FprEN 1672-2

SLOVENSKI STANDARD
oSIST prEN 1672-2:2019
01-julij-2019
Stroji za predelavo hrane - Osnovni koncepti - 2. del: Higienske zahteve
Food processing machinery - Basic concepts - Part 2: Hygiene requirements

Nahrungsmittelmaschinen - Allgemeine Gestaltungsleitsätze - Teil 2: Anforderungen an

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

Machines pour les produits alimentaires - Notions Nahrungsmittelmaschinen - Allgemeine

fondamentales - Partie 2 : Prescriptions relatives à Gestaltungsleitsätze - Teil 2: Anforderungen an

This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee

If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations

which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other

language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without

© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 1672-2:2019 E

European foreword ....................................................................................................................................................... 3

Introduction .................................................................................................................................................................... 4

1 Scope .................................................................................................................................................................... 5

2 Normative references .................................................................................................................................... 5

3 Terms and definitions ................................................................................................................................... 5

4 List of significant hazards ......................................................................................................................... 11

5 Hygiene and cleanability requirements............................................................................................... 12

5.1 Iterative hygiene risk reduction process ............................................................................................ 12

5.1.1 General ............................................................................................................................................................. 12

5.1.2 Comments related to the Figure “Iterative hygiene risk reduction process” ......................... 14

5.1.3 Determination of the limits of the machine ........................................................................................ 16

5.2 Food safety hazard identification ........................................................................................................... 17

5.2.1 General ............................................................................................................................................................. 17

5.2.2 Factors to be considered ........................................................................................................................... 17

5.2.3 Reasonably foreseeable hazards ............................................................................................................ 18

5.2.4 Hygiene risk estimation ............................................................................................................................. 19

5.3 Materials of construction .......................................................................................................................... 21

5.3.1 General requirements ................................................................................................................................ 21

5.3.2 Food area ......................................................................................................................................................... 21

5.3.3 Splash area...................................................................................................................................................... 21

5.3.4 Non-food area ................................................................................................................................................ 22

5.4 Design ............................................................................................................................................................... 22

5.4.1 General ............................................................................................................................................................. 22

5.4.2 Food area ......................................................................................................................................................... 22

5.4.3 Splash area...................................................................................................................................................... 33

5.4.4 Non-food area ................................................................................................................................................ 38

5.4.5 Cleaning ........................................................................................................................................................... 38

5.4.6 Services ............................................................................................................................................................ 44

6 Information for use ..................................................................................................................................... 45

6.1 General ............................................................................................................................................................. 45

6.2 Instruction handbook ................................................................................................................................. 45

6.2.1 General ............................................................................................................................................................. 45

6.2.2 Information relating to the intended use ............................................................................................ 45

6.2.3 Information relating to residual hygiene risks ................................................................................. 46

6.2.4 Information relating to hygienic installation .................................................................................... 46

6.2.5 Information relating to operator instructions .................................................................................. 46

6.2.6 Information relating to disposable parts ............................................................................................ 46

6.2.7 Information relating to cleaning, disinfection, rinsing and inspection for cleanliness...... 47

6.2.8 Information relating to maintenance ................................................................................................... 48

6.3 Marking ............................................................................................................................................................ 48

Annex A (informative) Examples of machinery which may be covered by this document ............... 49

Annex B (informative) Examples of hygiene risks and acceptable solutions ........................................ 50

Annex C (informative) Summary of main hygiene aspects for food processing machinery ............. 70

Bibliography ................................................................................................................................................................. 71

This document (prEN 1672-2:2019) has been prepared by Technical Committee CEN/TC 153 “Machinery

intended for use with foodstuffs and feed”, the secretariat of which is held by DIN.

The significant changes with respect to the previous edition EN 1672-2:2005+A1:2009 are listed below:

— All requirements regarding hygiene were upgraded, and new requirements regarding cleanability

This document gives general hygiene and cleanability requirements for machinery in the scope of this

standard. It is intended to be referred by type-C machinery-specific standards. This standard can be used

The machinery concerned and the extent to which hazards, hazardous situations and events are covered

Here it will distinguish between the hazards to the operator and the risks to the food (the product

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

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

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

1.1 This document specifies common hygiene and cleanability requirements for machinery and

machine components used in preparing and processing food for human (see informative Annex A) and,

where relevant, animal consumption to eliminate or minimize the risk of contagion, infection, illness or

injury arising from this food. It identifies the hazards which are relevant to the use of such food processing

machinery and describes design methods and information for use for the elimination or reduction of

Detailed hygiene and cleanability requirements may be given in applicable C-standards for specific

NOTE 1 Separate hygiene and cleanability requirements are contained in other EU-Directives or -Regulations

Examples of hygiene risks and acceptable solutions are given in the informative Annex B.

