................... 95
5.13.5 High level access................................................................................................................................. 96
5.14 Safety requirements for a multi-head weigher ................................................................................. 97
5.14.1 General ................................................................................................................................................. 97
5.14.2 Feed conveyor ..................................................................................................................................... 97
5.14.3 Vibratory conveyor, dispersion feeder and radial feeders.............................................................. 97
5.14.4 Pool and weigh hoppers ..................................................................................................................... 98
5.14.5 Timing hopper...................................................................................................................................... 98
5.14.6 Cleaning weigher components .......................................................................................................... 98
5.14.7 High level access................................................................................................................................. 98
5.14.8 Dusty products .................................................................................................................................... 98
5.14.9 Noise reduction ................................................................................................................................... 98
6 Verification of safety requirements ................................................................................................... 99
6.1 General ................................................................................................................................................. 99
6.2 Visual inspections with the machine stopped ................................................................................. 99
6.2.1 Mechanical parts ................................................................................................................................. 99
6.2.2 Pneumatic systems ............................................................................................................................. 99
6.2.3 Hydraulic systems ............................................................................................................................... 99
6.2.4 Electrical systems ............................................................................................................................... 99
6.2.5 Guards .................................................................................................................................................. 99
6.2.6 Design requirements ........................................................................................................................... 99
6.2.7 Marking and warning signs ................................................................................................................ 99
6.3 Measurements with the machine stopped ........................................................................................ 99
6.3.1 Guards .................................................................................................................................................. 99
6.3.2 Electrical testing .................................................................................................................................. 99
6.4 Visual inspections with the machine running ................................................................................ 100
6.4.1 Guards ................................................................................................................................................ 100
6.4.2 Safety related functions .................................................................................................................... 100
6.4.3 Dissipation of stored energy ............................................................................................................ 100
6.5 Measurements or tests with the machine running ........................................................................ 100
6.5.1 Electrical testing ................................................................................................................................ 100
6.5.2 Measurement of noise emission ...................................................................................................... 100
6.5.3 Temperature ....................................................................................................................................... 100
6.6 Verification procedures .................................................................................................................... 100
7 Information ......................................................................................................................................... 103
7.1 General ............................................................................................................................................... 103
7.2 Marking ............................................................................................................................................... 103
7.3 Warning of residual risks.................................................................................................................. 104
7.4 Instructions ........................................................................................................................................ 104
7.4.1 General ............................................................................................................................................... 104
7.4.2 All the machines in the scope of this standard .............................................................................. 104
7.4.3 Machines for use with food, cosmetics or pharmaceuticals ........................................................ 105
7.4.4 Specific requirements ....................................................................................................................... 105
Annex A (normative) Noise test code .......................................................................................................... 110
A1 General ....................................................................................................................................................... 110
A.2 Flow-wrapping machine .......................................................................................................................... 110
A.3 Vertical form, fill and machine ................................................................................................................ 110
A.4 Horizontal sachet form, fill and seal machine....................................................................................... 110
A.5 Thermoform, fill and seal machine Sound pressure measurement ................................................... 111
A.6 Tubular bag form, fill and seal machine ................................................................................................ 111
A.7 Mandrel form fill and seal machine ........................................................................................................ 111
A.8 Pre-made bag, erect, fill and seal machine ........................................................................................... 111
A.9 Cup or tub fill and seal machine ............................................................................................................ 111
A.10 Sack fill and seal machine .................................................................................................................... 111
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A.11 Auger filler ............................................................................................................................................. 112

A.12 Volumetric cup filler .............................................................................................................................. 112
A.13 Nett weigher ........................................................................................................................................... 112
A.14 Multi-head weigher ................................................................................................................................ 112
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 2006/42/EC ..................................................................................... 113
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prEN 415-3:2015 (E)
Foreword
This document (prEN 415-3:2017) has been prepared by Technical Committee CEN/TC 146 “Packaging
machines – Safety”, 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 June 2018, and conflicting national standards shall be withdrawn at
the latest by December 2018.
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
See informative Annex ZA, which is an integral part of this standard, for the relationship with EU Directive(s), ,.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France (incl. Guadeloupe, Martinique, Reunion & French-Guiana),
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,
Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United
Kingdom.
Other parts of this standard include:
EN 415 Safety of packaging machines;
 Part 1: Terminology and classification of packaging machines and associated equipment;
 Part 2: Pre-formed rigid container packaging machines.
 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 2 and 3 accuracy
 Part 10: General requirements
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Introduction
Form, fill and seal machines and fill and seal machines are used extensively in Europe, in an increasingly
wide range of industries. They contain many hazards and have the potential to cause serious injury.
The extent to which hazards are covered is indicated in the scope and clause 4 of this standard.
1 Scope
This European Standard establishes safety requirements for the main types of form, fill and seal machines, fill
and seal machines and auger fillers, volumetric cup fillers, nett weighers and multi-head weighers which are
frequently fitted to these machines.
Form fill and seal machines
 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
 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:
 Auger filler
 Volumetric cup filler
 Nett weigher
 Multi-head weigher.
Other types of form, fill and seal machine which are described in clause 3.3 have similar hazards to these
machines and clause 4 indicates which clauses of this standard are applicable to these machines.
This standard 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 part of EN 415 applies to machines manufactured after the date of issue of this standard.
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Exclusions
This standard does not apply to:
 Blow mould fill and seal machines
 Bulk container fill and seal machines
 Cartoning machines
 Food depositors, including volumetric piston depositors
 Thermoforming machines
This standard does consider hazards due to dust from the products being packed in these machines and
modified atmosphere gases, but does not consider other hazards caused by the product being packed.
2 Normative references
These documents, in whole or in part, are normatively referenced in this document and are indispensable for
its application. For dated references, only the edition cited applies. For undated references, the latest edition
of the referenced document (including any amendments) applies.
EN 349:1993+A1:2008, Safety of machinery — Minimum gaps to avoid crushing of parts of the human body
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 auxiliary equipment – Grade 2 and 3 accuracy
EN 415-10:2014, Safety of packaging machines – Part 10: General requirements
EN 574:1996+A1:2008 Safety of machinery. Two-hand control devices. Functional aspects. Principles for
design
EN 614-1:2006+A1:2009 Safety of machinery. Ergonomic design principles. Terminology and general

principles
EN 614-2:2000+A1:2008, Safety of machinery — Ergonomic design principles — Part 2: Interactions between

the design of machinery and work tasks
EN 618:2002+A1:2010 Continuous handling equipment and systems – Safety and EMC requirements for
equipment for mechanical handling of bulk materials except fixed belt conveyors
EN 620:2002+A1:2010 Continuous handling equipment and systems – Safety and EMC requirements for fixed
belt conveyors for bulk materials
EN 1005-2: 2003+A1:2008. Safety of machinery. Human physical performance. Manual handling of machinery
and component parts of machinery
EN 1005-3: 2002+A1:2008. Safety of machinery. Human physical performance. Recommended force limits for
machinery operation
EN 1005-4:2005+A1:2008. Safety of machinery. Human physical performance. Evaluation of working postures

and movements in relation to machinery
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EN 1005-5:2007. Safety of machinery. Human physical performance. Risk assessment for repetitive handling
at high frequency
EN 1672-2:2005+A1:2009, Food processing machinery — Basic concepts — Part 2: Hygiene requirements
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)
EN ISO 7010:2012+A5:2015, Graphical symbols – Safety colours and safety signs- Registered safety signs
EN 1127-1:2011 Explosive atmospheres. Explosion prevention and protection. Basic concepts and
methodology
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
EN ISO 13849-1:2015, Safety of machinery — Safety-related parts of control systems — Part 1: General
principles for design (ISO 13849-1:2006)
EN ISO 13855:2010, Safety of machinery — Positioning of safeguards with respect to the approach speeds of
parts of the human body (ISO 13855:2010)
EN ISO 13857:2008, Safety of machinery — Safety distances to prevent hazard zones being reached by
upper and lower limbs (ISO 13857:2008)
EN ISO 14119:2013, Safety of machinery. Interlocking devices associated with guards. Principles for design
and selection
EN ISO 14120: 2015, Safety of machinery — Guards — General requirements for the design and construction
of fixed and movable guards
EN ISO 14122-1:2016, Safety of machinery — Permanent means of access to machinery — Part 1: Choice of
fixed means and general requirements of access
EN ISO 14122-2:2016, Safety of machinery — Permanent means of access to machinery — Part 2: Working
platforms and walkways
EN ISO 14122-3:2016, Safety of machinery — Permanent means of access to machinery — Part 3: Stairs,
stepladders and guard-rails
EN ISO 14122-4:2016 Safety of machinery – Permanent means of access to machinery – Part 4: Fixed
ladders
EN ISO 14123-1:2015, Safety of machinery — Reduction of risks to health from hazardous substances
emitted by machinery — Part 1: Principles and specifications for machinery manufacturers
EN 15180:2014, Food processing machines – Food depositors – Safety and hygiene requirements
EN 60079-14:2014. Explosive atmospheres. Electrical installations design, selection and erection
EN 60204-1:2006+A1:2009, Safety of machinery. Electrical equipment of machines. General requirements
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EN 60204-31:2013, Safety of machinery. Electrical equipment of machines. Particular safety and EMC
requirements for sewing machines, units and systems
EN 60825-1:2014, Safety of laser products. Equipment classification and requirements
EN 61496-1:2013, Safety of machinery. Electro-sensitive protective equipment. General requirements and

tests
EN 61496-2:2013 Safety of machinery. Electro-sensitive protective equipment. Particular requirements for

equipment using active opto-electronic protective devices (AOPDs)
ISO 3864-1:2011 Graphical symbols – Safety colours and safety signs – Part 1: Design principles for safety
signs and safety markings
ISO 3864-2:2004 (R08) ED 1 Graphical symbols – Safety colours and safety signs – Part 2: Design principles
for product safety labels
ISO 3864-3:2012 Graphical symbols – Safety colours and safety signs – Part 3: Design principles for
graphical symbols for use in safety signs
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 12100:2010, EN 415-1:2014
and the following apply.
3.1 Definition of terms
3.1.1
bag
Flat or gusseted flexible container longitudinally seamed and closed at one or both ends made from paper,
plastic film, foil, laminate etc.
NOTE: Bags produced on form, fill and seal machines will typically have a seal at both ends and a longitudinal
seal running down the centre of the rear face of the bag
3.1.2
cold adhesive
adhesive that is liquid at room temperature
EXAMPLE PVA adhesive
3.1.3
cup; tub
thin walled tapered container
3.1.4
deformable material
material which can be formed by the application of pressure alone
3.1.5
film reel; packaging material reel
continuous sheet of paper, carton board, plastics film, metal foil or flexible laminate wound on a cylindrical
core
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3.1.6
film web
continuous sheet of paper, plastics film, metal foil or laminate
3.1.7
hot melt adhesive
adhesive that is solid at room temperature and which is melted and applied at elevated temperature
3.1.8
longitudinal seal
seal made on a package in line with the direction of material travel in the machine
3.1.9
pack; package
assembly of product and packaging materials produced by a packaging machine
3.1.10
pre-made bag
pre-formed flat or gusseted flexible container longitudinally seamed and closed at one end made from paper,
plastic film, foil, laminate or a woven material
3.1.11
pre-made sack
pre-formed flat or gusseted sack longitudinally seamed and closed at one or both ends made from paper,
plastic film, laminate, or a woven material
3.1.12
product
substance, article pack or package that is handled in the packaging machine
3.1.13
PVA adhesive
water dispersible emulsion adhesive made from polyvinyl acetate
3.1.14
sachet
flat package which when formed from two webs of flexible material is sealed on four sides and when formed
from one web is sealed on three or four sides
3.1.15
transverse seal
seal made on a package at right angles to the direction of material travel in the machine
3.1.16
change parts
machine parts designed to handle a specific product, packaging material or pack size that need to be changed
when the machine is set up to handle a different product, packaging material or pack size
3.1.17
magazine
mechanical assembly designed to hold stacks of cartons, carton blanks, pre-made bags, pre-made sacks,
leaflets, labels, lids or stackable containers
3.1.18
mandrel
mechanical assembly around which a flexible package or carton is formed
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3.1.19
modified atmosphere
atmosphere where the normal atmosphere within a package is completely or partially replaced by one or more
selected gases
NOTE: Usually the objective is to extend shelf or storage life of the packaged products
3.1.20
packaging material
material used to make a package
EXAMPLE Corrugated board, carton board, stretch film, paper, polypropylene
3.1.21
packaging material transport mechanism
mechanical assembly which transports packaging material through the packaging machine
3.1.22
suction cup
cup made of an elastic material to which a vacuum can be applied to lift a product
3.1.23
reclosing feature applicator
mechanism which applies a zip or self-adhesive packaging component to a package on a packaging machine
3.1.24
sack discharge mechanism
equipment that takes filled sacks away from the machine
3.1.25
sack placer
mechanism which places an empty pre-made sack onto a filling nozzle
3.1.26
sack transfer mechanism
mechanism which takes empty sacks from a sack magazine and transfers them to a sack placer
3.1.27
manually adjustable guard
adjustable guard where the adjustment is made manually and the adjustment remains fixed during a particular
operation
NOTE: A manually adjustable guard does not comply with this definition unless it has been dimensioned and
positioned using relevant tables of EN ISO 13857

3.1.28
change part guard
fixed or interlocking guard which has made to suit one product or pack size and must be changed every time
the product or pack size is changed
NOTE: A change part guard does not comply with this definition unless it has been dimensioned and
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3.1.29
fixed guard
guard affixed in such a manner (for example, by screws, nuts, and welding) that it can only be opened or
removed by the use of tools or by destruction of the means by which the guard is affixed
NOTE: A fixed guard does not comply with this definition unless it has been dimensioned and positioned using
relevant tables of EN ISO 13857
3.1.30
interlocking guard
guard associated with an interlocking device so that, together with the control system of the machine, the
following functions are performed:
— the hazardous machine functions “covered” by the guard cannot operate until the guard is closed;
— if the guard is opened while hazardous machine functions are operating, a stop command is given;
— when the guard is closed, the hazardous machine functions “covered” by the guard can operate (the
closure of the guard does not, by itself, start the hazardous machine functions)
Note 1: An interlocking guard does not comply with this definition unless it has been dimensioned and
Note 2: An interlocking guard does not comply with this definition unless the interlocking device complies with
EN ISO 14119: 2015
3.1.31
automatically adjustable guard
movable guard attached to a moveable machine element (e.g. moving side of a pre-made bag magazine) and
a fixed machine element (e.g. machine frame) which moves automatically when the moveable element is
adjusted
NOTE: An automatically adjustable guard does not comply with this definition unless it has been dimensioned
and positioned using relevant tables of EN ISO 13857
3.1.32
trip guard
interlocking guard which is designed to move easily when touched by someone and which stops the machine
before a danger zone can be reached
3.1.33
tubular bag
flexible container closed at both ends and made from a flat film tube
3.2 Definitions of machines covered by this standard
3.2.1 Form, fill and seal machines
3.2.1.1
flow-wrapping machine
horizontally operating form, fill and seal machine with material reel mounted above the operating level, the
product loaded horizontally and a longitudinal seal formed below the pack
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Figure 1 – Diagram showing the principle of operation of a typical flow-wrapping machine

3.2.1.2
vertical form, fill and seal machine
machine which uses flexible packaging material to form a tube, which is then filled vertically with product and
sealed in a sequence of operations whilst the packaging material is transported vertically downwards
Figure 2 – Diagram showing the principle of operation of a typical vertical form, fill and seal machine
3.2.1.3
horizontal sachet form, fill and seal machine
horizontally operating form, fill and seal machine in which packs are formed, sealed on 2 or 3 sides, filled
vertically with product and sealed on the remaining side whilst the film web is moved horizontally with the pack
vertical
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Figure 3 – Diagram showing the principle of operation of a typical horizontal sachet form, fill and seal
machine
3.2.1.4
thermoform, fill and seal machine
machine in which a web of thermoformable material is heated and formed with pressure and/or vacuum,
before being filled vertically with product, sealed with a top film or magazine fed lid and finally cut to produce
individual packs
NOTE: Machines can produce one or more lanes of packs and may incorporate equipment to evacuate packages
before they are sealed.
Figure 4 – Diagram showing the principle of operation of a typical thermoform, fill and seal machine
3.2.1.5
tubular bag form, fill and seal machine
machine which forms a bag or sack from a reel of lay flat tubular flexible packaging film, before it is filled with
product and sealed
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Figure 5 – Diagram showing the principle of operation of a typical tubular bag form, fill and seal
machine
3.2.1.6
mandrel form, fill and seal machine
machine which forms packs from a reel of flexible material or carton blanks, on one or more mandrels, before
filling the packs with product and sealing their tops within the machine
Figure 6 - Diagram showing the principle of operation of a typical mandrel form, fill and seal machine
3.2.2 Fill and seal machines
3.2.2.1
pre-made bag fill and seal machine
machine in which a pre-made bag is taken from a magazine, opened, filled with product and then sealed
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Figure 7 – Diagram showing the principle of operation of a typical pre-made bag fill and seal machine
3.2.2.2
sack fill and seal machine
machine in which a pre-made sack is taken from a magazine, before being opened, filled with product and
sealed
NOTE: The sacks may be filled in-line or on a rotary carousel
Figure 8 – Diagram showing the principle of operation of a typical in-line sack fill and seal machine
3.2.2.3
cup or tub fill and seal machine
machine in which a pre-made cup or tub is taken from a magazine, filled and then closed with a heat sealed
foil or a press-on lid
Figure 9 – Diagram showing the principle of operation of a typical cup/tub fill and seal machine
3.2.3 Filling machines
3.2.3.1
auger filling machine
filling machine which measures out a product, usually a powder, using an auger which rotates for a
predetermined number of revolutions
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3.2.3.2
volumetric cup filling machine
filling machine which measures out a product, usually free-flowing solids or powder, in a cup of predetermined
volume
3.2.3.3
nett weigher
filling machine which measures out a predetermined mass of product, usually free-flowing solids, before
dispensing it as a fill
3.2.3.4
multi-head weigher; selective combination weigher
nett weighing machine with multiple weighing units, which computes an appropriate combination of loads to
achieve the predetermined mass and discharges them together as a fill
3.3 Definition of machines which have similar hazards to those machines covered by this
standard
The following machines have similar hazards to those on the machines covered by this standard.
3.3.1
lower reel flow-wrapping machine
horizontally operating form, fill and seal machine, with film reel mounted below the operating level, the product
placed on to the film web and a longitudinal seal formed above the pack
Figure 10 – Diagram showing the method of operation of a typical lower reel flow-wrapping machine
3.3.2
stick packing machine
vertical form, fill and seal machine which produces small cross-section stick shaped packs
NOTE: Machines typically produce several lanes of packages at the same time.
3.3.3
edge sealing machine
horizontally operating form, fill and seal machine in which product is placed on a horizontal web of film before
being sealed on 3 or 4 sides to an upper web of film
NOTE: Machines can have one or two reels of film and can produce one or more lanes of packs.
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Figure 11 – Diagram showing the method of operation of a typical edge sealing machine
3.3.4
vertical sachet form, fill and seal machine
vertically operating form, fill and seal machine which uses one or two webs of film which are formed vertically,
filled with product and sealed to produce a 3 or 4 side sealed sachet
NOTE: Machines can have one or two reels of film and can produce one or more lanes of packs.
Figure 12 – Diagram showing the method of operation of a typical Vertical sachet form, fill and seal
machine
3.3.5
strip packing machine
vertically operating sachet form, fill and seal machine which produces strips of individually sealed packs joined
together in predetermined lengths
3.3.6
vertical form, fill and seal machine for cartonboard
vertically operating form fill and seal machine which uses a cartonboard laminate, which is formed, filled with
product and sealed to produce a pack resembling a carton usually filled with a liquid
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Figure 13 – Diagram showing the method of operation of a typical vertical form, fill and seal machine
for cartonboard
3.3.7
deep draw machine
machine in which a web of deformable material is formed under pressure in a die press, before being filled
vertically with product, sealed with a top film or magazine fed lid, and finally cut to produce individual packs
NOTE: Machines can produce one or more lanes of packs.
Figure 14 – Diagram showing the method of operation of a typical deep draw machine
3.3.8
count filling machine
filling machine which measures out solids according to a predetermined count
4 Hazards
4.1 Hazards which occur on all machines in the scope of this standard
The hazards described in tables 1, 2 and 3 can be present on all the machines in the scope of this standard.
The fourth column in each table refers to the applicable safety requirements for each hazard.
NOTE Additional hazards and hazardous situations which are specific to a certain type of machine are
provided in clauses 4.2 to 4.14. A risk assessment shall be carried out to identify any further hazards that
may be present.
Table 1 – Hazards found on all machines in the scope of this standard
Hazard Harm Examples of hazardous situations Safety
Requirement
Mechanical hazards from Crushing, cutting, Details in clauses 4.2 to 4.14 5.2 to 5.14
moving parts drawing-in, entanglement
and shearing
Mechanical hazards Crushing, cutting, and Guards trap operator’s hands or 5.1.1.2
caused by guards shearing arms
Impact Operator walks into an open guard 5.1.1.2
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Hazard Harm Examples of hazardous situations Safety

