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68. Ordinance of the Federal Minister for Health and Women, amending the Cosmetics Regulation
On the basis of § 27 (1) and (2) of the Food Law 1975, BGBl. N ° 86, as last amended by the Federal Law BGBl. I n ° 126/2004, shall be arranged:
The cosmetics regulation, BGBl. II No 375/1999, as last amended by the BGBl Regulation. II No 338/2003, shall be amended as follows:
1. § 5 (2) reads:
" (2) Cosmetic products not subject to the BGBl Regulation. II No 68/2005, but subject to the provisions currently in force, in so far as it concerns substances of No 411 of Appendix 1 or substances of No 60, 61 or 62 of Appendix 2, Part One, or the substance No 36 of Appendix 3, Part One, may be until 24 March. It will be placed on the market in 2005 and will be placed on the market until 25 September 2005. "
(2) The following paragraph 4 is added to § 5:
" (4) Cosmetic products not subject to the BGBl Regulation. As far as substances of Nos 289 and 452 to 1132 of Appendix 1 are concerned, the provisions currently in force may be placed on the market for a further period of three months after the entry into force of the Regulation and six months after the date of entry into force of the Regulation. remain on the market after the entry into force of the Regulation. "
(3) The following Directives are added to § 6:
" 2003/15/EC OJ L 327, 22. OJ L 66 of 11 March 2003, 2003 /83/EC OJ L 311, 28.11.2003, p. OJ L 238 of 25 September 2003, 2004 /87/EC OJ L 238, 30.9.2004, p OJ L 287 of 8 September 2004, 2004 /88/EC OJ L 287, 10.10.2004, p OJ L 287 of 8 September 2004, 2004 /93/EC OJ L 327, 30.12.2004, p OJ L 300 of 25 September 2004 and 2005 /9/EC OJ L 300, 25.9.2004, p OJ No L 27, 29. Jänner 2005. "
4. In Appendix 1 the numbers 178, 289 and 411 are as follows (the substances are inserted according to their alphabetical order):
" 178. 4-Benzyloxyphenol and 4-ethoxyphenol "
" 289. Lead and its compounds "
" 411. Secondary alkylamines and alkonolamines and their salts ".
5. In Appendix 1, the number 382 is deleted.
6. In Appendix 1 the following substances shall be inserted in accordance with their alphabetical order:
[List of inserted substances of Appendix 1 see Appendixes]
7. Appendix 1, footnote 1 ) is:
" 1 ) Numbers in accordance with Directive 76/768/EEC, Annex II, as last amended by Directive 2005 /9/EC
8. In Annex 2, Part One, the number 55 shall be deleted.
9. Annex 2, Part One, Nos. 14, 60, 61 and 62 are:
| Lfd. No. |
Fabric |
Application area and/or use |
Limitations Maximum permitted concentration in the finished cosmetic product |
More Limitations and requirements |
Mandatory indication of the conditions of use and warnings |
| A |
B |
C |
d |
e |
F |
| " 14 |
Hydroquinone (***) |
(a) Oxidation Hair Dye
1. General use
2. Commercial use
(b) Funds for artificial fingernail systems |
a) 0.3%
(b) 0.02% (after mixing for use) |
Commercial use only |
a) 1.-Do not use to dye eyelashes and eyebrows -In case of contact with the eyes rinse immediately with clear water -Contains hydroquinone
2.-Only for commercial use -Contains hydroquinone -In case of contact with the eyes rinse immediately with clear water
(b)-industrial use only -Avoid skin contact -Application notes please read carefully " |
| " 60 |
Fatty acid dialkylamides and Dialkanolamides |
Maximum level of secondary Amine: 0.5% |
-Do not use together with nitrosating systems -maximum level of secondary Amine: 5% (applies to raw materials) -maximum levels of nitrosamine: 50 µ g/kg -Keep in nitrite-free containers |
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| 61 |
Monoalkylamines, monoalkanolamines and their salts |
Maximum level of secondary Amine: 0.5% |
-Do not use together with nitrosating systems -purity at least 99% -maximum level of secondary Amine: 0.5% (applies to raw materials) -maximum levels of nitrosamine: 50 µ g/kg -Keep in nitrite-free containers |
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| 62 |
Trialkylamines, trialkanolamines and their salts |
(a) Funds not to be rinsed out (b) Other means |
(a) 2.5% |
