S.I. No. 6/2008 - European Communities (Cosmetic Products) (Amendment) Regulations 2008

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S.I. No. 6/2008 - European Communities (Cosmetic Products) (Amendment) Regulations 2008

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S.I. No. 6 of 2008
EUROPEAN COMMUNITIES (COSMETIC PRODUCTS) (AMENDMENT) REGULATIONS 2008
Notice of the making of this Statutory Instrument was published in
“Iris Oifigiúil” of 25th January, 2008.
I, MARY HARNEY, 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), and for the purpose of giving effect to Commission Directive 2007/1/EC 1 of 29 January 2007, Commission Directive 2007/17/EC 2 of 22 March 2007, Commission Directive 2007/22/EC 3 of 17 April 2007, Commission Directive 2007/53/EC 4 of 29 August 2007, Commission Directive 2007/54/EC 5 of 29 August 2007 and Commission Directive 2007/67/EC 6 of 22 November 2007,

and for the purpose of giving further effect to Commission Directive 95/17/EC 7 of 19 June 1995 (as last amended by Commission Directive 2006/81/EC 8 of 23 October 2006), hereby make the following regulations:
1. These Regulations may be cited as the European Communities (Cosmetic Products) (Amendment) Regulations 2008.
2. The collective citation “the European Communities (Cosmetic Products) Regulations 2004 to 2008” includes these Regulations.
3. (1) The title to the European Communities (Cosmetic Products) (Amendment No. 2) Regulations 2006 ( S.I. No. 64 of 2006 ) is amended by substituting for “European Communities (Cosmetic Products) (Amendment No. 2) Regulations 2006” the following title:
“European Communities (Cosmetic Products) (Amendment) Regulations 2006”.
(2) The title to the European Communities (Cosmetic Products) (Amendment No. 3) Regulations 2006 ( S.I. No. 373 of 2006 ) is amended by substituting for “European Communities (Cosmetic Products) (Amendment No. 3) Regulations 2006” the following title:
“European Communities (Cosmetic Products) (Amendment) (No. 2) Regulations 2006”.
(3) The title to the European Communities (Cosmetic Products) (Amendment No. 4) Regulations 2006 ( S.I. No. 506 of 2006 ) is amended by substituting for “European Communities (Cosmetic Products) (Amendment No. 4) Regulations 2006” the following title:
“European Communities (Cosmetic Products) (Amendment) (No. 3) Regulations 2006”.
(4) The title to the European Communities (Cosmetic Products) (Amendment No. 5) Regulations 2007 ( S.I. No. 235 of 2007 ) is amended by substituting for “European Communities (Cosmetic Products) (Amendment No. 5) Regulations 2007” the following title:
“European Communities (Cosmetic Products) (Amendment) Regulations 2007”.
(5) References in any instrument to the titles as amended under paragraphs (1), (2), (3) and (4) shall be construed as references to the new titles, as substituted by this Regulation.
4. (1) In these Regulations:
“Minister” means the Minister for Health and Children, and
“Principal Regulations” mean the European Communities (Cosmetic Products) Regulations 2004 ( S.I. No. 870 of 2004 ), as amended.
(2) (a) A reference in these Regulations to a Regulation is to a Regulation of these Regulations, unless it is indicated that reference to some other Regulations is intended.
(b) A reference in these Regulations to a paragraph or subparagraph is to the paragraph or subparagraph of the provision in which the reference occurs, unless it is indicated that reference to some other provision is intended.
(c) A reference in these Regulations to a Schedule is to a Schedule to these Regulations, unless it is indicated that reference to some other Regulations is intended.
5. Subject to Regulations 7, 8, 9, 10, 11 and 12, Regulation 4(1) of the Principal Regulations is amended by the addition to the definition of “Directive” of references to the following Commission Directives:
“2007/1/EC, 2007/17/EC, 2007/22/EC, 2007/53/EC, 2007/54/EC and 2007/67/EC”.
