Market Access Map - ESTADOS UNIDOS
Market Access Map - ESTADOS UNIDOS
Market Access Map - ESTADOS UNIDOS
EN FR ES RU (/en)
AR (HTTPS://M.MACMAP.ORG/AR)
https://www.macmap.org/en//query/results?reporter=842&partner=076&product=200799&level=6 1/32
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Customs tariffs
Preferential tariff for GSP countries 0.00% 0.00% Trade agreement details
Trade remedies
United States of America does not apply any trade remedy on the selected product.
https://www.macmap.org/en//query/results?reporter=842&partner=076&product=200799&level=6 2/32
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Regulatory requirements
1. Systems approach
Legislation title : Title 21 - Food and Drugs; PART 1�GENERAL ENFORCEMENT REGULATIONS - Subpart
L�Foreign Supplier Verification Programs for Food Importers
Legislation summary : What foreign supplier verification program (FSVP) must I have? (a) General. Except
as specified in paragraph (b) of this section, for each food you import, you must develop, maintain, and
follow an FSVP that provides adequate assurances that your foreign supplier is producing the food in
compliance with processes and procedures that provide at least the same level of public health protection
as those required under section 418 (regarding hazard analysis and risk-based preventive controls for
certain foods) or 419 (regarding standards for produce safety), if either is applicable, and the
implementing regulations, and is producing the food in compliance with sections 402 (regarding
adulteration) and 403(w) (if applicable) (regarding misbranding with respect to labeling for the presence
of major food allergens) of the Federal Food, Drug, and Cosmetic Act. (b) Low-acid canned foods
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 04.2016
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Food (Except: Importers of certain juice and seafo...
2. Systems approach
Legislation title : Title 21 Food and Drugs: PART 117�CURRENT GOOD MANUFACTURING PRACTICE,
HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD
Legislation summary : Subpart C
Implementation authority : Food and Drug Administration: Department of Health and Human Services
Validity : from 09.2015
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Food (food includes raw materials and ingredients)...
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A190 - Prohibitions/restrictions of imports for SPS reasons, not elsewhere specified (n.e.s.) 1
A220 - Restricted use of certain substances in foods and feeds and their contact materials 10
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1. Restricted use of certain substances in foods and feeds and their contact materials
Legislation title : Title 10 - Energy; Part 429 - CERTIFICATION, COMPLIANCE, AND ENFORCEMENT FOR
CONSUMER PRODUCTS AND COMMERCIAL AND INDUSTRIAL EQUIPMENT - �?429.25 Television sets.
Legislation summary : Certain substances are prohibited to be used in human food: Subpart A
Implementation authority : Department of Energy
Validity : from 10.2013
Other countries affected : World ...
Document (https://www.govinfo.gov/content/pkg/CFR-2018-title10-vol3/xml/CFR-2018-title10-vol3-
chapII.xml)
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Food ...
2. Restricted use of certain substances in foods and feeds and their contact materials
Legislation title : Title 21 - Food and Drugs; PART 170�FOOD ADDITIVES - � 170.45 Fluorine-containing
compounds.
Legislation summary : The Commissioner of Food and Drugs has concluded that it is in the interest of the
public health to limit the addition of fluorine compounds to foods (a) to that resulting from the fluoridation
of public water supplies, (b) to that resulting from the fluoridation of bottled water within the limitation
established in � 165.110(d) of this chapter, and (c) to that authorized by regulations (40 CFR part 180)
under section 408 of the Act.
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 03.2007
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Food ...
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3. Restricted use of certain substances in foods and feeds and their contact materials
Legislation title : Title 21 - Food and Drugs; PART 170�FOOD ADDITIVES - � 170.50 Glycine
(aminoacetic acid) in food for human consumption.
Legislation summary : (a) Heretofore, the Food and Drug Administration has expressed the opinion in
trade correspondence that glycine is generally recognized as safe for certain technical effects in human
food when used in accordance with good manufacturing practice; however: (1) Reports in scientific
literature indicate that adverse effects were found in cases where high levels of glycine were administered
in diets of experimental animals. (2) Current usage information indicates that the daily dietary intake of
glycine by humans may be substantially increasing due to changing use patterns in food technology.
