1、Designation: F 1640 03An American National StandardStandard Guide forSelection and Use of Packaging Materials for Foods to BeIrradiated1This standard is issued under the fixed designation F 1640; the number immediately following the designation indicates the year oforiginal adoption or, in the case
2、of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.INTRODUCTIONThis guide provides information on the selection and use of packaging materials intended to
3、holdfood during irradiation with ionizing energy (gamma-rays, X-rays, accelerated electrons). In general,irradiation is used to reduce the incidence of spoilage and pathogenic microorganisms and parasitesin foods, control sprouting of tubers and bulbs, and disinfest commodities (see Guides F 1355, F
4、 1356,F 1736, and F 1885). Packaging materials serve to protect the product from recontamination afterirradiation and may be used to complement other preservation techniques to extend shelf life of theirradiated food.1. Scope1.1 This guide provides a format to assist producers andusers of food packa
5、ging materials to in selecting materials thathave the desirable characteristics for their intended use andcomply with applicable standards or government authoriza-tions. It outlines parameters that should be considered whenselecting food-contact packaging materials intended for useduring irradiation
6、 of prepackaged foods and it examines thecriteria for fitness for their use.1.2 This guide identifies known regulations and regulatoryframeworks worldwide pertaining to packaging materials forholding foods during irradiation; but it does not address allregulatory issues associated with the selection
7、 and use ofpackaging materials for foods to be irradiated. It is theresponsibility of the user of this guide to determine thepertinent regulatory issues in each country where foods are tobe irradiated and where irradiated foods are distributed.1.3 This guide does not address all of the food safety i
8、ssuesassociated with the synergistic effects of irradiation and pack-aging as food preservation techniques on the extension of shelflife or food quality. It is the responsibility of the user of thisguide to determine the critical food safety issues and to conductappropriate product assessment tests
9、to determine the compat-ibility between the packaging application and irradiation rela-tive to changes in sensory attributes and shelf life.1.4 This guide does not address the use of irradiation as aprocessing aid for the production or sterilization of foodpackaging materials.1.5 This standard does
10、not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents22.1 ASTM Stand
11、ards:D 3985 Test Method for Oxygen Gas Transmission ThroughPlastic Film and Sheeting Using a Coulometric SensorE 170 Terminology Relating to Radiation Measurementsand DosimetryE 460 Practice for Determining Effect of Packaging onFood and Beverage Products During StorageE 462 Test Method for Odor and
12、 Taste Transfer fromPackaging FilmF 1355 Guide for Irradiation of Fresh Fruits for Disinfesta-tion as a Quarantine TreatmentF 1356 Guide for the Irradiation of Fresh and Frozen RedMeats and Poultry (to Control Pathogens)F 1736 Guide for Irradiation of Finfish and Shellfish toControl Pathogens and Sp
13、oilage MicroorganismsF 1885 Guide for Irradiation of Dried Spices, Herbs, and1This guide is under the jurisdiction of ASTM Committee E10 on NuclearTechnology and Applications and is the direct responsibility of SubcommitteeE10.01 on Radiation Processing: Dosimetry and Applications.Current edition ap
14、proved Oct. 1, 2003. Published January 2004. Originallyapproved in 1995. Last previous edition approved in 2001 as F 1640 95 (2001).2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume inform
15、ation, refer to the standards Document Summary page onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.Vegetable Seasonings to Control Pathogens and OtherMicroorganisms3. Terminology3.1 Definitions:3.1.1 absorbed dose
16、the quantity of energy from ionizingradiation absorbed per unit mass of specified material. The SIunit for absorbed dose is the gray (Gy). One gray is equal toone joule of absorbed energy per kilogram of specified mate-rial. Formerly, the unit of absorbed dose was the rad (1 rad =0.01 Gy).3.1.1.1 Di
17、scussionA standard definition of absorbed doseappears in Terminology E 170.3.1.2 absorbed-dose ratethe absorbed dose in a specifiedmaterial per incremental time interval; The SI unit forabsorbed-dose rate is Gysec-1.3.1.2.1 DiscussionA standard definition of absorbeddoses appears in Terminology E 17
18、0.3.1.3 anaerobic environmentan environment having alevel of oxygen that will not support the growth of oxygen-requiring microorganisms.3.1.4 good manufacturing practice (GMP)proceduresestablished and exercised throughout the production, manufac-turing, processing, packing, and distribution of foods
