SIST EN 1672-2:2021
(Main)Food processing machinery - Basic concepts - Part 2: Hygiene requirements
Food processing machinery - Basic concepts - Part 2: Hygiene requirements
This document specifies common hygiene requirements for machinery used in preparing and processing food for human and, where relevant, animal consumption to eliminate or minimise the risk of contagion, infection, illness or injury arising from this food. It identifies the hazards which are relevant to the use of such food processing machinery and describes design methods and information for use for the elimination or reduction of these risks.
This document does not deal with the hygiene related risks to personnel arising from the use of the machine.
This document applies to food processing machines – Examples of such groups of food processing machinery are given in an informative Annex of this standard.
In addition, the principles contained in this document can be applied to other machinery and equipment used to process food where similar risks apply. Examples of hygiene risks and acceptable solutions are given in an informative Annex in this standard.
Nahrungsmittelmaschinen - Allgemeine Gestaltungsleitsätze - Teil 2: Anforderungen an Hygiene und Reinigbarkeit
1.1 Dieses Dokument legt allgemeine Hygiene und Reinigbarkeitsanforderungen an Maschinen und Maschinenteile fest, die zur Vorbereitung und Verarbeitung von Lebensmitteln für den menschlichen Verzehr (siehe informativen Anhang A) und, wo zutreffend, zur Verarbeitung von Tierfutter verwendet werden, um das Risiko von Ansteckung, Infektion, Erkrankung, oder Verletzung, das vom Lebensmittel ausgehen kann, auszuschließen oder auf ein Mindestmaß herabzusetzen. Es identifiziert die Gefährdungen, die bei der Verwendung solcher Nahrungsmittelmaschinen typisch sind, und beschreibt Gestaltungsverfahren und gibt Benutzerinformationen zur Eliminierung oder Verminderung dieser Risiken.
Detaillierte Hygiene und Reinigbarkeitsanforderungen können in den geltenden C Normen für bestimmte Maschinen oder Maschinenkategorien festgelegt werden.
ANMERKUNG 1 Weitere Hygiene und Reinigbarkeitsanforderungen sind in anderen EU Richtlinien oder Verordnungen enthalten (siehe Literaturhinweise).
Beispiele für Hygienerisiken und annehmbare Lösungen sind im informativen Anhang B angegeben.
ANMERKUNG 2 Dieses Dokument kann auch für Maschinen, Bauteile oder andere Geräte verwendet werden, die für andere Zwecke als die Zubereitung oder Verarbeitung von Lebensmitteln verwendet werden, wenn eine Reinigbarkeit erforderlich ist.
1.2 Dieses Dokument behandelt nicht die hygienebedingten Risiken für das Personal, die bei der Verwendung der Maschine entstehen.
1.3 Dieses Dokument ist nicht anwendbar auf Maschinen, die vor dessen Veröffentlichung durch CEN hergestellt wurden.
Machines pour les produits alimentaires - Notions fondamentales - Partie 2 : Prescriptions relatives à l'hygiène et à la nettoyabilité
1.1 Le présent document établit les exigences d'hygiène et de nettoyabilité communes aux machines et aux composants de machine utilisés pour la préparation et le traitement d'aliments destinés à la consommation humaine (voir l’Annexe A informative) et, le cas échéant, à la consommation animale afin d'éliminer ou de minimiser le risque de contagion, d'infection, de maladie ou de lésion provenant de cet aliment. Il identifie les phénomènes dangereux qui sont propres à l'utilisation de telles machines et décrit les méthodes de conception et les informations pour l'utilisation visant à éliminer ou à réduire ces risques.
Des exigences détaillées d’hygiène et de nettoyabilité peuvent être données dans les normes de type C applicables à des machines ou catégories de machines spécifiques.
NOTE 1 Des exigences d'hygiène et de nettoyabilité sont données séparément dans d'autres Directives ou Règlements UE (voir la bibliographie).
Des exemples de risques hygiéniques et de solutions acceptables sont donnés dans l'Annexe B informative.
NOTE 2 Le présent document peut également être utilisé pour les machines, composants et autres équipements utilisés pour d’autres usages que la préparation et le traitement d'aliments, si la nettoyabilité s'impose.
1.2 Le présent document ne traite pas les risques hygiéniques encourus par le personnel du fait de l'utilisation de la machine.
1.3 Le présent document ne s'applique pas aux machines fabriquées avant la date de publication du présent document par le CEN.
Stroji za predelavo hrane - Osnovni koncepti - 2. del: Higienske zahteve
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 1672-2:2021
01-april-2021
Nadomešča:
SIST EN 1672-2:2005+A1:2009
Stroji za predelavo hrane - Osnovni koncepti - 2. del: Higienske zahteve
Food processing machinery - Basic concepts - Part 2: Hygiene requirements
Nahrungsmittelmaschinen - Allgemeine Gestaltungsleitsätze - Teil 2: Anforderungen an
Hygiene und Reinigbarkeit
Machines pour les produits alimentaires - Notions fondamentales - Partie 2 :
Prescriptions relatives à l'hygiène et à la nettoyabilité
Ta slovenski standard je istoveten z: EN 1672-2:2020
ICS:
67.260 Tovarne in oprema za živilsko Plants and equipment for the
industrijo food industry
SIST EN 1672-2:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 1672-2:2021
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SIST EN 1672-2:2021
EN 1672-2
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2020
EUROPÄISCHE NORM
ICS 67.260 Supersedes EN 1672-2:2005+A1:2009
English Version
Food processing machinery - Basic concepts - Part 2:
Hygiene and cleanability requirements
Machines pour les produits alimentaires - Notions Nahrungsmittelmaschinen - Allgemeine
fondamentales - Partie 2 : Prescriptions relatives à Gestaltungsleitsätze - Teil 2: Anforderungen an
l'hygiène et à la nettoyabilité Hygiene und Reinigbarkeit
This European Standard was approved by CEN on 30 November 2020.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1672-2:2020 E
worldwide for CEN national Members.
