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Royal Decree 1599/1997 of 17 October on the regulation of cosmetic products, compiled in a single text all the legislation in force in this field and incorporated into the Spanish legal order Directive 76 /768/EEC of the Council of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products and their subsequent amendments.
In order to incorporate the new Community directives, the aforementioned royal decree was subsequently amended by Royal Decree 2131/2004 of 29 October, and Royal Decree 209/2005 of 25 February, as well as successive ones. orders that have modified their attachments.
Following the publication in 2001 of a scientific study entitled 'Use of permanent hair dye and bladder cancer risk', a comprehensive strategy has been agreed between the European Commission, the Member States of the European Union and interested parties, in order to regulate the substances used in such products, in accordance with which the industry was required to present appropriate scientific studies for the assessment of their safety.
Having already issued definitive opinions on 17 substances used in hair dye products, it was therefore appropriate to amend Directive 76 /768/EEC, which is carried out with the adoption of the Directive. Commission Decision 2009 /36/EC of 16 April 2009 amending Council Directive 76 /768/EEC on cosmetic products in order to adapt Annex III thereto to technical progress, the provisions of which are transposed into national law (i) by means of this order, and for which it is necessary to make further changes to Annex III of the Royal Decree 1599/1997 of 17 October.
In the processing of this order the mandatory report of the Council of Consumers and Users, regulated by the Royal Decree 894/2005, of 22 July, modified by the Royal Decree 487/2009, of April 3, has been obtained, consulted to the sectors concerned.
This order is made in use of the enablement conferred by the final provision of Royal Decree 1599/1997 of 17 October, which empowers the holder of the Ministry of Health and Social Policy to update the its annexes when it is established by Community legislation.
In its virtue, I have:
Single item. Amendment of Annex III to Royal Decree 1599/1997 of 17 October on cosmetic products.
Annex III to Royal Decree 1599/1997 of 17 October on cosmetic products is hereby amended as follows:
One. In the first part of the Annex, the following order numbers 189-205 are added:
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No. | Substance | Restrictions | Conditions of employment and warnings that will be compulsorily entered on the | |||
|---|---|---|---|---|---|---|
| Field application and/or use | Maximum concentration authorized in the finished cosmetic product |
Other limitations and | ||||
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| b | c | d | e | f | |
| " 189 | 5-Hydroxy-1-(4-sulfophenyl) -4-(4-sulfophenylazo) pyrazole-3-carboxylate and its aluminium lacquer | Substance for non-oxidizing hair dye. | 0.5% |
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| 190 | Benzenetanaminium, N-ethyl-N-[4-[[4-[ethyl [(3-sulfophenyl) methyl] amino]-phenyl] (2-sulfophenyl) methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfo, internal salt, disodium salt and its ammonium and aluminium salts (15) | Substance for non-oxidizing hair dye. | 0.5% |
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| |
| 191 | 6-Hydroxy-5-[(2-methoxy-4-sulfonate-m-tolyl) azo] naphthalene-2-disodium sulfonate (15) | Substance for non-oxidizing hair dye. | 0.4% |
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| |
| 192 | 1-(1-Naftilazo) -2-hydroxynaphthalene-4 ', 6.8-trisodium, and its aluminum lacquer (15) | Substance for non-oxidizing capillaries. | 0.5% |
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| |
| 193 | 3,6-Bis (diethylamino) -9-(2,4-disulfonatophenyl)-xantilio sodium salt (15) | a) Substance for oxidative hair dye. |
| a) After mixing under oxidative conditions, the maximum concentration applied to the hair must not exceed 1,5%. | a) mixture will be compulsorily consigned to the label | |
|
| 5-Amino-4-hydroxy-3-(phenylazo)-naphthalene-2,7-disulfonate of disodium (15) | Substance for non-oxidizing hair dye. | 0.5% |
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| |
| 195 | 2-Sulfonato-1-amino-4-(cyclohexylamino) -9,10-dihydro-9,10-dioxoanthracene (15) | Substance for non-oxidizing capillaries. | 0.5% | Not to use with nitrous agents. |
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196 | 1-[(2 '-Methoxyethyl) amino] -2-nitro-4-[di-(2'-hydroxyethyl) amino] benzene (15) | Substance for non-oxidizing hair dye. | 2.0% | Do not use with agents nitrosants. |
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197 | 1,5-Di-(β-hydroxyethylamino) -2-nitro-4-chlorobenzene (15) | Substance for non-oxidizing hair dye. | 0.1% | Do not use with agents nitrosants. |
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198 | 3-Metillamino-4-nitrophenoxiethanol (15) | Substance for non-oxidizing capillaries. | 0.15% | Do not use with agents nitrosants |
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199 | 2,2 '-[[4-[(2-hydroxyethyl) amino] -3-nitrophenyl] imino] bisetanol (15) | Substance for non-oxidizing hair dye. | 2.8% | Do not use with agents nitrosants. | It may cause an allergic reaction | |
| 200 | 1-Propanol, 3-[[4-[bis (2-hydroxyethyl) amino] -2-nitrophenyl] amino] (15) | Substance for non-oxidizing hair dye. | 2.0% | Do not use with agents nitrosants. | It may cause an allergic reaction | |
|
201 | 2-Chloro-6-(ethylamino) -4-nitrophenol (15) | Substance for non-oxidizing hair dye. | 3.0% | Do not use with agents nitrosants. | It may cause an allergic reaction | |
|
202 | 4,4 '-[1,3-propanediylbis (oxy)]-bis (benzene-1,3-diamine) and its tetrachlorhydrate (15) | a) Substance for oxidative hair dye. |
| a) After mixing under oxidative conditions, the maximum concentration applied to the hair must not exceed 1,2% calculated on the basis of free (1.8% in tetrachlorhydrate salt). | a) The mixing ratio will be compulsorily entered on the label. | |
|
| 6-methoxy-N2-methyl-2,3-pyridiniamine hydrochloride and dihydrochloride (15) | a) Substance for oxidative hair dye. |
| a) After mixing under oxidative conditions, the maximum concentration applied to the hair must not exceed 0,68% calculated on a free basis (1,0% in dihydrochloride). | a) The mixing ratio will be mandatory on the label. | |
|
| 2,3-Dihydro-1H-indol-5,6-diol and its bromhydrate (15) | Substance for oxidizing hair dye. | 2.0% |
| Can cause an allergic reaction | |
|
| 4-Hydroxypropylamino-3-nitrophenol (15) | a) Substance for oxidative hair dye. |
| a) After mixing under oxidative conditions, the maximum concentration applied to the hair must not exceed 2,6% calculated on a free basis. | a) The mixing ratio will be compulsorily entered on the label. | |
(15) Except as prohibited in Annex II, the use of the free base and the salts of this capillary dye ingredient is authorised. "
Two. In the second part of the Annex, in order number 55, in columns "c" and "d", section b is deleted.
Three. In the second part of the Annex, reference numbers 7, 9, 14, 18, 24, 28, 47 and 58 are deleted.
Transitional disposition. Time limit for sale or transfer.
From May 15, 2010, cosmetic products that do not conform to the single article may not be sold or transferred to the final consumer.
Final disposition first. Incorporation of European Union law.
By this order, Commission Directive 2009 /36/EC of 16 April 2009 amending Council Directive 76 /768/EEC on cosmetic products, in order to adapt it, is incorporated into the internal legal order. its Annex III to technical progress.
Final disposition second. Entry into force.
This order shall enter into force on the day following that of its publication in the Official Gazette of the State.
Madrid, November 27, 2009. -Minister of Health and Social Policy, Trinidad Jiménez García-Herrera.
