ČÁST 1
Seznam filtrů ultrafialového záření (UV filtry) povolených pro kosmetické prostředky
Tyto UV filtry smějí být přidávány do kosmetických prostředků v limitech a za podmínek uvedených v této příloze.
Ostatní UV filtry, které jsou používány v kosmetických prostředcích pouze za účelem chránit výrobek proti UV paprskům, nejsou zahrnuty do seznamu.
+-------+--------------------------------+-----------------+-------------+-----------------------+
| Ref. | Látka | Maximální | Omezení | Podmínky použití |
| číslo | | povolená | a požadavky | a varování, která |
| | | koncentrace | | musí být vytištěna |
| | | koncentrace | | na obalu |
+-------+--------------------------------+-----------------+-------------+-----------------------+
| a | b | c | d | e |
+-------+--------------------------------+-----------------+-------------+-----------------------+
| 2 | N,N,N-Trimethyl-4-[4,7,7- | 6 % | | |
| | trimethyl-3-oxobi-cyklo | | | |
| | [2.2.1]heptan-2-yliden) | | | |
| | methyl]anilinium- | | | |
| | methylsulfát **) | | | |
| | /N,N,N-Trimethyl-4-(2- | | | |
| | oxoborn-3-lidenmethyl) | | | |
| | anilinium methyl sulphate/ | | | |
| | ***) | | | |
+-------+--------------------------------+-----------------+-------------+-----------------------+
| 3 | 3,3,5-trimethylcyklohexyl- | 10 % | | |
| | salicylát **) | | | |
| | /Homosalate/ *) | | | |
+-------+--------------------------------+-----------------+-------------+-----------------------+
| 4 | 2-Hydroxy-4-methoxybenzofenon; | 10 % | | Obsahuje Oxybenzon 1) |
| | 2-benzoyl-5-methoxyfenol **) | | | |
| | Oxybenzon | | | |
| | /Oxybenzone/ *) | | | |
+-------+--------------------------------+-----------------+-------------+-----------------------+
| 6 | Kyselina 2-fenylbenzimidazol- | 8 % v přepočtu | | |
| | 5-sulfonová **) | na kyselinu | | |
| | /2-Phenylbenzimidazole-5- | | | |
| | sulphonic acid/ ***) a její | | | |
| | draselné, sodné a | | | |
| | triethanolaminové soli | | | |
+-------+--------------------------------+-----------------+-------------+-----------------------+
| 7 | 3,3'-(1,4-Fenylendimethylen) | 10 % v přepočtu | | |
| | bis(7,7-dimethyl-|2- | na kyselinu | | |
| | oxobicyklo-[2.2.1]heptan-1- | | | |
| | methansulfonová kyselina) **); | | | |
| | /3,3'-(1,4-Phenylendi- | | | |
| | methylene)bis(7,7-dimethyl- | | | |
| | 2-oxo-bicyclo-[2.2.1]hept-1- | | | |
| | ylmethanesulphonic acid)/ ***) | | | |
| | a její soli | | | |
+-------+--------------------------------+-----------------+-------------+-----------------------+
| 8 | 1-(4-terc-Butylfenyl)-3-(4- | 5 % | | |
| | methoxyfenyl)propan-1,3-dion | | | |
| | **) | | | |
| | /1-(4-Tert-butylphenyl)-3-(4- | | | |
| | methoxyphenyl)propane-1,3- | | | |
| | ione/ ***) | | | |
+-------+--------------------------------+-----------------+-------------+-----------------------+
| 9 | 4-[(4,7,7-Trimethyl-3-oxobi | 6 % v přepočtu | | |
| | cyklo[2.2.1]yliden)methyl] | na kyselinu | | |
| | benzen-1-sulfonová kyselina | | | |
| | **) | | | |
| | /alpha-(2-Oxoborn-3-ylidene) | | | |
| | toluene-4-sulphonic acid/ ***) | | | |
| | a její soli | | | |
+-------+--------------------------------+-----------------+-------------+-----------------------+
| 10 | 2-Ethylhexyl-(2-kyan-3,3- | 10 % v přepočtu | | |
| | difenylakrylát) **) | na kyselinu | | |
| | /2-Cyano-3,3-diphenyl acrylic | | | |
| | acid, 2-ethylhexyl ester | | | |
