1、PAS 223:2011Prerequisite programmes and design requirements for food safety in the manufacture and provision of food packagingPAS223 2011.indd 1 21/06/2011 22:32Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 27/09/2011 08:26, Uncontrolled Copy, (c) BSI BSI July 2011PAS 223:2011Publishing and
2、 copyright informationThe BSI copyright notice displayed in this document indicates when the document was last issued. BSI 2011ISBN 978 0 580 74170 8ICS 67.020No copying without BSI permission except as permitted by copyright law.Publication historyFirst edition July 2011PAS223 2011.indd 2 21/06/201
3、1 22:32Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 27/09/2011 08:26, Uncontrolled Copy, (c) BSIPAS 223:2011 BSI July 2011iContentsForeword iiiIntroduction iv1 Scope 12 Normative references . 13 Terms and definitions . 24 Establishments 44.1 General requirements 44.2 Environment . 44.3 Loc
4、ations of establishments 45 Layout and workspace . 55.1 General requirements 55.2 Internal design, layout and traffic patterns 55.3 Internal structures and fittings . 55.4 Equipment 55.5 Temporary/mobile structures 55.6 Storage . 56 Utilities . 66.1 General requirements 66.2 Water supply 66.3 Air qu
5、ality and ventilation 66.4 Compressed air and other gases . 66.5 Lighting . 67 Waste . 77.1 General requirements 77.2 Containers for waste . 77.3 Waste management and removal . 77.4 Drains and drainage 78 Equipment suitability and maintenance . 88.1 General requirements 88.2 Hygienic design 88.3 Foo
6、d packaging contact surfaces 88.4 Testing and monitoring . 88.5 Preventive and corrective maintenance . 89 Purchased materials and services 99.1 General requirements 99.2 Selection and management of suppliers 99.3 Incoming raw materials . 910 Contamination and migration 1010.1 General requirements 1
7、010.2 Microbiological contamination . 10PAS223 2011.indd 1 21/06/2011 22:32Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 27/09/2011 08:26, Uncontrolled Copy, (c) BSIiiPAS 223:2011 BSI July 201110.3 Physical contamination 1010.4 Chemical contamination 1010.5 Chemical migration 1010.6 Allerge
8、n management . 1011 Cleaning . 1111.1 General requirements 1111.2 Cleaning agents and tools . 1111.3 Cleaning programmes . 1111.4 Monitoring cleaning programme effectiveness 1112 Pest control 1212.1 General requirements 1212.2 Pest control programmes 1212.3 Preventing access . 1212.4 Harbourage and
9、infestations 1212.5 Monitoring and detection . 1212.6 Eradication 1213 Personnel hygiene and facilities 1313.1 General requirements 1313.2 Personnel hygiene facilities and toilets . 1313.3 Staff canteens and designated eating areas 1313.4 Workwear and protective clothing . 1313.5 Illness and injurie
10、s . 1313.6 Personal cleanliness . 1313.7 Personal behaviour 1414 Rework 1414.1 General requirements 1414.2 Storage, identification and traceability . 1414.3 Rework usage . 1515 Withdrawal procedures 1515.1 General requirements 1515.2 Withdrawal requirements . 1516 Storage and transport 1616.1 Genera
11、l requirements 1616.2 Warehousing requirements . 1616.3 Vehicles, conveyances and containers 1617 Food packaging information and consumer awareness 1717.1 General requirements 1718 Food defence, biovigilance and bioterrorism . 1718.1 General requirements 1718.2 Access controls . 1719 Food packaging
12、design and development 1819.1 General requirements 1819.2 Communication and change control 1819.3 Design . 1819.4 Specifications . 1919.5 Process validation 19Bibliography . 20PAS223 2011.indd 2 21/06/2011 22:32Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 27/09/2011 08:26, Uncontrolled Cop
13、y, (c) BSIiii BSI July 2011PAS 223:2011ForewordThis Publicly Available Specification (PAS) has been prepared by the British Standards Institution (BSI) to specify requirements for prerequisite programmes and design to assist in controlling food safety hazards in the manufacture and provision of food
14、 packaging. This PAS is intended to be used in conjunction with BS EN ISO 22000 to support management systems designed to meet the requirements specified in BS EN ISO 22000. The development of this PAS was sponsored by SSAFE (Safe Supply of Affordable Food Everywhere). A Steering Group, consisting o
15、f leading global packaging and food manufacturing companies (listed below), was led by Neil Marshall on behalf of SSAFE. The technical authors for PAS 223 were Tracy Burton and Nancy Schouppe of The Coca-Cola Company.Acknowledgement is given to the following organizations that assisted with the deve
16、lopment of this PAS through membership of the Steering Group: Alpla Amcor Flexibles Danone Foundation for Food Safety Certification (FSSC) Institute of Packaging Professionals/FSAP (Food Safety Alliance for Packaging) Kraft Foods Nestl Owens-Illinois ProCert Rexam Tetra Pak The Coca-Cola Company Uni
17、leverBSI, SSAFE, the Technical Authors and the Steering Group greatly appreciate the considerable input during the consultation phase of the development of this PAS from numerous individuals and organizations around the world.Publishing informationThis PAS comes into effect on 1 July 2011.This PAS h
18、as been prepared and published by BSI, which retains its ownership and copyright. BSI reserves the right to withdraw or amend this PAS on receipt of authoritative advice that it is appropriate to do so. This PAS will be reviewed at intervals not exceeding two years, and any amendments arising from t
