Cosmetics - Analysis of cosmetic products - Quantitative determination of zinc pyrithione, piroctone olamine and climbazole in surfactant containing cosmetic anti-dandruff products

This European Standard specifies an analytical method for the detection and quantitative determination of the following anti-dandruff agents: zinc pyrithione, piroctone olamine and climbazole in surfactant-containing cosmetic products in the concentration range from 0,1 g/100 g to 1,0 g/100 g.
NOTE   The method is also suitable for the determination of ketoconazole and ciclopirox olamine (q.v. Annex A) in surfactant-containing cosmetic products and it is probably applicable for the determination of the substances in non surfactant-containing cosmetic products. For these purposes, the method has not been validated.

Kosmetische Mittel - Untersuchung von kosmetischen Mitteln - Quantitative Bestimmung von Zinkpyrithion, Pirocton-Olamin und Climbazol in tensidhaltigen kosmetischen Mitteln mit Antischuppenwirkstoffen

Diese Europäische Norm legt ein Analysenverfahren für die Detektion und die quantitative Bestimmung der folgenden Antischuppenwirkstoffe: Zinkpyrithion, Pirocton-Olamin und Climbazol, in tensidhaltigen kosmetischen Mitteln im Konzentrationsbereich von 0,1 g/100 g bis 1,0 g/100 g fest.
ANMERKUNG   Das Verfahren ist auch für die Bestimmung von Ketoconazol und Ciclopiroxolamin (siehe Anhang A) in tensidhaltigen kosmetischen Mitteln geeignet und es ist wahrscheinlich anwendbar bei der Bestimmung dieser Substanzen in nicht-tensidhaltigen kosmetischen Mitteln. Für diese Zwecke wurde das Verfahren jedoch nicht validiert.

Cosmétiques - Analyse des produits cosmétiques - Détermination quantitative de la pyrithione de zinc, de la piroctone olamine et du climbazole dans les produits cosmétiques antipelliculaires contenant des agents de surface

La présente Norme européenne spécifie une méthode d'analyse pour la détection et la détermination quantitative des agents antipelliculaires suivants : la pyrithione de zinc, la piroctone olamine et le climbazole présents dans des produits cosmétiques contenant des agents de surface, dans une gamme de concentration comprise entre 0,1 g/100 g et 1,0 g/100 g.
NOTE La méthode convient également pour la détermination du ketoconazole et de la ciclopirox olamine (voir l'Annexe A) présents dans des produits cosmétiques contenant des agents de surface et elle est probablement applicable pour la détermination de ces substances dans des produits cosmétiques qui ne contiennent pas d'agent de surface. Toutefois, la méthode n'a pas été validée pour ces applications.

Kozmetika - Analiza kozmetičnih izdelkov - Kvantitativno določevanje cinkovega piritiona, pirokton olamina in klimbazola v kozmetičnih izdelkih proti prhljaju, ki vsebujejo površinsko aktivne snovi

Ta evropski standard podrobno določa analitično metodo za ugotavljanje in kvantitativno določevanje snovi proti prhljaju, kot so cinkov piriton, pirokton olamin in klimbazol v kozmetičnih izdelkih, ki vsebujejo površinsko aktivne snovi v koncentracijah od 0,1 g/100 g do 1,0 g/100 g. OPOMBA Metoda je ustrezna tudi za določanje ketokonazola in ciklopiroks olamina (glej dodatek A) v kozmetičnih izdelkih, ki vsebujejo površinsko aktivne snovi in je verjetno uporabna tudi za določevanje snovi v kozmetičnih izdelkih, ki ne vsebujejo površinsko aktivnih snovi. Metoda za ta namen ni bila potrjena.

