SUPPLEMENT Alpha Amino Acid Chlorphenesin Panax Ginseng NEW DATA CIR EXPERT PANEL MEETING JUNE 10-11, 2012
Memorandum To: From: CIR Expert Panel Members and Liaisons Christina Burnett Scientific Analyst/Writer Date: August 30, 2012 Subject: Wave 2 data on α-amino Acid Ingredients as Used in Cosmetics Additional comments regarding the tentative report on α-amino acids were received from the Personal Care Products Council and will be incorporated into the report. Please see the attached memo from the Council. CIR Supplement Page 1
α-amino Acid Ingredients page - 2 - Distributed for Comment Only - Do Not Cite or Quote Table 4. Frequency and concentration of use according to duration and type of exposure # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) Alanine a Arginine Arginine HCl Totals* 294 (265) 3.0x10-7 -0.1 505 (440) 0.00002-18 52 (69) 0.004-0.1 Duration of Use Leave-On 252 (223) 3.0x10-7 -0.1 411 (328) 0.00002-2 33 (45) 0.004-0.02 Rinse-Off 42 5.0x10-7 -0.06 89 (107) 0.00004-18 19 (24) 0.004-0.1 Diluted for (Bath) Use NR NR 5 NR NR NR Exposure Type Eye Area 20 (15) 0.0004-0.05 58 (36) 0.00002-2 4 NR Incidental Ingestion NR 0.00003 1 0.00003-0.001 NR NR Incidental Inhalation-Spray NR 3.0x10-7 ; 0.0007 aerosols; 0.001-0.01 pump sprays NR 0.2; 0.0001-0.1 aerosols; 0.0003-0.1 pumps 6 NR Incidental Inhalation-Powder NR NR 1 (NR) NR NR NR Dermal Contact 263 (234) 3.0x10-7 -0.1 415 (358) 0.00002-18 26 (37) 0.02 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring 30 5.0x10-7 -0.05 71 (72) 0.00004-3 26 (32) 0.004-0.1 Hair-Coloring NR 0.05 1 0.004-0.8 NR NR Nail NR NR 1 0.5 NR 0.004 Mucous Membrane 2 0.00003 14 (25) 0.00003-0.001 NR NR Baby Products NR NR NR NR NR NR Asparagine Aspartic Acid b Calcium Glycinate Totals* 9 NR 165 (148) 0.000005-1 NR 3 Duration of Use Leave-On 4 NR 117 (105) 0.000005-0.6 NR 3 Rinse Off 5 NR 48 (43) 0.0001-1 NR NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area NR NR 10 (9) 0.2 NR NR Incidental Ingestion NR NR NR NR NR NR Incidental Inhalation-Spray NR NR NR 0.003-0.2 aerosols NR NR Incidental Inhalation-Powder NR NR NR NR NR NR Dermal Contact 3 NR 120 (111) 0.000005-0.2 NR 3 Deodorant (underarm) NR NR NR NR NR 3 (not spray) Hair - Non-Coloring 6 NR 45 (37) 0.0001-1 NR NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane NR NR NR NR NR NR Baby Products NR NR NR NR NR NR Cysteine c Cysteine HCl d Cystine Totals* 25 (20) 0.0001-5 5 0.0001-6 11 (10) 0.001-3 Duration of Use Leave-On 18 (17) 0.0001-0.05 1 0.0001 5 0.001 Rinse-Off 7 (3) 0.0001-5 4 0.0001-6 6 (5) 0.001-3 Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area NR NR NR NR NR NR Incidental Ingestion NR NR NR NR NR NR Incidental Inhalation-Spray 2 0.001 NR NR NR NR Incidental Inhalation-Powder NR 0.05 NR NR NR NR Dermal Contact 10 (8) 0.0009-0.05 1 NR 3 0.001 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring 11 (8) 0.0001-5 3 0.0001-6 8 (7) 0.001-3 Hair-Coloring NR NR 1 NR NR NR Nail 4 NR NR NR NR NR Mucous Membrane NR NR NR NR NR NR Baby Products NR NR NR NR NR NR CIR Supplement Page 2
α-amino Acid Ingredients page - 3 - Distributed for Comment Only - Do Not Cite or Quote Table 4. Frequency and concentration of use according to duration and type of exposure # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) Glutamic Acid e Glutamine f Glycine Totals 308 (274) 0.000004-2 16 (17) 0.002-0.005 364 (323) 0.0005-4 Duration of Use Leave-On 217 (190) 0.000004-0.4 15 0.002 252 (221) 0.0007-4 Rinse Off 91 (84) 0.00003-2 1 (2) 0.005 112 (102) 0.0005-4 Diluted for (Bath) Use NR 0.1 NR NR NR 0.2-0.4 Exposure Type Eye Area 21 (17) 0.000004-0.08 1 NR 21 0.001-0.3 Incidental Ingestion NR 0.00003 NR NR 1 0.01 Incidental Inhalation-Spray NR NR NR NR 8 0.3 0.0007 aerosols; 0.01-0.1 pump sprays Incidental Inhalation-Aerosol NR NR NR NR 1 NR Dermal Contact 208 (184) 0.000004-0.2 15 0.002-0.005 271 (239) 0.001-4 Deodorant (underarm) NR NR NR NR 4 0.5-4 (not spray) Hair - Non-Coloring 89 (81) 0.00003-2 1 (2) NR 83 (82) 0.0005-2 Hair-Coloring 5 0.01 NR NR 8 (NR) 0.004-4 Nail NR NR NR NR NR 0.5-1 Mucous Membrane 1 0.00003-0.1 NR NR 5 (6) 0.01-1 Baby Products NR NR NR NR 1 NR Histidine Histidine HCl g Isoleucine h Totals* 66 (59) 0.00009-0.05 11 (8) 0.00003-0.07 30 (28) 0.0003-0.002 Duration of Use Leave-On 51 (43) 0.00009-0.05 11 (8) 0.00003-0.07 25 (23) 0.0003-0.002 Rinse-Off 15 (16) 0.0004-0.0008 NR NR 5 0.001-0.002 Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 4 (2) NR 1 0.01 1 NR Incidental Ingestion NR 0.001 NR 0.00003 NR 0.001 Incidental Inhalation-Spray NR 0.00009 aerosols; NR NR NR 0.0003 aerosols 0.0003 pump sprays Incidental Inhalation-Powder NR NR 1 (NR) NR NR NR Dermal Contact 41 (33) 0.0003-0.05 11 (8) 0.01-0.07 26 (24) 0.001 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring 25 (26) 0.00009-0.0008 NR NR 4 0.0003-0.002 Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane NR 0.001 NR 0.00003 NR 0.001 Baby Products NR NR NR NR NR NR Leucine i Lysine j Lysine HCl k Totals* 33 0.0009-0.001 151 (132) 1.0x10-7 -0.7 47 (46) 0.00003-0.6 Duration of Use Leave-On 28 (27) 0.0009-0.001 139 (119) 0.00002-0.7 36 (30) 0.00003-0.6 Rinse-Off 5 (6) NR 12 (13) 1.0x10-7 -0.04 11 (16) 0.0008-0.1 Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area NR NR 10 (8) 0.00002-0.04 3 (1) 0.001 Incidental Ingestion NR 0.001 1 NR 1 (2) 0.00003-0.001 Incidental Inhalation-Spray NR NR NR NR 1 NR Incidental Inhalation-Powder NR NR NR NR NR NR Dermal Contact 28 (27) 0.0009 140 (120) 1.0x10-7 -0.7 18 (11) 0.0002-0.6 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring 5 (6) NR 10 (11) 0.00004 28 (33) 0.0008-0.2 Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane NR 0.001 1 NR 1 (2) 0.00003-0.001 Baby Products NR NR NR NR NR NR CIR Supplement Page 3