Requirement
Slip, trip and fall Impact and falling Operators slip on spilled product, 5.1.1.7
lubricants or discarded film on the
floor around the machine
Electrical Electric shock Direct contact with electrical 5.1.2
conductors
Electric shock Indirect contact e.g. due to 5.1.2
breakdown of insulation or ingress of
water when cleaning
Ergonomic Musculo-skeletal Loading packaging materials 5.1.8
disorders Loading or unloading products
Lifting machine parts during size
changing or maintenance
Fire Burning Packing a product which is 5.1.7
flammable or using a flammable
packaging material
Noise Hearing loss, tinnitus and Elevated noise levels e.g. from 5.1.4
other harms due to vibrating mechanisms
interference with speech The noise output of machines in the
communication scope of this standard may vary
depending on the product being
packed
Table 2 - Hazards which may be present on all the machines in the scope of this standard
Hazard Harm Examples of hazardous Safety
situations Requirement
Electrostatic Electric shock Electrostatic charges build up on 5.1.2.2
phenomena metal components and discharge
as a spark
Thermal Burns Operational tasks on heat sealing 5.1.3
mechanisms
Vibration Loss of feeling in hands Touching vibrating mechanisms 5.1.5
Hearing loss When the sound pressure level 5.1.4

exceeds 80dB(A).
Radiation Burns and other health Operational tasks and 5.1.6
damaging effects maintenance
Hazardous substances - Various health Operation and trouble shooting 5.1.7.1
products damaging effects
Hazardous substances - Chemical burn, hazards Process intervention, cleaning, 5.1.7.4
Sterilizing agents - to respiratory system maintenance, staying in the
EXAMPLE: peracetic and lungs vicinity, malfunction, leakage, 5.1.7.5
acid or hydrogen Oxidizing contact, inhalation
peroxide Exothermic spontaneous
decomposition due to
pollution
Modified atmosphere Asphyxiation Release of gas reduces the oxygen 5.1.7.4.2

packaging –carbon levels in the air around the
dioxide machine or inside machine parts
and has health damaging effects
Modified atmosphere Asphyxiation Release of gas reduces the oxygen 5.1.7.4.1
packaging – nitrogen levels in the air around the
machine or inside machine parts
Modified atmosphere Fire or explosion Contact of some products with 5.1.7.4.3
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Hazard Harm Examples of hazardous Safety

situations Requirement
packaging – oxygen oxygen concentrations higher than
21% for example:
- fat in products
- lubricants, e.g. in the vacuum
pump
- materials of the machine
Combustion products of packaging
materials increase the risk of fires
or explosions
Dusty products Various health Operators inhale or come into 5.1.7.2
damaging effects – for contract with product particles
example asthma
Burns and impact from A spark causes a dusty 5.1.7.3
flying debris atmosphere to explode
Inadequate hygienic Various health The food, cosmetic or 5.1.9
design damaging effects pharmaceutical product being
including food poisoning packed in the machine is
contaminated by the machine
Table 3 - Hazards related to work tasks which occur on all the machines in the scope of this standard
Work Task Examples of hazardous situations Harm Safety
Requirement
Transport Machine drops or falls over during Crushing 7.4
transport
Assembly installation Machine or machine assemblies drop Crushing impact 7.4
or fall over during assembly
Moving mechanisms Machine is started while someone is All hazards 5.1.1.8
while guards are open wholly or partly inside a danger zone
Setting Size parts drop or move unexpectedly Crushing impact 5.1.8.4
Size changing Lifting heavy parts Musculo-skeletal 5.1.8.4
disorders
Programming Programming error causes a hazard All mechanical 7.4
hazards
Touching live conductors in the Electric shock 5.1.2
electrical enclosure
Operation Operator removes a guard to gain All hazards 7.4
access to the machine but does not
replace it
Safety related parts of the control All mechanical 5.2.7
system fail to danger causing the hazards 5.3.12
machine to start unexpectedly 5.4.10
5.5.14
5.6.15
5.7.18
5.8.9
5.9.13
5.10.1.11
5.10.2.12
5.11.9
5.12.8
5.13.6
5.14.10
Inadequate ventilation in area where Heat exhaustion 7.4
machine is located
Fault finding Guards are removed or defeated to All hazards 7.1
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Work Task Examples of hazardous situations Harm Safety

Requirement
allow access while the machine is
running
Cleaning Machine run with guards removed All hazards 7.4
during cleaning
Guards removed for cleaning but not All hazards 5.1.1.2
replaced
Electrical enclosures fill with water Electric shock 5.1.2
Maintenance Isolation of energy supplies and stored Range of mechanical 7.4
energy dissipation causes parts to hazards
move unexpectedly
Dismantling/removal of parts, Crushing 7.4
components, devices of the machine Impact
Shearing
Parts move unexpectedly under gravity Crushing 7.4
Impact
Shearing
Necessary to enter danger zones to Falling 7.4
lubricate components Slipping
Dismantling Machine or machine assemblies drop Range of mechanical 7.4
or fall over hazards
4.2 Hazards on a flow wrapping machine
Figure 15 shows the hazard zones on a typical flow-wrapping machine and table 4 describes these hazards
and indicates which part of clause 5 of this standard provides the appropriate safety requirement. Table 5
shows the hazards on the optional equipment that is typically integrated with a flow-wrapping machine.
The hazards on a lower reel flow-wrapping machine (3.3.1) and an edge sealing machine (3.3.3) are similar to
those of a flow-wrapping machine.
Figure 15 - Hazard zones on a typical flow wrapping machine
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Table 4 - Hazards on a typical flow-wrapping machine

Zone Source of hazard Hazards Hazardous situations Safety
requirement
1 Infeed chain Drawing-in Accessing chain and 5.2.2

Shearing sprockets while running
Musculo-skeletal injuries Loading products by hand – 5.1.8.2
risk affected by
- height of conveyor
- mass of products
- frequency of
movement
- operator posture
2 Product pushers attached Drawing-in, impact and Loading products by hand 5.2.2.2
to the infeed chain shearing especially near the folding
box
Cleaning while running
3 Film reel unwind Drawing-in and shearing Access while running 5.2.3
mechanism Musculo-skeletal injuries Lifting and loading reels 5.1.8.1
Electrostatic shock Touching film rollers 5.1.2.2
Slipping and falling from a Working at height to load 5.1.8.1
height or thread film
4 Folding box Drawing-in Loading products by hand 5.2.4
5 Longitudinal sealing Crushing and drawing-in Threading a new reel of 5.2.4
mechanism film
Accessing while running
Unexpected start-up
Burning Cleaning broken products 5.2.4
Threading film
6 Transverse sealing and Crushing, cutting and Accessing while running 5.2.5
cutting mechanism drawing-in
Burning Cleaning jaws 5.2.5
Threading film
7 Flat belt discharge Drawing-in Accessing while running 5.2.6
conveyor
9 Drive mechanisms Crushing Accessing for 5.1.1.5
Drawing-in maintenance while
Shearing running
Table 5 - Hazards on optional equipment which is typically integrated with a flow-wrapping machine
Typically Source of hazard Hazards Hazardous situations Safety
added to requirement
zone
1 Flat belt infeed Drawing-in at rollers and Loading products by 5.2.2.3

conveyors between the moving belt hand especially near the
and fixed parts folding box
Drawing-in between the Handling products near 5.2.2.3
discharge of one belt belt transfers
conveyor and the infeed Cleaning while running
of another conveyor
Musculo-skeletal injuries Loading products by hand – 5.1.8.2
risk affected by
- height of conveyor
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zone
- mass of products
- frequency of
movement
- operator posture
1 Automatic product Crushing Loading products 5.2.2.4
dispensing devices – for Shearing Accessing while running
example side loading
pushers or pick and
place devices
3 Automatic reel splicing Crushing Access while running 5.2.3.5
mechanism Cutting Setting up new reel
3 Powered unwind Drawing-in Accessing while running 5.2.3.4
mechanism
3 Reclosing feature Drawing-in Accessing while running 5.2.3.7
applicator
Burning Accessing while 5.1.3
threading material
3 Thermal coder Crushing and drawing-in Accessing while running 5.2.3.3
Burning
3 Laser coder Burning Direct or indirect contact 5.2.3.3
Laser radiation with laser beam
8 Hand-wheel Entanglement, impact or If the wheel rotates while 5.1.1.6
9 shearing the machine is running
Musculo-skeletal injuries Excessive effort turning 5.1.8.3

hand-wheel
4.3 Hazards on a vertical form, fill and seal machine
Figure 16 shows the hazard zones on a typical vertical form fill and seal machine and table 6 describes these
hazards and indicates which parts of clause 5 of this standard provides the appropriate safety requirement.
Table 7 shows the hazards on the optional equipment that is typically integrated with a vertical form fill and
seal machine.
This clause also applies to the following machines:
- stick packing machine (3.3.2);
- vertical sachet form, fill and seal machine (3.3.4);
- strip packing machine (3.3.5);
- vertical form, fill and seal machine for cartons (3.3.6).
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Figure 16 - Hazard zones on a typical vertical form, fill and seal machine
Table 6 -Hazards on a typical vertical form, fill and seal machine

requirement
1 Filling machine See clauses 4.11 – 4.145.3.11 or EN 15180 for food depositors
2 Forming tube Musculo-skeletal injuries Changing the forming 5.3.11
Falling tube
Film spreader fingers Stabbing If the spreader fingers are 5.3.7
fitted to forming tube sharp or become sharp
due to wear
3 Packaging material reel Drawing-in and shearing Accessing while running 5.2.3
unwind mechanism Musculo-skeletal injuries Loading packaging 5.2.3
material reels
Slipping Packaging material left on 5.2.3
the floor
Falling from height Working at height to load 5.1.8.1
or thread film
4 Longitudinal sealing Crushing Threading new reel of film 5.3.4
mechanism Drawing-in Accessing while running
Threading film
5 Transverse sealing and Crushing and cutting Accessing while running 5.2.5
cutting mechanism Burning Threading film 5.2.5
Cleaning jaws
Cutting knife Cutting Maintenance 5.2.5
Threading film
6 Packaging material Drawing-in, impact and Accessing while running 5.2.5
transport mechanism Shearing
7 Discharge conveyor Drawing-in Accessing while running 5.2.6
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requirement
8 Drive mechanisms Crushing, drawing-in and Accessing while running 5.1.1.5

Shearing e.g. for maintenance
Table 7 - Hazards on optional equipment which is typically integrated with a vertical form, fill and seal
machine
Source of hazard Hazards Hazardous situations Safety
requirement
Typically
added to
zone
2 Modified atmosphere Asphyxiation Working in or near the 5.1.7.4

equipment machine
3 Automatic reel splicing Crushing and cutting Access while running 5.2.3.5
mechanism Setting up new reel
mechanism
applicator
Burning Threading material 5.1.3
3 Thermal coder Crushing, drawing-in and Accessing while running 5.2.3.3
burning
3 Laser coder Laser radiation Direct or indirect contact 5.2.3.3
with laser beam
5 Gussetting or top closing Crushing, drawing-in and Accessing while running 5.3.6
mechanism burning
5 Perforating mechanism Stabbing Accessing transverse 5.3.6
seal jaw area
5 Reciprocating packaging Crushing Access while running 5.3.6
material transport
mechanism
4.4 Hazards on typical horizontal sachet form, fill and seal machines
Figure 17 shows the hazard zones on a typical horizontal sachet form fill and seal machine and table 8
describes these hazards and indicates which parts of clause 5 of this standard provides the appropriate safety
requirement. Table 9 shows the hazards on the optional equipment that is typically integrated with a horizontal
sachet form fill and seal machine. Figure 17 shows a linear transport system but the hazards are the same on
machines where the transport system is rotary or partly rotary.
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Figure 17 - Hazard zones on a typical horizontal sachet form, fill and seal machine
Table 8 - Hazards on a typical horizontal sachet form, fill and seal machine
requirement
1 Film reel unwind Drawing-in, entanglement Access while running 5.2.3

mechanism and shearing
Musculo-skeletal injuries Loading reels 5.2.3
Slipping or falling Loading or threading film 5.2.3
Electrostatic discharge Touching film rollers 5.1.2.2
2 Vertical sealing Crushing Accessing while running 5.4.3
mechanism Burning Touching hot surfaces
3 Transport mechanism Impact and shearing Accessing while running 5.4.4
4 Filling machine See clauses 4.11 – 4.14 or EN 15180 for food depositors
5 Top sealing mechanism Crushing and drawing-in Accessing while running 5.4.7
Hot melt glue
Threading film
6 Cutting mechanism Cutting Threading film 5.4.8
Maintenance
7 Discharge mechanism Impact and shearing Reaching in to package 5.4.9
discharge opening
shearing
Table 9 - Hazards on optional equipment which is typically integrated with a horizontal sachet form, fill
and seal machine
Zone
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Zone

mechanism
applicator
Burning Threading material 5.1.3
Burning
with laser beam
4 Product settling Vibration Touching mechanisms 5.1.5
mechanism while running
6 Modified atmosphere Asphyxiation Oxygen levels in 5.1.7.4
equipment atmosphere reduced by
release of gas
6 Hand-wheel Entanglement, impact If the wheel rotates while 5.1.1.6
and shearing the machine is running
Musculo-skeletal Turning handwheel 5.1.8.3
7 Flat belt discharge Drawing-in Accessing while running 5.2.2.3
conveyor
4.5 Hazards on a thermoform, fill and seal machine
Figure 18 shows the hazard zones on a typical thermoform fill and seal machine and table 10 describes these
hazards and indicates which parts of clause 5 of this standard provides the appropriate safety requirement.
Table 11 shows the hazards on the optional equipment that is typically integrated with a thermoform fill and
seal machine. Figure 18 shows a linear transport system but the hazards are the same on machines where
the transport system is rotary or partly rotary.
This clause also applies to a deep draw machine (3.3.7).
Figure 18 - Hazard zones on a typical thermoform, fill and seal machine
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Table 10 - Hazards on a typical thermoform, fill and seal machine

requirement
1 Bottom film reel unwind Drawing-in and shearing Accessing while running 5.2.3
mechanism Musculo-skeletal injuries Loading reels 5.1.8.1
Slipping or falling Loading or threading film 5.1.8.1
2 Transport mechanism Crushing and drawing-in Accessing while running 5.5.3
3 Heating or pre-heating Crushing Accessing while running 5.5.4
chamber Burning Threading film 5.5.4
4 Forming die Crushing Reaching into forming 5.5.5
Shearing area to pull lower web
5 Product loading area Musculo-skeletal injuries Loading products by 5.5.6
hand
6 Top film reel unwind Drawing-in and shearing Accessing while running 5.2.3
mechanism Musculo-skeletal injuries Loading reels 5.1.8.1
Slipping or falling Loading or threading film 5.1.8.1
7 Sealing die Crushing and drawing-in Accessing while running 5.5.9
Burning Cleaning jaws and 5.5.9
threading film
8 Cutting mechanisms Cutting Threading film 5.5.10
Maintenance
9 Scrap reels Drawing-in Accessing while running 5.5.11
conveyor
shearing
Table 11 - Hazards on optional equipment which is typically integrated with a thermoform, fill and seal
machine
Zone
1 Automatic splicing Crushing Accessing while running 5.2.3.5
mechanism
5 Automatic loading Crushing and impact Accessing while running 5.1.1.2
equipment – for example
pick and place or
depositor
5 Pad or leaflet inserter Crushing Accessing while running 5.1.1.2
Musculo-skeletal injuries Loading pads or leaflets 5.1.8.1
6 Thermal coder Crushing Accessing while running 5.2.3.3
Drawing-in
Burning
Impact When coder moves 5.5.8
sideways
with laser beam
Impact When coder moves 5.5.8
sideways
6 Self-adhesive labelling Drawing-in Accessing while running 5.1.1.1
machine Impact When labeller moves 5.5.8
sideways
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Zone
release of gas
4.6 Hazards on a tubular bag form, fill and seal machine
Figure 19 shows the hazard zones on a typical tubular bag form, fill and seal machine and table 12 describes
these hazards and indicates which parts of clause 5 of this standard provide the appropriate safety
requirement. Table 13 describes hazards on the equipment typically integrated with a tubular bag form, fill and
seal machine.
Figure 19 - Hazard zones on a typical tubular bag form, fill and seal machine
Table 12 - Hazards on a typical tubular bag form, fill and seal machine
requirement
1 Film reel unwind Drawing-in and shearing Accessing while running 5.2.3
mechanism Musculo-skeletal injuries Loading film reels 5.1.8.1
Slipping and falling from Working at height to load 5.1.8.1
height or thread film
2 Drive Crushing, drawing-in and Accessing while running 5.6.3
mechanism shearing e.g. for maintenance
3 Transverse or corner Crushing, drawing-in and Accessing while running 5.6.3
sealing and cutting cutting
mechanism Threading film
Cutting knife Cutting Touching knife e.g. 5.6.5
during maintenance
4 Film draw and Drawing-in and shearing Accessing while running 5.6.6
compensator
5 Cooling mechanisms for Crushing and shearing Accessing while running 5.6.7
sealing
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requirement
6 Product feeding See clauses 4.11 – 4.14 or EN 15180 for food depositors
mechanism
7 Filling mechanism Crushing and shearing Accessing while running 5.6.8
Dust at filling station Various health damaging Contact with dust 5.1.7.2
effects
8 Bag opening Crushing and shearing Accessing while running 5.6.9
mechanism
9 Product settling Vibration Touching vibrating parts 5.6.10
mechanism Crushing and shearing Accessing while running 5.6.10
Bag sealing mechanism Burning Cleaning jaws 5.6.11
10 Conveyor Drawing-in Accessing while running 5.6.11
11 Conveyor height Crushing and shearing Adjusting conveyor height 5.6.13
adjustment
12 Bag transport Impact, crushing and Accessing while running 5.6.14
mechanism shearing
Table 13 - Hazards on equipment which is typically integrated with a tubular bag form, fill and seal
machine
Zone
1 Power unwind Drawing-in Accessing while running 5.2.3.4
mechanism
1 or 4 Thermal coder Crushing, drawing-in Accessing while running 5.2.3.3
Burning
1 or 4 Laser coder Laser Direct or indirect 5.2.3.3
radiation contact with laser beam
1 or 2 Gussetting mechanism Crushing and drawing-in Accessing while running 5.6.9
3 Perforating mechanism Stabbing Accessing while running 5.6.9
4.7 Hazards on a mandrel form, fill and seal machine
Figure 20 shows the hazard zones on a typical mandrel form, fill and seal machine which may incorporate a
film reel unwind assembly or carton blank magazine or both assemblies. Table 14 describes these hazards
and indicates which parts of clause 5 of this standard provide the appropriate safety requirement. Table 15
describes hazards on the equipment typically integrated with a mandrel form, fill and seal machine.
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Figure 20 - Hazard zones on the range of mandrel form, fill and seal machines
Table 14 Hazards on the range of mandrel form, fill and seal machines
requirement
1 Packaging material reel Drawing-in and Accessing while running 5.2.3
unwind mechanism shearing
Musculo-skeletal Loading packaging 5.1.8.2
injuries material reels
Slipping Packaging material left on 5.1.8.2
the floor
2 Cutting mechanism Cutting Accessing while running 5.7.3
Cutting Threading packaging 5.7.3

material
3 Heat sealing mechanisms Burning Touching hot surfaces 5.7.4
Crushing, shearing Accessing while running 5.7.4
4 Carton blank magazine Drawing-in Loading blanks into 5.7.5

magazine
Musculo-skeletal Loading blanks into 5.1.8

disorders magazine
5 Carton blank transfer Crushing, shearing Accessing while running 5.7.8

mechanism
6 Mandrel former Crushing, shearing, Accessing while running 5.7.6

drawing-in
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requirement
7 Compression mechanism Crushing, shearing Accessing while running 5.7.7
8 Transfer mechanism Crushing, shearing, Accessing while running 5.7.8

drawing-in
9 Transport mechanism Crushing, shearing, Accessing while running 5.7.9

drawing-in
10 Product feed See clauses 4.11 – 4.14 or EN 15180 for food depositors
11 Package closing mechanism Crushing, shearing Accessing while running 5.7.14
12 Discharge conveyor Crushing, shearing, Accessing while running 5.7.16

drawing-in
13 Drive mechanisms Crushing, drawing-in Accessing while running 5.1.1.5

and
shearing
Table 15 - Hazards on optional equipment which is typically integrated with a mandrel form, fill and
seal machine
requirement
4 Automatic carton stack Crushing, shearing, Accessing while running 5.1.1.4.1
feeding mechanism drawing-in
10 Sterilization section Burning Touching hot surfaces 5.1.3
Respiratory Injury Hazardous gas levels in 5.1.7.4.2

atmosphere
Sterilizing agents Chemical burn 5.1.7.4.2
Crushing Accessing the sterilization 5.1.1.2

media distributor while
running
10 Vibration settling devices Hand or arm vibration Accessing while running 5.1.5
11 Vacuum sealing mechanism Crushing Accessing while running 5.7.15
12 Pack reject mechanism Crushing, shearing, Accessing while running 5.1.1.1

drawing-in
13 Hand-wheel Entanglement, impact, Wheel rotates while 5.1.1.6

crushing, shearing, machine running
musculo-skeletal Excessive effort turning 5.1.8.3

