EN 17156:2018

Cosmetics - Analytical methods - LC/UV method for the identification and quantitative determination in cosmetic products of the 22 organic UV filters in use in the EU

This document specifies an analytical method, based on liquid-chromatography (LC) with ultraviolet/visible spectrometry (UV/Vis) detection for the detection and quantitative determination of 22 organic UV filters in use in the EU framework. This method has been validated for emulsion-based cosmetic products, lip-balms, lotions and waters.

Kosmetische Mittel - Untersuchungsverfahren - LC/UV-Verfahren für die Identifizierung und quantitative Bestimmung von den 22 in der EU verwendeten organischen UV-Filtern in kosmetischen Produkten

Diese Europäische Norm legt ein Analyseverfahren basierend auf Flüssigchromatographie (en: liquid chromatography, LC) mit UV/VIS Spektroskopie (für Wellenlängen des ultravioletten und sichtbaren (en: visible, VIS) Lichts) für die Detektion und quantitative Bestimmung der aktuell 22 organischen und im EU Rahmen verwendeten UV Filter fest. Dieses Verfahren wurde für emulsionsbasierte kosmetische Produkte, Lippenbalsame, Lotionen und Wasser validiert.

Cosmétiques - Méthodes analytiques - Procédé CL/UV pour l’identification et la détermination quantitative des 22 filtres UV organiques utilisés dans les produits cosmétiques au sein de l’UE

Le présent document spécifie une méthode analytique basée sur la chromatographie en phase liquide (CL) couplée à la détection par spectrométrie ultraviolet/visible (UV/Vis), pour la détection et la détermination quantitative des 22 filtres UV organiques utilisés dans le cadre de l’UE. Cette méthode a été validée pour les produits cosmétiques à base d’émulsion, les baumes à lèvres, les lotions et les eaux.

Kozmetika - Analizne metode - Metoda LC/UV za identifikacijo in kvantitativno določevanje 22 organskih UV-filtrov, ki se v EU uporabljajo v kozmetičnih izdelkih

Ta predlog je opisal niz postopkov HPLC/UV za identifikacijo in kvantitativno določevanje 22 organskih UV-filtrov, ki so v EU odobreni za uporabo v kozmetičnih izdelkih: benzalkonijev metasulfat kafra (CBM), homosalat (HS), benzofenon-3 (BZ3), fenilbenzimidazol sulfonska kislina (PBS), tereftaliden dikafra sulfonska kislina (TDS), butilmetoksi dibenzoilmetan (BDM), oktokrilen (OCR), etilheksil metoksicinamat (EMC), PEG-25 PABA (P25), izoamil p-metoksicinamat (IMC), etilheksil triazon (ET), drometrizol trisiloksan (DRT), dietilheksil butamidotriazon (DBT), 4-metilbenziliden kafra (MBC), etilheksil salicilat (ES), etilheksildimetil PABA (EDP), benzofenon-4/benzofenon-5 (BZ4), metilen bisbenzotriazolil tetrametilbutilfenol (MBP), dinatrijev fenil dibenzimidazol tetrasulfonat (PDT), bisetilheksiloksifenol metoksifenil triazin (EMT), polisilikon-15 (P-15), dietilamino hidroksibenzoil heksil benzoat (DHHB). To so vsi trenutno odobreni organski UV-filtri v EU, z izjemo treh, ki so zaščiteni s patenti in se ne uporabljajo več v kozmetičnih izdelkih (benziliden kafra sulfonska kislina, poliakrilamidometil benziliden kafra in 3-benziliden kafra).

General Information

• Status: Published
• Publication Date: 11-Dec-2018
• Withdrawal Date: 29-Jun-2019
• ICS: 71.100.70 - Cosmetics. Toiletries
• Technical Committee: CEN/TC 392 - Cosmetics
• Drafting Committee: CEN/TC 392/WG 1 - Analytical methods
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Start Date: 04-Jun-2025
• Completion Date: 23-Sep-2025
• Directive: 1223/2009 - Commission communication in the framework of the implementation of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products
• Ref Project: SIST EN 17156:2019 - Cosmetics - Analytical methods - LC/UV method for the identification and quantitative determination in cosmetic products of the 22 organic UV filters in use in the EU

Overview

EN 17156:2018 is a CEN European Standard that specifies an analytical procedure-based on liquid chromatography with ultraviolet/visible detection (LC/UV-Vis)-for identifying and quantitatively determining 22 organic UV filters used in cosmetic products across the EU. The method is validated for emulsion-based cosmetics, lip balms, lotions and waters and is designed for routine quality control and regulatory compliance testing.

