Food Safety and Standards (Food Products Standards and Food Additives) Second Amendment Regulations, 2022

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FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA

NOTIFICATION

New Delhi, the 27th October , 2022

F.No. STD/FA/A-1.30/No.1/2020-FSSAI(P-I).—Whereas the draft Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2021, were published as required by sub-section (1) of section 92 of the Food Safety and Standards Act, 2006 (34 of 2006) vide notification of the Food Safety and Standards Authority of India number F.No. STD/FA/A-1.30/No.1/2020-FSSAI(P-I), dated the 27th December, 2021, in the Gazette of India, Extraordinary, Part III, section 4, inviting objections and suggestions from persons likely to be affected thereby before the expiry of period of sixty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public;

And whereas copies of the said Gazette were made available to the public on the 4th January, 2022;

And whereas objections and suggestions received from the public in respect of the said draft regulations have been considered by the Food Safety and Standards Authority of India;

Now, therefore, in exercise of the powers conferred by clause (e) of sub-section (2) of section 92 of the Food Safety and Standard Act, 2006, the Food Safety and Standards Authority of India hereby makes the following regulations further to amend the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, namely:—

1. (1) These regulations may be called the Food Safety and Standards (Food Products Standards and Food Additives) Second Amendment Regulations, 2022.

(2) They shall come into force on the date of their publication in the Official Gazette.

2. In the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, in Appendix C, under the heading “II. USE OF PROCESSING AIDS IN FOOD PRODUCTS”, after TABLE 11 relating to “ENZYMES (for treatment or processing of raw materials, foods, or ingredients)”, the following Table shall be inserted, namely:—

“TABLE 11 A: Enzymes derived from Genetically Modified Microorganisms (GMM)

