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- What is the ingredient list?
- What is meant by the requirement to list ingredients in descending order of predominance by weight?
- Where is the ingredient list placed on the label?
- What type size is required for ingredient lists?
- Should water be listed as an ingredient?
- Should the common or usual name always be used for ingredients?
- Is it necessary to declare ingredients in “trace”, i.e., incidental amounts? Can sulfites be considered incidental additives?
- What foods may list alternative fat and oil ingredients?
- What ingredient listing is necessary for chemical preservatives?
- How are spices, natural flavors or artificial flavors declared in ingredient lists?
- If fruit is canned in juice from concentrate, does the water used to reconstitute the juice have to be declared?
- Can juice concentrates be grouped in the ingredient statement (e.g., Fruit Juice Concentrates (grape, apple, cherry)?
- When do you declare water as an ingredient in tomato concentrate?
- Can tomato paste, tomato puree, and tomato concentrate be used interchangeably in the ingredient statement?
- Do ingredients of standardized foods have to be listed when the standardized food is an ingredient in a non-standardized food?
- Do you have to parenthetically declare all of the ingredients in flavors that conform to a standard of identity?
- How do you declare protein hydrolysates that are made of blends of proteins?
- Food Allergen Labeling
Answer: The ingredient list on a food label is the listing of each ingredient in descending order of predominance.
“Ingredients: Pinto Beans, Water, and Salt” 21 CFR 101.4(a)
Answer: Listing ingredients in descending order of predominance by weight means that the ingredient that weighs the most is listed first, and the ingredient that weighs the least is listed last (see illustration for question 3 below).
21 CFR 101.4(a)
Answer: The ingredient list is placed on the same label panel as the name and address of the manufacturer, packer or distributor. This may be either the information panel or the PDP. It may be before or after the nutrition label and the name and address of the manufacturer, packer or distributor. 21 CFR 101.4
See also section 3, question 7 of this guidance for information on intervening material on the information panel.
Answer: Use a type size that is at least 1/16 inch in height (based on the lower case “o”) and that is prominent, conspicuous, and easy to read. See the type size, prominence, and clarity requirements for information panel labeling discussed in section 3, question 6 of this guidance. 21 CFR 101.2(c)
Answer: Water added in making a food is considered to be an ingredient. The added water must be identified in the list of ingredients and listed in its descending order of predominance by weight. If all water added during processing is subsequently removed by baking or some other means during processing, water need not be declared as an ingredient.
“INGREDIENTS: Water, Navy Beans, and Salt”
21 CFR 101.4(a); 21 CFR 101.4(c); Compliance Policy Guide 555.875
Answer: Always list the common or usual name for ingredients unless there is a regulation that provides for a different term. For instance, use the term “sugar” instead of the scientific name “sucrose.”
“INGREDIENTS: Apples, Sugar, Water, and Spices”
See also section 4 question 3. 21 CFR 101.4(a)
Answer: FDA does not define “trace amounts”; however, there are some exemptions for declaring ingredients present in “incidental” amounts in a finished food. If an ingredient is present at an incidental level and has no functional or technical effect in the finished product, then it need not be declared on the label. An incidental additive is usually present because it is an ingredient of another ingredient. Note that major food allergens (as discussed under Food Allergen Labeling), regardless of whether they are present in the food in trace amounts, must be declared.
Sulfites added to any food or to any ingredient in any food and that has no technical effect in that food are considered to be incidental only if present at less than 10 ppm. 21 CFR 101.100(a)(3) & (4)
Answer: Listing alternative fat and oil ingredients (“and/or” labeling) in parentheses following the declaration of fat and oil blends is permitted only in the case of foods in which added fats or oils are not the predominant ingredient and only if the manufacturer is unable to predict which fat or oil ingredient will be used.
“INGREDIENTS: . . . Vegetable Oil (contains one or more of the following: Corn Oil, Soybean Oil, or Safflower Oil) . . . .”
21 CFR 101.4(b)(14)
Answer: When an approved chemical preservative is added to a food, the ingredient list must include both the common or usual name of the preservative and the function of the preservative by including terms, such as “preservative,” “to
retard spoilage,” “a mold inhibitor,” “to help protect flavor,” or “to promote color retention.”
“INGREDIENTS: Dried Bananas, Sugar, Salt, and Ascorbic Acid to Promote Color Retention”
21 CFR 101.22(j)
Answer: These may be declared in ingredient lists by using either specific common or usual names or by using the declarations “spices,” “flavor” or “natural flavor,” or “artificial flavor.”
