Annex V

in force 2026-05-01 MODIFIED+470 −74§

Amended by Regulation (EU) 2026/78 32026R0078

applies from: unchanged

Sources disagree — the text comparison and the EU's own amendment metadata found this change; the amending act's instructions do not mention it. All are shown; none is overruled.

Entry 7, covering Biphenyl-2-ol, is expanded to also name 2-phenylphenol, 2-hydroxybiphenyl, and Sodium 2-biphenylate (Sodium o-Phenylphenate), adding a second CAS/EC identification pair alongside the original o-Phenylphenol entry.

The product-type/body-part column changes from separate rows for rinse-off and leave-on products to a combined (a)/(b) listing with the same percentage limits, and the conditions column adds a combined-concentration limit for when o-Phenylphenol and Sodium o-Phenylphenate are used together, plus a new instruction not to use in applications leading to inhalation exposure or in oral products, alongside the existing eye-contact warning.

Cited: Annex V, v1 · Annex V, v2

in force 2024-04-24 MODIFIED§

Amended by Regulation (EU) 2024/996 32024R0996

applies from: unknown (the text changed beyond its dates, so no date that moved can be read as the application date)

dates added to the text: 2024-04-23, 2024-12-31, 2025-10-31

Sources disagree — the text comparison and the EU's own amendment metadata found this change; the amending act's instructions do not mention it. All are shown; none is overruled.

A new transitional sentence has been added to the preamble text concerning the Climbazole-related restriction, stating that cosmetic products not complying with the conditions may still be placed on the Union market until 31 December 2024 if they comply with conditions applicable on 23 April 2024, and may continue to be made available until 31 October 2025 if already placed on the market by that date.

Entry 23 for Triclocarban has been rewritten to apply to all cosmetic products except mouthwash, to change the purity criteria wording from a strict inequality to a less-than-or-equal-to threshold for the tetrachloroazobenzene and tetrachloroazoxybenzene impurities, and to add a new restriction and labelling requirement for toothpaste intended for children under 6 years of age.

Entry 25 for Triclosan has been reformatted by replacing the lettered (a)/(b) product and concentration structure with a single semicolon-separated list of product types under one 0,3 % concentration, removing the separate 0,2 % mouthwash limit, and adding a new restriction and labelling requirement for toothpaste intended for children under 3 years of age.

Cited: Annex V, v2 · Annex V, v1

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in force 2022-12-17 MODIFIED§

Amended by Regulation (EU) 2022/1531 32022R1531 · Regulation (EU) 2022/2195 32022R2195

applies from: unchanged

Sources disagree — the text comparison found this change; the EU's own amendment metadata does not list it. Both are shown; neither is overruled.

The only textual difference between the two versions is that entry 51's ingredient name 'Sodium N-(hydroxymethyl)glycinate' has a line break inserted between 'glycinate' and the following word, splitting it across two lines, with no change to the substance identification, CAS/EC numbers, concentration limit, or wording of conditions.

Cited: Annex V, v1 · Annex V, v2

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in force 2022-10-06 MODIFIED§

Amended by Regulation (EU) 2022/1531 32022R1531

applies from: unchanged

Sources disagree — the text comparison and the EU's own amendment metadata found this change; the amending act's instructions do not mention it. All are shown; none is overruled.

In entry 51, the chemical name given for the substance changes from Sodium hydroxymethylamino acetate to Sodium N-(hydroxymethyl)glycinate.

The condition of use in entry 51 changes from a bar on use where the maximum theoretical concentration of releasable formaldehyde in the mixture as placed on the market is 0,1 % w/w or more, to a bar on use unless it can be shown that concentration is below 0,1 % w/w.