Sl. No.	Enzyme Name	Production Organism	Donor Organism or Source	Functional and technological purpose	Indicative food uses	Residu al level (mg/ kg) (Not more than)
1.	Glucose oxidase (EC No. 1.1.3.4)	Aspergillus oryzae	Aspergillus niger	Dough stabilizer	Baking and other cereal-based processes (bread, pasta, noodles, snacks)	GMP
		Aspergillus niger	Penicillium chrysogenum	Dough stabilizer, food preservative, color stabilizer and for reduced alcohol wine production	Bakery products and other cereal based products (e.g. pasta, noodles, snacks), Egg processing, fruit and vegetable processing, Production of beer and other cereal based beverages	GMP
		Aspergillus niger	Aspergillus niger	For conversion of glucose to gluconic acid in presence of dissolved oxygen	In food processing to remove glucose and oxygen and in bakery application	GMP
2.	Hexose oxidase (EC No. 1.1.3.5)	Hansenula polymorpha	Chondrus crispus	To catalyze the oxidation of C6 sugars into their corresponding lactones and hydrogen peroxide	In food processing of wide range of products for dough-strengthenin, oxygen scavenging, curd formation and to reduce the occurrence of excessive maillard reactions	GMP
3.	Catalase (EC No. 1.11.1.6)	Aspergillus niger	Aspergillus niger	Catalyzes the decomposition of hydrogen peroxide to water and oxygen	In food processing for enzymatic production of gluconic acid, removal of hydrogen peroxide or generation of oxygen in foods and beverages	GMP
3.	Catalase (EC No. 1.11.1.6)	Trichoderma reesei	Aspergillus niger	Catalyzes the decomposition of hydrogen peroxide to water and oxygen	For egg processing	GMP
4.	Peroxidase (EC No. 1.11.1.7)	Aspergillus niger	Marasmiusscorodonius	Preservation of raw milk, yoghurt and cheese	Dairy processing (whey processing) and Production of bakery products	GMP
5.	Phosphatidylcholi ne-sterol O- acyltransferase ( EC No. 2.3.1.43)	Bacillus licheniformis	Aeromonassalmonicida	Modification of phospholipids to lyso- phospholipids and cholesterol ester	Baking, dairy, egg processing, fats and oils Processing, meat processing	GMP
6.	1,4-alpha-glucan branching (EC No. 2.4.1.18)	Bacillus subtilis	Rhodothermus obamensis	Converts amylose into amylopectin	Starch processing
7.	4-α- glucanotransferase (amylomaltase) ( EC No. 2.4.1.25)	Bacillus amyloliquefaciens	Thermus thermophilus	Modification of the structural properties of starch to mimic fat.	Starch processing	GMP
8.	Triacylglycerol Lipase (EC No. 3.1.1.3)	Aspergillus niger	Fusarium culmorum	Improvement of texture of fat in bakery products, flavour modification, interesterification of fats, degumming of oils and fats	Production of bakery products dairy processing oils and fats processing	GMP
		Kluyveromyces lactis	Calf, goat, lamb	Improvement of texture of n bakery products, flavour modification, interesterification of fats, degumming of oils and fats	Production of bakery products dairy processing oils and fats processing	GMP
		Hansenula polymorpha	Fusarium heterosporum	Improvement of texture of bakery products, modifying egg yolk for use in cake preparation and degumming of oils and fats	Production of Bakery products, egg processing, fats and oils processing	GMP
		Aspergillus niger	Candida antarctica	Degumming of oils and fats	Oils and Fats processing	GMP
		Aspergillus oryzae	Humicola lanuginosa and Fusarium oxysporum	Improvement of texture of bakery products, flavour modification, modifying egg yolk for use in cake preparation interesterification of fats, degumming of oils and fats	Bakery and other cereal-based products(brea d, pasta, noodles, snacks), brewing and other cereal-based beverages, egg processing oils and fats processing	GMP
		Aspergillus oryzae	Fusarium oxysporum	Improvement of texture of bakery products, flavour modification, modifying egg yolk for use in cake preparation interesterification of fats, degumming of oils and fats	Bakery and other cereal-based products (bread, pasta, noodles, snacks) Egg processing, brewing and other cereal-based beverages	GMP
		Aspergillus oryzae	Thermomyces lanuginosus	Improvement of texture of bakery products, flavour modification, modifying egg yolk for use in cake preparation, interesterification of fats, degumming of oils and fats	Bakery and other cereal-based products (bread, pasta, noodles, snacks), brewing and other cereal-based beverages egg processing oils and fats processing	GMP
		Aspergillus Oryza	Rhizomucor miehei	Interesterification of fats, degumming of oils and fats	oils and fats processing	GMP
		Trichoderma reesei	Aspergillus niger	As a processing aid in food manufacturing to catalyze the hydrolysis of ester bonds in triglycerides primarily in 1 and 3 positions of fatty acids in triglycerides with release of fatty acids and glycerol	For use in baking and brewing process, in the manufacture of cereal beverage, in pasta production, and in potable alcohol production	GMP
9.	Phospholipase A2 (EC No. 3.1.1.4)	Aspergillus niger	Porcine pancreas	Oil degumming	Production of bakery products , egg processing, oils and fats processing	GMP
10.	Lysophospholipase (EC No. 3.1.1.5)	Aspergillus niger	Aspergillus niger	Dough stabilizer, Improvement of texture of bakery products, enhance filtration rate of syrups, De-gumming of oils and fats	Bakery and other cereal-based products(brea d, pasta, noodles, snacks) starch based products oils and fats processing	GMP
11.	Pectin esterase (EC No. 3.1.1.11)	Aspergillus niger	Aspergillus niger	Juice extraction, concentration and clarification of fruit juices, gelation of fruit, and to modify texture and rheology of fruit and vegetable-based products	Fruit and vegetable products, flavouring production	GMP
11.	Pectin esterase (EC No. 3.1.1.11)	Aspergillus oryzae	Aspergillus aculeatus	Juice extraction, concentration and clarification of fruit juices, gelation of fruit, and to modify texture and rheology of fruit and vegetable-based products	Fruit and vegetable products	GMP
