Current Animal Food GRAS Notices Inventory
The following table is provided on an interim basis, until the Animal Food GRAS Notices Inventory database is launched. The data provided are current through 2/8/2023. A decision on FDA's part to file a submission as a GRAS notice has not reflected our judgment as to whether the notice addressed all issues or discussed all critical data or information.
Persons using assistive technology may not be able to fully access information in the submissions. For assistance, please call 240-402-7002.
AGRN (select AGRN No. for detailed record) | Notifier | Substance | Intended Use | Intended Species | Date of Filing | FDA's Letter (select to view letter) |
---|---|---|---|---|---|---|
1 (PDF - 387 pages) |
Resonant Biosciences, Inc. | Chlorine dioxide | To be used as a processing aid, with a maximum application rate of 55 ppm per batch, in the production of non-food grade ethanol, food grade ethanol, and distillers grains for animal feed use for food-producing animals. | Food-producing animals. | 12/21/2010 | Notice does not provide a basis for a GRAS determination (PDF - 6 pages) |
2 | Lallemand Specialties Inc., doing business as Lallemand Ethanol Technology | Penicillin G potassium | To control the levels of contaminants and their by-products in the production of non-food grade and food grade ethanol and distillers grain for target animal feed use at a level not to exceed 6 ppm of commercial product or 2.7 ppm of penicillin G potassium, in the fermentor. | Beef cattle, dairy cows, broiler chickens, egg-laying chickens, swine, and sheep. Pets including dogs, cats, rabbits, guinea pigs and horses. | 12/23/2010 | At notifier's request, FDA ceased to evaluate the notice. (PDF - 2 pages) |
3 (PDF - 160 pages) |
Hill’s Pet Nutrition Inc. | alpha-Lipoic acid | To be used as an ingredient in dry foods for adult dogs at levels up to 150 ppm (150 mg/kg food or 0.0150%) as a cellular antioxidant and cofactor of enzymes involved in the metabolism of carbohydrates and amino acids. | Adult dogs (i.e., at least 1 year old). | 2/8/2011 | Notice does not provide a basis for a GRAS determination (PDF - 5 pages) |
4 | Lallemand Specialties Inc., doing business as Lallemand Ethanol Technology | Virginiamycin | To be used as a processing aid in the production of non-food grade and food grade ethanol at a level not to exceed 6 ppm of commercial product (3 ppm virginiamycin) in the fermentor. | Beef cattle, dairy cows, broiler chickens, egg-laying chickens, swine, and sheep. Pets including dogs, cats, rabbits, guinea pigs and horses. | 3/16/2011 | At notifier's request, FDA ceased to evaluate the notice. (PDF - 2 pages) |
5 (PDF - 67 pages) |
Emerald Carolina Chemicals LLC | Hydrophobic silica | As a defoaming component of a defoamer used in the removal of oil from condensed distillers solubles, at levels up to 20 ppm. | Beef cattle, dairy cattle, poultry (turkey, broiler chickens, and egg laying hens), sheep, goats, and swine. |
5/12/2011 | FDA has no questions. (PDF - 3 pages) |
6 (PDF - 57 pages) |
Emerald Carolina Chemicals LLC | Polyethylene glycol (400) dioleate | As an emulsifier component of a defoamer used in the removal of oil from condensed distillers, at levels up to 64 ppm. | Beef cattle, dairy cattle, poultry (turkey, broiler chickens, and egg laying hens), sheep, goats, and swine. |
5/12/2011 | FDA has no questions. (PDF - 3 pages) |
7 (PDF - 101 pages) |
Emerald Carolina Chemicals LLC | Polyoxyethylene (20) sorbitan monostearate (polysorbate 60) | As an emulsifier component of a defoamer used in the removal of oil from condensed distillers solubles, at levels up to 20 ppm. | Beef cattle, dairy cattle, poultry (turkey, broiler chickens, and egg laying hens), sheep, goats, and swine. |
5/12/2011 | FDA has no questions. (PDF - 3 pages) |
8 (PDF - 21 pages) |
Rubinum S.A. Animal Health | Bacillus cereus variant toyoi | To be used as an animal feed ingredient to help maintain the animal's gut microflora. | Swine, cattle, broiler chickens, turkeys, and rabbits. | 6/10/2011 | Notice does not provide a basis for a GRAS determination. (PDF - 4 pages) |
