Decree No. 334 / 2007 Coll.
Decree amending Decree No. 26 / 2001 of the Ministry of Health Coll., on sanitary requirements for cosmetic products, on the particulars of the application for the non-inclusion of ingredients on the packaging of cosmetic products and on the requirements for the education and practice of a natural person responsible for the manufacture of cosmetic products (cosmetic products decree), as amended
Valid
Order
Effective from 18.06.2008
334
DECLARATION
of 12 December 2007
amending Decree No. 26 / 2001 of the Ministry of Health Coll., on sanitary requirements for cosmetic products, on the particulars of the application for the non-inclusion of ingredients on the packaging of cosmetic products and on the requirements for the education and practice of a natural person responsible for the manufacture of cosmetic products (cosmetic products decree), as amended
The Ministry of Health provides pursuant to § 108 (1) of Act No. 258 / 2000 Coll., on the Protection of Public Health and on the Amendment of Certain Related Acts, as amended by Act No. 274 / 2001 Coll., Act No. 320 / 2002 Coll., Act No. 274 / 2003 Coll., Act No. 392 / 2005 Coll. and Act No. 222 / 2006 Coll.:
Decree of the Ministry of Health No. 26 / 2001 Coll., on sanitary requirements for cosmetic products, on the particulars of the application for the non-inclusion of ingredients on the packaging of cosmetic products and on the requirements for the education and practice of the natural person responsible for the manufacture of cosmetic products (Order on cosmetic products), as amended by Decree No. 268 / 2001 Coll., Decree No. 444 / 2004 Coll., Decree No. 126 / 2005 Coll., Decree No. 104 / 2006 Coll., Decree No. 260 / 2006 Coll., Decree No. 474 / 2006 Coll., Decree No. 112 / 2007 Coll., and Decree No. 230 / 2007 Coll., is amended as follows:
1. Paragraph 1, including footnote 1, reads as follows:
This decree incorporates the relevant European Communities1) and regulates the hygiene requirements for the composition and properties of cosmetic products, their labelling on the packaging and equipment by means of instructions for use, requirements for the extent of retained data on cosmetic products, the particulars of the application for non-inclusion on the packaging of cosmetic products and the particulars of the application for authorisation of the admissibility of substances other than those listed in the lists of authorised substances.
1) Council Directive 76 / 768 / EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products. Commission Directive 2003 / 83 / EC of 24 September 2003 adapting Annexes II, III and VI to Council Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products to technical progress. Commission Directive 2004 / 87 / EC of 7 September 2004 amending Council Directive 76 / 768 / EEC concerning cosmetic products for the purposes of adapting Annex III to technical progress. Commission Directive 2004 / 88 / EC of 7 September 2004 amending Council Directive 76 / 768 / EEC concerning cosmetic products for the purposes of adapting Annex III thereto to technical progress. Commission Directive 2004 / 94 / EC of 15 September 2004 amending Council Directive 76 / 768 / EEC as regards Annex IX. Commission Directive 2005 / 9 / EC of 28 January 2005 amending Council Directive 76 / 768 / EEC, concerning cosmetic products, for the purpose of adapting Annex VII thereto to technical progress. Commission Directive 2005 / 42 / EC of 20 June 2005 amending Council Directive 76 / 768 / EEC relating to cosmetic products for the purpose of adapting Annexes II, IV and VI thereto to technical progress. Commission Directive 2005 / 52 / EC of 9 September 2005 amending Council Directive 76 / 768 / EEC concerning cosmetic products for the purpose of adapting Annex III to technical progress. Commission Directive 2005 / 80 / EC of 21 November 2005 amending Council Directive relating to cosmetic products for the purpose of adapting Annexes II and III thereto to technical progress. Commission Directive 2006 / 65 / EC of 19 July 2006 amending Council Directive 76 / 768 / EEC relating to cosmetic products for the purpose of adapting Annexes II and III thereto to technical progress. Council Directive of 14 June 1993 No 93 / 35 / EEC amending for the sixth time Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products. Commission Directive 2006 / 78 / EC of 29 September 2006 amending Council Directive 76 / 768 / EEC, concerning cosmetic products, for the purpose of adapting Annex II thereto to technical progress. Commission Directive 2007 / 1 / EC of 29 January 2007 amending Council Directive 76 / 768 / EEC, concerning cosmetic products, for the purpose of adapting Annex II thereto to technical progress. Commission Directive 2007 / 17 / EC of 22 March 2007 amending Council Directive 76 / 768 / EEC, concerning cosmetic products, for the purpose of adapting Annexes III and VI thereto to technical progress. Commission Directive 2007 / 22 / EC of 17 April 2007 amending Council Directive 76 / 768 / EEC relating to cosmetic products for the purpose of adapting Annexes IV and VI thereto to technical progress. Commission Directive 2007 / 53 / EC of 29 August 2007 amending Council Directive 76 / 768 / EEC concerning cosmetic products for the purpose of adapting Annex III thereto to technical progress. Commission Directive 2007 / 54 / EC of 29 August 2007 amending Council Directive 76 / 768 / EEC concerning cosmetic products for the purpose of adapting Annexes II and III thereto to technical progress. Commission Directive 2007 / 67 / EC amending Council Directive 76 / 768 / EEC concerning cosmetic products for the purpose of adapting Annex III thereto to technical progress. ';
2. footnote 2 is deleted.
