Annex XIV
Registration, Evaluation, Authorisation and Restriction of Chemicals · 32006R1907 · every event for this act · on EUR-Lex
LIST OF SUBSTANCES SUBJECT TO AUTHORISATION
11 changes recorded across 11 events, newest first.
in force 2023-11-15 MODIFIED+129 −117§
Amended by Regulation (EU) 2023/2482 32023R2482 · Regulation (EU) 2026/1168 32026R1168 · Regulation (EU) 2023/1132 32023R1132 · Regulation (EU) 2023/2055 32023R2055
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: 2029-01-01, 2030-07-01 · dates removed: 2025-05-27
In entry 4 for DEHP, the derogation for uses in medical devices previously referencing Directives 90/385/EEC, 93/42/EEC and 98/79/EC with a latest application date of 27 November 2023 was replaced by a derogation referencing Regulations (EU) 2017/745 and (EU) 2017/746 with a latest application date of 1 January 2029.
Correspondingly, the sunset date for that same medical-devices derogation in entry 4 changed from 27 May 2025 to 1 July 2030, and the wording describing the derogation was adjusted from "by derogation of point (a)" to "by way of derogation from point (a)".
Cited: Annex XIV, v1 · Annex XIV, v2
text before / after
02006R1907-20230806 → 02006R1907-20231201
ANNEX XIV
LIST OF SUBSTANCES SUBJECT TO AUTHORISATION
Date referred to in Article 58(1)(c)(ii) of Regulation (EC) No 1907/2006.
Date referred to in Article 58(1)(c)(i) of Regulation (EC) No 1907/2006.
1 September 2021 for the use of the substance in the production of spare … 414 unchanged words … in:
food contact materials within the scope of Regulation (EC) No 1935/2004;
immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC;
mixtures containing DEHP at or above 0,1 % and below 0,3 % weight by weight;
(c) By by way of derogation of from point (a):
27 November 2023 1 January 2029 for uses in medical devices within the scope of Directives 90/385/EEC, 93/42/EEC Regulations (EU) 2017/745 and 98/79/EC. (EU) 2017/746. (a) 21 February 2015 (**)
(b) By way of derogation from point (a):
14 December 2024 for uses in:
food contact materials within the scope of Regulation (EC) No 1935/2004;
immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC;
mixtures containing DEHP at or above 0,1 % and below 0,3 % weight by weight;
(c) By by way of derogation of from point (a):
27 May 2025 1 July 2030 for uses in medical devices within the scope of Directives 90/385/EEC, 93/42/EEC Regulations (EU) 2017/745 and 98/79/EC. (EU) 2017/746. - -
5. Benzyl butyl phthalate
(BBP)
EC No
201-622-7
CAS No
85-68-7 Toxic for reproduction (category 1B)
Endocrine disrupting properties (Article 57(f) – human health) (a) 21 August 2013 (*)
(b) By way of derogation from point (a):
14 June 2023 for uses in:
immediate packaging of medicinal products … 1,464 unchanged words … 1B) 1 November 2023 1 May 2025 - -
59. Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE)
EC No: -
CAS No: - Toxic for reproduction (category 1B) 1 November 2023 1 May 2025 - -
in force 2022-05-01 MODIFIED§
Amended by Regulation (EU) 2022/586 32022R0586
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: 2023-11-01, 2025-05-01
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.
Five new entries, numbered 55 to 59, have been added to the table of substances subject to authorisation, covering tetraethyllead, a Michler's ketone/base-related trityl alcohol compound, a reaction product involving 4-heptylphenol, DOTE, and a reaction mass of DOTE and MOTE.
Each of these new entries lists 1 November 2023 as the latest application date and 1 May 2025 as the sunset date, with no exempted uses or review periods specified.
The earlier text, entries 1 through 54, contains no equivalent listings for these five substances.
Cited: Annex XIV, v2 · Annex XIV, v1
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in force 2022-01-08 MODIFIED§
Amended by Regulation (EU) 2021/979 32021R0979 · Regulation (EU) 2021/2045 32021R2045 · Regulation (EU) 2021/2030 32021R2030
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: 2023-06-14, 2024-12-14, 2025-05-27
Entries 4 through 7, covering DEHP, BBP, DBP and DIBP, now list additional intrinsic properties describing endocrine disrupting effects on human health and, for DEHP, on the environment, alongside the existing toxic-for-reproduction classification.
The transitional arrangements for these same four entries have been expanded to add new derogation dates and use-specific exemptions, including dates in mid-2023 for latest application and further dates in late 2024 and 2025 for the sunset date, replacing the simpler single-date structure previously shown.
Cited: Annex XIV, v2 · Annex XIV, v1
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in force 2021-01-04 MODIFIED§
Amended by Regulation (EU) 2020/2081 32020R2081 · Regulation (EU) 2019/1148 32019R1148 · Regulation (EU) 2021/57 32021R0057 · Regulation (EU) 2020/2096 32020R2096
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: 2017-04-05, 2022-06-22, 2023-12-22
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.
A footnote citing Regulation (EU) 2017/746 on in vitro diagnostic medical devices has been added to the list of reference notes at the top of the Annex.
