FprEN 16876
(Main)Food processing machinery - Soft ice cream machines - Safety and hygiene requirements
Food processing machinery - Soft ice cream machines - Safety and hygiene requirements
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.
Nahrungsmittelmaschinen - Maschinen zur Herstellung von Softeis - Sicherheits- und Hygieneanforderungen
Diese Europäische Norm gilt für Maschinen zur Verarbeitung und Ausgabe von Softeis, Joghurteis und anderen Lebensmitteln wie Schokolade und Teig, sowie für Milchmixgetränkemaschinen, wie in Abschnitt 3 beschrieben.
Die Europäische Norm gilt für feststehend installierte und ortsveränderliche Maschinen (die nicht dazu bestimmt sind, während des Betriebs bewegt zu werden), mit einer Nennfördermenge von nicht mehr als 150 kg/h.
Diese Europäische Norm behandelt alle signifikanten Gefährdungen, Gefährdungssituationen und Gefährdungsereignisse, 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 deckt die folgenden Arten von Maschinen ab:
- Softeis-, Joghurteis- und Milchmixgetränkemaschinen.
Diese Europäische Norm gilt nicht für Vorrichtungen zur Beschickung und Dosierung, zur Versorgung mit Inertgas, für Heiz- und Kühlgeräte und für Vorrichtungen zur Entnahme (Behälter, Entnahmeband usw.).
Diese Europäische Norm gilt nicht für Maschinen, die vor deren Veröffentlichung durch CEN hergestellt wurden.
Machines pour les produits alimentaires - Machines pur glace à l'italienne - Prescriptions relatives à la sécurité et à l'hygiène
La présente Norme européenne s'applique aux machines de manipulation et de distribution de glace à l'italienne, yaourt glacé, milk-shake et autres denrées alimentaires telles que le chocolat et les pâtisseries, comme décrit à l'Article 3.
La présente Norme européenne s'applique aux machines fixes et mobiles (non conçues pour être déplacées en cours de fonctionnement), d'une capacité nominale inférieure ou égale à 150 kg/h.
La présente Norme européenne traite de tous les phénomènes, situations et événements dangereux significatifs applicables aux machines dans les conditions d'utilisation normales et inappropriées, dès lors que ces dernières sont raisonnablement prévisibles 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, le déclassement, le démantèlement, la mise hors service et la mise au rebut de la machine.
La présente Norme européenne couvre les types de machines suivants :
- les machines à glace à l'italienne, yaourt glacé et milk-shake.
La présente Norme européenne ne s'applique pas à l'alimentation et au dosage des équipements, aux équipements, à l'alimentation en gaz inerte, aux équipements de chauffage et de refroidissement et aux dispositifs d'extraction (conteneur, courroie d'extraction, etc.).
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 - Stroji za izdelavo sladoleda - Varnostne in higienske zahteve
General Information
- Status
- Not Published
- Publication Date
- 12-Apr-2017
- 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
Overview
FprEN 16876 (draft prEN 16876:2015) is a CEN type‑C standard for food processing machinery focused on soft ice cream machines and related equipment. It sets safety and hygiene requirements for machines used to produce or dispense soft ice cream, frozen yogurt, milkshakes and similar food products (including some chocolate and pastry applications). The standard covers fixed and movable machines (not to be moved during operation) with a rated capacity up to 150 kg/h and applies to all phases from transport and assembly through operation, cleaning, maintenance and end‑of‑life. Machines manufactured before the publication date are excluded.
Key topics and technical requirements
- Scope and risk assessment: Defines the machinery covered and requires risk assessment in line with EN ISO 12100 principles.
- Hazard coverage: Addresses mechanical, electrical, thermal, noise, ergonomic, hygiene‑related hazards and stability/tipping risks (Clause 4).
- Safety measures: Requirements for elimination of hazards by design, guarding of rotating parts, transmission protection, emergency stop, prevention of unexpected start‑up and electrical safety (see Clauses 5.1–5.3).
- Hygiene and cleanability: Specific hygienic design and cleanability principles for food contact surfaces, splash areas and non‑food areas; refrigeration hygiene and disinfection testing procedures (Clauses 5.7 and Annexes B and C).
- Verification and testing: Noise measurement code (Annex A), verification of safety and hygiene measures, and prescribed tests for cleaning/disinfection and pasteurization processes (Annexes A–C).
- Information for use: Required machine documentation, user and service manuals, cleaning instructions and marking (Clause 7).
- Legal linkage: Supports essential requirements of EU Machinery Directive 2006/42/EC (Annex ZA).