9 (PDF - 82 pages) |
Vitamin Derivatives, Inc. | 1-alpha-Hydroxycholecalciferol | To be used as a dietary source of vitamin D up to 5 micrograms per kilogram in the finished feed. | Broiler chickens. | 7/13/2011 | Notice does not provide a basis for a GRAS determination. (PDF - 6 pages) |
10 (PDF - 61 pages) |
Gevo | Inactivated modified Saccharomyces cerevisiae | As a component of animal feed when used in the fermentation and distillation of corn to produce isobutanol. | Beef cattle, dairy cows, broiler chickens, egg-laying chickens, swine, sheep, dogs, cats, rabbits, guinea pigs and horses. | 8/25/2011 | Notice does not provide a basis for a GRAS determination. (PDF - 4 pages) |
11 | Lallemand Specialties Inc., doing business as Lallemand Ethanol Technology | Penicillin G potassium | To control the levels of contaminants and their byproducts in the production of food grade and no-food grade ethanol and distillers grain for target animal feed use at a level not to exceed 6 ppm of commercial product, or 3.0 ppm of Penicillin G in the fermentor. | Beef cattle, dairy cows, broiler chickens, egg-laying chickens, swine and sheep. Pets including dogs, cats, rabbits, guinea pigs and horses. | 9/15/2011 | At notifier's request, FDA ceased to evaluate the notice. (PDF - 2 pages) |
12 | Lallemand Specialties Inc., doing business as Lallemand Ethanol Technology | Virginiamycin | To be used as a processing aid in the production of food and non-food grade ethanol at a level not to exceed 6 ppm of commercial product (3 ppm Virginiamycin) in the fermentor. | Beef cattle, dairy cows, broiler chickens, egg-laying chickens, swine, and sheep. Pets including dogs, cats, rabbits, guinea pigs and horses. | 9/15/2011 | At notifier's request, FDA ceased to evaluate the notice. (PDF - 2 pages) |
13 | Gevo | Isobutanol distillers grain | To be used as a component of animal feed. | Beef cattle, dairy cows, broiler chickens, egg-laying chickens, swine and sheep. Pets include: dogs, cats, rabbits, guinea pigs, and horses. | 9/29/2011 | At notifier's request, FDA ceased to evaluate the notice. (PDF - 2 pages) |
14 (PDF - 576 pages) |
DSM Nutritional Products | Phytase enzyme produced by an Aspergillus oryzae strain expressing a synthetic gene coding for a 6-phytase from Citrobacter braakii | 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. | Poultry (turkey, broiler chickens, and egg laying hens) | 11/14/2012 | FDA has no questions. (PDF - 3 pages) |
15 (PDF - 505 pages) |
DSM Nutritional Products | Phytase enzyme produced by an Aspergillus oryzae strain expressing a synthetic gene coding for a 6-phytase from Citrobacter braakii | 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. | Swine | 8/8/2013 | FDA has no questions. (PDF - 3 pages) |
16 (PDF - 87 pages) |
Metabolic Explorer | L-methionine 85% produced by a bioengineered Escherichia coli K-12 | Nutrient at levels up to 0.3% in animal feed | All animals | 1/3/2014 | FDA has no questions. (PDF - 4 pages) |
17 (PDF - 170 pages) |
DSM Nutritional Products | Canthaxanthin | To be used in breeder hen diets at the rate of 6 mg /kg of feed as a nutritive antioxidant to support the development of chicks. | Breeder hens used for hatching egg production. | 7/22/2014 | FDA has no questions. (PDF - 4 pages) |
18 | DSM Innovation, Inc. BioProducts & Services Division |
Inactivated modified Saccharomyces cerevisiae | As a component of animal feed when used in the fermentation of corn to produce ethanol. | Poultry (broilers, layers, breeding chickens and turkeys), swine (piglets, growers, finishers, gestating and lactating sows), bovines (beef and dairy), fish (salmonoids, catfish, and tilapia), minor species (ducks, quail, sheep and goats) and pets. | 12/22/2014 | At notifier’s request, FDA ceased to evaluate the notice. (PDF - 2 pages) |
19 (PDF - 123 pages) |
Freedom Health L.L.C. | L-Glutamine | Utility information not evaluated for GRAS, see FDA’s letter for more information. | Post-weaning horses. | 3/22/2016 | FDA has no questions. (PDF - 3 pages) |