12.	Phospholipase A1 (EC No. 3.1.1.32)	Aspergillus oryzae	Fusarium venenatum	To modify the functionality of dairy products and its ingredients	Milk and dairy based products	GMP
		Aspergillus niger	Aspergillus niger	De-gumming of oils and fats	Oils and fats processing	GMP
		Aspergillus niger	Talaromyces leycettanus	De-gumming of oils and fats	Oils and Fats processing	GMP
13.	3-phytase (EC No. 3.1.3.8)	Aspergillus niger	Aspergillus niger (A. niger also include A. tubingensis)	Phytate reduction in cereals and legumes	Bakery products and other cereal and legume based products (e.g. pasta, noodles, snacks), soy sauce	GMP
14.	Phytase (EC No. 3.1.3.26)	Trichoderma reesei	Buttiauxella sp.	Hydrolysis of phytic acid	In potable alcohol production and in animal feed	GMP
15.	Phospholipase C (EC No. 3.1.4.3)	Pichia pastoris (now renamed as Komagataellapha ffiï)	Soil	De-gumming of oils and fats	Oils and fats processing	GMP
15.	Phospholipase C (EC No. 3.1.4.3)	Bacillus licheniformis	Bacillus thuringiensis	De-gumming of oils and fats	Oils and fats processing	GMP.
16.	Phosphoinositide phospholipase C (EC No. 3.1.4.11)	Pseudomonas fluorescens	Soil	De-gumming of oils and fats	Oils and fats processing	GMP
16.	Phosphoinositide phospholipase C (EC No. 3.1.4.11)	Bacillus licheniformis	Pseudomonas sp- 62186	De-gumming of oils and fats	Oils and Fats processing	GMP
17	Alpha –amylase (EC No. 3.2.1.1)	Bacillus subtilis	Alicyclobacillus pohliae	Antistaling agent in combination with lipase	Bakery products	GMP
		Bacillus licheniformis	Bacillus licheniformis	Liquefaction and thinning of starch, fermentation, Starch processing into dextrins and of oligosaccharides. High DE-maltodextrin production	Brewing, Potable alcohol production, Grain or Carbohydrate , nonalcoholic Beverages, and bakery products, processing of starch for other purposes	GMP
		Bacillus licheniformis	Geobacillus stearothermophilus	Liquefaction and thinning of starch, fermentation, starch processing into dextrins and oligosaccharides and high DE-maltodextrin.	Processing of starch for baking, brewing and fermentation	GMP
		Bacillus licheniformis	Cytophaga sp.	Liquefaction and thinning of starch, fermentation	Processing of starch for baking and brewing processes	GMP
		Pseudomonas fluorescens	Thermococcales	Starch processing into dextrins and oligosaccharides and high DE-maltodextrin	Processing of starch for baking, brewing and fermentation	GMP
		Aspergillus niger	Rhizomucor pusillus	Starch processing into dextrins and oligosaccharides and high DE-maltodextrin	Processing of starch for baking, brewing and fermentation and other processes	GMP
		Trichoderma reesei	Aspergillus clavatus	Starch processing into dextrins and of oligosaccharides. High DE-maltodextrin production	In Carbohydrate or starch processing, brewing and potable alcohol production	GMP
		Trichoderma reesei	Aspergillus kawachii	Starch processing into dextrins and of oligosaccharides. High DE-maltodextrin production	In Carbohydrate or starch processing, brewing and potable alcohol production	GMP
		Bacillus amyloliquefaciens	Bacillus amyloliquefaciens	As processing aid in food manufacturing to hydrolyze polysaccharides	Carbohydrate or grain processing, potable alcohol production, brewing, cereal processes, non-alcoholic beverages	GMP
		Trichoderma reesei	Aspergillus terreus	Starch processing into dextrins and of oligosaccharides. High DE-maltodextrin production	Brewing, Potable alcohol production, grain or carbohydrate, non-alcoholic beverages, cereal processes	GMP
18.	Beta-amylase (EC No. 3.2.1.2)	Bacillus licheniformis	Bacillus flexus	Starch processing into maltose	Starch processing for maltose-based syrups	GMP
19.	Glucoamylase (Glucan 1,4- alpha-glucosidase or Acid maltase or Amyloglucosidase) (EC No. 3.2.1.3)	Trichoderma reesei	Trichoderma reesei	Processing of polysaccharides and oligosaccharides for improved fermentation and liquefaction	Brewing, fermentation and starch liquifaction and saccharifactio n	GMP
		Aspergillus niger	Gloeophyllum trabeum	Processing of polysaccharides and oligosaccharides for improved brewing fermentation, clarification and starch liquefaction , starch liquefaction and Saccharification	Brewing, fermentation and starch liquifaction and saccharifactio n	GMP
		Aspergillus niger	Aspergillus niger	Processing of polysaccharides and oligosaccharides for improved brewing fermentation, clarification and starch liquefaction	Brewing, fermentation and starch liquefaction and saccharificati on	GMP
		Aspergillus niger	Talaromyces emersonii	Processing of polysaccharides and oligosaccharides for improved brewing fermentation, clarification and starch liquefaction	Brewing, fermentation and starch liquefaction and saccharificati on processes	GMP
		Aspergillus niger	Trametes cingulata	Processing of polysaccharides and oligosaccharides for improved brewing fermentation, clarification and starch liquefaction and Saccharification	Brewing, fermentation and starch liquefaction and saccharificati on processes	GMP
		Aspergillus niger	Penicillum oxalicum	Processing of polysaccharides and oligosaccharides for improved brewing fermentation, clarification and starch liquefactionandSaccharific ation	Brewing, fermentation and starch liquifaction and saccharifactio n	GMP
		Trichoderma reesei	Aspergillus fumigatus	Processing of polysaccharides and oligosaccharides for improved fermentation and liquefaction	For carbohydrate or grain processing, brewing and potable alcohol production	GMP
		Trichoderma reesei	Fusarium verticillioides	Processing of polysaccharides and oligosaccharides for improved fermentation and liquefaction	For carbohydrate or grain processing, brewing and potable alcohol production	GMP
