Version · Cosmetics Regulation
Version in force
Made by Regulation (EU) 2016/1120 32016R1120 on EUR-Lex (external, EUR-Lex) · Regulation (EU) 2016/1121 32016R1121 on EUR-Lex (external, EUR-Lex) · Regulation (EU) 2016/1143 32016R1143 on EUR-Lex (external, EUR-Lex)
Version 12 of 41 recorded for Cosmetics Regulation.
In force , . First seen by emendrix on , when it first read this version; that is not a legal date.
4 changes in this version
Consolidated versions 02009R1223-20160512 → 02009R1223-20160810. v1 is the previous version, v2 this one.The date in a version's code is the date EUR-Lex gives that consolidated text, which can differ from its in-force date: this version, coded 20160810, is in force from 3 August 2016.
Everything Regulation (EU) 2016/1120 changed
What changed
Annex III LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN, Modified§
Not in every listWhat this means
Found in the text, but not every source lists it — the text comparison found this change; the EU's own amendment metadata does not list it. The source that does not name it is the EU's own amendment metadata. Both are shown; neither is overruled.
Explanation, written by a model and checked against the cited text
The visible portions of Annex III are identical between the two versions, and the only detectable difference is that more text follows after the point where each excerpt was cut off, with the AFTER text truncated later than the BEFORE text.
Because both texts are cut short before reaching the end of the annex, any difference in the remaining, unseen entries cannot be described from what is shown here.
Cited: Annex III, v1 (external, EUR-Lex) · Annex III, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Each CAS and EC number in these tables links to its own page, which lists every entry that prints it across the acts this record holds.
9 entries added, 0 amended, 0 removed. 1 more changed only in whitespace and is not listed.
4 rows carry no key and are not compared.
9 entries added
| Identifiers | Reference number | Substance identification | Restrictions | Wording of conditions of use and warnings | |||||
|---|---|---|---|---|---|---|---|---|---|
| Chemical name/INN | 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 | |
| Reference number 288CAS 16517-75-2EC 605-392-2 | 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. |
| Reference number 289CAS 74578-10-2EC 277-929-5 | 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. |
| Reference number 290CAS 4403-90-1EC 224-546-6 | 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 % | ||
| Reference number 291CAS 4430-18-6EC 224-618-7 | 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 % | ||
| Reference number 292CAS 337906-36-2CAS 337906-37-3 | 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. | ||
| Reference number 293CAS 38866-20-5EC 254-161-9 | 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. |
| Reference number 294CAS 3179-89-3EC 221-665-5 | 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. |
| Reference number 295CAS 1064-48-8EC 213-903-1 | 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 % | ||
| Reference number 296CAS 5858-81-1EC 227-497-9 | 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 % | ||
Text from EUR-Lex, before and after
Previous version, in force 12 May 2016 02009R1223-20160512 → this version, in force 3 August 2016 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.
… 245 unchanged lines …
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 % (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
… 1,374 unchanged lines …
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 %
Annex IV LIST OF COLORANTS ALLOWED IN COSMETIC PRODUCTS, Modified§
Explanation, written by a model and checked against the cited text
Entry 126 for Carbon black (CI 77266) now lists additional CAS and EC numbers and adds detailed purity and impurity limits covering ash content, total sulphur, total PAH, benzo(a)pyrene, dibenz(a,h)anthracene, arsenic, lead and mercury, replacing the earlier entry that only carried a single EC number and a general purity-criteria reference.
A new entry 126a is added for Carbon black (nano), giving the same CAS/EC identifiers, a Black colour designation, a 10 % maximum concentration, a restriction against use where it could expose the end user's lungs by inhalation, and conditions requiring specific purity and a minimum primary particle size of 20 nm for the nanomaterial.
All other entries and the preamble text of the list remain the same between the two versions shown.
Cited: Annex IV, v2 (external, EUR-Lex) · Annex IV, v1 (external, EUR-Lex)
v1 is the previous version, v2 this one.
1 entry added, 1 amended, 0 removed.
