
1 

(1) These Regulations may be cited as the Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2000 and, except as provided by paragraphs (2) and (3) below, shall come into force on 31st October 2000.
(2) Regulation 3 and this regulation shall come into force on 11th October 2000.
(3) Regulation 2(c)-(h) shall come into force on 1st January 2001.
2 
The Cosmetic Products (Safety) Regulations 1996 (“the principal Regulations”) are amended as follows—
(a) in regulation 2(1), in the definition of “the Directive”, by deleting the word “and” before “Commission Directive 2000/41/EC” and by adding words “, Commission Directive 2000/6/EC and Commission Directive 2000/11/EC” 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—“
1a. Boric acid, borates, and tetraborates Talcum powder 5 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 products 0.1 per cent Not to be used in products intended for children under 3 years old. Do not swallow. Not to be used for children under three years old.
  Other products (excluding bath products and hair waving products) 3 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
1b. Tetraborates Bath products 18 per cent Not to be used in products for children under 3 years old. Not to be used for bathing children under three years old.
  Hair waving products 8 per cent The above-mentioned percentage are calculated as boric acid  Rinse well”;
(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—“
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—“
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, 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)”.
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(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 11α-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