IS 15757:2022
(Edition unknown)INFANT FOOD - FOLLOW- UP FORMULA - SPECIFICATION
Standard No.
IS 15757:2022
Category
product manual
Edition Year
unknown
Regulatory Status
Voluntary Reference
Certification
Scheme-I (ISI)
Issuing Authority
BIS
Specification Scope & Applicable Requirements
This Indian Standard establishes regulatory specifications, quality metrics, sampling procedures, and conformity criteria officially promulgated under the Bureau of Indian Standards Act.
Regulatory Context & Certification Architecture
| Regulatory Parameter | Gazetted Record |
|---|---|
| Compulsory QCO Status | Voluntary Standard Reference |
Sourced Documentary Evidence
PM/ IS 15757/3 November 2022 उत्पाद मान ु यल शिि ु आहार - अन ु सररत फाम म ूला - शिशिशि 15757: 2022 के अन ु सार PRODUCT MANUAL FOR INFANT FOOD - FOLLOW- UP FORMULA - SPECIFICATION ACCORDING TO IS 15757: 2022 भारतीय मानक ब्य ू रो (अन ु रूपता म ू लया ां कन) विवनयम 2018 की स्कीम-I के तहत यह उत्पाद मान ु यल प्रमाणीकरणके प्रचलन मे रीवत और पारदवशिता के स ु स ां गता स ु वनवित करने के वलए सभी क्षेत्रीय/शाखा कायािलयों एि ां लाइसेन्स धाररयों द्वारा स ां दभि सामग्री के रूप मे उपयोग वकया जाएगा। बीआईएस लाइसेन्स/प्रमाण पत्र प्राप्त करने के इच्छ ु क भािी आिेदकों द्वारा भी इस दस्तािेज़ का उपयोग वकया जा सकता है। This Product Manual shall be used as reference material by all Regional/Branch Offices & licensees to ensure coherence of practice and transparency in operation of certification under Scheme-I of Bureau of Indian Standards (Conformity Assessment) Regulations, 2018 for various products. The document may also be used by prospective applicants desirous of obtaining BIS certification licence/certificate. 1. उत्पाद Product : IS 15757: 2022 िीर्ूक Title : शिि ु आहार - अन ु सररत फाम म ूला Infant Food - Follow- Up Formula स ं िोधन स ं ख्या No. of Amendments
: 01 2. नम ु नाकरण शदिा शनदेि Sampling Guidelines: a) कच्चा माल Raw material : a) Manufacturer to submit declaration/ undertaking in compliance to Clause 4.3.1, 4.3.3 and 4.4 of IS 15757:2022. b) Manufacturer to maintain test report/test certificates w.r.t. fat and linoleic acid in compliance to Clause 4.3.2 of IS 15757:2022. Manufacturer to submit declaration/ undertaking w.r.t. partially hydrogenated oils and fats in compliance to Clause 4.3.2 of IS 15757:2022 c) In case the manufacturer opts for addition of any Optional Ingredients as per provisions of Cl. 4.5 of IS 15757:2022, undertakings/declaration in compliance to clause 5.7 and/or 5.7.1 of IS 14433:2022 to be submitted. d) In case the manufacturer opts for addition of any Food Additives, it is required to submit declaration/ undertaking in compliance to Clause 4.6.1 and/or Clause 4.6.2 of IS PM/ IS 15757/3 November 2022 15757:2022 e) In case of addition of pesticide residue, antibiotic and veterinary drug residues, naturally occurring toxins and other contaminants the manufacturer is required to submit
palmitate reference standard, Retinyl acetate reference standard, αtocopheryl acetate reference standard, α-tocopherol reference standard, Retinyl palmitate stock standard solution, Retinyl acetate stock standard solution, α-tocopheryl acetate stock standard solution, α-tocopherol stock standard solution, HPLC system, HPLC column, Water bath, Centrifuge, UV-VIS spectrometer, Analytical balance, Amber HPLC vials, Disposable centrifuge tubes, Laboratory mechanical test tube shaker, Sonicator bath, One-mark volumetric flasks, Vacuum filtration apparatus, Laboratory glass bottles 11. Vitamin K Cl 4.8, Table 1, Sl. No. (x) Acetic acid(glacial), Helium or nitrogen, Hexane( HPLC grade), Isooctane (2,2,4-trimethylpentane)(HPLC grade), Isopropanol (isopropyl alcohol)(HPLC grade), Methanol(HPLC grade),Phytonadione/ phylloquinone (vitamin K1), primary reference standard, distilled water, Ethanol, Sodium acetate(anhydrous), Zinc, Zinc chloride, HPLC system, Analytical balance(LC= 0.000 01 PM/ IS 15757/3 November 2022 g),Beakers, Centrifuge, Centrifuge tubes and caps, Gas regulator, compatible with helium or nitrogen, Gas sparge, tubing and filtering
assembly, Magnetic stirrer and stir bar, centrifuge tubes, Pipet, Spectrophotometer, Volumetric flasks, Volumetric pipets, Vortex mixers. 12. Thiamine Cl 4.8, Table 1, Sl. No. (xi) Niacinamide (nicotinamide), Niacin (nicotinic acid), Pyridoxine hydrochloride, Riboflavin, Thiamine hydrochloride, Pyridoxamine dihydrochloride, Pyridoxal hydrochloride, 2 H4 -Niacinamide, 2 H4 - Nicotinic acid, 13 C 4 -Pyridoxine: pyridoxine:HCl (4,5- bis(hydroxymethyl)- 13 C 4 ), 2 H3 -Pyridoxal, 2 H3 -Pyridoxamine, 13 C 4 -Thiamine chloride, 13 C 4 ,15 N 2-Riboflavin, Acid phosphatase, Papain from Carica papaya, α–amylase from aspergillus oryzae, Hydrochloric acid concentrated, Ammonium formate, Glacial acetic acid, Formic acid, Laboratory water, Methanol, Ethylenediaminetetracetic acid, disodium salt dihydrate (EDTA), Potassium phosphate dibasic, meta-Phosphoric acid, Buffer solutions for pH meter calibration, Phosphoric acid, Potassium hydroxide, Waters Acquity BEH C18 column2) or equivalent, UHPLC system, Waters Acquity Classic2), or equivalent, Tandem quadrupole mass
pressure assembly, Quartz wool, Pear-shaped flask, Evaporation assembly, e.g. rotary evaporator with vacuum stabiliser and water bath, Vials, brown glass with PTFE-lined septa, Stainless steel cocks, with stainless steel cone. Gas chromatograph OR Method as per EN 13130-1:2004 Cruciform specimen supports, Tubes, Glass rods and beads, food cells, thermostatically controlled ovens or incubators The above list is indicative only and may not be treated as exhaustive PM/ IS 15757/3 November 2022
declaration/undertaking in compliance to Clause 4.10 of IS 15757:2022 b) सम म शहकरण शदिा शनदेि Grouping guidelines : NA c) नम म नेका पररमाण Sample Size : 2 x 500gm 3. परीक्षण उपकरणो की स म ची List of Test Equipment : क ृ पया Annex-ए देखें Please see Annex – A 4. शनरीक्षण ि परीक्षण स्कीम Scheme of Inspection and Testing : क ृ पया Annex-B देखें Please see Annex – B 5. एक शदन में स ं भाशित परीक्षण Possible tests in a day : i) Description ii) Scorched Particles iii) Moisture iv) Total Milk Protein v) Total Fat vi) Total ash vii) Acid insoluble ash in dilute hydrochloric acid viii) Solubility Index ix) Iron x) Sodium xi) Potassium xii) Chloride xiii) Calcium xiv) Phosphorus xv) Magnesium 6. लाइसेन्स का कायूक्षेत्र / Scope of the Licence: IS 15757 : 2022 के अन ु सार मानक म ु हर का उपयोग करने के शलए लाइसेन्स शनम्नशलशित कायूक्षेत्रके शलए प्रदान शकया जाता है “Licence is granted to use Standard Mark as per 15757 : 2022 with the following scope: उत्पाद का नाम Name of the product शिि ु आहार - अन ु सररत फाम म ूला Infant Food - Follow- Up Formula BUREAU OF INDIAN STANDARDS Manak Bhawan, 9, Bahadur Shah Zafar Marg, New Delhi – 110002 PM/ IS 15757/3 November 2022
TO PRODUCT MANUAL FOR INFANT FOOD - FOLLOW- UP FORMULA ACCORDING TO IS 15757: 2022 List of test equipment Major test equipment required to test as per the Indian Standard Sr. No. Tests used in with Clause Reference Test equipment 1. Scorched particles Cl. 4.2 Balance (approximately 500 g capacity and LC=0.1 g), Mixer, Scorched Particles Filtering Discs, Scorched Particles Discs Test Cards, Scorched Particles Tester, Diglycol laurate S or Antifoam B emulsion, distilled water 2. Moisture Cl. 4.8, Table 1, Sl. No.(i) Hot Air Oven, Electronic Balance, Desiccator 3. Total milk protein Cl. 4.8, Table 1, Sl. No.(ii) Potassium sulfate (K2SO4) nitrogen free, Copper (II) sulfate pentahydrate solution, Sulfuric acid (H2SO4), Sodium hydroxide (NaOH) solution, methyl red, ethanol, bromocresol green, Boric acid solution, Hydrochloric acid, Ammonium sulfate, Tryptophan or lysine hydrochloride, Water Bath, Analytical balance, Burette or automatic pipette, Graduated measuring cylinders, Digestion flasks (Kjeldahl), of 500 ml or 800 ml capacities, Boiling aids, e.g. hard pieces of porcelain or high-purity amphoteric alundum (i.e. carbarundum) granules,
Digestion apparatus, Distillation apparatus, Digestion block and Digestion tubes, Exhaust manifold, Centrifugal scrubber apparatus or filter pump or aspirator, Distillation unit, Automatic titrator provided with a pH meter, Filter paper, Illuminated magnetic stirrer plate 4. Total fat Cl. 4.8, Table 1, Sl.No.(iii) Gravimetric Method (as per IS 11721) Reagents Ammonia solution, Ethanol (C2H5OH) or ethanol denatured by methanol, Congo red solution, Diethyl ether (C 2 H 5 O.C 2 H 5 ), Light petroleum Apparatus Analytical balance, Centrifuge, Distillation or evaporation apparatus, Drying oven, Water bath, Mojonnier-type fat-extraction flasks, boiling aids, Measuring cylinders, Pipettes, Tongs, Volumetric flask 5. Total ash Cl. 4.8,Table 1,Sl.No.(iv) Flat Bottom Dish, Muffle Furnace, Desiccator, Analytical Balance, Air- Oven, Burner 6. Acid insoluble ash in dilute hydrochloric acid Cl. 4.8, Table 1, Sl. No.(v) Flat-Bottom Dish of stainless-steel porcelain Silica or platinum, Muffle Furnace, Desiccator, Measuring Cylinder, Heating Mantle, Watch- glass, Water bath, Hot Air oven, Weighing Balance. Dil. HCl, Whatman Filter Paper No.42
