FprEN 16878

Food processing machinery - Combined machines and batch freezers - Safety and hygiene requirements

This document applies to discontinuous combined machines and batch freezers as described in 3.2.
The document applies to fixed and movable machinery (not designed to be moved during operation), with a capacity of not more than 200 l.
This document 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 document deals with the hazards which can arise during transport, assembly, commissioning, operation, cleaning, use, maintenance, decommissioning, dismantling, disabling and scrapping of the machine.
This document does not give requirements for heating and cooling equipment.
This document is not applicable to machines which are manufactured before the date of publication of this document by CEN.

Nahrungsmittelmaschinen - Kombi-Geräte und Eismixgefriergeräte - Sicherheits- und Hygieneanforderungen

Diese Europäische Norm gilt für diskontinuierliche Kombi Geräte und Eismixgefriergeräte, wie in 3.2 beschrieben.
Die Norm gilt für fest installierte und ortsveränderliche Maschinen (die nicht dazu bestimmt sind, während des Betriebs bewegt zu werden), mit einem Fassungsvermögen von nicht mehr als 200 l.
Diese Europäische Norm behandelt alle signifikanten Gefährdungen, gefahrbringende Situationen und Ereignisse, die auf diese Maschinen zutreffen, wenn sie bestimmungsgemäß und unter Bedingungen von durch den Hersteller vernünftigerweise vorhersehbaren Fehlanwendungen verwendet werden (siehe Abschnitt 4).
Diese Europäische Norm behandelt die Gefährdungen, die während Transport, Montage, Inbetriebnahme, Betrieb, Reinigung, Verwendung, Instandhaltung, Außerbetriebnahme, Demontage, Außerbetriebsetzung und Verschrottung der Maschine auftreten können.
Diese Europäische Norm legt keine Anforderungen für Heiz  und Kühlgeräte fest.
Diese Europäische Norm gilt nicht für Maschinen, die vor deren Veröffentlichung durch CEN hergestellt wurden.

Machines pour les produits alimentaires - Machines combinées et turbines à glace - Prescriptions relatives à la sécurité et à l'hygiène

La présente Norme européenne s'applique aux machines combinées à fonctionnement discontinu et aux turbines à glace telles que décrites en 3.2.
La présente norme s'applique aux machines fixes et mobiles (non conçues pour être déplacées en cours de fonctionnement) d'une capacité inférieure ou égale à 200 l.
La présente Norme européenne traite de tous les phénomènes dangereux, situations et événements dangereux significatifs applicables aux machines lorsqu'elles sont utilisées normalement et dans les conditions de mauvais usage raisonnablement prévisible par le fabricant (voir Article 4).
La présente Norme européenne traite des phénomènes dangereux qui peuvent survenir pendant le transport, l'assemblage, la mise en service, le fonctionnement, le nettoyage, l'utilisation, la maintenance, la mise hors service, le démontage et la mise au rebut de la machine.
La présente Norme européenne ne donne aucune prescription relative aux équipements de chauffage et de refroidissement.
La présente Norme européenne ne s’applique pas aux machines fabriquées avant la date de publication de la présente Norme européenne par le CEN.

Stroji za predelavo hrane - Kombinirani stroji in serije zamrzovalnikov - Varnostne in higienske zahteve

General Information

• Status: Not Published
• Publication Date: 12-Apr-2017
• ICS: 67.100.40 - Ice cream and ice confectionery
• ICS: 67.260 - Plants and equipment for the food industry
• Technical Committee: CEN/TC 153 - Food processing machinery - Safety and hygiene specifications
• Drafting Committee: CEN/TC 153/WG 6 - Artisan ice cream machinery
• Current Stage: 5098 - Decision to abandon - Formal Approval
• Start Date: 29-Sep-2021
• Completion Date: 14-Apr-2025
• Directive: 2006/42/EC - Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast)
• Mandate: M/396 - Mandate to CEN and Cenelec for standardisation in the field of machinery
• Ref Project: SIST EN 16878:2018 - Food processing machinery - Combined machines and batch freezers - Safety and hygiene requirements