a) b) -Do not use together with nitrosating systems -purity at least 99% -maximum level of secondary Amine: 0.5% (applies to raw materials) -maximum levels of nitrosamine: 50 µ g/kg -Keep in nitrite-free containers " |
10. Annex 2, Part One, shall be added to the following points:
| Lfd. No. |
Fabric |
Application Area and/or use |
Limits allowed maximum concentration in cosmetic products Finished Product |
Other limitations and requirements |
Mandatory indication of the application conditions and warnings |
| A |
B |
C |
d |
e |
F |
| " 67 |
Amylcinnamal (CAS No. 122-40-7) |
The substances in a concentration of more than: -0.001% in, Leave-on ' products -0.01% in, rinse-off ' products must be included in the list of ingredients in accordance with § 4 (4) of the Cosmetics Labelling Regulation, BGBl. No 891/1993, as amended. |
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| 68 |
Benzyl alcohol (CAS No. 100-51-6) |
The substances in a concentration of more than: -0.001% in, Leave-on ' products -0.01% in, rinse-off ' products must be included in the list of ingredients in accordance with § 4 (4) of the Cosmetics Labelling Regulation, BGBl. No 891/1993, as amended. |
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| 69 |
cinnamyl alcohol (CAS No. 104-54-1) |
The substances in a concentration of more than: -0.001% in, Leave-on ' products -0.01% in, rinse-off ' products must be included in the list of ingredients in accordance with § 4 (4) of the Cosmetics Labelling Regulation, BGBl. No 891/1993, as amended. |
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| 70 |
Citral (CAS No. 5392-40-5) |
The substances in a concentration of more than: -0.001% in, Leave-on ' products -0.01% in, rinse-off ' products must be included in the list of ingredients in accordance with § 4 (4) of the Cosmetics Labelling Regulation, BGBl. No 891/1993, as amended. |
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| 71 |
Eugenol CAS No. 97-53-0) |
The substances in a concentration of more than: -0.001% in, Leave-on ' products -0.01% in, rinse-off ' products must be included in the list of ingredients in accordance with § 4 (4) of the Cosmetics Labelling Regulation, BGBl. No 891/1993, as amended. |
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| 72 |
Hydroxycitronellal (CAS No. 107-75-5) |
The substances in a concentration of more than: -0.001% in, Leave-on ' products -0.01% in, rinse-off ' products must be included in the list of ingredients in accordance with § 4 (4) of the Cosmetics Labelling Regulation, BGBl. No 891/1993, as amended. |
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| 73 |
Isoeugenol (CAS No. 97-54-1) |
The substances in a concentration of more than: -0.001% in, Leave-on ' products -0.01% in, rinse-off ' products must be included in the list of ingredients in accordance with § 4 (4) of the Cosmetics Labelling Regulation, BGBl. No 891/1993, as amended. |
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| 74 |
Amylcinnamyl alcohol (CAS No. 101-85-9) |
The substances in a concentration of more than: -0.001% in, Leave-on ' products -0.01% in, rinse-off ' products must be included in the list of ingredients in accordance with § 4 (4) of the Cosmetics Labelling Regulation, BGBl. No 891/1993, as amended. |
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| 75 |
Benzyl salicylate (CAS No. 118-58-1) |
The substances in a concentration of more than: -0.001% in, Leave-on ' products -0.01% in, rinse-off ' products must be included in the list of ingredients in accordance with § 4 (4) of the Cosmetics Labelling Regulation, BGBl. No 891/1993, as amended. |
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| 76 |
Cinnamal (CAS No. 104-55-2) |
The substances in a concentration of more than: -0.001% in, Leave-on ' products -0.01% in, rinse-off ' products must be included in the list of ingredients in accordance with § 4 (4) of the Cosmetics Labelling Regulation, BGBl. No 891/1993, as amended. |
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| 77 |
Coumarin (CAS No. 91-64-5) |
The substances in a concentration of more than: -0.001% in, Leave-on ' products -0.01% in, rinse-off ' products in the list of ingredients in accordance with § 4 (4) of the Cosmetics Labelling Ordinance, BGBl. No 891/1993, as amended. |