PM/ IS 15757/3 November 2022 7. Solubility index Cl. 4.8,Table 1,Sl.No.(vi) Thermometer, Water bath, Electronic Balance, Centrifuge, Electric Mixer, Mixing Jar, Interval Time 8. Vitamin A (as retinol equivalent) Cl. 4.8, Table 1, Sl. No.(vii) Methyl-t-butyl ether, n-Hexane, Ethanol Methanol, Iso-octane (2,2,4- trimethylpentane), Papain (from Carica papaya), Hydroquinone, Glacial acetic acid, Anhydrous sodium acetate, Dilute hydrochloric acid solution, HPLC mobile phase A, HPLC mobile phase B, Retinyl palmitate reference standard, Retinyl acetate reference standard, αtocopheryl acetate reference standard, α-tocopherol reference standard, Retinyl palmitate stock standard solution, Retinyl acetate stock standard solution, α-tocopheryl acetate stock standard solution, α-tocopherol stock standard solution, HPLC system, HPLC column, Water bath, Centrifuge, UV-VIS spectrometer, Analytical balance, Amber HPLC vials, Disposable centrifuge tubes, Laboratory mechanical test tube shaker, Sonicator bath, One-mark volumetric flasks, Vacuum filtration apparatus, Laboratory glass bottles 9. Vitamin D (expressed as
chole-calciferol) Cl 4.8, Table 1, Sl.No. (viii) Vitamin D2(ergocalciferol), Vitamin D3 (cholecalciferol), d6-Vitamin D2, d6-Vitamin D3, PTAD (4-phenyl-1,2,4-triazoline-3,5-dione), Formic acid, Potassium hydroxide, Pyrogallol, Ethanol, Methanol, Isooctane, Acetone, Acetonitrile, Ultra high performance liquid chromatography (UHPLC) system, consisting of dual pump system, a sample injector unit, a degasser unit, and a column oven, Triple quadrupole mass spectrometer, Solid core silica column, Spectrophotometer, Centrifuge tubes(polypropylene), Boiling tubes(glass), Water bath (range= 20 °C to 70 °C), Disposable syringes, Syringe filters, Centrifuges, Pasteur pipette(glass), Horizontal shaker, Micro centrifuge tubes, Filter membranes( 0.45 μm), Cryogenic vials 10. Vitamin E(as α-tocopherol) Cl 4.8, Table 1, Sl. No. (ix) Methyl-t-butyl ether, n-Hexane, Ethanol Methanol, Iso-octane (2,2,4- trimethylpentane), Papain (from Carica papaya), Hydroquinone, Glacial acetic acid, Anhydrous sodium acetate, Dilute hydrochloric acid solution, HPLC mobile phase A, HPLC mobile phase B, Retinyl
spectrometer with ESI probe, Waters Xevo TQS2), or equivalent, Analytical balances, Water purifier, Water bath shaker, Bottle-top dispenser, pH meter, Vortex mixer, Multi-position magnetic stir plate, Room light shields, Graduated cylinders, Beakers, Volumetric flasks, Mobile phase bottles, Disposable plastic Pasteur pipettes, Amber bottles, Weighing vessels, Positive displacement pipettes, Positive displacement pipette tips, Plastic syringe, Syringe filters, Plastic centrifuge tubes, Autosampler vials, PTFE coated magnetic stir bars. 13. Riboflavin Cl 4.8, Table 1, Sl. No. (xii) Niacinamide (nicotinamide), Niacin (nicotinic acid), Pyridoxine hydrochloride, Riboflavin, Thiamine hydrochloride, Pyridoxamine dihydrochloride, Pyridoxal hydrochloride, 2 H4 -Niacinamide, 2 H4 - Nicotinic acid, 13 C 4 -Pyridoxine: pyridoxine:HCl (4,5- bis(hydroxymethyl)- 13 C 4 ), 2 H3 -Pyridoxal, 2 H3 -Pyridoxamine, 13 C 4 -Thiamine chloride, 13 C 4 ,15 N 2-Riboflavin, Acid phosphatase, Papain from Carica papaya, α–amylase from aspergillus oryzae, Hydrochloric acid concentrated, Ammonium formate, Glacial
acetic acid, Formic acid, Laboratory water, Methanol, Ethylenediaminetetracetic acid, disodium salt dihydrate (EDTA), Potassium phosphate dibasic, meta-Phosphoric acid, Buffer solutions for pH meter calibration, Phosphoric acid, Potassium hydroxide, Waters Acquity BEH C18 column2) or equivalent, UHPLC system, Waters Acquity Classic2), or equivalent, Tandem quadrupole mass spectrometer with ESI probe, Waters Xevo TQS2), or equivalent, Analytical balances, Water purifier, Water bath shaker, Bottle-top dispenser, pH meter, Vortex mixer, Multi-position magnetic stir plate, Room light shields, Graduated cylinders, Beakers, Volumetric flasks, Mobile phase bottles, Disposable plastic Pasteur pipettes, Amber bottles, Weighing vessels, Positive displacement pipettes, Positive displacement pipette tips, Plastic syringe, Syringe filters, Plastic PM/ IS 15757/3 November 2022 centrifuge tubes, Autosampler vials, PTFE coated magnetic stir bars 14. Niacin equivalent 4.8, Table 1, Sl.No. (xiii) Niacinamide (nicotinamide), Niacin (nicotinic acid), Pyridoxine hydrochloride, Riboflavin, Thiamine hydrochloride, Pyridoxamine
dihydrochloride, Pyridoxal hydrochloride, 2 H4 -Niacinamide, 2 H4 - Nicotinic acid, 13 C 4 -Pyridoxine: pyridoxine:HCl (4,5- bis(hydroxymethyl)- 13 C 4 ), 2 H3 -Pyridoxal, 2 H3 -Pyridoxamine, 13 C 4 -Thiamine chloride, 13 C 4 ,15 N 2-Riboflavin, Acid phosphatase, Papain from Carica papaya, α–amylase from aspergillus oryzae, Hydrochloric acid concentrated, Ammonium formate, Glacial acetic acid, Formic acid, Laboratory water, Methanol, Ethylenediaminetetracetic acid, disodium salt dihydrate (EDTA), Potassium phosphate dibasic, meta-Phosphoric acid, Buffer solutions for pH meter calibration, Phosphoric acid, Potassium hydroxide, Waters Acquity BEH C18 column2) or equivalent, UHPLC system, Waters Acquity Classic2), or equivalent, Tandem quadrupole mass spectrometer with ESI probe, Waters Xevo TQS2), or equivalent, Analytical balances, Water purifier, Water bath shaker, Bottle-top dispenser, pH meter, Vortex mixer, Multi-position magnetic stir plate, Room light shields, Graduated cylinders, Beakers, Volumetric flasks, Mobile phase bottles, Disposable plastic Pasteur pipettes, Amber
bottles, Weighing vessels, Positive displacement pipettes, Positive displacement pipette tips, Plastic syringe, Syringe filters, Plastic centrifuge tubes, Autosampler vials, PTFE coated magnetic stir bars 15. Pantothenic acid Cl 4.8, Table 1, Sl.No.(xiv) Calcium d-pantothenate, Calcium pantothenate- [13 C 6, 15 N 2], αAmylase, Acetonitrile, Ammonium acetate, Acetic acid, Formic acid, 1 % Formic acid in water, Balances, pH-meter, Homogenizer, Stir plate with magnetic stirrers, Filters, UHPLC-MS/MS system 16. Vitamin B 6 (pyridoxine) Cl 4.8, Table 1, Sl.No.(xv) Niacinamide (nicotinamide), Niacin (nicotinic acid), Pyridoxine hydrochloride, Riboflavin, Thiamine hydrochloride, Pyridoxamine dihydrochloride, Pyridoxal hydrochloride, 2 H4 -Niacinamide, 2 H4 - Nicotinic acid, 13 C 4 -Pyridoxine: pyridoxine:HCl (4,5- bis(hydroxymethyl)- 13 C 4 ), 2 H3 -Pyridoxal, 2 H3 -Pyridoxamine, 13 C 4 -Thiamine chloride, 13 C 4 ,15 N 2-Riboflavin, Acid phosphatase, Papain from Carica papaya, α–amylase from aspergillus oryzae, Hydrochloric acid concentrated, Ammonium formate, Glacial acetic acid, Formic acid, Laboratory water, Methanol,
Ethylenediaminetetracetic acid, disodium salt dihydrate (EDTA), Potassium phosphate dibasic, meta-Phosphoric acid, Buffer solutions for pH meter calibration, Phosphoric acid, Potassium hydroxide, Waters Acquity BEH C18 column2) or equivalent, UHPLC system, Waters Acquity Classic2), or equivalent, Tandem quadrupole mass spectrometer with ESI probe, Waters Xevo TQS2), or equivalent, PM/ IS 15757/3 November 2022 Analytical balances, Water purifier, Water bath shaker, Bottle-top dispenser, pH meter, Vortex mixer, Multi-position magnetic stir plate, Room light shields, Graduated cylinders, Beakers, Volumetric flasks, Mobile phase bottles, Disposable plastic Pasteur pipettes, Amber bottles, Weighing vessels, Positive displacement pipettes, Positive displacement pipette tips, Plastic syringe, Syringe filters, Plastic centrifuge tubes, Autosampler vials, PTFE coated magnetic stir bars 17. Dietary Folate Equivalent (DFE) Cl 4.8, Table 1, Sl. No. (xvi) UHPLC-MS/MS method as per AOAC 2013.13 UHPLC Column, liquid chromatograph, Detector, Amber glassware, Analytical balance, Homogeniser, pH meter, Water Bath, Whatman
filer paper, Solid-phase extraction cartridges, Amber vials, L-ascorbic acid, Ammonium acetate, Disodium hydrogen phosphate powder, aAmylase from porcine pancreas, α-Amylase from Bacillus subtilis, Protease from Streptomyces griseus, Ethanol, Methanol, Isopropanol, Acetonitrile, Formic acid, Acetic acid glacial, Sodium hydroxide solution, Hydrochloric acid, Ortho-phosphoric acid 18. Biotin Cl. 4.8, Table 1, Sl. No. (xvii) Laboratory reagent grade water, Sodium dihydrogen phosphate dihydrate, Disodium hydrogen phosphate dihydrate, Sodium hydroxide, Methanol, HPLC grade, Acetonitrile, HPLC grade, Ortho- phosphoric acid, PBS, Biotin, Biocytin, Sodium hydroxide, Sodium phosphate buffer, Phosphoric acid, HPLC system, Glass microfibre filters, Immunoaffinity column pack, SPE manifold, Autoclave, Centrifuge, Analytical balance, Amber glass screw-cap bottle, Horizontal shaker, Volumetric flasks, Pipettors, Measuring cylinder, Reaction vial, Heating block, Ultrasonic bath, Centrifuge tubes, Vortex mixer, Syringe filter, Disposable syringes, HPLC vials, HPLC System 19. Vitamin B 12 Cl. 4.8, Table 1, Sl. No.(xviii)
