EN ISO 24443:2021
(Main)Cosmetics - Determination of sunscreen UVA photoprotection in vitro (ISO 24443:2021, Corrected version 2022-02)
Cosmetics - Determination of sunscreen UVA photoprotection in vitro (ISO 24443:2021, Corrected version 2022-02)
This document specifies an in vitro procedure to characterize the UVA protection of sunscreen products. Specifications are given to enable determination of the spectral absorbance characteristics of UVA protection in a reproducible manner.
In order to determine relevant UVA protection parameters, the method has been created to provide an UV spectral absorbance curve from which a number of calculations and evaluations can be undertaken. These include calculation of the Ultraviolet-A protection factor (UVA-PF) [correlating with in vivo UVA-PF from the persistent pigment darkening (PPD) testing procedure], critical wavelength and UVA absorbance proportionality. These computations are optional and relate to local sunscreen product labelling requirements. This method relies on the use of static in vivo SPF results for scaling the UV absorbance curve.
This document is not applicable to powder products such as pressed powder and loose powder products.
Kosmetische Mittel - In-vitro-Bestimmung des UVA-Schutzes von Sonnenschutzmitteln (ISO 24443:2021, korrigierte Fassung 2022-02)
Dieses Dokument legt ein In vitro Verfahren zur Charakterisierung des UVA Schutzes von Sonnenschutz¬mitteln fest. Es werden Spezifikationen angegeben, die eine reproduzierbare Bestimmung der spektralen Extinktionseigenschaften des UVA Schutzes ermöglichen.
Zur Bestimmung von für den UVA Schutz relevanten Kenngrößen wurde ein Verfahren zur Aufstellung einer Kurve der spektralen Extinktion im UV Bereich entwickelt, auf dessen Grundlage eine Reihe von Berechnungen und Bewertungen vorgenommen werden können. Diese umfassen die Berechnung des UVA Schutzfaktors (UVA PF) [korreliert mit dem In vivo UVA Schutzfaktor aus dem Persistent-Pigment-Darkening (PPD) Prüfverfahren], der kritischen Wellenlänge und des UVA-Extinktionsverhältnisses. Diese Berechnungen sind optional und beziehen sich auf die örtlichen Anforderungen an die Kennzeichnung von Sonnenschutzmitteln. Dieses Verfahren basiert auf der Verwendung von statischen In vivo SPF Ergebnissen für die Skalierung der UV Extinktionskurve.
Dieses Dokument ist nicht anwendbar für pulverförmige Produkte, die z. B. gepresst oder lose vorliegen.
Cosmétiques - Détermination in vitro de la photoprotection UVA (ISO 24443:2021, Version corrigée 2022-02)
Le présent document spécifie un mode opératoire in vitro pour caractériser la protection UVA apportée par les produits de protection solaire. Des spécifications sont fournies pour permettre de déterminer les caractéristiques d’absorbance spectrale de la protection UVA de façon reproductible.
Afin de déterminer les paramètres de protection UVA pertinents, la méthode a été mise au point de sorte à fournir une courbe d’absorbance spectrale UV à partir de laquelle des calculs et des évaluations peuvent être effectués. Ces calculs comprennent le calcul du facteur de protection contre les ultraviolets A (FPUVA) [corrélé au FPUVA in vivo du mode opératoire d’essai de pigmentation persistante (PPD)], de la longueur d’onde critique et de la proportionnalité de l’absorbance des UVA. Ces calculs sont facultatifs et sont liés aux exigences d’étiquetage locales des produits de protection solaire. Cette méthode repose sur les résultats du FPS in vivo statique pour élaborer la courbe d’absorbance des UV.
Le présent document n’est pas applicable aux produits sous forme de poudre tels que les produits en poudre compacte ou en poudre libre.
Kozmetika - Določevanje zaščitnega faktorja UVA in vitro (ISO 24443:2021, popravljena izdaja 2022-02)
Ta dokument določa postopek in vitro za opredelitev zaščite pred žarki UVA varovalnih sredstev za zaščito kože pred soncem. Podane specifikacije omogočajo določitev lastnosti spektralne absorpcije zaščite pred žarki UVA na ponovljiv način.
Za določitev ustreznih parametrov zaščite pred žarki UVA je bila ustvarjena metoda za zagotovitev krivulje spektralne absorpcije UV, iz katere je mogoče izpeljati številne izračune in ocene.
Slednji vključujejo izračun ultravijoličnega A zaščitnega faktorja (UVA-PF) [ki se navezuje na UVA-PF in vivo iz preskusnega postopka obstojne pigmentacije (PPD)], kritične valovne dolžine in razmerja absorpcije žarkov UVA. Ti izračuni so izbirni in se navezujejo na zahteve glede označevanja izdelkov za zaščito kože pred soncem. Ta metoda temelji na uporabi rezultatov in vivo za statični zaščitni faktor pri določanju merila krivulje absorpcije žarkov UV.
