Market Access Map - ESTADOS UNIDOS

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17/05/2023, 19:52 Market Access Map

EN FR ES RU (/en)
AR (HTTPS://M.MACMAP.ORG/AR)

Market Access Map


Improving transparency in international trade and market access
(http://www.intracen.org/)

Market Access Conditions


Identify customs tariffs, tariff rate quotas, trade remedies, regulatory
requirements and preferential regimes applicable to your product.

https://www.macmap.org/en//query/results?reporter=842&partner=076&product=200799&level=6 1/32
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Customs tariffs 

For product  20079910 – Strawberry jam


Exported from Brazil to United States of America
Tariff year: 2023 (HS Rev.2022)
Source : ITC (Market Access Map)

Tariff regime  Applied AVE  Note


Tariff

MFN duties (Applied)  2.20% 2.20%

Preferential tariff for GSP countries  0.00% 0.00% Trade agreement details

Trade remedies 

For product  20079910 – Strawberry jam


Exported from Brazil to United States of America
Source : ITC (Market Access Map)

United States of America does not apply any trade remedy on the selected product.

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Regulatory requirements 

For product  20079910 – Strawberry jam


Exported from Brazil to United States of America
HS revision: HS Rev.2012
NTM Classification: NTM rev. 2019
NTM year: 2018
Source: UNCTAD

Import requirements applied to this product Total measures 52  

A130 - Systems approach  2

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)...

A150 - Authorization requirement for importers for SPS reasons  3

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1. Authorization requirement for importers for SPS reasons


 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 : (c)(1) Registration. A commercial processor, when first engaging in the
manufacture, processing, or packing of acidified foods in any State, as defined in section 201(a)(1) of the
act, shall, not later than 10 days after first so engaging, register and file with the Food and Drug
Administration on Form FDA 2541 (food canning establishment registration) information including, but not
limited to, the name of the establishment, principal place of business, the location of each establishment
in which that processing is carried on, the processing method in terms of acidity and pH control, and a list
of foods so processed in each establishment. These forms are available from the LACF Registration
Coordinator (HFS-303), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, or at any Food and Drug Administration district office. The
completed form shall be submitted to the Center for Food Safety and Applied Nutrition (HFS-565), Food
and Drug Administratio
 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. Authorization requirement for importers for SPS reasons


 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 : (c) Registration and process filing
 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...

3. Authorization requirement for importers for SPS reasons


 Legislation title : Title 21 - Food and Drugs; PART 1�GENERAL ENFORCEMENT REGULATIONS - Subpart
H�Registration of Food Facilities
 Legislation summary : (a) Registration. You must register before your facility begins to manufacture,
process, pack, or hold food for consumption in the United States. You may authorize an individual to
register the facility on your behalf. (b) Registration renewal. You must submit a registration renewal
containing the information required under
 Implementation authority : Food and Drug Administration, Department of Health and Human Services
 Validity : from 10.2013
 Other countries affected : World ...
 Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
 Additional comments : Food (food means (1) articles used for food or dri...

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A190 - Prohibitions/restrictions of imports for SPS reasons, not elsewhere specified (n.e.s.)  1

Prohibitions/restrictions of imports for SPS reasons, not elsewhere specified (n.e.s.)


 Legislation title : Title 21 - Food and Drugs; PART 1�GENERAL ENFORCEMENT REGULATIONS - Subpart
I�Prior Notice of Imported Food
 Legislation summary : A prior notice for an article of food may be submitted by any person with
knowledge of the required information. This person is the submitter. The submitter also may use another
person to transmit the required information on his/her behalf. The person who transmits the information
is the transmitter. The submitter and transmitter may be the same person.
 Implementation authority : Food and Drug Administration, Department of Health and Human Services
 Validity : from 05.2011
 Other countries affected : World ...
 Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
 Additional comments : Food products ...

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 ...

A310 - Labelling requirements  3

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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 ...

A330 - Packaging requirements  4

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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 ...

A420 - Hygienic practices during production related to SPS conditions  4

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1. Hygienic practices during production related to SPS conditions


 Legislation title : Title 21 - Food and Drugs; PART 113�THERMALLY PROCESSED LOW-ACID FOODS
PACKAGED IN HERMETICALLY SEALED CONTAINERS - Subpart E�Production and Process Controls
 Legislation summary : (a) Before using raw materials and ingredients susceptible to microbiological
contamination, the processor shall ensure that those materials and ingredients are suitable for use in
processing low-acid food. Compliance with this requirement may be accomplished by receiving the raw
materials and ingredients under a supplier's guarantee that they are suitable for use, by examining them
for their microbiological condition, or by other acceptable means. (b) Blanching by heat, when required in
the preparation of food for canning, should be effected by heating the food to the required temperature,
holding it at this temperature for the required time, and then either rapidly cooling the food or passing it to
subsequent processing without delay. Thermophilic growth and contamination in blanchers should be
minimized by the use of adequate operating temperatures and by cleaning. If the blanched food product is
washed before filling, potable water should be used. (c) The filling of containers, either mechanically or by
h
 Implementation authority : Food and Drug Administration, Department of Health and Human Services
 Validity : from 03.1979
 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...