| | (Octocrylene)/ ***) | | | |
+-------+--------------------------------+-----------------+-------------+-----------------------+
| 11 | Poly(N-/2(4)-[(4,7,7- | 6 % | | |
| | trimethyl-3-oxobicyklo[2.2.1] | | | |
| | heptan-2-yliden]methyl]benzyl/ | | | |
| | akryl-amid) **) | | | |
| | /Polymer of N-/(2 and 4)-[(2- | | | |
| | oxoborn-3-ylidene)methyl] | | | |
| | benzyl/acrylamide/ ***) | | | |
+-------+--------------------------------+-----------------+-------------+-----------------------+
| 12 | Oktyl-3-(methoxyfenyl) | 10 % | | |
| | propenoát **) | | | |
| | /Octylmethoxycinnamate/ ***) | | | |
+-------+--------------------------------+-----------------+-------------+-----------------------+
| 13 | Ethoxylovaný ethyl-4- | 10 % | | |
| | aminobenzoát; Ethyl-4- | | | |
| | /[oligo(oxyethylen)]amino/ | | | |
| | benzoát **) (PEG-25 PABA) | | | |
| | /Ethoxylated ethyl-4- | | | |
| | aminobenzoate | | | |
| | (PEG-25 PABA)/ ***) | | | |
+-------+--------------------------------+-----------------+-------------+-----------------------+
| 14 | Isopentyl-3-(4-methoxyfenyl) | 10 % | | |
| | propenoát; | | | |
| | Isopentyl-3-(4-methoxyfenyl) | | | |
| | akrylát **) | | | |
| | /Isopentyl-4-methoxy- | | | |
| | cinnamate (Isoamyl | | | |
| | p-methoxycinnamate)/ ***) | | | |
+-------+--------------------------------+-----------------+-------------+-----------------------+
| 15 | 2 4 6 | 5 % | | |
| | N ,N ,N -Tris[4-(2- | | | |
| | ethylhexyloxy)fenyl]-1,3,5- | | | |
| | triazin-2,4,6-triamin **) | | | |
| | /2,4,6-Trianilino-(p-carbo-2'- | | | |
| | ethylhexyl-1'-oxy)-1,3,5- | | | |
| | triazine (Octyl Triazone)/ | | | |
| | ***) | | | |
+-------+--------------------------------+-----------------+-------------+-----------------------+
| 16 | 2-(2H-Benzotriazol-2-yl)-6- | 15 % | | |
| | /[3-(1,1,1,3,5,5,5- | | | |
| | heptamethyltrisiloxan-3-yl]- | | | |
| | 2-methylpropyl/-4-methylfenol | | | |
| | **) | | | |
| | /Phenol, 2-(2H-benzotriazol-2- | | | |
| | yl)-4-methyl-6-(2-methyl-3- | | | |
| | (1,3,3,3-tetramethyl-1- | | | |
| | (trimethylsilyl)oxy)- | | | |
| | disiloxanyl)propyl) | | | |
| | (Drometrizole Trisiloxane)/ | | | |
| | ***) | | | |
+-------+--------------------------------+-----------------+-------------+-----------------------+
| 17 | Bis(2-ethylhexyl)-4,4-(/6-[4- | 10 % | | |
| | (N-terc-butylkarbamo-yl) | | | |
| | anilino]-1,3,5-triazin-2,4- | | | |
| | diyl/diimino)dibenzoát **) | | | |
| | /Benzoic acid, 4,4-((6-(((1,1- | | | |
| | dimethylethyl)amino)carbonyl) | | | |
| | phenyl)amino)-1,3,5-triazine- | | | |
| | 2,4-diyl)diimino)bis-,bis | | | |
| | (2-ethylhexyl)ester)/ ***) | | | |
+-------+--------------------------------+-----------------+-------------+-----------------------+
| 18 | 3-(4-Methylbenzyliden)-dl- | 4 % | | |
| | kafr **); | | | |
| | /(4-Methylbenzylidene | | | |
| | Camphor)/ ° | | | |
+-------+--------------------------------+-----------------+-------------+-----------------------+
| 19 | 3-Benzylidenkafr | 2 % | | |
| | 3-Benzyliden-1,7,7-trimethyl- | | | |
| | bicyklo [2.2.1]heptan-2-on **) | | | |
| | /3-Benzylidene Camphor/ ***) | | | |
+-------+--------------------------------+-----------------+-------------+-----------------------+
| 20 | 2-Ethylhexyl-salicylát | 5 % | | |
| | 2-ethylhexyl-2-hydroxy- | | | |
| | benzoát **) | | | |
| | /(Octyl-salicylate)/ ***) | | | |
