ASTM F1640-2016 Standard Guide for Selection and Use of Contact Materials for Foods to Be Irradiated《被辐射食品用接触材料的选择和使用标准指南》.pdf

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1、Designation: F1640 09F1640 16Standard Guide forSelection and Use of PackagingContact Materials for Foodsto Be Irradiated1This standard is issued under the fixed designation F1640; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the

2、 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 packagingcontact materials forpackaging intended

3、to hold food during irradiationtreatment with ionizing energy (gamma-rays,X-rays, accelerated electrons). In general, irradiation is used to reduce the incidence of spoilage andpathogenic microorganisms and parasites in foods, control sprouting of tubers and bulbs, and disinfestcommodities (see Guid

4、es F1355, F1356, F1736, and F1885). Packaging Food contact materials serveto protect the product from recontamination after irradiation and may be used to complement otherpreservation techniques to extend shelf life of the irradiated food. Molecules from food contactmaterials can migrate to the food

5、 when these materials are in contact with the food. Because of this,in many countries regulations are made to ensure food safety. The amended FDirradiation, but it does not address all regulatory issues associated with the selection and use ofpackaging materials for foods to be irradiated. It is the

6、 responsibility of the user of this guide to determine the pertinent regulatoryissues in each country where foods are to be irradiated and where irradiated foods are distributed.1.3 This guide does not address all of the food safety issues associated with the synergistic effects of irradiation and p

7、ackagingas food preservation techniques on the extension of shelf life or food quality. It is the responsibility of the user of this guide todetermine the critical food safety issues and to conduct appropriate product assessment tests to determine the compatibilitybetween the packaging application a

8、nd irradiation relative to changes in sensory attributes and shelf life.1.4 This guide does not address the use of irradiation as a processing aid for the production or sterilization of food packagingmaterials.1.5 The values stated in SI units are to be regarded as standard. No other units of measur

9、ement are included in this standard.1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatorylimita

10、tions prior to use.1 This guide is under the jurisdiction of ASTM Committee E61 on Radiation Processing and is the direct responsibility of Subcommittee E61.05 on Food Irradiation.Current edition approved Feb. 1, 2009June 1, 2016. Published March 2009July 2016. Originally approved in 1995. Last prev

11、ious edition approved in 20032009 asF1640 03.F1640 09. DOI: 10.1520/F1640-09.10.1520/F1640-16.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically poss

12、ible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, We

13、st Conshohocken, PA 19428-2959. United States12. Referenced Documents2.1 ASTM Standards:2E170 Terminology Relating to Radiation Measurements and DosimetryE460 Practice for Determining Effect of Packaging on Food and Beverage Products During StorageE462 Test Method for Odor and Taste Transfer From Pa

14、ckaging Film (Withdrawn 1998)3F1355 Guide for Irradiation of Fresh Agricultural Produce as a Phytosanitary TreatmentF1356 Guide for Irradiation of Fresh, Frozen or Processed Meat and Poultry to Control Pathogens and Other MicroorganismsF1736 Guide for Irradiation of Finfish and Aquatic Invertebrates

15、 Used as Food to Control Pathogens and SpoilageMicroorganismsF1885 Guide for Irradiation of Dried Spices, Herbs, and Vegetable Seasonings to Control Pathogens and Other Microorganisms3. Terminology3.1 Definitions:3.1.1 absorbed dosedose (D)quantity of ionizingICRU-85a, 5.2.5 quotient of d radiation

16、by dm, where denergyimparted per unit mass of specified material. is the mean incremental energy imparted by ionizing radiation to matter of mass dm,The thusSID 5d/dmunit for absorbed dose is the gray (Gy), where one gray is equivalent to the absorption of 1 joule per kilogram of the specifiedmateri

17、al (1Gy = 1 J/kg).3.1.1.1 DiscussionA standard definitionThe SI unit of absorbed dose appears in Terminologyis the gray E170.(Gy), where 1 gray is equivalent to theabsorption of 1 joule per kilogram of the specified material (1 Gy=1 J/kg).3.1.2 absorbed-dose rateabsorbed dose rate (D)the absorbed do

