[X1ANNEX XIV U.K. LIST OF SUBSTANCES SUBJECT TO AUTHORISATION

Editorial Information

a

Date referred to in Article 58(1)(c)(ii) of Regulation (EC) No 1907/2006.

b

Date referred to in Article 58(1)(c)(i) of Regulation (EC) No 1907/2006.

c

[F21 September 2021 for the use of the substance in the production of spare parts as articles or as complex products for the repair of articles or complex products, the production of which ceased or will have ceased before the sunset date indicated in the entry for that substance, where that substance was used in the production of those articles or complex products and these cannot function as intended without that spare part and the spare part cannot be produced without that substance, and for the use of the substance (on its own or in a mixture) for the repair of such articles or complex products where that substance on its own or in a mixture was used in the production of those articles or complex products and they cannot be repaired otherwise than by using that substance.

d

1 March 2023 for the use of the substance in the production of spare parts as articles or as complex products for the repair of articles or complex products the production of which ceased or will have ceased before the sunset date indicated in the entry for that substance, where that substance was used in the production of those articles or complex products and these cannot function as intended without those spare parts and the spare part cannot be produced without that substance, and for the use of the substance (on its own or in a mixture) for the repair of such articles or complex products, where that substance on its own or in a mixture was used in the production of those articles or complex products and they cannot be repaired otherwise than by using that substance.

e

Does not meet the criteria for identification as a carcinogen if it contains < 0,005 % (w/w) benzo[a]pyrene (Einecs No 200-028-5).]

f

[F3Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU ( OJ L 117, 5.5.2017, p. 176 ).] ] ] ]

[X2 [F1 Entry Nr Substance Intrinsic property(ies) referred to in Article 57 Transitional arrangements Exempted (categories of) uses Review periods
Latest application date a Sunset date b
1.

5-tert-butyl-2,4,6-trinitro-m-xylene

( Musk xylene )

EC No

:

201-329-4

CAS No

:

81-15-2

vPvB 21 February 2013 21 August 2014 — —
2.

4,4’-Diaminodiphenylmethane

(MDA)

EC No

:

202-974-4

CAS No

:

101-77-9

Carcinogenic

(category 1B)

21 February 2013 21 August 2014 — —
3.

Hexabromocyclododecane

( HBCDD )

EC No

:

221-695-9,

247-148-4,

CAS No

:

3194-55-6

25637-99-4

alpha-hexabromocyclododecane

CAS No

:

134237-50-6,

beta-hexabromocyclododecane

CAS No

:

134237-51-7

gamma-hexabromocyclododecane

CAS No

:

134237-52-8

PBT 21 February 2014 21 August 2015 — —
4.

Bis(2-ethylhexyl) phthalate

( DEHP )

EC No

:

204-211-0

CAS No

:

117-81-7

Toxic for reproduction

(category 1B)

21 August 2013 c 21 February 2015 d Uses in the immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, [F4the Veterinary Medicines Regulations 2013 or the Human Medicines Regulations 2012] .
5.

Benzyl butyl phthalate

( BBP )

EC No

:

201-622-7

CAS No

:

85-68-7

Toxic for reproduction

(category 1B)

21 August 2013 c 21 February 2015 d Uses in the immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC.
6.

Dibutyl phthalate

( DBP )

EC No

:

201-557-4

CAS No

:

84-74-2

Toxic for reproduction

(category 1B)

21 August 2013 c 21 February 2015 d Uses in the immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC.
[F57.

Diisobutyl phthalate (DIBP)

EC No: 201-553-2

CAS No: 84-69-5

Toxic for reproduction

(category 1B)

21 August 2013 c 21 February 2015 d — —
8.

Diarsenic trioxide

EC No: 215-481-4

CAS No: 1327-53-3

Carcinogenic

(category 1A)

21 November 2013 21 May 2015 — —
9.

Diarsenic pentaoxide

EC No: 215-116-9

CAS No: 1303-28-2

Carcinogenic

(category 1A)

21 November 2013 21 May 2015 — —
10.

Lead chromate

EC No: 231-846-0

CAS No: 7758-97-6

Carcinogenic

(category 1B)

Toxic for reproduction

(category 1A)

21 November 2013 c 21 May 2015 d — —
11.

Lead sulfochromate yellow

(C.I. Pigment Yellow 34)

EC No: 215-693-7

CAS No: 1344-37-2

Carcinogenic

(category 1B)

Toxic for reproduction

(category 1A)

21 November 2013 c 21 May 2015 d — —
12.

Lead chromate molybdate sulphate red

(C.I. Pigment Red 104)

EC No: 235-759-9

CAS No: 12656-85-8

Carcinogenic

(category 1B)

Toxic for reproduction

(category 1A)

21 November 2013 c 21 May 2015 d
13.

Tris (2-chloroethyl) phosphate

(TCEP)

EC No: 204-118-5

CAS No: 115-96-8

Toxic for reproduction

(category 1B)