Therefore, the Food and Drug Administration no longer regards glycine and its salts as generally
recognized as safe for use in human food and all outstanding letters expressing sanction for such use are
rescinded. (b) The Commissioner of Food and Drugs concludes that by May 8, 1971, manufacturers: (1)
Shall reformulate food products for human use to eliminate added glycine and its salts; or (2) Shall bring
such products into
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 03.1977
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Human food ...
4. Restricted use of certain substances in foods and feeds and their contact materials
Legislation title : Title 21 - Food and Drugs; PART 172�FOOD ADDITIVES PERMITTED FOR DIRECT
ADDITION TO FOOD FOR HUMAN CONSUMPTION - PART 172�FOOD ADDITIVES PERMITTED FOR
DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION
Legislation summary : Tolerance limits for different food additives in Food
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 03.1977
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Food ...
5. Restricted use of certain substances in foods and feeds and their contact materials
Legislation title : Title 21 - Food and Drugs; PART 250�SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN
DRUGS - �250.201 Preparations for the treatment of pernicious anemia.
Legislation summary : (f) Under section 409 of the Federal Food, Drug, and Cosmetic Act, intrinsic factor
and intrinsic factor concentrate are regarded as food additives. No food additive regulation nor existing
extension of the effective date of section 409 of the act authorizes these additives in foods, including
foods for special dietary uses. Any food containing added intrinsic factor or intrinsic factor concentrate
will be regarded as adulterated within the meaning of section 402(a)(2)(C) of the act.
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 02.2002
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Food ...
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6. Restricted use of certain substances in foods and feeds and their contact materials
Legislation title : Title 21 - Food and Drugs; PART 73 - LISTING OF COLOR ADDITIVES EXEMPT FROM
CERTIFICATION - Subpart A�Foods
Legislation summary : Requirements related to use of color additives in food and feed
products:Conditions regarding the use of following color additives in food products: Annatto extract.
Astaxanthin. Astaxanthin dimethyldisuccinate. Dehydrated beets (beet powder). Ultramarine blue.
Canthaxanthin. Caramel. �-Apo-8'-carotenal. �-Carotene. Cochineal extract; carmine. Sodium copper
chlorophyllin. Toasted partially defatted cooked cottonseed flour. Ferrous gluconate. Ferrous lactate.
Grape color extract. Grape skin extract (enocianina). Haematococcus algae meal. Synthetic iron oxide.
Fruit juice. Vegetable juice. Dried algae meal. Tagetes (Aztec marigold) meal and extract. Carrot oil. Corn
endosperm oil. Paprika. Paprika oleoresin. Mica-based pearlescent pigments. Paracoccus pigment.
Phaffia yeast. Riboflavin. Saffron. Titanium dioxide. Tomato lycopene extract; tomato lycopene
concentrate. Turmeric. Turmeric oleoresin.
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 03.1977
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Food products ...
7. Restricted use of certain substances in foods and feeds and their contact materials
Legislation title : Title 21 - Food and Drugs; PART 74 - LISTING OF COLOR ADDITIVES SUBJECT TO
CERTIFICATION - Subpart A�Foods
Legislation summary : Requirements related to use of color additives in food and feed products.
Conditions regarding the use of following color additives in food products: FD&C Blue No. 1. FD&C Blue
No. 2. FD&C Green No. 3. Orange B. Citrus Red No. 2. FD&C Red No. 3. FD&C Red No. 40. FD&C Yellow No.
5. FD&C Yellow No. 6.
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 03.1977
Other countries affected : World ...
Document (http://www.gpo.gov/fdsys/pkg/CFR-2014-title21-vol1/pdf/CFR-2014-title21-vol1-part80.pdf)
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Food products ...
