kSIST FprEN 16876:2017

SLOVENSKI STANDARD
oSIST prEN 16876:2015
01-september-2015
Stroji za predelavo hrane - Stroji za izdelavo sladoleda - Varnostne in higienske
zahteve
Food processing machinery - Soft ice cream machines - Safety and hygiene
requirements
Nahrungsmittelmaschinen - Maschinen zur Herstellung von Softeis - Sicherheits- und
Hygieneanforderungen
Machines pour les produits alimentaires - Machines pour glace à l'italienne -
Prescriptions relatives à la sécurité et l'hygiène
Ta slovenski standard je istoveten z: prEN 16876
ICS:
67.100.40 6ODGROHGLQOHGHQHVODãþLFH Ice cream and ice
confectionery
67.260 Tovarne in oprema za Plants and equipment for the
živilsko industrijo food industry
oSIST prEN 16876:2015 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 16876:2015

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oSIST prEN 16876:2015

EUROPEAN STANDARD
DRAFT
prEN 16876
NORME EUROPÉENNE

EUROPÄISCHE NORM

June 2015
ICS 67.100.40; 67.260
English Version
Food processing machinery - Soft ice cream machines - Safety
and hygiene requirements
Machines pour les produits alimentaires - Machines pour Nahrungsmittelmaschinen - Maschinen zur Herstellung von
glace à l'italienne - Prescriptions relatives à la sécurité et Softeis - Sicherheits- und Hygieneanforderungen
l'hygiène
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 153.

If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations which
stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other language
made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 16876:2015 E
worldwide for CEN national Members.

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Contents Page
Foreword .4
Introduction .5
1 Scope .6
2 Normative references .6
3 Terms and definitions and description of machines .7
3.1 Terms and definitions .7
3.2 Description of machines .8
4 List of significant hazards . 10
4.1 General . 10
4.2 Mechanical hazards . 10
4.3 Electrical hazards . 12
4.4 Thermal hazards . 12
4.5 Hazards generated by noise . 12
4.6 Hazard generated by neglecting ergonomic principles . 12
4.7 Hazard generated by neglecting hygienic design principles . 13
4.8 Hazards generated by loss of stability or tipping . 13
5 Safety and hygiene requirements and/or protective measures . 13
5.1 General . 13
5.2 Mechanical hazards . 13
5.2.1 Elimination of hazards by design . 13
5.2.2 Zone 1 – Access to trapping points between the reserve tank mixture and the reserve tank
mixture lid . 13
5.2.3 Zone 2 – Access to the rotating devices through the cylinder opening . 13
5.2.4 Zone 3 – Access to the transmission mechanism of the mixing device . 14
5.2.5 Zone 4 – Loss of stability of machine – access to areas adjacent to the machine . 14
5.3 Electrical hazards . 14
5.3.1 General . 14
5.3.2 Safety requirements relating to electromagnetic phenomena . 14
5.3.3 Protection against electric shock . 14
5.3.4 Power circuits . 14
5.3.5 Earth faults . 15
5.3.6 Emergency stop . 15
5.3.7 Start function . 15
5.3.8 Unexpected start-up . 15
5.3.9 Motor enclosures . 15
5.3.10 Electrical requirements of controls . 15
5.4 Thermal hazards . 15
5.5 Noise control . 15
5.6 Ergonomic design principles . 15
5.7 Hygiene requirements . 16
5.7.1 General . 16
5.7.2 Food area . 16
5.7.3 Splash area . 16
5.7.4 Non-food area . 16
5.7.5 Refrigeration . 16
5.8 Harmful substance. 17
6 Verification of safety and hygiene requirements and/or protective measures . 17
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7 Information for use . 18
7.1 General . 18
7.2 Instruction handbook . 18
7.3 Service manual . 19
7.4 Cleaning . 19
7.5 Marking . 19
Annex A (normative) Noise test code (Grade 2 of accuracy) . 21
A.1 Terms and definitions . 21
A.2 Installation and mounting conditions . 21
A.3 Operating conditions . 21
A.4 Emission sound pressure level determination . 21
A.5 Measurement uncertainties . 21
A.6 Information to be recorded . 22
A.7 Information to be reported . 22
A.8 Declaration and verification of noise emission values . 22
Annex B (normative) Principles of design to ensure the cleanability of the machinery . 23
B.1 Terms and definitions . 23
B.2 Material of construction . 23
B.3 Design . 24
Annex C (normative) Testing Disinfection of Soft Ice Cream Machines . 41
C.1 Testing disinfection by cleaning . 41
C.2 Testing of the pasteurization process . 41
C.3 Testing during soft ice cream production . 42
Annex ZA (informative) Relationship between this European Standard and the Essential Requirements

