(a) General Provisions.(1) "Typical Substrates" are listed to provide guidance and are not all-inclusive.(2) "Supported Use" references additional enzyme functionality beyond that listed under "Function" and does not limit the enzyme functionality statement to specific animal species.(3) The purpose statement of a product label shall include the statement "Contains a source of (enzymatic activity) which can ("Function" and/or "Supported Use" as stated in this section)" if enzymatic activity is represented in any manner. For enzymes obtained from microorganisms, ingredient names shall use one of the applicable definitions (Dried [Specify] Fermentation Extract, Dried [Specify] Fermentation Solubles, Dried [Specify] Fermentation Product, or Liquid [Specify] Fermentation Product) using the source organism that produced the specific enzyme. For example, the name Dried Aspergillus niger Fermentation Extract may be used for a dry alpha-amylase enzyme product because Aspergillus niger is an accepted source organism for alpha-amylase. Enzymes obtained from plants or animals shall use an appropriate common or usual name that accurately describes the ingredient obtained from the source organism, such as dried pineapple stem for bromelain, fig extract for ficin, or dried pork stomach mucosa powder for pepsin. In the case of microbial enzymes, it is understood that they are produced from nonpathogenic and nontoxigenic strains.(b) Fumonisin Esterase (21 CFR 573.485). The food additive fumonisin esterase may be safely used to degrade fumonisins in swine and poultry feed in accordance with the following prescribed conditions: (1) Fumonisin esterase, a carboxylesterase, is produced by a nontoxigenic and nonpathogenic yeast, Komagataella phaffii, genetically engineered to express the fumonisin esterase gene from the bacterium Sphingopyxis sp. Hydrolyzed fumonisin and two tricarballylic acid molecules are the reaction products of fumonisin hydrolysis by this 493 amino acid fumonisin esterase enzyme.(2) The additive shall meet the following specifications: The fermentation media for the Komagataella phaffii shall not contain methanol. Viable genetically engineered Komagataella phaffii shall not be present. One unit of fumonisin esterase activity is defined as the amount of enzymatic activity required to release one micromole of tricarballylic acid (CAS 99-14-9) per minute from 100 micromolar fumonisin B1 in 20 millimolar Tris-hydrochloride buffer (pH 8.0) containing 0.1 milligram per milliliter of bovine serum albumin at 30 degrees Celsius.(3) The additive is incorporated at a minimum of 15 units of fumonisin esterase activity per kilogram of complete feed: Complete swine feeds cannot contain more than 10 parts per million of total fumonisins. Complete feed for poultry being raised for slaughter cannot contain more than 50 parts per million of total fumonisins. Complete feed for breeding poultry and hens laying eggs for human consumption cannot contain more than 15 parts per million of total fumonisins.(4) To assure safe use of the additive, in addition to the other information required by the FD&C: The label and labeling of the additive, any feed premix, and complete feed shall contain the common or usual name of the additive's source, dried Komagataella phaffii fermentation product. The label and labeling of the additive and any feed premix shall also contain: adequate directions for use including a statement that the additive must be uniformly applied and thoroughly mixed into complete feeds; a guarantee for the minimum amount of fumonisin esterase activity, expressed in accordance with this section, and the unit of weight being consistent with the inclusion rate stated in the directions for use; appropriate warning and safety precaution statements concerning the additive as a respiratory sensitizer; and a cautionary statement concerning the maximum fumonisin content as established in this section.(c) Carbohydrases.(1) alpha-Amylase. (A) Source Organism: Animal pancreatic tissue, Aspergillus niger, var., Aspergillus oryzae, var., Bacillus amyloliquefaciens, Bacillus lentus, Bacillus licheniformis, Bacillus licheniformis containing a Bacillus stearothermophilus gene for alpha-amylase Bacillus stearothermophilus Bacillus subtilis containing a Bacillus megaterium gene for alpha-amylase, Bacillus subtilis containing a Bacillus stearothermophilus gene for alpha-amylase, Bacillus subtilis, var., Barley malt, Paenibacillus lentus, Rhizopus niveus, Rhizopus oryzae, var.