20 (PDF- 899 pages) |
DSM Innovation, Inc. BioProducts & Services Division |
Inactivated modified Saccharomyces cerevisiae | As a component of animal feed when used in the fermentation of corn to produce ethanol. | Pets, 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. | 4/29/2016 | FDA has no questions. (PDF - 4 pages) |
21 (PDF – 598 pages) |
Agrivida, Inc. | 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) | 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. | Poultry | 7/28/2016 | FDA has no questions. (PDF – 4 pages) |
22 (PDF – 86 pages) |
Royal Canin U.S., Inc. | Marigold extract | To be used in food and treats for dogs and cats at a level sufficient to provide no more than 5 mg lutein per 1000 kcal metabolizable energy (ME) as a nutritive antioxidant. | Dogs and cats | 8/3/2016 | Notice does not provide a basis for a GRAS determination. (PDF – 4 pages) |
23 (PDF – 253 pages) |
Aker BioMarine Antarctic | Euphausia superba (krill) meal | To be used as a source of protein and lipid in food for adult dogs at a maximum inclusion level of 3% by weight of dry food. | Adult dogs | 01/06/2017 | At notifier’s request, FDA ceased to evaluate the notice. (PDF- 1 page) |
24 (PDF - 194 pages) | CJ CheilJedang Corporation | L-methionine 90% produced by a bioengineered Escherichia coli K-12 | To be used as a nutrient in animal food. | All animals | 8/17/2017 | FDA has no questions. (PDF - 4 pages) |
25 (PDF - 136 pages) | G-Science, Inc. | clinoptilolite of sedimentary origin | To be used as an anticaking agent at levels up to 2% by weight in the complete diet. | Cattle, swine, goats, sheep, poultry, cats, and dogs. | 8/21/2017 | At notifier’s request, FDA ceased to evaluate the notice. (PDF - 1 page) |
26 |
KnipBio, Inc. | Dried Methylobacterium extorquens biomass | To be used as a source of protein in food for finfish species at a level up to 10% of the diet. | Finfish species. | 2/7/2018 | FDA has no questions. (PDF - 5 pages) |
27 (PDF- 177 pages) | Agrivida, Inc. | 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) | 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. | Swine | 9/6/2018 | FDA has no questions. (PDF - 4 pages) |
28 (PDF – 346 pages) | CJ CheilJedang Corporation | L-Threonine Fermentation Product (75%) produced by a bioengineered Corynebacterium glutamicum | To be used as a source of the nutrient L-threonine in the diets of livestock and poultry. | Livestock and poultry. | 11/6/2018 | At notifier’s request, FDA ceased to evaluate the notice. (PDF - 2 pages) |
29 (PDF - 138 pages) | G-Science, Inc. | clinoptilolite of sedimentary origin | To be used as an anti-caking agent at levels up to 1% by weight in the complete diet. | Cattle, swine, goats, sheep, broiler chickens, turkeys for meat, cats and dogs. | 12/11/2018 | FDA has no questions. (PDF - 5 pages) |
30 (PDF – 307 pages) | Aker BioMarine Antarctic | Euphausia superba (krill) meal | To be used as a source of protein and lipid in food for adult dogs at a maximum inclusion level of 3% by weight of dry food. | Adult dogs | 2/19/2019 | FDA has no questions. (PDF - 4 pages) |
31 (PDF - 208 pages) | Agrivida, Inc. | 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) | To decrease the viscosity of digesta in poultry consuming feed containing high amounts of soluble non-starch polysaccharides when used to provide 200 – 500 beta-glucanase activity units per kg of complete feed. | Poultry | 7/15/2019 | FDA has no questions. (PDF- 4 pages) |
32 (PDF - 105 pages) | Agrivida, Inc. | 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) | 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, or poultry feeds when used to provide 250-6000 FTU/kg complete feed. | Swine and poultry | 7/24/2019 | FDA has no questions. (PDF - 4 pages) |
33 (PDF – 64 pages) | KnipBio, Inc. | Dried Methylobacterium extorquens biomass | To be used as a source of protein in food for aquaculture crustacean species at a level up to 6% of the diet. | Crustacean species | 9/20/2019 | FDA has no questions. (PDF – 4 pages) |
