Packaged food and beverages
Which rules apply to packaged food and beverages?
We track 7,263 rules for these in 19 of 21 markets, including California's Prop 65 list of 883 chemicals. Check your product free, no account needed.
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Packaged food and beverages
Packaged foods and beverages sold prepacked to consumers, shelf-stable or chilled, imported or domestic: 'food' per EU Reg. 178/2002 Art. 2, FD&C Act sec. 201(f), the Korean Food Sanitation Act and the Japanese Food Sanitation Act. Excluded from v0: dietary supplements and health functional foods, infant formula and baby foods, alcoholic beverages beyond general labelling, organic and GI schemes, fresh meat, poultry and eggs (USDA), fresh produce, food-contact materials (covered under Home and kitchen goods), pet food.
Default childrens product: noRules
Rules by market
Open a market to read its rules for this category.
Main sources, from 7 Oct 2026 · What is covered
Federal food regulations as published on 7 Oct 2026.
United States (federal): main sources stored. Modelled: TSCA section 8(a)(7) PFAS reporting and recordkeeping (40 CFR 705), shown as applying only if the product contains a PFAS; 21 CFR 101 food labelling (statement of identity, net quantity, ingredient list, allergen declaration incl. sesame under FALCPA and FASTER, nutrition facts, name and place of business); FD&C Act sec. 403 misbranding (21 U.S.C. 343); 21 CFR 170-189 additive status where listable (172 direct additives, 173, 180, 182 GRAS substances, 184); facility registration (21 CFR 1 subpart H); prior notice (subpart I); FSMA FSVP (21 CFR 1 subpart L). Not stored: GRAS notices outside the listed 21 CFR parts; standards of identity (21 CFR 130-169); Part 117 preventive-control details (only who must comply and the qualified-facility rules are encoded); seafood and juice HACCP; FPLA and 16 CFR 500; FDA action levels and guidance levels for contaminants (not binding limits); state laws other than listed; USDA-regulated meat; poultry and egg products; dietary supplements; infant formula.
Importer of food into the United States
Must meet the conditions of For each food imported, develop, maintain and follow a foreign supplier verification program (FSVP) giving adequate assurance that the foreign supplier produces the food to the same level of public health protection as section 418 or 419 of the FD&C Act
Exemptions (2)
Juice and seafood importers whose foreign supplier complies with part 120 or 123; food imported for research or evaluation
“(b) Exemptions for juice and seafood—(1) Importers of certain juice”
Importers deemed in compliance as receiving facilities under part 117 or 507 (except 1.509)
“(c) Importers subject to section 418 of the Federal Food, Drug, and Cosmetic Act. You are deemed to be in compliance with the requirements of this subpart for a food you import, except for the requirements in § 1.509, if you are a receiving facility as defined in § 117.3 or § 507.3 of this chapter and you are in compliance with the following requirements of part 117 or part 507 of this chapter, as applicable: (1) You implement preventive controls for the hazards in the food in accordance with § 117.135 or § 507.34 of this chapter;”
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Imported into the market of sale
- Your role: Importer
Depends on: imported, economic operator role
In force since 27 Nov 2015
Applies to products imported on or after 27 Nov 2015
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
“(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”
Very small importers and importers of food from certain small foreign suppliers
Must meet the conditions of A very small importer or an importer of food from a qualified facility or small farm may meet the modified FSVP requirements of 1.512 (documentation of eligibility, written assurances) in place of 1.502-1.508
The start date is not stated in the text (date unknown).
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Imported into the market of sale
- Your role: Importer
Depends on: imported, economic operator role
In force, start date unknown
In force no later than 2026-10-07 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.
“(a) Eligibility. This section applies only if: (1) You are a very”
FSVP importer conducts a hazard analysis for each imported food
Must meet the conditions of 21 CFR 1.504: hazard analysis to identify known or reasonably foreseeable hazards for each food imported
The start date is not stated in the text (date unknown).
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Imported into the market of sale
- Your role: Importer
Depends on: imported, economic operator role
In force, start date unknown
In force no later than 2026-10-07 (the stored eCFR version date); earlier commencement is not stated in the published text.
“you must conduct a hazard analysis to identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of food you import to determine whether there are any hazards requiring a control.”
(a) You must ensure that, for each line entry of food product offered for import
Declaration required
(a) You must ensure that, for each line entry of food product offered for importation into the United States, your name, electronic mail address, and
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Imported into the market of sale
- Your role: Importer
Depends on: imported, economic operator role
In force since 27 Nov 2015
Applies to products imported on or after 27 Nov 2015
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
“(a) You must ensure that, for each line entry of food product offered for importation into the United States, your name, electronic mail address, and”
FSVP records maintained and available to FDA
Declaration required
FSVP records kept for at least 2 years and available to FDA on request
The start date is not stated in the text (date unknown).
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Imported into the market of sale
- Your role: Importer
Depends on: imported, economic operator role
In force, start date unknown
In force no later than 2026-10-07 (the stored eCFR version date); earlier commencement is not stated in the published text.
“How must I maintain records of my FSVP? (a)”
Importer identified at entry with a unique facility identifier
Disclosure to authority
name, email address and unique facility identifier of the FSVP importer at entry
The start date is not stated in the text (date unknown).
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Imported into the market of sale
- Your role: Importer
Depends on: imported, economic operator role
In force, start date unknown
In force no later than 2026-10-07 (the stored eCFR version date); earlier commencement is not stated in the published text.
“How must the importer be identified at entry?”
(4) For the purposes of paragraph (a)(3) of this section, any sulfiting agent (s
Label required
(4) For the purposes of paragraph (a)(3) of this section, any sulfiting agent (sulfur dioxide, sodium sulfite, sodium bisulfite, potassium bisulfite, sodium metabisulfite, and potassium
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Sulfiting agent added
Depends on: sulfiting agent added
In force since 15 Mar 1977
Applies to products sold on or after 15 Mar 1977
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
“(4) For the purposes of paragraph (a)(3) of this section, any sulfiting agent (sulfur dioxide, sodium sulfite, sodium bisulfite, potassium bisulfite, sodium metabisulfite, and potassium”
Nutrient content claim on the label or in labeling
Must meet the conditions of A nutrient content claim may be made only in accordance with 21 CFR 101.13 and the applicable regulations in subpart D of part 101 (and parts 105 and 107)
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Carries a nutrition or health claim
Depends on: nutrition claim
In force since 6 Jan 1993
Applies to products sold on or after 6 Jan 1993
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
“(b) A claim that expressly or implicitly characterizes the level of a nutrient of the type required to be in nutrition labeling under § 101.9 or under § 101.36 (that”
(c)(1) All words, statements, and other information required by or under authori
Label required
(c)(1) All words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear thereon
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
Every product in the category
In force since 15 Mar 1977
Applies to products sold on or after 15 Mar 1977
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
“(c)(1) All words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear thereon”
Food to which any colouring has been added: colouring declared in the ingredient statement
Label required
Declaration of the added colouring in the statement of ingredients (as the colour additive's name or as artificial colour, per 101.22(k))
The start date is not stated in the text (date unknown).
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
Every product in the category
In force, start date unknown
In force no later than 2026-10-07 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.
“(k) The label of a food to which any coloring has been added shall declare the coloring in the statement of ingredients in the manner”
Food with artificial flavor, artificial colour or chemical preservative: statement
Label required
Statement of artificial flavoring, artificial coloring, or chemical preservative on the food or its container or wrapper
The start date is not stated in the text (date unknown).
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
Every product in the category
In force, start date unknown
In force no later than 2026-10-07 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.
“(c) A statement of artificial flavoring, artificial coloring, or chemical preservative shall be placed on the food or on its container or wrapper, or on any two or all three of these, as may be necessary to render such statement likely to be read by the ordinary person under customary conditions of purchase and use of such food.”
(b) All information required to appear on the label of any package of food under
Label required
(b) All information required to appear on the label of any package of food under §§ 101.4, 101.5, 101.8, 101.9, 101.13, 101.17, 101.36, subpart D
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Sold prepacked
Depends on: sold prepacked
In force since 15 Mar 1977
Applies to products sold on or after 15 Mar 1977
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
“(b) All information required to appear on the label of any package of food under §§ 101.4, 101.5, 101.8, 101.9, 101.13, 101.17, 101.36, subpart D”
Packaged food: statement of identity on the principal display panel
Label required
Statement of identity (the name specified by law, else the common or usual name, else a descriptive term) as a principal feature of the principal display panel
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Sold prepacked
Depends on: sold prepacked
In force since 15 Mar 1977
Applies to products sold on or after 15 Mar 1977
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
“(a) The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity. (b) Such statement of identity shall be in terms of: (1) The name now or hereafter specified in or required by any applicable Federal law or regulation;”
Packaged food made from two or more ingredients: ingredient declaration
Label required
List of ingredients by common or usual name in descending order of predominance by weight
Exemptions (1)
Ingredients exempted by 21 CFR 101.100 (including incidental additives, assortments of different items, bulk food displayed with a sign)
“(a) The following foods are exempt from compliance with the requirements of section 403(i)(2) of the act (requiring a declaration on the label of the common or usual name of each ingredient when the food is fabricated from two or more ingredients).”
