Food processing machinery - Basic concepts - Part 2: Hygiene and cleanability requirements

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.

Nahrungsmittelmaschinen - Allgemeine Gestaltungsleitsätze - Teil 2: Anforderungen an Hygiene und Reinigbarkeit

1.1 Dieses Dokument legt allgemeine Hygiene  und Reinigbarkeitsanforderungen an Maschinen und Maschinenbauteile fest, die zur Vorbereitung und Verarbeitung von Lebensmitteln für den menschlichen Verzehr (siehe informativen Anhang A) und, wo relevant, zur Verarbeitung von Tierfutter verwendet werden, um das Risiko von Ansteckung, Infektion, Erkrankung oder Verletzung, das vom Lebensmittel ausgehen kann, auszuschließen oder auf ein akzeptables Niveau herabzusetzen. Es identifiziert die Gefährdungen, die bei der Verwendung solcher Nahrungsmittelmaschinen signifikant sind, und beschreibt Gestaltungsverfahren und gibt Benutzerinformationen zur Eliminierung oder Verminderung dieser Risiken.
Zusätzliche und/oder abweichende Hygiene  und Reinigbarkeitsanforderungen dürfen in anwendbaren C Normen für bestimmte Maschinen oder Maschinenkategorien festgelegt werden.
ANMERKUNG Separate Hygiene  und Reinigbarkeitsanforderungen sind in anderen EU Richtlinien oder  Verordnungen enthalten (siehe Literaturhinweise).
Beispiele für Hygienerisiken und akzeptable Lösungen sind im informativen Anhang B angegeben.
Dieses Dokument darf auch für Maschinen, Bauteile oder andere Geräte verwendet werden, die für andere Zwecke als die Vorbereitung oder Verarbeitung von Lebensmitteln verwendet werden, falls eine Reinigbarkeit erforderlich ist.
1.2 Dieses Dokument behandelt nicht die hygienebedingten Risiken für die Bediener, die durch die Verwendung der Maschine entstehen.
1.3 Dieses Dokument ist nicht anzuwenden für 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 prescriptions 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, au traitement des aliments pour animaux afin d'éliminer ou de réduire à un niveau acceptable 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 supplémentaires et/ou 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   D'autres exigences d'hygiène et de nettoyabilité sont données dans d'autres Directives ou Règlements UE (voir Bibliographie).
Des exemples de risques hygiéniques et de solutions acceptables sont donnés dans l'Annexe B informative.
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 les opérateurs 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

Status
Published
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
23-Dec-2020
Completion Date
23-Dec-2020

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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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SIST EN 1672-2:2021
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

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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SIST EN 1672-2:2021
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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SIST EN 1672-2:2021
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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SIST EN 1672-2:2021
EN 1672-2:2020 (E)
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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SIST EN 1672-2:2021
EN 1672-2:2020 (E)
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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SIST EN 1672-2:2021
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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SIST EN 1672-2:2021
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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SIST EN 1672-2:2021
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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SIST EN 1672-2:2021
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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SIST EN 1672-2:2021
EN 1672-2:2020 (E)

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
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