Section 2811 - GRAS Notified Substances Intended for Animal Food(a) General Provisions.(1) The following is a list of GRAS Notices filed voluntarily by the notifiers pursuant to 21 CFR 570.205 that the FDA has evaluated (21 CFR 570.265) and determined that it had no questions regarding the conclusion that the notified animal food substance is GRAS under the intended conditions of use.(b) Hydrophobic silica. Common or Usual Name: Hydrophobic silica. Intended Use: As a defoaming component of a defoamer used in the removal of oil from condensed distillers solubles, at levels up to 20 parts per million. Intended Species: Beef cattle, dairy cattle, poultry (turkey, broiler chickens, and egg laying hens), sheep, goats, and swine.(c) Polyethylene glycol (400) dioleate. Common or Usual Name: Polyethylene glycol (400) dioleate. Intended Use: As an emulsifier component of a defoamer used in the removal of oil from condensed distillers, at levels up to 64 parts per million. Intended Species: Beef cattle, dairy cattle, poultry (turkey, broiler chickens, and egg laying hens), sheep, goats, and swine.(d) Polyoxyethylene (20) sorbitan monostearate (polysorbate 60). Common or Usual Name: Polysorbate 60. Intended Use: As an emulsifier component of a defoamer used in the removal of oil from condensed distillers solubles, at levels up to 20 parts per million. Intended Species: Beef cattle, dairy cattle, poultry (turkey, broiler chickens, and egg laying hens), sheep, goats, and swine.(e) Phytase enzyme produced by an Aspergillus oryzae strain expressing a synthetic gene coding for a 6-phytase from Citrobacter braakii. Common or Usual Name: Phytase. Intended Use: To increase the digestibility of phytin-bound phosphorous or to increase phosphorous availability from phytate in poultry diets when fed at the rate of 250-4000 FYT/kg feed. Intended Species: Poultry (turkey, broiler chickens, and egg laying hens).(f) Phytase enzyme produced by an Aspergillus oryzae strain expressing a synthetic gene coding for a 6-phytase from Citrobacter braakii. Common or Usual Name: Phytase. Intended Use: To increase the digestibility of phytin-bound phosphorous or to increase phosphorous availability from phytate in swine diets when fed at the rate of 500-4000 FYT/kg feed. Intended Species: Swine.(g) L-methionine 85 percent produced by a bioengineered Escherichia coli K-12. Common or Usual Name: L-methionine 85 percent. Intended Use: Nutrient at levels up to 0.3 percent in animal feed. Intended Species: All animals.(h) Canthaxanthin. Common or Usual Name: Canthaxanthin. Intended Use: To be used in breeder hen diets at the rate of six (6) milligrams per kilogram of feed as a nutritive antioxidant to support the development of chicks. Intended Species: Breeder hens used for hatching egg production.(i) L-Glutamine. Common or Usual Name: L-Glutamine. Intended Use: Utility information not evaluated for GRAS, see FDA's letter for more information. Intended Species: Post-weaning horses.(j) Inactivated modified Saccharomyces cerevisiae. Common or Usual Name: Saccharomyces cerevisiae expressing xylose isomerase from Piromyces sp. E2. Intended Use: As a component of animal feed when used in the fermentation of corn to produce ethanol. Intended Species: Poultry (broilers, layers, and breeding chickens; turkeys), swine (piglets, growers, finishers, gestating and lactating sows), bovine (beef and dairy), fish (salmonoids, catfish, tilapia), and minor species such as ducks, quail, sheep, and goats.(k) Ground grain obtained from a corn (Zea mays) variety that expresses an altered appA 6-phytase gene obtained from Escherichia coli strain K12. Common or Usual Name: Phytase. Intended Use: To increase the digestibility of phytin-bound phosphorous or to increase phosphorous availability from phytate in poultry feeds when used at a rate of 75 g to 1.7 kg per ton of complete feed and providing 250-6000 phytase units (FTU)/kg complete feed. Intended Species: Poultry.