Determination by Reversed Phase High Performance Liquid Chromatography (RP-HPLC) as per IS 16640:2018 Reagents Glacial acetic acid, Acetonitrile(HPLC grade), Drierite (anhydrous calcium sulfate), Ethanol, Formic acid, Potassium cyanide, Riboflavin, Sodium acetate anhydrous or sodium acetate trihydrate, TakaDiastase, Triethylamine(HPLC grade), Vitamin B12 (cyanocobalamin) primary reference standard Apparatus HPLC system, Oven(capable of maintaining temperatures of 95 °C ± 5 °C and 105 °C ± 5 °C), pH-meter, Analytical balance(LC= 0.00001 g), Beakers, glass, Bottle top dispenser, Cylinders, Desiccator, Filter paper, Whatman 2V 2 ) or equivalent OR Ultra-High-Performance Liquid Chromatography method as per AOAC 2014.02 Balances, Sonicator, Oven, water bath, Rotary shaker, Heating block with nitrogen evaporation, Vortex, Homogenizer, Erlenmeyer flask, PM/ IS 15757/3 November 2022 Whatman filer paper 602 ½ or 597 ½, Amber vials, Chromatographic system, Methanol, Acetonitrile, Acetic acid glacial, Sodium cyanide puriss, TFA for spectroscop, Sodium acetate tri hydrate, Vitamin B„ (cyanocobalamin), Sodium hypachloride, α-Amylase from Bacillus
subtilis 20. Vitamin C Cl. 4.8, Table 1, Sl. No.(xix) 2,6 -Dichlorophenol Indophenol Method as per IS 5838 Trichloracetic Acid, Metaphosphoric Acid, Standard Ascorbic Acid Solution, Standard Indophenol Solution, Analytical Balance, Glass Stoppered Graduated Flask, Dessicator, Sodium Bicarbonate, Fluted Filter Paper, Amber Glass Stoppered Bottle, Refrigerator, Erlenmeyer Flasks, Titration Assembly, Mortar, Acid Washed Sand 2,4-Dinitrophenylhydrazine Method as per IS 5838 Photoelectric Colorimeter, Standard Ascorbic Acid Solution, Sulphuric Acid Solution, 2,4 Dinitrophenylhydrazine, Thiourea, Trichloroacetic Acid, Acid Washed Animal Charcoal, Sulphuric Acid, Mortar, Acid Washed Sand, Homogenizing Tube and Rod, Whatman No.42 Filter Paper, General Glasswares, Incubator, Titration Assembly Determination of Vitamin C by (Ultra) High Performance Liquid Chromatography with Ultraviolet Detection ((U) HPLC-UV) as per IS 17176 Acetonitrile, Ascorbic acid , Decylamine, Phosphoric acid, Ultra-pure water, Sodium acetate trihydrate, Trichloroacetic acid (TCA), Tris [2- carboxyethyl]phosphine (TCEP), Isoascorbic acid, Orotic acid,
Balances, Volumetric flasks, Beaker, pH meter, Paper filter, Membrane filters, UHPLC column, HPLC column, LC system, HPLC or UHPLC system 21. Choline Cl. 4.8, Table 1, Sl. No.(xx) Water, purified, MS grade or equivalent purity, Acetonitrile, Ammonium formate, Formic acid, Nitric acid, Isopropanol, Desiccant, L-carnitine, inner salt, Choline bitartrate, L-carnitine-d3 HCL, Choline-1,1,2,2-d 4 chloride, HPLC system, MS/MS system, Mass spectrometry software, Analytical column, Microwave, Microwave turntable Vortex mixer, Analytical balance, Horizontal shaker, Magnetic stir plate, Positive displacement pipets, Repeater positive displacement pipet, Polypropylene tubes, Digestion vessels for microwave digestion, graduated polypropylene tube, Glass containers, Syringe filters, Disposable syringes, Graduated cylinders, Magnetic stir bars, Autosampler vials and caps, Microcentrifuge tubes, Bottle top dispenser, Desiccator 22. Iron Cl. 4.8, Table 1, Sl. No.(xxi) Inductively coupled plasma atomic emission spectrometry (ICPAES) method as per ISO 15151:2018
Water, Nitric acid (HNO3), Nitric acid solution (HNO3), Element stock solutions of Ca, P, K, Standard working solution of Fe, Internal standard solution H2O2, Analytical balance, One-mark volumetric PM/ IS 15757/3 November 2022 flasks, One-mark pipettes, Micropipettes, Dispenser, High-density polyethylene bottles, Pressurized microwave assisted wet digestion system, ICP-AES instrument, Water bath, Appropriate grinding device, Sampler tubes, Cyclonic spray chamber, Concentric nebulize Inductively coupled plasma mass spectrometry (ICP-MS) method as per ISO 21424 Methanol, Nitric acid (HNO3) concentrated ultrapure reagent grade, Nitric acid (HNO3), trace metal grade H2O2, Laboratory water, Surfactant, Argon gas, Helium gas, Hydrogen gas, Iron Standard Stock Solution, Standard Reference Material (SRM)of cereal with certified values of Fe, inductively coupled plasma mass spectrometer, Microwave oven, Hydrogen generator, Magnetic stir plate and PTFEcoated magnetic stir bars, Analytical balance, Fume hood, Common laboratory glassware/plasticware, Repipetter, Bottle top dispenser, Volumetric pipettes, Digital pipettes
Method as per AOAC 985.35 Glassware, Evaporating dish, Atomic absorption spectrophotometer, Furnace, Water, Standard stock solution of Fe, Nitric acid, Lanthanum oxide, Lanthanum chloride solution, Cesium chloride solution, Filter pulp, Microwave Oven, Analytical Balance, Hot Plate, Steam Bath 23. Sodium Cl. 4.8, Table 1, Sl. No.(xxii) Atomic Absorption Spectrometric Method as per IS 12760:2012 Reagents:- Nitric acid (HNO3), concentrated, with a mass fraction of 65 %,Nitric acid (HNO3),Lanthanum trichloride solution, Calcium ion stock solution, Sodium ion stock solution, Potassium ion stock solution, Magnesium ion stock solution, Standard working solution, containing 100 mg/l calcium, 20 mg/l sodium, 20 mg/l potassium and 10 mg/l magnesium ions, Light petroleum (petroleum ether), Hydrogen peroxide (H2O2) Equipment:- Analytical balance, capable of weighing to the nearest 1 mg, with a readability of 0.1 mg One-mark volumetric flasks, of nominal capacities 20 ml, 50 ml, 100 ml, 250 ml and 1000 ml, complying with the requirements of ISO 1042 One-mark pipettes, of nominal
capacities 1 ml, 2 ml, 5 ml and 10 ml, complying with the requirements of ISO 648 Micropipette, capable of adjusting to between 1 ml and 5 ml, with plastic pipette tips, Graduated measuring cylinder, of capacity 10 ml High-density polyethylene (PE-HD) bottles, Silica crucibles, of capacity between 25 ml and 50 ml, Programmable furnace oven, capable of attaining a minimum temperature of 550 °C ± 25 °C and of programming with a heating rate of 50 °C/h, Open focused microwave-assisted wet digestion PM/ IS 15757/3 November 2022 system, Pressurized microwave-assisted wet digestion system, provided with temperature and pressure controllers and an air cooling device, equipped with appropriate vessels of capacity 50 ml, commercially available or equivalent, Decomposition vessels, made of stainless steel, with adapted PTFE inner vessels of capacity 23 l with screw caps (pressurized wet decomposition PTFE vessel), commercially available or equivalent, Oven, capable of attaining a temperature of 150 °C (for digestion bombs), Flame atomic
absorption spectrometer, with an air– acetylene burner; equipped with hollow cathode lamps of single element type or combined type, Water baths, Centrifuge, capable of producing a radial acceleration of 2500g, with tubes of capacity at least 150 ml, Appropriate grinding device, Sieve, free of contaminated material, with nominal size of aperture 0.5 mm Inductively coupled plasma atomic emission spectrometry (ICP- AES) method as per ISO 15151:2018 Water, Nitric acid (HNO3), Nitric acid solution (HNO3), Element stock solutions of Ca, P, K, Standard working solution of Fe, Internal standard solution H2O2, Analytical balance, One-mark volumetric flasks, One-mark pipettes, Micropipettes, Dispenser, High-density polyethylene bottles, Pressurized microwave assisted wet digestion system, ICP-AES instrument, Water bath, Appropriate grinding device, Sampler tubes, Cyclonic spray chamber, Concentric nebulizer Inductively coupled plasma mass spectrometry (ICP-MS) method as per ISO 21424 Methanol, Nitric acid (HNO3) concentrated ultrapure reagent grade, Nitric acid (HNO3), trace metal grade H2O2, Laboratory water, Surfactant, Argon gas, Helium gas, Hydrogen gas, Iron Standard
