Contains Non-binding Recommendations
Draft-Not for Implementation
Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 12
A1.5.4 The Food Subcategories in the Tables in Appendix 1 Address Raw
Materials, Other Ingredients, and Multi-Component Foods
Most foods contain multiple raw materials and other ingredients. Although many of the foods in
the Tables are multi-component foods, it is not practical to include all multi-component foods in
the tables, because the ingredients and processing methods can vary widely (e.g., entrées, side
dishes, sandwiches). To assess the biological and chemical hazards for these multi-component
foods, you should consider the hazards associated with the individual raw materials/ingredients,
as well as the hazards that may arise from the processing methods used in making them.
Some Tables, such as the “Food Additives, Color Additives, and GRAS Substances” Food
Group Table, address food materials that are almost exclusively used as ingredients in the
production of other foods. Examples of foods in the “Food Additives, Color Additives, and GRAS
Substances” Food Group are emulsifiers, stabilizers and thickeners, enzymes, colors, flavors,
and other ingredients (such as antimicrobials and preservatives).
Other Tables address Food Groups with Food Categories and Food Subcategories that are
both commonly used as raw materials or other ingredients in the production of multi-
component foods and commonly consumed as finished foods. When using these Tables, the
known or reasonably foreseeable hazards (“potential hazards”) that you should consider for an
ingredient that you use in manufacturing/processing one of these food products could depend
on how you use the ingredient. For example:
• Food products that are in the “Whole, Grains” Food Subcategory in Table 1J (e.g., barley,
quinoa) are commonly sold both to manufacturers/processors for use as an ingredient in
multi-component foods and to consumers. Multi-component foods manufactured/processed
using whole grains as an ingredient can be dry foods (such as dry mixes that consumers
use in cooking) or high-moisture foods (such as cooked grain bowls and cooked grain-based
side dishes) in which the whole grains are hydrated during manufacturing/processing. You
should consider Bacillus cereus as a known or reasonably foreseeable hazard (“potential
hazard”) when you use the whole grains to manufacture/process a cooked high-moisture
product (where B. cereus could grow), but not when you distribute dry whole grains to
consumers or use the dry whole grains to manufacture/process a dry mix that consumers
will cook.
• Food products that are in the “Dry Mixes, Powders” Food Subcategory in the “Soups,
Sauces, Gravies” Food Category in Table 1N are commonly sold both to
manufacturers/processors for use as an ingredient in multi-component foods (such as
refrigerated or frozen meals) and to consumers (e.g., for use in an entrée prepared at home
by rehydration followed by cooking). You should consider pathogenic sporeformers such as
B. cereus and C. perfringens as known or reasonably foreseeable hazards (“potential
hazards”) when you use a dry mix or powder as an ingredient of a sauce that you use to
manufacture/process a frozen meal, but not when you use the dry mix or powder to
manufacture/process a dry sauce mix packaged for retail sale to consumers.
• Food products that are in the “Dried, Ground, Cracked, or Whole” Food Subcategory in the
“Spices” Food Category in Table 1O are commonly sold both to manufacturers/processors
for use as an ingredient in multi-component foods (such as high-moisture dips, sauces, and
refrigerated and frozen meals) and to consumers (e.g., for use in an entrée prepared at
home). You should consider pathogenic sporeformers such as B. cereus and C. perfringens
as known or reasonably foreseeable hazards (“potential hazards”) when you use a product