General Information

Status
Published
Public Enquiry End Date
19-Mar-2012
Publication Date
05-Jun-2013
ICS
71.100.70 - Cosmetics. Toiletries
Technical Committee
KDS - Cosmetics, chemical disinfectants and surface active agents
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
09-May-2013
Due Date
14-Jul-2013
Completion Date
06-Jun-2013
Ref Project
EN 16342:2013 - Cosmetics - Analysis of cosmetic products - Quantitative determination of zinc pyrithione, piroctone olamine and climbazole in surfactant containing cosmetic anti-dandruff products

Overview

EN 16342:2013 (CEN) specifies an analytical method for the detection and quantitative determination of the anti-dandruff agents zinc pyrithione, piroctone olamine and climbazole in surfactant-containing cosmetic products (e.g., shampoos) in the concentration range 0.1 g/100 g to 1.0 g/100 g. The procedure uses solvent extraction followed by reversed‑phase HPLC with UV/DAD detection and external standard calibration. The method is published by CEN and intended for routine laboratory use to demonstrate compliance with regulatory limits for anti-dandruff actives.

Key topics and technical requirements

  • Scope and analytes: Zinc pyrithione, piroctone olamine, climbazole; method also shown to be suitable (not fully validated) for ketoconazole and ciclopirox olamine (Annex A).
  • Principle: Solvent extraction (dichloromethane + methanol), filtration, then separation by reversed‑phase HPLC and detection by photodiode array (DAD) or UV detector.
  • Sample preparation: Typically ~250 mg sample extracted with 5 ml dichloromethane + 5 ml methanol, ultrasonic bath (10 min, 35–40 °C), diluted to 50 ml and filtered.
  • Chromatography: Reversed‑phase column (e.g., C18 monolithic column), gradient elution between aqueous oxalic acid/EDTA buffer (Eluent A, pH 4.0) and acetonitrile (Eluent B). Typical run time ≈ 6 minutes.
  • Detection wavelengths: Zinc pyrithione ~340 nm, piroctone olamine ~305 nm, climbazole ~277 nm. Detector must resolve the lowest climbazole calibration level (5 µg/ml) at S/N ≥ 6:1.
  • Calibration & evaluation: External standard linear regression; calibration correlation coefficient r ≥ 0.996. Results expressed in g/100 g, rounded to three significant figures.
  • Performance: Inter-laboratory data (Annex A) show recoveries ≈ 99–100% and acceptable repeatability/reproducibility for routine QC.

Applications

  • Quality control of anti-dandruff cosmetics (shampoos, rinse-off products) to verify label claims and formulation consistency.
  • Regulatory compliance testing to demonstrate conformity with EU cosmetic limits (e.g., Regulation (EC) No 1223/2009).
  • Batch release and stability testing where quantitative monitoring of zinc pyrithione, piroctone olamine or climbazole is required.
  • Analytical method transfer and validation in contract testing and in‑house laboratories.

Who should use EN 16342:2013

  • Cosmetic testing laboratories and QC analysts
  • Manufacturers and contract laboratories producing anti-dandruff products
  • Regulatory authorities assessing compliance with EU cosmetic rules
  • R&D teams performing formulation and stability assessments

Related standards and notes

  • Linked regulatory context: Regulation (EC) No 1223/2009 on cosmetic products (limits for zinc pyrithione, climbazole, piroctone olamine).
  • Annexes in EN 16342 provide inter-laboratory results and example chromatograms to support method implementation.

Keywords: EN 16342:2013, zinc pyrithione, piroctone olamine, climbazole, HPLC, cosmetics, anti-dandruff, surfactant-containing, quantitative determination, CEN.

Frequently Asked Questions

SIST EN 16342:2013 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Cosmetics - Analysis of cosmetic products - Quantitative determination of zinc pyrithione, piroctone olamine and climbazole in surfactant containing cosmetic anti-dandruff products". This standard covers: This European Standard specifies an analytical method for the detection and quantitative determination of the following anti-dandruff agents: zinc pyrithione, piroctone olamine and climbazole in surfactant-containing cosmetic products in the concentration range from 0,1 g/100 g to 1,0 g/100 g. NOTE The method is also suitable for the determination of ketoconazole and ciclopirox olamine (q.v. Annex A) in surfactant-containing cosmetic products and it is probably applicable for the determination of the substances in non surfactant-containing cosmetic products. For these purposes, the method has not been validated.