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SIST EN 1672-2:2021
EN 1672-2:2020 (E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 List of significant hazards . 11
5 Hygiene and cleanability requirements. 12
5.1 Iterative hygiene risk reduction process . 12
5.1.1 General . 12
5.1.2 Hygiene risk assessment (see Figure 2, Item 27) . 14
5.1.3 Hygiene risk reduction process (see Figure 2, Item 28) . 19
5.1.4 Other elements of the iterative hygiene risk reduction process . 21
5.2 Materials of construction . 22
5.2.1 General requirements . 22
5.2.2 Food area . 22
5.2.3 Splash area. 22
5.2.4 Non-food area . 23
5.3 Design . 23
5.3.1 General design . 23
5.3.2 Food area design. 23
5.3.3 Splash area design . 36
5.3.4 Non-food area design . 40
5.3.5 Clearance and accessibility for cleaning . 40
5.3.6 Services . 46
6 Information for use . 47
6.1 General . 47
6.2 Instruction handbook . 47
6.2.1 General . 47
6.2.2 Information relating to the intended use . 48
6.2.3 Information relating to residual hygiene risks . 48
6.2.4 Information relating to hygienic installation . 48
6.2.5 Information relating to operator instructions . 49
6.2.6 Information relating to disposable parts . 49
6.2.7 Information relating to cleaning, disinfection, rinsing and inspection for cleanliness. 49
6.2.8 Information relating to maintenance . 51
6.3 Marking . 51
Annex A (informative) Examples of machinery which can be covered by this document . 52
Annex B (informative) Examples of hygiene risks and acceptable solutions . 53
Bibliography . 69
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SIST EN 1672-2:2021
EN 1672-2:2020 (E)
European foreword
This document (EN 1672-2:2020) 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 European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by June 2021, and conflicting national standards shall be
withdrawn at the latest by June 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 1672-2:2005+A1:2009.
The significant changes with respect to the previous edition EN 1672-2:2005+A1:2009 are listed below:
— the list of terms and definitions was upgraded;
— new methodology “Iterative hygiene risk reduction process”;
— all requirements regarding hygiene were upgraded, and new requirements regarding cleanability
were added;
— Annex ZA was deleted to be in line with the HAS consultant recommendation.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association.
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,
Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North
Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United
Kingdom.
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SIST EN 1672-2:2021
EN 1672-2:2020 (E)
Introduction
This document gives general hygiene and cleanability requirements for machinery in the scope of this
document. It is intended to be referred by type-C machinery-specific standards. This document can be
used as a general guide for machinery without type-C-specific standards.
The machinery concerned and the extent to which hazards, hazardous situations and events are covered
are indicated in the scope of this document.
In almost all cases at least one of the different methods of design, safeguarding or other safety measures
can be chosen which will meet both safety and hygiene essential requirements and adequately control
both risks. The option to satisfy both hygiene and safety risks may not be the most obvious option which
would have been adopted had the risk only been to safety or to hygiene, but will have to be the one chosen
to meet both.
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SIST EN 1672-2:2021
EN 1672-2:2020 (E)
1 Scope
1.1 This document specifies common hygiene and cleanability requirements for machinery and
machine components used in preparing and processing food for human (see informative Annex A) and,
where relevant, animal feed processing to eliminate or minimize the risk of contagion, infection, illness
or injury arising from this food to an acceptable level. It identifies the hazards which are significant to the
use of such food processing machinery and describes design methods and information for use for the
elimination or reduction of these risks.
Additional and/or deviant hygiene and cleanability requirements may be given in applicable C-standards
for specific machines or categories of machinery.
NOTE Separate hygiene and cleanability requirements are contained in other EU-Directives or -Regulations
(see Bibliography).
Examples of hygiene risks and acceptable solutions are given in the informative Annex B.
This document may also be used for machinery, components or other equipment used for other purposes
than food preparing or processing, if cleanability is required.
1.2 This document does not deal with the hygiene-related risks to operators arising from the use of the
machine.
1.3 This document is not applicable to machines manufactured before the date of publication of this
document by CEN.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN ISO 12100:2010, Safety of machinery — General principles for design — Risk assessment and risk
reduction (ISO 12100:2010)
EN ISO 21469:2006, Safety of machinery — Lubricants with incidental product contact — Hygiene
requirements (ISO 21469:2006)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 12100:2010 and the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp
3.1
food
any product, ingredient or material intended to be orally consumed by human or animal
Note 1 to entry: The definition means food according to Article 2 of Regulation (EC) No. 178/2002 and feed.