α-amino Acid Ingredients page - 4 - Distributed for Comment Only - Do Not Cite or Quote Table 4. Frequency and concentration of use according to duration and type of exposure # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) Magnesium Aspartate Methionine l Phenylalanine Totals* 107 (94) 0.00005-0.1 30 (24) 0.0001-0.07 39 (36) 0.00009-0.03 Duration of Use Leave-On 87 (76) 0.0003-0.1 24 (18) 0.0001-0.005 30 (27) 0.00009-0.03 Rinse-Off 19 (18) 0.00005-0.06 6 (5) 0.0001-0.07 9 0.0004-0.0008 Diluted for (Bath) Use 1 (NR) NR NR (1) NR NR NR Exposure Type Eye Area 19 (16) 0.005-0.05 NR NR 2 0.005 Incidental Ingestion NR (1) 0.001 NR NR NR NR Incidental Inhalation-Spray NR NR NR NR NR 0.00009 aerosols Incidental Inhalation-Powder NR 0.0003 NR NR 1 (NR) NR Dermal Contact 106 (92) 0.0003-0.1 23 (18) 0.001-0.005 29 (26) 0.0004-0.03 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring 1 0.00005-0.005 7 (6) 0.0001-0.07 9 0.00009-0.001 Hair-Coloring NR NR NR NR NR NR Nail NR 0.001 NR NR NR NR Mucous Membrane 2 0.0005-0.003 NR (1) NR NR NR Baby Products NR 0.0003-0.005 NR NR NR NR # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) Potassium Aspartate Proline m Serine n Totals* 14 (15) 0.0003-0.008 279 (273) 0.00001-2 334 (298) 0.00003-2 Duration of Use Leave-On 9 (10) 0.0003-0.008 223 (210) 0.0001-2 299 (258) 0.00003-2 Rinse-Off 5 0.005 56 (59) 0.00001-1 35 (40) 0.0002-1 Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area NR NR 14 (11) 0.0001-0.2 38 (28) 0.002-0.3 Incidental Ingestion NR (1) 0.001 1 NR NR 0.00003-0.05 Incidental Inhalation-Spray NR NR 4 (NR) 0.0003 aerosols NR 0.08; 0.0005 aerosols Incidental Inhalation-Powder NR 0.0003 NR NR 9 NR Dermal Contact 13 0.0003-0.008 232 (219) 0.0001-1 309 (275) 0.002-2 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring 1 0.005 15 (18) 0.00001-0.03 14 0.0002-1 Hair-Coloring NR NR 29 NR NR NR Nail NR NR 2 2 2 0.004 Mucous Membrane NR (1) 0.001 2 NR 2 0.00003-0.05 Baby Products NR 0.0003-0.005 NR (2) NR 1 NR # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) Sodium Glutamate Sodium Glycinate Threonine o Totals* 19 0.01-2 16 (15) NR 170 (146) 0.00002-0.05 Duration of Use Leave-On 18 0.01-2 NR NR 126 (102) 0.00003-0.02 Rinse-Off 1 0.01 16 (15) NR 44 0.00002-0.05 Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 1 0.5-2 NR NR 10 (6) 0.0002-0.003 Incidental Ingestion NR 0.2 NR NR NR 0.00003-0.001 Incidental Inhalation-Spray NR NR NR NR NR 0.0003 aerosols Incidental Inhalation-Powder NR NR NR NR NR NR Dermal Contact 19 0.01-2 NR NR 130 (106) 0.0001-0.02 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR 1 NR NR 10 0.00002-0.002 Hair-Coloring NR 0.01 16 (15) NR 29 0.05 Nail NR NR NR NR 1 0.004 Mucous Membrane 1 0.2 NR NR 1 0.00003-0.001 Baby Products NR NR NR NR NR NR CIR Supplement Page 4
α-amino Acid Ingredients page - 5 - Distributed for Comment Only - Do Not Cite or Quote Table 4. Frequency and concentration of use according to duration and type of exposure # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) Tryptophan Tyrosine Valine Totals* 15 (10) 0.0001 56 (54) 0.0005-1 32 (31) 0.0004-1 Duration of Use Leave-On 13 (8) NR 49 (47) 0.0009-1 26 (25) 0.0004-0.5 Rinse-Off 2 0.0001 7 0.0005-0.001 6 0.002-1 Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 2 (NR) NR 3 0.004-1 1 NR Incidental Ingestion NR NR NR NR NR 0.001 Incidental Inhalation-Spray NR NR 9 NR NR 0.0004 aerosols Incidental Inhalation-Powder NR NR 1 (NR) 0.05 NR NR Dermal Contact 13 (8) NR 47 (45) 0.0009-1 28 (27) 0.0009-0.02 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring 2 0.0001 9 0.0005 4 0.0004-1 Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane NR NR NR NR NR 0.001 Baby Products NR NR NR NR NR NR * Because each ingredient may be used in cosmetics with multiple exposure types, the sum of all exposure types my not equal the sum of total uses. NR no reported uses a The VCRP listed separate entries for Alanine and L-Alanine, which have been combined in this table. L-Alanine has a total of 19 uses, 9 in rinse-off products and 10 in leave-on products. 13 uses lead to a dermal exposure, and 6 uses are to hair (non-coloring). b The VCRP listed separate entries for Aspartic Acid and L-Aspartic Acid, which have been combined in this table. L-Aspartic Acid has a total of 3 uses, 2 in rinse-off products and 1 in leave-on products. 1 use leads to a dermal exposure, and 2 uses are to hair (non-coloring). c The VCRP listed separate entries for Cysteine and L-Cysteine, which have been combined in this table. L-Cysteine has a total of 3 uses, all in rinse-off products. 1 use leads to a dermal exposure, and 2 uses are to hair (non-coloring). d The VCRP only listed an entry for L-Cysteine HCl. This data has been combined with the concentration of use data for Cysteine HCl. e The VCRP listed separate entries for Glutamic Acid, DL-Glutamic Acid, and L-Glutamic Acid, which have been combined in this table. DL- Glutamic Acid has a total of 2 uses, all in leave-on products. Both uses are a dermal exposure. L-Glutamic Acid has a total of 14 uses, 8 uses in leave-on products and 6 uses in rinse-off products. 8 uses are a dermal exposure, and 6 uses are to hair (non-coloring). f The VCRP only listed an entry for L-Glutamine. This data has been combined with the concentration of use data for Glutamine. g The VCRP only listed an entry for L-Histidine HCl. This data has been combined with the concentration of use data for Histidine HCl. h The VCRP only listed an entry for L-Isoleucine. This data has been combined with the concentration of use data for Isoleucine. i The VCRP only listed an entry for L-Leucine. This data has been combined with the concentration of use data for Leucine. j The VCRP listed separate entries for Lysine, DL-Lysine, and L-Lysine, which have been combined in this table. DL-Lysine has 1 use in a leave-on product with dermal exposure. L-Lysine has a total of 16 uses, 13 uses in leave-on products and 3 uses in rinse-off products. 