SIST EN ISO 24442:2022
(Main)Cosmetics - Sun protection test methods - In vivo determination of sunscreen UVA protection (ISO 24442:2022)
Cosmetics - Sun protection test methods - In vivo determination of sunscreen UVA protection (ISO 24442:2022)
This document specifies a method for the in vivo determination of UVA protection factor (UVAPF) of
sunscreen products. It is applicable to products that contain any component able to absorb, reflect or
scatter ultraviolet (UV) rays and which are intended to be placed in contact with human skin.
This document provides a basis for the evaluation of sunscreen products for the protection of human
skin against UVA radiation induced by solar ultraviolet rays.
Kosmetik - Prüfverfahren für Sonnenschutzmittel - In-vivo-Bestimmung des UVA-Sonnenschutzes (ISO 24442:2022)
Dieses Dokument legt ein Verfahren zur In-vivo-Bestimmung des UVA-Schutzfaktors (UVASF) von Sonnen¬schutzmitteln fest. Es gilt für Erzeugnisse, welche jegliche Komponenten enthalten, die ultraviolette (UV )Strahlen absorbieren, reflektieren oder streuen können, und dazu bestimmt sind, mit der menschlichen Haut in Kontakt gebracht zu werden.
Dieses Dokument dient als Basis für die Bewertung von Sonnenschutzmitteln zum Schutz der menschlichen Haut vor ultravioletten Sonnenstrahlen, die durch UVA-Strahlung induziert werden.
Cosmétiques - Méthodes d’essai de protection solaire - Détermination in vivo de la protection UVA d’un produit de protection solaire (ISO 24442:2022)
Le présent document spécifie une méthode de détermination in vivo du facteur de protection contre les UVA (FPUVA) des produits de protection solaire. Il peut s’appliquer à des produits qui contiennent tout composant pouvant absorber, refléter ou diffuser les rayons ultraviolets (UV) et qui sont destinés à être mis en contact avec la peau humaine.
Le présent document fournit une base pour l’évaluation des produits de protection solaire destinés à la protection de la peau humaine contre les rayonnements UVA induits par les rayons ultraviolets solaires.
Kozmetika - Metode za preskušanje zaščite pred soncem - Določevanje zaščitnega faktorja UVA in vivo (ISO 24442:2022)
Ta dokument določa metodo za določevanje faktorja zaščite pred soncem (UVAPF) in vivo sredstev za zaščito kože pred soncem. Uporablja se za izdelke, ki vsebujejo katero koli sestavino za vpijanje, odbijanje ali
razpršitev ultravijoličnih žarkov in ki so namenjeni nanosu na človeško kožo.
Ta dokument zagotavlja podlago za vrednotenje izdelkov za zaščito človeške kože pred sevanjem UVA, ki ga povzročijo ultravijolični sončni žarki.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 24442:2022
01-september-2022
Nadomešča:
SIST EN ISO 24442:2012
Kozmetika - Metode za preskušanje zaščite pred soncem - Določevanje zaščitnega
faktorja UVA in vivo (ISO 24442:2022)
Cosmetics - Sun protection test methods - In vivo determination of sunscreen UVA
protection (ISO 24442:2022)
Kosmetik - Prüfverfahren für Sonnenschutzmittel - In-vivo-Bestimmung des UVA-
Sonnenschutzes (ISO 24442:2022)
Cosmétiques - Méthodes d’essai de protection solaire - Détermination in vivo de la
protection UVA d’un produit de protection solaire (ISO 24442:2022)
Ta slovenski standard je istoveten z: EN ISO 24442:2022
ICS:
71.100.70 Kozmetika. Toaletni Cosmetics. Toiletries
pripomočki
SIST EN ISO 24442:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 24442:2022
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SIST EN ISO 24442:2022
EN ISO 24442
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2022
EUROPÄISCHE NORM
ICS 71.100.70 Supersedes EN ISO 24442:2011
English Version
Cosmetics - Sun protection test methods - In vivo
determination of sunscreen UVA protection (ISO
24442:2022)
Cosmétiques - Méthodes d'essai de protection solaire - Kosmetik - Prüfverfahren für Sonnenschutzmittel - In-
Détermination in vivo de la protection UVA d'un vivo-Bestimmung des UVA-Sonnenschutzes (ISO
produit de protection solaire (ISO 24442:2022) 24442:2022)
This European Standard was approved by CEN on 3 June 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 NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 24442:2022 E
worldwide for CEN national Members.
