http://www.legislation.gov.uk/uksi/2004/2152The Cosmetic Products (Safety) Regulations 2004Consumer protectionSafetyCONSUMER PROTECTION2024-05-20Statute Law Database2004-09-11 These Regulations revoke and re-enact the Cosmetic Products (Safety) Regulations 2003 (S.I. 2003/835) (“the 2003 Regulations”). The 2003 Regulations give effect to Council Directive 76/768/EEC (O.J. No. L262, 27.9.76, p.169) (“the Directive”) on the approximation of the laws of the Member States relating to cosmetic products, as amended by the Community instruments listed in Schedule 2 to these Regulations. The Cosmetic Products (Safety) Regulations 2004reg 5The Cosmetic Products (Safety) (Amendment) Regulations 2006reg 2The Cosmetic Products (Safety) Regulations 2004sch 2The Cosmetic Products (Safety) (Amendment) Regulations 2006reg 2The Cosmetic Products (Safety) Regulations 2004sch 4The Cosmetic Products (Safety) (Amendment) Regulations 2006reg 2The Cosmetic Products (Safety) Regulations 2004reg. 5(15)(d)The Cosmetic Products (Safety) (Amendment) (No. 3) Regulations 2006reg. 2reg. 1The Cosmetic Products (Safety) Regulations 2004reg. 5(15)(d)The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(2)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 2(46)The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(3)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 17The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(4)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 23The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(4)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 40The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(4)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 42The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(4)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 1The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(a)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 2The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(a)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 8The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(a)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 13The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(a)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 15The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(a)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 30The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(a)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 34The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(a)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 41The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(a)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 43The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(a)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 45The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(a)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 46The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(a)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 51The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(a)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 52The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(a)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 53The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(a)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 54The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(a)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 57The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(a)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 59The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(a)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 60The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(a)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 3The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 4The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 5The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 6The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 7The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 9The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 10The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 11The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 12The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 14The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 16The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 18The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 19The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 20The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 21The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 22The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 24The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 25The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 26The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 27The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 28The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 29The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 31The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 32The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 33The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 35The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 36The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 37The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 38The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 39The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 44The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 47The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 48The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 49The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 50The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 55The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 56The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2 entry 58The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2006reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 9 Pt. 1The Cosmetic Products (Safety) (Amendment) Regulations 2004reg. 2 Sch. Pt. 1reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 9 Pt. 2The Cosmetic Products (Safety) (Amendment) Regulations 2004reg. 2 Sch. Pt. 2reg. 1(1)The Cosmetic Products (Safety) Regulations 2004reg. 5(15)The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2004reg. 2(2)(a)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004reg. 5(16)The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2004reg. 2(2)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004reg. 12(1)The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2004reg. 2(3)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004reg. 13(2)The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2004reg. 2(4)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004reg. 16(1)(a)The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2004reg. 2(5)(a)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004reg. 16(3A)(3B)The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2004reg. 2(5)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 2 para. 38-41The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2004reg. 2(6)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 3 Pt. 1 Entry 425The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2004reg. 2(7)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 1 Entry 51The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2004reg. 2(8)(a)(i) Sch. Pt. 1reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 1 Entry 53The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2004reg. 2(8)(a)(i) Sch. Pt. 1reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 1 Entry 65The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2004reg. 2(8)(a)(i) Sch. Pt. 1reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 1 Entry 66The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2004reg. 2(8)(a)(i) Sch. Pt. 1reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 1 Entry 55The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2004reg. 2(8)(a)(ii)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 1 Entry 60The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2004reg. 2(8)(a)(iii)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 1The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2004reg. 2(8)(a)(iv) Sch. Pt. 2reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2004reg. 2(8)(b)(i)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2004reg. 2(8)(b)(ii)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 5 Pt. 1The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2004reg. 2(9)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 6The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2004reg. 2(10)(a)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 6The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2004reg. 2(10)(b)(i)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 6The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2004reg. 2(10)(b)(ii)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 6 Pt. 1 Entry 5The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2004reg. 2(10)(c)(i) Sch. Pt. 3reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 6 Pt. 1 Entry 54The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2004reg. 2(10)(c)(ii)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 7 Pt. 1 Entry 11The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2004reg. 2(11)(a)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 7 Pt. 1 Entry 19The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2004reg. 2(11)(b)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 13The Cosmetic Products (Safety) (Amendment) (No.2) Regulations 2004reg. 2 (12)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004reg. 7(2)(c)reg. 7(9)(b)The Cosmetic Products (Safety) Regulations 2004reg. 1(2)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 1The Cosmetic Products (Safety) Regulations 2004reg. 1(2)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 2The Cosmetic Products (Safety) Regulations 2004reg. 1(2)The Cosmetic Products (Safety) Regulations 2004Sch. 5 Pt. IThe Cosmetic Products (Safety) Regulations 2004reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 5 Pt. IIThe Cosmetic Products (Safety) Regulations 2004reg. 1(2)The Cosmetic Products (Safety) Regulations 2004Sch. 6 Pt. IThe Cosmetic Products (Safety) Regulations 2004reg. 1(2)The Cosmetic Products (Safety) Regulations 2004Sch. 6 Pt. 2The Cosmetic Products (Safety) Regulations 2004reg. 1(2)The Cosmetic Products (Safety) Regulations 2004Sch. 7 Pt. 1The Cosmetic Products (Safety) Regulations 2004reg. 1(2)The Cosmetic Products (Safety) Regulations 2004Sch. 7 Pt. IIThe Cosmetic Products (Safety) Regulations 2004reg. 1(2)The Cosmetic Products (Safety) Regulations 2004Sch. 9 Pt. 2The Cosmetic Products (Safety) Regulations 2004reg. 1(2)The Cosmetic Products (Safety) Regulations 2004reg 5The Cosmetic Products (Safety) (Amendment) Regulations 2005reg 3(1) (2)The Cosmetic Products (Safety) Regulations 2004Sch 2The Cosmetic Products (Safety) (Amendment) Regulations 2005reg 3(1) (3)The Cosmetic Products (Safety) Regulations 2004Sch 3 Pt 1The Cosmetic Products (Safety) (Amendment) Regulations 2005reg 3(1) reg 3(4)(a) Schedule Pt 2The Cosmetic Products (Safety) Regulations 2004Sch 3 Pt 2The Cosmetic Products (Safety) (Amendment) Regulations 2005reg 3(1) reg 3(4)(b) Schedule Pt 3The Cosmetic Products (Safety) Regulations 2004Sch 4 Pt 1The Cosmetic Products (Safety) (Amendment) Regulations 2005reg 3(1) reg 3(5)(a)(i) reg 3(5)(a)(iii) reg 3(5)(a)(vi) (vii)The Cosmetic Products (Safety) Regulations 2004Sch 4 Pt 1The Cosmetic Products (Safety) (Amendment) Regulations 2005reg 3(1) reg 3(5)(a)(ii) reg 3(5)(a)(iv) reg 3(5)(a)(v) (viii)–(x) Schedule Pt 4The Cosmetic Products (Safety) Regulations 2004Sch 4 Pt 2The Cosmetic Products (Safety) (Amendment) Regulations 2005reg 3(1) reg 3(5)(b)The Cosmetic Products (Safety) Regulations 2004Sch 5 Pt IThe Cosmetic Products (Safety) (Amendment) Regulations 2005reg 3(1) (6)The Cosmetic Products (Safety) Regulations 2004Sch 6 Pt IThe Cosmetic Products (Safety) (Amendment) Regulations 2005reg 3(1) reg 3(7)(a) Schedule Pt 5The Cosmetic Products (Safety) Regulations 2004Sch 6 Pt IThe Cosmetic Products (Safety) (Amendment) Regulations 2005reg 3(1) reg 3(7)(b)The Cosmetic Products (Safety) Regulations 2004Sch 7 Pt 1The Cosmetic Products (Safety) (Amendment) Regulations 2005regs 2 3(1) (8) Schedule Pts 1 6The Cosmetic Products (Safety) Regulations 2004reg 5The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2005reg 2(1) (2)The Cosmetic Products (Safety) Regulations 2004Sch 2 paras 43 44The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2005reg 2(1) (3)The Cosmetic Products (Safety) Regulations 2004Sch 3 Pt 1The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2005reg 2(1) reg 2(4)(a) Schedule Pt 1The Cosmetic Products (Safety) Regulations 2004Sch 3 Pt 2The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2005reg 2(1) reg 2(4)(b)The Cosmetic Products (Safety) Regulations 2004Sch 4 Pt 2The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2005reg 2(1) (5)The Cosmetic Products (Safety) Regulations 2004Sch 5 Pt IThe Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2005reg 2(1) reg 2(6) (7)The Cosmetic Products (Safety) Regulations 2004Sch 6 Pt IThe Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2005reg 2(1) (8) Schedule Pt 2The Cosmetic Products (Safety) Regulations 2004reg. 9(5)(a)The Pharmacists and Pharmacy Technicians Order 2007Sch. 1 para. 39The Cosmetic Products (Safety) Regulations 2004reg. 5(2)(c)The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2007reg. 2(2)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004reg. 5(15)The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2007reg. 2(3)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 2 para. 48 49The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2007reg. 2(4)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 4 Pt. 1The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2007Sch. 2 Pt. 1reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 6 Pt. 1The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2007reg. 2(6)(a)reg. 2(7)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 6 Pt. 1The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2007reg. 2(6)(b)reg. 2(7)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 6 Pt. 1The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2007reg. 2(6)(c) Sch. 2 Pt. 2reg. 2(7)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 6 Pt. 1The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2007reg. 2(6)(d) Sch. 2 Pt. 3reg. 2(7)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004Sch. 6 Pt. 1The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2007reg. 2(6)(e)reg. 2(7)reg. 1(1)The Cosmetic Products (Safety) Regulations 2004RegulationsThe Cosmetic Products (Safety) Regulations 2008Sch. 1reg. 1(1) 2004 No. 2152 CONSUMER PROTECTION The Cosmetic Products (Safety) Regulations 2004 Made 17th August 2004 Laid before Parliament 19th August 2004 Coming into force for the purpose of regulations 7(2)(c) and 7(9)(b) 11th March 2005 for all other purposes 11th September 2004

Whereas the Secretary of State has, in accordance with section 11(5) of the Consumer Protection Act 1987, consulted such organisations as appear to her to be representative of interests substantially affected by these Regulations, such other persons as she considers appropriate and the Health and Safety Commission;

And whereas the Secretary of State is a Minister designated for the purposes of section 2 of the European Communities Act 1972 in relation to measures for safety and consumer protection as respects cosmetic products and any provisions concerning the composition, labelling, marketing, classification or description of cosmetic products and in relation to indication of origin on imported goods;