(B) Typical Substrate: Corn silage, corn, corn feed meal, corn protein feed, soybean meal, wheat, wheat middlings, barley, grain sorghum, pea, oat, tapioca, millet, rice.(C) Function: Hydrolyzes starch.(2) Maltogenic alpha-amylase. (A) Source Organism: Bacillus subtilis containing a Bacillus stearothermophilus gene for maltogenic alpha-amylase.(B) Typical Substrate: See alpha-amylase.(C) Function: Hydrolyzes starch with production of maltose.(3) beta-Amylase. (A) Source Organism: Barley malt.(B) Typical Substrate: See alpha-amylase.(C) Function: Hydrolyzes starch with production of maltose.(4) Cellulase. (A) Source Organism: Aspergillus niger, var., Humicola insolens, Trichoderma longibrachiatum (also known as T. reesei or T. viride).(B) Typical Substrate: Corn, barley, wheat, wheat, bran, rye, grain sorghum.(C) Function: Breaks down cellulose.(5) alpha-Galactosidase.(A) Source Organism: Aspergillus niger, var., Morteirella vinaceae var. raffinoseutilizer, Saccharomyces sp.(B) Typical Substrate: Sweet lupin, soybean meal.(C) Function: Hydrolyzes oligosaccharides.(6) beta-Glucanase.(A) Source Organism: Aspergillus niger, var., Aspergillus aculeatus, Bacillus lentus, Bacillus subtilis, var., Humicola insolens, Paenibacillus lentus, Talaromyces funiculosus, Talaromyces versatilis overexpressing glucanase, Trichoderma longibrachiatum (also known as T. reesei or T. viride).(B) Typical Substrate: Wheat, barley, canola meal, wheat by-product, oat groats, rye, triticale, grain sorghum.(C) Function: Hydrolyzes beta-glucans, a type of non-starch polysaccharide.(D) Supported Use: Reduction of digesta viscosity with barley-based poultry diets, reduces soluble non-starch polysaccharides in digesta.(7) beta-Glucosidase. (A) Source Organism: Aspergillus niger, var.(B) Typical Substrate: Plant cell wall constituents.(C) Function: Hydrolyzes cellulose degradation products to glucose.(8) Glucoamylase (amyloglucosidase).(A) Source Organism: Aspergillus niger, var., Aspergillus oryzae, var., Rhizopus niveus, Rhizopus oryzae, var.(B) Typical Substrate: See alpha-amylase.(C) Function: Hydrolyzes starch with production of glucose.(9) Hemicellulase. (A) Source Organism: Aspergillus aculeatus, Aspergillus niger, var., Bacillus lentus, Bacillus subtilis, var., Humicola insolens, Paenibacillus lentus, Trichoderma longibrachiatum (also known as T. reesei or T. viride).(B) Typical Substrate: Corn, soybean meal, guar meal, barley, rye, grain sorghum, wheat, oats, peas, lentils.(C) Function: Breaks down hemicellulose.(D) Supported Use: Reduction in stickiness of excreta in poultry fed guar meal.(10) Invertase. (A) Source Organism: Aspergillus niger, var., Saccharomyces sp.(B) Typical Substrate: Sucrose containing products and by-products.(C) Function: Hydrolyzes sucrose to glucose and fructose.(11) Lactase.(A) Source Organism: Aspergillus niger, var., Aspergillus oryzae, var., Candida pseudotropicalis, Kluyveromyces marxianis var. lactis (formerly Saccharomyces sp.).(B) Typical Substrate: Lactose containing products and by-products.(C) Function: Hydrolyzes lactose to glucose and galactose.(12) beta-Mannanase. (A) Source Organism: Aspergillus niger, var., Bacillus lentus, Paenibacillus lentus, Trichoderma longibrachiatum (also known as T. reesei or T. viride).(i) Typical Substrate: Corn, soybean meal, guar meal, copra meal.(ii) Function: Hydrolyzes beta-mannans, a component of hemicellulose.(iii) Supported Use: Reduction in stickiness of excreta in poultry fed guar meal.(B) Source Organism: Bacillus subtilis, var.(i) Typical Substrate: Distillers dried grains with solubles.(ii) Function: Hydrolyzes beta-mannans, a component of hemicellulose.(iii) Supported Use: Reduction of digesta viscosity with swine diets.(13) Pectinase. (A) Source Organism: Aspergillus aculeatus, Aspergillus niger, var., Rhizopus oryzae.(B) Typical Substrate: Corn, wheat.(C) Function: Breaks down pectin.(14) Pullulanase. (A) Source Organism: Bacillus acidopullulyticus, Bacillus licheniformis containing a Bacillus deramificans gene for pullulanase.(B) Typical Substrate: See alpha-amylase.(C) Function: Hydrolyzes starch.