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Sold prepacked
Depends on: sold prepacked
In force since 15 Mar 1977
Applies to products sold on or after 15 Mar 1977
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
“(a)(1) Ingredients required to be declared on the label or labeling of a food, including foods that comply with standards of identity, except those ingredients exempted by § 101.100, shall be listed by common or usual name in descending order of predominance by weight on either the principal display panel or the information panel in accordance with the provisions of § 101.2, except that ingredients in dietary supplements that are listed in the nutrition label in accordance with § 101.36 need not be repeated in the ingredient list.”
Packaged food: name and place of business
Label required
Name and place of business of the manufacturer, packer, or distributor (street address, city, State, ZIP code)
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Sold prepacked
Depends on: sold prepacked
In force since 15 Mar 1977
Applies to products sold on or after 15 Mar 1977
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
“(a) The label of a food in packaged form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor. (b)”
Packaged food: net quantity of contents on the principal display panel
Label required
Net quantity of contents in weight, measure, or numerical count (fluid measure for liquids, weight for solids)
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Sold prepacked
Depends on: sold prepacked
In force since 15 Mar 1977
Applies to products sold on or after 15 Mar 1977
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
“(a) The principal display panel of a food in package form shall bear a declaration of the net quantity of contents. This shall be expressed in the terms of weight, measure, numerical count, or a combination of numerical count and weight or measure.”
(j) A food to which a chemical preservative(s) is added shall, except when exemp
Label required
(j) A food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100 bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”.
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Contains an added chemical preservative
Depends on: chemical preservative added
In force since 15 Mar 1977
Applies to products sold on or after 15 Mar 1977
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
(j) A food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100 bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”.
(e) Under the provisions of section 403(c) of the Federal Food, Drug, and Cosmet
Label required
(e) Under the provisions of section 403(c) of the Federal Food, Drug, and Cosmetic Act, a food shall be deemed to be misbranded if it
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Represented as an imitation or substitute
Depends on: imitation food claim
In force since 15 Mar 1977
Applies to products sold on or after 15 Mar 1977
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
“(e) Under the provisions of section 403(c) of the Federal Food, Drug, and Cosmetic Act, a food shall be deemed to be misbranded if it”
(a) General requirements. Except as provided in paragraph (e) of this section, a
Must meet the conditions of (a) General requirements. Except as provided in paragraph (e) of this section, a claim about the level of a nutrient in a food in relation
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Claim: high protein or source of fibre
In force since 6 Jan 1993
Applies to products sold on or after 6 Jan 1993
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
“(a) General requirements. Except as provided in paragraph (e) of this section, a claim about the level of a nutrient in a food in relation”
(a) General requirements. A claim about the calorie or sugar content of a food m
Must meet the conditions of (a) General requirements. A claim about the calorie or sugar content of a food may only be made on the label or in the labeling
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Claim: low sugar or no added sugar
In force since 6 Jan 1993
Applies to products sold on or after 6 Jan 1993
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
“(a) General requirements. A claim about the calorie or sugar content of a food may only be made on the label or in the labeling”
(a) General requirements. A claim about the level of sodium or salt in a food ma
Must meet the conditions of (a) General requirements. A claim about the level of sodium or salt in a food may only be made on the label or in the labeling of the food if: (1) The claim uses one of the terms defined in this section in accordance with the definition for that term;
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Claim: reduced salt
In force since 6 Jan 1993
Applies to products sold on or after 6 Jan 1993
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
“(a) General requirements. A claim about the level of sodium or salt in a food may only be made on the label or in the labeling of the food if: (1) The claim uses one of the terms defined in this section in accordance with the definition for that term;”
(a) General requirements. A claim about the level of fat, fatty acid, and choles
Must meet the conditions of (a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a food may only be made on the label or in the labeling of foods if: (1) The claim uses one of the terms defined in this section in accordance with the definition for that term;
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Claim: low fat
In force since 6 Jan 1993
Applies to products sold on or after 6 Jan 1993
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
“(a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a food may only be made on the label or in the labeling of foods if: (1) The claim uses one of the terms defined in this section in accordance with the definition for that term;”
(a) Nutrition information relating to food shall be provided for all products in
Label required
(a) Nutrition information relating to food shall be provided for all products intended for human consumption and offered for sale unless an exemption is provided
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Sold by a restaurant or retail food establishment (US): no
Depends on: restaurant or retail service
In force since 6 Jan 1993
Applies to products sold on or after 6 Jan 1993
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
“(a) Nutrition information relating to food shall be provided for all products intended for human consumption and offered for sale unless an exemption is provided”
Food intended for human consumption and offered for sale: nutrition labeling
Label required
Nutrition information (Nutrition Facts) for the food, in the format of 21 CFR 101.9, for each serving
Exemptions (2)
Food offered by a retailer or other direct seller with annual gross sales to consumers of not more than $500,000 (or food sales of not more than $50,000), if the label bears no nutrition claims
“(1)(i) Food offered for sale by a person who makes direct sales to consumers (e.g., a retailer) who has annual gross sales made or business done in sales to consumers that is not more than $500,000 or has annual gross sales made or business done in sales of food to consumers of not more than $50,000, Provided, That the food bears no nutrition claims or other nutrition information in any context on the label or in labeling or advertising.”
Food served in restaurants and similar establishments for immediate consumption, if no nutrition claims
“(2) Except as provided in § 101.11, food products that are: (i) Served in restaurants, Provided, That the food bears no nutrition claims or other nutrition information in any context on the label or in labeling or advertising.”
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Sold by a restaurant or retail food establishment (US): no
Depends on: restaurant or retail service
In force since 6 Jan 1993
Applies to products sold on or after 6 Jan 1993
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
“(a) Nutrition information relating to food shall be provided for all products intended for human consumption and offered for sale unless an exemption is provided”
(b) Requirements. (1) A food that bears the claim “gluten-free” in its labeling
Must meet the conditions of (b) Requirements. (1) A food that bears the claim “gluten-free” in its labeling and fails to meet the requirements of paragraph (a)(3) of this section
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Carries a gluten-free claim
Depends on: gluten free claim
In force since 5 Aug 2013
Applies to products sold on or after 5 Aug 2013
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
(b) Requirements. (1) A food that bears the claim “gluten-free” in its labeling and fails to meet the requirements of paragraph (a)(3) of this section
- Conformity
Importer of food into the United States
Must meet the conditions of For each food imported, develop, maintain and follow a foreign supplier verification program (FSVP) giving adequate assurance that the foreign supplier produces the food to the same level of public health protection as section 418 or 419 of the FD&C Act
Exemptions (2)
Juice and seafood importers whose foreign supplier complies with part 120 or 123; food imported for research or evaluation
“(b) Exemptions for juice and seafood—(1) Importers of certain juice”
21 CFR 1.501(b)-(c) (excerpt) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR 1.500-1.514 (eCFR, version of 2026-10-07)(opens in a new tab) Importers deemed in compliance as receiving facilities under part 117 or 507 (except 1.509)
“(c) Importers subject to section 418 of the Federal Food, Drug, and Cosmetic Act. You are deemed to be in compliance with the requirements of this subpart for a food you import, except for the requirements in § 1.509, if you are a receiving facility as defined in § 117.3 or § 507.3 of this chapter and you are in compliance with the following requirements of part 117 or part 507 of this chapter, as applicable: (1) You implement preventive controls for the hazards in the food in accordance with § 117.135 or § 507.34 of this chapter;”
21 CFR 1.502(c) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR 1.500-1.514 (eCFR, version of 2026-10-07)(opens in a new tab) Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Imported into the market of sale
- Your role: Importer
Depends on: imported, economic operator role
- Effective
In force since 27 Nov 2015
Applies to products imported on or after 27 Nov 2015
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
- Source
“(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”
1.502(a) (excerpt) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR 1.500-1.514 (eCFR, version of 2026-10-07)(opens in a new tab)
- Conformity
Very small importers and importers of food from certain small foreign suppliers
Must meet the conditions of A very small importer or an importer of food from a qualified facility or small farm may meet the modified FSVP requirements of 1.512 (documentation of eligibility, written assurances) in place of 1.502-1.508
The start date is not stated in the text (date unknown).
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Imported into the market of sale
- Your role: Importer
Depends on: imported, economic operator role
- Effective
In force, start date unknown
In force no later than 2026-10-07 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.
- Source
“(a) Eligibility. This section applies only if: (1) You are a very”
21 CFR 1.512(a) (excerpt) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR 1.500-1.514 (eCFR, version of 2026-10-07)(opens in a new tab)
- Conformity
FSVP importer conducts a hazard analysis for each imported food
Must meet the conditions of 21 CFR 1.504: hazard analysis to identify known or reasonably foreseeable hazards for each food imported
The start date is not stated in the text (date unknown).
