ASTM F1640-95(2001)
(Guide)Standard Guide for Packaging Materials for Foods to Be Irradiated
Standard Guide for Packaging Materials for Foods to Be Irradiated
SCOPE
1.1 This guide outlines parameters that should be considered when selecting food-contact packaging materials intended for use during the irradiation of prepackaged foods.
1.2 This guide highlights the role of packaging in conjunction with irradiation in controlling microbial and chemical spoilage processes.
1.3 This guide does not address all regulatory issues associated with packaging materials for foods to be irradiated. It is the responsibility of the user of this guide to determine the pertinent regulatory issues in each country where irradiated foods are to be produced or distributed.
1.4 This guide does not address all of the food safety issues associated with the synergistic effects of irradiation and packaging as food preservation techniques on the extension of shelf life. It is the responsibility of the user of this guide to conduct appropriate risk analyses to determine the critical food safety issues.
1.5 This guide does not address all the effects of irradiation and packaging on food quality and shelf life. It is the responsibility of the user of this guide to conduct appropriate product assessment tests to determine the compatibility between the packaging application and irradiation relative to changes in sensory attributes and shelf life.
1.6 This guide does not address the use of irradiation as a processing aid for the manufacture or sterilization of food packaging materials.
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
General Information
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Standards Content (Sample)
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 1640 – 95 (Reapproved 2001)
Standard Guide for
Packaging Materials for Foods to Be Irradiated
This standard is issued under the fixed designation F 1640; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
This guide provides information on the selection and use of packaging materials intended to hold
food during irradiation with ionizing energy. In general, irradiation is used to reduce the incidence of
spoilage and pathogenic microorganisms and parasites in foods, control sprouting of tubers and bulbs,
and serve as a quarantine treatment for insect disinfestation in fresh fruits and other commodities.
Packaging materials serve to protect the product from recontamination after irradiation and may be
used to complement other preservation techniques to extend the shelf life of the irradiated food.
This guide serves the following purposes: (1) identifying known regulations worldwide pertaining
to packaging materials for holding foods during irradiation; (2) examining the selection of packaging
materials for intended uses (for example, product protection or preservation effect); and (3) examining
the criteria for fitness for use. This guide should be regarded as providing a format to assist
manufacturers and users in selecting materials that comply with applicable regulations and have
characteristics desirable for their intended uses.
1. Scope 1.6 This guide does not address the use of irradiation as a
processing aid for the manufacture or sterilization of food
1.1 This guide outlines parameters that should be consid-
packaging materials.
ered when selecting food-contact packaging materials intended
1.7 This standard does not purport to address all of the
for use during the irradiation of prepackaged foods.
safety concerns, if any, associated with its use. It is the
1.2 This guide highlights the role of packaging in conjunc-
responsibility of the user of this standard to establish appro-
tion with irradiation in controlling microbial and chemical
priate safety and health practices and determine the applica-
spoilage processes.
bility of regulatory limitations prior to use.
1.3 This guide does not address all regulatory issues asso-
ciated with packaging materials for foods to be irradiated. It is
2. Referenced Documents
the responsibility of the user of this guide to determine the
2.1 ASTM Standards:
pertinent regulatory issues in each country where irradiated
D 3985 Test Method for Oxygen Gas Transmission Through
foods are to be produced or distributed.
Plastic Film and Sheeting Using a Coulometric Sensor
1.4 This guide does not address all of the food safety issues
E 460 Practice for Determining Effect of Packaging on
associated with the synergistic effects of irradiation and pack-
Food and Beverage Products During Storage
aging as food preservation techniques on the extension of shelf
E 462 Test Method for Odor and Taste Transfer from
life. It is the responsibility of the user of this guide to conduct
Packaging Film
appropriate risk analyses to determine the critical food safety
F 1355 Guide for Irradiation of Fresh Fruits for Disinfesta-
issues.
tion as a Quarantine Treatment
1.5 This guide does not address all the effects of irradiation
F 1356 Guide for the Irradiation of Fresh and Frozen Red
and packaging on food quality and shelf life. It is the
Meats and Poultry (to Control Pathogens)
responsibility of the user of this guide to conduct appropriate
2.2 Other Standards:
product assessment tests to determine the compatibility be-
Canada Food and Drug Act, Division 23, Sec. B23.001
tween the packaging application and irradiation relative to
Relatif aux dossiers de demande d’autorisation d’emploi
changes in sensory attributes and shelf life.
des constituants de materiaux et objets mis ou destines a ê
1 2
This guide is under the jurisdiction of ASTM Committee E10 on Nuclear Annual Book of ASTM Standards, Vol 15.09.