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EN 1672-2:2020 (E)
3.2
hygiene
taking of all measures during the preparation and processing of food to ensure that it is fit for human or
animal consumption
3.3
access distance
P
distance from the nearest free access point of the machine, according to the intended installation, to reach
the furthest point of all areas to be cleaned
Note 1 to entry: Access points are given in Figure 21.
3.4
adverse influence
effect which gives a significant reduction of the fitness for consumption of a food
Note 1 to entry: A food can be adversely influenced, in particular by microbial pathogens or other unwanted
microorganisms, toxins, vermin and other contaminants.
3.5
areas of machinery and machine components
food area, splash area and non-food area as following defined (see 3.5.1 to 3.5.3) and as illustrated in
Figure 1
Note 1 to entry: These areas are not to be confused with any others amongst those defined in other standards
(e.g. electro-technical standards).
3.5.1
food area
machine and machine components surfaces which are exposed to food or from which food or other
materials can drain, drip, diffuse or be drawn into the food
3.5.2
splash area
area composed of surfaces on which part of the food can splash or flow along under intended conditions
of use and does not return into the food
Note 1 to entry: Part of the food in the splash area is no more food in the sense of 3.1.
3.5.3
non-food area
any area other than food area or splash area
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SIST EN 1672-2:2021
EN 1672-2:2020 (E)
Key
a food area (3.5.1)
b food (3.1)
c splash area (3.5.2)
d non-food area (3.5.3)
Figure 1 — Areas of equipment
3.6
cleaning
removal of soils
3.6.1
cleanable
designed and constructed so that soils can be removed
3.6.2
easily cleanable
designed and constructed to be cleanable by a simple cleaning method, where necessary after removing
easily dismountable parts
Note 1 to entry: Simple cleaning methods could be, e.g. vacuum cleaning, cleaning in place (CIP) or cleaning after
dismantling parts without the need of tools (e.g. spanner) for dismantling.
3.6.3
wet cleaning
cleaning with the use of liquids
3.6.4
dry cleaning
cleaning without the use of liquids
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EN 1672-2:2020 (E)
3.7
consumer
human and/or animal
3.8
contamination
presence of soils
3.8.1
cross contamination
transfer of soil from one part of the machine into the food during use of the machine
3.9
corrosion-resistant material
material resistant to normally occurring action of chemical or electrochemical nature
Note 1 to entry: It includes food processing, cleaning and disinfection according to the instructions for use.
3.10
crevice
surface defect, e.g. crack, fissure, which adversely affects cleanability
3.11
dead space
unaccessible space wherein a product, ingredient, cleaning or disinfecting agents or soils can be trapped,
retained and not removed during operation or operation of cleaning
3.12
disinfection
inactivation of all pathogens and a wide range of other micro-organisms to a level consistent with
hygienic application of the equipment
3.13
durable
ability of a surface to withstand the intended conditions of use, except for unavoidable wear and tear
Note 1 to entry: Damage of the surfaces can be caused by e.g.:
— the action of the process;
— contact with the food being processed;
— thermal actions;
— handling and contact with any cleaning or disinfecting agents specified;
— utensils and supplies for cleaning.
3.14
easily accessible
designed and constructed to permit removal, visual inspection and replacement, where necessary after
removing easily dismountable parts
Note 1 to entry: Easily dismountable means without the need of tools (e.g. spanner).
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EN 1672-2:2020 (E)
3.15
hazard
potential source that can lead to health harm
[SOURCE: EN ISO 12100:2010, 3.6, modified – Note 1 to entry has been added]
Note 1 to entry: Hazard means food safety hazard which can lead to unsafe food.
3.15.1
hazardous event
event that can cause health harm
[SOURCE: EN ISO 12100:2010, 3.9, modified – Note 1 to entry has been added]
Note 1 to entry: A hazardous event can occur over a short period of time or over an extended period of time.
3.15.2
hazardous situation
circumstance in which at least one consumer is exposed to at least one hazard
[SOURCE: EN ISO 12100:2010, 3.10, modified – Note 1 to entry has been added]
Note 1 to entry: The exposure can result in health harm immediately or over a period of time.
3.16
health harm
physical injury, infection, sickness or contagion caused by unsafe food
[SOURCE: EN ISO 12100:2010, 3.5, modified – “health” and “infection, sickness or contagion caused by
unsafe food” have been added]
3.17
joint
junction of two or more pieces of material
3.17.1
joined surfaces
surfaces between which no particle of product becomes trapped in small crevices, thus becoming difficult
to dislodge and so introduce a contamination hazard
3.18
lubrication zone
place where the lubricant fulfills its function
3.18.1
lubricant outlet
discharge for lubricant drainage (e.g. for pressure relief)
3.19
non-absorbent material
material which, under intended conditions of use, does not retain substances with which it comes into
contact
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3.20
non-toxic material
material which does not produce or release substances in quantities injurious to health under intended
conditions of use
3.21
portable
manually liftable and movable
3.22
open process
process in which food has contact with the environment
3.22.1
closed process
process in which food has no contact with the environment (except inlet and outlet of food, if relevant)
3.23
rinsing
removal of residues or any other matter by flowing liquid
3.24
seal
component or assembly of components used for sealing
3.25
sealing
closing of an aperture so as to effectively prevent the unwanted entry or passage of soil
3.26
self draining
design and construction of the shape and surface finish so as to prevent liquid from being retained
3.27
smooth surface
surface which satisfies operational, hygiene and cleanability requirements
3.28
soil
any matter which can make food unsafe; including but not limited to product residues, micro-organisms,
residual detergent, chemicals or disinfecting agents, except substances migrating (or released metallic
ions) from food contact materials into the food
3.29
unsafe food
adversely influenced (see 3.4) food
Note 1 to entry: Machines which do not fulfill the requirements of this document can produce unsafe food.