Now, therefore, the Secretary of State in exercise of the powers conferred on her by sections 11, 28 and 30 of the 1987 Act and by section 2(2) of the 1972 Act, hereby makes the following Regulations— Citation and commencement and transitory provisions 1 1 These Regulations may be cited as the Cosmetic Products (Safety) Regulations 2004 and shall come into force on 11th September 2004 other than the provisions set out in paragraph (2) below. 2 The following provisions of these Regulations shall come into force on 11th March 2005— a regulation 7(2)(c); and b regulation 7(9)(b). 3 Schedules 3,4 and 6 to these Regulations shall have effect until 24th March 2005 with the insertion of the entries referred to in Part 1 of Schedule 1 to these Regulations as they appear in the Cosmetic Products (Safety) Regulations 2003 in place of the corresponding entries in the Schedules to these Regulations and thereafter these entries shall have effect as they appear in the Schedules to these Regulations. 4 The entries referred to in Part 2 of Schedule 1 to these Regulations shall not form part of Schedules 3, 4 and 6 to these Regulations until 24th March 2005. Revocation 2 The Cosmetic Products (Safety) Regulations 2003 are hereby revoked. Interpretation 3 1 In these Regulations— “agent” means an agent established within the Community appointed by a manufacturer of a cosmetic product to act on his behalf in relation to these Regulations; “alternative method” means a testing method which is listed in Schedule 12 to these regulations; “approved supply list” shall have the same meaning as in regulation 2(1) of the CHIP Regulations; “the CHIP Regulations” means in Great Britain the Chemicals (Hazard Information and Packaging for Supply) Regulations 2002 and in Northern Ireland the Chemicals (Hazard Information and Packaging for Supply) Regulations (Northern Ireland) 2002 ; “common ingredients nomenclature” means the labelling nomenclature designated in the inventory of ingredients employed in cosmetic products, drawn up in accordance with the provisions of the Directive and contained in Commission Decision 96/335/EC, as amended or substituted from time to time; “the Community” means the European Community and other States in the European Economic Area; “the Confidentiality Directive” means Commission Directive 95/17/EC; “the 1987 Act” means the Consumer Protection Act 1987; “cosmetic ingredient” means any chemical substance or preparation of synthetic or natural origin, except for perfume and aromatic compositions, used in the composition of a cosmetic product; “cosmetic product” means any substance or preparation intended to be placed in contact with any part of the external surfaces of the human body (that is to say, the epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours except where such cleaning, perfuming, protecting, changing, keeping or correcting is wholly for the purpose of treating or preventing disease; “cosmetic product intended to come into contact with the mucous membranes” means a cosmetic product intended to be applied in the vicinity of the eyes, on the lips, in the oral cavity or to the external genital organs, and does not include any cosmetic product which is intended to come into only brief contact with the skin; “the Directive” means Council Directive 76/768/EEC as amended by the Community instruments set out in Schedule 2; “EEA Agreement” means the Agreement on the European Economic area signed at Oporto on 2nd May 1992 as amended from time to time; “finished cosmetic product” means the cosmetic product in its final formulation as placed on the market and made available to the final consumer, or its prototype; “market research experiment” means any activity conducted for the purpose of ascertaining the opinion of persons of— any cosmetic product; anything in, on or with which the cosmetic product is supplied; the appearance or any other characteristic of the cosmetic product or any such thing; or the name or description under which the cosmetic product is supplied; but a cosmetic product is not the subject of a market research experiment unless— any person to whom a cosmetic product is supplied in the course of the experiment is informed, at or before the time at which it is supplied to him, that it is supplied for the purpose of a market research experiment; and no consideration in money or money’s worth is given by such a person for the cosmetic product or any other cosmetic product supplied to him for comparison; “Member State” means a State which is a Contracting Party to the EEA Agreement; “preservative” means a substance which is added to a cosmetic product for the primary purpose of inhibiting the development of micro-organisms in that product; “prototype” means a first model or design that has not been produced in batches and from which the finished cosmetic product is copied or finally developed; “supply” includes offering to supply, agreeing to supply, exposing for supply and possessing for supply, and cognate expressions shall be construed accordingly; and “UV filter” means a substance which is added to a sunscreen cosmetic product for the primary purpose of filtering ultra violet rays for the purpose of protecting the epidermis of the user from harmful effects of such ultra violet rays. 2 Unless the contrary intention appears, references in these Regulations to a numbered regulation or Schedule are references to the regulation or Schedule so numbered in these Regulations. General requirements 4 1 Subject to paragraph (2) below, no person shall supply any cosmetic product which is liable to cause damage to human health when it is applied under— a normal conditions of use; or b conditions of use which are reasonably foreseeable taking into account all the circumstances, including the cosmetic product’s presentation, labelling, any instructions for its use and disposal and any other information or indication provided by the manufacturer, his agent or the person who supplies the cosmetic product on the first occasion that it is supplied in the Community. 2 Paragraph (1) above shall apply only to the supply by the manufacturer in or importer into the United Kingdom or, in the case of cosmetic products manufactured or imported into the United Kingdom on behalf of another person, by that other person. 3 The provision of any instructions, information or indication referred to in sub-paragraph (b) of paragraph (1) above shall not exempt any person from the obligation to comply with any other provisions of these Regulations which are applicable to him. Particular requirements 5 1 The following provisions of this regulation are without prejudice to regulation 4 and are subject to regulation 6. 2 No person shall supply a cosmetic product which contains— a any substance listed in column 2 of Part I of Schedule 3, provided that no account shall be taken of any such substance which is present only as a trace which could not reasonably have been removed during or after manufacture; b any substance listed in column 2 of Part II of Schedule 3 which is used as a fragrance ingredient in relation to a cosmetic product, provided that no account shall be taken of any such substance which is present only as a trace which could not reasonably have been removed during or after manufacture; c any substance listed in column 2 of Schedule 4, unless the requirements in column 3, 4, 5 and (in the case of Part II) 7 of that Schedule in relation to that substance are satisfied; d any colouring agent listed in columns 1 and 2 of Schedule 5 with the exception of a cosmetic product containing a colouring agent intended solely to colour hair unless— i the requirements in columns 3 and 4 of Part I of that Schedule in relation to that colouring agent are satisfied; or ii the requirements in columns 3 and 4 of Part II of that Schedule in relation to that colouring agent are satisfied and the cosmetic product in question was supplied on or before the date specified in column 5 of that Part; e any colouring agent which is not listed in Schedule 5 with the exception of a cosmetic product containing a colouring agent intended solely to colour hair; f any preservative listed in column 2 of Schedule 6 unless— i the requirements in columns 3, 4 and 5 of Part I of that Schedule in relation to that preservative are satisfied; or ii the requirements in columns 3, 4 and 5 of Part II of that Schedule in relation to that preservative are satisfied and the cosmetic product in question is supplied on or before the date specified in column 7 of that Part; g any preservative which is not listed in Schedule 6; h any preservative listed in column 2 of Part II of Schedule 6 after the date specified in column 7 of that Part; i any UV filter listed in column 2 of Schedule 7 unless— i the requirements in columns 3 and 4 of Part I of that Schedule in relation to that UV filter are satisfied; or ii the requirements in columns 3 and 4 of Part II of that Schedule in relation to that UV filter are satisfied and the cosmetic product in question is supplied on or before the date specified in column 6 of that Part; or j any UV filter which is not listed in Schedule 7. 3 Subject to paragraphs (4) to (6) below, no person shall supply a cosmetic product which contains any of the substances designated as a specified risk material in Annex V to Regulation (EC) No. 999/2001 of the European Parliament and of the Council, or any ingredient derived from any of those substances. 4 For the purposes of paragraph (3) above, no account shall be taken of any substance referred to in that paragraph which is present in the cosmetic product only as a trace which could not reasonably have been removed during or after manufacture. 5 Paragraph (3) above shall not prohibit the supply of a cosmetic product which contains any tallow derivative so long as the relevant method set out in Schedule 8 was used in the manufacture of that derivative and the manufacturer of the derivative has certified that that method was used in its manufacture. 6 Paragraph (3) above shall not prohibit the supply of any cosmetic product which contains any substance or ingredient referred to in that paragraph but which was manufactured before 1st April 1998. 7 Subject to paragraph (8) below, no person shall supply a cosmetic product where the final formulation has been tested on animals in order that the cosmetic product might satisfy any requirements of these Regulations or the Directive using a method other than an alternative method where— a an alternative method is listed in column 4 of Part 1 or 2 of Schedule 12 to these Regulations; and b the final formulation is tested after the date given in column 5 of Part 1 or 2 of Schedule 12. 8 No person shall supply a cosmetic product where the final formulation has been tested on animals in order that the cosmetic product might satisfy any requirements of these Regulations or the Directive using a method other than an alternative method after— a 11th March 2013 in relation to tests concerning repeated dose toxicity, reproductive toxicity and toxicokinetics; or b 11th March 2009 in relation to all other tests. 9 Subject to paragraph (10) below, no person shall supply a cosmetic product which contains any ingredients or combination of ingredients which have been tested on animals in order that the cosmetic product, ingredient or combination of ingredients might satisfy any requirements of these Regulations or the Directive using a method other than an alternative method where— a an alternative method is listed in column 4 of Part 1 or 2 of Schedule 12 to these Regulations; and b the ingredient or combination of ingredients is tested after the date given in column 5 of Part 1 or 2 of Schedule 12. 10 No person shall supply a cosmetic product which contains any ingredients or combination of ingredients which have been tested on animals in order that the cosmetic product might satisfy any requirements of these Regulations or the Directive using a method other than an alternative method after— a 11th March 2013 in relation to tests concerning repeated dose toxicity, reproductive toxicity and toxicokinetics; or b 11th March 2009 in relation to all other tests. 11 No person shall test a finished cosmetic product on animals where such testing is undertaken in order that the said product might satisfy any requirements of these Regulations or the Directive. 12 Subject to paragraph (13) below, no person shall test any ingredient or combination of ingredients on animals in order to satisfy any requirement of these Regulations or the Directive using a method other than an alternative method where— a an alternative method is listed in column 4 of Part 1 or 2 of Schedule 12 to these Regulations; and b The ingredient or combination of ingredients is tested after the date given in column 5 of Part 1 or 2 of Schedule 12. 13 No person shall test any ingredient or combination of ingredients on animals in order to satisfy any requirement of these Regulations or the Directive using a method other than an alternative method after 11th March 2009. 14 The supply of any cosmetic product in respect of which a claim that the product or its ingredients have not been tested on animals appears on the packaging or in any document, notice, label, ring or collar accompanying or referring to the product is only permitted if— a the manufacturer and his supplier have not carried out any such tests on the finished product, its prototype or on any of the ingredients contained in the finished product or its prototype; b the manufacturer and his supplier have not commissioned any such tests on the finished product, its prototype or on any of the ingredients contained in the finished product or its prototype; c the cosmetic product contains no ingredients which have been tested on animals by others for the purpose of developing new cosmetic products. 15 No person shall supply a cosmetic product containing any substances classified as carcinogenic, mutagenic or toxic for reproduction of category 1, 2 or 3 in the approved supply list unless the substance is listed in Schedule 13 to these Regulations. 16 Paragraphs (14) and (15) above shall not apply to any cosmetic product placed on the market in a Member State before 11th September 2004. Authorisation by the Secretary of State 6 1 The Secretary of State may authorise the use in a cosmetic product for a maximum period of three years of a particular substance, not being a substance or ingredient referred to in regulation 5(3) or a substance listed in Schedule 3 or 4. 2 In giving an authorisation the Secretary of State may impose conditions relating to the use of a particular substance in a cosmetic product, and such conditions may relate to any matter which the Secretary of State considers appropriate including— a the purpose of the substance; b the type of cosmetic product; c the maximum concentration of the substance in any cosmetic product; and d information and marking requirements. 3 The Secretary of State may on reasonable notice vary or revoke any authorisation given under paragraph (1) above. 4 On giving, varying or revoking an authorisation, the Secretary of State shall arrange for the authorisation, variation or revocation, as the case may be, to be published in such manner as she considers appropriate for bringing it to the attention of persons who, in her opinion, would be likely to have an interest in it. 5 No person shall be convicted of an offence under section 12 of the 1987 Act by reason of a cosmetic product containing a particular substance provided that at the time when but for this regulation an offence would have been committed— a the use of that particular substance in that cosmetic product was duly authorised; and b all of the conditions imposed by the authorisation were complied with. Marking 7 1 Subject to paragraphs (5)(b) and (9) to (12) below, no person shall supply a cosmetic product unless the packaging in which it is supplied bears, in lettering which is visible, indelible and easily legible, a list of its cosmetics ingredients (preceded by the word “ingredients”) in descending order of weight, the weight to be determined at the time the ingredients are added to the product. 2 Subject to paragraphs (3), (4), (5)(a), (6) to (8), (13) and (14) below, no person shall supply a cosmetic product unless the container and packaging in which it is supplied bear the following particulars in lettering and other symbols (where appropriate) which is visible, indelible and easily legible— a the name or trade name and the address or registered office of the manufacturer of the product or of the supplier thereof, being a manufacturer or supplier established within a Member State of the Community; b in the case of a cosmetic product likely before the end of 30 months from the manufacture thereof to cease either to comply with the requirements of regulation 4 or to fulfil the purpose for which it was intended, the words “Best before” immediately followed by— i the earliest date on which it is likely so to cease; or ii an indication of where that date appears on the labelling, and any particular precautions to be observed to ensure that the product does not so cease before that date; c in the case of a cosmetic product— i not falling within sub-paragraph (b) above; and ii which may cease to comply with the requirements of regulation 4 after the container in which the product is contained has been opened, the symbol given in Part II of Schedule 9 to these regulations together with an indication of the period of time after opening after which the cosmetic product is likely to cease to comply with the requirements of regulation 4; d in the case of a cosmetic product containing a substance listed in column 2 of Schedule 4, the information specified in column 6 of that Schedule in relation to that substance; e in the case of a cosmetic product containing a preservative listed in column 2 of Schedule 6, the information specified in column 6 of that Schedule in relation to that preservative; f in the case of a cosmetic product containing a UV filter listed in column 2 of Schedule 7, the information specified in column 5 of that Schedule in relation to that UV filter; g any particular precautions to be observed in use and any special precautionary information on a cosmetic product for professional use, in particular in hairdressing (not being precautions included in the information referred to in sub-paragraphs (b), (d), (e) and (f) above); h a means of identifying the batch in which the product was manufactured (or, if the product was not manufactured in a batch, a reference from which the date and place of manufacture can be identified); and i the function of the product unless this is clear from its presentation; Provided that the requirements specified in sub-paragraphs (b), (c) and (h) above need not be complied with in relation to a cosmetic product which is the subject of a market research experiment. 3 The particulars referred to in paragraph (2)(a) above may be abbreviated if such abbreviation does not prevent the person concerned from being identified. 4 The date referred to in paragraph (2)(b) above shall include the month and the year or the day, month and year in the order given in this paragraph. 5 The particulars referred to— a in paragraph (2)(b) to (g) and (i) above shall be in English, but this shall not prohibit the additional use of other languages; b in paragraph (1) above shall be in a language easily understood by the consumer. 6 Where it is impossible for practical reasons for the particulars referred to in paragraph (2)(c) to (g) above to appear on the container and packaging, they shall appear on a leaflet, label, tag, tape or card enclosed with the cosmetic product, to which the consumer is referred either by abbreviated information or by the symbol given in Part 1 of Schedule 9, which must appear on the container and packaging; and where it is impracticable for reasons of size or shape for the particulars so to appear, they shall appear on a label, tag, tape or card attached to the product. 7 Where it is impossible, for reasons of size, for the particulars referred to in paragraph (2)(h) above to appear on the container and packaging, it shall be sufficient for the said particulars to appear only on the packaging. 8 In the case of a supply of soap which is not in a container, either the soap itself or the packaging in which it is exposed for supply or the container in which it was last contained before the supply shall bear the particulars referred to in paragraph (2)(a) and (h) above, and in so far as any of the particulars referred to in paragraph (2)(b) to (g) and (i) above are required they shall appear on a leaflet which shall be delivered to the buyer with the soap; and where either of the particulars referred to in paragraph (2)(a) and (h) above appears on the soap itself the requirement of indelibility shall apply only until it has been put into use. 9 In relation to the compilation of the list of ingredients referred to in paragraph (1) above— a the following shall not be regarded as cosmetic ingredients— i impurities in the raw materials used; ii subsidiary technical materials used in the preparation of the cosmetic product but not present in the final product; iii materials used in strictly necessary quantities as solvents or as carriers for perfumes and aromatic compositions; b perfume and aromatic compositions and their raw materials shall be referred to by the words “perfume” or “aroma” except where the substance— i is listed in column 2 of Schedule 4 to these regulations; and ii is required to be mentioned by a requirement in column 5 of that Schedule; c ingredients in concentrations of less than 1 per cent may be listed in any order after those in concentrations of 1 per cent or more; d colouring agents may be listed in any order after the other ingredients, in accordance with the colour index number or denomination given in Schedule 5; e for decorative cosmetic products marketed in several colour shades, all colouring agents used in the range may be listed, provided that the words “may contain” or the symbol “+/-” are added; and f an ingredient shall be identified by the name provided for in the International Nomenclature of Cosmetic Ingredients (INCI) or in the absence of such identification, by its chemical name, its CTFA name, its European Pharmacopoeia name, its International Non-proprietary Name (INN) as recommended by the World Health Organization, its EINECS, IUPAC or CAS identification reference or its colour index number. 10 Subject to paragraph (11) below, where a cosmetic product has no packaging or it is impossible for practical reasons for the list of ingredients referred to in paragraph (1) above to appear on the packaging, the list shall appear on the container; and where a cosmetic product is supplied or delivered pursuant to any supply in neither a container nor packaging, the list shall appear on the container in which the product is exposed for supply or a notice in immediate proximity to that container. 11 Subject to paragraph (12) below, where it is impossible for practical reasons for the list of ingredients referred to in paragraph (1) above to appear on the packaging or container of a cosmetic product, it shall appear on a leaflet, label, tag, tape or card enclosed with the product, to which the consumer is referred either by abbreviated information or by the symbol given in Part 1 of Schedule 9, which must appear on the packaging; and where it is impracticable for reasons of size and shape for the list so to appear, it shall appear on a label, tag, tape or card attached to the cosmetic product. 12 In the case of soap, bathballs and other small products, where it is impracticable for reasons of size or shape for the list of ingredients referred to in paragraph (1) above to appear on an enclosed leaflet or on a label, tag, tape or card enclosed with or attached to the product, it shall appear on a notice in immediate proximity to the consumer in which the cosmetic product is exposed for sale. 13 Where two or more cosmetic products are supplied together as a single item, each product being in a separate container and the containers being enclosed together in packaging which bears clear and conspicuous instructions to the effect that the products must be mixed together in specified proportions before use, the particulars referred to in paragraph (2)(d) to (g) above shall appear on an enclosed leaflet and an indication shall appear on both the containers and the packaging referring the consumer to the information in the leaflet. 14 Where a cosmetic product other than soap is supplied or delivered pursuant to a supply in neither a container nor packaging, the particulars referred to in paragraph (2) above shall appear on the container in which the product is exposed for supply or a notice in immediate proximity to that container. 15 Paragraphs 7(2)(c) and 7(9)(b) above shall not apply to cosmetic products placed on the market in the Community prior to 11th March 2005. Responsible Persons and Competent Authorities 8 1 For the purposes of regulations 9 (except regulation 9(5) and (6)), 10, 11 and 12— a “responsible person” means, in relation to a relevant cosmetic product, i the manufacturer of that product; ii the manufacturer’s agent; iii the person to whose order that cosmetic product is manufactured; or iv where the manufacturer or the person to whose order the cosmetic product is manufactured is not established in the Community and either— aa the manufacturer has not appointed an agent; or bb the manufacturer’s agent is not the supplier of that cosmetic product, the person who first supplies the cosmetic product in the Community; b “competent authority” means a body responsible for requiring and receiving the information provided for in Articles 7.3, 7a.1 and 7a.4 of the Directive and granting and refusing requests for confidentiality pursuant to Article 4 of the Confidentiality Directive, and which is— i a United Kingdom competent authority pursuant to paragraph (2) below; or ii for the time being a competent authority of a Member State other than the United Kingdom, having been notified as a competent authority by the Member State concerned to the Commission pursuant to Articles 7.3 and 7a.5 of the Directive and Article 10 of the Confidentiality Directive. 2 The United Kingdom competent authority shall be the Secretary of State provided that she may from time to time appoint such person as she thinks fit to be a United Kingdom competent authority in addition to or in substitution for herself. Product Information 9 1 Subject to paragraph (8) below, where a cosmetic product is manufactured or supplied in the United Kingdom a responsible person shall for control purposes keep easily accessible to a United Kingdom competent authority at the address or registered office specified on the container or packaging of the cosmetic product in accordance with regulation 7(2)(a) above the following information— a the qualitative and quantitative composition of the product, except to the extent that the product is composed of any perfume or perfume composition, in which case the responsible person shall only be required to keep the name and code number of the perfume or perfume composition and the identity of the supplier; b the physico-chemical and microbiological specifications of the raw materials and the finished product and the purity and microbiological control criteria of the cosmetic product; c the method of manufacture which shall be in accordance with good manufacturing practice, that is to say that the cosmetic product shall be manufactured in such a way that under normal and reasonably foreseeable conditions of use it shall not endanger human health or safety; d an assessment of the safety for human health of the finished product taking into consideration the matters specified in paragraph (2) below; e a specific assessment of the safety for human health of the finished product taking into consideration the matters specified in paragraph (2) below in respect of cosmetic products intended for use on children under the age of 3 and for cosmetic products intended exclusively for use in external intimate hygiene; f the name and address of the person or persons, qualified in accordance with paragraph (5) below, responsible for the assessments referred to in sub-paragraphs (d) and (e) above; g existing data on undesirable effects on human health resulting from use of the cosmetic product; h proof of the effect claimed for the cosmetic product, where justified by the nature of the effect or product; and i data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety evaluation of the product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of countries which are not Member States; 2 The assessments referred to in paragraphs (1)(d) and (1)(e) above shall be carried out in accordance with the principles of good laboratory practice referred to in Article 1 of European Parliament and Council Directive 2004/10/EC on the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances and shall take particular account of the following— a the general toxicological profile of each ingredient used; b the chemical structure of each ingredient; c the level of exposure of each ingredient; d the specific exposure characteristics of the areas on which the cosmetic product will be applied; and e the specific exposure characteristics of the class of individuals for whom the cosmetic product is intended. 3 Subject to paragraph (4) below and without prejudice to the protection in particular of commercial secrecy and of intellectual property rights where a cosmetic product is manufactured or supplied in the United Kingdom a responsible person shall ensure that the information specified in paragraphs (1)(a) and (1)(g) above shall be made easily accessible to the public by any appropriate means. 4 For the purposes of paragraph (3) above, the quantitative information required under paragraph (1)(a) shall be limited to information relating to dangerous substances covered by Directive 67/548/EEC as amended. 5 The person referred to in paragraph (1)(f) must be— a subject to paragraph (6) below, the holder of an appropriate European diploma within the meaning of section 4A of the Pharmacy Act 1954 or any other person who has the right, granted by a competent authority in a Member State, to take up and pursue the activities of a pharmaceutical chemist; b subject to paragraph (6) below, a person who is entitled to be registered under section 3(1) of the Medical Act 1983 as a fully registered medical practitioner and who has the right, granted by a competent authority in a Member State, to take up and pursue the activities of a doctor; or c the holder of a diploma within the meaning of regulation 2(1) of the European Communities (Recognition of Professional Qualifications) Regulations 1991 showing that the holder has the qualifications required to practise as a chartered biologist or that he has the qualifications required to practise as a chartered chemist or that he has the qualifications required to practise a profession equivalent to the profession of chartered biologist or chartered chemist in a Member State other than the United Kingdom. 6 Any diploma or other evidence of qualification required for the purposes of paragraph (5)(a) or (b) above shall satisfy that requirement only if— a the education and training attested were received mainly within the European Community; or b the holder has spent at least three years in lawful pursuit in a Member State of the relevant profession, and such professional experience has been certified by a competent authority in a Member State (being a State which recognised a diploma or other evidence of qualification obtained in a non-Member State). 7 Where the responsible person is the manufacturer or the person who first imports the cosmetic product into the Community he must possess appropriate experience or an appropriate level of professional qualification in accordance with the legislation and practice of the United Kingdom if it is the place of manufacture or first importation. 8 Where the manufacturer manufactures a cosmetic product at two or more places within the Community, and one of those places is within the United Kingdom, the responsible person may choose a single place of manufacture within the Community where the information referred to in paragraph (1) above will be kept available provided that, if requested by a United Kingdom competent authority, he informs the said authority of the location at which the said information is to be kept. 9 Where the information referred to in paragraph (1) above is to be kept accessible to a United Kingdom competent authority it must be in English or a language readily understood by the said authority. 10 Paragraphs 9(1)(e), 9(1)(i), 9(2)(d) and 9(2)(e) above shall not apply in respect of cosmetic products placed on the market in the Community prior to 11th September 2004. 10 Where the place of manufacture or initial importation into the Community of a type of cosmetic product is within the United Kingdom, the responsible person shall notify a United Kingdom competent authority of the address of the place of manufacture or, as the case may be, initial importation into the Community of that type of cosmetic product before its first supply in the Community. 11 1 A United Kingdom competent authority may, where difficulties are encountered in providing prompt and appropriate medical treatment, require that any holder of appropriate and adequate information on substances used in cosmetic products make such information available to it, where the difficulties referred to may be overcome or eased by the provision of the said information. 2 Where the information referred to in paragraph (1) above is made available, the United Kingdom competent authority shall ensure that it is used solely for the purposes of the treatment referred to in paragraph (1) above. 12 1 Without prejudice to the provisions of regulations 4, 5, 9 and 12, a responsible person who for reasons of trade secrecy wishes not to include one or more cosmetic ingredients in the list of cosmetic ingredients referred to in regulation 7(1) above shall submit a request to that effect to the competent authority. 2 In this regulation “applicant” means a responsible person who submits a request for confidentiality. 3 The applicant shall ensure that— a the request for confidentiality includes the particulars laid down in Part I of Schedule 10; and b any amendments to the particulars provided for in sub-paragraph (a) above are communicated as quickly as possible to the competent authority and, in particular, that all changes to the names of cosmetic products containing the cosmetic ingredient in respect of which confidentiality is or has been sought, are communicated to the competent authority at least 15 days before those cosmetic products are supplied under their new names. 4 Within four months of the receipt of a request for confidentiality in respect of which the requirements of paragraph (3)(a) above are satisfied, the competent authority shall examine the request and inform the applicant in writing of its decision. 5 If the competent authority decides to grant its approval to the applicant’s request it shall, in notifying the applicant of its decision, in accordance with paragraph (4) above, also notify him of the registration number which will replace the cosmetic ingredient in question in the list referred to in regulation 7(1), the said number to be allocated to the product in accordance with the procedure provided for in Part II of Schedule 10. 6 If the competent authority decides to refuse to grant its approval to the applicant’s request it shall, in its notification of this refusal, include a statement of the reasons for refusal and a clear explanation of appeals procedures and their time limits. 7 In exceptional cases the competent authority may inform the applicant in writing that a period of two months in addition to the four-month period referred to in paragraph (4) above is required for the examination of the request. 8 Subject to paragraphs (9), (10), (11) and (12) below, a decision granting confidentiality shall be valid for a period of five years. 9 An applicant may, by submitting a reasoned request to the competent authority, request that the period of confidentiality referred to in paragraph (8) above be extended. 10 In the event of a reasoned request being submitted in accordance with paragraph (9) above, the competent authority shall deal with the request in accordance with paragraphs (4), (5) and (6) above. 11 Any extension of the period of confidentiality shall not exceed three years. 12 The competent authority may withdraw its approval to an applicant’s request for confidentiality if it considers this appropriate taking into account— a any amendments to the particulars provided for in paragraph (3)(a) above which are communicated to it in accordance with paragraph (3)(b) above; and b any new information which comes to its attention which makes it imperative, particularly for compelling reasons of public health, for it to so act, and in withdrawing its approval the competent authority shall comply with the provisions of paragraphs (4), (6) and (7) above. Contravention of these Regulations with the exception of regulations 5(7) to 5(13) 13 1 Subject to paragraph (2) below, any contravention of a requirement of these regulations with the exception of regulations 5(7)-5(13) shall be treated for all purposes as though it were a contravention of a requirement of safety regulations made under section 11 of the 1987 Act. 2 The term of imprisonment to which a person guilty of an offence under regulations 9, 10 or 11 shall be liable on summary conviction shall not exceed three months. Contravention of Regulations 5(7) to 5(13) 14 1 Any person who contravenes regulation 5(7), 5(8), 5(9),5(10), 5(11),5(12) or 5(13) or causes or permits another person to contravene those regulations, shall be guilty of an offence. 2 Any person guilty of an offence under paragraph (1) above shall be liable, on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment not exceeding three months and, on conviction on indictment, to a fine or to imprisonment not exceeding six months. 3 Where an offence under paragraph (1) committed by a body corporate is proved— a to have been committed with the consent or connivance of an officer, or b to be attributable to any neglect on his part, the officer as well as the body corporate shall be guilty of that offence and shall be liable to be proceeded against and punished accordingly. 4 In paragraph (3), “officer” in relation to a body corporate, means a director, manager, secretary or other similar officer of the body, or a person purporting to act in any such capacity. 5 If the affairs of the body corporate are managed by its members, paragraph (3) shall apply in relation to the acts and defaults of a member in connection with his functions of management as if he were a director of the body corporate. 6 Where an offence under paragraph (1) committed by a partnership in Scotland is proved— a to have been committed with the consent and connivance of the partner, or b to be attributable to any neglect on his part, the partner as well as the partnership shall be guilty of that offence and liable to be proceeded against and punished accordingly. 7 In paragraph (6), partner includes a person purporting to act as a partner. 15 For the purposes of enforcing regulations 5(7), 5(8), 5(9), 5(10), 5(11),5(12) and 5(13), those regulations shall be treated as if they were safety regulations made under section 11 of the 1987 Act provided that section 12 of that Act shall not apply. Enforcement 16 1 No proceedings shall be brought and no enforcement action taken in respect of— a any failure to comply with regulations 4, 5 (with the exception of 5(11) and 5(12)), 7, 9, 10 and 11 in any case in which the cosmetic product is supplied for the purposes of exporting that product to any country which is not a Member State; or b any failure to comply with regulation 7(5)(a) in any case in which the enforcement authority is satisfied that the person supplying the cosmetic product reasonably believes that it will not be used in the United Kingdom. 2 No proceedings shall be brought and no enforcement action taken in respect of any contravention of regulation 5(7) of the Cosmetic Products (Safety) Regulations 2003 once these regulations have come into force. 3 No proceedings shall be brought and no enforcement action taken in respect of any contravention or failure to comply with these Regulations insofar as an entry in Part 2 of Schedule 1 to these Regulations is concerned in respect of a new substance in such an entry or where the cosmetic product in question complied with the entry as it appeared before 24th March 2005 and where the cosmetic product in question was— i placed on the market before 24th March 2005; and ii supplied before 24th September 2005. 4 For the purposes of this regulation, “enforcement action” means any action taken pursuant to or in connection with sections 13, 14, 16, 17, 28, 29, 30 or 31 of the 1987 Act. 17 Any test of goods purchased under section 28 or seized under section 29 of the 1987 Act (which relate to enforcement) by or on behalf of an enforcement authority for the purpose of ascertaining whether the provisions of these Regulations have been contravened shall in all cases be carried out in accordance with the provisions of paragraphs 2 to 5 Schedule 11 and any test for which a method is specified in paragraph 6 of Schedule 11 shall be carried out in accordance with that method. Proceedings 18 No proceedings for an offence under these Regulations shall be commenced after— a the end of the period of three years beginning with the date of the commission of the offence, or b the end of the period of one year beginning with the date of the discovery of the offence by the prosecutor, whichever is earlier. Gerry Sutcliffe, Parliamentary Under Secretary of State for Employment Relations, Competition and Consumers Department of Trade and Industry 17th August 2004 SCHEDULE 1Regulations 1(3), 1(4) and 16(3) PART 1

Schedules 3,4 and 6 to these Regulations shall have effect until 24th March 2005 with the insertion of the entries set out in Part 1 of this Schedule as they appear in the Cosmetic Products (Safety) Regulations 2003 in place of the corresponding entries in the those Schedules to these Regulations.
SubstanceReference number or entry numberSchedule and Part number in the Cosmetic Products (Safety) Regulations 2003
Benzoyl peroxide90Schedule 3, Part 1
Hydroquinone monobenzyl, monoethyl and monomethyl ethers391Schedule 3, Part 1
4-Methoxyphenol458Schedule 3, Part 1
Secondary dialkanolamines643Schedule 3, Part 1
Hydroquinone14Schedule 4, Part 1
Fatty acid dialkanolamides60Schedule 4, Part 1
Monoalkanolamines61Schedule 4, Part 1
Trialkanolamines62Schedule 4, Part 1
1,2-Dibromo-2,4-dicyanobutane [Methyldibromo glutaronitrile]36Schedule 6, Part 1

PART 2

Subject to regulation 1(3), the entries referred to in Part 2 of this Schedule shall not form part of the Schedules referred to in column 3 below until 24th March 2005.
SubstanceReference number or entry numberSchedule and Part number in these Regulations
Secondary alkyl- and alkanolamines and their salts643Schedule 3, Part 1
Hydroquinone monobenzyl and monoethyl ethers391Schedule 3, Part 1
Hydroquinone14Schedule 4, Part 1
Fatty acid dialkylamides and dialkanolamides60Schedule 4, Part 1
Monoalkylamines, Monoalkanolamines and their salts 61Schedule 4, Part 1
Trialkylamines, trialkanolamines and their salts62Schedule 4, Part 1
2,4-Diamino-pyrimidine-3-oxide (CAS No 74638-76-9) 93Schedule 4, Part 1
Benzoyl peroxide94Schedule 4, Part 1
Hydroquinone methyl ether95Schedule 4, Part 1
1,2-Dibromo-2,4-dicyanobutane [Methyldibromo glutaronitrile]36Schedule 6, Part 1

SCHEDULE 2Regulation 3(1)1Council Directive 82/368/EEC (N.J. No. L167, 15.6.82, p.1).2Commission Directive 82/147/EEC (O.J. No. L63, 6.3.82, p.26).3Commission Directive 83/191/EEC (O.J. No. L109, 26.4.83, p.25).4Commission Directive 83/341/EEC (O.J. No. L188, 13.7.83, p.15).5Council Directive 83/574/EEC (O.J. No. L332, 28.11.83, P.38.)6Commission Directive 83/496/EEC (O.J. L275, 8.10.83, P.20).7Commission Directive 84/415/EEC (O.J. No. L228, 25.8.84, p.31).8Commission Directive 85/391/EEC (O.J. L224, 22.8.85, p.40).9Commission Directive 86/179/EEC (O.J. No. L138, 24.5.86, p.40).10Commission Directive 86/199/EEC (O.J. No. L149, 3.6.86, p.38).11Commission Directive 87/137/EEC (O.J. No. L56, 26.2.87, p.20).12Commission Directive 88/233/EEC (O.J. L105, 26.4.88, p.11).13Council Directive 88/667/EEC (O.J. No. L382, 31.12.88, p.46).14Commission Directive 89/174/EEC (O.J. No, L64, 8.3.89, p.10).15Council Directive 89/679/EEC (O.J. No. L398, 30.12.89, p.25).16Commission Directive 90/12/EEC (O.J. No. L71, 17.3.90, p.40).17Commission Directive 91/184/EEC (O.J. No. L91, 12.4.91, p.59).18Commission Directive 92/8/EEC (O.J. No. L70, 17.3.92, p.23)19Commission Directive 92/86/EEC (O.J. No.L325, 11.11.92, p.18).20Commission Directive 93/47/EEC (O.J. No. L203, 13.8.93, p.24).21Council Directive 93/35/EEC (O.J. No. L151, 23.6.93, p.32).22Commission Directive 94/32/EC (O.J. No. L181, 15.7.94, p.31).23Commission Directive 95/34/EC (O.J. No. L167, 18,7.95, p.19)24Commission Directive 96/41/EC (OJ No. L198, 8.8.96, p.36).25Commission Directive 97/18/EC (O.J. No. L114, 1.5.97, p.43).26Commission Directive 97/45/EC (O.J. No. L196, 24.7.97, p.77).27Commission Directive 98/16/EC (O.J. No. L77, 14.3.98, p.44).28Commission Directive 98/62/EC (O.J. No. L253, 15.9.98, p.20).29Commission Directive 2000/6/EC (O.J. No. L56, 1.3.00, p.42).30Commission Directive 2000/11/EC (O.J. No. L65, 14.3.00, p.22).31Commission Directive 2000/41/EC (O.J. No. L145, 20.6.00, p.25).32Commission Directive 2003/1/EC (O.J. No. L102, 18.4.02, p.19).33Commission Directive 2003/1/EC (O.J. No. L5, 10.1.03, p.14).34Commission Directive 2003/16/EC (O.J. No. L46, 20.2.03, p.24).35Commission Directive 2003/15/EC (O.J. No. L66, 11.3.03, p.26).36Commission Directive 2003/80/EC (O.J. No. L224, 6.9.2003, p.27).37Commission Directive 2003/83/EC (O.J. No. L238, 25.9.03, p.23)SCHEDULE 3 LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN Regulations 5(2) and 6(1)

The alphabetical list set out in column 2 of this Schedule contains one or more of the names of each of the substances referred to in regulation 5(2); in certain cases a name is given of a group of substances, the names of particular examples of which are also given, and in such a case all substances comprised in the group are included, whether or not more specifically named.

