Cosmetics Regulation

02009R1223-20160512 → 02009R1223-20160810

compared line by line: this provision is too large to compare word by word, so a marked line is a line that changed somewhere

ANNEX III LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 1.For use as a preservative, see Annex V, No. 5.Only if the concentration exceeds 0,05 %.These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 2.The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In cases of mixtures, the sum should not exceed the limits given in column g.The concentration of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In case of mixtures, the sum should not exceed the limits given in column g.For use as a preservative, see Annex V, No. 34.For use as a preservative, see Annex V, No 43.For use as a preservative, see Annex V, No. 54.For use as a preservative, see Annex V, No 3.Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin.For use as a preservative, see Annex V, No 9.For use as a preservative, see AnnexV, No 23.For use as a preservative, see Annex V, No 8.OJ L 255, 30.9.2005, p. 22.This limit applies to the substance and not to the finished cosmetic product.The sum of those substances used in combination should not exceed the limits given as Maximum concentration in ready for use preparation.The free base and salts of this hair colouring ingredient, unless prohibited under Annex II, are permitted for use.For use as a preservative, see Annex V, No 58.For use as a preservative, see Annex V, entry No 44.For other uses of potassium hydroxide, see Annex III, No 15d.For other uses of Potassium hydroxide, see Annex III, No 15a. … 214 unchanged lines … 4,5 % Professional use For professional use only Avoid contact with eyes Can cause blindness (c) pH adjuster for depilatories (c) pH < 12,7 (c) Keep out of reach of children (c) pH adjuster for depilatories (c) pH < 12,7 (c) Keep out of reach of children Avoid contact with eyes (d) Other uses as pH adjuster (d) pH < 11 15b Lithium hydroxide Lithium hydroxide 1310-65-2 215-183-4 (a) Hair straighteners 2 % General use (a) Contains alkali (d) Other uses as pH adjuster (d) pH < 11 15b Lithium hydroxide Lithium hydroxide 1310-65-2 215-183-4 (a) Hair straighteners 2 % General use (a) Contains alkali Avoid contact with eyes Can cause blindness Keep out of reach of children … 1,258 unchanged lines … (c) Leave-on face products (c) 0,5 % for the individual concentrations or the sum of the individual concentrations of cetrimonium chloride and steartrimonium chloride 287 C22-alkyltrimethylammonium chloride Behentrimonium chloride 17301-53-0 241-327-0 (a) Rinse-off hair products (a) 5,0 % for the individual concentration of behentrimonium chloride or the sum of the individual concentrations of cetrimonium chloride, steartrimonium chloride and behentrimonium chloride, while at the same time respecting the relevant maximum concentration for the sum of cetrimonium chloride and steartrimonium chloride set out in entry 286. For purposes other than inhibiting the development of micro-organisms in the product. The purpose has to be apparent from the presentation of the product. (b) Leave-on hair products (b) 3,0 % for the individual concentration of behentrimonium chloride or the sum of the individual concentrations of cetrimonium chloride, steartrimonium chloride and behentrimonium chloride, while at the same time respecting the relevant maximum concentration for the sum of cetrimonium chloride and steartrimonium chloride set out in entry 286. (c) Leave-on face products (c) 3,0 % for the individual concentration of behentrimonium chloride or the sum of the individual concentrations of cetrimonium chloride, steartrimonium chloride and behentrimonium chloride, while at the same time respecting the relevant maximum concentration for the sum of cetrimonium chloride and steartrimonium chloride set out in entry 286. x 2-(2-Ethoxyethoxy)ethanol 288 3-[(4-amino-3-methyl-9,10-dioxo-9,10-dihydroanthracen-1-yl)amino]-N,N,N -trimethylpropan-1-aminium, methylsulfate salt HC Blue No 17 16517-75-2 605-392-2 (a) Hair dye substance in oxidative hair dye products (b) Hair dye substance in non-oxidative hair dye products (b) 2,0 % (a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % For (a) and (b): Do not use with nitrosating agents Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers (a) To be printed on the label: The mixing ratio. Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary black henna tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary black henna tattoo in the past. 289 Phosphoric acid compound with 4-[(2,6-dichlorophenyl) (4-imino-3,5-dimethyl-2,5-cyclohexadien-1-ylidene) methyl]-2,6-dimethylaniline (1:1) HC Blue No 15 74578-10-2 277-929-5 (a) Hair dye substance in oxidative hair dye products (b) Hair dye substance in non-oxidative hair dye products (b) 0,2 % (a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,2 % (a) To be printed on the label: The mixing ratio. Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary black henna tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary black henna tattoo in the past. 290 Disodium 2,2′-(9,10-dioxoanthracene-1,4-diyldiimino)bis(5-methylsulphonate) Acid Green 25 4403-90-1 224-546-6 Hair dye substance in non-oxidative hair dye products 0,3 % 291 Sodium, 4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]toluene-3-sulphonate Acid Violet 43 4430-18-6 224-618-7 Hair dye substance in non-oxidative hair dye products 0,5 % 292 1,4-Benzenediamine, 2-(methoxymethyl) 1,4-Benzenediamine, 2-(methoxymethyl)-, sulfate 2-Methoxymethyl-p-Phenylenediamine 2-Methoxymethyl-p-Phenylenediamine Sulfate 337906-36-2 337906-37-3 Hair dye substance in oxidative hair dye products After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,8 % (calculated as free base) To be printed on the label: The mixing ratio. Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary black henna tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary black henna tattoo in the past. 293 1-N-Methylmorpholiniumpropylamino-4-hydroxyanthraquinone, methyl sulfate Hydroxyanthraquinone-aminopropyl Methyl Morpholinium Methosulfate 38866-20-5 254-161-9 Hair dye substance in non-oxidative hair dye products 0,5 % Do not use with nitrosating agents Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers To be printed on the label: Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary black henna tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary black henna tattoo in the past. 294 Ethanol, 2,2′-[[3-methyl-4-[(E)-(4-nitrophenyl)azo]phenyl]imino]bis- Disperse Red 17 3179-89-3 221-665-5 (a) Hair dye substance in oxidative hair dye products (b) Hair dye substance in non-oxidative hair dye products (b) 0,2 % (a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % For (a) and (b): Do not use with nitrosating agents Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers (a) To be printed on the label: The mixing ratio. Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary black henna tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary black henna tattoo in the past. 295 4-Amino-5-hydroxy-3-(4-nitrophenylazo)-6-(phenylazo)-2,7-naphthalenedisulfonic acid, disodium salt Acid Black 1 1064-48-8 213-903-1 Hair dye substance in non-oxidative hair dye products 0,5 % 296 Disodium 3-hydroxy-4-[(E)-(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate Pigment Red 57 5858-81-1 227-497-9 Hair dye substance in non-oxidative hair dye products 0,4 % x 2-(2-Ethoxyethoxy)ethanol Diethylene Glycol Monoethyl Ether (DEGEE) Ethoxydiglycol 111-90-0 203-919-7 (a) Oxidative hair dye products (a) 7 % (a) to (e): The level of ethylene glycol impurity in Ethoxydiglycol must be ≤ 0,1 %. Not to be used in eye products and oral products. (b) Non-oxidative hair dye products (b) 5 % (c) Rinse-off products other than hair dye products (c) 10 % (d) Other non-spray cosmetic products (d) 2,6 % (e) The following spray products: fine fragrances, hair sprays, antiperspirants and deodorants (e) 2,6 %