“INGREDIENTS: Apple Slices, Water, Cane Syrup, Corn Syrup, Modified Corn Starch, Spices, Salt, Natural Flavor and Artificial Flavor”
However, products that are spices or spice blends, flavors or colors must list each ingredient by name. FD&C Act 403(i)(2) and 21 CFR 101.22(h)(1)
Answer: Yes. The reconstituted juice in which the fruit is canned is prepared from juice concentrate and water, thus both ingredients have to be declared.
21 CFR 101.4(a)
Answer: No. “Fruit juice concentrates” is not established as a common or usual name, nor is it established as an appropriate collective name for a variety of different concentrated fruit juices.
Answer: Water that is added to adjust the Brix level of the standardized food within the permitted range of soluble solids (e.g., water used to adjust a Brix of 28° to 24° in tomato paste, or to adjust a Brix of 16° to 10° in tomato puree) does not have to be declared. However, water added to tomato paste (Brix of 24° ) to make a product with a Brix of 16° (tomato puree) would have to be declared.
21 CFR 155.191(a)(3)(iv)
Answer: Tomato paste and tomato puree are different foods based on the amount of soluble solids present in the product, and thus, the names can not be used interchangeably in the ingredient statement. However, the term “tomato concentrate” may be used in lieu of tomato paste, tomato pulp, or tomato puree when the concentrate complies with the requirements of such foods and the statement “for remanufacturing purposes only” appears on the label of packages equal to or less than 3.1 kilograms or 109 oz. Further, tomato concentrate may be used in lieu of tomato paste, tomato pulp, or tomato puree in the ingredient labeling of catsup. 21 CFR 155.191(a)(3)(i), 21 CFR 155.194(a)(3)(ii)(b)
Answer: The sub ingredients of a food that is an ingredient in another food may be declared parenthetically following the name of the ingredient or may be declared by dispersing each ingredient in its order of predominance in the ingredient statement without naming the original ingredient. 21 CFR 101.4(b)(2)
Answer: If the flavor is declared by the standardized name (eg. vanilla extract), each ingredient must also be declared parenthetically following the standardized name. However, the standardized flavor may simply be declared as flavoring, natural flavoring, artificial flavoring, as appropriate. 21 CFR 101.22(i) and 21 CFR 169
Answer: For proteins that are blended prior to being hydrolyzed an appropriate name for the hydrolyzed protein product must be sufficiently descriptive of the protein product and must include all of the various proteins that were used to make the hydrolyzed protein. For example a hydrolyzed protein made from a blend of corn and soy protein would be “hydrolyzed corn and soy protein.” However, if the proteins are hydrolyzed prior to blending, then the common or usual name must be specific to each individual hydrolyzed protein (e.g., “hydrolyzed corn protein” and “hydrolyzed soy protein”), and the ingredients must be declared in their order of predominance. In addition, any other ingredients that are blended with the hydrolyzed protein products must also be declared by their common or usual names in the ingredient statement in order of predominance.
21 CFR 101.22(h)(7)
C1. What ingredient listing is used for vegetable powder?
Answer: Vegetable powders must be declared by common or usual name, such as "celery powder." 21 CFR 101.22(h)(3)
C2. What listing is used for a spice that is also a coloring?
Answer: Spices, such as paprika, turmeric, saffron and others that are also colorings must be declared either by the term "spice and coloring" or by the actual (common or usual) names, such as "paprika." 21 CFR 101.22(a)(2)
C3. What ingredient listing is used for artificial colors?
Answer: It depends on whether the artificial color is a certified color:
Certified colors: List by specific or abbreviated name such as "FD&C Red No. 40" or "Red 40."
Non-certified colors: List as "artificial color," "artificial coloring," or by their specific common or usual names such as "caramel coloring" and "colored with beet juice."
21 CFR 101.22(k)(1) and (2), 21 CFR 74
C4. Do certified color additive lakes have to be declared separately from the certified color in the ingredient statement?
Answer: Yes. Certified color additives and their lakes are separate ingredients and, thus, must be declared separately in the ingredient statement. 21 CFR 101.22 (k)(1)
F1. What is the Food Allergen Labeling and Consumer Protection Act of 2004?
Answer: The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (or Title II of Public Law 108-282) is a law that was enacted in August 2004. Among other issues, FALCPA addresses the labeling of all packaged foods regulated by the FDA. We recommend that producers of meat products, poultry products, and egg products, which are regulated by the U.S. Department of Agriculture (USDA), contact appropriate USDA agency staff regarding the labeling of such products. Also see Food Allergens for more information about the agency's food allergen activities and related guidance documents that address additional FALCPA questions and answers.
