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11 ·

15 ·

16 ·

11 ·

15 ·

3a · 34woH

9 · v.

11 ·

12 ·

14 ·

3 · (i) (ii) (iii) (iv)

100 · f3.5 TTH

8 · 4

0 · 12

0 · 65 (0.75)

0 · 5

2 · 5)3)7 20

0 · 85

3 · 5

0 · 54

5 · 25

2 · 25

0 · 015

0 · 12

0 · 06

0 · 5

0 · 02

0 · 12

0 · 08

0 · 5

0 · 02

0 · 12

0 · 08

0 · 5

0 · 22

0 · 75

0 · 9

2 · 5

12 · 5

0 · 017

0 · 17

0 · 07

0 · 7

0 · 035

0 · 35

0 · 15

1 · 5

0 · 18

1 · 8

0 · 75

7 · 5

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100 · f&.5 RTaH

7 · 2

7 · 2

295 · 175) 250)1

8 · 4) 12)'

4 · T

97 · &1 P

0 · 5

250 · fAafT (HRU<r & 154

100 · 250 fAciuT (HR3<v & 75q + (5 d F &4 Taj & 8Yul & fag fIg T 4 G1 &

3r · 5a

34 · Ta

0 · 5-2 TTH (TT3rv & +54 #)

71 · 313

0 · 5_1 TTA

4 · TTa

5a · 58 dTdTTYTTrZT rTava 31f14RT

0 · 5-1 MTA

0 · 5-1 MTA

0 · 5-1.0 MTH (HR<r & 14 #) ( VTT & 84 W w12 Twai & 3quit &7 & f&K frrfgt T 4 urf 8)

71 · RT

341 · Ka

5a · 71 qaq d

313f · Plzv 254 32Tc1f9-da4

77 · _v

87T · RaTe

0 · 25-0.5 HTH (HT3<v & 65q 4) (Trfare & &R :rfa 78 f441 GTTT

5a · #1 TaT T4o du TRTGt du *T da TT Ff<v 3k-efylfaT4T (f96Z4. 3R tuT.) Raa. 4c1 #q

311391 · vel VRH Fbie (31q ) 31391 Frgelet (a) iai2 & +9 # TNT GT 81)

81 · &a

5 · _10 TT

37 · T

518 · garWI

125 · fAdm (HR3<v % +54 #)

85 · 4TTHT

1 · 2 MTF

313 · 884 TTT Wa

250 · 500 fAai1 (4R3Tr & 69 4)

441 · qrtawaT

20 · 40 MIH (l & +4

20 · 30 TTH (Toof} & v4 #)

20 · _ 30 MT

20 · 40 TTF (57 & 14 #)

378747T · 1c TET dlTTacl

0 · 5-1 MTF

20 · _ 30 HTH (ooft & 14 #) 2-4 MTH (HR3T & vq #) 1-2 TITH (3135 & +4 4)

0 · 25 1.0 TTTH (TTU17 _ 3fem HIT 4 3qut Tr W Ta 311 Vad 8) 0.25 ~1 MTH (418rr w 754

84 · HTTT

0 · 5 22 MTA

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0 · 25 _1 MTA

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64 · TaT

0 · 5-_1 TTH

3 · _ 5 J& (da & 154 #)

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0 · 5-1 TTH (3135)

337 · 5 V A

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21 ·

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39 ·

300 · fTaTTMTA fa@1MTF

50 · failTT / faau1 5000 fdflmH / fdua4mF

10 ·

250 · fafT / f&@1ut 50 fcTTTH , faa1HTF 33 fAaiuA , faamA

2200 · fHafuTA / fasalum

50 · fAaiuA , faamA 1000 fAdT / f~@41F 50 fAd ,_ faamA 5000 falluT / fabaitumF

17 ·

18 ·

19 ·

300 · fAaium / f&@1A 200 fAcflTH , faaum 1500 fafTTH / fya1uTF 350 fafTuTH , faamA 400 fdfA / f~aum 5000 fAHTTH / faalTuTA 50 fcTTTH , fa@1T

20 ·

21 ·

23 ·

24 ·

25 ·

5 · H.