Overview

FprEN 16878 is a European Standard developed by CEN that specifies safety and hygiene requirements for combined machines and batch freezers used in food processing. It applies to discontinuous, fixed or movable machinery with a capacity of up to 200 liters, primarily focusing on ensuring safe operation and hygienic design. This standard addresses significant hazards throughout the machinery lifecycle-including transport, assembly, operation, cleaning, and decommissioning-highlighting foreseeable misuse scenarios to protect users and maintain food safety.

This standard is essential for manufacturers, safety engineers, and quality managers working with food processing machinery, ensuring compliance with EU Directive 2006/42/EC and facilitating safer, cleaner, and more reliable equipment in the food industry.

Key Topics

• Scope and Application

  • Applies to combined machines and batch freezers (discontinuous operation).
  • Covers safety during all phases: transport, commissioning, operation, cleaning, maintenance, and dismantling.
  • Excludes heating and cooling equipment requirements.
  • Targets machines made after the publication date by CEN.

• Hazard Identification

  • Addresses mechanical, electrical, thermal, noise, ergonomic, hygienic, and stability hazards.
  • Focuses on zones with trapping points, rotating parts, transmission mechanisms, and risk of tipping.
  • Anticipates risks from reasonable misuse and environmental factors.

• Safety Measures

  • Mechanical hazard elimination via design.
  • Electrical protections including prevention of electric shock, proper motor enclosures, and emergency stops.
  • Controls to avoid unexpected startup.
  • Thermal protections to prevent burns or cold injuries.
  • Noise control guidelines and ergonomic considerations.
  • Design principles to ensure cleanability and hygiene in food, splash, and non-food areas.

• Verification and Testing

  • Requires verification of safety and hygiene protective measures.
  • Includes noise emission testing protocols to meet Grade 2 accuracy.
  • Implements comprehensive documentation including instruction handbooks, service manuals, cleaning procedures, and machine marking.

Applications

FprEN 16878 is vital for:

• Manufacturers of Food Processing Machinery: Ensures product designs meet current safety and hygiene regulations, reducing liabilities and improving market acceptance.
• Food Industry Plants: Helps operators select compliant machinery that minimizes hazards during processing, handling, and cleaning.
• Safety Inspectors and Auditors: Provides clear guidelines and verification methods to assess machine safety performance.
• Maintenance and Cleaning Personnel: Offers hygienic design principles that simplify maintenance tasks and reduce contamination risks.
• Regulatory Bodies: Standardizes safety and hygiene requirements supporting EU directives for machinery safety.

By adhering to the requirements of this standard, companies enhance workplace safety, protect food integrity, and ensure smooth regulatory compliance across European markets.

Related Standards

• EN 60529: Degrees of protection provided by enclosures (IP Code), referenced for electrical equipment protection.
• EU Directive 2006/42/EC: Machinery Directive outlining essential health and safety requirements for machinery placed on the EU market.
• Other standards under CEN/TC 153 focusing on machinery for foodstuffs and feed, contributing to harmonized safety protocols in the food processing sector.

---

By implementing FprEN 16878, stakeholders in the food processing industry can assure the safety and hygiene of combined machines and batch freezers-key equipment for producing safe, high-quality food products in compliance with European safety mandates.