injuries
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4.8 Hazards on a pre-made bag erect, fill and seal machine
Figure 21 shows the hazard zones on a typical pre-made bag erect, fill and seal machine and table 16
describes these hazards and indicates which parts of clause 5 of this standard provides the appropriate safety
requirement. Table 17 shows the hazards on the optional equipment that is typically integrated with a pre-
made bag erect, fill and seal machine. Figure 21 shows a rotary transport system but the hazards are the
same on machines where the transport system is linear or partly linear.
Figure 21 - Hazard zones on a typical pre-made bag erect, fill and seal machine
Table 16 - Hazards on a typical pre-made bag erect, fill and seal machine
requirement
1 Bag magazine Drawing-in Loading bags into 5.7.5
magazine
Cutting Handling bags 7.4.4.7
Manual handling Handling bags 5.1.8.1
2 Bag dispensing and Crushing Reaching through 5.8.3
opening mechanism Shearing magazine to the
mechanism
3 Bag transport mechanism Crushing and shearing Accessing while running 5.8.4
5 Product settling Vibration Touching vibrating 5.8.6
mechanism mechanism
6 Bag closing or sealing Crushing and drawing-in Accessing while running 5.8.7
mechanism Burning Touching hot surfaces 5.8.7
conveyor
shearing
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Table 17 - Hazards on optional equipment which is typically integrated with a pre-made bag erect, fill
and seal machine
Zone
release of gas
5 Hot melt glue sealing Burning and scalding Filling glue and trouble 5.7.14
equipment shooting
burning
with laser beam
8 Hand-wheel Entanglement, impact If the wheel rotates while 5.1.1.6
and shearing the machine is running
Musculo-skeletal injuries Excessive effort turning 5.1.8.3
hand-wheel
4.9 Hazards on a cup or tub fill and seal machine
Figure 22 shows the hazard zones on a typical cup or tub fill and seal machine equipped with a film reel
unwind mechanism and figure 23 shows the hazard zones on a typical cup or tub fill and seal machine
equipped for pre-cut foils and lids.
Table 18 describes these hazards and indicates which parts of clause 5 of this standard provides the
appropriate safety requirement. Table 19 shows the hazards on the optional equipment that is typically
integrated with a cup or tub fill and seal machine. Figures 22 and 23 show linear transport systems but the
hazards are the same on machines where the transport system is rotary or partly rotary.
Figure 22 - Hazard zones on a typical cup or tub fill and seal machine with reel fed top foil
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Figure 23 - Hazard zones on a typical cup or tub fill and seal machine for pre-cut top foils
Table 18 - Hazards on a typical cup or tub fill and seal machine

requirement
1 Container magazine Crushing Shearing Reaching from 5.9.2
magazine into the
machine
Crushing Cup support mechanism 5.9.2
moves unexpectedly
Musculo-skeletal Loading cups into 5.1.8.1
injuries magazine
2 Container dispensing Crushing Shearing Reaching from 5.9.3
mechanism magazine into the
machine
3 Container transport Drawing-in Shearing Reaching from 5.9.4
machine
5 Top film reel unwind Drawing-in Access while running 5.2.3
mechanism Shearing
Musculo-skeletal Loading reels 5.1.8.1
injuries
Slipping and falling Loading or threading 5.1.8.1
film
6 Sealing die Crushing and drawing- Accessing while running 5.5.9
in
Threading film
7 Scrap reel Drawing-in Accessing while running 5.5.11
8a Container discharge Crushing Shearing Reaching from 5.9.12
machine
8b Flat belt discharge Drawing-in Accessing while running 5.9.12
conveyor
Slat band discharge Drawing-in Accessing while running 5.9.12
conveyor
9 Drive mechanisms Crushing and shearing Accessing while running 5.1.1.5
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Table 19 - Hazards on optional equipment which is typically integrated with a cup or tub fill and seal
machine
Zone
Rotary container Drawing-in Shearing Loading containers 5.9.2
magazine during operation
In-line container Drawing-in Loading containers 5.9.2
magazine during operation
10a Foil magazine Crushing Shearing Reaching from magazine 5.9.7
into the machine
10b Foil placing mechanism Crushing Shearing Reaching from magazine 5.9.11
into the machine
11a Lid magazine Crushing Shearing Reaching from magazine 5.9.7
into the machine
11b Lid placing mechanism Crushing Shearing Reaching from magazine 5.9.11
into the machine
release of gas
9 Thermal coder Crushing and drawing-in Accessing while running 5.2.3.3
Burning
with laser beam
4.10 Hazards on a sack fill and seal machine
4.10.1 Hazards on an in-line sack fill and seal machine
Figure 24 shows the hazard zones of a typical in-line sack fill and seal machine and the equipment typically
attached to or combined with an in-line sack fill and seal machine.
Table 20 describes the hazards and indicates which parts of clause 5 of this standard provide the appropriate
safety requirement. Table 21 describes hazards on the equipment typically attached to or combined with an
in-line sack fill and seal machine.
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Figure 24 - Hazard zones on a typical in-line pre-made sack fill and seal machine
Table 20 - Hazards on a typical in-line sack fill and seal machine

requirement
1 Product feeding Crushing and shearing Accessing while running 5.10.1.2
mechanism
2 Sack holding mechanism Crushing Accessing while running 5.10.1.3
3 Sealing mechanism Impact, crushing and Accessing while running 5.10.1.4
shearing
Burning Touching hot surfaces 5.1.3
4 Dust in filling nozzle area Various health damaging Contact with dusty 5.10.1.5
effects products
Burns and impact Spark ignites potentially 5.1.7.3
explosive dust cloud
5 Holding and positioning Impact, crushing and Accessing while running 5.10.1.6
mechanism shearing
6 Flow regulating Crushing and shearing Accessing while running 5.10.1.7
mechanism
7 Conveying system Crushing, drawing-in and Accessing while running 5.10.1.8
shearing
Table 21 - Hazards on the equipment typically attached to or combined with an in-line sack fill and seal
machine
requirement
8 Sack placer Impact Crushing Access while running 5.10.1.9
Shearing
9 Sack discharge conveyor Drawing-in Accessing while running 5.10.1.10
Falling Standing on the 5.1.1.7
conveyor
4.10.2 Hazards on a typical rotary sack fill and seal machine
Figure 25 shows the hazard zones of a typical rotary sack fill and seal machine and the equipment typically
attached to or combined with this type of machine.
Table 22 describes the hazards and indicates which parts of clause 5 of this standard provide the appropriate
safety requirement. Table 23 describes hazards on the equipment typically attached to or combined with an
rotary sack fill and seal machine.
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Figure 25 - Hazard zones on a typical rotary sack fill and seal machine
Table 22 - Hazards on a typical rotary sack fill and seal machine
requirement
1 Carousel Crushing, entanglement, Accessing while running 5.10.2.2
impact and shearing
Sack holding mechanism Crushing Accessing while running 5.10.2.3
Flow regulating Crushing and shearing Accessing while running 5.10.2.4
mechanism
Holding and positioning Impact, crushing and Accessing while running 5.10.2.5
mechanism shearing
Sealing mechanism Crushing and shearing Accessing while running 5.10.2.6
Burning Touching hot surfaces 5.1.3
Dust at filling nozzle area Various health damaging Contact with dusty 5.10.2.7
effects products
Table 23 - Hazards on equipment typically attached to or combined with a rotary sack fill and seal
machine
requirement
2 Sack magazine Crushing, impact and Accessing while running 5.10.2.8
shearing
3 Sack transfer Crushing, impact and Accessing while running 5.10.2.9
mechanism shearing
4 Sack placer Crushing, impact and Accessing while running 5.10.2.10
shearing
5 Sack discharge conveyor Drawing-in Accessing while running 5.10.2.11
Falling Standing on the 5.1.1.7
conveyor
4.11 Hazards on an auger filler
Figure 26 shows the hazard zones on a typical auger filler and table 24 describes these hazards and indicates
which parts of clause 5 or 7 of this standard provides the appropriate safety requirement.
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Figure 26 - Hazard zones on a typical auger filler
Table 24 - Hazards on a typical auger filler

requirement
1 Screw feed conveyor Entanglement Reaching in to 5.11.3
Shearing mechanism
2 Hopper Inhalation of dust Operation cleaning 5.11.2

Musculo-skeletal injuries Loading product manually 5.1.8.2
Falling from height Loading product manually 5.1.1.7
3 Auger screw Drawing-in Reaching in to 5.11.2
Shearing mechanism
4 Stirrers Entanglement Reaching in to 5.11.2

mechanism
5 Cut-off device Crushing Reaching in to 5.11.4

mechanism
6 Drive mechanism Drawing-in Operation cleaning 5.1.1.5

maintenance
Dusty products Various health damaging Contact with dusty 5.1.7.2
effects products
Whole machine Falling from a height Access during operation 5.1.1.7
cleaning or maintenance
4.12 Hazards on a volumetric cup filler
Figure 27 shows the hazard zones on a typical volumetric cup filler and table 25 describes these hazards and
indicates which parts of clause 5 or 7 of this standard provides the appropriate safety requirement.
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Figure 27 - Hazard zones on a typical volumetric cup filler

Table 25 - Hazards on a typical volumetric cup filler
requirement
1 Hopper Inhalation of dust Operation cleaning
Musculo-skeletal injuries Loading product 5.12.2
manually
Falling from height Loading product 5.1.1.7
manually
2 Cup plates Shearing Reaching into the 5.12.3

Crushing assembly
2 Hinged cup bases Crushing Reaching into the 5.12.3
Shearing assembly
2 Rotary brush Drawing-in Reaching into the 5.12.3
Entanglement assembly
4 Drive mechanism Drawing-in Reaching into the 5.1.1.5

assembly
5 Discharge hopper Shearing Operating machine when 5.12.4
hopper is removed
Dust Various health damaging Contact with dusty 5.1.7.2
effects products
Whole machine Falling from a height Access during operation 5.1.1.7
cleaning or maintenance
4.13 Hazards on a nett weigher
Figure 28 shows the hazard zones on a typical nett weigher and table 26 describes these hazards and
The hazards on a count filling machine (3.3.8) are similar to those on a nett weigher.
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Figure 28 - Hazard zones on a typical nett weigher
Table 26 - Hazards on a typical nett weighing machine

requirement
1 Bulk product feed Vibration Touching mechanism 5.13.3
mechanism – vibratory
trough
Product control flaps Crushing and shearing Accessing while running 5.13.3
1 Bulk product feed Drawing-in Accessing while running 5.13.2
mechanism - Belt
conveyor (flat or trough)
1 Bulk product feed Drawing-in Accessing while running 5.13.2
mechanism - screw
conveyor
2 Weigh hopper Crushing, impact and Accessing while running 5.13.4
shearing
3 Discharge Impact Falling products 5.13.4
chute
1, 2 & 3 Dust Various health damaging Contact with dusty 5.1.7.2
effects products
1, 2 & 3 Whole machine Slipping Access during operation 5.1.1.7
Falling from a height or cleaning
4.14 Hazards on a multi-head weigher
Figure 29 shows the hazard zones on a typical multi-head weigher. Table 27 describes these hazards and
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Figure 29 - Hazard zones on a typical multi-head weigher
Table 27 - Hazards on a typical multi-head weigher

requirement
1 Bulk product feed Noise Operation 5.14.2
mechanism – vibratory
trough
1 Bulk product feed Drawing-in Operation cleaning 5.14.2
mechanism - Belt
conveyor (flat or trough)
2 Vibratory dispersion Noise Operation 5.14.3
feeder Musculo-skeletal injuries Loading product 5.14.3
manually
Falling from height Loading product 5.14.7
manually
3 Vibrating radial feeders Noise Operation 5.14.3
4 Pool hoppers Crushing Reaching into hopper or 5.14.4
Shearing mechanism e.g. to
remove jammed
products
5 Weigh hoppers Crushing Reaching into hopper or 5.14.4
remove jammed
products
6 Discharge chute Impact Falling products 5.14.4
7 Timing hopper Crushing Reaching into hopper or 5.14.5
remove jammed
products
8 Support platform Slipping Access during operation 5.14.7
Falling from a height or cleaning
Dust Various health damaging Contact with dusty 5.1.7.2
effects products
Whole machine Noise Running with noisy 5.14.9
products
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5 Safety requirements
5.1 General requirements
All the machines in the scope of this standard shall comply with the safety requirements and protective or risk
reduction measures in clause 5.1 and the relevant machine specific clauses 5.2 to 5.14 where the equivalent
hazard exists.
Where a machine has hazards, which are not on a typical machine and so are not described in clause 4, the
machine shall be designed according to EN 415-10: 2014.
5.1.1 Requirements to minimize mechanical risks
5.1.1.1 Inherently safe design
Inherently safe design measures shall be applied as far as possible to eliminate or reduce risks, and shall
comply with the requirements of clause 5.2.1.1 of EN 415-10:2014. Clauses 5.2 to 5.14 identify some of the
mechanisms where inherently safe design measures can typically be applied, for example by limiting the
forces applied by the mechanisms.
With the exception of cutting mechanisms accessible parts of the machine shall have no sharp edges, no
sharp angles and no rough surfaces likely to cause injury.
5.1.1.2 Design of guards
Guards shall comply with subclauses 5.2.1.2, 5.2.1.3 and 5.2.1.4 of EN 415-10:2014.
Where the smallest dimension of a rectangular opening or diameter of a circular opening in a guard is less
than or equal to 120 mm the safety distances in tables 3, 4 and 6 of EN ISO 13857 shall apply. Where the
opening is larger than 120 mm, the safety distances shown in clause 5.2.1.3 of EN 415-10: 2014 shall apply.
When a guard is opened, it shall not be possible to reach a danger zone before the hazardous movement has
stopped. Where this objective is not achieved, a guard locking device or internal baffle which prevents direct
access to the danger zone shall be fitted.
Where guards are made of a transparent material and there is a risk of someone walking into the open guard,
the guard shall be marked or fitted with features which make the guard clearly visible when it is open.
The design of guards and interlocking devices shall avoid the risk of people being trapped inside the machine.
5.1.1.3 Pneumatic and hydraulic equipment
Pneumatic components and piping shall comply with the requirements of EN ISO 4414. Hydraulic components
and piping shall comply with the requirements of EN ISO 4413.
Where control functions are performed by hydraulic or pneumatic systems, these circuits shall comply with the
requirements of clauses 5.14 and 5.15 of EN 415-10: 2014.
Where the machine is designed to pack foodstuffs, cosmetics, pharmaceuticals or other products where
contamination is a significant risk, the design shall ensure that hydraulic oil or pneumatic lubricating oil cannot
come into contact with the product. For example compressed air can be filtered but not lubricated and
compressed air exhausts can be directed away from the product.
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The machine shall be equipped with an isolation device for each supply for fluid power. These isolation
devices shall not be located in a danger zone and shall be readily accessible, clearly labelled, and have
features to allow them to be locked in the off position. The machine shall have the facility to release stored
pneumatic and hydraulic energy in a safe manner. Pneumatic isolation valves shall comply with clause 5.2.8
of EN ISO 4414:2010 and hydraulic isolation valves shall comply with clause 5.4.7.2.1 of EN ISO 4413:2010.
5.1.1.4 Size or product changing
5.1.1.4.1 Design of guards
The design of the machine and its guards shall ensure that danger zones on the machine are safeguarded
without the need for adjustment of safeguards, for all the product and pack sizes for which the machine has
been specified.
Where this is not possible adjustable guards or change part guards shall be used.
Adjustable guards shall be either:

a) adjusted in a positive mode by adjusting the functional parts either manually or under power, or
b) fitted with interlocking devices which ensure that the machine cannot be started or operated unless
the guards are adjusted correctly.
Change part guards shall be either:

a) connected to the functional parts so that the machine cannot function without the appropriate guarding
being fitted, or
b) fitted with interlocking devices so that the machine cannot be started or operated without the required
guard in place.
Where the design of guards causes shadows that prevent a good view of the process inside the machine, the
manufacturer shall provide internal lighting.
5.1.1.4.2 Size or product changing under power
Where parts of the machine are adjusted under power, the risks presented by these powered movements
shall be eliminated using the following hierarchy of measures:
a) ensuring that the movements are not hazardous by following the safety by design principles described in
clause 5.2.1.1 of EN 415-10: 2014, or;
b) if a) is not possible by ensuring that movements can only take place when the machine’s interlocking
movable guards are closed or;
c) where it is not possible to fulfil the requirements of a) or b), the movement can only take place using a
hold-to-run control device complying with clause 5.16.3 of EN 415-10: 2014.
5.1.1.5 Drive mechanisms
Drive mechanisms shall be enclosed with fixed or interlocking guards.
5.1.1.6 Hand-wheels
Where handles or hand-wheels are provided to operate mechanisms manually, they should be disconnected
when the machine runs automatically.
If the hand-wheel is designed to rotate under power during automatic operation it shall comply with clause
5.20.5 of EN 415-10: 2014.
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5.1.1.7 Measures to minimize slip, trip and fall risks
The measures described in clause 5.2.2 of EN 415-10:2014 shall apply.
5.1.1.8 Tasks requiring guards to be open while mechanisms are moved under power
The design of the machine shall avoid the need to carry out any task where it is necessary to move machine
mechanisms while a guard is open. If mechanisms need to be moved in manual mode, this shall only be
possible with all the interlocking guards in the closed position.
Where for technical reasons this is not practicable, movement of the machine parts shall only be possible if all
of the requirements of clause 5.16.3 of EN 415-10 have been satisfied.
5.1.2 Electrical equipment
5.1.2.1 General requirements
Electrical equipment fitted to machines in the scope of this standard shall comply with EN 60204-1 and
clauses 5.3, 5.5 and 5.6 of EN 415-10.
5.1.2.2 Electrostatic phenomena
On machines where hazards may arise from the generation of static electricity, the manufacturer shall provide
sufficient earth bonding or static elimination equipment to ensure that hazardous levels of static electricity do
not occur. This equipment shall ensure that electrostatic discharge shall lead neither to any injury nor to the
ignition of potentially explosive atmospheres or combustible substances.
High voltage static elimination devices shall be protected using interlocking guards and the control system
shall ensure that the static elimination device is turned off when the interlocking guard is open.
5.1.3 Thermal hazards
The external temperature of exposed parts of the machine, like guards, control panels and electric motors,
shall not exceed the burn threshold temperatures stated in clause 4.2 of EN ISO 13732-1:2008, which take
into account the contact material and the foreseen contact time.
Where the machine includes parts, like heating mechanisms with a foreseeable temperature greater than the
burn thresholds described in EN ISO 13732-1, the manufacturer shall minimize the risk of accidental contact,
for instance by fitting insulation or guards to prevent unintentional contact and by fitting the “warning hot
surface” pictogram specified in 7.3 on the outside of the machine or adjacent to the hot parts (see Figure 62).
If having taken these measures, there is still a residual risk of touching hot surfaces this shall be stated in the
instructions together with the measures which can be taken to avoid burn injuries, like wearing gloves or other
personal protection equipment.
5.1.4 Noise reduction
Machines in the scope of this standard shall be designed to minimize noise at its source using state of the art
noise reduction technology.
Noise shall be reduced by the methods stated in this standard. Where these measures are not applicable or
insufficient, additional measures stated in EN ISO 11688-1 shall be applied to reduce noise at source.
The criterion for assessing the efficiency of noise reduction measures is the actual noise emission values of
the machine and not the nature of the reduction measure itself.
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The method of noise measurement and wording of the noise declaration shall comply with EN 415-9. The
microphones for noise measurement shall be placed in the positions indicated in Annex A of this standard.
The running conditions of the machine shall comply with those stated in Annex A of this standard.
5.1.5 Vibrating mechanisms
Machines fitted with vibrating mechanisms shall be designed so that harmful levels of vibration are not
transmitted to other parts of the machine or the surface on which the machine is fixed. The vibrating
mechanisms shall be designed so it is not necessary for operators to touch or hold the parts while they are
vibrating.
5.1.6 Radiation
Where machines incorporate radiation sources the manufacturer shall comply with the requirements of clause
5.9 of EN 415-10: 2014.
Where ultra-violet (UV) light is used to sterilise packaging materials or components, the machine shall be
designed so, that no hazardous amounts of UV-light are emitted from the machine. Where the UV light
causes thermal hazards, clause 5.1.3 shall apply.
5.1.7 Products and substances used on machines which pose a risk
5.1.7.1 Hazardous products
Where the machine has been specified to pack a hazardous product, the manufacturer shall comply with the
requirements of clause 5.10 of EN 415-10: 2014.
5.1.7.2 Dusty products
Where the machine is specified to pack a dusty product, the manufacturer shall supply local exhaust
ventilation equipment with the machine which prevents hazardous levels of dust developing outside guarded
areas. The local exhaust ventilation equipment shall comply with EN ISO 14123-1:2016.
5.1.7.3 Potentially explosive dusty products
Where the machine is specified to pack potentially explosive dusty products, the manufacturer shall comply
with the requirements of EN 1127-1 and electrical equipment shall comply with EN 60079-14.
5.1.7.4 Modified atmosphere packaging
5.1.7.4.1 General
Where machines are fitted with modified atmosphere packing equipment, all vessels, pipes and fittings shall
be designed to safely contain the modifying gas.
The gas supply shall be fitted with an isolation valve which can be locked in the off position and with a means
to extract gas from the machine safely.
Where a space inside the machine contains a hazardous modified atmosphere and the opening of a guard
exposes the operator to this hazardous atmosphere, this guard shall be interlocked with a guard locking
device and controlled so that this guard cannot be opened until the atmosphere inside the machine is safe to
breathe. This guard door shall be released either by a sensor that can determine that the atmosphere is safe
to breathe or after a time delay which is sufficient for the harmful substances to be extracted by the local
exhaust ventilation system.
Where gases like nitrogen are used to reduce oxygen levels in packages, the design of the machine and the
gas control system shall ensure that oxygen levels within 1 m of the machine do not fall below 19%.
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5.1.7.4.2 Gases harmful to health
Where gases harmful to health are used, the design of the machine and the gas control system shall ensure
that dangerous levels of the gas do not build up around the machine and that guard locking devices prevent
exposure to dangerous concentrations of the gas inside parts of the machine accessible by operators. The
concentration of the modifying gas shall be measured at 500 mm from possible gas emission points like the
gas chamber.
Note: For carbon dioxide (CO2), the concentration should not exceed 0,5 vol.% (5000 ml/m³ or 9000 mg/m³)
and for carbon monoxide (CO), the concentration should not exceed 0,003 vol. % (30 ml/m³ or. 35 mg/m³).
To prevent the emission of hazardous amounts of harmful gases, the manufacturer shall:
a) Fit a solenoid valve to shut off the supply of the modifying gas automatically when the machine stops.
This valve will be open during normal operation but shall not be the same valve that controls the gas
flow;
b) Fit a pressure reducer and a safety relief valve at the interface with the gas supply;
c) Fit a manual supply disconnection device at the interface to the gas supply;
d) Provide extraction equipment to remove or disperse dangerous levels of the modifying gas;
e) Where the installation incorporates flexible hoses, fit a solenoid valve upstream of each flexible hose
which can shut off the supply of the modifying gas automatically if a hose ruptures or the gas flow
exceeds normal limits;
f) Ensure the design of connections for different gases are different so it is not possible to mix them up;
g) Fit signs next to the gas supply and to the connection to the machine to indicate the kind of gas to be
used.
On machines where mixtures of gases can be selected, instrumentation shall be provided which displays the
concentration of the different gases which are being delivered to the machine.
The instructions shall detail:
- The gases that can be used with the machine;