3137Q · vi 950

10 ·

3137Q · vi 472e

12 ·

250 · fafTTH / f&aTA 50 fAafTuTH / f~alTH 33 fHdiumA, faa1um

13 ·

15 ·

2200 · fialTuT / faauTH

50 · fuT , faauTH 1000 fAaiMTF _ faa1um 50 fdfTH _ faT1TH 5000 fafuTH ,_ faa1um 300 fafuTH , fdT1TMTH 300 fAaIumA ,_ faauH 1500 fAdlTTH / f414TH 270 fcfuT / f@1uTF 320 fHaIm / f&@uTA 5000 fHauTA / fasa1uTH 50 fHdiumA , faa1um

19 ·

20 ·

23 ·

25 ·

26 ·

5 · .

7 · .

1100 · (i)

1100 · (vi)

1100 · (iv)

1100 · (ii)

1100 · (iii)

22 · 23

24 · 25 26

552 · 516

56 · 57. 58 59

1504 · (i) 1504 (ii)

71 ·

72 · 73 74

76 · 77_

83 · 84

93 · 94

103 ·

530 · 553(1) 518 296

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9197 · "ifyufo 3F sdu

280 · 1101()

147 ·

161 ·

576 · 500(ii)

0 · 5% 0.5% 0.59

0 · 59 oflvrc %

10 · 11_

12 · 13_

29 · 29 2%

16 ·

18 · 19_

20 · 21_

22 ·

23 ·

24 ·

25 · 26_

27 ·

28 · 29_ 30. 31_

32 · 33. 34 35. 36.

159 · ofg4} 200 faiuTH 4fat 3wa oflgrdt ofgr4}

37 · 38. 39. 40. 41. 42_

0 · 59 0.59 oflge4 0.39 29 oflgrdt

48 · 49.

154 · 9 vA

50 · 51. 52.

55 · 56. 57.

59 · 0.02% ofle4}

58 ·

59 · 60. 61_

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65 · 66_

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68 · 69 70. 71_ 72_ 73. 74_

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3 · M.

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3 · v

1 · . 2. 3_ 4.