Entry 42, concerning 4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated, has had its latest application date and sunset date columns replaced with a split provision: the original single dates are kept as point (a), and a new point (b) sets out a later derogated date and describes specific uses tied to medicinal products and medical devices under listed directives and regulations, including Regulation (EU) 2017/746, in connection with the diagnosis, treatment or prevention of COVID-19.
Cited: Annex XIV, v2 · Annex XIV, v1
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in force 2020-04-28 MODIFIED§
Amended by Regulation (EU) 2020/507 32020R0507
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 differences visible are formatting changes in the rows for entries 47 to 50, where the latest application date and sunset date now appear on the same line instead of separate lines, and the em-dash placeholders for EC No and CAS No in entry 50 are rendered as plain hyphens.
No substance entries were added, removed, or changed in substantive content such as intrinsic properties, dates, or exemptions.
Cited: Annex XIV, v1 · Annex XIV, v2
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in force 2020-02-27 MODIFIED§
Amended by Regulation (EU) 2020/171 32020R0171
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: 2021-08-27, 2021-09-01, 2021-11-27, 2022-02-27, 2022-05-27, 2023-02-27, 2023-03-01, 2023-05-27, 2023-08-27, 2023-11-27 · dates removed: 2019-09-01, 2021-03-01
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 transitional arrangement dates referring to Article 58(1)(c)(ii) and (i) were changed from 1 September 2019 and 1 March 2021 to 1 September 2021 and 1 March 2023, with corresponding wording added covering spare parts as articles or complex products and specifying that the spare part cannot be produced without that substance.
New entries numbered 44 through 54 were added to the table, listing additional substances with their intrinsic properties, latest application dates and sunset dates spanning 27 August 2021 through 27 November 2023.
Cited: Annex XIV, v1 · Annex XIV, v2
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in force 2019-10-30 MODIFIED§
Amended by Regulation (EU) 2019/1691 32019R1691 · Regulation (EU) 2020/2160 32020R2160
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. Both are shown; neither 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 2017-07-04 MODIFIED§
Amended by Regulation (EU) 2017/999 32017R0999 · Regulation (EU) 2017/1000 32017R1000
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: 2019-01-04, 2019-04-04, 2019-07-04, 2019-09-01, 2020-07-04, 2020-10-04, 2021-01-04, 2021-03-01
The after text adds several new introductory notes on transitional dates for spare parts and repair uses, and a note on the benzo[a]pyrene threshold for carcinogen identification, none of which appear in the before text.
The after text also adds twelve new entries (numbers 32 to 43) covering additional substances such as 1-Bromopropane, several phthalates, anthracene oil, coal tar pitch, and two ethoxylated phenols, each with its own latest application and sunset dates, which are not present in the before text.
Cited: Annex XIV, v2 · Annex XIV, v1
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in force 2014-08-22 MODIFIED§
Amended by Regulation (EU) No 895/2014 32014R0895
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: 2016-02-22, 2016-05-22, 2017-07-22, 2017-08-22, 2017-11-22, 2019-01-22
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 later text adds nine new entries (numbers 23 through 31) covering substances including technical MDA, arsenic acid, bis(2-methoxyethyl) ether, 1,2-dichloroethane, MOCA, dichromium tris(chromate), strontium chromate, potassium hydroxyoctaoxodizincatedichromate and pentazinc chromate octahydroxide, each with its own intrinsic property, latest application date and sunset date.
The entry for Hexabromocyclododecane (HBCDD) has its latest application date and sunset date changed from 21 February 2013 and 21 August 2014 to 21 February 2014 and 21 August 2015.
Cited: Annex XIV, v2 · Annex XIV, v1
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in force 2013-04-21 MODIFIED§
Amended by Regulation (EU) No 348/2013 32013R0348
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: 2014-10-21, 2016-03-21, 2016-04-21, 2017-09-21
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 later text keeps all fourteen entries from the earlier list unchanged and adds eight new entries, numbered 15 through 22, covering additional substances such as Trichloroethylene, Chromium trioxide, and several chromate and dichromate compounds.
Each newly added entry sets out its own intrinsic property classification, latest application date, and sunset date, with dates in 2014 or 2016 and 2016 or 2017 respectively, and shows no exempted uses or review periods.
Cited: Annex XIV, v1 · Annex XIV, v2
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in force 2012-02-18 MODIFIED§
Amended by Regulation (EU) No 125/2012 32012R0125 · Regulation (EU) No 494/2011 32011R0494 · Regulation (EU) No 109/2012 32012R0109
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: 2013-11-21, 2015-05-21
The list of substances in Annex XIV has been expanded from six entries to fourteen, adding Diisobutyl phthalate, Diarsenic trioxide, Diarsenic pentaoxide, Lead chromate, Lead sulfochromate yellow, Lead chromate molybdate sulphate red, Tris (2-chloroethyl) phosphate, and 2,4-Dinitrotoluene, each with its own intrinsic property, latest application date and sunset date.
The six entries already present in the earlier version are carried over with the same substance identifiers, properties, and dates, and only formatting differences such as line breaks separate the two presentations of those rows.
Cited: Annex XIV, v1 · Annex XIV, v2
text before / after, on the event page →