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN 16878:2015
01-september-2015
Stroji za predelavo hrane - Kombinirani stroji in serije zamrzovalnikov - Varnostne
in higienske zahteve
Food processing machinery - Combined machines and batch freezers - Safety and
hygiene requirements
Nahrungsmittelmaschinen - Kombi-Geräte und Eismixgefriergeräte - Sicherheits- und
Hygieneanforderungen
Machines pour les produits alimentaires - Machines combinées et turbines à glace -
Prescriptions relatives à la sécurité et l'hygiène
Ta slovenski standard je istoveten z: prEN 16878
ICS:
27.200 Hladilna tehnologija Refrigerating technology
67.260 Tovarne in oprema za Plants and equipment for the
živilsko industrijo food industry
oSIST prEN 16878:2015 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN 16878:2015
oSIST prEN 16878:2015
EUROPEAN STANDARD
DRAFT
prEN 16878
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2015
ICS 67.100.40; 67.260
English Version
Food processing machinery - Combined machines and batch
freezers - Safety and hygiene requirements
Nahrungsmittelmaschinen - Kombi-Geräte und
Eismixgefriergeräte - Sicherheits- und
Hygieneanforderungen
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 16878:2015 E
worldwide for CEN national Members.

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prEN 16878:2015 (E)
Contents Page
Foreword .5
Introduction .6
1 Scope .7
2 Normative references .7
3 Terms and definitions and description of machines .8
3.1 Terms and definitions .8
3.2 Description of machines .9
3.2.1 Combined machines .9
3.2.2 Batch freezers . 10
4 List of significant hazards . 11
4.1 General . 11
4.2 Mechanical hazards . 11
4.2.1 General . 11
4.2.2 Combined machines . 12
4.2.3 Batch freezers . 13
4.3 Electrical hazards . 14
4.4 Thermal hazards . 14
4.5 Hazards generated by noise . 14
4.6 Hazard generated by neglecting ergonomic principles . 14
4.7 Hazard generated by neglecting hygienic design principles . 14
4.8 Hazards generated by loss of stability or tipping . 14
5 Safety and hygiene requirements and/or protective measures . 15
5.1 General . 15
5.2 Mechanical hazards . 15
5.2.1 Elimination of hazards by design . 15
5.2.2 Zone 1 – Access to trapping points between the tank and the machinery’s lid . 15
5.2.3 Zone 2 – Access to the rotating devices through the feed opening . 15
5.2.4 Zone 3 – Access to the rotating parts through the draw-off opening . 15
5.2.5 Zone 4 – Access to the transmission mechanism of the mixing device . 16
5.2.6 Zone 5 – Loss of stability of machine – access to areas adjacent to the machine . 16
5.3 Electrical hazards . 17
5.3.1 General . 17
5.3.2 Safety requirements relating to electromagnetic phenomena . 17
5.3.3 Protection against electric shock . 17
5.3.4 Power circuits . 17
5.3.5 Earth faults . 17
5.3.6 Emergency stop . 17
5.3.7 Degrees of protection of external enclosures of electrical equipment (see EN 60529) . 17
5.3.8 Start function . 17
5.3.9 Unexpected start-up . 17
5.3.10 Motor enclosures . 18
5.3.11 Electrical requirements of controls . 18
5.4 Thermal hazards . 18
5.5 Noise control . 18
5.6 Ergonomic design principles . 18
5.7 Hygiene requirements . 18
5.7.1 General . 18
5.7.2 Food area . 18
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5.7.3 Splash area . 19
5.7.4 Non-food area . 19
5.7.5 Refrigeration . 19
5.8 Harmful substance . 21
6 Verification of safety and hygiene requirements and/or protective measures . 21
7 Information of use . 22
7.1 General . 22
7.2 Instruction handbook . 22
7.3 Service manual . 24
7.4 Cleaning. 24
7.5 Marking . 24
Annex A (normative) Noise test code (Grade 2 of accuracy) . 25
A.1 Terms and definitions . 25
A.2 Installation and mounting conditions . 25
A.3 Operating conditions . 25
A.4 Emission sound pressure level determination . 25
A.5 Measurement uncertainties . 26
A.6 Information to be recorded . 26
A.7 Information to be reported. 26
A.8 Declaration and verification of noise emission values . 26
Annex B (normative) Principles of design to ensure the cleanability of the machinery . 27
B.1 Terms and definitions . 27
B.2 Material of construction . 27
B.2.1 Type of materials . 27
B.2.2 Surface conditions . 27
B.3 Design . 28
B.3.1 Connection of internal surfaces . 28
B.3.1.1 General . 28
B.3.1.2 Connections of internal surfaces for food area . 28
B.3.1.3 Connections of internal surfaces for splash area . 31
B.3.1.4 Connections of internal surfaces for non-food area . 32
B.3.2 Surface assemblies and overlaps . 32
B.3.2.1 General . 32
B.3.2.2 Surface assemblies and overlaps for food area . 33
B.3.2.2.1 Surface assembly . 33
B.3.2.2.2 Surface overlapping . 33
B.3.2.3 Surface assemblies and overlaps for splash area . 35
B.3.2.4 Surface assemblies and overlaps for non-food area . 36
B.3.3 Fasteners . 37
B.3.3.1 Fasteners for food area . 37
B.3.3.1.1 General . 37
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B.3.3.1.2 Spot-facing . 37
B.3.3.1.3 Pin drive systems . 37
B.3.3.2 Fasteners for splash area . 37
B.3.3.3 Fasteners for non-food area . 38
B.3.4 Feet, support and bases for cleaning the machines underneath . 38
B.3.4.1 Table-top machines . 38
B.3.4.2 Machines on the floor . 40
B.3.4.2.1 Fixed machines with or without a base . 40
B.3.4.2.2 Mobile machines . 41
B.3.5 Ventilation openings . 42
B.3.5.1 Ventilation openings for non-food area . 42
B.3.5.2 Ventilation openings for splash area . 42
B.3.6 Hinges . 42
B.3.7 Control panel . 43
B.3.7.1 Control panel in the non-food area . 43
B.3.7.2 Control panel in the splash area . 43
Annex ZA (informative) Relationship between this European Standard and the Essential