19、, encom-passing maintenance of sanitation systems, quality control andassurance, qualification of personnel and other relevant activi-ties, to ensure the delivery of a commercially acceptable andsafe product.3.1.4.1 DiscussionIn the United States, the GMP regula-tions, which deal primarily with sani
20、tation, are CFR, Title 21,Part 110. (1)33.1.5 modified-atmosphere packaging (MAP)a packagingsystem for maintaining an environment around the product thatis different from the gaseous composition of air. The modifiedatmosphere can be obtained by application of a vacuum orbygas flushing, and may be ma
21、intained by use of gas scavengers.4. Significance and Use4.1 The judicious selection of a packaging material is part ofGood Manufacturing Practices (GMPs) for the irradiation ofprepackaged foods. This guide recognizes the need to evaluatethe impact of packaging materials on the safety and quality of
22、foods irradiated to control the proliferation of food bornepathogens, as well as their impact on foods irradiated for otherpurposes, such as prevention of re-infestation, delay of ripen-ing, or shelf life extension.4.2 As part of the evaluation, the packaging selectionprocess should consider the eff
23、ects of irradiation on thechemical and physical properties of the packaging material.4.3 Packaging is not considered to be a food preservationtechnique for overcoming any deficiencies attributable toinadequate GMPs during preparation, storage, or treatment offoods to be irradiated. The quality of th
24、e irradiated food willdepend heavily on its initial quality, control of the irradiationprocess, storage temperature and handling of the food afterirradiation.5. Regulatory Considerations5.1 Compliance with regulatory requirements within eachcountry where an irradiated food is to be sold should becon
25、sidered when selecting an appropriate packaging materialto hold food during its irradiation. Typically, the requirementsfor packaging materials for holding foods during irradiationwould be that they: (1) are approved for contact with the foodto be irradiated, (2) are resistant to ionizing radiation
26、withrespect to their physical properties, and (3) are not sources ofsubstances that have toxicological significance as a result oftheir migration into the food (2-4).5.2 Canada and the United States have specific regulatoryrequirements for packaging materials that are permitted to holdfood during ir
27、radiation. Other countries, in general, do notprovide a specific list of packaging materials that are permittedto hold food during irradiation. However, a regulatory frame-work may exist in these countries which provides for the directirradiation of foods.5.3 A review of the regulations of food irra
28、diation has beencompiled by the International Consultative Group on FoodIrradiation (ICGFI) under the aegis of the Food andAgricultureOrganization (FAO), the International Atomic Energy Agency(IAEA), and the World Health Organization (WHO). Regula-tions specific to the use of packaging materials for
29、 foodirradiation for some of the participating countries is availablein the ICGFI publication “Regulations in the Field of FoodIrradiation” published by the IAEA. (5) (See Appendix X1.)6. Fitness for Use6.1 Chemical EffectsThe irradiation of packaging materi-als will lead to the formation of free ra
30、dicals or ions, formationof unsaturated molecular bonds and scission and cross-linkingof polymeric chains. These reactions may modify the physicalproperties of packaging materials and produce low molecularweight radiolytic products with potential to migrate into food.The extent of the radiation-indu
31、ced changes is a function ofpolymer type, additives in the material, the absorbed dose andabsorbed-dose rate, and the atmosphere during irradiation.These factors should be taken into account when evaluating thesuitability of a packaging material and to ensure that the natureand quantity of any subst
32、ances that may migrate from thepackaging material into the food will not render the foodunsafe or otherwise undesirable for consumption.6.2 Physical PropertiesPhysical properties, such asstrength, opacity, color, seal integrity, interlaminar bondstrength, brittleness resulting from age or temperatur
33、e, and gasmoisture transmission rates, should be examined for changeafter processing. In general, the absorbed dose ranges used toirradiate foods for pasteurization or disinfestation (3,6) do notadversely affect the functional and protective behavior charac-teristics of packaging materials.6.3 Senso
34、rial EffectsFoods packaged prior to irradiationmay become tainted with volatile compounds from the pack-aging materials during and following irradiation. The signifi-cance of this effect should be determined with appropriatesensory tests. Odor intensity of irradiated packaging materialalone is not a