Cited: Annex V, v1 · Annex V, v2

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in force 2022-07-31 MODIFIED§

Amended by Regulation (EU) 2022/1181 32022R1181 · Regulation (EU) 2022/1176 32022R1176

applies from: unknown (the text changed beyond its dates, so no date that moved can be read as the application date)

dates added to the text: 2022-07-30, 2024-07-31, 2026-07-31

Paragraph 2 changes the required warning wording from "contains formaldehyde" to "releases formaldehyde" and lowers the labelling trigger from a formaldehyde concentration exceeding 0,05 % to a total released formaldehyde concentration exceeding 0,001 % (10 ppm), also specifying that this applies regardless of whether one or more formaldehyde-releasing substances are present.

The after text adds a new subparagraph stating that finished products containing such substances which comply with Regulation (EC) No 1223/2009 as applicable on 30 July 2022 may still 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 · Annex V, v2

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in force 2022-03-01 MODIFIED§

Amended by Regulation (EU) 2021/1902 32021R1902 · Regulation (EU) 2022/135 32022R0135

applies from: unchanged

In entry 51, covering Sodium Hydroxymethylglycinate, a new restriction has been added stating that the substance 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 more.

The prior version of entry 51 contained no such restriction on releasable formaldehyde concentration.

Cited: Annex V, v2 · Annex V, v1

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in force 2020-05-01 MODIFIED§

Amended by Regulation (EU) 2019/1966 32019R1966

applies from: unchanged

Sources disagree — the text comparison and the EU's own amendment metadata found this change; the amending act's instructions do not mention it. All are shown; none is overruled.

Entry 3 for salicylic acid and its salts, which previously listed salicylic acid together with its various salts in a single row sharing one set of conditions, is now split into two separate rows: one for salicylic acid alone and one for the other listed salts, each with its own restriction text.

The restriction wording for salicylic acid now adds statements that it is 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, in addition to the prior restriction on use in products for children under 3 years of age.

A minor wording change also appears earlier in the preamble text, where the phrase about uses other than as a preservative for entry 98 is rephrased.

Cited: Annex V, v1 · Annex V, v2

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in force 2019-11-27 MODIFIED§

Amended by Regulation (EU) 2019/1858 32019R1858 · Regulation (EU) 2019/698 32019R0698 · Regulation (EU) 2019/1857 32019R1857

applies from: unknown (the text changed beyond its dates, so no date that moved can be read as the application date)

dates added to the text: 2019-11-27, 2020-02-27

The preamble note text was extended with an additional footnote covering 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one, stating dates from which non-complying cosmetic products containing it shall not be placed on or made available on the Union market, and a new cross-reference to Annex III entry 310 was added.

Entry 32, for Climbazole, changed from a single product type with one maximum concentration of 0,5 % to four separate product types (hair lotions, face creams, foot care products, and rinse-off shampoo) each with its own maximum concentration, three at 0,2 % and one at 0,5 %.

A new entry 60 for 4-(3-ethoxy-4-hydroxyphenyl)butan-2-one, listed under the common name Hydroxyethoxyphenyl Butanone, was added with a maximum concentration of 0,7 %.

Cited: Annex V, v2 · Annex V, v1

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in force 2019-06-12 MODIFIED§

Amended by Regulation (EU) 2019/831 32019R0831 · Regulation (EU) 2019/681 32019R0681 · Regulation (EU) 2019/1966 32019R1966 · Regulation (EU) 2019/698 32019R0698 · Regulation (EU) 2018/1847 32018R1847 · Regulation (EU) 2019/680 32019R0680

applies from: unknown (the text changed beyond its dates, so no date that moved can be read as the application date)

dates added to the text: 2019-06-17, 2019-09-17

Paragraph 2 of the preamble no longer mentions formaldehyde itself alongside substances releasing it, and two new sentences were added stating placing-on-market and making-available restrictions for cosmetic products containing Biphenyl-2-ol that do not comply with the conditions, tied to specific 2019 dates.