of EU Directive 2006/42/EC . 43
Bibliography . 44

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Foreword
This document (prEN 16876:2015) has been prepared by Technical Committee CEN/TC 153 “Machinery intended
for use with foodstuffs and feed”, the secretariat of which is held by DIN.
This document is currently submitted to the CEN Enquiry.
This document 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 2006/42/EC.
For relationship with EU Directive 2006/42/EC, see informative Annex ZA, which is an integral part of this document.
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Introduction
This European Standard is a type C standard as stated in EN ISO 12100:2010.
The machinery concerned and the extent to which hazards, hazardous situations and hazardous events are covered
are indicated in the scope of this document.
When provisions of this type C standard are different from those which are stated in type-A- or –B-standards, the
provisions of this type-C-standard take precedence over the provisions of the other standards for machines that
have been designed and built according to the provisions of this type-C-standard.
Complementary to the hygiene requirements common to all food processing machines, specific requirements for
cleanability and sanitation of the machines in the scope are formulated.
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1 Scope
This European Standard applies to machines of handling and delivery of soft ice cream, frozen yogurt, milk shake
machinery and other food products as chocolate and pastry, as described in Clause 3.
The European Standard applies to fixed and movable machinery (not designed to be moved during operation), with
a rated capacity of not more than 150 kg/h.
This European Standard deals with all significant hazards, hazardous situations and events relevant to the
machinery, when they are used as intended and under conditions of misuse which are reasonably foreseeable by
the manufacturer (see Clause 4).
This European Standard deals with the hazards which can arise during transport, assembly, commissioning,
operation, cleaning, use, maintenance, decommissioning, dismantling, disabling and scrapping of the machine.
This European Standard covers the following types of machines:
— soft ice cream, frozen yogurt and milk shake machinery;
This European Standard does not apply to equipment feeding and dosing, equipment, supply of inert gas and
heating and cooling equipment and any extraction (container, extraction belt, etc.).
This European Standard is not applicable to machines which are manufactured before the date of publication of this
European Standard by CEN.
2 Normative references
The following 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 953:1997+A1:2009, Safety of machinery ― Guards ― General requirements for the design and construction of
fixed and movable guards
EN 1672-2:2005+A1:2009, Food processing machinery ― Basic concepts ― Part 2: Hygiene requirements
EN 60204-1:2006, Safety of machinery ― Electrical equipment of machines ― Part 1: General requirements (IEC
60204:2005, modified)
EN 60529, Degrees of protection provided by enclosures (IP Code) (IEC 60529)
EN ISO 3744:2010, Acoustics ― Determination of sound power levels and sound energy levels of noise sources
using sound pressure ― Engineering methods for an essentially free field over a reflecting plane (ISO 3744:2010)
EN ISO 4287, Geometrical product specifications (GPS) ― Surface texture: Profile method ― Terms, definitions and
surface texture parameters (ISO 4287)
EN ISO 4871, Acoustics ― Declaration and verification of noise emission values of machinery and equipment (ISO
4871)
EN ISO 11201, Acoustics ― Noise emitted by machinery and equipment ― Determination of emission sound
pressure levels at a work station and at other specified positions in an essentially free field over a reflecting plane
with negligible environmental corrections (ISO 11201)
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EN ISO 11688-1, Acoustics ― Recommended practice for the design of low-noise machinery and equipment ― Part
1: Planning (ISO/TR 11688-1)
EN ISO 12100:2010, Safety of machinery ― General principles for design ― Risk assessment and risk reduction
(ISO 12100:2010)
EN ISO 13732-1, Ergonomics of the thermal environment ― Methods for the assessment of human responses to
contact with surfaces ― Part 1: Hot surfaces (ISO 13732-1)
EN ISO 13732-3, Ergonomics of the thermal environment ― Methods for the assessment of human responses to
contact with surfaces ― Part 3: Cold surfaces (ISO 13732-3)
EN ISO 13849-1:2008, Safety of machinery ― Safety-related parts of control systems ― Part 1: General principles
for design (ISO 13849-1:2006)
EN ISO 13850, Safety of machinery ― Emergency stop ― Principles for design (ISO 13850)
