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U.S. Department of Health and Human Services

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Volume IV - 10.1 Food Standards

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Orientation and Training

Food and Drug Administration


Section 10 - Food Standards & Additives

EFFECTIVE DATE: 09-01-05REVISED: 05-02-14

"Food Standards" is our common designation for Standards of Identity, Standards of Quality, and Standards of Fill of Container promulgated under the FD&C Act. They are to be distinguished from grade standards often referred to as "U.S. Standards," which are promulgated by the U.S. Department of Agriculture.

 10.1.1  Introduction

Food within our jurisdiction, represented as or purporting to be a food for which standards have been set under the Act, must comply with the requirements of the standard, or it is misbranded. For this reason, FDA Food Standards have been called mandatory.

In contrast, "U.S. Standards" are voluntary. It is not required that foods be labeled to show these grades. For instance, a canner who is packing canned corn that only comes up to "U.S. Grade C" requirement has the option to omit any reference to grade on the labels. However, if such canned corn is mislabeled as "U.S. Grade B", its labeling is "false or misleading".

This section is intended to acquaint the analyst with food standards, the law authorizing such standards, their basis, the procedures and techniques used in determining compliance with the standards, and the significance of results. The work in this section need not be taken in order. This introduction, however, should be read and discussed before examining samples in the succeeding exercises.

The work in this section will be almost entirely unfamiliar to a trainee. The methods are rigidly prescribed and are to be followed meticulously. Although these methods have a more or less empirical flavor, facts determined by such methods are called for in legal actions. The methods are published in the Code of Federal Regulations (CFR) or as final in the Federal Register prior to codification in the CFR. The specified method must be used to determine compliance with the standard, and the analytical report references the method as cited in the regulation.

The purpose of food standards is to maintain the integrity of food products so consumers get what they reasonably expect. So that they will be meaningful to the layperson, standards, as far as is practical, are established under the common or usual name of the food product.

Because food standards have legislative effect, they are phrased in such definite terms and with such precision as to stand up in court when challenged. Identity standards specify the required ingredients and the optional ingredients that are permitted in the food. Ingredients not recognized in the standard are not permitted. Some ingredients are specified quantitatively. For example, the identity standard requires oleomargarine to have not less than 80 percent fat as determined by a specified method.

Quality standards specify the quality factors covered by the standard and objective methods for measuring these factors. For example, green beans that are highly fibrous do not have good eating quality. The quality standard for canned green beans sets a limit for fiber and prescribes the method to be followed to determine the fiber content.

Fill of container standards prescribe how much of the defined product must be in the container. This standard has been promulgated only for certain fruits, vegetables, fish, shellfish, and nuts that are canned, packed in glass, or packed in semi rigid containers. Fill standards vary widely, from those without methods (e.g. canned peaches) to those where both method and apparatus are specified in detail (e.g. press weight for tuna). Except for certain canned fruits, fill standards specify the method and apparatus to be used to determine compliance. Some standards (e.g. canned applesauce) prescribe  "sampling and acceptance" procedures, which state the number of units to be examined for a specified size lot and the number of units that exceed the acceptance level before the lot is below standard.

 10.1.2 Exercises

The trainee should carefully read sections of the Act applicable to food standards 401, 403(g) and (h), and 701(e)(1) and examine CFR Parts 130-169 to become familiar with the products that have been standardized. 

Not any time has been planned in the Food Standards program area; therefore the laboratory will have the option of performing the following exercises. Canned Vegetables and Fruits

A.  Introduction

This exercise involves the determination of a canned food’s compliance with a defined standard.

B.  Assignment

The trainer will supply one or more of each of the following categories of canned foods: a canned corn or tomato product, canned peas or beans, and a canned fruit. Compliance with the standard should be determined according to applicable sections of the CFR.

C. References

  1. Code of Federal Regulations. Title 21,  Pts. 145-Canned Fruits, 155-Canned Vegetables, and 156-Vegetable Juices. Washington DC: Office of the Federal Register National Archives and Records Administration.

    Retrieve from  http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfrv2_01.html

  2. U.S. Food & Drug Administration, Center for Food Safety and Applied Nutrition. Bacteriological analytical manual, current edition.
  3. Official Methods of Analysis of AOAC International, AOAC International, (current ed.). Gaithersburg MD

D.  Questions

  1. What are food standards?  How do they differ from grade standards?
  2. What consumer protection was presumed in the promulgation of food standards?
  3. When is the packing liquid included in net weight calculations?
  4. Define edible portion.
  5. What is the basis for determining the solids content by use of the refractive index?
  6. Why isn't the product allowed to "drain" completely in a drained weight determination? Why is two minutes specified in 21 CFR 145.3(n)?
  7. What is the basis for the determination of alcohol in soluble solid in canned vegetables?
  8. What are the requirements for the fill of a container?
  9. Can the net contents be satisfactory and fill of container fail?
  10. Define "degrees Brix."  Cheese

A.  Introduction

This exercise involves preparing a composite, checking compliance with standards, and determining a food additive.