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| 78 |
Geraniol (CAS No. 106-24-1) |
The substances in a concentration of more than: -0.001% in, Leave-on ' products -0.01% in, rinse-off ' products must be included in the list of ingredients in accordance with § 4 (4) of the Cosmetics Labelling Regulation, BGBl. No 891/1993, as amended. |
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| 79 |
Hydroxy-methylpentyl-cyclohexenecarboxaldehyde (CAS No. 31906-04-4) |
The substances in a concentration of more than: -0.001% in, Leave-on ' products -0.01% in, rinse-off ' products must be included in the list of ingredients in accordance with § 4 (4) of the Cosmetics Labelling Regulation, BGBl. No 891/1993, as amended. |
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| 80 |
Anisyl alcohol (CAS No. 105-13-5) |
The substances in a concentration of more than: -0.001% in, Leave-on ' products -0.01% in, rinse-off ' products must be included in the list of ingredients in accordance with § 4 (4) of the Cosmetics Labelling Regulation, BGBl. No 891/1993, as amended. |
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| 81 |
Benzyl cinnamate (CAS No. 103-41-3) |
The substances in a concentration of more than: -0.001% in, Leave-on ' products -0.01% in, rinse-off ' products must be included in the list of ingredients in accordance with § 4 (4) of the Cosmetics Labelling Regulation, BGBl. No 891/1993, as amended. |
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| 82 |
Farnesol (CAS No. 4602-84-0) |
The substances in a concentration of more than: -0.001% in, Leave-on ' products -0.01% in, rinse-off ' products in the list of ingredients in accordance with § 4 (4) of the Cosmetics Labelling Ordinance, BGBl. No 891/1993, as amended. |
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| 83 |
2-(4-tert-butethylbenzyl) propionaldehyde (CAS No. 80-54-6) |
The substances in a concentration of more than: -0.001% in, Leave-on ' products -0.01% in, rinse-off ' products must be included in the list of ingredients in accordance with § 4 (4) of the Cosmetics Labelling Regulation, BGBl. No 891/1993, as amended. |
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| 84 |
Linalool (CAS No. 78-70-6) |
The substances in a concentration of more than: -0.001% in, Leave-on ' products -0.01% in, rinse-off ' products in the list of ingredients in accordance with § 4 (4) of the Cosmetics Labelling Ordinance, BGBl. No 891/1993, as amended. |
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| 85 |
Benzyl benzoate (CAS No. 120-51-4) |
The substances in a concentration of more than: -0.001% in, Leave-on ' products -0.01% in, rinse-off ' products must be included in the list of ingredients in accordance with § 4 (4) of the Cosmetics Labelling Regulation, BGBl. No 891/1993, as amended. |
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| 86 |
Citronellol (CAS No. 106-22-9 |
The substances in a concentration of more than: -0.001% in, Leave-on ' products -0.01% in, rinse-off ' products must be included in the list of ingredients in accordance with § 4 (4) of the Cosmetics Labelling Regulation, BGBl. No 891/1993, as amended. |
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| 87 |
Hexylcinnamaldehyde (CAS No. 101-86-0) |
The substances in a concentration of more than: -0.001% in, Leave-on ' products -0.01% in, rinse-off ' products must be included in the list of ingredients in accordance with § 4 (4) of the Cosmetics Labelling Regulation, BGBl. No 891/1993, as amended. |
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| 88 |
d-Limonen (CAS No. 5989-27-5) |
The substances in a concentration of more than: -0.001% in, Leave-on ' products -0.01% in, rinse-off ' products must be included in the list of ingredients in accordance with § 4 (4) of the Cosmetics Labelling Regulation, BGBl. No 891/1993, as amended. |
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| 89 |
Methyl heptincarbonate (CAS No. 111-12-6) |