7w · 4TR @1 370

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7 · 31 VaT w {E T<T 8rG TT

33d · ~VIII

3 · 7

2 · 3 4 5 6 7

2 · Definitions - In these regulations, unless the context otherwise requires, (a) "Act ' means the Food Safety and Standards Act; 2006 (34 of 2006); 'Food Authority= means the Food Safety and Standards Authority of India established under section 4 of the Act; "food for special dietary use" shall have the meaning assigned t0 it in section 22 of the Act; (d) ~food for special medical purpose" means food intended for particular dietary use specially processed o formulated; (ii) the dietary management of persons and used only under medical advice; (iii) the exclusive or partial feeding of persons with limited, impaired or disturbed capacity to take, digest; absorb, metabolize or excrete ordinary foodstuffs O certain nutrients contained therein O metabolites; Or (iv) other medically determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet, by food for specific nutritional use, Or a combination of them; (e_ sfood with added prebiotic ingredients" means food that contains added prebiotic ingredients which are non- viable food components that confer health benefits to the consumer by modulation of gut microbiota; sfood with added probiotic ingredients" means food with live micro-organisms beneficial to human health; which when ingested in adequate numbers as single strain Or as a combination of cultures, confer one O more specified Or demonstrated health benefits in human beings; ~functional food shall have the meaning assigned t0 it in section 22 of the Act; ~hhealth supplements" shall have the meaning assigned to it in section 22 of the Act; snon-food? means an ingredient or a substance which is not food' as referred t0 in clause of section 3 of the Act; snovel food" shall have the meaning assigned to it in section 22 of the Act; ~nutraceuticals" shall have the meaning assigned to it in section 22 of the Act; "nutritional ingredients" means the ingredients specified in Schedules other than the food additives specified in Schedule VA to Schedule VF, packed and made available in a form not for retail-consumer use, but meant for use in formulating product falling under various categories of these regulations O other categories specified in the Food Safety and Standards (Food Products Standards and Food Additves) Regulations, 2011; (m) "nutrient ingredients" means vitamins, minerals, and amino acids as specified in Schedule I and Schedule II; n) "pre-mixes" means combination of two O more ingredients specified in the Schedules in specific proportion with o without additives, packed and meant for use in formulating product falling under any category of these regulations O1 under the categories specified in the Food Safety and Standards Food Products Standards and Food Additves) Regulations, 2011; (0) "specialty food containing plant or botanical ingredients" means food which is shown to be containing plant or botanical ingredients with history of safe usage; and ~Schedules" means the Schedules to these regulations_ 3. General requirements - (1) The articles of food sold in capsule format; hard 0r soft or vegetarian, shall comply with the general monograph and quality requirements specified for them in Indian Pharmacopoeia: Provided that the food business operator may use the approved colours and additives permitted in Schedule VF; Provided further that the food business operator may use the natural flavors or nature identical flavours or synthetic flavors in accoradance with the provisions of regulation 3.3.1 of Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011. For the purposes of sub-regulation (1) the food business operator may declare the addition of flavour on labels of such products in accoradance with the provisions of Food Safety and Standards (Labelling and Packaging) Regulations, 2011. The tablets, capsules and syrups shall fulfil the general quality requirements and standards as specified in Indian Pharmacopoeia, British Pharmacopoeia or United States Pharmacopoeia. The quantity of nutrients added to the articles of food shall not exceed the recommended daily allowance as specified by the Indian Council of Medical Research and in case such standards are not specified, the standards laid down by international food standards body, namely, Codex Alimentarius Commission, shall apply.

10 ·

10 ·

11 ·

12 ·

13 · 14. 15.

16 ·

10 ·

11 ·

12 ·

13 ·

14 ·

2 · Minerals

100 · 250 mg (as powder) (Not recommended for children below 5 years Seed Akarkara 100 250 mg (as powder) (Not recommended for children below 5 years) Ananas comosus (L:) Merr. Pineapple 50-100 g (as fruit) 50-100 ml (as juice) (Not recommended during pregnancy) Anethum sowa Roxb. ex Flem: (Now known as Anethum graveolens L.) Fruit Sowa 3-6 g (as powder (fruit)) Leaf Sowa 10-20 g (as powder (leaf)) Angelica glauca Edgew / Angelica archangelica L_ Root and Root stock Chora 1-3 g (as powder) Annona squamosa LIA reticulata /A muricatal A Cherimola

0 · 5-1g

66 · 67

5 · -10 g 50-100 g (as vegetable)

166 · 167

125 · mg; Max (as powder)

250 · 500 mg As powder

0 · 25- 1.0 g (Caution: excessive use may cause giddiness) 0.25 -1 g (as powder)

0 · 5 2 g

0 · 25 -1g 2-5 g 20-40 g

251 · 252 253

278 · 279

0 · 5-1g

0 · 5-1g (as extract)

950 · 304,305 951 962 901 210,211,212,213 133 320 321 902 150c 150d 903 160a(ii) 160a(i) , (iii), 160e, 160f 1503 141(i),(ii)

2 · 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15.

16 ·

17 ·

18 ·

150 · mg/kg_ 600 mg/kg 500 mg/kg 300 mg/kg 90 mg/kg 2,200 mg/kg

25 · 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. 36. 37. 38.

39 ·

500 · mg/kg 1,000 mg/kg 500 mglkg 1,500 mglkg Brilliant blue FCF 50 mg/kg Caramel III Ammonia caramel 20,000 mglkg Caramel IV Sulfite Ammonia caramel 20,000 mglkg beta-Carotenes (vegetable) 600 mg/kg

210 · 213

7 · _

50 · mg/kg 5,000 mglkg

10 ·

11 ·

250 · mg/kg 50 mg/kg 33 mg/kg 2,200 mglkg

13 ·

15 · .