Requirements of EU Directive 2006/42/EC . 45
Bibliography . 46

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Foreword
This document (prEN 16878:2015) 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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prEN 16878:2015 (E)
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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prEN 16878:2015 (E)
1 Scope
This European Standard applies to machines of handling and delivery of ice cream mixes, pasty liquid
products for gelato, pastry, chocolate and food processing, as described in Clause 3.
The standard applies to fixed and movable machinery (not designed to be moved during operation), with a
rated capacity of not more than 100 L.
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:
— combined machines (pasteurizers and batch freezer);
— batch freezer.
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 614-1, Safety of machinery — Ergonomic design principles — Part 1: Terminology and general principles
EN 953, 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 60204-1:2005, 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)
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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)
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
tank lid
mobile guard used to close the tank which contains the mixing device
3.1.2
mixing device
suitable device to ensure mixing and circulation of the mixture
3.1.3
draw-off device
suitable device to allow the extraction of the finished product
3.1.4
tank
part of the machinery suitable to contain the mixture during the work cycle
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3.1.5
compression type machines
machines where the cooling is performed by means of a refrigerant liquid at low pressure in a heat exchanger
(evaporator), the steam thus formed becoming a liquid by a mechanical compression higher pressure and
cooling in another heat exchanger (condenser)
3.1.6
condenser
heat exchanger in which after compression, the vaporized refrigerant is liquefied, giving off heat to external
cooling system
3.1.7
evaporator
heat exchanger in which, after the reduction of pressure, the refrigerant is vaporized by absorbing heat from
the medium which shall be cooled
3.1.8
heating and freezing devices
device suitable to the heating and/or freezing food mixtures
3.2 Description of machines
3.2.1 Combined machines
The machines covered by this standard are designed to pasteurize and freezing batches of liquid pasty,
whose main ingredients are generally milk and its derivatives.
When the tank of pasteurization and freezing is in the load phase, the machine receives the ingredients
weighed or measured. This operation is controlled by the operator of the machine.
The machine pasteurizes and freezes the ingredients during a period of time defined by a user cycle. At the
end of the cycle of pasteurization and freezing, the product is downloaded through a draw-off device. The
machine can be operated manually or fully automatically. The single tank or double tank can be heated or
cooled. Figure 1 illustrates a typical machine combined with the following main elements:
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prEN 16878:2015 (E)
Key
1 tank
2 cover of flange
3 agitation device
4 extraction device
5 heating or freezing device
6 compressor
7 condensing unit
8 wheels or feet
Figure 1 — Typical layout of combined machines
3.2.2 Batch freezers
Batch freezers perform only the operations of freezing of the liquid mixture, not providing the opportunity to
pasteurize the product.
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prEN 16878:2015 (E)
Key
1 tank
2 cover of flange
3 agitation device
4 extraction device
5 heating or freezing device
6 compressor
7 condensing unit
8 wheels or feet
Figure 2 — Typical layout of batch freezers
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
4.2.1 General
The example in Figure 3 and 4 shows the position of danger zones associated with mechanical hazards for
each type of machinery:
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4.2.2 Combined machines
Key
1 zone 1
2 zone 2
3 zone 3
4 zone 4
5 zone 5
Figure 3 — Danger zones of combined machines
Zone 1: Access to trapping points between the tank and the combined machine lid
− crushing hazard of fingers and hands between the edge of pasteurization and freezing tank and
the lid.
Zone 2: Access to the rotating devices through the feed opening
− hazards of trapping and shearing of arms between the blades of mixing device and the
