Annex XIV LIST OF SUBSTANCES SUBJECT TO AUTHORISATIONX1
United Kingdom
| Date referred to in Article 58(1)(c)(i) of Regulation (EC) No 1907/2006. | ||||||
| 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. | ||||||
| 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. | ||||||
| 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). | ||||||
| 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 ). | ||||||
| Entry Nr | Substance | Intrinsic property(ies) referred to in Article 57 | Transitional arrangements | Exempted (categories of) uses | Review periods | |
|---|---|---|---|---|---|---|
| Latest application date f1 | Sunset date f2 | |||||
| 1. | 5-tert-butyl-2,4,6-trinitro-m-xylene ( Musk xylene ) EC No201-329-4 81-15-2 | vPvB | 21 February 2013 | 21 August 2014 | — | — |
| 2. | 4,4’-Diaminodiphenylmethane (MDA) EC No202-974-4 101-77-9 | Carcinogenic (category 1B) | 21 February 2013 | 21 August 2014 | — | — |
| 3. | Hexabromocyclododecane ( HBCDD ) EC No221-695-9, 247-148-4, 3194-55-6 25637-99-4 alpha-hexabromocyclododecane CAS No134237-50-6, beta-hexabromocyclododecane CAS No134237-51-7 gamma-hexabromocyclododecane CAS No134237-52-8 | PBT | 21 February 2014 | 21 August 2015 | — | — |
| 4. | Bis(2-ethylhexyl) phthalate ( DEHP ) EC No204-211-0 117-81-7 | Toxic for reproduction (category 1B) | 21 August 2013 f3 | 21 February 2015 f4 | 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 No201-622-7 85-68-7 | Toxic for reproduction (category 1B) | 21 August 2013 | 21 February 2015 | 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 No201-557-4 84-74-2 | Toxic for reproduction (category 1B) | 21 August 2013 | 21 February 2015 | 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 | 21 February 2015 | — | — |
| 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 | 21 May 2015 | — | — |
| 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 | 21 May 2015 | — | — |
| 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 | 21 May 2015 | ||
| 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 | 21 August 2015 | ||
| F615. | Trichloroethylene EC No: 201-167-4 CAS No: 79-01-6 | Carcinogenic (category 1B) | 21 October 2014 | 21 April 2016 | — | — |
| 16. | Chromium trioxide EC No: 215-607-8 CAS No: 1333-82-0 |
| 21 March 2016 | 21 September 2017 | — | — |
| 17. | Acids generated from chromium trioxide and their oligomers Group containing:
| Carcinogenic (category 1B) | 21 March 2016 | 21 September 2017 | — | — |
| 18. | Sodium dichromate EC No: 234-190-3 CAS No: 7789-12-0 10588-01-9 |
| 21 March 2016 | 21 September 2017 | — | — |
| 19. | Potassium dichromate EC No: 231-906-6 CAS No: 7778-50-9 |
| 21 March 2016 | 21 September 2017 | — | — |
| 20. | Ammonium dichromate EC No: 232-143-1 CAS No: 7789-09-5 |
| 21 March 2016 | 21 September 2017 | ||
| 21. | Potassium chromate EC No: 232-140-5 CAS No: 7789-00-6 |
| 21 March 2016 | 21 September 2017 | ||
| 22. | Sodium chromate EC No: 231-889-5 CAS No: 7775-11-3 |
| 21 March 2016 | 21 September 2017 | ||
| 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 | 22 August 2017 | — | — |
| 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 | 22 August 2017 | — | — |
| 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 | 22 November 2017 | — | — |
| 28. | Dichromium tris(chromate) EC No: 246-356-2 CAS No: 24613-89-6 | Carcinogenic (category 1B) | 22 July 2017 | 22 January 2019 | — | — |
| 29. | Strontium chromate EC No: 232-142-6 CAS No: 7789-06-2 | Carcinogenic (category 1B) | 22 July 2017 | 22 January 2019 | — | — |
| 30. | Potassium hydroxyoctaoxodizincatedichromate EC No: 234-329-8 CAS No: 11103-86-9 | Carcinogenic (category 1A) | 22 July 2017 | 22 January 2019 | — | — |
| 31. | Pentazinc chromate octahydroxide EC No: 256-418-0 CAS No: 49663-84-5 | Carcinogenic (category 1A) | 22 July 2017 | 22 January 2019 | — | — |
| F832. | 1-Bromopropane (n-propyl bromide) EC No203-445-0 106-94-5 | Toxic for reproduction (category 1B) | 4 January 2019 | 4 July 2020 | — | — |
| 33. | Diisopentylphthalate EC No210-088-4 605-50-5 | 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 No276-158-1 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 No271-084-6 68515-42-4 | Toxic for reproduction (category 1B) | 4 January 2019 | 4 July 2020 | — | — |
| 36. | 1,2-Benzenedicarboxylic acid, dipentylester, branched and linear EC No284-032-2 84777-06-0 | Toxic for reproduction (category 1B) | 4 January 2019 | 4 July 2020 | — | — |
| 37. | Bis(2-methoxyethyl) phthalate EC No204-212-6 117-82-8 | Toxic for reproduction (category 1B) | 4 January 2019 | 4 July 2020 | — | — |
| 38. | Dipentylphthalate EC No205-017-9 131-18-0 | Toxic for reproduction (category 1B) | 4 January 2019 | 4 July 2020 | — | — |