8. Restricted use of certain substances in foods and feeds and their contact materials
Legislation title : Title 21 - Food and Drugs; PART 81 - GENERAL SPECIFICATIONS AND GENERAL
RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS
Legislation summary : The restrcition on the use of some color additives
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 03.1977
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Food ...
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9. Restricted use of certain substances in foods and feeds and their contact materials
Legislation title : Title 21 - Food and Drugs; PART 82�LISTING OF CERTIFIED PROVISIONALLY LISTED
COLORS AND SPECIFICATIONS - Subpart A�General Provisions; Subpart B�Foods, Drugs, and
Cosmetics
Legislation summary : The requirements on the use of some color additives in foods: Lakes (FD&C). FD&C
Blue No. 1. FD&C Blue No. 2. FD&C Green No. 3. FD&C Red No. 4. FD&C Yellow No. 5. FD&C Yellow No. 6.
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 03.1977
Other countries affected : World ...
Document (http://www.gpo.gov/fdsys/pkg/CFR-2014-title21-vol1/pdf/CFR-2014-title21-vol1-part74.pdf)
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Food products ...
10. Restricted use of certain substances in foods and feeds and their contact materials
Legislation title : Title 21 - Food and Drugs;PART 173�SECONDARY DIRECT FOOD ADDITIVES
PERMITTED IN FOOD FOR HUMAN CONSUMPTION - PART 173�SECONDARY DIRECT FOOD ADDITIVES
PERMITTED IN FOOD FOR HUMAN CONSUMPTION
Legislation summary : Tolerance limits for different food additives in Food
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 03.1977
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Food ...
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1. Labelling requirements
Legislation title : Title 21 - Food and Drugs; PART 101 - FOOD LABELING - PART 101�FOOD LABELING
Legislation summary : Food labeling requirements concerning the safety of consumers: Principal display
panel of package form food. The term principal display panel as it applies to food in package form and as
used in this part, means the part of a label that is most likely to be displayed, presented, shown, or
examined under customary conditions of display for retail sale. The principal display panel shall be large
enough to accommodate all the mandatory label information required to be placed thereon by this part
with clarity and conspicuousness and without obscuring design, vignettes, or crowding. Where packages
bear alternate principal display panels, information required to be placed on the principal display panel
shall be duplicated on each principal display panel. For the purpose of obtaining uniform type size in
declaring the quantity of contents for all packages of substantially the same size, the term area of the
principal display panel means the area of the side or surface that bears the principal display panel, which
ar
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 03.1977
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Food ...
2. Labelling requirements
Legislation title : Title 21 - Food and Drugs; PART 102�COMMON OR USUAL NAME FOR
NONSTANDARDIZED FOODS - Subpart A�General Provisions- �102.5 General principles.
Legislation summary : (a) The common or usual name of a food, which may be a coined term, shall
accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food or
its characterizing properties or ingredients. The name shall be uniform among all identical or similar
products and may not be confusingly similar to the name of any other food that is not reasonably
encompassed within the same name. Each class or subclass of food shall be given its own common or
usual name that states, in clear terms, what it is in a way that distinguishes it from different foods. (b) The
common or usual name of a food shall include the percentage(s) of any characterizing ingredient(s) or
component(s) when the proportion of such ingredient(s) or component(s) in the food has a material
bearing on price or consumer acceptance or when the labeling or the appearance of the food may
otherwise create an erroneous impression that such ingredient(s) or component(s) is present in an
amount greater than is actually the cas
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 03.1977
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Food ...
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3. Labelling requirements
Legislation title : Title 21 - Food and Drugs; PART 130�FOOD STANDARDS: GENERAL
Legislation summary : (a) Any standardized food that contains a sulfiting agent or combination of
sulfiting agents that is functional and provided for in the applicable standard or that is present in the
finished food at a detectable level is misbranded unless the presence of the sulfiting agent or agents is
declared on the label of the food. A detectable amount of sulfiting agent is 10 parts per million or more of
the sulfite in the finished food.
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 03.1998
Other countries affected : World ...
Document (http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html)
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Standardized food ...