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SIST EN ISO 24442:2022
EN ISO 24442:2022 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 24442:2022
EN ISO 24442:2022 (E)
European foreword
This document (EN ISO 24442:2022) 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 December 2022, and conflicting national standards
shall be withdrawn at the latest by December 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 24442:2011.
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 24442:2022 has been approved by CEN as EN ISO 24442:2022 without any modification.
3
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SIST EN ISO 24442:2022
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SIST EN ISO 24442:2022
INTERNATIONAL ISO
STANDARD 24442
Second edition
2022-06
Cosmetics — Sun protection test
methods — In vivo determination of
sunscreen UVA protection
Cosmétiques — Méthodes d’essai de protection solaire —
Détermination in vivo de la protection UVA d’un produit de protection
solaire
Reference number
ISO 24442:2022(E)
© ISO 2022
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SIST EN ISO 24442:2022
ISO 24442:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
© ISO 2022 – All rights reserved
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SIST EN ISO 24442:2022
ISO 24442:2022(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General principle .3
5 Test subjects . 3
5.1 Selection of the test subjects . 3
5.1.1 General . 3
5.1.2 Skin colour of the test subjects . 4
5.1.3 Age restriction . . 4
5.1.4 Frequency of participation in tests . 4
5.1.5 Ethics and consent . 4
5.2 Number of test subjects . 4
6 Apparatus and materials— Source of ultraviolet radiation . 4
6.1 General . 4
6.2 Quality of ultraviolet radiation . 5
6.3 Total irradiance (UV, visible and near infrared rays) . 5
6.4 Uniformity of beam . 5
6.4.1 General . 5
6.4.2 Film densitometry . 5
6.4.3 UV sensor . 6
6.4.4 Large beam source . 6
6.4.5 Small beam source . 6
7 Maintenance and monitoring the UV solar simulator output . 7
7.1 Spectroradiometry . 7
7.2 Radiometry . 8
8 Reference sunscreen formulations .8
8.1 General . 8
8.2 Reference standard to be used . 9
9 Procedure .9
9.1 Main steps . 9
9.2 Test conditions . 10
9.3 Position of the test subjects . 10
9.4 Product application . 10
9.4.1 Overview . 10
9.4.2 General . 10
9.4.3 Amount of product applied . 10
9.4.4 Mode of delivery . 11
9.4.5 Evaluation of application uniformity . 13
9.4.6 Drying time between application and UV exposure . .13
9.4.7 Exposure sub-sites . 13
9.5 UV exposure . 13
9.5.1 Provisional MPPDD . 13
iu
9.5.2 Estimated MPPDD .13
iu
9.5.3 Incremental progression of UV dose . 13
9.6 Product removal . 14
9.7 Procedure for MPPDD assessment . 14
9.7.1 General . 14
9.7.2 Time of assessment of MPPDD . 14
9.7.3 Grading scale for the MPPDD s . 15
i
iii
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SIST EN ISO 24442:2022
ISO 24442:2022(E)
9.7.4 Erythema responses .15
9.7.5 Data rejection criteria . 15
9.7.6 Test failure criteria . . 16
9.7.7 Expression of MPPDDs . 16
10 Calculation of the UVA protection factor and statistics .16
10.1 Calculation of the individual UVAPF (UVAPF ) . 16
i
10.2 Calculation of product UVAPF . 17
10.3 Statistical criterion . 17
10.4 Validation of the test . 17
11 Test report .17
11.1 Overview . 17
11.2 General information. 17
11.3 Data in tabular for each test subject . 18
11.4 Statistics for the test products . 18
Annex A (normative) Selection criteria for the test subjects .19
Annex B (normative) Definition of the source of UVA radiation .21
Annex C (normative) UVAPF reference sunscreens formulations.24
Annex D (normative) Calculations and statistics .37
Annex E (normative) Colorimetric determination of skin colour typing .43
Annex F (informative) Visual guidance for PPD grading— Visual appearance of PPD .45
Annex G (informative) Sample report form .52
Bibliography .56
iv
© ISO 2022 – All rights reserved
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SIST EN ISO 24442:2022
ISO 24442:2022(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. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 217, Cosmetics, in collaboration with
the European Committee for Standardization (CEN) Technical Committee CEN/TC 392, Cosmetics, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 24442:2011), which has been technically
revised.
