Cosmetics Regulation · 32009R1223 · every version of this act · on EUR-Lex (external, EUR-Lex)
19 changes recorded across 19 versions, newest first.
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Amended by Regulation (EU) 2026/909 32026R0909 on EUR-Lex (external, EUR-Lex)
Applies from: no date changed
Explanation, written by a model and checked against the cited text
The AFTER text adds a new entry, numbered 61, for Silver zinc zeolite (Ammonium Silver Zinc Aluminium Silicate), listing its CAS and EC numbers, restricting it to deodorant spray and powder foundation product types at a maximum concentration of 1%, with an added condition that the silver content in the substance must not exceed 2,5% for those two product types.
This entry is absent from the BEFORE text, which ends at entry 60.
Cited: Annex V, v2 (external, EUR-Lex) · Annex V, v1 (external, EUR-Lex)
v1 is the previous version, v2 this one.
1 entry added, 0 amended, 0 removed.
1 entry added
Text from EUR-Lex, before and after
Previous version, in force 1 May 2026 02009R1223-20260501 → this version, in force 18 May 2026 02009R1223-20260518
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 … 2,169 unchanged words … 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 % 61 Silver zinc zeolite Ammonium Silver Zinc Aluminium Silicate 130328-20-0 603-404-0 (a) Deodorant spray
(b) Powder foundation (a) and (b)
1 % For (a) and (b) the silver content in Ammonium Silver Zinc Aluminium Silicate must not exceed 2,5 %.
Amended by Regulation (EU) 2026/78 32026R0078 on EUR-Lex (external, EUR-Lex)
Applies from: no date changed
Explanation, written by a model and checked against the cited text
Entry 7 now covers Biphenyl-2-ol (o-Phenylphenol) together with a second substance, Sodium 2-biphenylate (Sodium o-Phenylphenate), adding its CAS and EC numbers alongside the original ones.
The product-type and body-part column is restated as rinse-off and leave-on categories with the same maximum concentrations as phenol, but a new condition sets a combined maximum concentration when both substances are used together in the same product.
The wording of conditions of use and warnings for entry 7 is expanded to add restrictions on lung-exposure applications and oral products, in addition to the existing warning to avoid contact with eyes.
Cited: Annex V, v2 (external, EUR-Lex) · Annex V, v1 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, on this version's page
Amended by Regulation (EU) 2024/996 32024R0996 on EUR-Lex (external, EUR-Lex)
Applies from: not readable (the text changed beyond its dates, so no date that moved can be read as the application date) why
dates added to the text: 2024-04-23, 2024-12-31, 2025-10-31
Explanation, written by a model and checked against the cited text
A new preamble sentence was added stating that cosmetic products containing the substance referred to (Triclocarban/Triclosan context) that do not comply with the new conditions may, if they comply with the conditions applicable on 23 April 2024, be placed on the Union market until 31 December 2024 and continue to be made available until 31 October 2025.
Entry 23 (Triclocarban) was changed from listing specific product types with separate concentration limits to a single entry covering all cosmetic products except mouthwash at 0,2%, with the purity criteria wording changed from '<1 ppm' to '≤ 1 ppm' and a new restriction and labelling requirement added for toothpaste intended for children under 6 years of age.
Entry 25 (Triclosan) was restructured from separate (a) and (b) product categories with different percentages into a single list of product types all subject to 0,3%, and a new restriction and labelling requirement was added for toothpaste intended for children under 3 years of age.
Cited: Annex V, v2 (external, EUR-Lex) · Annex V, v1 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, on this version's page
Amended by Regulation (EU) 2022/1531 32022R1531 on EUR-Lex (external, EUR-Lex) · Regulation (EU) 2022/2195 32022R2195 on EUR-Lex (external, EUR-Lex)
Applies from: no date changed
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 two texts are identical apart from a minor spacing change in entry 51, where the substance name "Sodium N-(hydroxymethyl)glycinate" has an added space before "glycinate" in the later version.
