Decree No. 220 / 2010 Coll.
Decree amending Decree No. 448 / 2009 Coll., laying down sanitary requirements for cosmetic products, as amended by Decree No. 89 / 2010 Coll.
Valid
Order
Effective from 01.09.2010
Text versions:
01.09.2010
16.07.2010
220
DECLARATION
of 29 June 2010
amending Decree No 448 / 2009 Coll., laying down health requirements for cosmetic products, as amended by Decree No 89 / 2010 Coll.
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 No. 448 / 2009 Coll., laying down health requirements for cosmetic products, as amended by Decree No. 89 / 2010 Coll., is amended as follows:
1. footnote 1 shall read:
"(1) Council Directive 76 / 768 / EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products. Council Directive 79 / 661 / EEC of 24 July 1979 amending Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products. Commission Directive 82 / 147 / EEC of 11 February 1982 adapting Annex II to Council Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products to technical progress. Council Directive 82 / 368 / EEC of 17 May 1982 amending for the second time Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products. Second Commission Directive 83 / 191 / EEC of 30 March 1983 adapting Annexes II, III, IV and V to Council Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products to technical progress. Third Commission Directive 83 / 341 / EEC of 29 June 1983 adapting Annexes II, III and V to Council Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products to technical progress. Fourth Commission Directive 83 / 496 / EEC of 22 September 1983 adapting Annex VI to Council Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products to technical progress. Council Directive 83 / 574 / EEC of 26 October 1983 amending for the third time Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products. Fifth Commission Directive 84 / 415 / EEC of 18 July 1984 adapting Annexes II, III, IV, V 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. Sixth Commission Directive 85 / 391 / EEC of 16 July 1985 adapting Annexes II, III, IV, V 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. Seventh Commission Directive 86 / 179 / EEC of 28 February 1986 adapting Annexes II, III, IV and V to Council Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products to technical progress. Eighth Commission Directive 86 / 199 / EEC of 26 March 1986 adapting Annexes II, IV 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. Ninth Commission Directive 87 / 137 / EEC of 2 February 1987 adapting Annexes II, III, IV, V and VI to Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products to technical progress. Tenth Commission Directive 88 / 233 / EEC of 2 March 1988 adapting Annexes II, III, IV 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. Council Directive 88 / 667 / EEC of 21 December 1988 amending for the fourth time Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products. 11th Commission Directive 89 / 174 / EEC of 21 February 1989 adapting to technical progress Annexes II, III, IV, V, VI and VII to Council Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products. Council Directive 89 / 679 / EEC of 21 December 1989 amending for the fifth time Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products. Twelve Commission Directive 90 / 121 / EEC of 20 February 1990 adapting to technical progress Annexes II, III, IV, V and VI to Council Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products. 13th Commission Directive 91 / 184 / EEC of 13 March 1991 adapting to technical progress Annexes II, III, IV, V, VI and VII to Council Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products. 14th Commission Directive 92 / 8 / EEC of 18 February 1992 adapting to technical progress Annexes III, IV, VI and VII to Council Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products. 15th Commission Directive 92 / 86 / EEC of 21 October 1992 adapting to technical progress Annexes II, III, IV, V, VI and VII to Council Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products. Council Directive 93 / 35 / EEC of 14 June 1993 amending for the sixth time Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products. 16th Commission Directive 93 / 47 / EEC of 22 June 1993 adapting to technical progress Annexes II, III, V, VI and VII to Council Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products. 