6. Subject to Regulations 7, 8, 9, 10, 11 and 12, the Schedules to the Principal Regulations are amended in the manner set out in the Schedules to these Regulations.
7. (1) Subject to paragraph (2), the provisions of these Regulations, insofar as such provisions relate to Commission Directive 2007/1/EC 1 and the requirements of Schedule 1, shall come into operation on the date these Regulations are signed by the Minister.
(2) Insofar as cosmetic products fail to comply with the provisions and requirements referred to in paragraph (1), the prohibition on sales and disposals to the final consumer shall not come into operation until 21 February 2008.
8. (1) Subject to paragraph (2), the provisions of these Regulations, insofar as such provisions relate to Commission Directive 2007/17/EC 2 and the requirements of Schedule 2, shall come into operation on 23 March 2008.
(2) Insofar as cosmetic products fail to comply with the provisions and requirements referred to in paragraph (1), the prohibition on sales and disposals to the final consumer shall not come into operation until 23 June 2008.
9. (1) Subject to paragraph (2), the provisions of these Regulations, insofar as such provisions relate to Commission Directive 2007/22/EC 3 and the requirements of Schedule 3, shall come into operation on 18 October 2008.
(2) Insofar as cosmetic products fail to comply with the provisions and requirements referred to in paragraph (1), the prohibition on sales and disposals to the final consumer shall not come into operation until 18 April 2009.
10. The provisions of these Regulations, insofar as such provisions relate to Commission Directive 2007/53/EC 4 and the requirements of Schedule 4, shall come into operation on 19 January 2009.
11. The provisions of these Regulations, insofar as such provisions relate to Commission Directive 2007/54/EC 5 and the requirements of Schedule 5, shall come into operation on 18 June 2008.
12. The provisions of these Regulations, insofar as such provisions relate to Commission Directive 2007/67/EC 6 and the requirements of Schedule 6, shall come into operation on the date these Regulations are signed by the Minister.
13. From the date these Regulations are signed by the Minister, Schedule 10 to the Principal Regulations shall be amended in accordance with Schedule 7 to these Regulations.
SCHEDULE 1
1. Schedule 2 to the Principal Regulations is hereby amended as follows:
(a) the following reference numbers 1234 to 1243 are added:
Ref. No.
Chemical Name/INCI Name
CAS No.
1234.
PEG-3,2,2-di--phenylenediamine
144644-13-3
1235.
6-Nitro-o-toluidine
570-24-1
1236.
HC Yellow No. 11
73388-54-2
1237.
HC Orange No. 3
81612-54-6
1238.
HC Green No. 1
52136-25-1
1239.
HC Red No. 8 and its salts
97404-14-3,13556-29-1
1240.
Tetrahydro-6-nitroquinoxaline and its salts
158006-54-3,41959-35-7
1241.
Disperse Red 15, except as impurity in Disperse Violet 1
116-85-8
1242.
4-Amino-3-fluorophenol
399-95-1
1243.
N,N-Dihexadecyl-N,N-bis(2-hydroxyethyl) propanediamide (Bishydroxyethyl biscetyl malonamide)
149591-38-8
(b) The entry under reference number 1182 is deleted.
(c) The entry under reference number 663 is replaced by the following:
‘(2RS,3RS)-3-(2-Chlorophenyl)-2-(4-fluorophenyl)-[1H-1,2,4-triazol-1-yl)methyl]oxirane; epoxiconazole (CAS No 133855-98-8)’.
SCHEDULE 2
1. Part 1 of Schedule 3 to the Principal Regulations is hereby amended by the addition of the following reference numbers 98 to 101 as indicated in the table below:
Restrictions
Reference No
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
’98.
Salicylic acid (9)
(a) Rinse-off hair products
(a) 3,0%
Not to be used in preparations for children under three years of age,
Not to be used for children under three years of age (10)
(CAS No
except for
69-72-7)
(b) Other products
(b) 2,0%
shampoos.
For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product.
99.
Inorganic sulfites and bisulfites (11)
(a) Oxidative hair dye products
