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Aw Consolidate Page 1-160 1 1/30/13, 2:33 PM 2 Consolidated Version of Cosmetic Regulation aw consolidate page 1-4 1 1/30/13, 12:52 AM aw consolidate page 1-4 2 1/30/13, 12:52 AM Food and Drug Administration §”π” μ—Èß·μàªï æ.». 2551 °ÆÀ¡“¬‡§√◊ËÕß ”Õ“ß ‰¥âª√—∫·°â‰¢°Æ√–‡∫’¬∫„π°“√§«∫§ÿ¡‡§√◊ËÕß ”Õ“ß ‚¥¬¬°‡≈‘°‡§√◊ËÕß ”Փߧ«∫§ÿ¡æ‘‡»…∑’ËμâÕߢ÷Èπ∑–‡∫’¬π ‡ªìπ°”Àπ¥„À⇧√◊ËÕß ”Õ“ß∑ÿ°ª√–‡¿∑‡ªì𠇧√Õß ”Փߧ«∫§◊Ë ¡∑ÿμ’Ë Õß·®â ß√“¬≈–‡Õâ ¬¥º≈’ μ¿‘ ≥±— ‡§√å Õß ”Õ“ß°◊Ë Õπº≈à μÀ√‘ Õπ”‡¢◊ “‡æâ Õ®”Àπ◊Ë “¬à ·≈–μ“¡∑’Ë ª√–‡∑»‰∑¬‚¥¬√—∞¡πμ√’‡»√…∞°‘®Õ“‡´’¬π‰¥â≈ßπ“¡„π¢âÕμ°≈ß Agreement on ASEAN Harmonized Cosmetic Regulatory Scheme (AHCRS) ‡æ◊ËÕª√—∫°Æ√–‡∫’¬∫‡°’ˬ«°—∫‡§√◊ËÕß ”Õ“ß„Àâ Õ¥§≈âÕß°—π ·≈–‰¥®â ¥∑”— ASEAN cosmetic Directive (∫∑∫≠≠— μ— ‡§√‘ Õß ”Õ“ß·À◊Ë ßÕ“‡´à ¬π)’ ´ß¢÷Ë Õ°”Àπ¥μ“¡∫∑∫â ≠≠— μ— ‘ ‡§√◊ËÕß ”Փߥ—ß°≈à“«‰¥â°”Àπ¥„Àâª√–‡∑» ¡“™‘°μâÕߧ«∫§ÿ¡°”°—∫¥Ÿ·≈ „Àâº≈‘μ¿—≥±å‡§√◊ËÕß ”Õ“ß∑’Ë«“ß ®”Àπà“¬ μâÕ߇ªìπ‰ªμ“¡¢âÕμ°≈ß∑—Èß„π‡√◊ËÕß√“¬°“√ “√∑’Ë„™â‡ªìπ à«πº ¡ ©≈“°º≈‘μ¿—≥±å °“√®—¥∑”¢âÕ¡Ÿ≈ º≈‘μ¿—≥±å·≈–°“√ª√–‡¡‘𧫓¡ª≈Õ¥¿—¬¢Õߺ≈‘μ¿—≥±å‡§√◊ËÕß ”Õ“ß ‡æ◊ËÕ„Àâº≈‘μ¿—≥±å¡’§«“¡ª≈Õ¥¿—¬ μàÕºŸâ∫√‘‚¿§‡¡◊ËÕ«“ß®”Àπà“¬„πª√–‡∑»·≈– àßÕÕ°‡æ◊ËÕ„Àâ Õ¥§≈âÕß°—∫§ÿ≥¿“æ¡“μ√∞“π “°≈ √«¡∑—Èß„πªï æ.». 2558 ®–¡’°“√‡™◊ËÕ¡‚¬ß¢âÕ¡Ÿ≈ “√ π‡∑»°—∫ª√–‡∑» ¡“™‘°Õ“‡´’¬π∑”„ÀâμâÕ߇μ√’¬¡§«“¡æ√âÕ¡ ¥“π°ÆÀ¡“¬â ·≈–¥ “𧫓¡ª≈Õ¥¿â ¬¢Õ߇§√— Õß ”Փ߇æ◊Ë Õ‡¢◊Ë “ â °“√‡™Ÿà Õ¡‚¬ß¢◊Ë Õ¡â ≈°Ÿ ∫Àπ— «¬ß“π¿“§√à ∞¥— «¬°â π— ‚¥¬°“√ª√—∫·°â‰¢°Æ√–‡∫’¬∫„π°“√§«∫§ÿ¡‡§√◊ËÕß ”Õ“ß∑”„À⺟âª√–°Õ∫∏ÿ√°‘®‡§√◊ËÕß ”Õ“ßμâÕߪ√—∫μ—«·≈– »÷°…“°Æ√–‡∫’¬∫Õ¬à“ß√Õ∫§Õ∫ ·≈–‡ΩÑ“√–«—ߺ≈‘μ¿—≥±å„Àâ¡’§«“¡ª≈Õ¥¿—¬μàÕºŸâ∫√‘‚¿§ πÕ°®“°π—Èπ °“√‡¢“∂â ߢ÷ Õ¡â ≈Ÿ ∑‡°’Ë ¬«¢’Ë Õß°â ∫ “√‡§¡— ∑’ „™’Ë ‡ªâ π ì «πº ¡„π°“√º≈à 쇧√‘ Õß ”Õ“ß¡◊Ë ‡æ’ ¡¡“°¢‘Ë π÷È ∑”„À‡®â “Àπâ “∑â ’Ë ·≈–ºŸâ‡°’ˬ«¢âÕßμâÕß»÷°…“¢âÕ¡Ÿ≈‡™‘ß≈÷° √«¡∂÷ß„π·μà≈–ªï®–¡’°“√ª√–™ÿ¡ ASEAN Cosmetic Committee (ACC) ·≈– ASEAN Cosmetic Scientific Body (ACSB) ªï≈– 2 §√—Èß ®“°°“√ª√–™ÿ¡¥—ß°≈à“« °≈ÿࡧ«∫§ÿ¡‡§√◊ËÕß ”Õ“ßμâÕßπ”°Æ√–‡∫’¬∫·≈–¢âÕ¡Ÿ≈¥â“π«‘™“°“√μà“ßÊ∑’˺à“π°“√‡ÀÁπ™Õ∫®“° ACC ¡“ª√—∫·°â‰¢°ÆÀ¡“¬„πª√–‡∑»„Àâ Õ¥§≈âÕß°—π ·≈–‡º¬·æ√à„À⺟âª√–°Õ∫°“√·≈–Àπà«¬ß“π¿“§√—∞ À√◊ÕÀπ૬ߓπÕ◊Ëπ∑’ˇ°’ˬ«¢âÕß ”À√—∫ çÀπ—ß ◊Õ√«¡°ÆÀ¡“¬‡°’ˬ«°—∫‡§√◊ËÕß ”Õ“ßé ©∫—∫π’È®—¥∑”¢÷Èπ‡æ◊ËÕ„À⇰‘¥ª√–‚¬™πå„π°“√ „™â°ÆÀ¡“¬„Àâ¡’¡“μ√∞“π·≈–‡ªìπ‰ª„π·π«∑“߇¥’¬«°—π ·≈– ◊ËÕ„À⺟⇰’ˬ«¢âÕ߉¥â‡¢â“„®‰¥âßà“¬·≈–𔉪 ∂◊ժؑ∫—쑉¥âÕ¬à“ߧ≈àÕßμ—«·≈–™—¥‡®π ß“π°”Àπ¥¡“μ√∞“π °≈ÿࡧ«∫§ÿ¡‡§√◊ËÕß ”Õ“ß ”π—°§«∫§ÿ¡‡§√◊ËÕß ”Õ“ß·≈–«—μ∂ÿÕ—πμ√“¬ ”π—°ß“π§≥–°√√¡°“√Õ“À“√·≈–¬“ °—𬓬π æ.». 