This European Standard specifies an analytical method for the detection and quantitative determination of the following anti-dandruff agents: zinc pyrithione, piroctone olamine and climbazole in surfactant-containing cosmetic products in the concentration range from 0,1 g/100 g to 1,0 g/100 g. NOTE The method is also suitable for the determination of ketoconazole and ciclopirox olamine (q.v. Annex A) in surfactant-containing cosmetic products and it is probably applicable for the determination of the substances in non surfactant-containing cosmetic products. For these purposes, the method has not been validated.

SIST EN 16342:2013 is classified under the following ICS (International Classification for Standards) categories: 71.100.70 - Cosmetics. Toiletries. The ICS classification helps identify the subject area and facilitates finding related standards.

SIST EN 16342:2013 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)


2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Kosmetische Mittel - Untersuchung von kosmetischen Mitteln - Quantitative Bestimmung von Zinkpyrithion, Pirocton-Olamin und Climbazol in tensidhaltigen kosmetischen Mitteln mit AntischuppenwirkstoffenCosmétiques - Analyse des produits cosmétiques - Détermination quantitative de la pyrithione de zinc, de la piroctone olamine et du climbazole dans les produits cosmétiques antipelliculaires contenant des agents de surfaceCosmetics - Analysis of cosmetic products - Quantitative determination of zinc pyrithione, piroctone olamine and climbazole in surfactant containing cosmetic
anti-dandruff products71.100.70SULSRPRþNLCosmetics. ToiletriesICS:Ta slovenski standard je istoveten z:EN 16342:2013SIST EN 16342:2013en,fr,de01-julij-2013SIST EN 16342:2013SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 16342
May 2013 ICS 71.100.70 English Version
Cosmetics - Analysis of cosmetic products - Quantitative determination of zinc pyrithione, piroctone olamine and climbazole in surfactant containing cosmetic
anti-dandruff products
Cosmétiques - Analyse des produits cosmétiques - Détermination quantitative de la pyrithione de zinc, de la piroctone olamine et du climbazole dans les produits cosmétiques antipelliculaires contenant des agents de surface
Kosmetische Mittel - Untersuchung von kosmetischen Mitteln - Quantitative Bestimmung von Zinkpyrithion, Pirocton-Olamin und Climbazol in tensidhaltigen kosmetischen Mitteln mit Antischuppenwirkstoffen This European Standard was approved by CEN on 25 April 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 16342:2013: ESIST EN 16342:2013

0,5 % other products Remark: Not to be used in oral products
Climbazole: No. 32: 0,5 %
Piroctone olamine: No. 35: 1,0 % rinse-off products
0,5 % other products
substances, added to hair care products, active against the development of microorganism e.g. zinc pyrithione, piroctone olamine and climbazole 3 Principle The anti-dandruff agents are extracted from the cosmetic sample matrix using dichloromethane and methanol. Each analyte present in the sample extract is separated using reversed phase HPLC with UV (DAD) detection. The quantitative determination is made using the external standard method of calibration. 4 Reagents 4.1 General If not otherwise specified, as a minimum analytical-grade chemicals shall be used; water shall be distilled or of a corresponding purity. "Solution" shall be understood as an aqueous solution unless otherwise specified. 4.2 Methanol, CAS number: 67-56-1. 4.3 Dichloromethane, CAS number: 75-09-02. 4.4 Acetonitrile, CAS number: 75-05-8. 4.5 Ethylenediaminetetraacetic acid (EDTA) disodium salt dihydrate (Na2EDTA ⋅ 2H2O), CAS number: 6381-92-6. 4.6 Oxalic acid dihydrate, CAS number: 6153-56-6. 4.7 Acetic acid (glacial), CAS number: 64-19-7, mass fraction w = 99,8 g/100 g. 4.8 Acetic acid, molar concentration c = 0,02 mol/l. Weigh 1,20 g of acetic acid glacial (4.7) into a 1-l-volumetric flask and fill with water up to the calibration mark. 4.9 Methanol/acetic acid mixture Mix 80 parts by volume of methanol (4.2) and 20 parts by volume of acetic acid (4
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