1 use is in the eye area, 13 uses are a dermal exposure, and 3 uses are to hair (non-coloring). k The VCRP only listed an entry for L-Lysine HCl. This data has been combined with the concentration of use data for Lysine HCl. l The VCRP listed separate entries for Methionine and L-Methionine, which have been combined in this table. L-Methionine has a total of 2 uses, both in leave-on products with a dermal exposure. m The VCRP listed separate entries for Proline and DL-Proline, which have been combined in this table. DL-Proline has a total of 9 uses, 3 in leave-on products and 6 in rinse-off products. 1 use may lead to incidental ingestion, 1 use may be to the mucous membranes, 2 uses are dermal exposures, and 6 uses are to the hair (coloring). n The VCRP listed separate entries for Serine and L-Serine, which have been combined in this table. L-Serine has a total of 40 uses, 32 in leaveon products and 8in rinse-off products. 2 uses are in the eye area, 1 use is in nail products, 34 uses are dermal exposures, and 5 uses are to hair (non-coloring). o The VCRP listed separate entries for Threonine and L-Threonine, which have been combined in this table. L-Threonine has a total of 7 uses, 5 in leave-on products and 2 in rinse-off products. 5 uses are dermal exposures and 2 are to the hair (non-coloring). CIR Supplement Page 5
α-amino Acid Ingredients page - 6 - Distributed for Comment Only - Do Not Cite or Quote 2012 FDA VCRP RAW DATA 03C - Eye Shadow 6898948 ALANINE 1 03D - Eye Lotion 6898948 ALANINE 4 03F - Mascara 6898948 ALANINE 1 03G - Other Eye Makeup Preparations 6898948 ALANINE 14 05A - Hair Conditioner 6898948 ALANINE 12 05C - Hair Straighteners 6898948 ALANINE 1 05F - Shampoos (non-coloring) 6898948 ALANINE 4 05G - Tonics, Dressings, and Other Hair 6898948 ALANINE 6 Grooming Aids 05I - Other Hair Preparations 6898948 ALANINE 1 07C - Foundations 6898948 ALANINE 10 07H - Makeup Fixatives 6898948 ALANINE 1 07I - Other Makeup Preparations 6898948 ALANINE 3 10E - Other Personal Cleanliness Products 6898948 ALANINE 2 11A - Aftershave Lotion 6898948 ALANINE 2 11G - Other Shaving Preparation Products 6898948 ALANINE 1 12A - Cleansing 6898948 ALANINE 6 12C - Face and Neck (exc shave) 6898948 ALANINE 56 12D - Body and Hand (exc shave) 6898948 ALANINE 28 12F - Moisturizing 6898948 ALANINE 88 12G - Night 6898948 ALANINE 10 12H - Paste Masks (mud packs) 6898948 ALANINE 7 12I - Skin Fresheners 6898948 ALANINE 5 12J - Other Skin Care Preps 6898948 ALANINE 12 05A - Hair Conditioner 56417 ALANINE, L- 2 05D - Permanent Waves 56417 ALANINE, L- 1 05F - Shampoos (non-coloring) 56417 ALANINE, L- 2 05H - Wave Sets 56417 ALANINE, L- 1 07C - Foundations 56417 ALANINE, L- 2 12A - Cleansing 56417 ALANINE, L- 2 12C - Face and Neck (exc shave) 56417 ALANINE, L- 3 12F - Moisturizing 56417 ALANINE, L- 5 12H - Paste Masks (mud packs) 56417 ALANINE, L- 1 02B - Bubble Baths 74793 ARGININE 5 03B - Eyeliner 74793 ARGININE 2 03D - Eye Lotion 74793 ARGININE 16 03E - Eye Makeup Remover 74793 ARGININE 2 03F - Mascara 74793 ARGININE 16 03G - Other Eye Makeup Preparations 74793 ARGININE 22 05A - Hair Conditioner 74793 ARGININE 19 05C - Hair Straighteners 74793 ARGININE 3 05E - Rinses (non-coloring) 74793 ARGININE 2 05F - Shampoos (non-coloring) 74793 ARGININE 19 05G - Tonics, Dressings, and Other Hair 74793 ARGININE 13 Grooming Aids 05I - Other Hair Preparations 74793 ARGININE 15 CIR Supplement Page 6
α-amino Acid Ingredients page - 7 - Distributed for Comment Only - Do Not Cite or Quote 06A - Hair Dyes and Colors (all types 74793 ARGININE 1 requiring caution statements and patch tests) 07B - Face Powders 74793 ARGININE 1 07C - Foundations 74793 ARGININE 5 07E - Lipstick 74793 ARGININE 1 07I - Other Makeup Preparations 74793 ARGININE 3 08B - Cuticle Softeners 74793 ARGININE 1 10A - Bath Soaps and Detergents 74793 ARGININE 4 10E - Other Personal Cleanliness Products 74793 ARGININE 4 11G - Other Shaving Preparation Products 74793 ARGININE 1 12A - Cleansing 74793 ARGININE 26 12C - Face and Neck (exc shave) 74793 ARGININE 93 12D - Body and Hand (exc shave) 74793 ARGININE 16 12F - Moisturizing 74793 ARGININE 131 12G - Night 74793 ARGININE 24 12H - Paste Masks (mud packs) 74793 ARGININE 8 12I - Skin Fresheners 74793 ARGININE 12 12J - Other Skin Care Preps 74793 ARGININE 40 03D - Eye Lotion 1119342 ARGININE HYDROCHLORIDE 4 05A - Hair Conditioner 1119342 ARGININE HYDROCHLORIDE 6 05E - Rinses (non-coloring) 1119342 ARGININE HYDROCHLORIDE 1 05F - Shampoos (non-coloring) 1119342 ARGININE HYDROCHLORIDE 11 05G - Tonics, Dressings, and Other Hair 1119342 ARGININE HYDROCHLORIDE 1 Grooming Aids 05I - Other Hair Preparations 1119342 ARGININE HYDROCHLORIDE 7 12C - Face and Neck (exc shave) 1119342 ARGININE HYDROCHLORIDE 10 12F - Moisturizing 1119342 ARGININE HYDROCHLORIDE 3 12G - Night 1119342 ARGININE HYDROCHLORIDE 1 12H - Paste Masks (mud packs) 1119342 ARGININE HYDROCHLORIDE 1 12J - Other Skin Care Preps 1119342 ARGININE HYDROCHLORIDE 1 13B - Indoor Tanning Preparations 1119342 ARGININE HYDROCHLORIDE 6 05A - Hair Conditioner 70473 ASPARAGINE 2 05F - Shampoos (non-coloring) 70473 ASPARAGINE 3 05G - Tonics, Dressings, and Other Hair 70473 ASPARAGINE 1 Grooming Aids 12J - Other Skin Care Preps 70473 ASPARAGINE 3 03C - Eye Shadow 6899032 ASPARTIC ACID 1 03D - Eye Lotion 6899032 ASPARTIC ACID 3 03G - Other Eye Makeup Preparations 6899032 ASPARTIC ACID 6 05A - Hair Conditioner 6899032 ASPARTIC ACID 33 05F - Shampoos (non-coloring) 6899032 ASPARTIC ACID 4 05G - Tonics, Dressings, and Other Hair 6899032 ASPARTIC ACID 2 Grooming Aids 05H - Wave Sets 6899032 ASPARTIC ACID 1 05I - Other Hair Preparations 6899032 ASPARTIC ACID 3 07C - Foundations 6899032 ASPARTIC ACID 10 CIR Supplement Page 7