pasteurization and freezing tank.
Zone 3: Access to the rotating parts through the draw-off opening
− hazard of trapping and shearing of arms between the blades of rotating device and the
pasteurization and freezing tank.
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Zone 4: Access to the transmission mechanism of the mixing device
− hazard of trapping and shearing of whole part of body.
Zone 5: 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.
4.2.3 Batch freezers
Key
1 zone 1
2 zone 2
3 zone 3
4 zone 4
5 zone 5
Figure 4 — Danger zones of batch freezers
Zone 1: Access to trapping points between the tank and the batch freezer’s lid
− crushing hazard of fingers and hands between the edge of the batch freezer’s tank and the lid.
Zone 2: Access to the rotating devices through the feed opening
− hazards of trapping and shearing of arms between the blades of mixing device and the batch
freezer’s tank.
Zone 3: Access to the rotating parts through the draw-off device
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− hazard of trapping and shearing of arms between the blades of rotating device and batch freezer
tank.
Zone 4: Access to the transmission mechanism of the mixing device
− hazard of trapping and shearing of whole part of body.
Zone 5: Loss of stability of machine – access to areas adjacent to the machine
− hazard of trapping and crushing of whole 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 liquid 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 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 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 tank especially at heights can create a risk of injury to the body from lifting, pushing
and pulling of heavy loads.
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 the body, in particular resulting from machinery with castors.
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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 guard 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. 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.
Openings in guards shall comply with EN ISO 13857:2008, Table 4.
5.2.2 Zone 1 – Access to trapping points between the tank and the machinery’s lid
Covers of tanks shall be stable when they are in the open position to prevent unintentional closing (e.g. with
balancing systems). The speed of closure of the lids, having a mass greater than 2,8 kg, shall not be greater
than 50 mm/s when the distance from the hopper/tank to the front edge of the lid is less than 200 mm. The
interlocking device of the lid shall operate at a maximum opening of the lid of 30 mm. For ergonomic
requirements see 5.6.
5.2.3 Zone 2 – Access to the rotating devices through the feed opening
Access to moving parts that contribute to the work, e.g. spatulas, scrapers mixing unit shall be prevented by
fixed or movable guards in accordance with EN 953. Movable guards shall be designed with interlocking
devices in accordance with EN ISO 14119:2013. The opening of the interlocked guard shall cause the arrest
of dangerous movements by 4 s. Openings in guards shall be in accordance with EN ISO 13857:2008,
Table 4.
5.2.4 Zone 3 – Access to the rotating parts through the draw-off opening
It shall not be possible to operate the mixing element when the guards are open. Opening of a guard shall be
stopped the mixing element within 4 s when the machine is empty. Access to the area in which the mixing
device moves shall be prevented using a guard at a fixed distance or interlocked. The dimension of the guard
shall comply with the safety distances in EN ISO 13857:2008, Table 4. The guards shall be constructed in
accordance with the requirements of EN 953. The guards shall be designed so that there is a good view of the
area behind the guards, e.g. you can use grids.
Alternative solutions can be adopted, e.g.:
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prEN 16878:2015 (E)
— a solid slide or a hopper attached to the draw-off device of the machine to collect the product in
accordance with EN ISO 13857:2008, Table 4;
— a draw-off opening with a protection device (see Figure 5), obtained with a mobile guard hinged on the
top which under the pressure of the gelato opens automatically. Its closure in the safety position is
obtained by gravity when the output of the gelato stopped. Opening of this device shall be permitted only
in the direction of the draw-off. The opening angle of the mobile guard shall be ≤ 50°.
The whole device shall be fitted with an interlock device on the fixed part.

