Annex VI

in force 2025-05-01 MODIFIED±0§

Amended by Regulation (EU) 2024/996 32024R0996

applies from: unknown

Sources disagree, and there is no text on either side — the EU's own amendment metadata found this change; the text comparison finds no difference in the provision's text and the amending act's instructions do not mention it. All are shown; none is overruled.

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in force 2022-12-17 MODIFIED§

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

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: 2025-01-01, 2025-07-01

The introductory notes for Annex VI gained a new phase-out passage stating that from 1 January 2025 cosmetic products containing that substance and not complying with the conditions shall not be placed on the Union market, and that from 1 July 2025 such non-complying products shall not be made available on the Union market, along with a new sentence limiting the combined use of Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine and its nano form to 10 %.

Entry 3 (Homosalate) had its product type and body parts column changed from an unrestricted listing to face products with the exception of propellant spray products, and its maximum concentration changed from 10 % to 7,34 %.

Two new entries, 33 and 34, were added for Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine and its nano form, each with identification data, a 10 % maximum concentration, and for the nano form additional conditions on purity, particle size, and a restriction against inhalation exposure.

Cited: Annex VI, v2 · Annex VI, v1

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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 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.

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 · Annex VI, 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: 2022-07-27, 2023-01-28, 2023-07-28

A transitional statement was added allowing cosmetic products containing the substance and complying with the Regulation as it applied on 27 July 2022 to remain on the Union market until 28 January 2023 and to be made available until 28 July 2023, together with a new statement that Benzophenone as an impurity and/or degradation product of Octocrylene shall be kept at trace level.

The entry for Oxybenzone (Benzophenone-3) was changed from a single maximum concentration and warning to separate maximum concentrations and conditions for face, hand and lip products, for body products, and for other products, each with its own percentage limit and wording on use as a UV filter versus product protection.

The entry for Octocrylene was changed from a single 10% maximum concentration to separate maximum concentrations of 9% for propellant spray products and 10% for other products.

Cited: Annex VI, v2 · Annex VI, v1

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in force 2021-10-01 MODIFIED§

Amended by Regulation (EU) 2021/850 32021R0850

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 the entry for Titanium Dioxide (entry 27), the after text adds a new column (i) note stating that titanium dioxide in powder form containing 1% or more of particles with aerodynamic diameter of 10 micrometres or less is to be used in compliance with Annex III, No 321, and that for the product types under letter (c) of column (f) in Annex III, No 321, the maximum concentration in ready for use preparation given in column (g) of this entry applies.

The corresponding entry 27 in the before text contains no such note in column (i) for Titanium Dioxide.

Cited: Annex VI, v2 · Annex VI, v1

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in force 2020-12-03 MODIFIED§

Amended by Regulation (EU) 2017/745 32017R0745 · Regulation (EU) 2020/1683 32020R1683 · Regulation (EU) 2020/1682 32020R1682 · Regulation (EU) 2020/1684 32020R1684

applies from: unchanged

The table of allowed UV filters gains a new entry, reference number 32, for Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate, listing its CAS and EC numbers and a maximum concentration of 3 %.

The new entry carries conditions stating it is not to be used in applications that may lead to exposure of the end-user's lungs by inhalation, that it must not be used with nitrosating agents with a maximum nitrosamine content of 50 μg/kg, and that it must be kept in nitrite-free containers.

All other entries and the introductory notes of the annex remain as they were in the earlier version.

Cited: Annex VI, v2 · Annex VI, v1

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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: unchanged

The entry for Titanium Dioxide (nano) under reference number 27a now lists three additional permitted coating combinations, each specifying maximum concentrations of the coating substances, alongside the previously listed coating agents.

A new restriction has been added stating that face products containing Titanium Dioxide (nano) coated with the Alumina and Manganese Dioxide combination are not to be used on the lips.

The earlier version of the entry for reference number 27a did not include these additional coating combinations or the lip-use restriction.