Entry 7 (Biphenyl-2-ol) was rewritten: the list of salts (sodium, potassium, MEA o-phenylphenate) and their CAS/EC numbers were removed, leaving only o-Phenylphenol, and the single 0,2% (as phenol) limit was replaced with a split limit distinguishing rinse-off products at 0,2% with an added eye-contact warning and leave-on products at 0,15%.

Entry 28 (Polyaminopropyl biguanide) was changed by adding a chemical name, adding further CAS and EC numbers, and adding a new usage restriction concerning exposure of the end-user's lungs by inhalation, none of which appeared in the earlier version.

Cited: Annex V, v2 · Annex V, v1

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in force 2017-07-27 MODIFIED§

Amended by Regulation (EU) 2017/1224 32017R1224

applies from: unchanged

Sources disagree — the text comparison and the EU's own amendment metadata found this change; the amending act's instructions do not mention it. All are shown; none is overruled.

In entry 57, for Methylisothiazolinone in rinse-off products, the maximum concentration in the ready for use preparation is changed from 0,01 % to 0,0015 %.

Cited: Annex V, v1 · Annex V, v2

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in force 2017-03-03 MODIFIED§

Amended by Regulation (EU) 2017/237 32017R0237

applies from: unchanged

Sources disagree — the text comparison found this change; the EU's own amendment metadata does not list it and the amending act's instructions do not mention it. All are shown; none is overruled.

The only textual difference found between the two versions of Annex V is a minor formatting change in entry 12, where a line break in the substance description before 'Ethyl-' was removed.

All other text, including the preamble, substance entries, CAS and EC numbers, concentration limits, and conditions of use, remains identical between the two versions.

Cited: Annex V, v1 · Annex V, v2

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in force 2016-08-12 MODIFIED§

Amended by Regulation (EU) 2016/1198 32016R1198

applies from: unchanged

Sources disagree — the text comparison and the EU's own amendment metadata found this change; the amending act's instructions do not mention it. All are shown; none is overruled.

In entry 57, the product type/body parts column now specifies 'Rinse-off products' where it was previously left blank, alongside the unchanged 0,01 % maximum concentration for Methylisothiazolinone.

The preamble footnote concerning the relationship between entry 39 and entry 57 was reworded to refer to 'entry 39 of Annex V in a mixture with methylchloroisothiazolinone' instead of 'entry 39 in a mixture with Methylchloroisothiazolinone'.

Cited: Annex V, v1 · Annex V, v2

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in force 2016-08-03 MODIFIED§

Amended by Regulation (EU) 2016/1120 32016R1120 · Regulation (EU) 2016/1121 32016R1121 · Regulation (EU) 2016/1143 32016R1143

applies from: unchanged

Entry 58 for Ethyl Lauroyl Arginate HCl now splits the conditions of use into two categories instead of one single maximum concentration and restriction.

A new subcategory (a) for mouthwashes sets a maximum concentration of 0,15 % and states that use is not to be in preparations for children under 10 years of age, while subcategory (b) for other products retains a 0,4 % maximum and restricts use in lip products, oral products other than mouthwashes, and spray products.

The prior single limit of 0,4 % with a restriction on lip products, oral products, and spray products, shown in the earlier text, no longer appears in this undivided form.

Cited: Annex V, v2 · Annex V, v1

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in force 2015-07-16 MODIFIED§

Amended by Regulation (EU) No 1003/2014 32014R1003

applies from: unchanged

Sources disagree — the text comparison and the EU's own amendment metadata found this change; the amending act's instructions do not mention it. All are shown; none is overruled.

The preamble gains two added notes stating that Methylisothiazolinone entry 57 and the Methylchloroisothiazolinone/Methylisothiazolinone mixture entry 39 are mutually exclusive, meaning the mixture cannot be used in the same product as Methylisothiazolinone alone.

Entry 39 itself changes its restriction column from an unrestricted maximum concentration figure to one limited specifically to rinse-off products, and the concentration figure is now enclosed in parentheses at the end of the value.

