Annex V, Last Update: 02/08/2021
Total Page:16
File Type:pdf, Size:1020Kb
File creation date: 26/09/2021 Annex V, Last update: 02/08/2021 LIST OF PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS Substance identification Conditions Wording of Reference Maximum conditions of Name of Common Ingredients Product Type, body concentration Update date number Chemical name / INN CAS Number EC Number Other use and Glossary parts in ready for use warnings preparation 1 Benzoic acid and its sodium salt BENZOIC ACID; SODIUM 65-85-0 / 532-32-1 200-618-2 / a) Rinse-off products, a) 2.5% (acid) 25/10/2010 BENZOATE 208-534-8 except oral care b) 1.7% (acid) products c) 0.5% (acid) b) Oral care products c) Leave-on products 1a Salts of benzoic acid other than AMMONIUM BENZOATE / 1863-63-4 /2090-05-3 / 582-25-2 217-468-9 / 0.5% (acid) 16/10/2010 that listed under reference BUTYL BENZOATE / / 553-70-8 / 4337-66-0 / 93-58-3 218-235-4 / number 1 and esters of benzoic CALCIUM BENZOATE / / 93-89-0 / 2315-68-6 / 136-60-7 209-481-3 / acid ETHYL BENZOATE / / 1205-50-3 / 939-48-0 / 93-99-2 209-045-2 / ISOBUTYL BENZOATE / 224-387-2 / ISOPROPYL BENZOATE / 202-259-7 / MAGNESIUM BENZOATE / 202-284-3 / MEA-BENZOATE / METHYL 219-020-8 / BENZOATE / PHENYL 205-252-7 / BENZOATE / POTASSIUM 204-401-3 / BENZOATE / PROPYL 213-361-6 / BENZOATE 202-293-2 2 Propionic acid and its salts PROPIONIC ACID / 79-09-4 / 17496-08-1 / 201-176-3 / 2% (acid) 16/10/2010 AMMONIUM PROPIONATE / 4075-81-4 / 557-27-7 / 327-62-8 241-503-7 / CALCIUM PROPIONATE / / 137-40-6 223-795-8 / MAGNESIUM PROPIONATE / 209-166-0 / POTASSIUM PROPIONATE / 206-323-5 / SODIUM PROPIONATE 205-290-4 3 Salicylic acid and its salts SALICYLIC ACID, CALCIUM 69-72-7[1]/ 824-35-1[2]/ 200-712-3[1]/ Salicylic acid: Salicylic acid: Salicylic acid: 27/07/2020 SALICYLATE, MAGNESIUM 18917-89-0[3]/ 59866-70-5[4]/ 212-525-4[2]/ 0,5 % (acid) Not to be used SALICYLATE, MEA- 54-21-7[5]/ 578-36-9[6]/ 242-669-3[3]/ Not to be used for children SALICYLATE, SODIUM 2174-16-5[7] 261-963-2[4]/ Salicylic acid in products for under 3 years of SALICYLATE, POTASSIUM 200-198-0[5]/ salts: 0,5 % children under 3 age** SALICYLATE, TEA- 209-421-6[6]/ (acid) years of age. **Solely for SALICYLATE 218-531-3[7] Not to be used products which in oral products. might be used Not to be used for children in applications under 3 years of that may lead to age. exposure of the end-user’s lungs Salicylic acid by inhalation. salts: Not to be used for children Salicylic acid under 3 years of Page 1/9 Substance identification Conditions Wording of Reference Maximum conditions of Name of Common Ingredients Product Type, body concentration Update date number Chemical name / INN CAS Number EC Number Other use and Glossary parts in ready for use warnings preparation salts: age*** ***Solely for Not to be used products which in products for might be used children under 3 for children years of age, under 3 years of except for age and which shampoos. remain