18、se in a material per incremental time interval; ie., thequotient of ICRU-85a, 5.2.6quotient of ddDD by ddtt (D =where dD disD/dt). The SI unit for absorbed-dose rate is Gys theincrement of absorbed dose in the time-1. interval dt, thusD 5dD/dt3.1.2.1 DiscussionA standard definition of absorbed dose

19、appears in Terminology E170.(1) The SI unit is Gy-s1. However, the absorbed-dose rate is often specified in terms of its average value over longer timeintervals, for example, in units of Gymin1 or Gyh1.(2) In gamma industrial irradiators, dose rate may be significantly different at different locatio

20、ns.(3) In electron-beam irradiators with pulsed or scanned beam, there are two types of dose rate: average value over severalpulses (scans) and instantaneous value within a pulse (scan). These two values can be significantly different.3.1.3 anaerobic environmentan environment having a level of oxyge

21、n that will not support the growth of oxygen-requiringmicroorganisms.3.1.4 food contact material (also referred to as contact materialany material (not only packaging) that is expected to comeinto contact with food.3.1.4.1 DiscussionFood contact materials are either intended to be brought into conta

22、ct with food, are already in contact with food, or can reasonablybe brought into contact with food which could lead to the transfer of their constituents to the food under normal or foreseeableuse. Food contact materials can be constructed from a variety of materials like plastics, rubber, paper, co

23、atings, metal, etc. In manycases a combination is used; for example, a carton box for juices can include (from the inside to the outside): plastic layer,aluminum, paper, printing and top coating.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at s

24、erviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.3 The last approved version of this historical standard is referenced on www.astm.org.F1640 1623.1.5 good manufacturing practice (GMP)procedures established and exerc

25、ised throughout the production, manufacturing,processing, packing, and distribution of foods, encompassing maintenance of sanitation systems, quality control and assurance,qualification of personnel and other relevant activities, to ensure the delivery of a commercially acceptable and safe product.3

26、.1.5.1 DiscussionIn the United States, the GMP regulations, which deal primarily with sanitation, are CFR, Title 21, Part 110. (1)43.1.6 modified-atmosphere packaging (MAP)a packaging system for maintaining an environment around the product that isdifferent from the gaseous composition of air. The m

27、odified atmosphere can be obtained by application of a vacuum or by gasflushing, and may be maintained by use of gas scavengers.3.1.6.1 DiscussionThe modified atmosphere can be obtained by application of a vacuum or by gas flushing, and may be maintained by use of gasscavengers.4. Significance and U

28、se4.1 The judicious selection of a packagingcontact material is part of Good Manufacturing Practices (GMPs) for the irradiationof prepackaged foods. This guide recognizes the need to evaluate the impact of packaging materials on the safety and quality offoods irradiated to control the proliferation

29、of food borne food-borne pathogens, as well as their impact on foods irradiated for otherpurposes, such as prevention of re-infestation, delay of ripening, or shelf life shelf-life extension.4.2 As part of the evaluation, the selection process should consider the effects of irradiation on the chemic

30、al and physicalproperties of the packagingcontact material.4.3 Packaging is not considered to be a food preservation technique for overcoming any deficiencies attributable to inadequateGMPs during preparation, storage, or treatment of foods to be irradiated. The quality of the irradiated food will d

31、epend heavilyon its initial quality, control of the irradiation process, storage temperature and handling of the food after irradiation.5. Regulatory Considerations5.1 Compliance with regulatory requirements within each country where an irradiated food is to be sold should be consideredwhen selectin

32、g an appropriate packagingcontact material to hold food during its irradiation. Typically, the requirements forpackagingcontact materials for holding foods during irradiation would be that they: (1) are approved for contact with the food tobe irradiated, (2) are resistant to ionizing radiation with

33、respect to their physical properties, and (3) are not sources of substancesthat have toxicological significance as a result of their migration into the food (2-4).5.2 Canada and the United States have specific regulatory requirements for packagingcontact materials that are permitted to holdfood duri