(15) Xylanase. (A) Source Organism: Aspergillus niger, var., Aspergillus oryzae expressing a Thermomyces lanuginosus xylanase gene, Bacillus lentus, Bacillus subtilis, var., Humicola insolens, Paenibacillus lentus, Talaromyces funiculosus, Talaromyces versatilis overexpressing xylanase Trichoderma longibrachiatum (also known as T. reesei or T. viride).(B) Typical Substrate: Corn, barley, rye, wheat, grain sorghum, triticale, oats.(C) Function: Hydrolyzes xylans, a component of hemicellulose.(D) Supported Use: Reduction of digesta viscosity with poultry diets.(d) Lipases. (1) Lipase. (A) Source Organism: Animal pancreatic tissue, Aspergillus niger, var., Aspergillus oryzae, var., Candida rugosa (formerly cylindracea), Edible forestomach of calves, kids, and lambs, Rhizomucor (Mucor-)miehei, Rhizopus oryzae.(B) Typical Substrate: Plant and animal sources of fats and oils.(C) Function: Hydrolyzes triglycerides.(e) Proteases. (1) Bromelain. (A) Source Organism: Pineapples-stem, fruit.(B) Typical Substrate: Plant and animal proteins.(C) Function: Hydrolyzes proteins.(2) Ficin.(A) Source Organism: Figs.(B) Typical Substrate: Plant and animal proteins.(C) Function: Hydrolyzes proteins.(3) Keratinase.(A) Source Organism: Bacillus licheniformis.(B) Typical Substrate: Plant and animal proteins.(C) Function: Hydrolyzes proteins.(4) Papain. (A) Source Organism: Papaya.(B) Typical Substrate: Plant and animal proteins.(C) Function: Hydrolyzes proteins.(5) Pepsin. (A) Source Organism: Porcine or other animal stomachs.(B) Typical Substrate: Plant and animal proteins.(C) Function: Hydrolyzes proteins.(6) Protease (general). (A) Source Organism: Aspergillus niger, var., Aspergillus oryzae, var., Bacillus amyloliquefaciens Bacillus licheniformis Bacillus subtilis, var.(i) Typical Substrate: Plant and animal proteins.(ii) Function: Hydrolyzes proteins.(B) Source Organism: Bacillus licheniformis expressing serine protease genes from Nocardiopsis prasine. (i) Typical Substrate: Plant proteins.(ii) Function: Hydrolyzes proteins.(iii) Supported Use: Increases the digestibility of protein in corn-soybean meal based diets.(C) Source Organism: Bacillus subtilis containing a Bacillus amyloliquefaciens gene for protease.(i) Typical Substrate: Plant proteins.(ii) Function: Hydrolyzes proteins.(7) Trypsin.(A) Source Organism: Animal pancreas.(B) Typical Substrate: Plant and animal proteins.(C) Function: Hydrolyzes proteins.(f) Oxidoreductases. (1) Catalase. (A) Source Organism: Aspergillus niger, var., Micrococcus lysodeikticus.(B) Typical Substrate: Hydrogen peroxide.(C) Function: Produces water and oxygen from hydrogen peroxide.(2) Glucose oxidase.(A) Source Organism: Aspergillus niger, var.(B) Typical Substrate: Glucose.(C) Function: Degrades glucose to hydrogen peroxide and gluconic acid.(g) Phosphatases. (1) Phytase. (A) Source Organism: Aspergillus niger, var., Aspergillus oryzae, var., Aspergillus oryzae expressing the Peniophora lycii phytase gene, Phytase canola (Brassica napus expressing the Aspergillus niger phytase gene), Komagataella pastoris expressing a phytase gene from a Risk Group 1 Escherichia coli, Schizosaccharomyces pombe expressing an Excherichia coli strain B phytase gene, Trichoderma reesei expressing an altered phytase gene from a Risk Group 1 Escherichia coli, Trichoderma reesei expressing an altered phytase gene from a Buttiauxella sp. (i) Typical Substrate: Corn, soybean meal, sunflower meal, hominy, tapioca, plant by-products.(ii) Function: Hydrolyzes phytate.(iii) Supported Use: Increases the digestibility of phytin-bound phosphorus in poultry and swine diets.(B) Source Organism: Talaromyces funiculosus.(i) Function: Hydrolyzes phytate.(ii) Supported Use: Increases the digestibility of phytin-bound phosphorus in poultry diets.Cal. Code Regs. Tit. 3, § 2782
Note: Authority cited: Sections 407 and 14902, Food and Agricultural Code. Reference: Sections 14992 and 15011, Food and Agricultural Code.
Note: Authority cited: Sections 407 and 14902, Food and Agricultural Code. Reference: Sections 14992 and 15011, Food and Agricultural Code.
1. Editorial correction of NOTE filed 8-17-82 (Register 82, No. 34).
2. Amendment filed 1-30-2002; operative 1-30-2002 pursuant to Government Code section 11343.4(Register 2002, No. 5).
3. Repealer and new section heading and section filed 11-12-2024 as an emergency; operative 11/12/2024 (Register 2024, No. 46). A Certificate of Compliance must be transmitted to OAL by 5-12-2025 or emergency language will be repealed by operation of law on the following day.