SIST EN 16342:2013
(Main)Cosmetics - Analysis of cosmetic products - Quantitative determination of zinc pyrithione, piroctone olamine and climbazole in surfactant containing cosmetic anti-dandruff products
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
Dieser Normentwurf beschreibt ein Analysenverfahren für die Detektion und die quantitative Bestimmung der folgenden Antischuppenwirkstoffe: Zinkpyrithion, Pirocton-Olamin und Climbazol, in tensidhaltigen kosme-tischen Mitteln im Konzentrationsbereich von 0,1 g/100 g bis 1,0 g/100 g.
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
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
SIST EN 16342:2013
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
EN 16342:2013 (E) 2 Contents Page Foreword .3 Introduction .4 1 Scope .5 2 Terms and definitions .5 3 Principle .5 4 Reagents .5 5 Apparatus and equipment .7 6 Sampling .7 7 Procedure .8 8 Evaluations .9 9 Test report . 10 Annex A (informative) Results of the inter-laboratory test . 11 Annex B (informative) Sample Chromatogram . 12 Bibliography . 13
SIST EN 16342:2013
EN 16342:2013 (E) 3 Foreword This document (EN 16342:2013) has been prepared by Technical Committee CEN/TC 392 “Cosmetics”, the secretariat of which is held by AFNOR. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by November 2013, and conflicting national standards shall be withdrawn at the latest by November 2013. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: 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 the United Kingdom. SIST EN 16342:2013
EN 16342:2013 (E) 4 Introduction Special hair products contain substances to help prevent dandruff. These substances mainly inhibit the development of microorganisms, which often are the cause of dandruff. The most commonly used substances are zinc pyrithione, piroctone olamine and climbazole. The substances are regulated by Council Directive of 27 July 1976 on the approximation of the laws of the member states relating to cosmetic products (EC 76/768/EEC) as well as Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. Limits for these substances are listed in the annexes regulating preservatives in cosmetic products. Zinc pyrithione is additionally listed in Annex III of both regulative documents named above. NOTE As the Regulation (EC) 1223/2009 applies in total from 11 July 2013 and replaces Directive 76/768/EEC the following details relate only to Regulation (EC) 1223/2009. Reference Number, maximum authorised concentration in hair products, limitations and requirements: Annex III Regulation (EC) 1223/2009 Zinc pyrithione: No. 101: 0,1 % leave-on hair products Remark: For purposes other than inhibiting the development of microorganisms in the product. This purpose has to be apparent from the presentation of the product. Annex V Regulation (EC) 1223/2009 Zinc pyrithione: No. 8: 1,0 % hair products Remark: Only in rinse-off products
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
SIST EN 16342:2013
EN 16342:2013 (E) 5 1 Scope 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. 2 Terms and definitions For the purposes of this document, the following term and definition applies. 2.1 anti-dandruff agents
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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SLOVENSKI STANDARD
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01-februar-2012
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Cosmetics - Analysis of cosmetic products - Quantitative determination of zinc pyrithione,
piroctone olamine and climbazole in cosmetic products
Kosmetische Mittel - Untersuchung von kosmetischen Mitteln - Quantitative Bestimmung
von Zinkpyrithion, Pirocton-Olamin und Climbazol in tensidhaltigen kosmetischen Mitteln
mit Antischuppenwirkstoffen
Cosmétiques - Détermination quantitative du zinc pyrithione, de la piroctone olamine et
du climbazole dans les produits cosmétiques
Ta slovenski standard je istoveten z: prEN 16342
ICS:
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
oSIST prEN 16342:2012 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN 16342:2012
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oSIST prEN 16342:2012
EUROPEAN STANDARD
DRAFT
prEN 16342
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2011
ICS 71.100.70
English Version
Cosmetics - Analysis of cosmetic products - Quantitative
determination of zinc pyrithione, piroctone olamine and
climbazole in cosmetic products
Cosmétiques - Détermination quantitative du zinc Kosmetische Mittel - Untersuchung von kosmetischen
pyrithione, de la piroctone olamine et du climbazole dans
Mitteln - Quantitative Bestimmung von Zinkpyrithion,
les produits cosmétiques Pirocton-Olamin und Climbazol in tensidhaltigen
kosmetischen Mitteln mit Antischuppenwirkstoffen
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 392.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 16342:2011: E
worldwide for CEN national Members.
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oSIST prEN 16342:2012
prEN 16342:2011 (E)
Contents Page
Foreword .3
Introduction .4
1 Scope .5
2 Terms and definitions .5
3 Principle .5
4 Reagents .5
5 Apparatus and equipment .7
6 Sampling .7
7 Procedure .8
8 Evaluations .9
9 Test report . 10
Annex A (informative) Results of the inter-laboratory test . 11
Annex B (informative) Sample Chromatogram . 12
Bibliography . 13
2
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oSIST prEN 16342:2012
prEN 16342:2011 (E)
Foreword
This document (prEN 16342:2011) has been prepared by Technical Committee CEN/TC 392 “Cosmetics”, the
secretariat of which is held by AFNOR.
This document is currently submitted to the CEN Enquiry.
3
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oSIST prEN 16342:2012
prEN 16342:2011 (E)
Introduction
Special hair products contain substances to help prevent dandruff. These substances mainly inhibit the
development of microorganisms, which often are the cause of dandruff. The most commonly used substances
are zinc pyrithione, piroctone olamine and climbazole. The substances are regulated by Council Directive of
27 July 1976 on the approximation of the laws of the member states relating to cosmetic products
(EC 76/768/EEC) as well as Regulation (EC) No 1223/2009 of the European Parliament and of the Council of
30 November 2009 on cosmetic products. Limits for these substances are listed in the annexes regulating
preservatives in cosmetic products. Zinc pyrithione is additionally listed in Annex III of both regulative
documents named above.
NOTE As the Regulation (EC) 1223/2009 applies in total from 11 July 2013 and replaces Directive 76/768/EEC the
following details relate only to Regulation (EC) 1223/2009.
Reference Number, maximum authorized concentration in hair products, limitations and requirements:
Annex III Regulation (EC) 1223/2009
Zinc pyrithione: No. 101: 0,1 % leave-on hair products Remark: For purposes other than inhibiting
the development of microorganisms in the
product. This purpose has to be apparent
from the presentation of the product.
Annex V Regulation (EC) 1223/2009
Zinc pyrithione: No. 8: 1,0 % hair products Remark: Only in rinse-off products
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
4
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oSIST prEN 16342:2012
prEN 16342:2011 (E)
1 Scope
This draft standard describes 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’s probably applicable for the determination of the substances in non
surfactant-containing cosmetic products. For these purposes the method has not been validated.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
anti-dandruff agents
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, 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 (Na EDTA × 2H O), CAS number
2 2
6381-92-6
4.6 Oxalic acid dehydrate 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 (4.8).
5
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oSIST prEN 16342:2012
prEN 16342:2011 (E)
4.10 Sodium hydroxide solution, molar concentration c = 1 mol/l
4.11 Eluents
4.11.1 Eluent A: 0,0027 mol/l of oxalic acid dihydrate (4.6) and 0,001 mol/l of EDTA (4.5) in water, pH 4,0:
Pre-dissolve 0,37 g of EDTA in water, add 0,35 g of oxalic acid dihydrate (0,025 % of oxalic acid) and adjust
to pH = 4,0 with sodium hydroxide solution (4.10) using a pH-Meter. Then fill with water up to the
...
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