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Imported into the market of sale
- Your role: Importer
Depends on: imported, economic operator role
- Effective
In force, start date unknown
In force no later than 2026-10-07 (the stored eCFR version date); earlier commencement is not stated in the published text.
- Source
“you must conduct a hazard analysis to identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of food you import to determine whether there are any hazards requiring a control.”
21 CFR 1.504(a) (excerpt) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 1 subpart L (eCFR, versioner 2026-10-07)(opens in a new tab)
- Declaration
(a) You must ensure that, for each line entry of food product offered for import
Declaration required
(a) You must ensure that, for each line entry of food product offered for importation into the United States, your name, electronic mail address, and
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Imported into the market of sale
- Your role: Importer
Depends on: imported, economic operator role
- Effective
In force since 27 Nov 2015
Applies to products imported on or after 27 Nov 2015
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
- Source
“(a) You must ensure that, for each line entry of food product offered for importation into the United States, your name, electronic mail address, and”
1.509(a) (excerpt) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR 1.500-1.514 (eCFR, version of 2026-10-07)(opens in a new tab)
- Declaration
FSVP records maintained and available to FDA
Declaration required
FSVP records kept for at least 2 years and available to FDA on request
The start date is not stated in the text (date unknown).
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Imported into the market of sale
- Your role: Importer
Depends on: imported, economic operator role
- Effective
In force, start date unknown
In force no later than 2026-10-07 (the stored eCFR version date); earlier commencement is not stated in the published text.
- Source
“How must I maintain records of my FSVP? (a)”
21 CFR 1.510 · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 1 subpart L (eCFR, versioner 2026-10-07)(opens in a new tab)
- Disclosure
Importer identified at entry with a unique facility identifier
Disclosure to authority
name, email address and unique facility identifier of the FSVP importer at entry
The start date is not stated in the text (date unknown).
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Imported into the market of sale
- Your role: Importer
Depends on: imported, economic operator role
- Effective
In force, start date unknown
In force no later than 2026-10-07 (the stored eCFR version date); earlier commencement is not stated in the published text.
- Source
“How must the importer be identified at entry?”
21 CFR 1.509 · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 1 subpart L (eCFR, versioner 2026-10-07)(opens in a new tab)
- Label
(4) For the purposes of paragraph (a)(3) of this section, any sulfiting agent (s
Label required
(4) For the purposes of paragraph (a)(3) of this section, any sulfiting agent (sulfur dioxide, sodium sulfite, sodium bisulfite, potassium bisulfite, sodium metabisulfite, and potassium
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Sulfiting agent added
Depends on: sulfiting agent added
- Effective
In force since 15 Mar 1977
Applies to products sold on or after 15 Mar 1977
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
- Source
“(4) For the purposes of paragraph (a)(3) of this section, any sulfiting agent (sulfur dioxide, sodium sulfite, sodium bisulfite, potassium bisulfite, sodium metabisulfite, and potassium”
101.100(a)(4) (excerpt) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 101 (eCFR, version of 2026-10-07)(opens in a new tab)
- Conformity
Nutrient content claim on the label or in labeling
Must meet the conditions of A nutrient content claim may be made only in accordance with 21 CFR 101.13 and the applicable regulations in subpart D of part 101 (and parts 105 and 107)
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Carries a nutrition or health claim
Depends on: nutrition claim
- Effective
In force since 6 Jan 1993
Applies to products sold on or after 6 Jan 1993
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
- Source
“(b) A claim that expressly or implicitly characterizes the level of a nutrient of the type required to be in nutrition labeling under § 101.9 or under § 101.36 (that”
101.13(b) (excerpt) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 101 (eCFR, version of 2026-10-07)(opens in a new tab)
- Label
(c)(1) All words, statements, and other information required by or under authori
Label required
(c)(1) All words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear thereon
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
Every product in the category
- Effective
In force since 15 Mar 1977
Applies to products sold on or after 15 Mar 1977
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
- Source
“(c)(1) All words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear thereon”
101.15(c)(1) (excerpt) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 101 (eCFR, version of 2026-10-07)(opens in a new tab)
- Label
Food to which any colouring has been added: colouring declared in the ingredient statement
Label required
Declaration of the added colouring in the statement of ingredients (as the colour additive's name or as artificial colour, per 101.22(k))
The start date is not stated in the text (date unknown).
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
Every product in the category
- Effective
In force, start date unknown
In force no later than 2026-10-07 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.
- Source
“(k) The label of a food to which any coloring has been added shall declare the coloring in the statement of ingredients in the manner”
21 CFR 101.22(k) (excerpt) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 101 (eCFR, version of 2026-10-07)(opens in a new tab)
- Label
Food with artificial flavor, artificial colour or chemical preservative: statement
Label required
Statement of artificial flavoring, artificial coloring, or chemical preservative on the food or its container or wrapper
The start date is not stated in the text (date unknown).
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
Every product in the category
- Effective
In force, start date unknown
In force no later than 2026-10-07 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.
- Source
“(c) A statement of artificial flavoring, artificial coloring, or chemical preservative shall be placed on the food or on its container or wrapper, or on any two or all three of these, as may be necessary to render such statement likely to be read by the ordinary person under customary conditions of purchase and use of such food.”
21 CFR 101.22(c) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 101 (eCFR, version of 2026-10-07)(opens in a new tab)
- Label
(b) All information required to appear on the label of any package of food under
Label required
(b) All information required to appear on the label of any package of food under §§ 101.4, 101.5, 101.8, 101.9, 101.13, 101.17, 101.36, subpart D
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Sold prepacked
Depends on: sold prepacked
- Effective
In force since 15 Mar 1977
Applies to products sold on or after 15 Mar 1977
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
- Source
“(b) All information required to appear on the label of any package of food under §§ 101.4, 101.5, 101.8, 101.9, 101.13, 101.17, 101.36, subpart D”
101.2(b) (excerpt) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 101 (eCFR, version of 2026-10-07)(opens in a new tab)
- Label
Packaged food: statement of identity on the principal display panel
Label required
Statement of identity (the name specified by law, else the common or usual name, else a descriptive term) as a principal feature of the principal display panel
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Sold prepacked
Depends on: sold prepacked
- Effective
In force since 15 Mar 1977
Applies to products sold on or after 15 Mar 1977
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
- Source
“(a) The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity. (b) Such statement of identity shall be in terms of: (1) The name now or hereafter specified in or required by any applicable Federal law or regulation;”
101.3(a) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 101 (eCFR, version of 2026-10-07)(opens in a new tab)
- Label
Packaged food made from two or more ingredients: ingredient declaration
Label required
List of ingredients by common or usual name in descending order of predominance by weight
Exemptions (1)
Ingredients exempted by 21 CFR 101.100 (including incidental additives, assortments of different items, bulk food displayed with a sign)
“(a) The following foods are exempt from compliance with the requirements of section 403(i)(2) of the act (requiring a declaration on the label of the common or usual name of each ingredient when the food is fabricated from two or more ingredients).”
21 CFR 101.100(a) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 101 (eCFR, version of 2026-10-07)(opens in a new tab) Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Sold prepacked
Depends on: sold prepacked
- Effective
In force since 15 Mar 1977
Applies to products sold on or after 15 Mar 1977
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
- Source
“(a)(1) Ingredients required to be declared on the label or labeling of a food, including foods that comply with standards of identity, except those ingredients exempted by § 101.100, shall be listed by common or usual name in descending order of predominance by weight on either the principal display panel or the information panel in accordance with the provisions of § 101.2, except that ingredients in dietary supplements that are listed in the nutrition label in accordance with § 101.36 need not be repeated in the ingredient list.”
101.4(a)(1) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 101 (eCFR, version of 2026-10-07)(opens in a new tab)
- Label
Packaged food: name and place of business
Label required
Name and place of business of the manufacturer, packer, or distributor (street address, city, State, ZIP code)
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Sold prepacked
Depends on: sold prepacked
- Effective
In force since 15 Mar 1977
Applies to products sold on or after 15 Mar 1977
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
- Source
“(a) The label of a food in packaged form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor. (b)”
101.5(a) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 101 (eCFR, version of 2026-10-07)(opens in a new tab)
- Label
Packaged food: net quantity of contents on the principal display panel
Label required
Net quantity of contents in weight, measure, or numerical count (fluid measure for liquids, weight for solids)
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Sold prepacked
Depends on: sold prepacked
- Effective
In force since 15 Mar 1977
Applies to products sold on or after 15 Mar 1977
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
- Source
“(a) The principal display panel of a food in package form shall bear a declaration of the net quantity of contents. This shall be expressed in the terms of weight, measure, numerical count, or a combination of numerical count and weight or measure.”
101.7(a) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 101 (eCFR, version of 2026-10-07)(opens in a new tab)
- Label
(j) A food to which a chemical preservative(s) is added shall, except when exemp
Label required
(j) A food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100 bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”.
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Contains an added chemical preservative
Depends on: chemical preservative added
- Effective
In force since 15 Mar 1977
Applies to products sold on or after 15 Mar 1977
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
- Source
(j) A food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100 bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”.