Stock Solution, Standard Reference Material (SRM)of cereal with certified values of Fe, inductively coupled plasma mass spectrometer, Microwave oven, Hydrogen generator, Magnetic stir plate and PTFEcoated magnetic stir bars, Analytical balance, Fume hood, Common laboratory glassware/plasticware, Repipetter, Bottle top dispenser, Volumetric pipettes, Digital pipette 24. Potassium Cl. 4.8, Table 1, Sl. No.(xxiii) Atomic Absorption Spectrometric Method as per IS 12760:2012 Reagents:- Nitric acid (HNO3), concentrated, with a mass fraction of 65 %,Nitric acid (HNO3),Lanthanum trichloride solution, Calcium ion stock solution, Sodium ion stock solution, Potassium ion stock solution, Magnesium ion stock solution, Standard working solution, containing 100 mg/l calcium, 20 mg/l sodium, 20 mg/l potassium and 10 mg/l magnesium ions, Light petroleum (petroleum ether), Hydrogen peroxide (H2O2) PM/ IS 15757/3 November 2022 Equipment:- Analytical balance, capable of weighing to the nearest 1 mg, with a readability of 0.1 mg One-mark volumetric flasks, of nominal capacities 20 ml, 50 ml, 100 ml, 250 ml and 1000 ml, complying with
the requirements of ISO 1042 One-mark pipettes, of nominal capacities 1 ml, 2 ml, 5 ml and 10 ml, complying with the requirements of ISO 648 Micropipette, capable of adjusting to between 1 ml and 5 ml, with plastic pipette tips, Graduated measuring cylinder, of capacity 10 ml High-density polyethylene (PE-HD) bottles, Silica crucibles, of capacity between 25 ml and 50 ml, Programmable furnace oven, capable of attaining a minimum temperature of 550 °C ± 25 °C and of programming with a heating rate of 50 °C/h, Open focused microwave-assisted wet digestion system, Pressurized microwave-assisted wet digestion system, provided with temperature and pressure controllers and an air cooling device, equipped with appropriate vessels of capacity 50 ml, commercially available or equivalent, Decomposition vessels, made of stainless steel, with adapted PTFE inner vessels of capacity 23 l with screw caps (pressurized wet decomposition PTFE vessel), commercially available or equivalent, Oven, capable of attaining a temperature of 150 °C (for digestion bombs), Flame atomic
absorption spectrometer, with an air– acetylene burner; equipped with hollow cathode lamps of single element type or combined type, Water baths, Centrifuge, capable of producing a radial acceleration of 2500g, with tubes of capacity at least 150 ml, Appropriate grinding device, Sieve, free of contaminated material, with nominal size of aperture 0.5 mm Inductively coupled plasma atomic emission spectrometry (ICP- AES) method as per ISO 15151:2018 Water, Nitric acid (HNO3), Nitric acid solution (HNO3), Element stock solutions of Ca, P, K, Standard working solution of Fe, Internal standard solution H2O2, Analytical balance, One-mark volumetric flasks, One-mark pipettes, Micropipettes, Dispenser, High-density polyethylene bottles, Pressurized microwave assisted wet digestion system, ICP-AES instrument, Water bath, Appropriate grinding device, Sampler tubes, Cyclonic spray chamber, Concentric nebulizer Inductively coupled plasma mass spectrometry (ICP-MS) method as per ISO 21424 Methanol, Nitric acid (HNO3) concentrated ultrapure reagent grade, Nitric acid (HNO3), trace metal grade H2O2, Laboratory water,
Surfactant, Argon gas, Helium gas, Hydrogen gas, Iron Standard Stock Solution, Standard Reference Material (SRM)of cereal with certified values of Fe, inductively coupled plasma mass spectrometer, Microwave oven, Hydrogen generator, Magnetic stir plate and PM/ IS 15757/3 November 2022 PTFEcoated magnetic stir bars, Analytical balance, Fume hood, Common laboratory glassware/plasticware, Repipetter, Bottle top dispenser, Volumetric pipettes, Digital pipette 25. Chloride Cl. 4.8, Table 1, Sl. No.(xxiv) Atomic Absorption Spectrometric Method as per IS 12760:2012 Reagents:- Nitric acid (HNO3), concentrated, with a mass fraction of 65 %,Nitric acid (HNO3),Lanthanum trichloride solution, Calcium ion stock solution, Sodium ion stock solution, Potassium ion stock solution, Magnesium ion stock solution, Standard working solution, containing 100 mg/l calcium, 20 mg/l sodium, 20 mg/l potassium and 10 mg/l magnesium ions, Light petroleum (petroleum ether), Hydrogen peroxide (H2O2) Equipment:- Analytical balance, capable of weighing to the nearest 1 mg, with a readability of 0.1 mg One-mark volumetric flasks, of nominal
capacities 20 ml, 50 ml, 100 ml, 250 ml and 1000 ml, complying with the requirements of ISO 1042 One-mark pipettes, of nominal capacities 1 ml, 2 ml, 5 ml and 10 ml, complying with the requirements of ISO 648 Micropipette, capable of adjusting to between 1 ml and 5 ml, with plastic pipette tips, Graduated measuring cylinder, of capacity 10 ml High-density polyethylene (PE-HD) bottles, Silica crucibles, of capacity between 25 ml and 50 ml, Programmable furnace oven, capable of attaining a minimum temperature of 550 °C ± 25 °C and of programming with a heating rate of 50 °C/h, Open focused microwave-assisted wet digestion system, Pressurized microwave-assisted wet digestion system, provided with temperature and pressure controllers and an air cooling device, equipped with appropriate vessels of capacity 50 ml, commercially available or equivalent, Decomposition vessels, made of stainless steel, with adapted PTFE inner vessels of capacity 23 l with screw caps (pressurized wet decomposition PTFE vessel), commercially available or equivalent, Oven, capable of attaining a
temperature of 150 °C (for digestion bombs), Flame atomic absorption spectrometer, with an air– acetylene burner; equipped with hollow cathode lamps of single element type or combined type, Water baths, Centrifuge, capable of producing a radial acceleration of 2500g, with tubes of capacity at least 150 ml, Appropriate grinding device, Sieve, free of contaminated material, with nominal size of aperture 0.5 mm Inductively coupled plasma atomic emission spectrometry (ICP- AES) method as per ISO 15151:2018 Water, Nitric acid (HNO3), Nitric acid solution (HNO3), Element stock solutions of Ca, P, K, Standard working solution of Fe, Internal standard solution H2O2, Analytical balance, One-mark volumetric PM/ IS 15757/3 November 2022 flasks, One-mark pipettes, Micropipettes, Dispenser, High-density polyethylene bottles, Pressurized microwave assisted wet digestion system, ICP-AES instrument, Water bath, Appropriate grinding device, Sampler tubes, Cyclonic spray chamber, Concentric nebulizer Inductively coupled plasma mass spectrometry (ICP-MS) method as per ISO 21424 Methanol, Nitric acid (HNO3) concentrated ultrapure reagent grade,
Nitric acid (HNO3), trace metal grade H2O2, Laboratory water, Surfactant, Argon gas, Helium gas, Hydrogen gas, Iron Standard Stock Solution, Standard Reference Material (SRM)of cereal with certified values of Fe, inductively coupled plasma mass spectrometer, Microwave oven, Hydrogen generator, Magnetic stir plate and PTFEcoated magnetic stir bars, Analytical balance, Fume hood, Common laboratory glassware/plasticware, Repipetter, Bottle top dispenser, Volumetric pipettes, Digital pipette 26. Calcium Cl. 4.8, Table 1, Sl. No.(xxv) Atomic Absorption Spectrometric Method as per IS 12760:2012 Reagents:- Nitric acid (HNO3), concentrated, with a mass fraction of 65 %,Nitric acid (HNO3),Lanthanum trichloride solution, Calcium ion stock solution, Sodium ion stock solution, Potassium ion stock solution, Magnesium ion stock solution, Standard working solution, containing 100 mg/l calcium, 20 mg/l sodium, 20 mg/l potassium and 10 mg/l magnesium ions, Light petroleum (petroleum ether), Hydrogen peroxide (H2O2) Equipment:- Analytical balance, capable of weighing to the nearest 1 mg, with a
readability of 0.1 mg One-mark volumetric flasks, of nominal capacities 20 ml, 50 ml, 100 ml, 250 ml and 1000 ml, complying with the requirements of ISO 1042 One-mark pipettes, of nominal capacities 1 ml, 2 ml, 5 ml and 10 ml, complying with the requirements of ISO 648 Micropipette, capable of adjusting to between 1 ml and 5 ml, with plastic pipette tips, Graduated measuring cylinder, of capacity 10 ml High-density polyethylene (PE-HD) bottles, Silica crucibles, of capacity between 25 ml and 50 ml, Programmable furnace oven, capable of attaining a minimum temperature of 550 °C ± 25 °C and of programming with a heating rate of 50 °C/h, Open focused microwave-assisted wet digestion system, Pressurized microwave-assisted wet digestion system, provided with temperature and pressure controllers and an air cooling device, equipped with appropriate vessels of capacity 50 ml, commercially available or equivalent, Decomposition vessels, made of stainless steel, with adapted PTFE inner vessels of capacity 23 l with screw caps (pressurized wet decomposition PTFE vessel),