20	Cellulase (EC No. 3.2.1.4)	Trichoderma reesei	Aspergillus fumigatus	Hydrolysis of amorphous cellulose	Brewing	GMP
		Trichoderma reesei	Penicillium emersonii	Hydrolysis of amorphous cellulose. Saccharification	Brewing	GMP
		Trichoderma reesei	Trichoderma reesei	As processing aid in food manufacturing or breakdown of cellulose	For carbohydrate processing, potable alcohol production, maceration in fruit and vegetable processing, brewing and wine production and in food processing of other wide range of products like coffee	GMP
21.	Beta-glucanase (endo-beta glucanase or endo- 1,3-beta glucanase) (EC No. 3.2.1.6)	Bacillus subtilis	Bacillus subtilis	Hydrolysis of beta- glucans, to improve the brewing properties of beer	Brewing processes	GMP
22.	Xylanase (Endo-1,4-beta- xylanase) (EC No. 3.2.1.8)	Aspergillus niger	Aspergillus niger	Hydrolysis of plant carbohydrates to improve quality of bakery products (firmness, stiffness, consistency and others)	Bakery and other cereal based products	GMP
		Aspergillus oryzae	Humicola lanuginosus	Dough stabilizer, enhancing loaf volume, enhance crumb structure and bloom	Bakery products	GMP
		Bacillus subtilis	Bacillus subtilis	Dough stabilizer, ehancing loaf volume, enhance crumb structure bloom and loaf softening, hydrolysis of plant carbohydrates to improve quality of bakery products (firmness, stiffness, consistency and others)	Bakery products, carbohydrate or starch processing, Brewing, Potable alcohol production, non-alcoholic beverages processing	GMP
		Trichoderma reesei	Talaromyces leycettanus	To improve filtration in brewing, Starch liquefaction and enhance oil extraction from grain	Baking and Brewing and oil extraction –	GMP
		Aspergillus niger	Rasamsonia emersonii	Dough stabilizer, enhancing loaf volume, crumb structure, bloom and loaf softening, improving filtration in brewing, starch liquefaction	Bakery products production of beer and other cereal based beverages	GMP
		Trichoderma reesei	Aspergillus niger	Dough stabilizer, enhancing loaf volume, crumb structure, bloom and loaf softening, to improve filtration in brewing, starch liquefaction	Brewing and baking productspota ble alcohol production, non-alcoholic beverages	GMP
		Aspergillus oryzae	Aspergillus aculeatus	Dough stabilizer, enhance loaf volume, crumb structure, bloom and loaf softening, to improve filtration in brewing, starch liquefaction	Baking brewing and other cereal-based beverages and starch processing	GMP
		Bacillus licheniformis	Bacillus licheniformis	Dough stabilizer, enhancer of loaf volume, enhance crumb structure,bloom and loaf softening. starch liquefaction	Baking and brewing processes grain treatment	GMP
		Trichoderma reesei	Fusarium verticillioides	Hydrolysis of plant carbohydrates to improve quality of bakery products (firmness, stiffness, consistency and others)	As processing aid in carbohydrate or starch processing and potable alcohol production	GMP
23.	Endo- Polygalacturonase (Pectinase) (EC No 3.2.1.15)	Aspergillus niger	Aspergillus niger	Extraction and clarification of juice from fruits and vegetables, extraction of flavors	Fruit and vegetable processing, flavouring production	GMP
24.	Alpha-glucosidase (EC No 3.2.1.20)	Trichoderma reesei	Aspergillus niger	Aids in fermentation, hydrolysis of terminal, non-reducing (1 ~4)- linked alpha-D-glucose residues with release of alpha-D-glucose	Brewing and starch processing	GMP
25.	Lactase (Beta- galactosidase) (EC No 3.2.1.23)	Kluyveromyces lactis	Kluyveromyces lactis	Hydrolysis of lactose content of in whey or milk	Dairy products and processing	GMP
		Bacillus subtilis	Bifidobacterium bifidum	Hydrolysis of lactose content of whey or milk	Dairy products and , production of GOS (galacto-oligosacchari de)	GMP
		Aspergillus niger	Aspergillus oryzae	Hydrolysis of lactose content of whey or milk	Dairy products and processing	GMP
		Bacillus licheniformis	Bifidobacterium bifidum	Hydrolysis of lactose content of whey or milk	Dairy products and processing	GMP
		Bacillus subtilis	Lactobacillus delbrueckii subsp. bulgaricus	Hydrolysis of lactose content of in whey or milk	In dairy processing, GOS (galacto-oligosacchari de) production and production of low lactose products	GMP
		Aspergillus oryzae	Aspergillus oryzae	Hydrolysis of lactose content of in whey or milk	In dairy processing, GOS (galacto-oligosacchari de) production and production of low lactose products	GMP
26.	Trehalase (EC No 3.2.1.28)	Trichoderma reesei	Trichoderma reesei	Starch processing for fermentation	Brewing process	GMP
26.	Trehalase (EC No 3.2.1.28)	Aspergillus niger	Myceliophthorasepedo nium	Starch processing for fermentation	Brewing process	GMP
27.	Pullulanase (EC No 3.2.1.41)	Bacillus licheniformis	Bacillus deramificans	Hydrolysis of pullulan in starch processing, as processing aid in efficient starch hydrolysis and saccharification	Brewing processes and production of sweeteners, manufacture of starch or carbohydrate processing	GMP
		Bacillus subtilis	Bacillus acidopullulyticus	Hydrolysis of pullulan in starch processing	Brewing processes and manufacture of sweeteners	GMP
		Bacillus subtilis	Bacillus deramificans	Hydrolysis of pullulan in grain processing	Brewing and starch processing	GMP
28.	Alpha arabinofuranosida se (EC No. 3.2.1.55)	Trichoderma reesei	Talaromyces pinophilus	Separation of soluble and starch or gluten fractions	Potable alcohol production	GMP
29.	Maltotetraohydrol ase or glucan 1,4-alpha- maltotetraohydrol ase (EC No. 3.2.1.60)	Bacillus licheniformis	Pseudomonas stutzeri (saccharophila)	Dough stabilizer, anti- staling agent in baking, antiretrogradation agent to enhance the quality attributes of bakery products	Baking, carbohydrate or grain processing	GMP
30.	Mannan endo-1,4- beta- mannosidase (β-mannanase) (EC No. 3.2.1.78)	Aspergillus niger	Talaromyces leycettanus	Hydrolysis of mannan to inhibit gel formation during freeze-drying of the instant coffee	Coffee processing	GMP.