02009R1223-20160512 → 02009R1223-20160810

ANNEX IV LIST OF COLORANTS ALLOWED IN COSMETIC PRODUCTS Preamble Without prejudice to other provisions in this Regulation, a colorant shall include its salts and lakes and when a colorant is expressed as a specific salt, its other salts and lakes shall also … 1,586 unchanged words … oxide 77015 Red 122 Barium sulfate 77120 White 123 Bismuth chloride oxide 77163 White 124 Calcium carbonate 77220 207-439-9/215-279-6 White Purity criteria as set out in Commission Directive 95/45/EC (E 170) 125 Calcium sulfate 77231 White 126 Carbon black 77266 215-609-9 1333-86-4, 7440-44-0 215-609-9, 231-153-3, 931-328-0, 931-334-3 Black Purity criteria as set out > 97 %, with the following impurity profile: Ash content ≤ 0,15 %, total sulphur ≤ 0,65 %, total PAH ≤ 500 ppb and benzo(a)pyrene ≤ 5 ppb, dibenz(a,h)anthracene ≤ 5 ppb, total As ≤ 3 ppm, total Pb ≤ 10 ppm, total Hg ≤ 1 ppm. 126a Carbon black 77266 (nano) Carbon Black (nano) 1333-86-4, 7440-44-0 215-609-9, 231-153-3, 931-328-0, 931-334-3 Black 10 % Not to be used in Commission Directive 95/45/EC (E 153) applications that may lead to exposure of the end user's lungs by inhalation. Only nanomaterials having the following characteristics are allowed: Purity > 97 %, with the following impurity profile: Ash content ≤ 0,15 %, total sulphur ≤ 0,65 %, total PAH ≤ 500 ppb and benzo(a)pyrene ≤ 5 ppb, dibenz(a,h)anthracene ≤ 5 ppb, total As ≤ 3 ppm, total Pb ≤ 10 ppm, and total Hg ≤ 1 ppm; Primary particle size ≥ 20 nm. 127 Charcoal, bone. A fine black powder obtained by burning animal bones in a closed container. It consists primarily of calcium phosphate and carbon 77267 Black 128 Coke black 77268:1 Black 129 Chromium (III) oxide 77288 Green free from chromate ion 130 Chromium (III) hydroxide 77289 Green free from chromate ion 131 Cobalt Aluminum Oxide 77346 Green 132 Copper 77400 Brown 133 Gold 77480 231-165-9 Brown Purity criteria as set out in Commission Directive 95/45/EC (E 175) 134 Iron oxide 77489 Orange 135 Iron Oxide Red 77491 215-168-2 Red Purity criteria as set out in Commission Directive 95/45/EC (E 172) 136 Iron Oxide Yellow 77492 51274-00-1 257-098-5 Yellow Purity criteria as set out in Commission Directive 95/45/EC (E 172) 137 Iron Oxide Black 77499 235-442-5 Black Purity criteria as set out in Commission Directive 95/45/EC (E 172) 138 Ferric Ammonium Ferrocyanide 77510 Blue free from cyanide ions 139 Magnesium carbonate 77713 White 140 Ammonium manganese(3+) diphosphate 77742 Violet 141 Trimanganese bis (orthophosphate) 77745 Red 142 Silver 77820 231-131-3 White Purity criteria as set out in Commission Directive 95/45/EC (E 174) 143 Titanium dioxide 77891 236-675-5 White Purity criteria as set out in Commission Directive 95/45/EC (E 171) 144 Zinc oxide 77947 White 145 Riboflavin Lactoflavin 201-507-1/204-988-6 Yellow Purity criteria as set out in Commission Directive 95/45/EC (E 101) 146 Caramel Caramel 232-435-9 Brown Purity criteria as set out in Commission Directive 95/45/EC (E 150a-d) 147 Paprika extract, Capsanthin, capsorubin Capsanthin, capsorubin 207-364-1/207-425-2 Orange Purity criteria as set out in Commission Directive 95/45/EC (E 160c) 148 Beetroot red Beetroot Red 7659-95-2 231-628-5 Red Purity criteria as set out in Commission Directive 95/45/EC (E 162) 149 Anthocyanins (Cyanidin, Peonidin Malvidin Delphinidin Petunidin Pelargonidin) Anthocyanins 528-58-5 134-01-0 528-53-0 643-84-5 134-04-3 208-438-6 205-125-6 211-403-8 208-437-0 — 205-127-7 Red Purity criteria as set out in Commission Directive 95/45/EC (E 163) 150 Aluminium, zinc, magnesium and calcium stearates Aluminum stearate Zinc stearate Magnesium stearate Calcium stearate 7047-84-9 557-05-1 557-04-0 216-472-8 230-325-5 209-151-9 209-150-3 216-472-8 White 151 Phenol, 4,4'-(3H-2,1-benzoxathiol-3-ylidene)bis[2-bromo-3-methyl-6-(1-methylethyl)-, S,S-dioxide Bromothymol blue 76-59-5 200-971-2 Blue Rinse-off products 152 Phenol, 4,4'-(3H-2,1-benzoxathiol-3-ylidene)bis[2,6-dibromo-3-methyl-,S,S-dioxide Bromocresol green 76-60-8 200-972-8 Green Rinse-off products 153 Sodium 4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonate Acid red 195 12220-24-5 — Red Not to be used in products applied on mucous membranes

