SIST EN 1672-2:2021

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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

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.
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.
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.
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
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
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).
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
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
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.
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.
NOTE Explanations to numbers 1 to 28 are given in 5.1.2 to 5.1.4.
Figure 2 — Iterative hygiene risk reduction process
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).
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.
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 process;
— intended use (single food type, more than one food type – simultaneously or consecutively);
— stage of processing (upstream process stage, last process stage), all processes (e.g. cooking, baking,
pasteurizing) to be performed by the food processing machine as well as their effects on the food;
— the food processing machine functions (e.g. washing, cutting, mixing) to be performed with it.
The different areas of equipment shall be taken into account (see 3.5).
5.1.2.2.4 Reasonably foreseeable hazards
In addition, reasonably foreseeable hazards not directly related to the food, its processing and the
machine function shall be identified, e.g.:
— human interaction during the whole life cycle of the machine such as:
— tasks to be performed by operators (e.g. manual feeding and handling, manual intervention);
— stopping the machine in case of emergency;
— recovery of operation from jam or blockage;
— maintenance works;
— cleaning and, where required, disinfection methods (dry or wet);
— possible states of the food processing machine:
— the machine performs the intended function (the machine operates normally);
— the machine does not perform the intended function, including unwanted variation of properties
of the processed food;
— wear or failure of one or more of machine component parts;
— external disturbances (e.g. loss of one or more required energy supplies), design error or deficiency
(e.g. unsuitable surface finish of material); and
— unwanted surrounding conditions (e.g. uncooled environment, UV-radiation).
5.1.2.2.5 Hygiene risk estimation (see Figure 2, Item 4)
5.1.2.2.5.1 General
After food safety hazard identification, hygiene risk estimation shall be carried out for each hazard.
The elements of risk given in 5.1.2.2.5.2 to 5.1.2.2.5.4 as well as aspects to be considered given in
5.1.2.2.5.5 to 5.1.2.2.5.8 shall be taken into account.
Food safety hazards can lead to unsafe food, and its consumption can lead to health harm.
The hygiene risk associated with a particular hazard depends on the following elements:
— the severity of health harm caused by the hazard,
— the probability of occurrence of that health harm,
— existing possibilities to avoid or limit health harm.
NOTE Possibilities to avoid or limit health harm are measures such as washing, peeling, cooking, baking, before
consuming (this is not applicable to ready-to-eat food).
5.1.2.2.5.2 Severity of health harm
The severity of health harm caused by the hazard can be estimated by taking into account the following:
— the severity of health harm, e.g.:
— low (slight),
— medium (serious),
— high (death).
— the extent of health harm to e.g.:
— one consumer,
— a group of consumers,
— any consumer.
5.1.2.2.5.3 Probability of occurrence of health harm
Factors to be considered when estimating the probability of occurrence of health harm from unsafe food
include among others:
— experience based on Good Manufacturing Practice;
— market observation;
— consideration of exposed consumers (see also 5.1.2.2.5.5);
— medical data (e.g. occurrence of infections or allergies) as far as known or available.
5.1.2.2.5.4 Existing possibilities to avoid or limit health harm
Before consuming, existing possibilities to avoid or limit health harm are measures such as washing,
peeling, cooking, baking.
NOTE This is not applicable to ready-to-eat food.
5.1.2.2.5.5 Consumers
Hygiene risk estimation shall take into account the following groups of consumers of food, e.g.:
— healthy;
— health-burdened (e.g. allergies, intolerance);
— sick (e.g. hospitalized patients);
— part of a health risk group, e.g. younger (infants) or elderly people or people with immune system
deficiencies.
5.1.2.2.5.6 Combination of hazards
The effects of combinations of food safety hazards shall be considered.
5.1.2.2.5.7 Human factors
Human factors can affect hygiene risks and shall be taken into account in the hygiene risk estimation,
including, e.g.:
— the interaction of person(s) with the machinery (e.g. cross contamination, foreign bodies);
— the capacity of persons to be aware of hygiene risks in a given situation depending on their training,
experience and ability (e.g. countermeasures, production stop).