NOTE 2 This document can also be used for machinery, components or other equipment used for other purposes

1.2 This document does not deal with the hygiene-related risks to personnel arising from the use of the

1.3 This document is not applicable to machines manufactured before the date of publication of this

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

EN ISO 21469, Safety of machinery — Lubricants with incidental product contact — Hygiene requirements

For the purposes of this document, the terms and definitions given in EN ISO 12100:2010 and the

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

any product, ingredient or material intended to be orally consumed by human or animal

Note 1 to entry: It includes food and feed according to Article 2 of Regulation (EC) No. 178/2002.

taking of all measures during the preparation and processing of food to ensure that it is fit for human or

distance from the nearest free access point of the machine, according to the intended installation, to reach

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

food area, splash area and non-food area as following defined (see 3.5.1 to 3.5.3) and as illustrated in

Note 1 to entry: These areas are not to be confused with any others amongst those defined in other standards

machinery surfaces which are exposed to food or from which food or other materials can drain, drip,

area composed of surfaces on which part of the food may splash or flow along under intended conditions

Note 1 to entry: Part of the food in the splash area is no more food in the sense of 3.1.

designed and constructed to be cleanable by a simple cleaning method, where necessary after removing

Note 1 to entry: Simple cleaning methods could be, e.g. vaccum cleaning, cleaning in place (CIP) or cleaning after

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.

space wherein a product, ingredient, cleaning or disinfecting agents or soils may be trapped, retained or

not completely removed during operation of cleaning (see example given in Figure B.14)

inactivation of all pathogens and a wide range of other micro-organisms to a level consistent with

ability of a surface to withstand the intended conditions of use, except for unavoidable wear and tear

designed and constructed to permit removal, visual inspection and replacement, where necessary after

Note 1 to entry: A hazardous event can occur over a short period of time or over an extended period of time.

Note 1 to entry: The exposure can result in health harm immediately or over a period of time.

physical injury and/or infection, sickness or contagion caused by unwanted components in or of food

design and construction of equipment/machinery that can be easily freed from soil by cleaning with or

surfaces between which no particle of product becomes trapped in small crevices, thus becoming difficult

material which, under intended conditions of use, does not retain substances with which it comes into

material which does not produce or release substances injurious to health under intended conditions of

process in which food has no contact with the environment (except inlet and outlet of food, if relevant)

removal of residues or any other matter after cleaning or disinfection by flowing liquid

closing of an aperture so as to effectively prevent the unwanted entry or passage of soil

design and construction of the shape and surface finish so as to prevent liquid from being retained

condition of a surface which satisfies operational, hygiene and cleanability requirements

any unwanted matter, including product residues, micro-organisms, residual detergent or disinfecting

service devices and/or transporting devices (e.g pipes, tubes, cables) for power, supports (air, water,

Note 1 to entry: Machines which do not fulfill the requirements of this standard may produce unsafe food.

animals (including mammals, birds, reptiles and insects) which may adversely influence the food

1) pathogens (e.g opportunistic pathogens like salmonella, enterobacter, coliform bacteria);

2) microbiological toxins (e.g. Bacillus cereus, Staphylococcus aureus) and biogenic amines of

c) Foreign bodies, 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

Microbiological hazards can cause spoilage of the food, food poisoning or other related illness in

Chemical hazards can cause contamination or leave residues in the food causing injury to health (e.g.

Foreign bodies can contaminate food and cause physical injuries (e.g. choking, lacerations).

When considering the design of a machine it is necessary to consider the implications of any of the

hazards and the measures necessary to eliminate or reduce the hazard. The informative Annex C gives

The hygiene and cleanability requirements of the different areas of equipment are described in Clause 5.

They depend upon the significant hazards as described in Clause 4, the functions of the area of the

In applying the principles of design (see 5.3) the primary objective is to eliminate or reduce the risks to

an acceptable level. The risk assessment and risk reduction follow the methodology described in

EN ISO 12100:2010. In order to deal with hygiene risk and cleanability, the process has been modified as

shown in Figure 2. To apply this method, follow the steps and answer to questions in the order shown in

It is recommended to do the iterative hygiene risk reduction process by a team rather than by one person

All risk reduction measures shall be applied in the following sequence, referred to as the four-step

The first step in the hygiene risk reduction process is to consider if the hygienic hazard can be eliminated.

If the hazard is eliminated, no corresponding hygiene risk can occur, and the risk assessment process

This question should clarify whether there are possibilities to reduce the identified hygiene risk with the

The first step in the hygiene risk reduction process is the elimination of the hygiene risk by hygienic

For this purpose, it shall be considered whether the hygienic and cleanalibity requirements laid down in

sublause 5.4 of this document in the various areas can be fulfilled. If not, check if the hygiene risk can be

reduced by other additional hygienic effective measures (technical measures and/or cleaning and

Clarify the question whether the design measure minimizes the hygiene risk so that the existing residual

If the residual hygiene risk is not acceptable, check whether it can be eliminated or reduced to an

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.

NOTE 1 Reducing humidity, sorting out contaminated materials, etc. are examples of technical measures.

Clarify the question whether the technical measures minimize the hygiene risk so that the existing

If the residual hygiene risk is not acceptable, check whether it can be eliminated or reduced to an

Clarify the question whether a technical measure has led to a change in the hygiene risk assessment.

If hygienic hazards cannot be eliminated by hygienic design or technical measures or reduced to an

acceptable level, check whether this can be achieved by appropriate cleaning and where required

EXAMPLE 1 Intermediate cleaning and intermediate disinfection of knives, using special cleaning utensils.

Apply cleaning/disinfection measures to further reduce the hygiene risk (see Item 7).

Clarify the question whether thecleaning/disinfection measures minimize the hygiene risk so that the

If the residual hygiene risk is not acceptable, check whether it can be eliminated or reduced to an

If hygienic hazards cannot be eliminated or be reduced to an acceptable level by hy