(a) 0,67% expressed as free SO2
For purposes other than inhibiting the development ofmicro-organisms in
(b) Hair straightening products
(b) 6,7% expressed as free SO2
the product. This purpose has to be apparent from the presentation of the
(c) Self tanning products for the face
(c) 0,45% expressed as free SO2
product.
(d) Other self tanning products
(d) 0,40% expressed as free SO2
(9) As a preservative, see Schedule 4, Part 1, No. 3.
(10) Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin.
(11) As a preservative, see Schedule 6, Part 1, No. 9.
Restrictions
Reference No
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
100.
Triclocarban (12)
Rinse-off products
1.5%
Purity criteria:
3,3,4,4-Tetrachloroazobe
(CAS No101-20-2)
nzene 1 ppm
3,3,4,4-Tetrachloroazoxybenzene 1 ppm
For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product.
101.
ZincPyrithione (13)
Leave-on hair products
0,1%
For purposes other than inhibiting the development of micro-organisms in
(CAS No 13463-41-7)
the product. This purpose has to be apparent from the presentation of the product.’
(12) As a preservative, see Schedule 6, Part 1, No. 23.
(13) As a preservative, see Schedule 6, Part 1, No. 8.
2. Part 1 of Schedule 6 to the Principal Regulations is hereby amended as follows:
(a) In Column b, the symbol ‘(O)’ is deleted for substance reference numbers 1, 2, 4, 7, 12, 14, 18, 19, 21, 22, 24, 25, 26, 27, 28, 29, 30, 32, 33, 35, 37, 42 and 47.
(b) In Column b, the symbol ‘(O)’ is added for the substance reference numbers 5 and 43.
(c) Substance reference number 1 is replaced by the following:
Reference No
Substance
Maximum authorised concentration
Limitations or requirements
Conditions of use and warnings which must be printed on the label
a
b
c
d
e
‘1.
Benzoic acid (CAS No 65-85-0) and its sodium salt (CAS No 532-32-1)
Rinse-off products, except oral care products: 2,5% (acid)Oral care products: 1,7% (acid)Leave-on products: 0,5% (acid)
1a.
Salts of benzoic acid other than that listed under reference number 1 and esters of benzoic acid
0,5 % (acid)’
(d) Substance reference number 8 is replaced by the following:
Reference No
Substance
Maximum authorised concentration
Limitations or requirements
Conditions of use and warnings which must be printed on the label
a
b
c
d
e
‘8.
Zinc pyrithione (O)(CAS No 13463-41-7)
Hair products: 1,0%Other products: 0,5%
Rinse-off products only.No use in products for oral hygiene.’
(e) Substance reference number 36 is deleted.
SCHEDULE 3
1. Part 1 of Schedule 4 to the Principal Regulations is hereby amended by the deletion of colouring agent CI 45425.
2. Part 1 of Schedule 6 to the Principal Regulations is hereby amended as follows:
(a) substance reference number 10 is deleted;
(b) substance reference number 56 is replaced by the following:
Reference No
Substance
Maximum authorised concentration
Limitations or requirements
Conditions of use and warnings which must be printed on the label
a
b
c
d
e
’56.
Iodopropynyl butylcarbamate
(a) rinse-off products: 0,02 %
Not to be used in oral hygiene and lip care products
(a) “Not to be used for children
(IPBC)
under three
(a) Not to be used
years of
3-Iodo-2-propynyl butylcarbamate
in preparations for children under three years of age, except in bath products,
age” (**)
CAS No:
shower gels and
55406-53-6
shampoo
(b) leave-on products: 0,01 %, except in deodorants/antiperspirants: 0,0075 %
(b) Not to be used in body lotion and body cream (*)
(b) “Not to be used forchildren under threeyears of age”
Not to be used in preparations for children under three years of age
(***)
(*) Concerns any products aimed to be applied on a large part of the body.
(**) Solely for products, other than bath products/shower gels and shampoo, which might be used for children under three years of age.
(***) Solely for products which might be used for children under three years of age.’
SCHEDULE 4
Part 1 of Schedule 3 to the Principal Regulations is hereby amended as follows:
In reference numbers 26 to 43, and in reference numbers 47 and 56, the following text is added after each entry in column f:
‘For any toothpaste containing 0.1 to 0.15% fluoride, unless it is already labelled as contra-indicated for children (e.g. “for adult use only”), the following labelling is obligatory:
“Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.” ’.
SCHEDULE 5
(1) Schedule 2 to the Principal Regulations is hereby amended by the addition of the following reference numbers 1244 to 1328:
Ref. No.
Chemical Name/INCI Name
1244.
1-Methyl-2,4,5-trihydroxybenzene (CAS No 1124-09-0) and its salts, when used as a substance in hair dye products
1245.
2,6-Dihydroxy-4-methylpyridine (CAS No 4664-16-8) and its salts, when used as a substance in hair dye products
1246.
5-Hydroxy-1,4-benzodioxane (CAS No 10288-36-5) and its salts, when used as a substance in hair dye products
1247.
3,4-Methylenedioxyphenol (CAS No 533-31-3) and its salts, when used as a substance in hair dye products
1248.
3,4-Methylenedioxyaniline (CAS No 14268-66-7) and its salts, when used as a substance in hair dye products
1249.
Hydroxypyridinone (CAS No 822-89-9) and its salts, when used as a substance in hair dye products
1250.
3-Nitro-4-aminophenoxyethanol (CAS No 50982-74-6) and its salts, when used as a substance in hair dye products
1251.
2-methoxy-4-nitrophenol (CAS No 3251-56-7) (4-Nitroguaiacol) and its salts, when used as a substance in hair dye products
1252.
C.I. Acid Black 131 (CAS No 12219-01-1) and its salts, when used as a substance in hair dye products
1253.
1,3,5-Trihydroxybenzene (CAS No 108-73-6) (Phloroglucinol) and its salts, when used as a substance in hair dye products
1254.
1,2,4-Benzenetriacetate (CAS No 613-03-6) and its salts, when used as a substance in hair dye products
1255.
Ethanol, 2,2-iminobis-, reaction products with epichlorohydrin and 2-nitro-1,4-benzenediamine (CAS No 68478-64-8) (CAS 158571-58-5) (HC Blue No 5) and its salts, when used as a substance in hair dye products
1256.
N-Methyl-1,4-diaminoanthraquinone, reaction products with epichlorohydrin and monoethanolamine (CAS No 158571-57-4) (HC Blue No 4) and its salts, when used as a substance in hair dye products
1257.
4-Aminobenzenesulfonic acid (CAS No 121-57-3) and its salts, when used as a substance in hair dye products
1258.
3,3-(Sulfonylbis(2-nitro-4,1-phenylene)imino)bis(6-(phenylamino)) benzenesulfonic acid and its salts, when used as a substance in hair dye products
1259.
3(or 5)-((4-(Benzylmethylamino)phenyl)azo)-1,2-(or1,4)-dimethyl-1H-1,2,4-triazolium and its salts, when used as a substance in hair dye products
Ref. No.
Chemical Name/INCI Name
1260.
2,2-((3-Chloro-4-((2,6-dichloro-4-nitrophenyl)azo)phenyl)imino) bisethanol (CAS No 23355-64-8) (Disperse Brown 1) and its salts, when used as a substance in hair dye products
1261.
Benzothiazolium, 2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methyl- and its salts, when used as a substance in hair dye products
1262.
2-[(4-Chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutanamide (CAS No 13515-40-7) (Pigment Yellow 73) and its salts, when used as a substance in hair dye products
1263.
2,2-[(3,3-Dichloro[1,1-biphenyl]-4,4-diyl)bis(azo)]bis[3-oxo-N-phenylbutanamide] (CAS No 6358-85-6) (Pigment Yellow 12) and its salts, when used as a substance in hair dye products
1264.
2,2-(1,2-Ethenediyl)bis[5-((4-ethoxyphenyl)azo]benzenesulfonic acid) and its salts, when used as a substance in hair dye products
1265.
2,3-Dihydro-2,2-dimethyl-6-[(4-(phenylazo)-1-naphthalenyl)azo]-1H-pyrimidine (CAS No 4197-25-5) (Solvent Black 3) and its salts, when used as a substance in hair dye products
1266.
3(or 5)-[[4-[(7-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo]-1-naphthyl]azo]salicylic acid and its salts, when used as a substance in hair dye products
1267.
2-Naphthalenesulfonic acid, 7-(benzoylamino)-4-hydroxy-3-[[4-[(4-sulfophenyl)azo]phenyl]azo]- and its salts, when used as a substance in hair dye products
