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ANNEX XIV: LIST OF SUBSTANCES SUBJECT TO AUTHORISATION


Entry Nr

Substance

Intrinsic property(ies) referred to in Article 57

Transitional arrangements

Exempted (categories of) uses

Review periods

Latest application date (1)

Sunset date (2)

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 ►M43   (*1)  ◄

21 February 2015 ►M43   (*2)  ◄

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.

 

5.

Benzyl butyl phthalate

(BBP)

EC No: 201-622-7

CAS No: 85-68-7

Toxic for reproduction

(category 1B)

21 August 2013 ►M43   (*1)  ◄

21 February 2015 ►M43   (*2)  ◄

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 ►M43   (*1)  ◄

21 February 2015 ►M43   (*2)  ◄

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.

 

▼M15

7.

Diisobutyl phthalate (DIBP)

EC No: 201-553-2

CAS No: 84-69-5

Toxic for reproduction

(category 1B)

21 August 2013 ►M43   (*1)  ◄

21 February 2015 ►M43   (*2)  ◄

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 ►M43   (*1)  ◄

21 May 2015 ►M43   (*2)  ◄

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 ►M43   (*1)  ◄

21 May 2015 ►M43   (*2)  ◄

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 ►M43   (*1)  ◄

21 May 2015 ►M43   (*2)  ◄

 

 

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 ►M43   (*1)  ◄

21 August 2015 ►M43   (*2)  ◄

 

 

▼M22

15.

Trichloroethylene

EC No: 201-167-4

CAS No: 79-01-6

Carcinogenic

(category 1B)

21 October 2014 ►M43   (*1)  ◄

21 April 2016 ►M43   (*2)  ◄

16.

Chromium trioxide

EC No: 215-607-8

CAS No: 1333-82-0

Carcinogenic

(category 1A)

Mutagenic

(category 1B)

21 March 2016 ►M43   (*1)  ◄

21 September 2017 ►M43   (*2)  ◄

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 ►M43   (*1)  ◄

21 September 2017 ►M43   (*2)  ◄

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 ►M43   (*1)  ◄

21 September 2017 ►M43   (*2)  ◄

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 ►M43   (*1)  ◄

21 September 2017 ►M43   (*2)  ◄

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 ►M43   (*1)  ◄

21 September 2017 ►M43   (*2)  ◄

 

 

21.

Potassium chromate

EC No: 232-140-5

CAS No: 7789-00-6

Carcinogenic

(category 1B)

Mutagenic

(category 1B)

21 March 2016 ►M43   (*1)  ◄

21 September 2017 ►M43   (*2)  ◄

 

 

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 ►M43   (*1)  ◄

21 September 2017 ►M43   (*2)  ◄

 

 

▼M28

23.

Formaldehyde, oligomeric reaction products with aniline (technical MDA)

EC No: 500-036-1

CAS No: 25214-70-4

Carcinogenic

(category 1B)

22 February 2016 ►M43   (*1)  ◄

22 August 2017 ►M43   (*2)  ◄

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 ►M43   (*1)  ◄

22 August 2017 ►M43   (*2)  ◄

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 ►M43   (*1)  ◄

22 November 2017 ►M43   (*2)  ◄

28.

Dichromium tris(chromate)

EC No: 246-356-2

CAS No: 24613-89-6

Carcinogenic

(category 1B)

22 July 2017 ►M43   (*1)  ◄

22 January 2019 ►M43   (*2)  ◄

29.

Strontium chromate

EC No: 232-142-6

CAS No: 7789-06-2

Carcinogenic

(category 1B)

22 July 2017 ►M43   (*1)  ◄

22 January 2019 ►M43   (*2)  ◄

30.

Potassium hydroxyoctaoxodizincatedichromate

EC No: 234-329-8

CAS No: 11103-86-9

Carcinogenic

(category 1A)

22 July 2017 ►M43   (*1)  ◄

22 January 2019 ►M43   (*2)  ◄

31.

Pentazinc chromate octahydroxide

EC No: 256-418-0

CAS No: 49663-84-5

Carcinogenic

(category 1A)

22 July 2017 ►M43   (*1)  ◄

22 January 2019 ►M43   (*2)  ◄

▼M43

32.

1-Bromopropane (n-propyl bromide)

EC No: 203-445-0

CAS No: 106-94-5

Toxic for reproduction

(category 1B)

4 January 2019

4 July 2020

33.

Diisopentylphthalate

EC No: 210-088-4

CAS No: 605-50-5

Toxic for reproduction

(category 1B)

4 January 2019

4 July 2020

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

4 July 2020

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

4 July 2020

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

4 July 2020

37.

Bis(2-methoxyethyl) phthalate

EC No: 204-212-6

CAS No: 117-82-8

Toxic for reproduction

(category 1B)

4 January 2019

4 July 2020

38.

Dipentylphthalate

EC No: 205-017-9

CAS No: 131-18-0

Toxic for reproduction

(category 1B)

4 January 2019

4 July 2020

39.

N-pentyl-isopentylphthalate

EC No: —

CAS No: 776297-69-9

Toxic for reproduction

(category 1B)

4 January 2019

4 July 2020

40.

Anthracene oil

EC No: 292-602-7

CAS No: 90640-80-5

Carcinogenic

(category 1B) (*3), PBT, vPvB

4 April 2019

4 October 2020

41.

Pitch, coal tar, high temp.

EC No: 266-028-2

CAS No: 65996-93-2

Carcinogenic

(category 1B), PBT, vPvB

4 April 2019

4 October 2020

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)

4 July 2019

4 January 2021

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

4 January 2021

▼C1

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

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

(*1)   1 September 2019 for the use of the substance in the production of spare parts for the repair of articles the production of which ceased or will cease before the sunset date indicated in the entry for that substance, where that substance was used in the production of those articles and the latter cannot function as intended without that spare part, and for the use of the substance (on its own or in a mixture) for the repair of such articles where that substance on its own or in a mixture was used in the production of those articles and the latter cannot be repaired otherwise than by using that substance.

(*2)   1 March 2021 for the use of the substance in the production of spare parts for the repair of articles the production of which ceased or will cease before the sunset date indicated in the entry for that substance, where that substance was used in the production of those articles and the latter cannot function as intended without those spare parts, and for the use of the substance (on its own or in a mixture) for the repair of such articles, where that substance was used in the production of those articles and the latter cannot be repaired otherwise than by using that substance.

(*3)   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).