The references given in columns 3 and 4 are for information only. Those in column 3 are cross-references to other names listed for the same substance (except that where a name is that of a group of substances, the cross-references are to particular examples of that group, and any cross-reference in parenthesis is to the name of a group of substances within which the particular substances falls).

Regulation 1(3) provides that until 24th March 2005 entries 90, 391, 458 and 643 shall be inserted into Part 1 of this Schedule as they appear Part 1, Schedule 3 to the Cosmetic Products (Safety) Regulations 2003. From 24th March 2005 the above entries shall have effect as they appear in Part 1 of this Schedule.

PART 1 SUBSTANCES PROHIBITED IN ALL COSMETIC PRODUCTS
(1)(2)(3)(4)
Number in this ScheduleName of substanceCross-reference to this ScheduleCross-reference to Annex II of the Directive
1Acenocoumarol (INN)397254
2Acetonitrile—393
33-(α-Acetonylbenzyl)-4-hydroxycoumarin and its salts399, 762203
42-Acetoxethyltrimethylammonium hydroxide and its salts62
52-Acetylamino-5-chlorobenzoxazole1631
6Acetylcholine and its salts42
7Acetylene chlorides250, 759126
8Acetylenic alcohols, their esters, ethers and salts1716
9Acetylethyltetramethyltetralin (AETT)342362
107α-Acetylthio-3-oxopregn-4-ene-17α,17β-propionolactone6524
11Aconitine and its salts—12
12Aconitum napellus L. (leaves, roots and galenical preparations)—11
13Adonis vernalis L. and its preparations—13
14Adrenaline270,31514
15Alkali pentacyanonitrosylferrate(2-)-605-6, 647-8255
16O-Alkyldithiocarbonic acids, salts of763336
17Alkyne alcohols, their esters, ethers and salts816
18Alloclamide (INN) and its salts2218
19Allyl isothiocynate—18
202-(4-Allyl-2-methoxyphenoxy)-N,N-diethylacetamide and its salts—224
21N-Allylnormorphine, its salts and ethers49420
222-Allyloxy-4-chloro-N-[2-(diethylamino)ethyl]-benzamide and its salts1819
23Alypine and its salts45, 107143
24Ambenonium chloride (INN)(529)132
254-(or p-)Aminobenzonic acid esters—167
262-Amino-1,2-bis(4-methoxyphenyl)ethanol and its salts—29
27Aminocaproic acid (INN) and its salts317
282-Amino-5-chlorobenzoxazole76924
294-Amino-N-(2-diethylaniaminoethyl)benzamide, its salts and derivatives61025
30Aminoheptane, its isomers and salts75125
316-Aminohexanoic acid and its salts277
32α-(Aminomethyl)-3,4-dihydroxybenzyl alcohol and its salts519-520257
334-Amino-N1o-methylfolic acid4526
342-Amino-6-methylheptane and its salts288, 52528
352-Amino-4-methylhexane and its salts289, 47130
362-Amino-4-nitrophenol—383
372-Amino-5-nitrophenol—384
384-Amino-2-nitrophenol—412
394-(or p-)Aminosalicylic acid and its salts—31
40Aminotoluenes, their isomers, salts and halogenated and sulphonated derivatives71932
41Aminoxylenes, their isomers, salts and halogenated and sulphonated derivatives76533
42Amitriptyline (INN) and its salts284146
43Ammi majus and its galenical preparations—35
44Amphetamine (INN), its salts and derivatives and salts of those derivatives(681)21
45Amydricaine and its salts23, 107143
46Amylene chloride25136
47Amyl 4-dimethylaminobenzoate, mixed isomers534381
48Amyl nitrites—247
49Amylobarbitone and its salts(69)220
50Amylocaine and its salts28250
51Anamirta cocculus L. (fruit)—106
52Substances with androgenic effect—37
53Aniline, its salts and halogenated and sulphonated derivatives—22
54Anthracene oil—38
55Anti-androgens with steroid structure—390
56Antibiotics—39
57Antimony and its compounds—40
58Apocynum cannabinum L. and its preparations—41
59Apomorphine and its salts69742
60Apronalide420216
61Arecoline482238
62Aristolochic acid and its salts—365
63Arsenic and its preparations—43
64Atropa belladonna L. and its preparations—44
65Antropine, its salts and derivatives—45
66Azacyclonol (INN) and its salts305286
67Azamethonium bromide (INN)(473)121
68Barbitone and its salts(69)220
69Barbituratesvarious220
70Barium salts (except barium sulphate, barium sulphide under the condition laid down in Part I of Schedule 4 for alkaline earth sulphides, and lakes, salts and pigments prepared from those colouring agents identified in column 1 of Schedule 5 by “*” immediately after the name or colour index number)—46
71Bemegride (INN) and its salts337, 338183
72Benactyzine (INN)258157
73Bendrofluazide and its derivatives74, 8953
74Bendroflumethiazide (INN) and its derivatives73, 8953
75Benzamine and its salts74451
76Benzatropine (INN) and its salts301158
77Benzazepines, their salts and derivatives8849
78Benzene—47
79Benzene-1,2-diol152, 630408
80Benzene-1,2,3-triol631409
812-Benzhydryloxyethyldimethylamine and its salts296339
82Benzidine24326
83Benzilonium bromide (INN)9360
842-Benziloyloxymethyl-1,1-dimethylpyrrolidinium methyl sulphate602239
85Benzimidozolone86, 26748
86Benzimidazol-2(3H)-one;85, 26748
87Benzoates of 4-hydroxy-3-methoxycinnamyl alcohol (except natural content of essences)211357
88Benzodiazepines, their salts and derivatives7749
89Benzothiadiazine and its derivatives73, 7453
90ENTRY DELETED
913-(N-Benzylhydrazinocarbonyl)-5-methylisoxazole41552
92Benzylideneacetone567356
933-Benzyloxy-1,1-diethylpyrrolidine hydrobromide8360
944-Benzyloxyphenol(391), 487178
952-[Benzyl-N-(2-pyridyl)amino]ethyldimethylamine626, 748347
96Bergapten(e) (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg(357)358
97Beryllium and its compounds—54
98Betamethasone (INN)(361)300
99Betoxycaine (INN) and its salts25723
100BHC (ISO) (gamma-BHC)370, 372, 428195
101Bietammiverine (INN)261287
1021,6-Bis(2-chloroethylamino)-1,6-dideoxymannitol and its salts43689
1032-[Bis(2-chloroethyl)amino]-1-oxa-3-aza-2-phosphacyclohexane 2-oxide and its salts106, 23188
104N,N-Bis(2-chloroethyl)methylamine and its salts159 49287
105N,N-Bis(2-chloroethyl)methylamine N-oxide and its salts49386
106N,N-Bis(2chloroethyl)-1,3,2-oxazaphosphinan-2-ylamine P-oxide and its salts103, 23188
1071,1-Bis(dimethylaminomethyl)propyl benzoate and its salts23, 45143
108Bis(hydroxyalkyl)amines, not further N-substituted255, 274, (643)411
1092,2-Bis(hydroxymethyl)butan-1-ol trinitrate616206
1102,6-Bis(β-hydroxyphenethyl)-1-methylpiperidine and its salts430219
1113,3-Bis(4-hydroxyphenyl)phthalide560417
112Bis(8-hydroxyquinolinium) sulphate, except for the uses provided for in entry number 51 in Part 1 of Schedule 4(401, 533)395
113Bithionol (INN)708352
114Bretylium tosilate (INN) (Bretylium tosylate)11756
115Bromine, elemental—55
116Bromisoval (INN)11958
117 p-Bromobenzylethyldimethylammonium p-toluenesulphonate 11456
1182-Bromo-2-ethylbutyrylurea14857
1192-Bromo-3-methylbutylrylurea11658
1201-p-Bromophenyl-l-(2-pyridyl)-3-dimethylaminopropane and its salts12159
121Brompheniramine (INN) and its salts12059
122Brucine—62
123Butanilicaine (INN) and its salts46690
124Butobarbitone and its salts(69)220
125Butopiprine (INN) and its salts127288
1262-Butoxy-N-(2-diethylaminoethyl)cinchoninamide and its salts190129
1272-Butoxyethyl phenyl(piperidino)acetate and its salts125288
1281-Butyl-3-(N-crotonoylsulphanilyl)urea—108
1294-Butyl-1,2-diphenylpylpyrazolidine-3,5-dione56667
1304-tert-Butyl-3-methhoxy-2,6-dinitrotoluene490414
1314-Butyl-l-phenylpyrazolidine-3,5-dione48664
1321-Butyl-3-(p-methylenzenesulphonyl)urea71865
1331-Butyl-3-sulphanilylurea14966
1344-Butylthiobenzhydryl 2-(dimethylamino)ethyl sulphide142140
1351-tert-Butyl-3,4,5-trimethyl-2,6-dinitrobenzene491422
136Cadmium and its compounds—68
137Calabar bean588281
138Calciferol317, (761)335
139Cantharides, Cantharis vesicatoria65069
140Cantharidin37970
141Captan (ISO)737370
142Captodiame (INN)134140
143Caramiphen (INN) and its salts570169
144N-(3-Carbamoyl-3,3-diphenylpropyl)-N,N-diisopropylmethylammonium salts419156
145Carbazole, nitroderivatives of51072
146Carbon disulphide—73
147Carbon tetrachloride693315
148Carbromal (INN)11857
149Carbutamide (INN)13366
150Carisoprodol (INN)480235
151Catalase—74
152Catechol79, 630408
153Cells, tissues or products of human origin—416
154Cephaeline and its salts—75
155Chenopodium ambrosioides (essential oil)—76
156Cherry laurel water621291
157Chloral hydrate73577
158Chlorine—78
159Chlormethine (INN) and its salts104, 49287
160Chlormezanone (INN)17491
1614-Chlorobenzene-1,3-disulfonamide19385
1625-Chloro-1,3-benzoxazol-2(3H)-one18582
163N-5-Chlorobenzoxazol-2-ylacetamide51
1642-Chloro-9-[3-dimethylamino-6-methylpyrimidine168, 216,83
1652-Chloro-9-[3-(dimethylamino)-propylidene]thioxanthene (cis-form) and its salts18284
166Chloroethane32896
167Chloroform737366
1682-Chloro-6-methylpyrimidin-4-yldimethylamine164, 21683
169Chlorophacinone (ISO)17593
1701-(p-Chloro-α-phenylbenzyl)-4-(2-hydroxyethoxyethyl)piperazine402240
1712-(4-Chlorophenyl)-1-[4-2-diethyl-aminoethoxyl)]phenyl-1-p-tolyethanol74792
1724-[4-(4-Chlorophenyl)-4-hydroxypiperidin-1-yl]-1-(4-fluorophenyl)butan-1-one369185
1732-(4-Chlorophenyl)-3-methylbutane-2,3-diol55495
1742-(4-Chlorophenyl-3-methyl-1,3-thiazinan-4-one 1,1-dioxide16091
1752-[2-(4-Chlorophenyl)-2-phenylacetyl]indane-1,3-dione16993
1762-[1-(4-Chlorophenyl)-1-phenylethoxy]ethyl-(dimethyl)amine17994
177Chloropicrin738325
1783-(4-Chloro-3-sulphamoylphenyl)-3-hydroxyisoindolin-1-one183, 184262
179Chlorphenoxamine (INN)17694
180Chlorpromazine (INN)(561)320
181Chlorpropamide (INN)61779
182Chlorprohixene (INN) and its salts16584
183Chlortalidone (INN)178, 184262
184Chlorthalidone178, 184262
185Chlorzoxazone (INN)16282
186Cholecalciferol(761)335
187Choline salts and their esters—168
188Chromium, chromic acid and salts of the acid—97
189Chrysoidine citrate hydrochloride56581
190Cinchocaine (INN) and its salts126129
191Cincophen (INN), its salts and derivatives and salts of those derivatives5808
192Claviceps purpurea Tul., its alkaloids and galenical preparations31898
193Clofenamide (INN)16185
194Clofenotane (INN)734123
195Coal tar, crude and refined218420
196Cobalt benzenesulphonate—101
197Cocculin592282
198Colchicine, its salts and derivatives—102
199Colchicoside and its derivatives—103
200Colchicum automnale L, and its galenical preparations—104
201Colouring agent CI 12075 and its lakes, pigments and salts—397
202Colouring agent CI 12140—378
203Colouring agent CI 13065—387
204Colouring agent CI 15585—401
205Colouring agent CI 26105—379
206Colouring agent CI 42535—388
207Colouring agents CI 42555, 42555:1 and 42555:2—380
208Colouring agent CI 42640—386
209Colouring agent CI 45170 and CI 45170:1—398
210Colouring agent CI 61554—389
211Coniferyl benzoate (except natural content of essences)87357
212Coniine618290
213Conium maculatum L. (fruit, powder, galenical preparations)—99
214Convallatoxin—105
215Coumetarol (INN)454225
216Crimidine (ISO)164, 16883
217Croton tiglium (oil)—107
218Crude and refined coal tars195420
219Curare and curarine—109
220Curarizants, synthetic—110
2211-(3-Cyano-3,3-diphenylpropyl)-4-ethoxycarbonyl-4-phenylpiperidinium chloride29780
222Cyclarbamate (INN)230122
223Cyclizine (INN) and its salts302159
224Cyclobarbitone and its salts(69)220
225Cyclocoumarol268234
2262-a-Cyclohexylbenzyl(N,N,N’,N’-tetraethyl)trimethylenediamine555112
2272-Cyclohexyl-3,5-dimethylphenol and its salts229113
228Cyclohexyl-3-(p-methylbenzenesulphonyl)urea364100
229Cyclomenol (INN) and its salts227113
230Cyclopentane-1,1-dimethanol dicarbanilate222122
231Cyclophosphamide (INN) and its salts103, 10688
232Datura stranibuyn L. and its galenical preparations54301
233DDT (ISO) (pp’-DDT)194 734123
234Deanol aceglumate (INN)2793
235Decamethonuium bromide (INN)(236)214
236Decamethylene-bis(trimethylammonium) salts235214
237Dextromethorphan (INN) and its salts457226
238Dextropropoxyphene (INN)281116
239O,O’-Diacetyl-N-allyl-N-normorphine—117
2402,4-Diaminoanisole and its salts455, 461376
2412,5-Diaminoanisole and its salts456, 460377
2421,2-Diaminobenzene and its salts573363
243p,p’-Diaminodiphenyl8226
2442-(2,4-Diaminophenyl)ethanol and its salts—407
2451,4:3,6-Dianhydrosorbitol 2,5-dinitrate422148
2465-(α,β-Dibromophenethyl)-5-methylhydantoin—119
247Dibromosalicylanilides248, 443351
248Dibromsalan (INN)(247)351
249Dichloroethanes330, 335125
250Dichloroethylenes7, 759126
2512,3-Dichloro-2-methylbutane4636
252Dichlorosalicylanilides—349
253Dicoumarin254, 469231
254Dicoumarol (INN)253, 469231
255Diethanolamine(108, 643)411
256 2-Diethylaminoethoxy)ethyl α-phenylpiperidine-1-acetate dimethiodide 601137
2572-Diethylaminoethyl 3-amino-4-butoxybenzoate and its salts9923
2582-Diethylaminoethyl benzilate72157
2592-Diethylaminoethyl 4-ethoxybenzoate and its salts411, 538179
2602-Diethylaminoethyl 3-hydroxy-4-phenylbenzoate and its salts—128
2612-Diethylaminoethyl phenyl(piperidino)acetate101287
2623-Diethylaminopropyl cinnamate—130
263Diethyl 4-nitrophenyl phosphate536170
264O,O-Diethyl O-4-nitrophenyl phosphorothioate537131
265Difencloxazine INN)569270
266Digitaline and all heterosides of Digitalis purpureaL.—134
2674.5-Dihydrobenzimidazol-4-one85 8648
2683,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H,5H-pyrano[3,2-c]-[1]]-benzopyran-5-one225234
269Dihydrotachacysterol (INN)–342
2703,4-Dihydroxy-α-(methylaminomethyl)benzyl alcohol14, 31514
2714,4’-Dihydroxy-3,3’-(3-methylthiopropylideneI)dicoumarin–207
2721-(3,4-Dihydroxyphenyl)-2-ethylaminopropan-1-ol and its salts294136
2731-(3,4-Dihydroxyphenyl)-2-isopropylaminoethanol418, 42117
274Diisopropanolamine(108, 643)411
2755,5’-Di-isopropyl-2,2’-dimethylbiphenyl-4,4’-diyldihypoiodite413361
276Dimethoxane286368
2774-[2-(3,4-Dimethoxyphenyl)ethyl]-1-(2-chlorophenyl)piperazine and its salts438141
278Dimethylamine—142
2792-Dimethylaminoethyl N-acetylglutamate2343
2802-Dimethylaminoethyl p-butylaminobenzoate and its salts69063
281(+)-4-Dimethylamino-3-methyl-1,2-diphenyl-2-propionyloxybutane238116
2821-Dimethylaminomethyl-1-methylpropyl benzoate and its salts5050
2832-Dimethylaminopropiophenone and its salts445145
2843-(3-Dimethylaminopropylidene)-1,2,4,5-dibenzocyclohepta-1,4-diene and its salts42146
2851,1-Dimethylbiguanide and its salts447147
2862,6-Dimethyl-1,3-dioxan-4-yl- acetate276368
287Dimethylformamide–355
2881,5-Dimethylhexylamine and its salts34, 52528
2891,3-Dimethylpentylamine and its salts35, 47130
290Dimethyl sulfoxide (INN)—338
291Dimevamide (INN) and its salts298153
292Dinitrophenol isomers—151
293Dioxane—343
294Dioxethedrin (INN) and its salts272136
2952,5-Dioxo-3,3-diethyl-5-methylpiperidine and its salts483133
296Diphenhydramine (INN) and its salts81339
297Diphenoxylate hydrochloride (INNM)22180
2982,2-Diphenyl-4-dimethylaminovaleramide and its salts291153
2995,5-Diphenyl-4-imidazolidone—160
3004-Diphenylmethoxy-1-methylpiperidine and its salts306154
3013-Diphenylmethoxytropane and its salts76158
3021-Diphenylmethyl-4-methylpiperazine and its salts223159
3031,2-Diphenyl-4-(2-phenylsulphinylethyl)-pyrazolidine-3,5-dione664155
304α,α-Diphenyl-2-piperidinemethanol and its salts600285
305α,α-Diphenyl-4-piperidinemethanol and its salts66286
306Diphenylpyraline (INN) and its salts300154
3072,5-Dipropoxy-3,6-bis(ethyleneimino)-1,4-benzoquinone410152
3084-Dipropylsulphamoylbenzoic acid609161
309Disulfiram (INN)702, 713162
310Dithio-2,2’-bis(pyridine 1-oxide) 1,1’ (additive with trihydrated magnesium sulphate)628396
311Doxylamine (INN) and its salts579176
312Emetine, its salts and derivatives—163
313Endrin (ISO)373196
314Ephedrine and its salts—164
315Epinephrine (INN)14, 27014
3161,2-Epoxybutane—400
317Ergocalciferol (INN)138 (761)335
318Ergot and its alkaloids19298
319Eserine and its salts589166
320Ethionamide (INN)336319
321Ethoheptazine (INN) and its salts476173
322Ethopropazine and its salts(561)320
3234-Ethoxyphenol(391)178
3244-Ethoxy-m-phenylenediamine and its salts—406
3252-Ethylamino-5-phenyloxazolin-4-one345180
326Ethyl bis(4-hydroxycoumarinyl)acetate and salts of the acid327204
327Ethyl bis(4-hydroxy-2-oxo-1-benzopyran-3-yl)acetate and salts of the acid326204
328Ethyl chloride16696
329Ethyl 1,3-dimethyl-4-phenylazepane-4-carboxylate and its salts446171
330Ethylene dichloride(249)125
331Ethylene oxide—182
3322-Ethyl-2,3-epoxyhexamide and its derivatives530165
333Ethyl p-fluorophenyl sulphone348189
334Ethyl 1-(2-hydroxy-2-phenylethyl)-4-phenylpiperidine-4-carboxylate and its salts532172
335Ethylidene dichloride(249)125
3363-Ethylisothionicotinamide320319
3373-Ethyl-3-methylglutarimide and its salts71, 338183
3384-Ethyl-4-methylpiperidine-2,6-dione and its salts71, 337183
3392-Ethyl-3-methylvaleramide755184
340Ethylphenacemide556, 568272
3412-Ethyl-2-phenylglutarimide and its salts362181
3423’-Ethyl-5’,6’,7’,8’-tetrahydro-5’,5’,8’,8’-tetramethyl-2’-acetonaphthone9362
343Ethyl urocanate(406)418
344Fenadiazole (INN)528208
345Fenozolone (INN)325180
346Fenyramidol (INN)578, 582274
347Fluanisone (INN)351187
348Fluoresone (INN)333189
3494’-Fluoro-4-[4-hydroxy-4-(α,α,α-trifluoro-m-tolyl)piperino]butyrophenone741188
3506-Fluoro-16-methyl-11β,17α,21-trihydroxypregna-1,4-diene-3,20-dione535186
3511-(4-Fluorophenyl)-4-[4-(2-methoxyphenyl)-1-piperazinyl]butan-1-one347187
3525-Fluoropyrimidine-2,4-dione353190
353Fluorouracil (INN)352190
354Fluphenazine (INN)(561)320
355Furazolidone (INN)513252
356Furfuryltrimethylammonium salts358192
357Furocoumarins (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg96, 462, 623, 746358
358Furtrethonium iodide (INN)(356)192
359Galantamine (INN)—193
360Gallamine triethiodide (INN)518329
361Glucocorticoids98300
362Glutethimide (INN) and its salts341181
363Glycerol trinitrate514, 615253
364Glycyclamide (INN)228100
365Gold salts—296
366Guaifenesin (INN)459230
367Guanethidine (INN) and its salts368259
368N-(2-Guanidinoethyl)azocane and its salts367259
369Haloperidol (INN)172185
370HCH (ISO) (gamma-HCH)100, 372, 428195
371HETP378316
3721,2,3,4,5,6-Hexachlorocyclohexane100, 370, 428195
373(1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-6,7-epoxy-1,4,4a,5,6,7,8,8a-octahydro-1,4:5,8 dimethanonaphthalene313196
374Hexachloroethane—197
3753,3’4,4’6,6’-Hexachloro-2,2’-methylenediphenol376371
376Hexachlorophene (INN)375371
377(1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4:5,8-dimethanonaphthalene416198
378Hexaethyl tetraphosphate371316
379(1R,2S)-Hexahydro-1,2-dimethyl-3,6-epoxyphthalic anhydride14070
380(3S,5aR,9bS)-3,3a,4,5,5a,9b-Hexahydro-3,5a,9-trimethylnaphtho[1,2-b]furan-2,8-dione639217
381Hexamethonium bromide (INN)(382)124
382N-N’-Hexamethylenebis(trimethylammonium) salts381124
383Hexapropymate (INN)619115
384Hydrastine, hydrastinine and their salts—199
385Hydrazides and their salts—200
386Hydrazine, its derivatives and their salts—201
3872-Hydrazino-octane and its salts523202
388Hydrocyanic acid and its salts390, 409, 604111
389Hydrofluoric acid, its normal salts, complexes and hydrofluorides (except those listed in Part I of Schedule 4)—191
390Hydrogen cyanide and its salts388, 409, 604111
391Hydroquinone monobenzyl and monoethyl ethers487178
3927-[2-Hydroxy-3-(2-hydroxyethyl-N-methylamino)propyl]theophylline764135
393[4-[4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl] acetic acid and its salts7425
3943-[4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]propionic acid and its salts7169
3952-Hydroxy-3-(2-methoxyphenyl)propyl carbamate450205
3961-Hydroxymethyl-1-cyclohexcylacetic acid, sodium salt646114