3. In Annex No 2, the following entries under reference numbers 1244 to 1328 are added:
"1244.1-methyl-2,4,5-trihydroxybenzene (CAS 1124-09-0) and its salts, when used as a substance in hair dye products
1245. 2,6-Dihydroxy-4-methylpyridine (CAS 4664-16-8) and its salts, when used as a substance in hair dye products
1246.5-hydroxy-1,4-benzodioxane (CAS 10288-36-5) and its salts, when used as a substance in hair dye products
1247. 3,4-Methylenedioxyphenol (CAS 533-31-3) and its salts, when used as a substance in hair dye products
1248. 3,4-Methylenedioxyaniline (CAS 14268-66@-@ 7) and its salts, when used as a substance in hair dye products
1249. Hydroxypyridinone (CAS 822-89@-@ 9) and its salts, when used as a substance in hair dye environments
1250.3-Nitro-4-aminophenoxyethanol (CAS 50982-74-6) and its salts, when used as a substance in hair dye products
1251.2-methoxy-4-nitrophenol (CAS 3251-56-7) (4-Nitroguaiacol) and its salts, when used as a substance in hair dye products
1252. Black C.I. Acid Black 131 (CAS 12219-01-1) and its salts, when used as a substance in hair dye products
1253. 1,3,5-trihydroxybenzene (CAS 108- 73-6) (Phloroglucinol) and its salts, when used as a substance in hair dye products
1,2,4-Benzenetriacetate (CAS 613-03-6) and its salts, when used as a substance in hair dye products
1255. reaction products of 2,2 '-iminobisethanol with epichlorohydrin and 2-nitro-1,4-benzenediamine (CAS 68478-64-8) (CAS 158571-58-5) (HC Blue No. 5) and its salts, when used as a substance in hair dye products
1256. reaction products of N-methyl-1,4-diaminoanthraquinone, epichlorohydrin and monoethanol amine (CAS 158571-57-4) (HC Blue No. 4) and its salts, when used as a substance in hair dye products
1257.4-aminobenzenesulfonic acid (CAS 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
1253.3 (or 5) -4- (benzylmethylamino) phenyl) azo) -2- (or 1,4) -dimethyl-1H-1,2,4-triazole and its salts, when used as a substance in hair dye products
1260. 2,2 '- ((3-chloro-4- ((2,6- dichlor-4-nitrophenyl) azo) phenyl) imino) bisethanol (CAS 23355-64-8) (Disperse Brown 1) and its salts, when used as a substance in hair dye products
1262- [[4- [ethyl (2-hydroxyethyl) amino] phenyl] azo] -6-methoxy-3-methylbenzothiazole and its salts, when used as a substance in hair dye products
1262- [(4-chloro-2-nitrophenyl) azo] -N- (2-methoxyphenyl) -3-oxobutanamide (CAS 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 6358-85-6) (Pigment Yellow 12) and its salts, when used as a substance in hair dye products
1264.2,2 '- (1,2-ethendiyl) 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-naphthalene) azo] -1H-pyrimidine (CAS 4197-25-5) (Solvent Black 3) and its salts, when used as a substance in hair dye products
126.3 (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 the hair dye subheadings
1267.7- (benzoylamino) -4-hydroxy-3- [[4- [(4-sulfophenyl) azo] phenyl] azo] -2-naphthalene sulphonic acid and its salts, when used as a substance in hair dye products
1268. (μ- (7,7 ′ -iminobis (4-hydroxy-3- ((2-hydroxy-5- (N-methylsulfamoyl) phenyl) azo) naphthalene-2-sulfonate) (6-))) dicuprate (2-) and its salts, when used as a substance in hair dye products
12693- [(4- (acetylamino) phenyl) azo] -4-hydroxy-7- [[[[5-hydroxy-6- (phenylazo) -7- sulfo-2-naphthalene] amino] carbonyl] amino] -2-naphthalene sulfonic acid and its salts, when used as a substance in hair dye products
1270. 7,7 '- (carbonyl diimino) bis (4-hydroxy-3- [[2-sulfo-4- [(4-sulfophenyl) azo] phenyl] azo] -2-naphthalene sulphonic acid (CAS 25188-41-4) and its salts, when used as a substance in hair dye products
1271. N- (4- [bis [4- (diethylamino) phenyl] methylene] -2,5-cyclohexadien-1-ylidene) -N-ethyl-ethanamine and its salts, when used as a substance in hair dye diodes
1272 2- [[(4-methoxyphenyl) methylhydrazono] methyl] -1,3,3-trimethyl-3H-indole and its salts, when used as a substance in hair dye products
1272- (2- ((2,4-dimethoxyphenyl) amino) ethenyl) -1,3,3-trimethyl-3H-indole and its salts, when used as a substance in hair dye products
1274. Alcohol-soluble nitrosine (CAS 11099@-@ 03@-@ 9) (Solvent Black 5) when used as a substance in hair dye products
