Statutory Instrument 2000 No. 2765

The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2000

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© Crown Copyright 2000

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(a) in regulation 2(1), in the definition of "the Directive", by deleting the word "and" before "Commission Directive 2000/41/EC"[4] and by adding words ", Commission Directive 2000/6/EC[5] and Commission Directive 2000/11/EC[6]" at the end of the definition;

(b) in Schedule 1, by the deletion of entry number 423, and

(c) in Part I of Schedule 2 - 

(i) by the substitution for entry number 1 of the following - 

(ii) by the substitution for entry number 14 of the following - 

14	Hydroquinone	Oxidising colouring agent for hair dyeing for general use	0.3 per cent subject to the provisions of "Combination Rule B" set out below	-	Contains hydroquinone. Do not use to dye eye-lashes or eyebrows. Rinse eyes immediately if product comes into contact with them.
		Oxidising colouring agent for hair dyeing for professional use	0.3 per cent subject to the provisions of the "Combination Rule B" set out below	-	Contains hydroquinone. For professional use only. Rinse eyes immediately if product comes into contact with them";

(iii) by the insertion after entry number 64 of the following - 

65	Benzalkonium chloride (INN), bromide and saccharinate (eg. Cetalkonium chloride Stearalkonium chloride, Cetearalkonium bromide)	Hair care products rinsed off after use	3 per cent calculate as benzalkonium chloride	In 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 chloride.	Avoid contact with the eyes.
		Other products	0.1 per cent calculated as benzalkonium chloride		Avoid contact with the eyes";

(d) In Part I of Schedule 4 by adding the following entries after entry number 54[7] - 

55	Benzylhemi-formal	Products rinsed off after use	0.15 per cent	-	-
56	3-Iodoprop-2-ynyl butylcarbamate (Iodopropynl butylcarbamate)	Not to be used in oral hygiene and lip products	0.05 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)";

(e) In Part II of Schedule 4, by the deletion of entry numbers 21 and 29;

(f) In Part I of Schedule 5, by adding the following entries after entry number 20[8] - 

21	2-Ethylhexyl 4-dimethylaminobenzoate [Octyl dimethyl PABA]	8 per cent	-	-
22	2-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)	-	-
23	2-2'-Methylenebis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol]	10 per cent	-	-
24	diSodium 2,2'-(1,4-phenylene)bis(1H-benzimidazole-4,6-disulfonate)	10 per cent (expressed as acid)	-	-
25	5,5'-Bis(2-ethylhexyloxy)-2,2'-(6-p-methoxyphenyl-1,3,5-triazine-2,4-diyl)diphenol	10 per cent	-	- ";

(g) In Part II of Schedule 5, by the deletion of entry numbers 5, 17 and 29;

(h) In Schedule 5A[9], by the substitution for sub-paragraph (b)(ii) of the following - 

" (ii) Transesterification or hydrolysis at a temperature of at least 200°C and at an appropriate corresponding pressure, for 20 minutes (glycerol, fatty acids and fatty acid esters)".

     3.  - (1) The following entries in Schedule 1 shall continue to have effect in relation to any supply of a cosmetic product to which regualtion 4(2)(a) of the principal Regulations applies on or after 17th March 2000 but shall cease to have effect in relation to any such supply of cosmetic products occurring prior to that date and no investigation, legal proceeding or remedy may be instituted, continued or enforced, and no penalty, forfeiture or punishment may be imposed in respect of any such supply - 

2	Acetonitrile	-	393
9	Acetylethyltetramethyltetralin (AETT)	341	362
55	Anti-androgens with steroid structure	-	390
62	Aristolochic acid and its salts	-	365
208	Colouring agent CI 42640	-	386
341	3'-Ethyl-5',6',7',8'-tetrahydro-5',5',8',8'-tetramethyl-2'-acetonaphthone	9	362
399	11[alpha]-Hydroxypregn-4-ene-3,20-dione and its esters	-	385
485	Minoxidil (INN), its salts and derivatives	596	372
587	Phytolacca spp and their preparations	-	374
596	6-(Piperidinyl)-2,4-pyrimidinediamine 3-oxide, its salts and derivatives	485	372
688	2,3,7,8-Tetrachlorodibenzo-p-dioxin	-	367
697	Tetrahydrozoline and its salts	-	394
727	Tribromsalan (INN)	728	373
728	3,4',5-Tribromosalicylanilide	727	373
766	Zirconium and its compounds (except aluminium zirconium chloride hydroxide complexes and aluminium zirconium chloride hydroxide glycine complexes under the conditions laid down in Part I of Schedule 2 and zirconium lakes, salts and pigments prepared from those colouring agents identified in column 1 of Part I of Schedule 3 by "*" immediately after the name or colour index number)	-	391";

    (2) Entry number 749 of Schedule 1 shall be deleted.


Kim Howells,
Parliamentary Under-Secretary of State for Consumers and Corporate Affairs, Department of Trade and Industry

9th October 2000

     8. Delete entry number 749 (Tyrothricin (INN)) from the list of prohibited substances in Schedule 1 (regulation 3(2)). However the use of Tyrothricin (which is an antibiotic) in cosmetics will continue to be prohibited by entry number 56 which prohibits the use of antibiotics.

The Regulations also remove laurel oil of unspecified origin from Schedule 1 which had been incorrectly added (regulation 2(b)).

The Regulations come into force on 31st October 2000 except as provided by Regulation 1(2) and (3).

[2] 1972 c. 68.back

[3] S.I. 1996/2925, amended by S.I. 1997/2914, S.I. 1998/1727, S.I. 1999/1552 and S.I. 2000/1679.back

[4] The reference to Commission Directive 2000/41/EC was added to S.I. 1996/2925 by S.I. 2000/1679.back

[5] O.J. No. L56, 1.3.2000, p.42.back

[6] O.J. No. L65, 14.3.2000, p.22.back

[7] Entry number 54 was added to S.I. 1996/2925 by S.I. 1999/1552.back

[8] Entry number 20 was added to S.I. 1996/2925 by S.I. 1999/1552.back

[9] Schedule 5A was added to S.I. 1996/2925 by S.I. 1998/1727.back