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 Bis(2-ethylhexyl) phthalate (DEHP), the derogation date for uses in medical devices under point (c) of the latest application date column changed from 27 November 2023, referencing Directives 90/385/EEC, 93/42/EEC and 98/79/EC, to 1 January 2029, referencing Regulations (EU) 2017/745 and (EU) 2017/746.
The corresponding sunset date derogation under point (c) for the same medical device uses changed from 27 May 2025 to 1 July 2030, with the same substitution of the referenced medical device Regulations for the previously cited Directives.
Cited: Annex XIV, v1 · Annex XIV, v2
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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 … 415 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 … 1,530 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 — 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 five new numbered entries, 55 through 59, covering substances including tetraethyllead and several phthalate- and phenol-related compounds, each with a latest application date of 1 November 2023 and a sunset date of 1 May 2025.
The BEFORE text ends at entry 54 and does not contain these five additional entries.
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, also on the environment, alongside the previously listed toxicity for reproduction.
For these same entries, the transitional arrangements and exempted-use text have been expanded with new lettered derogations and additional latest application dates and sunset dates, including dates in mid-2023, late 2023, December 2024 and May 2025, replacing the single latest application date and sunset date shown for these entries in the earlier version.
All other entries in the list, numbered 1 to 3 and 8 to 54, remain unchanged between the two versions.
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 — the text comparison found this change; the EU's own amendment metadata does not list it. Both are shown; neither is overruled.
A reference to Regulation (EU) 2017/746 on in vitro diagnostic medical devices has been added as an explanatory footnote near the top of the annex.
For entry 42, the latest application date and sunset date columns, previously each a single date, now each contain a two-part structure: a general date and a derogation date tied to specified COVID-19-related research, development, production and diagnostic/treatment/prevention uses involving medicinal products and medical devices referencing Directive 2001/83/EC, Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC and Regulation (EU) 2017/746.
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 — 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 visible difference is in entry 50, where the EC No and CAS No fields, previously shown with an em-dash placeholder, are now shown with a plain hyphen placeholder.
No other entry, heading, or transitional text in the annex differs between the two versions shown.
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 — 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 transitional-arrangements text has been revised so that the repair-related spare-parts provisions now also cover complex products in addition to articles, and the two reference dates within that text were changed from 1 September 2019 and 1 March 2021 to 1 September 2021 and 1 March 2023 respectively.
The AFTER text adds eleven new numbered entries, 44 through 54, each listing a substance with its EC and CAS numbers, intrinsic properties, and latest application and sunset dates ranging from 27 August 2021 through 27 November 2023, which are not present in the BEFORE text.
Entries 1 through 43 remain textually identical between the two versions.
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 — 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 updated Annex adds new introductory transitional-use text concerning spare parts and repair of articles, tied to 1 September 2019 and 1 March 2021 dates, and adds a note on a benzo[a]pyrene concentration threshold, none of which appeared in the earlier version.
The later text also adds twelve new numbered entries, numbers 32 through 43, covering substances such as 1-Bromopropane, several phthalate esters, anthracene oil, coal tar pitch, and two nonylphenol/octylphenol ethoxylate entries, each with its own latest application and sunset dates, which are not present in the earlier version.
Entries 1 through 31 remain textually the same in both versions.
Cited: Annex XIV, v1 · Annex XIV, v2
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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 — 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 list of substances subject to authorisation now includes nine additional entries, numbered 23 through 31, covering substances such as technical MDA, arsenic acid, diglyme, 1,2-dichloroethane, MOCA, dichromium tris(chromate), strontium chromate, potassium hydroxyoctaoxodizincatedichromate and pentazinc chromate octahydroxide, each with its own EC and CAS numbers, intrinsic properties, latest application dates and sunset dates.
The entries numbered 1 through 22 remain otherwise the same in substance and identifying details between the two versions.
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 — 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 list of substances subject to authorisation gains seven additional entries, numbered 15 through 22, covering Trichloroethylene, Chromium trioxide, acids generated from chromium trioxide and their oligomers, Sodium dichromate, Potassium dichromate, Ammonium dichromate, Potassium chromate and Sodium chromate.
Each newly added entry specifies its own intrinsic properties, latest application date and sunset date, while the entries already present in the earlier version (numbers 1 through 14) remain unchanged in their wording and dates.
Cited: Annex XIV, v2 · Annex XIV, v1
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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 subject to authorisation has been extended with eight additional entries, numbered 7 through 14, covering substances such as 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 EC and CAS numbers, intrinsic properties, and latest application and sunset dates.
The six entries that were already present in the earlier version, covering Musk xylene, MDA, HBCDD, DEHP, BBP and DBP, remain unchanged in their substance identifiers, properties, and dates.
Cited: Annex XIV, v2 · Annex XIV, v1
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