1268.
(-((7,7-Iminobis(4-hydroxy-3-((2-hydroxy-5-(N-methylsulphamoyl)phenyl)azo)naphthalene-2-sulphonato))(6-)))dicuprate(2-) and its salts, when used as a substance in hair dye products
1269.
3-[(4-(Acetylamino)phenyl)azo]-4-hydroxy-7-[[[[5-hydroxy-6-(phenylazo)-7-sulfo-2-naphthalenyl]amino]carbonyl]amino]-2-naphthalenesulfonic acid and its salts, when used as a substance in hair dye products
1270.
2-Naphthalenesulfonic acid, 7,7-(carbonyldiimino)bis(4-hydroxy-3-[[2-sulfo-4-[(4-sulfophenyl)azo] phenyl]azo]-, (CAS No 25188-41-4) and its salts, when used as a substance in hair dye products
1271.
Ethanaminium, N-(4-[bis[4-(diethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene)-N-ethyl- and its salts, when used as a substance in hair dye products
1272.
3H-Indolium, 2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl- and its salts, when used as a substance in hair dye products
1273.
3H-Indolium, 2-(2-((2,4-dimethoxyphenyl)amino)ethenyl)-1,3,3-trimethyl- and its salts, when used as a substance in hair dye products
1274.
Nigrosine spirit soluble (CAS No 11099-03-9) (Solvent Black 5), when used as a substance in hair dye products
1275.
Phenoxazin-5-ium, 3,7-bis(diethylamino)-, (CAS No 47367-75-9) and its salts, when used as a substance in hair dye products
1276.
Benzo[a]phenoxazin-7-ium, 9-(dimethylamino)-, and its salts, when used as a substance in hair dye products
Ref. No.
Chemical Name/INCI Name
1277.
6-Amino-2-(2,4-dimethylphenyl)-1H-benz[de]isoquinoline-1,3(2H)-dione (CAS No 2478-20-8) (Solvent Yellow 44) and its salts, when used as a substance in hair dye products
1278.
1-Amino-4-[[4-[(dimethylamino)methyl]phenyl]amino]anthraquinone (CAS No 12217-43-5) and its salts, when used as a substance in hair dye products
1279.
Laccaic Acid (CI Natural Red 25) (CAS No 60687-93-6) and its salts, when used as a substance in hair dye products
1280.
Benzenesulfonic acid, 5-[(2,4-dinitrophenyl)amino]-2-(phenylamino)-, (CAS No 15347-52-1) and its salts, when used as a substance in hair dye products
1281.
4-[(4-Nitrophenyl)azo]aniline (CAS No 730-40-5) (Disperse Orange 3) and its salts, when used as a substance in hair dye products
1282.
4-Nitro-m-phenylenediamine (CAS No 5131-58-8) and its salts, when used as a substance in hair dye products
1283.
1-Amino-4-(methylamino)-9,10-anthracenedione (CAS No 1220-94-6) (Disperse Violet 4) and its salts, when used as a substance in hair dye products
1284.
N-Methyl-3-nitro-p-phenylenediamine (CAS No 2973-21-9) and its salts, when used as a substance in hair dye products
1285.
N1-(2-Hydroxyethyl)-4-nitro-o-phenylenediamine (CAS No 56932-44-6) (HC Yellow No 5) and its salts, when used as a substance in hair dye products
1286.
N1-(Tris(hydroxymethyl))methyl-4-nitro-1,2-phenylenediamine (CAS No 56932-45-7) (HC Yellow No 3) and its salts, when used as a substance in hair dye products
1287.
2-Nitro-N-hydroxyethyl-p-anisidine (CAS No 57524-53-5) and its salts, when used as a substance in hair dye products
1288.
N,N-Dimethyl-N-Hydroxyethyl-3-nitro-p-phenylenediamine (CAS No 10228-03-2) and its salts, when used as a substance in hair dye products
1289.
3-(N-Methyl-N-(4-methylamino-3-nitrophenyl)amino)propane-1,2-diol (CAS No 93633-79-5) and its salts, when used as a substance in hair dye products
1290.
4-Ethylamino-3-nitrobenzoic acid (CAS No 2788-74-1) (N-Ethyl-3-Nitro PABA) and its salts, when used as a substance in hair dye products
1291.
(8-[(4-Amino-2-nitrophenyl)azo]-7-hydroxy-2-naphthyl)trimethylammonium and its salts, except Basic Red 118 (CAS 71134-97-9) as impurity in Basic Brown 17), when used as a substance in hair dye products
1292.
5-((4-(Dimethylamino)phenyl)azo)-1,4-dimethyl-1H-1,2,4-triazolium and its salts, when used as a substance in hair dye products
1293.
m-Phenylenediamine, 4-(phenylazo)-, (CAS No 495-54-5) and its salts, when used as a substance in hair dye products