- The maximum pressure of the gas supply;
- The safe procedure for connecting the gas supply;
- The specifications of the pressure reducer and a safety relief valve to ensure safe operation;
- The specification for the extraction system needed to remove the modifying gas to a safe area;
- All necessary information on the requirements for the exhaust ducting or system that shall be
connected to the machine;
- The possible need of room ventilation and the required air exchange rate to prevent hazardous
concentrations of harmful gases building up or to prevent oxygen levels being depleted;
- That the machine shall not be operated with the modifying gas if the film is damaged or not present;
5.1.7.4.3 Oxygen
Where the modifying gas is oxygen, this clause also applies.
All components which can encounter oxygen, such as pumps, hoses, pipes, fittings, instruments, seals or
containers, shall be suitable for the use with oxygen.
Devices shall be fitted to detect any leakage of oxygen that may occur during operation and to automatically
shut off the oxygen supply if a leak is detected.
The design or the control system shall prevent the generation of inflammable concentrations of gas and
ensure that the temperature of heat sealing mechanisms do not exceed 200 °C.
Where the sealing temperature is greater than 200°C, the instructions shall state that the ignition temperature
of the film shall be at least 50 K below this ignition temperature of the gas mixture and how this is to achieved.
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The design shall ensure that oxygen does not come into contact with fat or oil. Where there is a risk of contact
with fat or oil the manufacturer shall ensure that:
1. No lubricants or sealants are used which could self-ignite in contact with oxygen;
2. The flow rate of oxygen is restricted to 25 m/s;
3. Where a vacuum system is used to remove ambient atmospheres, the control system ensures that either
a) the vacuum pump is designed so it can operate safely in high concentrations of oxygen or if this is not
reasonably practicable;
b) the concentration of oxygen passing through the vacuum pump is controlled so it does not exceed
21%.
NOTE: One method of achieving this is by designing the control system so that the vacuum valve is
closed before the gas mixture can enter the vacuum chamber and before the vacuum valve opens
again no gas mixture remains in the chamber.
The instructions shall state:
- The lubricants which can be used;

- The parts that fat or oil shall be cleaned from before the equipment is used;
- Cleaning instructions to remove any debris from parts which can come into contact with oxygen;
- The measures to be taken to avoid hazards caused by oxygen concentrations higher than 21% when
emptying the system and ensuring that no ignition sources such as hot surfaces, electrostatic or
electrical ignition sparks are present during emptying;
- The need for regular inspections of seals to prevent hazardous oxygen concentrations;
- The need for oxygen measurements during commissioning and the frequency of routine
measurements around the machine to ensure that the oxygen concentration does not exceed 22%
and the specification of the necessary measurement equipment.
5.1.7.5 Substances used to sterilise packaging materials and components
Machines using hazardous substances (for example hydrogen peroxide) to sterilise or disinfect packaging
materials and components shall be designed so that all foreseen interventions inside the machine can be
carried out safely and so that airborne emissions of the sterilising substance from the machine to the work
area around the machine are kept to a minimum.
The sterilising substance shall be kept in as closed a system as possible, and the seals and gaskets fitted to
guard doors and other possible leakage points shall be made of materials that resist the sterilising substance
being used.
Movable guards shall be interlocked with guard locking devices to prevent access to areas of the machine that
contain a hazardous concentration of the sterilising substance. The guard locking shall be controlled either by
automatic concentration measurement device or by time. Where time is used the time delay shall be
determined for the worst-case conditions.
If interventions are foreseen in an area while a hazardous concentration of the sterilising substance exists,
suitable additional measures shall be provided, such as:
- fitting the machine with an extraction system to evacuate the sterilising substance;
- spraying the area with water to absorb the sterilising substance into water; or
- fitting the machine with glove boxes.
Where measures such as extraction or spraying systems are provided for the above purpose, these shall be
dimensioned to function under the worst-case conditions and shall be interlocked to prevent access to the
area if the extraction or spraying system is not functioning.
The supply system of the sterilising substance shall be designed to safely contain the sterilising substance.
Pipe connections shall be used that can only be dismounted using tools. If the sterilising substance is supplied
from an external source (i.e., not from a container) the machine shall be fitted with an isolation valve that can
be locked in the off position.
Where airborne emissions of the sterilising substance occur, for example at discharge points, measures shall
be provided to prevent the build-up of hazardous levels of the substance near the machine, such as:
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- fitting extraction systems at, for example, discharge tunnels;

NOTE: to avoid carryover of the substances by the conveyors, the transfer from the discharge conveyor should
be positioned within the machine or the discharge tunnel.
- ducting air streams to points where they can be connected to an extraction system; and
- rinsing sterilising substances from the outside of packages within the machine.
The user instructions shall contain the following information, where it is relevant:
- intervals and criteria for inspection and replacement of seals and gaskets to prevent leakage of
sterilising substances;
- instructions for inspection and maintenance of any fitted extraction or spraying system;
- safe working procedures for access to areas where hazardous concentrations of sterilising
substances may occur;
- safe working procedures to conduct maintenance on the supply system of the sterilising substance;
- the technical specifications for the room ventilation in the area where the machine will be installed;
and
- the specifications of any personal protective equipment to be used.
5.1.8 Ergonomic design
5.1.8.1 Loading points for packaging materials
The requirements of clause 5.20.6.3 of EN 415-10 shall apply.
5.1.8.2 Product loading or unloading points
On machines where products are fed or unloaded manually, the design of the hand loading or unloading area
shall follow the ergonomic design principles indicated in EN 1005-2, EN 1005-3 and EN 1005-4 to minimize
the risk of muscular or skeletal injuries.
NOTE Information on the risk assessment for repetitive handling at high frequency is given in EN 1005–5:2007.
5.1.8.3 Hand-wheels
Where a hand-wheel is used to move a mechanism by hand, the force that must be applied to the
circumference of the hand-wheel to move the mechanism shall not exceed 20 N if one hand is used and 30 N
if two hands are used.
5.1.8.4 Change parts
On machines where change parts are used, hazards from excessive effort or strain shall be eliminated or
reduced by the following measures:
a) Change parts are designed in compliance with EN 1005-2 so that they can be lifted, installed and
removed easily. Mref in table 1 of EN 1005-2:2008 is 25 kg;
b) Where the design of the machine and of the change parts allows two people to lift the parts into place, Mref
may be taken as 40 kg . If two people are required to lift or fit change parts, this shall be stated clearly in
the instruction manual.
c) Where the measures described in a) and b) are not possible for technical reasons, the manufacturer shall
provide suitable mechanical lifting or handling equipment to move the part;
d) Change parts with a mass greater than 25 kg shall be listed in the instruction manual.
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5.1.9 Hygienic design requirements
Where machines are designed or specified to pack foodstuffs, cosmetics, pharmaceuticals or other products
where hygiene is an issue, the manufacturer shall:
a) identify the level of hygienic design appropriate for the product. When the machine manufacturer is unable
to find this information, he shall define the limitation of use for the machine and clearly state this in the
instructions, for example “This machine has been designed to pack foodstuffs with the following
characteristics”;
b) comply with the requirements of EN 1672-2 including:
1) use of contact materials complying with clause 5.2 of EN 1672-2:2005+A1:2009, which are
appropriate for the product, the contact time, the temperature, chemical reactions, physical
characteristics (such as abrasion) and the cleaning method and cleaning substances;
2) design food and splash areas (as defined in clauses 3.4.1 and 3.4.2 of EN 1672-2:2005+A1:2009) so
they are free from crevices and ledges;
3) designing food and splash areas so that they can be easily cleaned and inspected for cleanliness;
4) prevent lubricating oils from coming into contact with the product, for example by fitting filters to
compressed air exhausts;
c) describe appropriate and safe cleaning procedures in the instructions including information on the
cleaning or disinfection agents that shall be used;
d) design the machine so that fallen packs or spilled products or substances can be easily detected and
removed from the machine;
e) where parts of the machine must be dismounted for cleaning, design the machine and the parts so that
they can be easily removed and mounted as describe in clause 5.1.8.4.
5.2 Safety requirements for a flow-wrapping machine
5.2.1 General
The hazards described in 4.2 shall be eliminated or safeguarded by the following measures and those
described in 5.1.
These safety requirements also apply to a lower reel flow-wrapping machine (3.3.1) and an edge sealing
machine (3.3.3) where the equivalent hazard exists.
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A - Infeed chain guard

B - Infeed trip device
C - Longitudinal seal guards
D - Transverse seal mechanism infeed guard
E - Transverse seal mechanism discharge guard
F - Drive mechanism guard
Figure 30 - Guarding requirements for a typical flow-wrapping machine
5.2.2 Product Feed
On machines which are to be fed by hand, the feeding area shall be designed to eliminate shearing, crushing
and entanglement hazards, but at the same time shall allow access to the product pushing devices, using the
methods described in 5.2.2.1, 5.2.2.2 and 5.2.2.3.
5.2.2.1 Chains and drives
The return chain run with its pushing devices and drive and tail sprockets of the chain infeed conveyor shall be
safeguarded with fixed or interlocking guards. Any openings in the guards, for example to allow debris to fall
out of the guarded area shall be dimensioned using tables 3, 4 or 6 of EN ISO 13857.
If these guards need to be removed once a day or more frequently, they shall be fitted with interlocking
devices complying with EN ISO 14119 and comply with the requirements for interlocking guards. Where
cables make this area of the machine difficult to clean, mechanical trapped key interlocking devices complying
with EN ISO 14119 type 2 can be used.
The tail sprocket guard shall be designed to avoid shearing hazards for example by creating a tunnel guard.
Where machines are equipped with product side guides which are adjustable without the need for tools,
movement of these guides shall not expose any hazard.
5.2.2.2 Product pushing devices
Product pushing devices shall be designed so that they do not present cutting, shearing or crushing hazards
in the hand loading area and where they enter the folding box.
The risk of impact between a pusher and the hand of an operator in the hand loading area can be considered
negligible if the pusher has no sharp edges, there is no risk of entanglement or drawing-in and the speed of
the conveyor is lower than 2 m/s.
Other methods of eliminating hazards from pushing devices include the following:
a) Pushing devices designed so that they come away from the chain in the event of a lateral force greater
than 135 N being applied to them. The impact force shall not exceed 180N and the static pressure on the
body surface shall not exceed 60 N/cm2.
NOTE: These limits assume that the pushing devices will be applying the force to hands or fingers.
b) Pushing devices designed so that they can bend when a lateral force greater than 135 N is applied to
them. The impact force shall not exceed 180 N and the static pressure on the body surface shall not
exceed 60 N/cm2.
NOTE: These limits assume that the pushing devices will be applying the force to hands or fingers.
c) Pushing device linkages designed so that the pushing devices are free to bend backwards as they enter
the folding box;
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d) A trip guard fitted with an interlocking device complying with EN ISO 14119 like the one in figure 31 which
stops the infeed conveyor when someone’s hand moves the trip guard. The trip guard shall comply with
the requirements of clause 5.2.1.3.9 of EN 415-10: 2014;
e) Another safeguarding method which provides at least the same or a higher level of protection.
Figure 31 – Guards and trip device fitted in front of the folding box
5.2.2.3 Flat belt infeed conveyor
Where flat belt conveyors are used to feed products, the following requirements shall apply.
5.2.2.3.1 Danger zones at power transmission parts
Power transmission parts shall be safeguarded with fixed or interlocking guards.
5.2.2.3.2 Drawing-in hazards at belt drive or support rollers
The drawing-in hazards between drive or support rollers and the belt shall be safeguarded in one of the
following ways:
a) A combination of the conveyor body and the conveyor belt prevent access to these rollers as shown in
figure 32;
b) Fixed shaped blocks at each drawing-in point prevent access as shown in figure 33;
c) A combination of the conveyor frame and a guard which can be removed for cleaning prevents access
as shown in figure 34.
Key
1 Drive roller
2 Tail roller
3 Conveyor belt
4 Side frame
Figure 32 - Belt conveyor — Example of using the side frame and belt to prevent access to danger
zones
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Key
1 Drive roller
2 Tail roller
3 Filling pieces
4 Conveyor belt
Figure 33 - Belt conveyor — Example of using filling pieces to prevent access to danger zones
Key
1 Drive roller
2 Tail roller
3 Tension rollers
4 Conveyor belt
5 Guard
Figure 34 - Belt conveyor — Example of using a guard to prevent access to danger zones
5.2.2.3.3 Drawing-in hazards between the moving belt and fixed parts
The gap between the moving belt and fixed parts like guide rails shall either be less than 4 mm or more than
80 mm.
5.2.2.3.4 Drawing-in hazards between two belt conveyors
Where there is a drawing-in hazard between one conveyor and another, for instance because the first
conveyor can run faster than the second or the second conveyor can stop while the first continues to run, one
of the following methods shall be used to eliminate the drawing-in hazard:
a) A deadplate is fixed between the conveyors with gaps between the conveyor belts and the deadplate
of no more than 4 mm as shown in figure 35; or
b) A gap between the conveyors of no less than 80 mm, or
c) A moveable deadplate or roller which is designed so it can pop out if someone’s fingers or clothing
are drawn into the gaps between the first conveyor belt and the deadplate or roller. The force
required to release the deadplate or roller shall not exceed 135 N.
NOTE: The pop-out roller or deadplate can be fitted with springs so it does not get lost and returns to its
correct position.
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1 2
2 3
Key
1 belt
2 deadplate
3 drive roller
Figure 35 - Belt conveyor transfer— Example of a fixed deadplate – side view
5.2.2.3.5 Drawing-in hazards between the moving belt and a deadplate
Where a belt conveyor feeds products on to a deadplate, the drawing-in hazard between the belt and the
deadplate shall be safeguarded in one of the following ways:
a) A fixed deadplate with the gap between the conveyor belt and the deadplate of no more than 4 mm; or
d) A moveable deadplate which is designed so it can pop out if someone’s fingers or clothing are drawn
into the gap between the belt and the deadplate. The force required to release the deadplate or roller
shall not exceed 135 N.
b)
NOTE: The pop-out deadplate can be fitted with springs so it does not get lost and returns to its correct
position.
5.2.2.3.6 Drawing-in and entanglement hazards underneath belt conveyors
Where the clearance under a conveyor is higher than 600 mm but lower than 2100 mm one of the following
measures shall be used to protect against drawing-in and entanglement hazards, especially of hair if someone
passes under the conveyor:
a) Fitting a fixed guard which prevents hair coming into contact with the moving belt or rollers, or
b) Fitting barriers under the conveyor to prevent access under the conveyor and providing a permanent
or mobile means of access to cross over the conveyor.
5.2.2.3.7 Cleaning the conveyor
Where the conveyor belt requires frequent cleaning, the manufacturer shall design the belt conveyor so that
the belt can be removed easily for cleaning and describe the method of cleaning in the instruction manual.
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5.2.2.4 Automatic product feeding mechanisms
Where automatic product feeding mechanisms are not safe by design as defined by clause 5.2.1.1 of EN 415-
10, they shall be enclosed with interlocking guards.
5.2.3 Film reel unwind mechanism
5.2.3.1 General
The film reel unwind mechanism shall be designed and positioned in accordance with 5.1.8.1.
Film reel unwind mechanisms shall either be made safe by design using the measures indicated in clause
5.2.1.1 of EN 415-10: 2014 or they shall be enclosed with interlocking guards.
Where the moving film edge presents a cutting hazard, the film path shall be enclosed with fixed or
interlocking guards.
5.2.3.2 Tension roller assembly
The shearing hazard between the tension roller assembly and the machine frame shall be eliminated either by
ensuring that the moving assembly is at least 25 mm from the frame or by incorporating one of the devices
shown in figure 36.
Where the film braking or compensating mechanism cannot be made safe by design, it shall be enclosed in
interlocking guards.
A - Solid piece eliminates shearing hazard B - Plate attached to the machine frame eliminates hazard
Figure 36 - Methods of safeguarding the tension roller assembly
5.2.3.3 Coders
Where a coding device is integrated with the film reel unwind mechanism, the power supplies for the coder
(for example electricity and compressed air) shall be isolated when the machine’s isolators are turned off.
The coder shall be installed following the coder manufacturer’s instructions.
Thermal coders shall be guarded or insulated so touchable surfaces do not exceed the burn thresholds
indicted in EN ISO 13732-1:2006. Where there is a residual risk of burning a “warning hot surface” pictogram
shall be fitted.
Laser coders rated as class 3 or 4 shall be mounted in a class 1 safety enclosure that complies with EN
60825-4. For all classes of laser coder, a laser hazard warning pictogram (EN ISO 7010/W004) shall be fixed
on the machine housing next to the coder or on the class 1 safety enclosure. Instructions for safe use,
adjustment and maintenance of the laser coder shall be included in the instruction manual.
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Where the coder is fitted in a hazardous area of the machine, the machine’s hazardous functions shall be
stopped and maintained in a stopped condition by a safety-related stop function, when the coder needs to be
accessed, for example because of a malfunction or to refill printing ink
5.2.3.4 Power unwind mechanism
Drive mechanisms for power unwind devices shall be fitted with fixed guards. The in-running nips of the film
driving rollers shall be safeguarded by one of the methods shown in figure 37 or the assembly shall be
enclosed with interlocking guards.
The clearance between the guard and roller (A in figure 37) shall be less than or equal to 4 mm. The safety
distance (C in figure 37) shall be determined according to Table 28, depending on the film opening (B in
Figure 37). The guard design shall ensure that it is not possible to access the rollers from the sides.
Table 28 – Safety distance (C) for different film openings (B) in Figure 37
Film opening (B) Safety distance (C)
0 mm < B ≤ 4 mm 2 mm
4 mm < B ≤ 6 m 10 mm
B > 6 mm See table 4 of EN ISO 13857:2008
A – Clearance between guard and roller (≤ 4 mm)

B - Film opening
C - Safety distance
Figure 37 - Methods of safeguarding power unwind mechanism
5.2.3.5 Automatic splicing mechanism
Where the automatic splicing mechanism cannot be made safe by design using the methods described in
clause 5.2.1.1 of EN 415-10: 2014 or the mechanism incorporates a cutting device, the mechanism shall be
enclosed with an interlocking guard. This interlocking guard shall be interlocked so that the splicer cannot
operate when the splicer guard is open, but allows the main machine to continue to run.
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The design of the guards shall ensure that danger zones on the main machine cannot be reached when the
splicer’s guard is open.
NOTE: This can usually be achieved with fixed guards.
5.2.3.6 Static elimination equipment
Where elimination equipment presents a hazard, it shall be protected with an interlocking guard and the
control system shall ensure that the static elimination equipment is turned off when this interlocking guard is
open.
5.2.3.7 Reclose feature mechanism
Mechanisms for attaching a reclose feature to a package shall be enclosed with interlocking guards. The
reclose feature reel unwind mechanism shall comply with 5.2.3.2. Where heat is used to attach the reclose
feature 5.1.3 shall apply.
5.2.4 Longitudinal sealing mechanism
The longitudinal sealing mechanism shall be safeguarded in one of the following ways:
a) enclosing the mechanism with an interlocking guard fitted with a trip guard as described in 5.2.2.2 (d)
and shown as “D” in figure 31 or
b) using a series of curved fixed guards in front of each set of rollers as shown in figure 38. The
clearance between the curved fixed guards “E” and the drive rollers “A” shall be less than or equal to
4 mm. Where the film opening “B” is less than or equal to 4 mm, the safety distance to the danger
zone “C” shall be at least 2mm. Where the film opening “B” is less than or equal to 6mm, the safety
distance to the danger zone “C” shall be at least 10 mm. Where the film opening is greater than 6 mm
the safety distance shall comply with table 4 of EN ISO 13857.
A – Clearance between guard and roller (≤ 4 mm)