34、ng irradiation. Other countries, in general, do not provide a specific list of packagingcontact materials that are permittedto hold food during irradiation. However, a regulatory framework may exist in these countries which provides for the directirradiation of foods.5.3 A review of the regulations

35、of food irradiation has been compiled by the International Consultative Group on FoodIrradiation (ICGFI) under the aegis of the Food and Agriculture Organization (FAO), the International Atomic Energy Agency(IAEA), and the World Health Organization (WHO). Regulations specific to the use of packaging

36、 materials for food irradiation forsome of the participating countries is available in the ICGFI publication “Regulations in the Field of Food Irradiation” publishedby the IAEA. (5) (See Appendix X1.)6. Fitness for Use6.1 Chemical EffectsThe irradiation of packagingcontact materials will lead to the

37、 formation of free radicals or ions, formationof unsaturated molecular bonds and scission and cross-linking of polymeric chains. These reactions may modify the physicalproperties of packagingcontact materials and produce low molecular weight radiolytic products with potential to migrate into food.Th

38、e extent of the radiation-induced changes is a function of polymer 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 packagingcontact material and to ensure t

39、hat the nature and quantity of any substances that may migrate from thepackagingcontact material into the food will not render the food unsafe or otherwise undesirable for consumption.6.2 Physical PropertiesPhysical properties, such as strength, opacity, color, seal integrity, interlaminar bond stre

40、ngth,brittleness resulting from age or temperature, and gas moisture transmission rates, should be examined for change after processing.4 The boldface numbers in parenthesis refer to the list of references at the end of this standard.F1640 163In general, the absorbed dose ranges used to irradiate fo

41、ods for pasteurization or disinfestation (3,6) are not likely to affect thefunctional and protective behavior characteristics of packagingcontact materials.6.3 Sensorial EffectsFoods packaged prior to irradiation may become tainted with volatile compounds from the packaging-contact materials during

42、and following irradiation. The significance of this effect should be determined with appropriate sensorytests. Odor intensity of irradiated packagingcontact material alone is not always an adequate measure of potential tainting of thefood. Appropriate methods for evaluating these effects are describ

43、ed in Practice E460, Test Method E462, and Ref (7).6.4 Microbiological EffectsPackaging systems and irradiation treatments that combine to enhance shelf-life extension shouldbe assessed for their risk of contributing to a favorable environment for growth of foodborne pathogens undesirable microorgan

44、ismand subsequent development of a toxic or infectious an inferior product.NOTE 1For example, attention should be given to foods that may harbor spores of Clostridium botulinum, particularly when the product environmentis anaerobic, the temperature is neither refrigerated nor frozen, the product is

45、low-acid and the product medium is capable of supporting the outgrowthof C. botulinum spores. Irradiation at absorbed-dose ranges recommended for the pasteurization of foods effectively reduces the spoilage bacteria but maybe insufficient to destroy spores of C. botulinum. The spoilage microflora of

46、 foods is recognized as an important hurdle to the growth of C. botulinum.The rate of spoilage and characteristics of the spoiled product are dependent on factors such as the microbial load before and after irradiation, storagetemperature, and the use of a modified atmosphere or other processes (8).

47、 Furthermore, the proliferation of spoilage microflora and the resulting spoilagecan be an indicator of product temperature abuse.7. Packaging Applications7.1 Protecting FoodMany foods are packaged before being irradiated to prevent their recontamination or re-infestation withmicroorganisms or pests

48、 following the irradiation treatment. Splits or punctures in packagingcontact materials, seal failures, orother defects can compromise protection.7.2 Preserving FoodThe effect of irradiation on foods usually does not remove the reliance on packaging as a foodpreservation technique. Food products int

49、ended for irradiation must be of good initial quality and be processed and storedaccording to GMPs to minimize changes in chemical or microbial processes that may contribute to product spoilage. The effectsof irradiation on oxidative processes and the succession of surviving microorganisms may raise sensory and food safety concernsthat will influence the selection of the packaging material or processing system used for a food. Modified Atmosphere Packaging(MAP) of foods is often used to complement other preservation techniques to mini