101.22(j) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 101 (eCFR, version of 2026-10-07)(opens in a new tab)
- Label
(e) Under the provisions of section 403(c) of the Federal Food, Drug, and Cosmet
Label required
(e) Under the provisions of section 403(c) of the Federal Food, Drug, and Cosmetic Act, a food shall be deemed to be misbranded if it
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Represented as an imitation or substitute
Depends on: imitation food claim
- Effective
In force since 15 Mar 1977
Applies to products sold on or after 15 Mar 1977
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
- Source
“(e) Under the provisions of section 403(c) of the Federal Food, Drug, and Cosmetic Act, a food shall be deemed to be misbranded if it”
101.3(e) (excerpt) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 101 (eCFR, version of 2026-10-07)(opens in a new tab)
- Conformity
(a) General requirements. Except as provided in paragraph (e) of this section, a
Must meet the conditions of (a) General requirements. Except as provided in paragraph (e) of this section, a claim about the level of a nutrient in a food in relation
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Claim: high protein or source of fibre
- Effective
In force since 6 Jan 1993
Applies to products sold on or after 6 Jan 1993
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
- Source
“(a) General requirements. Except as provided in paragraph (e) of this section, a claim about the level of a nutrient in a food in relation”
101.54(a) (excerpt) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 101 (eCFR, version of 2026-10-07)(opens in a new tab)
- Conformity
(a) General requirements. A claim about the calorie or sugar content of a food m
Must meet the conditions of (a) General requirements. A claim about the calorie or sugar content of a food may only be made on the label or in the labeling
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Claim: low sugar or no added sugar
- Effective
In force since 6 Jan 1993
Applies to products sold on or after 6 Jan 1993
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
- Source
“(a) General requirements. A claim about the calorie or sugar content of a food may only be made on the label or in the labeling”
101.60(a) (excerpt) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 101 (eCFR, version of 2026-10-07)(opens in a new tab)
- Conformity
(a) General requirements. A claim about the level of sodium or salt in a food ma
Must meet the conditions of (a) General requirements. A claim about the level of sodium or salt in a food may only be made on the label or in the labeling of the food if: (1) The claim uses one of the terms defined in this section in accordance with the definition for that term;
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Claim: reduced salt
- Effective
In force since 6 Jan 1993
Applies to products sold on or after 6 Jan 1993
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
- Source
“(a) General requirements. A claim about the level of sodium or salt in a food may only be made on the label or in the labeling of the food if: (1) The claim uses one of the terms defined in this section in accordance with the definition for that term;”
101.61(a) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 101 (eCFR, version of 2026-10-07)(opens in a new tab)
- Conformity
(a) General requirements. A claim about the level of fat, fatty acid, and choles
Must meet the conditions of (a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a food may only be made on the label or in the labeling of foods if: (1) The claim uses one of the terms defined in this section in accordance with the definition for that term;
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Claim: low fat
- Effective
In force since 6 Jan 1993
Applies to products sold on or after 6 Jan 1993
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
- Source
“(a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a food may only be made on the label or in the labeling of foods if: (1) The claim uses one of the terms defined in this section in accordance with the definition for that term;”
101.62(a) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 101 (eCFR, version of 2026-10-07)(opens in a new tab)
- Label
(a) Nutrition information relating to food shall be provided for all products in
Label required
(a) Nutrition information relating to food shall be provided for all products intended for human consumption and offered for sale unless an exemption is provided
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Sold by a restaurant or retail food establishment (US): no
Depends on: restaurant or retail service
- Effective
In force since 6 Jan 1993
Applies to products sold on or after 6 Jan 1993
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
- Source
“(a) Nutrition information relating to food shall be provided for all products intended for human consumption and offered for sale unless an exemption is provided”
101.9(a) (excerpt) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 101 (eCFR, version of 2026-10-07)(opens in a new tab)
- Label
Food intended for human consumption and offered for sale: nutrition labeling
Label required
Nutrition information (Nutrition Facts) for the food, in the format of 21 CFR 101.9, for each serving
Exemptions (2)
Food offered by a retailer or other direct seller with annual gross sales to consumers of not more than $500,000 (or food sales of not more than $50,000), if the label bears no nutrition claims
“(1)(i) Food offered for sale by a person who makes direct sales to consumers (e.g., a retailer) who has annual gross sales made or business done in sales to consumers that is not more than $500,000 or has annual gross sales made or business done in sales of food to consumers of not more than $50,000, Provided, That the food bears no nutrition claims or other nutrition information in any context on the label or in labeling or advertising.”
21 CFR 101.9(j)(1)(i) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 101 (eCFR, version of 2026-10-07)(opens in a new tab) Food served in restaurants and similar establishments for immediate consumption, if no nutrition claims
“(2) Except as provided in § 101.11, food products that are: (i) Served in restaurants, Provided, That the food bears no nutrition claims or other nutrition information in any context on the label or in labeling or advertising.”
21 CFR 101.9(j)(2) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 101 (eCFR, version of 2026-10-07)(opens in a new tab) Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Sold by a restaurant or retail food establishment (US): no
Depends on: restaurant or retail service
- Effective
In force since 6 Jan 1993
Applies to products sold on or after 6 Jan 1993
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
- Source
“(a) Nutrition information relating to food shall be provided for all products intended for human consumption and offered for sale unless an exemption is provided”
101.9(a) (excerpt) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 101 (eCFR, version of 2026-10-07)(opens in a new tab)
- Conformity
(b) Requirements. (1) A food that bears the claim “gluten-free” in its labeling
Must meet the conditions of (b) Requirements. (1) A food that bears the claim “gluten-free” in its labeling and fails to meet the requirements of paragraph (a)(3) of this section
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Carries a gluten-free claim
Depends on: gluten free claim
- Effective
In force since 5 Aug 2013
Applies to products sold on or after 5 Aug 2013
Date stated in the published text: the first Federal Register date of the section history note (or of the part Source line where the section has none), used as the provision date.
- Source
(b) Requirements. (1) A food that bears the claim “gluten-free” in its labeling and fails to meet the requirements of paragraph (a)(3) of this section
101.91(b) (excerpt) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR Part 101 (eCFR, version of 2026-10-07)(opens in a new tab)
Gaps
Markets without rules for this category
We have no rules for this category in these markets. That doesn't mean none apply, so a check here says Not covered, never clear.
ClaraDB gives a verdict only for PFAS state laws for cookware and bakeware, California Proposition 65 consumer-product warning check for BPA, BPS, formaldehyde, styrene, antimony trioxide, vinyl acetate, lead and cadmium, California Proposition 65 warning check for candles and ceramicware (lead, cadmium, formaldehyde, acetaldehyde, benzene, naphthalene, carbon monoxide, benzo[a]pyrene), US packaging EPR producer size thresholds (California, Colorado, Maryland, Minnesota, Oregon, Washington) for a brand-owning manufacturer, US lead in children's products and furniture (lead paint and total lead content), US lead in toys and child care articles (lead paint and total lead content), US lead in children's products (other) and bags (lead paint and total lead content), US phthalates in children's toys and child care articles (DEHP, DBP, BBP, DINP, DIBP, DPENP, DHEXP, DCHP) and US children's product certificate and tracking label for children's tableware (AI-checked, quotes verified word for word). Every other answer shows the laws and quotes found without saying whether they apply. Not checked: Consumer electronics (FCC equipment authorization, 47 CFR Parts 2 and 15, energy rules). What ClaraDB has checked
Show 2 markets
- Coverage
- Main sources; no modeled rule is scoped to this category. Not covered: other rules that may apply.
- Coverage
- Main sources; no modeled rule is scoped to this category. Not covered: other rules that may apply.
Facts
What we need to know about your product
Some rules depend on details of your product. Until you tell us, a check says Needs answers and asks for what's missing.