B - Film opening
C - Safety distance
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D – Hinged plates
E – Curved fixed guards
Figure 38 – Curved guard longitudinal sealing mechanism guarding solution

c) using interlocked flat plates as shown in figure 39. Where the film opening “B” is less than or equal to
4 mm, the safety distance to the danger zone “C” shall be at least 2mm. Where the film opening “B” is
less than or equal to 6mm, the safety distance to the danger zone “C” shall be at least 10 mm. Where
the film opening is greater than 6 mm the safety distance shall comply with table 4 of EN ISO 13857.
Figure 39 - Flat guard longitudinal sealing mechanism guarding solution

Where the longitudinal sealing mechanism is heated, the requirements of 5.1.3 shall apply.
When any of the interlocking guards described in 5.2.4 (a), (b) or (c) are open the control system shall ensure
that the mechanisms cannot move unexpectedly, however it is not necessary for the heating circuit to be
disconnected.
5.2.5 Transverse sealing and cutting mechanisms
The transverse sealing and cutting mechanisms shall be safeguarded with interlocking guards which prevent
access to the mechanisms through both the infeed and discharge openings as illustrated by the guards
marked as “D” and “E” in figure 30.
Where the width or height of the product infeed or discharge opening in the guards is 20 mm or less the
distance away from the nearest danger zone shall be at least 120 mm. Where the opening width or height is
greater than 20 mm but less than 200 mm, the minimum distance away from the nearest danger zone shall be
at least 850 mm. Where the opening width or height is greater than 200 mm the safety distance shall comply
with clause 5.2.1.3 of EN 415-10: 2014.
Where the transverse sealing mechanism is pneumatically operated, it shall incorporate a brake mechanism
or solenoid valve to ensure that the mechanism does not move unexpectedly when the guards are open or the
compressed air supply is disconnected.
Where the transverse sealing mechanism is heated, the requirements of 5.1.3 shall apply.
When the transverse sealing mechanism interlocking guard is open the control system shall ensure that the
mechanisms cannot move unexpectedly, however it is not necessary for the heating circuit to be
disconnected.
5.2.6 Discharge mechanism
Where the discharge mechanism is a flat belt conveyor it shall comply with 5.2.2.3. Other discharge
mechanisms which are not safe by design shall be enclosed with interlocking guards.
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5.2.7 Integrity of safety related control systems
The safety related control systems of flow-wrapping machines shall as a minimum comply with the following
performance levels of EN ISO 13849-1:2015.
Safety function PLr

Stopping the sealing and cutting mechanisms when the interlocking guard is opened d
Preventing unexpected startup of the sealing and cutting mechanisms when the d
interlocking guard is open
Isolating and dissipating energy from the static eliminator when the interlocking guard is c
opened
Stopping the chains and drives when the interlocking guard is opened d
Stopping the infeed conveyor when the trip guard is touched d
Stopping transmission parts when their interlocking guard is opened c
Stopping product feeding devices when their interlocking guard is opened c
Stopping the film reel unwind mechanism when the interlocking guard is opened c
Stopping the discharge mechanism when the interlocking guard is opened c
Stopping the tension roller assembly when its interlocking guard is opened c
Stopping the automatic splicing mechanism when its interlocking guard is opened c
Stopping all hazardous processes by the emergency stop circuit c
5.3 Safety requirements for a vertical form, fill and seal machine
5.3.1 General
The hazards described in 4.3 shall be safeguarded by the following methods and those described in 5.1.
These requirements also apply to a stick packing machine (3.3.2), vertical sachet form, fill and seal machine
(3.3.4), strip packing machine (3.3.5) and vertical form, fill and seal machine for cartonboard (3.3.6) where the
equivalent hazards exists.
A – Drive mechanisms guard

B – Product feed mechanism guard
C – Interlocking guard
D – Tunnel guard
Figure 40 - Guarding requirements for a typical vertical form fill and seal machine
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5.3.2 Product feeding devices
The safety requirements for four typical feeding devices are described in 5.11, 5.12, 5.13 and 5.14. The
product feeding device shall be guarded and interlocked with the vertical form fill and seal machine in such a
way that it is not possible to reach danger zones inside the product feeding device from inside the guards of
the machine or danger zones inside the machine from inside the guards of the feeding device.
5.3.3 Packing material reel unwind mechanism
The requirements of clause 5.2.3 also apply to a vertical form fill and seal machine.
5.3.4 Longitudinal sealing mechanism
The longitudinal mechanism shall be guarded with interlocking guards similar to the one marked “C” in figure
40. Where the interlocking guard is open at the top, the dimensions for the guard shall be taken from table 2 of
EN ISO 13857 and consider that operators could stand on the discharge conveyor or tunnel guard.
Where the longitudinal sealing mechanism is heated, the requirements of 5.1.3 shall apply.
The longitudinal sealing mechanism shall not present a risk of burning when changing the packaging material.
NOTE – This can be achieved by making it possible to move the longitudinal sealing mechanism when
changing the packaging material.
When the longitudinal sealing mechanism interlocking guard is open the control system shall ensure that the
disconnected.
5.3.5 Packaging material transport mechanism
The packaging material transport mechanism shall be guarded with interlocking guards and a tunnel guard as
illustrated by the guards marked “C” and “D” in figure 40.
Where the interlocking guard is open at the top, the dimensions for the guard shall be taken from table 2 of EN
ISO 13857 and consider that operators could stand on the discharge conveyor or the tunnel guard.
5.3.6 Transverse sealing and associated mechanisms
The transverse sealing and associated mechanisms shall be guarded with interlocking guards and a tunnel
guard as illustrated by those marked “C” and “D” in figure 40.
Where the height of the discharge opening is 200 mm or less the safety distance from the discharge opening
in the tunnel guard to the nearest danger zone on the transverse sealing or associated mechanism shall be at
least 850 mm. Where the height of the opening is greater than 200mm the safety distances and safeguarding
solutions shown in clause 5.2.1.3 of EN 415-10 shall apply.
To prevent access by reaching with an arm under the interlocking guard, for example to remove empty
packages from the sealing mechanism, the gap under the guard and the safety distance to the nearest danger
zone shall comply with table 4 of EN ISO 13857. Where additional guards are fitted that restrict the
movement of an arm or hand, the safety distances shown in tables 3 and 6 of EN ISO 13857 can be used.
Where the transverse sealing mechanism is heated, the requirements of 5.1.3 shall apply.
The machine shall be provided with a facility to feed packaging material through the machine automatically or
the design of the sealing mechanism shall allow packaging material to be threaded through the jaws while
they are hot without a risk of burning.
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When the transverse sealing mechanism interlocking guard is open the control system shall ensure that the
disconnected.
5.3.7 Cutting and perforating mechanisms
The design of the cutting and perforating mechanism shall minimise the risk of injury during a typical operator
intervention to thread packaging material or clear a jam. This can be achieved by designing the cutting or
perforating mechanism so it retracts into an enclosed area when the interlocking guard is opened.
The machine shall be fitted with a facility to inhibit the cutting mechanism during set up or at the start of
production to ensure that empty packages will be discharged without the need for operator intervention.
5.3.8 Product discharge opening
in the tunnel guard to the nearest danger zone on the transverse sealing or associated mechanism shall be at
least 850 mm. Where the height of the opening is greater than 200 mm the safety distances and safeguarding
solution shown in clause 5.2.1.3 of EN 415-10 shall apply.
5.3.9 Discharge conveyor
Where the packs are taken away from the machine with a conveyor, the conveyor shall be interlocked with the
machine so that when the interlocking guard of the machine is open the conveyor stops.
Where the conveyor forms part of the guarding, it shall either be fixed in relationship to the machine, or
interlocked so that the machine cannot operate unless the conveyor is in its correct position.
Where the discharge conveyor is a flat belt conveyor it shall comply with5.2.2.3. Other types of conveyor shall
comply with clause 5.20.4.2 of EN 415-10.
5.3.10 Discharge into bins
On machines where the product is discharged into bins without the use of a discharge conveyor, one of the
following safeguarding solutions shall be used.
a) the machine guards shall extend downwards round the bin far enough to prevent access to the transverse
seal and associated mechanisms whether the bin is in place or not;
b) The bin is detected with an interlocking device, conforming to EN ISO 14119 incorporated into the control
system so that the machine can only operate when a bin is in its correct position. In this case, the
combination of the bin and interlocking guards shall prevent access to the danger zones.
5.3.11 Provision for changing the forming tube
The manufacturer shall design the forming tube so it can be installed and removed without a manual handling
risk. Methods of achieving this include:
a) Lightweight forming tubes;
b) Mechanisms to support the forming tube during the installation and removal process;
c) Trolleys to support the forming tube.
The requirements of clause 5.20.6.3 of EN 415-10 shall also apply.
Where it is likely that operators will stand on either the discharge conveyor or the tunnel guard to change the
forming tube, the manufacturer shall either design the conveyor or the tunnel guard so they are safe to stand
on or provide an alternative means of access and make it clear using the “Do not stand here” pictogram where
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it is not safe to stand. Where the tunnel guard is used as a step it shall comply with EN ISO 14122-3 which
requires handrails to be provided where a step has a height greater than or equal to 500 mm.
Figure 41 - Tunnel guard designed to be stood on when changing the forming tube
The manufacturer shall ensure that it is not possible to reach danger zones in the machine over guards when
standing on the means of access described in this clause. Where guards are open at the top the safety
distances in table 2 of EN ISO 13857: 2008 shall apply.
The safety related control systems of vertical form, fill and machines shall as a minimum comply with the
following performance levels of EN ISO 13849-1:2015.
Safety function PLr

Stopping sealing, perforating and cutting mechanisms when the interlocking guard is d
opened
Preventing unexpected startup of sealing, perforating and cutting mechanisms when the d
interlocking guard is open
Isolating and dissipating energy from the static eliminator when the interlocking guard is c
opened
Stopping the sealing, perforating and cutting mechanisms when the discharge bin is not in d
place
Stopping the sealing, perforating and cutting mechanisms when the discharge conveyor is d
not in place
Stopping the packaging material transport mechanism when the interlocking guard is c
opened
Stopping the discharge conveyor when the interlocking guard is opened c
5.4 Safety requirements for a horizontal sachet form, fill and seal machine
5.4.1 General
The hazards described in 4.4 shall be safeguarded by the following methods and those described in 5.1. The
drawing shows a linear transport system, but the safety requirements are the same on machines where the
transport system is rotary or partly rotary.
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A – Reel unwind mechanism

B – Product feed device
C – Interlocked guards
D – Product discharge chute
E - Drive mechanisms guard
Figure 42 - Guarding requirements for a typical horizontal sachet form fill and seal machine
The requirements of clause 5.2.3 also apply to a typical horizontal sachet form fill and seal machine.
5.4.3 Vertical seal mechanism
The vertical seal mechanism shall be guarded with interlocking guards similar to those shown in figure 42.
Where the closing medium is heat 5.1.3 applies.
5.4.4 Transport mechanism
The transport mechanism shall be guarded with interlocking guards as shown in figure 42.
5.4.5 Product feeding devices
The safety requirements for typical feeding devices are described in 5.11, 5.12. 5.13 and 5.14 and EN 15180:
2014.
5.4.6 Product settling mechanism
The requirements of 5.1.5 apply.
5.4.7 Top sealing mechanism
The top seal mechanism shall be guarded with interlocking guards similar to those shown in figure 42.
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Where the closing medium is heat 5.1.3 shall apply.
5.4.8 Cutting mechanism
The cutting mechanism shall be enclosed with interlocking guards, interlocked so the cutting mechanism
cannot operate when the guard is open. The blade of this device shall be designed either to withdraw into a
recess or be fitted with a guard to prevent injury when the interlocking guard is open.
5.4.9 Discharge chute or conveyor
Where the height of the discharge opening is 20 mm or less the opening shall be a t least 120 mm away from
the nearest danger zone. Where the height of the opening is greater than 20 mm but less than 120 mm the
distance from the discharge end of the opening to the nearest danger zone shall be 850 mm, which may
require the use of a tunnel guard.
Where the discharge mechanism is a flat belt conveyor it shall comply with 5.2.2.3.
The safety related control systems of horizontal sachet form, fill and seal machines shall as a minimum
comply with the following performance levels of EN ISO 13849-1:2015.
Safety function PLr

Stopping the sealing and cutting mechanisms when the interlocking guard is opened d
Isolating and dissipating energy from the static eliminator by the interlocking guard d
Stopping the transport mechanism When the interlocking guard is opened c
Stopping vibration devices when the interlocking guard is opened c
5.5 Safety requirements for a thermoform, fill and seal machine
5.5.1 General
drawing shows a linear transport system but the safety requirements are the same on machines where the
These requirements also apply to a deep draw machine (3.3.7) where the equivalent hazard exists.
A - Lower reel unwind mechanism

B - Forming die guard
C - Product loading area
D - Upper reel unwind mechanism
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E - Sealing die guard

F - Cutting mechanism guard
G - Scrap reels
H - Product discharge conveyor
J - Side guards
Figure 43 - Guarding requirements for a typical thermoform fill and seal machine
5.5.2 Lower web reel unwind mechanism
The requirements of clause 5.2.3 apply to the lower web reel unwind mechanism.
Transport mechanisms shall be safeguarded as follows.
5.5.3.1 Counter rotating rollers
The transport mechanisms of machines of this type shall be guarded with fixed or interlocking guards.
5.5.3.2 Chains and clamps
Machines with chain and clamp transport mechanisms where products are manually fed shall be safeguarded
with fixed guards which incorporate a slot for the lower film web no wider than 4 mm. Where this cannot be
achieved the relationship between the slot width and the distance from the hazard shall comply with table 4 of
EN ISO 13857.
Where the machine is automatically fed, the mechanisms shall be guarded as in paragraph 1 or with
interlocking guards that also guard the automatic feeding mechanisms.
5.5.4 Heating chamber
The machine shall be designed in such a way that when the machine stops there is no risk of the film catching
fire.
The heating chamber and forming die shall be safeguarded with interlocking guards. In addition, the control
system shall ensure that the heating chamber and forming die cannot move under gravity when the power
supplies are disconnected. This may involve fitting a mechanical or pneumatic device which prevents the die
from moving when power is removed.
The safety distance through openings in these guards shall be in accordance with table 29.
A “warning hot surface” pictogram shall be fitted to the heating chamber to warn of a residual burning hazard if
this exists.
The requirements of 5.1.3 shall apply.
5.5.5 Forming die
The forming die shall be guarded with interlocking guards.
5.5.6 Packaging material apertures
The risk of impact from the moving parts of the packaging material transport mechanism in the loading area
can be considered negligible if the moving parts are smooth without sharp edges and the speed is lover than 2
m/s.
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The apertures for the packaging material shall be safeguarded using one of the methods described in 5.5.6.1,
5.5.6.2, 5.5.6.3, 5.5.6.4, 5.5.6.5 or 5.5.6.6.
The methods described in 5.5.6.2, 5.5.6.3, 5.5.6.4, 5.5.6.5 or 5.5.6.6. shall only be used where the stopping
time of the hazardous movement does not exceed 0,5 s.
The objective of all the safeguarding solutions described is to ensure that the machine stops before a danger
zone can be reached. The manufacturer shall check that the chosen safeguarding method achieves this
objective using the methods described in EN ISO 13855.
Where the opening is less than 20 mm the safety distances in table 4 of EN ISO 13857 shall apply.
Where the opening is greater than 200 mm the safety distances in clause 5.2.1.3 of EN 415-10: 2014 shall
apply.
5.5.6.1 Fixed Guards
Access to the forming and sealing dies shall be limited by fitting a false base in the product loading area.
Where fixed guards are used to prevent access to danger zones, the safety distance through openings in the
guards to the danger zones shall comply with dimension B in table 29.
Table 29 - Safety distances for different types of guard

Type of Guard A is
Safety A is A is A is A is > 120
> 60 to
Distance > 20 to ≤30 > 30 to ≤40 > 40 to ≤60 to ≤200
≤120
Fixed guard B 230 550 850 850 850
Trip guard C 230 350 450 550 850
Trip guard with AOPD D 230 300 400 500 550
ESPE E 230 300 400 500 550
Linked guard F 230 230 230 230 230
Automatic guard G 5 5 5 5 5
Dimensions in millimetres
5.5.6.2 Trip guard
This comprises a moveable interlocking guard which can move easily if someone reaches into the opening.
The maximum force to lift and activate the guard shall not exceed 50N. The interlocking device fitted to the
guard shall comply with EN ISO 14119: 2014 and shall be interlocked in such a way that if the guard is lifted
by 10 mm or less, the hazardous movements shall stop or reverse to a safe position. For this type of guard,
safety distance C, in table 29 and figure 44 shall be used. The stopping time of the machine shall not exceed
0.5 s.
The instructions shall warn the user that this type of guard can become ineffective if a heavy object is placed
on top of the guard.
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1 - Interlocked trip guard A – Depth of opening

2 – Direction of access into danger zone C – Safety distance
3 – False base
4 – Hazardous movement
Figure 44 - Trip guard
5.5.6.3 Trip guard with AOPD device
This comprises a moveable interlocking guard supplemented with an Active Opto-electronic Protective Device
(AOPD). The AOPD shall comply with EN 61496-2 and the interlocking device fitted to the guard shall comply
with EN ISO 14119: 2014. The control system shall ensure that if the guard is lifted 10 mm or the AOPD is
activated the hazardous movements shall stop or if safe to do so reverse. The maximum force to lift and
activate the guard shall not exceed 50N. The control circuit shall comply with PL “d” of EN ISO 13849-1:
2015.
For this type of guard, safety distance D, in table 29 and figure 45 shall be used. The AOPD shall be set at 20
mm from the trip guard. The stopping time of the machine shall not exceed 0.5 s.
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2 – ESPE D – Safety distance
3 - Direction of access into danger zone X – Horizontal ESPE offset distance
4 - False base Y – Vertical ESPE offset distance
Figure 45 - Trip guard with ESPE device

5.5.6.4 ESPE trip device
This comprises a moveable interlocking guard supplemented with electro-sensitive protective equipment
(ESPE) which monitors the whole opening. The ESPE shall comply with EN 61496-1 type 4, the interlocking
device shall comply with EN ISO 14119: 2014. The control system shall ensure that if the guard is lifted 10
mm or the ESPE is activated the hazardous movements shall stop or if safe to do so reverse. The maximum
force to lift and activate the guard shall not exceed 50N. The control circuit shall comply with PL “d” of EN ISO
13849-1: 2015.
The distance E shown in table 29 and figure 46 shall be used. The stopping time of the machine shall not
exceed 0.5 s.
1 – Trip guard A – Depth of opening

2 - Direction of access into danger zone E – Safety distance
3 - False base
4 - ESPE
5 - Hazardous movement
Figure 46 - ESPE trip device
5.5.6.5 Linked automatic guard
This comprises a guard which is attached to the moving part of the forming or sealing die mechanism which
moves into place when the hazardous movements of the forming or sealing dies begin. The guard shall be
interlocked with the machine to stop hazardous movements/or bring the die into a safe position, if there is an
obstruction is detected. The control system shall ensure that if the guard is lifted 10 mm the hazardous
movements shall stop or if safe to do so reverse. The maximum force to lift and activate the guard shall not
exceed 50N. The control circuit shall comply with PL “d” of EN ISO 13849-1: 2015.
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Where the force of the guard exceeds those listed in clause 5.2.1.1 of EN 415-10:2014, a pressure sensitive
device, complying with EN 1760-2 shall be fitted to the guard, that will stop the hazardous movement if an
obstruction is detected.
The interlocking device shall comply with EN ISO 14119: 2014 and the control circuit shall comply with PL “d”
of EN ISO 13849-1: 2015.
The distance between the vertical part of the linked automatic guard and fixed parts shall not exceed 4
mm in any position.
For a linked automatic guard, the safety distance F, in table 29 and figure 47 shall be used.