02009R1223-20160512 → 02009R1223-20160810

ANNEX V LIST OF PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS Preamble 1. For the purposes of this list: Salts is taken to mean: salts of the cations sodium, potassium, calcium, magnesium, ammonium and ethanolamines; salts of the anions chloride, bromide, sulphate, acetate. Esters is taken to … 1,623 unchanged words … (a) Not to be used for children under 3 years of age (b) and (c) Not to be used for children under 3 years of age 57 2-Methyl-2H-isothiazol-3-one Methylisothiazolinone 2682-20-4 220-239-6 0,01 % 58 Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloride Ethyl Lauroyl Arginate HCl 60372-77-2 434-630-6 (a) Mouthwashes (a) 0,15 % (a) Not to be used in preparations for children under 10 years of age (a) Not to be used for children under 10 years of age (b) Other products (b) 0,4 % (b) Not to be used in lip products, oral products (other than mouthwashes), and spray products 59 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, monohydrate and 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, silver(1+) salt, monohydrate Citric acid (and) Silver citrate — 460-890-5 0,2 %, corresponding to 0,0024 % of silver Not to be used in oral products and eye products

02009R1223-20160512 → 02009R1223-20160810

ANNEX VI LIST OF UV FILTERS ALLOWED IN COSMETIC PRODUCTS Not required if concentration is 0,5 % or less and when it is used only for product protection purposes.For use other than as a colorant, see Annex IV, No. No 143.In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit given in column g.In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit given in column g. Reference number Substance identification Conditions Wording of conditions of use and warnings Chemical name/INN/XAN Name of Common Ingredients Glossary CAS number EC number Product type, body parts Maximum concentration in ready for use preparation Other a b c d e f g h i 1 2 N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl sulfate Camphor Benzalkonium Methosulfate 52793-97-2 258-190-8 6 % 3 Benzoic acid, 2-hydroxy-, 3,3,5-trimethylcyclohexyl ester/Homosalate Homosalate 118-56-9 204-260-8 10 % 4 2-Hydroxy-4-methoxybenzophenone/Oxybenzone Benzophenone-3 131-57-7 205-031-5 10 % Contains Benzophenone-3 5 Moved or deleted 6 2-Phenylbenzimidazole-5-sulfonic acid and its potassium, sodium and triethanolamine salts/Ensulizole Phenylbenzimidazole Sulfonic Acid 27503-81-7 248-502-0 8 %(as acid) 7 3,3'-(1,4-Phenylenedimethylene) bis(7, 7-dimethyl-2-oxobicyclo-[2.2.1]hept-1-yl-methanesulfonic acid) and its salts/Ecamsule Terephthalylidene Dicamphor Sulfonic Acid 92761-26-7, 90457-82-2 410-960-6 10 %(as acid) 8 1-(4-tert-Butylphenyl)-3-(4-methoxyphenyl)propane-1,3-dione/Avobenzone Butyl Methoxydibenzoylmethane 70356-09-1 274-581-6 5 % 9 alpha-(2-Oxoborn-3-ylidene)-toluene-4-sulphonic acid and its salts Benzylidene Camphor Sulfonic Acid 56039-58-8 6 % (as acid) 10 2-Cyano-3,3-diphenyl acrylic acid, 2-ethylhexyl ester/Octocrilene Octocrylene 6197-30-4 228-250-8 10 % (as acid) 11 Polymer of N-{(2 and 4)-[(2-oxoborn-3-ylidene)methyl]benzyl} acrylamide Polyacrylamidomethyl Benzylidene Camphor 113783-61-2 6 % 12 2-Ethylhexyl 4-methoxycinnamate/Octinoxate Ethylhexyl Methoxycinnamate 5466-77-3 226-775-7 10 % 13 Ethoxylated ethyl-4-aminobenzoate PEG-25 PABA 116242-27-4 10 % 14 Isopentyl-4-methoxycinnamate/Amiloxate Isoamyl p-Methoxycinnamate 71617-10-2 275-702-5 10 % 15 2,4,6-Trianilino-(p-carbo-2'-ethylhexyl-1'-oxy)-1,3,5-triazine Ethylhexyl Triazone 88122-99-0 402-070-1 5 % 16 Phenol,2-(2H-benzotriazol-2-yl)-4-methyl-6-(2-methyl-3-(1,3,3,3-tetramethyl-1-(trimethylsilyl)oxy)-disiloxanyl)propyl) Drometrizole Trisiloxane 155633-54-8 15 % 17 Benzoic acid, 