Show 74 facts
- Whether the listed substance or group is present
- Markets
- EU, GB, US, US-CA, US-VT
- Rules
- 7,504
- Eu food category code
- Markets
- EU, GB
- Rules
- 5,149
- Number of employees at the seller
- Markets
- US-CA
- Rules
- 972
- Contaminant food category
- Markets
- EU, GB
- Rules
- 804
- Sold prepacked
- Markets
- EU, GB, JP, KR, US
- Rules
- 161
- Economic operator role
- Markets
- EU, GB, JP, KR, US
- Rules
- 50
- Imported
- Markets
- EU, GB, JP, KR, US
- Rules
- 41
- Allergens present
- Markets
- EU, GB, JP, KR, US
- Rules
- 36
- Special storage required
- Markets
- EU, GB, JP, KR
- Rules
- 35
- Glass bottle reusable unlabelled
- Markets
- EU, GB
- Rules
- 32
- Contains gmo
- Markets
- JP, KR
- Rules
- 31
- Component content declared
- Markets
- KR
- Rules
- 28
- Precaution statement required
- Markets
- KR
- Rules
- 28
- Operates food facility
- Markets
- EU, GB, JP, US
- Rules
- 25
- Jp processed food
- Markets
- JP
- Rules
- 18
- Jp general use food
- Markets
- JP
- Rules
- 18
- List of ingredients present
- Markets
- EU, GB
- Rules
- 11
- Materials
- Markets
- US
- Rules
- 11
- Irradiated
- Markets
- EU, GB, KR, US
- Rules
- 10
- Beverage
- Markets
- EU, GB
- Rules
- 8
- Annex ix sold by number or loss
- Markets
- EU, GB
- Rules
- 8
- Prepacked for direct sale
- Markets
- GB
- Rules
- 6
- Facility registration exempt
- Markets
- US
- Rules
- 6
- Frozen
- Markets
- KR
- Rules
- 5
- Qualified facility
- Markets
- US
- Rules
- 5
- Facility registration required
- Markets
- US
- Rules
- 5
- Annual gross revenue usd
- Markets
- US-CO, US-MD, US-MN, US-OR, US-WA
- Rules
- 5
- Contains glycyrrhizinic acid
- Markets
- EU, GB
- Rules
- 4
- Liquorice in name or ingredients
- Markets
- EU, GB
- Rules
- 4
- Sweeteners present
- Markets
- EU, GB
- Rules
- 4
- Small package area cm2
- Markets
- EU, GB
- Rules
- 4
- Whether it is sold online
- Markets
- EU, GB
- Rules
- 4
- Name of food refers to allergen
- Markets
- EU, GB
- Rules
- 4
- Use difficult without instructions
- Markets
- EU, GB
- Rules
- 4
- Alcohol abv
- Markets
- EU, GB
- Rules
- 4
- Annex v exempt product
- Markets
- EU, GB
- Rules
- 4
- Offered by distance communication
- Markets
- GB
- Rules
- 4
- Aspartame present
- Markets
- EU, GB, KR
- Rules
- 3
- Food additive present
- Markets
- EU, GB, JP
- Rules
- 3
- Oem consignment manufactured
- Markets
- KR
- Rules
- 3
- Added polyols over 10 percent
- Markets
- EU, GB
- Rules
- 2
- Caffeine mg per l
- Markets
- EU, GB
- Rules
- 2
- Engineered nanomaterial ingredient
- Markets
- EU, GB
- Rules
- 2
- Refrigerated
- Markets
- EU, GB
- Rules
- 2
- Post opening storage appropriate
- Markets
- EU, GB
- Rules
- 2
- Label implies different origin
- Markets
- EU, GB
- Rules
- 2
- Country of origin stated
- Markets
- EU, GB
- Rules
- 2
- Operator knows noncompliant
- Markets
- EU, GB
- Rules
- 2
- Chemical detoxification applied
- Markets
- EU, GB
- Rules
- 2
- Jp annex 20 food
- Markets
- JP
- Rules
- 2
- Jp permit business type
- Markets
- JP
- Rules
- 2
- Canned or bottled
- Markets
- KR
- Rules
- 2
- Distributed in exporting country
- Markets
- KR
- Rules
- 2
- Restaurant or retail service
- Markets
- US
- Rules
- 2
- Coating type
- Markets
- US
- Rules
- 2
- Sorting destined lot
- Markets
- EU
- Rules
- 1
- Contains meat
- Markets
- GB
- Rules
- 1
- Schedule 3 food
- Markets
- GB
- Rules
- 1
- Oral disclosure intended
- Markets
- GB
- Rules
- 1
- Gmo annex 17 ingredient
- Markets
- JP
- Rules
- 1
- Additive undesignated
- Markets
- JP
- Rules
- 1
- Sulfiting agent added
- Markets
- US
- Rules
- 1
- Nutrition claim
- Markets
- US
- Rules
- 1
- Chemical preservative added
- Markets
- US
- Rules
- 1
- Imitation food claim
- Markets
- US
- Rules
- 1
- Gluten free claim
- Markets
- US
- Rules
- 1
- Direct additive used
- Markets
- US
- Rules
- 1
- Ca gross sales usd
- Markets
- US-CA
- Rules
- 1
- Packaging tons co
- Markets
- US-CO
- Rules
- 1
- Packaging tons md
- Markets
- US-MD
- Rules
- 1
- Packaging tons mn
- Markets
- US-MN
- Rules
- 1
- Packaging tonnes or
- Markets
- US-OR
- Rules
- 1
- Fluorine treated container
- Markets
- US-VT
- Rules
- 1
- Packaging tons wa
- Markets
- US-WA
- Rules
- 1
Changes
Upcoming changes
Rules for this category that start in the next 24 months, or are proposed or on hold.
Show 41 upcoming changes
Warning required when exposure exceeds the threshold (no NSRL listed for this row)
This product can expose you to N-Methyl-N-Formylhydrazine, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
Exemptions (1)
No warning is required where the exposure poses no significant risk of cancer (at or below the NSRL).
a warning is not required if the business causing the exposure can demonstrate that the exposure occurs at a level that poses “no significant risk
Official text, current to 31 Jul 2026. OEHHA's own Prop 65 list (XLSX), list dated July 31, 2026.
- Seller has 10 or more employees
- Your business has 10 or more employees and the product knowingly and intentionally exposes someone in California to this chemical
Depends on: number of employees at the seller
Takes effect 8 Dec 2026
Applies to products sold on or after 8 Dec 2026
Listed 2025-12-08 (cancer). Grace period: "Proposition 65 warning requirements do not apply until 12 months after the chemical has been listed" (Appendix A); listing date plus 12 months.
- Chemical
- N-Methyl-N-Formylhydrazine
- Type of toxicity
- cancer
- Listed by
- the State's Qualified Experts (SQE)
- CAS No.
- 758-17-8
- Date listed
- 8 Dec 2025
Prop 65 list row: N-Methyl-N-Formylhydrazine · fetched 2026-10-08
California OEHHA: 27 CCR 27001(opens in a new tab)Warning required when exposure exceeds the threshold (no MADL listed for this row)
This product can expose you to Bisphenol S (BPS), which is known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.
Exemptions (1)
No warning is required for a reproductive toxicant where the exposure will produce no observable effect at 1,000 times the level in question (at or below the MADL).
“a warning is not required if the business causing the exposure can demonstrate that the exposure will produce no observable effect, even at 1,000 times the level in question.”
Official text, current to 31 Jul 2026. OEHHA's own Prop 65 list (XLSX), list dated July 31, 2026.
- Seller has 10 or more employees
- Your business has 10 or more employees and the product knowingly and intentionally exposes someone in California to this chemical
Depends on: number of employees at the seller
Takes effect 8 Dec 2026
Applies to products sold on or after 8 Dec 2026
Listed 2025-12-08 (developmental). Grace period: "Proposition 65 warning requirements do not apply until 12 months after the chemical has been listed" (Appendix A); listing date plus 12 months.
- Chemical
- Bisphenol S (BPS)
- Type of toxicity
- developmental toxicity
- Listed by
- the State's Qualified Experts (SQE)
- CAS No.
- 80-09-1
- Date listed
- 8 Dec 2025
Prop 65 list row: Bisphenol S (BPS) · fetched 2026-10-08
California OEHHA: 27 CCR 27001(opens in a new tab)Warning required when exposure exceeds the threshold (no NSRL listed for this row)
This product can expose you to Tacrolimus, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
Exemptions (1)
No warning is required where the exposure poses no significant risk of cancer (at or below the NSRL).
a warning is not required if the business causing the exposure can demonstrate that the exposure occurs at a level that poses “no significant risk
Official text, current to 31 Jul 2026. OEHHA's own Prop 65 list (XLSX), list dated July 31, 2026.
- Seller has 10 or more employees
- Your business has 10 or more employees and the product knowingly and intentionally exposes someone in California to this chemical
Depends on: number of employees at the seller
Takes effect 17 Jul 2027
Applies to products sold on or after 17 Jul 2027
Listed 2026-07-17 (cancer). Grace period: "Proposition 65 warning requirements do not apply until 12 months after the chemical has been listed" (Appendix A); listing date plus 12 months.
- Chemical
- Tacrolimus
- Type of toxicity
- cancer
- Listed by
- the Labor Code (LC)
- CAS No.
- 104987-11-3
- Date listed
- 17 Jul 2026
Prop 65 list row: Tacrolimus · fetched 2026-10-08
California OEHHA: 27 CCR 27001(opens in a new tab)Warning required when exposure exceeds the threshold (no NSRL listed for this row)
This product can expose you to Hydrochlorothiazide, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
Exemptions (1)
No warning is required where the exposure poses no significant risk of cancer (at or below the NSRL).
a warning is not required if the business causing the exposure can demonstrate that the exposure occurs at a level that poses “no significant risk
Official text, current to 31 Jul 2026. OEHHA's own Prop 65 list (XLSX), list dated July 31, 2026.
- Seller has 10 or more employees
- Your business has 10 or more employees and the product knowingly and intentionally exposes someone in California to this chemical
Depends on: number of employees at the seller
Takes effect 17 Jul 2027
Applies to products sold on or after 17 Jul 2027
Listed 2026-07-17 (cancer). Grace period: "Proposition 65 warning requirements do not apply until 12 months after the chemical has been listed" (Appendix A); listing date plus 12 months.