Cited: Annex V, v1 (external, EUR-Lex) · Annex V, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, on this version's page
Amended by Regulation (EU) 2022/1531 32022R1531 on EUR-Lex (external, EUR-Lex)
Applies from: no date changed
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.
Text from EUR-Lex, on this version's page
Amended by Regulation (EU) 2022/1181 32022R1181 on EUR-Lex (external, EUR-Lex) · Regulation (EU) 2022/1176 32022R1176 on EUR-Lex (external, EUR-Lex)
Applies from: not readable (the text changed beyond its dates, so no date that moved can be read as the application date) why
dates added to the text: 2022-07-30, 2024-07-31, 2026-07-31
Explanation, written by a model and checked against the cited text
Paragraph 2 of the preamble changes the required warning wording from "contains formaldehyde" to "releases formaldehyde", and changes the labelling trigger from a formaldehyde concentration exceeding 0,05 % to a total released formaldehyde concentration exceeding 0,001 % (10 ppm), now applying irrespective of whether one or more formaldehyde-releasing substances are present.
A new sentence is added after paragraph 2 stating that finished products containing the substances referred to in that paragraph which comply with the Regulation as applicable on 30 July 2022 may be placed on the Union market until 31 July 2024 and made available on the Union market until 31 July 2026.
Cited: Annex V, v1 (external, EUR-Lex) · Annex V, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, on this version's page
Amended by Regulation (EU) 2021/1902 32021R1902 on EUR-Lex (external, EUR-Lex) · Regulation (EU) 2022/135 32022R0135 on EUR-Lex (external, EUR-Lex)
Applies from: no date changed
Explanation, written by a model and checked against the cited text
Entry 51, for sodium hydroxymethylglycinate, now includes an additional 'Other' condition stating that it is not to be used if the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is 0,1% w/w or higher.
In the earlier version, entry 51 contained no such condition in the 'Other' column.
Cited: Annex V, v2 (external, EUR-Lex) · Annex V, v1 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, on this version's page
Amended by Regulation (EU) 2019/1966 32019R1966 on EUR-Lex (external, EUR-Lex)
Applies from: no date changed
Explanation, written by a model and checked against the cited text
Entry 3, covering salicylic acid and its salts, is restructured so that salicylic acid itself is now listed on its own line with its own CAS and EC numbers, separated from the other salicylate salts, which are grouped on a second line with their own identifiers.
The conditions and wording column for entry 3 now adds statements that salicylic acid is not to be used in products for children under 3 years of age, not to be used in oral products, and not to be used in applications that may lead to exposure of the end-user's lungs by inhalation, alongside the restriction that the other salicylate salts are not to be used in products for children under 3 years of age except for shampoos.
A minor wording change also occurs in the preamble note that previously read "For use other than as a preservative, see Annex III, No. 98," which now reads "For uses other than preservative, see Annex III, No 98."
Cited: Annex V, v1 (external, EUR-Lex) · Annex V, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, on this version's page
Amended by Regulation (EU) 2019/1858 32019R1858 on EUR-Lex (external, EUR-Lex) · Regulation (EU) 2019/698 32019R0698 on EUR-Lex (external, EUR-Lex) · Regulation (EU) 2019/1857 32019R1857 on EUR-Lex (external, EUR-Lex)
Applies from: not readable (the text changed beyond its dates, so no date that moved can be read as the application date) why
dates added to the text: 2019-11-27, 2020-02-27
Explanation, written by a model and checked against the cited text
The preamble gains two new notes tied to entry 32, one cross-referencing Annex III entry 310 and the other giving two dates, 27 November 2019 and 27 February 2020, concerning cosmetic products containing 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one that do not comply with the stated conditions.
Entry 32 itself is rewritten from a single unrestricted 0,5% maximum concentration for Climbazole into four separate product-type rows (hair lotions, face creams, foot care products, and rinse-off shampoo) each with its own maximum concentration of 0,2% or 0,5%.
A new entry 60 for Hydroxyethoxyphenyl Butanone is added at the end of the list, with its CAS and EC numbers and a maximum concentration of 0,7%.