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1. Packaging requirements
Legislation title : Title 21 - Food and Drugs; PART 109�UNAVOIDABLE CONTAMINANTS IN FOOD FOR
HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL - Subpart B�Tolerances for Unavoidable
Poisonous or Deleterious Substances �109.30 Tolerances for polychlorinated biphenyls (PCB's).
Legislation summary : Tolerances for polychlorinated biphenyls (PCB's):10 parts per million in paper food-
packaging material intended for or used with human food, finished animal feed and any components
intended for animal feeds. The tolerance shall not apply to paper food-packaging material separated from
the food therein by a functional barrier which is impermeable to migration of PCB's
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 11.2001
Other countries affected : World ...
Document (http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html)
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Food ...
2. Packaging requirements
Legislation title : Title 21 - Food and Drugs; PART 113�THERMALLY PROCESSED LOW-ACID FOODS
PACKAGED IN HERMETICALLY SEALED CONTAINERS - Subpart D�Control of Components, Food Product
Containers, Closures, and In-Process Materials
Legislation summary : (a) Closures. Regular observations shall be maintained during production runs for
gross closure defects. Any such defects shall be recorded and corrective action taken and recorded. At
intervals of sufficient frequency to ensure proper closure, the operator, closure supervisor, or other
qualified container closure inspection person shall visually examine either the top seam of a can randomly
selected from each seaming head or the closure of any other type of container being used and shall
record the observations made. For double-seam cans, each can should be examined for cutover or
sharpness, skidding or deadheading, false seam, droop at the crossover or lap, and condition of inside of
countersink wall for evidence of broken chuck. Such measurements and recordings should be made at
intervals not to exceed 30 minutes. Additional visual closure inspections shall be made immediately
following a jam in a closing machine, after closing machine adjustment, or after startup of a machine
following a prolonged shutdow
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 03.2011
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Thermally processed low-acid foods packaged in her...
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3. Packaging requirements
Legislation title : Title 21 - Food and Drugs; PART 175�INDIRECT FOOD ADDITIVES: ADHESIVES AND
COMPONENTS OF COATINGS - PART 175�INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS
OF COATINGS
Legislation summary : Restrictions on the materials to be used for packaging, coating of food
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 03.1977
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Food ...
4. Packaging requirements
Legislation title : Title 21 - Food and Drugs; PART 178�INDIRECT FOOD ADDITIVES: ADJUVANTS,
PRODUCTION AIDS, AND SANITIZERS - PART 178�INDIRECT FOOD ADDITIVES: ADJUVANTS,
PRODUCTION AIDS, AND SANITIZERS
Legislation summary : Requirements on Packaging, contact materials on food
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 03.1977
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Food ...
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1. Testing requirement
Legislation title : Title 21 - Food and Drugs; PART 114�ACIDIFIED FOODS - Subpart E�Production and
Process Controls-�114.90 Methodology
Legislation summary : Methods that may be used to determine pH or acidity for acidified foods include,
but are not limited to, the following: (a) Potentiometric method for the determination of pH
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 03.1998
Other countries affected : World ...
Document (http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html)
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Acidified foods ...
2. Testing requirement
Legislation title : Title 21 - Food and Drugs; PART 130�FOOD STANDARDS: GENERAL
Legislation summary : The level of sulfite in the finished food will be determined using sections 20.123
through 20.125, �Sulfurous Acid (Total) in Food Modified Monier-Williams Method Final Action� in
�Official Methods of Analysis of the Association of Official Analytical Chemists,� 14th ed. (1984), which
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, and the refinements of
the �Total Sulfurous Acid� procedure in the �Monier-Williams Procedure (with Modifications) for
Sulfites in Foods,� which is appendix A to part 101 of this chapter. A copy of sections 20.123 through
20.125 of the �Official Methods of Analysis of the Association of Official Analytical Chemists� is
available from AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877 , or
available for at the National Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call 202-741-6030
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 03.1998
Other countries affected : World ...
Document (http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html)
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Standardized food ...
