1、PUBLISHED DOCUMENT PD CEN/TR 15623:2008 Food processing machinery Route map Materials for food area ICS 67.260 PD CEN/TR 15623:2008 This Published Document was published under the authority of the Standards Policy and Strategy Committee on 29 February 2008 BSI 2008 ISBN 978 0 580 58191 5 National fo
2、reword This Published Document is the UK implementation of CEN/TR 15623:2008. The UK participation in its preparation was entrusted by Technical Committee MCE/3, Safeguarding of machinery, to Subcommittee MCE/3/5, Food industry machines. A list of organizations represented on this committee can be o
3、btained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Amendments/corrigenda issued since publication Date CommentsTECHNICALREPORT RAPPORTTECHNIQUE TECHNISCHERBERICHT CEN/TR15623
4、 January2008 ICS67.260 EnglishVersion FoodprocessingmachineryRoutemapMaterialsforfood area MachinespourlesproduitsalimentairesCarteroutire Matriauxdestinslazonealimentaire NahrungsmittelmaschinenLeitlinieWerkstoffeim Nahrungsmittelbereich ThisTechnicalReportwasapprovedbyCENon16June2007.Ithasbeendraw
5、nupbytheTechnicalCommitteeCEN/TC153. CENmembersarethenationalstandardsbodiesofAustria,Belgium,Bulgaria,Cyprus,CzechRepublic,Denmark,Estonia,Finland, France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,P ortugal, Romania,Slovakia,Slovenia,Sp
6、ain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2008CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.CEN/TR15623:2008:E2
7、Contents Page Foreword3 1 Scope4 2 Terms and definitions .4 3 Selection method for the materials4 3.1 Global consideration.4 3.2 Example list of considerations to be taken into account at each stage of the flow chart (see Figure 2)5 4 Legal and normative references for materials7 5 Migration test me
8、thods .11 Annex A (informative) Useful websites addresses 12 Bibliography 13 CEN/TR 15623:20083 Foreword This document (CEN/TR 15623:2008) 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. CEN/TR 15623:
9、20084 1 Scope This document gives guidance to machinery manufacturers for the selection of suitable materials which will be used in the food area of machines intended for the production of food. It provides a selection process, showing those matters that need to be taken into consideration and the d
10、ecisions that have to be made. NOTE Be aware that references of this document can be amended, deleted or new references can become available. 2 Terms and definitions For the purposes of this document, the following terms and definitions apply. 2.1 food any product, ingredient or material intended to
11、 be orally consumed by human or animal EN 1672-2:2005, definition 3.1 2.2 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 EN 1672-2:2005, definition 3.4.1 3 Sele
12、ction method for the materials 3.1 Global consideration 3.1.1 Not only the production conditions shall be considered but for instance also environmental and cleaning conditions, economical considerations, hygienic aspects will influence the choice of the materials see Figures 1 and 2. e. g. solidity
13、 threshold values, density, elastic module, hardness e. g. availability, costs, production cost e. g. Ability of recycling, ability of re-use, waste products e. g. allergenic effect, toxicity, mutagenicity, teratogenicity e. g. Corrosion resistance, surface condition, ability of cleaning and disinfe
14、ction Figure 1 Schematic approach to the choice of materials CEN/TR 15623:20085 Figure 2 Flow chart for the choice of materials 3.1.2 Materials shall be suitable for intended use. Surfaces of materials and coatings shall be durable, cleanable and where required capable of being disinfected, without
15、breaks, resistant to cracking, chipping, flaking and abrasion and prevent penetration of unwanted matter under intended use. NOTE This subclause corresponds to 5.2.1 of EN 1672-2:2005. 3.1.3 In addition to the general requirements (see 3.1.2), under intended conditions of use, the materials shall be
16、: 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; not contribute either to the contamination of food or have any adverse influence on the food. NOTE This subclause
17、 corresponds to 5.2.2 of EN 1672-2:2005. 3.2 Example list of considerations to be taken into account at each stage of the flow chart (see Figure 2) a) Consider the nature of the food and physical environmental conditions: description of the food coming into contact with the surface in the food area:
18、 type of food (vinegar, salted products, fruit juice, sausage, presence of abrasives particles, stones of fruits, tough powder, etc.); type of additives (citric acid, acetic acid, colorants, etc.); CEN/TR 15623:20086 composition of the elements in contact: pH of the food product; combined with high