3974-Hydroxy-3-[1-(4-nitrophenyl)-3-oxobutyl]coumarin1254
3988-Hydroxy-5-nitroquinoline and its salts517209
3994-Hydroxy-3-(3-oxo-1-phenylbutyl)coumarin and its salts3, 762203
40011α-Hydroxypregn-4-ene-3,20-dione and its esters—385
401Hydroxy-8-quinoline and its sulphate, except for the uses provided for in entry number 51 in Part I of Schedule 4112, 533, 633395
402Hydroxyzine (INN)170240
403Hyoscine, its salts and derivatives641295
404Hyoscyamine, its salts and derivatives—210
405Hyoscyamus niger L. (leaves, seeds, powder and galenical preparations)—211
4063-Imidazol-4-ylacrylic acid and its ethyl ester343, 753418
4072-Imino-5-phenyloxazolidin-4-one and its salts540212
408Imperatorin46534
409Inorganic cyanides(388, 390), 604111
410Inproquone (INN)307152
411Intracaine and its salts259, 538179
412Iodine—213
413Iodothymol275361
414Ipecacuanha (Cephaelis ipecacuanha Brot. and related species) (roots, powder and galenical preparations)—215
415Isocarboxazid (INN)9152
416Isodrin377198
417Isometheptene (INN) and its salts463228
418Isoprenaline (INN)273, 42117
419Isopropamide iodide (INN)(144)156
420(2-Isopropylpent-4-enoyl)urea60216
421Isoproterenol273, 41817
422Isosorbide dinitrate (INN)245148
423Juniperus Sabina L (leaves, essential oil and galenical preparations)—294
424Laurus nobilis L. (oil from seeds)—359
425Lead and its compounds (except lead acetate subject to the restrictions laid down in entry number 55 in Part I of Schedule 4)—289
426Levophacetoperane and its salts597284
427Lidocaine (INN) (Lignocaine)—399
428Lindane100, 370, 372195
429Lobelia inflata L. and its galenical preparations—218
430Lobeline (INN) and its salts110219
431LSD(433 434)127
432Lupinidine and its salts651299
433Lysergic acid diethylamide and its salts431, 434127
434Lysergide (INN) and its salts431, 433127
435Malononitrile—149
436Mannomustine (INN) and its salts10289
437Mecamylamine (INN)701229
438Mefeclorazine (INN) and its salts277141
439Mephenesin (INN) and its esters721322
440Meprobamate (INN)481236
441Mercury and its compounds (except those listed in Part I of Schedule 6)—221
442Mescaline and its salts743222
443Metabromsalan (INN)(247)351
444Metaldehyde603223
445Metamfepramone (INN) and its salts283145
446Metethoheptazine (INN) and its salts329171
447Metformin (INN) and its salts285147
448Methapyrilene (INN) and its salts627144
449Metheptazine (INN) and its salts468174
450Methocarbamol (INN)395205
451Methohexitone and its salts(69)220
452Methotrexate (INN)336
4532-[4-Methoxybenzyl-N-(2-pyridyl)amino]-ethyldimethylamine maleate625346
4541-Methoxy-2,2-bis(4-hydroxy-3-coumarinyl)ethane215225
4551-Methoxy-2,4-diaminobenzene and its salts240, 461376
4561-Methoxy-2,5-diaminobenzene and its salts241, 460377
457(+)-3-Methoxy-N-methylmorphinan and its salts237226
458ENTRY DELETED
4593-(2-Methoxyphenoxy)propane-1,2-diol366230
4602-Methoxy-p-phenylenediamine and its salts241, 456377
4614-Methoxy-m-phenylenediamine and its salts240, 455376
462Methoxypsoralens (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg(357)358
4636-Methylamino-2-methylhept-2-ene and its salts417228
4642-Methyl-1,2-bis(3-pyridyl)propan-1-one484292
4659-(3-Methylbut-2-enyloxy)furo-[3,2-g]chromen-7-one40834
4662-Methyl-6-chloroanilide of n-butylaminoacetic acid and its salts12390
4671-Methyl-2,4-diaminobenzene and its salts477364
468Methyl 1,2-dimethyl-4-phenylazepane-4-carboxylate and its salts449174
4693,3-Methylenebis-(4-hydroxycoumarin)253, 254231
4702-Methylheptylamine and its salts—227
4714-Methyl-2-hexylamine and its salts35, 28930
4721-Methylimidazole-2-thiol474, 707233
473N,N’ [Methylimino)diethylene]bis-(ethyldimethylammonium) salts67121
4741-Methyl-2-mercaptoimidazole472, 707233
475Methylphenidate (INN) and its salts575175
4761-Methyl-4-phenyl-4-carbethoxyhexa-methyleneimine and its salts321173
4774-Methyl-m-phenylenediamine and its salts467364
4782-Methyl-m-phenylenediamine—413
4793-Methyl-2-phenylmorpholine, its derivatives and salts558232
4802-Methyl-2-propyl-1-isopropylcarbamoyloxy-3-carbamoyloxypropane150235
4812-Methyl-2-propyltrimethylene dicarbamate440236
482N-Methyl-1,2,5,6-tetrahydro-3-nicotine acid methyl ester61238
483Methyprylon (INN) and its salts295133
484Metyrapone (INN)464292
485Minoxidil (INN), its salts and derivatives599372
486Mofebutazone (INN)13164
487Monobenzone (INN)94, (391)178
488Morpholine and its salts—344
489Moskene546421
490Musk ambrette130414
491Musk tibetene135422
492Mustine and its salts104, 15987
493Mustine N-oxide and its salts10586
494Nalorphine (INN), its salts and ethers2120
495Naphazoline (INN) and its salts501244
4962-Naphthol497241
497β-Naphthol496241
4981-and 2-Naphthylamines and their salts499242
499α-and β-Naphthylamines and their salts498242
5003-(1-Naphthyl)-4-hydroxycoumarin—243
5012-(1-Naphthylmethyl)-2-imidazoline and its salts495244
502Narcotics, natural and synthetic: All substances listed in Tables I and II of the Single Convention on Narcotic Drugs 1961 (Treaty Series No. 34 (1965), Cmnd. 2631)—306
503Narcotine and its salts521258
504Neodymium and its salts—309
505Neostigmine and its salts—245
506Nicotine and its salts—246
507Nitrites, inorganic (except sodium nitrite)—248
508Nitrobenzene—249
509Nitrocresols and their alkali metal salts—250
510Nitroderivatives of carbazole14572
511Nitrofurantoin (INN)512251
512N-(5-Nitro-2-furfurylidene)-1-aminohydantoin511251
5133-(5-Nitrofurfurylideneamino)oxazolidin-2-one355252
514Nitroglycerine363, 615253
515Nitrosamines—410
516Nitrostilbenes, their homologues and derivatives—256
517Nitroxoline (INN) and its salts398209
518N,N,N,N’,N’,N”,N”,N”-Nonaethyl-2,2’2”-(benzene-1,2,3-triyltrioxy)-tris(ethanaminium) triiodide360329
519Noradrenaline and its salts32, 520257
520Norepinephrine (INN) and its salts32, 519257
521Noscapine (INN) and its salts503258
522Nux Vomica and its preparations(661)305
523Octamoxin (INN) and its salts387202
524Octamylamine (INN) and its salts—267
525Octodrine (INN) and its salts34, 28828
526Oestrogens—260
527Oleandrin—261
5282-(1,3,4-Oxadiazol-2-yl)phenol344208
529[Oxalylbis(iminoethylene)]bis[(o-chlorobenzyl)diethylammonium] salts24132
530Oxanamide (INN) and its derivatives332165
5312-Oxo-3-isobutyl-9,10-dimethoxy-1,2,3,4,6,7-hexahydro-11b-H-benzo[a]quinolizine and its salts688139
532Oxpheneridine (INN) and its salts334172
533Oxyquinoline and its sulphate, except for the uses provided for in entry number 51 in Part I of Schedule 4112, 401, 633395
534Padimate A47381
535Paramethasone (INN)350186
536Paraoxon263170
537Parathion (ISO)264131
538Parethoxycaine (INN) and its salts259, 411179
539Pelletierine and its salts598263
540Pemoline (INN) and its salts407212
541Pentachloroethane—264
542Pentaerythritol chloral552266
543Pentaerythritol tetranitrate544, 551265
544Pentaerythrityl tetranitrate (INN)543, 551265
545Pentamethonium bromide (INN)(547)120
5461,1,3,3,5-Pentamethyl-4,6-dinitroindane489421
547N,N’-Pentamethylenebis(trimethylammonium) salts545120
548Pentobarbitone and its salts(69)220
549Perchloroethylene692314
550Perphenazine (INN) and its salts(561)320
551PETN543, 544265
552Petrichloral (INN)542266
553Phenacemide (INN)564269
554Phenaglycodol (INN)17395
555Phenetamine226112
556Pheneturide (INN)340, 568272
557Phenindone (INN)574271
558Phenmetrazine (INN), its derivatives and salts479232
559Phenobarbitone and its salts(69)220
560Phenolphthalein (INN)111417
561Phenothiazine (INN) and its compoundsvarious320
562Phenprobamate (INN)57671
563Phenprocoumon (INN)577273
564N-Phenylacetylurea553269
5654-Phenylazophenylene-1,3-diamine citrate hydrochloride18981
566Phenylbutazone (INN)12967
5674-Phenylbut-3-en-2-one92356
568(2-Phenylbutyryl)urea340, 556272
569N-[2-(α-Phenyl-p-chlorobenzyl)ethyl]morpholine265270
5701-Phenylcyclopentanecarboxylic acid diethylaminoethyl ester and its salts143169
5712-Phenycyclopropylamine (trans-form) and its salts722324
5721-Phenyl-2,3-dimethyl-4-isopropylpyrazol-5-one620138
573o-Phenylenediamine and its salts242363
5742-Phenylindan-1,3-dione557271
575α-Phenyl-2-piperidineacetic acid methyl ester and its salts475175
5763-Phenylpropyl carbamate56271
5773-(α-Phenylpropyl)-4-hydroxycoumarin563273
5781-Phenyl-2-(2-pyridylamino)ethanol346, 582274
5792-[1-Phenyl-1-(2-pyridyl)ethoxy]-ethyldimethylamine and its salts311176
5802-Phenylquinoline-4-carboxylic acid its salts and derivatives and salts of those derivatives1918
5816-Phenyl-2,4,7-triaminopteridine and its salts725275
582Phenyramidol346, 578274
583Phosphides, metal—279
584Phosphorus—279
5854-Phosphoryloxy-N,N-dimethyltryptamine622278
5863-Phthalimidopiperidine-2,6-dione and its salts704280
587Phthalylsulphathiazole (INN) and its salts(678)307
588Physostigma veneriosum Balf.137281
589Physostigmine and its salts319166
590Phytolacca spp and their preparations—374
591Picric acid745268
592Picrotoxin197282
593Pilocarpine and its salts—283
594Pilocarpus jaborandi Holmes and its galenical preparations—311
595Pipazetate (INN) and its salts596118
5962-(2-Piperidinoethoxy)ethyl 10-thia-1,9-diazaanthracene-9-carboxylate and its salts95118
597α-Piperidin-2-ylbenzyl acetate laevorotatory threo-form and its salts426284
5981-(2-Piperidyl)propan-2-one and its salts539263
5996-(Piperidinyl)-2,4-pyrimidinediamine 3-oxide, its salts and derivatives485372
600Pipradrol (INN) and its salts304285
601Piprocurarium idodide (INN)256137
602Poldine metilsulfate (INN) (Poldine methylsulphate)84239
603Polyacetaldehyde444223
604Potassium cyanide(388, 390, 409)111
605Potassium nitroferricyanide(15), 606255
606Potassium nitroprusside(15), 605255
607Pramocaine (INN)608405
608Pramoxine607405
609Probenecid (INN)308161
610Procainamide (INN) its salts and derivatives2925
611Prochlorperazine (INN) and its salts(561)320
612Progestogens—194
613Promazine (INN) and its salts(561)320
614Promethazine (INN) and its salts(561)320
615Propane-1’,2,3-triyl trinitrate363, 514253
616Propatylnitrate (INN)109206
6171-Propyl-3-(4-chlorobenzenesulphonyl)urea18179
6182-Propylpiperidine212290
6191-(2-Propynyl)cyclohexyl carbamate383115
620Propyphenazone(INN)572138
621Prunus laurocerasus L.156291
622Psilocybine (INN)585278
623Psoralen (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg(357)358
624Pyrethrum album L. and its galenical preparations—345
625Pyrianisamine maleate453346
626Pyribenzamine95, 748347
6272-(N-2-Pyridyl-N-2-thienylamino)ethyl-dimethylamine and its salts448144
628Pyrithione disulphide + magnesium sulphate310396
629Pyrithione sodium—369
630Pyrocatechol79, 152408
631Pyrogallol80409
632Quinalbarbitone and its salts(69)220
633Quinolin-8-ol (except for the uses provided for in entry number 51 in Part I of Schedule 4)(401, 533)395
634Radioactive substances (within the meaning of Article 1 of Council Directive 96/29/Euratom(a) laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation)—293
635Rauwlfia serpentine alkaloids and their salts63615
636Reserpine (INN) and its salts(635)15
637Retinoic acid and its salts724, 760375
638Safrole (except natural content of essences in cases where the concentration of such safrole in the cosmetic product does not exceed— (a) in the case of oral hygiene or dental products other than toothpaste intended specifically for children, 50 mg/kg; or (b) in the case of products other than oral hygiene or dental products, 100 mg/kg)—360
639α-Santonin380214
640Schoenocaulon officinale Lind. (seeds and galenical preparations)—332
641Scopolamine, its salts and derivatives403295
642Secbutobarbitone and its salts(69)220
643Secondary alkyl- and alkanolamines and their salts108, 255, 274411
644Selenium and its compounds (except when permitted under the restrictions laid down in Part I of Schedule 4)—297
645Sodium cyanide(388, 390, 409)111
646Sodium hexacyclonate (INN)396114
647Sodium nitroferricyanide(15), 648255
648Sodium nitroprusside(15), 647255
649Solanum nigrum L. and its galenical preparations–298
650Spanish Fly13969
651Sparteine (INN) and its salts432299
652Spironolactone (INN)104
653Squill and its preparations752330
654Stramonium and its preparations232301
655Strontium lactate-402
656Strontium nitrate-403
657Strontium polycarboxylate-404
658Strophanthines and their aglucones and their respective derivatives-302
659Strophanthus species and their galenical preparations-303
660Strychnine and its salts-304
661Strychnos species and their galenical preparations522305
662Succinonitrile-150
663Succinylsulphathiazole and its salts(678)307
664Sulfinpyrazone (INN)303155
665Sulphacetamide and its salts(678)307
666Sulphadiazine and its salts(678)307
667Sulphadimethoxine and its salts(678)307
668Sulphadimidine and its salts(678)307
669Sulphafurazole and its salts(678)307
670Sulphaguanidine and its salts(678)307
671Sulphamethizole and its salts(678)307
672Sulphamethoxazole and its salts(678)307
673Sulphamethoxydiazine and its salts(678)307
674Sulphamethoxypyridazine and its salts(678)307
675Sulphanilamide and its salts(678)307
676Sulphapyridine and its salts(678)307
677Sulphathiazole and its salts(678)307
678Sulphonamides (sulphanilamide and its derivatives obtained by substitution of one or more H-atoms of the -NH2 groups) and their salts665-677307
679Sulthiame680, 699308
680Sultiame (INN)679, 699308
681Sympathomimetic amines acting on the central nervous system: any substance contained in the first list of medicaments which are subject to medical prescription and are referred to in resolution AP (69) 2 of the Council of Europe4421
682Tefazoline (INN) and its salts698237
683Tellurium and its compounds-312
684TEPP (ISO)696276
6852-(4-tert-Butyl-2,6-dimethylbenzyl)-2-imidazoline and its salts766313
6864-tert-Butylphenol-340
6874-tert-Butylpyrocatechol-341
688Tetrabenazine (INN) and its salts531139
689Tetrabromosalicylanilides-367
690Tetracaine (INN) and its salts28063
6912,3,7,8-Tetrachlorodibenzo-p-dioxin-367
692Tetrachloroethylene549314
693Tetrachloromethane147315
694Tetrachlorosalicylanilides-348
695Tetraethylammonium bromide70361
696Tetraethyl pyrophosphate684276
697(R)-5,6,6a,7-Tetrahydro-6-methyl-4H-dibenzo[de,g]quinoline-10,11-diol and its salts5942
6982-(5,6,7,8-Tetrahydro-1-naphthylmethylmethyl)-2-imidazoline and its salts682237
6994-(Tetrahydro-2H-1,2-thiazin-2-yl)-benzenesulphonamide S,S-dioxide679, 680308
700Tetrahydrozoline and its salts-394
701N,2,3,3-Tetramethyl-2-nocamphanamine437229
702Tetramethylthiuram disulphide713162
703Tetrylammonium bromide (INN)69561
704Thalidomide (INN) and its salts586280
705Thallium and its compounds-317
706Thevetia neriifolia Juss., glycoside extract-318
707Thiamazole (INN)472, 474233
7082,2’-Thiobis(4,6-dichlorophenol)113352
709Thiopentone and its salts(69)220
710Thioridazine (INN) and its salts(561)320
711Thiotepa (INN)726310
712Thiourea and its derivatives (except those listed Part I of Schedule 4)-321
713Thiram (ISO)702162
714Thiuram disulphides-354
715Thuiram monosulphides-353
716Thyropropic acid (INN) and its salts3949
717Tolboxane (INN)720177
718Tolbutamide (INN)13265
719Toluidines, their isomers, salts and halogenated and sulphonated derivatives4032
720p-Tolyboric acid ester of 2-methyl-2-propylpropane-1,3-diol717177
7213-o-Tolyoxypropane-1,2-diol(439)322
722Tranylcypromine (INN) and its salts571324
723Tretamine (INN)727328
724Tretinoin (INN) and its salts637, 760375
725Triamterene (INN) and its salts581275
726Tri(aziridin-1-yl)phosphine sulphide711310
7272,4,6-Tri(aziridin-l-yl)-1,3-triazine723328
7282,2,2-Tribromeothanol(729)326
729Tribromoethyl alcohol728326
730Tribromsalan (INN)731373
7313,4’,5-Tribromosalicylanilde730373
732Trichlormethine (INN) and its salts749327
733Trichloroacetic acid-10
7341,1,1-Trichloro-2,2-bis(4-chlorophenyl)ethane194, 233123
7352,2,2-Trichloroethane-1,1-diol15777
736Trichloromethane167366
737N-(Trichloromethylthio)cyclohex-4-ene-1,2-dicarboximide141370
738Trichloronitromethane177325
739Tricresyl phosphate750277
740Trifluoperazine (INN) and its salts(561)320
741Trifluperidol (INN)349188
7423,3’,5-Triiodothyroacetic acid and its salts3935
7433,4,5-Trimethoxyphenethylamine and its salts442222
7442.2,6-Trimethyl 1-4-piperidyl benzoate and its salts7551
7452,4,6-Trinitrophenol591268
746Trioxysalen (INN) (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg(357)358
747Triparanol (INN)17192
748Tripelennamine (INN)95, 626347
749Tris(2-chloroethyl)amine732327
750Tritolyl phosphate739277
751Tauminoheptane (INN), its isomers and salts3027
752Urginea scilla Stern. and its galenical preparations653330
753Urocanic acid(406)418
754Vaccines, toxins and serums listed in the Annex to Council Directive No. 75/319/EEC(a)-323
755Valnoctamide (INN)339184
756Veratrine, its salts and galenical preparations-331
757Veratrun spp and their preparations-333
758Vinyl chloride monomer-334
759Vinylidene chloride(7,250)126
760Vitamin A acid and its salts637, 724375
761Vitamins D2 and D3138, 186, 317335
762Warfarin (ISO) and its salts3, 399203
763Xanthates16336
764Xanthinol392135
765Xylidines, their isomers, salts and halogenated and sulphonated derivatives4133
766Xylometazoline (INN) and its salts685313
767Yohimbine and its salts-337
768Zirconium and its compounds (except aluminium chloride hyroxide complexes and aluminium zirconium chloride hydroxide glycine complexes under the conditions laid down in Part I of Schedule 4 and zirconium lakes, salts and pigments prepared from those colouring agents identified in column 1 Part I of Schedule 5 by “*” immediately after the name or colour index number)-391
769Zoxazolamine (INN)2824
PART 2 SUBSTANCES PROHIBITED WHEN USED AS A FRAGRANCE INGREDIENT Regulation 5(2)
(1)(2)(3)(4)
Number in this ScheduleName of substanceCross-reference to this ScheduleCross-reference to Annex II of the Directive
1Alanroot oil (Inula helenium)-423
2Benzyl cyanide31424
3Cyclamen alcohol22425
4Decahydro-6-isopropyl-2-naphthol21441
5Diethyl maleate-426
6Dihydrocoumarin8427
76,7-Dihydrogeraniol10429
83,4-Dihydroxycoumarin6427
92,4-Dihydroxy-3-methylbenzaldehyde-428
103,7-Dimethyl-2-octen-1-ol7429
114,6-Dimethyl-8-tert-butylcoumarin-430
12Dimethyl citraconate-431
137,11-Dimethyl-4,6-10-dodecatrien-3-one-432
146,10-Dimethyl-3,5,9-undecatrien-2-one-433
15Diphenylamine-434
16Ethyl acrylate-435
17Fig leaf absolute (Ficus carica)-436
18trans-2-Heptenal-437
19trans-2-Hexenal diethyl acetal-438
20trans-2-Hexenal dimethyl acetal-439
21Hydroabietyl alcohol-440
226-Isopropyl-2-decahydronaphthalenol4441
233-(4-Isopropylphenyl)-2-methylpropan-1-ol3425
247-Methoxycoumarin-442
254-(4-Methoxyphenyl)-3-butene-2-one-443
261-(4-Methoxyphenyl)-1-penten-3-one-444
27Methyl trans-2-butenoate-445
287-Methylcoumarin-446
29 Methyleugenol (except for normal content in the natural essences used, and provided that the concentration does not exceed: 0.01 per cent in fine fragrance; 0.004 per cent in eau de toilette; 0.002 per cent in fragrance cream; 0.001 per cent in rinse-off products; and 0.0002 per cent in other leave-on products and oral hygiene products) -451
305-Methyl-2,3-hexanedione447
312-Pentylidenecyclohexanone-448
322-Phenylacetonitrile2424
333,6,10-Trimethyl-3,5,9-undecatrien-2-one-449
34Verbena oil (Lippia citriodora Kunth.)-450
SCHEDULE 4 LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS Regulations 5(2), 6(1) and 7(2), 7(9)

