Call us: +44 870 8 200 310
Or write: experts@regartis.com
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 |
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 |
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) |
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) |
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) |
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. |
|
||
|
7. |
Diisobutyl phthalate (DIBP) EC No: 201-553-2 CAS No: 84-69-5 |
Toxic for reproduction (category 1B) |
— |
— |
||
|
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) |
— |
— |
||
|
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) |
— |
— |
||
|
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) |
|
|
||
|
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) |
|
|
||
|
15. |
Trichloroethylene EC No: 201-167-4 CAS No: 79-01-6 |
Carcinogenic (category 1B) |
— |
— |
||
|
16. |
Chromium trioxide EC No: 215-607-8 CAS No: 1333-82-0 |
Carcinogenic (category 1A) Mutagenic (category 1B) |
— |
— |
||
|
17. |
Acids generated from chromium trioxide and their oligomers Group containing: |
Carcinogenic (category 1B) |
— |
— |
||
|
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) |
— |
— |
||
|
19. |
Potassium dichromate EC No: 231-906-6 CAS No: 7778-50-9 |
Carcinogenic (category 1B) Mutagenic (category 1B) Toxic for reproduction (category 1B) |
— |
— |
||
|
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. |
Potassium chromate EC No: 232-140-5 CAS No: 7789-00-6 |
Carcinogenic (category 1B) Mutagenic (category 1B) |
|
|
||
|
22. |
Sodium chromate EC No: 231-889-5 CAS No: 7775-11-3 |
Carcinogenic (category 1B) Mutagenic (category 1B) Toxic for reproduction (category 1B) |
|
|
||
|
23. |
Formaldehyde, oligomeric reaction products with aniline (technical MDA) EC No: 500-036-1 CAS No: 25214-70-4 |
Carcinogenic (category 1B) |
— |
— |
||
|
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) |
— |
— |
||
|
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) |
— |
— |
||
|
28. |
Dichromium tris(chromate) EC No: 246-356-2 CAS No: 24613-89-6 |
Carcinogenic (category 1B) |
— |
— |
||
|
29. |
Strontium chromate EC No: 232-142-6 CAS No: 7789-06-2 |
Carcinogenic (category 1B) |
— |
— |
||
|
30. |
Potassium hydroxyoctaoxodizincatedichromate EC No: 234-329-8 CAS No: 11103-86-9 |
Carcinogenic (category 1A) |
— |
— |
||
|
31. |
Pentazinc chromate octahydroxide EC No: 256-418-0 CAS No: 49663-84-5 |
Carcinogenic (category 1A) |
— |
— |
||
|
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 |
4 April 2019 |
4 October 2020 |
— |
— |
|
41. |
Pitch, coal tar, high temp. EC No: 266-028-2 CAS No: 65996-93-2 |
Carcinogenic |
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 |
— |
— |
|
(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). |
||||||