35、lways an adequate measure of potential tainting of3The boldface numbers in parenthesis refer to the list of references at the end ofthis standard.F1640032the food. Appropriate methods for evaluating these effects aredescribed in Practice E 460, Test Method E 462, and Ref (7).6.4 Microbiological Effe
36、ctsPackaging systems and irra-diation treatments that combine to enhance shelf-life extensionshould be assessed for their risk of contributing to a favorableenvironment for growth of foodborne pathogens and subse-quent development of a toxic or infectious product.NOTE 1For example attention should b
37、e given to foods that mayharbor spores of Clostridium botulinum, particularly when the productenvironment is anaerobic, the temperature is neither refrigerated norfrozen, the product is low-acid and the product medium is capable ofsupporting the outgrowth of C. botulinum spores. Irradiation at absor
38、bed-dose ranges recommended for the pasteurization of foods effectivelyreduces the spoilage bacteria but may be insufficient to destroy spores ofC. botulinum. The spoilage microflora of foods is recognized as animportant hurdle to the growth of C. botulinum. The rate of spoilage andcharacteristics o
39、f the spoiled product are dependent on factors such as themicrobial load before and after irradiation, storage temperature, and theuse of a modified atmosphere or other processes (8). Furthermore, theproliferation of spoilage microflora and the resulting spoilage can be anindicator of product temper
40、ature abuse.7. Packaging Applications7.1 Protecting FoodMany foods are packaged beforebeing irradiated to prevent their recontamination or re-infestation with microorganisms or pests following the irradia-tion treatment. Splits or punctures in packaging materials, sealfailures, or other defects can
41、compromise protection.7.2 Preserving FoodThe effect of irradiation on foodsusually does not remove the reliance on packaging as a foodpreservation technique. Food products intended for irradiationmust be of good initial quality and be processed and storedaccording to GMPs to minimize changes in chem
42、ical ormicrobial processes that may contribute to product spoilage.The effects of irradiation on oxidative processes and thesuccession of surviving microorganisms may raise sensory andfood safety concerns that will influence the selection of thepackaging material or processing system used for a food
43、.Modified Atmosphere Packaging (MAP) of foods is often usedto complement other preservation techniques to minimize therate of product deterioration (8).8. Sensory Changes in Food8.1 Irradiation should not result in unacceptable sensorychanges in the food. The degree and nature of radiation-induced c
44、hanges in the food is a function of the absorbed dose,the absorbed-dose rate, the presence of oxygen during irradia-tion, the composition of the food, product temperature at thetime of irradiation, and other factors. The effects of irradiationon sensory attributes can also be affected by methods ofp
45、roduct formulation, packaging, and cooking conditions. Theeffects of radiation-induced changes can be minimized bycontrolling these factors.8.2 Oxidative ChangesSpecial attention should be givento assessing flavor, odor, and color changes of fresh or frozenfatty foods (for example, coconut products,
46、 dairy products,grains and meats). Irradiation, through the generation of freeradicals, can promote the oxidation of fats in such foods. Ingeneral, the higher the absorbed dose and irradiation tempera-ture, the greater the probability of producing sensory changesin food. Packaging of foods in a low
47、oxygen atmosphere canreduce the extent of oxidative changes of the food duringirradiation, especially if the product is kept frozen during thetreatment (9).8.3 Other Sensory ChangesIn general, packaging is ex-pected to prevent post-irradiation re-infestation by insects orre-inoculation with microorg
48、anisms, and minimize moistureloss. Additionally, the use of packaging in conjunction withirradiation should not contribute to pitting of the surface tissueof the food, irreversibly impair the ripening process, or causeuncharacteristic textural changes.9. Keywords9.1 bacteria; food; irradiation; MAP;
49、 modified atmospherepackaging; packaging; pathogensF1640033APPENDIX(Nonmandatory Information)X1. NATIONAL REGULATIONS ON PACKAGING MATERIALSX1.1 Argentina“The packaging material shall not have aharmful effect on the contents and shall not produce abnormalodors or toxic products during irradiation. It shall requireapproval by the National Health Authority” (Food Code,Article 174, Para. 5.1 of the Annex).X1.2 Bangledesh“The packaging materials to be used inthe irradiation of prepackaged foods shall be defined in thenational authorization for the specific food item”