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 (ISO 14119:2013)
3 Terms and definitions and description of machines
3.1 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 12100:2010 and the following apply.
3.1.1
closure of storage liquid soft ice cream’s tank
mobile guard used for the tank which contains the liquid soft ice cream
3.1.2
storage liquid soft ice cream’s tank
tank with direct or indirect cooling used to contain, preserve or heat-treating the liquid soft ice cream
3.1.3
cylinder
part of machinery suitable for the treatment of the liquid soft ice cream
3.1.4
mixing device
suitable device for mixing the liquid soft ice cream
3.1.5
dispenser
suitable device to dispense the finished product
3.1.6
feed opening device
suitable device to transfer the product from the liquid soft ice cream to the tank
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3.2 Description of machines
Combined machines
The machines covered by this standard are designed to prepare soft ice cream machinery (soft ice cream, frozen
yogurt and milk shake, whose main ingredients are generally milk and its derivatives. When the tub is in the load
position, the machine receives the ingredients are weighed or measured. This operation is controlled by the operator
of the machine.
The machine works the ingredients over a period of time defined by a user cycle.
At the end of the processing cycle, the product is downloaded into a mobile container through a regulator controlled
by the tap.
The machine can be operated manually or fully automatically.
In Figure 1 is shown a machine for ice cream expressed typical single tank with the following main elements:
— closure of storage liquid soft ice cream’s tank;
— storage liquid soft ice cream’s tank;
— feed opening device;
— mixing device;
— cylinder;
— dispenser;
— condensing unit;
— wheels or feet.
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Key
1 lid of storage liquid soft ice cream’s tank 8 cooling device
2 storage liquid soft ice cream’s tank 9 condensing unit
3 pump 10 compressor
4 mixing device 11 wheels or feet
5 cylinder
6 dispenser
7 refrigerated compartment
Figure 1 — Typical layout of soft ice cream machinery
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4 List of significant hazards
4.1 General
This clause contains all the significant hazards, hazardous situations and events, as far as they are dealt with in this
European Standard, identified by risk assessment as significant for this type of machinery and which require action
to eliminate or reduce the risk.
4.2 Mechanical hazards
The example shown in Figure 2 illustrates the position of danger zones associated with mechanical hazards for each
type of machinery:
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Key
1 zone 1
2 zone 2
3 zone 3
4 zone 4
Figure 2 — Danger zones of soft ice cream machinery
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Zone 1: Access to trapping points between the storage liquid soft ice cream’s tank and the lid of the storage liquid
soft ice cream’s tank.
— crushing hazard of fingers and hands between the edge of the storage liquid soft ice cream’s tank and the lid.
Zone 2: Access to the rotating devices through the cylinder opening;
— hazards of trapping and shearing of arms between the blades of mixing device and the cylinder.
Zone 3: Access to the transmission mechanism of the mixing device;
— hazard of trapping and shearing of whole part of body.
Zone 4: Loss of stability of machine – access to areas adjacent to the machine;
— hazard of trapping and crushing of whole or part of body if machine overturns.
4.3 Electrical hazards
Hazard of electric shock from direct or indirect contact with live components.
Hazard of external influences on electrical equipment (e.g. cleaning with water).
If liquids such as spilled products or cleaning agents such as water come into contact with the electrical conductors,
there is a danger of electric shock.
4.4 Thermal hazards
High temperature of external parts and hand operated components creates a hazard of scalds and burns.
This hazard can be present also when the machinery is switched off.
4.5 Hazards generated by noise
Machinery can generate an airborne noise being able to involve a deterioration of hearing or to cause accidents due
to the interferences with the oral communication and the perception of the acoustical signals.
The noise can produce:
— ringing in the ears;
— tiredness, stress, etc.;
— other effects such as loss of balance, loss of perception;
— interference with speech communication;
— inability to hear acoustic warning signals.
4.6 Hazard generated by neglecting ergonomic principles
During operation, cleaning and maintenance, there could be the risk for safety and health resulting from awkward
body postures or from an excessive effort.