The main changes are as follows:
— this document has been aligned with the revised ISO 24444.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
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© ISO 2022 – All rights reserved
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SIST EN ISO 24442:2022
ISO 24442:2022(E)
Introduction
This document specifies the procedure to determine the Ultraviolet A Protection Factor (UVAPF) of
a sunscreen product using the persistent pigment darkening method according to the principles
[1]
recommended by the Japan Cosmetic Industry Association (JCIA) in 1995 . The outcome of this test
method can be used to determine the UVA classification of topical sunscreen products according to
local regulatory requirements.
Topical sunscreen products are primarily rated and labelled according to their ability to protect against
sunburn, using a test method to determine the in vivo sun protection factor (see ISO 24444). This rating
evaluates filtration of sunburn generating radiation across the electromagnetic UV spectrum (290 nm
to 400 nm). However, knowledge of the sun protection factor (SPF) rating does not provide explicit
information on the magnitude of the protection provided specifically in the UVA range of the spectrum
(320 nm to 400 nm), as it is possible to have high SPF products with very modest UVA protection [for
example SPF 50 with a UVA protection factor (UVAPF) of only 3 to 4]. There is demand among medical
professionals, as well as knowledgeable consumers, to have fuller information on the UVA protection
provided by their sunscreen product, in addition to the SPF, in order to make a more informed choice of
product, providing a more balanced and broader-spectrum protection. Moreover, there is also a demand
to prevent UVA-induced darkening of the skin from a cultural point of view even without sunburn.
Thus, persistent pigment darkening (PPD) was selected as an endpoint relevant to UVA. Although PPD
[2]
reflects merely photo-polymerization of melanin monomers , it is evaluated as a representative of
the biological reactions. The UVAPF value of a product provides information on the magnitude of the
[3][4][5]
protection provided explicitly in the UVA portion of the spectrum, independent of the SPF values .
The test method outlined in this document is derived primarily from the UVAPF test methods as
developed by the JCIA. Modifications have been made to attempt to be in line with updated International
Standards for determination of sun protection factor without changing the integrity of the fundamental
underlying principles of the test method.
vi
© ISO 2022 – All rights reserved
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SIST EN ISO 24442:2022
INTERNATIONAL STANDARD ISO 24442:2022(E)
Cosmetics — Sun protection test methods — In vivo
determination of sunscreen UVA protection
1 Scope
This document specifies a method for the in vivo determination of UVA protection factor (UVAPF) of
sunscreen products. It is applicable to products that contain any component able to absorb, reflect or
scatter ultraviolet (UV) rays and which are intended to be placed in contact with human skin.
This document provides a basis for the evaluation of sunscreen products for the protection of human
skin against UVA radiation induced by solar ultraviolet rays.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 24444, Cosmetics — Sun protection test methods — In vivo determination of the sun protection factor
(SPF)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
ultraviolet radiation
UVR
electromagnetic radiation in the range of 290 nm to 400 nm
3.1.1
ultraviolet B
UVB
electromagnetic radiation in the range of 290 nm to 320 nm
3.1.2
ultraviolet A
UVA
electromagnetic radiation in the range of 320 nm to 400 nm
Note 1 to entry: UVA II = 320 nm to 340 nm; UVA I = 340 nm to 400 nm.
