EN 16344:2013

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.NURPDWRJUDILMRKosmetische Mittel - Untersuchung von kosmetischen Mitteln - Screening und quantitative Bestimmung von 10 UV-Filtern in Sonnenschutzmitteln, HPLC-VerfahrenCosmétiques - Analyse des produits cosmétiques - Détection des filtres UV dans les produits cosmétiques et détermination quantitative de 10 filtres UV par CLHPCosmetics - Analysis of cosmetic products - Screening for UV-filters in cosmetic products and quantitative determination of 10 UV-filters by HPLC71.100.70SULSRPRþNLCosmetics. ToiletriesICS:Ta slovenski standard je istoveten z:EN 16344:2013SIST EN 16344:2013en,fr,de01-november-2013SIST EN 16344:2013SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 16344
July 2013 ICS 71.100.70 English Version
Cosmetics - Analysis of cosmetic products - Screening for UV-filters in cosmetic products and quantitative determination of 10 UV-filters by HPLC.
Cosmétiques - Analyse des produits cosmétiques - Détection des filtres UV dans les produits cosmétiques et détermination quantitative de 10 filtres UV par CLHP
Kosmetische Mittel - Untersuchung von kosmetischen Mitteln - Screening und quantitative Bestimmung von 10 UV-Filtern in Sonnenschutzmitteln, HPLC-Verfahren This European Standard was approved by CEN on 29 May 2013.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.
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Results of the inter-laboratory test . 16 Annex B (informative)
Sample Chromatogram 1 . 22 Annex C (informative)
Sample chromatogram 2 . 24 Bibliography. 25
4.6 Sodium hydroxide solution, molar concentration c = 1 mol/l. 4.7 Ethylenediaminetetraacetic acid (EDTA) disodium salt dihydrate (Na2EDTA ⋅ 2H2O, CAS 6381-92-6, purity > 99 %). 4.8 EDTA solution Weigh 1,8 g of EDTA disodium salt dihydrate (4.7) into a 100 ml volumetric flask and fill up to the calibration mark with water. 4.9 Ethanol, HPLC grade. 4.10 Lauryl Trimethyl Ammonium Bromide (LTAB, synonym: dodecyltrimethylammonium bromide. CAS 1119-94-4), if possible HPLC quality (purity ≥ 98 %). 4.11 Ammonium bromide (CAS 12124-97-9, purity ≥ 99 %). 4.12 Reference substances SIST EN 16344:2013

EUa Abbrev. INCIb
and other common names 4.12.1 A2 CBM Camphor Benzalkonium Methosulfate, CAS 52793-97-2 4.12.2 A6 PBSA Phenylbenzimidazole Sulfonic Acid (2-phenylbenzimidazole-5-sulfonic acid), CAS 27503-81-7 4.12.3 A7 TDSA Terephthalylidene Dicamphor Sulfonic Acid, CAS 90457-82-2, present as triethanolamine salt (molecular weight m = 860 g/mol), free acid (molecular weight m = 562 g/mol) 4.12.4 A22 B-4/5 Benzophenone-4/5 (2-hydroxy-4-methoxybenzophenone-5-sulfonic acid, Sulisobenzone), CAS 4065-45-6 4.12.5 A24 DPDT Disodium Phenyl Dibenzimidazole Tetrasulfonate, CAS 180898-37-7 4.12.6 A28 DHHB Diethylamino Hydroxybenzoyl Hexyl Benzoate, CAS 302776-68-7 a EU = serial number in accordance with Annex VI of (EC) No 1223/2009. b INCI = International Nomenclature of Cosmetic Ingredients. Table 2 — Medium polar UV-filters (calibration solution in methanol acetone (1:1))
EUa
Abbrev. INCIb
and other common names 4.12.7 A4 B-3 Benzophenone-3 (oxybenzonum, 2-hydroxy-4-methoxy-benzophenone), CAS 131-57-7 4.12.8 A10 OC Octocrylene (2-ethylhexyl-2-cyano-3,3-diphenylacrylate), CAS 6197-30-4 4.12.9 A12 EHMC Ethylhexyl Methoxycinnamate (octylmethoxycinnamate), CAS 5466-77-3 4.12.10 A14 IMC Isoamyl p-Methoxycinnamate, CAS 71617-10-2 4.12.11 A18 MBC 4-Methylbenzylidene Camphor (3-(4-methylbenzylidene)-dl-camphor), CAS 36861-47-9 4.12.12 A19 3-BC 3-Benzylidene Camphor, CAS 15087-24-8 4.12.13 A21 EHDP Ethylhexyl Dimethyl PABA (2-ethylhexyl-4-dimethylaminobenzoate), CAS 21245-02-3 a EU = serial number in accordance with Annex VI of (EC) No 1223/2009. b INCI = International Nomenclature of Cosmetic Ingredients. Table 3 — Non polar UV-filters (calibration solution in THF)
EUa
Abbrev. INCIb
and other common names 4.12.14 A3 HMS Homosalate (3,3,5-trimethylcyclohexylsalicylate), CAS 118-56-9 4.12.15 A8 BMDM Butyl Methoxydibenzoylmethane (4-tert-butyl-4’-methoxydibenzoylmethane), CAS 70356-09-1 4.12.16 A15 EHT Ethylhexyl Triazone (octyltriazone), CAS 88122-99-0 4.12.17 A16 DTS Drometrizole Trisiloxane (2-benzotriazole-2-yl-methylphenol trisiloxane), CAS 155633-54-8
4.12.18 A17 DEBT Diethylhexyl Butamido Triazone, CAS 154702-15-5 4.12.19 A20 EHS Ethylhexyl Salicylate (2-ethylhexylsalicylate), CAS 118-60-5 4.12.20 A23 MBBT Methylene Bis-Benzotriazol Tetramethylbutylphenol, CAS 103597-45-1 4.12.21 A25 BEMT Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine (anisotriazine), CAS 187393-00-6 a EU = serial number in accordance with Annex VI of (EC) No 1223/2009. b INCI = International Nomenclature of Cosmetic Ingredients. SIST EN 16344:2013