19、he review will be published as an amended PAS and publicized in Update Standards. This PAS is not to be regarded as a British Standard, European Standard or International Standard. In the event that this PAS is put forward to form the basis of a full British Standard, European Standard or Internatio
20、nal Standard, it will be withdrawn.Use of this document It has been assumed in the preparation of this PAS that the execution of its provisions will be entrusted to appropriately qualified and experienced people, for whose use it has been produced.Presentational conventionsThe provisions of this PAS
21、 are presented in roman (i.e. upright) type. Its requirements are expressed in sentences in which the principal auxiliary verb is “shall”. Commentary, recommendations, explanation and general informative material are presented in smaller italic type, using the heading NOTE, and do not constitute nor
22、mative elements.Contractual and legal considerationsThis publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with this PAS does not in itself confer immunity from legal obligations. PAS223 2011.indd 3 21/06/
23、2011 22:32Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 27/09/2011 08:26, Uncontrolled Copy, (c) BSIivPAS 223:2011 BSI July 2011IntroductionBS EN ISO 22000 sets out specific food safety requirements for any organization in the food chain. One such requirement is that organizations establish
24、, implement and maintain prerequisite programmes (PRPs) to assist in controlling food safety hazards. This PAS is intended to be used by food packaging manufacturing organizations to support management systems designed to meet the requirements for PRPs specified in BS EN ISO 22000, and it sets out t
25、he detailed requirements for those programmes. Requirements for design have been included in this PAS because of the potential food safety risk that can arise if the food packaging is not suitable for the intended use. It is essential that the proposed uses of the food packaging are fully understood
26、 so that any food safety risks can be identified and addressed through appropriate food packaging design.PAS223 2011.indd 4 21/06/2011 22:32Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 27/09/2011 08:26, Uncontrolled Copy, (c) BSIPAS 223:2011 BSI July 20111This Publicly Available Specificat
27、ion (PAS) specifies requirements for establishing, implementing and maintaining prerequisite programmes (PRPs) and design requirements to assist in controlling food safety hazards in the manufacture of food packaging. This PAS is applicable to all organizations, regardless of size or complexities, t
28、hat manufacture food packaging. This PAS is not designed or intended for use in other parts of the food chain. Food packaging manufacturing organizations are diverse in nature, and not all of the requirements specified in this PAS apply to an individual organization. Each organization is required to
29、 conduct a documented food safety hazard and risk assessment that includes each requirement. Where exclusions are made or alternative measures are implemented, these need to be justified by the food safety hazard and risk assessment. This PAS is not a management system standard and is intended to be
30、 used by food packaging manufacturing organizations that wish to implement PRPs in such a way as to address the requirements specified in BS EN ISO 22000.This PAS is intended to be used in conjunction with BS EN ISO 22000, not in isolation.NOTE For the purpose of this PAS, the term food includes bev
31、erages.1 Scope2 Normative referencesThe 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.BS EN ISO 2200
32、0, Food safety management systems Requirements for any organization in the food chainPAS223 2011.indd 1 21/06/2011 22:32Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 27/09/2011 08:26, Uncontrolled Copy, (c) BSIPAS 223:2011 BSI July 201123 Terms and definitionsFor the purposes of this PAS, t
33、he following terms and definitions apply.The terms and definitions given in BS EN ISO 22000 also apply.3.1 certificate of analysis (CoA) document provided by the supplier that indicates results of specific tests/analysis, including test methodology, performed on a defined lot of the suppliers materi
34、al3.2 certificate of conformance (CoC)document that confirms conformance to relevant specifications or regulationsNOTE This is sometimes referred to as a certificate of compliance or declaration of compliance (DoC).3.3 cleaningremoval of solvents, grease or lubricant, ink residues or other objection
35、able matter3.4 contaminantany biological or chemical agent, foreign matter or other substance not intentionally added to the product that may compromise its safety or suitabilityAdapted from Codex Alimentarius, 2.3NOTE Measures for prevention of malicious contamination are outside the scope of this
36、PAS. For further information and guidance on approaches to the protection of food businesses from all forms of malicious attack, see PAS 96, Defending food and drink. Guidance for the deterrence, detection and defeat of ideologically motivated and other forms of malicious attack on food and drink an
37、d their supply arrangements.3.5 contaminationintroduction or occurrence of a contaminant in the product or the production environmentAdapted from Codex Alimentarius, 2.3NOTE In the context of this PAS, “contamination” may also refer to the introduction of non-intentionally added substances (NIAS).3.