Training, experience and ability can affect risk; nevertheless, none of these factors shall be used as a
substitute for the removal of a hazard, risk reduction by hygienic design or technical measures, wherever
these protective measures can be practically implemented.
5.1.2.2.5.8 Tools for hygiene risk estimation
For the risk assessment, one of the many risk assessment tools should be selected and used (see
ISO/TR 14121-2:2012, Clause 6).
5.1.2.3 Hygiene risk evaluation (see Figure 2, Item 5)
After hygiene risk estimation, hygiene risk evaluation shall be carried out to determine if hygiene risk
reduction is required or whether food safety has been achieved by reducing risks to an acceptable level.
The objective of the hygiene risk assessment is to decide which hazard to food safety, if any, requires
further risk reduction.
Care should be taken that simple and effective measures for reducing relatively low risks are not
overlooked due to an exclusive focus on the highest risks.
5.1.2.4 Question: “Has the hygiene risk been adequately reduced?” (see Figure 2, Item 6)
If an existing hygiene risk is not acceptable, it has to be reduced. The risk reduction measure shall be
determined using the subsequent multi-step procedure.
5.1.3 Hygiene risk reduction process (see Figure 2, Item 28)
5.1.3.1 General
All risk reduction measures shall be applied in the following sequence, referred to as the four-step
method:
a) hygiene risk reduction by hygienic design or hazard elimination;
b) hygiene risk reduction by technical measures;
c) hygiene risk reduction by cleaning/disinfection measures;
d) hygiene risk reduction by additional measures.
5.1.3.2 Removal of the hygiene hazard or hygiene risk reduction by hygienic design
5.1.3.2.1 Question: “Can the hygiene hazard be removed?” (see Figure 2, Item 7)
The first step in the hygiene risk reduction process is to consider if the hygiene hazard can be eliminated.
NOTE If the hazard is eliminated, no corresponding hygiene risk is present.
5.1.3.2.2 Question: “Can the hygiene risk be reduced by hygienic design?” (see Figure 2, Item 8)
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 requirements laid down in subclauses of 5.3 in the
various areas can be fulfilled. If not, check if the hygiene risk can be reduced by other technical measures
with an effect on hygiene.
NOTE Hygienic design is understood as material requirements as well as the constructive design as described
in this document (see Figure 2, Note 1).
5.1.3.2.3 Hygiene risk reduction by hygienic design or hygiene hazard removal (see Figure 2,
Item 9)
Implement hazard removal or hygienic design measures.
5.1.3.2.4 Question: “Is the intended hygiene risk reduction achieved?” (see Figure 2, Item 10)
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).
5.1.3.2.5 Hygiene risk reduction by technical measures
5.1.3.2.5.1 Question: “Can the hygiene risk be reduced by technical measures?” (see Figure 2,
Item 11)
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.
5.1.3.2.5.2 Hygiene risk reduction by technical measures (see Figure 2, Item 12)
Implement selected technical measures.
NOTE Temperature setting, reducing humidity, sorting out contaminated materials are examples of technical
measures.
5.1.3.2.5.3 Question: “Is the intended hygiene risk reduction achieved?” (see Figure 2, Item 13)
Clarify the question whether the technical 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 cleaning/disinfection (see 5.1.3.2.5.1).
5.1.3.2.6 Hygiene risk reduction by cleaning/disinfection measures
5.1.3.2.6.1 Question: “Can the hygiene risk be reduced by cleaning/disinfection?” (see Figure 2,
Item 15)
If hygiene 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 Intermediate cleaning and intermediate disinfection of knives, using special cleaning utensils.
NOTE These measures can be automated or involve the user of the machine.
5.1.3.2.6.2 Hygiene reduction by cleaning/disinfection (see Figure 2, Item 16)
Apply cleaning/disinfection measures to reduce the hygiene risk.
NOTE Provide space for disassembly and disassembly instruction if necessary/required (see Figure 2, Note 2).
5.1.3.2.6.3 Question: “Is the intended hygiene risk reduction achieved?” (see Figure 2, Item 17)
Evaluate 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 5.1.3.2.7).
