EN ISO 21392:2021

Cosmetics - Analytical methods - Measurement of traces of heavy metals in cosmetic finished products using ICP/MS technique (ISO 21392:2021, Corrected version 2021-12)

This document provides a method for quantification of trace levels of heavy metals in cosmetic products.
This document refers only to chromium, cobalt, nickel, arsenic, cadmium, antimony and lead. The methodology can apply to other elements, however, it is the responsibility of the analyst to demonstrate that it fits that purpose.

Kosmetische Mittel - Untersuchungsverfahren - Messung von Schwermetallspuren in kosmetischen Endprodukten mittels ICP MS (ISO 21392:2021, korrigierte Fassung 2021-12)

In diesem Dokument wird ein Verfahren zur Quantifizierung von Spurenanteilen von Schwermetallen in kosmetischen Mitteln bereitgestellt.
Dieses Dokument bezieht sich nur auf Chrom, Cobalt, Nickel, Arsen, Cadmium, Antimon und Blei. Das Verfahren kann auf andere Elemente angewendet werden, es liegt jedoch in der Verantwortung des Analytikers nachzuweisen, dass es für diesen Zweck geeignet ist.

Cosmétiques - Méthodes d’analyse - Mesurage des éléments traces métalliques par ICP-MS dans les produits cosmétiques finis (ISO 21392:2021, Version corrigée 2021-12)

Le présent document fournit une méthode de quantification des teneurs en éléments traces métalliques dans les produits cosmétiques.
Le présent document ne traite que du chrome, du cobalt, du nickel, de l’arsenic, du cadmium, de l’antimoine et du plomb. La méthode peut s’appliquer à d’autres éléments, cependant, il incombe à l’analyste de démontrer qu’elle est adaptée aux fins recherchées.

Kozmetika - Analizne metode - Določevanje težkih kovin v sledovih v končnih kozmetičnih izdelkih z masno spektrometrijo z induktivno sklopljeno plazmo (ICP/MS) (ISO 21392:2021)

Ta dokument podaja metodo za količinsko opredelitev težkih kovin v sledovih v kozmetičnih izdelkih.
Navezuje se samo na krom, kobalt, nikelj, arzen, kadmij, antimon in svinec. Metodologijo je mogoče uporabiti tudi za druge elemente, vendar mora analitik dokazati,
da ustreza temu namenu.

General Information

• Status: Published
• Publication Date: 31-Aug-2021
• Withdrawal Date: 30-Mar-2022
• ICS: 71.100.70 - Cosmetics. Toiletries
• Technical Committee: CEN/TC 392 - Cosmetics
• Drafting Committee: CEN/TC 392/WG 1 - Analytical methods
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 01-Sep-2021
• Completion Date: 01-Sep-2021
• 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 ISO 21392:2022 - Cosmetics - Analytical methods - Measurement of traces of heavy metals in cosmetic finished products using ICP/MS technique (ISO 21392:2021)

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2022
Kozmetika - Analizne metode - Določevanje težkih kovin v sledovih v končnih
kozmetičnih izdelkih z masno spektrometrijo z induktivno sklopljeno plazmo
(ICP/MS) (ISO 21392:2021)
Cosmetics - Analytical methods - Measurement of traces of heavy metals in cosmetic
finished products using ICP/MS technique (ISO 21392:2021)
Kosmetische Mittel - Untersuchungsverfahren - Messung von Spuren von
Schwermetallen in fertigen kosmetischen Mitteln mittels ICP-MS (ISO 21392:2021)
Cosmétiques - Méthodes d’analyse - Mesurage des éléments traces métalliques par
ICP-MS dans les produits cosmétiques finis (ISO 21392:2021)
Ta slovenski standard je istoveten z: EN ISO 21392:2021
ICS:
71.100.70 Kozmetika. Toaletni Cosmetics. Toiletries
pripomočki
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 21392
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2021
EUROPÄISCHE NORM
ICS 71.100.70
English Version
Cosmetics - Analytical methods - Measurement of traces of
heavy metals in cosmetic finished products using ICP/MS
technique (ISO 21392:2021)
Cosmétiques - Méthodes d'analyse - Mesurage des Kosmetische Mittel - Untersuchungsverfahren -
éléments traces métalliques par ICP-MS dans les Messung von Spuren von Schwermetallen in fertigen
produits cosmétiques finis (ISO 21392:2021) kosmetischen Mitteln mittels ICP-MS (ISO
21392:2021)
This European Standard was approved by CEN on 2 August 2021.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21392:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 21392:2021) has been prepared by Technical Committee ISO/TC 217
"Cosmetics" in collaboration with 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 March 2022, and conflicting national standards shall
be withdrawn at the latest by March 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a Standardization Request given to CEN by the European
Commission and the European Free Trade Association.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN websites.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 21392:2021 has been approved by CEN as EN ISO 21392:2021 without any modification.

INTERNATIONAL ISO
STANDARD 21392
First edition
2021-08
Cosmetics — Analytical methods
— Measurement of traces of heavy
metals in cosmetic finished products
using ICP/MS technique
Cosmétiques — Méthodes d’analyse — Mesurage des éléments traces
métalliques par ICP-MS dans les produits cosmétiques finis
Reference number
ISO 21392:2021(E)
©
ISO 2021
ISO 21392:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

ISO 21392:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 1
5 Reagents . 2
6 Apparatus and equipment . 2
7 Preparation of standards solutions . 3
7.1 General . 3
7.2 Diluted nitric acid . 3
7.3 Diluting solution . 4
7.4 Internal standard solutions. 4
7.4.1 General. 4
7.4.2 Rhodium standard solution, 1 mg/l . 4
7.4.3 Lutetium standard solution, 1 mg/l . 4
7.5 Standard solutions . 4
7.5.1 General. 4
7.5.2 High concentration mixed standard solution, 10 mg/l . 5
7.5.3 Low concentration mixed standard solution, 0,1 mg/l . 5
7.6 Calibration blank solution . 5
7.7 Calibration solutions . 5
8 Procedure. 6
8.1 Preparation of samples . 6
8.2 Pressure assisted digestion . 6
8.2.1 General. 6
8.2.2 Preparation of sample by digestion — General case . 6
8.2.3 Preparation of sample by digestion — Specific cases . 7
8.2.4 Microwave digestion procedure . 7
8.2.5 Preparation of measurement solutions . 8
8.3 Inductively coupled plasma mass spectrometry . 8
8.3.1 ICP-MS operating conditions . 8
8.3.2 Quantification of the analytes by ICP-MS . 8
8.4 Quality control of the analysis . 9
8.4.1 General. 9
8.4.2 During digestion .10
8.4.3 During analysis .11
8.4.4 Example of ICP-MS sequence .11
9 Calculation .12
10 Method performance .12
11 Test report .13
Annex A (informative) Performance of the method determined by the accuracy profile
methodology .14
Annex B (informative) Evaluation of the method via ISO 5725 statistical approach .22
Bibliography .
...