- Chemical
- Hydrochlorothiazide
- Type of toxicity
- cancer
- Listed by
- the Labor Code (LC)
- CAS No.
- 58-93-5; 125727-50-6; 8049-49-8
- Date listed
- 17 Jul 2026
Prop 65 list row: Hydrochlorothiazide · fetched 2026-10-08
California OEHHA: 27 CCR 27001(opens in a new tab)Warning required when exposure exceeds the threshold (no NSRL listed for this row)
This product can expose you to Voriconazole, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
Exemptions (1)
No warning is required where the exposure poses no significant risk of cancer (at or below the NSRL).
a warning is not required if the business causing the exposure can demonstrate that the exposure occurs at a level that poses “no significant risk
Official text, current to 31 Jul 2026. OEHHA's own Prop 65 list (XLSX), list dated July 31, 2026.
- Seller has 10 or more employees
- Your business has 10 or more employees and the product knowingly and intentionally exposes someone in California to this chemical
Depends on: number of employees at the seller
Takes effect 17 Jul 2027
Applies to products sold on or after 17 Jul 2027
Listed 2026-07-17 (cancer). Grace period: "Proposition 65 warning requirements do not apply until 12 months after the chemical has been listed" (Appendix A); listing date plus 12 months.
- Chemical
- Voriconazole
- Type of toxicity
- cancer
- Listed by
- the Labor Code (LC)
- CAS No.
- 137234-62-9; 188416-29-7; 173967-54-9
- Date listed
- 17 Jul 2026
Prop 65 list row: Voriconazole · fetched 2026-10-08
California OEHHA: 27 CCR 27001(opens in a new tab)Warning required when exposure exceeds the threshold (no NSRL listed for this row)
This product can expose you to Welding Fumes, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
Exemptions (1)
No warning is required where the exposure poses no significant risk of cancer (at or below the NSRL).
a warning is not required if the business causing the exposure can demonstrate that the exposure occurs at a level that poses “no significant risk
Official text, current to 31 Jul 2026. OEHHA's own Prop 65 list (XLSX), list dated July 31, 2026.
- Seller has 10 or more employees
- Your business has 10 or more employees and the product knowingly and intentionally exposes someone in California to this chemical
Depends on: number of employees at the seller
Takes effect 17 Jul 2027
Applies to products sold on or after 17 Jul 2027
Listed 2026-07-17 (cancer). Grace period: "Proposition 65 warning requirements do not apply until 12 months after the chemical has been listed" (Appendix A); listing date plus 12 months.
- Chemical
- Welding Fumes
- Type of toxicity
- cancer
- Listed by
- the Labor Code (LC)
- CAS No.
- none given
- Date listed
- 17 Jul 2026
Prop 65 list row: Welding Fumes · fetched 2026-10-08
California OEHHA: 27 CCR 27001(opens in a new tab)Limit 500 µg/kg (content basis)
Consolidated text (not the authentic legal edition), current to 19 Aug 2026. EUR-Lex consolidated text: a documentation tool without legal effect; the acts published in the Official Journal are authentic. Consolidated version CELEX 02023R0915-20260819 from the Publications Office, the latest when read.
- Food category (contaminant tables): Vegetable oils and fats, fish oils and oils from other marine organisms destined for the production of baby food and processed cereal-based food for infants and young children [EU:5.3.2]
Depends on: contaminant food category
Takes effect 1 Jan 2027
Applies to products placed on the market on or after 1 Jan 2027
The row states this level as from 2027-01-01.
From the consolidated text: 5.3.2 · Vegetable oils and fats, fish oils and oils from other marine organisms destined for the production of baby food and processed cereal-based food for infants and young children · 750 500 as from 1 January 2027 · When the product is a mixture of different oils or fats of the same or of different botanical origins, the maximum level applies for the mixture. The oils and fats used as ingredients for the mixture shall comply with the maximum level established for the oils and fats in point 5.3.1.
Annex I rows, point 5.3.2: Vegetable oils and fats, fish oils and oils from other marine organisms destined for the production of baby food and processed cereal-based food for infants and young children — Sum of 3-monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters, expressed as 3-MCPD · fetched 2026-10-17
European Commission / Publications Office (CELLAR): Regulation (EU) 2023/915 (consolidated 2026-08-19)(opens in a new tab)Limit 50 µg/kg (content basis)
Consolidated text (not the authentic legal edition), current to 19 Aug 2026. EUR-Lex consolidated text: a documentation tool without legal effect; the acts published in the Official Journal are authentic. Consolidated version CELEX 02023R0915-20260819 from the Publications Office, the latest when read.
- Food category (contaminant tables): Baby food; Processed cereal based food for infants and young children [EU:5.3.4]
Depends on: contaminant food category
Takes effect 1 Jan 2027
Applies to products placed on the market on or after 1 Jan 2027
The row states this level as from 2027-01-01.
From the consolidated text: 5.3.4. · Baby food; Processed cereal based food for infants and young children · 50 as from 1 January 2027 · The maximum level applies to the product as placed on the market.
Annex I rows, point 5.3.4: Baby food; Processed cereal based food for infants and young children — Sum of 3-monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters, expressed as 3-MCPD · fetched 2026-10-17
European Commission / Publications Office (CELLAR): Regulation (EU) 2023/915 (consolidated 2026-08-19)(opens in a new tab)Limit 250 µg/kg (content basis)
Consolidated text (not the authentic legal edition), current to 19 Aug 2026. EUR-Lex consolidated text: a documentation tool without legal effect; the acts published in the Official Journal are authentic. Consolidated version CELEX 02023R0915-20260819 from the Publications Office, the latest when read.
- Food category (contaminant tables): Vegetable oils and fats, fish oils and oils from other marine organisms destined for the production of baby food and processed cereal-based food for infants and young children [EU:5.4.2]
Depends on: contaminant food category
Takes effect 1 Jan 2027
Applies to products placed on the market on or after 1 Jan 2027
The row states this level as from 2027-01-01.
From the consolidated text: 5.4.2 · Vegetable oils and fats, fish oils and oils from other marine organisms destined for the production of baby food and processed cereal-based food for infants and young children · 500 250 as from 1 January 2027 · When the product is a mixture of different oils or fats of the same or of different botanical origins, the maximum level applies for the mixture. The oils and fats used as ingredient for the mixture shall comply with the maximum level established for the oils and fats in point 5.4.1.
Annex I rows, point 5.4.2: Vegetable oils and fats, fish oils and oils from other marine organisms destined for the production of baby food and processed cereal-based food for infants and young children — Glycidyl fatty acid esters, expressed as glycidol · fetched 2026-10-17
European Commission / Publications Office (CELLAR): Regulation (EU) 2023/915 (consolidated 2026-08-19)(opens in a new tab)Limit 25 µg/kg (content basis)
Consolidated text (not the authentic legal edition), current to 19 Aug 2026. EUR-Lex consolidated text: a documentation tool without legal effect; the acts published in the Official Journal are authentic. Consolidated version CELEX 02023R0915-20260819 from the Publications Office, the latest when read.
- Food category (contaminant tables): Baby food; Processed cereal based food for infants and young children [EU:5.4.4]
Depends on: contaminant food category
Takes effect 1 Jan 2027
Applies to products placed on the market on or after 1 Jan 2027
The row states this level as from 2027-01-01.
From the consolidated text: 5.4.4 · Baby food; Processed cereal based food for infants and young children · 25 As from 1 January 2027 · The maximum level applies to the product as placed on the market.
Annex I rows, point 5.4.4: Baby food; Processed cereal based food for infants and young children — Glycidyl fatty acid esters, expressed as glycidol · fetched 2026-10-17
European Commission / Publications Office (CELLAR): Regulation (EU) 2023/915 (consolidated 2026-08-19)(opens in a new tab)- WarningUS-CAN-Methyl-N-Formylhydrazine (CAS 758-17-8)
Warning required when exposure exceeds the threshold (no NSRL listed for this row)
This product can expose you to N-Methyl-N-Formylhydrazine, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
Exemptions (1)
No warning is required where the exposure poses no significant risk of cancer (at or below the NSRL).
a warning is not required if the business causing the exposure can demonstrate that the exposure occurs at a level that poses “no significant risk
Appendix A (summary), Exposures that pose no significant risk of cancer (excerpt) · fetched 2026-10-08California OAG / OEHHA: 27 CCR 27001(opens in a new tab) Official text, current to 31 Jul 2026. OEHHA's own Prop 65 list (XLSX), list dated July 31, 2026.
- Applies when
- Seller has 10 or more employees
- Your business has 10 or more employees and the product knowingly and intentionally exposes someone in California to this chemical
Depends on: number of employees at the seller
- Effective
Takes effect 8 Dec 2026
Applies to products sold on or after 8 Dec 2026
Listed 2025-12-08 (cancer). Grace period: "Proposition 65 warning requirements do not apply until 12 months after the chemical has been listed" (Appendix A); listing date plus 12 months.
