Annex VI

in force 2025-05-01 MODIFIED±0§

Amended by Regulation (EU) 2024/996 32024R0996

applies from: unknown

Sources disagree — 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 as `disputed`.

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 gain two new sentences setting placing-on-the-market and making-available cut-offs of 1 January 2025 and 1 July 2025 for products containing a substance that does not comply with the conditions, and a new sentence capping the combined use of Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine and its nano form at 10 %.

Entry 3 for Homosalate changes from a flat 10 % maximum with no product-type restriction to a 7,34 % maximum limited to face products excluding propellent spray products.

Two new rows, 33 and 34, are added for Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine and its nano form, each listed with a 10 % maximum concentration, with the nano entry carrying additional purity, particle-size and inhalation-exposure conditions.

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 — 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 identified between the two versions of Annex VI is the name given to substance entry 10, which changes from the plural form 'Octocrylenes' to the singular 'Octocrylene' in the Name of Common Ingredients Glossary column.

All other entries, conditions, wording, maximum concentrations and introductory notes in Annex VI remain identical between the two texts.

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

The introductory notes gain two additional sentences, one setting out transitional market placement and availability dates tied to 27 July 2022, 28 January 2023 and 28 July 2023, and another stating that Benzophenone as an impurity and/or degradation product of Octocrylene shall be kept at trace level.

Entry 4 for Benzophenone-3 is restructured to split the maximum concentration and conditions by product type into face, hand and lip products, body products, and other products, with differing percentage limits and added wording on maximum UV filter levels when used at 0,5 % for product protection.

Entry 10 for Octocrylene is changed from a single 10 % maximum concentration to a split limit distinguishing propellant spray products at 9 % from other products at 10 %.

Cited: Annex VI, v2

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in force 2021-10-01 MODIFIED§

Amended by Regulation (EU) 2021/850 32021R0850

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 27 for Titanium Dioxide, the "Other" column has been changed from blank to a new statement noting 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 the ready-for-use preparation given in column (g) of this entry applies.

The corresponding entry 27 in the earlier text contained no such wording in that column.

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

A new entry, numbered 32, has been added to the table for the substance Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate, with its chemical name, CAS and EC numbers, and a maximum concentration of 3 % listed.

The new entry carries conditions restricting use to avoid exposure of the end-user's lungs by inhalation, prohibiting use with nitrosating agents with a stated maximum nitrosamine content of 50 μg/kg, and requiring storage in nitrite-free containers.

All other entries and wording in the list remain the same as 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

Entry 27a for Titanium Dioxide (nano) now lists three additional permitted coating combinations — Silica with Cetyl Phosphate, Alumina with Manganese Dioxide, and Alumina with Triethoxycaprylylsilane, each with specified maximum concentrations — alongside the previously listed coating substances.

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 remaining text of entry 27a, including the purity, particle size, aspect ratio and photostability conditions, is unchanged between the two versions.

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

The AFTER text adds a new entry, numbered 31, for the substance Phenylene Bis-Diphenyltriazine (3,3′-(1,4-Phenylene)bis(5,6-diphenyl-1,2,4-triazine)), identified by CAS number 55514-22-2 and EC number 700-823-1, with a maximum concentration of 5 %.

This new entry also carries a condition that it is not to be used in applications that may lead to exposure of the end user's lungs by inhalation, a condition absent from the BEFORE list which ended at 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 — 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 introductory notes now include an additional sentence stating that where Methylene Bis-Benzotriazolyl Tetramethylbutylphenol and its nano form are used together, the combined amount must not exceed the maximum concentration listed in column g.

A new entry numbered 23a for Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (nano) has been added alongside the existing entry 23, with its own restriction against use in applications that may expose the end user's lungs by inhalation and a set of purity, solubility, partition coefficient, coating and particle size conditions for the nanomaterial.

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 ready-for-use preparation is lowered from 10% to 6%.

A new condition of use is added for entry 4 stating that it is not to be more than 0,5% when used to protect the product formulation, alongside the existing note that it 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 now says the colorant cross-reference to Annex IV No 143 applies when the substance is used as a colorant, whereas before it applied when used for a purpose other than as a colorant, and a new sentence has been added stating that where Titanium Dioxide and Titanium Dioxide (nano) are combined, their sum must not exceed the column g limit.

Entry 27 for Titanium Dioxide is retained with its maximum concentration, but a new entry 27a for Titanium Dioxide (nano) has been added, carrying its own maximum concentration, a warning against use in applications that may lead to inhalation exposure, and a list of required nanomaterial characteristics including purity, crystalline form and coating requirements.

Cited: Annex VI, v1 · Annex VI, v2

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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 introductory notes gain a new sentence stating that when zinc oxide and zinc oxide (nano) are used together, their combined amount must not exceed the maximum concentration set out in column g.

Two new entries, numbered 30 and 30a, are added to the table for Zinc Oxide and Zinc Oxide (nano), each listing a maximum concentration of 25%, a restriction against use in applications that may expose the end-user's lungs to inhalation, and, for the nano form, additional conditions on purity, crystalline structure, particle size distribution, water solubility and permitted coatings.

The earlier version of the annex, by contrast, ends after entry 29 and its nanomaterial conditions, without any zinc oxide entries.

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 — 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 as `disputed`.

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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 after text adds a new entry, numbered 29, for 1,3,5-Triazine, 2,4,6-tris[1,1'-biphenyl]-4-yl-, including as nanomaterial, listed under the names Tris-biphenyl triazine and Tris-biphenyl triazine (nano), with an allowed maximum concentration of 10 %.

This new entry states that the substance is not to be used in sprays and that only nanomaterials meeting stated characteristics are allowed, namely a median primary particle size greater than 80 nm, a purity of at least 98 %, and being uncoated.

No such entry, name, CAS number, or set of nanomaterial conditions appears in the earlier version of Annex VI.

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

Entry 1 (4-Aminobenzoic acid/PABA, CAS 150-13-0, EC 205-753-0, 5% maximum concentration) has been removed, with only the row number retained and the substance details left blank.

Entry 21's maximum concentration figure has changed from 8% to a blank field, and entry 28's chemical name and Common Ingredients Glossary name are worded slightly differently with punctuation and spacing changes.

The overall table layout has also been reformatted from a running-text style into a line-by-line presentation, without altering the remaining substantive entries.

Cited: Annex VI, v1 · Annex VI, v2

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