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1. Inspection requirement
Legislation title : Title 21 - Food and Drugs; PART 108�EMERGENCY PERMIT CONTROL - Subpart
B�Specific Requirements and Conditions for Exemption From or Compliance With an Emergency Permit,
�108.25 Acidified foods.
Legislation summary : (j) Imports. (1) This section applies to any foreign commercial processor engaged
in the processing of acidified foods and offering those foods for import into the United States except that,
in lieu of providing for the issuance of an emergency permit under paragraph (a) of this section, the
Commissioner will request the Secretary of the Treasury to refuse admission into the United States, under
section 801 of the act, to any acidified foods which the Commissioner determines, after investigation, may
result in the distribution in interstate commerce of processed foods that may be injurious to health as set
forth in paragraph (a) of this section. (2) Any acidified food so refused admission shall not be admitted
until the Commissioner determines that the commercial processor offering the food for import has
complied with the requirements of this section and that the food is not injurious to health. To assist the
Commissioner in making this determination, a duly authorized employee of the Food and Drug Administr
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 11.2001
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : acidified foods ...
2. Inspection requirement
Legislation title : Title 21 - Food and Drugs; PART 108�EMERGENCY PERMIT CONTROL - Subpart
B�Specific Requirements and Conditions for Exemption From or Compliance With an Emergency Permit,
�108.35 Thermal processing of low-acid foods packaged in hermetically sealed container
Legislation summary : (k) Imports. (1) This section shall apply to any foreign commercial processor
engaged in the thermal processing of low-acid foods packaged in hermetically sealed containers and
offering such foods for import into the United States except that, in lieu of providing for the issuance of an
emergency permit under paragraph (a) of this section, the Commissioner will request the Secretary of the
Treasury to refuse admission into the United States, pursuant to section 801 of the act, of any such low-
acid foods which the Commissioner determines, after investigation, may result in the distribution in
interstate commerce of processed foods that may be injurious to health as set forth in paragraph (a) of
this section. (2) Any such food refused admission shall not be admitted until such time as the
Commissioner may determine that the commercial processor offering the food for import is in
compliance with the requirements and conditions of this section and that such food is not injurious to
health. For the purpose of maki
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 11.2001
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : low-acid foods packaged in hermetically sealed con...
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Traceability requirements
Legislation title : Title 21 - Food and Drugs; PART 1�GENERAL ENFORCEMENT REGULATIONS - Subpart
J�Establishment, Maintenance, and Availability of Records
Legislation summary : Requirement to establish, keep and make available the records. What information
must nontransporters establish and maintain to identify the nontransporter and transporter immediate
subsequent recipients of food? (a) If you are a nontransporter, you must establish and maintain the
following records for food you release: (1) The name of the firm, address, telephone number, and, if
available, the fax number and e-mail address of the nontransporter immediate subsequent recipient,
whether domestic or foreign; (2) An adequate description of the type of food released, to include brand
name and specific variety (e.g., brand x cheddar cheese, not just cheese; or romaine lettuce, not just
lettuce); (3) The date you released the food; (4) For persons who manufacture, process, or pack food, the
lot or code number or other identifier of the food (to the extent this information exists); (5) The quantity
and how the food is packaged (e.g., 6 count bunches, 25 lb carton, 12 oz bottle, 100 gal tank); (6) The
name of the firm,
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 02.2012
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Food products ...
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1. Processing history
Legislation title : Title 21 - Food and Drugs; PART 108�EMERGENCY PERMIT CONTROL - Subpart
B�Specific Requirements and Conditions for Exemption From or Compliance With an Emergency Permit,
�108.25 Acidified foods.
Legislation summary : (2) Process filing. A commercial processor engaged in the thermal processing of
low-acid foods packaged in hermetically sealed containers shall, not later than 60 days after registration
and prior to the packing of a new product, provide the Food and Drug Administration information as to the
scheduled processes including but not limited to the processing method, type of retort or other thermal
processing equipment employed, minimum initial temperatures, times and temperatures of processing,
sterilizing value (Fo), or other equivalent scientific evidence of process adequacy, critical control factors
affecting heat penetration, and source and date of the establishment of the process, for each such low-
acid food in each container size: Provided, that the filing of such information does not constitute approval
of the information by the Food and Drug Administration, and that information concerning processes and
other data so filed shall be regarded as trade secrets within the meaning of 21 U.S.C. 331(j) and 18 U.S
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 11.2001
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : acidified foods ...