Ta dokument se ne uporablja za izdelke v prahu, kot so na primer pudri v kamnu in prahu.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2022
Nadomešča:
SIST EN ISO 24443:2012
Kozmetika - Določevanje zaščitnega faktorja UVA in vitro (ISO 24443:2021,
popravljena izdaja 2022-02)
Cosmetics - Determination of sunscreen UVA photoprotection in vitro (ISO 24443:2021,
Corrected version 2022-02)
Kosmetische Mittel - In-vitro-Bestimmung des UVA Schutzes von Sonnenschutzmitteln
(ISO 24443:2021, korrigierte Fassung 2022-02)
Cosmétiques - Détermination in vitro de la photoprotection UVA (ISO 24443:2021,
Version corrigée 2022-02)
Ta slovenski standard je istoveten z: EN ISO 24443:2021
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 24443
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2021
EUROPÄISCHE NORM
ICS 71.100.70 Supersedes EN ISO 24443:2012
English Version
Cosmetics - Determination of sunscreen UVA
photoprotection in vitro (ISO 24443:2021, Corrected
version 2022-02)
Cosmétiques - Détermination in vitro de la Kosmetische Mittel - In-vitro-Bestimmung des UVA
photoprotection UVA (ISO 24443:2021, Version Schutzes von Sonnenschutzmitteln (ISO 24443:2021,
corrigée 2022-02) korrigierte Fassung 2022-02)
This European Standard was approved by CEN on 17 October 2021.
This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 16 March 2022.
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 NORMALISATIO N
EUROPÄISCHES KOMITEE FÜR NORMUN G
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 24443:2021 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 24443:2021) 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 June 2022, and conflicting national standards shall be
withdrawn at the latest by June 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 supersedes EN ISO 24443:2012.
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 website.
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 24443:2021, Corrected version 2022-02 has been approved by CEN as
INTERNATIONAL ISO
STANDARD 24443
Second edition
2021-12
Corrected version
2022-02
Cosmetics — Determination of
sunscreen UVA photoprotection in
vitro
Cosmétiques — Détermination in vitro de la photoprotection UVA
Reference number
ISO 24443:2021(E)
ISO 24443:2021(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
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Published in Switzerland
ii
ISO 24443:2021(E)
Contents Page
Foreword .iv
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms, definitions, symbols and abbreviated terms . 1
3.1 Terms and definitions . 1
3.2 Symbols and abbreviated terms . 2
4 Principle . 3
5 Apparatus . 3
5.1 Spectrophotometer specifications . 3
5.2 Calibration of the spectrophotometer . 4
5.3 Calibration of the UV exposure source . 4
5.4 Monitoring of the UV exposure source . 5
5.5 Calibration of the UVA radiometer used to monitor the test sample irradiation . 5
5.6 Substrate/plate . 5
6 Test method . 6
6.1 Outline of the test procedure . 6
6.2 Equipment calibration and validation of test plates . 6
6.3 Absorption measurements through the plate . 6
6.4 Sample application . 7
6.5 Absorbance measurements of the product-treated plate . 8
6.6 Number of determinations . 8
6.7 Determination of initial calculated SPF (SPF ), “C” value, initial UVA-PF
in vitro,0
(UVA-PF ), and UV exposure dose . 8
6.7.1 Determination of initial in vitro SPF (SPF ) . 8
in vitro,0
6.7.2 Determination of “C” value . 8
6.7.3 Determination of initial UVA protection factor before UV exposure (UVA-
PF ) . 9
6.7.4 Determination of the UV exposure dose . 10
6.8 UV exposure of sample plates . 10
6.9 Calculation of UVA-PF of plates after UV exposure of the sample . 10
6.10 Calculation of critical wavelength of plates after UV exposure of the sample . 11
7 Procedure using the spreadsheet in this document .11
8 Product reference sunscreen .12
8.1 Formula S2. 12
8.2 Standard P8 .12
9 Test report .12
Annex A (normative) Calibration of spectrophotometer and plate transmission test .14
Annex B (normative) Radiometer calibration to spectroradiometric irradiance procedure .18
Annex C (normative) Computation values: PPD and erythema action spectra and UVA and
UV‑SSR spectral irradiances .20
Annex D (normative) PMMA substrate plate surface specifications .23
Annex E (normative) Product reference sunscreen formulations .26
Annex F (informative) Statistical calculations .32
Annex G (informative) Definition and examples of valid results/Factor “C” .35
Bibliography .36
iii
ISO 24443:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. Internati
...
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