1、Designation: F 1640 09An 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 () indicates an editorial change since the last revision or reapproval.INTRODUCTIONThis guide provides information on the selection and use of packaging materials intended to h
3、oldfood 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 packag
5、ing materials 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 of
6、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 and
7、 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 issue
8、sassociated 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 to d
9、etermine 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 The values stated in SI
10、 units are to be regarded asstandard. No other units of measurement are included in thisstandard.1.6 This standard does 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
11、practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2E 170 Terminology Relating to Radiation Measurementsand DosimetryE 460 Practice for Determining Effect of Packaging onFood and Beverage Products During StorageE 462 Test Metho
12、d for Odor and Taste Transfer fromPackaging Film3F 1355 Guide for Irradiation of Fresh Agricultural Produceas a Phytosanitary TreatmentF 1356 Practice for Irradiation of Fresh and Frozen RedMeat and Poultry to Control Pathogens and Other Micro-organisms1This guide is under the jurisdiction of ASTM C
13、ommittee E10 on NuclearTechnology and Applications and is the direct responsibility of SubcommitteeE10.01 on Radiation Processing: Dosimetry and Applications.Current edition approved Feb. 1, 2009. Published March 2009. Originallyapproved in 1995. Last previous edition approved in 2003 as F 1640 03.2
14、For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Withdrawn. The last approved version of this historical stand
15、ard is referencedon www.astm.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.F 1736 Guide for Irradiation of Finfish and Aquatic Inver-tebrates Used as Food to Control Pathogens and SpoilageMicroorganismsF 1885 Guide for Irradiat
16、ion of Dried Spices, Herbs, andVegetable Seasonings to Control Pathogens and OtherMicroorganisms3. Terminology3.1 Definitions:3.1.1 absorbed dosequantity of ionizing radiation energyimparted per unit mass of specified material. The SI unit forabsorbed dose is the gray (Gy), where one gray is equival
17、ent tothe absorption of 1 joule per kilogram of the specified material(1Gy = 1 J/kg).3.1.1.1 DiscussionA standard definition of absorbed doseappears in Terminology E 170.3.1.2 absorbed-dose ratethe absorbed dose in a materialper incremental time interval; ie., the quotient of dDbydt (D= dD/dt). The
18、SI unit for absorbed-dose rate is Gys-1.3.1.2.1 DiscussionA standard definition of absorbed doseappears in Terminology E 170.3.1.3 anaerobic environmentan environment having alevel of oxygen that will not support the growth of oxygen-requiring microorganisms.3.1.4 good manufacturing practice (GMP)pr
19、oceduresestablished and exercised throughout the production, manufac-turing, processing, packing, and distribution of foods, encom-passing maintenance of sanitation systems, quality control andassurance, qualification of personnel and other relevant activi-ties, to ensure the delivery of a commercia
20、lly acceptable andsafe product.3.1.4.1 DiscussionIn the United States, the GMP regula-tions, which deal primarily with sanitation, are CFR, Title 21,Part 110. (1)43.1.5 modified-atmosphere packaging (MAP)a packagingsystem for maintaining an environment around the product thatis different from the ga
21、seous composition of air. The modifiedatmosphere can be obtained by application of a vacuum or bygas flushing, and may be maintained 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 o
22、fprepackaged foods. This guide recognizes the need to evaluatethe impact of packaging materials on the safety and quality offoods 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
23、 of ripen-ing, or shelf life extension.4.2 As part of the evaluation, the selection process shouldconsider the effects of irradiation on the chemical and physicalproperties of the packaging material.4.3 Packaging is not considered to be a food preservationtechnique for overcoming any deficiencies at
24、tributable toinadequate GMPs during preparation, storage, or treatment offoods to be irradiated. The quality of the irradiated food willdepend heavily on its initial quality, control of the irradiationprocess, storage temperature and handling of the food afterirradiation.5. Regulatory Considerations
25、5.1 Compliance with regulatory requirements within eachcountry where an irradiated food is to be sold should beconsidered when selecting an appropriate packaging materialto hold food during its irradiation. Typically, the requirementsfor packaging materials for holding foods during irradiationwould
26、be that they: (1) are approved for contact with the foodto be irradiated, (2) are resistant to ionizing radiation 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 U
27、nited States have specific regulatoryrequirements for packaging materials that are permitted to holdfood during irradiation. 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