3.2
erythema
reddening of the skin caused by UV radiation
1
© ISO 2022 – All rights reserved
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SIST EN ISO 24442:2022
ISO 24442:2022(E)
3.3
persistent pigment darkening
PPD
skin darkening that persists more than 2 h after the end of UVA exposure
3.4
sunscreen products
products containing any component able to absorb, reflect or scatter UV rays, which are intended to be
placed on the surface of human skin with the purpose of protecting against erythema (3.2) and other
ultraviolet induced damage
3.5
minimal persistent pigment darkening dose
MPPDD
lowest UVA dose that produces the first perceptible unambiguous persistent pigment darkening
response with over more than 50 % of UV exposure subsite, observed between 2 h and 24 h after the
end of the UVA exposure
3.5.1
MPPDD
u
MPPDD on unprotected skin
3.5.1.1
MPPDD
iu
MPPDD of an individual subject on unprotected skin
3.5.2
MPPDD
p
MPPDD on product protected skin
3.5.2.1
MPPDD
ip
MPPDD of an individual subject on protected skin
3.6
UVA protection factor
UVAPF
ratio of the minimal PPD dose on product protected skin (MPPDD ) to the minimal PPD dose on
p
unprotected skin (MPPDD ) of the same subject:
u
MPPDD
p
UVAPF=
MPPDD
u
Note 1 to entry: UVAPF is expressed to one decimal place by truncation.
3.6.1
individual UVA protection factor
UVAPF
i
ratio of the individual minimal PPD dose on product protected skin (MPPDD ) to the individual minimal
ip
PPD dose on unprotected skin (MPPDD ) of the same subject:
iu
MPPDD
ip
UVAPF =
i
MPPDD
iu
Note 1 to entry: UVAPF is expressed to one decimal place by truncation.
i
3.6.2
product UVAPF
arithmetic mean of all valid individual UVAPF values obtained from all subjects in the test
i
2
© ISO 2022 – All rights reserved
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SIST EN ISO 24442:2022
ISO 24442:2022(E)
3.7
test area
area for testing on the back between the scapula line and the waist
Note 1 to entry: Skeletal protrusions and extreme areas of curvature should be avoided.
3.8
test site
area of the skin where a product is applied, or the site used for the determination of the unprotected
MPPDD
3.9
exposure sub-sites
areas of skin that are exposed to UV-irradiation within a test site (3.8)
3.10
individual typology angle
ITA°
value characterizing the skin colour of the subject as measured by a skin contact reflectance
spectrophotometer or skin colorimeter
Note 1 to entry: Refer to Annex E for the detailed requirements of the equipment/measurement.
4 General principle
The UVAPF test method is analogous to the test method used to determine the SPF of a sunscreen
product. However, it utilizes only the UVA portion of the xenon arc lamp solar simulator of defined and
known output to determine the protection provided by sunscreen products on human skin in the UVA
portion of the spectrum.
The UVAPF test method uses
...