in prolonged contact with the skin. 4 Hexa-2,4-dienoic acid and its SORBIC ACID / CALCIUM 110-44-1 / 7492-55-9 / 203-768-7 / 0.6% (acid) 16/10/2010 salts SORBATE / SODIUM 7757-81-5 / 24634-61-5 231-321-6 / SORBATE / POTASSIUM 231-819-3 / SORBATE 246-376-1 7 Biphenyl-2-ol O-PHENYLPHENOL 90-43-7 201-993-5 The use of 28/07/2020 o-phenylphenol as a preservative should be allowed with a maximum concentration of 0,15 % (as phenol) in leave-on and 0,2 % (as phenol) in rinse-off cosmetic products. Contact with eyes should be avoided. The use of sodium o-phenylphenate , potassium o-phenylphenate and MEA o-phenylphenate as preservatives should not be allowed. 9 Inorganic sulphites and SODIUM SULFITE / 7757-83-7 / 10192-30-0 / 231-821-4 / 0.2% (as free 16/10/2010 hydrogensulphites (5) AMMONIUM BISULFITE / 10196-04-0 / 10117-38-1 / 233-469-7 / SO2) AMMONIUM SULFITE / 7773-03-7 / 7631-90-5 / 233-484-9 / POTASSIUM SULFITE / 7681-57-4 / 16731-55-8 233-321-1 / Page 2/9 Substance identification Conditions Wording of Reference Maximum conditions of Name of Common Ingredients Product Type, body concentration Update date number Chemical name / INN CAS Number EC Number Other use and Glossary parts in ready for use warnings preparation POTASSIUM HYDROGEN 231-870-1 SULFITE / SODIUM /231-548-0 / BISULFITE / SODIUM 231-673-0 / METABISULFITE / 240-795-3 POTASSIUM METABISULFITE 11 Chlorobutanol CHLOROBUTANOL 57-15-8 200-317-6 0.5% Not to be used Contains 16/10/2010 in aerosol Chlorobutanol dispensers (sprays) 12 4-Hydroxybenzoic acid and its 4-HYDROXYBENZOIC ACID / 99-96-7 /99-76-3 /36457-19-9 202-804-9 0,4% (as acid) 11/08/2020 Methyl- and Ethyl-esters, and METHYLPARABEN /16782-08-4 /5026-62-0 /202-785-7 for single ester their salts /POTASSIUM /35285-68-8 /120-47-8 /114-63-6 /253-048-1 0,8% (as acid) ETHYLPARABEN /26112-0-2 /69959-44-0 /240-830-2 for mixtures of /POTASSIUM PARABEN /225-714-1 esters /SODIUM METHYLPARABEN /252-487-6 /SODIUM ETHYLPARABEN /204-399-4 /ETHYLPARABEN /SODIUM /204-051-1 PARABEN / POTASSIUM /247-464-2 METHYLPARABEN / /274-235-4 CALCIUM PARABEN 12 a Butyl 4-hydroxy-benzoate and its BUTYLPARABEN/PROPYLPA 94-26-8/ 94-13-3/ 35285-69-9/ 202-318-7/ - 0,14% (as Not to be used For leave-on 02/08/2021 salts Propyl 4-hydroxy-benzoate RABEN/SODIUM 36457-20-2/ 38566-94-8/ 202-307-7/ acid) for the sum in leave-on products and its salts PROPOYLPARABEN/SODIUM 84930-16-5 252-488-1/ of the individual products designed for BUTYLPARABEN/POTASSIU 253-049-7/ concentrations designed for children under M 254-009-1/ application on three years of BUTYLPARABEN/POTASSIU 284-597-5 - 0,8% (as acid) the nappy area age: "Do not use M PROPYLPARABEN for mixtures of of children on the nappy substances under three area" mentioned in years of age. entry 12 and 12a, here the sum of the individual concentrations of butyl and propylparaben and their salts does not exceed 0,14% 13 3-Acetyl-6-methylpyran-2,4(3H)- DEHYDROACETIC ACID / 520-45-6 / 4418-26-2 / 