Food ingredients may be "food additives" that are approved by FDA for specific uses or GRAS (generally recognized as safe) substances. A substance may be GRAS only if its general recognition of safety is based on the views of experts qualified to evaluate the safety of the substance. GRAS status may be based either on a history of safe use in food prior to 1958 or on scientific procedures, which require the same quantity and quality of evidence as would be required to obtain a food additive regulation. Because GRAS status may be either affirmed by FDA or determined independently by qualified experts, FDA's regulations do not include all GRAS ingredients and the specific uses described in the GRAS regulations may not be comprehensive for the listed ingredients.
The list below includes some ingredients that are not listed in 21 CFR but have been the subject of opinion letters from FDA to individuals who asked whether FDA would object to the use of the ingredient in food on the basis of an independent GRAS determination. Because the list is not updated on a regular basis, questions about the regulatory status of microorganisms or microbial-derived ingredients that are not on this list may be directed to us via electronic mail at Premarkt@fda.hhs.gov
The following list, which derives partially from FDA's regulations in Title 21 of the Code of Federal Regulations (21 CFR), includes approved food additives, substances whose GRAS status has been affirmed by FDA and substances that FDA listed as GRAS based on a history of safe use in food. In addition, microorganisms and microbial-derived ingredients may be the subject of a GRAS notice. For further information, consult the summary listing of GRAS ingredients.
The following is a compilation of food additives listed in Title 21 of the Code of Federal Regulations (21 CFR) Part 172 and 173, which are derived from microorganisms. This list also includes seaweed sources. Conditions for their use are prescribed in the referent regulations and are predicated on the use of good manufacturing practices.
To access the specific regulations listed below, type in the title number, use the links below to access the Government Printing Office web site.
|Regulation in 21 CFR||Ingredient|
|§172.155||Natamycin derived from Streptomyces natalensis and Streptomyces chattanoogensis|
|§172.325||Bakers yeast protein derived from Saccharomyces cerevisiae|
|§172.590||Yeast-malt sprout extract, derived from Saccharomyces cerevisiae, Saccharomyces fragilis, Candida utilis|
|§172.620||Carrageenan, a hydrocolloid extracted from the following members of the families Gigartinaceae and Soliericeae of the class Rodophyceae (red seaweed): Chondrus crispus, Chondrus ocellatus, Eucheuma cottonii, Eucheuma spinosum, Gigartina acicularis, Gigartina pistillata, Gigartina radula, Gigartina stellata|
|§172.655||Furcelleran, the refined hydrocolloid extracted from Furcellaria fastigiata of the class Rodophyceae (red seaweed)|
|§172.695||Xanthan Gum derived from Xanthomonas campestris|
|§172.725||Gibberellic acid derived by fermentation from Fusarium moniliforme|
|§172.896||Dried yeasts, Saccharomyces cerevisiae, Saccharomyces fragilis, and dried torula yeast, Candida utilis|
|§172.898||Bakers yeast glycan from Saccharomyces cerevisiae|
|§173.110||Amyloglucosidase derived from Rhizopus niveus for use in degrading gelatinized starch into constituent sugars|
|§173.120||Carbohydrase and cellulase derived from Aspergillus niger for use in clam and shrimp processing|
|§173.130||Carbohydrase derived from Rhizopus oryzae for use in the production of dextrose from starch|
|§173.135||Catalase derived from Micrococcus lysodeikticus for use in the manufacture of cheese|
|§173.140||Esterase-lipase derived from Mucor miehei var. Cooney et Emerson as a flavor enhancer in cheeses, fats and oils, and milk products|
|§173.145||Alpha-galactosidase derived from Morteirella vinaceae var. raffinoseutilizer for use in the production of sucrose from sugar beets|
|§173.150||Milk-clotting enzymes, microbial for use in the production of cheese (Milk-clotting enzymes are derived from Endothia parasitica, Bacillus cereus, Mucor pusillus Lindt and Mucor miehei and Aspergillus oryzae modified to contain the gene for aspartic proteinase from Rhizomucor miehei var Cooney et Emerson|
|§173.160||Candida guilliermondii as the organism for fermentation production of citric acid|
|§173.165||Candida lipolytica for fermentation production of citric acid.|
|§173.280||A solvent extraction process for recovery of citric acid from Aspergillus niger fermentation liquor|
The following is a compilation of GRAS affirmed substances listed in 21 CFR part 184 which are derived from microorganisms. This list also includes seaweed sources. Conditions for their use are prescribed in the referent regulations and are predicated on the use of nonpathogenic and nontoxicogenic strains of the respective organisms and on the use of current good manufacturing practice (184.1(b)). Please be aware that not all GRAS substances have been recorded as such and so this does not represent a complete list of all microbial derived GRAS food ingredients.