1275. 3,7-bis (diethylamino) -phenoxazin-5-ium (CAS 47367-75-9) and its salts, when used as a substance in hair dye products
1276.9- (dimethylamino) -benzo [a] phenoxazin-7-ium and its salts, when used as a substance in hair dye products
1277.6-amino-2- (2,4-dimethylphenyl) -1H-benz [de] isoquinoline-1,3 (2H) -dione (CAS 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 12217-43-5) and its salts, when used as a substance in hair dye products
1279. Laccaic Acid (red CI Natural Red 25) (CAS 60687-93-6) and its salts, when used as a substance in hair dye products
1285- [(2,4-dinitrophenyl) amino] -2- (phenylamino) benzenesulfonic acid (CAS 15347-52-1) and its salts, when used as a substance in hair dye products
1284- [(4-nitrophenyl) azo] aniline (CAS 730-40-5) (Disperse Orange 3) and its salts, when used as a substance in hair dye products
1282.4-Nitro-m- Phenylenediamine (CAS 5131-58-8) and its salts, when used as a substance in hair dye products
1283. 1-amino-4- (methylamino) -9,10-anthracedione (CAS 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 2973@-@ 21-9) and its salts, when used as a substance in hair dye products
1285. N1- (2hydroxyethyl) -4- nitro-o-phenylenediamine (CAS 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 56932@-@ 45-7) (HC Yellow No. 3) and its salts, when used as a substance in hair dye products
1287.2-nitro-N-hydroxyethylpanisidine (CAS 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 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) propan-1,2-diol (CAS 93633-79@-@ 5) and its salts, when used as a substance in hair dye products
4-ethylamino-3-nitrobenzoic acid (CAS 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, with the exception of Basic Red 118 (CAS 71134-97-9) as an 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-triazole and its salts, when used as a substance in hair dye products
1294- (phenylazo) -m-phenylenediamine (CAS 495-54-5) and its salts, when used as a substance in hair dye products
1294. 4-methyl-6- (phenylazo) -1,3-benzenediamine and its salts, when used as a substance in hair dye products
1295. 5- (acetylamino) -4-hydroxy-3- ((2-methylphenyl) azo) -2,7-naphthalene disulfonic acid and its salts, when used as a substance in hair dye products
1296.4,4 '- [(4-methyl-1,3-phenylene) bis (azo)] bis [6-methyl-1,3-benzenediamine] (CAS 4482-25-1) (Basic Brown 4) and its salts, when used as a substance in hair dye products
1293- [[4- [[diamino (phenylazo) phenyl] azo] -2-methylphenyl] azo] -N, N, N-trimethylbenzenamine and its salts, when used as a substance in hair dye products
1293- [[4- [[diamino (phenylazo) phenyl] azo] -1-naphthalene] azo] -N, N, N-trimethylbenzenamine and its salts, when used as a substance in hair dye products
1299. N- [4- [(4- (diethylamino) phenyl) phenylmethylene] -2,5-cyclohexadien-1-ylidene] -N-ethyl-ethanamine and its salts, when used as a substance in hair dye products
1300.1- [(2hydroxyethyl) amino] -4- (methylamino) -9,10-anocudione (CAS 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-anthracedione (CAS 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 3179-90-6) (Disperse Blue 7) and its salts, when used as a substance in hair dye products
133.1- [(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 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 56330-88-2) (HC Red No. 9) and its salts, when used as a substance in hair dye products
1306. 3,7- bis (dimethylamino) -phenothiazin-5-ium 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
5-Amino-2,6-Dimethoxy-3-Hydroxypyridine (CAS 104333-03-1) and its salts, when used as a substance in hair dye products
1309. 4,4 '-Diaminodiphenylamine (CAS 537-65-5) and its salts, when used as a substance in hair dye products
1310.4-diethylaminootoluidine (CAS 148-71-0) and its salts, when used as a substance in hair dye products
1311.N, N-diethyl-p-phenylenediamine (CAS 93-05-0) and its salts, when used as a substance in hair dye products
1312.N, N-Dimethyl-p-phenylenediamine (CAS 99@-@ 98-9) and its salts, when used as a substance in hair dye products
1313. Toluene-3,4-Diamine (CAS 496-72-0) and its salts, when used as a substance in hair dye products
1314.2,4-diamino-5-methylphenoxyethanol (CAS 141614-05-3) and its salts, when used as a substance in hair dye products