F2. What is a "major food allergen?"
Answer: Under FALCPA, a "major food allergen" is an ingredient that is one of the following eight foods or food groups or an ingredient that contains protein derived from one of them:
- Crustacean shellfish
- tree nuts
Although more than 160 foods have been identified to cause food allergies in sensitive individuals, the "major food allergens" account for 90 percent of all food allergies. Allergens other than the major food allergens are not subject to FALCPA labeling requirements.
F3. When did the labeling requirements of the FALCPA become effective for packaged foods sold in the United States?
Answer: All packaged foods regulated by FDA under the FD&C Act that are labeled on or after January 1, 2006, must comply with FALCPA's food allergen labeling requirements.
F4. Are flavors, colors, and incidental additives subject to FALCPA labeling requirements?
Answer: Yes. FALCPA labeling requirements apply to foods that are made with any ingredient, including flavorings, colorings, or incidental additives (e.g., processing aids), that is or contains a major food allergen.
F5. Do retail and foodservice establishments have to comply with FALCPA's labeling requirements?
Answer: FALCPA's labeling requirements extend to foods packaged by a retail or foodservice establishment that are offered for human consumption. However, FALCPA's labeling requirements do not apply to foods provided by a retail food establishment that are placed in a wrapper or container in response to a consumer's order - such as the paper or box used to convey a sandwich that has been prepared in response to a consumer's order.
F6. Are there any foods exempt from FALCPA labeling requirements?
Answer: Yes. Under FALCPA, raw agricultural commodities (generally fresh fruits and vegetables) are exempt as are highly refined oils derived from one of the eight major food allergens and any ingredient derived from such highly refined oil. In addition, FALCPA provides mechanisms by which a manufacturer may request that a food ingredient may be exempt from FALCPA's labeling requirements.
See FALCPA Section 203 for details on how to request allergen labeling exemptions: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm106187.htm.
F7. Are molluscan shellfish considered a major food allergen under FALCPA?
Answer: No. Under FALCPA, molluscan shellfish (e.g., such as oysters, clams, mussels, or scallops) are not major food allergens. However, Crustacean shellfish (e.g., crab, lobster, or shrimp), and ingredients that contain protein derived from Crustacean shellfish, are major food allergens.
F8. Does FALCPA provide any specific direction for declaring the presence of ingredients from the three food groups that are designated as "major food allergens (i.e., tree nuts, fish, and Crustacean shellfish)"?
Answer: Yes. FALCPA requires that in the case of tree nuts, the specific type of nut must be declared (e.g., almonds, pecans, or walnuts). The species must be declared for fish (e.g., bass, flounder, or cod) and Crustacean shellfish (crab, lobster, or shrimp).
F9. Under section 403(w)(1) of the FD&C Act, a major food allergen must be declared using the name of the food source from which the major food allergen is derived. Section 403(w)(2) of the FD&C Act provides that, in the case of fish or Crustacean shellfish, the term "name of the food source from which the major food allergen is derived" means the "species" of fish or Crustacean shellfish. What is the "species" of fish or Crustacean shellfish for purposes of section 403(w)(2)?
Answer: A declaration of the "species" of fish or Crustacean shellfish for purposes of complying with section 403(w)(2) should be made using the acceptable market name provided in FDA's The Seafood List. The Seafood List is a compilation of existing acceptable market names for imported and domestically available seafood. We note, however, that if a "Contains" statement is used to declare the source of the fish or Crustacean shellfish, we would not object to just the type of fish or Crustacean shellfish being used, e.g., "Contains salmon" or "Contains trout."
F10. Section 201(qq) of the FD&C Act defines the term "major food allergen" to include "tree nuts." In addition to the three examples provided in section 201(qq) (almonds, pecans, and walnuts), what nuts are considered "tree nuts?"
Answer: The following are considered "tree nuts" for purposes of section 201(qq). The name listed as "common or usual name" should be used to declare the specific type of nut as required by section 403(w)(2).
|Common or usual name||Scientific name|
|Beech nut||Fagus spp.
|Brazil nut||Bertholletia excelsa
|Chestnut (Chinese, American, European, Seguin)||Castanea spp.
|Coconut||Cocos nucifera L.
(Arecaceae (alt. Palmae)
|Ginko nut||Ginkgo biloba L.
|Hickory nut||Carya spp.
|Lichee nut||Litchi chinensis Sonn.
|Macadamia nut/Bush nut||Macadamia spp.
|Pine nut/Pinon nut||Pinus spp.
|Pistachio||Pistacia vera L.
|Sheanut||Vitellaria paradoxa C.F. Gaertn.
|Walnut (English, Persian, Black, Japanese, California), Heartnut||Juglans spp.