3.30
vermin
animals (including mammals, birds, reptiles and insects) which can adversely influence the food
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3.31
tilting
raising one end of the machine for accessibility
4 List of significant hazards
The significant hazards can arise from:
a) microbiological causes, e.g.:
1) pathogens (from e.g. opportunistic pathogens like salmonella, enterobacter, coliform bacteria);
2) microbiological toxins (from e.g. Bacillus cereus, Staphylococcus aureus) and biogenic amines of
pathogens;
3) microorganism;
4) other biological causes, e.g.:
— mono- and multicellular vermin (e.g. toxoplasms, tapeworm);
— unconventional transmissible agents.
b) Chemical causes, e.g.:
1) cleaning and disinfection agents;
— lubricants;
— veterinary drugs;
— agricultural pesticides;
— contaminants, e.g. allergens, dioxins, polychlorinated biphenyl (PCB), mycotoxins, heavy
metals;
— substances released by materials.
c) Physical causes:
1) foreign bodies (e.g. bone fragments, metal parts and broken glass);
— contaminants and radiation arising from raw material, machinery or other sources.
For each of these hazards there can be a risk of contamination of the food and/or risks to the health of
the consumer.
Microorganisms can cause spoilage of the food, food poisoning or other related illness in consumers.
Chemical can cause contamination or leave residues in the food causing injury to health (e.g. burns) or
illness.
Foreign bodies can contaminate food and cause physical injuries (e.g. choking, lacerations).
When considering the design of a machine it is necessary to consider the implications of any of the
hazards and the measures necessary to eliminate or reduce the hazard.
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EN 1672-2:2020 (E)
5 Hygiene and cleanability requirements
5.1 Iterative hygiene risk reduction process
5.1.1 General
The hygiene and cleanability requirements of the different areas of equipment are described in 5.2. They
depend upon the significant hazards as described in Clause 4, the functions of the areas of equipment.
The primary objective is to eliminate or reduce the risks to an acceptable level. The hygiene risk
assessment and hygiene risk reduction process follow the methodology described in EN ISO 12100:2010.
In order to deal with hygiene risk and cleanability, the process has been modified as shown in Figure 2.
To apply this method, the steps and answer to questions shall be followed in the order shown in this
figure.
This iterative risk reduction process shall be carried out separately for each hazard, hazardous situation,
under each condition of use.
It is recommended to do the iterative hygiene risk reduction process by a team rather than by one person
only.
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EN 1672-2:2020 (E)
NOTE Explanations to numbers 1 to 28 are given in 5.1.2 to 5.1.4.
Figure 2 — Iterative hygiene risk reduction process
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EN 1672-2:2020 (E)
5.1.2 Hygiene risk assessment (see Figure 2, Item 27)
5.1.2.1 General
Risk assessment comprises:
a) hygiene risk analysis;
b) hygiene risk evaluation.
5.1.2.2 Hygiene risk analysis (see Figure 2, Item 26)
5.1.2.2.1 General
Hygiene risk analysis, comprising:
a) determination of the limits of the machinery,
b) food safety hazard identification, and
c) hygiene risk estimation.
Hygiene risk analysis provides information required for the hygiene risk evaluation (see 5.1.2.3), which
in turn allows judgments to be made about whether or not risk reduction is required (see 5.1.2.4).
5.1.2.2.2 Determination of the limits of the machine (see Figure 2, Item 2)
5.1.2.2.2.1 General
The risk assessment shall start with the determination of the limits of the machinery, taking into account
all the phases of the machinery life.
5.1.2.2.2.2 Use limits
Use limits shall include the intended use and the reasonably foreseeable misuse, failure or malfunction.
One machine can be used for one specific purpose only (single food type), for which hazards are readily
identifiable. Another machine can be used for a wide range of food products (more than one food type)
under various conditions.
In connection with hygienic aspects, the following issues shall be considered:
a) the different machine operating modes (e.g. food processing, cleaning, maintenance);
b) the type of users:
1) professional and/or non-professional;
2) the anticipated foreseeable users’ level of training, experience or ability (e.g. operators, cleaning
personnel, maintenance personnel).
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EN 1672-2:2020 (E)
5.1.2.2.2.3 Space limits
The following aspects of space limits shall be taken into account:
a) the range of movement of the machine and of all its parts (e.g. access to maintenance openings);
b) space requirements for persons interacting with the machine during operation, cleaning and
maintenance.
NOTE Space requirements can include necessary space for e.g. cleaning, removing parts.