Cited: Annex VI, v2 · Annex VI, 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: unchanged

A new entry, numbered 31, has been added to the table listing Phenylene Bis-Diphenyltriazine, identified by its chemical name, CAS number 55514-22-2 and EC number 700-823-1, with a maximum concentration of 5 % and a condition restricting use to avoid exposure of the end user's lungs by inhalation.

This entry is not present in the earlier version of the annex, which ends its list of substances after entry 30a.

Cited: Annex VI, v2 · Annex VI, v1

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in force 2018-07-11 MODIFIED§

Amended by Regulation (EU) 2018/885 32018R0885

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.

A new combined-use sentence is added stating that in case of combined use of Methylene Bis-Benzotriazolyl Tetramethylbutylphenol and its nano form, the sum shall not exceed the limit given in column g.

Entry 23 for Bisoctrizole/Methylene Bis-Benzotriazolyl Tetramethylbutylphenol is retained, and a new entry 23a is added for the nanomaterial form of that substance, including a maximum concentration and a set of conditions covering inhalation exposure, purity, isomer fraction, solubility, partition coefficient, coating status, and particle size.

Cited: Annex VI, v2 · Annex VI, v1

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in force 2017-09-03 MODIFIED§

Amended by Regulation (EU) 2017/1410 32017R1410 · Regulation (EU) 2017/1413 32017R1413 · Regulation (EU) 2017/238 32017R0238

applies from: unchanged

For entry 4, Benzophenone-3, the maximum concentration in the ready-for-use preparation was lowered from 10 % to 6 %.

A new condition was added to entry 4 limiting use to not more than 0,5 % when the substance is used to protect the product formulation, alongside the existing wording noting that the product contains Benzophenone-3.

Cited: Annex VI, v1 · Annex VI, 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

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 · Annex VI, v1

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in force 2016-05-12 MODIFIED§

Amended by Regulation (EU) 2016/622 32016R0622 · Regulation (EU) 2016/621 32016R0621

applies from: unchanged

The revised list adds a new introductory statement covering the combined use of zinc oxide and zinc oxide (nano), specifying that the sum of both shall not exceed the limit given in column g.

Two new entries, numbered 30 and 30a, are added to the table for zinc oxide and zinc oxide (nano) respectively, each listing a 25% maximum concentration, a restriction against use in applications that may lead to inhalation exposure, and, for entry 30a, additional conditions on permitted nanomaterial characteristics such as purity, crystalline structure, particle size distribution, water solubility and coating.

Cited: Annex VI, v2 · Annex VI, v1

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in force 2015-08-18 MODIFIED§

Amended by Regulation (EU) 2015/1298 32015R1298

applies from: unknown

Sources disagree, and there is no text on either side — the EU's own amendment metadata found this change; the text comparison finds no difference in the provision's text and the amending act's instructions do not mention it. All are shown; none is overruled.

No explanation shipped — the structural diff did not see this change, so it carries no text; another signal named the unit and the disagreement ships marked disputed.

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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 updated table adds a new entry, numbered 29, for the substance identified as 1,3,5-Triazine, 2,4,6-tris[1,1'-biphenyl]-4-yl-, also referred to by the common names Tris-biphenyl triazine and Tris-biphenyl triazine (nano), with CAS number 31274-51-8 and a maximum concentration of 10%.

This new entry carries conditions stating it is not to be used in sprays and that only nanomaterials meeting specified characteristics, including a median primary particle size greater than 80 nm, purity of at least 98%, and being uncoated, are allowed.

All other entries and wording in the list, as they appeared in the earlier version, remain unchanged.

Cited: Annex VI, v2 · Annex VI, 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 table retains the same entries and values but its formatting is changed from a run-together row layout into a line-by-line layout, and entry 1 (4-Aminobenzoic acid/PABA) no longer shows any substance identification or concentration data in the row.

Entry 21's maximum concentration figure is changed from 8 % to 8 % with the qualifier "as acid" removed, and entry 28's chemical name wording has minor punctuation and spacing differences.

The phrase "in sunscreen products" that appeared after entry 28's concentration figure in the earlier text is absent from the later text.

Cited: Annex VI, v1 · Annex VI, v2

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