2. Hygienic practices during production related to SPS conditions


 Legislation title : Title 21 - Food and Drugs; PART 114�ACIDIFIED FOODS - Subpart A�General
Provisions, Subpart E�Production and Process Controls
 Legislation summary : The criteria in ��?114.10, 114.80, 114.83, 114.89, and 114.100, as well as the
criteria in parts 110 and 117 of this chapter, apply in determining whether an article of acidified food is
adulterated: (a) Within the meaning of section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act in
that it has been manufactured under such conditions that it is unfit for food; or (b) Within the meaning of
section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act in that it has been prepared, packed, or held
under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have
been rendered injurious to health. ....Requirements on personnel, production process and controls
 Implementation authority : Food and Drug Administration, Department of Health and Human Services
 Validity : from 03.1979
 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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3. Hygienic practices during production related to SPS conditions


 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 : Conditions and limitations on the use of adjuvants, production aids and sanitizers
 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. Hygienic practices during production related to SPS conditions


 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 : Personnel. The management of the establishment must take reasonable measures
and precautions to ensure the following: (a) Disease control. Any person who, by medical examination or
supervisory observation, is shown to have, or appears to have, an illness, open lesion, including boils,
sores, or infected wounds, or any other abnormal source of microbial contamination by which there is a
reasonable possibility of food, food-contact surfaces, or food-packaging materials becoming
contaminated, must be excluded from any operations which may be expected to result in such
contamination until the condition is corrected, unless conditions such as open lesions, boils, and infected
wounds are adequately covered (e.g., by an impermeable cover). Personnel must be instructed to report
such health conditions to their supervisors. (b) Cleanliness. All persons working in direct contact with
food, food-contact surfaces, and food-packaging materials must conform to hygienic practices while on
duty to the extent necessary to pro
 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)...

A630 - Food and feed processing  3

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1. Food and feed processing


 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 : (3) Process adherence and information
 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. Food and feed processing


 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 : 3) Process adherence and information. (i) A commercial processor engaged in the
thermal processing of low-acid foods packaged in hermetically sealed containers in any registered
establishment shall process each low-acid food in each container size in conformity with at least the
scheduled processes and modifications filed pursuant to paragraph (c)(2) of this section.(g) All operators
of retorts, thermal processing systems, aseptic processing and packaging systems, or other thermal
processing systems, and container closure inspectors shall be under the operating supervision of a
person who has attended a school approved by the Commissioner for giving instruction in retort
operations, aseptic processing and packaging systems operations or other thermal processing systems
operations, and container closure inspections, and has satisfactorily completed the prescribed course of
instruction: Provided, That this requirement shall not apply in the State of California as listed in paragraph
(j) of this section. The Com
 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...

3. Food and feed processing


 Legislation title : Title 21 - Food and Drugs; PART 113�THERMALLY PROCESSED LOW-ACID FOODS
PACKAGED IN HERMETICALLY SEALED CONTAINERS - Subpart A�General Provisions, Subpart
C�Equipment, Subpart E�Production and Process Controls
 Legislation summary : Requirements on personnel, equipment etc.
 Implementation authority : Food and Drug Administration, Department of Health and Human Services
 Validity : from 12.2011
 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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A640 - Storage and transport conditions  1

Storage and transport conditions


 Legislation title : Title 21 - Food and Drugs; PART 1�GENERAL ENFORCEMENT REGULATIONS - Subpart
O�Sanitary Transportation of Human and Animal Food
 Legislation summary : What requirements apply to vehicles and transportation equipment? (a) Vehicles
and transportation equipment used in transportation operations must be so designed and of such
material and workmanship as to be suitable and adequately cleanable for their intended use to prevent the
food they transport from becoming unsafe, i.e., adulterated within the meaning of section 402(a)(1), (2),
and (4) of the Federal Food, Drug, and Cosmetic Act during transportation operations. (b) Vehicles and
transportation equipment must be maintained in such a sanitary condition for their intended use as to
prevent the food they transport from becoming unsafe during transportation operations. (c) Vehicles and
transportation equipment used in transportation operations for food requiring temperature control for
safety must be designed, maintained, and equipped as necessary to provide adequate temperature control
to prevent the food from becoming unsafe during transportation operations. (d) Vehicles and
transportation equipment must be
 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 ...

A820 - Testing requirement  2

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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 ...

A840 - Inspection requirement  2

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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...