28、 in these countries which provides for the directirradiation of foods.5.3 A review of the regulations of food irradiation has beencompiled by the International Consultative Group on FoodIrradiation (ICGFI) under the aegis of the Food andAgricultureOrganization (FAO), the International Atomic Energy
29、Agency(IAEA), and the World Health Organization (WHO). Regula-tions specific to the use of packaging materials for 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
30、. Fitness for Use6.1 Chemical EffectsThe irradiation of packaging materi-als will lead to the formation of free radicals or ions, formationof unsaturated molecular bonds and scission and cross-linkingof polymeric chains. These reactions may modify the physicalproperties of packaging materials and pr
31、oduce low molecularweight radiolytic products with potential to migrate into food.The extent of the radiation-induced 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 acc
32、ount when evaluating thesuitability of a packaging material and to ensure that the natureand quantity of any substances 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 a
33、sstrength, opacity, color, seal integrity, interlaminar bondstrength, brittleness resulting from age or temperature, and gasmoisture transmission rates, should be examined for changeafter processing. In general, the absorbed dose ranges used toirradiate foods for pasteurization or disinfestation (3,
34、6) are notlikely to affect the functional and protective behavior charac-teristics of packaging materials.4The boldface numbers in parenthesis refer to the list of references at the end ofthis standard.F16400926.3 Sensorial EffectsFoods packaged prior to irradiationmay become tainted with volatile c
35、ompounds 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 always an adequate measure of potential tainting ofthe food. Appropriate methods f
36、or evaluating these effects aredescribed in Practice E 460, Test Method E 462, and Ref (7).6.4 Microbiological EffectsPackaging 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 fo
37、odborne pathogens and subse-quent development of a toxic or infectious product.NOTE 1For example attention should be given to foods that mayharbor spores of Clostridium botulinum, particularly when the productenvironment is anaerobic, the temperature is neither refrigerated norfrozen, the product is
38、 low-acid and the product medium is capable ofsupporting the outgrowth of C. botulinum spores. Irradiation at absorbed-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
39、 foods is recognized as animportant hurdle to the growth of C. botulinum. The rate of spoilage andcharacteristics of 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). F
40、urthermore, theproliferation of spoilage microflora and the resulting spoilage can be anindicator of product temperature abuse.7. Packaging Applications7.1 Protecting FoodMany foods are packaged beforebeing irradiated to prevent their recontamination or re-infestation with microorganisms or pests fo
41、llowing the irradia-tion treatment. Splits or punctures in packaging materials, sealfailures, or other defects can 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
42、irradiationmust be of good initial quality and be processed and storedaccording to GMPs to minimize changes in chemical ormicrobial processes that may contribute to product spoilage.The effects of irradiation on oxidative processes and thesuccession of surviving microorganisms may raise sensory andf
43、ood safety concerns that will influence the selection of thepackaging material or processing system used for a food.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 Irr
44、adiation should not result in unacceptable sensorychanges in the food. The degree and nature of radiation-induced changes 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
45、irradiation, and other factors. The effects of irradiationon sensory attributes can also be affected by methods ofproduct formulation, packaging, and cooking conditions. Theeffects of radiation-induced changes can be minimized bycontrolling these factors.8.2 Oxidative ChangesSpecial attention should
46、 be givento assessing flavor, odor, and color changes of fresh or frozenfatty foods (for example, coconut products, 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 irra
47、diation tempera-ture, the greater the probability of producing sensory changesin food. Packaging of foods in a low 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 g
48、eneral, packaging is ex-pected to prevent post-irradiation re-infestation by insects orre-inoculation with microorganisms, and minimize moistureloss. Additionally, the use of packaging in conjunction withirradiation should not contribute to pitting of the surface tissueof the food, irreversibly impa
49、ir the ripening process, or causeuncharacteristic textural changes.9. Keywords9.1 bacteria; food; irradiation; MAP; modified atmospherepackaging; packaging; pathogensF1640093APPENDIX(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 us
