S.I. No. 150/2000 - European Communities (Cosmetic Products) (Amendment No. 2) Regulations, 2000.

I, MICHEÁL MARTIN, Minister for Health and Children, in exercise of the powers conferred on me by section 3 of the European Communities Act, 1972 (No. 27 of 1972), for the purpose of giving effect to Commission Directives 98/62/EC, 2000/6/EC and 2000/11/EC of the 3 September 1998, 29 February 2000 and 10 March 2000 respectively, hereby make the following Regulations:—

1. These Regulations may be cited as the European Communities (Cosmetic Products) (Amendment No. 2) Regulations, 2000.

2. These Regulations shall be construed as one with the European Communities (Cosmetic Products) Regulations, 1997 and 1998 and may be cited with those Regulations as the European Communities (Cosmetic Products) Regulations, 1997 to 2000.

3. In these Regulations “the Principal Regulations” means the European Communities (Cosmetic Products) Regulations, 1997.

4. The Principal Regulations are hereby amended by

(a) the insertion of the following definition in regulation 4(1) thereof—

““the Irish Medicines Board” means the Board established under the Irish Medicines Board Act, 1995 (No. 29 of 1995)”,

(b) the addition to the definition of “the Principal Directive”, in regulation 4(1) thereof of the references “98/62/EC⁴⁴ ”, “2000/6/EC⁴⁵ ” and “2000/11/EC⁴⁶ ”, and

“(1) These Regulations may be enforced by officers of the Minister, by the health boards and their officers and by officers of the Irish Medicines Board.”

5. The Schedules to the Principal Regulations are hereby amended in the manner set-out in the Schedule to these Regulations.

6. (1) The provisions of these Regulations, as they apply to those substances referred to in the Schedule hereto that are included in the Annex to Commission Directive 98/62/EC, shall not apply to the sale or supply of cosmetic products to the final consumer until 1st July 2000.

(2) The provisions of these Regulations, as they apply to those substances referred to in the Schedule hereto that are included in the Annex to Commission Directive 2000/6/EC, shall not apply to the sale or supply of cosmetic products to the final consumer until 2nd January 2001.

Schedule

1. Schedule 2 to the Principal Regulations is amended as follows:—

(a) The following new entries are added:—

“421. 1,1,3,3,5-Pentamethyl-4,6-dinitroindane (Moskene)”

“422. 5-tert-Butyl-1,2,3-trimethyl-4,6-dinitrobenzene (Musk tibetene)”

(b) The entries numbered 362, 365, 367, 372, 373, 374, 385, 386, 390, 391, 393, 394 and 419 are substituted as follows:—

“362. 3' -Ethyl-5',6',7',8'-tetrahydro-5',5',8',8'-tetramethyl-2'-acetonaphthone or 7-Acetyl-6-ethyl-1,1,4,4 - tetramethyl - 1,2,3,4-tetrahydronaphtalen”

“365 Aristolochic acid and its salts; Aristolochia spp. and their preparations”

“367 2,3,7,8-Tetrachlorodibenzo-p-dioxin”

“372 6-(Piperidinyl)-2,4-pyrimidinediamine-3-oxide (Minoxidil) and its salts”

“373 3,4',5-Tribromosalicylanilide”

“374 Phytolacca spp. and their preparations”

“385 11α-Hydroxypregn-4-ene-3,20-dione and its esters”

“386 Colouring agent C.I. 42 640”

“390 Antiandrogens of steroidal structure”

“391 Zirconium and its compounds, with the exception of those zirconium substances listed under reference number 50 in Schedule 3, Part 1, and the zirconium lakes, pigments or salts of the colouring agents identified with the reference number (3) in Schedule 4, Part 1”

“393 Acetonitrile”

“394 Tetrahydrozoline and its salts”

“419 (a) the skull, including the brain, eyes, tonsils and spinal cord of:

—bovine animals aged over 12 months,

—ovine and caprine animals which are aged over 12 months or have a permanent incissor tooth erupted through the gum;

(b) the spleens of ovine and caprine animals and the ingredients derived therefrom.

However, tallow derivatives may be used in cosmetic products provided that the following methods have been used and strictly certified by the producer of such derivatives:

—transesterification or hydrolysis at not less than 200°C and at an appropriate corresponding pressure, for 20 minutes (glycerol, fatty acids and fatty acid esters).

—saponification with sodium hydroxide 12M (glycerol and soap).

—batch process at 95°C for 3 hours, or

—continuous process at 140°C, 2 bars (2,000 hPa) for 8 minutes or equivalent conditions.”

2. Schedule 3 to the Principal Regulations is amended as follows:—

(a) In Part 1, the entries numbered 1, 14 and 57 are substituted in the manner set out in the following Table:

Reference Number	Substance	Field of application and/or use	Maximum authorised concentration in the finished cosmetic product	Other limitations and requirements	Conditions of use and warnings which must be printed on the label
a	b	c	d	e	f
1a	Boric acid, borates and tetraborates.	(a) Talc	(a) 5% (by mass/mass as boric acid).	(a) 1. Not to be used in products for children under 3 years of age.	(a) 1. Not to be used for children under 3 years of age.
				2. Not to be used on peeling or irritated skin if the concentration of free soluble borates exceeds 1.5% (by mass/mass as boric acid).	2. Not to be used on peeling or irritated skin.
		(b) Products for oral hygiene.	(b) 0.1% (by mass/mass as boric acid.	(b) 1. Not to be used in products for children under 3 years of age.	(b) 1. Not to be swallowed.
					2. Not to be used for children under 3 years of age.
		(c) Other products (excluding bath products and hair waving products	(c) 3% (by mass/mass as boric acid).	(c) 1. Not to be used in products for children under 3 years of age.	(c) 1. Not to be used for children under 3 years of age.
				2. Not to be used on peeling or irritated skin if the concentration of free soluble borates exceeds 1.5% (by mass/mass as boric acid).	2. Not to be used on peeling or irritated skin.
1b	Tetraborates	(a) Bath products	(a) 18% (by mass/mass as boric acid).	(a) Not to be used in products for children under 3 years of age.	(a) Not to be used for bathing children under 3 years of age.
		(b) Hair waving products.	(b) 8% (by mass/mass as boric acid).		(b) Rinse well.
14	Hydroquinone (See note (b) at end of this Part of this Schedule)	Oxidising colouring agent for hair- dyeing:	0.3%
		(i) general use			(i)- Do not use to dye eyelashes or eyebrows
					- Rinse the eyes immediately if the product comes into contact with them.
					- Contains hydroquinone
		(ii) professional use			(ii)- For professional use only
					- Contains hydroquinone

3. Schedule VI to the Principal Regulations is amended as follows:—

(a) In Part I the following new entries are added:—

Reference Number	Substance	Maximum authorised concentration	Limitations and requirements	Conditions of use and warnings which must be printed on the label
a	b	c	d	e
54	Benzalkonium chloride, bromide and saccharate (O)	0.1% calculated as benzalkonium chloride		Avoid contact with the eyes
55	Benzylhemiformal	0.15%	Only for products to be removed by rinsing
56	3-Iodo-2- propynylbuty Icarbamate	0.05%	1. Not to be used for oral hygiene and lipcare products
			2.If the concentration in products intended to remain on the skin exceeds 0.02%, add the phrase “Contains Iodine”	2. Contains Iodine

(b) In Part 2 the entries numbered 16, 21 and 29 are deleted.

4. The following new entries are added to Part 1 of Schedule 7 to the Principal Regulations:

Reference Number	Substance	Maximum authorised concentration	Other Limitations and requirements	Conditions of use and warnings which must be printed on the label
a	b	c	d	e
13	Ethoxylated Ethyl 4- aminobenzoate (PEG-25 PABA)	10%
14	Isopentyl 4- methoxy- cinnamate (Isoamyl p- methoxycinnamate)	10%
15	2,4,6-Trianilino- (p-carbo-2'- ethylhexyl-1'- oxy)-1,3,5- triazine (Octyl triazone)	5%
16	Phenol,2-(2H- benzotriazol-2- yl)-4-methyl-6- (2-methyl-3- (1.3.3.3- tetramethyl-1- (trimethylsilyl) oxy)-disiloxanyl) propyl (Drometrizole trisiloxane)	15%
17	Benzoic acid, 4,4-{(6((((1,1- Dimethylethyl) amino)carbonyl) phenyl)amino)- 1,3,5-triazine- 2,4-diyl)diimino} bis-,bis(2- ethylhexyl)ester	10%
18	3-(4'- Methylbenzy lidene) dl- camphor (4- Methylbenzy lidene camphor)	4%
19	3-Benzylidene camphor	2%
20	2-Ethylhexyl salicylate (Octylsalicylate)	5%
21	Ethyl-2-hexyl 4- dimethylamino benzoate (Octyldimethyl PABA)	8%
22	2-Hydroxy-4- methoxybenz ophen one-5- sulphonic acid (Benzophenone- 5) and its sodium salt	5% (as acid)
23	2,2'-Methylene- bis-6-(2H- benzotriazol-2- yl)-4- (tetramethyl butyl)-1,1,3,3- phenol	10%
24	Monosodium 2,2'-bis-(1,4- phenylene)-1H- benzimidazole- 4,6-disulphonate	10% (as acid)
25	2,4-bis((4-(2- Ethylhexyloxy)- 2-hydroxy)- phenyl)-6-(4- methoxyphenyl)- (1,3,5)-triazine	10%

5. Part 2 of Schedule 7 to the Principal Regulations is amended by the deletion of those substances having the reference numbers 2, 5, 6, 12, 17, 25, 26, 29 and 32 respectively.

	GIVEN under my Official Seal, this 30th day of May, 2000.
	MICHEÁL MARTIN TD,
	Minister for Health and Children.

EXPLANATORY NOTE.

(This note is not part of the Instrument and does not purport to be a legal interpretation.)

These Regulations update the law in relation to the manufacure, placing on the market and sale of cosmetic products in accordance with the twenty-third, twenty-fourth and twenty-fifth Commission Directives as referred to above. In general the principal effects of the Regulations include the making available of further substances which, in accordance with the prescribed conditions, may be used as preservatives or as UV filters for sunscreen products. Also the use and placing on the market of skin lightening products containing hydroquinone is prohibited. The Regulations also assign powers of enforcement in regard to cosmetic products to officers of the Irish Medicines Board.

^44. 98/62/EC - Official Journal of the European Communities, No. L.253, 15/9/1998 (pages 20-23) (Twenty-third Commission Directive).

^45. 2000/6/EC - Official Journal of the European Communities, No. L56, 1/3/2000 (pages 42-46) (Twenty-fourth Commission Directive).

^46. 2000/11/EC - Official Journal of the European Communities, No. L65, 14/2/2000 (pages 22-25) (Twenty-fifth Commission Directive).