Cited: Annex V, v2 · Annex V, v1

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in force 2015-04-16 MODIFIED§

Amended by Regulation (EU) No 1004/2014 32014R1004

applies from: unchanged

Sources disagree — the text comparison and the EU's own amendment metadata found this change; the amending act's instructions do not mention it. All are shown; none is overruled.

Entry 12, which previously covered 4-hydroxybenzoic acid and its salts and esters other than the isopropyl, isobutyl, phenyl, benzyl and pentyl esters, is narrowed to cover only the substance itself together with its methyl and ethyl esters and their salts.

A new entry 12a is added for butyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate and their salts, setting a maximum concentration of 0,14 % for the sum of individual concentrations and 0,8 % for mixtures combining entries 12 and 12a where the butyl- and propylparaben portion does not exceed 0,14 %, together with wording restricting use on the nappy area for leave-on products designed for children under three years of age.

The substances formerly grouped under entry 12 as butylparaben, propylparaben, and their sodium and potassium salts now appear instead under the new entry 12a, with the same CAS and EC numbers retained.

Cited: Annex V, v1 · Annex V, v2

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in force 2014-08-29 MODIFIED§

Amended by Regulation (EU) No 866/2014 32014R0866

applies from: unchanged

Sources disagree — the text comparison and the EU's own amendment metadata found this change; the amending act's instructions do not mention it. All are shown; none is overruled.

The footnote block in the preamble gains two additional cross-reference notes pointing to Annex III entries No 287 and No 286, which are not present in the earlier version.

Entry 44 (Alkyl (C12-22) trimethyl ammonium bromide and chloride) is reformatted from a single consolidated row listing all six substances with their CAS and EC numbers together into a layout that pairs each substance name with its own CAS and EC number on separate lines, while the same maximum concentration of 0,1 % is retained.

A new entry, numbered 59 and covering citric acid and silver citrate, appears at the end of the list in the later text with an EC number, a maximum concentration of 0,2 % corresponding to 0,0024 % of silver, and a restriction against use in oral products and eye products, none of which appears in the earlier text.

Cited: Annex V, v2 · Annex V, v1

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in force 2014-04-30 MODIFIED§

Amended by Regulation (EU) No 358/2014 32014R0358

applies from: unchanged

Sources disagree — the text comparison and the EU's own amendment metadata found this change; the amending act's instructions do not mention it. All are shown; none is overruled.

Entry 12, covering 4-hydroxybenzoic acid and its salts and esters, now excludes esters of isopropyl, isobutyl, phenyl, benzyl and pentyl from the listed substances, and the individual salts and esters are broken out with their own separate CAS and EC numbers rather than being grouped together in shared columns.

Entry 25, for Triclosan, adds specific product types and separate maximum concentrations for two categories, labelled (a) for toothpastes, hand soaps, body soaps/shower gels, non-spray deodorants, face powders and blemish concealers, and certain nail products at 0,3 %, and (b) for mouthwashes at 0,2 %, where the earlier text listed only a single 0,3 % maximum concentration with no such subdivision.

Cited: Annex V, v2 · Annex V, v1

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in force 2013-07-11 MODIFIED§

Amended by Regulation (EU) No 344/2013 32013R0344 · Regulation (EU) No 1197/2013 32013R1197

applies from: unchanged

The preamble footnotes are reworded: one former note referencing Annex III entries No. 45 and 68 is replaced by a note referencing only Annex III entry No 45, and a new footnote referencing Annex III entry No 197 is added.

A new entry, numbered 58, is added to the substance table for Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloride (Ethyl Lauroyl Arginate HCl), with its CAS and EC numbers, a maximum concentration of 0,4 %, and a condition restricting its use in lip products, oral products and spray products.

The remaining entries of the list, numbered 1 to 57, are unchanged in substance between the two versions.

Cited: Annex V, v2 · Annex V, v1

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