In this Schedule, the matters specified in columns 3, 4, 5 and 6 which apply to a particular substance are those set out to the right of its name as mentioned in column 2; and the matters specified in columns 4, 5 and 6 which apply in any particular case are those set out to the right of the matter specified in column 3 which applies in that case. The substance may not be used except for the purposes or contained other than in the types of product specified in column 3. The concentration of the substance in a product may not exceed the limit specified in column 4: where the names of two or more substances are mentioned in a single item as set out in column 2 and a product contains more than one of those substances, the limit specified in column 4 is the limit for all of those substances taken together; and where a product is intended to be mixed with another product in specified proportions before use, the level of concentration shall be calculated by reference to the mixture. Other requirements are specified in column 5. In column 4 of this Schedule, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.

Names which appear in square brackets in column 2 are the International Nomenclature Cosmetic Ingredient names of the substances in question given in the inventory of ingredients employed in cosmetic products drawn up in accordance with the provisions of the Directive and contained in Commission Decision 96/335/EC.

Regulation 1(3) provides that until 24th March 2005 entries 14, 60, 61 and 62 shall be inserted into Part 1 of this Schedule as they appear in Part 1 of Schedule 4 to the Cosmetic (Products) (Safety) Regulations 2003. From 24th March 2005 the above entries shall have effect as they appear in Part 1 of this Schedule.

Regulation 1(4) provides that entries 93,94 and 95 in Part 1 of this Schedule shall not form part of this Schedule until 24th March 2005.

PART 1 SUBSTANCES LISTED IN ANNEX <Acronym Expansion="3">III</Acronym>, PART I OF THE DIRECTIVE AS SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN
(1)(2)(3)(4)(5)(6)
Reference NumberName of substancePurpose of substance or type of productMaximum concentration of substance in productOther requirementsRequired information
1aBoric acid, borates, and tetraborates‘Talcum power5 per cent Not to be used in products intended for children under three years old Not to be used in products intended for peeling or irritated skin if the concentration of free soluble borate exceeds 1.5 per cent calculated as boric acid Not to be used for bathing children under three years old Do not use on peeling or irritated skin (Only required if the concentration of free soluble borate exceeds 1.5 per cent calculated as boric acid)
Oral hygiene products0.1 per centNot to be used in products intended for children under three years old Do not swallow Not to be used for children under three years old
Other products (excluding bath products and hair waving products3 per cent Not to be used in products intended for children under three years old Not to be used in products intended for peeling or irritated skin if the concentration of free soluble borate exceeds 1.5 per cent calculated as boric acid Not to be used for children under three years old Do not use on peeling or irritated skin (Only required if the concentration of free soluble borate exceeds 1.5 per cent calculated as boric acid)
The above-mentioned percentages are calculated as boric acid
1bTetraboratesBath products18 per centNot to be used in products for children under three years oldNot to be used for bathing children under three years old
2aThioglycolic acid and its salts a Hair waving or straightening products for general use 8 per centpH 7 to 9.5Contains thioglycolate. Follow the instructions. Keep out of reach of children.
b Hair waving or straightening products for professional use 11 per cent ready for usepH 7 to 9.5Contains thioglycolate. Follow the instructions. Keep out of reach of children. For professional use only
c Depilatories 5 per cent ready for usepH 7 to 12.7Contains thioglycolate. Follow the instructions. Keep out of reach of children
d Other hair-care products which are removed after application 2 per cent ready for usepH 7 to 9.5Contains thioglycolate. Follow the instructions. Keep out of reach of children
The above-mentioned percentages are calculated as thioglycolic acid (a), (b), (c) and (d): The directions for use must incorporate the following: Avoid contact with eyes In the event of contact with eyes, rinse immediately with plenty of water and seek medical advice Wear suitable gloves ((a), (b) and (d) only)
2bThioglycolic acid esters a Hair waving or straightening products for general use 8 per cent ready for usepH 6 to 9.5Contains thioglycolate. Follow the instructions. Keep out of reach of children
b Hair waving or straightening products for professional use 11 per cent ready for usepH 7 to 9.5Contains thioglycolate. Follow the instructions. Keep out of reach of children. For professional use only
The above-mentioned percentages are calculated as thioglycolic acid (a) and (b): The directions for use must incorporate the following: May cause sensitization in the event of skin contact Avoid contact with eyes In the event of contact with eyes, rinse immediately with plenty of water and seek medical advice Wear suitable gloves
3Oxalic acid, its esters and alkaline saltsHair-care products5 per cent-For professional use only
4AmmoniaAll purposes and products6 per cent calculated as NH3-Contains ammonia (not required when concentration is not more than 2 per cent)
5Tosylchloramide sodium (INN) [Chloramine-T]All purposes and products0.2 per cent--
6Chlorates of alkali metalsToothpaste5 per cent--
Other uses3 per cent--
7DichloromethaneAll purposes and products35 per cent (and when mixed with 1,1,1-trichloroethane, total concentration must not exceed 35 per cent)Purity of the dichloromethane must be not less than 99.8 per cent-
8 m- and p-Phenylenedi-amines, their N-substituted derivatives and their salts; N-substituted derivatives of o-phenylenediamines (see Note 1), with the exception of those derivatives listed elsewhere in this Schedule) Oxidizing colouring agents for hair dyeing for general use6 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below-Contains phenylenediamines Can cause an allergic reaction. Do not use to dye eyelashes or eyebrows
Oxidizing colouring agents for hair dyeing for professional use10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below-Contains phenylenediamines. For professional use only. Can cause an allergic reaction. Wear suitable gloves
9Methylphenylenedimines (other than 4-methyl-m-phenylenediamine and its salts), their N-substituted derivatives and their salts (Toluenediamines (other than toluene-1,3-diamine and its salts), their N-substituted derivatives and their salts) (see Note 1)Oxidizing colouring agents for hair dyeing for general use10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below-Contains phenylene-diamines. Can cause an allergic reaction. Do not use to dye eyelashes or eyebrows
Oxidizing colouring agents for hair dyeing for professional use10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below-Contains phenylenediamines. For professional use only. Can cause an allergic reaction. Wear suitable gloves
10Diaminophenols (see Note 1)Oxidizing colouring agents for hair dyeing for general use10 per cent calculated as free base, subject to the provisions of “Combination Rule A” set out below-Contains diaminophenols. Can cause allergic reaction. Do not use to dye eyelashes or eyebrows
Oxidizing colouring agents for hair dyeing for professional use10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below-Contains diaminophenols. For professional use only. Can cause allergic reaction. Wear suitable gloves
11Dichlorophen (INN) [Dichlorophene]All purposes and products0.5 per cent-Contains dichlorophen
12Hydrogen peroxide and other compounds or mixtures that release hydrogen peroxide including hydrogen peroxide-urea (hydrogen peroxide-carbamide) and zinc peroxide a Hair-care preparations 12 per cent of H2O2 present or released- a Wear suitable gloves Contains hydrogen peroxide. Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them
b Skin-care preparations 4 per cent of H2O2 present or released-Contains hydrogen peroxide. Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them
c Nail hardening preparations 2 per cent of H2O2 present or released-Contains hydrogen peroxide. Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them
d Oral hygiene products 0.1 per cent of H2O2 present or released--
13Formaldehyde (see also Part I of Schedule 6)Nail hardeners5 per cent-Contains formaldehyde. Protect cuticles with grease or oil. (Not required when concentration is not more than 0.05 per cent)
14HydroquinoneOxidizing colouring agent for hair dyeing for general use0.3 per cent subject to the provisions of “Combination Rule B” set out below-Contains hydroquinone. Do not use to dye eyelashes or eyebrows. Rinse eyes immediately if product comes into contact with them
Oxidizing colouring agent for hair dyeing for professional use0.3 per cent subject to the provisions of “Combination Rule B” set out below-For professional use only. Contains hydroquinone. Rinse eyes immediately if product comes into contact with them
Artificial nail systems for professional use0.02 per cent (after mixing for use) subject to the provisions of “Combination Rule B” set out below- For professional use only Avoid skin contact Read directions for use carefully
15aPotassium hydroxide and sodium hydroxideNail cuticle solvent 5 per cent calculated as sodium hydroxide (see Note 2) -Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children
Hair straightener for general use2 per cent calculated as sodium hydroxide (see Note 2)-Contain alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children
Hair straightener for professional use4.5 per cent calculated as sodium hydroxide (see Note 2)-For professional use only. Avoid contact with eyes. Can cause blindness
pH adjuster for depilatoriesPH value not to exceed 12.7Keep out of reach of children Avoid contact with the eyes
Other uses as pH adjusterPH value not to exceed 11-
15bLithium hydroxideHair straightener for general use2 per cent calculated as sodium hydroxide (see Note 2)-Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children
Hair straightener for professional use4.5 per cent calculated as sodium hydroxide (see Note 2)-For professional use only. Avoid contact with eyes. Can cause blindness
pH adjuster for depilatoriesPH value not to exceed 12.7Contains alkali. Keep out of reach of children. Avoid contact with eyes
Other uses as pH adjuster (for rinse-off products only)PH value not to exceed 11-
15cCalcium hydroxideHair straighteners containing two components; calcium hydroxide and a guanidine salt7 per cent by weight of calcium hydroxide-Contains alkali. Avoid contact with eyes. Keep out of reach of children. Can cause blindness
pH adjuster for depilatoriespH value not to exceed 12.7Contains alkali. Avoid contact with eyes. Keep out of reach of children.
Other uses e.g. pH adjuster processing aidpH value not to exceed 11
16α-Naphthol [1-Naphthol] and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction
17Sodium nitriteRust inhibitor0.2 per centDo not use with secondary and/or tertiary amines or other substances forming nitrosamines-
18NitromethaneRust inhibitor0.3 per cent--
19Phenol and its alkali saltsSoaps and shampoos1 per cent calculated as phenol-Contains phenol
20ENTRY DELETED
21Quinine and its saltsShampoos0.2 per cent calculated as quinine base--
Hair lotions0.5 per cent calculated as quinine base--
22ResorcinolOxidizing colouring agent for hair dyeing for general use5 per cent subject to the provisions of “Combination Rule B” set out below-Contains resorcinol. Rinse hair well after application. Do not use to dye eyelashes or eyebrows. Rinse eyes immediately if product comes into contact with them
Oxidizing colouring agent for hair dyeing for professional use5 per cent subject to the provisions of “Combination Rule B” set out below-Contain resorcinol. For professional use only. Rinse eyes immediately if product comes into contact with them
Hair lotions and shampoos0.5 per cent subject to the provisions of “Combination Rule B” set out below-Contains resorcinol
23aAlkali sulphidesDepilatories2 per cent calculated as sulphurPH value not to exceed 12.7Keep out of reach of children. Avoid contact with eyes
23bAlkaline earth sulphidesDepilatories6 per cent calculated as sulphurPH value not to exceed 12.7Keep out of reach of children. Avoid contact with eyes
24Water-soluble zinc salts with the exception of zinc 4-hydroxybenzene-sulphonateAll purposes and products1 per cent calculated as zinc--
25 Zinc 4-hydroxybenzene-sulphonate [Zinc phenolsulfonate] Deodorants, antiperspirants and astringent lotions6 per cent calculated as percentage of anhydrous substance-Avoid contact with eyes
26Ammonium monofluoro-phosphateOral hygiene products0.15 per cent calculated as fluorine. When mixed with other fluorine compounds the total fluorine concentration must not exceed 0.15 per cent-Contains ammonium monofluorophosphate
27Sodium monofluoro-phosphateOral hygiene productsAs for ammonium monofluorophosphate-Contains sodium monofluoro-phosphate
28Potassium monofluoro-phosphateOral hygiene productsAs for ammonium monofluorophosphate-Contains potassium monofluorophosphate
29Calcium monofluoro-phosphateOral hygiene productsAs for ammonium monofluorophosphate-Contains calcium monofluorophosphate
30Calcium fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains calcium fluoride
31Sodium fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains sodium fluoride
32Potassium fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains potassium fluoride
33Ammonium fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains ammonium fluoride
34Aluminium fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains aluminium fluoride
35Stannous fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains stannous fluoride
36Hexadecylammonium fluoride [Cetylamine hydrofluoride]Oral hygiene productsAs for ammonium monofluorophosphate-Contains hexadecylammonium fluoride
37 3-(n-Hexadecyl-N-2-hydroxyethylammonio)-propylbis(2-hydroxy-ethyl)ammonium difluoride [Stearyl trihydroxyethyl propylenediamine dihydrofluoride] Oral hygiene productsAs for ammonium monofluorophosphate-Contains 3-(n-hexadecyl-N-2-hydroxyethylammonio)- propylbis(2-hydroxyethyl)-ammonium difluoride
38N,N’,N’—Tris(polyoxyethylene)-N-hexadecylpropylene-diamine dihydrofluoride [Palmityltrihydroxyethyl propylenediamine dihydrofluoride]Oral hygiene productsAs for ammonium monofluorophosphate-Contains N,N’,N’-tris (polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride
39Octadecenylammonium fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains octadecenylammonium fluoride
40Sodium fluorosilicateOral hygiene productsAs for ammonium monofluorophosphate-Contains sodium fluorosilicate
41Potassium fluorosilicateOral hygiene productsAs for ammonium monofluorophosphate-Contain potassium fluorosilicate
42Ammonium fluorosilicateOral hygiene productsAs for ammonium monofluorophosphate-Contains ammonium fluorosilicate
43Magnesium fluorosilicateOral hygiene productsAs for ammonium monofluorophosphate-Contains magnesium fluorosilicate
441,3-Bis(hydroxymethyl)-imidazolidene-2-thione [Dimethylol ethylene thiourea]Hair care preparations2 per centNot to be used in aerosol dispensersContains 1,3-bis(hydroxymethyl) imidazolidine-2-thione
45Benzyl alcohol (See also Part I of Schedule 6)Solvent, perfumes and flavourings--
466-Methylcoumarin0.003 per cent0.003 per cent--
47Nicomethanol hydrofluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains nicomethanol hydrofluoride
48Silver nitrateProducts to dye eyelashes or eyebrows4 per cent-Contains silver nitrate. Rinse eyes immediately if product comes into contact with them
49Selenium disulphide [Selenium sulphide]Anti-dandruff shampoos1 per cent-Contains selenium disulphide. Avoid contact with eyes or damaged skin
50Aluminium zirconium chloride hydroxide complexes AlxZr(OH)y Clz and aluminium hydroxide glycine complexesAnti-perspirants20 per cent anhydrous aluminium zirconium chloride hydroxide, 5.4 per cent as zirconium The ratio of the number of aluminium atoms to that of zirconium atoms must be between 2 to 10 The ratio of the number of (Al + Zr) atoms to chlorine atoms must be between 0.9 and 2.1 Not to be used in aerosol dispensers (sprays) Do not apply to irritated or damaged skin
51Quinolin-8-ol and bis(8-hydroxyquinolinium sulphate) (See also Part I of Schedule 3) [Oxyquinoline and Oxyquinoline sulphate]Stabilizer for hydrogen peroxide in rinse-off hair care preparations0.3 per cent calculated as base--
Stabilizer for hydrogen peroxide in non rinse-off hair car preparations0.3 per cent calculated as base--
52MethanolDenaturant for ethanol and isopropyl alcohol5 per cent calculated as a percentage of ethanol and isopropyl alcohol--
53Etidronic acid and its saltsHair care1.5 per cent expressed as etidronic acid--
54 1-Phenoxy-propan-2-ol (See also Part I of Schedule 6) [Phenoxyisopropanol] Products rinsed off after use2 per centProhibited in oral hygiene products-
55Lead acetateOnly for hair dyeing0.6 per cent calculated as lead-Contains lead acetate. Keep away from children. Avoid all contact with the eyes. Wash hands after use. Do not use to dye eyelashes, eyebrows or moustaches. If irritation develops discontinue use
56Magnesium fluorideDental hygiene products0.15 per cent calculated as fluoride. When mixed with other fluorine compounds the total fluorine concentration must not exceed 0.15 per cent-Contains magnesium fluoride
57Strontium chloride hexahydrate a Toothpaste 3.5 per cent calculated as strontium. When mixed with other permitted strontium compounds the total strontium content must not exceed 3.5 per cent-Contains strontium chloride Frequent use by children is not advisable
b Shampoo and face care products 2.1 per cent calculated as strontium. When mixed with other permitted strontium compounds the total strontium content must not exceed 2.1 per cent--
58Strontium acetate hemihydrateToothpaste3.5 per cent calculated as strontium. When mixed with other permitted strontium products the total strontium content must not exceed 3.5 per cent-Contains strontium acetate. Use by children is not advisable
59Talc: hydrated magnesium a Powdery products intended to be used for children under three years of age -- a Keep powder away from children’s and mouth
b other products ---
60Fatty acid dialkylamides and dialkanolamidesAll purposes and productsMaximum secondary amine content: 0.5 per centDo not use with nitrosating systems. Maximum secondary amine content: 5 per cent (applies to raw materials. Maximum nitrosamine content: 50 μg/kg (applies to raw materials). Keep in nitrite-free containers-
61Monoalkylamines, Monoalkanolamines and their saltsAll purposes and productsMaximum secondary amine content: 0.5 per cent Do not use with nitrosating systems. Minimum purity: 99 per cent. Maximum secondary amine content: 0.5 per cent (applies to raw materials). Maximum nitrosamine content: 50 μg/kg (applies to raw materials). Keep in nitrite-free containers. -
62Trialkylamines, trialkanolamines and their salts a non-rinse-off products a 2.5 per cent Do not use with nitrosating systems. Minimum purity: 99 per cent. Maximum secondary amine content: 0.5 per cent (applies to raw materials) Maximum nitrosamine content: 50 μg/kg (applies to raw materials). Keep in nitrite free containers-
b other products Do not use with nitrosating systems. Minimum purity: 99 per cent. Maximum secondary amine content: 0.5 per cent (applies to raw materials) Maximum nitrosamine content: 50 μg/kg (applies to raw materials). Keep in nitrite free containers -
63Strontium hydroxidepH-regulator in depilatory products3.5 per cent calculated as strontiumpH value not to exceed 12.7Keep out of reach of children. Avoid contact with the eyes
64Sodium peroxideRinse-off hair care preparations for professional use4.5 per cent calculated as strontium in the ready-for-use preparationAll products must meet the hydrogen peroxide release requirementsAvoid contact with eyes. Rinse eyes immediately if product comes into contact with them. For professional use only. Wear suitable gloves
65Benzalkonium chloride (INN), bromide and saccharinate (eg. Cetalkonium chloride Stearalkonium chloride, Cetearalkonium bromide)Hair care products rinsed off after use3 per cent calculated as benzalkonium chlorideIn the finished product the concentration of benzalkonium chloride, bromide and saccharinate with an alkyl chain-length of C14 or less must not exceed 0.1 per cent calculated as benzalkonium chlorideAvoid contact with the eyes
66PolyacrylamidesBody-care leave-on productsMaximum residual acrylamide content 0.1 mg/kg Maximum residual acrylamide content 0.5 mg/kg-
67 Amyl cinnamal (CAS No 122-40-7) The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds: 0.001 per cent in leave-on products 0.01 per cent in rinse-off products -
68 Benzyl alcohol (CAS No 100-51-6) The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds: 0.001 per cent in leave-on products 0.01 per cent in rinse-off products -
69 Cinnamyl alcohol (CAS No 104-54-1) The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds: 0.001 per cent in leave-on products 0.01 per cent in rinse off products -
70 Citral (CAS No 5392-40-5) The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds: 0.001 per cent in leave-on products 0.01 per cent in rinse off products -
71 Eugenol (CAS No 97-53-0) The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds: 0.001 per cent in leave-on products 0.01 per cent in rinse-off products -
72Hydroxycitronellal (CAS No 107-75-5) The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds: 0.001 per cent in leave-on products 0.01 per cent in rinse-off products -
73 Isoeugenol (CAS No 97-54-1) The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds: 0.001 per cent in leave-on products 0.01 per cent in rinse-off products -
74 Amylcinnamylalcohol (CAS No 101-85-9) The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds: 0.001 per cent in leave-on products 0.01 per cent in rinse-off products -
75 Benzyl salicylate (CAS No 118-58-1) The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds: 0.001 per cent in leave-on products 0.01 per cent in rinse-off products -
76 Cinnamal (CAS No 104-55-2) The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds: 0.001 per cent in leave-on products 0.01 per cent in rinse-off products -
77 Coumarin (CAS No 91-64-5) The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds: 0.001 per cent in leave-on products 0.01 per cent in rinse-off products -
78 Geraniol (CAS No 106-24-1) The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds: 0.001 per cent in leave-on products 0.01 per cent in rinse-off products -
79 Hydroxymethylpentyl-cyclohexene-carboxaldehyde (CAS No 31906-04-4) The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds: 0.001 per cent in leave-on products 0.01 per cent in rinse-off products -
80 Anisyl alcohol (CAS No 105-13-5) The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds: 0.001 per cent in leave-on products 0.01 per cent in rinse-off products -
81 Benzyl cinnamate (CAS No 103-41-3) The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds: 0.001 per cent in leave-on products 0.01 per cent in rinse-off products -
82 Farnesol (CAS No 4602-84-0) The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds: 0.001 per cent in leave-on products 0.01 per cent in rinse-off products -
83 2-(4-tert-Butylbenzyl) propionaldehyde (CAS No 80-54-6) The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds: 0.001 per cent in leave-on products 0.01 per cent in rinse-off products -
84 Linalool (CAS No 78-70-6) The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds: 0.001 per cent in leave-on products 0.01 per cent in rinse-off products -
85 Benzyl benzoate (CAS No 120-51-4) The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds: 0.001 per cent in leave-on products 0.01 per cent in rinse-off products -
86 Citronellol (CAS No 106-22-9) The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds: 0.001 per cent in leave-on products 0.01 per cent in rinse-off products -
87 Hexyl cinnamaldehyde (CAS No 101-86-0) The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds: 0.001 per cent in leave-on products 0.01 per cent in rinse-off products -
88 d-Limonene (CAS No 5989-27-5) The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds: 0.001 per cent in leave-on products 0.01 per cent in rinse-off products -
89 Methyl heptin carbonate (CAS No 111-12-6) The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds: 0.001 per cent in leave-on products 0.01 per cent in rinse-off products -
90 3-Methyl-4(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one (CAS No 127-51-5) The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds: 0.001 per cent in leave-on products 0.01 per cent in rinse-off products -
91 Oak moss extract (CAS No 90028-68-5) The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds: 0.001 per cent in leave-on products 0.01 per cent in rinse-off products -
92 Treemoss extract (CAS No 90028-67-4) The presence of the substance must be indicated in the list of ingredients referred to in regulation 7(1) when its concentration exceeds: 0.001 per cent in leave-on products 0.01 per cent in rinse-off products -
93 2,4-Diaminopyrimidine 3-oxide (CAS No 74638-76-9) Hair care formulations1.5 per cent--
94 Benzoyl peroxide (CAS No 94-36-0) Artificial nail systems for professional use0.7 per cent (after mixing for use)- For professional use only Avoid skin contact Read directions for use carefully
95Hydroquinone methyl ether (4-methoxyphenol) (CAS No 150-76-5)Artificial nail systems for professional use0.02 per cent (after mixing for use)- For professional use only Avoid skin contact Read directions for use carefully
PART 2 SUBSTANCES LISTED IN ANNEX III, PART 2 OF THE DIRECTIVE AS SUBSTANCES PROVISIONALLY ALLOWED
(1)(2)(3)(4)(5)(6)(7)
Reference NumberName of substancePurpose of substance or type of productMaximum concentration of substance in productOther requirementsRequired informationPermitted for supply until
Combination Rules Where a cosmetic product contains two or more substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 1. Where a cosmetic product contains the substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 2; but the concentration of each substances shall not in any event exceed the limit specified for the substance in respect of the product in column 4 above. The relevant quotient for each substance is the actual concentration of the substance in the product divided by the maximum concentration specified for the substance in respect of the product in Column 4 of this Schedule.
Note 1: May be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 1.
Note 2: The concentration of sodium, potassium or lithium hydroxide is expressed as a percentage of sodium hydroxide. In cases of mixtures, the sun must not exceed the limits given in column 4.
1 C.I. Basic Blue 7 (CAS No 2390-60-5) Non-oxidising colouring agents for hair dyeing0.2 per cent—Can cause allergic reaction30.9.2004
22-Amino-3-nitrophenol (CAS No 603-85-0) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
Non-oxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
34-Amino-3-nitrophenol (CAS No 610-81-1) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
Non-oxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
4Naphthalene-2,7-diol (CAS No 582-17-2) and its saltsOxidising colouring agents for hair dyeing1 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per cent—30.9.2004
53-Aminophenol (CAS No 591-27-5) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction30.9.2004
63,4-Dimethylpyridine-2,6-diol (CAS No 84540-47-6) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction30.9.2004
74-(3-Hydroxypropyl)amino-3-nitrophenol (CAS No 92952-81-3) and its saltsOxidising colouring agents for hair dyeing5.2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 2.6 per centCan cause allergic reaction30.9.2004
Non-oxidising colouring agents for hair dyeing2.6 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 2.6 per centCan cause allergic reaction30.9.2004
86-Nitropyridine-2,5-diamine (CAS No 69825-83-8) and its saltsNon-oxidising colouring agent for hair dyeing3 per cent—Can cause allergic reaction30.9.2004
9HC Blue No. 11 (CAS No 23920-15-2) and its saltsOxidising colouring agent for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
Non-oxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
102-(2-Nitro-p-toluidino)-ethanol (CAS No 100418-33-5) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction30.9.2004
Non-oxidising colouring agents for hair dyeing1 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction30.9.2004
112-(2-Hydroxyethylamino)-4,6-dinitrophenol (CAS No 99610-72-7) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
Non-oxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
124-Methylaminophenol (CAS No 150-75-4) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
132-(2,4-Diamino-5-methylphenoxy)ethanol (CAS No 141614-05-3) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
14HC Violet No. 2 (CAS No 104226-19-9) and its saltsNon-oxidising colouring agent for hair dyeing2 per cent——30.9.2004
152-(2,6-Dinitro-p-anisidino)ethanol (CAS No 122252-11-3) and its saltsNon-oxidising colouring agent for hair dyeing3 per cent—Can cause allergic reaction30.9.2004
16HC Blue No. 12 (CAS No 104516-93-0) and its saltsOxidising colouring agents for hair dyeing1.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.75 per centCan cause allergic reaction30.9.2004
Non-oxidising colouring agent for hair dyeing1.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.75 per centCan cause allergic reaction30.9.2004
174-Ethoxy-6-methyl-m-phenylenediamine (CAS No 113715-25-6) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction30.9.2004
184,4’-(Trimethylenedioxy)di-m-phenylenediamine (CAS No 81892-72-0) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction30.9.2004
193-Amino-2,4-dichlorophenol (CAS No 61693-43-4) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction30.9.2004
203-Methyl-l-phenyl-5-pyrazolone (CAS No 89-25-8) and its saltsOxidising colouring agents for hair dyeing0.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per centCan cause allergic reaction30.9.2004
215-(2-Hydroxyethyl)amino- o-cresol (CAS No 55302-96-0) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction30.9.2004
223,4 Dihydro-2H-1,4-benzoxazin-6-ol (CAS No 26021-57-8) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per centCan cause allergic reaction30.9.2004
23Naphthalene-1,7-diol (CAS No 575-38-2) and its saltsOxidising colouring agents for hair dyeing1 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per centCan cause allergic reaction30.9.2004
24HC Yellow No.10 (CAS No 109023-83-8) and its saltsNon-oxidising colouring agents for hair dyeing0.2 per cent——30.9.2004
252,6-Dimethoxy-3,5- pyridinediamine (CAS No 85679-78-3) and its saltsOxidising colouring agents for hair dyeing0.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per centCan cause allergic reaction30.9.2004
26HC Orange No.2 (CAS No 85765-48-6) and its saltsNon-oxidising colouring agent for hair dyeing1 per cent——30.9.2004
27HC Violet No.1 (CAS No 82576-75-8) and its saltsOxidising colouring agents for hair dyeing0.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent—30.9.2004
Non-oxidising colouring agents for hair dyeing0.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent—30.9.2004
282-(3-Methylamino-4-nitrophenoxy)ethanol (CAS No 59820-63-2) and its saltsNon-oxidising colouring agents for hair dyeing1 per cent——30.9.2004
292-(2-Methoxy-4-nitroanilino)ethanol (CAS No 66095-81-6) and its saltsNon-oxidising colouring agents for hair dyeing1 per cent——30.9.2004
302-(4-Amino-2-chloro-5-nitroanilino)ethanol (CAS No 50610-28-1) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent—30.9.2004
Non-oxidising colouring agents for hair dyeing1 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent—30.9.2004
31HC Red No. 13 (CAS No 94158-13-1)Oxidising colouring agents for hair dyeing2.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.25 per cent—30.9.2004
Non-oxidising colouring agents for hair dyeing2.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.25 per cent—30.9.2004
32Naphthalene-1,5-diol (CAS No 83-56-7) and its saltsOxidising colouring agents for hair dyeing1 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per cent—30.9.2004
332,2’-[2-Hydroxy-trimethylenebis(4-aminophenyl)imino]diethanol (CAS No 128729-30-6) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per centCan cause allergic reaction30.9.2004
342-Aminophenol (CAS No 95-55-6) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent—30.9.2004
355-Amino-o-cresol (CAS No 2835-95-2) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent—30.9.2004
362-(2,4-Diamino-phenoxy)ethanol (CAS No 66422-95-5) and its saltsOxidising colouring agents for hair dyeing4 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 2 per cent—30.9.2004
372-Methylresorcinol (CAS No 608-25-3) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent—30.9.2004
384-Amino-m-cresol (CAS No 2835-99-6) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent—30.9.2004
392-Amino-4-hydroxyethyl-aminoanisole (CAS No 83763-47-7) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent—30.9.2004
403,4-Diaminobenzoic acid (CAS No 619-05-6) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent—30.9.2004
416-Amino-o-cresol (CAS No 17672-22-9) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent—30.9.2004
422-Aminomethyl-p-aminophenol (CAS No 79352-72-0) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent—30.9.2004
432-Amino-2-(2-hydroxyethylaminomethyl) (CAS No 110952-46-0 and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent—30.9.2004
44N-(2-Hydroxyethyl)-3,4-methylenedioxyaniline (CAS No 81329-90-0) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent—30.9.2004
45C.I. Acid Black 52 (CAS No 3618-58-4) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.per cent—30.9.2004
462-Nitro-p-phenylenediamine (CAS No 5307-14-2) and its saltsOxidising colouring agents for hair dyeing0.3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.15 per cent—30.9.2004
Non-oxidising colouring agents for hair dyeing0.3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.15 per cent—30.9.2004
47HC Blue No.2 (CAS No 33229-34-4) and its saltsNon-oxidising colouring agents for hair dyeing2.8 per cent——30.9.2004
484-(2-Hydroxyethylamino)-3-nitrophenol (CAS No 65235-31-6) and its saltsOxidising colouring agents for hair dyeing6 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 3 per cent—30.9.2004
Non-oxidising colouring agents for hair dyeing6 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 3 per cent—30.9.2004
492-(4-Nitrophenylamino)-ethylurea (CAS No 27080-42-8) and its saltsOxidising colouring agents for hair dyeing0.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent—30.9.2004
Non-oxidising colouring agents for hair dyeing0.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent—30.9.2004
50HC Red No. 10 (CAS No 95576-89-9) + HC Red No. 11 (CAS No 95576-92-4) and their saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent—30.9.2004
Non-oxidising colouring agents for hair dyeing1 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent—30.9.2004
51HC Yellow No. 6 (CAS No 104333-00-8) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent—30.9.2004
Non-oxidising colouring agents for hair dyeing1 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent—30.9.2004
52HC Yellow No.12 (CAS No 59320-13-7) and its saltsOxidising colouring agents for hair dyeing1 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per cent—30.9.2004
Non-oxidising colouring agents for hair dyeing0.5 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per cent—30.9.2004
53HC Blue No. 10 (CAS No 102767-27-1) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent—30.9.2004
54HC Blue No. 9 (CAS No 114087-47-1) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent—30.9.2004
Non-oxidising colouring agents for hair dyeing1 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent—30.9.2004
552-Chloro-6-ethylamino-4-nitrophenol (CAS No 131657-78-8) and its saltsOxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent—30.9.2004
Non-oxidising colouring agents for hair dyeing3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent—30.9.2004
562-Amino-6-chloro-4-nitrophenol (CAS No 6358-09-4) and its saltsOxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent—30.9.2004
Non-oxidising colouring agents for hair dyeing2 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent—30.9.2004
57C.I. Basic Blue 26 (CAS No 2580-56-5) (C.I. No. 44045)Oxidising colouring agents for hair dyeing0.5%In combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent—30.9.2004
Non-oxidising colouring agents for hair dyeing0.5%In combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent—30.9.2004
58 C.I. Acid Red 33 (CAS No 3567-66-6) (C.I. No. 17200) Non-oxidising colouring agents for hair dyeing2 per cent——30.9.2004
59 C. I. Food Red 1 (CAS No 4548-53-2) (C.I. No. 14700) Non-oxidising colouring agents for hair dyeing2 per cent——30.9.2004
60 C.I. Basic Violet 14 (CAS No 632-99-5) (C.I. No. 42510) Oxidising colouring agents for hair dyeing0.3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.15 per cent—30.9.2004
Non-oxidising colouring agents for hair dyeing0.3 per centIn combination with hydrogen peroxide the maximum use concentration upon application is 0.15 per cent—30.9.2004
61 1-tert-Butyl-3,5-dimethyl-2,4,6-trinitrobenzene (CAS No 81-15-2) (musk xylene) All cosmetic products, with the exception of oral care products 1 per cent in fine fragrance 0.4 per cent in eau de toilette 0.03 per cent in other products ——30.9.2004
624’-tert-Butyl-2’,6’-dimethyl-3’, 5’-dinitroacetophenone (CAS No 81-14-1) (musk ketone)All cosmetic products, with the exception of oral care products 1.4 per cent in fine fragrance 0.56 per cent in eau de toilette 0.042 per cent in other products ——30.9.2004
SCHEDULE 5 LIST OF COLOURING AGENTS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT COLOURING AGENTS INTENDED SOLELY TO COLOUR HAIR AND EXCEPT SUBJECT TO RESTRICTIONS Regulation 5(2) and 7(9)