2555 aw consolidate page 1-4 3 1/30/13, 12:52 AM Consolidated version of Cosmetic Regulation “√∫—≠ §”π” “√∫—≠ I. ª√–°“»°√–∑√«ß “∏“√≥ ÿ¢ ‡√◊ËÕß °”À𥫗μ∂ÿ∑’ËÀâ“¡„™â‡ªìπ à«πº ¡„π°“√º≈‘쇧√◊ËÕß ”Õ“ß 1 II. ª√–°“»°√–∑√«ß “∏“√≥ ÿ¢ ‡√◊ËÕß °”Àπ¥™◊ËÕ·≈–ª√‘¡“≥¢Õß«—μ∂ÿ∑’ËÕ“®„™â‡ªìπ à«πº ¡ 63 „π°“√º≈‘쇧√◊ËÕß ”Õ“ß III. ª√–°“»°√–∑√«ß “∏“√≥ ÿ¢ ‡√◊ËÕß °”Àπ¥ ’∑’ËÕ“®„™â‡ªìπ à«πº ¡„π°“√º≈‘쇧√◊ËÕß ”Õ“ß 103 IV. ª√–°“»°√–∑√«ß “∏“√≥ ÿ¢ ‡√◊ËÕß °”À𥫗μ∂ÿ°—π‡ ’¬∑’ËÕ“®„™â‡ªìπ à«πº ¡„π°“√º≈‘쇧√◊ËÕß ”Õ“ß 122 V. ª√–°“»°√–∑√«ß “∏“√≥ ÿ¢ ‡√◊ËÕß º≈‘μ¿—≥±å‡§√◊ËÕß ”Õ“ß∑’Ë¡’ “√ªÑÕß°—π· ß·¥¥ 142 aw consolidate page 1-4 4 1/30/13, 12:52 AM Food and Drug Administration 1 ª√–°“»°√–∑√«ß “∏“√≥ ÿ¢ ‡√◊ËÕß °”À𥫗μ∂ÿ∑’ËÀâ“¡„™â‡ªìπ à«πº ¡ „π°“√º≈‘쇧√◊ËÕß ”Õ“ß aw consolidate page 1-160 1 1/30/13, 2:33 PM 2 Consolidated version of Cosmetic Regulation aw consolidate page 1-160 2 1/30/13, 2:33 PM Food and Drug Administration 3 aw consolidate page 1-160 3 1/30/13, 2:33 PM 4 Consolidated version of Cosmetic Regulation «—μ∂ÿ∑’ËÀâ“¡„™â‡ªìπ à«πº ¡„π°“√º≈‘쇧√◊ËÕß ”Õ“ß ≈”¥∫∑— ’Ë Chemical name / INN CAS Number ·À≈àßÕâ“ßÕ‘ß 1. N-5-Chlorobenzoxazol-2-ylacetamide 35783-57-4 1. ª√–°“»°√–∑√«ß “∏“√≥ ÿ¢ 2. (2-Acetoxyethyl)trimethylammonium hydroxide 51-84-3 ‡√◊ËÕß °”À𥫗μ∂ÿ∑’ËÀâ“¡„™â‡ªìπ acetylcholine)†and its salts à«πº ¡„π°“√º≈‘쇧√◊ËÕß ”Õ“ß 3. Deanol aceglumate 3342-61-8 ª√–°“» ≥ «—π∑’Ë 26 ¡’π“§¡ 4. Spironolactone 52-01-7 æ.». 2551 5. [4-(4-Hydroxy-3-iodophenoxy)-3,5- 51-24-1 diiodophenyl]acetic acid (Tiratricol)†and its salts 2. REGULATION (EC) No 1223 6. Methotrexate 59-05-2 /2009 OF THE EUROPEAN 7. Aminocaproic acid†and its salts 60-32-2 PARLIAMENT AND OF THE 8. Cinchophen,†its salts,†derivatives and salts of 132-60-5/5949-18-8 COUNCIL of 30 November these derivatives 2009 on cosmetic products 9. Thyropropic acid†and its salts 51-26-3 10. Trichloroacetic acid 76-03-9 3. International Cosmetic 11. Aconitum napellus L. (leaves,†roots and galenical 84603-50-9 Ingredient Dictionary and preparations) Handbook Twelfth Edition 2008 12. Aconitine (principal alkaloid of Aconitum 302-27-2 napellus L.)