Practical applications and users
Who will use FprEN 16876:
- Manufacturers and machine designers of soft ice cream and milkshake equipment - to design safe, hygienic machines and prepare CE documentation.
- Food plant engineers and maintenance teams - to follow cleaning, disinfection and servicing requirements.
- Procurement and quality managers - to specify compliant equipment and ensure hygienic design for food safety.
- Notified bodies and conformity assessors - to verify compliance with Machinery Directive requirements. Practical uses include risk reduction during design, establishing cleaning schedules, emergency stop and guarding layouts, noise declarations and commissioning checks.
Related standards
Normative references cited include EN ISO 12100 (risk assessment), EN 1672‑2 (hygiene for food machinery), EN 60204‑1 (electrical equipment), EN ISO 13849‑1 (control system safety), EN ISO 11201/4871 (noise), EN 349/EN 953 (guarding) - useful cross‑references when implementing FprEN 16876.
Keywords: soft ice cream machines, safety and hygiene requirements, FprEN 16876, food processing machinery, hygienic design, cleanability, risk assessment, Machinery Directive.
Frequently Asked Questions
FprEN 16876 is a draft published by the European Committee for Standardization (CEN). Its full title is "Food processing machinery - Soft ice cream machines - Safety and hygiene requirements". This standard covers: 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.
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.
FprEN 16876 is classified under the following ICS (International Classification for Standards) categories: 67.100.40 - Ice cream and ice confectionery; 67.260 - Plants and equipment for the food industry. The ICS classification helps identify the subject area and facilitates finding related standards.
FprEN 16876 is associated with the following European legislation: EU Directives/Regulations: 2006/42/EC; Standardization Mandates: M/396. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase FprEN 16876 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
Standards Content (Sample)
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.
oSIST prEN 16876:2015
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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prEN 16876:2015 (E)
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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prEN 16876:2015 (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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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 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.
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 of 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
conductors.
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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. If nevertheless an emergency stop is necessary, it shall
comply with EN ISO 13850.
5.3.7 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.
5.3.8 Unexpected start-up
The hazards from mechanical parts unexpectedly restarting by restoration of energy supply after an interruption shall
be prevented by conforming to EN 60204-1:2006, 7.5.
5.3.9 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).
5.3.10 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
The surface temperatures of cylinders and storage liquid soft ice cream tanks shall be in conformity to
EN ISO 13732-1 for hot surfaces and to EN ISO 13732-3 for cold surfaces.
The contact period for surfaces intended to be touched during operation of the mixer shall be assumed to be not less
than 3 s.
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 614-1:2006+A1:2009. 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.
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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.
Annex B of this European Standard gives additional information. The instructions for use shall include
recommendations for cleaning procedures and advice on suitable and – if appropriate – unsuitable cleaning
materials, as well as any means necessary to protect the operator, such as personal protective equipment. The
three zones defined in EN 1672-2:2005+A1:2009 are shown in Figure 3; 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:
— inside of the storage liquid soft ice cream’s tank and inside of the lid;
— cylinder and mixing device;
— inside of dispensers;
— feed opening devices;
— dispenser of cones and its accessories;
— syrup dispenser.
5.7.3 Splash area
The splash area is as follows:
— outer part of the dispensers;
— gather drops.
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
pasteurization shall be documented in such a way that it can be verified.
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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.
Food area
Splash area
Non-food area
Figure 3 — Hygiene areas of soft ice cream machinery
5.8 Harmful substance
Because the precaution requested will depend on the actual cleaning agent used, it is not possible to give any
technical requirement in this standard. The manufacturer shall give in the instruction handbook details on cleaning
products and the personal protective equipment to be used (gloves and aprons).
6 Verification of safety and hygiene requirements and/or protective measures
This clause contains the methods of the verification of the compliance with the safety requirements of this European
Standard. As far as the criteria for acceptance and the conditions during verification are self-evident, they can also
be found in the Table 1. Verification of the requirements can be made by means of inspection, calculation or testing.
These shall be applied to a machine in a fully commissioned condition but partial dismantling may be necessary for
the purpose of some checks. Such partial dismantling shall not invalidate the result of verification.
Table 1 — Methods of the verification of the compliance with the safety requirements
Relevant clause Method of verification
5.2.2 By verification of the function of the interlocking guard with guard locking and
the electrical circuit diagram
By measurement of the dimension
5.2.3 By visual inspection and verification of the function of the interlocking guard
with guard locking and the electrical circuit diagram
By functional test
5.2.4 By verification of the function of the interlocking guard with guard locking and
the electrical circuit diagram
By measurement of the dimension
5.2.5 By tilting test at 10° and verification of the instruction handbook
5.3 Verification shall be in accordance with EN 60204–1:2006, Clause 18
5.4 By measurement of the temperature
5.5 In accordance with Annex A
5.6 By visual inspection and verification of the instruction handbook
5.7 In accordance with of EN 1672–2:2005+A1:2009, Clause 6, and visual
examination
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7 Information for use
7.1 General
Information for use shall meet the requirements of EN ISO 12100:2010, Clause 6. An instruction handbook shall be
provided.