In this Schedule the colouring agents referred to in regulation 5(2)(d) are— i those identified in column 1 either by name or by colour index number (the colour index numbers being those specified in the fourth edition of The Colour Index published by the Society of Dyers and Colourists and the American Society of Textile Chemists and Colourists (available by on-line subscription at http://www.colour-index.org/). ; ii lakes or salts of these colouring agents which do not use substances prohibited under Schedule 3.

In the case of colouring agents identified by the addition of (*) to the name or colour index number, the insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will be determined by the procedure laid down in Article 8 of the Directive.

Colouring agents whose number is preceded by the letter ‘E’ in accordance with the EEC Directive of 23rd October 1962 on the approximation of the rules of Member States concerning foodstuffs and colouring matter , as amended adapted and replaced in part must fulfil the purity requirements laid down in those Directives.

PART ICOLOURING AGENTS LISTED IN ANNEX <Acronym Expansion="4">IV</Acronym>, PART 1 OF THE DIRECTIVE AS COLOURING AGENTS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWNField of application

In column 3 of this Schedule, the entry “X” in a sub-column means that the colouring agent must not be used other than as follows—

Sub-column 1 = Colouring agents allowed in all cosmetic products;

Sub-column 2 = Colouring agents allowed in all cosmetic products except those intended to be applied in the vicinity of the eyes, in particular eye make-up and eye make-up remover;

Sub-column 3 = Colouring agents allowed exclusively in cosmetic products except cosmetic products intended to come into contact with the mucous membranes;

Sub-column 4 = Colouring agents allowed exclusively in cosmetic products intended to come into contact only briefly with the skin
(1)(2)(3)(4)
Name or colour index numberColourType of production Field of applicationOther requirement
1234
10006GreenX
10020GreenX
10316*YellowX
11680YellowX
11710YellowX
11725OrangeX
11920OrangeX
12010RedX
12085*RedX3 per cent maximum concentration in the finished product
12120RedX
12150RedX
12370RedX
12420RedX
12480BrownX
12490RedX
12700YellowX
13015YellowXE 105
14270OrangeXE 103
14700RedX
14720RedXE 122
14815RedXE 125
15510*OrangeX
15525RedX
15580RedX
15620RedX
15630*RedX3 per cent maximum concentration in the finished product
15800RedX
15850*RedX
15865*RedX
15800RedX
15980OrangeXE 111
15985*YellowXE 110
16035RedX
16185RedXE 123
16230OrangeX
16255*RedXE 124
16290RedXE 126
17200*RedX
18050RedX
18130RedX
18690YellowX
18736RedX
18820YellowX
18965YellowX
19140*YellowXE 102
20040YellowXMaximum 3,3’-dimethyl-benzidine concentration in the colouring agent:5 mg/kg
20170OrangeX
20470BlackX
21100YellowXMaximum 3,3’-dichloro-benzidine concentration in the colouring agent: 5 mg/kg
21108YellowXMaximum 3,3’-dichloro-benzidine concentration in the colouring agent: 5 mg/kg
21230YellowX
24790RedX
26100RedXPurity criteria: aniline ≤ 0.2 per cent, 2-naphthol ≤ 0.2 per cent, azobenzen-4-amine ≤ 0.1 per cent, 1-phenylazo-2- naphthol ≤ 3 per cent, 1-[2-(phenylazo)phenylazo]-2-naphthol ≤ 2 per cent
27290*RedX
27755BlackXE 152
28440BlackXE 151
40215OrangeX
40800OrangeX
40820OrangeXE 160e
40825OrangeXE 160f
40850OrangeXE 161g
42045BlueX
42051*BlueX
42053GreenX
42080BlueX
42090BlueX
42100GreenX
42170GreenX
42510VioletX
42520VioletXMaximum concentration in the finished product: 5 mg/kg
42735BlueX
44045BlueX
44090GreenXE 142
45100RedX
45190VioletX
45220RedX
45350YellowX6 per cent. maximum concentration in the finished product
45370OrangeXNot more than 1 per cent 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid and 2 per cent 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid
45380*RedXAs immediately above
45396OrangeXWhen used in lipstick, the colouring agent is allowed only in free acid form and in a maximum concentration of 1 per cent
45405RedXNot more than 1 per cent 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid
45410*RedXAs immediately above
45425RedXNot more than 1 per cent 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid and 3 per cent 2-(iodo-6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid
45430*RedXAs immediately above, E 127
47000YellowX
47005YellowXE 104
50325VioletX
50420BlackX
51319VioletX
58000RedX
59040GreenX
60724VioletX
60725VioletX
60730VioletX
61565GreenX
61570GreenX
61585BlueX
62045BlueX
69800BlueXE 130
69825BlueX
71105OrangeX
73000BlueX
73015BlueXE 132
73360RedX
73385VioletX
73900VioletX
73915RedX
74100BlueX
74160BlueX
74180BlueX
74260GreenX
75100YellowX
75120OrangeXE 160b
75125YellowXE 160d
75130OrangeXE 160a
75135YellowXE 161d
75170WhiteX
75300YellowXE 100
75470RedXE 120
75810GreenXE 140 and E 141
77000WhiteX
77002WhiteX
77004WhiteX
77007BlueX
77015RedX
77120WhiteX
77163WhiteX
77220WhiteXE 170
77231WhiteX
77266BlackX
77267BlackX
77268:1BlackXE 153
77288GreenXFree from chromate ions
77289GreenXFree from chromate ions
77346GreenX
77400BrownX
77480BrownXE 175
77489OrangeXE 172
77491RedXE 172
77492YellowXE 172
77499BlackXE 172
77510BlueXFree from cyanide ions
77713WhiteX
77742VioletX
77745RedX
77820WhiteXE 174
77891WhiteXE 171
77947WhiteX
Acid Red 195RedX
Aluminium, zinc, magnesium and calcium stearatesWhiteX
AnthocyaninsRedXE 163
Beetroot redRedXE 162
Bromocresol greenGreenX
Bromothymol blueBlueX
CaramelBrownXE 150
Capsanthin, capsorubinOrangeXE 160c
LactoflavinYellowXE 101

 PART II COLOURING AGENTS LISTED IN ANNEX IV, PART 2 OF THE DIRECTIVE AS COLOURING AGENTS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN AND WHERE COSMETIC PRODUCT SUPPLIED BEFORE A CERTAIN DATE Field of application

In column 3 of this Schedule, the entry “X” in a sub-column means that the colouring agent must not be used other than as follows—

Sub-column 1 = Colouring agents allowed in all cosmetic products;

Sub-column 2 = Colouring agents allowed in all cosmetic products except those intended to be applied in the vicinity of the eyes, in particular eye make-up and eye make-up remover;

Sub-section 3 = Colouring agents allowed exclusively in cosmetic products intended not to come into contact with the mucous membranes;

Sub-column 4 = Colouring agents allowed exclusively in cosmetic products intended to come into contact only briefly with the skin.
(1)(2)(3)(4)(5)
Name or colour index numberColourType of production Field of applicationOther requirementCosmetic product supplied until
Note: There are no entries in this Part at the date that these Regulations are made.
1234

SCHEDULE 6 LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS Regulations 5(2) and 7(2)

In this Schedule, the matters specified in columns 3, 4, 5 and 6 which apply to a particular substance are those set out to the right of its name as mentioned in column 2; and the matters specified in column 4, 5 and 6 which apply in any particular case are those set out to the right of the matter specified in column 3 which applies in that case. The substance may not be used or contained other than in the types of product specified in column 3. The concentration of the substance, when it is used as a preservative, in a product may not exceed the limit set out in column 4. Where a product is intended to be mixed with another product in specified proportions before use, the level of concentration shall not calculated by reference to the mixture. Other requirements are specified in column 5.