2 - Direction of access into danger zone F – Safety distance
3 - False base
4 - Guard fixed to die
5 - Hazardous movement
Figure 47 - Linked automatic guard
5.5.6.6 Automatic Guard
The automatic guard is powered independently of other movements on the machine and moves into
place after the transport cycle ends and before the forming and sealing cycles start. Dimension “G”
applies when the automatic guard is completely closed.
The control system shall ensure that the forming and sealing cycles cannot start until the automatic guard is
completely closed and shall comply with PL “d” of EN ISO 13849-1: 2015.
Where the force of the automatic guard exceeds those forces listed in clause 5.2.1.1 of EN 415-
10:2014, a pressure sensitive device, complying with EN 1760-2 shall be fitted to the guard, that will
stop the movement of the automatic guard if an obstruction is detected.
For an automatic guard the safety distance G, in table 29 and figure 48 shall be used.
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1 – Direction of access into danger zone A – Depth of opening

2 - False base G – Safety distance
3 – Automatic guard
Figure 48 - Automatic guard
5.5.7 Automatic product feeding devices
Automatic product feeding devices shall be safeguarded with interlocking guards.
Where the automatic feeding device is a belt conveyor it shall comply with 5.2.2.3.
5.5.8 Upper film reel unwind mechanism
The requirements of clause 5.2.3 shall apply to the upper web reel unwind mechanism.
Where the coder moves across the film web to apply several codes, the coding assembly shall either be made
safe by design as indicated in clause 5.2.1.1 of EN 415-10 or it shall be enclosed with interlocking guards.
5.5.9 Sealing die
The sealing die shall be safeguarded with interlocking guards. Where the sealing die is heated clause 5.1.3
applies.
5.5.10 Cutting devices
Rotary and reciprocating cutting devices shall be safeguarded with interlocking guards similar to those shown
in figure 43.
5.5.11 Scrap reel
The drawing-in hazard on the scrap reel shall be reduced in one of the following ways:
- Enclosing the scrap reel with an interlocking guard, or
- Limiting the torque of the reel drive mechanism, so that the reel stops when a force of 60 N is applied to it.
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5.5.12 Discharge mechanism
Where the discharge mechanism is a flat belt conveyor it shall comply with 5.2.2.3. Access to danger zones
inside the machine from the discharge opening shall be prevented using a tunnel guard or interlocked trip
guard which provides an 850 mm safety distance.
5.5.13 Pad or leaflet inserters
The requirements for carton magazines in clause 5.7.5 shall apply.
The safety related control systems of thermoform, fill and seal machines shall as a minimum comply with the
Safety function PLr

Stopping forming, filling, sealing and cutting mechanisms when the interlocking guard is d
opened
Stopping and/or reversing hazardous movements to a safe position when the trip guard is d
moved
Stopping hazardous movements when the ESPE device is actuated d
Stopping the transport mechanisms when the interlocking guard is opened c
Stopping the discharge mechanism when the interlocked trip guard is moved d
Stopping the scrap reel when its interlocking guard is opened c
5.6 Safety requirements for a tubular bag form, fill and seal machine
5.6.1 General
A – Interlocking guard for product feeding mechanism

B – Film reel assembly
C - Interlocking guard
D – Discharge conveyor
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Figure 49 - Guarding requirements for a typical tubular bag form fill and seal machine
The requirements of clause 5.2.3 apply to the film reel unwind mechanism.
If the film reel loading mechanism is not guarded, it shall be provided with a hold to run control placed where
there is a clear view of the danger zone.
The design of the machine shall allow the film reel to be transported and loaded into the film reel unwind
mechanism using standard lifting equipment such as a fork lift truck. If film reels can only be lifted using
specially designed lifting equipment, the manufacturer shall supply this special lifting equipment with the
machine.
5.6.3 Transverse or corner sealing and cutting mechanism
This mechanism shall be guarded with a combination of fixed and interlocking guards as indicated by “C” in
figure 49. Where the sealing mechanism is heated clause 5.1.3 shall apply.
5.6.4 Openings in guards
The safety distance from any openings in the guards shall be as follows:
Smallest dimension of opening Safety distance

≤ 120 mm As indicated by tables 3, 4 or 6 of EN ISO 13857
 120 mm ≤ 200 mm 850 mm
 200 mm As indicated by clause 5.2.1.3.5 of EN 415-10:2014
5.6.5 Cutting and perforating mechanisms
The requirements of clauses 5.2.1.2 and 5.20.1 of EN 415-10:2014 shall apply.
5.6.6 Film draw and compensator
The requirements of clause 5.2.1.2 of EN 415-10:2014 shall apply.
5.6.7 Cooling mechanism
5.6.8 Filling station
The filling station shall be guarded with a combination of fixed and interlocking guards as indicated by “C” in
figure 49.
Where the machine is specified to pack a hazardous or dusty product, clause 5.10.2.1 of EN 415-10:2014
shall apply. Where the local exhaust ventilation system is not delivered with the machine, the manufacturer
shall provide a detailed specification for the local exhaust ventilation system in the instructions which includes
the details for the connection and the required airflow at the connection point.
5.6.9 Bag opening mechanism
The bag opening mechanism shall be guarded with a combination of fixed and interlocking guards as
indicated by “C” in figure 49.
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5.6.10 Product settling mechanism
The product settling mechanism shall be guarded with a combination of fixed and interlocking guards as
indicated by “C” in figure 49.
The requirements of clause 5.1.5 shall apply.
5.6.11 Bag sealing mechanism
This mechanism shall be guarded with a combination of fixed and interlocking guards as indicated by “C” in
figure 49. Where the bag sealing mechanism is heated clause 5.1.3 shall apply.
5.6.12 Discharge conveyor
The discharge conveyor shall comply with clause 5.20.4 of EN 415-10.
5.6.13 Conveyor height adjustment
Where the conveyor adjustment mechanism is not guarded or safe by design, as defined by clause 5.2.1.2 of
EN 415-10:2014, it shall be fitted with a hold to run control device which shall be located where there is a
clear view of the danger zone.
5.6.14 Bag transport mechanism
On automatic machines, the bag transport mechanism shall be guarded by a combination of fixed and
interlocking guards similar to those shown as “C” in figure 49.
to the nearest danger zone shall be at least 850 mm. Where the height of the opening is greater than 200mm
the safety distances and safeguarding solution shown in clause of 5.2.1.3 EN 415-10 shall be used.
The safety related control systems of tubular bag form, fill and seal machines shall as a minimum comply with
the following performance levels of EN ISO 13849-1:2015.
Safety function PLr

Stopping the forming, opening, sealing, perforating and cutting mechanisms when the c
interlocking guard is opened
Preventing unexpected start-up of the forming, opening, sealing, perforating and cutting d
mechanisms when the interlocking guard is open
Stopping the filling device when the interlocking guard is opened c
Stopping the discharge conveyor, product settling device and bag transport mechanism c
when the interlocking guard is opened
Enabling the film reel loading mechanism movement hold to run control c
Enabling the conveyor height adjustment hold to run control c
5.7 Safety requirements for a mandrel form, fill and seal machine
5.7.1 General
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A – Reel unwind mechanism

B – Product feed device
C – Interlocked guards
D – Product discharge chute
E - Drive mechanisms guard
Figure 50 - Guarding requirements for a mandrel form fill and seal machine
5.7.2 Packaging material reel unwind mechanism
On machines fitted with a reel unwind mechanism, the requirements of clause 5.2.3 shall apply.
5.7.3 Cutting mechanism
On machines fitted with a cutting mechanism, the cutting mechanism shall be enclosed with interlocking
guards, interlocked so the cutting mechanism cannot operate when the guard is open. The blade of this
device shall be designed either to withdraw into a recess or be fitted with a guard to prevent injury when the
interlocking guard is open.
5.7.4 Sealing mechanisms
Where the closing medium is heat or hot melt adhesive, 5.1.3 shall apply.
Hot melt gluing systems shall comply with clause 5.20.7 of EN 415-10.
Where a spray gluing system or hot melt gluing system is fitted, the guards shall be capable of containing any
foreseeable glue over spray and the system shall comply with the requirements of clause 5.7 of EN 415-10:
2014.
5.7.5 Carton blank magazine
On machines fitted with a carton blank magazine that is loaded by hand, the following requirements shall
apply:
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a) Where the carton magazine is adjustable for different sizes of carton, the design shall ensure that it is
not possible to reach around the stack of cartons to danger zones in the machine for every size of
carton for which the machine has been specified;
NOTE - It is preferable for the guards around the carton magazine to be self-adjusting guards, which
are fixed to the size adjustment parts so that they are adjusted automatically when the size
adjustment part is moved as shown in figure 51;
b) Where change part guards or manually adjustable guards are used, interlocking devices complying
with EN IS0 14119: 2014 shall be fitted to prevent the machine from running when these guards are
not in place or not adjusted correctly;
c) The carton magazine shall be fitted with a system of carton sensing devices, for instance electro-
sensitive protection devices complying with EN 61496-1 which stop the machine when a pre-
determined number of cartons are left in the carton magazine or if the cartons are removed from the
magazine, exposing the carton transfer mechanism;
d) The carton sensing system shall be designed to minimise the risk of being deliberately defeated.
Methods of minimizing the risk of deliberate defeat include:
a. sensors mounted on both sides of the magazine or above and on one side of the magazine;
b. monitoring a pre-determined sequence of signals;
c. sensors looking for an object at a pre-determined distance from the sensor
Where the carton blank magazine is fitted with an automatic carton loading mechanism, this mechanism
shall be guarded with interlocking guards.
A – Self-adjusting guard
B – Carton sensor
C – Carton magazine
Figure 51 - Carton magazine
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5.7.6 Mandrel former
This mechanism shall be safeguarded with fixed or interlocking guards.
5.7.7 Compression mechanism
5.7.8 Transfer mechanisms
These mechanisms shall be safeguarded with fixed or interlocking guards.
5.7.9 Transport section
5.7.10 Product feed
The safety requirements for typical feeding mechanisms are indicated in 5.11, 5.12, 5.13 and 5.4.
The product feed device and the connection to the machine shall be designed so that it is not possible to
reach hazard zones in the machine from the product feed device and vice versa. Where these hazard zones
could be reached through interlocking guards the interlocking shall stop both the machine and the product
feed device. Movable elements like hoppers that will be opened once a week or more often shall be
interlocked in the same way.
5.7.11 Product settling devices
Where the device uses vibration to the settle the product, the requirements of clauses 5.1.5 shall apply.
This mechanism shall be guarded with interlocking guards, interlocked so that the vibration devices stop
vibrating when the guards are opened.
5.7.12 Sterilization section
This mechanism shall be safeguarded with fixed or interlocking guards and shall comply with relevant
requirements of clause 5.1.7.
5.7.13 Auxiliary media injection
5.7.14 Package closing mechanism
The pack closing mechanism shall be guarded with interlocking guards.
Where the closing medium is heat or hot melt adhesive, 5.1.3 shall apply.
Where a spray gluing system or hot melt gluing system, is fitted the guards shall be capable of containing any
2014.
5.7.15 Vacuum sealing mechanism
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5.7.16 Discharge or compression conveyor
Where the discharge conveyor is a flat belt conveyor it shall comply with 5.2.2.3. Where the discharge
conveyor applies compression to the packs it shall be fitted with interlocking guards and a tunnel guard which
provides an 850mm safety distance from the discharge end of the tunnel guard to the nearest danger zone.
5.7.17 Pak reject mechanism
Belt conveyors shall comply with 5.2.2.3 and other types of conveyor shall comply with clause 5.20.4 of EN
415-10:2014.
The safety related control systems of mandrel form, fill and seal machines shall as a minimum comply with the
Safety function PLr

Stopping f e e d i n g , forming, filling, sealing and closing mechanisms when the d
Stopping the film reel unwind mechanism when the interlocking guard is opened d
Stopping the carton blank magazine when the interlocking guard is opened d
Stopping the filling device when the interlocking guard is opened c
Stopping the transport mechanism when the interlocking guard is opened c
Stopping the discharge mechanism when the interlocking guard is opened c
5.8 Safety requirements for a pre-made bag, erect, fill and close machine
5.8.1 General
drawing shows a rotary transport system but the safety requirements are the same on machines where the
transport system is linear or partly linear.
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A – Bag magazine
B – Interlocked guards
C – Product feed device
D – Tunnel guard and discharge conveyor
E - Drive mechanisms guards
Figure 52 - Guarding requirements for a typical pre-made bag fill and seal machine
5.8.2 Bag magazine
The bag magazine shall comply with clause 5.7.5.
5.8.3 Bag erecting mechanism
This mechanism shall be guarded with interlocking guards similar to those shown in figure 52.
This mechanism shall be guarded with interlocking guards similar to those shown in figure 52.
5.8.5 Product feed
The safety requirements for typical feeding mechanisms are indicated in 5.11, 5.12, 5.13 and 5.14 and EN
15180: 2014.
The product feed and the connection to the machine shall be designed so that it is not possible to reach
hazard zones in the machine from the product feed and vice versa. Where these hazard zones could be
reached through interlocking guards the interlocking shall stop both the machine and the product feed.
Movable elements like hoppers that will be opened once a week or more often shall be interlocked in the
same way.
5.8.6 Product settling devices
This mechanism shall be guarded with interlocking guards similar to those shown in figure 52, interlocked so
that the vibration devices stop vibrating when the guards are opened.
5.8.7 Bag closing mechanism
The bag closing mechanism shall be guarded with interlocking guards similar to those shown in figure 52.
Where a spray gluing system or hot melt gluing system, is fitted the guards shall be capable of containing any
2014.
Where the closing medium is heat or hot melt adhesive, clause 5.1.3 shall apply.
5.8.8 Discharge or compression conveyor
Where the discharge conveyor is a flat belt conveyor it shall comply with 5.2.2.3. Where the discharge
conveyor applies compression to the packs it shall be fitted with interlocking guards and a tunnel guard which
provides an 850 mm safety distance from the discharge end of the tunnel guard to the nearest danger zone.
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The safety related control systems of bag erect, fill and seal machines shall as a minimum comply with the
Safety function PLr

Stopping the erecting, filling, transport, sealing and cutting mechanisms when the d
Stopping the machine when the bag magazine interlocking guard is opened and/or d
electro-sensitive protection devices are actuated
Stopping the vibration devices when the interlocking guard is opened c
5.9 Safety requirements for a cup or tub fill and seal machine
5.9.1 General
drawing shows a linear transport system but the safety requirements are the same on machines where the
A – Cup magazine
B – Interlocking guards
C - Product feed devices
D – Lid magazine
E = Tunnel guard/discharge conveyor
F – Drive mechanism guards
Figure 53 - Guarding requirements for a typical cup fill and seal machine
5.9.2 Cup magazine
Change part guards like the one in figure 55 shall be provided for each type of cup, dimensioned using table 4
of EN ISO 13857 so it is not possible to reach danger zones around the stacks of cups.
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The magazine shall be fitted with an interlocking device, for example an electro-sensitive protection device
complying with EN 61496-1 which stops the machine before the last few cups are removed from the
magazine, exposing the cup dispensing and transport mechanisms.
Where the machine incorporates automatic cup or tub stack loading mechanisms, these mechanisms shall be
guarded with interlocking guards, or electro-sensitive protective equipment complying with EN 61496-1 during
the cycle when the stack is moved.
1 Stack of cups 1 Fixed or interlocking guard

2 AOPDOR 2 Stack of cups
3 Cup separation mechanism 3 Cup separation mechanism
Figure 54 – Methods of safeguarding the cup magazine
5.9.3 Cup dispensing mechanism
Access to the hazardous movements of the cup or tray dispensing mechanism through the cup or tray
magazine shall be prevented by one of the following methods:
a) Enclosing the cup magazine in a combination of fixed and interlocked guards as shown in figure 54;
b) Designing the cup or tray guides as tubes or funnels complying with 5.1.1.2 as shown in figure 55.
Where change part guards are used or to assist product changing guides must be removed, these
parts shall be fitted with interlocking devices to prevent the machine from running when these parts
are not in place.
Where the dimensions of the guards do not comply with 5.1.1.2, a system of safety protection devices, for
example a combination of electro-sensitive protection devices complying with EN 61496-1 capable of
measuring distance to objects shall be used. These devices shall stop the machine when only a pre-
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determined number of cups or trays is in the magazine or if the cups or trays are removed from the magazine,
exposing the hazard zone.
The cup sensing system shall be designed to minimise the risk of being deliberately defeated. Methods of
minimizing the risk of deliberate defeat include:
a. sensors mounted on both sides of the magazine or above and on one side of the magazine;
b. monitoring a pre-determined sequence of signals;
c. sensors looking for an object at a pre-determined distance from the sensor.
This mechanism shall be guarded with interlocking guards like those shown in figure 54.
5.9.5 Product feed devices
The safety requirements for volumetric piston depositors can be found in EN 15180: 2014. The safety
requirements for other feeding mechanisms are indicated in 5.11, 5.12, 5.13 and 5.14.
5.9.6 Manual product loading
Where the product is loaded by hand clause 5.1.8.1 shall apply.
5.9.7 Foil and lid magazines
5.9.8 Reel unwind mechanisms
Reel unwind mechanisms shall comply with clause 5.2.3.
5.9.9 Foil sealing mechanisms
Foil sealing mechanisms shall comply with clause 5.5.9.
5.9.10 Scrap reels
Scrap reels shall comply with clause 5.5.11.
5.9.11 Lid placing mechanism
This mechanism shall be guarded with interlocking guards like those shown in figure 54.
5.9.12 Discharge mechanism and conveyor
The discharge mechanism and conveyor shall be fitted with interlocking guards and a tunnel guard which
provides an 850 mm safety distance from the discharge end of the tunnel guard to the nearest danger zone.
Where the discharge conveyor is a flat belt conveyor is shall comply with 5.2.2.3.
The safety related control systems of cup or tub fill and seal machines shall as a minimum comply with the
Safety function PLr

Stopping the dispensing, filling, sealing and transport mechanisms when the interlocking d
guard is opened
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Stopping the cup, foil or lid magazine when the interlocking guard is opened and/or d
electro-sensitive protection devices are actuated
5.10 Safety requirements for a sack fill and seal machine
5.10.1 Safety requirements for an in-line sack fill and seal machine
5.10.1.1 General
The hazards described in 4.10.1 shall be safeguarded by the following methods and those described in 5.1.
A - Flow regulation mechanism guard

B - Product conveying system guard
C - Product feeding mechanism guard
D - Interlocking guard
E - Sack placer interlocking guard
Figure 55 - Guarding requirements for a typical in-line sack fill and seal machine
5.10.1.2 Product feed mechanism
The safety requirements for typical product feeding mechanisms are indicated in 5.11, 5.12, 5.13 and 5.14.
The product feed and the connection to the machine shall be designed so that it is not possible to reach
hazard zones in the machine from the product feed and vice versa. Where these hazard zones could be
reached through interlocking guards the interlocking shall stop both the machine and the product feed.
Movable elements like hoppers that will be opened once a week or more often shall be interlocked in the
same way.
5.10.1.3 Sack holding mechanism
On automatic machines, this mechanism shall be guarded with fixed and interlocking guards.
On semi-automatic machines, at least one of the following measures shall be applied:
a) Ensuring the gap between the holding mechanism and the filling nozzle is no greater than 5 mm;
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b) Where the gap is greater than 5 mm, ensuring the static force applied by the mechanism is no greater
than 135 N and the pressure applied is no greater than 60 N/cm²;
c) Providing a two-hand control which complies with type III A of EN 574:1996+A1:2008. The control
system shall ensure that movement is stopped or, if no hazard is generated, reversed, when one of
the two hand control devices is released;
d) Electro-sensitive protective equipment (ESPE) that complies with EN 61496-1. This ESPE shall be
positioned and designed according to EN ISO 13855.
5.10.1.4 Sealing mechanism
On automatic machines, this mechanism shall be guarded with fixed and interlocking guards.
On semi-automatic machines, at least one of the following measures shall be applied:
a) Providing a two-hand control which complies with type III A of EN 574:1996+A1:2008. The control
the two hand control devices is released;
b) Electro-sensitive protective equipment (ESPE) that complies with EN 61496-1. This ESPE shall be
positioned and designed according to EN ISO 13855.
5.10.1.5 Filling nozzle area
The machine shall be fitted with a local exhaust ventilation system complying with clause 5.1.7.2.
shall provide a detailed specification for the local exhaust ventilation system in the instructions which includes
the details for the connection and the required airflow at the connection point.
Where the machine is specified to pack a hazardous product or a product which has a temperature greater
than 55 °C, the filling nozzle shall be fitted with a sack sensor which ensures that filling cannot start if there is
no sack on the filing nozzle.
5.10.1.6 Sack holding and positioning mechanism
On automatic machines, this mechanism shall be guarded with interlocking guards.
On semi-automatic machines, where the sack holding mechanism cannot be made safe by design as defined
by Clause 5.2 of EN 415-10: 2014, at least one of the following measures shall be applied:
a) Providing a two-hand control which complies with type III A of EN 574:1996+A1:2008. The control
the two hand control devices is released
b) Electro-sensitive protective equipment (ESPE) that complies with EN ISO 61496-2. This ESPE shall
be positioned and designed according to EN ISO 13855.
5.10.1.7 Flow regulating mechanism
The flow regulating mechanism shall be fitted with interlocking guards.
5.10.1.8 Conveying system
The conveying system shall comply with clause 5.20.4 of EN 415-10:2014.
5.10.1.9 Sack placer
On automatic machines, this mechanism shall be guarded with fixed or interlocking guards.
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The control system shall ensure that all hazardous movements of the sack placer are stopped before the in-
line sack fill and seal machine can be operated in manual mode.
5.10.1.10 Sack discharge conveyor
The conveyor shall comply with 5.2.2.3.
to the nearest danger zone shall be at least 850 mm. Where the height of the opening is greater than 200mm
the safety distances and safeguarding solution shown in EN 415-10 clause 5.2.1.3 shall apply.
5.10.1.11 Integrity of safety related control systems
The safety related control systems of an in-line sack fill and seal machine shall as a minimum comply with the
Safety function PLr

Stopping the product feeding mechanism and product feed when their interlocking guard c
is opened
Enabling the sealing mechanism using the two-hand control device on semi-automatic d
machines
Stopping the sealing mechanism when electro-sensitive protective equipment (ESPE) is d
actuated on semi-automatic machines
Enabling of machine operation only if the extraction system is running where the product c
is hazardous
Stopping sack holding, sealing, holding and positioning mechanisms when the interlocking c
guard is opened on an automatic machine and the disable function
Enabling the sack holding and positioning mechanism using the two-hand control on c
semi-automatic machines
Stopping the sack holding and positioning mechanism when electro-sensitive protective c
equipment (ESPE) on semi-automatic machines is actuated
Stopping the flow regulating mechanism and product flow when the interlocking guard is c
opened
Stopping the product conveying system when the interlocking guard of the product c
conveying system is opened
Stopping the sack placer when the interlocking guard is opened c
Stopping the sack discharge conveyor when the interlocking guard on automatic c
machines is opened
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5.10.2 Safety requirements for a rotary sack fill and seal machine
5.10.2.1 General
The hazards described in 4.10.2 shall be safeguarded by the following methods and those described in
Clause 5.1.
A - Sack magazine guard