1294.
1,3-Benzenediamine, 4-methyl-6-(phenylazo)- and its salts, when used as a substance in hair dye products
1295.
2,7-Naphthalenedisulfonic acid, 5-(acetylamino)-4-hydroxy-3-((2-methylphenyl)azo)- and its salts, when used as a substance in hair dye products
Ref. No.
Chemical Name/INCI Name
1296.
4,4-[(4-Methyl-1,3-phenylene)bis(azo)]bis[6-methyl-1,3-benzenediamine] (CAS No 4482-25-1) (Basic Brown 4) and its salts, when used as a substance in hair dye products
1297.
Benzenaminium, 3-[[4-[[diamino(phenylazo)phenyl]azo]-2-methylphenyl]azo]-N,N,N-trimethyl and its salts, when used as a substance in hair dye products
1298.
Benzenaminium, 3-[[4-[[diamino(phenylazo)phenyl]azo]-1-naphthalenyl]azo]-N,N,N-trimethyl and its salts, when used as a substance in hair dye products
1299.
Ethanaminium, N-[4-[(4-(diethylamino)phenyl)phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- and its salts, when used as a substance in hair dye products
1300.
9,10-Anthracenedione, 1-[(2-hydroxyethyl)amino]-4-(methylamino)- (CAS No 86722-66-9) and its derivatives and salts, when used as a substance in hair dye products
1301.
1,4-Diamino-2-methoxy-9,10-anthracenedione (CAS No 2872-48-2) (Disperse Red 11) and its salts, when used as a substance in hair dye products
1302.
1,4-Dihydroxy-5,8-bis[(2-hydroxyethyl)amino]anthraquinone (CAS No 3179-90-6) (Disperse Blue 7) and its salts, when used as a substance in hair dye products
1303.
1-[(3-Aminopropyl)amino]-4-(methylamino)anthraquinone and its salts, when used as a substance in hair dye products
1304.
N-[6-[(2-Chloro-4-hydroxyphenyl)imino]-4-methoxy-3-oxo-1,4-cyclohexadien-1-yl]acetamide (CAS No 66612-11-1) (HC Yellow No 8) and its salts, when used as a substance in hair dye products
1305.
[6-[[3-Chloro-4-(methylamino)phenyl]imino]-4-methyl-3-oxocyclohexa-1,4-dien-1-yl]urea (CAS No 56330-88-2) (HC Red No 9) and its salts, when used as a substance in hair dye products
1306.
Phenothiazin-5-ium, 3,7-bis(dimethylamino)- and its salts, when used as a substance in hair dye products
1307.
4,6-Bis(2-Hydroxyethoxy)-m-phenylenediamine and its salts, when used as a substance in hair dye products
1308.
5-Amino-2,6-dimethoxy-3-hydroxypyridine (CAS No 104333-03-1) and its salts, when used as a substance in hair dye products
1309.
4,4-Diaminodiphenylamine (CAS No 537-65-5) and its salts, when used as a substance in hair dye products
1310.
4-Diethylamino-o-toluidine (CAS No 148-71-0) and its salts, when used as a substance in hair dye products
1311.
N,N-Diethyl-p-phenylenediamine (CAS No 93-05-0) and its salts, when used as a substance in hair dye products
1312.
N,N-Dimethyl-p-phenylenediamine (CAS No 99-98-9) and its salts, when used as a substance in hair dye products
1313.
Toluene-3,4-diamine (CAS No 496-72-0) and its salts, when used as a substance in hair dye products
1314.
2,4-Diamino-5-methylphenoxyethanol (CAS No 141614-05-3) and its salts, when used as a substance in hair dye products
Ref. No.
Chemical Name/INCI Name
1315.
6-Amino-o-cresol (CAS No 17672-22-9) and its salts, when used as a substance in hair dye products
1316.
Hydroxyethylaminomethyl-p-aminophenol (CAS No 110952-46-0) and its salts, when used as a substance in hair dye products
1317.
2-Amino-3-nitrophenol (CAS No 603-85-0) and its salts, when used as a substance in hair dye products
1318.
2-Chloro-5-nitro-N-hydroxyethyl-p-phenylenediamine (CAS No 50610-28-1) and its salts, when used as a substance in hair dye products
1319.
2-Nitro-p-phenylenediamine (CAS No 5307-14-2) and its salts, when used as a substance in hair dye products
1320.
Hydroxyethyl-2,6-dinitro-p-anisidine (CAS No 122252-11-3) and its salts, when used as a substance in hair dye products
1321.
6-Nitro-2,5-pyridinediamine (CAS No 69825-83-8) and its salts, when used as a substance in hair dye products
1322.
Phenazinium, 3,7-diamino-2,8-dimethyl-5-phenyl- and its salts, when used as a substance in hair dye products
1323.