38、6 establishmentany building or area in which raw materials, intermediate materials, chemicals or finished food packaging are handled, and the surroundings under the control of the same managementAdapted from Codex Alimentarius, 2.33.7 finished food packagingphysical final output of any kind of produ
39、ction process that takes place in food packaging manufacturing organizations3.8 food packagingany product to be used for containment, protection, handling, delivery, storage, transport and presentation of foodNOTE Food packaging may have direct, indirect and no contact with the food. Direct food con
40、tact surfaces or materials are in contact (i.e. physically touching the food or in contact with the headspace) or will be in contact with the food during normal use of the food packaging. Indirect food contact surfaces or materials are not in direct contact with the food during normal use of the foo
41、d packaging, but there is the possibility for substances to transfer into the food. Non-contact surfaces or materials are not in direct contact with the food during normal use of the food packaging, and there is no possibility for substances to transfer into the food. Figure 1 illustrates this conce
42、pt.3.9 food packaging withdrawalremoval of nonconforming food packaging from the market, trade warehouses, distribution centres or customer operations and warehouses because it does not meet specified food safety standards or requirements3.10 intermediate materialphysical output of part of the produ
43、ction process that still requires further processing to create finished food packagingNOTE For example, a plastic powder, granules or flakes (including “masterbatch”), ink, coating, adhesive, pre-polymer, any semi-finished material and article such PAS223 2011.indd 2 21/06/2011 22:32Licensed Copy: W
44、ang Bin, ISO/EXCHANGE CHINA STANDARDS, 27/09/2011 08:26, Uncontrolled Copy, (c) BSIPAS 223:2011 BSI July 20113as a film, sheet or laminate requiring further processing/reformulation steps to become a finished material or article. In short, this is any product that is not a basic chemical and not yet
45、 a finished material or article, and includes part-processed, semi-converted and converted materials.3.11 labelprinted matter that is, or is intended to be, part of the finished package conveying specific information about the contents of the package, the food ingredients and any storage and prepara
46、tion requirementsNOTE This includes the package itself, printed matter that is, or is intended to be, attached to the package or a sticker used for over-labelling.3.12 migrationtransfer of substances from an external source (e.g. packaging material, environment) to food NOTE Transfer of substances c
47、an take place by migration through the substrate, by set-off to the reverse side and subsequent migration into food, or by gas phase transfer.3.13 non-intentionally added substance (NIAS)impurity in the materials used in, or a decomposition or reaction product formed during, the production process3.
48、14 packing materialsmaterials used to hold and protect food packaging during shipping, transport and storage3.15 set-offtransfer of substances from one side of a material or product to the other side through direct contact between the sides caused by the stacking or reeling of the material or produc
49、t3.16 specification detailed description of the properties and requirements of a material or product, in particular its technical and specific suitability3.17 waste any substance or object that the food packaging manufacturing organization discards or intends or is required to discardFigure 1 Food packaging concepts and food contactPrinted boxesCorrugated board protective wrappingPacking filmFood-containing bags within the boxesPalletPAS223 2011.indd 3 21/06/2011 22:32Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 27/09/2011 08:26,