commercially available or equivalent, Oven, capable of attaining a PM/ IS 15757/3 November 2022 temperature of 150 °C (for digestion bombs), Flame atomic absorption spectrometer, with an air– acetylene burner; equipped with hollow cathode lamps of single element type or combined type, Water baths, Centrifuge, capable of producing a radial acceleration of 2500g, with tubes of capacity at least 150 ml, Appropriate grinding device, Sieve, free of contaminated material, with nominal size of aperture 0.5 mm Inductively coupled plasma atomic emission spectrometry (ICP- AES) method as per ISO 15151:2018 Water, Nitric acid (HNO3), Nitric acid solution (HNO3), Element stock solutions of Ca, P, K, Standard working solution of Fe, Internal standard solution H2O2, Analytical balance, One-mark volumetric flasks, One-mark pipettes, Micropipettes, Dispenser, High-density polyethylene bottles, Pressurized microwave assisted wet digestion system, ICP-AES instrument, Water bath, Appropriate grinding device, Sampler tubes, Cyclonic spray chamber, Concentric nebulizer Inductively coupled plasma mass spectrometry (ICP-MS) method
as per ISO 21424 Methanol, Nitric acid (HNO3) concentrated ultrapure reagent grade, Nitric acid (HNO3), trace metal grade H2O2, Laboratory water, Surfactant, Argon gas, Helium gas, Hydrogen gas, Iron Standard Stock Solution, Standard Reference Material (SRM)of cereal with certified values of Fe, inductively coupled plasma mass spectrometer, Microwave oven, Hydrogen generator, Magnetic stir plate and PTFEcoated magnetic stir bars, Analytical balance, Fume hood, Common laboratory glassware/plasticware, Repipetter, Bottle top dispenser, Volumetric pipettes, Digital pipette 27. Phosphorus Cl. 4.8, Table 1, Sl. No.(xxvi) Atomic Absorption Spectrometric Method as per IS 12760:2012 Reagents:- Nitric acid (HNO3), concentrated, with a mass fraction of 65 %,Nitric acid (HNO3),Lanthanum trichloride solution, Calcium ion stock solution, Sodium ion stock solution, Potassium ion stock solution, Magnesium ion stock solution, Standard working solution, containing 100 mg/l calcium, 20 mg/l sodium, 20 mg/l potassium and 10 mg/l magnesium ions, Light petroleum (petroleum ether), Hydrogen peroxide (H2O2)
Equipment:- Analytical balance, capable of weighing to the nearest 1 mg, with a readability of 0.1 mg One-mark volumetric flasks, of nominal capacities 20 ml, 50 ml, 100 ml, 250 ml and 1000 ml, complying with the requirements of ISO 1042 One-mark pipettes, of nominal capacities 1 ml, 2 ml, 5 ml and 10 ml, complying with the requirements of ISO 648 Micropipette, capable of adjusting to PM/ IS 15757/3 November 2022 between 1 ml and 5 ml, with plastic pipette tips, Graduated measuring cylinder, of capacity 10 ml High-density polyethylene (PE-HD) bottles, Silica crucibles, of capacity between 25 ml and 50 ml, Programmable furnace oven, capable of attaining a minimum temperature of 550 °C ± 25 °C and of programming with a heating rate of 50 °C/h, Open focused microwave-assisted wet digestion system, Pressurized microwave-assisted wet digestion system, provided with temperature and pressure controllers and an air cooling device, equipped with appropriate vessels of capacity 50 ml, commercially available or equivalent, Decomposition vessels, made
of stainless steel, with adapted PTFE inner vessels of capacity 23 l with screw caps (pressurized wet decomposition PTFE vessel), commercially available or equivalent, Oven, capable of attaining a temperature of 150 °C (for digestion bombs), Flame atomic absorption spectrometer, with an air– acetylene burner; equipped with hollow cathode lamps of single element type or combined type, Water baths, Centrifuge, capable of producing a radial acceleration of 2500g, with tubes of capacity at least 150 ml, Appropriate grinding device, Sieve, free of contaminated material, with nominal size of aperture 0.5 mm Inductively coupled plasma atomic emission spectrometry (ICP- AES) method as per ISO 15151:2018 Water, Nitric acid (HNO3), Nitric acid solution (HNO3), Element stock solutions of Ca, P, K, Standard working solution of Fe, Internal standard solution H2O2, Analytical balance, One-mark volumetric flasks, One-mark pipettes, Micropipettes, Dispenser, High-density polyethylene bottles, Pressurized microwave assisted wet digestion system, ICP-AES instrument, Water bath, Appropriate grinding
device, Sampler tubes, Cyclonic spray chamber, Concentric nebulizer Inductively coupled plasma mass spectrometry (ICP-MS) method as per ISO 21424 Methanol, Nitric acid (HNO3) concentrated ultrapure reagent grade, Nitric acid (HNO3), trace metal grade H2O2, Laboratory water, Surfactant, Argon gas, Helium gas, Hydrogen gas, Iron Standard Stock Solution, Standard Reference Material (SRM)of cereal with certified values of Fe, inductively coupled plasma mass spectrometer, Microwave oven, Hydrogen generator, Magnetic stir plate and PTFEcoated magnetic stir bars, Analytical balance, Fume hood, Common laboratory glassware/plasticware, Repipetter, Bottle top dispenser, Volumetric pipettes, Digital pipette 28. Magnesium Cl. 4.8, Table 1, Sl. No.(xxvii) Atomic Absorption Spectrometric Method as per IS 12760:2012 Reagents: - Nitric acid (HNO 3 ), concentrated, with a mass fraction of 65 %, Nitric acid (HNO 3 ), Lanthanum trichloride solution, Calcium ion PM/ IS 15757/3 November 2022 stock solution, Sodium ion stock solution, Potassium ion stock solution, Magnesium ion stock solution, Standard working solution, containing 100 mg/l calcium, 20 mg/l sodium, 20 mg/l potassium and
10 mg/l magnesium ions, Light petroleum (petroleum ether), Hydrogen peroxide (H 2 O 2 ) Equipment: - Analytical balance, capable of weighing to the nearest 1 mg, with a readability of 0.1 mg One-mark volumetric flasks, of nominal capacities 20 ml, 50 ml, 100 ml, 250 ml and 1000 ml, complying with the requirements of ISO 1042 One-mark pipettes, of nominal capacities 1 ml, 2 ml, 5 ml and 10 ml, complying with the requirements of ISO 648 Micropipette, capable of adjusting to between 1 ml and 5 ml, with plastic pipette tips, Graduated measuring cylinder, of capacity 10 ml High-density polyethylene (PE-HD) bottles, Silica crucibles, of capacity between 25 ml and 50 ml, Programmable furnace oven, capable of attaining a minimum temperature of 550 °C ± 25 °C and of programming with a heating rate of 50 °C/h, Open focused microwave-assisted wet digestion system, Pressurized microwave-assisted wet digestion system, provided with temperature and pressure controllers and an air cooling device, equipped with appropriate vessels of capacity 50 ml,
commercially available or equivalent, Decomposition vessels, made of stainless steel, with adapted PTFE inner vessels of capacity 23 l with screw caps (pressurized wet decomposition PTFE vessel), commercially available or equivalent, Oven, capable of attaining a temperature of 150 °C (for digestion bombs), Flame atomic absorption spectrometer, with an air– acetylene burner; equipped with hollow cathode lamps of single element type or combined type, Water baths, Centrifuge, capable of producing a radial acceleration of 2500g, with tubes of capacity at least 150 ml, Appropriate grinding device, Sieve, free of contaminated material, with nominal size of aperture 0.5 mm Inductively coupled plasma atomic emission spectrometry (ICP- AES) method as per ISO 15151:2018 Water, Nitric acid (HNO3), Nitric acid solution (HNO3), Element stock solutions of Ca, P, K, Standard working solution of Fe, Internal standard solution H2O2, Analytical balance, One-mark volumetric flasks, One-mark pipettes, Micropipettes, Dispenser, High-density polyethylene bottles, Pressurized microwave assisted wet digestion
system, ICP-AES instrument, Water bath, Appropriate grinding device, Sampler tubes, Cyclonic spray chamber, Concentric nebulizer Inductively coupled plasma mass spectrometry (ICP-MS) method as per ISO 21424 PM/ IS 15757/3 November 2022 Methanol, Nitric acid (HNO3) concentrated ultrapure reagent grade, Nitric acid (HNO3), trace metal grade H2O2, Laboratory water, Surfactant, Argon gas, Helium gas, Hydrogen gas, Iron Standard Stock Solution, Standard Reference Material (SRM)of cereal with certified values of Fe, inductively coupled plasma mass spectrometer, Microwave oven, Hydrogen generator, Magnetic stir plate and PTFEcoated magnetic stir bars, Analytical balance, Fume hood, Common laboratory glassware/plasticware, Repipetter, Bottle top dispenser, Volumetric pipettes, Digital pipette 29. Iodine Cl. 4.8, Table 1, Sl. No.(xxviii) KOH pellets, Ammonium hydroxide, Sodium thiosulfate, Surfactant, Concentrated nitric acid, Perchloric acid (HClO4), Purified water(18 MΩ/cm), Iodide standard solution, triethylamine (TEA), Praseodymium (Pr) standard solution, Polypropylene tubes, capacity 50 ml and 100 ml, Oven (105 °C ± 5 °C), Open-vessel microwave