In column 4 of this Schedule, “A” indicates that the concentration of the substance in a product may exceed the limit set out in that column provided that — b the presence of any excess of the substance in a product over the concentration so set out is not for the primary purpose of inhibiting the development of micro-organisms; and c the purpose for which any such excess is present in the product is apparent from the labelling of the product.

In this Schedule— “salt” means salts of the cations sodium, potassium, calcium, magnesium, ammonium and ethanolamines and of the anions chloride, bromide, sulphate and acetate; “ester” means esters of methyl, ethyl, propyl, isopropyl, butyl, isobutyl and phenyl.

In column 4 of this Schedule, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.

All preservative substances containing formaldehyde or any substances named in this Schedule which release formaldehyde must be labelled with the warning “contains formaldehyde” when the concentration of formaldehyde in the final product exceeds 0.05 per cent.

Names which appear in square brackets in column 2 of this Schedule are the International Nomenclature Cosmetic Ingredient names of the substances in question given in the inventory of ingredients employed in cosmetic products drawn up in accordance with the provisions of the Directive and contained in Commission Decision 96/335/EC .

Regulation 1(3) provides that until 24th March 2005 entry 36 in Part 1 of this Schedule shall be inserted into Part 1 of this Schedule as it appears in the Cosmetic Products (Safety) Regulations 2003. From 24th March 2004 entry 36 shall have effect as it appears in Part 1 of this schedule.

PART I PRESERVATIVES LISTED IN ANNEX <Acronym Expansion="6">VI</Acronym>, PART 1 OF THE DIRECTIVE AS PRESERVATIVES WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN
(1)(2)(3)(4)(5)(6)
Reference NumberName of substancePurpose of substance or type of productMaximum concentration of substance in productOther requirementsRequired information
1Benzoic acid, its salts and estersAll products0.5 per cent (expressed as acid)A ——
2Propionic acid and its saltsAll products2 per cent (expressed as acid)A ——
3Salicylic acid and its saltsAll products0.5 per cent (expressed as acid)A Not to be used in preparations for children under three years of age except for shampoosNot to be used for children under three years of age (solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin)
4Sorbic acid (hexa-2,4-dienoic acid) and its saltsAll products0.6 per cent (expressed as acid)A ——
5Formaldehyde and para-formaldehydeFor oral hygiene0.1 per cent (expressed as free formaldehyde)Not to be used in aerosol dispensers (sprays)—
6ENTRY DELETED
7 Biphenyl-2-ol [o-phenylphenol] and its salts All products0.2 per cent (expressed as the phenol)A ——
8 Pyrithione zinc (INN) [Zinc pyrithione] Products rinsed off after use0.5 per centA Not to be used in oral hygiene products—
9Inorganic sulphites and hydrogen sulphitesAll products0.2 per cent (expressed as free SO2)A ——
10Sodium iodateProducts rinsed off after use0.1 per cent——
11Chlorobutanol (INN)All products0.5 per centNot to be used in aerosol dispensers (sprays)Contains chlorobutanol
12 4-Hydroxybenzoic acid and its salts and esters [the Parabens] All products0.4 per cent (expressed as acid) for 1 ester, 0.8 per cent (expressed as acid) for mixtures of estersA ——
133-Acetyl-6-methylpyran-2,4(3H)-dione [Dehydroacetic acid] and its saltsAll products0.6 per cent(expressed as acid)Not to be used in aerosol dispensers (sprays)—
14Formic acid and its sodium saltAll products0.5 per cent (expressed as acid)A ——
153,3’-Dibromo-4,4’-hexa-methylenedioxydibenzamidine [Dibromohexamidine] and its salts (including isethionate)All products0.1 per cent——
16 Thiomersal (INN) [Thimerosal] Eye make-up and eye make-up remover0.007 per cent calculated as mercury. When mixed with other authorised mercury compounds total mercury concentration must not exceed 0.007 per cent—Contains thiomersal
17 Phenylmercuric salts (including borate) Eye make-up and eye make-up remover0.007 per cent calculated as mercury. When mixed with other authorised mercury compounds total mercury concentration must not exceed 0.007 per cent—Contains phenylmercuric compounds
18Undec-10-enoic acid [Undecylenic acid] and its saltsAll products0.2 per cent (expressed as acid)A ——
19Hexetidine (INN)Products rinsed off after use0.1 per centA ——
205-Bromo-5-nitro-1,3-dioxaneProducts rinsed off after use0.1 per centAvoid formatation of nitrosamines—
21Bronopol (INN) [2-Bromo-2-nitropropane-1,3-diol]All products0.1 per centA Avoid formatation of nitrosamines—
222,4-Dichlorobenzyl alcohol [Dichlorobenzyl alcohol]All products0.15 per centA ——
23Triclocarban (INN)All products0.2 per centA Purity criteria: 3,3’,4,4’-tetra-chloroazobenzene < 1 mg/kg—
24 4-Chloro-m-cresol [p-Chloro-m-cresol] Not to be used in products intended to come into contact with mucous membranes0.2 per centA ——
25Triclosan (INN)All products0.3 per centA ——
264-Chloro-3,5-xylenol [Chloroxylenol]All products0.5 per centA ——
27 3,3’-Bis(l-hydroxymethyl-2,5-dioxoimidazolidin-4-yl)-1,1’-methylenediurea [Imidazolidinyl urea] All products0.6 per centA ——
28Poly(l-hexamethylenebiguanide hydrochloride) [Polyaminopropyl biguanide]All products0.3 per centA ——
292-Phenoxyethanol [Phenoxyethanol]All products1.0 per centA ——
30Hexamethylenetetramine (Methenamine (INN)) [Methenamine]All products0.15 per centA ——
31 Methenamine 3-chloroallylo-chloride (INNM) [Quaternium-15] All products0.2 per cent——
32 1-(4-Chlorophenoxy)-1-(imidazol-l-yl)-3,3-dimethylbutan-2-one (Climbazole (INN)) [Climbazole] All products0.5 per centA ——
331,3-Bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione [DMDM Hydantoin]All products0.6 per centA ——
34 Benzyl alcohol (see also Part I of Schedule 4) All products1.0 per centA ——
351-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone and its monoethanolamine salt [Piroctone olamine]Products rinsed off after use1.0 per centA ——
Other products0.5 per centA —
362-Bromo-2-(bromomethyl) glutaronitrile (1,2-dibromo-2,4-dicyanobutane)[Methyldibromo glutaronitrile]Rinse-off products only0.1 per cent——
376,6-Dibromo-4,4-dichloro-2,2’-methylenediphenol [Bromochlorophen]All products0.1 per centA ——
38 4-Isopropyl-m-cresol [o-Cymen-5-ol] All products0.1 per cent——
39Mixture of 5-chloro-2-methylisothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one with magnesium chloride and magnesium nitrate [Methylchloroisothiazolinone and Methylisothiazolinone]All products0.0015 per cent of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol-3(2H)-one to 2-methylisothiazol-3(2H)-one——
402-Benzyl-4-chlorophenol [Chlorophene]All products0.2 per cent——
412-Chloroacetamide [Chloroacetamide]All products0.3 per cent—Contains chloroacetamide
42Chlorhexidine (INN) and its digluconate, diacetate and dihydrochlorideAll products0.3 per centA ——
431-Phenoxypropan-2-ol [Phenoxyisopropanol] (see also Part 1 of Schedule 4)Products rinsed off after use1.0 per cent——
44Alkyl (C12-C22)-trimethyl-ammonium bromide and chloride (Cetrimonium bromide (INN) and Cetrimonium chloride (INNM))All products0.1 per centA ——
454,4-Dimethyl-1,3-oxazolidine [Dimethyloxazolidine]All products0.1 per centThe pH of the finished product must not be lower than 6—
461-[1,3-Bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea [Diazolidinyl urea]All products0.5 per cent——
47 Hexamidine (INN) (4,4’-(Hexamethylenedioxy)-dibenzamidine) and its salts, including isethionate and p-hydroxybenzoate All products0.1 per centA ——
48Glutaraldehyde (pentane-1,5-dial) [Glutaral]All products0.1 per centProhibited in aerosols (sprays)Contains glutaraldehyde (where glutaraldehyde concentration in the finished product exceeds 0.05 per cent)
49 5-Ethyl-3,7-dioxa-1-azabicyclo[3.3.0]octane [7-Ethylbicyclo-oxazolidine] All products0.3 per centProhibited in oral hygiene products and in products intended to come into contact with mucous membranes—
50Chlorphenesin (INN) [Chlorphensin]All products0.3 per cent——
51Sodium N-hydroxymethyl-glycinate [Sodium hydroxymethylglycinate]All products0.5 per cent——
52Silver chloride deposited on titanium dioxideNot to be used in products for children under three years of age, in oral hygiene products and in products intended for application around the eyes and on the lips0.004 per cent, calculated as silver chlorideThe ratio of titanium dioxide to silver chloride shall be 4:1 by mass—
53Benzethonium chloride (INN) [Benzethonium chloride]Products rinsed off after use0.1 per cent——
54Benzalkonium chloride, bromide and saccharinateAll products0.1 per cent calculated as benzalkonoium chlorideA —Avoid contact with eyes
55BenzylhemiformalProducts rinsed off after use0.15 per cent——
56 3-lodoprop-2-ynyl butylcarbamate [Iodopropynyl butylcarbamate] Not to be used in oral hygiene and lip products0.05 per cent—Contains iodine (Only required where the 3-iodoprop-2-ynyl butylcarbamate concentration in products intended to remain on the skin exceeds 0.02 per cent)
PART 2 PRESERVATIVES LISTED IN ANNEX VI, PART 2 OF THE DIRECTIVE AS PRESERVATIVES WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LIAD DOWN AND WHERE SUPPLIED BEFORE A CERTAIN DATE
(1)(2)(3)(4)(5)(6)(7)
Reference NumberName of substancePurpose of substance or type of productMaximum concentration of substance in productOther requirementsRequired informationPermitted for supply until
Note: There are no entries in this Part at the date that these Regulations are made.
SCHEDULE 7 LIST OF UV FILTERS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS Regulations 5(2), 7(2) and 7(9)

In this schedule, the matters specified in columns 3, 4 and 5 which apply to a particular substance are those set out to the right of its name as mentioned in column 2. The concentration of the substance in a product may not exceed the limit specified in column 3. Where a product is intended to be mixed with another product in specified proportions before use, the level of concentration shall be calculated by reference to the mixture. Other requirements are specified in column 4. In column 3 of this Schedule, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.

Names which appear in square brackets in column 2 are the International Nomenclature Cosmetic Ingredient names of the substances in question given in the inventory of ingredients employed in cosmetic products drawn up in accordance with the provisions of the Directive and contained in Commission Decision 96/335/EC

PART 1 UV FILTERS LISTED IN ANNEX <Acronym Expansion="7">VII</Acronym>, PART 1 OF THE DIRECTIVE AS UV FILTERS WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN
(1)(2)(3)(4)(5)
Reference NumberName of substanceMaximum concentration of substance in productOther requirementsRequired information
14-Aminobenzoic acid [PABA]5 per cent——
2N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl)anilinium methyl sulphate [Camphor benzalkonium methosulfate]6 per cent——
3Homosalate (INN)10 per cent——
4 Oxybenzone (INN) [Benzophenone-3] 10 per cent—Contains oxybenzone. (Not required when concentration is not more than 0.5 per cent, and when the substance is only intended to protect the product)
5ENTRY DELETED
62-Phenylbenzimidazole-5-sulphonic acid [Phenylbenzimidazole sulfonic acid] and its potassium, sodium and triethanolamine salts8 per cent (expressed as acid)——
73,3-(1,4-Phenylenedimethylene)bis(7,7-dimethyl-2-oxo-bicyclo[2.2.1]hept-1-ylmethanesulfonic acid) [Terephthalylidene dicamphor sulfonic acid] and its salts10 per cent (expressed as acid)——
8 1-(4-tert-Butylphenyl)-3-(4-methoxyphenyl)-propane-1,3-dione (Avobenzone (INN)) [Butyl methoxy dibenzoylmethane] 5 per cent——
9α-(2-Oxoborn-3-ylidine)toluene-4-sulphonic acid [Benzylidene camphor sulfonic acid] and its salts6 per cent (expressed as acid)——
102-Ethylhexyl 2-cyano-3,3-diphenylacrylate [Octocrylene]10 per cent (expressed as acid)——
11 Polymer of N-[(2 and 4)-[2-oxoborn-3-ylidene)methyl]benzyl]acrylamide Polyacrylamidomethyl benzylidene camphor] 6 per cent——
12 2-Ethylhexyl 4-methoxycinnamate [Octyl methoxycinnamate] 10 per cent——
13 Ethoxylated ethyl-4-aminobenzoate [PEG-25 PABA] 10 per cent——
14 Isopentyl 4-methoxycinnamate [Isoamyl p-methoxycinnamate] 10 per cent——
15 Tris(2-ethylhexyl) 4,4’4”-(1,3,5-triazine-2,4,6-triyltriimino)tribenzoate [Octyl triazone] 5 per cent——
16 2-(2H-Benzotriazol-2-yl)-4-methyl-6-[2-methyl-3-[1,3,3,3-tetramethyl-l-(trimethylsilyloxy)-disiloxan-1-yl]propyl]phenol [Drometrizole trisiloxane] 15 per cent——
17Bis(2-ethylhexyl) 4,4’-[6-tert-butylcarbamoylanilino)-1,3,5-triazine-2,4-diyldiimino]dibenzoate10 per cent——
18 3-(4-Methylbenzylidine)bornan-2-one [4-Methylbenzylidene camphor] 4 per cent——
19 3-Benzylodenebornan-2-one [3-Benzylidene camphor 2 per cent——
20 2-Ethylhexyl salicylate [Octyl salicylate] 5 per cent——
21 2-Ethylhexyl 4-dimethylaminobenzoate [Octyl dimethyl PABA] 8 per cent——
222-Hydroxy-4-methoxybenzophenone-5-sulfonic acid [Benzophenone-4] and its sodium salt [Benzophenone-5] (Sulisobenzone (INN) and Sulisobenzone sodium (INNM))5 per cent (expressed as acid)——
232-2’-Methylenebis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol]10 per cent——
24diSodium 2,2’-(1,4-phenylene)bis(lH-benzimidazole-4,6-disulfonate)10 per cent (expressed as acid)——
255,5’-Bis(2-ethylhexyloxy)-2,2’-(6-p-methoxyphenyl-1,3,5-triazine-2, 4-diyl)diphenol10 per cent——
26 α-(Trimethylsilyl)-w-(trimethylsilyloxy)poly-[oxy(dimethyl)silylene]-co-[oxy(methyl)(2-[p-[2,2-bis(ethoxycarbonyl)vinyl]phenoxy]-1-methyleneethyl)silylene]-co-[oxy(methyl)(2-[p-[2,2-bis(ethoxycarbonyl)vinyl)]phenoxy]prop-1-enyl)silylene] where there are usually 60 polymeric units, of which the first part of the copolymer provides 56 (Dimethicodiethylbenzyalmalonate) (CAS No. 207574-74-1) 10 per cent——
27Titanium dioxide25 per cent——
PART II UV FILTERS LISTED IN ANNEX <Acronym Expansion="8">VIII</Acronym>, PART 2 OF THE DIRECTIVE AS UV FILTERS WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN AND WHERE SUPPLIED BEFORE A CERTAIN DATE
(1)(2)(3)(4)(5)(6)
Reference NumberName of substanceMaximum concentration of substance in productOther requirementsRequired informationUV filter supplied until
Note: There are no entries in this Part at the date that these Regulations are made.
SCHEDULE 8 METHODS OF MANUFACTURE OF TALLOW DERIVATIVES Regulation 5(5)

The following are the methods of manufacture referred to in regulation 5(5)— a transesterification or hydrolysis at a temperature of at least 200ºC and at an appropriate corresponding pressure for 20 minutes (glycerol, fatty acids and fatty acid esters); b saponification with sodium hydroxide solution, c(NaOH) = 12mol/l (glycerol and soap)— i batch process: at 95°C for three hours; or ii continuous process: at 140°C, two bars (2,000hPa) for eight minutes, or equivalent conditions.

SCHEDULE 9Regulations 7(2), 7(6) and 7(11) PART 1 SYMBOL IN ANNEX VIII OF THE DIRECTIVE WHICH IS REQUIRED FOR THE PURPOSES OF REGULATIONS 7(6) AND 7(11)

PART 2 SYMBOL IN ANNEX VIIIa OF THE DIRECTIVE WHICH IS REQUIRED FOR THE PURPOSES OF REGULATION 7(2)(c)

