EN 16344:2013

Cosmetics - Analysis of cosmetic products - Screening for UV-filters in cosmetic products and quantitative determination of 10 UV-filters by HPLC.

This European Standard specifies a multi-screening method using reversed-phase HPLC for the detection of UV-filters listed in the cosmetic regulations. The method is applicable for the quantitative determination of 10 UV-filters, which are mainly used in emulsion-based cosmetic products and sunscreen sprays particularly with regard to the maximum concentration listed in the cosmetic regulation.
Other analytical methods for the qualification and quantification of UV-filters may be used if they lead to comparable results.

Kosmetische Mittel - Untersuchung von kosmetischen Mitteln - Screening und quantitative Bestimmung von 10 UV-Filtern in Sonnenschutzmitteln, HPLC-Verfahren

Diese Europäische Norm legt ein Multi-Screening-Verfahren unter Anwendung der Umkehrphasen-HPLC zum Nachweis von in der Kosmetik Verordnung aufgelisteten UV-Filtern fest. Das Verfahren ist auf die quantitative Bestimmung von 10 UV-Filtern anwendbar, die vorwiegend in emulsionsbasierten kosmetischen Produkten und Sonnenschutzsprays eingesetzt werden, insbesondere in Bezug auf die in der Kosmetik Verordnung aufgelistete Höchstkonzentration.
Weitere Analysenverfahren zur qualitativen und quantitativen Bestimmung von UV-Filtern dürfen eingesetzt werden, sofern sie zu vergleichbaren Ergebnissen führen.

Cosmétiques - Analyse des produits cosmétiques - Détection des filtres UV dans les produits cosmétiques et détermination quantitative de 10 filtres UV par CLHP

La présente Norme européenne spécifie une méthode utilisant la chromatographie liquide haute performance (CLHP) en phase inverse pour détecter les filtres UV listés dans la réglementation sur les cosmétiques. La méthode est applicable à la détermination quantitative de 10 filtres UV qui sont principalement utilisés dans les produits cosmétiques à base d'émulsion et les sprays de protection solaire, tout particulièrement dans le respect de la concentration maximale indiquée dans la réglementation sur les cosmétiques.
D'autres méthodes analytiques pour la qualification et la quantification des filtres UV peuvent être utilisées si elles donnent des résultats comparables.

Kozmetika - Analiza kozmetičnih izdelkov - Detekcija UV-filtrov v kozmetičnih izdelkih in kvantitativno določevanje 10 UV-filtrov s tekočinsko kromatografijo visoke ločljivosti (HPLC)

Ta evropski standard določa metodo večkratne detekcije z reverzno fazno tekočinsko kromatografijo visoke ločljivosti (HPLC) za detekcijo UV-filtrov, navedenih v uredbah o kozmetičnih izdelkih. Metoda se uporablja za kvantitativno določevanje 10 UV-filtrov, ki se uporabljajo predvsem v emulzijskih kozmetičnih izdelkih in izdelkih za zaščito pred soncem v obliki razpršila, zlasti glede največje dovoljene koncentracije, ki je navedena v uredbi o kozmetičnih izdelkih. Druge analizne metode za kvalifikacijo in kvantifikacijo UV-filtrov se lahko uporabijo, če zagotavljajo primerljive rezultate.

General Information

• Status: Published
• Publication Date: 23-Jul-2013
• Withdrawal Date: 30-Jan-2014
• ICS: 71.100.70 - Cosmetics. Toiletries
• Technical Committee: CEN/TC 392 - Cosmetics
• Drafting Committee: CEN/TC 392/WG 1 - Analytical methods
• Current Stage: 9020 - Submission to 2 Year Review Enquiry - Review Enquiry
• Start Date: 15-Jul-2024
• Completion Date: 15-Jul-2024
• Ref Project: SIST EN 16344:2013 - Cosmetics - Analysis of cosmetic products - Screening for UV-filters in cosmetic products and quantitative determination of 10 UV-filters by HPLC

Standards Content (Sample)

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.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 16344:2013: ESIST EN 16344:2013

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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