- Source
- Chemical
- N-Methyl-N-Formylhydrazine
- Type of toxicity
- cancer
- Listed by
- the State's Qualified Experts (SQE)
- CAS No.
- 758-17-8
- Date listed
- 8 Dec 2025
Prop 65 list row: N-Methyl-N-Formylhydrazine · fetched 2026-10-08
California OEHHA: 27 CCR 27001(opens in a new tab)
- WarningUS-CABisphenol S (BPS) (CAS 80-09-1)
Warning required when exposure exceeds the threshold (no MADL listed for this row)
This product can expose you to Bisphenol S (BPS), which is known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.
Exemptions (1)
No warning is required for a reproductive toxicant where the exposure will produce no observable effect at 1,000 times the level in question (at or below the MADL).
“a warning is not required if the business causing the exposure can demonstrate that the exposure will produce no observable effect, even at 1,000 times the level in question.”
Appendix A (summary), Exposures that will produce no observable reproductive effect (excerpt) · fetched 2026-10-08California OAG / OEHHA: 27 CCR 27001(opens in a new tab) Official text, current to 31 Jul 2026. OEHHA's own Prop 65 list (XLSX), list dated July 31, 2026.
- Applies when
- Seller has 10 or more employees
- Your business has 10 or more employees and the product knowingly and intentionally exposes someone in California to this chemical
Depends on: number of employees at the seller
- Effective
Takes effect 8 Dec 2026
Applies to products sold on or after 8 Dec 2026
Listed 2025-12-08 (developmental). Grace period: "Proposition 65 warning requirements do not apply until 12 months after the chemical has been listed" (Appendix A); listing date plus 12 months.
- Source
- Chemical
- Bisphenol S (BPS)
- Type of toxicity
- developmental toxicity
- Listed by
- the State's Qualified Experts (SQE)
- CAS No.
- 80-09-1
- Date listed
- 8 Dec 2025
Prop 65 list row: Bisphenol S (BPS) · fetched 2026-10-08
California OEHHA: 27 CCR 27001(opens in a new tab)
- WarningUS-CATacrolimus (CAS 104987-11-3)
Warning required when exposure exceeds the threshold (no NSRL listed for this row)
This product can expose you to Tacrolimus, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
Exemptions (1)
No warning is required where the exposure poses no significant risk of cancer (at or below the NSRL).
a warning is not required if the business causing the exposure can demonstrate that the exposure occurs at a level that poses “no significant risk
Appendix A (summary), Exposures that pose no significant risk of cancer (excerpt) · fetched 2026-10-08California OAG / OEHHA: 27 CCR 27001(opens in a new tab) Official text, current to 31 Jul 2026. OEHHA's own Prop 65 list (XLSX), list dated July 31, 2026.
- Applies when
- Seller has 10 or more employees
- Your business has 10 or more employees and the product knowingly and intentionally exposes someone in California to this chemical
Depends on: number of employees at the seller
- Effective
Takes effect 17 Jul 2027
Applies to products sold on or after 17 Jul 2027
Listed 2026-07-17 (cancer). Grace period: "Proposition 65 warning requirements do not apply until 12 months after the chemical has been listed" (Appendix A); listing date plus 12 months.
- Source
- Chemical
- Tacrolimus
- Type of toxicity
- cancer
- Listed by
- the Labor Code (LC)
- CAS No.
- 104987-11-3
- Date listed
- 17 Jul 2026
Prop 65 list row: Tacrolimus · fetched 2026-10-08
California OEHHA: 27 CCR 27001(opens in a new tab)
- WarningUS-CAHydrochlorothiazide
Warning required when exposure exceeds the threshold (no NSRL listed for this row)
This product can expose you to Hydrochlorothiazide, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
Exemptions (1)
No warning is required where the exposure poses no significant risk of cancer (at or below the NSRL).
a warning is not required if the business causing the exposure can demonstrate that the exposure occurs at a level that poses “no significant risk
Appendix A (summary), Exposures that pose no significant risk of cancer (excerpt) · fetched 2026-10-08California OAG / OEHHA: 27 CCR 27001(opens in a new tab) Official text, current to 31 Jul 2026. OEHHA's own Prop 65 list (XLSX), list dated July 31, 2026.
- Applies when
- Seller has 10 or more employees
- Your business has 10 or more employees and the product knowingly and intentionally exposes someone in California to this chemical
Depends on: number of employees at the seller
- Effective
Takes effect 17 Jul 2027
Applies to products sold on or after 17 Jul 2027
Listed 2026-07-17 (cancer). Grace period: "Proposition 65 warning requirements do not apply until 12 months after the chemical has been listed" (Appendix A); listing date plus 12 months.
- Source
- Chemical
- Hydrochlorothiazide
- Type of toxicity
- cancer
- Listed by
- the Labor Code (LC)
- CAS No.
- 58-93-5; 125727-50-6; 8049-49-8
- Date listed
- 17 Jul 2026
Prop 65 list row: Hydrochlorothiazide · fetched 2026-10-08
California OEHHA: 27 CCR 27001(opens in a new tab)
- WarningUS-CAVoriconazole
Warning required when exposure exceeds the threshold (no NSRL listed for this row)
This product can expose you to Voriconazole, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
Exemptions (1)
No warning is required where the exposure poses no significant risk of cancer (at or below the NSRL).
a warning is not required if the business causing the exposure can demonstrate that the exposure occurs at a level that poses “no significant risk
Appendix A (summary), Exposures that pose no significant risk of cancer (excerpt) · fetched 2026-10-08California OAG / OEHHA: 27 CCR 27001(opens in a new tab) Official text, current to 31 Jul 2026. OEHHA's own Prop 65 list (XLSX), list dated July 31, 2026.
- Applies when
- Seller has 10 or more employees
- Your business has 10 or more employees and the product knowingly and intentionally exposes someone in California to this chemical
Depends on: number of employees at the seller
- Effective
Takes effect 17 Jul 2027
Applies to products sold on or after 17 Jul 2027
Listed 2026-07-17 (cancer). Grace period: "Proposition 65 warning requirements do not apply until 12 months after the chemical has been listed" (Appendix A); listing date plus 12 months.
- Source
- Chemical
- Voriconazole
- Type of toxicity
- cancer
- Listed by
- the Labor Code (LC)
- CAS No.
- 137234-62-9; 188416-29-7; 173967-54-9
- Date listed
- 17 Jul 2026
Prop 65 list row: Voriconazole · fetched 2026-10-08
California OEHHA: 27 CCR 27001(opens in a new tab)
- WarningUS-CAWelding Fumes
Warning required when exposure exceeds the threshold (no NSRL listed for this row)
This product can expose you to Welding Fumes, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
Exemptions (1)
No warning is required where the exposure poses no significant risk of cancer (at or below the NSRL).
a warning is not required if the business causing the exposure can demonstrate that the exposure occurs at a level that poses “no significant risk
Appendix A (summary), Exposures that pose no significant risk of cancer (excerpt) · fetched 2026-10-08California OAG / OEHHA: 27 CCR 27001(opens in a new tab) Official text, current to 31 Jul 2026. OEHHA's own Prop 65 list (XLSX), list dated July 31, 2026.
- Applies when
- Seller has 10 or more employees
- Your business has 10 or more employees and the product knowingly and intentionally exposes someone in California to this chemical
Depends on: number of employees at the seller
- Effective
Takes effect 17 Jul 2027
Applies to products sold on or after 17 Jul 2027
Listed 2026-07-17 (cancer). Grace period: "Proposition 65 warning requirements do not apply until 12 months after the chemical has been listed" (Appendix A); listing date plus 12 months.
- Source
- Chemical
- Welding Fumes
- Type of toxicity
- cancer
- Listed by
- the Labor Code (LC)
- CAS No.
- none given
- Date listed
- 17 Jul 2026
Prop 65 list row: Welding Fumes · fetched 2026-10-08
California OEHHA: 27 CCR 27001(opens in a new tab)
- LimitEUSum of 3-MCPD and 3-MCPD fatty acid esters, expressed as 3-MCPD
Limit 500 µg/kg (content basis)
Consolidated text (not the authentic legal edition), current to 19 Aug 2026. EUR-Lex consolidated text: a documentation tool without legal effect; the acts published in the Official Journal are authentic. Consolidated version CELEX 02023R0915-20260819 from the Publications Office, the latest when read.
- Applies when
- Food category (contaminant tables): Vegetable oils and fats, fish oils and oils from other marine organisms destined for the production of baby food and processed cereal-based food for infants and young children [EU:5.3.2]
Depends on: contaminant food category
- Effective
Takes effect 1 Jan 2027
Applies to products placed on the market on or after 1 Jan 2027
The row states this level as from 2027-01-01.
