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  1. Generally Recognized as Safe (GRAS) Notification Program

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 2/27/2024. 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
Part 1 (PDF - 385 pages)
Part 2 (PDF - 190 pages)
Part 3 (PDF - 191 pages)

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 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 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 (PDF - 821 pages) 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 (PDF - 595 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 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 (PDF - 83 pages) 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 (PDF - 779 pages) Gnubiotics Sciences  SA Porcine oligosaccharides-peptides complex Utility information not evaluated for GRAS, see FDA’s letter for more information. Cats and dogs 5/11/2022 FDA has no questions. (PDF - 3 pages)
60 (PDF - 305 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 6/2/2022 FDA has no questions. (PDF - 3 pages)
61 (PDF - 49 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 swine diets at 500-2,000 U/kg in complete feed. Swine 2/10/2023 FDA has no questions.
(PDF - 4 pages)
62 Corbion (Purac Biochem BV) Sodium salts of Lauric and Myristic Acids (C12/C14 Lactylates) For use a nutritional ingredient (source of lauric and myristic acids (C12/C14 lactylates)) in the food of all categories and species of animals All animal species  8/22/2023 Pending
63 Phileo, Division of S.I. Lesaffre purified yeast cell wall To be used as a source of beta-glucans in food for all animals at a use level depending on the animal species and life stage.  All animals 10/4/2023 Pending
64 CJ CheilJedang Corporation Dried L-Tryptophan Fermentation Product For use as a source of L-tryptophan in swine feed. Swine 11/30/2023 Pending
65 Proteon Pharmaceuticals, S.A. Bacteriophage preparation To reduce the presence of Salmonella species in poultry feed at 2 X 105 PFU/g of poultry food. Poultry 12/30/2023 Pending

 

 
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