31.	Glucan 1,4-alpha- maltohydrolase (Maltogenic alpha- amylase ) (EC No 3.2.1.133)	Bacillus subtilis	Geobacillus stearothermophilus	Anti-staling agent to prevent retrodegradation of starch in baking, industry. Production of tailor-made sweetener syrups with low viscosity, high maltose contents	Bakery products and sweetener syrups	GMP
31.		Bacillus licheniformis	Geobacillus stearothermophilus	Anti-staling agent to prevent retro-degradation of starch in baking, industry. Production of tailor-made sweetener syrups with low viscosity, high maltose contents	As processing aid in bakery, starch processing, brewing and potable alcohol	GMP
32.	Carboxypeptidase (EC No. 3.4.16.5)	Aspergillus niger	Aspergillus niger	Used to accelerate the development of flavors and the de-bittering during the ripening process of cheese. debitteringagent in cheese manufacture.	Cheese, enzyme modified cheese, cheese powders and fermented meat	GMP
33.	Chymotrypsin (EC No. 3.4.21.1)	Bacillus licheniformis	Nocardio psisprasina	Increased digestibility of protein and reduce allergenicity	Protein hydrolysis, yeast processing	GMP.
34.	Serine protease with trypsin specificity Or (Trypsin) (EC No. 3.4.21.4)	Fusarium venenatum	Fusarium oxysporum	Increased digestibility of protein and reduce allergenicity	Dairy processing protein hydrolysis	GMP
35.	Acid prolylendopeptida se (EC No. 3.4.21.26)	Aspergillus niger	Aspergillus niger	Degradation of cereal storage proteins to smaller peptides for optimal fermentation beer stability, prevention of chill haze without loss of foam properties	Beer and other cereal based beverages	GMP
36.	Serine protease (Subtilisin) (EC No. 3.4.21.62)	Bacillus subtilis	Bacillus amyloliquefaciens	Facilitates protein hydrolysis during processing	Protein processing	GMP
		Bacillus licheniformis	Pyrococcus furiosus	Hydrolysis of proteins	Protein hydrolysis and protein hydrolysates	GMP
		Bacillus subtilis	Bacillus lentus	To catalyze protein hydrolysis	As processing aid in plant protein processing, fish and seafood protein processing, yeast processing, animal protein processing, xanthan gum processing, and microalgae processing	GMP.
37.	Chymosin (EC No. 3.4.23.4)	Trichoderma reesei	Bos taurus (bovine)	Milk Coagulant, processing aid in cheese manufacturing. Chymosin helps in coagulating milk by hydrolyzing milk protein	Milk or dairy processing, production of cheese, whey and lactose	GMP
37.	Chymosin (EC No. 3.4.23.4)	Kluyveromyces lactis	Bovine pro-chymosin	Milk Coagulant	Milk processing	GMP
38.	Aspergillopepsin I, aspartic protease) (EC No. 3.4.23.18)	Trichoderma reesei	Trichoderma reesei	Catalyses hydrolysis of proteins with broad specificity	Processing of proteins, clarification of fruit and vegetable juices and alcoholic drinks, modification of wheat gluten in bakery products	GMP
39.	Mucorpepsin (Mucor rennin) (EC No. 3.4.23.23)	Aspergillus oryzae	Rhizomucor miehei	Milk coagulation in cheese making.	Dairy processing	GMP.
40.	Bacillolysin (Bacillus metalloendopeptid ase) (EC No. 3.4.24.28)	Bacillus amylolique faciens	Bacillus amylolique faciens	Protein processing into peptides and hydrolysate	Production of bakery products and other cereal based products (e.g. pasta, noodles, snacks), production of beer and other cereal based beverages, dairy processing, flavouring production, production of cereal based distilled alcoholic beverages, protein processing and yeast processing	GMP
40.		Bacillus subtilis	Bacillus amyloliquefaciens	Protein processing into peptides and hydrolysate	Production of bakery products and other cereal based products (e.g. pasta, noodles, snacks), production of beer and other cereal based beverages, dairy processing, flavouring production, production of cereal based distilled alcoholic beverages, protein processing and yeast processing	GMP
41.	Asparaginase (EC No 3.5.1.1)	Aspergillus niger	Aspergillus niger	Reduce acrylamide levels	Production of bakery products and other cereal based products (e.g. pasta, noodles, snacks) potato processing and coffee processing	GMP
		Aspergillus oryzae	Aspergillus oryzae	Reduce acrylamide levels	Baking and other cereal-based processes (bread, pasta, noodles, snacks) coffee processing and potato processing	GMP
		Bacillus subtilis	Pyrococcus furiosus	Reduce acrylamide levels	Baking and other cereal-based processes (bread, pasta, noodles, snacks) coffee and cocoa processing fruit and vegetable processing	GMP
42.	Glutaminase (EC No. 3.5.1.2)	Bacillus licheniformis	Bacillus licheniformis	In controlling the taste and flavor of fermented foods containing ingredients such as; casein, whey protein, soy and wheat protein	Dairy processing egg processing protein processing yeast processing	GMP
43.	Acetolactate decarboxylase (Alpha – acetolactate decarboxylase) (EC No. 4.1.1.5)	Bacillus licheniformis	Bacillus brevis	In brewing beverage processes and beverage alcohol (distilling) processes 1) Reduces formation of diacetyl during fermentation and thereby a reduction of the off-flavours 2) Enhances maturation process and thereby reduces production time.	Brewing and other production of cereal based alcoholic beverages	GMP
43.		Bacillus subtilis	Brevibacillus brevis	Butanoate metabolism and C-5 branched dibasic acid metabolism	In brewing and potable alcohol production	GMP
44.	Pectin lyase (EC No. 4.2.2.10)	Aspergillus niger	Aspergillus niger	Enhances juice extraction from vegetables and fruits and for juice clarification	Fruit and vegetable processing, production of wine, flavouring production and coffee processing	GMP
45.	Glucose isomerase (EC No. 5.3.1.5)	Streptomyces rubiginosus	Streptomyces rubiginosus	Reversible isomerization of glucose to fructose	Production of high fructose corn syrup	GMP .”.