|Section in 21 CFR||Ingredient or Substance|
|§184.1005||Acetic acid may be produced by fermentation|
|§184.1011||Alginic acid made from certain brown algae|
|§184.1012||Alpha-amylase enzyme preparation from Bacillus stearothermophilus used to hydrolyze edible starch to produce maltodextrin and nutritive carbohydrate sweeteners.|
|§184.1027||Mixed carbohydrase and protease enzyme product derived from Bacillus licheniformis for use in hydrolyzing proteins and carbohydrates in the preparation of alcoholic beverages, candy, nutritive sweeteners and protein hydrolysates|
|§184.1061||Lactic acid may be produced by fermentation|
|§184.1081||Propionic acid from bacterial fermentation|
|§184.1115||Agar-agar, extracted from a number of related species of red algae class Rhodophyceae|
|§184.1120||Brown algae, to be used dried as a flavor enhancer, are seaweeds of the species: Analipus japonicus, Eisenia bicyclis, Hizikia fusiforme, Kjellmaniella gyrata, Laminaria angustata, Laminaria longirruris, Laminaria Longissima, Laminaria ochotensis, Laminaria claustonia, Laminaria saccharina, Laminaria digitata, Laminaria japonica, Macrocystis pyrifera, Petalonia fascia, Scytosiphon lome|
|§184.1121||Red algae, to be used dried as a flavor enhancer, are seaweeds of the species: Gloiopeltis furcata, Porphyra crispata, Porhyra deutata, Porhyra perforata, Porhyra suborbiculata, Porphyra tenera, Rhodymenis palmata|
|§184.1133||Ammonium alginate from certain brown algae|
|§184.1187||Calcium alginate from certain brown algae|
|§184.1318||Glucono delta-lactone, by oxidation of D-glucose by microorganisms that are nonpathogenic and nontoxicogenic to man or other animals. These include but are not restricted to Aspergillus niger and Acetobactor suboxydans|
|§184.1372||Insoluble glucose isomerase enzyme preparations are derived from recognized species of precisely classified, nonpathogenic, and nontoxicogenic microorganisms, including Streptomyces rubiginosus, Actinoplane missouriensis, Streptomyces olivaceus, Streptomyces olivochromogenes, and Bacillus coagulans grown in a pure culture fermentation that produces no antibiotic|
|§184.1387||Lactase enzyme preparation from Candida pseudotropicalis for use in hydrolyzing lactose to glucose and galactose|
|§184.1388||Lactase enzyme preparation from Kluyveromyces lactis (previously called Saccharomyces lactis)for use in hydrolyzing lactose in milk|
|§184.1420||Lipase enzyme preparation from Rhizopus niveus used in the interesterfication of fats and oils.|
|§184.1538||Nisin preparation from Lactococcus lactis Lancefield Group N for use as an antimicrobial agent to inhibit the outgrowth of Clostridium botulinum spores and toxin formation in pasteurized cheese spreads.|
|§184.1610||Potassium alginate, the potassium salt of alginic acid, derived from certain brown algae|
|§184.1685||Rennet (animal derived) and chymosin preparation from Escherichia coli K-12, Kluyveromyces marxianus var. lactis or Aspergillus niger var. awamori to coagulate milk in cheeses and other dairy products|
|§184.1695||Riboflavin biosynthesized by Eremothecium ashbyii|
|§184.1724||Sodium alginate, the sodium salt of alginic acid, derived from certain brown algae|
|§184.1848||Butter starter distillate from milk cultures of Streptococcus lactis, Streptococcus cremoris. Streptococcus lactis subspecies diacetylactis, Leuconostoc citovorum, Leuconostoc dextranicum|
|§184.1924||Urease enzyme preparation from Lactobacillus fermentum for use in the production of wine|
|§184.1945||Vitamin B12 from Streptomyces griseus|
|§184.1950||Vitamin D, produced by ultraviolet irradiation of ergosterol isolated from yeast and related fungi|
|§184.1983||Bakers Yeast extract from Saccharomyces cerevisiae|
|§184.1985||Aminopeptidase enzyme preparation from Lactococcus lactis used as an optional ingredient for flavor development in the manufacture of cheddar cheese.|
The following GRAS affirmed substances are listed in 21 CFR Part 186 and are affirmed for use as substances added indirectly to food. Conditions for their use are prescribed in the referent regulations and are predicated on the use of nonpathogenic and nontoxicogenic strains of the respective organisms and on the use of current good manufacturing practice (186.1(b)).
|Section in 21 CFR||Substance|
|§186.1275||Dextrans, made by fermentation of sucrose by Leuconostoc mesenteroides strain NRRL B-512(F)|
|§186.1839||Sorbose, made by oxidation of sorbitol by Acetobacter xylinum or by Acetobacter suboxydans|
The following is a compilation of microbial derived enzymes which the FDA recognized as GRAS in opinion letters issued in the early 1960's. The opinions are predicated on the use of nonpathogenic and nontoxicogenic strains of the respective organisms and on the use of current good manufacturing practice.
|Carbohydrase, cellulase, glucose oxidase-catalase, pectinase, and lipase from Aspergillus niger|
|Carbohydrase and protease from Aspergillus oryzae|
|Carbohydrase and protease from Bacillus subtilis|
|Invertase from edible baker's yeast or brewer's yeast (Saccharomyces cerevisiae)|
The following is a compilation of foods for human consumption listed in 21 CFR Parts 131, 133, 136 and 137 that may contain or be derived from microorganisms.
|Section in 21 CFR||Standardized Food|
|§131.111||Acidified milk, with or without the addition of characterizing microbial organisms, and aroma - and flavor - producing microbial culture. Conditions for their use are prescribed in the referent regulations|
|§131.200||Yogurt made by the lactic acid-producing bacteria Lactobacillus bulgaricus and Streptococcus thermophilus|
|§131.106||Blue cheese, characterized by the presence of the mold Penicillium roquefortii|
|§133.113||Cheddar cheese, subjected to the action of a lactic acid producing bacterial culture and clotting enzymes of animal, plant or microbial origin used in curing or flavor development|
|§136.110||Bread, rolls, and buns may contain as optional ingredients lactic-acid producing bacteria|
|§137.105||Flour may contain alpha-amylase obtained from the fungus Aspergillus oryzae|
Prior sanctions were granted for the use of harmless lactic acid producing bacteria, such as Lactobacillus acidophilus, as optional ingredients in specified standardized foods. These bacteria are permitted for use in cultured milk (which includes buttermilk) (§ 131.112), sour cream (§ 131.160), cottage cheese (§ 133.128), and yogurt (§ 131.200), provided that the mandatory cultures of Lactobacillus bulgaricus and Streptococcus thermophillus are also used in the yogurt.