†and its salts 4. EU Cosmetics Cosing 13. Adonis vernalis L. and its preparations 84649-73-0 14. Epinephrine 51-43-4 15. Rauwolfia serpentia L.,†alkaloids and their salts 90106-13-1 16. Alkyne alcohols,†their esters,†ethers and salts - 17. Isoprenaline 7683-59-2 18. Allyl isothiocyanate 57-06-7 19. Alloclamide†and its salts 5486-77-1 20. Nalorphine,†its salts and ethers 62-67-9 21. Sympathicomimetic amines acting on the central 300-62-9 nervous system 22. Aniline,†its salts and its halogenated and 62-53-3 sulphonated derivatives 23. Betoxycaine†and its salts 3818-62-0 24. Zoxazolamine 61-80-3 25. Procainamide,†its salts and derivatives 51-06-9 26. Benzidine 92-87-5 27. Tuaminoheptane,†its isomers and salts 123-82-0 1. ª√–°“»°√–∑√«ß “∏“√≥ ÿ¢ 28. Octodrine†and its salts 543-82-8 ‡√◊ËÕß °”À𥫗μ∂ÿ∑’ËÀâ“¡„™â‡ªìπ 29. 2-Amino-1,2-bis(4-methoxyphenyl)ethanol and 530-34-7 à«πº ¡„π°“√º≈‘쇧√◊ËÕß ”Õ“ß its salts ª√–°“» ≥ «—π∑’Ë 26 ¡’π“§¡ æ.». 30. 1,3-Dimethylpentylamine and its salts 105-41-9 2551 31. 4-Aminosalicylic acid and its salts 65-49-6 aw consolidate page 1-160 4 1/30/13, 2:33 PM Food and Drug Administration 5 ≈”¥∫∑— ’Ë Chemical name / INN CAS Number ·À≈àßÕâ“ßÕ‘ß 32. Toluidines,†their isomers,†salts and halogenated 26915-12-8 2. REGULATION (EC) No 1223/ and sulphonated derivatives 2009 OF THE EUROPEAN PAR- 33. Xylidines,†their isomers,†salts and halogenated 1300-73-8 LIAMENT AND OF THE COUN- and sulphonated derivatives CIL of 30 November 2009 on 34. Imperatorin (9-(3-methylbut-2-enyloxy)furo[3,2-g] 482-44-0 cosmetic products chromen-7-one) 35. Ammi majus L. and its galenical preparations 90320-46-0 3. International Cosmetic 36. 