Table 4 — Other UV-filter or UV absorber (not listed in Annex VI of the (EC) No 1223/2009)
Abbrev. INCIb
and other common names 4.12.22
MA Menthyl Anthranilate, CAS 134-09-8 4.12.23
PABA PABA (4-aminobenzoic acid), CAS 150-13-0 4.12.24
B-1 Benzophenone-1 (2,4-dihydroxybenzophenone), CAS 131-56-6 4.12.25
B-2 Benzophenone-2 (2,2’,4,4’-tetrahydroxybenzophenone), CAS 131-55-5 4.12.26
DPLT Dimethyl-PABAmidopropyl Laurdimonium Tosylate, CAS 156679-41-3 4.12.27
B-6 Benzophenone-6 (2,2’-dihydroxy-4,4'-dimethoxybenzophenone), CAS 131-54-4 4.12.28
B-8 Benzophenone-8 (2,2’-dihydroxy-4-methoxybenzophenone, dioxybenzone),CAS 131-53-3 4.12.29
B-9 Benzophenone-9 (disodium 3,3'-carbonylbis[4-hydroxy-6-methoxybenzenesulphonate]), CAS 76656-36-5 4.12.30
B-10 Benzophenone-10 (2-hydroxy-4-methoxy-4'-methylbenzophenone), CAS 1641-17-4 4.12.31
SA Sodium Salicylate, CAS 54-21-7 b INCI = International Nomenclature of Cosmetic Ingredients. NOTE The following UV-filters listed in Annex VI of the Regulation (EC) No 1223/2009 are not part of this method: −
A 9: 3-(4'-sulfo)-benzylidene-bornan-2-one, CAS 56039-58-8 −
A 11: polymer of N-(2(and 4)-(2-oxoborn-3-ylidenemethyl)benzyl)acrylamid, CAS 113783-61-2
(the
substances are no longer commercially available) −
A 13: ethoxylated ethyl-4-aminobenzoate, CAS 116242-27-4
(can be determined only qualitatively) −
A 26: dimethicodiethylbenzalmalonate, CAS 207574-74-1
(cannot be determined using this standard) 4.13 Extraction solution 4.13.1 Acetone/methanol mixture (for the preparation of the reference solutions and for extraction). Mix 500 ml of acetone (4.3) and 500 ml of methanol (4.2) in a 1 000 ml conical flask. 4.13.2 Acetone/tetrahydrofuran mixture (for extraction of non-polar UV-filters). Mix 500 ml of acetone (4.3) and 500 ml of tetrahydrofuran (4.4) in a 1 000 ml conical flask. 4.13.3 Methanolic-aqueous sodium hydroxide solution (for extraction of polar UV-filters). Mix 800 ml of methanol (4.2) and 200 ml of water and 10 ml of sodium hydroxide solution (4.6) in a 1 000 ml conical flask. 4.13.4 Acetone/methanol/EDTA mixture (for extraction of BMDM-containing samples with unsatisfactory peak shape). Add 1,0 ml of EDTA solution (4.8) to 200 ml of acetone/methanol mixture (4.13.1) in a 200 ml conical flask. As the solution i
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