5.1.2.2.2.4 Time limits
The following aspects of time limits shall be taken into account:
a) the life limit of the machinery and/or of some of its components (parts that can wear, seals etc.),
taking into account its intended use and reasonably foreseeable misuse;
b) recommended maintenance intervals; and
c) recommended cleaning intervals.
5.1.2.2.2.5 Other limits
Examples of other limits:
a) state of food, properties of the input material(s) to be processed and the output material(s) and food
sensitivity (e.g. perishable or non-perishable food);
b) stage of processing levels;
c) variations in local, national or international properties of food, products and ingredients;
d) consumption group (healthy, vulnerable group, i.e. elderly or infant, allergic persons etc.);
e) open or closed process;
f) cleaning processes (e.g. dry or wet cleaning);
g) the level of cleanliness required; and
h) environmental – the recommended minimum and maximum temperatures, whether the machine can
be operated indoors or outdoors, in dry or wet atmosphere, in direct sunlight, tolerance to dust and
humidity etc.
5.1.2.2.3 Food safety hazard identification (see Figure 2, Item 3)
5.1.2.2.3.1 General
After determination of the limits of the food processing machine, the most important step in the risk
assessment is the identification of hazards that can lead to unsafe food.
The identification of the food safety hazard by the manufacturer shall take into account the significant
hazards defined in Clause 4.
Only when a hazard (incl. hazardous situations and/or hazardous events) has been identified, it is
possible to take action to eliminate them or to reduce resulting associated risks.
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Unidentified hazards can lead to unsafe food which can cause health harm of its consumers.
The objective of the food hazard identification is to create a list of all the hazards to hygiene that arise
from contact with food processing machines and/or their processing steps.
For the identification of food safety hazards the following factors described in 5.1.2.2.3.2 to 5.1.2.2.3.4
shall be considered.
5.1.2.2.3.2 Phases of life cycle of the machine
Causes for hazards that can lead to unsafe food during the following phases of the machine life cycle shall
be identified:
— assembly and installation;
— start-up;
— operation;
— cleaning and, where required, disinfection and therefore necessary dismantling;
— maintenance;
— temporarily disabling.
5.1.2.2.3.3 Hygiene risk associated with the food
The hygiene risk associated with the food depends on many factors that shall be identified and
determined, e.g.:
— type or types of food to be processed (e.g. perishable or non-perishable);
— status of food (e.g. raw material, partly processed, ready-to-eat food);
— other properties of the food (e.g. pH, dry, wet, glutinous).
NOTE The type and condition of food can change depending on the processing stage.
5.1.2.2.3.4 Process
The factors to be considered from the process as well as the processing method for the foods, which can
influence the hazards, shall be determined, e.g.:
— open or closed proce
...
SLOVENSKI STANDARD
oSIST prEN 1672-2:2019
01-julij-2019
Stroji za predelavo hrane - Osnovni koncepti - 2. del: Higienske zahteve
Food processing machinery - Basic concepts - Part 2: Hygiene requirements
Nahrungsmittelmaschinen - Allgemeine Gestaltungsleitsätze - Teil 2: Anforderungen an
Hygiene und Reinigbarkeit
Machines pour les produits alimentaires - Notions fondamentales - Partie 2 :
Prescriptions relatives à l'hygiène et à la nettoyabilité
Ta slovenski standard je istoveten z: prEN 1672-2
ICS:
67.260 Tovarne in oprema za Plants and equipment for the
živilsko industrijo food industry
oSIST prEN 1672-2:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN 1672-2:2019
DRAFT
EUROPEAN STANDARD
prEN 1672-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2019
ICS 67.260 Will supersede EN 1672-2:2005+A1:2009
English Version
Food processing machinery - Basic concepts - Part 2:
Hygiene and cleanability requirements
Machines pour les produits alimentaires - Notions Nahrungsmittelmaschinen - Allgemeine
fondamentales - Partie 2 : Prescriptions relatives à Gestaltungsleitsätze - Teil 2: Anforderungen an
l'hygiène et à la nettoyabilité Hygiene und Reinigbarkeit
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, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 1672-2:2019 E
worldwide for CEN national Members.
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Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 List of significant hazards . 11
5 Hygiene and cleanability requirements. 12
5.1 Iterative hygiene risk reduction process . 12
5.1.1 General . 12
5.1.2 Comments related to the Figure “Iterative hygiene risk reduction process” . 14
5.1.3 Determination of the limits of the machine . 16
5.2 Food safety hazard identification . 17
5.2.1 General . 17
5.2.2 Factors to be considered . 17
5.2.3 Reasonably foreseeable hazards . 18
5.2.4 Hygiene risk estimation . 19
5.3 Materials of construction . 21
5.3.1 General requirements . 21
5.3.2 Food area . 21
5.3.3 Splash area. 21
5.3.4 Non-food area . 22
5.4 Design . 22
5.4.1 General . 22
5.4.2 Food area . 22
5.4.3 Splash area. 33
5.4.4 Non-food area . 38
5.4.5 Cleaning . 38
5.4.6 Services . 44
6 Information for use . 45
6.1 General . 45
6.2 Instruction handbook . 45
6.2.1 General . 45
6.2.2 Information relating to the intended use . 45
6.2.3 Information relating to residual hygiene risks . 46
6.2.4 Information relating to hygienic installation . 46
6.2.5 Information relating to operator instructions . 46
6.2.6 Information relating to disposable parts . 46
6.2.7 Information relating to cleaning, disinfection, rinsing and inspection for cleanliness. 47
6.2.8 Information relating to maintenance . 48
6.3 Marking . 48
Annex A (informative) Examples of machinery which may be covered by this document . 49
Annex B (informative) Examples of hygiene risks and acceptable solutions . 50
Annex C (informative) Summary of main hygiene aspects for food processing machinery . 70
Bibliography . 71
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European foreword
This document (prEN 1672-2:2019) 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 will supersede EN 1672-2:2005+A1:2009.