The substances in a concentration of more than: -0.001% in, Leave-on ' products -0.01% in, rinse-off ' products must be included in the list of ingredients in accordance with § 4 (4) of the Cosmetics Labelling Regulation, BGBl. No 891/1993, as amended. |
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| 90 |
3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl) -3-buten-2-one (CAS No. 127-51-5) |
The substances in a concentration of more than: -0.001% in, Leave-on ' products -0.01% in, rinse-off ' products must be included in the list of ingredients in accordance with § 4 (4) of the Cosmetics Labelling Regulation, BGBl. No 891/1993, as amended. |
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| 91 |
Oak moss and tree moosextrakt (CAS No. 90028-68-5) |
The substances in a concentration of more than: -0.001% in, Leave-on ' products -0.01% in, rinse-off ' products must be included in the list of ingredients in accordance with § 4 (4) of the Cosmetics Labelling Regulation, BGBl. No 891/1993, as amended. |
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| 92 |
Tree-Moosextrakt (CAS No. 90028-67-4) |
The substances in a concentration of more than: -0.001% in, Leave-on ' products -0.01% in, rinse-off ' products must be included in the list of ingredients in accordance with § 4 (4) of the Cosmetics Labelling Regulation, BGBl. No 891/1993, as amended. |
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| 93 |
2,4-Diamino-pyrimidine-3-oxide (CAS No. 74638-76-9) |
Hair care products |
1.5% |
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| 94 |
Benzoyl peroxide |
Means for artificial fingernail systems |
0.7% (after mixing for use) |
Commercial use only |
-For commercial use only -Avoid skin contact -Application instructions carefully read |
| 95 |
Hydroquinone methyl ether |
Means for artificial fingernail systems |
0.02% (after mixing for use) |
Commercial use only |
-For commercial use only -Avoid skin contact -Application instructions carefully read |
| 96 |
musk (CAS No. 81-15 -2) |
All cosmetic products other than oral care products |
(a) 1.0% in Parfum b) 0.4% in Eau de Toilette (c) 0.03% in other products |
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| 97 |
musk ketones (CAS No. 81-14-1) |
All cosmetic products other than oral care products |
a) 1.4% in perfume b) 0.56% in Eau de Toilette (c) 0.042% in other products " |
11. In Appendix 2, Part One, the following footnote is inserted:
" ( *** ) These substances may be used individually or in combination, provided that the sum of the share values of the individual substances in the cosmetic product, expressed as the maximum permissible value, does not exceed 2. "
12. In Annex 2, Part 2, points 61 and 62 are deleted.
13. In Annex 2, Part II, No 1 to 60, the date in column g shall be: "30.9.2004" by the date "31.12.2005" replaced.
14. In Annex 2, Part II, No 46, the maximum permitted concentration in the finished cosmetic product for non-oxidising hair dye in column d is:
"0.3%"
15. In Appendix 2, second part, the CAS No. Numbers 17, 19, 31, 36, 45 and 53:
" Lfd. No. 17: (CAS No. 113715 -25-6) "
" Lfd. No. 19: (CAS No. 61693-43-4) "
" Lfd. N ° 31: (CAS No. 94158-13-1) "
" Lfd. N ° 36: (CAS No: 66422-95-5) "
" Lfd. No. 45: (CAS No. 3618-58-4) "
" Lfd. No. 53: (CAS No. 102767-27-1) "
16. Annex 3, Part One, No 36 reads:
| Lfd. No. |
Fabric |
Allowed Maximum concentration |
Limitations and requirements |
Mandatory indication of the conditions of use and warnings |
| A |
B |
C |
d |
e |
| " 36 |
1,2-dibromo-2,4-dicyanobutane (methyldibromo-glutaronitriles) |
0.1% |
Only in appropriations which: to be washed out " |
17. The following point shall be added to Appendix 4:
| No. |
EC No. * ) |
Fabric |
INCI ** ) |
Maximum quantity in g/100g |
More Limitations and Requirements |
Compulsory special Application Conditions/Warning Information |
| " 6.27 |
28 |
2-[-4-(diethylamino) -2-hydroxybenzoyl]-benzoesic acid hexylester CAS No.: 302776-68-7 |
Diethylamino Hydroxybenzoyl Hexyl Benzoates |
10 in sunscreen products " |
18. Appendix 4, footnote * ) is:
" * ) Numbers in accordance with Directive 76/768/EEC, Annex VII, as last amended by Directive 2005 /9/EC. "
Smoke-Kallat
