Version · Cosmetics Regulation
Version in force
Made by Regulation (EU) 2022/1531 32022R1531 on EUR-Lex (external, EUR-Lex)
Version 32 of 41 recorded for Cosmetics Regulation.
First seen by emendrix on , when it first read this version; that is not a legal date.
3 changes in this version
Consolidated versions 02009R1223-20220731 → 02009R1223-20221006. v1 is the previous version, v2 this one.
What changed
Annex V LIST OF PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS, Modified§
Explanation, written by a model and checked against the cited text
Also missing from the earlier list, entry 51's chemical name for the substance changed from Sodium hydroxymethylamino acetate to Sodium N-(hydroxymethyl)glycinate.
The condition of use for that entry changed from a prohibition applying when the maximum theoretical concentration of releasable formaldehyde is 0,1% w/w or greater, to a prohibition applying unless it can be shown that concentration is below 0,1% w/w.
Cited: Annex V, v1 (external, EUR-Lex) · Annex V, 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.
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 51CAS 70161-44-3EC 274-357-8 | Before | 51 | Sodium | Sodium Hydroxymethylglycinate | 70161-44-3 | 274-357-8 | 0,5 % | Not to be used | ||
| After | 51 | Sodium N-(hydroxymethyl)glycinate | Sodium Hydroxymethylglycinate | 70161-44-3 | 274-357-8 | 0,5 % | Not to be used unless it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is < 0,1 % w/w | |||
Text from EUR-Lex, before and after
Previous version, in force 31 July 2022 02009R1223-20220731 → this version, in force 6 October 2022 02009R1223-20221006
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 … 1,627 unchanged words … to be used in aerosols (sprays) Contains glutaral
49 5-Ethyl-3,7-dioxa-1-azabicyclo [3.3.0] octane 7-Ethylbicyclooxazolidine 7747-35-5 231-810-4 0,3 % Not to be used in oral products and in products applied on mucous membranes 50 3-(p-Chlorophenoxy)-propane-1,2 diol Chlorphenesin 104-29-0 203-192-6 0,3 % 51 Sodium hydroxymethylamino acetate N-(hydroxymethyl)glycinate Sodium Hydroxymethylglycinate 70161-44-3 274-357-8 0,5 % Not to be used if unless it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, if in the mixture as placed on the market is ≥ < 0,1 % w/w 52 Silver chloride deposited on titanium dioxide Silver chloride 7783-90-6 232-033-3 0,004 % (as AgCl) 20 % AgCl (w/w) on TiO2. Not to be used in products for children under 3 years of age, in oral products and in eye and lip products 53 Benzenemethanaminium, N,N-dimethyl-N-[2-[2-[4-(1,1,3,3,-tetramethylbutyl)phenoxy]ethoxy] ethyl]-, chloride Benzethonium Chloride 121-54-0 204-479-9 (a) Rinse-off products
(b) Leave-on products other than oral products 0,1 % 54 Benzalkonium chloride, bromide and saccharinate
Benzalkonium chloride, benzalkonium bromide, benzalkonium saccharinate 8001-54-5, 63449-41-2, 91080-29-4, 68989-01-5, 68424-85-1, 68391-01-5, 61789-71-7, 85409-22-9 264-151-6, 293-522-5, 273-545-7, 270-325-2, 269-919-4, 263-080-8, 287-089-1 0,1 % (as benzalkonium chloride) Avoid contact with eyes
55 Methanol, (phenylmethoxy-) Benzylhemiformal 14548-60-8 238-588-8 Rinse-off products 0,15 % 56 3-Iodo-2-propynylbutylcarbamate Iodopropynyl butylcarbamate 55406-53-6 259-627-5 (a) Rinse-off products
(b) Leave-on products
(c) Deo-dorants/anti-perspirants (a) 0,02 %
(b) 0,01 %,
(c) 0,0075 % Not to be used in oral and lip products
(a) Not to be used in products for children under 3 years of age, except in bath products/shower gels and shampoo
(b) Not to be used in body lotion and body cream
(b) and (c) Not to be used in products for children under 3 years 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 Rinse-off products 0,0015 % 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 60 4-(3-ethoxy-4-hydroxyphenyl)butan-2-one Hydroxyethoxyphenyl Butanone 569646-79-3 933-435-8 0,7 %
Annex VI LIST OF UV FILTERS ALLOWED IN COSMETIC PRODUCTS, 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
Comparing the two texts, the only visible difference is the removal of a stray letter "s" that appeared on its own line after entry 10 (Octocrylene) in the earlier version, which is absent in the later version.