The significant changes with respect to the previous edition EN 1672-2:2005+A1:2009 are listed below:
— The list of terms and definitions was upgraded;
— New methodology “Iterative hygiene risk reduction process”;
— All requirements regarding hygiene were upgraded, and new requirements regarding cleanability
were added;
— Annex ZA was deleted to be in line with the HAS consultant recommendation.
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Introduction
This document gives general hygiene and cleanability requirements for machinery in the scope of this
standard. It is intended to be referred by type-C machinery-specific standards. This standard can be used
as a general guide for machinery without type-C-specific standards.
The machinery concerned and the extent to which hazards, hazardous situations and events are covered
are indicated in the scope of this document.
Here it will distinguish between the hazards to the operator and the risks to the food (the product
processed by the machinery).
This document addresses only those hazards which are commonly occurring on food processing
machines and for which technical specifications can be set which will apply to all (or most) of the classes
of machines within the scope of the standard which have that hazard.
In almost all cases at least one of the different methods of design, safeguarding or other safety measures
can be chosen which will meet both safety and hygiene essential requirements and adequately control
both risks. The option to satisfy both hygiene and safety risks may not be the most obvious option which
would have been adopted had the risk only been to safety or to hygiene, but will have to be the one chosen
to meet both.
The first choice is to select a design method which removes both hygiene and safety risks. If this is not
within the state of the art then safeguarding options for both, or if not, one of the risks should be selected.
Where no design or safeguarding options are within the state of the art to adequately control both
hygiene and safety risks then one of the risks, or both, would have to be dealt with by safety measures,
including instructions to the user. The assessment of the respective safety and hygiene risks will indicate
their relative significance, and the higher level of protection (i.e. safeguarding) should be implemented to
deal with the severest risk and safety measures for the lesser risk.
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1 Scope
1.1 This document specifies common hygiene and cleanability requirements for machinery and
machine components used in preparing and processing food for human (see informative Annex A) and,
where relevant, animal consumption to eliminate or minimize the risk of contagion, infection, illness or
injury arising from this food. It identifies the hazards which are relevant to the use of such food processing
machinery and describes design methods and information for use for the elimination or reduction of
these risks.
Detailed hygiene and cleanability requirements may be given in applicable C-standards for specific
machine or categories of machinery.
NOTE 1 Separate hygiene and cleanability requirements are contained in other EU-Directives or -Regulations
(see the Bibliography).
Examples of hygiene risks and acceptable solutions are given in the informative Annex B.
NOTE 2 This document can also be used for machinery, components or other equipment used for other purposes
than food preparing or processing, if cleanability is required.
1.2 This document does not deal with the hygiene-related risks to personnel arising from the use of the
machine.
1.3 This document is not applicable to machines manufactured before the date of publication of this
document by CEN.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN ISO 12100:2010, Safety of machinery — General principles for design — Risk assessment and risk
reduction (ISO 12100:2010)
EN ISO 21469, Safety of machinery — Lubricants with incidental product contact — Hygiene requirements
(ISO 21469)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 12100:2010 and the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp
3.1
food
any product, ingredient or material intended to be orally consumed by human or animal
Note 1 to entry: It includes food and feed according to Article 2 of Regulation (EC) No. 178/2002.
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3.2
hygiene
food hygiene
taking of all measures during the preparation and processing of food to ensure that it is fit for human or
animal consumption
3.3
access distance
P
distance from the nearest free access point of the machine, according to the intended installation, to reach
the furthest point of all areas to be cleaned
3.4
adverse influence
effect which gives a significant reduction of the fitness for consumption of a food
Note 1 to entry: A food can be adversely influenced, in particular by microbial pathogens or other unwanted
microorganisms, toxins, vermin and other contaminants.
3.5
areas of equipment
food area, splash area and non-food area as following defined (see 3.5.1 to 3.5.3) and as illustrated in
Figure 1
Note 1 to entry: These areas are not to be confused with any others amongst those defined in other standards
(e.g. electro-technical standards).
3.5.1
food area
machinery surfaces which are exposed to food or from which food or other materials can drain, drip,
diffuse or be drawn into (self-returned) the food or food container
3.5.2
splash area
area composed of surfaces on which part of the food may splash or flow along under intended conditions
of use and does not return into the food
Note 1 to entry: Part of the food in the splash area is no more food in the sense of 3.1.
