SIST EN 1672-2:2005+A1:2009
(Main)Food processing machinery - Basic concepts - Part 2: Hygiene requirements
Food processing machinery - Basic concepts - Part 2: Hygiene requirements
This document specifies common hygiene requirements for machinery used in preparing and processing food for human and, where relevant, animal consumption to eliminate or minimise the risk of contagion, infection, illness or injury arising from this food. It identifies the hazards which are relevant to the use of such food processing machinery and describes design methods and information for use for the elimination or reduction of these risks.
This document does not deal with the hygiene related risks to personnel arising from the use of the machine.
This document applies to food processing machines. Examples of such groups of food processing machinery are given in 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.
Nahrungsmittelmaschinen - Allgemeine Gestaltungsleitsätze - Teil 2: Hygieneanforderungen
Machines pour les produits alimentaires - Notions fondamentales - Partie 2 : Prescriptions relatives à l'hygiène
Le présent document établit les prescriptions d'hygiène communes aux machines utilisées pour la préparation et le
traitement d'aliments destinés à la consommation humaine et, le cas échéant, à la consommation animale afin
d'éliminer ou de minimiser le risque de contagion, d'infection, de maladie ou de lésion provenant de cet aliment.
Elle identifie les phénomènes dangereux qui sont propres à l'utilisation de telles machines et elle décrit les méthodes
de conception et les informations pour l'utilisation visant à éliminer ou à réduire ces risques.
Le présent document ne traite pas les risques hygiéniques concernant le personnel, survenant pendant l'utilisation
de la machine.
Le présent document s'applique aux machines pour produits alimentaires dont des exemples sont donnés dans
l’Annexe informative B.
NOTE D'autres exigences d'hygiène sont données dans d'autres Directives UE (voir la bibliographie).
Les principes définis dans le présent document peuvent également être appliqués à d'autres machines et à d'autres
équipements utilisés pour la transformation d'aliments lorsque des risques similaires s'y rencontrent.
Des exemples de risques hygiéniques et de solutions acceptables sont donnés dans l'Annexe informative A.
Le présent document ne s 'applique pas aux machines fabriquées avant la date de publication du présent document
par le CEN.
Stroji za predelavo hrane - Osnovni koncepti - 2. del: Higienske zahteve
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Stroji za predelavo hrane - Osnovni koncepti - 2. del: Higienske zahteveNahrungsmittelmaschinen - Allgemeine Gestaltungsleitsätze - Teil 2: HygieneanforderungenMachines pour les produits alimentaires - Notions fondamentales - Partie 2 : Prescriptions relatives à l'hygièneFood processing machinery - Basic concepts - Part 2: Hygiene requirements67.260Tovarne in oprema za živilsko industrijoPlants and equipment for the food industryICS:Ta slovenski standard je istoveten z:EN 1672-2:2005+A1:2009SIST EN 1672-2:2005+A1:2009en,fr01-maj-2009SIST EN 1672-2:2005+A1:2009SLOVENSKI
STANDARDSIST EN 1672-2:20051DGRPHãþD
SIST EN 1672-2:2005+A1:2009
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1672-2:2005+A1
March 2009 ICS 67.260 Supersedes EN 1672-2:2005English Version
Food processing machinery - Basic concepts - Part 2: Hygiene requirements
Machines pour les produits alimentaires - Notions fondamentales - Partie 2: Prescriptions relatives à l'hygiène Nahrungsmittelmaschinen - Allgemeine Gestaltungsleitsätze - Teil 2: Hygieneanforderungen This European Standard was approved by CEN on 14 February 2005 and includes Amendment 1 approved by CEN on 29 December 2008.
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 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 Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1672-2:2005+A1:2009: ESIST EN 1672-2:2005+A1:2009
EN 1672-2:2005+A1:2009 (E) 2 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 Annex ZB (informative)
!!!!Relationship between this European Standard and the
Essential Requirements of EC Directive 2006/42/EC"""" . 40 Bibliography . 41
SIST EN 1672-2:2005+A1:2009
EN 1672-2:2005+A1:2009 (E) 3 Foreword This document (EN 1672-2:2005+A1:2009) 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 September 2009, and conflicting national standards shall be withdrawn at the latest by December 2009. This document includes Amendment 1, approved by CEN on 2008-12-29. This document supersedes !EN 1672-2:2005". The start and finish of text introduced or altered by amendment is indicated in the text by tags ! ". 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(s), see informative Annexes ZA and ZB, which are integral parts 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, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. SIST EN 1672-2:2005+A1:2009
EN 1672-2:2005+A1:2009 (E) 4 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.
SIST EN 1672-2:2005+A1:2009
EN 1672-2:2005+A1:2009 (E) 5 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 SIST EN 1672-2:2005+A1:2009
EN 1672-2:2005+A1:2009 (E) 6 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 SIST EN 1672-2:2005+A1:2009
EN 1672-2:2005+A1:2009 (E) 7 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. SIST EN 1672-2:2005+A1:2009
EN 1672-2:2005+A1:2009 (E) 8 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. SIST EN 1672-2:2005+A1:2009
EN 1672-2:2005+A1:2009 (E) 9
Figure 1 — Hygiene risk assessment SIST EN 1672-2:2005+A1:2009
EN 1672-2:2005+A1:2009 (E) 10 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?
Severity High LH MH HH 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. SIST EN 1672-2:2005+A1:2009
EN 1672-2:2005+A1:2009 (E) 11 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; SIST EN 1672-2:2005+A1:2009
EN 1672-2:2005+A1:2009 (E) 12 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. SIST EN 1672-2:2005+A1:2009
EN 1672-2:2005+A1:2009 (E) 13 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 treated (coated or painted) so as to be corrosion resistant. These surfaces shall be cleanable and, where required, capable of being disinfected and shall not contaminat
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