5.1.3.2.6.4 Provide information for use (see Figure 2, Item 21)
Describe in the user information all necessary cleaning/disinfection measures and/or additional
measures leading to the elimination or reduction of the residual risk to an acceptable level.
5.1.3.2.7 Hygiene risk reduction by additional measures
5.1.3.2.7.1 Question: “Can the hygiene risk be reduced by additional measures?” (see Figure 2,
Item 18)
If hygiene hazards cannot be eliminated or be reduced to an acceptable level by hygienic design or
technical measures, or cleaning/disinfection measures, check whether this can be achieved by additional
measures (e.g. requirements for personnel hygiene, specific training).
NOTE Such additional measures are always implemented by the user of the machine.
5.1.3.2.7.2 Hygiene reduction by additional measures (see Figure 2, Item 19)
Apply additional measures to further reduce the hygiene risk.
Information on these additional measures shall be given in the instructions for use (see Clause 6).
5.1.3.2.7.3 Question: “Is the intended hygiene risk reduction achieved?” (see Figure 2, Item 20)
Clarify the question whether the additional measures minimize the hygiene risk so that the existing
residual hygienic risk is eliminated or acceptable.
If the remaining hygiene risk cannot be eliminated or reduced to an acceptable level despite all the
measures applied so far, restart the process.
5.1.3.2.7.4 Provide information for use (see Figure 2, Item 21)
Describe in the user information all necessary cleaning/disinfection measures and/or additional
measures leading to the elimination or reduction of the residual risk to an acceptable level (see
5.1.3.2.6.4).
5.1.4 Other elements of the iterative hygiene risk reduction process
5.1.4.1 Question: “Are elements of the hygiene risk assessment changed?” (see Figure 2, Item 14)
If a technical measure has led to a change in the hygiene risk assessment the process shall be restarted.
5.1.4.2 Question: “Are other hygiene hazards generated?” (see Figure 2, Item 22)
If other hygiene hazards are generated the process shall be restarted.
EXAMPLE To inspect a specific area it is necessary to bend over the food area. This can create a contamination
hazard.
5.1.4.3 Question: “Is there a conflict between hygiene and safety?” (see Figure 2, Item 23)
If the hygiene risk reduction measures lead to a conflict between hygiene and safety the risk reduction
process shall be carried out for both the hygiene (according to this document) and the safety (according
to EN ISO 12100:2010) until the risk is reduced to an acceptable level (see Figure 2, Item 24).
EXAMPLE A circular blade designed without blade protection allows access for cleaning. However, an
accessible knife represents a cutting point with high risk on injury.
NOTE The question is only asked in the initial process. In the second run, this question is no longer asked (see
Figure 2, Note 3).
5.1.4.4 Documentation (see Figure 2, Item 25)
Documentation shall comply with EN ISO 12100:2010, Clause 7.
NOTE For additional information see ISO/TR 14121-2:2012, Clause 10.
5.2 Materials of construction
5.2.1 General requirements
All materials of construction shall be suitable for the intended use. In order to avoid reasonably
foreseeable misuse, information about unsuitable conditions for operation, cleaning methods and
cleaning agents as well as disinfection shall be given in the instruction handbook.
The surfaces of materials shall be durable, cleanable and where required capable of being disinfected,
without breaks, resistant to cracking, chipping, flaking and abrasion, and they shall prevent penetration
of unwanted matter under intended use.
NOTE A surface of a material can be a coating.
5.2.2 Food area
In addition to the general requirements (see 5.2.1):
— materials shall be:
— corrosion-resistant;
— non-toxic;
— non-absorbent (except when technically or functionally unavoidable); and
— the materials shall:
— not transfer undesirable odours, colours or taint to the food;
— neither contribute to the contamination of food nor have any adverse influence on the food.
NOTE Examples of Regulations for food contact materials are the Framework Regulation (EC) No. 1935/2004,
the GMP Regulation (EC) No. 2023/2006 and measures applicable to specific groups of materials such as Regulation
(EU) No.10/2011 for plastics. Such European specific measures can define a list of authorized substances (positive
list). Materials without specific measure adopted at the European level for the group they belong to (in this case,
specific national measures can apply) can be used in contact with food if they satisfy the principle of inertia defined
in Article 3
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