Cited: Annex V, v2 (external, EUR-Lex) · Annex V, v1 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, on this version's page
Amended by Regulation (EU) 2019/831 32019R0831 on EUR-Lex (external, EUR-Lex) · Regulation (EU) 2019/681 32019R0681 on EUR-Lex (external, EUR-Lex) · Regulation (EU) 2019/1966 32019R1966 on EUR-Lex (external, EUR-Lex) · Regulation (EU) 2019/698 32019R0698 on EUR-Lex (external, EUR-Lex) · Regulation (EU) 2018/1847 32018R1847 on EUR-Lex (external, EUR-Lex) · Regulation (EU) 2019/680 32019R0680 on EUR-Lex (external, EUR-Lex)
Applies from: not readable (the text changed beyond its dates, so no date that moved can be read as the application date) why
dates added to the text: 2019-06-17, 2019-09-17
Explanation, written by a model and checked against the cited text
The preamble text about formaldehyde-releasing substances in the finished-product warning rule was reworded slightly, dropping the phrase referring to formaldehyde itself as a substance in the list, and a new paragraph was added stating transition dates for cosmetic products containing Biphenyl-2-ol that do not comply with the conditions, one for placing on the market and one for making available on the market.
Entry 7 for Biphenyl-2-ol was changed from covering biphenyl-2-ol together with its salts (sodium, potassium and MEA o-phenylphenate) at a single maximum concentration of 0,2% as phenol, to covering only Biphenyl-2-ol/o-Phenylphenol itself, with separate maximum concentrations of 0,2% for rinse-off products and 0,15% for leave-on products, and an added instruction to avoid contact with eyes.
Entry 28 was changed from identifying the substance as Poly(methylene),.alpha.,.omega.-bis[[[(aminoiminomethyl)amino]iminomethyl]amino]-, dihydrochloride with three CAS numbers and no EC numbers or usage restriction, to identifying it as Polyhexamethylene biguanide hydrochloride with four CAS numbers, two EC numbers, and an added restriction against use in applications that may lead to exposure of the end-user's lungs by inhalation.
Cited: Annex V, v1 (external, EUR-Lex) · Annex V, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, on this version's page
Amended by Regulation (EU) 2017/1224 32017R1224 on EUR-Lex (external, EUR-Lex)
Applies from: no date changed
Explanation, written by a model and checked against the cited text
In entry 57, the maximum concentration allowed for Methylisothiazolinone in rinse-off products was changed from 0,01 % to 0,0015 %.
Cited: Annex V, v1 (external, EUR-Lex) · Annex V, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, on this version's page
Amended by Regulation (EU) 2017/237 32017R0237 on EUR-Lex (external, EUR-Lex)
Applies from: no date changed
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 only textual difference between the two versions is a minor formatting change in entry 12's header, where a line break and a space before "esters" were removed so the phrase reads as a single continuous line.
No substances, concentrations, conditions, or wording of warnings were altered anywhere else in the list.
Cited: Annex V, v1 (external, EUR-Lex) · Annex V, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, on this version's page
Amended by Regulation (EU) 2016/1198 32016R1198 on EUR-Lex (external, EUR-Lex)
Applies from: no date changed
Explanation, written by a model and checked against the cited text
In entry 39's footnote, the reference to entry 39 was clarified by adding "of Annex V" and by changing the capitalisation of methylchloroisothiazolinone to lower case.
In entry 57, the product type/body parts column was changed from being blank to specifying "Rinse-off products" alongside the unchanged maximum concentration of 0,01 %.
Cited: Annex V, v1 (external, EUR-Lex) · Annex V, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, on this version's page
Amended 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)
Applies from: no date changed
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.
Text from EUR-Lex, on this version's page
Amended by Regulation (EU) No 1003/2014 32014R1003 on EUR-Lex (external, EUR-Lex)
Applies from: no date changed
Explanation, written by a model and checked against the cited text
Two new preamble notes were added stating that Methylisothiazolinone (entry 57) and the Methylchloroisothiazolinone/Methylisothiazolinone mixture (entry 39) are mutually exclusive and cannot both be used in the same product.