Technology and Applications and is the direct responsibility of Subcommittee Annual Book of ASTM Standards, Vol 15.07.
E10.06 on Food Irradiation Processing and Packaging. Available from Canada Communications Group, Supply & Service, Publishing
Current edition approved Sept. 10, 1995. Published November 1995. Centre, 45 Sacre-Couer Blvd., Hull, Quebec, K1A 0S9, Canada.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F 1640
tre mis au contact des denrees, produits et boissons 4.4 Packaging is not considered to be a food preservation
alimentaires (Journal officiel du 4 Decembre 1986) technique for overcoming any deficiencies attributable to
2.3 Federal Standards: inadequate GMPs during preparation, storage, or treatment of
Code of Federal Regulations (CFR), Title 21, § 171.1 foods to be irradiated. The quality of the irradiated food will
Petitions depend heavily on its initial quality, control of the irradiation
21CFR, Part 110, Current Manufacturing Practice in Manu- process, and storage temperature of the food after irradiation.
facturing, Processing, Packing, or Holding Human Food
5. Regulatory Compliance
CFR, Title 21, § 179.45 Packaging materials for use during
5.1 Argentina—Packaging materials recognized by the
the irradiation of prepackaged foods
United States Food and Drug Administration (FDA) and listed
in 21 CFR § 179.45 are acceptable for the holding of foods
3. Terminology
during irradiation.
3.1 Definitions:
5.2 Canada—Approval for materials for packaging food to
3.1.1 aerobic environment—an environment having a level
be irradiated must comply with the general food packaging
of oxygen that will support the growth of microorganisms
material regulation Sec B23.001 of the Canada Food and Drug
requiring molecular oxygen for respiration.
Act. Approval is sought through Health Canada, Health Pro-
3.1.2 anaerobic environment—an environment having a
tection Branch, Ottawa. Each material is evaluated on the basis
level of oxygen that will not support the growth of oxygen-
of the food type, postpackaging use conditions and irradiation
requiring microorganisms.
process.
3.1.3 barrier material—packaging material capable of re-
5.3 France—Regulations for packaging materials used to
stricting the transmission of any substance (for example,
hold food during irradiation are published in the Journal
moisture, oxygen, carbon dioxide, microorganisms and insects)
Offıciel, 04.12, 1986.
between the product and ambient environment at a level to
5.4 Mexico—Packaging materials recognized by the FDA
achieve the desired effect.
and listed in 21 CFR § 179.45 are acceptable for the holding of
3.1.4 good manufacturing practice (GMP)—systems for
foods during irradiation.
sanitation, quality control and assurance, qualification of per-
5.5 United States— Packaging materials for use during the
sonnel, and other procedures established and exercised
irradiation of pre-packaged foods are subject to the regulations
throughout the production, manufacturing, processing, pack-
promulgated by the FDA and listed in 21 CFR § 179.45.
ing, and distribution of foods. In the United States, the
5.5.1 Packaging materials used for the irradiation of poultry
regulations, which deal primarily with sanitation, are 21CFR,
must allow oxygen to enter the package to minimize the
Part 110. While the details of the application of such systems
development of a strict anaerobic environment.
may vary, their fundamental relevance at all stages in the food
5.5.2 Regulation of materials that are not the subject of
chain should be recognized.
existing regulations can be pursued with the U.S. Food and
3.1.5 modified atmosphere packaging (MAP)—the use of a
Drug Administration (FDA), Center for Food Safety and
packaging system to produce an environment around the
Applied Nutrition (CFSAN) through the petition process (see
product which is different from the gaseous composition of air.
21 CFR § 171.1). Data submitted should establish that the
The process can include vacuum or gas flush packaging and
irradiation process does not cause the transfer of odor, flavor,
gas scavengers.
or any substance that may have toxicological significance from
the packaging material to the food, or cause the packaging
4. Significance and Use
material to exceed the specific limitation for migration or
4.1 Compliance with regulatory requirements within each
extractables provided by regulation.
country where an irradiated food is to be sold should be
5.6 Other Countries— Sweden and Germany do not permit
considered when selecting an appropriate packaging material
the irradiation or sale of irradiated foods. Other countries, in
to hold food to be irradiated.
general, do not provide a specific list of packaging materials
4.2 The selection of a packaging material is only one step in
that are permitted to hold food during irradiation. However,
a Good Manufacturing Practice (GMP) program for the irra-
regulations may exist in these countries which make provisions
diation of prepackaged foods. This selection process recog-
to permit
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