TECHNICAL ADVISOR'S REPORT TO THE FOOD, DRUG, AND COSMETIC PACKAGING MATERIALS COMMITTEE

December 4, 1998

Lester Borodinsky, Ph.D.

FDA's Food Classification Systems

Introduction
FDA's Food Classification Systems
Food Types Enumerated in 21 C.F.R. § 176.170
Food Types Identified in Testing "Recommendations"
Food Categories Defined in 21 C.F.R. § 170.3
Food Type Interpretations
Conclusion
Table I. 21 C.F.R. § 176.170(c)Types of Raw and Proceed Foods
Table II. 21 C.F.R. § 176.170(c)
Table III. Examples of Foods Corresponding to Food Types I-IX
Table IV. Food Categories Defined in 21 C.F.R. § 170.3

Introduction

Ladies and Gentlemen:

It is a great pleasure for me to be with you once again in the role of the Committee's Technical Advisor. This report will describe one of the technical issues that you encounter in establishing satisfactory regulatory positions for plastic packaging materials. Specifically, there is often a need to establish compliance of components of food-contact articles on the basis of the type of food with which the articles will be in contact. The difference between one type of food and another may be critical, because different types of food usually have different testing requirements. While the Food and Drug Administration (FDA) has set forth definitions of food types and stipulated their specific testing requirements, the definitions of the types of food are very general and often lead to more questions than answers. Since the ways in which FDA has related actual food items to generalizations for types of food varies from situation to situation, case-by-case considerations usually are needed when interpreting regulatory clearances with regard to food types. The purpose of this report is to highlight some of the more confusing aspects of FDA's food types and to provide some concepts to consider when categorizing actual food items.

All foods are not created equally, a desirable attribute since, otherwise, all food would taste the same. Not only do foods differ from each other in terms of their content of flavors, aromas, and textures, but also they differ in their composition - water, proteins, carbohydrates, fats, salts. These compositional differences allow the food to exhibit distinct tastes; they also enable the food to exert differing extractive capabilities with regard to components of food-contact materials. As you know, because of these differences in extractive capabilities, the Food and Drug Administration (FDA) has developed its compliance stratagem for many food-contact substances to account for the difference in potential extractability due to the difference in the properties of food. However, the Agency has recognized that it would be impractical to impose limits on specific foods (although FDA has, on occasion, employed such limitations) and, instead, relies on general groupings of food that possess common characteristics; in addition, FDA relies on the use of food simulating solvents, as extraction testing using food is impractical in most instances. This report will examine the food classification systems employed by FDA.

FDA'S FOOD CLASSIFICATION SYSTEMS

FDA has developed several different classification schemes for foods or food types. Although these varying classifications are used by FDA for diverse reasons, they are all useful for consideration here since they each shed light on how FDA has used and continues to use different systems under different circumstances. It is critical to recognize that the appropriate food classification system to use may vary from situation to situation; the specific requirements for each situation will be dictated by the language of the regulatory clearance. Some examples of regulatory language will be considered later on; first, a review of the FDA food-classification systems.

Food Types Enumerated in 21 C.F.R. § 176.170

Section 176.170 lists the components that FDA has cleared for use in the manufacture of paper and paperboard in contact with aqueous and fatty foods. Although this regulation is not directly relevant for most substances used as components of other types of food packaging, many of FDA's regulations for indirect food additives refer to Table 1 in Section 176.170(c), which enumerates nine Food Types (see Table I).¹ The reason that the agency continues to cross-reference this tabulation of Food Types is that FDA finds it more convenient to refer to an established reference consistently rather than to create a set of food type limitations each time a new food additive listing is promulgated. In addition, while not specifically designed to set forth Food Type classifications, attached below as Table II is FDA's companion Table 2 in 176.170(c), a table that sets forth compliance testing conditions for the often-referenced Conditions of Use A through H. As discussed in more detail below, solvents for the compliance or end tests specified in Table 2 vary according to the food types, as classified in Table 1.

As can be seen from the Food Type classification in Section 176.170(c), Table 1, some of the Food Types are based on gross physical characteristics (e.g., dry solid food or aqueous food), whereas others are based on "grocery" classifications (e.g., beverages or bakery products). This difference within the classification scheme sometimes leads to confusion as tothe assignment of a food item to a Food Type.² It would seem that some specific items of food could fit into more than one Food Type category. For example, milk is a food that (a) is "nonacid/aqueous may contain salt/sugar or both" (Food Type I), (b) is amongst a group that are "dairy products and modifications: oil-in-water emulsions, high or low fat" (Food Type IV-B), and (c) is a "beverage, nonalcoholic" (Food Type VI-B). While it seems that milk can be associated with more than one Food Type designation, it is generally classified as a Food Type IV-B food, because this category is the most specific one amongst the apparent alternatives for this particular food item. Nonetheless, this example is an indication that the classification system can lead to different interpretations.