B – Sack transfer mechanism guard
C - Sack placer interlocking guard
D - Sack discharge guard
E - Carousel guard
F - Trip guard
G – Interlocked access door
H – Manual sack placing position
Figure 56 - Guarding requirements for a typical rotary sack fill and seal machine
5.10.2.2 Carousel
On automatic machines, access to the carousel shall be prevented by a combination of fixed and interlocking
guards like those marked "G" and "E" in figure 57.
Where it is necessary to move around the carousel inside the guards, the minimum distance between these
guards and parts of the carousel shall be 600 mm. Where there is insufficient space to allow this method of
access, the carousel guard “E” shall comprise as series of interlocking guards so the carousel can be
accessed from outside the guards.
In the area for manual sack placing “H”, the distance between the guards and the carousel shall be at least
1000 mm. Access to areas where there is less than 1000 mm clearance shall be prevented by a trip guard like
the one marked "F" in figure 57.
The trip guard “F” shall be designed so that it can move easily both in the direction of rotation of the carousel
and in the opposite direction if it is pushed by the operator. The trip guard “F” shall be interlocked and
positioned following the requirements of EN ISO 13855 and clause 5.14.7 of EN 415-10: 2014 to ensure that
the carousel has stopped before the operator can reach a danger zone.
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It shall only be possible to select manual mode using a key or password.
In addition to the emergency stop device on the control panel, a pull-cord operated emergency stop device
shall be installed in the interior of the safeguarded area all around the machine.
5.10.2.3 Sack holding mechanism
On machines where sacks are placed manually, the holding mechanism shall be safeguarded by a trip guard
like the one marked "F" in figure 57.
5.10.2.4 Flow regulating mechanism
On machines where sacks are placed manually, the flow regulating mechanism shall be safeguarded by a trip
guard like the one marked "F" in figure 57.
5.10.2.5 Sack holding and positioning mechanism
On machines where manual sack placing is foreseeable, the holding and positioning mechanism shall be
safeguarded by a trip guard like the one marked "F" in figure 57.
5.10.2.6 Sealing mechanism
On machines where manual sack placing is foreseeable, the sealing mechanism shall be safeguarded by a
trip guard like the one marked "F" in figure 57.
5.10.2.7 Filling nozzle area
shall provide a detailed specification for a suitable local exhaust ventilation system in the instructions which
includes details for the connection to the machine and the required airflow at the connection point.
On machines where manual sack placing is foreseeable, the filling process shall only be started in the zone
which is safeguarded by the trip guard marked "F" in figure 57.
5.10.2.8 Sack magazine
5.10.2.9 Sack transfer mechanism
The sack transfer mechanism shall be safeguarded with fixed and interlocking guards.
5.10.2.10 Sack placing mechanism
On automatic machines, the sack placing mechanism shall be safeguarded with an interlocking guard.
The sack placing mechanism shall not operate when the machine is in manual mode. The sack placing
mechanism shall only operate when the interlocked access door marked "G" in figure 57 is closed.
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5.10.2.11 Sack discharge conveyor
The discharge conveyor shall comply with clause 5.20.4.1 of EN 415-10: 2014.
to the nearest danger zone shall be at least 850 mm. Where the height of the opening is greater than 200 mm
the safety distances and safeguarding solutions shown in EN 415-10 clause 5.2.1.3 shall apply.
5.10.2.12 Integrity of safety related control systems
The safety related control systems of a rotary sack fill and seal machine shall as a minimum comply with the
Safety function PLr

Stopping the carousel when the interlocking guard is opened on automatic machines d
Stopping the carousel when the trip guard is moved on machines where sacks are placed d
manually
Stopping the sack holding, flow regulating, sealing, holding and positioning mechanisms c
when the interlocking guard is opened on automatic machines
Stopping the sack holding, flow regulating, sealing, holding and positioning mechanisms c
when the trip guard is moved and the disable function on machines where sacks are
placed manually
Enabling machine operation only if the extraction system is running where the product is c
hazardous
Stopping the sack holding, sealing, holding and positioning mechanisms on machines c
where sacks are placed manually with the positioning control in the manual sack placing
position
Selection of manual mode by key or code word c
Stopping the transfer mechanism when the interlocking guard is opened c
Stopping the sack placer when the interlocking guard is opened c
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5.11 Safety requirements for an auger filler
5.11.1 General
The hazards described in 4.11 shall be safeguarded by the following methods and those shown in 5.1. These
requirements apply when an auger filler is fitted to one of the machines in the scope of this standard.
A – Product infeed point

B – Screw conveyor
C – Fixed guard
D – Hopper
E – Cut-off mechanism
Figure 57 - Guarding requirements on an auger filler
5.11.2 Auger, stirrers and hopper
The hopper and top cover of the auger filler shall act as a guard for the auger and stirring mechanisms. Where
the hopper can be removed from the top cover without the use of a tool it shall be fitted with an interlocking
device which complies with EN ISO 14119, integrated with the control system so that the auger cannot run
unless the hopper is fitted correctly.
5.11.3 Screw feeder
The screw feeder shall be guarded with fixed guards. The socks that connect the screw feeder to the auger
and the screw feeder to the product feed system shall be attached with fixings which can only be removed
using a tool.
5.11.4 Auger discharge and cut off devices
The control system of the auger shall be integrated with the form, fill and seal or fill and seal machine in such
a way that the auger and cut-off devices cannot run when the interlocking guards of the form fill and seal or fill
and seal machine or fill and seal machine are open.
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5.11.5 Power supplies
The power supplies for the auger shall be integrated with those of the form fill and seal or fill and seal machine
so that the auger is isolated when the form fill and seal or fill and seal machine is isolated.
5.11.6 Ergonomic design requirements
The hopper, auger, auger funnel and any other components which must be removed regularly for cleaning,
shall be designed to avoid the risk of injury due to excessive effort. Where the mass of such components is
greater than 25 kg, the manufacturer shall design the parts so that two operators can lift them or so that lifting
equipment can be used to lift them into and out of position.
5.11.7 High level access
If the filler is mounted in a position where it cannot be reached for cleaning or maintenance from the floor, one
of the following shall be provided.
a) A permanent means of access complying with EN ISO 14122-2 and EN ISO 14122-3, or;
b) A permanent platform around the filler which complies with EN ISO 14122-2 that can be accessed safely
from mobile steps that comply with EN ISO 14122-3.
5.11.8 Dusty products
Where the product being packed produces a hazardous amount of dust, the machine shall be enclosed with
interlocking guards and local exhaust ventilation (LEV) shall be provided. The interlocked guards shall be
fitted with guard locking devices that will only release the doors when either a sensor indicates that the
atmosphere inside the guards is safe to breathe or after a time delay long enough for the LEV system to
remove the hazardous dust. Clause 5.1.7.2 shall apply.
The safety related control systems of the auger filler shall as a minimum comply with the following
Safety function PLr

Stopping the auger and stirring mechanisms when the hopper is not fitted correctly d
Preventing unexpected startup of the auger and stirring mechanisms when the hopper is d
removed
Enabling machine operation only if the extraction system is running where the product is d
hazardous
Stop of all hazardous processes by emergency stop circuit c
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5.12 Safety requirements for a volumetric cup filler
5.12.1 General
The hazards described in 4.12 shall be safeguarded by the following methods and the requirements in 5.1.
These requirements apply when a volumetric cup filler is fitted to one of the machines in the scope of this
standard.
A – Interlocking guard
B – Interlocking hopper guard
C – Infeed hopper
E – Drive mechanism guard
D – Discharge hopper
Figure 58 - Guarding requirements on a volumetric cup filler
5.12.2 Hopper
Where the hopper is fed automatically, the connection between the feeding equipment and the hopper shall
be fixed and any openings shall be dimensioned and positioned using appropriate tables of EN ISO 13857 so
it is not possible to reach danger zones in the machine through the hopper.
Where the hopper is fed from a mezzanine floor above the hopper, it is foreseeable that someone may put
their feet into the hopper and so in that case table 7 of EN ISO 13857 shall be used to determine safety
distances when designing fixed or interlocking guards.
Where the hopper is fed manually, the hopper shall either be fitted with a fixed mesh or fixed bars
dimensioned using table 4 of EN ISO 13857, or fitted with an interlocking guard as shown in by “B” in figure 59
or with ESPE complying with EN 61496-1.
5.12.3 Cup plates
The cup plates shall be enclosed with fixed or interlocking guards as shown as “A” in figure 59.
To avoid an accident during cleaning, the cup filler shall either be equipped with an isolator, accessible from
the cleaning area or the discharge hopper and other guards giving access to the shearing hazard, shall be
interlocked with devices complying with EN ISO 14119: 2013 to prevent the machine operating when the
hopper or guards are removed.
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5.12.4 Discharge hopper
The discharge hopper shall be designed to prevent access to danger zones in the cup filler when it is fitted in
place on the form fill and seal or fill and seal machine and shall either be fixed with fixings which can only be
undone with a tool or fitted with an interlocking device which complies with EN ISO 14119: 2013.
5.12.5 Ergonomic design requirements
The hopper, cups, cup plates and any other components which must be removed regularly for cleaning, shall
be designed to avoid the risk of injury due to excessive effort. Where the mass of such components is greater
than 25 kg, the manufacturer shall design the parts so that two operators can lift them or so that lifting
equipment can be used to lift them into and out of position.
If the cup filler is mounted in a position where it cannot be reached for cleaning or maintenance from the floor,
clause 5.11.7 shall apply.
Where the product being packed produces a hazardous amount of dust, the cup filler shall be enclosed with
interlocking guards and local exhaust ventilation shall be provided. Clause 5.1.7.2 shall apply.
The safety related control systems of a cup filling machine shall as a minimum comply with the following
Safety function PLr

Stopping the feeding and cup plate mechanisms when the interlocking guard is opened d
hazardous
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5.13 Safety requirements for a nett weigher
5.13.1 General
These requirements also apply to a count filling machine (3.3.8) where the equivalent hazard exists.
A – Fixed or interlocking guard

B - Product feed
C – Weigh hopper
Figure 59 - Guarding requirements for a typical net weigher
5.13.2 Product feed
Where the feed conveyor is a flat belt conveyor it shall comply with 5.2.2.3. Other types of feed conveyor shall
comply with clause 5.20.4.5 of EN 415-10:2014.
The feed conveyor shall be equipped with its own isolator.
The feed conveyor and it’s isolator shall be accessible from floor level or by the means of access for the
weigher as stated in 5.13.5 without the need for an additional means of access.
5.13.3 Vibratory feeders
The vibration tray linkages shall either be safe by design as defined by clause 5.2.1.1 of EN 415-10, or
designed in accordance with EN 349 to ensure that they do not present crushing hazards or they shall be
enclosed with fixed or interlocking guards. The method of mounting of these mechanisms shall ensure that no
hazardous vibration is transmitted to the supporting structures.
5.13.4 Weigh hopper
Where the opening and closing mechanisms of the weigh hopper are not safe by design, as defined by clause
5.2.1.1 of EN 415-10 they shall be enclosed with a fixed or an interlocking guard.
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if the weigher is mounted in a position where it cannot be reached for cleaning or maintenance from the floor,
clause 5.11.7 shall apply.
For nett weighers which are mounted on moveable packaging machines, the means of access may be a fixed
ladder complying with EN ISO 14122-4.
The safety related control systems of a nett weigher shall as a minimum comply with the following
Safety function PLr

Stopping the nett weigher when the interlocking guard is opened c
Preventing unexpected startup of the nett weigher when the interlocking guard is open d
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5.14 Safety requirements for a multi-head weigher
5.14.1 General
The hazards described in 4.14 shall be safeguarded by the following methods and the requirements in 5.1.
These requirements apply when a multi-head weigher is fitted to one of the machines in the scope of this
standard.
A – Feed conveyor
B – Interlocking guard
C – Support platform
D – Hand-rails
E – Timing hopper guard
Figure 60 - Guarding requirements on multi-head weigher
5.14.2 Feed conveyor
Where the feed conveyor is a flat belt conveyor it shall comply with clause 5.2.2.3. Where the feed conveyor
is a trough belt it shall comply with EN 620. Where the feed conveyor is some other kind of bulk feed conveyor
it shall comply with EN 618.
The feed conveyor shall be equipped with its own isolator which is accessible from the weigher support
platform without the need for mobile steps.
5.14.3 Vibratory conveyor, dispersion feeder and radial feeders
The vibration tray linkages shall either be designed in accordance with EN 349 to ensure that they do not
present crushing hazards or enclosed with fixed guards. The method of mounting of these mechanisms shall
ensure that no hazardous vibration is transmitted to the supporting structures.
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5.14.4 Pool and weigh hoppers
Where the opening and closing mechanisms of the pool and weigh hoppers are not safe by design, as defined
by clause 5.2.1.1 of EN 415-10 they shall be enclosed with interlocking guards as shown by “B” in figure 61.
5.14.5 Timing hopper
Where the opening and closing mechanisms of the timing hopper is not safe by design, as defined by clause
5.2.1.1 of EN 415-10 it shall be enclosed with an interlocking guard as shown by “E” in figure 61.
5.14.6 Cleaning weigher components
Where the weigher components need to be dismantled and cleaned more than two times a week, provision for
cleaning shall be provided on the same level as the multi-head weigher so it is not necessary to carry
components up and down access stairs.
The support platform shall comply with EN ISO 14122-2 and shall be provided with access stairs and
handrails which comply with EN ISO 14122-3.
Where the product being weighed produces a hazardous amount of dust the feed conveyor and weigher shall
be enclosed with interlocking guards and local exhaust ventilation shall be provided.
5.14.9 Noise reduction
Where the sound pressure level of the weigher running with the specified product is potentially hazardous, the
manufacturer shall:
a) Reduce noise at source by reducing product falling heights, using servomotors to close flaps or
changing contact materials or;
b) Enclosing the weigher in an acoustic enclosure which reduces the sound pressure level outside the
enclosure to a safe level.
The safety related control systems of a multi-head weigher shall as a minimum comply with the following
performance levels of EN ISO 13849-1: 2015.
Safety function PLr

Stopping the bulk feeder and multi-head weigher when the interlocking guard is opened d
hazardous
Stopping of all hazardous processes by the emergency stop circuit c
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6 Verification of safety requirements
6.1 General
The following verification procedures shall be adhered to for each machine unless stated otherwise hereafter.
6.2 Visual inspections with the machine stopped
6.2.1 Mechanical parts
Check that mechanical components are securely fixed and all unnecessary sharp edges have been removed.
6.2.2 Pneumatic systems
Check that pneumatic components and piping conform to the safety requirements of EN ISO 4414 and are
correctly installed.
6.2.3 Hydraulic systems
Check that hydraulic components and piping conform to the safety requirements of EN ISO 4413 and are
correctly installed.
6.2.4 Electrical systems
Check that documentation complies with clause 17 of EN 60204-1:2006,.
6.2.5 Guards
Check that all guards are in place and securely fixed and that the guards and their dimensions are suitable for
the hazards expected and their dimensions are according to the design. Check that all interlocking devices are
fitted. Check that adjustable guards can be properly adjusted to the specified products and pack sizes.
6.2.6 Design requirements
Check for each type of machine, that the design features stipulated in Clause 5 have been incorporated.
Check for each type of machine, that the appropriate design requirements for the packaging materials
intended to be used and the product intended to be packed have been followed.
6.2.7 Marking and warning signs
Check that the required markings and warning signs are fitted permanently and at the required position.
6.3 Measurements with the machine stopped
6.3.1 Guards
For every type of machine, check that the dimensions of the guards comply with the relevant part of clause 5
and that the relationship between the size of any openings in the guards and their safety distance from the
nearest hazard zone comply with the requirements.
6.3.2 Electrical testing
Carry out the tests required by clause 18 EN 60204-1:2006.
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6.4 Visual inspections with the machine running
6.4.1 Guards
Check with the machine running that the guards conform to the safety requirements and that the interlocking
movable guards and ESPE are working correctly.
6.4.2 Safety related functions
Check the operation of all safety related functions. Check that following the operation of an emergency stop or
interlocking device all hazardous functions cease within the required stopping time and that the machine does
not restart without resetting the emergency stop device or the interlocking devices and without an intentional
start command.
6.4.3 Dissipation of stored energy
For each type of machine check that stored energy is either dissipated automatically or a manual means of
releasing this stored energy has been provided.
6.5 Measurements or tests with the machine running
6.5.1 Electrical testing
For each machine, carry out the functional tests stated in clause 18.6 of EN 60204-1:2006.
6.5.2 Measurement of noise emission
For each type of machine, measure the noise emission values as stated in EN415-9.
6.5.3 Temperature
For every type of machine, with the machine fully warmed up, identify all the areas of the machine where the
temperature will be greater than the burn thresholds indicated in EN ISO 13732-1.
6.6 Verification procedures
Verification procedures for each safety requirement detailed in 5.1 are shown in Table 28. Verification
procedures for form, fill and seal machines are in table 29. Verification procedures for fill and seal machines
are in table 30. Verification procedures for filling machines are in table 31.
Table 30 - Verification procedures for safety requirements in clause 5.1

Visual inspection
Visual inspection
Measurement
Measurement
Function test
Function test
requirement
requirement
Calculation
Calculation
Safety
Safety
5.1.1.1 X X X X 5.1.2 X X X X
5.1.1.2 X X X 5.1.3 X X X
5.1.1.3 X X X X 5.1.4 X X X
5.1.1.4 X X X 5.1.5 X X
5.1.1.5 X X X 5.1.6 X X X
5.1.1.6 X 5.1.7 X X X X
5.1.1.7 X X X 5.1.8 X X X X
5.1.1.8 X X X 5.1.9 X X X
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Table 31 - Verification procedures for form, fill and seal machines
Visual inspection
Visual inspection
Measurement
Measurement
Function test
Function test
requirement
requirement
Calculation
Calculation
Safety
Safety
5.2 Flow-wrapping machine 5.5 Thermoform fill and seal machine
5.2.2 X X X 5.5.2 X X X
5.2.3 X X X 5.5.3 X X X
5.2.4 X X X 5.5.4 X X X
5.2.5 X X X 5.5.5 X X X
5.2.6 X X X 5.5.6 X X X
5.2.7 X X 5.5.7 X X X
5.5.8 X X X
5.3 Vertical form, fill and seal machine 5.5.9 X X X
5.3.3 X X X 5.5.10 X X X
5.3.4 X X X 5.5.11 X X X
5.3.5 X X X 5.5.12 X X X
5.3.6 X X X 5.5.13 X X X
5.3.7 X X X 5.5.14 X x
5.3.8 X X X 5.6 Tubular bag form, fill and seal machine
5.3.9 X X X 5.6.2 X X X
5.3.10 X X X 5.6.3 X X X
5.3.11 X X X 5.6.4 X X X
5.3.12 X X 5.6.5 X X X
5.6.6 X X X
5.6.7 X X X
5.6.8 x x x
5.4 Horizontal sachet form, fill and seal machine 5.6.9 X X X
5.4.2 X X X 5.6.10 X X X
5.4.3 X X X 5.6.11 X X X
5.4.4 X X X 5.6.12 X X X
5.4.5 X X X 5.6.13 X X X
5.4.6 X X X 5.6.14 X X X
5.4.7 X X X 5.6.15 X X
5.4.8 X X X
5.4.9 X X X
5.4.10 X X
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requirement
requirement
Measureme
Measureme
Calculation
Calculation
inspection
inspection
Function
Function
Safety
Safety
Visual
Visual
test
test
nt
nt
5.7.2 X X X 5.7.11 X X X
5.7.3 X X X 5.7.12 X X X
5.7.4 X X X 5.7.13 X X X
5.7.5 X X X 5.7.14 X X X
5.7.6 X X X 5.7.15 X X X
5.7.7 X X X 5.7.16 X X X
5.7.8 X X X 5.7.17 X X X
5.7.9 X X X 5.7.18 X X
5.7.10 X X X
Table 32 - Verification procedures for fill and seal machines

Measurement
Measurement
Function test
Function test
requirement
requirement
Calculation
Calculation
inspection
inspection
Safety
Safety
Visual
Visual
5.8 Pre-made bag fill and seal machine 5.10.1 In-line sack fill and seal machine
5.8.2 X X X 5.10.1.2 X X X
5.8.3 X X X 5.10.1.3 X X X
5.8.4 X X X 5.10.1.4 X X X
5.8.5 X X X X X X
5.8.6 X X X 5.10.1.5 X X X
5.8.7 X X X 5.10.1.6 X X X
5.8.8 X X X 5.10.1.7 X X X
5.8.9 X X 5.10.1.8 X X X
5.10.1.9 X X X
5.9 Cup or tub fill and seal machine 5.10.1.10 X X X
5.10.1.11 X X
5.9.2 X X X 5.10.2 Rotary sack fill and seal machine
5.9.3 X X X 5.10.2.2 X X X
5.9.4 X X X 5.10.2.3 X X X
5.9.5 X X X 5.10.2.4 X X X
5.9.6 X X X 5.10.2.5 X X X
5.9.7 X X X 5.10.2.6 X X X
5.9.8 X X X 5.10.2.7 X X X
5.9.9 X X X 5.10.2.8 X X X
5.9.10 X X X 5.10.2.9 X X X
5.9.11 X X X 5.10.2.10 X X X
5.9.12 X X X 5.10.2.11 X X X
5.9.13 X X 5.10.2.12 X X
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Table 33 - Verification procedures for filling machines
Measurement
Measurement
Function test
Function test
requirement
requirement
Calculation
Calculation
inspection
inspection
Safety
Safety
Visual
Visual
5.11 Auger filling machine 5.13 Nett weigher
5.11.2 X X X 5.13.2 X X X
5.11.3 X X X 5.13.3 X X X
5.11.4 X X X 5.13.4 X X X
5.11.5 X X X 5.13.5 X X X
5.11.6 X X X 5.13.6 X x
5.11.8 X X X
5.11.9 X X
5.12 Cup filling machine 5.14 Multi-head weigher