The foregoing list reflects FDA's current best judgment as to those nuts that are "tree nuts" within the meaning of Section 201(qq). In order to be comprehensive, this list employs broad scientific categories that may include a species that currently has no food use. The fact that a species falls within a scientific category on this list does not mean that the species is appropriate for food use. FDA further advises that, as with any guidance, the list may be revised consistent with the process for revising guidance documents in our regulation on good guidance practices in 21 CFR 10.115.
Answer: The term "wheat" in Section 201(qq) means any species in the genus Triticum. Thus, for the purposes of Section 201(qq), wheat would include grains such as common wheat (Triticum aestivum L.), durum wheat (Triticum durum Desf.), club wheat (Triticum compactum Host.), spelt (Triticum spelta L.), semolina (Triticum durum Desf.), Einkorn (Triticum monococcum L. subsp. Monococcum), emmer (Triticum turgidumL. subsp. dicoccon (Schrank) Thell.), kamut (Triticum polonicum L.), and triticale (x Triticosecale ssp. Wittm.).
F12. May singular terms be substituted for the plural terms "peanuts," "soybeans" and the different types of "tree nuts" (e.g., almonds, pecans, or walnuts), and may synonyms for the term "soybean" be used to satisfy the labeling requirements of FALCPA?
Answer: Yes. FDA believes that the singular terms "peanut," and "soybean," as well as the singular terms (e.g., almond, pecan, or walnut) for the different types of tree nuts are acceptable substitutes for the plural terms for these major food allergens for the purpose of satisfying the FALCPA labeling requirements. Also, the terms "soybean," "soy," and "soya" are reasonable synonyms for the common or usual name "soybeans," and any one of these terms may be used to identify the food source of the major food allergen "soybeans." However, packaged foods that are made using "soybeans" as an ingredient or as a component of a multi-component ingredient (e.g., soy sauce or tofu) should continue to use the word "soybeans" as the appropriate common or usual name for this ingredient to identify properly the ingredient (e.g., "soy sauce (water, wheat, soybeans, salt)").
F13. How must major food allergens be declared on food labels to comply with FALCPA?
Answer: FALCPA requires food manufacturers to label food products that are made with an ingredient that is a major food allergen in one of the following two ways:
F14. Are single ingredient foods that are major food allergens required to comply with FALCPA?
Answer: Yes. Single ingredient foods must comply with the allergen declaration requirements in Section 403(w)(1). A single ingredient food that is, or contains protein derived from milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, or soybeans, may identify the food source in the name of the food (e.g., “all-purpose wheat flour”) or use the “Contains” statement format. FDA recommends that if a “Contains” statement format is used, the statement be placed immediately above the manufacturer, packer, or distributor statement. For single ingredient foods intended for further manufacturing where the “Contains” statement format is used, the statement should be placed on the PDP of the food.
F15. May a "Contains" statement on a food label provided in accordance with FALCPA list only the names of the food sources of the major food allergens that are not already identified in the ingredient list for a packaged food?
Answer: No. If a “Contains” statement is used on a food label, the statement must include the names of the food sources of all major food allergens used as ingredients in the packaged food. For example, if “sodium caseinate,” “whey,” “egg yolks,” and “natural peanut flavor” are declared in a product's ingredients list, any “Contains” statement appearing on the label immediately after or adjacent to that statement is required to identify all three sources of the major food allergens present (e.g., “Contains milk, egg, peanuts”) in the same type (i.e., print or font) size as that used for the ingredient list.
F16. Is there more than one way to word a "Contains" statement used to declare the major food allergens in a packaged food?
Answer: Yes. The wording for a "Contains" statement may be limited to just stating the word "Contains" followed by the names of the food sources of all major food allergens that either are or are contained in ingredients used to make the packaged product. Alternatively, additional wording may be used for a "Contains" statement to more accurately describe the presence of any major food allergens, provided that the following three conditions are met:
The word "Contains" with a capital "C" must be the first word used to begin a "Contains" statement. (The use of bolded text and punctuation within a "Contains" statement is optional.)
The names of the food sources of the major food allergens declared on the food label must be the same as those specified in the FALCPA, except that the names of food sources may be expressed using singular terms versus plural terms (e.g., walnut versus walnuts) and the synonyms "soy" and "soya" may be substituted for the food source name "soybeans."
If included on a food label, the "Contains" statement must identify the names of the food sources for all major food allergens that either are in the food or are contained in ingredients of the food.
For questions regarding this document, contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-2371.