SIST EN 1672-2:2005

SLOVENSKI STANDARD
SIST EN 1672-2:2005
01-julij-2005
1DGRPHãþD
SIST EN 1672-2:2000
SIST EN 1672-2:2000/AC:2000
Stroji za predelavo hrane – Osnovni koncepti – 2. del: Higienske zahteve
Food processing machinery - Basic concepts - Part 2: Hygiene requirements
Nahrungsmittelmaschinen - Allgemeine Gestaltungsleitsätze - Teil 2:
Hygieneanforderungen
Machines pour les produits alimentaires - Notions fondamentales - Partie 2: Prescriptions
relatives a l'hygiene
Ta slovenski standard je istoveten z: EN 1672-2:2005
ICS:
67.260 Tovarne in oprema za Plants and equipment for the
živilsko industrijo food industry
SIST EN 1672-2:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

EUROPEAN STANDARD
EN 1672-2

NORME EUROPÉENNE

EUROPÄISCHE NORM
April 2005
ICS 67.260 Supersedes EN 1672-2:1997
English version
Food processing machinery - Basic concepts - Part 2: Hygiene
requirements
Machines pour les produits alimentaires - Notions Nahrungsmittelmaschinen - Allgemeine
fondamentales - Partie 2: Prescriptions relatives à l'hygiene Gestaltungsleitsätze - Teil 2: Hygieneanforderungen
This European Standard was approved by CEN on 14 February 2005.

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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.

CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.




EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1672-2:2005: E
worldwide for CEN national Members.

---------------------- Page: 2 ----------------------

EN 1672-2:2005 (E)
Contents
Page
Foreword.3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions .5
4 List of significant hazards .7
5 Hygiene requirements .8
5.1 Hygiene risk assessment.8
5.1.1 General.8
5.1.2 Determination of the limits of the machine.10
5.1.3 Hygiene risk estimation .10
5.1.4 Hygiene risk evaluation.11
5.1.5 Hygiene risk reduction .11
5.2 Materials of construction .11
5.2.1 General requirements.11
5.2.2 Food area.11
5.3 Design .12
5.3.1 Food area.12
5.3.2 Splash area.13
5.3.3 Non food area.13
5.3.4 Services .14
6 Verification of hygiene requirements and/or measures .14
7 Information for use .15
7.1 General.15
7.2 Instruction handbook .15
7.2.1 General.15
7.2.2 Information relating to installation.15
7.2.3 Information relating to the machine itself .15
7.2.4 Information relating to cleaning and disinfection .16
7.2.5 Information relating to maintenance.16
7.3 Marking .16
Annex A (informative) Figures .17
Annex B (informative) Examples of machinery which may be covered by this document .37
Annex C (informative) Summary of main hygiene aspects for food processing machinery.38
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/37/EC .39
Bibliography .40

2

---------------------- Page: 3 ----------------------

EN 1672-2:2005 (E)
Foreword
This document (EN 1672-2:2005) has been prepared by Technical Committee CEN/TC 153 “Food processing
machinery — Safety and hygiene specifications”, 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 October 2005, and conflicting national standards shall be withdrawn at the latest
by October 2005.
This document supersedes EN 1672-2:1997.
This document has been prepared under a mandate given to CEN by the European Commission and the European
Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with the EU Directive, see informative Annex ZA, which is an integral part of this document.
This document is complemented by prCEN/TR 1672-1 which deals with safety rules to protect operators.
This document includes a Bibliography.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark,
Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
3

---------------------- Page: 4 ----------------------

EN 1672-2:2005 (E)
Introduction
This document is a type C standard as stated in EN ISO 12100-1.
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 has to be distinguished 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.
The technical requirements given in the prCEN/TR 1672-1 and in this document permit both objectives to be met
for those significant and common risks identified as justifying common requirements in this document.
Other hazards, for which such common requirements can not be set, remain to be covered in machinery specific
type C standard and/or by reference to EN ISO 12100-2 and type A and type B standards.
When provisions of this type C standard are different from those which are stated in type A or B standards, the
provisions of this type C standard take precedence over the provisions of the other standards, for machines that
have been designed and built according to the provisions of this type C standard.
NOTE The essential requirements of the Machinery Directive should met in respect of both safety risks to the operator of
the machinery and hygiene risks to the food (product processed by the machinery). The Directive requirements and the safety
and hygiene risks identified by the risk assessment process required by EN 1050 can each usually equally well be met by a
range of safeguarding or hygiene design options.