1 entry added
| Identifiers | Reference number | Substance identification | Conditions | Wording of conditions of use and warnings | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Chemical Name | Colour index Number/Name of Common Ingredients Glossary | CAS number | EC number | Colour | Product type, Body parts | Maximum concentration in ready for use preparation | Other | |||
| a | b | c | d | e | f | g | h | i | j | |
| Reference number 126aCAS 1333-86-4CAS 7440-44-0EC 215-609-9EC 231-153-3EC 931-328-0EC 931-334-3 | 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 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. | ||
1 entry amended
| Identifiers | Version | Reference number | Substance identification | Conditions | Wording of conditions of use and warnings | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Chemical Name | Colour index Number/Name of Common Ingredients Glossary | CAS number | EC number | Colour | Product type, Body parts | Maximum concentration in ready for use preparation | Other | ||||
| a | b | c | d | e | f | g | h | i | j | ||
| Reference number 126CAS 1333-86-4CAS 7440-44-0EC 215-609-9EC 231-153-3EC 931-328-0EC 931-334-3 | Before | 126 | Carbon black | 77266 | Black | Purity | |||||
| After | 126 | Carbon black | 77266 | 1333-86-4, 7440-44-0 | 215-609-9, 231-153-3, 931-328-0, 931-334-3 | Black | 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, total Hg ≤ 1 ppm. | ||||
Text from EUR-Lex, before and after
Previous version, in force 12 May 2016 02009R1223-20160512 → this version, in force 3 August 2016 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
Annex V LIST OF PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS, Modified§
Explanation, written by a model and checked against the cited text
Entry 58, for Ethyl Lauroyl Arginate HCl, was split into two separate product-type rows: one for mouthwashes with a maximum concentration of 0,15% and a restriction on use in preparations for children under 10 years of age, and another for other products with a maximum concentration of 0,4% and a restriction on use in lip products, oral products other than mouthwashes, and spray products.
In the earlier version, entry 58 set a single maximum concentration of 0,4% with a single restriction covering lip products, oral products, and spray products, without any mouthwash-specific limit or age-based restriction.
Cited: Annex V, v2 (external, EUR-Lex) · Annex V, v1 (external, EUR-Lex)
v1 is the previous version, v2 this one.
0 entries added, 1 amended, 0 removed.
1 entry amended
| Identifiers | Version | Reference number | Substance identification | Conditions | Wording of conditions of use and warnings | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| Chemical name/INN | 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 | ||
| Reference number 58CAS 60372-77-2EC 434-630-6 | Before | 58 | Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloride | Ethyl Lauroyl Arginate HCl | 60372-77-2 | 434-630-6 | Not to be used in | |||
| After | 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 | ||||||||
Text from EUR-Lex, before and after
Previous version, in force 12 May 2016 02009R1223-20160512 → this version, in force 3 August 2016 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 … 1,611 unchanged words … of age (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
Annex VI LIST OF UV FILTERS ALLOWED IN COSMETIC PRODUCTS, Modified§
Explanation, written by a model and checked against the cited text
The introductory note on Annex IV No 143 was changed from referring to use other than as a colorant to referring to use as a colorant, and a new sentence was added stating that when zinc oxide and zinc oxide (nano) are combined, the sum must not exceed the limit in column g, alongside an added analogous sentence for combined use of Titanium Dioxide and Titanium Dioxide (nano).
Entry 27 for Titanium Dioxide was reformatted with line breaks in its CAS and EC numbers, and a new entry 27a for Titanium Dioxide (nano) was added, carrying its own conditions including a restriction on inhalation exposure and a detailed list of required nanomaterial characteristics such as purity, crystalline form, particle size, aspect ratio, surface area, permitted coatings, photocatalytic activity, and photostability.
Cited: Annex VI, v2 (external, EUR-Lex) · Annex VI, v1 (external, EUR-Lex)
v1 is the previous version, v2 this one.
1 entry added, 1 amended, 0 removed. 1 more changed only in whitespace and is not listed.
1 entry added
| Identifiers | 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 | |
| Reference number 27aCAS 1317-70-0CAS 1317-80-2CAS 13463-67-7EC 215-280-1EC 215-282-2EC 236-675-5 | 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. | ||
1 entry amended
| Identifiers | Version | 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 | ||
| Reference number 27CAS 1317-70-0CAS 1317-80-2CAS 13463-67-7EC 205-280-1EC 215-280-1EC 215-282-2EC 236-675-5 | Before | 27 | Titanium dioxide | Titanium Dioxide | 25 % | |||||
| After | 27 | Titanium dioxide | Titanium Dioxide | 13463-67-7/ 1317-70-0/ 1317-80-2 | 236-675-5/ 215-280-1/ 215-282-2 | 25 % | ||||
Text from EUR-Lex, before and after
Previous version, in force 12 May 2016 02009R1223-20160512 → this version, in force 3 August 2016 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.
The full entry is committed at eu/32009R1223/CHANGELOG.md.