SCHEDULE 10Regulation 12(3) and (5) PART 1 PARTICULARS TO BE INCLUDED WITH A REQUEST FOR CONFIDENTIALITY 1 The name or trade name and address or registered office of the applicant. 2 Precise identification of the cosmetic ingredient for which confidentiality is requested, namely— a where they exist, the CAS, EINECS and colour index numbers, the chemical name, the IUPAC name, the INCI name, the European Pharmacopoeia name, the International Non-proprietary Name as recommended by the World Health Organization and the common name as provided for in the common ingredients nomenclature; b the European List of Notified Chemical Substances (ELINCS) name and the official number allocated to it if it has been notified pursuant to Council Directive 67/548/EEC and an indication of the decision to approve or refuse any request for confidentiality made under Article 19 of that Directive; c where the names or numbers referred to in sub-paragraphs (a) and (b) above do not exist, for example in the case of certain ingredients of natural origin, the name of the base material, the name of the part of the plant or animal used and the names of the cosmetic ingredient’s compounds, such as solvents. 3 The evaluation of the safety for human health of the cosmetic ingredient as used in the finished cosmetic product or products taking into account the cosmetic ingredient’s toxicological profile, chemical structure and the level of exposure as specified in regulation 9(1)(d)and (e) and carried out in accordance with the requirements of regulations 9(2), 9(3) and 9(4). 4 The envisaged use of the cosmetic ingredient and in particular the different categories of cosmetic products in which it will be used. 5 A detailed justification of why confidentiality is sought addressing for example— a the fact that the identify of the cosmetic ingredient or its function in the cosmetic product to be supplied has not been described in the literature accompanying the cosmetic product and is unknown to other manufacturers or suppliers of cosmetic products; b the fact that the information is not yet in the public domain even though a patent application has been lodged for the cosmetic ingredient or its use; c the fact that if the information were known it would be easily reproducible, to the detriment of the applicant. 6 1 If known, the name of each cosmetic product which is to contain the cosmetic ingredient and if different names are to be used in other Member States, precise details of each one of them. 2 If the name of a cosmetic product is not yet known, it may be communicated at a later date, but at least 15 days before the cosmetic product is supplied. 3 If the cosmetic ingredient is used in several products, one request shall suffice, provided that the cosmetic products are clearly indicated to the competent authority. 7 A statement setting out whether a request has been submitted to the competent authority of any other Member State in respect of the cosmetic ingredient for which confidentiality is sought and particulars on the outcome of any such request. PART II PROCEDURE FOR GRANT OF REGISTRATION NUMBER 1 The registration number referred to in regulation 12(5) shall consist of seven digits, the first two corresponding to the year of approval of confidentiality, the second two to the code assigned to each Member State, as referred to in paragraph 2 below, and the final three digits assigned by the competent authority. 2 The code allocated to the United Kingdom is 06. SCHEDULE 11 SAMPLING AND TESTING Regulation 17 1 In this Schedule— “Annex A” means the Annex to Commission Directive No. 80/1335/EEC as amended by Commission Directive No.87/143/EEC “Annex B” means the Annex to Commission Directive No. 82/434/EEC as amended by Commission Directive No.90/207/EEC “Annex C” means the Annex to Commission Directive No. 83/514/EEC; “Annex D” means the Annex to Commission Directive No. 85/490/EEC; “Annex E” means the Annex to Commission Directive No. 93/73/EEC; “Annex F” means the Annex to Commission Directive No. 95/32/EC; “Annex G” means the Annex to Commission Directive No. 96/45/EC; “purchase” means purchase for the purpose of carrying out a test. 2 An enforcement authority intending to purchase a cosmetic product shall purchase a sufficient laboratory sample, as defined in paragraph 2.3 of Part 1 of Annex A, for the purpose of Annex A; and, for the purposes of the definition of “total sample” in paragraph 2.2 of Part 1 of Annex A; samples shall be regarded as having the sample batch number if— a the means of identifying the batch referred to in regulation 7(2)(h) above shows that they were manufactured in the same batch; b in the case of a product not manufactured in a batch, the reference referred to in regulation 7(2)(h) above shows that they are derived from the same unit of production; or c in the case of a product which does not comply with the requirements of regulation 7(2)(h) above, the officer effecting the purchase has reasonable cause to believe that they were manufactured in the same batch or are derived from the same unit of production, as the case may be. 3 The immediate container, if any, of a cosmetic product purchased by an enforcement authority shall not have been opened by, on behalf of or at the request of the enforcement authority before the purchase takes place and the container shall not thereafter be opened except in accordance with paragraph 5.3 of Part I of Annex A and paragraph 1.2 of Part II of Annex A. 4 As soon as an enforcement authority has purchased a cosmetic product, the officer effecting the purchase shall— a either— i place a seal on the product’s container or outer packaging; or ii place the product in a container and forthwith place a seal on that container, in such a way that the product’s immediate container cannot be opened or (in the case of a product which was not in a container when it was purchased) the product cannot be touched without (in either case) the seal being broken in such a manner that it would be apparent thereafter that it had been broken, and b attach to the product a label indicating— i the name of the product, ii the date, time and place at which the product was purchased, iii his own name, and iv the name of the enforcement authority making the purchase. 5 1 Subject to sub-paragraph (2) below, the provisions of Part 1 of Annex A, other than paragraphs 3.1, 3.2 and 4, and of Part II of Annex A, other than paragraph 1.4, shall be complied with in the sampling of cosmetic products and the laboratory preparation of test portions. 2 Where, because of the way in which a cosmetic product is put up for sale, it is not practicable for Part II of Annex A to be complied with, it shall be prepared for testing in accordance with good analytical practice, and the person so preparing it shall record in writing the method of preparation which he has used. 6 1 Any test to determine whether a cosmetic product contains a significant amount of free sodium hydroxide or free potassium hydroxide shall be carried out in accordance with paragraphs 1 to 4 of Part III of Annex A. 2 Any test to determine the amount of free sodium hydroxide or free potassium hydroxide in a hair straightener product or a nail cuticle solvent product shall be carried out in accordance with paragraphs 1, 2, 3 and 5 of Part III of Annex A. 3 Any test to determine whether a hair-care product contains oxalic acid or any alkaline salt of oxalic acid or to determine the amount of such a substance in a hair-care product shall, subject to the limitation specified in the second sentence of paragraph 1 of Part IV of Annex A, be carried out in accordance with the said Part IV. 4 Any test to determine the amount of chloroform in toothpaste shall, subject to the limitation specified in the second sentence of paragraph 1 of Part V of Annex A, be carried out in accordance with the said Part V. 5 Any test to determine the amount of zinc chloride, zinc sulphate or zinc 4-hydroxybenzene- sulphonate by virtue of their zinc contents in a cosmetic product shall be carried out in accordance with Part VI of Annex A and Commission Directive 87/143/EEC, and shall take into account paragraph 11 of Part VII of Annex A. 6 Any test to determine whether a cosmetic product contained in an aerosol dispenser or a cream, emulsion, lotion, gel or oil intended to be applied to the skin contains 4-hydroxybenzene-sulphonic acid, or to determine the amount of that acid in such a product, shall be carried out in accordance with Part VII of Annex A. 7 Any test to determine whether a hair-care product contains persulphate, bromate or hydrogen peroxide shall be carried out in accordance with Part A of Part I of Annex B. 8 Any test to determine whether a hair-care product contains barium peroxide shall be carried out in accordance with Part B of Part 1 of Annex B. 9 Any test to determine the amount of hydrogen peroxide in a hair-care product shall be carried out in accordance with Part C of Part I of Annex B. 10 Any test to determine whether a hair dye contains any of the oxidation colourants specified in paragraph 1 of Part II of Annex B, or to determine the amount of such a substance in a hair-dye, shall be carried out in accordance with the said Part II. 11 Any test to determine whether a cosmetic product contains nitrite, or to determine the amount of that substance in a cosmetic product, shall be carried out in accordance with Part III of Annex B. 12 Any test to determine whether a cosmetic product contains free formaldehyde, or to determine the amount of that substance in a cosmetic product, shall be carried out in accordance with Part IV of Annex B. 13 Any test to determine the amount of resorcinol in a shampoo or hair lotion shall, subject to the limitation specified in the second sentence of paragraph 1 of Part V of Annex B, be carried out in accordance with the said Part V. 14 Any test to determine the amount of methanol in relation to ethanol or propan-2-ol in a cosmetic product shall be carried out in accordance with Part VI of Annex B. 15 Any test to determine the amount of dichloromethane or 1,1,1-trichloroethane in a cosmetic product shall be carried out in accordance with paragraphs 1 to 10 of that part of Annex C which is headed “Determination of dichloromethane and 1,1,1-trichloroethane”. 16 Any test to determine whether a cosmetic product contains quinolin-8-ol or bis(8-hydroxyquinolinium) sulphate, or to determine the amount of such a substance in a cosmetic product, shall be carried out in accordance with paragraphs 1 to 9 of that part of Annex C which is headed “Identification and determination of quinolin-8-ol-and bis(8-hydroxyquinolinium) sulphate”. 17 Any test to determine the amount of ammonia in a cosmetic product shall be carried out in accordance with paragraphs 1 to 8 of that part of Annex C which is headed “Determination of ammonia”. 18 Any test to determine whether a cosmetic product contains nitromethane, or to determine the amount of that substance in a cosmetic product, shall be carried out in accordance with paragraphs 1 to 7 of that part of Annex C which is headed “Identification and determination of nitromethane”. 19 Any test to determine whether a hair waving, hair straightening or depilatory product contains mercaptoacetic acid (thioglycolic acid), or to determine the amount of that substance in such a product, shall be carried out in accordance with paragraphs 1 to 6 of that part of Annex C which is headed “Identification and determination of mercaptoacetic acid in hair waving, hair straightening and depilatory products”. 20 Any test to determine whether a cosmetic product contains hexachlorophene (INN) shall be carried out in accordance with paragraphs 1 to 7 of Part A of that part of Annex C which is headed “Identification and determination of hexachlorophene”. 21 Any test to determine the amount of hexachlorophene (INN) in a cosmetic product shall be carried out in accordance with paragraphs 1 to 9 of Part B of that part of Annex C which is headed “Identification and determination of hexachlorophene”. 22 Any test to determine the amount of tosylchloramide sodium (INN) in a cosmetic product shall be carried out in accordance with paragraphs 1 to 9 of that part of Annex C which is headed “Quantitative determination of tosylchloramide sodium (INN) (chloramine-T)”. 23 Any test to determine the total amount of fluorine in dental creams shall be carried out in accordance with paragraphs 1 to 8 of that part of Annex C which is headed “Determination of total fluorine in dental creams”. 24 Any test to determine whether a cosmetic product contains organomercury compounds shall be carried out in accordance with paragraphs 1 to 4 of Part A of that part of Annex C which is headed “Identification and determination of organomercury compounds”. 25 Any test to determine the amount of organomercury compounds in a cosmetic product shall be carried out in accordance with paragraphs 1 to 7 of Part B of that part of Annex C which is headed “Identification and determination of organomercury compounds”. 26 Any test to determine the amount of alkali sulphides or alkaline earth sulphides in a cosmetic product shall be carried out in accordance with paragraphs 1 to 8 of that part of Annex C which is headed “Determination of alkali and alkaline earth sulphides”. 27 Any test for the identification and determination of the amount of glycerol 1-(4-aminobenzoate) in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of glycerol 1-(4-aminobenzoate)”. 28 Any test to determine the amount of chlorobutanol (INN) in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Determination of chlorobutanol”. 29 Any test for the identification and determination of the amount of quinine in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of quinine”. 30 Any test for the identification and determination of inorganic sulphites and hydrogen sulphites in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of inorganic sulphites and hydrogen sulphites”. 31 Any test for the identification and determination of chlorates of the alkali metals in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of chlorates of the alkali metals”. 32 Any test for the identification and determination of sodium iodate in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of sodium iodate”. 33 Any test for the identification and determination of silver nitrate in a cosmetic product shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of silver nitrate in cosmetic products”. 34 Any test for the identification and determination of selenium disulphide in anti-dandruff shampoos shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of selenium disulphide in anti-dandruff shampoos”. 35 Any test for the determination of soluble barium and soluble strontium in pigments in the form of salts or lakes shall be carried out in accordance with that part of Annex E which is headed “Determination of soluble barium and strontium in pigments in the form of salts or lakes”. 36 Any test for the identification and determination of benzyl alcohol in a cosmetic product shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of benzyl alcohol in cosmetic products”. 37 Any test for the identification of zirconium and the determination of zirconium, aluminium and chlorine in non-aerosol anti-perspirants shall be carried out in accordance with that part of Annex E which is headed “identification of zirconium, and determination of zirconium, aluminium and chlorine in non-aerosol anti-perspirants”. 38 Any test for the identification and determination of hexamidine, dibromohexamidine, dibromopropamidine and chlorhexidine in a cosmetic product shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of hexamidine, dibromohexamidine, dibromopropamidine and chlorhexidine”. 39 Any test for the identification and determination of benzoic acid, 4-hydroxybenzoic acid, sorbic acid, salicylic acid and propionic acid in a cosmetic product shall be carried out in accordance with that part of Annex F which is headed “Identification and determination of benzoic acid, 4-hydroxybenzoic acid, sorbic acid, salicylic acid and propionic acid in cosmetic products”. 40 Any test for the identification and determination of hydroquinone, hydroquinone monomethyl ether, hydroquinone monoethyl ether and hydroquinone monobenzyl ether (monobenzone) in a cosmetic product shall be carried out in accordance with that part of Annex F which is headed “Identification and determination of hydroquinone, hydroquinone monomethyl ether, hydroquinone monoethyl ether and hydroquinone monobenzyl ether in cosmetic products”. 41 Any test for the identification and determination of 2-phenoxyethanol, 1-phenoxypropan-2-ol, and methyl, ethyl, propyl, butyl and benzyl 4-hydroxybenzoate in a cosmetic product shall be carried out in accordance with Annex G. SCHEDULE 12 List of Alternative Methods to Animal Testing Regulation 3(1), 5(7), (9) and (12) PART 1

Part 1 of this Schedule lists the alternative methods validated by the European Centre for the Validation of Alternative Methods (“ECVAM”) which are necessary to meet the requirements of these Regulations and which are listed in Annex V to Council Directive 67/548/EEC of 27th June 1967 on the approximation of laws, regulations and administrative provisions relating to classification, packaging and labelling of dangerous substances .

The reference number given in the second column of the table in Part 1 refers to the reference number under which the type of test is listed in Annex V to Directive 67/548/EEC.
Entry NumberReference NumberType of Test (toxicological endpoint)Alternative Test MethodDate after which this method is required to be used
1B40Skin corrosionRat skin TER assay11.9.04
2B40Skin corrosionHuman skin model assay11.9.04
3B41PhototoxicityIn vitro 3T3 NRU phototoxicity test11.9.04

PART 2

Part 2 of this Schedule lists the alternative methods validated by ECVAM which are necessary to meet the requirements of these Regulations and which are listed in Annex IX to the Directive. As an alternative method may not replace completely the experimentation on animals, column 3 of the table below specifies whether the alternative method fully or partially replaces the animal test.
Entry NumberReference NumberNature of replacementAlternative Test MethodDate after which this method is required to be used
Note: There are no entries in this Part at the date that these Regulations are made.

SCHEDULE 13 LIST OF SUBSTANCES CLASSIFIED AS CARCINOGENIC, MUTAGENIC OR TOXIC FOR REPRODUCTION OF CATEGORY 3 UNDER DIRECTIVE <Citation URI="http://www.legislation.gov.uk/european/directive/1967/0548" id="c00061" Class="EuropeanEconomicCommunityDirective" Year="1967" Number="548">67/548/EEC</Citation> WHICH APPEAR IN THE APPROVED SUPPLY LIST Regulation 5(15)

The substances listed in this table are classified as carcinogenic, mutagenic or toxic for reproduction under directive 67/548/EEC and in the approved supply list. These substances have been evaluated as safe by the Scientific Committee on Cosmetic Products in accordance with article 4b of the Directive and are permitted for use in cosmetic products.
SubstanceIndex NumberEC NumberCAS Number
Note: There are no entries in this Part at the date that these Regulations are made.

(This note is not part of the Order)

These Regulations revoke and re-enact the Cosmetic Products (Safety) Regulations 2003 (S.I. 2003/835) (“the 2003 Regulations”). The 2003 Regulations give effect to Council Directive 76/768/EEC (O.J. No. L262, 27.9.76, p.169) (“the Directive”) on the approximation of the laws of the Member States relating to cosmetic products, as amended by the Community instruments listed in Schedule 2 to these Regulations.

These Regulations also give effect for the first time to Council Directive 2003/15/EC (O.J. L66, 11.3.2003, p.26) which amends Directive 67/548/EEC for the 7th time, as follows: a Prohibit the supply of cosmetic products where the final formulation or ingredients have been tested on animals using a method other than an “alternative method”. The Regulations also introduce an outright prohibition in respect of the supply of cosmetic products after specified dates (2009 and 2013); b Prohibit the testing of “finished cosmetic products” on animals with immediate effect; c Prohibit the testing of ingredients for use in cosmetic products after specified dates; d Introduce provisions governing the use by cosmetic product manufacturers of claims in respect of animal testing; e Prohibit the use in cosmetic products of substances which are classified under directive 67/548/EEC as carcinogenic, mutagenic or toxic to reproduction (and listed in the approved supply list) subject to an exemption in respect of substances which have been evaluated as safe by the Scientific Committee on Cosmetic Products; f Requires manufacturers to label products with a symbol (contained in Schedule 9, Part 2) indicating the time after opening after which the product may harm the consumer (this only applies to products with a minimum durability of more than 30 months); g Requires certain perfumes and aromatic compositions to be specifically listed on product packaging; h Requires a specific safety assessment to be undertaken in respect of cosmetic products intended for children or for intimate hygiene; i Inserts further entries into Schedule 4 to these Regulations;

These Regulations also give effect to Council Directive 2003/80/EC (O.J. No. 224, 6.9.2003, p.27) which amends the Directive for the 30th time. Directive 2003/80/EC amends the Directive by inserting a new Annex VIIIa containing a symbol to be used by manufacturers to indicate the time after opening after which the product may harm the consumer (as required by Directive 2003/15/EC).

These Regulations also give effect to Council Directive 2003/83 (O.J. No. L238, 25.9.2003, p.23) which amends the Directive by inserting, deleting or amending entries in Annexes II, III and VI. These Regulations make appropriate amendments to Schedules 3,4 and 6, which implement those Annexes. Directive 2003/83/EC requires Member States to ensure that cosmetic products, which fail to comply with that directive, shall not be placed on the market from 24th March 2005 and that they shall not be supplied to the final consumer from 24th September 2005. Accordingly, regulations 1(3) and 1(4) provide that newly inserted or amended entries in the schedules to the regulations shall not have effect until 24th March 2005. Equally, these regulations provide that certain entries, which are amended or deleted by 2003/83, shall continue to operate in their existing form (i.e. as they appear in the Cosmetic Products (Safety) Regulations 2003) until 24th March 2005. Regulation 16(3) provides that no proceedings or enforcement action shall be taken in respect of the new or amended entries where the cosmetic product in question is placed on the market before 24th March 2005 and is supplied before 24th September 2005.

The Colour Index referred to in these Regulations may be obtained from the Society of Dyers and Colourists and the American Society of Textile Chemists and Colourists by on-line subscription at http://www.colour-index.org/.

A full regulatory impact assessment of the effect that this instrument will have on costs to business is available from the Consumer and Competition Policy Directorate of the Department of Trade and Industry, 1 Victoria Street, London SW1H 0ET. Copies of a transposition note relating to these Regulations have been placed in the libraries of both Houses of Parliament. Copies are also available to the public from the Consumer and Competition Policy Directorate of the Department of Trade and Industry, 1 Victoria Street, London SW1H 0ET.

1987 c. 43. S.I. 1972/1811, S.I. 1975/1707 and S.I. 1993/2661. 1972 c. 68. S.I. 2003/835 O.J. No. L132, 1.6.96, p.1. O.J. No L140, 23.6.95, p. 26. O.J. No. L262, 27.9.76, p. 169. O.J No. L147, 31.5.01, p.1. An ingredient’s CTFA name is the name given to it by the Cosmetics, Toiletries and Fragrances Association (CTFA) and listed in the tenth edition of the International Cosmetic Ingredient Dictionary and Handbook (ISBN 1-882621-34-4) published in 2004 by The Cosmetic Toiletry and Fragrance Association. Its EINECS identification reference is the reference given in the European Inventory of Existing Commercial Chemical Substances. Its IUPAC identification reference is the reference given by the International Union of Pure and Applied Chemistry. Its CAS identification reference is the reference assigned by the Chemical Abstracts Service. An ingredient’s colour index number is the number specified in the fourth edition of The Colour Index published by the Society of Dyers and Colourists and the American Society of Textile Chemists and Colourists (available by on-line subscription at http://www.colour-index.org/). European Pharmacopoeia names, International Non-proprietary Names and EINECS, IUPAC and CAS identification references are listed in Commission Decision 96/335/EC (O.J.No. L132, 1.6.96, p.1.). O.J. No. L50, 20.2.2004, p. 44, implemented by the Good Laboratory Practice (Codification Amendment Etc.) Regulations (S.I. 2004/994). 1954 c. 61. 1983 c. 54. S.I. 1991/824, to which there is an amendment not relevant to these Regulations. SI 2003/835 revoked by these regulations S.I. 2003/835. O.J. No. L132, 1.6.1996, p.1. SI 2003/835 Note 2: The concentration of sodium, potassium or lithium hydroxide is expressed as a percentage of sodium hydroxide. In cases of mixtures, the sun must not exceed the limits given in column 4. O.J. No. 115, 11.11.62, p.2645. Council Directives Nos. 65/469/EEC, 67/653/EEC, 68/419/EEC, 70/358/EEC, 76/399/EEC, 78/144/EEC, 81/20/EEC and 85/7/EEC (O.J. Nos. L178, 26.10.65, p.2793; L263, 30.10.67, p. 4; L309, 24.12.68, p.24; L157, 18.7.70, p.36; L108,26.4.76, p.19; L44, 15.2.78, p.20; L43, 14.2.81, p.11; L2, 3.1.85, p.22). Annexes 1 and VII to the Act of Accession of 22nd January 1972, as adjusted by the Council Decision of 1st January 1973 (O.J. No. L2, 1.1.73, p.1). Council Directive 94/36/EC (O.J) No. L237, 10.9.94, p.13) and Commission Directive 95/45/EC (O.J. No. L226, 22.9.95, p.1). O. J. No. L132, 1.6..96, p.1. SI 2003/835 O.J. No. L132, 1.6.96, p.1. O.J. l 196, 16.8.1967, p.1 as last amended by Directive 2004/73/EEC (O.J. L152, 30.4.2004, p.1) O.J. No. L383, 31.12.80, p.27. O,J. No. L57, 27.2.87, p.56. O.J. No. L185, 30.6.82, p.1. O.J. No. L108, 28.4.90, p.92. O.J. No. L291, 24.10.83, p.9. O.J. No. L295, 7.11.85, p.30. O.J. No. L231, 14.9.93, p.34. O.J. No.L178, 28.7.95, p.20. O.J. No. L213, 2.7.96, p.8. O.J. No. L57, 27.2.87, p.56. O.J. l 196, 16.8.1967, p.1 as last amended by Directive 2004/73/EC (O.J. L152, 30.4.2004, p.1) Council Directive 1967/548/EEC (OJ 196,16.8.67, p.1) as last amended by 2004/73/EC (O.J. L152, 30.4.2004, p.1) the Scientific Committee on Cosmetic Products was previously called the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (“SCCNFP”) the Scientific Committee on Cosmetic Products was previously called the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (“SCCNFP”) Reg. 16 in force at 11.9.2004, see reg. 1(1)Sch. 13 in force at 11.9.2004, see reg. 1(1)Sch. 9 Pt. 1 in force at 11.9.2004 as commenced by inducing reg. 7(6)(11) , see reg. 1(1)Sch. 3 Pt. 1 in force at 11.9.2004, see reg. 1(1)Reg. 13 in force at 11.9.2004, see reg. 1(1)Sch. 11 para. 2 in force at 11.9.2004, see reg. 1(1)Sch. 10 Pt. II para. 2 in force at 11.9.2004, see reg. 1(1)Sch. 1 Pt. 1 in force at 11.9.2004, see reg. 1(1)Sch. 10 Pt. 1 para. 2 in force at 11.9.2004, see reg. 1(1)Reg. 15 in force at 11.9.2004, see reg. 1(1)Sch. 11 para. 1 in force at 11.9.2004, see reg. 1(1)Sch. 10 para. 7 in force at 11.9.2004, see reg. 1(1)Sch. 1 Pt. 2 in force at 11.9.2004, see reg. 1(1)Sch. 9 Pt. 2 in force at 11.3.2005 as commenced by reg. 7(2), see reg. 1(2)Reg. 18 in force at 11.9.2004, see reg. 1(1)Sch. 7 Pt. 1 in force at 11.9.2004 in so far as commenced by inducing reg. 5(2), see reg. 1(1)Sch. 8 in force at 11.9.2004, see reg. 1(1)Sch. 4 Pt. 1 in force at 11.9.2004 in so far as commenced by inducing regs. 5(2), 6(1), see reg. 1(1)Reg. 8 in force at 11.9.2004, see reg. 1(1)Sch. 4 Pt. 2 in force at 11.9.2004 in so far as commencd by inducing regs. 5(2), 6(1), see reg. 1(1)Reg. 7(2)(c)(9)(b) in force at 11.3.2005, see reg. 1(2)Sch. 10 Pt. II para. 1 in force at 11.9.2004, see reg. 1(1)Sch. 10 Pt. 1 para. 1 in force at 11.9.2004, see reg. 1(1)Sch. 12 Pt. 2 in force at 11.9.2004, see reg. 1(1)Sch. 10 para. 4 in force at 11.9.2004, see reg. 1(1)Sch. 11 para. 4 in force at 11.9.2004, see reg. 1(1)Sch. 4 Pt. 1 in force at 11.3.2005 in so far as commenced by inducing reg. 7(2)(9), see reg. 1(2)Reg. 4 in force at 11.9.2004, see reg. 1(1)Sch. 6 Pt. 2 in force at 11.3.2005 in so far as commenced by indcuing reg. 7(2), see reg. 1(2)Sch. 11 para. 3 in force at 11.9.2004, see reg. 1(1)Sch. 11 para. 5 in force at 11.9.2004, see reg. 1(1)Sch. 5 Pt. I in force at 11.3.2005 in so far as commenced by inducing reg. 7(9), see reg. 1(2)Reg. 5 in force at 11.9.2004, see reg. 1(1)Reg. 14 in force at 11.9.2004, see reg. 1(1)Sch. 7 Pt. II in force at 11.3.2005 in so far as commenced by inducing reg. 7(2)(9), see reg. 1(2)Sch. 6 Pt. I in force at 11.9.2004 in so far as commenced by inducing reg. 5(2), see reg. 1(1)Sch. 10 para. 5 in force at 11.9.2004, see reg. 1(1)Reg. 3 in force at 11.9.2004, see reg. 1(1)Reg. 2 in force at 11.9.2004, see reg. 1(1)Sch. 6 Pt. I in force at 11.3.2005 in so far as commenced by inducing reg. 7(2), see reg. 1(2)Sch. 10 para. 6 in force at 11.9.2004, see reg. 1(1)Sch. 5 Pt. II in force at 11.9.2004 in so far as commenced by inducing reg. 5(2), see reg. 1(1)Sch. 7 Pt. II in force at 11.9.2004 in so far as commenced by inducing reg. 5(2), see reg. 1(1)Reg. 17 in force at 11.9.2004, see reg. 1(1)Reg. 7(1)(2)(a)(b)(d)-(i)(3)-(9)(a)(c)-(f)(10)-(15) in force at 11.9.2004, see reg. 1(1)Reg. 1 in force at 11.9.2004, see reg. 1(1)Sch. 12 Pt. 1 in force at 11.9.2004, see reg. 1(1)Sch. 5 Pt. II in force at 11.3.2005 in so far as commence by inducing reg. 7(9), see reg. 1(2)Sch. 7 Pt. 1 in force at 11.3.2005 in so far as commenced by inducing reg. 7(2)(9), see reg. 1(2)Sch. 3 Pt. 2 in force at 11.9.2004, see reg. 1(1)Reg. 11 in force at 11.9.2004, see reg. 1(1)Reg. 9 in force at 11.9.2004, see reg. 1(1)Reg. 6 in force at 11.9.2004, see reg. 1(1)Sch. 10 para. 3 in force at 11.9.2004, see reg. 1(1)Sch. 11 para. 6 in force at 11.9.2004, see reg. 1(1)Reg. 10 in force at 11.9.2004, see reg. 1(1)Sch. 5 Pt. I in force at 11.9.2004 in so far as commenced by inducing reg. 5(2), see reg. 1(1)Sch. 6 Pt. 2 in force at 11.9.2004 in so far as commenced by inducing reg. 5(2), see reg. 1(1)Reg. 12 in force at 11.9.2004, see reg. 1(1)Sch. 4 Pt. 2 in force at 11.3.2005 in so far as commenced by inducing reg. 7(2)(9), see reg. 1(2)Sch. 2 in force at 11.9.2004, see reg. 1(1)