to get a complimentary download version - (FKM), VertrÃƒÂ¤ge und ...

More documents

Recommendations

Info

18 Legal requirements for hygienic design in EuropeEU Regulation 1935/2004 on materials and articlesintended to come into contact with food covers the followingequipment processing machinery and lling equipment, andkitchen equipment, containers, and packaging materials. Theregulation specically requires that food-contact materialsand equipment comply with the followingNo human health hazardsNo indefensible modication of food compositionNo detraction from organoleptic food propertiesNo misdirection of customersUse of ‘for food contact or the symbol (Figure 2). (Thissymbol is only needed, if there is no instruction manualand if it is not obvious that this is for food contact).Traceability on all manufacturing and distribution stepsEU Regulation 2023/2006 of 22 December 2006 on good manufacturingpractice (GMP) for materials and articles intended to comeinto contact with food requires that the following must be set up andinstalled for all producers of materials intended to come into contactwith food and are covered by EU Regulation 1935/2004Quality assurance systemQuality control systemDocumentationAccording to Article 2 of EC 2023/2006 “This regulation shallapply to all sectors and all stages of manufacture, processingand distribution of materials and articles, up to but excludingthe production of starting substances.” This means that,for example, all producers of plastic materials must have aquality system that includes the required documentation ifthey produce materials intended to come in food contact.Depending on the risk assessment, this documentation mustbe more or less detailed, corresponding to the known orpotential risk.To prevent consumers from absorbing toxic substancesthat may leach from plastics that come into contact withfoods, the European Commission has issued EU Regulation10/2011 on plastic materials and articles intended to comeinto contact with food. Rubber and silicone materials are notcovered by this regulation. Since there is nothing specicfor seals in Europe, the US Food and Drug Administration(FDA) Code of Federal Regulations (CFR) 21 is commonlyused in Europe.Food safety is the core interest of the European Commission.EC Directive 2006/42/EC, or the Machinery Directive, whichcame into force at the end of 2009, sets up the essentialrequirements for machinery. All machines brought to theEuropean market must full these requirements. The CEmark, which identies industrial equipment as in compliancewith all the of safety requirements established by theEuropean Union must appear on each unit (Figure 1).Annex I of the Machinery Directive describes in detail whathas to be taken into consideration to build safe machines.Of particular interest to the food industry is Chapter 2.1 ofAnnex I, entitled ‘Foodstuffs machinery and machinery forcosmetics or pharmaceutical products. This chapter not onlytakes into consideration potentially hazardous situationsfor equipment operators and the environment in which themachine is used, but it is the only chapter in this directivethat refers to the potential hazards for the consumer of theproduct produced on these machines. Essentially, this meansthat mistakes caused by neglecting these requirements canhave a strong impact on public health.The Machinery Directive states that all surfaces (with the exceptionof disposable parts), including joining areas that come into productcontact mustBe smooth, without ridges or crevicesReduce projections, edges and recesses to a minimumBe easily cleaned and disinfectedInside surfaces must have curves of a radius sufcientto allow sufcient cleaningFrom a hygienic design perspective, the following re quirementsare particularly noteworthyIt must be possible for liquids, gases and aerosolsderiving from products and from cleaning, disinfectingand rinsing uids to be completely discharged from themachinery.Machinery must be designed and constructed in sucha way as to prevent any substances or living creatures,in particular insects, from entering, or any organicmatter from accumulating.Machinery must be designed and constructed in sucha way that no ancillary substances that are hazardousto health, including the lubricants used, can come intocontact with products.Figure 2. EU food contact symbol used for marking materialsintended to come into contact with food in the European Union asdened in EU Regulation 1935/2004.For food processing machines, so-called “C-Standards”also are provided in some detail, including how the designof the machine (e.g., the roughness of the surfaces)should be addressed in machines used in contact withspecic products. The standards EN ISO 14159, “Safetyof machinery - Hygiene requirements for the design ofmachinery” and EN 1672-2, “Food processing machinery -Basic concepts - Part 2 Hygiene requirements” describe theaim of the Directive through examples.In addition to these standards, the European HygienicEngineering & Design Group (EHEDG) Guideline 8 criteriaand the EHEDG Guideline 13, Hygienic design of equipmentfor open processing, offer additional guidance. The content