4,4-((6-((4-(((1,1-dimethylethyl)amino)carbonyl)phenyl)amino)-1,3,5-triazine-2,4-diyl)diimino)bis-, bis (2-ethylhexyl) ester/Iscotrizinol (USAN) Diethylhexyl Butamido Triazone 154702-15-5 10 % 18 3-(4-Methylbenzylidene)-d1 camphor/Enzacamene 4-Methylbenzylidene Camphor 38102-62-4/36861-47-9 - / 253-242-6 4 % 19 3-Benzylidene camphor 3-Benzylidene Camphor 15087-24-8 239-139-9 2 % 20 2-Ethylhexyl salicylate/Octisalate Ethylhexyl Salicylate 118-60-5 204-263-4 5 % 21 2-Ethylhexyl 4-(dimethylamino)benzoate/Padimate O (USAN:BAN) Ethylhexyl Dimethyl PABA 21245-02-3 244-289-3 8 % 22 2-Hydroxy-4-methoxybenzophenone-5-sulfonic acid and its sodium salt/Sulisobenzone Benzophenone-4, Benzophenone-5 4065-45-6/6628-37-1 223-772-2 / - 5 % (as acid) 23 2,2'-Methylene-bis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethyl-butyl)phenol) / Bisoctrizole Methylene Bis-Benzotriazolyl Tetramethylbutylphenol 103597-45-1 403-800-1 10 % 24 Sodium salt of 2,2'-bis(1,4-phenylene)-1H-benzimidazole-4,6-disulfonic acid) / Bisdisulizole disodium (USAN) Disodium Phenyl Dibenzimidazole Tetrasulfonate 180898-37-7 429-750-0 10 % (as acid) 25 2,2'-(6-(4-Methoxyphenyl)-1,3,5-triazine-2,4-diyl)bis(5-((2-ethylhexyl)oxy)phenol) / Bemotrizinol Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine 187393-00-6 10 % 26 Dimethicodiethylbenzalmalonate Polysilicone-15 207574-74-1 426-000-4 10 % 27 Titanium dioxide Titanium Dioxide 13463-67-7/1317-70-0/1317-80-2 236-675-5/205-280-1/215-282-2 13463-67-7/ 1317-70-0/ 1317-80-2 236-675-5/ 215-280-1/ 215-282-2 25 % 27a Titanium dioxide Titanium Dioxide (nano) 13463-67-7/ 1317-70-0/ 1317-80-2 236-675-5/ 215-280-1/ 215-282-2 25 % Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation Only nanomaterials having the following characteristics are allowed: purity ≥ 99 %, rutile form, or rutile with up to 5 % anatase, with crystalline structure and physical appearance as clusters of spherical, needle, or lanceolate shapes, median particle size based on number size distribution ≥ 30 nm, aspect ratio from 1 to 4,5, and volume specific surface area ≤ 460 m2/cm3, coated with Silica, Hydrated Silica, Alumina, Aluminium Hydroxide, Aluminium Stearate, Stearic Acid, Trimethoxycaprylylsilane, Glycerin, Dimethicone, Hydrogen Dimethicone, Simethicone; photocatalytic activity ≤ 10 % compared to corresponding non-coated or non-doped reference, nanoparticles are photostable in the final formulation. 28 Benzoic acid, 2-[-4-(diethylamino)-2-hydroxybenzoyl]-. Hexylester Diethylamino Hydroxy benzoyl Hexyl Benzoate 302776-68-7 443-860-6 10 % 29 1,3,5-Triazine, 2,4,6-tris[1,1'-biphenyl]-4-yl-, including as nanomaterial Tris-biphenyl triazine Tris-biphenyl triazine (nano) 31274-51-8 — 10 % Not to be used in sprays. Only nanomaterials having the following characteristics are allowed: median primary particle size > 80 nm; Purity ≥ 98 %; Uncoated 30 Zinc oxide Zinc Oxide 1314-13-2 215-222-5 25 % Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation. 30a Zinc oxide Zinc Oxide (nano) 1314-13-2 215-222-5 25 % Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation. Only nanomaterials having the following characteristics are allowed: purity ≥ 96 %, with wurtzite crystalline structure and physical appearance as clusters that are rod-like, star-like and/or isometric shapes, with impurities consisting only of carbon dioxide and water, whilst any other impurities are less than 1 % in total, median diameter of the particle number size distribution D50 (50 % of the number below this diameter) > 30 nm and D1 (1 % below this size) > 20 nm, water solubility < 50 mg/L uncoated, or coated with triethoxycaprylylsilane, dimethicone, dimethoxydiphenylsilanetriethoxycaprylylsilane cross-polymer, or octyl triethoxy silane.