4

---------------------- Page: 5 ----------------------

EN 1672-2:2005 (E)
1 Scope
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 the informative Annex B.
NOTE Separate hygiene requirements are contained in other EU Directives (see Bibliography).
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 the informative Annex A.
This document is not applicable to machines manufactured before the date of publication of this document by CEN.
2 Normative references
The following referenced documents are indispensable for the application 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 4288, Geometrical product specifications (GPS) — Surface texture: Profile method — Rules and
procedures for the assessment of surface texture (ISO 4288:1996)
EN ISO 12100-1:2003, Safety of machinery — Basic concepts, general principles for design — Part 1: Basic
terminology, methodology (ISO 12100-1:2003)
EN ISO 12100-2:2003, Safety of machinery — Basic concepts, general principles for design — Part 2: Technical
principles (ISO 12100-2:2003)
3 Terms and definitions
For the purposes of this document, the terms and definitions given EN ISO 12100-1:2003 and the following apply.
3.1
food
any product, ingredient or material intended to be orally consumed by human or animal
3.2
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
adverse influence
effect which gives a significant reduction of the fitness for consumption of a food. A food can be adversely
influenced, in particular by microbial pathogens or other unwanted micro-organisms, toxins, vermin and other
contaminants
5

---------------------- Page: 6 ----------------------

EN 1672-2:2005 (E)
3.4 areas of equipment
NOTE These areas are not to be confused with any others amongst those defined in other standards (e.g. electro-technical
standards).
3.4.1
food area
machinery surfaces which are exposed to the food and from which the food or other materials can drain, drip,
diffuse or be drawn into (self returned) the food or food container (see Figure A.1)
3.4.2
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 (see Figure A.1)
3.4.3
non food area
any area other than those specified above (see Figure A.1)
3.5
cleaning
removal of soils
cleanable
designed and constructed so that soils are removed by recommended cleaning methods (see 7.2.4)
3.6
contamination
presence of soils
3.7
corrosion resistant material
material resistant to normally occurring action of chemical or electrochemical nature. It includes food processing,
cleaning and disinfection according to the instructions for use
3.8
crevice
surface defect e.g. crack, fissure, which adversely affects cleanability
3.9
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 Figures A.15 and A.16)
3.10
disinfection
inactivation of all pathogens and a wide range of other micro-organisms to a level consistent with hygienic
application of the equipment
3.11
durable
ability of a surface to withstand the intended conditions of use, for example: to resist to damage 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
3.12
joint
junction of two or more pieces of material
6

---------------------- Page: 7 ----------------------

EN 1672-2:2005 (E)
3.13
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
3.14
non toxic material
material which does not produce or release substances injurious to health under intended conditions of use
3.15
seal
closing of an aperture so as to effectively prevent the unwanted entry or passage of any matter
3.16
self draining
design and construction of the shape and surface finish so as to prevent liquid from being retained
3.17
smooth
condition of a surface which satisfies operational and hygienic requirements
3.18
soil
any unwanted matter, including product residues, micro-organisms, residual detergent or disinfecting agents
3.19
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:
 biological causes such as pathogens, spoilage micro organisms, toxins or vermin;
 chemical causes including those from cleaning, disinfecting agents and lubricant substances;
 foreign bodies arising from raw materials, 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.
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. Informative Annex C gives examples.
7

---------------------- Page: 8 ----------------------

EN 1672-2:2005 (E)
5 Hygiene requirements
5.1 Hygiene risk assessment
5.1.1 General
The hazards shall be eliminated or the associated risks reduced by ensuring machinery is properly designed,
constructed and capable of being properly installed, operated, cleaned and maintained.
The hygiene requirements of the different areas of the equipment depend upon the functions of the area, the type
of food to be processed and the nature of hazards to the food.
In applying the design and construction criteria the primary objective shall be to eliminate or reduce the risks to an
acceptable level (see Figure 1).
The hygiene risk assessment follows the methodology described in EN 1050.
8