SLOVENSKI STANDARD
oSIST prEN ISO 24442:2021
01-april-2021
Kozmetika - Preskusne metode za zaščito pred soncem - Določevanje zaščitnega
faktorja UVA in vivo (ISO/DIS 24442:2021)
Cosmetics - Sun protection test methods - In vivo determination of sunscreen UVA
protection (ISO/DIS 24442:2021)
Kosmetik - Prüfverfahren für Sonnenschutzmittel - In-vivo-Bestimmung des UVA-
Sonnenschutzes (ISO/DIS 24442:2021)
Cosmétique -- Méthodes d'évaluation de la protection solaire -- Détermination in vivo de
la protection UVA (ISO/DIS 24442:2021)
Ta slovenski standard je istoveten z: prEN ISO 24442
ICS:
71.100.70 Kozmetika. Toaletni Cosmetics. Toiletries
pripomočki
oSIST prEN ISO 24442:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 24442:2021
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oSIST prEN ISO 24442:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 24442
ISO/TC 217 Secretariat: ISIRI
Voting begins on: Voting terminates on:
2021-02-22 2021-05-17
Cosmetics — Sun protection test methods — In vivo
determination of sunscreen UVA protection
Cosmétique — Méthodes d'évaluation de la protection solaire — Détermination in vivo de la protection UVA
ICS: 71.100.70
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 24442:2021(E)
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. ISO 2021
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oSIST prEN ISO 24442:2021
ISO/DIS 24442:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© 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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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oSIST prEN ISO 24442:2021
ISO/DIS 24442:2021(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General principle . 3
5 Test subjects . 3
5.1 Selection of the test subjects . 3
5.1.1 General. 3
5.1.2 Skin colour of the test subjects . 3
5.1.3 Age restriction. 4
5.1.4 Frequency of participation in tests . 4
5.1.5 Ethics and consent. 4
5.2 Number of test subjects . 4
6 Apparatus and materials— Source of ultraviolet radiation . 4
6.1 General . 4
6.2 Quality of ultraviolet radiation . 4
6.3 Total irradiance (UV, visible and near infrared rays) . 5
6.4 Uniformity of beam . 5
6.4.1 General. 5
6.4.2 Film densitometry . 5
6.4.3 UV sensor . 6
6.4.4 Large beam source . 6
6.4.5 Small beam source. 6
7 Maintenance and monitoring the UV solar simulator output . 7
7.1 Spectroradiometry . 7
7.2 Radiometry . 7
8 Reference sunscreen formulations . 8
8.1 General . 8
8.2 Reference standard to be used . 8
9 Procedure. 9
9.1 Main steps . 9
9.2 Test conditions . 9
9.3 Position of the test subjects . 9
9.4 Product application . 9
9.5 UV exposure .13
9.5.1 Provisional MPPDD .
iu 13
9.5.2 Estimated MPPDD .
iu 13
9.5.3 Incremental progression of UV dose .13
9.6 Product removal .13
9.7 Procedure for MPPDD assessment .14
9.7.1 General.14
9.7.2 Time of assessment of MPPDD .14
9.7.3 Grading scale for the MPPDD s .14
i
9.7.4 Erythema responses .14
9.7.5 Data rejection criteria . .15
9.7.6 Test Failure Criteria .15
9.7.7 Expression of MPPDDs .15
10 Calculation of the UVA protection factor and statistics .16
10.1 Calculation of the individual UVAPF (UVAPF ) . .16
i
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oSIST prEN ISO 24442:2021
ISO/DIS 24442:2021(E)
10.2 Calculation of product UVAPF .16
10.3 Statistical criterion .16
10.4 Validation of the test .16
11 Test report .16
11.1 Overview .16
11.2 General Information .17
11.3 Data in tabular for each test subject .17
11.4 Statistics for the test products .18
Annex A (normative) Selection criteria for the test subjects .19
Annex B (normative) Definition of the source of UVA radiation .21
Annex C (normative) UVAPF reference sunscreens formulations .24
Annex D (normative) Calculations and statistics .37
Annex E (normative) Colourimetric determination of skin colour typing .43
Annex F (informative) Visual Guidance For PPD Grading .45
Annex G (informative) Sample Report Form .52
Bibliography .56
iv © ISO 2021 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 24442:2021
ISO/DIS 24442:2021(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. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 217, Cosmetics.
This second edition cancels and replaces the first edition (ISO 24442:2011), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— Revision in accordance with revision of relevant ISO Standard, ISO 24444.
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oSIST prEN ISO 24442:2021
ISO/DIS 24442:2021(E)
Introduction
This International Standard specifies the procedure to determine the Ultraviolet A Protection
Factor (UVAPF) of a sunscreen product using the persistent pigment darkening method according to
[1]
the principles recommended by the Japan Cosmetic Industry Association (JCIA) in 1995 . The outcome
of this test method can be used to determine the UVA classification of topical sunscreen products
according to local regulatory requirements.