Key
1 draw-off tilting device
2 mobile guard hinged
3 contactless coded sensor
4 interlocking device
5 open door lever
Figure 5 — Safety device
5.2.5 Zone 4 – Access to the transmission mechanism of the mixing device
Access to the area in which the mixing device operate 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, 4.2.
5.2.6 Zone 5 – 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 dimensions of the anchor points
provided.
Free standing machines without castors shall not fall or tip over when tilted 10° from the horizontal plane in the
most unfavourable direction and containing the most unfavourable load.
Free standing machines with castors shall have at least two castors (or sets of castors) fitted with a locking
device to prevent rolling or turning.
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prEN 16878:2015 (E)
5.3 Electrical hazards
5.3.1 General
Unless otherwise specified, the electrical equipment shall comply with EN 60204-1:2006, with the following
precision.
5.3.2 Safety requirements relating to electromagnetic phenomena
The machines shall have sufficient immunity to electromagnetic disturbances to enable them to operate safely
as intended and not fail to danger when exposed to the levels and types of disturbances intended by the
manufacturer. The manufacturer of the machines shall design, install and wire the equipment and sub-
assemblies taking into account the recommendations of the suppliers of these sub-assemblies.
5.3.3 Protection against electric shock
The electrical equipment shall comply with EN 60204-1:2006, Clause 6.
For movable machines the instruction handbook shall contain recommended practice, such as disconnecting
the machine from the electrical supply before moving it and the need to avoid damaging the supply cable
during movement.
5.3.4 Power circuits
Devices for detection and interruption of over-current shall be applied to each live conductor in compliance
with EN 60204-1:2006, 7.2.3. In case of single phase machines, no such device is required for earthed neutral
conductor.
5.3.5 Earth faults
When equipment within the scope of this European Standard is supplied from a single phase conductor and
an earthed neutral conductor, there is no requirement for double pole interruption in the control circuit,
according to EN 60204-1:2006, 9.4.3.1.
5.3.6 Emergency stop
These machines do not require an emergency stop device. Nevertheless, if it is necessary to have an
emergency stop, it shall comply with EN ISO 13850.
5.3.7 Degrees of protection of external enclosures of electrical equipment (see EN 60529)
Enclosures including control actuating devices, signals and display elements exposed motor shall be at least
IP54.
5.3.8 Start function
Start devices shall be designed to reduce the risk of inadvertent operation by conforming to EN 60204-1:2006,
10.6. The start function can be actuated by closing the lid.
5.3.9 Unexpected start-up
The hazards from mechanical parts unexpectedly restarting by restoration of energy supply after an
interruption shall be provided by conforming to EN 60204-1:2006, 7.5.
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prEN 16878:2015 (E)
5.3.10 Motor enclosures
Where a motor has a degree of protection lower than IP23 (see EN 60529), it shall be mounted inside an
enclosure (see EN 60204-1:2006, 14.2) that guarantees a minimum degree of protection of IP23 (see
EN 60529). The whole machine frame shall have a degree of protection IP24 (see EN 60529).
5.3.11 Electrical requirements of controls
Control actuating devices, signals and display elements shall have a degree of protection IP54 (see
EN 60529).
5.4 Thermal hazards
Where tanks are heated and/or cooled, the temperatures of touchable surfaces in the working area shall