Because actual foods are not easily matched to the nine Food Types (and their subtypes), questions have always occurred regarding this classification since its inception in the early 1960s. For this reason, FDA has, from time to time on request, issued lists of examples of food items that fit in each of the Food Types. Some of these examples are summarized in Table III.³

While Table 1 in Section 176.170(c) is designed to set forth the definitions of Food Types I through IX, its companion Table 2 is designed to set forth the testing conditions for determining compliance for Conditions of Use A through H. In setting out the framework in Table 2, FDA also employs the Food Types from Table 1 to differentiate among the types of food that should be tested with specific compliance food simulants (i.e., water, heptane, 8% ethanol, and 50% ethanol). As an example, let us consider the prescribed testing for Condition of Use A (High temperature heat-sterilized, e.g., over 212 F); Table 2 indicates that, for establishing compliance for use under Condition of Use A, packaging materials for Food Types I, IV-B, and VII-B should be tested using water (250 F for 2 hours) and Food Types III, IV-A, and VII-A should be tested using both water (250 F for 2 hours) and heptane (150 F for 2 hours). A question may be asked - what about the other Food Types that are not specified for Condition of Use A (i.e., Food Types II, V, VI (A, B, and C), VIII, and IX)? Does this mean that these latter Food Types may not be used under Condition of Use A? The answer is that Table 2 does not prescribe which types of food may be used under the specified Conditions of Use; rather, its intention is to spell out the testing conditions for different applications. In this example, it is apparent that, in establishing the test conditions for the specified Food Types, Table 2 also is setting out a paradigm to follow for the non-specified Food Types, i.e., the non-specified Food Types that have an aqueous component should use water (Food Types II an VI) whereas those with fatty components should use heptane (Food Types V and IX).⁴ Since it is evident that much more than is intended can be "read into" Table 2, it is important to remember the purpose of this tabulation.

Food Types Identified in Testing "Recommendations"

FDA has issued a guidance document entitled "Recommendations for Chemistry Data for Indirect Food Additive Petitions," (June 1995), for use in collecting the necessary data for clearing a new indirect food additive. One important data area is that of the possible migration of the component of the food-contact article to food. The "Recommendations" includes a discussion of the factors that need to be considered in performing migration studies, including the recommended migration test solvents. To correlate actual types of food with these solvents used to simulate the action of food in contact with food-contact materials, FDA has identified four types of food: aqueous, acidic, alcoholic, and fatty.⁵ Although the agency has not elaborated in detail on how to distinguish amongst these four types of food,⁶ FDA has correlated the four testing-related types of food with the nine Food Types listed in Section 176.170, as follows:

It is important to recognize that FDA has set forth the above "simple" view of these four types of food mainly so as to associate the results of migration testing using food simulants with types of food. Specifically, migration testing is generally performed using 10% ethanol (as a simulant for aqueous, acidic,⁷ and low-alcohol content food ⁸ (15% alcohol or less)) and a fatty food simulant (edible oil, "synthetic" oil, or specified aqueous ethanol solutions). FDA uses the results of such testing and apportions the migration test results according to the distribution of the four general types of food. Where it is necessary, because of the conditions under which the testing may have been performed, FDA will limit a clearance by reference to one or more of the nine Food Types, using the above correlation of the four types of food and the nine Food Types. It is important to realize that this is a "simple" assignment, since some of the so-called fatty foods also contain a significant amount of moisture. For example, the definition of Food Type III, generally considered to be a fatty food, is "aqueous, acid, or nonacid products containing free oil or fat; may contain salt, and including water-in-oil emulsions of low- or high-fat content," which indicates that water is present. A scan of the examples for Food Type III, tabulated below in Table III - fresh meat fish, and poultry - confirms the notion that there is a significant amount of moisture in some fatty foods. The main reason that Food Type III is deemed a fatty food (and not also an aqueous food) is that fatty food simulants give higher migration than aqueous food simulants. It is for such instances that FDA has classified Food Type III as a fatty food, since such a designation would be the worst case situation. However, there are instances in which an aqueous food simulant gives greater migration than a fatty food simulant. In these situations, FDA often categorizes Food Type III as an aqueous food, since that would be the worst case.⁹

Food Categories Defined in 21 C.F.R. § 170.3

FDA has defined general food categories in Section 170.3(n) for establishing tolerances or limitations for the use of direct human food ingredients. Although these categories are not of specific significance for indirect food additives or other components of food-contact materials, this listing (Table IV below) is included here to set forth an additional food type classification system employed by FDA.