A850 - Traceability requirements  1

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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 ...

A851 - Origin of materials and parts  1

Origin of materials and parts


 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) Except as provided by paragraphs (b) and (c) of this section, all records
required by this part are subject to all requirements of this subpart. (b) The requirements of
 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)...

A852 - Processing history  6

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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)...

A900 - SPS measures, n.e.s.  1

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SPS measures, n.e.s.


 Legislation title : Title 21 Food and Drugs: PART 121�MITIGATION STRATEGIES TO PROTECT FOOD
AGAINST INTENTIONAL ADULTERATION
 Legislation summary : Food defense plan. (a) Requirement for a food defense plan. You must prepare, or
have prepared, and implement a written food defense plan. (b) Contents of a food defense plan. The
written food defense plan must include: (1) The written vulnerability assessment, including required
explanations, to identify significant vulnerabilities and actionable process steps as required by �?
121.130(c); (2) The written mitigation strategies, including required explanations, as required by �?
121.135(b); (3) The written procedures for the food defense monitoring of the implementation of the
mitigation strategies as required by �?121.140(a); (4) The written procedures for food defense corrective
actions as required by �?121.145(a)(1); and (5) The written procedures for food defense verification as
required by �?121.150(b). (c) Records. The food defense plan required by this section is a record that is
subject to the requirements of subpart D of this part.
 Implementation authority : Food and Drug Administration: Department of Health and Human Services
 Validity : from 05.2016
 Other countries affected : World ...
 Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
 Additional comments : Food ...

B310 - Labelling requirements  5

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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 ...

B330 - Packaging requirements  1

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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 ...

B700 - Product quality, safety or performance requirement  1

Product quality, safety or performance requirement


 Legislation title : Title 21 - Food and Drugs; PART 102�COMMON OR USUAL NAME FOR
NONSTANDARDIZED FOODS - Subpart B�Requirements for Specific Nonstandardized Foods - �102.26
Frozen �heat and serve� dinners
 Legislation summary : (a) A frozen �heat and serve� dinner: (1) Shall contain at least three
components, one of which shall be a significant source of protein and each of which shall consist of one
or more of the following: meat, poultry, fish, cheese, eggs, vegetables, fruit, potatoes, rice, or other cereal
based products (other than bread or rolls). (2) May also contain other servings of food (e.g., soup, bread
or rolls, beverage, dessert).
 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-vol2/pdf/CFR-2014-title21-vol2-part104.pdf)
 Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
 Additional comments : Frozen “heat and serve” dinners ...

C900 - Other formalities, n.e.s.  1

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Other formalities, n.e.s.


 Legislation title : Title 21 - Food and Drugs; PART 1�GENERAL ENFORCEMENT REGULATIONS - Subpart
D�Electronic Import Entries
 Legislation summary : General. When filing an entry in ACE, the ACE filer shall submit the following
information for food contact substances, drugs, biological products, HCT/Ps, medical devices, radiation-
emitting electronic products, cosmetics, and tobacco products. (a) Product identifying information for the
article that is being imported or offered for import. This consists of: (1) FDA Country of Production, which
is the country where the article was last manufactured, processed, or grown (including harvested, or
collected and readied for shipment to the United States). The FDA Country of Production for an article that
has undergone any manufacturing or processing is the country where that activity occurred provided that
the manufacturing or processing had more than a minor, negligible, or insignificant effect on the article.
(2) The Complete FDA Product Code, which must be consistent with the invoice description of the
product. (3) The Full Intended Use Code. (b) Importer of record contact information, which is the
telephone a
 Implementation authority : Food and Drug Administration, Department of Health and Human Services
 Validity : from 11.2016
 Other countries affected : World ...
 Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
 Additional comments : Food contact substances, drugs, biological product...

Import requirements applied to all goods Total measures 6  

A510 - Cold/heat treatment  2

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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 ...

E320 - Prohibition for non-economic reasons  1

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Prohibition for non-economic reasons


 Legislation title : Title 16 - Commercial Practices: PART 311�TEST PROCEDURES AND LABELING
STANDARDS FOR RECYCLED OIL - �?311.4Testing.
 Legislation summary : Section 1. Except to the extent provided in statutes or in licenses, regulations,
orders, or directives that may be issued pursuant to this order, and notwithstanding any contract entered
into or any license or permit granted prior to the date of this order, the importation into the United States,
directly or indirectly, of any goods, services, or technology from North Korea is prohibited.
 Implementation authority : Federal Trade Commission
 Validity : from 06.2011
 Other countries affected : North Korea ...
 Link (http://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2014&go=Go)
 Additional comments : All goods ...

FUNDERS

(https://ec.europa.eu/commission/index_en)

(http://www.grips.ac.jp/en)

PARTNER

(http://www.aladi.org/sitioaladi/)

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