3.5.3
non-food area
any area other than those specified above
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Key
a) food area (3.5.1)
b) food
c) splash area (3.5.2)
d) non-food area (3.5.3)
Figure 1 — Areas of equipment
3.6
cleaning
removal of soils
3.6.1
cleanable
designed and constructed so that soils can be removed
3.6.2
easily cleanable
designed and constructed to be cleanable by a simple cleaning method, where necessary after removing
easily dismantled parts
Note 1 to entry: Simple cleaning methods could be, e.g. vaccum cleaning, cleaning in place (CIP) or cleaning after
dismantling parts without the need of tools (e.g spanner) for dismantling.
3.6.3
wet cleaning
cleaning with the use of liquids
3.6.4
dry cleaning
cleaning without the use of liquids
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3.7
consumer
human and/or animal
3.8
contamination
presence of soils
3.8.1
cross contamination
transfer of soil from one location to another location
3.9
corrosion-resistant material
material resistant to normally occurring action of chemical or electrochemical nature
Note 1 to entry: It includes food processing, cleaning and disinfection according to the instructions for use.
3.10
crevice
surface defect, e.g. crack, fissure, which adversely affects cleanability
3.11
dead space
space wherein a product, ingredient, cleaning or disinfecting agents or soils may be trapped, retained or
not completely removed during operation of cleaning (see example given in Figure B.14)
3.12
disinfection
inactivation of all pathogens and a wide range of other micro-organisms to a level consistent with
hygienic application of the equipment
3.13
durable
ability of a surface to withstand the intended conditions of use, except for unavoidable wear and tear
Note 1 to entry: Damage, for example, can be caused by:
— the action of the process;
— contact with the food being processed;
— thermal actions;
— handling and contact with any cleaning or disinfecting agents specified;
— recommended or required utensils.
3.14
easily accessible
designed and constructed to permit removal, visual inspection and replacement, where necessary after
removing easily dismantled parts
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3.15
hazard
potential source that can lead to health harm
[SOURCE: EN ISO 12100:2010, 3.6, modified]
Note 1 to entry: Hazard means food safety hazard which can lead to unsafe food.
3.15.1
hazardous event
event that can cause health harm
[SOURCE: EN ISO 12100:2010, 3.9, modified]
Note 1 to entry: A hazardous event can occur over a short period of time or over an extended period of time.
3.15.2
hazardous situation
circumstance in which at least one consumer is exposed to at least one hazard
[SOURCE: EN ISO 12100:2010, 3.10, modified]
Note 1 to entry: The exposure can result in health harm immediately or over a period of time.
3.16
health harm
physical injury and/or infection, sickness or contagion caused by unwanted components in or of food
and/or food contaminants alone
3.17
hygienic equipment / hygienic machinery
design and construction of equipment/machinery that can be easily freed from soil by cleaning with or
without dismantling
3.18
joint
junction of two or more pieces of material
3.18.1
joined surfaces
surfaces between which no particle of product becomes trapped in small crevices, thus becoming difficult
to dislodge and so introduce a contamination hazard
3.19
lubrication point
place where the lubricant fulfills its function
3.19.1
lubricant outlet
discharge for lubricant drainage (e.g. for pressure relief)
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3.20
non-absorbent material
material which, under intended conditions of use, does not retain substances with which it comes into
contact so that it has no adverse influence on food
3.21
non-toxic material
material which does not produce or release substances injurious to health under intended conditions of
use
3.22
portable
manually liftable and movable
3.23
open process
process in which food has contact with the environment
3.23.1
closed process
process in which food has no contact with the environment (except inlet and outlet of food, if relevant)
[SOURCE: EN ISO 12100:2010, 3.5, modified]
3.24
rinsing
removal of residues or any other matter after cleaning or disinfection by flowing liquid
3.25
seal
component or assembly of components used for sealing
3.26
sealing
closing of an aperture so as to effectively prevent the unwanted entry or passage of soil
3.27
self draining
design and construction of the shape and surface finish so as to prevent liquid from being retained
3.28
smooth
condition of a surface which satisfies operational, hygiene and cleanability requirements
3.29
soil
any unwanted matter, including product residues, micro-organisms, residual detergent or disinfecting
agents
3.30
supply circuits
service devices and/or transporting devices (e.g pipes, tubes, cables) for power, supports (air, water,
etc.), data and ancillary substances which are integral parts of the machine
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3.31
unsafe food
adversely influenced (see 3.4) food or feed
Note 1 to entry: Machines which do not fulfill the requirements of this standard may produce unsafe food.
3.32
vermin
animals (including mammals, birds, reptiles and insects) which may adversely influence the food
4 List of significant hazards
The significant hazards can arise from:
a) microbiological causes, e.g.:
1) pathogens (e.g opportunistic pathogens like salmonella, enterobacter, coliform bacteria);
2) microbiological toxins (e.g. Bacillus cereus, Staphylococcus aureus) and biogenic amines of
pathogens;
3) antibiotic-resistant microorganisms;
4) other biological causes, e.g;
i) mono- and multicellular vermin (e.g. toxoplasms, tapeworm);
ii) bovine spongiform encephalopathy (BSE).
b) Chemical causes, e.g.:
1) cleaning and disinfection agents;
2) lubricants;
3) veterinary drugs;
4) agricultural pesticides;
5) contaminants (like dioxins, PCBs, mycotoxins, heavy metals);
6) substances released by materials.
c) Foreign bodies, contaminants and radiation arising from raw material, machinery or other sources,
e.g.:
1) bone fragments;
2) metal parts and broken glass;
3) radioactive elements.