2,3-Dichloro-2-methylbutane 507-45-9 Ingredient Dictionary and 37. Substances with androgenic effect - Handbook Twelfth Edition 2008 38. Anthracene oil 120-12-7 39. Antibiotics 1404-88-2† 4. EU Cosmetics Cosing 40. Antimony and its compound 7440-36-0 41. Apocynum cannabium L. and its preparations 84603-51-0 42. Apomorphine ((R)-5,6,6a,7-tetrahydro-6-methyl-4H- 58-00-4 dibenzo[de,g]quinoline-10,11-diol))†and its salts 43. Arsenic and its compounds 7440-38-2 44. Atropa belladonna L. and its preparations 8007-93-0 45. Atropine,†its salts and derivatives 51-55-8 46. Barium salts,†¬°‡«âπ «—μ∂ÿ∑’Ë√–∫ÿ‰«â„πª√–°“»°√–∑√«ß 7440-39-3 “∏“√≥ ÿ¢∑’ËÕÕ°μ“¡§«“¡„π¡“μ√“ 5 (5) ‡°’ˬ«°—∫ °“√°”Àπ¥™◊ËÕ ·≈–ª√‘¡“≥¢Õß«—μ∂ÿ∑’ËÕ“®„™â‡ªìπ à«πº ¡ „π°“√º≈‘쇧√◊ËÕß ”Õ“ß 47. Benzene 71-43-2 48. Benzimidazol-2(3H)-one 615-16-7 49. Benzazepines and benzodiazepines 12794-10-4 50. 1-Dimethylaminomethyl-1-methylpropyl benzoate 644-26-8 (amylocaine)†and its salts 51. 2,2,6-Trimethyl-4-piperidyl benzoate (benzamine) 500-34-5 and its salts 52. Isocarboxazid 59-63-2 1. ª√–°“»°√–∑√«ß “∏“√≥ ÿ¢ 53. Bendroflumethiazide†and its derivatives 73-48-3 ‡√◊ËÕß °”À𥫗μ∂ÿ∑’ËÀâ“¡„™â‡ªìπ à«π 54. Beryllium and its compounds 7440-41-7 º ¡„π°“√º≈‘쇧√◊ËÕß ”Õ“ß 55. Bromine,†elemental 7726-95-6 ª√–°“» ≥ «—π∑’Ë 26 ¡’π“§¡ æ.». 56. Bretylium tosilate 61-75-6 2551 57. Carbromal 77-65-6 58. Bromisoval 496-67-3 2. REGULATION (EC) No 1223/ 59. Brompheniramine†and its salts 86-22-6 2009 OF THE EUROPEAN 60. Benzilonium bromide 1050-48-2 PARLIAMENT AND OF THE 61. Tetrylammonium bromide 71-91-0 COUNCIL of 30 November 62. Brucine 357-57-3 2009 on cosmetic products 63. Tetracaine and its salts 94-24-6 64. Mofebutazone 2210-63-1 aw consolidate page 1-160 5 1/30/13, 2:33 PM 6 Consolidated version of Cosmetic Regulation ≈”¥∫∑— ’Ë Chemical name / INN CAS Number ·À≈àßÕâ“ßÕ‘ß 65. Tolbutamide 64-77-7 3. International Cosmetic 66. Carbutamide 339-43-5 Ingredient Dictionary and 67. Phenylbutazone 50-33-9 Handbook Twelfth Edition 2008 68. Cadmium and its compounds 7440-43-9 69. Cantharides,†Cantharis vesicatoria 92457-17-5 4. EU Cosmetics Cosing 70. (1R,2S)-Hexahydro-1,2-dimethyl-3,6-epoxyphthalic 56-25-7 anhydride (Cantharidine) 71. Phenprobamate 673-31-4 72. Nitroderivatives of carbazole - 73. Carbon disulphide 75-15-0 74. Catalase 9001-05-2 75. Cephaeline and its salts 483-17-0 76.
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