3-Hydroxy-4-[(2-hydroxynaphthyl)azo]-7-nitronaphthalene-1-sulphonic acid (CAS No 16279-54- 2) and its salts, when used as a substance in hair dye products
1324.
3-[(2-nitro-4-(trifluoromethyl)phenyl)amino]propane-1,2-diol (CAS No 104333-00-8) (HC Yellow No 6) and its salts, when used as a substance in hair dye products
1325.
2-[(4-chloro-2-nitrophenyl)amino]ethanol (CAS No 59320-13-7) (HC Yellow No 12) and its salts, when used as a substance in hair dye products
1326.
3-[[4-[(2-Hydroxyethyl)methylamino]-2-nitrophenyl]amino]-1,2-propanediol (CAS No 173994- 75-7) and its salts, when used as a substance in hair dye products
1327.
3-[[4-[Ethyl(2-hydroxyethyl)amino]-2-nitrophenyl]amino]-1,2-propanediol (CAS No 114087-41-1) and its salts, when used as a substance in hair dye products
1328.
Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- and its salts, when used as a substance in hair dye products.’
(2) Part 1 of Schedule 3 to the Principal Regulations is hereby amended as follows:
(i) in column b of reference number 8, the words therein are replaced by the following ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine (1) , with the exception of those derivatives listed elsewhere in this Schedule and under reference numbers 1309, 1311, and 1312 in Schedule 2’.
(ii) in column b of reference number 9, the words therein are replaced by the following ‘Methylphenylenediamines, their N-substituted derivatives and their salts (1) with the exception of substances under reference numbers 364, 1310 and 1313 in Schedule 2’.
(3) In Part 2 of the aforementioned Schedule 3, reference numbers 1, 2, 8, 13, 15, 30, 41, 43, 45, 46, 51, 52, 53, and 54 are hereby deleted.
SCHEDULE 6
Part 2 of Schedule 3 to the Principal Regulations is hereby amended by the substitution in column g, in the case of substance reference numbers 3, 4, 5, 6, 7, 9, 10, 11, 12, 14, 16, 18, 19, 20, 21, 22, 24, 25, 26, 27, 28, 29, 31, 32, 33, 34, 35, 36, 37, 38, 39, 44, 47, 48, 49, 50, 55, 56, 57, 58, 59, and 60, of the date ’31.12.2009’ for the date ‘31.12.2007’.
SCHEDULE 7
1. Part 2 of Schedule 10 to the Principal Regulations is hereby amended by the insertion of the following new paragraph after paragraph 2:
‘3. The codes allocated to the other Member States are as follows:
Code
Member State
Code
Member State
01
France
15
Sweden
02
Belgium
16
Czech Republic
03
Netherlands
17
Estonia
04
Germany
18
Cyprus
05
Italy
19
Latvia
06
United Kingdom
20
Lithuania
08
Denmark
21
Hungary
09
Luxembourg
22
Malta
10
Greece
23
Poland
11
Spain
24
Slovenia
12
Portugal
25
Slovakia
13
Finland
26
Bulgaria
14
Austria
27
Romania’
GIVEN under my Official Seal,
15 January 2008
MARY HARNEY.
Minister for Health and Children.
EXPLANATORY NOTE
(This note is not part of the Instrument and does not purport to be a legal interpretation)
The purpose of these Regulations is to update the law in relation to the manufacture, marketing and sale of cosmetic products by the implementation of Commission Directives 2007/1/EC 1 , 2007/17/EC 2 , 2007/22/EC 3 , 2007/53/EC 4 , 2007/54/EC 5 , 2007/67/EC 6 , 95/17/EC 7 and 2006/81/EC 8 with a view to improving the safety of such products.
These Regulations further amend the European Communities (Cosmetic Products) Regulations 2004, as amended.
These Regulations may be cited as the European Communities (Cosmetic Products) (Amendment) Regulations 2008.
1 OJ L 25, 1.2.2007, p. 9.

2 OJ L 82, 23.3.2007, p. 27.

3 OJ L 101, 18.4.2007, p. 11.

4 OJ L 226, 30.8.2007, p. 19.

5 OJ L 226, 30.8.2007, p. 21.

6 OJ L 305, 23.11.2007, p. 22.

7 OJ L 140, 23.6.1995, p. 26.

8 OJ L 362, 20.12.2006, p. 92.

(9) As a preservative, see Schedule 4, Part 1, No. 3.

(10) Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin.

(11) As a preservative, see Schedule 6, Part 1, No. 9.

(12) As a preservative, see Schedule 6, Part 1, No. 23.

(13) As a preservative, see Schedule 6, Part 1, No. 8.

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