Legal requirements for hygienic design in Europe 19of these two guidelines is comparable with the two EuropeanCommittee for Standardisation (CEN) standards, and insome cases, the examples used are the same. There aresome minor differences in the denition of the food zone,but the design of the units should be such that they can bereadily cleaned within an appropriate time. Ultimately, everymachine has to be cleaned, and depending on the overallcleanability of a machine and its components, this can betime-consuming. For this reason it is much cheaper for foodprocessors to invest in machines that are designed properlywith high cleanability rather than buying cheaper machineswith low cleanability, which might cause product spoilage orcontamination triggered by product residues and/or cleaningagents left behind.For machines that do not meet the “easy to clean”requirements of the Machinery Directive and the relevantstandards, the CE conformity is not valid. The only questionis, who decides if something is cleanable or not? For this,EHEDG provides certication for various types of equipment.This is a voluntary approval scheme that provides a highlevel of condence that the equipment conforms with theMachinery Directive. EHEDG is working on new certicationschemes and guidelines to improve the machines for moreefcient cleanability.3-A Sanitary Standards, Inc.Promoting Food Safety Through Hygienic DesignLeads the development of modern hygienic design standardsfor equipment and accepted practices for processing systems.Oversees the comprehensive Third Party Verification inspectionprogram required for 3-A Symbol authorization and voluntarycertificates for processing systems and replacement parts.Provides specialized education resources to enhance the knowledgeof equipment fabricators, processors and regulatory professionals.Learn, network, and share insights on hygienic design with some ofthe most qualified and trusted authorities from around the world.3-A Sanitary Standards Inc.3-A Sanitary Standards, Inc.www.3-a.org
Page 1 and 2: EHEDGYearbook 2013/2014European Hyg
Page 3 and 4: Contents 3An example of the develop
Page 5 and 6: European Hygienic Engineering & Des
Page 9 and 10: EHEDG Executive Committee members 9
Page 11 and 12: EHEDG Company and Institute members
Page 13 and 14: EHEDG Company and Institute members
Page 15 and 16: EHEDG membership 15EHEDG membership
Page 22: 22 The importance of hygienic desig
Page 26: European Hygienic Engineering & Des
Page 31 and 32: Research on hygienic flooring syste
Page 33 and 34: PROVIDING LEVEL & FLOW INSTRUMENTAT
Page 39 and 40: Precise, safe and fast : GEMÜ 660h
Page 44 and 45: 44 Hygienic design of floor drainag
Page 46 and 47: 46 Hygienic design of floor drainag
Page 48 and 49: 48 Hygienic design of high performa
Page 52 and 53: 52 Performance testing of air filte
Page 56 and 57: 56 Spray cleaning systems in food p
Page 58 and 59: 58 Spray cleaning systems in food p
Page 62 and 63: 62 Environmentally friendly water b
Page 64 and 65: 64 Environmentally friendly water b
Page 68 and 69:
68 Flow behaviour of liquid jets im
Page 70 and 71:
European Hygienic Engineering & Des
Page 72 and 73:
72 ptimisation of tank cleaningThe
Page 74 and 75:
74 ptimisation of tank cleaningReal
Page 76 and 77:
Page 78 and 79:
78 Effective tank and vessel cleani
Page 80 and 81:
80 Effective tank and vessel cleani
Page 82 and 83:
Figure 8a/b. In-line sprayer (a)
Page 84 and 85:
84 Practical considerations for cle
Page 86 and 87:
86 Integrated hygienic tamper-free
Page 88 and 89:
88 Damage scenarios for valves: Ide
Page 90 and 91:
90 Damage scenarios for valves: Ide
Page 92 and 93:
Page 94 and 95:
Page 96:
Page 99 and 100:
Page 101 and 102:
solidscomponents andcomplete plants
Page 103 and 104:
Page 105 and 106:
Material and design optimisation ca
Page 107 and 108:
Improved hygienic design and perfor
Page 109 and 110:
Smart hygienic solutions for the fo
Page 111 and 112:
A cleaner,healthierfuture.Cleaning
Page 113 and 114:
Examination of food allergen remova
Page 115 and 116:
Page 117 and 118:
Page 119 and 120:
Hygienic automation technology in f
Page 121 and 122:
Cleanability test of a hygienic des
Page 123 and 124:
Aspects of compounding rubber mater
Page 125 and 126:
New developments for upgrading stai
Page 127 and 128:
New developments for upgrading stai
Page 129 and 130:
International Hygienic Study Award
Page 131 and 132:
EHEDG Regional Sections 131MEICOPro
Page 133 and 134:
EHEDG Regional Sections 133In Octob
Page 135 and 136:
EHEDG Regional Sections 135EHEDG De
Page 137 and 138:
EHEDG Regional Sections 137EHEDG Ge
Page 139 and 140:
EHEDG Regional Sections 139Members
Page 141 and 142:
EHEDG Regional Sections 141EHEDG Li
Page 143 and 144:
EHEDG Regional Sections 143Beside t
Page 145 and 146:
EHEDG Regional Sections 145To promo
Page 147 and 148:
EHEDG Regional Sections 147EHEDG Ru
Page 149 and 150:
EHEDG Regional Sections 149and adva
Page 151 and 152:
EHEDG Regional Sections 151Translat
Page 153 and 154:
EHEDG Regional Sections 153EHEDG Uk
Page 155 and 156:
EHEDG Guidelines 155Doc. 7. A metho
Page 157 and 158:
EHEDG Guidelines 157Doc. 18. Passiv
Page 159 and 160:
EHEDG Guidelines 159Doc. 28. Safe a
Page 161 and 162:
EHEDG Guidelines 161Doc. 37. Hygien
Page 163 and 164:
EHEDG Guidelines 163EHEDG Congresse
Page 165 and 166:
EHEDG Subgroups 165design, selectio
Page 167 and 168:
EHEDG Subgroups 167Given a clean su
Page 169 and 170:
EHEDG Subgroups 169Doc. 26 Hygienic
Page 171 and 172:
EHEDG Subgroups 171It will address
Page 173 and 174:
EHEDG Subgroups 173EHEDG Subgroup
Page 175 and 176:
EHEDG Subgroups 175Chairman:Andy Ti
Page 177 and 178:
EHEDG Subgroups 177EHEDG Subgroup
Page 180:
show all

to get a complimentary download version - (FKM), VertrÃƒÂ¤ge und ...

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?