conform to EN ISO 13732-1. The contact period for surfaces intended to be touched during operation of the
mixer shall be assumed to be not less than 3 s.
Where tanks are cooled, the requirements for the touchable surfaces shall be according to EN ISO 13732-3.
The temperature of external condensing unit surfaces shall be in conformity with EN ISO 13732-1.
5.5 Noise control
The machines shall be designed and constructed so that the risk due to the airborne noise emission is
reduced to the lowest levels, by applying in particular measures at source to control the noise
(EN ISO 11688-1). The success of the applied noise reduction measures is assessed on the basis of the
actual noise emission values (see Annex A) in relation to other machines of the same family.
5.6 Ergonomic design principles
The design of the machines shall take account of the principles given in EN 614-1.
The force required to open manually operated covers shall not exceed 150 N, e.g. by counterbalancing.
Awkward body postures during maintenances and cleaning as well as when filling and emptying the tank shall
be avoided. This can be achieved through good ergonomic design and by using automatic loading and
discharge equipment. Under best lifting conditions the use of the machine shall not involve a person lifting
more than 25 kg.
5.7 Hygiene requirements
5.7.1 General
Machines shall be designed and manufactured in accordance with the requirements of EN 1672-
2:2005+A1:2009, and Annex B of this European Standard gives additional information.
The instructions for use shall include recommendations for cleaning procedures and advices on suitable and
(if appropriate) unsuitable cleaning materials, as well as any means necessary to protect the operator, such as
personal protective equipment.
The 3 zones defined in EN 1672-2:2005+A1:2009 are shown in Figure 6 and 7; the precise boundary between
the areas depends on the detailed design of the machine.
5.7.2 Food area
The food area is as follows:
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prEN 16878:2015 (E)
— inside of the pasteurization and freezing tank and the lid;
— mixing device;
— draw-off device.
5.7.3 Splash area
The splash area is as follows:
— outer part of the pasteurization and freezing tank;
— parts of the frame which face the draw-off device.
5.7.4 Non-food area
The rest of the machine.
5.7.5 Refrigeration
The soft ice cream machines and refrigeration and freezing equipment shall be designed and manufactured in
such a way that they meet the following requirements:
a) Soft ice cream machines shall be fitted with a temperature gauge or temperature range gauge to control
the temperature of the soft ice cream mix in the tank. The measuring point shall be selected in such a
way that the displayed temperature corresponds to the product temperature of the soft ice cream mix in
the tank.
b) It shall be possible to hold the product temperature of the soft ice cream mix in the tank at 5 °C or colder.
c) The soft ice cream located in the cylinder shall be frozen.
d) If the soft ice cream mix in a tank is being heated or the soft ice cream mix is added to the tank at a
higher product temperature, then it shall be possible to cool the soft ice cream mix to at least 5 °C or
lower at an ambient temperature of 25 °C in no longer than 120 min when heated to 63 °C to 65 °C and in
no longer than 150 min at a temperature of 72 °C to 75 °C. A temperature gauge is also required for this
area. The successful pasteurisation shall be documented in such a way that it can be verified.
e) The pre-cooling requirements specified in a) and b) do not apply when using a sterile soft ice cream mix
with a direct connection to the freezing equipment.
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