210.Appendix_A.I.3.c Ingredients that serve a useful purpose such as to fortify the protein or facilitate production of the food are the safe and suitable ingredients referred to in paragraph (a) under Enriched Macaroni Products with Fortified Protein in this appendix. This does not include color additives, artificial flavorings, artificial sweeteners, chemical preservatives, or starches. Ingredients deemed suitable for use by this paragraph are added in amounts that are not in excess of those reasonably required to achieve their intended purposes. Ingredients are deemed to be safe if they are not food additives within the meaning of section 201(s) of the Federal Food, Drug and Cosmetic Act, or in case they are food additives if they are used in conformity with regulations established pursuant to section 409 of the act.

210.Appendix_A.I.3.d.1 The name of any food covered by this section is "Enriched Wheat ________________ Macaroni Product with Fortified Protein", the blank being filled in with appropriate word(s) such as "Soy" to show the source of any flours or meals used that were made from non-wheat cereals or from oilseeds. In lieu of the words "Macaroni Product" the words "Macaroni", "Spaghetti", or "Vermicelli" as appropriate, may be used if the units conform in shape and size to the requirements of 21 CFR 139.110 (b), (c), or (d).

210.Appendix_A.I.3.d.2 When any ingredient not designated in the part of the name prescribed in paragraph (d)(1) under Enriched Macaroni Products with Fortified Protein in this appendix, is added in such proportion as to contribute 10 percent or more of the quantity of protein contained in the finished food, the name shall include the statement "Made with ________________", the blank being filled in with the name of each such ingredient, e.g. "Made with nonfat milk".

210.Appendix_A.I.3.d.3 When, in conformity with paragraph (d)(1) or (d)(2) under Enriched Macaroni Products with Fortified Protein in this appendix, two or more ingredients are listed in the name, their designations shall be arranged in descending order of predominance by weight.

210.Appendix_A.I.3.d.4 If a food is made to comply with a section of 21 CFR part 139, but also meets the compositional requirements of the Enriched Macaroni with Fortified Protein Appendix, it may alternatively bear the name set out in the other section.

210.Appendix_A.I.3.e Each ingredient used shall declare its common name as required by the applicable section of 21 CFR part 101. In addition, the ingredients statement shall appear in letters not less than one half the size of that required by 21 CFR 101.105 for the declaration of net quantity of contents, and in no case less than one-sixteenth of an inch in height.

210.Appendix_A.II.A What Are the Criteria for Alternate Protein Products Used in the National School Lunch Program?

210.Appendix_A.II.A.1 An alternate protein product used in meals planned under the food-based menu planning approaches in Sec. 210.10(k) must meet all of the criteria in this section.

210.Appendix_A.II.A.2 An alternate protein product whether used alone or in combination with meat or other meat alternates must meet the following criteria:

210.Appendix_A.II.A.2.a The alternate protein product must be processed so that some portion of the non-protein constituents of the food is removed. These alternate protein products must be safe and suitable edible products produced from plant or animal sources.

210.Appendix_A.II.A.2.b The biological quality of the protein in the alternate protein product must be at least 80 percent that of casein, determined by performing a Protein Digestibility Corrected Amino Acid Score (PDCAAS).

210.Appendix_A.II.A.2.c The alternate protein product must contain at least 18 percent protein by weight when fully hydrated or formulated. ("When hydrated or formulated" refers to a dry alternate protein product and the amount of water, fat, oil, colors, flavors or any other substances which have been added).

210.Appendix_A.II.A.2.d Manufacturers supplying an alternate protein product to participating schools or institutions must provide documentation that the product meets the criteria in paragraphs A2. a through c of this appendix.

210.Appendix_A.II.A.2.e Manufacturers should provide information on the percent protein contained in the dry alternate protein product and on an as prepared basis.

210.Appendix_A.II.A.2.f For an alternate protein product mix, manufacturers should provide information on:

210.Appendix_A.II.A.2.f.1 the amount by weight of dry alternate protein product in the package;

210.Appendix_A.II.A.2.f.2 hydration instructions; and

210.Appendix_A.II.A.2.f.3 instructions on how to combine the mix with meat or other meat alternates.

210.Appendix_A.II.B How Are Alternate Protein Products Used in the National School Lunch Program?

210.Appendix_A.II.B.1 Schools, institutions, and service institutions may use alternate protein products to fulfill all or part of the meat/meat alternate component discussed in Sec. 210.10.

210.Appendix_A.II.B.2 The following terms and conditions apply:

210.Appendix_A.II.B.2.a The alternate protein product may be used alone or in combination with other food ingredients. Examples of combination items are beef patties, beef crumbles, pizza topping, meat loaf, meat sauce, taco filling, burritos, and tuna salad.

210.Appendix_A.II.B.2.b Alternate protein products may be used in the dry form (nonhydrated), partially hydrated or fully hydrated form. The moisture content of the fully hydrated alternate protein product (if prepared from a dry concentrated form) must be such that the mixture will have a minimum of 18 percent protein by weight or equivalent amount for the dry or partially hydrated form (based on the level that would be provided if the product were fully hydrated).

210.Appendix_A.II.C How Are Commercially Prepared Products Used in the National School Lunch Program?

Schools, institutions, and service institutions may use a commercially prepared meat or meat alternate product combined with alternate protein products or use a commercially prepared product that contains only alternate protein products.