digestion unit(optional), Analytical balance(LC=0.0001 g), Top- loader balance (LC= 0.01 g), ICP-MS system, Autosampler for ICP- MS, Adjustable volumetric pipets, Re-pipet volumetric dispensers, Polypropylene or polytetrafluoroethylene (PTFE) bottles, Disposable plastic syringes, Syringe filters, Beakers, Pump tubing 30. Copper Cl. 4.8, Table 1, Sl. No.(xxix) Method as per IS 1599 Kjeldahl flask, Atomic absorption spectrophotometer, hydride generation vessel accessory, potentiometric recorder, Nitric acid, Perchloric acid, Sulphuric acid, Hydrochloric acid, Metal free water, Sodium sulphate, Sodium borohydride pellets, Potassium chloride Standard zinc solution, Weighing Balance, General Glasswares, Burner/ Heating Element/ Hot Plate Inductively coupled plasma atomic emission spectrometry (ICP- AES) method as per ISO 15151:2018 Water, Nitric acid (HNO3), Nitric acid solution (HNO3), Element stock solutions of Ca, P, K, Standard working solution of Zn, Cu, Internal standard solution H2O2, Analytical balance, One-mark volumetric flasks, One-mark pipettes, Micropipettes, Dispenser,
High-density polyethylene bottles, Pressurized microwave assisted wet digestion system, ICP-AES instrument, Water baths, Appropriate grinding device, Sampler tubes, Cyclonic spray chamber, Concentric nebulizer Inductively coupled plasma mass spectrometry (ICP-MS) method as per ISO 21424 Methanol, Nitric acid (HNO3) concentrated ultrapure reagent grade, Nitric acid (HNO3), trace metal grade H2O2, Laboratory water, Surfactant, Argon gas, Helium gas, Hydrogen gas, Iron Standard Stock Solution, Standard Reference Material (SRM)of cereal with certified values of Fe, inductively coupled plasma mass spectrometer, Microwave oven, Hydrogen generator, Magnetic stir plate and PTFE PM/ IS 15757/3 November 2022 coated magnetic stir bars, Analytical balance, Fume hood, Common laboratory glassware/plasticware, Repipetter, Bottle top dispenser, Volumetric pipettes, Digital pipettes 31. Zinc Cl. 4.8, Table 1, Sl. No.(xxx) Method as per IS 1699 Kjeldahl flask, Atomic absorption spectrophotometer, hydride generation vessel accessory, potentiometric recorder, Nitric acid, Perchloric acid, Sulphuric acid, Hydrochloric acid, Metal free water,
Sodium sulphate, Sodium borohydride pellets, Potassium chloride Standard zinc solution, Weighing Balance, General Glasswares, Burner/ Heating Element/ Hot Plate Inductively coupled plasma atomic emission spectrometry (ICPAES) method as per ISO 15151:2018 Water, Nitric acid (HNO3), Nitric acid solution (HNO3), Element stock solutions of Ca, P, K, Standard working solution of Zn, Cu, Internal standard solution H2O2, Analytical balance, One-mark volumetric flasks, One-mark pipettes, Micropipettes, Dispenser, High-density polyethylene bottles, Pressurized microwave assisted wet digestion system, ICP-AES instrument, Water baths, Appropriate grinding device, Sampler tubes, Cyclonic spray chamber, Concentric nebulizer Inductively coupled plasma mass spectrometry (ICP-MS) method as per ISO 21424 Methanol, Nitric acid (HNO3) concentrated ultrapure reagent grade, Nitric acid (HNO3), trace metal grade H2O2, Laboratory water, Surfactant, Argon gas, Helium gas, Hydrogen gas, Iron Standard Stock Solution, Standard Reference Material (SRM)of cereal with certified values of Fe, inductively coupled plasma mass spectrometer,
Microwave oven, Hydrogen generator, Magnetic stir plate and PTFEcoated magnetic stir bars, Analytical balance, Fume hood, Common laboratory glassware/plasticware, Repipetter, Bottle top dispenser, Volumetric pipettes, Digital pipettes 32. Manganese Cl. 4.8, Table 1, Sl. No.(xxxi) Inductively coupled plasma atomic emission spectrometry (ICPAES) method as per ISO 15151:2018 Water, Nitric acid (HNO3), Nitric acid solution (HNO3), Element stock solutions of Ca, P, K, Standard working solution of Zn, Cu, Internal standard solution H2O2, Analytical balance, One-mark volumetric flasks, One-mark pipettes, Micropipettes, Dispenser, High-density polyethylene bottles, Pressurized microwave assisted wet digestion system, ICP-AES instrument, Water baths, Appropriate grinding device, Sampler tubes, Cyclonic spray chamber, Concentric nebulizer Inductively coupled plasma mass spectrometry (ICP-MS) method as per ISO 21424 PM/ IS 15757/3 November 2022 Methanol, Nitric acid (HNO3) concentrated ultrapure reagent grade, Nitric acid (HNO3), trace metal grade H2O2, Laboratory water, Surfactant, Argon gas, Helium gas, Hydrogen gas, Iron Standard
Stock Solution, Standard Reference Material (SRM)of cereal with certified values of Fe, inductively coupled plasma mass spectrometer, Microwave oven, Hydrogen generator, Magnetic stir plate and PTFEcoated magnetic stir bars, Analytical balance, Fume hood, Common laboratory glassware/plasticware, Repipetter, Bottle top dispenser, Volumetric pipettes, Digital pipettes 33. Selenium Cl. 4.8, Table 1, Sl. No.(xxii) Method as per IS 15303 Atomic Absorption Spectrometer, Source Lamps, Graphite Furnace, Readout Sample Dispensers, Vent, Cooling Water Supply, Membrane Filter Apparatus, Metal-Free-Water, Hydrochloric Acid, Nitric Acid, Magnesium Nitrate, Nickel, Nitrate, Phosphoric Acid, Palladium Nitrate, Citric Acid, Stock Selenium Solution, Chelating Resin, General Glasswares, Hot Plate Inductively coupled plasma atomic emission spectrometry (ICP- AES) method as per ISO 15151:2018 Water, Nitric acid (HNO3), Nitric acid solution (HNO3), Element stock solutions of Ca, P, K, Standard working solution of Se, Internal standard solution H2O2, Analytical balance, One-mark volumetric flasks, One-mark pipettes, Micropipettes, Dispenser, High-density
polyethylene bottles, Pressurized microwave assisted wet digestion system, ICP-AES instrument, Water baths, Appropriate grinding device, Sampler tubes, Cyclonic spray chamber, Concentric nebulizer Determination by Inductively coupled plasma mass spectrometry (ICP-MS) method as per ISO 20649 Purified water, Concentrated nitric acid (HNO 3 ), Hydrogen peroxide (H 2 O 2 ), Methanol, Potassium solution, Standard Solutions and Reference Materials, Microwave oven, ICP-MS, Various plasticware and pipettes, Analytical balance 34. Inositol Cl. 4.8, Table 1, Sl. No.(xxiii) Acetic acid, glacial, Chloroform, Diethyl ether, Drierite, Helium, Hexane, Hydrochloric acid, Metaphosphoric acid, Methanol, Myoinositol, Sodium chloride, Sodium hydroxide, Analytical balance, Centrifuge, Desiccator, Nitrogen evaporator, Oven, pH- meter, Stir plate, Vacuum manifold, Vortex mixer, System HPLC Columns, Beakers, Centrifuge tubes, Syringe filters, Filter paper, Conical flasks, Volumetric flasks, Funnels, Pipettes, Solid-phase extraction (SPE) cartridge, Syringes 35. Taurine Cl. 4.8, Table 1, Sl. No.(xxxiv) Liquid Chromatographic method as per AOAC 997.05
Equipment: Liquid Chromatograph, LC Column, Filters, Glassware, pH Meter, Vortex mixer Reagents: PM/ IS 15757/3 November 2022 Purified water, Acetonitrile, Acetic Acid, Sodium acetate buffer, Sodium carbonate, Carrez 1 and 2 reagent, Dansyl chloride reagent, Methylamine hydrochloride, Taurine standard 36. Aerobic Plate count Cl. 4.8, Table 2, Sl. No. (i) Diluents, Agar Medium, Oven, Incubator, Water bath, pH-meter, Petri dishes, Total delivery graduated pipettes, Colony-counting equipment, Tubes, flasks or bottles 37. Coliform count Cl. 4.8, Table 2, Sl. No. (ii) Crystal violet neutral red bile lactose (VRBL) agar, Brilliant green lactose bile broth, Apparatus for dry sterilization (oven) or wet sterilization (autoclave), Incubator, Water bath, Colony-counting equipment, Tubes, flasks or bottles, Durham tubes, pH-meter, Loop of platinum-iridium or nickel-chromium 38. Staphylococcus aureus (Coagulase positive) Cl. 4.8, Table 2, Sl. No. (iii) Diluent, Baird-parker Agar Medium, Potassium Tellurite solution, Egg Yolk Emulsion, Sulfamethazine, Brain-heart infusion broth, Rabbit Plasma, Apparatus for dry sterilization (oven) or wet
sterilization (autoclave), Incubator, Drying cabinet or incubator, Water bath, Test tubes, flasks or bottles with screw caps, Petri dishes, Straight wire, Pasteur pipette, Total-delivery graduated pipettes, Spreaders, pH meter 39. Yeast and mould count Cl. 4.8, Table 2, Sl. No. (iv) pH meter, Diluents and Culture Medium, Yeast Extract- DextroseChloramphenicol-Agar, Medium Apparatus for Dry Sterilization (Oven) or Wet Sterilization (Autoclave), Incubator, Water-Bath, Temperature Compensated pH Meter, Culture Bottles or Flasks, Graduated Pipettes, Petri Dishes 40. Salmonella sp. Cl. 4.8, Table 2, Sl. No. (v) Buffered peptone water, Rappaport-Vassiliadis medium with soya (RVS broth) or Modified Semi-solid Rappaport-Vassiliadis (MSRV) agar and Muller-Kauffmann tetrathionate-novobiocin broth (MKTT) broth, Xylose Lysine Deoxycholate agar (XLD agar), Apparatus for dry sterilization (oven) or wet sterilization (autoclave), Drying cabinet or oven, Incubator, Water bath, Refrigerator, Freezer Sterile loops, pH-meter, Sterile tubes, bottles, or flasks, Sterile Petri dishes 41.