50 · mg/kg 1,000 mg/kg 50 mg/kg 5,000 mglkg 300 mg/kg 200 mg/kg 1,500 mglkg 350 mg/kg 400 mg/kg 5,000 mglkg 50 mg/kg

16 ·

17 ·

18 ·

19 ·

20 ·

21 ·

23 ·

24 ·

25 ·

450 · mg/kg Ascorbyl Esters 500 mg/kg Aspartame 800 mg/kg Aspartame-acesulfame salt 450 mg/kg Benzoates 1,500 mg/kg Brilliant blue FCF 50 mglkg Caramel III Ammonia caramel 20,000 mg/kg Caramel IV Sulfite Ammonia caramel 20,000 mg/kg Beta-Carotenes (vegetable) 600 mg/kg Carotenoids 50 mglkg Diacetyltartaric and fatty acid esters of 5,000 mg/kg glycerol

210 · 213

7 · .

10 ·

11 ·

250 · mg/kg 50 mglkg 33 mglkg 2,200 mg/kg

50 · mglkg 1,000 mg/kg 50 mglkg 5,000 mg/kg 300 mg/kg 300 mg/kg 1,500 mg/kg 270 mg/kg 320 mglkg 5,000 mg/kg 50 mglkg

17 ·

432 · 436

19 ·

20 ·

21 · _

954 · (i)-(iv) 200-203

22 ·

23 ·

24 ·

25 ·

26 ·

1451 · 1401 406

1402 · 1100 (i)

10 ·

1100 · (vi)

12 ·

1100 · (ii)

1100 · (iii) 264 403

20 · 21_

22 · 23.

24 · 25. 26.

162 · 1403 1101(iii)

27 · 28. 29. 30. 31_

629 · 633 634

263 · 404

32 · 33.

302 · 170()

34 · 35. 36. 37. 38. 39. 40. 41_

509 · 623 578 526 327 352(ii) 529 282 552 516

42 · 43_

150a · 290

45 ·

410 · 407

427 · 140 1001 330 472c

50 · 51_

466 · 468

55 ·

56 · 57. 58. 59. 60. 61_

458 · 1504 (i) 1504 (ii) 1400 628 627 631 635 1412 315 968 462 467 297 418

62 · 63. 64_

65 · 66. 67_

68 · 69 70. 71_

575 · 1102 620 422 626 412

75 · 76_

78 ·

79 · 80.

507 · 463

1440 · 630 953

84 · 85.

86 ·

87 ·

88 · 89. 90_

270 · 472b

966 · 322(i)

92 · 93_

1104 · 160d(iii) 160d(i) 160d (ii) 504(i)

95 · 96.

98 · 99_

625 · 580

100 · 101.

528 · 504(ii)

102 · 103_ 104_ 105_ 106. 107 .

329 · 530 553(i) 518 296 965(i)

108 ·

109 ·

110 ·

465 · 460(i)

112 ·

113 · 114.

115 · 116_

622 · 621 1410 941

121 ·

125 · 126.

127 · 128. 129.

632 · 261 402

130 · 131.

303 · 501(i) 508

132 ·

142 ·

143 ·

145 ·

280 · 1101(i)

148 · 149.

1204 · 470(i)

150 ·

151 ·

551 · 262(i) 401

152 · 153.

301 · 500(i)

155 ·

157 ·

158 ·

159 · 160.

365 · 576 500(ii)

165 · 166_ 167.

168 · 169.

281 · 500(iii)

172 ·

1420 · 1450 1405 473a

178 · 179. 180. 181.

957 · 171

1518 · 380 333(iii)

186 · 187.

188 · 189.

0 · 5% 0.5%

0 · 5% 0.5% GMP

1 · %

10 · 11_

29 · 29 29 29 2-5%

29 · GMP

20 · 21. 22

23 ·

25 · 26.

27 ·

28 · 29.