---------------------- Page: 9 ----------------------

EN 1672-2:2005 (E)

Figure 1 — Hygiene risk assessment
9

---------------------- Page: 10 ----------------------

EN 1672-2:2005 (E)
5.1.2 Determination of the limits of the machine
Risk assessment shall take into account:
 the phases of machine life;
 the limits of the machine (see 5.2 of EN ISO 12100-1:2003) including the intended use (both the correct use
and operation of the machinery as well as the consequences of reasonably foreseeable misuse or malfunction)
in accordance with 3.22 of EN ISO 12100-1:2003, for example: will the machine be used for one specific
purpose only, for which hazards are readily identifiable, or could the machine be used for a wide range of food
products in many industries (e.g. a pump)?;
 the full range of foreseeable uses of the machinery (e.g. industrial, non-industrial and domestic) by persons
identified by sex, age, dominant hand usage, or limiting physical abilities (e.g. visual or hearing impairment,
size, strength);
 the anticipated level of training, experience or ability of the foreseeable users.
5.1.3 Hygiene risk estimation
The estimation of the hygiene risk by the manufacturer shall be related to the three significant hazards defined in
Clause 4 and restricted to the hazards caused by the intended use of the machine, as defined in 3.22 of
EN ISO 12100-1:2003:
 estimate the severity of the possible harm from the considered hazard;
 estimate the probability of the occurrence of that harm from the considered hazard: see example below.
EXAMPLE
When all hygienic hazards are identified, they can be scored, one by one, with the help of the Figure 2.
The questions to raise are:
1 – Does the hazard have a low, medium or high impact if it occurs?
2 – Is the probability of occurrence that the hazard occurs low, medium or high?

High LH MH HH
Severity
Medium LM MM HM
Low LL ML HL

Low Medium High

Probability of occurrence
Figure 2 — Example of tool for the risk estimation - Risk ranking diagram
NOTE It is recommended to make or realise the estimation with a team rather than by one person only.
10

---------------------- Page: 11 ----------------------

EN 1672-2:2005 (E)
5.1.4 Hygiene risk evaluation
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. If hygiene risk
reduction is required, then appropriate food safety measures shall be selected and applied, and the procedure
repeated (see Figure 1). During this iterative process, it is important for the designer to check whether additional
hazards are created when new food safety measures are applied. If additional hazards are identified, they shall be
added to the list of identified hazards.
The achievement of the hygiene risk reduction objectives and a favourable outcome of risk comparison give
confirmation that the machinery is safe.
5.1.5 Hygiene risk reduction
Achievement of the following conditions shall indicate the satisfactory hygiene risk reduction process:
 the hazard has been eliminated or the hygiene risk reduced by:
a) design or by the substitution of less hazardous materials and substances;
b) safeguarding the hygienic conditions;
 the information on the intended use of the machinery is sufficiently clear (see Clause 7) when:
a) the operating procedures for the use of the machinery are consistent with the ability of personnel who use
the machinery or other persons who can introduce hazards to the food;
b) the recommended hygienic working practices for the use of the machinery and the related training
requirements have been adequately described;
c) the user is sufficiently informed about hazards occurring during the different phases of the life of the
machinery;
d) the use of personal protective equipment is recommended, the need for such equipment and the training
requirements for its use have been adequately described.
5.2 Materials of construction
5.2.1 General requirements
Materials shall be suitable for intended use.
Surfaces of materials and coatings shall be durable, cleanable and where required capable of being disinfected,
without breaks, resistant to cracking, chipping, flaking and abrasion and prevent penetration of unwanted matter
under intended use.
5.2.2 Food area
In addition to the general requirements (see 5.2.1), under intended conditions of use, the materials shall be:
 corrosion resistant;
 non toxic;
 non absorbent (except when technically or functionally unavoidable).
The materials shall:
 not transfer undesirable odours, colours or taint to the food;
11