- Source
From the consolidated text: 5.3.2 · Vegetable oils and fats, fish oils and oils from other marine organisms destined for the production of baby food and processed cereal-based food for infants and young children · 750 500 as from 1 January 2027 · When the product is a mixture of different oils or fats of the same or of different botanical origins, the maximum level applies for the mixture. The oils and fats used as ingredients for the mixture shall comply with the maximum level established for the oils and fats in point 5.3.1.
Annex I rows, point 5.3.2: Vegetable oils and fats, fish oils and oils from other marine organisms destined for the production of baby food and processed cereal-based food for infants and young children — Sum of 3-monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters, expressed as 3-MCPD · fetched 2026-10-17
European Commission / Publications Office (CELLAR): Regulation (EU) 2023/915 (consolidated 2026-08-19)(opens in a new tab)
- LimitEUSum of 3-MCPD and 3-MCPD fatty acid esters, expressed as 3-MCPD
Limit 50 µg/kg (content basis)
Consolidated text (not the authentic legal edition), current to 19 Aug 2026. EUR-Lex consolidated text: a documentation tool without legal effect; the acts published in the Official Journal are authentic. Consolidated version CELEX 02023R0915-20260819 from the Publications Office, the latest when read.
- Applies when
- Food category (contaminant tables): Baby food; Processed cereal based food for infants and young children [EU:5.3.4]
Depends on: contaminant food category
- Effective
Takes effect 1 Jan 2027
Applies to products placed on the market on or after 1 Jan 2027
The row states this level as from 2027-01-01.
- Source
From the consolidated text: 5.3.4. · Baby food; Processed cereal based food for infants and young children · 50 as from 1 January 2027 · The maximum level applies to the product as placed on the market.
Annex I rows, point 5.3.4: Baby food; Processed cereal based food for infants and young children — Sum of 3-monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters, expressed as 3-MCPD · fetched 2026-10-17
European Commission / Publications Office (CELLAR): Regulation (EU) 2023/915 (consolidated 2026-08-19)(opens in a new tab)
- LimitEUGlycidol (CAS 556-52-5)
Limit 250 µg/kg (content basis)
Consolidated text (not the authentic legal edition), current to 19 Aug 2026. EUR-Lex consolidated text: a documentation tool without legal effect; the acts published in the Official Journal are authentic. Consolidated version CELEX 02023R0915-20260819 from the Publications Office, the latest when read.
- Applies when
- Food category (contaminant tables): Vegetable oils and fats, fish oils and oils from other marine organisms destined for the production of baby food and processed cereal-based food for infants and young children [EU:5.4.2]
Depends on: contaminant food category
- Effective
Takes effect 1 Jan 2027
Applies to products placed on the market on or after 1 Jan 2027
The row states this level as from 2027-01-01.
- Source
From the consolidated text: 5.4.2 · Vegetable oils and fats, fish oils and oils from other marine organisms destined for the production of baby food and processed cereal-based food for infants and young children · 500 250 as from 1 January 2027 · When the product is a mixture of different oils or fats of the same or of different botanical origins, the maximum level applies for the mixture. The oils and fats used as ingredient for the mixture shall comply with the maximum level established for the oils and fats in point 5.4.1.
Annex I rows, point 5.4.2: Vegetable oils and fats, fish oils and oils from other marine organisms destined for the production of baby food and processed cereal-based food for infants and young children — Glycidyl fatty acid esters, expressed as glycidol · fetched 2026-10-17
European Commission / Publications Office (CELLAR): Regulation (EU) 2023/915 (consolidated 2026-08-19)(opens in a new tab)
- LimitEUGlycidol (CAS 556-52-5)
Limit 25 µg/kg (content basis)
Consolidated text (not the authentic legal edition), current to 19 Aug 2026. EUR-Lex consolidated text: a documentation tool without legal effect; the acts published in the Official Journal are authentic. Consolidated version CELEX 02023R0915-20260819 from the Publications Office, the latest when read.
- Applies when
- Food category (contaminant tables): Baby food; Processed cereal based food for infants and young children [EU:5.4.4]
Depends on: contaminant food category
- Effective
Takes effect 1 Jan 2027
Applies to products placed on the market on or after 1 Jan 2027
The row states this level as from 2027-01-01.
- Source
From the consolidated text: 5.4.4 · Baby food; Processed cereal based food for infants and young children · 25 As from 1 January 2027 · The maximum level applies to the product as placed on the market.
Annex I rows, point 5.4.4: Baby food; Processed cereal based food for infants and young children — Glycidyl fatty acid esters, expressed as glycidol · fetched 2026-10-17
European Commission / Publications Office (CELLAR): Regulation (EU) 2023/915 (consolidated 2026-08-19)(opens in a new tab)
Records
Recalls and alerts
Recalls, safety alerts and Prop 65 notices that name Packaged food and beverages, with a link to the original. A Prop 65 notice is a claim by the sender, not a ruling.
2,152 records dated 4 Jan 2023 to 26 Oct 2026. Most recent shown.
Show the 8 most recent records
- Prop 65 notices
Filthy, Blue Cheese Stuffed Olives, UPC#899682002811, Filthy, Piri Piri Pepper Stuffed Olives, UPC#899682002859, Filthy, Pimento Olives, UPC#899682002828
Packaged food and beverages
- Substance
- Lead and lead compounds
- Party
- Filthy Brands, LLC
- Category
- Preserved fruit, vegetables and jams
- Prop 65 notices
Gymkhana, Tikka Medium Masala Simmer Sauce, UPC#860014094828, Gymkhana, Korma Mild Simmer Sauce, UPC#860014094842, Gymkhana, Madras Hot Simmer Sauce, UPC#860014094835
Packaged food and beverages
- Substance
- Lead and lead compounds
- Party
- GK Fine Foods Inc.
- Category
- Sauces and condiments
- Prop 65 notices
Rishi Turmeric Ginger Chai, UPC# 741391976443
Packaged food and beverages
- Substance
- Lead
- Party
- Diaspora Tea & Herb Company, LLC, Good Food Holdings, LLC, Good Food Holdings, LLC dba Lazy Acres Market, E-Mart Inc., E-Mart America, Inc.
- Category
- Coffee, tea and infusions
- Prop 65 notices
Luke's Classic Lobster Ravioli with Vodka Sauce
Packaged food and beverages
- Substance
- Cadmium
- Party
- Lukes Seafood LLC, Mrs. Gooch's Natural Food Markets, Inc.
- Category
- Noodles and pasta
- Prop 65 notices
Sola Blueberry Bagels
Packaged food and beverages
- Substance
- Lead
- Party
- Spring Sola, LLC d/b/a Sola, Amazon.com Services LLC
- Category
- Bakery products
- Prop 65 notices
Blue Elephant – Thai Green Curry Sauce , Blue Elephant – Thai Red Curry Sauce
Packaged food and beverages
- Substance
- Lead
- Party
- Sequoia Southeast, Inc., Walmart Inc., Blue Elephant Bangkok Co Limited
- Category
- Sauces and condiments
- Prop 65 notices
Sprouts Gluten Free Cheese Ravioli
Packaged food and beverages
- Substance
- Lead
- Party
- Sprouts Farmers Market, Inc., Sprouts Inc., Manini’s LLC
- Category
- Noodles and pasta
- Prop 65 notices
Bigger Raspberry Lemonade Juice
Packaged food and beverages
- Substance
- Lead
- Party
- good2grow LLC
- Category
- Fruit and vegetable juices
Sub-categories
Further rules in sub-categories
These apply only to the sub-categories below, not to the whole category.
- Sugar confectionery4 additional rules
- Chocolate and cocoa products2 additional rules
- Nuts and seeds2 additional rules
- Preserved fruit, vegetables and jams1 additional rule
- Rice, grains and flour7 additional rules
- Canned and retorted foods1 additional rule
- Soups and broths1 additional rule
- Frozen and chilled ready meals2 additional rules
- Plant-based drinks and dairy alternatives27 additional rules
- Non-alcoholic beverages29 additional rules
- Alcoholic drinks27 additional rules
- Shelf-stable seafood products1 additional rule
See also
Related categories
- Bakery and confectionery
Sweet and baked goods.
- Snacks, nuts and dried produce
Snack foods and preserved plant produce.
- Staples and prepared meals
Grain, noodle, canned and ready-meal products.
- Dairy and plant-based alternatives
Dairy products and plant-based drinks.
- Non-alcoholic beverages
Ready-to-drink and drink-preparation products (EU 1169/2011 Annex III caffeine wording, sweetener wording and KR high-caffeine labelling attach to this group).
- Alcoholic drinks
Fermented and distilled alcoholic beverages sold prepacked: beer, wine, rice wine, spirits and liqueurs (KR 식품등의 표시기준 Ⅲ. 1. 거 주류; JP 食品表示基準 酒類; EU 1169/2011 Art. 16(4) and Art. 28 beverages over 1.2 % vol; GB and EU labelling of alcoholic strength).
- Seasonings, spreads, oils and sweeteners
Condiments, spices, edible oils and sugar-based spreads.
- Seafood and fermented foods
Shelf-stable seafood and fermented vegetables.
Alerts
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