S GOPALAKRISHNAN, Chief Executive Officer
[ADVT.-III/4/Exty./355/2022-23]

Note. — The principal regulations were published in the Gazette of India, Extraordinary, Part III, Section 4, vide notification number F. No. 2-15015/30/2010, dated the 1st August, 2011 and subsequently amended vide notification numbers :—

1) F.No. 4/15015/30/2011, dated 7th June, 2013;

2) F.No. P. 15014/1/2011-PFA/FSSAI, dated 27th June, 2013;

3) F. No. 5/15015/30/2012, dated 12th July, 2013;

4) F.No. P. 15025/262/2013-PA/FSSAI, dated 5th December, 2014;

5) F.No. 1-83F/Sci. Pan- Noti/FSSAI-2012, dated 17th February, 2015;

6) F.No. 4/15015/30/2011, dated 4th August, 2015;

7) F.No. P.15025/264/13-PA/FSSAI, dated 4th November, 2015;

8) F.No. P. 15025/263/13-PA/FSSAI, dated 4th November, 2015;

9) F.No. P. 15025/261-PA/FSSAI, dated 13th November, 2015;

10) F.No. P. 15025/208/2013-PA/FSSAI, Dated 13th November, 2015;

11) F.No. 7/15015/30/2012, dated 13th November, 2015;

12) F.No. 1-10(1)/Standards/SP(Fish and Fisheries Products)/FSSAI-2013, dated 11th January, 2016;

13) No. 3-16/Specified Foods/Notification(Food Additives)/FSSAI-2014, dated 3rd May, 2016;

14) F.No. 15-03/Enf/FSSAI/2014, Dated 14th June, 2016;

15) No. 3-14F/Notification (Nutraceuticals)/FSSAI-2013, dated 13th July, 2016;

16) F.No. 1-12/Standards/SP (Sweets, Confectionery)/FSSAI-2015, dated 15th July, 2016;

17) F.No. 1-120(1)/Standards/Irradiation/FSSAI-2015, dated 23rd August, 2016;

18) F. No. 11/09/Reg/Harmoniztn/2014, dated 5th September, 2016;

19) F.No. Stds/CPLQ.CP/EM/FSSAI-2015, dated 14th September, 2016;

20) F.No. 11/12 Reg/Prop/FSSAI-2016, dated 10th October, 2016;

21) F.No. 1-110(2)/SP (Biological Hazards)/FSSAI/2010, dated 10th October, 2016;

22) F.No. Stds/SP (Water & Beverages)/Notif (2)/FSSAI-2016, dated 25th October, 2016;

23) F.No. 1-11(1)/Standards/SP (Water & Beverages)/FSSAI-2015, Dated 15th November, 2016;

24) F.No. P.15025/93/2011-PFA/FSSAI, Dated 2nd December, 2016;

25) F.No. P. 15025/6/2004-PFS/FSSAI, dated 29th December, 2016;

26) F.No. Stds/O&F/Notification(1)/FSSAI-2016, dated 31st January, 2017;

27) F.No. 1-12/Standards/2012-FSSAI, dated 13th February, 2017;