19、level of salt, with high temperature; quality of water (TH, CaCO 3 , Fe, Cl, etc.); presence of pieces of food, flour, etc; description of the cleaning and disinfecting products: composition of the cleaning and disinfecting agents; parameters during cleaning and disinfecting (time, concentration and
20、 pH, temperature, flow rate, etc; temperature: during production time; during cleaning time; humidity of the environment. b) Consider the conditions of production, cleaning, disinfection and/or sterilisation: conditions of circulation, agitation (speed, turbulence); thermal stress (hot, cold, cyclin
21、g); pressure stress; radiation (Ultra Violet, Infra Red, etc.); mechanical erosion (mixing, scraping); chemical corrosion; condensation. c) Consider the material: type of materials (metals, alloys, plastics, rubbers, etc.); structure and composition; corrosion (galvanic, pitting, stress, etc.); stat
22、e of the material at the delivery (relief treatment, temper, etc.); surface treatment (mechanical, electrolytic, thermal, coating, etc.); stress zone (welding area, deflection, etc.). d) Consider the need for testing (corrosion tests, qualification of thermal or chemical treatment, mechanical proper
23、ties, cleanability, etc.). CEN/TR 15623:20087 4 Legal and normative references for materials The Regulation (EC) No. 1935/2004 entry into force on 6 December 2004 (20 days after publication) and 27 October 2006 in the case of article 17 on traceability requirements. This regulation repeals directive
24、s 80/590/EEC and 89/109/EEC. Also the Regulation 2023/2006 is published. The main content is defined below. The recourse to regulations as a legal instrument for execution provisions, in place of specific execution provisions, will allow provisions to be applied in a uniform manner throughout the Eu
25、ropean Union. A regulation need not be transcribed into national law for it to become applicable. The inclusion of “active and intelligent materials and articles”. The procedure for the authorisation of new substances and for their addition to an existing positive list is detailed. Request is to be
26、submitted to the relevant national authority which informs and forwards the application to the European Food Safety Authority (EFSA instituted by regulation EC no. 178/2002). EFSA informs the other member states and the Commission, checks the validity of the dossier and must issue an opinion within
27、six months (possibly 6 months more with justification). It should also be noted that there will be general access to applications except for parts which are clearly marked as and accepted as being confidential (Article 20 of the Regulation). NOTE Guidance on the administrative and technical data req
28、uired and on the format for formal submissions is available on the EFSA website address (see Annex A). Requirements for establishing systems for good manufacturing practices (GMP) are introduced for materials intended to come into contact with food. NOTE Regulation 2023/2006 applies from 1 stAugust
29、2008. Traceability requirements for materials and articles intended to come into contact with food are provided in article 17 (see also consideration 18). Specific safeguarding measures for materials and articles intended to come into contact with food are provided in article 18. These may be taken
30、by a member state, should circumstances so require it, in the event of a risk to human health. Reference laboratories: A community reference laboratory and several national reference laboratories shall be designated according to article 24 (see also consideration 23). New materials that may be subje
31、ct to specific directives: In addition to “active and intelligent materials and articles”, there are plans to add two additional groups of materials, these being ion exchange resins and glues. Annex 1 of the regulation 1935/2004 gives a list of groups of materials for which specific measures may be
32、adopted, such as (see article 5 of the regulation for the complete list of the “Specific measures for groups of materials and articles“): a. a list of substances authorised for use in the manufacturing; b. purity standards for substances referred to in (1); c. limits on the migration of certain cons
33、tituents; d. global limit of migration, etc. The elements of this list are indicated below in the Table 1. CEN/TR 15623:20088 Table 1 Groups of materials Legal references Standards references Other references All materials Regulation 1935/2004 Regulation 2023/2006 Materials in contact with food EHED
