Annex V

in force 2026-05-01 MODIFIED+470 −74§

Amended by Regulation (EU) 2026/78 32026R0078

applies from: unchanged

Sources disagree about what is listed, not about the text — 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 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 · Annex V, v1

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 about what is listed, not about the text — 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 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 · 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 about what is listed, not about the text — the text comparison found this change; the EU's own amendment metadata does not list it. Both are shown; neither is overruled.

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 · 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 about what is listed, not about the text — 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.

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 · 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 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 · 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

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 · 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 about what is listed, not about the text — 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, 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 · 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 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 · 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

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 · Annex V, v2

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in force 2017-07-27 MODIFIED§

Amended by Regulation (EU) 2017/1224 32017R1224

applies from: unchanged

Sources disagree about what is listed, not about the text — 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 maximum concentration allowed for Methylisothiazolinone in rinse-off products was 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 about what is listed, not about the text — 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 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 · 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 about what is listed, not about the text — 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 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 · 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, 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 · 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 about what is listed, not about the text — 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.

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 · 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 about what is listed, not about the text — 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 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 · 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 about what is listed, not about the text — 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 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 · 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 about what is listed, not about the text — 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 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 · Annex V, v2

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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 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 · Annex V, v1

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