5.14.2 X X X
5.12.2 X X X 5.14.3 X X X
5.12.3 X X X 5.14.4 X X X
5.12.4 X X X 5.14.5 X X X
5.12.5 X X X 5.14.6 X X X
5.12.6 X X X 5.14.7 X X X
5.12.7 X X X 5.14.8 X X X
5.12.8 X X 5.14.9 X
5.14.10 X X
7 Information
7.1 General
The information provided by the manufacturer with the machine shall comply with the following clauses and
EN ISO 12100:2010, 6.4.
7.2 Marking
All machinery in the scope of this standard shall be marked visibly legibly and indelibly with the following
minimum information:
a) the business name and full address of the manufacturer and, where applicable, his authorized
representative;
b) designation of the machinery;
c) mandatory marks if appropriate, for example the CE marking;
d) designation of series or type;
e) serial number, if any;
f) year of construction, that is the year in which the manufacturing process is completed;
g) electrical markings as indicated in EN 60204-1:2006, Clause 16;
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h) rating information required for lifting equipment, if appropriate, e.g. carrying capacity, working load limit,
centre of gravity, gross weight.
7.3 Warning of residual risks
Where required in Clause 5 the following pictograms shall be fitted to the machine permanently and in such a
way that the related hazard is clearly identifiable. These warning pictograms shall comply with EN ISO 7010:
2012, reproduced below. The shape and colour of these warning pictograms shall comply with ISO 3864-1,
ISO 3864-2 and ISO 3864-3.
Warning; Hot surface Warning; Corrosive Warning; Crushing of Warning; Sharp

W017 - EN ISO 7010: substance W023 - EN hands W024- EN ISO element W022 EN ISO
2012 ISO 7010: 2012 7010: 2012 7010: 2012
Warning; Electricity Warning; Laser beam Warning; Optical No reaching in P015 -

W012- EN ISO 7010: W004 - EN ISO 7010: radiation W027 - EN EN ISO 7010: 2012
2012 2012 ISO 7010: 2012
Figure 61 - Pictograms for use on machines in the scope of this standard

7.4 Instructions
7.4.1 General
The instructions shall contain all the information listed in clause 6.4.5.1 of EN ISO 12100:2010, where the
equivalent hazard exists. In addition, the instructions shall contain the information that is specific to the
machines in the scope of this standard as stated in 7.4.4.2 to 7.4.4.12.
7.4.2 All the machines in the scope of this standard
The instructions shall contain the following information:
a) an explanation of the markings on the machine as stipulated in 7.2;
b) a description of the intended use for the machine;
c) a description of the work stations likely to be occupied by operators;
d) instructions on how to move the machine safely;
e) instructions routine maintenance, inspection and testing;
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f) where there is a risk of products or liquids spilling onto the floor around the machine, the
instructions shall indicate the importance of clearing these spills to avoid slip hazards;
g) where access is required above floor level to parts of the machine, the instructions shall explain
how this can be done safely without the risk of slipping, tripping and falling;
h) details of how to install steps and platforms supplied with the machine;
i) details of temporary means of access that the user is to provide for other purposes than
operation, cleaning or routine maintenance;
j) a description of any tests that shall be carried out before the machine is used for the first time;
k) Instructions on how to fit change parts, the fitting of change part guards and the adjustment of
adjustable guards so that the machine is safe to use following a size or product change;
l) a record and explanation of all the warning devices, signs or pictograms attached to the machine
and the warning signals provided by the machine;
m) details of the control systems including circuit diagrams for the electrical, pneumatic and
hydraulic systems. The diagrams shall show the interfaces between all permanently wired parts
and programmable devices. Wiring diagrams and documentation of the electrical equipment shall
comply with EN 60204-1:2006, Clause 17;
n) noise emission declaration required by annex A;
o) where appropriate, instructions on how the machine shall be installed to minimize noise;
p) where harmful dusts, smoke, aerosols, gas or fumes may be emitted by the machine, the
manufacturer shall provide information on a suitable collection and extraction system for these
substances, including the required air speed at the emission point;
q) specifications of fluids to be used in the machine e.g. lubricating oil, hydraulic fluid;
r) details of drainage requirements and any residual spillage risks;
s) a statement indicating whether the machine is or is not suitable for use in a potentially explosive
atmosphere.
7.4.3 Machines for use with food, cosmetics or pharmaceuticals
Where the machine is intended for use with food, cosmetics or pharmaceuticals or other products which can
be contaminated if hygienic design principles are neglected, the instructions shall indicate how the machine
shall be cleaned and disinfected, together with details of appropriate and inappropriate cleaning and
disinfecting materials. The instructions shall indicate any limitation for use with these products.
7.4.4 Specific requirements
7.4.4.1 Flow-wrapping machine
In addition to the requirements of 7.4, the instructions for a flow-wrapping machine shall include the following
information:
a) Where removable feeding devices are fitted, information on how the machine can be operated safely when
the devices have been removed;
b) The correct way to lift film reels onto the film reel unwind mechanism to avoid strain injuries;
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c) The method of earthing the reel unwind mechanisms to avoid static build up;
d) The correct temperature for the sealing jaws for each packaging material to avoid the risk of fire;
e) The ventilation requirements to remove packaging materials fumes;
f) The correct method for controlling modified controlled atmosphere packing systems;
g) The correct method of operating material sterilising systems.
7.4.4.2 Vertical form, fill and seal machine
In addition to the requirements of 7.4, the instructions for a vertical form, fill and seal machine shall include the
following information where the equivalent hazard exists.
a) The method of installing feeding devices;
d) The correct parameters for sealing each packaging material to avoid the risk of fire;
f) The correct method of operating modified atmosphere packing systems;
g) The correct method of operating materials sterilising systems.
7.4.4.3 Horizontal sachet form, fill and seal machines
In addition to the requirements of 7.4, the instructions for a horizontal sachet form, fill and seal machine shall
include the following information.
d) The correct temperature for each packaging material for the sealing jaws to avoid the risk of fire;
f) The correct method of operating modified atmosphere packing systems.
7.4.4.4 Thermoform, fill and seal machine
In addition to the requirements of 7.4, the instructions for a thermoform, fill and seal machine shall include the
following information.
b) The correct way to lift film reels onto the film reel unwind mechanisms to avoid strain
injuries;
c) The method of earthing the machine to avoid static build up;
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d) The correct temperature for each packaging material for the heating chamber and sealing dies to avoid the
risk of fire;
e) The ventilation requirements to remove packaging materials fumes.
7.4.4.5 Tubular bag form, fill and seal machine
In addition to the requirements of 7.4, the instructions for a tubular bag form, fill and seal machine shall
include the following information.
c) The method of earthing the film reel unwind mechanisms to avoid static build up;
d) The correct temperature for each packaging material for the sealing jaws and adhesive heating devices to
avoid the risk of fire;
e) The ventilation requirements to remove packaging materials or adhesive fumes.
7.4.4.6 Mandrel form fill and seal machine
In addition to the requirements of 7.4, the instructions for a mandrel form, fill and seal machine shall include
the following information.
c) The method of earthing the film reel unwind mechanisms to avoid static build up;
d) The correct temperature for each packaging material for the sealing jaws and adhesive heating devices to
avoid the risk of fire;
e) The ventilation requirements to remove packaging materials or adhesive fumes.
7.4.4.7 Pre-made bag fill and seal machine
In addition to the requirements of 7.4, the instructions for a pre-made bag fill and close machine shall include
the following information.
b) The way to load the bag magazine to avoid strain injuries;
c) The method of earthing the machine to avoid static build up;
d) The correct temperature for each packaging material for the sealing jaws to avoid the risk of fire;
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prEN 415-3:2015 (E)
7.4.4.8 Cup or tub fill and seal machine
In addition to the requirements of 7.4, the instructions for a cup or tub fill and seal machine shall include the
b) The correct method of loading cups, lids and foils
c) The correct way to load film reels onto the film reel unwind mechanisms to avoid strain
injuries;
d) The method of earthing the machine to avoid static build up;
e) The correct temperature for each packaging material for the heating chamber and sealing dies to avoid
the risk of fire;
f) The ventilation requirements to remove packaging materials fumes.
7.4.4.9 Sack fill and seal machine
In addition to the requirements of 7.4, the instructions for a sack fill and seal machine shall include the
b) The way to load sacks into the sack magazine to avoid strain injuries;
7.4.4.10 Auger filler
In addition to the requirements of 7.4, the instructions for an auger filler shall include the following information.
a) The method of installing the filler onto a form, fill and seal or fill and seal machine;
b) The way to clean the filler to avoid strain injuries and the risk of falls;
c) The ventilation requirements to avoid dangerous dust atmospheres developing.
7.4.4.11 Volumetric cup filler
In addition to the requirements of 7.4, the instructions for a volumetric cup filler shall include the following
information.
b) The way to clean the filler to avoid strain injuries and the risk of falls;
7.4.4.12 Nett weigher
In addition to the requirements of 7.4, the instructions for a nett weigher shall include the following information.
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b) The way to clean the weigher to avoid strain injuries and the risk of falls;
7.4.4.13 Multi-head weigher
In addition to the requirements of 7.4, the instructions for a multi-head weigher shall include the following
information.
a) The method of installing the weigher onto a form, fill and seal or fill and seal machine;
b) The way to clean the weigher to avoid strain injuries and the risk of falls;
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Annex A
(normative)
Noise test code
A1 General
The noise output from machines in the scope of this standard shall be measured using the methods shown in
EN 415-9.
Measurements shall be carried out on a packaging machine with it making empty packs at its normal speed
and making filled packages with either the specified product or if this is not practicable for instance because
the specified product is fragile or the machine has been specified to pack a wide range of products, a product
that is known to generate a similar amount of noise to the specified product(s).
Measurements shall be carried out on a filling machine with it running without product at its normal speed and
with either the specified product or if this is not practicable for instance because the specified product is fragile
or frozen or the machine has been specified to fill a wide range of products, a product that is known to
generate a similar amount of noise to the specified product(s).
Sound power level measurements shall be made using the methods described in EN 415-9.
The measurement positions for sound pressure level measurements shall comply with the following machine
specific requirements.
A.2 Flow-wrapping machine
The sound pressure level measurements shall be made with the machine at floor level at the following points:
 0,75 m normal distance from the main control panel at a height of 1.6 m;
 1.0 m normal distance from the centre of the back of the machine at a height of 1.6 m;
 On machines that are fed manually, 0.5 m from the machine guards in the centre of the manual
loading area at a height of 1.6 m.
A.3 Vertical form, fill and machine
The sound pressure level measurement shall be made with the machine at floor level and fitted with its
product filling device at the following points:
 1.0 m normal distance from the centre of the back of the machine at a height of 1.6 m.
A.4 Horizontal sachet form, fill and seal machine
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A.5 Thermoform, fill and seal machine Sound pressure measurement
The sound pressure level measurements shall be made with the machine at floor level at the following points:
 On machines that are fed manually, 0.5 m from the machine guards in the centre of the loading area
at a height of 1.; m.
A.6 Tubular bag form, fill and seal machine
A.7 Mandrel form fill and seal machine
A.8 Pre-made bag, erect, fill and seal machine
A.9 Cup or tub fill and seal machine
A.10 Sack fill and seal machine
The sound pressure level measurements shall be made with the machine at floor level and fitted with its
 On machines where the sack is placed on the filling spout manually, 0.5 m from the machine guards
in the centre of the loading area at a height of 1.6 m.
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A.11 Auger filler
The sound pressure level measurement shall be made with the machine supported 2.0 m above floor level
and at the following points:
 1.0 m normal distance from the centre line of the front of the machine’s guards at a height of 1.6 m;
A.12 Volumetric cup filler
A.13 Nett weigher
A.14 Multi-head weigher
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prEN 415-3:2015 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential

Requirements of EU Directive 2006/42/EC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 2006/42/EC on machinery.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the normative
clauses of this standard confers, within the limits of the scope of this standard, a presumption of conformity
with the relevant Essential Requirements of that Directive and associated EFTA regulations.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
EHSR of Heading Requirement in EN 415-3

the
Machinery
Directive
1.1.2 Principles of safety integration 5.1.1.1
1.1.3 Materials and products 5.1.7.4, 5.1.7.5, 5.7.12, 7.4
1.1.4 Lighting 5.1.1.4.1
1.1.5 Design of machinery to facilitate its 7.4
handling
1.1.6 Ergonomics 5.1.8, 5.3.11, 5.9.6, 5.11.6, 5.12.5, 5.14.6,
1.1.7 Operating positions Not applicable
1.1.8 Seating Not applicable
1.2.1 Safety and reliability of control systems 5.1,2.1, 5.2.7, 5.3.12, 5.4.10, 5.5.14, 5.6.15,
5.7.18, 5.8.9, 5.9.13, 5.10.1.11, 5.10.2.12, 5.11.9,
5.12.8, 5.13.6, 5.14.10
1.2.2 Control 5.1.2.1
1.2.3 Starting 5.1.2.1
1.2.4 Stopping 5.1.2.1
1.2.4.1 Normal stop 5.1.2.1
1.2.4.2 Operational stop 5.1.2.1
1.2.4.3 Emergency stop 5.1.2.1
1.2..4.4 Assembly of machinery 5.11./, 5.12.?, 5.13.?, 5.14.?
1.2.5 Selection of control or operating modes 5.1.1.8
1.2.6 Failure of power supply 5.1.2.1
1.3.1 Risk of loss of stability 7.4
1.3.2 Risk of break up during operation 7.4
1.3.3 Risks due to falling or ejected objects 5.7.16
1.3.4 Risks due to surfaces, edges or angles 5.1.1.1
1.3.5 Risks related to combined machinery Not applicable
1.3.6 Risks related to variations in operating 5.1.2.1
conditions
1.3.7 Risks related to moving parts 5.1.1.4.2, 5.1.1.6, 5.2.2, 5.2.3, 5.2.4, 5.2.5, 5.2.6,
5.3.2, 5.3.3, 5.3.4, 5.3.5, 5.3.6, 5.3.7, 5.3.9, 5.4.2,
5.4.3, 5.4.4, 5.4.5, 5.4.6, 5.4.7, 5.4.8, 5.4.9, 5.5.2,
5.5.3, 5.5.4, 5.5.5, 5.5.7, 5.5.8, 5.5.9, 5.5.10,
5.5.11, 5.5.12, 5.5.14, 5.6.2, 5.6.3, 5.6.5, 5.6.6,
5.6.7, 5.6.8, 5.6.9, 5.6.10, 5.6.11, 5.6.12, 5.6.13,
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prEN 415-3:2015 (E)
EHSR of Heading Requirement in EN 415-3

the
Machinery
Directive
5.6.14, 5.7.2, 5.7.3, 5.7.4, 5.7.5, 5.7.6, 5.7.7,
5.7.8, 5.7.9, 5.7.10, 5.7.11, 5.7.13, 5.7.14, 5.7.15,
5.7.16, 5.8.2, 5.8.3, 5.8.4, 5.8.5, 5.8.7, 5.8.8,
5.9.2, 5.9.3, 5.9.4, 5.9.5, 5.9.7, 5.9.8, 5.9.9,
5.9.10, 5.9.11, 5.9.12, 5.10.1.2, 5.10.1.3,
5.10.1.4, 5.10.1.5, 5.10.1.6, 5.10.1.7, 5.10.1.8,
5.10.1.9, 5.10.1.10, 5.10.2.2, 5.10.2.3, 5.10.2.4,
5.10.2.5, 5.10.2.6, 5.10.2.7, 5.10.2.8, 5.10.2.9,
5.10.2.10, 5.10.2.11, 5.11.2, 5.11.3, 5.11.4,
5.12.2, 5.12.3, 5.12.4, 5.13.2, 5.13.4, 5.14.2,
5.14.4, 5.14.5,
1.3.8 Choice of protection against risks 5.1.1.5
arising from moving parts
1.3.9 Risks of uncontrolled movements 5.1.2.1
1.4.1 General requirements 5.1.1.2, 5.1.1.4.1
1.4.2.1 Fixed Guards 5.3.8, 5.5.6.1, 5.6.4,
1.4.2.2 Interlocking movable guards 5.2.4, 5.2.5, 5.3.10, 5.5.6
1.4.2.3 Adjustable guards restricting access 5.7.4
1.4.2.4 Special requirements for protective 5.5.6,
devices
1.5.1 Electricity Supply 5.1.2.1
1.5.2 Static Electricity 5.1.2.2, 5.2.3.6
1.5.3 Energy supply other than electricity 5.1.1.3
1.5.4 Errors of fitting 7.4
1.5.5 Extreme temperatures 5.1.3, 5.2.3.3, 5.5.4
1.5.6 Fire 5.1.2.1, 5.1.3
1.5.7 Explosion 5.1.7.3
1.5.8 Noise 5.1.4, 5.14.7 Annex A
1.5.9 Vibrations 5.1.5, 5.7.15, 5.8.6, 5.13.3, 5.14.3,
1.5.10 Radiation 5.1.6
1.5.11 External radiation 5.1.2.1
1.5.12 Laser radiation 5.2.3.3
1.5.13 Emissions of hazardous materials and 5.1.7.1, 5.1.7.2, 5.11.8, 5.12.7, 5.14.8
substances
1.5.14 Risk of being trapped in a machine 5.1.1.2
1.5.15 Risk of slipping, tripping or falling 5.1.1.7, 5.11.7, 5.12.6, 5.13.5, 5.14.6
1.5.16. Lightning Not applicable
1.6.1 Machinery maintenance 7.4
1.6.2 Access to operating position and 5.1.1.7, 5.11.7, 5.12.6, 5.13.5, 5.14.6
servicing points
1.6.3 Isolation of energy sources 5.11.5
1.6.4 Operator intervention 5.1.1.8
1.6.5 Cleaning of internal parts 5.1.7
1.7.1 Information and warnings on the 7.3
machine
1.7.2 Warning of residual risks 7.3
1.7.3 Marking of machinery 7.2
1.7.4 Instructions 7.4
2.1 Foodstuffs machinery and machinery for 5.1.9
cosmetics and pharmaceutical products
114

CEN-TC146-WG2 N0050 EN 415-3 E August 2017

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prEN 415-3 : 2017

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C:\Users\Martin\Documents\Standards\WG 2\EN 415-3\EN_415-3_(E) August 2017.doc STD Version 2.5a

5.3.3 Packing material reel unwind mechanism ........................................................................................ 63

5.7.7 Transfer mechanisms ..........................................................................................................................79

5.13.2 Product feed ......................................................................................................................................... 95

A.11 Auger filler ............................................................................................................................................. 112

Other parts of this standard include:

EN 415 Safety of packaging machines;

 Part 1: Terminology and classification of packaging machines and associated equipment;

 Part 2: Pre-formed rigid container packaging machines.

 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 10: General requirements

Form fill and seal machines

 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

 Pre-made bag, erect, fill and seal machine

 Cup or tub fill and seal machine

 Sack fill and seal machine

 Volumetric cup filler

This standard does not apply to:

 Blow mould fill and seal machines

 Bulk container fill and seal machines

 Food depositors, including volumetric piston depositors

EN 415-1:2014, Safety of packaging machines – Part 1: Terminology and classification of packaging

EN 415-10:2014, Safety of packaging machines – Part 10: General requirements

EN 614-1:2006+A1:2009 Safety of machinery. Ergonomic design principles. Terminology and general

EN 614-2:2000+A1:2008, Safety of machinery — Ergonomic design principles — Part 2: Interactions between

EN 1005-4:2005+A1:2008. Safety of machinery. Human physical performance. Evaluation of working postures

EN 1672-2:2005+A1:2009, Food processing machinery — Basic concepts — Part 2: Hygiene requirements

EN 60079-14:2014. Explosive atmospheres. Electrical installations design, selection and erection

EN 60204-1:2006+A1:2009, Safety of machinery. Electrical equipment of machines. General requirements

EN 60825-1:2014, Safety of laser products. Equipment classification and requirements

EN 61496-1:2013, Safety of machinery. Electro-sensitive protective equipment. General requirements and

EN 61496-2:2013 Safety of machinery. Electro-sensitive protective equipment. Particular requirements for

3 Terms and definitions

3.1 Definition of terms

EXAMPLE PVA adhesive

EXAMPLE Corrugated board, carton board, stretch film, paper, polypropylene

3.2 Definitions of machines covered by this standard

3.2.1 Form, fill and seal machines

Figure 1 – Diagram showing the principle of operation of a typical flow-wrapping machine

3.2.2 Fill and seal machines

NOTE: The sacks may be filled in-line or on a rotary carousel

3.2.3 Filling machines

NOTE: Machines can produce one or more lanes of packs.

Hazard Harm Examples of hazardous situations Safety

Hearing loss When the sound pressure level 5.1.4

Modified atmosphere Asphyxiation Release of gas reduces the oxygen 5.1.7.4.2

Modified atmosphere Fire or explosion Contact of some products with 5.1.7.4.3

Hazard Harm Examples of hazardous Safety

Work Task Examples of hazardous situations Harm Safety

4.2 Hazards on a flow wrapping machine