2. Processing history
Legislation title : Title 21 - Food and Drugs; PART 108�EMERGENCY PERMIT CONTROL - Subpart
B�Specific Requirements and Conditions for Exemption From or Compliance With an Emergency Permit,
�108.35 Thermal processing of low-acid foods packaged in hermetically sealed container
Legislation summary : (2) Process filing. A commercial processor engaged in the thermal processing of
low-acid foods packaged in hermetically sealed containers shall, not later than 60 days after registration
and prior to the packing of a new product, provide the Food and Drug Administration information as to the
scheduled processes including but not limited to the processing method, type of retort or other thermal
processing equipment employed, minimum initial temperatures, times and temperatures of processing,
sterilizing value (Fo), or other equivalent scientific evidence of process adequacy, critical control factors
affecting heat penetration, and source and date of the establishment of the process, for each such low-
acid food in each container size: Provided, that the filing of such information does not constitute approval
of the information by the Food and Drug Administration, and that information concerning processes and
other data so filed shall be regarded as trade secrets within the meaning of 21 U.S.C. 331(j) and 18 U.S
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 11.2001
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : low-acid foods packaged in hermetically sealed con...
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3. Processing history
Legislation title : Title 21 - Food and Drugs; PART 113�THERMALLY PROCESSED LOW-ACID FOODS
PACKAGED IN HERMETICALLY SEALED CONTAINERS - Subpart F�Records and Reports
Legislation summary : (a) Processing and production information shall be entered at the time it is
observed by the retort or processing system operator, or other designated person, on forms that include
the product, the code number, the date, the retort or processing system number, the size of container, the
approximate number of containers per coding interval, the initial temperature, the actual processing time,
the temperature-indicating device and temperature-recording device readings, and other appropriate
processing data. Closing machine vacuum in vacuum-packed products, maximum fill-in or drained weight,
or other critical factors specified in the scheduled process shall also be recorded. In addition, the
following records shall be maintained: (1) Still retorts. Time steam on; time temperature up to processing
temperature; time steam off; venting time and temperature to which vented. (2) Agitating retorts.
Functioning of condensate bleeder; retort speed; and, when specified in the scheduled process,
headspace, consistency, ma
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 03.2011
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Thermally processed low-acid foods packaged in her...
4. Processing history
Legislation title : Title 21 - Food and Drugs; PART 114�ACIDIFIED FOODS - Subpart F�Records and
Reports
Legislation summary : (a) Records shall be maintained of examinations of raw materials, packaging
materials, and finished products, and of suppliers' guarantees or certifications that verify compliance with
Food and Drug Administration regulations and guidance documents or action levels. (b) Processing and
production records showing adherence to scheduled processes, including records of pH measurements
and other critical factors intended to ensure a safe product, shall be maintained and shall contain
sufficient additional information such as product code, date, container size, and product, to permit a public
health hazard evaluation of the processes applied to each lot, batch, or other portion of production. (c) All
departures from scheduled processes having a possible bearing on public health or the safety of the food
shall be noted and the affected portion of the product identified; these departures shall be recorded and
made the subject of a separate file (or log identifying the appropriate data) delineating them, the action ta
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 09.2000
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Acidified foods ...
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5. Processing history
Legislation title : Title 21 - Food and Drugs; PART 1�GENERAL ENFORCEMENT REGULATIONS - Subpart
O�Sanitary Transportation of Human and Animal Food
Legislation summary : What record retention and other records requirements apply to shippers, receivers,
loaders, and carriers engaged in transportation operations? (a) Shippers must retain records: (1) That
demonstrate that they provide specifications and operating temperatures to carriers as required by
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 04.2016
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Food products ...