α-amino Acid Ingredients page - 8 - Distributed for Comment Only - Do Not Cite or Quote 07F - Makeup Bases 6899032 ASPARTIC ACID 1 07H - Makeup Fixatives 6899032 ASPARTIC ACID 1 11A - Aftershave Lotion 6899032 ASPARTIC ACID 2 11G - Other Shaving Preparation Products 6899032 ASPARTIC ACID 1 12A - Cleansing 6899032 ASPARTIC ACID 1 12C - Face and Neck (exc shave) 6899032 ASPARTIC ACID 23 12D - Body and Hand (exc shave) 6899032 ASPARTIC ACID 20 12F - Moisturizing 6899032 ASPARTIC ACID 31 12G - Night 6899032 ASPARTIC ACID 2 12H - Paste Masks (mud packs) 6899032 ASPARTIC ACID 6 12I - Skin Fresheners 6899032 ASPARTIC ACID 3 12J - Other Skin Care Preps 6899032 ASPARTIC ACID 8 05A - Hair Conditioner 56848 ASPARTIC ACID, L- 1 05D - Permanent Waves 56848 ASPARTIC ACID, L- 1 07C - Foundations 56848 ASPARTIC ACID, L- 1 02A - Bath Oils, Tablets, and Salts 7018077 MAGNESIUM ASPARTATE 1 03B - Eyeliner 7018077 MAGNESIUM ASPARTATE 4 03D - Eye Lotion 7018077 MAGNESIUM ASPARTATE 4 03G - Other Eye Makeup Preparations 7018077 MAGNESIUM ASPARTATE 11 05I - Other Hair Preparations 7018077 MAGNESIUM ASPARTATE 1 07C - Foundations 7018077 MAGNESIUM ASPARTATE 1 10A - Bath Soaps and Detergents 7018077 MAGNESIUM ASPARTATE 1 11A - Aftershave Lotion 7018077 MAGNESIUM ASPARTATE 3 12A - Cleansing 7018077 MAGNESIUM ASPARTATE 11 12C - Face and Neck (exc shave) 7018077 MAGNESIUM ASPARTATE 25 12D - Body and Hand (exc shave) 7018077 MAGNESIUM ASPARTATE 1 12F - Moisturizing 7018077 MAGNESIUM ASPARTATE 17 12G - Night 7018077 MAGNESIUM ASPARTATE 11 12H - Paste Masks (mud packs) 7018077 MAGNESIUM ASPARTATE 7 12I - Skin Fresheners 7018077 MAGNESIUM ASPARTATE 2 12J - Other Skin Care Preps 7018077 MAGNESIUM ASPARTATE 7 05I - Other Hair Preparations 7259258 POTASSIUM ASPARTATE 1 07C - Foundations 7259258 POTASSIUM ASPARTATE 1 11A - Aftershave Lotion 7259258 POTASSIUM ASPARTATE 1 12A - Cleansing 7259258 POTASSIUM ASPARTATE 2 12D - Body and Hand (exc shave) 7259258 POTASSIUM ASPARTATE 3 12F - Moisturizing 7259258 POTASSIUM ASPARTATE 1 12H - Paste Masks (mud packs) 7259258 POTASSIUM ASPARTATE 3 12J - Other Skin Care Preps 7259258 POTASSIUM ASPARTATE 2 05A - Hair Conditioner 4371522 CYSTEINE 2 05B - Hair Spray (aerosol fixatives) 4371522 CYSTEINE 1 05F - Shampoos (non-coloring) 4371522 CYSTEINE 2 05G - Tonics, Dressings, and Other Hair 4371522 CYSTEINE 1 Grooming Aids 05I - Other Hair Preparations 4371522 CYSTEINE 3 CIR Supplement Page 8
α-amino Acid Ingredients page - 9 - Distributed for Comment Only - Do Not Cite or Quote 07C - Foundations 4371522 CYSTEINE 1 07D - Leg and Body Paints 4371522 CYSTEINE 1 07I - Other Makeup Preparations 4371522 CYSTEINE 1 08A - Basecoats and Undercoats 4371522 CYSTEINE 2 08E - Nail Polish and Enamel 4371522 CYSTEINE 2 12C - Face and Neck (exc shave) 4371522 CYSTEINE 2 12D - Body and Hand (exc shave) 4371522 CYSTEINE 1 12F - Moisturizing 4371522 CYSTEINE 1 12I - Skin Fresheners 4371522 CYSTEINE 1 13B - Indoor Tanning Preparations 4371522 CYSTEINE 1 05A - Hair Conditioner 52904 CYSTEINE, L- 1 05C - Hair Straighteners 52904 CYSTEINE, L- 1 12H - Paste Masks (mud packs) 52904 CYSTEINE, L- 1 05C - Hair Straighteners 7048046 CYSTEINE HCL MONOHYDRATE 1 05C - Hair Straighteners 52891 CYSTEINE, L-, HYDROCHLORIDE 1 05D - Permanent Waves 52891 CYSTEINE, L-, HYDROCHLORIDE 1 06A - Hair Dyes and Colors (all types 52891 CYSTEINE, L-, HYDROCHLORIDE 1 requiring caution statements and patch tests) 12J - Other Skin Care Preps 52891 CYSTEINE, L-, HYDROCHLORIDE 1 05A - Hair Conditioner 56893 CYSTINE 3 05F - Shampoos (non-coloring) 56893 CYSTINE 3 05G - Tonics, Dressings, and Other Hair 56893 CYSTINE 2 Grooming Aids 12C - Face and Neck (exc shave) 56893 CYSTINE 3 03C - Eye Shadow 6899054 GLUTAMIC ACID 1 03D - Eye Lotion 6899054 GLUTAMIC ACID 2 03F - Mascara 6899054 GLUTAMIC ACID 6 03G - Other Eye Makeup Preparations 6899054 GLUTAMIC ACID 12 05A - Hair Conditioner 6899054 GLUTAMIC ACID 60 05C - Hair Straighteners 6899054 GLUTAMIC ACID 2 05D - Permanent Waves 6899054 GLUTAMIC ACID 1 05E - Rinses (non-coloring) 6899054 GLUTAMIC ACID 1 05F - Shampoos (non-coloring) 6899054 GLUTAMIC ACID 4 05G - Tonics, Dressings, and Other Hair 6899054 GLUTAMIC ACID 7 Grooming Aids 05I - Other Hair Preparations 6899054 GLUTAMIC ACID 8 06H - Other Hair Coloring Preparation 6899054 GLUTAMIC ACID 5 07C - Foundations 6899054 GLUTAMIC ACID 9 07H - Makeup Fixatives 6899054 GLUTAMIC ACID 1 07I - Other Makeup Preparations 6899054 GLUTAMIC ACID 3 10E - Other Personal Cleanliness Products 6899054 GLUTAMIC ACID 1 11A - Aftershave Lotion 6899054 GLUTAMIC ACID 2 11G - Other Shaving Preparation Products 6899054 GLUTAMIC ACID 1 12A - Cleansing 6899054 GLUTAMIC ACID 6 12C - Face and Neck (exc shave) 6899054 GLUTAMIC ACID 50 CIR Supplement Page 9