7.2 Instruction handbook
The manufacturer shall provide an instruction handbook in accordance with EN ISO 12100:2010, 6.5.
The instruction handbook shall include a training program for the operator. The program shall include the instruction
that the operators shall not:
a) access at any time to the machine without having first isolated the main power supply;
b) attempt to carry out electrical or mechanical repairs on the machine, unless properly authorized;
c) remove guards from the machine, unless properly authorized;
d) interfere with the interlocking devices on the machine;
e) handle the scrapers/blades without using protective devices;
f) allow an untrained person to take charge of a machine without supervision;
g) use any unauthorized or improvised means of gaining access to parts of the machines which are normally
inaccessible;
h) move the machine, except for applying precautions described in the handbook to avoid electrical risks and
tipping-over risks.
The instruction handbook shall recommend that the user arranges a program of inspections to be carried out
regularly by a responsible person to verify that all guards and cover are secure and properly in position and that all
protective devices are functioning correctly.
NOTE The manufacturer gives the periods between inspections.
The instruction handbook shall provide:
— minimum specifications for extraction equipment, if required;
— values of forces at the fixing points and their dimensions, where the machine is fixed on the floor;
— warning to the operator during maintenance about the hazard of residual voltage especially on capacitors;
— information about prevention measures which have to be taken by the user including warning to use suitable
flooring to prevent slipping;
— instructions for isolating the machine in a safe condition in the event of repair or maintenance;
— instructions that cleaning shall be only be performed when the power supply is turned off;
— methods of cleaning food areas, splash areas and non-food areas and the recommended cleaning products
(see 7.4);
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— the limits that shall be respected and the measures to be taken for ensuring stability during use, transportation,
assembly, dismantling when out of service, testing or foreseeable breakdown;
— the operating method to be followed in the event of accident or breakdown; if a blockage is likely to occur, the
operating method to be followed so as to enable the equipment to be safely unblocked;
— the specifications of the spare parts to be used, when these affect the health and safety of operators;
— if need be: the description of the adjustment and maintenance operations to be carried out by the user and the
preventive maintenance measures to be observed;
— if need be: instructions designed to enable adjustments and maintenance to be carried out safely, including the
protective measures to be taken during these operations;
— in the case of machinery capable of being plugged into an electricity supply: information warning the user that
he shall be able to check that the plug remains visible from any of the points to which he has access;
The instruction handbook (and any sales literature describing the performances of the machine) shall contain the
following information on airborne noise emissions, determined and declared in accordance with Annex A:
— the A-weighted emission sound pressure level at workstations, where this exceeds 70 dB(A); where this level
does not exceed 70 dB(A), this fact shall be indicated;
— the peak C-weighted instantaneous sound pressure value at workstations, where this exceeds 63 Pa (130 dB in
relation to 20 μPa);
— the A-weighted sound power level emitted by the machinery, where the A-weighted emission sound pressure
level at workstations exceeds 80 dB(A).
Whenever sound emission values are indicated the uncertainties “K” surrounding these values shall be specified.
The operating conditions of the machinery during measurement and the measuring methods used shall be
described.
7.3 Service manual
Machine manufacturers shall specify in the service manual a routine procedure for systematically testing,
maintaining, repairing or renewing all safety features incorporated in the machine together with guidance as to the
frequency of inspections/maintenance.
7.4 Cleaning
Instructions shall be provided for cleaning and rinsing: the cleaning products to be used, the recommended
implements, the procedures and frequency, any necessary warning (for example, the cleaning shall be done once
the machine is stopped, using water and soap with plastic scraper. Metallic implements are not recommended).
If hazardous detergents are used the personal protective equipment which has to be used shall be mentioned in the
instruction handbook.
If there is a need to remove particles of product from inside the machine, the operator shall use tolls designed for
that job which shall be described in the instruction handbook.
7.5 Marking
The minimum markings shall include:
— the business name and full address of the manufacturer and, where applicable, his authorized representative;
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— mandatory marking ;
— the year of construction, that is the year in which the manufacturing process is completed;
— designation of series or type, if any;
— serial or identification number, if any;
— rating information (mandatory for electro-technical products; voltage, frequency, power, etc.);
— designation of the machinery;
— type of
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