Amendment Of The Cosmetics Directive

Original Language Title: Änderung der Kosmetikverordnung

Read the untranslated law here: http://www.ris.bka.gv.at/Dokumente/BgblAuth/BGBLA_2013_II_28/BGBLA_2013_II_28.html

28 regulation of the Federal Minister for health, modifies the cosmetics regulation

On the basis of § 20 of the food safety and Consumer Protection Act - LMSVG, Federal Law Gazette I no. 13/2006, as last amended by Federal Law Gazette I no. 95/2010, is prescribed:

The cosmetic regulations, BGBl. II No 375/1999, as last amended by regulation BGBl. II No 60/2012, is amended as follows:

1. paragraph 5 paragraph 2:

"(2) cosmetic products, the meeting the requirements of regulation Federal Law Gazette II No. 60/2012, until 31 August 2013 in traffic allowed, except fabric No. 12 of Appendix 2 the first part."

2. paragraph 3 to 8 is § 5.

3. paragraph 6:

„§ 6. This regulation is the Directive 76/768/EEC, OJ No. L 262 of September 27, 1976, on the approximation of the laws of the Member States relating to cosmetic products, as last amended by the implementing directive 2012/21/EC, OJ No. L 208 of August 3, 2012, into Austrian law implemented."

4. in Appendix 1, the following materials according to their alphabetical sequence shall be inserted:

"1373. N-(2-Nitro-4-aminophenyl)-allylamin (HC Red No." "16) and its salts (CAS no 160219-76-1)"

5. footnote (1)) is in annex 1:

"(1) numbers according to Directive 76/768/EEC, annex II, last edited by 2012/21/EC implementing directive."

6. in annex 2, first part, the number 12 is as follows:



"Item No. No.





Fabric





Application area and/or use





Limitations-gen permissible Höchstkonzen concentration in the finished cosmetic product





Additional restrictions and requirements





Whether League Tori c specification of the application conditions and warnings







a





b





c





d





e





f







12





Compounds releasing hydrogen peroxide and other hydrogen peroxide or mixtures, Carbamide Peroxide and zinc peroxide





(a) Haarbe action





(a) 12% H 2 (40 strength-zent), 2O contained therein or thereof released





 





wear a) appropriate gloves.

a) b) c) e) contains hydrogen peroxide. Avoid contact with the eyes. Rinse the eyes immediately if the product with the eyes.







 





 





b) skin care products





(b) 4% H 2O 2, contained or released from this





 





 







 





 





(c) mixtures of nail hardening





(c) 2% H 2O 2, contained or released from this





 





 







 





 





(d) hygiene (including mouthwash, toothpaste and Tooth Whitener and bleach)





d) ≤ 0.1% H 2O 2, contained or released from this





 





 







 





 





(e) Tooth Whitener and-bleichmittel





e) > 0.1% ≤ 6% H 2O 2, that contain or released from this e) should be given only to dentists. In each cycle of the application, the first application must always a dentist within the meaning of Directive 2005/36/EC on the recognition of professional qualifiationen, OJ No L 255 of 30 September 2005, as last amended by Regulation (EC) No. 623/2012, OJ No. L 180 by July 12, 2012, be reserved or occur under his direct supervision, if an equivalent level of safety is ensured. Then, the means must be provided the consumer for the remaining application cycle. Do not use e for people under the age of 18) is contained or released from this H 2O2-concentration in % specify. Do not use on persons under 18 years of age. May be delivered only to dentists. In each application cycle, the first application must be always reserved for a dentist or occur under his direct supervision, if an equivalent level of safety is ensured. Then the means must be deployed the consumers for the remaining application cycle."





7. in annex 2, first part be added following numbers:



"Item No. No.





Fabric





Application area and/or use





Limitations permissible Höchstkonzen concentration in the finished cosmetic products





Additional restrictions and requirements





Whether League Tori c specification of the application conditions and warnings







a





b





c





d





e





f







253





2,2'-[(4-Aminophenyl))imino]bis (ethanol) sulfate N,N-bis(2-Hydroxyethyl)-p-Phenylenediamine sulfate CAS No. 54381-16-7 EC-No. 259-134-5





Haarfärbestoff in oxidative hair dye





 





After mixing under oxidative conditions the maximum concentration in the application on the hair shall not exceed (expressed as sulphate) 2.5%.

-Together with NITROSATING agents use - maximum content of nitrosamine: 50 μg/kg - in nitrite-free containers keep





As in column f serial number 205 (letter a) indicated







254





1.3 resorcinol, 4-chloro 4-Chlororesorcinol CAS-No. 95-88-5 EC No. 202-462-0 Haarfärbestoff in oxidative hair dye





 





After mixing under oxidative conditions, the maximum concentration in the application on the hair shall not exceed 2.5%.





As in column f serial number 205 (letter a) specified.







255





2,4,5,6-Tetraaminopyrimidin sulfate TetraaminopyrimidineSulfate CAS-No. 5392-28-9 EC No. 226-393-0





a) Haarfärbestoff in oxidative hair dye b) Haarfärbestoff in non oxidative hair dye







(b) 3.4% (expressed as sulphate)





(a) after the mixing under oxidative conditions the maximum concentration in the application on the hair shall not exceed (expressed as sulphate) 3.4%.