208-293-9 / 0.6% (as acid) Not to be used 16/10/2010 dione and its salts SODIUM 16807-48-0 224-580-1 / - in aerosol DEHYDROACETATE dispensers (sprays) 14 Formic acid and its sodium salt FORMIC ACID / SODIUM 64-18-6 / 141-53-7 200-579-1 / 0.5% (as acid) 16/10/2010 Page 3/9 Substance identification Conditions Wording of Reference Maximum conditions of Name of Common Ingredients Product Type, body concentration Update date number Chemical name / INN CAS Number EC Number Other use and Glossary parts in ready for use warnings preparation FORMATE 205-488-0 15 3,3'-Dibromo-4,4'-hexamethylene DIBROMOHEXAMIDINE 93856-83-8 299-116-4 0.1% 16/10/2010 dioxydibenzamidine and its salts ISETHIONATE (including isethionate) 16 Thiomersal THIMEROSAL 54-64-8 200-210-4 Eye products 0.007% (of Hg) Contains 16/10/2010 If mixed with Thiomersal other mercurial compounds authorized by this Regulation, the maximum concentration of Hg remains fixed at 0.007% 17 Phenylmercuric salts (including PHENYL MERCURIC 62-38-4 / 94-43-9 200-532-5 / Eye products 0.007% (of Hg) Contains 16/10/2010 borate) ACETATE / PHENYL 202-331-8 If mixed with Phenylmercuric MERCURIC BENZOATE other mercurial compounds compounds authorized by this Directive, the maximum concentration of Hg remains fixed at 0.007% 18 Undec-10-enoic acid and its salts UNDECYLENIC ACID / 112-38-9 / 6159-41-7 / 203-965-8 / - / 0.2% (as acid) 16/10/2010 POTASSIUM 3398-33-2 / 1322-14-1 / 222-264-8 / UNDECYLENATE / SODIUM 84471-25-0 / 56532-40-2 215-331-8 / UNDECYLENATE / CALCIUM 282-908-9 / UNDECYLENATE / 260-247-7 MEA-UNDECYLENATE / TEA-UNDECYLENATE 19 5-Pyrimidinamine, HEXETIDINE 141-94-6 205-513-5 0.1% 16/10/2010 1,3-bis(2-ethylhexyl)hexahydro-5 -methyl- 20 5-Bromo-5-nitro-1,3-dioxane 5-BROMO-5-NITRO-1,3-DIOX 30007-47-7 250-001-7 Rinse-off products 0.1% Avoid formation 02/08/2021 ANE of nitrosamines 21 Bronopol 2-BROMO-2-NITROPROPANE 52-51-7 200-143-0 0.1% Avoid formation 02/08/2021 -1,3-DIOL of nitrosamines 22 2,4-Dichlorobenzyl alcohol DICHLOROBENZYL 1777-82-8 217-210-5 0.15% 16/10/2010 ALCOHOL 23 1-(4-Chlorophenyl)-3-(3,4-dichlo TRICLOCARBAN 101-20-2 202-924-1 0.2% Purity criteria: 25/10/2010 rophenyl)urea (6) 3, 3', 4, 4'-Tetrachloroaz Page 4/9 Substance identification Conditions Wording of Reference Maximum conditions of Name of Common Ingredients Product Type, body concentration Update date number Chemical name / INN CAS Number EC Number Other use and Glossary parts in ready for use warnings preparation obenzene<1ppm ; 3, 3', 4, 4'-Tetrachloroaz oxybenzene<1p pm 24 Chlorocresol P-CHLORO-M-CRESOL 59-50-7 200-431-6 Not to be used in 0.2% 25/10/2010 products applied on mucous membranes 25 5-Chloro-2-(2,4-dichlorophenoxy TRICLOSAN 3380-34-5 222-182-2 (a) Toothpastes Hand (a) 0.3% 11/08/2020 )phenol soaps Body soaps/ Shower gels Deodorants (b) 0.2% (non-spray) Face powders and blemish concealers Nail products for cleaning the fingernails and toenails before the application of artificial nail systems.