6. Processing history
Legislation title : Title 21 Food and Drugs: PART 117�CURRENT GOOD MANUFACTURING PRACTICE,
HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD
Legislation summary : (a) Be kept as original records, true copies (such as photocopies, pictures, scanned
copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic
records; (b) Contain the actual values and observations obtained during monitoring and, as appropriate,
during verification activities; (c) Be accurate, indelible, and legible; (d) Be created concurrently with
performance of the activity documented; (e) Be as detailed as necessary to provide history of work
performed; and (f) Include: (1) Information adequate to identify the plant or facility (e.g., the name, and
when necessary, the location of the plant or facility); (2) The date and, when appropriate, the time of the
activity documented; (3) The signature or initials of the person performing the activity; and (4) Where
appropriate, the identity of the product and the lot code, if any. (g) Records that are established or
maintained to satisfy the requirements of this part and that meet the definition of electronic records i
Implementation authority : Food and Drug Administration: Department of Health and Human Services
Validity : from 09.2015
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Food (food includes raw materials and ingredients)...
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1. Labelling requirements
Legislation title : Title 21 - Food and Drugs; PART 101 - FOOD LABELING - PART 101�FOOD LABELING
Legislation summary : Food; name and place of business of manufacturer, packer, or distributor; Nutrition
labeling of food..: Principal display panel of package form food. The term principal display panel as it
applies to food in package form and as used in this part, means the part of a label that is most likely to be
displayed, presented, shown, or examined under customary conditions of display for retail sale. The
principal display panel shall be large enough to accommodate all the mandatory label information
required to be placed thereon by this part with clarity and conspicuousness and without obscuring design,
vignettes, or crowding. Where packages bear alternate principal display panels, information required to be
placed on the principal display panel shall be duplicated on each principal display panel. For the purpose
of obtaining uniform type size in declaring the quantity of contents for all packages of substantially the
same size, the term area of the principal display panel means the area of the side or surface that be
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 03.1977
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Food ...
2. Labelling requirements
Legislation title : Title 21 - Food and Drugs; PART 102�COMMON OR USUAL NAME FOR
NONSTANDARDIZED FOODS - Subpart A�General Provisions- �102.5 General principles.
Legislation summary : (a) The common or usual name of a food, which may be a coined term, shall
accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food or
its characterizing properties or ingredients. The name shall be uniform among all identical or similar
products and may not be confusingly similar to the name of any other food that is not reasonably
encompassed within the same name. Each class or subclass of food shall be given its own common or
usual name that states, in clear terms, what it is in a way that distinguishes it from different foods. (b) The
common or usual name of a food shall include the percentage(s) of any characterizing ingredient(s) or
component(s) when the proportion of such ingredient(s) or component(s) in the food has a material
bearing on price or consumer acceptance or when the labeling or the appearance of the food may
otherwise create an erroneous impression that such ingredient(s) or component(s) is present in an
amount greater than is actually the cas
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 03.1977
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Food ...
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3. Labelling requirements
Legislation title : Title 21 - Food and Drugs; PART 102�COMMON OR USUAL NAME FOR
NONSTANDARDIZED FOODS - Subpart B�Requirements for Specific Nonstandardized Foods - �102.28
Foods packaged for use in the preparation of �main dishes� or �dinners.�
Legislation summary : (a) The common or usual name of a packaged food which is represented on the
principal display panel by word or vignette to be used in the preparation of a
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 03.1977
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Foods packaged for use in the preparation of “main...
4. Labelling requirements
Legislation title : Title 21 - Food and Drugs; PART 1�GENERAL ENFORCEMENT REGULATIONS - Subpart
B�General Labeling Requirements
Legislation summary : Presence of mandatory label information. In the regulations specified in
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 11.2013
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Food products ...
5. Labelling requirements
Legislation title : Title 21 - Food and Drugs; PART 206�IMPRINTING OF SOLID ORAL DOSAGE FORM
DRUG PRODUCTS FOR HUMAN USE
Legislation summary : (b) The common or usual name of the food consists of all of the following: (1) The
phrase
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 04.2004
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Frozen “heat and serve” dinners ...