Key topics and technical requirements

• Analytical principle: LC separation with UV/Vis detection (LC/UV-Vis).
• Target analytes: 22 organic UV filters permitted and in use within the EU regulatory framework at the time of validation.
• Sample preparation: samples are weighed and dissolved in ethanol; sonication or vortexing can aid dissolution. Aliquots are then diluted according to the UV filter group.
• Three analytical workflows:
  • Water‑soluble UV filters: measured on a reversed-phase column using an ethanol : acetate buffer mobile phase.
  • Fat‑soluble UV filters: analyzed on a reversed‑phase column with an ethanol + aqueous formic acid mobile phase modified with hydroxypropyl‑β‑cyclodextrin (HP‑β‑CD).
  • Polymeric UV filter (Polysilicone‑15, P15): determined using a size‑exclusion column with tetrahydrofuran (THF) as mobile phase.
• Reagents and standards: LC‑grade ethanol and THF, HP‑β‑CD, formic and acetic acids, acetate buffer, and multi‑component stock and calibration standards (specified concentrations).
• Equipment: LC‑UV/Vis system with gradient pump, autosampler, column oven; syringe membrane filter (0.45 µm); analytical balance; ultrasonic bath or vortex; pH meter. Column examples given: Purospher® STAR RP‑18 and PLgel Mixed D.
• Validation: includes intra‑laboratory validation and inter‑laboratory (ring trial) results (Annex A and B in the standard).

Practical applications and users

Who uses EN 17156:

• Cosmetic manufacturers for in‑house quality control and batch release testing.
• Contract and third‑party analytical laboratories performing composition verification.
• Regulatory and market surveillance bodies ensuring compliance with EU Regulation 1223/2009 on cosmetic ingredients and maximum allowed concentrations.
• R&D/QA teams verifying formulation consistency, ingredient identity, and label claims (e.g., SPF performance implications).

Typical use cases:

• Routine screening and quantification of organic UV filters in creams, lotions, lip balms and waters.
• Confirming product compliance with EU cosmetic regulations.
• Troubleshooting batch deviations, cross‑contamination or manufacturing errors affecting UV filter content.

Related standards and references

• EN 17156 references the regulatory framework EU Regulation 1223/2009 for permitted UV filters and limits.
• Terminology guidance is aligned with ISO and IEC term databases (ISO Online Browsing Platform, IEC Electropedia).

Keywords: EN 17156, LC/UV, LC‑UV/Vis, cosmetics analytical method, UV filters, EU cosmetics regulation, liquid chromatography, cosmetic product testing, quality control.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.YDQWLWDWLYQRKosmetische Mittel - Untersuchungsverfahren - LC/UV Verfahren für die Identifizierung und qualitative Bestimmung von den 22 in der EU verwendeten organischen UV-Filtern in kosmetischen ProduktenCosmétiques - Méthodes analytiques - Procédé CL/UV pour l’identification et la détermination quantitative des 22 filtres UV organiques utilisés dans les produits cosmétiques au sein de l’UECosmetics - Analytical methods - LC/UV method for the identification and quantitative determination in cosmetic products of the 22 organic UV filters in use in the EU71.100.70SULSRPRþNLCosmetics. ToiletriesICS:Ta slovenski standard je istoveten z:EN 17156:2018SIST EN 17156:2019en,fr,de01-februar-2019SIST EN 17156:2019SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 17156
December
t r s z ICS
y sä s r rä y r English Version
Cosmetics æ Analytical methoidentification and quantitative determination in cosmetic products of the
t t organic UV filters in use in the EU pour l 5identification et la détermination quantitative des
t t filtres UV organiques utilisés dans les produits cosmétiques au sein de l 5UE Verfahren für die Identifizierung und qualitative Bestimmung von den
t t in der EU verwendeten organischen UVæFiltern in kosmetischen Produkten This European Standard was approved by CEN on
w November
t r s zä
egulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterationä Upætoædate lists and bibliographical references concerning such national standards may be obtained on application to the CENæCENELEC Management Centre or to any CEN memberä
translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä
CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Serbiaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey and United Kingdomä
EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Rue de la Science 23,
B-1040 Brussels
t r s z CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN
s y s w xã t r s z ESIST EN 17156:2019