Listeria monocytogenes Cl. 4.8, Table 2, Sl. No. (vi) Acriflavine and nalidixic acid, Fraser broth, Listeria Agar, Apparatus for dry sterilization (oven) or wet sterilization (autoclave), Drying cabinet, Incubators, Water bath, Sterile loops, pH meter, Graduated pipettes or automatic pipettes, Petri dishes, Microscope, Refrigerator 42. Bacillus cereus Cl. 4.8, Table 2, Sl. No. (vii) Dilution fluid, Agar medium, Polymyxin B solution, Egg yolk emulsion, Complete medium (MYP agar), Sheep blood agar, Defibrinated sheep blood, Apparatus for dry sterilization (oven) or wet sterilization (autoclave), Drying cabinet, Incubator, Water baths, pH-meter, Petri dishes, Graduated pipettes, Spreaders 43. Sulphite reducing clostridia Cl. 4.8, Table 2, Sl. No. (viii) Horizontal method for enumeration of sulfite-reducing bacteria growing under anaerobic conditions as per ISO 15213 Iron sulfite agar, Saline peptone diluents, Homogenization equipment, Water bath, Anaerobic jars, Incubator, Test tubes 44. E. coli Cl. 4.8, Table 2, Sl. No. (ix) Method as per IS 5887(Part-1) Nutrient Broth, Nutrient Agar, MacConkey Broth and Agar Medium,
Eosin Methylene Blue Lactose Agar Medium, Tergitol7 Agar PM/ IS 15757/3 November 2022 Medium, TSI Medium, Medium for Urease Test, Medium for Indole Production, Media for Methyl Red and Voges-Proskaner Tests, Simmion’s Citrate Agar, Peptone Water Media for Carbohydrate Fermentation Tests, Apparatus for dry sterilization (oven) or wet sterilization (autoclave), Incubators, Water bath, Sterile loops, pH meter, Graduated pipettes or automatic pipettes, Petri dishes, Microscope, Refrigerator 45. Lead Cl. 4.11, Table 3, Sl. No. (i) Method as per IS 12074 Atomic Absorption Spectrophotometer, Pure Lead Metal, Concentrated Nitric Acid, Concentrated Hydrochloric Acid, Standard Lead Solution, Drying Oven, Filter Papers, General Glasswares Inductively Coupled Plasma-Mass Spectrometry Method as per AOAC 2015.01 ICP-MS instrument, High-purity grade liquid argon 99 .996%, Analytical Balance, Clean Room Gloves, Microwave Digestion System, Autosampler Vials and Cups, Spatulas, Nitric acid (HNO3), Hydrogen peroxide (H2O2), Stock standard solution, Single-element standards, Second source standard, Multi Element Stock Standard
Solution, Internal Standard Solution, Certified Reference Materials, Analytical Balance 46. Arsenic Cl. 4.11, Table 3, Sl. No. (ii) Method as per IS 11124 Atomic Absorption Spectrophotometer, Vapour Generation Kit, Concentrated Hydrochloric Acid, Concentrated Nitric Acid, Concentrated Sulphuric Acid, Potassium Iodide, Sodium Borohydride, Standard Arsenic Solution, Quartz Tube, Burner, Inert Gas Supply, Reaction Vessel, Stopper Assembly, Stirrer, Laboratory Glasswares Inductively Coupled Plasma-Mass Spectrometry Method as per AOAC 2015.01 ICP-MS instrument, High-purity grade liquid argon 99 .996%, Analytical Balance, Clean Room Gloves, Microwave Digestion System, Autosampler Vials and Cups, Spatulas, Nitric acid (HNO3), Hydrogen peroxide (H2O2), Stock standard solution, Single-element standards, Second source standard, Multi Element Stock Standard Solution, Certified Reference Materials, Analytical Balance 47. Tin Cl. 4.11, Table 3, Sl. No. (iii) Water, Hydrochloric acid, Tin stock solution, Tin standard working solution, Tin standard working solution in diluted (evaporated) milk, Matrix modifier solutions, Balance, Water bath, One-mark
volumetric flasks, Dosing pipettes, Atomic absorption spectrometer 48. Cadmium Cl. 4.11, Table 3, Sl. No. (iv) Method as per IS 1699 Kjeldahl flask, Atomic absorption spectrophotometer, hydride generation vessel accessory, potentiometric recorder, Nitric acid, Perchloric acid, Sulphuric acid, Hydrochloric acid, Metal free water, Sodium sulphate, Sodium borohydride pellets, Potassium chloride PM/ IS 15757/3 November 2022 Standard zinc solution, Weighing Balance, General Glasswares, Burner/ Heating Element/ Hot Plate Inductively Coupled Plasma-Mass Spectrometry Method as per AOAC 2015.01 ICP-MS instrument, High-purity grade liquid argon 99 .996%, Analytical Balance, Clean Room Gloves, Microwave Digestion System, Autosampler Vials and Cups, Spatulas, Nitric acid (HNO3), Hydrogen peroxide (H2O2), Stock standard solution, Single-element standards, Second source standard, Multi Element Stock Standard Solution, Certified Reference Materials, Analytical Balance 49. Melamine Cl. 4.11, Table 3, Sl. No. (v) Simultaneous quantitative determination of melamine by liquid chromatography electrospray ionization tandem mass
spectrometry Water, Acetonitrile, Ammonium acetate, Melamine and its standard solutions, Conical tubes, Centrifuge, Volumetric pipettes, Automatic micropipette, Nylon syringe filter, Degassing system, Analytical balance, Sonification device, Vials, LC-MS/MS equipment, HPLC Column, One-mark volumetric flasks Quantitative analysis melamine in milk-based infant formula and cow milk by liquid chromatography using linear ion-trap mass spectrometry Water, Acetonitrile, Ammonium acetate, Formic acid, Melamine and its standard solutions, Centrifuge tubes, Centrifuge, HPLC Column, Plastic syringes, Syringe filters, HPLC Surveyor MS pump, Analytical balance, One-mark volumetric flasks 50. Bisphenol A(BPA) Cl. 5.1.1 Gas chromatographic-mass spectrometric determination of Bisphenol A by ISO 18857-2 Hydrochloric acid or sulfuric acid, Acetone, Internal standard solutions, 2,2,2-Trifluoro-N-methyl-N-(trimethylsilyl)acetamide, Solid-phase material, on styrene-divinylbenzene polymer basis, Sand, Nitrogen, Sodium thiosulfate pentahydrate, Narrow-neck flat bottomed glass bottles, Solid-phase extraction cartridges, Vacuum or
TO PRODUCT MANUAL FOR INFANT FOOD - FOLLOW- UP FORMULA ACCORDING TO IS 15757: 2022 Scheme of Inspection and Testing 1. LABORATORY - A laboratory shall be maintained which shall be suitably equipped (as per the requirement given in column 2 of Table 1) and staffed, where different tests given in the specification shall be carried out in accordance with the methods given in the specification. 1.1 The manufacturer shall prepare and implement a calibration plan for the test equipments. 2. TEST RECORDS – The manufacturer shall maintain test records for the tests carried out to establish conformity. 3. PACKING AND MARKING- –The Standard Mark, as given in the Schedule of the licence, shall be marked on the containers of Infant Food - Follow- Up Formula, or printed on the label applied to it, as the case may be, provided always that the product in each container to which this mark is thus applied, conform to every requirements of the specification. 3.1 Packing – The material shall be packed in suitable form of packing as per provisions of Clause 5.1.1 of IS 15757:2022. However, the packaging material shall be free from Bisphenol A(BPA), when tested as per
ISO 18857-2 :2009 or EN 13130-13 3.2 The product shall be packed in quantities as stipulated under Legal Metrology (Packaged Commodities) Rules, 2011 and in accordance with requirements under the Food Safety and Standards (Packaging) Regulations, 2018 as per provisions of Clause 5.1.2 of IS 15757:2022. 3.3 Marking – The containers of the product shall bear legibly and indelibly the information as mentioned under clause 5.2.1 of IS 15757:2022 In addition, the following details shall be mentioned on each container: a) BIS Licence No. CM/L __________ b) BIS website details i.e – “For details of BIS Certification please visit www.bis.gov.in”. 3.3.1 In case of flexible packs, the following information as per provisions of Clause 5.2.1.1 of IS 15757:2022 shall be printed on the container: “On opening, transfer the contents of the pack to a clear air tight container. After each use, replace the lid tightly and store in a cool dry place.” 3.4 In case of manufacturers who have opted for ECO-Mark, the product package/leaflet accompanying it, may also display the information as per provisions of Clause 4.13.1.3, 4.13.1.6 and 4.13.2.3 (if fruit juice/pulp is added) of IS 15757:2022.
4. CONTROL UNIT – For the purpose of this scheme, the entire quantity of Infant Food - Follow- Up Formula manufactured and filled continuously in a day shall constitute a control unit. PM/ IS 15757/3 November 2022 5. LEVELS OF CONTROL – The tests as indicated in column 1 of Table 1 and the levels of control submitted by the manufacturer in column 3 of Table 1, shall be carried out on the whole production of the factory which is covered by this plan and appropriate records maintained in accordance with paragraph 2.0 above. 5.1 All the production which conforms to the Indian Standards and covered by the licence should be marked with Standard Mark. 5.2 In case of manufacturers who have opted for ECO-Mark, the sample(s) shall also be tested for the additional requirements for ECO-Mark, as per clause 4.13 of IS 15757:2022. 6. HYGIENIC CONDITIONS – The product shall be manufactured and packed under strict hygienic conditions as per provisions of IS 2491, cross-referred in clause 4.12 of IS 15757: 2022. 7. REJECTIONS –Disposal of non-conforming product shall be done in such a way so as to ensure that there is no violation of provisions of BIS Act, 2016.