Topical sunscreen products are primarily rated and labelled according to their ability to protect against
sunburn, using a test method to determine the in vivo Sun Protection Factor (see ISO 24444). This rating
evaluates filtration of sunburn generating radiation across the electromagnetic UV spectrum (290 nm
to 400 nm). However, knowledge of the Sun Protection Factor (SPF) rating does not provide explicit
information on the magnitude of the protection provided specifically in the UVA range of the spectrum
(320 nm to 400 nm), as it is possible to have high SPF products with very modest UVA protection
(e.g. SPF 50 with a UVA protection factor (UVAPF) of only 3 to 4). There is demand among medical
professionals, as well as knowledgeable consumers, to have fuller information on the UVA protection
provided by their sunscreen product, in addition to the SPF, in order to make a more informed choice of
product, providing a more balanced and broader-spectrum protection. Moreover, there also a demand
to prevent UVA-induced darkening of the skin from a cultural point of view even without sunburn.
Thus, persistent pigment darkening (PPD) was selected as an endpoint relevant to UVA. Although PPD
[2]
reflects merely photo-polymerization of melanin monomers , it is evaluated as a representative of
the biological reactions. The UVAPF value of a product provides information on the magnitude of the
[3] [4] [5]
protection provided explicitly in the UVA portion of the spectrum, independent of the SPF values .
The test method outlined in this International Standard is derived primarily from the UVAPF test
methods as developed by the JCIA. Modifications have been made to attempt to be in line with updated
International Standards for determination of sun protection factor without changing the integrity of
the fundamental underlying principles of the test method.
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oSIST prEN ISO 24442:2021
DRAFT INTERNATIONAL STANDARD ISO/DIS 24442:2021(E)
Cosmetics — Sun protection test methods — In vivo
determination of sunscreen UVA protection
1 Scope
This International Standard specifies a method for the in vivo determination of UVA protection factor
(UVAPF) of sunscreen products. This International standard is applicable to products that contain any
component able to absorb, reflect or scatter ultraviolet (UV) rays and which are intended to be placed
in contact with human skin.
It provides a basis for the evaluation of sunscreen products for the protection of human skin against
UVA radiation induced by solar ultraviolet rays.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 24442:2012, Cosmetics — Sun protection test method — In vivo determination of sunscreen UVA
[6]
protection
ISO 24444:2019, Cosmetics — Sun protection test methods — In vivo determination of the sun protection
[7]
factor (SPF)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
ultraviolet radiation
UVR
electromagnetic radiation in the range of 290 nm to 400 nm
3.1.1
ultraviolet B
UVB
electromagnetic radiation in the range of 290 nm to 320 nm
3.1.2
ultraviolet A
UVA
electromagnetic radiation in the range of 320 nm to 400 nm
Note 1 to entry: UVA II = 320 nm to 340 nm; UVA I = 340 nm to 400 nm.
3.2
erythema
reddening of the skin caused by UV radiation
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3.3
persistent pigment darkening
PPD
skin darkening that persists more than 2 h after the end of UVA exposure
3.4
sunscreen products
products containing any component able to absorb, reflect or scatter UV rays, which are intended to
be placed on the surface of human skin with the purpose of protecting against erythema and other
ultraviolet induced damage
3.5
minimal persistent pigment darkening dose
MPPDD
lowest Ultraviolet A (UVA) dose that produces the first perceptible unambiguous persistent pigment
darkening response with defined borders appearing over most of the field of UVA exposure, observed
between 2 h and 24 h after the end of the UVA exposure
3.5.1
MPPDD
u
MPPDD on unprotected skin
3.5.1.1
MPPDD
iu
MPPDD of an individual subjected on unprotected skin
3.5.2
MPPDD
p
MPPDD on product protected skin
3.5.2.1
MPPDD
ip
MPPDD of an individual subjected on protected skin
3.6
individual UVA protection factor
UVAPF
i
ratio of the individual minimal PPD dose on product protected skin (MPPDD ) to the individual minimal
ip
PPD dose on unprotected skin (MPPDD ) of the same subject:
iu
MPPDD
ip
UVAPF =
i
MPPDD
iu
Note 1 to entry: UVAPF is expressed to one decimal place by truncation.