FOOD TYPE INTERPRETATIONS

There are some regulatory clearances that include limitations that specify actual food items. For example, food-contact articles containing one of the antistatic agents cleared under Section 178.3130 ("Antistatic and/or antifogging agents in food-packaging material"), identified as "N,N-Bis(2-hydroxyethyl)dodecanamide produced when diethanolamine is made to react with methyl laurate," are permitted in contact with only "honey, chocolate syrup, liquid sweeteners, condiments, flavor extracts and liquid flavor concentrates, grated cheese, light and heavy cream, yogurt, and foods of Type VIII." This is a most unusual clearance in that it is quite explicit as to the permissible food items. It is rare that a clearance is so specific.

In the case of many of the regulatory clearances, it is, nonetheless, reasonably clear as to the relationship between the permissible uses and actual food items. For example, some of the additives cleared in 21 C.F.R. § Part 178 may be used only in food-contact articles that contact specified food types and most of these limitations refer to the Food Types set forth in Section 176.170(c), Table 1. In this way, most of the antioxidants and stabilizers cleared under Section 178.2010 ("Antioxidants and/or stabilizers for polymers") that have food type limitations refer to Table 1. In these cases, the food examples that FDA has provided over the years (summarized below in Table III) are useful in determining what specific foods are covered by the food-type limitations. However, not all clearances are this straightforward in specifying the food-type limitation according to the classifications set forth in Table 1.

For example, the limitation on the use of 4,4'-bis( , -dimethylbenzyl)diphenylamine under Section 178.2010 is that the food-contact articles are limited to contact with "non-fatty foods only." Neither Section 176.170(c), Table 1, nor any other regulation in Parts 174 through 178 specifies which foods are "non-fatty." Therefore, one must turn to other sources for guidance; for example, FDA's "Recommendations" guideline notes that fatty foods are Food Types III, IV-A, V, VII-A, and IX, which implies that the non-fatty foods would be categorized as Food Types I, II, IV-B, VI-A, VI-B, VI-C, and VIII.

Other regulations are even less clear. For example, the prior sanction listing under Section 181.27 ("Plasticizers") for di(2-ethylhexylphthalate) is limited so that the finished article employing the substances may be used in contact with "foods of high water content only." How much water is necessary for a food item to qualify as "high water content?" Is 10% enough, does it need to be greater than 50%, does it need to be no lower than 90%? The answers to these questions are not clear, as there are no guidelines upon which to rely. It seems to me that one must evaluate each item of food packaged using this material on a case-by-case basis.

CONCLUSION

The foregoing illustrates the different ways in which FDA has related actual food items to generalizations for types of food. These differences highlight the need for careful consideration of the uses of finished packaging materials for use in contact with specific items of food.

Table I. 21 C.F.R. § 176.170(c)
Table 1 - Types of Raw and Proceed Foods

1. Nonacid, aqueous products; may contain salt or sugar or both (pH above 5.0).
2. Acid, aqueous products; may contain salt or sugar or both, and including oil-in-water emulsions of low- or high-fat content.
3. Aqueous, acid or nonacid products containing free oil or fat; may contain salt, and including water-in-oil emulsions of low- or high-fat content.
4. Dairy products and modifications:
   A. Water-in-oil emulsions, high- or low-fat.
   B. Oil-in-water emulsions, high- or low-fat.
5. Low-moisture fats and oils.
6. Beverages:
   A. Containing up to 8 percent of alcohol.
   B. Nonalcoholic.
   C. Containing more than 8 percent alcohol.
   
7. Bakery products other than those included under Types VIII or IX of this table:
   A. Moist bakery products with surface containing free fat or oil.
   B. Moist bakery products with surface containing no free fat or oil.
   
8. Dry solids with the surface containing no free fat or oil (no end test required).
9. Dry solids with the surface containing free fat or oil.

Table IV. Food Categories Defined in 21 C.F.R. § 170.3

(1) Baked goods and baking mixes, including all ready-to-eat and ready-to-bake products, flours, and mixes requiring preparation before serving.

(2) Beverages, alcoholic, including malt beverages, wines, distilled liquors, and cocktail mix.

(3) Beverages and beverage bases, nonalcoholic, including only special or spiced teas, soft drinks, coffee substitutes, and fruit and vegetable flavored gelatin drinks.

(4) Breakfast cereals, including ready-to-eat and instant and regular hot cereals.

(5) Cheeses, including curd and whey cheeses, cream, natural, grating, processed, spread, dip, and miscellaneous cheeses.

(6) Chewing gum, including all forms.

(7) Coffee and tea, including regular, decaffeinated, and instant types.