Entry 39 was rewritten so that the substance identification column now names the ingredient as Methylchloroisothiazolinone (and) Methylisothiazolinone rather than describing it only as a mixture of the two chemical names with magnesium chloride and magnesium nitrate, and the maximum concentration condition is now restricted to rinse-off products with the same 0,0015% ratio limit, whereas before no such rinse-off restriction was stated.
Cited: Annex V, v2 (external, EUR-Lex) · Annex V, v1 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, on this version's page
Amended by Regulation (EU) No 1004/2014 32014R1004 on EUR-Lex (external, EUR-Lex)
Applies from: no date changed
Explanation, written by a model and checked against the cited text
Entry 12 was narrowed so that it now covers only 4-hydroxybenzoic acid and its methyl- and ethyl-esters and their salts, removing butyl-, propyl-, isobutyl-, isopropyl-, benzyl- and pentyl-related substances from its scope while keeping the same 0,4% single-ester and 0,8% mixture maximum concentrations.
A new entry 12a was added covering butyl and propyl 4-hydroxybenzoate and their salts, with its own maximum concentration limits (0,14% for the sum of individual concentrations and 0,8% for mixtures with entry 12 substances) and a new condition restricting use on the nappy area for leave-on products intended for children under three years of age.
Cited: Annex V, v1 (external, EUR-Lex) · Annex V, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, on this version's page
Amended by Regulation (EU) No 866/2014 32014R0866 on EUR-Lex (external, EUR-Lex)
Applies from: no date changed
Explanation, written by a model and checked against the cited text
The preamble now includes two additional footnote lines referencing Annex III entries No 287 and No 286, which were not present before.
A new entry, reference number 59, has been added for citric acid and silver citrate, with its CAS/EC identifiers, a maximum concentration of 0,2 % (corresponding to 0,0024 % of silver), and a restriction against use in oral products and eye products.
The formatting of the row for reference number 44 (alkyl C12-22 trimethyl ammonium bromide and chloride) has changed, listing each substance name alongside its own CAS and EC number in a rearranged layout rather than as grouped lists.
Cited: Annex V, v2 (external, EUR-Lex) · Annex V, v1 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, on this version's page
Amended by Regulation (EU) No 358/2014 32014R0358 on EUR-Lex (external, EUR-Lex)
Applies from: no date changed
Explanation, written by a model and checked against the cited text
Entry 12 changes its scope for parabens: the AFTER text excludes esters of isopropyl, isobutyl, phenyl, benzyl and pentyl from the substances covered, and it also removes potassium ethylparaben and phenylparaben from the listed substance identifications while adjusting some of the accompanying CAS and EC numbers.
Entry 25 for Triclosan now sets out separate maximum concentrations and specific product types (toothpastes, hand soaps, body soaps/shower gels, non-spray deodorants, face powders and blemish concealers, and certain nail products at 0,3 percent, and mouthwashes at 0,2 percent), where the BEFORE text simply stated a single 0,3 percent maximum concentration with no such product breakdown.
Cited: Annex V, v1 (external, EUR-Lex) · Annex V, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, on this version's page
Amended by Regulation (EU) No 344/2013 32013R0344 on EUR-Lex (external, EUR-Lex) · Regulation (EU) No 1197/2013 32013R1197 on EUR-Lex (external, EUR-Lex)
Applies from: no date changed
Explanation, written by a model and checked against the cited text
The preamble notes referencing Annex III entries were updated, with the note about entry No. 45, 68 replaced by a note referencing only entry No 45, and a new footnote referencing Annex III entry No 197 was added.
A new entry, numbered 58, for Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloride (Ethyl Lauroyl Arginate HCl) was added to the table, with its CAS and EC numbers, a maximum concentration of 0,4 %, and a restriction against use in lip products, oral products and spray products.
The remainder of the substance list, entries 1 through 57, is unchanged in substance between the two versions.
Cited: Annex V, v2 (external, EUR-Lex) · Annex V, v1 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, on this version's page