α-amino Acid Ingredients page - 10 - Distributed for Comment Only - Do Not Cite or Quote 12D - Body and Hand (exc shave) 6899054 GLUTAMIC ACID 21 12F - Moisturizing 6899054 GLUTAMIC ACID 63 12G - Night 6899054 GLUTAMIC ACID 9 12H - Paste Masks (mud packs) 6899054 GLUTAMIC ACID 4 12I - Skin Fresheners 6899054 GLUTAMIC ACID 3 12J - Other Skin Care Preps 6899054 GLUTAMIC ACID 10 12C - Face and Neck (exc shave) 617654 GLUTAMIC ACID, DL- 2 05A - Hair Conditioner 56860 GLUTAMIC ACID, L- 3 05D - Permanent Waves 56860 GLUTAMIC ACID, L- 1 05F - Shampoos (non-coloring) 56860 GLUTAMIC ACID, L- 1 05G - Tonics, Dressings, and Other Hair 56860 GLUTAMIC ACID, L- 1 Grooming Aids 07C - Foundations 56860 GLUTAMIC ACID, L- 2 12C - Face and Neck (exc shave) 56860 GLUTAMIC ACID, L- 2 12F - Moisturizing 56860 GLUTAMIC ACID, L- 3 12H - Paste Masks (mud packs) 56860 GLUTAMIC ACID, L- 1 03B - Eyeliner 56859 GLUTAMINE, L- 1 05G - Tonics, Dressings, and Other Hair 56859 GLUTAMINE, L- 1 Grooming Aids 12C - Face and Neck (exc shave) 56859 GLUTAMINE, L- 2 12D - Body and Hand (exc shave) 56859 GLUTAMINE, L- 4 12F - Moisturizing 56859 GLUTAMINE, L- 2 12G - Night 56859 GLUTAMINE, L- 2 12H - Paste Masks (mud packs) 56859 GLUTAMINE, L- 1 12I - Skin Fresheners 56859 GLUTAMINE, L- 1 12J - Other Skin Care Preps 56859 GLUTAMINE, L- 2 01B - Baby Lotions, Oils, Powders, and 56406 GLYCINE 1 Creams 03D - Eye Lotion 56406 GLYCINE 13 03F - Mascara 56406 GLYCINE 1 03G - Other Eye Makeup Preparations 56406 GLYCINE 7 04E - Other Fragrance Preparation 56406 GLYCINE 1 05A - Hair Conditioner 56406 GLYCINE 34 05C - Hair Straighteners 56406 GLYCINE 1 05D - Permanent Waves 56406 GLYCINE 2 05E - Rinses (non-coloring) 56406 GLYCINE 1 05F - Shampoos (non-coloring) 56406 GLYCINE 37 05G - Tonics, Dressings, and Other Hair 56406 GLYCINE 5 Grooming Aids 05H - Wave Sets 56406 GLYCINE 1 05I - Other Hair Preparations 56406 GLYCINE 2 06A - Hair Dyes and Colors (all types 56406 GLYCINE 8 requiring caution statements and patch tests) 07C - Foundations 56406 GLYCINE 1 07E - Lipstick 56406 GLYCINE 1 07I - Other Makeup Preparations 56406 GLYCINE 3 CIR Supplement Page 10
α-amino Acid Ingredients page - 11 - Distributed for Comment Only - Do Not Cite or Quote 10A - Bath Soaps and Detergents 56406 GLYCINE 1 10B - Deodorants (underarm) 56406 GLYCINE 4 10E - Other Personal Cleanliness Products 56406 GLYCINE 3 11A - Aftershave Lotion 56406 GLYCINE 1 11G - Other Shaving Preparation Products 56406 GLYCINE 1 12A - Cleansing 56406 GLYCINE 15 12C - Face and Neck (exc shave) 56406 GLYCINE 64 12D - Body and Hand (exc shave) 56406 GLYCINE 26 12F - Moisturizing 56406 GLYCINE 82 12G - Night 56406 GLYCINE 10 12H - Paste Masks (mud packs) 56406 GLYCINE 8 12I - Skin Fresheners 56406 GLYCINE 5 12J - Other Skin Care Preps 56406 GLYCINE 22 13B - Indoor Tanning Preparations 56406 GLYCINE 2 13C - Other Suntan Preparations 56406 GLYCINE 1 06A - Hair Dyes and Colors (all types requiring caution statements and patch tests) 999002568 SODIUM GLYCINATE 16 03D - Eye Lotion 71001 HISTIDINE 3 03G - Other Eye Makeup Preparations 71001 HISTIDINE 1 05A - Hair Conditioner 71001 HISTIDINE 8 05F - Shampoos (non-coloring) 71001 HISTIDINE 4 05G - Tonics, Dressings, and Other Hair 71001 HISTIDINE 13 Grooming Aids 12C - Face and Neck (exc shave) 71001 HISTIDINE 7 12D - Body and Hand (exc shave) 71001 HISTIDINE 7 12F - Moisturizing 71001 HISTIDINE 8 12G - Night 71001 HISTIDINE 1 12H - Paste Masks (mud packs) 71001 HISTIDINE 3 12I - Skin Fresheners 71001 HISTIDINE 2 12J - Other Skin Care Preps 71001 HISTIDINE 9 03D - Eye Lotion 645352 HISTIDINE HCL 1 07B - Face Powders 645352 HISTIDINE HCL 1 12C - Face and Neck (exc shave) 645352 HISTIDINE HCL 2 12F - Moisturizing 645352 HISTIDINE HCL 6 12G - Night 645352 HISTIDINE HCL 1 03D - Eye Lotion 73325 ISOLEUCINE 1 05A - Hair Conditioner 73325 ISOLEUCINE 1 05G - Tonics, Dressings, and Other Hair 73325 ISOLEUCINE 1 Grooming Aids 05I - Other Hair Preparations 73325 ISOLEUCINE 2 12C - Face and Neck (exc shave) 73325 ISOLEUCINE 6 12D - Body and Hand (exc shave) 73325 ISOLEUCINE 1 12F - Moisturizing 73325 ISOLEUCINE 5 12H - Paste Masks (mud packs) 73325 ISOLEUCINE 4 12I - Skin Fresheners 73325 ISOLEUCINE 3 CIR Supplement Page 11
α-amino Acid Ingredients page - 12 - Distributed for Comment Only - Do Not Cite or Quote 12J - Other Skin Care Preps 73325 ISOLEUCINE 6 05A - Hair Conditioner 61905 LEUCINE 1 05F - Shampoos (non-coloring) 61905 LEUCINE 1 05G - Tonics, Dressings, and Other Hair 61905 LEUCINE 1 Grooming Aids 05H - Wave Sets 61905 LEUCINE 1 05I - Other Hair Preparations 61905 LEUCINE 1 07C - Foundations 61905 LEUCINE 1 12C - Face and Neck (exc shave) 61905 LEUCINE 10 12D - Body and Hand (exc shave) 61905 LEUCINE 2 12G - Night 61905 LEUCINE 2 12H - Paste Masks (mud packs) 61905 LEUCINE 2 12I - Skin Fresheners 61905 LEUCINE 3 12J - Other Skin Care Preps 61905 LEUCINE 8 03C - Eye Shadow 6899065 LYSINE 1 03D - Eye Lotion 6899065 LYSINE 4 03G - Other Eye Makeup Preparations 6899065 LYSINE 4 05A - Hair Conditioner 6899065 LYSINE 2 05C - Hair Straighteners 6899065 LYSINE 1 05G - Tonics, Dressings, and Other Hair 6899065 LYSINE 3 Grooming Aids 05I - Other Hair Preparations 6899065 LYSINE 1 07C - Foundations 6899065 LYSINE 2 07E - Lipstick 6899065 LYSINE 1 07F - Makeup Bases 6899065 LYSINE 1 07I - Other Makeup Preparations 6899065 LYSINE 6 12A - Cleansing 6899065 LYSINE 4 12C - Face and Neck (exc shave) 6899065 LYSINE 41 12D - Body and Hand (exc shave) 6899065 LYSINE 10 12F - Moisturizing 6899065 LYSINE 33 12G - Night 6899065 LYSINE 6 12H - Paste Masks (mud packs) 6899065 LYSINE 2 12I - Skin Fresheners 6899065 LYSINE 3 12J - Other Skin Care Preps 6899065 LYSINE 9 03D - Eye Lotion 657272 LYSINE HCL, L- 2 03G - Other Eye Makeup Preparations 657272 LYSINE HCL, L- 1 05A - Hair Conditioner 657272 LYSINE HCL, L- 9 05F - Shampoos (non-coloring) 657272 LYSINE HCL, L- 2 05G - Tonics, Dressings, and Other Hair 657272 LYSINE HCL, L- 13 Grooming Aids 05I - Other Hair Preparations 657272 LYSINE HCL, L- 4 07E - Lipstick 657272 LYSINE HCL, L- 1 12C - Face and Neck (exc shave) 657272 LYSINE HCL, L- 3 12F - Moisturizing 657272 LYSINE HCL, L- 6 12G - Night 657272 LYSINE HCL, L- 2 12I - Skin Fresheners 657272 LYSINE HCL, L- 1 CIR Supplement Page 12