34 (PDF – 494 pages) | C J CheilJedang Corporation | Dried L-Threonine Fermentation Product (≥75% L-threonine) produced by bioengineered Corynebacterium glutamicum KCCM80178. | To be used as a source of the nutrient L-threonine in food for livestock and poultry. | Livestock and poultry | 11/26/2019 | FDA has no questions. (PDF - 4 pages) |
35 (PDF-1214 pages) | C J CheilJedang Corporation | Dried L-Valine Fermentation Product (≥72% L-valine) produced by bioengineered Corynebacterium glutamicum KCCM80058 | To be used as a source of the nutrient L-valine in food for livestock and poultry. | Livestock and poultry | 12/18/2019 | At notifier’s request, FDA ceased to evaluate the notice. (PDF – 2 pages) |
36 Part 1 (PDF – 1023 pages) Part 2 (PDF – 1023 pages) |
Veramaris USA LLC | Marine microalgae oil from Schizochytrium sp. | To be used as a source of long chain polyunsaturated fatty acids (PUFAs), docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) in canned and dry/extruded dog foods. | Dogs | 1/2/2020 | FDA has no questions. (PDF - 4 pages) |
37 Part 1 (PDF - 400 pages) Part 2 (PDF - 585 pages) |
Veramaris USA LLC | Marine microalgae oil from Schizochytrium sp. | To be used as a source of long chain polyunsaturated fatty acids (PUFAs), docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) in canned and dry/extruded cat foods. | Cats | 6/29/2020 | FDA has no questions. (PDF - 4 pages) |
38 Part 1 (PDF - 273 pages) Part 2 (PDF-331 pages) |
Native Microbials, Inc. (formerly known as Ascus Biosciences) | Pichia kudriavzevii ASCUSDY21 | To be used as a viable microorganism in diets of dairy cattle at an intended use rate 1x108 colony forming units (CFU)/cow/day. | Dairy Cattle | 7/13/2020 | At notifier’s request, FDA ceased to evaluate the notice. (PDF - 1 page) |
39 (PDF-594 pages) | BASF Enzymes LLC | Phytase enzyme produced by Pseudomonas fluorescens strain BD50104 expressing an altered appA 6-phytase gene from Escherichia coli strain K12 | To increase the availability of phytin-bound phosphorus in poultry diets at 250-2000 U/kg in complete feed. | Poultry | 7/14/2020 |
At notifier’s request, FDA ceased to evaluate the notice. (PDF - 1 page) |
40 (PDF-620 pages) | Calysta, Inc. | Dried Methylococcus capsulatus Product | To be used as a source of protein in food for salmonid species at a level up to 18% of the diet. | Salmonid species | 8/13/2020 |
At notifier’s request, FDA ceased to evaluate the notice. (PDF - 1 page) |
41 Part 1 (PDF - 446 pages) Part 2 (PDF - 644 pages) |
Native Microbials, Inc. (formerly known as Ascus Biosciences) | Clostridium beijerinckii ASCUSDY20 | To be used as a viable microorganism in diets of dairy cattle at an intended use rate 1x107 colony forming units (CFU)/cow/day. | Dairy cattle | 8/18/2020 | At notifier’s request, FDA ceased to evaluate the notice. (PDF - 1 page) |
42 Part 1 (PDF - 307 pages) Part 2 (PDF - 307 pages) |
Native Microbials, Inc. | Butyrivibrio fibrisolvens ASCUSDY19 | Utility information not evaluated for GRAS, see FDA’s letter for more information. | Dairy cattle | 2/12/2021 | FDA has no questions. (PDF - 3 pages) |
43 | Danisco US Inc. | Phytase from Trichoderma reesei, expressed as a variant of consensus bacterial phytase | To be used to increase phosphate availability at a use rate not to exceed 4000 FTU/kg. | Swine and poultry | 2/18/2021 | At notifier’s request, FDA ceased to evaluate the notice. (PDF - 1 page) |
44 (PDF - 424 pages) | BioResource International, Inc. | Xylanase enzyme prepared from Komagataella phaffii expressing the gene encoding xylanase from Orpinomyces sp. | Utility information not evaluated for GRAS, see FDA’s letter for more information. | Swine and poultry | 2/25/2021 | FDA has no questions. (PDF - 4 pages) |
45 | Native Microbials, Inc. | Dried fat encapsulated Succinivibrio dextrinosolvens strain ASCUSBF53 (NRRL B-67550) | To be used as a viable microorganism in diets of beef cattle at an intended use rate of 1x108 colony forming units (CFU)/head/day. | Beef cattle | 3/16/2021 | FDA has no questions. (PDF - 3 pages) |
