Regulation 2

The Cosmetic Products (Safety) Regulations 1996^f1 (“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”^f2 and by adding words “, Commission Directive 2000/6/EC^f3 and Commission Directive 2000/11/EC^f4” 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^f5—

“

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^f6—

“

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^f7, 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)”.

Annotations

Footnotes

f1: S.I. 1996/2925, amended by S.I. 1997/2914, S.I. 1998/1727, S.I. 1999/1552 and S.I. 2000/1679.
f2: The reference to Commission Directive 2000/41/EC was added to S.I. 1996/2925 by S.I. 2000/1679.
f3: O.J. No. L56, 1.3.2000, p.42.
f4: O.J. No. L65, 14.3.2000, p.22.
f5: Entry number 54 was added to S.I. 1996/2925 by S.I. 1999/1552.
f6: Entry number 20 was added to S.I. 1996/2925 by S.I. 1999/1552.
f7: Schedule 5A was added to S.I. 1996/2925 by S.I. 1998/1727.

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

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

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

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)

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	—	—