21 February 2014 21 August 2015
14.

2,4-Dinitrotoluene (2,4-DNT)

EC No: 204-450-0

CAS No: 121-14-2

Carcinogenic

(category 1B)

21 February 2014 c 21 August 2015 ] d
[F615.

Trichloroethylene

EC No: 201-167-4

CAS No: 79-01-6

Carcinogenic

(category 1B)

21 October 2014 c 21 April 2016 d — —
16.

Chromium trioxide

EC No: 215-607-8

CAS No: 1333-82-0

  • Carcinogenic

    (category 1A)

  • Mutagenic

    (category 1B)

21 March 2016 c 21 September 2017 d — —
17.

Acids generated from chromium trioxide and their oligomers

Group containing:

  • Chromic acid

    EC No: 231-801-5

    CAS No: 7738-94-5

  • Dichromic acid

    EC No: 236-881-5

    CAS No: 13530-68-2

  • Oligomers of chromic acid and dichromic acid

    EC No: not yet assigned

    CAS No: not yet assigned

Carcinogenic

(category 1B)

21 March 2016 c 21 September 2017 d — —
18.

Sodium dichromate

EC No: 234-190-3

CAS No: 7789-12-0

10588-01-9

  • Carcinogenic

    (category 1B)

  • Mutagenic

    (category 1B)

  • Toxic for reproduction

    (category 1B)

21 March 2016 c 21 September 2017 d — —
19.

Potassium dichromate

EC No: 231-906-6

CAS No: 7778-50-9

  • Carcinogenic

    (category 1B)

  • Mutagenic

    (category 1B)

  • Toxic for reproduction

    (category 1B)

21 March 2016 c 21 September 2017 d — —
20.

Ammonium dichromate

EC No: 232-143-1

CAS No: 7789-09-5

  • Carcinogenic

    (category 1B)

  • Mutagenic

    (category 1B)

  • Toxic for reproduction

    (category 1B)

21 March 2016 c 21 September 2017 d
21.

Potassium chromate

EC No: 232-140-5

CAS No: 7789-00-6

  • Carcinogenic

    (category 1B)

  • Mutagenic

    (category 1B)

21 March 2016 c 21 September 2017 d
22.

Sodium chromate

EC No: 231-889-5

CAS No: 7775-11-3

  • Carcinogenic

    (category 1B)

  • Mutagenic

    (category 1B)

  • Toxic for reproduction

    (category 1B)

21 March 2016 c 21 September 2017 ] d
[F723.

Formaldehyde, oligomeric reaction products with aniline (technical MDA)

EC No: 500-036-1

CAS No: 25214-70-4

Carcinogenic

(category 1B)

22 February 2016 c 22 August 2017 d — —
24.

Arsenic acid

EC No: 231-901-9

CAS No: 7778-39-4

Carcinogenic

(category 1A)

22 February 2016 22 August 2017 — —
25.

Bis(2-methoxyethyl) ether (diglyme)

EC No: 203-924-4

CAS No: 111-96-6

Toxic for reproduction

(category 1B)

22 February 2016 c 22 August 2017 d — —
26.

1,2-dichloroethane (EDC)

EC No: 203-458-1

CAS No: 107-06-2

Carcinogenic

(category 1B)

22 May 2016 22 November 2017 — —
27.

2,2′-dichloro-4,4′-methylenedianiline (MOCA)

EC No: 202-918-9

CAS No: 101-14-4

Carcinogenic

(category 1B)

22 May 2016 c 22 November 2017 d — —
28.

Dichromium tris(chromate)

EC No: 246-356-2

CAS No: 24613-89-6

Carcinogenic

(category 1B)

22 July 2017 c 22 January 2019 d — —
29.

Strontium chromate

EC No: 232-142-6

CAS No: 7789-06-2

Carcinogenic

(category 1B)

22 July 2017 c 22 January 2019 d — —
30.

Potassium hydroxyoctaoxodizincatedichromate

EC No: 234-329-8

CAS No: 11103-86-9

Carcinogenic

(category 1A)

22 July 2017 c 22 January 2019 d — —
31.

Pentazinc chromate octahydroxide

EC No: 256-418-0

CAS No: 49663-84-5

Carcinogenic

(category 1A)

22 July 2017 c 22 January 2019 d — —]
[F832.

1-Bromopropane (n-propyl bromide)

EC No

:

203-445-0

CAS No

:

106-94-5

Toxic for reproduction

(category 1B)

4 January 2019 c 4 July 2020 d — —
33.

Diisopentylphthalate

EC No

:

210-088-4

CAS No

:

605-50-5

Toxic for reproduction

(category 1B)

4 January 2019 c 4 July 2020 d — —
34.

1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7 rich

EC No

:

276-158-1

CAS No

:

71888-89-6

Toxic for reproduction

(category 1B)

4 January 2019 c 4 July 2020 d — —
35.

1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters

EC No

:

271-084-6

CAS No

:

68515-42-4

Toxic for reproduction

(category 1B)

4 January 2019 c 4 July 2020 d — —
36.

1,2-Benzenedicarboxylic acid, dipentylester, branched and linear

EC No

:

284-032-2

CAS No

:

84777-06-0

Toxic for reproduction

(category 1B)

4 January 2019 c 4 July 2020 d — —
37.

Bis(2-methoxyethyl) phthalate

EC No

:

204-212-6

CAS No

:

117-82-8

Toxic for reproduction

(category 1B)

4 January 2019 c 4 July 2020 d — —
38.

Dipentylphthalate

EC No

:

205-017-9

CAS No

:

131-18-0

Toxic for reproduction

(category 1B)

4 January 2019 c 4 July 2020 d — —
39.

N-pentyl-isopentylphthalate

EC No

:

—

CAS No

:

776297-69-9

Toxic for reproduction

(category 1B)

4 January 2019 c 4 July 2020 d — —
40.

Anthracene oil

EC No

:

292-602-7

CAS No

:

90640-80-5

Carcinogenic

(category 1B) e , PBT, vPvB

4 April 2019 c 4 October 2020 d — —
41.

Pitch, coal tar, high temp.

EC No

:

266-028-2

CAS No

:

65996-93-2

Carcinogenic

(category 1B), PBT, vPvB

4 April 2019 c 4 October 2020 d — —
42.

4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated

(covering well-defined substances and UVCB substances, polymers and homologues)

EC No

:

—

CAS No

:

—

Endocrine disrupting properties (Article 57(f) — environment)

[F3(a)

4 July 2019 c ;

(b)

by way of derogation from point (a), 22 June 2022 for uses as follows:

  • — for the research, development and production of medicinal products falling within the scope of [F9the Human Medicines Regulations 2012] or [F10relevant] medical devices or [F11relevant] accessories to medical devices F12 ... in view of their use for the diagnosis, treatment or prevention of the coronavirus disease (COVID-19),

  • — in [F13relevant] medical devices or [F14relevant] accessories to medical devices F15 ... for the diagnosis, treatment or prevention of COVID-19.]

[F16(a)

4 January 2021 d ;

(b)

by way of derogation from point (a), 22 December 2023 for uses as follows:

  • — for the research, development and production of medicinal products falling within the scope of [F17the Human Medicines Regulations 2012] or [F18relevant] medical devices or [F19relevant] accessories to medical devices F20 ... in view of their use for the diagnosis, treatment or prevention of COVID-19,

  • — in [F21relevant] medical devices or [F22relevant] accessories to medical devices F23 ... for the diagnosis, treatment or prevention of COVID-19.]

— —
43.

4-Nonylphenol, branched and linear, ethoxylated

(substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, ethoxylated covering UVCB- and well-defined substances, polymers and homologues, which include any of the individual isomers and/or combinations thereof)

EC No

:

—

CAS No

:

—

Endocrine disrupting properties (Article 57(f) — environment) 4 July 2019 c 4 January 2021 d — —]
[F24 [X344.

1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear

EC No: 271-093-5

CAS No: 68515-50-4

Toxic for reproduction (category 1B) 27 August 2021 c 27 February 2023 d — —
45.

Dihexyl phthalate

EC No: 201-559-5

CAS No: 84-75-3

Toxic for reproduction (category 1B) 27 August 2021 c 27 February 2023 d — —
46.

1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0,3 % of dihexyl phthalate (EC No 201-559-5)

EC No: 271-094-0; 272-013-1

CAS No: 68515-51-5; 68648-93-1

Toxic for reproduction (category 1B) 27 August 2021 c 27 February 2023 d — —
47.

Trixylyl phosphate

EC No: 246-677-8

CAS No: 25155-23-1

Toxic for reproduction (category 1B) 27 November 2021 27 May 2023 — —
48.

Sodium perborate; perboric acid, sodium salt

EC No: 239-172-9; 234-390-0

CAS No: -

Toxic for reproduction (category 1B) 27 November 2021 27 May 2023 — —
49.

Sodium peroxometaborate

EC No: 231-556-4

CAS No: 7632-04-4

Toxic for reproduction (category 1B) 27 November 2021 27 May 2023 — —
50.

5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof]

EC No: -

CAS No: -

vPvB 27 February 2022 27 August 2023 — —
51.

2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328)

EC No: 247-384-8

CAS No: 25973-55-1

PBT, vPvB 27 May 2022 27 November 2023 — —
52.

2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327)

EC No: 223-383-8

CAS No: 3864-99-1

vPvB 27 May 2022 27 November 2023 — —
53.

2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350)

EC No: 253-037-1

CAS No: 36437-37-3

vPvB 27 May 2022 27 November 2023 — —
54.

2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320)

EC No: 223-346-6

CAS No: 3846-71-7

PBT, vPvB 27 May 2022 27 November 2023 — —] ]

Editorial Information

Textual Amendments