46 | Agromed Austria GmbH | Wood-based lignocellulose | To be used as a source of dietary fiber in complete feed at a use rate up to 2% for pigs, piglets, broilers, laying hens, and turkeys and 4% for sows. | Swine and poultry | 4/9/2021 | At notifier’s request, FDA ceased to evaluate the notice. (PDF - 1 page) |
47 | IRP Health Pty Ltd | Berberine | To be used as preservative in broiler chicken feed at a maximum concentration of 0.03 g/kg. | Poultry | 4/15/2021 | At notifier’s request, FDA ceased to evaluate the notice. (PDF - 1 page) |
48 (PDF - 1119 pages) | CJ CheilJedang Corporation |
Dried L-Valine Fermentation Product (≥72% L-valine) produced by bioengineered Corynebacterium glutamicum KCCM80240 |
To be used as a source of L-Valine in livestock and poultry feed. | Livestock and poultry | 5/14/2021 | FDA has no questions. (PDF - 4 pages) |
49 | Native Microbials, Inc. | Clostridium beijerinckii ASCUSBR67 | To be used as a viable microorganism in diets of poultry at an intended use rate of 1x104 colony forming units (CFU)/bird/day. | Poultry | 10/01/2021 | At notifier's request, FDA ceased to evaluate the notice. (PDF - 1 page) |
50 (PDF - 50 pages) | Agrivida, Inc. | 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) | Utility information not evaluated for GRAS, see FDA’s letter for more information. | Swine | 10/25/2021 | FDA has no questions. (PDF - 4 pages) |
51 (PDF - 366 pages) | Protekta Inc. | synthetic sodium aluminosilicate | To be used to maintain calcium balance in periparturient dairy cows fed at a level of 400 g synthetic sodium aluminosilicate/head/day for at least 14 days and no more than 28 days. | Dairy cattle | 10/28/2021 | At notifiers request, FDA ceased to evaluate the notice. (PDF - 2 pages) |
52 | Jiminy’s LLC | Crickets | As a source of protein in complete food or treats for adult dogs. | Dogs | 11/15/2021 | At notifiers request, FDA ceased to evaluate the notice. (PDF - 2 pages) |
53 | Native Microbials, Inc. | Ruminococcus bovis ASCUSDY10 | For use as a viable microorganism in dairy cattle feed at an intended use rate of 1X108 colony forming units (CFU)/cow/day. | Dairy cattle | 11/23/2021 | At notifiers request, FDA ceased to evaluate the notice. (PDF - 1 page) |
54 | CJ CheilJedang Corp. | Dried L-Tryptophan Fermentation Product | To be used as a source of L-Tryptophan in livestock and poultry feed. | Livestock and poultry | 12/28/2021 | At notifiers request, FDA ceased to evaluate the notice. (PDF - 1 page) |
55 | BASF Enzymes LLC | Phytase enzyme produced by Pseudomonas fluorescens strain BD50104 expressing an altered appA 6-phytase gene from Escherichia coli strain K12 | To increase the availability of phytin-bound phosphorus in broiler diets at 500-2,000 U/kg in complete feed. | Broiler chickens | 1/20/2022 | FDA has no questions. (PDF - 4 pages) |
56 | Phileo, Division of S.I.Lesaffre | Purified yeast cell wall | To be used as a source of fermentable fiber, especially beta-glucans, in food for all animals at a use level depending on the animal species and life stage. | All animals | 3/8/2022 | At notifiers request, FDA ceased to evaluate the notice. (PDF - 2 pages) |
57 | BASF Corporation | Mannanase 19287 enzyme produced by T Thermophilus strain DSM33149 | For use in reducing the viscosity of intestinal digesta at 800 Thermostable Mannanase units /kg of feed | Poultry | 4/29/2022 | At notifiers request, FDA ceased to evaluate the notice. (PDF - 1 page) |
58 | Hill’s Pet Nutrition Inc. | Alpha-Lipoic Acid | Utility information not evaluated for GRAS, see FDA’s letter for more information. | Adult dogs (non-gestating and non-lactating) | 5/2/2022 | FDA has no questions. (PDF - 3 pages) |
59 | Gnubiotics Sciences SA | Porcine oligosaccharides-peptides complex | To be used as a source of amino acids, peptides and glycopeptides in food for cats and dogs at a level not to exceed 1.5% by weight/complete feed. | Cats and dogs | 5/11/2022 | FDA has no questions. (PDF - 3 pages) |
60 | Calysta, Inc. | Dried Methylococcus capsulatus Product | To be used as a source of protein in food for salmonid species at a level up to 18% of the diet. | Salmonid species | 6/2/2022 | Pending |