B.  Assignment

The trainer will provide one or more types of cheese.

  1. Determine moisture and fat in duplicate by the method specified in the CFR.
  2. Determine the sorbic acid content according to the method designated by the trainer.

C.  References

  1. Code of Federal Regulation. (2003). Title 21, Pt. 133-Cheeses and Related Cheese Products. Washington DC: Office of the Federal Register National Archives and Records Administration.

    Retrieve from http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr133_01.html

  2. Official Methods of Analysis of AOAC International, AOAC International, (current ed.). Gaithersburg MD.

D. Questions

  1. Why is speed essential in sample preparation?
  2. Differentiate between a cheese spread and cheese food.
  3. Why are preservatives added? Must they be declared on labels?
  4. List two kinds of cheese in which sorbic acid is permitted and include the conditions under which it might be used. List two kinds of cheese for which sorbic acid is not permitted.
  5. What is a processed cheese?
  6. In the CFR procedure, is the moisture content directly determined?
  7. In the cheese fat extraction, what other substances may be found?
  8. Why is petroleum ether used for the extraction?  Jams, Jelly, and Orange Juice

A.  Introduction

These foods are highly susceptible to adulteration for economic gain. An economic cheat involves the substitution of a cheap, easily obtainable ingredient, such as water, for a more expensive one, such as fruit. Tests have been devised to check certain indices or ratios of indices related to product composition to determine their compliance with standards.

B.  Assignment

The trainer will provide one or more of this type of product. 

  1. Make the following determinations:
    1. Net contents
    2. Soluble solids by refractometry
    3. Ash
    4. Potassium oxide (K2O) by atomic absorption spectrometry
  2. Compare results with established standards.

C.  References

  1. Code of Federal Regulations. Title 21, Pts. 146-Canned Fruit Juices and 150-Fruit Butters, Jellies, Preserves, and Related Products. Washington DC: Office of the Federal Register National Archives and Records Administration.

    Retrieve from http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfrv2_01.html  (CFR,  Chap. 1, Parts 100-169, Table of Contents)

D.  Questions

  1. What is jam?
  2. What is an imitation jelly?
  3. What orange products are standardized?
  4. Why are K2O and ash used as criteria to determine fruit content?
  5. Are the literature values of K2O and ash definitive for fruit?  Mixed Nuts

A.  Introduction

Packaged mixed nuts present several unique opportunities for economic cheating: labeling the product with a misleading vignette; representing the product as containing a high percentage of expensive nuts, although it actually contains a majority of relatively cheap peanuts; or presenting the product in a large container, labeling the net weight correctly, but substituting packaging material for a large excess volume. The analyst is to be aware of the law in examining any product for standards.

B.  Assignment

The trainer will provide a sample of mixed nuts. Examine a minimum of six units for net weight and compliance with food standards. (Check the CFR for the number of units required to be analyzed to determine compliance with the standard.)

C.  References

  1. Code of Federal Regulation. (2003). Title 21, Pt. 164-Tree Nut and Peanut Products. Washington DC: Office of the Federal Register National Archives and Records Administration.

    Retrieve from http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr164_01.html

D.  Questions

  1. Be prepared to discuss the sections of the Act that apply to the examples of cheating given in the Introduction.
  2. Differentiate between misbranding and adulteration in regard to question 1.
  3. Why do the standards specify both amount and type of nuts?
  4. How does the shape of the container affect the net weight determination?
  5. What is the maximum amount of peanuts allowed in mixed nuts?
  6. What, if any, is the relationship between the vignette and the contents? Egg Noodles

A.  Introduction

Eggs are the most expensive ingredient in egg noodles. If the egg content does not meet the standard, the product cannot be shipped legally in interstate commerce.

B.  Assignment

  1. Prepare a well-mixed composite.
  2. Determine total solids and moisture in duplicate.
  3. Determine the cholesterol content by the AOAC digitonin and fluorometric methods. Compare the results. 

C.  References

  1. Code of Federal Regulations. Title 21,  Pt. 139-Milk and Cream. Washington DC: Office of Federal Register National Archives and Records Administration.

    Retrieve from http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr139_01.html

  2. Official Methods of Analysis of AOAC International, AOAC International, (current ed.). Gaithersburg MD.

D.  Questions

  1. Are eggs the only possible source of cholesterol in this product?
  2. Does the label have an ingredient statement? Why?
  3. Do all noodle products contain eggs?
  4. Compare the two drying methods. Which one is to be used to determine compliance with the standard for total solids?
  5. What is accomplished in each step of AOAC 954.03?
  6. Why is there a precaution in AOAC  954.03 to retain solid material in the separator?
  7. How would an analyst cope with an emulsion if it formed?
  8. What is the difference between macaroni and noodles?