| 39. | N-pentyl-isopentylphthalate EC No— 776297-69-9 | Toxic for reproduction (category 1B) | 4 January 2019 | 4 July 2020 | — | — |
| 40. | Anthracene oil EC No292-602-7 90640-80-5 | Carcinogenic (category 1B) f5 , PBT, vPvB | 4 April 2019 | 4 October 2020 | — | — |
| 41. | Pitch, coal tar, high temp. EC No266-028-2 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— — | Endocrine disrupting properties (Article 57(f) — environment) | ( a ) 4 July 2019 ; ( b ) by way of derogation from point (a), 22 June 2022 for uses as follows:
| ( F16a ) 4 January 2021 ; ( b ) by way of derogation from point (a), 22 December 2023 for uses as follows:
| — | — |
| 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— — | Endocrine disrupting properties (Article 57(f) — environment) | 4 July 2019 | 4 January 2021 | — | — |
| 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 | 27 February 2023 | — | — |
| 45. | Dihexyl phthalate EC No: 201-559-5 CAS No: 84-75-3 | Toxic for reproduction (category 1B) | 27 August 2021 | 27 February 2023 | — | — |
| 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 | 27 February 2023 | — | — |
| 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 | — | — |
Annotations
Textual amendments
- F1
- F2
- F3
- F4
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Words in Annex 14 Table substituted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 3 para. 10; 2020 c. 1, Sch. 5 para. 1(1)
- F5
- F6
- F7
- F8
- F9
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Words in Annex 14 Table substituted (30.9.2021) by The REACH etc. (Amendment) Regulations 2021 (S.I. 2021/904), regs. 1(2), 7(2)(a)(i)
- F10
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Word in Annex 14 Table inserted (30.9.2021) by The REACH etc. (Amendment) Regulations 2021 (S.I. 2021/904), regs. 1(2), 7(2)(a)(ii)
- F11
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Word in Annex 14 Table inserted (30.9.2021) by The REACH etc. (Amendment) Regulations 2021 (S.I. 2021/904), regs. 1(2), 7(2)(a)(iii)
- F12
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Words in Annex 14 Table omitted (30.9.2021) by virtue of The REACH etc. (Amendment) Regulations 2021 (S.I. 2021/904), regs. 1(2), 7(2)(a)(iv)
- F13
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Word in Annex 14 Table inserted (30.9.2021) by The REACH etc. (Amendment) Regulations 2021 (S.I. 2021/904), regs. 1(2), 7(2)(b)(i)
- F14
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Word in Annex 14 Table inserted (30.9.2021) by The REACH etc. (Amendment) Regulations 2021 (S.I. 2021/904), regs. 1(2), 7(2)(b)(ii)
- F15
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Words in Annex 14 Table omitted (30.9.2021) by virtue of The REACH etc. (Amendment) Regulations 2021 (S.I. 2021/904), regs. 1(2), 7(2)(b)(iii)
- F16
- F17
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Words in Annex 14 Table substituted (30.9.2021) by The REACH etc. (Amendment) Regulations 2021 (S.I. 2021/904), regs. 1(2), 7(3)(a)(i)
- F18
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Word in Annex 14 Table inserted (30.9.2021) by The REACH etc. (Amendment) Regulations 2021 (S.I. 2021/904), regs. 1(2), 7(3)(a)(ii)
- F19
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Word in Annex 14 Table inserted (30.9.2021) by The REACH etc. (Amendment) Regulations 2021 (S.I. 2021/904), regs. 1(2), 7(3)(a)(iii)
- F20
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Words in Annex 14 Table omitted (30.9.2021) by virtue of The REACH etc. (Amendment) Regulations 2021 (S.I. 2021/904), regs. 1(2), 7(3)(a)(iv)
- F21
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Word in Annex 14 Table inserted (30.9.2021) by The REACH etc. (Amendment) Regulations 2021 (S.I. 2021/904), regs. 1(2), 7(3)(b)(i)
- F22
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Word in Annex 14 Table inserted (30.9.2021) by The REACH etc. (Amendment) Regulations 2021 (S.I. 2021/904), regs. 1(2), 7(3)(b)(ii)
- F23
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Words in Annex 14 Table omitted (30.9.2021) by virtue of The REACH etc. (Amendment) Regulations 2021 (S.I. 2021/904), regs. 1(2), 7(3)(b)(iii)
- F24
Editorial notes
- X1
- X2
- X3
Footnotes
- f1
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Date referred to in Article 58(1)(c)(ii) of Regulation (EC) No 1907/2006.
- f2
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Date referred to in Article 58(1)(c)(i) of Regulation (EC) No 1907/2006.
- f3
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1 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.
- f4
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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.
- f5
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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).