28) F.No. 1-10(7)/Standards/SP (Fish & Fisheries Products)/FSSAI-2013, dated 13th February, 2017;

29) F. No. Stds /SCSS&H/ Notification (02)/FSSAI-2016, dated 15th May, 2017;

30) F. No. Stds/03/Notification (LS)/ FSSAI-2017, dated 19th June, 2017;

31) F.No. 1/Additives/Stds/14.2Notification/FSSAI/2016, dated 31st July, 2017;

32) F.No. Stds/F&VP/Notification(01)/FSSAI-2016, dated 2nd August, 2017;

33) F.No. 1-94(1)/FSSAI/SP(Labelling)/2014, dated 11th September, 2017;

34) F.No. Stds/M&MPIP(1)/SP/FSSAI-2015, dated 15th September, 2017;

35) No. Stds/SP (Water & Beverages)/Noti(1)/FSSAI-2016,dated 15th September,2017;

36) F.No.1-10(8)/Standards/SP (Fish and Fisheries Products)/FSSAI-2013, dated 15th September, 2017;

37) File No. 2/Stds/CPL & CP/Notification/FSSAI-2016, dated 18th September, 2017;

38) F. No. A-1 (1)/Standard/MMP/2012, dated 12th October, 2017;

39) F. No. Stds/O&F/Notification (3)/FSSAI-2016, dated 12th October, 2017;

40) F. No. 2/Stds/CPL & CP/Notification/FSSAI-2016(part), dated the 24th October, 2017;

41) F. No. A-1/Standards/Agmark/2012-FSSAI(pt.I), dated 17th November, 2017;

42) F.No. 1/Additives/Stds/BIS Notification/FSSAI/2016, dated 17th November, 2017;

43) F. No. Stds/O&F/Notification (5)/FSSAI-2016, dated 20th February , 2018;

44) F.No. Stds/01-SP(fortified & Enriched Foods)-Reg/FSSAI-2017, dated 13th March, 2018;

45) F. No. 1/Infant Nutrition/Stds/Notification/FSSAI/2016, dated 13th March, 2018;

46) F. No.1-110(3)/SP (Biological Hazards)/FSSAI/2010, dated the 21st March, 2018;

47) File No. Stds/SCSS&H/ Notification (03)/FSSAI-2016, dated the 10th April, 2018;

48) No. Stds/CPL&CP/Notification/FSSAI-2016, dated 4th May, 2018;

49) F.No. Stds/SP(SCSSH)/Ice lollies notification/FSSAI-2018, Dated 20th July,2018;

50) F.No. Stds/SP(Water & Beverages)/Notif(3)/FSSAI-2016, Dated 20th July,2018;

51) Stds/CPL&CP/ Draft Notification/FSSAI-2017, Dated 31st July, 2018;

52) File No.1/Additional Additives/Stds/Notification/FSSAI/2016, Dated 8th November, 2018and

53) F.No. Stds/03/Notification (CFOI&YC)/FSSAI-2017, Dated 16th November, 2018.

54) F. No. Stds/O&F/Notification (7)/FSSAI-2017, dated 19th November, 2018;

55) F.No. Stds/M&MP/Notification (02)/FSSAI-2016, dated 19th November, 2018;

56) F. No. Stds/F&VP/Notifications (04)/FSSAI-2016, dated 19th November, 2018;

57) F. No. 1-116/Scientific Committee (Noti.)/2010-FSSAI, dated 26thNovember, 2018;

58) F. No. 02-01/Enf-1(1)/FSSAI-2012, dated 29th January, 2019;

59) F.No. Stds/F&VP/Notification (07)/FSSAI-2018, dated 5th July, 2019;

60) F.No.Stds/O&F/Notification(10)/FSSAI-2017, dated 5th July, 2019;

61) F.No. Stds/SP (Water & Beverages)/Notification(5) FSSAI-2018, dated 30th October, 2019 ;

62) F.No. M&MP/Misc. Stds/Notification (03)/FSSAI-2018, dated 28th November, 2019;

63) F.No.1-110/SP (Biological Hazards)/Amendment-1/FSSAI/2018, dated 23rd June, 2020;

64) F. No. Stds/CPL & CP/Notification/01/FSSAI-2018, dated 9th July, 2020;

65) F. No. Stds/CPL & CP/Notification/01/FSSAI-2017, dated 9th July, 2020;

66) F. No. Stds/ M&MPIP (3)/SP/FSSAI-2018, dated 9th July, 2020;

67) F.No.A-1/Standards/Agmark/2012-FSSAI (p+1) , dated 23rd July, 2020;

68) F. No. Stds./M&MP/Notification (04)/FSSAI-2019, dated 2nd September, 2020;

69) F. No. Stds/Additives-1/Notification/FSSAI/2018, dated 16th September, 2020;

70) F. No. 1/Additional Additives-III/Stds/Notification/FSSAI/2017, dated 9th October, 2020;

71) F. No. Stds/Processing aids/Notification/FSSAI/2018, dated 9th October, 2020;