All other wording, entries, substance identifications, concentration limits and conditions of use in the list remain identical between the two versions.
Cited: Annex VI, v1 (external, EUR-Lex) · Annex VI, v2 (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/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 10CAS 6197-30-4EC 228-250-8 | Before | 10 | 2-Cyano-3,3-diphenyl acrylic acid, 2- ethylhexyl ester/Octocrylene
| Octocrylene | 6197-30-4 | 228-250-8 | a) Propellant spray products b) Other products | a) 9 % b) 10 % | ||
| After | 10 | 2-Cyano-3,3-diphenyl acrylic acid, 2- ethylhexyl ester/Octocrylene | Octocrylene | 6197-30-4 | 228-250-8 | a) Propellant spray products b) Other products | a) 9 % b) 10 % | |||
Text from EUR-Lex, before and after
Previous version, in force 31 July 2022 02009R1223-20220731 → this version, in force 6 October 2022 02009R1223-20221006
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 as a colorant, see Annex IV, 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.
In case of combined use of Methylene Bis-Benzotriazolyl Tetramethylbutylphenol and Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (nano), the sum shall not exceed the limit given in column g.
However, cosmetic products containing that substance and complying with the restrictions set out in Regulation (EC) No 1223/2009 as applicable on 27 July 2022 may be placed on the Union market until 28 January 2023 and be made available on the Union market until 28 July 2023.
Benzophenone as an impurity and/or degradation product of Octocrylene shall be kept at trace level.
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-methoxy-benzophenone/Oxybenzone
Benzophenone-3 131-57-7 205-031-5 a) Face products, hand products, and lip products, excluding propellant and pump spray products
b) Body products, including propellant and pump spray products
c) Other products a) 6 %
b) 2,2 %
c) 0,5 % For a) and b) Not more than 0,5 % to protect product formulation
a) If used at 0,5 % to protect product formulation, the levels used as UV filter must not exceed 5,5 %.
b) If used at 0,5 % to protect product formulation, the levels used as UV filter must not exceed 1,7 %. For a) and b):
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/Octocrylene
s
Octocrylene 6197-30-4 228-250-8 a) Propellant spray products
b) Other products a) 9 %
b) 10 % 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 … 715 unchanged words … (2Z)-2-cyano-2-[3-(3-methoxypropylamino) cyclohex-2-en-1-ylidene]acetate Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate 1419401-88-9 700-860-3 3 % Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation
Do not use with nitrosating agents – Maximum nitrosamine content: 50 μg/kg
Keep in nitrite-free containers
1 provision named with no text to show
Each row carries the provision and the source that named it, and opens in place from the § link at its end. None was dropped and every one still counts where sources differ above.
Annex II, Modified named by the EU's own amendment metadata§
No text foundWhat this means
A source lists it, but there is no text to show — the EU's own amendment metadata found this change; the text comparison finds no difference in the provision's text. Only the EU's own amendment metadata names it, and it carries no text. Both are shown; neither is overruled.
No explanation shipped — the text comparison did not see this change, so it carries no text; another source named the provision, and it is listed where sources differ.
Text from EUR-Lex: none to show
No text on either side: this unit was named by a signal that carries no text, and only the structural diff carries any.
The full entry is committed at eu/32009R1223/CHANGELOG.md.