34、G document 32. Active and intelligent materials and articles No specific Directive - - Adhesives No specific Directive - - Ceramics Directive 84/500/EEC Directive 2005/31/EC 1) Directive 69/493/EEC (Crystal glass) - - Cork No specific Directive - Resolution AP (2004) 2 Rubbers Directive 93/11/EEC Re
35、solution AP (2004) 4 Policy statement concerning rubber products Glass Directive 69/493/EEC (Crystal glass) 2) Guidelines on lead leaching from glass tableware into foodstuffs Ion-exchange resins No specific Directive Resolution AP (2004) 3 Metals and alloys General Policy statement Guidelines on me
36、tals and alloys Metals and alloys Aluminium and aluminium alloys No specific Directive EN 573-3 EN 601 EN 602 Guidelines on metals and alloys used as food contact materials Metals and alloys Steels No specific Directive EN 10333 EN 10334 EN 10335 EN 14392:2007 1) Second modification of the directive
37、 84/500/EC planned to establish stricter migration limits on lead and cadmium and to extend its scope to glass and enamelled articles. 2) In fact, this directive does not relate to the food aspects of crystal glass, but solely to the designations authorised depending on the composition. CEN/TR 15623
38、:20089 Table 1 (continued) Groups of materials Legal references Standards references Other references Metals and alloys Stainless steels There is no directive which deals with migration test for metals and alloys. EN 10020 EN 10028-7 EN 10088-1 EN 10088-2 EN 10088-3 EN 10095 EN 10151 EN 10213-4 EN 1
39、0216-5 EN 10217-7 EN 10222-5 EN 10217-7 EN 10222-5 EN 10250-4 EN 10263-5 EN 10264-4 EN 10270-3 EN 10272 EN 10283 prEN 10296-2 Paper and board Resolution AP (version 2, 13-04- 2005) on paper and board materials and articles Policy statement (2004) CEN/TR 15623:200810 Table 1 (continued) Groups of mat
40、erials Legal references Standards references Other references Plastics 3) Directive 2002/72/EC (Lists of usable monomers, migration limits, list of additives) Directive 2004/1/EC Directive 2004/19/EC Directive 2005/79/EC Directive 2007/19/EC Directive 82/711/EEC (migration test) Directive 93/8/EEC D
41、irective 97/48/EC Directive 85/572/EEC (list of simulant) Directive 2002/16/EC Epoxy (BADGE, BFDGE, NOGE) Directive 2004/13/EC Directive 78/142/EEC (vinyl chloride monomer) Directive 80/766/EEC (vinyl chloride monomer) Directive 81/432/EEC (vinyl chloride monomer) Resolution AP (89) 1 Resolution AP
42、(92) 2 Printing inks Resolution AP (2005) 2 3) Regulations for plastic materials do not apply to materials or articles comprised of two or more layers, when at least one of these layers contains a material other than plastic. These are based on a positive list principle (monomers and other authorise
43、d starting compounds), which sets global migration limits and, for certain monomers, a specific migration limit or maximum quantity of the residual substance. Draft amendment dated 20/2/2003 already ready. A new regulation is currently being drafted to replace all the directives on plastics: Directi
44、ve 2002/72/EC and its amendments (2004/ 1, 2004/ 19, 2005/79, 2007/ 19). The regulation will also replace the directive 82/7 11 and its two amendments, 93/8/EEC and 97/48/EC, as well as the three directives on vinyl chloride monomer: 78/ 142/EEC, 80/766/EEC and 8 1/432/EEC (see the chapter on tests
45、methods). CEN/TR 15623:200811 Table 1 (continued) Groups of materials Legal references Standards references Other references Regenerated cellulose Directive 93/10/EEC (regenerated cellulose) 4) Directive 93/111/EC (Amendment 1) Directive 2004/14/EC (Amendment 2) Silicones No specific directive Resol
46、ution AP (2004) 5 textiles Varnishes and coatings Framework Resolution AP (2004) 1 Policy statement concerning coatings waxes wood 5 Migration test methods The migration test shall consider the application of the materials. The time of contact between material and food product could not be compared
47、between a package and a machine. Moreover certain machines process tons of products per hours, so the migration is highly diluted. 4) Future modifications to directive 93/ 10/EEC should enable compatibility with recycling laws to be attained. The previous directive 83/229/EEC relating to materials a
48、nd articles made from regenerated cellulose film and its modifications (directives 86/388/EEC and 92/ 15/EEC) have been repealed by directive 93/ 10/EEC. CEN/TR 15623:200812 Annex A (informative) Useful websites addresses Council of Europe: http:/www.coe.int/soc-sp EFSA: http:/www.efsa.eu.int/science/afc/afc_guidance/722_en.html EHEDG: http:/www.ehedg.org/ European Commission