17th Commission Directive 94 / 32 / EC of 29 June 1994 adapting to technical progress Annexes II, III, V, VI and VII to Council Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products. Commission Directive 95 / 17 / EC of 19 June 1995 laying down detailed rules for the application of Council Directive 76 / 768 / EEC as regards the non-inclusion of one or more additives in the list used for the labelling of cosmetic products. Eighteenth Commission Directive 95 / 34 / EC of 10 July 1995 adapting to technical progress Annexes II, III, VI and VII to Council Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products. Commission Directive 96 / 41 / EC of 25 June 1996 adapting to technical progress Annexes II, III, VI and VII to Council Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products. 20th Commission Directive 97 / 1 / EC of 10 January 1997 adapting to technical progress Annexes II, III, VI and VII to Council Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products. Twenty-first Commission Directive 97 / 45 / EC of 14 July 1997 adapting to technical progress Annexes II, III, VI and VII to Council Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products. The 22nd Commission Directive 98 / 16 / EC of 5 March 1998 adapting to technical progress Annexes II, III, VI and VII to Council Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products. Twenty-third Commission Directive 98 / 62 / EC of 3 September 1998 adapting to technical progress Annexes II, III, VI and VII to Council Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products. 24th Commission Directive 2000 / 6 / EC of 29 February 2000 adapting to technical progress Annexes II, III, VI and VII to Council Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products. The 25th Commission Directive 2000 / 11 / EC of 10 March 2000 adapting to technical progress Annex II to Council Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products. Commission Directive 2000 / 41 / EC of 19 June 2000 delaying for the second time the date after which animal testing for additives or combinations of cosmetic products will be prohibited. Twenty-sixth Commission Directive 2002 / 34 / EC of 15 April 2002 adapting to technical progress Annexes II, III and VII to Council Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products. Commission Directive 2003 / 1 / EC of 6 January 2003 adapting to technical progress Annex II to Council Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products. Commission Directive 2003 / 16 / EC of 19 February 2003 adapting to technical progress Annex III to Council Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products. Directive 2003 / 15 / EC of the European Parliament and of the Council of 27 February 2003 amending Council Directive 76 / 768 / EEC on the approximation of the laws of the Member States relating to cosmetic products. Commission Directive 2003 / 80 / EC of 5 September 2003 establishing the symbol for the durability of cosmetic products set out in Annex VIIIa to Council Directive 76 / 768 / EEC. 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 21 September 2004 amending Council Directive 76 / 768 / EEC concerning cosmetic products for the purpose of adapting Annexes II and III 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, concerning 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 76 / 768 / EEC 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. 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 relating to cosmetic products for the purpose of adapting Annexes II and III thereto to technical progress. Commission Directive 2007 / 67 / EC of 22 November 2007 amending Council Directive 76 / 768 / EEC as regards cosmetic products for the purpose of adapting Annex III thereto to technical progress. Commission Directive 2008 / 14 / EC of 15 February 2008 amending Council Directive 76 / 768 / EEC, concerning cosmetic products, for the purpose of adapting Annex III thereto to technical progress. Commission Directive 2008 / 42 / EC of 3 April 2008 amending Council Directive 76 / 768 / EEC relating to cosmetic products for the purpose of adapting Annexes II and III thereto to technical progress. Commission Directive 2008 / 88 / EC of 23 September 2008 amending Council Directive 76 / 768 / EEC relating to cosmetic products for the purpose of adapting Annexes II and III thereto to technical progress. Directive 2008 / 112 / EC of the European Parliament and of the Council of 16 December 2008 amending Council Directive 76 / 768 / EEC, Directives 88 / 378 / EEC, 1999 / 13 / EC and Directives 2000 / 53 / EC, 2002 / 96 / EC and 2004 / 42 / EC of the European Parliament and of the Council to adapt them to Regulation (EC) No 1272 / 2008 on classification, labelling and packaging of substances and mixtures. Commission Directive 2008 / 123 / EC of 18 December 2008 amending Council Directive 76 / 768 / EEC relating to cosmetic products for the purpose of adapting Annexes II and VII thereto to technical progress. Commission Directive 2009 / 6 / EC of 4 February 2009 amending Council Directive 76 / 768 / EEC relating to cosmetic products for the purpose of adapting Annexes II and III thereto to