PM/ IS 15757/3 November 2022 TABLE 1 (Levels of Control) (Para 5 of Scheme of Inspection and Testing) (1) (2) (3) Test Details Test equipment requirement R: required (or) S: Sub- contracting permitted Levels of Control Cl. Requirement Test Method No. of Sample Frequency Remarks Clause Reference 4.1 Description ---- 4.1 a) Shall be free from lumps and coarse particles; and shall be uniform in appearance. It shall also be free from dirt, and extraneous matter, preservatives, added colour and flavour and from any material, which are harmful to infant’s health. The flavor of the product in dry condition or of reconstituted feed shall be fresh and sweet. ---- IS 15757 --- One Every half an hour See Note 3 below b) Free from rancid taste and musty odour ---- IS 10641 R One Every half an hour See Note 3 below 4.2 Scorched particles ---- IS 13500 R Two Each control unit See Note 4 below 4.9 Protein Efficiency Ratio (PER) --- IS 7481 --- ---- ----- To be kept under abeyance PM/ IS 15757/3 November 2022 4.8,Table 1,Sl.No.(i) Moisture --- IS 16072 (Routine purpose) & IS 11623 (Reference purpose) R Two Each control unit See Note 4 below 4.8, Table 1,
Sl.No.(ii) Total milk protein -- IS 11917 R Two Every control unit See Note 4 below 4.8, Table 1, Sl.No.(iii) Total fat --- IS 11721 R Two Each control unit See Note 4 below 4.8,Table 1,Sl.No.(iv) Total ash IS 14433 R Two Each control unit See Note 4 below 4.8,Table 1,Sl.No.(v) Acid insoluble ash in dilute hydrochloric acid
IS 14433 R Two Each control unit See Note 4 below 4.8,Table 1,Sl.No.(vi) Solubility Index --- IS 12759 R Two Each control unit See Note 4 below 4.8,Table 1,Sl.No.(vii) Vitamin A (as retinol equivalent) -- IS 16639 S One Once in a month See note 6 below 4.8, Table 1, Sl.No. (viii) Vitamin D (expressed as chole-calciferol) -- IS 17177 S One Once in a month See note 6 below 4.8, Table 1, Sl. No. (ix) Vitamin E(as α- tocopherol) -- IS 16639 S One Once in a month See note 6 below 4.8, Table 1, Sl. No. (x) Vitamin K -- IS/ISO 21446 S One Once in a month See note 6 below 4.8, Table 1, Sl. No. (xi) Thiamine ---- IS 17669 S One Once in a month See note 6 below 4.8, Table 1, Sl. No. (xii) Riboflavin ---- IS 17669 S One Once in a month See note 6 below 4.8, Table 1, Sl.No. (xiii) Niacin equivalent ---- IS 17669 S One Once in a month See note 6 below 4.8, Table 1, Sl.No. (xiv) Pantothenic acid --- IS 16642 S One Once in a month See note 6 below PM/ IS 15757/3 November 2022 4.8, Table 1, Sl.No. (xv) Vitamin B 6 (pyridoxine) ---- IS 17669 S One Once in a month See note 6 below 4.8, Table 1, Sl. No. (xvi) Dietary Folate Equivalent (DFE) -- AOAC 2013.13 S One Once in a month
See note 6 below 4.8, Table 1, Sl.No. (xvii) Biotin -- IS 17670 S One Once in a month See note 6 below 4.8,Table 1, Sl.No.(xviii) Vitamin B 12 --- IS 16640 or AOAC 2014.02 S One Once in a month See note 6 below 4.8,Table 1, Sl.No.(xix) Vitamin C -- IS 5838 or IS 17176 S One Once in a month See note 6 below 4.8,Table 1, Sl.No.(xx) Choline --- IS 17668 S One Once in a month See note 6 below 4.8,Table 1, Sl.No.(xxi) Iron ----- AOAC 985.35 or ISO 15151 or ISO 21424 R One Each control unit See note 5 below 4.8,Table 1, Sl.No.(xxii) Sodium ---- IS 12760 or ISO 15151 or ISO 21424 R One Each control unit See Note 5 below 4.8,Table 1, Sl.No.(xxiii) Potassium ---- IS 12760 or ISO 15151 or ISO 21424 R One Each control unit See Note 5 below 4.8,Table 1, Sl.No.(xxiv) Chloride ---- IS 11763 or AOAC 2016.03 R One Each control unit See Note 5 below 4.8,Table 1, Sl.No.(xxv) Calcium ---- IS 12760 or ISO 15151 or ISO 21424 R One Each control unit See Note 5 below 4.8,Table 1, Sl.No.(xxvi) Phosphorus ---- IS 12756 or ISO 15151 or ISO 21424 R One Each control unit See Note 5 below PM/ IS 15757/3 November 2022 4.8,Table 1, Sl.No.(xxvii) Magnesium ---- IS 12760 or ISO 15151 or ISO 21424 R One Each control unit
See Note 5 below 4.8,Table 1, Sl.No.(xxviii) Iodine ---- IS 17379 S One Once in a month See note 6 below 4.8,Table 1, Sl.No.(xxix) Copper 15 of IS 1699 IS 1699 or ISO 15151 or ISO 21424 S One Once in a month See note 6 below 4.8,Table 1, Sl.No.(xxx) Zinc 15 of IS 1699 IS 1699 or ISO 15151 or ISO 21424 S One Once in a month See note 6 below 4.8,Table 1, Sl.No.(xxxi) Manganese ---- ISO 15151 or ISO 21424 S One Once in a month See note 6 below 4.8,Table 1, Sl.No.(xxii) Selenium ---- IS 15303 or ISO 15151 or ISO 20649 S One Once in a month See note 6 below 4.8,Table 1, Sl.No.(xxiii) Inositol --- IS 16649 S One Once in a month See note 6 below 4.8, Table 1, Sl.No.(xxxiv) Taurine --- AOAC 2018.06 or AOAC 997.05 S One Once in a month See note 6 below 4.8, Table 1, Sl.No.(xxxv) Essential amino acids -- Any validated international method S One Once in a month See note 5 below 4.8, Table 2, Sl. No. (i) Aerobic Plate count -- IS 5402 (Part-1) R One Each Control Unit See note 5 below 4.8, Table 2, Sl. No. (ii) Coliform count -- IS 5401 (Part-1) R One Each Control Unit See note 5 below PM/ IS 15757/3 November 2022 4.8, Table 2, Sl. No. (iii) Staphylococcus aureus (Coagulase positive) -- IS 5887(Part
8/ Sec 1 or 2) S One Once in a month See note 6 below 4.8,Table 2, Sl. No. (iv) Yeast and mould count -- IS 5403 or IS 16609-1 (for liquid formula) or IS 16069-2 (for powdered formula) R One Each control unit See note 5 below 4.8, Table 2, Sl. No. (v) Salmonella sp. -- IS 5887 (Part 3/ Sec 1) S One Once in a month See note 6 below 4.8, Table 2, Sl. No. (vi) Listeria monocytogenes -- IS 14988 (Part 1) S One Once in a month See note 6 below 4.8, Table 2, Sl. No. (vii) Bacillus cereus IS 5887(Part-6) S One Once in a month See note 6 below 4.8, Table 2, Sl. No. (viii) Sulphite reducing clostridia --- ISO 15213 S One Once in a month See note 6 below 4.8, Table 2, Sl. No. (ix) E. Coli -- IS 5887(Part 1) or IS 16424 S One Once in a month See note 6 below 4.11, Table 3, Sl. No. (i) Lead -- IS 12074 or AOAC 2015.01 S One Once in a month See note 6 below 4.11, Table 3, Sl. No. (ii) Arsenic --- IS 11124 or AOAC 2015.01 S One Once in a month See note 6 below 4.11, Table 3, Sl. No. (iii) Tin --- ISO 14377 S One Once in a month See note 6 below 4.11, Table 3, Sl. No. (iv) Cadmium 15 of IS 1699 IS 1699 or AOAC 2015.01 S One Once in a month See note 6 below 4.11, Table 3, Sl. No. (v)
Melamine --- IS 16195 S One Once in a month See note 6 below PM/ IS 15757/3 November 2022 5.1.1 Bisphenol A(BPA) -- ISO 18857-2: 2009 or EN 13130-13 S One Each consignment of raw material received Manufacturer to obtain test report/ test certificate from raw material supplier Note 1: Whether test equipment is required or sub-contracting is permitted in column 2 shall be decided by the Bureau and shall be mandatory. Sub- contracting is permitted to a laboratory recognized by the Bureau or Government laboratories empaneled by the Bureau. Note 2: Levels of control given in column 3 are only recommendatory in nature. The manufacturer may define the control unit/batch/lot and submit his own levels of control in column 3 with proper justification for approval by BO Head. Note-3: A sample shall be taken at the packing/repacking stage after every half an hour which shall be examined visually to be free from lumps and coarse particles; uniform in appearance. It shall also be free from dirt, and extraneous matter, preservatives, added colour and flavour and from any material, which are harmful to infant’s health. The flavor of the product in dry condition or of reconstituted feed shall be fresh and sweet. The product
shall be examined by organoleptic methods for freedom from rancid taste and musty odour. If the sample does not conform to the specification in any one or more of these requirements, the material manufactured during the half an hour prior to drawal of sample shall be rejected for its conformity to these requirements of the specification Note 4: Two samples shall be drawn from every control unit-one during the first half of the packing period and other during the second half of the packing period. These samples shall be individually tested for Scorched particles, Moisture, Total Milk Protein, Total Fat, Total ash, Total ash, Acid Insoluble Ash in dilute hydrochloric acid and Solubility Index. If any one of these sample(s) fail to conform to any one or more of these requirements(s) as given in the specification, the entire control unit shall either be rejected or reprocessed for its conformity to these requirements. Note-5: One sample from every control unit shall be tested for the requirements of Iron, Sodium, Potassium, Chloride, Calcium, Phosphorus, Magnesium, Aerobic plate count, Coliform count and Yeast and Mould count as laid down in the Indian Standard. If any of these samples fail to
conform to any one or more of these requirements as laid down in the Indian Standard, the entire control unit shall either be rejected or reprocessed for its conformity to these requirements Note-6: A sample shall be tested every month for Vitamin A, Vitamin E(as α-tocopherol), Vitamin D, Vitamin K, Thiamine, Riboflavin, Niacin equivalent, Pantothenic acid, Vitamin B 6 (pyridoxine), Dietary Folate equivalent (DFE), Biotin, Vitamin B 12,, Vitamin C, Choline, Iodine, Copper, Zinc, Manganese, Selenium, Inositol, Taurine, Essential amino acids, Staphylococcus aureus, Salmonella, Listeria monocytogenes, Bacillus cereus, Sulphite reducing Clostridia, E. Coli, Lead, Arsenic, Tin, Cadmium, Melamine. In case of failure of the sample in any one or more of these parameter(s), the root cause of failure shall be investigated, Corrective actions/Preventive be taken and dispatch to be kept on hold. Thereafter, the samples from two consecutive control units shall be tested for the parameter(s) where failure has occurred and once the same has been found to be conforming, original frequency of testing be restored and dispatch resumed.