30 · 31_

1 · %

32 · 33. 34. 35. 36.

37 · 38. 39. 40_

0 · 59 0.59

29 · GMP

48 · 49.

50 · 51_

52 ·

53 ·

54 ·

55 · 56 57.

0 · 02%

58 ·

59 · 60. 61_

65 · 66. 67.

29 · GMP

68 · 69. 70. 71_

74 · 75. 76. 77 .

10 · Glucosamine hydrochloride 11. Glucosamine sulphate

12 · Gymnema sylvestre extract Gudmar extract] Gymnemic acid content powder 13. Lactase (B-galactosidase) Enzyme activity

14 · Panax ginseng Syn;Korean Ginseng) extract (obtained from 0.6 to 2.0 gm of Ginseng root; (Panaxginseng.€ A_ Meyer, Araliaceae 15 . Phycocynin from Spirulina plantesis (Aethrospira plantesis _ Dried powder 16. Piper nigrum Piper longum extract

90 · 400 mg Iday; Max

17 · Quercetin obtained from extracts of citrus fruits and other vegetables 18. Schizandra berry extract

1 · - 3 g / day, Max

19 · Scutellaria bicalensis

250 · 1,000 mgl day; Max

20 · Selenium Yeast

21 · Siberian ginseng - obtained Ginseng from 0.6 to 2.0 gm of extract Ginseng root (A canthopanax senticosus, belonging to panax type, € A. Meyer; Araliaceae) 22. Silybum marianum extract Milk Thistle Standardized extract silimarin 250 1,000 mg/ (silymarin extract) content day 23. Spirulina (algae) from Spirulina (Protein (min. 55% 500 3,000 mg Spirulina platensis carbohydrates (max.)-30%, fats day (Arthrospira platensis) (lipid) not more than 10%, minerals (ash)-5-10%, moisture- 3- 69 (also fatty acid profile to be mentioned on the package) 24. Vaccinium myrstillus Bilberry Anthocyanin content 50 _ 600 mg day. extract extract Max

7 · _

10 ·

14 ·

15 ·

16 ·

19 ·

23 ·

28 · 29. 30.

35 · 36.

37 ·

38 ·

39 ·

48 ·

50 ·

53 ·

55 ·

57 ·

58 · 59.

60 ·

67 · _

70 ·

71 ·

73 · 74.

75 ·

77 · _

78 ·

79 ·

80 ·

83 ·

88 · 89_

90 ·

95 ·

97 · _

98 ·

99 ·

100 ·

104 · Lutein/zeaxanthin complex 105. Lycopene 106. Lycium eleagnus fruit dried powder concentrate standardized 107 . Maltase * 108. Medicago sativa extract 109. Medium chain triglycerides 110. Menyanth estrifoliata Leaf powder 1113 Millets and their powder 112_ Momordica charantia fruit seed extract 113_ Monodora myristica Gaertn: Dunal oil extract 114. Morinda citrifolia extract 115_ Moringa oleifera leaf pods seed extract powder 116. Mulberry tea leaf fruit extract 117. Myrica cerifera bark extract 118. Myristica fragrans 119. N-Acetyl D-glucosamine 120. Nasturtium officinale extract 121_ Nattokinase enzyme (as Soy Bean Fibrinase) 122_ Ocimum tenuiflorum /Ocimum sanctum aerial parts seed extract Omega-3 fatty acids (docosahexaenoic acid eicosapentaenoic acid 123. alpha linolenic acid)

124 ·

151 ·

153 ·

166 · Soya protein isolate/ edible legume seed protein isolate 167 . Spearmint leaf and distillate 168. Stanols and sterols including cholesterols 169. Tagetes sp_ petals oleo resin extract 170. Tea catechins (epigallo catechin gallate, epicatechin, catechin gallates) 171. Terminalia arjuna bark /leaf extract standardized extract) 172. Terminalia bellerica fruit extract 173. Terminalia chebulia fruit extract

175 ·

176 ·

177 · .

178 · 179.

10 · 11. 12