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Packaging requirements
Legislation title : Title 21 - Food and Drugs; PART 100 - GENERAL - Subpart F�Misbranding for Reasons
Other Than Labeling
Legislation summary : In accordance with section 403(d) of the act, a food shall be deemed to be
misbranded if its container is so made, formed, or filled as to be misleading. (a) A container that does not
allow the consumer to fully view its contents shall be considered to be filled as to be misleading if it
contains nonfunctional slack-fill. Slack-fill is the difference between the actual capacity of a container and
the volume of product contained therein. Nonfunctional slack-fill is the empty space in a package that is
filled to less than its capacity for reasons other than: (1) Protection of the contents of the package; (2) The
requirements of the machines used for enclosing the contents in such package; (3) Unavoidable product
settling during shipping and handling; (4) The need for the package to perform a specific function (e.g.,
where packaging plays a role in the preparation or consumption of a food), where such function is inherent
to the nature of the food and is clearly communicated to consumers; (5) The fact that the p
Implementation authority : Food and Drug Administration, Department of Health and Human Services
Validity : from 01.1994
Other countries affected : World ...
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Food ...
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1. Cold/heat treatment
Legislation title : Title 7 - Agriculture. Subtitle B - Regulations of the Department of Agriculture
(Continued). CHAPTER III - ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE. PART 305�PHYTOSANITARY TREATMENTS.
Legislation summary : Heat treatment
Implementation authority : Animal and Plant Health Inspection Service, USDA
Validity : from 01.2010
Other countries affected : World ...
Document (http://www.aphis.usda.gov/import_export/plants/manuals/index.shtml)
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Feeds and milled products, finely ground oily meal...
2. Cold/heat treatment
Legislation title : Title 7 - Agriculture. Subtitle B - Regulations of the Department of Agriculture
(Continued). CHAPTER III - ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE. PART 305�PHYTOSANITARY TREATMENTS.
Legislation summary : Heat treatment
Implementation authority : Animal and Plant Health Inspection Service, USDA
Validity : from 01.2010
Other countries affected : World ...
Document (http://www.aphis.usda.gov/import_export/plants/manuals/index.shtml)
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : sorptive materials. ...
A530 - Fumigation 3
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1. Fumigation
Legislation title : Title 7 - Agriculture. Subtitle B - Regulations of the Department of Agriculture
(Continued). CHAPTER III - ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE. PART 305�PHYTOSANITARY TREATMENTS.
Legislation summary : Methyl bromide treatment required
Implementation authority : Animal and Plant Health Inspection Service, USDA
Validity : from 01.2010
Other countries affected : World ...
Document (http://www.aphis.usda.gov/import_export/plants/manuals/index.shtml)
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Nonfood materials ...
2. Fumigation
Legislation title : Title 7 - Agriculture. Subtitle B - Regulations of the Department of Agriculture
(Continued). CHAPTER III - ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE. PART 305�PHYTOSANITARY TREATMENTS.
Legislation summary : Methyl bromide treatment required
Implementation authority : Animal and Plant Health Inspection Service, USDA
Validity : from 01.2010
Other countries affected : World ...
Document (http://www.aphis.usda.gov/import_export/plants/manuals/index.shtml)
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Nonplant articles ...
3. Fumigation
Legislation title : Title 7 - Agriculture. Subtitle B - Regulations of the Department of Agriculture
(Continued). CHAPTER III - ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE. PART 305�PHYTOSANITARY TREATMENTS.
Legislation summary : Methyl bromide treatment required
Implementation authority : Animal and Plant Health Inspection Service, USDA
Validity : from 01.2010
Other countries affected : World ...
Document (http://www.aphis.usda.gov/import_export/plants/manuals/index.shtml)
Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
Additional comments : Nonplant products ...
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FUNDERS
(https://ec.europa.eu/commission/index_en)
(http://www.grips.ac.jp/en)
PARTNER
(http://www.aladi.org/sitioaladi/)
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