(l) L-methionine 90 percent produced by a bioengineered Escherichia coli K-12. Common or Usual Name: L-methionine 90 percent. Intended Use: To be used as a nutrient in animal food. Intended Species: All animals.(m) Dried Methylobacterium extorquens biomass. Common or Usual Name: Dried Methylobacterium extorquens biomass. Intended Use: To be used as a source of protein in food for finfish species at a level up to 10 percent of the diet. Intended Species: Finfish species.(n) Ground grain obtained from a corn (Zea mays) variety that expresses an altered appA 6-phytase gene obtained from Escherichia coli strain K12 (transformation event PY203). Common or Usual Name: Phytase. Intended Use: To increase the digestibility of phytin-bound phosphorous or to increase phosphorous availability from phytate in swine feeds when used to provide 500-4500 phytase activity units (FTU)/kg complete feed. Intended Species: Swine.(o) Clinoptilolite of sedimentary origin. Common or Usual Name: Clinoptilolite of sedimentary origin. Intended Use: To be used as an anti-caking agent at levels up to one (1) percent by weight in the complete diet. Intended Species: Cattle, swine, goats, sheep, broiler chickens, turkeys for meat.(p) Ground grain obtained from a corn (Zea mays) variety that expresses an altered AC1 beta-glucanase gene obtained from an environmental DNA library (transformation event FG259). Common or Usual Name: Beta-glucanase. Intended Use: To decrease viscosity of digesta in poultry consuming feeds containing high amounts of soluble non-starch polysaccharides when used to provide 200-400 beta-glucanase activity units per kg of complete feed. Intended Species: Poultry.(q) Ground grain obtained from a corn (Zea mays) variety that expresses an altered appA 6-phytase gene obtained from Escherichia coli strain K12 (transformation event PY1203). Common or Usual Name: Phytase. Intended Use: To increase the digestibility of phytin-bound phosphorus or to increase phosphorous availability from phytate in swine feeds when used to provide 500-4500 phytase activity units (FTU)/kg complete feed, or poultry feeds when used to provide 250-6000 FTU/ kg complete feed. Intended Species: Swine and poultry.(r) Dried Methylobacterium extorquens biomass. Common or Usual Name: Dried Methylobacterium extorquens biomass. Intended Use: To be used as a source of protein in food for aquaculture crustacean species at a level up to six (6) percent of the diet. Intended Species: Crustacean species.(s) Dried L-threonine fermentation product (2:75 percent L-threonine) produced by bioengineered Cornybacterium glutamicum. Common or Usual Name: Dried L-threonine fermentation product. Intended Use: To be used as a source of the nutrient L-threonine in food for livestock and poultry. Intended Species: Livestock and poultry.(t) Butyrivibrio fibrisolvens ASCUSDY19. Common or Usual Name: Dried Butyrivibrio fibrisolvens fermentation product. Intended Use: Utility information not evaluated for GRAS, see FDA's letter for more information. Intended Species: Dairy cattle.(u) Xylanase enzyme prepared from Komagataella phaffii expressing the gene encoding xylanase from Orpinomyces sp. Common or Usual Name: Endo-1,4-B-xylanase enzyme. Intended Use: Utility information not evaluated for GRAS, see FDA's letter for more information. Intended Species: Swine and poultry.(v) Dried L-valine fermentation product. Common or Usual Name: Dried L-valine fermentation product. Intended Use: To be used as a source of L-valine in livestock and poultry feed. Intended Species: Livestock and poultry.(w) Ground grain obtained from a corn (Zea mays) variety that expresses an altered AC1 betaglucanase gene obtained from an environmental DNA library (transformation event FG259). Common or Usual Name: Beta-glucanase. Intended Use: Utility information not evaluated for GRAS, see FDA's letter for more information. Intended Species: Swine.Cal. Code Regs. Tit. 3, § 2811
Note: Authority cited: Sections 407 and 14902, Food and Agricultural Code. Reference: Sections 14992 and 15011, Food and Agricultural Code.
1. New 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.