(a) how in column f serial number 205 (letter a) specified.







256





3-(2-hydroxyethyl)-p-phenylendiammonium sulfate hydroxyethyl-p-Phenylenediamine sulfate CAS No. 93841-25-9 EC-No. 298-995-1





Haarfärbestoff in oxidative hair dye





 





After mixing under oxidative conditions the maximum concentration in the application on the hair shall not exceed (expressed as sulphate) 2.0%.





As in column f serial number 205 (letter a) indicated







257





1H-Indol-5,6-diol Dihydroxyindole CAS-Nr. 3131-52-0 EC No 412-130-9





a) Haarfärbestoff in oxidative hair dye b) Haarfärbestoff in non oxidative hair dye







(b) 0.5%





(a) after the mixing under oxidative conditions, the maximum concentration in the application on the hair shall not exceed 0.5%.





(a) how in column f serial number 205 (letter a) specified.

(b) how in column f number 208 indicated.







258





5-amino-4-chloro 2-methylphenolhydro hydrochloride 5-amino-4-chloro-o-CresolHCl CAS-No. 110102-85-7





Haarfärbestoff in oxidative hair dye





 





After mixing under oxidative conditions the maximum concentration in the application on the hair shall not exceed (calculated as hydrochloride) 1.5%





As in column f serial number 205 (letter a) indicated







259





1H-Indol-6-OL 6-hydroxyindole CAS-No. 2380-86-1 EC No. 417-020-4





Haarfärbestoff in oxidative hair dye





 





After mixing under oxidative conditions, the maximum concentration in applying the hair must not exceed 0.5%.





As in column f serial number 205 (letter a) specified.







260





1H-Indol-2,3-Dion Isatin CAS No. 91-56-5 EC-No. 202-077-8





Haarfärbestoff in unoxidizable hair dye





1.6%





 





As in column f number 208 indicated.







261





2-Pyridin-3-ol 2-amino-3-Hydroxypyridine CAS-No. 16867-03-1 EC No. 240-886-8





Haarfärbestoff in oxidative hair dye





 





After mixing under oxidative conditions, the maximum concentration in the application on the hair shall not exceed 1.0%.





As in column f serial number 205 (letter a) specified.







262





2-methyl-1-naphthyl acetate 1-Acetoxy-2-Methylnaphthalene CAS-No. 5697-02-9 EC No. 454-690-7





Haarfärbestoff in oxidative hair dye





 






After mixing under oxidative conditions, the maximum concentration in applying the hair must not exceed 2.0%. (The recipe of a Haarfärbemittels containing 2-methyl-1-naphthol as well as 1-Acetoxy-2-Methylnaphthalene, should not exceed the maximum concentration of 2-methyl-1-naphthol head 2.0%.)





As in column f serial number 205 (letter a) indicated







263





1-Hydroxy-2--methylnaphthalen 2-methyl-1-naphthol CAS No. 7469-77-4 EC-No. 231-265-2





Haarfärbestoff in oxidative hair dye





 





After mixing under oxidative conditions, the maximum concentration in applying the hair must not exceed 2.0%. (The recipe of a Haarfärbemittels containing 2-methyl-1-naphthol as well as 1-Acetoxy-2-Methylnaphthalene, should not exceed the maximum konzentrationan 2-methyl-1-naphthol head 2.0%.)





As in column f serial number 205 (letter a) indicated







264





Disodium 5.7 dinitro-8-oxide-2-naphthalensulfonat acid yellow 1 CAS No. 846-70-8 EC-No. 212-690-2 CI 10316





a) Haarfärbestoff in oxidative hair dye b) Haarfärbestoff in non oxidative hair dye







(b) 0,2%





(a) after the mixing under oxidative conditions, the maximum concentration in the application on the hair shall not exceed 1.0%.





(a) how in column f serial number 205 (letter a) specified.

(b) how in column f number 208 indicated.







265





4-Nitro-1,2 Phenylenediamine 4-Nitro-o-Phenylenediamine CAS-No. 99-56-9 EC No. 202-766-3





Haarfärbestoff in oxidative hair dye





 





After mixing under oxidative conditions, the maximum concentration in applying the hair must not exceed 0.5%.





As in column f serial number 205 (letter a) specified.







266





2-(4-amino-3-nitroanilin)ethanol HC Red No. 7 CAS No. 24905-87-1, EC No. 246-521-9





Haarfärbestoff in unoxidizable hair dye





1.0%





-Together with NITROSATING agents use - maximum content of nitrosamine: 50 μg/kg - in nitrite-free containers keep





As in column f number 208 indicated.