+-------+--------------------------------+-----------------+-------------+-----------------------+
| 21 | 2-Ethylhexyl-4-(dimethyl- | 8 % | | |
| | amino)benzoát **) | | | |
| | /4-Dimethyl-amino-benzoate | | | |
| | of ethyl-2-hexyl (octyl | | | |
| | dimethyl PABA)/ ***) | | | |
+-------+--------------------------------+-----------------+-------------+-----------------------+
| 22 | 2-Hydroxy-4-methoxybenzofenon- | 5 % v přepočtu | | |
| | 5-sulfonová kyselina **); | na kyselinu | | |
| | /2-Hydroxy-4-methoxybenzo- | | | |
| | phenone-5-sulfonic acid/; ° | | | |
| | /(Benzophenone-5)/ ° | | | |
+-------+--------------------------------+-----------------+-------------+-----------------------+
| 23 | 2,2'-Methylenbis[6-(2H- | 10 % | | |
| | benzotriazol-2-yl)-4-(1,1,3,3- | | | |
| | tetramethyl-butyl)fenol] **) | | | |
| | /2,2'-Methylene-bis-6-(2H- | | | |
| | benzotriazol-2-yl)-4-(tetra- | | | |
| | methyl-butyl)-1,1,3,3- | | | |
| | phenol/ ***) | | | |
+-------+--------------------------------+-----------------+-------------+-----------------------+
| 24 | 2,2'-(1,4-Fenylen)bis(1H- | 10 % v přepočtu | | |
| | benzimidazol-4,6-disulfonová | na kyselinu | | |
| | kyselina), monosodná sůl **) | | | |
| | /Monosodium salts of 2-2''- | | | |
| | bis-(1,4-phenylene)1H- | | | |
| | benzimidazole-4,6-disulphonic | | | |
| | acid/ ***) | | | |
+-------+--------------------------------+-----------------+-------------+-----------------------+
| 25 | 2,4-Bis[4-(2-ethylhexyloxy)- | 10 % | | |
| | 2-hydroxyfenyl]-6-(4- | | | |
| | methoxyfenyl)-1,3,5-triazin | | | |
| | **) | | | |
| | /(1,3,5)-Triazine-2,4-bis((4- | | | |
| | (2-ethyl-hexyloxyl)-2- | | | |
| | hydroxy)-phenyl)-6-(4- | | | |
| | methoxyphenyl)/ ***) | | | |
+-------+--------------------------------+-----------------+-------------+-----------------------+
| 26 | Dimethikodiethylbenzal-malonát | 10 % | | |
| | **) | | | |
| | (CAS 207574-74-1) | | | |
| | /Dimethicodiethylbenzal- | | | |
| | malonate/ ***) | | | |
+-------+--------------------------------+-----------------+-------------+-----------------------+
| 27 | Oxid titaničitý **) | 25 % | | |
| | CI 77891 | | | |
| | /Titanium dioxide/ ***) | | | |
| | TITANIUM DIOXIDE ****) | | | |
+-------+--------------------------------+-----------------+-------------+-----------------------+
| 28 | hexyl-2-[4-(diethylamino)-2- | 10 % | | |
| | hydroxybenzoyl]benzoát | | | |
| | DIETHYLAMINO | | | |
| | HYDROXYBENZOL | | | |
| | HEXYL BENZOATE ****) | | | |
| | CAS 302776-68-7 | | | |
+-------+--------------------------------+-----------------+-------------+-----------------------+
1) Upozornění se neuvádí, jestliže použitá koncentrace je rovná nebo nižší než 0,5 procenta a látka slouží pouze pro ochranu výrobku.
Poznámky
*) V této příloze je tímto způsobem označen název publikovaný v seznamu mezinárodně nechráněných názvů pro farmaceutické výrobky "Computer print-out 1975, International Non-proprietary Names (INN) for pharmaceutical products Lists 1-33 of proposed INN", WHO, Geneva, August 1975.
**) V této příloze je tímto způsobem označen název vytvořený podle "Průvodce názvoslovím organických sloučenin podle IUPAC (Doporučení 1993)", Academia, Praha 2000.
***) V této příloze je tímto způsobem označen název v anglickém jazyce, převzatý z originálu "The Cosmetics Directive 76/768/EEC", v platném znění.
****) V této příloze je tímto způsobem označen název v nomenklatuře dle INCI.