α-amino Acid Ingredients page - 13 - Distributed for Comment Only - Do Not Cite or Quote 12J - Other Skin Care Preps 657272 LYSINE HCL, L- 2 13B - Indoor Tanning Preparations 657272 LYSINE HCL, L- 1 12C - Face and Neck (exc shave) 70542 LYSINE, DL- 1 03D - Eye Lotion 56871 LYSINE, L- 1 05A - Hair Conditioner 56871 LYSINE, L- 1 05F - Shampoos (non-coloring) 56871 LYSINE, L- 1 05I - Other Hair Preparations 56871 LYSINE, L- 1 12D - Body and Hand (exc shave) 56871 LYSINE, L- 1 12F - Moisturizing 56871 LYSINE, L- 3 12H - Paste Masks (mud packs) 56871 LYSINE, L- 1 12J - Other Skin Care Preps 56871 LYSINE, L- 7 05A - Hair Conditioner 59518 METHIONINE 3 05F - Shampoos (non-coloring) 59518 METHIONINE 1 05G - Tonics, Dressings, and Other Hair 59518 METHIONINE 1 Grooming Aids 05I - Other Hair Preparations 59518 METHIONINE 2 07C - Foundations 59518 METHIONINE 1 12C - Face and Neck (exc shave) 59518 METHIONINE 10 12D - Body and Hand (exc shave) 59518 METHIONINE 1 12F - Moisturizing 59518 METHIONINE 1 12H - Paste Masks (mud packs) 59518 METHIONINE 2 12I - Skin Fresheners 59518 METHIONINE 2 12J - Other Skin Care Preps 59518 METHIONINE 4 12J - Other Skin Care Preps 63683 METHIONINE, L- 2 03D - Eye Lotion 63912 PHENYLALANINE 1 03F - Mascara 63912 PHENYLALANINE 1 05A - Hair Conditioner 63912 PHENYLALANINE 3 05F - Shampoos (non-coloring) 63912 PHENYLALANINE 3 05G - Tonics, Dressings, and Other Hair 63912 PHENYLALANINE 2 Grooming Aids 05I - Other Hair Preparations 63912 PHENYLALANINE 1 07B - Face Powders 63912 PHENYLALANINE 1 12C - Face and Neck (exc shave) 63912 PHENYLALANINE 8 12D - Body and Hand (exc shave) 63912 PHENYLALANINE 1 12F - Moisturizing 63912 PHENYLALANINE 9 12H - Paste Masks (mud packs) 63912 PHENYLALANINE 3 12I - Skin Fresheners 63912 PHENYLALANINE 3 12J - Other Skin Care Preps 63912 PHENYLALANINE 3 03D - Eye Lotion 147853 PROLINE 7 03G - Other Eye Makeup Preparations 147853 PROLINE 7 05A - Hair Conditioner 147853 PROLINE 7 05C - Hair Straighteners 147853 PROLINE 1 05F - Shampoos (non-coloring) 147853 PROLINE 1 CIR Supplement Page 13
α-amino Acid Ingredients page - 14 - Distributed for Comment Only - Do Not Cite or Quote 05G - Tonics, Dressings, and Other Hair 147853 PROLINE 4 Grooming Aids 05I - Other Hair Preparations 147853 PROLINE 2 06A - Hair Dyes and Colors (all types 147853 PROLINE 23 requiring caution statements and patch tests) 07C - Foundations 147853 PROLINE 2 07I - Other Makeup Preparations 147853 PROLINE 3 08B - Cuticle Softeners 147853 PROLINE 2 10E - Other Personal Cleanliness Products 147853 PROLINE 1 11A - Aftershave Lotion 147853 PROLINE 3 12A - Cleansing 147853 PROLINE 9 12C - Face and Neck (exc shave) 147853 PROLINE 45 12D - Body and Hand (exc shave) 147853 PROLINE 21 12F - Moisturizing 147853 PROLINE 75 12G - Night 147853 PROLINE 17 12H - Paste Masks (mud packs) 147853 PROLINE 8 12I - Skin Fresheners 147853 PROLINE 7 12J - Other Skin Care Preps 147853 PROLINE 21 13A - Suntan Gels, Creams, and Liquids 147853 PROLINE 4 06A - Hair Dyes and Colors (all types 609369 PROLINE, DL- 6 requiring caution statements and patch tests) 07E - Lipstick 609369 PROLINE, DL- 1 12F - Moisturizing 609369 PROLINE, DL- 1 12J - Other Skin Care Preps 609369 PROLINE, DL- 1 01B - Baby Lotions, Oils, Powders, and 6898959 SERINE 1 Creams 03D - Eye Lotion 6898959 SERINE 9 03F - Mascara 6898959 SERINE 9 03G - Other Eye Makeup Preparations 6898959 SERINE 18 05A - Hair Conditioner 6898959 SERINE 3 05C - Hair Straighteners 6898959 SERINE 1 05G - Tonics, Dressings, and Other Hair 6898959 SERINE 4 Grooming Aids 05I - Other Hair Preparations 6898959 SERINE 1 07B - Face Powders 6898959 SERINE 8 07C - Foundations 6898959 SERINE 1 07I - Other Makeup Preparations 6898959 SERINE 4 08B - Cuticle Softeners 6898959 SERINE 1 10E - Other Personal Cleanliness Products 6898959 SERINE 2 11A - Aftershave Lotion 6898959 SERINE 2 12A - Cleansing 6898959 SERINE 13 12C - Face and Neck (exc shave) 6898959 SERINE 72 12D - Body and Hand (exc shave) 6898959 SERINE 12 12F - Moisturizing 6898959 SERINE 89 12G - Night 6898959 SERINE 13 12H - Paste Masks (mud packs) 6898959 SERINE 8 12I - Skin Fresheners 6898959 SERINE 3 12J - Other Skin Care Preps 6898959 SERINE 20 CIR Supplement Page 14
α-amino Acid Ingredients page - 15 - Distributed for Comment Only - Do Not Cite or Quote 03D - Eye Lotion 56451 SERINE, L- 2 05A - Hair Conditioner 56451 SERINE, L- 2 05F - Shampoos (non-coloring) 56451 SERINE, L- 2 05H - Wave Sets 56451 SERINE, L- 1 08G - Other Manicuring Preparations 56451 SERINE, L- 1 12A - Cleansing 56451 SERINE, L- 2 12C - Face and Neck (exc shave) 56451 SERINE, L- 9 12D - Body and Hand (exc shave) 56451 SERINE, L- 3 12F - Moisturizing 56451 SERINE, L- 10 12H - Paste Masks (mud packs) 56451 SERINE, L- 1 12I - Skin Fresheners 56451 SERINE, L- 2 12J - Other Skin Care Preps 56451 SERINE, L- 5 03D - Eye Lotion 36676503 THREONINE 3 03G - Other Eye Makeup Preparations 36676503 THREONINE 7 05A - Hair Conditioner 36676503 THREONINE 2 05C - Hair Straighteners 36676503 THREONINE 1 05F - Shampoos (non-coloring) 36676503 THREONINE 1 05G - Tonics, Dressings, and Other Hair 36676503 THREONINE 3 Grooming Aids 05I - Other Hair Preparations 36676503 THREONINE 1 06A - Hair Dyes and Colors (all types 36676503 THREONINE 29 requiring caution statements and patch tests) 07C - Foundations 36676503 THREONINE 1 07I - Other Makeup Preparations 36676503 THREONINE 3 08B - Cuticle Softeners 36676503 THREONINE 1 10E - Other Personal Cleanliness Products 36676503 THREONINE 1 12A - Cleansing 36676503 THREONINE 4 12C - Face and Neck (exc shave) 36676503 THREONINE 34 12D - Body and Hand (exc shave) 36676503 THREONINE 10 12F - Moisturizing 36676503 THREONINE 42 12G - Night 36676503 THREONINE 7 12H - Paste Masks (mud packs) 36676503 THREONINE 4 12I - Skin Fresheners 36676503 THREONINE 1 12J - Other Skin Care Preps 36676503 THREONINE 8 05A - Hair Conditioner 72195 THREONINE, L- 1 05F - Shampoos (non-coloring) 72195 THREONINE, L- 1 12F - Moisturizing 72195 THREONINE, L- 4 12I - Skin Fresheners 72195 THREONINE, L- 1 03D - Eye Lotion 6912863 TRYPTOPHAN 1 03G - Other Eye Makeup Preparations 6912863 TRYPTOPHAN 1 05A - Hair Conditioner 6912863 TRYPTOPHAN 2 12C - Face and Neck (exc shave) 6912863 TRYPTOPHAN 7 12G - Night 6912863 TRYPTOPHAN 1 12J - Other Skin Care Preps 6912863 TRYPTOPHAN 3 CIR Supplement Page 15