---------------------- Page: 12 ----------------------

EN 1672-2:2005 (E)
 not contribute either to the contamination of food or have any adverse influence on the food.
5.3 Design
5.3.1 Food area
5.3.1.1 Surfaces
Surface finish shall be suitable for intended use.
Surfaces shall be cleanable and where required capable of being disinfected. For this purpose they shall be
smooth, continuous or sealed.
The surface design and finish shall be such that the product is prevented as far as possible from becoming
accidentally separated from the food area and from returning to it, if that return would cause a hazard to the
processed food.
Surfaces shall have a finish so that no particle of product becomes trapped in small crevices, thus becoming
difficult to dislodge and so introduce a contamination hazard.
These above requirements also apply to dismountable parts, which are removable for cleaning.
NOTE Guidance for measurement of surface finish (roughness specification Rz and/or Ra) can be found in EN ISO 4288.

Additional requirements for surface finish can be found in some machinery specific type C standards.
5.3.1.2 Joints
5.3.1.2.1 Permanent joints
Joints shall be sealed and hygienic. Recesses, gaps, crevices, protruding ledges, inside shoulders and dead
spaces shall be avoided (see Figures A.3, A.4 and A.5). If technically impossible adequate solutions (e.g. cleaning,
disinfection, instructions, etc.) shall be given.
5.3.1.2.2 Dismountable joints
Dismountable joints shall present a true and hygienic fit (see Figures A.6, A.7, A.8 and A.9).
5.3.1.3 Fasteners
Fasteners such as screws, bolts, rivets and so on, shall be avoided If technically impossible adequate solutions
(e.g. cleaning, disinfection, instructions, etc.) shall be given (see Figure A.10).
5.3.1.4 Drainage
It shall be ensured that the machinery is preferably self draining, or that the residual liquid can be removed by other
means (see Figures A.11, A.12 and A.13).
5.3.1.5 Internal angles and corners
Internal angles and corners shall be so constructed that they are effectively cleanable and where required capable
of being disinfected (see Figure A.14).
Internal angles and corners shall comply with technical requirements which are given in machinery specific C
standards.
12

---------------------- Page: 13 ----------------------

EN 1672-2:2005 (E)
5.3.1.6 Dead spaces
Dead spaces shall be avoided unless technically impossible in the design, construction and installation of the
machinery (see Figures A.15 and A.16).
Dead spaces, which are unavoidable, shall be constructed in such a way that they are drainable/cleanable and
capable of being disinfected, where required.
5.3.1.7 Bearings and shaft entry points
Bearings shall be either located outside of the food area except where this is technically unavoidable, or designed
for and lubricated with food grade lubricant, cleanable and where required capable of being disinfected (see
Figures A.17 and A.18).
Shaft seals and moving shafts in the food area shall be self (or product)-lubricated or should be designed for and
lubricated with food grade lubricant, cleanable and, where required, capable of being disinfected.
NOTE Requirements for equipment used in aseptic processing may be found in specific C standards.
5.3.1.8 Instrumentation and sampling devices
Instrumentation and sampling devices shall comply with the relevant sections of this Clause 5 (see Figures A.19,
A.20 and A.21).
5.3.1.9 Panels, covers, doors
These parts shall be so designed that they avoid any adverse influence (e.g. entry and/or accumulation of any soil)
and shall be cleanable and, where required, capable of being disinfected.
5.3.1.10 Control devices
If there is no manual contact with the food, these items or areas of machinery which are handled for control
reasons by the operator, shall be considered as non food areas. In case of manual contact with the food, where
cross contamination can occur these areas or items shall be covered by the definition of a food area (see 3.4.1).
5.3.2 Splash area
The splash area shall be designed and constructed following the same principles for the food area.
As the food does not return to the food area, the technical design criteria may be less stringent than in the food
area in areas such as the following provided that there is no adverse effect on the food:
 technical requirements for surface finish may allow for higher Rz and/or Ra values;
 internal angles and corners may be of smaller radius, provided they are still cleanable and, where required,
capable of being disinfected;
 bearings, seals, moving shafts, etc., located in a splash area, may be lubricated by non-food grade lubricants,
provided there is no adverse influence on the food.
Regarding fasteners see the Figure A.22.
5.3.3 Non food area
In addition to the general requirements (see 5.2.1) exposed surfaces used in the non-food area shall be made of
corrosion resistant material or material that is treat
...