For each of these hazards there can be a risk of contamination of the food and/or risks to the health of
the consumer.
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Microbiological hazards can cause spoilage of the food, food poisoning or other related illness in
consumers.
Chemical hazards can cause contamination or leave residues in the food causing injury to health (e.g.
burns) or illness.
Foreign bodies can contaminate food and cause physical injuries (e.g. choking, lacerations).
When considering the design of a machine it is necessary to consider the implications of any of the
hazards and the measures necessary to eliminate or reduce the hazard. The informative Annex C gives
examples.
5 Hygiene and cleanability requirements
5.1 Iterative hygiene risk reduction process
5.1.1 General
The hygiene and cleanability requirements of the different areas of equipment are described in Clause 5.
They depend upon the significant hazards as described in Clause 4, the functions of the area of the
machinery and machine components
In applying the principles of design (see 5.3) the primary objective is to eliminate or reduce the risks to
an acceptable level. The risk assessment and risk reduction follow the methodology described in
EN ISO 12100:2010. In order to deal with hygiene risk and cleanability, the process has been modified as
shown in Figure 2. To apply this method, follow the steps and answer to questions in the order shown in
this figure.
It is recommended to do the iterative hygiene risk reduction process by a team rather than by one person
only.
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Figure 2 — Iterative hygiene risk reduction process
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5.1.2 Comments related to the Figure “Iterative hygiene risk reduction process”
Item 6: Has the hygiene risk been adequately reduced? (answer: NO)
All risk reduction measures shall be applied in the following sequence, referred to as the four-step
method:
1) hygiene risk reduction by hygienic design or hazard elimination;
2) hygiene risk reduction by technical measures;
3) hygiene risk reduction by cleaning/disinfection measures;
4) hygiene risk reduction by additional measures.
Item 7: Can the hygiene hazard be removed?
The first step in the hygiene risk reduction process is to consider if the hygienic hazard can be eliminated.
If the hazard is eliminated, no corresponding hygiene risk can occur, and the risk assessment process
shall be restarted from the beginning.
Item 8: Can the hygiene risk be reduced by hygienic design?
This question should clarify whether there are possibilities to reduce the identified hygiene risk with the
help of the hygienic design.
The first step in the hygiene risk reduction process is the elimination of the hygiene risk by hygienic
design.
For this purpose, it shall be considered whether the hygienic and cleanalibity requirements laid down in
sublause 5.4 of this document in the various areas can be fulfilled. If not, check if the hygiene risk can be
reduced by other additional hygienic effective measures (technical measures and/or cleaning and
disinfection measures).
Item 9: Hygiene risk reduction by hygienic design or hazard elimination
Implement selected design measures.
Item 10: Is the intended hygiene risk reduction achieved?
Clarify the question whether the design measure minimizes the hygiene risk so that the existing residual
hygienic risk is eliminated or acceptable.
If the residual hygiene risk is not acceptable, check whether it can be eliminated or reduced to an
acceptable level by technical measures (see Item 11).
Item 11: Can the hygienic risk be reduced by technical measures?
If hygienic risks cannot be eliminated or reduced to an acceptable level by hygienic design, consider
technical measures. Cleaning and disinfection measures are not considered to be technical measures.
Item 12: Hygiene risk reduction by technical measures
Implement selected technical measures.
NOTE 1 Reducing humidity, sorting out contaminated materials, etc. are examples of technical measures.
Item 13: Is the intended hygiene risk reduction achieved?
Clarify the question whether the technical measures minimize the hygiene risk so that the existing
residual hygienic risk is eliminated or acceptable.
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If the residual hygiene risk is not acceptable, check whether it can be eliminated or reduced to an
acceptable level by cleaning/disinfection (see Item 15).
Item 14: Are elements of the hygienic risk assessment changed?
Clarify the question whether a technical measure has led to a change in the hygiene risk assessment.
If yes, restart the process.
Item 15: Can the hygienic risk be reduced by cleaning/disinfection?
If hygienic hazards cannot be eliminated by hygienic design or technical measures or reduced to an
acceptable level, check whether this can be achieved by appropriate cleaning and where required
disinfection measures.
EXAMPLE 1 Intermediate cleaning and intermediate disinfection of knives, using special cleaning utensils.
NOTE 2 These measures can be automated or involve the user of the machine.
Item 16: Hygienic risk reduction by cleaning/disinfection measures
Apply cleaning/disinfection measures to further reduce the hygiene risk (see Item 7).
Item 17: Is the intended hygiene risk reduction achieved?
Clarify the question whether thecleaning/disinfection measures minimize the hygiene risk so that the
existing residual hygienic risk is eliminated or acceptable.
If the residual hygiene risk is not acceptable, check whether it can be eliminated or reduced to an
acceptable level by additional measures (see Item 18).
Item 18: Can the hygienic risk be reduced by additional measures?
If hygienic hazards cannot be eliminated or be reduced to an acceptable level by hygienic design or
technical meas
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