α-amino Acid Ingredients page - 16 - Distributed for Comment Only - Do Not Cite or Quote 03D - Eye Lotion 60184 TYROSINE 1 03G - Other Eye Makeup Preparations 60184 TYROSINE 2 05A - Hair Conditioner 60184 TYROSINE 3 05F - Shampoos (non-coloring) 60184 TYROSINE 3 05G - Tonics, Dressings, and Other Hair 60184 TYROSINE 2 Grooming Aids 05I - Other Hair Preparations 60184 TYROSINE 1 07B - Face Powders 60184 TYROSINE 1 07C - Foundations 60184 TYROSINE 1 07I - Other Makeup Preparations 60184 TYROSINE 1 12C - Face and Neck (exc shave) 60184 TYROSINE 15 12D - Body and Hand (exc shave) 60184 TYROSINE 3 12F - Moisturizing 60184 TYROSINE 4 12G - Night 60184 TYROSINE 2 12H - Paste Masks (mud packs) 60184 TYROSINE 1 12I - Skin Fresheners 60184 TYROSINE 2 12J - Other Skin Care Preps 60184 TYROSINE 5 13B - Indoor Tanning Preparations 60184 TYROSINE 8 13C - Other Suntan Preparations 60184 TYROSINE 1 03D - Eye Lotion 72184 VALINE 1 05A - Hair Conditioner 72184 VALINE 1 05F - Shampoos (non-coloring) 72184 VALINE 1 05H - Wave Sets 72184 VALINE 1 05I - Other Hair Preparations 72184 VALINE 1 07C - Foundations 72184 VALINE 1 12C - Face and Neck (exc shave) 72184 VALINE 7 12D - Body and Hand (exc shave) 72184 VALINE 2 12F - Moisturizing 72184 VALINE 5 12G - Night 72184 VALINE 2 12H - Paste Masks (mud packs) 72184 VALINE 3 12I - Skin Fresheners 72184 VALINE 2 12J - Other Skin Care Preps 72184 VALINE 5 CIR Supplement Page 16
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Memorandum To: From: CIR Expert Panel Members and Liaisons Christina Burnett Scientific Analyst/Writer Date: August 30, 2012 Subject: Wave 2 data on Fatty Acid Amidopropyl Dimethylamines as Used in Cosmetics The Personal Care Products Council has advised CIR that additional studies on Stearamidopropyl Dimethylamine are being performed for the REACH dossier. At this time, we do not know what the studies are. Please see the attached memo from the Council. CIR Supplement Page 18
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August 30, 2012 Memorandum To: From: Subject: CIR Expert Panel Wilbur Johnson, Jr. Manager/Lead Specialist Wave 2 Data on Chlorphenesin A mammalian genotoxicity study on chlorphenesin, received from the Council on June 12, 2012, is attached for the Expert Panel s review. Data from this study are summarized in the draft final report; however, the pdf data file was not included with meeting materials mailed earlier this month and the study is not mentioned in the transmittal memorandum for the draft final report. CIR Supplement Page 20
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August 30, 2012 MEMORANDUM To: From: Subject: CIR Expert Panel and Liaisons Lillian C. Becker, M.S. Scientific Analyst and Writer Discussion of Ginseng-Root Related Ingredients It came to our attention that the aerosol part of the Discussion was missing from the ginsengroot related ingredient report. The paragraph shown below is provided for the Panel s review and insertion into the Final Report. Because these ingredients were reported to be used in products that may be aerosolized, including deodorants, face powders, foot powders and sprays, and perfumes, the Panel discussed the issue of incidental inhalation exposure. The Panel considered that the preponderance of the data indicate that incidental inhalation exposures to these ingredients in aerosolized cosmetic products would not cause adverse health effects, as follows. The Panel considered other data available to characterize the potential for ginseng root-derived ingredients to cause systemic toxicity, irritation, sensitization, reproductive and developmental toxicity, genotoxicity, and phototoxicity. They noted the lack of systemic toxicity at high doses in acute and subchronic oral exposure studies and no irritation or sensitization in multiple tests of dermal and ocular exposure. There was no genotoxicity in in vitro and in vivo tests. Further, these ingredients are reportedly used at concentrations 0.1% in cosmetic products that may be aerosolized. The Panel noted that 95% 99% of droplets/particles produced in cosmetic aerosols would not be respirable to any appreciable amount. Coupled with the small actual exposure in the breathing zone and the concentrations at which the ingredients are used, the available information indicates that incidental inhalation would not be a significant route of exposure that might lead to local respiratory or systemic effects. A detailed discussion and summary of the Panel s approach to evaluating incidental inhalation exposures to ingredients in cosmetic products that may be aerosolized is available at http://www.cirsafety.org/cir-findings. CIR Supplement Page 41