267





2-[bis(2-hydroxyethyl)amino]-5-nitrophenol HC yellow No.. 4 CAS no 59820-43-8 EC-No. 428-840-7





Haarfärbestoff in unoxidizable hair dye





1.5%





-Together with NITROSATING agents use - maximum content of nitrosamine: 50 μg/kg - in nitrite-free containers keep





 







268





2-[(2-Nitrophenyl)amino] ethanol HC yellow No.. 2 CAS No. 4926-55-0 EC No. 225-555-8





a) Haarfärbestoff in oxidative hair dye b) Haarfärbestoff in non oxidative hair dye







(b) 1.0%





(a) after the mixing under oxidative conditions, the maximum concentration in the application on the hair shall not exceed 0.75%.

Applies to a and b: - use together with NITROSATING agents - maximum content of nitrosamine: keep a 50 μg/kg - in nitrite-free containers) as in column f specified number 205 (letter a).







269





HC Orange No. 4-[(2-Nitrophenyl)amino]phenol. 1 CAS No. 54381-08-7 EC-No. 259-132-4





Haarfärbestoff in unoxidizable hair dye





1.0%





 





 







270





2-Nitro-N1-phenyl benzene 1,4-diamine HC Red No. 1 CAS No. 2784-89-6 EC-No. 220-494-3





Haarfärbestoff in unoxidizable hair dye





1.0%





 





As in column f number 208 indicated.







271





1-methoxy-3-(β-aminoethyl) amino-4-nitrobenzene, HC yellow No. hydrochloride. 9 CAS No. 86419-69-4 EC-No. 415-480-1





Haarfärbestoff in unoxidizable hair dye





0,5% (expressed as hydrochloride





-Together with NITROSATING agents use - maximum content of nitrosamine: 50 μg/kg ' - in nitrite-free containers keep





 







272





1-(4'-Aminophenylazo)-2-methyl-4-(bis-2-hydroxyethyl) of aminobenzene HC yellow No.. 7 CAS no 104226-21-3 EC-No. 146-420-6





Haarfärbestoff in unoxidizable hair dye





0.25%





 





 







273





N-(2-hydroxyethyl)-2-Nitro-4-trifluormethylanilin HC yellow No.. 13 CAS No. 10442-83-8 EC-No. 443-760-2





a) Haarfärbestoff in oxidative hair dye b) Haarfärbestoff in non oxidative hair dye







(b) 2.5%





(a) after the mixing under oxidative conditions, the maximum concentration in the application on the hair shall not exceed 2.5%.

For a and b shall apply: - use together with NITROSATING agents - maximum content of nitrosamine: 50 μg/kg - in nitrite-free containers keep





(a) how in column f serial number 205 (letter a) specified.







274





Benzolaminium, 3-[(4,5-Dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl) azo]-N, N, Ntrimethyl, chloride basic yellow 57 CAS No. 68391-31-1, EC No. 269-943-5





Haarfärbestoff in unoxidizable hair dye





2.0%





 





 







275





[[Ethanol, 2,2'-[[4-[(4-Aminophenyl) azo] phenyl] imino]-disperse black 9 CAS no 20721-50-0 EC No. 243-987-5





Haarfärbestoff in unoxidizable hair dye





0.3% (of the mixture in the ratio of 1:1 of 2, 2'-[4-(4-Aminophenylazo) phenylimino] diethanol and Lignosulfat)





 





 







276





9,10-Anthracendion, 1,4-up [(2,3-Dihydroxypropyl)amino]-HC blue No. 14 CAS No. 99788-75-7 EC-No. 421-470-7





Haarfärbestoff in unoxidizable hair dye





0.3%





-Together with NITROSATING agents use - maximum content of nitrosamine: 50 μg/kg - in nitrite-free containers keep





 







277





2-(4-methyl-2-nitroanilin)ethanol hydroxyethyl-2-Nitro-p-Toluidine CAS-no 100418-33-5 EC No. 408-090-7





a) Haarfärbestoff in oxidative hair dye b) Haarfärbestoff in non oxidative hair dye







(b) 1.0%





(a) after the mixing under oxidative conditions, the maximum concentration in the application on the hair shall not exceed 1.0%.

For a and b shall apply: - use together with NITROSATING agents - maximum content of nitrosamine: 50 μg/kg - in nitrite-free containers keep





(a) how in column f serial number 205 (letter a) specified.







278





1-amino-2-nitro-4--(2',3'-dihydroxypropyl) amino-5-chloro benzene + 1.4-to-(2',3'-Dihydroxypropyl) amino-2-nitro-5 - chloro benzene HC Red No. 10 + HC Red No. 11 CAS No. 95576-89-9 + 95576-92-4





a) Haarfärbestoff in oxidative hair dye b) Haarfärbestoff in non oxidative hair dye







(b) 2.0%





(a) after the mixing under oxidative conditions, the maximum concentration in the application on the hair shall not exceed 1.0%.

For a and b shall apply: - use together with NITROSATING agents - maximum content of nitrosamine: 50 μg/kg - in nitrite-free containers keep





(a) how in column f serial number 205 (letter a) specified."





8. in annex 2 part numbers 10 and 50 are eliminated.

9 footnote *) is in Appendix 4:

"(*) Numbers according to Directive 76/768/EEC, Appendix VII, as last amended by the 2012/21/EC implementing directive."

Sands