Results of the intra-laboratory validation . 15 A.1 General . 15 A.2 Water-soluble UV filters . 15 A.3 Fat-soluble UV filters . 18 A.4 UV filter P15 . 23 Annex B (informative)
Results of the inter-laboratory validation (Ring trial) . 24 B.1 General . 24 B.2 Water-soluble UV filters ring trial . 25 B.3 Fat-soluble UV filters ring trial. 26 B.4 UV filter P15 ring trial . 28 Bibliography . 29
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
IEC Electropedia: available at http://www.electropedia.org/
ISO Online browsing platform: available at http://www.iso.org/obp 4 Principles The cosmetic sample is weighed and solved in ethanol. For difficult-to-solve samples, the use of ultrasound or vortex can help. After that, depending on the UV filters to be determined, aliquots are taken and diluted with a mixture of ethanol:acetate buffer, ethanol or tetrahydrofuran for the determination of the water-soluble group, the fat-soluble group or P15 (which is a polymer), respectively. Regarding the water-soluble group, the 6 UV filters are measured by employing a reversed-phase column and a mobile phase of ethanol and acetate buffer. Regarding the fat-soluble group, the 15 UV filters are determined by employing a reversed-phase column and a mobile phase of ethanol and aqueous formic acid containing hydroxypropyl-beta-cyclodextrin as mobile phase modifier. Finally, for P15 determination, a size-exclusion column and tetrahydrofuran as mobile phase are used. 5 Reagents If not otherwise specified, analytical-grade chemicals shall be used. 5.1 Ethanol (EtOH), LC-grade. 5.2 Tetrahydrofuran (THF), LC-grade. 5.3 Deionized water, 18,2 ·cm resistivity. 5.4 2-Hydroxypropyl--cyclodextrin (HP--CD), 1 309 g/mol molecular weight. 5.5 Formic acid, 98 %, d = 1,22 g/ml. 5.6 Glacial acetic acid, > 99 %, d = 1,05 g/ml. 5.7 Sodium hydroxide, pellets. 5.8 Sodium hydroxide, 10 % (w/w) aqueous solution. Weigh 10 g of sodium hydroxide (5.7) and dissolve in 100 ml of deionized water (5.3). SIST EN 17156:2019

UV filters Benzophenone-3 (BZ3) 131–57–7 Isoamyl p-Methoxycinnamate (IMC) 71617–10–2 4-Methylbenzylidene Camphor (MBC) 36861–47–9 Diethylamino Hydroxybenzoyl Hexyl Benzoate (DHHB) 302776–68–7 Octocrylene (OC) 6197–30–4 Ethylhexyl Dimethyl PABA (EHDP) 21245–02–3 Butyl Methoxydibenzoylmethane (BMDM) 70356–09–1 Ethylhexyl Methoxycinnamate (EHMC) 5466–77–3 Ethylhexyl Salicylate (EHS) 118–60–5 Homosalate (HMS) 118–56–9 Diethylhexyl Butamido Triazone (DEBT) 154702–15–5 Ethylhexyl Triazone (EHT) 88122–99–0 Drometrizole Trisiloxane (DTS) 155633–54–8 Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (MBBT) 103597–45–1 Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine (BEMT) 187393–00–6 Polymeric
UV filter Polysilicone-15 (P15) 207574–74–1 SIST EN 17156:2019

1) For identification purposes, diode-array detector is recommended. 2) Purospher® STAR RP-18 Endcapped and PLgel Mixed D are examples of suitable products available commercially. This information is given for the convenience of users of
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