(8) Condiments and relishes, including plain seasoning sauces and spreads, olives, pickles, and relishes, but not spices or herbs.

(9) Confections and frostings, including candy and flavored frostings, marshmallows, baking chocolates, and brown, lump, rock, maple, powdered, and raw sugars.

(10) Dairy product analogs, including nondairy milk, frozen or liquid creamers, coffee whiteners, toppings and other nondairy products.

(11) Egg products, including liquid, frozen, or dried eggs, and egg dishes made therefrom, i.e., egg roll, egg foo young, egg salad, and frozen multicourse egg meals, but not fresh eggs.

(12) Fats and oils, including margarine, dressings for salads, butter salad oils, shortenings and cooking oils.

(13) Fish products, including all prepared main dishes, salads, appetizers, frozen multicourse meals, and spreads containing fish, shellfish, and other aquatic animals, but not fresh fish.

(14) Fresh eggs, including cooked eggs and egg dishes made only from fresh shell eggs.

(15) Fresh fish, including only fresh and frozen fish, shellfish, and other aquatic animal.

(16) Fresh fruits and fruit juices, including only raw fruits, citrus, melons, and berries, and home-prepared "ades" and punches made therefrom.

(17) Fresh meats, including only fresh or home-frozen beef or veal, pork, lamb or mutton and home-prepared fresh meat-containing dishes, salads, appetizers, or sandwich spreads made therefrom.

(18) Fresh poultry, including only fresh or home-frozen poultry or game birds and home-prepared fresh poultry-containing dishes, salads, appetizers, or sandwich spreads made therefrom.

(19) Fresh vegetables, tomatoes, and potatoes, including only fresh and home-prepared vegetables.

(20) Frozen dairy desserts and mixes, including ice cream, ice milks, sherbets, and other frozen dairy desserts and specialties.

(21) Fruit and water ices, including all frozen fruit and water ices.

(22) Gelatins, puddings, and fillings, including flavored gelatin desserts, puddings, custards, parfaits, pie fillings, and gelatin base salads.

(23) Grain products and pastas, including macaroni and noodle products, rice dishes, and frozen multicourse meals, without meat or vegetables.

(24) Gravies and sauces, including all meat sauces and gravies, and tomato, milk, buttery, and specialty sauces.

(25) Hard candy and cough drops, including all hard type candies.

(26) Herbs, seeds, spices, seasonings, blends, extracts, and flavorings, including all natural and artificial spices, blends, and flavors.

(27) Jams and jellies, home-prepared, including only home-prepared jams, jellies, fruit butters, preserves, and sweet spreads.

(28) Jams and jellies, commercial, including only commercially processed jams, jellies, fruit butters, preserves, and sweet spreads.

(29) Meat products, including all meats and meat containing dishes, salads, appetizers, frozen multicourse meat meals, and sandwich ingredients prepared by commercial processing or using commercially processed meats with home preparation.

(30) Milk, whole and skim, including only, whole, lowfat, and skim fluid milks.

(31) Milk products, including flavored milks and milk drinks, dry milks, toppings, snack dips, spreads, weight control milk beverages, and other milk origin products.

(32) Nuts and nut products, including whole or shelled tree nuts, peanuts, coconut, and nut and peanut spreads.

(33) Plant protein products, including the National Academy of Sciences/National Research Council "reconstituted vegetable protein" category, and meat, poultry, and fish substitutes, analogs, and extender products made from plant proteins.

(34) Poultry products, including all poultry and poultry-containing dishes, salads, appetizers, frozen multicourse poultry meals, and sandwich ingredients prepared by commercial processing or using commercially processed poultry with home preparation.

(35) Processed fruits and fruit juices, including all commercially processed fruits, citrus, berries, and mixtures; salads, juices and juice punches, concentrates, dilutions, "ades," and drink substitutes made therefrom.

(36) Processed vegetables and vegetable juices, including all commercially processed vegetables, vegetable dishes, frozen multicourse vegetable meals, and vegetable juices and blends.

(37) Snack foods, including chips, pretzels, and other novelty snacks.

(38) Soft candy, including candy bars, chocolates, fudge, mints, and other chewy or nougat candies.

(39) Soups, home-prepared, including meat, fish, poultry, vegetable, and combination home-prepared soups.

(40) Soups and soup mixes, including commercially prepared meat, fish, poultry, vegetable, and combination soups and soup mixes.

(41) Sugar, white, granulated, including only white granulated sugar.

(42) Sugar substitutes, including granulated, liquid, and tablet sugar substitutes.

(43) Sweet sauces, toppings, and syrups, including chocolate, berry, fruit, corn syrup, and maple sweet sauces and toppings.

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