Movement or filling of the storage liquid soft ice cream’s tank especially at heights can create a risk of injury to the
body from lifting, pushing and pulling of heavy loads.
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4.7 Hazard generated by neglecting hygienic design principles
The neglect of hygienic principles can create unacceptable contamination of foodstuff and therefore a risk to human
health of the operator and consumer, i.e. through physical, chemical or microbial pollution.
4.8 Hazards generated by loss of stability or tipping
Risk of impact or crushing of the body, in particular resulting from machinery with castors.
5 Safety and hygiene requirements and/or protective measures
5.1 General
Machinery shall be designed according to the principles of EN ISO 12100:2010 for hazards relevant but not
significant, which are not dealt with by this standard (e.g. sharp edges).
This specific risk assessment shall be part of the general risk assessment of the machine.
When fixed guards or parts of the machine acting as such, are not permanently fixed, e.g. by welding, their fixing
systems shall remain attached to the guards or to the machinery when the guards are removed.
5.2 Mechanical hazards
5.2.1 Elimination of hazards by design
Unless otherwise specified, interlocking guards shall be at least interlocking without guard blocking as defined in
EN ISO 14119:2013, 4.2, and they shall comply with EN ISO 14119:2013, Clause 5, 7 and 8.
Access to dangerous zones of drive shafts, coupling between the motor and the reduction gear shall be prevented
by fixed guards or movable interlocking guards in accordance with EN 953:1997+A1:2009.
Any gaps between moving parts and fixed parts of the machinery shall be so arranged that either it is not possible
for a finger to enter the gap (i.e. a gap of 6 mm or less), or the gap shall be sufficiently large to prevent trapping and
crushing in accordance with EN 349:1993+A1:2008, Table 1.
The safety-related parts of the control system shall meet at least a performance level “c” defined in accordance with
EN ISO 13849-1:2008. Openings in guards shall comply with EN ISO 13857:2008, Table 4.
5.2.2 Zone 1 – Access to trapping points between the reserve tank mixture and the reserve tank mixture
lid
Covers of the storage liquid soft ice cream’s tank shall be stable when they are in the open position to prevent
unintentional closing (e.g. with balancing systems). The speed of closure of lids of the storage liquid soft ice cream’s
tank shall not be greater than 50 mm/s when the distance from the tank to the front edge of the cover is less than
200 mm. For ergonomic requirements, see 5.6.
5.2.3 Zone 2 – Access to the rotating devices through the cylinder opening
Access to moving parts that contribute to the work, e.g. mixing devices, shall be prevented by fixed or movable
guards in accordance with EN 953:1997+A1:2009. Movable guards shall be designed with interlocking devices in
accordance with EN ISO 14119:2013. The opening of the interlocked guard shall stop any dangerous movements
within 4 s with the machine being empty.
Openings in guards shall be in accordance with EN ISO 13857:2008, Table 4.
Access to mixing device shall be prevented through the dispenser device, e.g. using a fixed or interlocked guard.
Guards shall prevent the access from any side of the machinery. The dimensions of the guard shall comply with the
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safety distances in EN ISO 13857:2008, Table 2. Guards shall fulfil the requirements given in
EN 953:1997+A1:2009. The guards shall be designed so that there is a good view of the area behind it, e.g. using
grids. Openings in guards shall be in accordance with EN ISO 13857:2008, Table 4.
It shall not be possible to operate the mixing element when the guards are opened, and the opening of a guard shall
stop the mixing element with 4 s when the machine is empty. If this is not possible, guards shall be interlocked with
guard locking which is released only when the mixing device is stopped.
5.2.4 Zone 3 – Access to the transmission mechanism of the mixing device
Access to the area in which the mixing device operates shall be prevented by an interlocked solid guard, movable
with lock control guard (see EN ISO 14119:2013, 4.3). Openings and/or loading slides in cover or in the tank shall be
in accordance with EN ISO 13857:2008, 4.5. For small openings shall be used to EN ISO 13857:2008, Table 4.
5.2.5 Zone 4 – Loss of stability of machine – access to areas adjacent to the machine
Machines shall be designed to be stable. For machines designed to be fixed to the floor, the instruction handbook
shall indicate the values of forces at the fixing points and the d
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