1315.6- Amino-o-cresol (CAS 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 60385-0) and its salts, when used as a substance in hair dye products
1318.2-Chloro-5-nitro-N-hydroxyethyl-p-phenylenediamine (CAS 50610-28-1) and its salts, when used as a substance in hair dye products
1319.2-Nitro-p-phenylenediamine (CAS 5307- 14-2) and its salts, when used as a substance in hair dye products
1320. Hydroxyethyl-2,6-dinitropanisidine (CAS 122252-11-3) and its salts, when used as a substance in hair dye products
1321.6-Nitro-2,5-pyridinediamine (CAS 69825-83-8) and its salts, when used as a substance in hair dye products
1322. 3,7-diamino- 2,8-dimethyl-5-phenylphenazine 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 16279-54-2) and its salts, when used as a substance in hair dye products
1324.3- [(2N-4- (trifluoromethyl) phenyl) amino] propan-1,2-diol (CAS 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 59320-13-7) (HC Yellow No. 12) and its salts, when used as a substance in hair dye products
13263- [[4- [(2-hydroxyethyl) methylamino] -2-nitrophenyl] amino] -1,2-propanediol (CAS 173994-75-7) and its salts, when used as a substance in hair dye products
13273- [[4- [ethyl (2-hydroxyethyl) amino] -2-nitrophenyl] amino] -1,2-propanediol (CAS 114087-41-1) and its salts, when used as a substance in hair dye products
1328. N- [4- [[4- (diethylamino) phenyl] [4- (ethylamino) -1-naphthalene] methylene] -2,5-cyclohexadien-1-ylidene] -N- ethyl-ethanamine and its salts, when used as a substance in hair dye products'.
4. In Annex 3, Part 1, under reference number 8 in box b, the words "p-Phenylenediamine, its substituted derivatives and its salts; N-substituted derivatives of o-phenylenediamine, except those listed elsewhere in this Annex, are replaced by" p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-phenylenediamine, except those listed elsewhere in this Annex and under reference numbers 1309, 1311 and 1312 in Annex 2 '.
5. In Annex 3, Part 1, under reference number 9 in box b, the words "Methyl phenylenediamines, their N-substituted derivatives and their salts, with the exception of substance No 364 in Annex No 2 'are replaced by the words" Methyl phenylenediamines, their N-substituted derivatives and their salts, with the exception of substances under reference numbers 364, 1310 and 1313 in Annex No 2'.
6. In Annex 3, Part 1, for items under reference numbers 26 to 43 and reference numbers 47 and 56, in box f, the following shall be added: "For any toothpaste containing 0,1 - 0,15% fluorine, unless it bears a label on the packaging which prohibits the use in children (for example, for use only in adults), the following labelling is mandatory:" Children under 6 years of age, including under adult supervision. To brush your teeth, use a quantity the size of a pea grain to minimise swallowing of the paste. If the fluorine is received from other sources, consult a dentist or a practitioner. '
7. In Annex 3, Part 2, the entries under reference numbers 1, 2, 8, 13, 15, 30, 41, 43, 45, 46, 51, 52, 53 and 54 are deleted.
8. in Annex 3, Part 2, for the entries under 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 under the heading "2007" shall be replaced by "2009."
Efficacy
This Decree shall take effect on 18 June 2008, with the exception of Article I (6), which shall take effect on 19 January 2009, and Article I (8), which shall take effect on 1 January 2008.
Minister:
Dr. Julinek, MBA v. r.
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Regulation Information
| Citation | Decree No. 334 / 2007 Coll., amending Decree No. 26 / 2001 of the Ministry of Health Coll., on sanitary requirements for cosmetic products, on the particulars of the application for the non-inclusion of ingredients on the packaging of cosmetic products and on the requirements for the education and practice of a natural person responsible for the manufacture of cosmetic products (cosmetic products decree), as amended |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 14.12.2007 |
|---|---|
| Effective from | 18.06.2008 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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