72) F. No. 1-116/Scientific Committee/Notif./2010-FSSAI, dated the 29th December, 2020;

73) F.No. 1-116/Scientific Committee/Notif.27/2010-FSSAI(E), dated the 4th March, 2021;

74) F. No. Stds/O&F/Notification (5)/FSSAI-2017dated 18th March, 2021;

75) File No. 1-116/Scientific Committee/Notif.28.4/2010-FSSAI (1), dated 26th July, 2021;

76) F. No. 1-116/Scientific Committee/Notif.28.4/2010-FSSAI(1) (Pt.F), dated 3rd November, 2021;

77) F. No. Stds/SC/A-1.34/N-1, dated 15th November, 2021;

78) F. No. M&MP/Notification(05)/FSSAI-2019, dated 27th December, 2021; and

79) F. No. 1-116/Scientific Committee/Notif.28.4/2010-FSSAI(2), dated 13 September, 2022.

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Food Safety and Standards (Food Products Standards and Food Additives) Second Amendment Regulations, 2022

Sl. No.

Enzyme Name

Production Organism

Donor Organism or Source

Functional and technological purpose

Indicative food uses

Residu al level (mg/ kg) (Not more than)

1.

Glucose oxidase (EC No. 1.1.3.4)

Aspergillus oryzae

Aspergillus niger

Dough stabilizer

Baking and other cereal-based processes (bread, pasta, noodles, snacks)

GMP

Aspergillus niger

Penicillium chrysogenum

Dough stabilizer, food preservative, color stabilizer and for reduced alcohol wine production

Bakery products and other cereal based products (e.g. pasta, noodles, snacks), Egg processing, fruit and vegetable processing, Production of beer and other cereal based beverages

GMP

Aspergillus niger

Aspergillus niger

For conversion of glucose to gluconic acid in presence of dissolved oxygen

In food processing to remove glucose and oxygen and in bakery application

GMP

2.

Hexose oxidase (EC No. 1.1.3.5)

Hansenula polymorpha

Chondrus crispus

To catalyze the oxidation of C6 sugars into their corresponding lactones and hydrogen peroxide

In food processing of wide range of products for dough-strengthenin, oxygen scavenging, curd formation and to reduce the occurrence of excessive maillard reactions

GMP

3.

Catalase (EC No. 1.11.1.6)

Aspergillus niger

Aspergillus niger

Catalyzes the decomposition of hydrogen peroxide to water and oxygen

In food processing for enzymatic production of gluconic acid, removal of hydrogen peroxide or generation of oxygen in foods and beverages

GMP

Trichoderma reesei

Aspergillus niger

Catalyzes the decomposition of hydrogen peroxide to water and oxygen

For egg processing

GMP

4.

Peroxidase

(EC No. 1.11.1.7)

Aspergillus niger

Marasmiusscorodonius

Preservation of raw milk, yoghurt and cheese

Dairy processing (whey processing) and Production of bakery products

GMP

5.

Phosphatidylcholi ne-sterol O- acyltransferase

( EC No. 2.3.1.43)

Bacillus licheniformis

Aeromonassalmonicida

Modification of phospholipids to lyso- phospholipids and cholesterol ester

Baking, dairy, egg processing, fats and oils Processing, meat processing

GMP

6.

1,4-alpha-glucan branching

(EC No. 2.4.1.18)

Bacillus subtilis

Rhodothermus obamensis

Converts amylose into amylopectin

Starch processing

7.

4-α-

glucanotransferase (amylomaltase)

( EC No. 2.4.1.25)

Bacillus amyloliquefaciens

Thermus thermophilus

Modification of the structural properties of starch to mimic fat.

Starch processing

GMP

8.

Triacylglycerol Lipase

(EC No. 3.1.1.3)

Aspergillus niger

Production
Organism

Donor Organism or
Source

Functional and
technological purpose

Indicative
food uses

Residu
al level
(mg/
kg)
(Not
more
than)

Aspergillus
oryzae

Penicillium
chrysogenum

Dough stabilizer, food preservative, color
stabilizer and for reduced alcohol wine production

Catalyzes the decomposition of hydrogen peroxide to
water and oxygen

Trichoderma
reesei

Bacillus
licheniformis

Modification of phospholipids to lyso- phospholipids and
cholesterol ester

Rhodothermus
obamensis

Modification of the structural properties of
starch to mimic fat.

Improvement of texture of fat in bakery products, flavour modification,
interesterification of fats, degumming of oils and fats

Kluyveromyces
lactis

Hansenula
polymorpha

Fusarium
heterosporum

bakery products,
modifying egg yolk for use in cake preparation and degumming of oils and fats

Aspergillus
oryzae

Humicola lanuginosa
and Fusarium
oxysporum

Aspergillus
oryzae

modification, modifying
egg yolk for use in cake preparation interesterification of fats, degumming of oils and fats

Aspergillus
oryzae

Thermomyces
lanuginosus

Aspergillus
Oryza

Trichoderma
reesei