technical progress. Commission Directive 2009 / 36 / EC of 16 April 2009 amending Council Directive 76 / 768 / EEC, concerning cosmetic products, for the purpose of adapting Annex III thereto to technical progress. Commission Directive 2009 / 129 / EC of 9 October 2009 amending Council Directive 76 / 768 / EEC concerning cosmetic products for the purpose of adapting Annex III thereto to technical progress. Commission Directive 2009 / 130 / EC of 12 October 2009 amending Council Directive 76 / 768 / EEC, concerning cosmetic products, for the purpose of adapting Annex III thereto to technical progress. Commission Directive 2009 / 134 / EC of 28 October 2009 amending Council Directive 76 / 768 / EEC concerning cosmetic products for the purpose of adapting Annex III thereto to technical progress. Commission Directive 2009 / 159 / EU of 16 December 2009 amending, for the purposes of its adaptation to technical progress, Annex III to Council Directive 76 / 768 / EEC as regards cosmetic products. Commission Directive 2009 / 164 / EU of 22 December 2009 amending, for the purposes of its adaptation to technical progress, Annexes II and III to Council Directive 76 / 768 / EEC as regards cosmetic products. Commission Directive 2010 / 3 / EU of 1 February 2010 amending, for the purposes of its adaptation to technical progress, Annexes III and VI to Council Directive 76 / 768 / EEC concerning cosmetic products. Commission Directive 2010 / 4 / EU of 8 February 2010 amending Annex III to Council Directive 76 / 768 / EEC relating to cosmetic products. ';
2. In Annex 3, Part 1, the following entries under reference numbers 207 to 209 are added:
| „207 | Ethyl Lauroyl Arginate HCl (12) Ethyl-N2 dodekanoyl-L-argininát-hydrochlorid CAS 60372-77-2 ES 434-630-6 | a) mýdlo b) šampony proti lupům c) deodoranty jiné než ve spreji | 0,8 % | Pro jiné účely než potlačení růstu mikroorganismů v přípravku. Tento účel musí být zřejmý ze způsobu obchodní úpravy výrobku. | |
| 208 | 1-(2-aminoethyl)-amino-4-(2-hydroxyethyl) oxy-2-nitrobenzen 2 a jeho soli HC Orange No. 2 CAS 85765-48-6 EINECS 416-410-1 | Látka k barvení vlasů v neoxidačních prostředcích k barvení vlasů. | 1,0% | - Nepoužívejte se systémy s nitrosačním účinkem. - Nejvyšší obsah nitrosaminů: 50µg/kg -Uchovávejte v nádobách bez obsahu dusitanů. | Přečtěte si instrukce a řiďte se jimi. Tento výrobek není určen k používání pro osoby mladší 16 let. Dočasné tetování černou hennou může zvýšit riziko alergie. Nebarvěte si vlasy, pokud: – máte vyrážku na obličeji nebo citlivou, podrážděnou a poškozenou pokožku hlavy, – jste již někdy zaznamenali nějakou reakci po barvení vlasů, – jste v minulosti zaznamenali reakci na dočasné tetování černou hennou. |
| 209 | 2-(2-methoxy-4-nitroanilino)ethan-1-ol 2 a jeho soli 2-hydroxyethylamino-5-nitroanisole CAS 66095-81-6 EINECS 266-138-0 | Látka k barvení vlasů v neoxidačních prostředcích k barvení vlasů. | 0,2% | - Nepoužívejte se systémy s nitrosačním účinkem. - Nejvyšší obsah nitrosaminů: 50µg/kg -Uchovávejte v nádobách bez obsahu dusitanů. |
(12) For use as a preservative see Annex 6, Part 1, Ref. No 58. '
3. In Annex 3, Part 2, the entries under reference numbers 26 and 29 are deleted.
4. In Annex 6, Part 1, the following entry with reference number 58 is added:
| „58 | Ethyl lauroyl Arginate HCl (*) (5) Ethyl-N2 dodekanoyl-L-argininát-hydrochlorid CAS 60372-77-2 ES 434-630-6 | 0,4% | Nepoužívat v přípravcích na rty, přípravcích pro ústní hygienu a v přípravcích ve spreji. |
(5) For uses other than as preservative (Annex 3, Part 1), ref. No 207. '
Transitional provisions
1. Article 4 (2) Point 4 for the entry under reference number 58 shall be assessed in accordance with existing legislation until 28 February 2011.
2. Point 2 for entries under reference numbers 208 and 209 shall be assessed in accordance with existing legislation until 30 November 2010, except for the labelling obligations in column "f 'for the entry under reference number 208.
3. Point 2 (i) for the designation in column "f 'for the entry under reference number 208 shall be assessed for placing on the market or imports under existing legislation until 31 October 2011; for distribution, sale or offering to the consumer by 31 October 2012.
Efficacy
This Decree shall take effect on 1 September 2010.
Minister:
Juraskova v. r.
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Regulation Information
| Citation | Decree No. 220 / 2010 Coll., amending Decree No. 448 / 2009 Coll., laying down health requirements for cosmetic products, as amended by Decree No. 89 / 2010 Coll. |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 16.07.2010 |
|---|---|
| Effective from | 01.09.2010 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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