Memorandum To: CIR Expert Panel Members and Liaisons From: Director, CIR Subject: Wave 2 data on triclosan and parabens Date: August 30, 2012 Out of Isaac Pessah s lab at UC Davis comes another study on triclosan (in PNAS early edition), but with an entirely different endpoint. Pessah s current research focuses on the structure, function, and pharmacology of the ryanodine-sensitive calcium channels (RyRs) found in sarcoplasmic and endoplasmic reticulum of muscle cells and neurons. In this study, triclosan (i.p. in mice, in water in larval fathead minnows, and in vitro in murine cardiomyocytes and skeletal muscle cells) reportedly impairs calcium and RyR channel signaling, to affect muscle contractility. In the discussion, the authors challenge some of what we thought was understood about triclosan metabolism to glucuronide and sulfate conjugates. They suggest that some individuals may be less able to clear triclosan and be more at risk of muscle-weakening effects. Additional comments regarding triclosan and parabens were received from the Women s Voices for the Earth. Enclosures: 1. Cherednichenko G, et al. Triclosan impairs excitation-contraction coupling and Ca2+ dynamics in striated muscle. PNAS 2012 2. Women s Voices for the Earth (Alexandra Scranton) email. CIR Supplement Page 42
Kevin S. Fries From: Sent: To: Subject: Attachments: CIRINFO Monday, August 27, 2012 11:48 AM Alan Andersen FW: New Data on triclosan and parabens Letter to CIR from WVE.docx To: Cosmetic Ingredient Review Expert Panel Members and Liaisons, In reviewing the agenda for the upcoming CIR meeting in September, we were pleased to see the item regarding new data on triclosan and parabens. It is an excellent practice to bring important new data to the attention of the CIR even when ingredients are not yet up for review. We have reviewed this study as well and have great concern for the impact of these chemicals on the immune system of children. According to the study, children with the highest urine levels of triclosan had nearly twice the risk of environmental allergies as children with the lowest urinary concentrations. Those with highest levels of propyl paraben in the urine had twice the risk of an environmental allergy. Food allergy risk was more than twice as pronounced in children with the highest levels of urinary triclosan as in children with the lowest triclosan levels. As the Director of the CIR stated in his memo, the authors of this study deal only with hypotheses as to the mechanisms causing these effects, and have not established any causal relationships. As you are well aware, this is a trait common to many journal articles when groundbreaking research is being discussed. However, fully understanding the mechanism behind the health impacts is not needed before preventive measures can be taken. (For example, the public health system in the US rightly issued warnings and recommendations against smoking decades before we understood how cigarette smoking actually causes lung cancer.) We are concerned that children with the greatest exposures to these chemicals, (exposure which can and does occur from cosmetic products) are unnecessarily suffering from lifelong allergies. We hope the CIR will study this research closely in your assessment of the safety of these ingredients. Also, we offer the following abstracts of other recent research on parabens and triclosan that we believe are worth the consideration of the CIR at this time. Thank you in advance for your consideration of these concerns, Alexandra Scranton alexs@womensvoices.org Director of Science and Research Women s Voices for the Earth 1 CIR Supplement Page 43
J Appl Toxicol. 2012 Jun 29. doi: 10.1002/jat.2753. [Epub ahead of print] Parabens enable suspension growth of MCF- 10A immortalized, non-transformed human breast epithelial cells. Khanna S, Darbre PD. Source Biomedical Sciences Section, School of Biological Sciences, University of Reading, Reading, RG6 6UB, UK. J Appl Toxicol. 2012 Mar;32(3):219-32. doi: 10.1002/jat.1786. Epub 2012 Jan 12. Measurement of paraben concentrations in human breast tissue at serial locations across the breast from axilla to sternum. Barr L, Metaxas G, Harbach CA, Savoy LA, Darbre PD. Source The Genesis Breast Cancer Prevention Centre, University Hospital of South Manchester NHS Foundation Trust, Wythenshawe, Manchester, M23 9LT, UK. Proc Natl Acad Sci U S A. 2012 Aug 13. [Epub ahead of print] Triclosan impairs excitation-contraction coupling and Ca2+ dynamics in striated muscle. Cherednichenko G, Zhang R, Bannister RA, Timofeyev V, Li N, Fritsch EB, Feng W, Barrientos GC, Schebb NH, Hammock BD, Beam KG, Chiamvimonvat N, Pessah IN. Source Department of Molecular Biosciences, School of Veterinary Medicine, Division of Cardiovascular Medicine, Department of Internal Medicine, and Department of Entomology and Cancer Center, University of California, Davis, CA 95616. CIR Supplement Page 44
Triclosan impairs excitation contraction coupling and Ca2+ dynamics in striated muscle Gennady Cherednichenkoa,1, Rui Zhanga,1, Roger A. Bannisterb,1, Valeriy Timofeyevc, Ning Lic, Erika B. Fritscha, Wei Fenga, Genaro C. Barrientosa, Nils H. Schebbd, Bruce D. Hammockd,2, Kurt G. Beame, Nipavan Chiamvimonvatc,f, and Isaac N. Pessaha,2 adepartment of Molecular Biosciences, School of Veterinary Medicine, cdivision of Cardiovascular Medicine, Department of Internal Medicine, and ddepartment of Entomology and Cancer Center, University of California, Davis, CA 95616; bcardiology Division, Department of Medicine, and edepartment of Physiology and Biophysics, University of Colorado Denver-Anschutz Medical Campus, Aurora, CO 80045; and fdepartment of Veterans Affairs, Northern California Health Care System, Mather, CA 95655 Contributed by Bruce D. Hammock, July 13, 2012 (sent for review June 18, 2012) www.pnas.org/cgi/doi/10.1073/pnas.1211314109 CIR Supplement Page 45