i
3.7
UVA protection factor of a product: UVAPF
arithmetic mean of all valid individual UVAPF values obtained from all subjects in the test
i
Note 1 to entry: UVAPF is expressed to one decimal place by truncation.
3.8
test area
area for testing on the back between the scapula line and the waist
Note 1 to entry: Skeletal protrusions and extreme areas of curvature should be avoided.
3.9
test site
area of the skin where a product is applied or the site used for the determination of the unprotected
MPPDD
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3.10
exposure sub-sites
areas of skin that are exposed to UV-irradiation within a test site
3.11
individual typology angle
ITA°
value characterizing the skin colour of the subject as measured by a skin contact reflectance
spectrophotometer or skin colourimeter
Note 1 to entry: Refer to Annex E for the detailed requirements of the equipment/measurement.
4 General principle
The UVAPF test method is analogous to the test method used to determine the SPF of a sunscreen
product. However, it utilizes only the UVA portion of the xenon arc lamp solar simulator of defined and
known output to determine the protection provided by sunscreen products on human skin in the UVA
portion of the spectrum.
The UVAPF test method uses PPD responses of the skin as the end point for evaluating transmitted UVA
radiation.
The test shall be restricted to the area of the back of selected human subjects.
A section of each subject’s skin is exposed to UVA radiation without any protection while another
(different) section is exposed after application of the sunscreen product under test. One further section
is exposed after application of an UVAPF reference sunscreen formulation, which is used for validation
of the procedure.
To determine the UVAPF, incremental series of PPD responses are induced on a number of small
sub-sites on the skin. These responses are visually assessed for presence of PPD 2 to 24 h after UVA
radiation, by the judgment of a trained and competent evaluator.
The MPPDD and the MPPDD shall be determined on the same subject on the same day. An UVAPF for
iu ip i
each subject tested is calculated as the ratio of MPPDD divide by MPPDD , as in the formula given in
ip iu
item 3.6
The UVAPF is the arithmetic mean of all valid UVAPF results from each subject in the test expressed to
i
one decimal place.
5 Test subjects
5.1 Selection of the test subjects
5.1.1 General
There are strict requirements governing the inclusion and non-inclusion of test subjects which should
be adhered to. The criteria shall be set out in Annex A.
5.1.2 Skin colour of the test subjects
Test subjects included in the UVAPF test shall have an ITA° value between 18° and 43° by colourimetric
methods (see Annex A and E) and be untanned on the test area.
A trained and competent scientist or technician should examine each subject to ensure that there is no
condition which might put the subject at risk and that the outcome of the test cannot be compromised
by adverse skin conditions such as sun damage, pigmentation marks and previous history of abnormal
response to the sun (see Annex A).
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The test sites intended for UV exposure shall be free from blemishes and hair, and have an even colour
tone with no variation in ITA° greater than 5° from each other or the MPPDD test area.
u
5.1.3 Age restriction
Test subjects below the locally regulated age of consent or older than 70 years shall not be included in
the UVAPF test panel.
5.1.4 Frequency of participation in tests
Subjects may participate in a test provided that at least 8 weeks have elapsed since they participated
in a previous UV exposure study (i.e. SPF, UVAPF, photoallergy, phototoxicity test), and all skin tanned
marks from that previous test have cleared from the test sites on the back and are no longer visible.
5.1.5 Ethics and consent
[8]
All testing shall be done in accordance with the Declaration of Helsinki and national regulations
regarding human studies should also be taken into account.
Informed, written (signature) consent shall be obtained from all test subjects and retained.
5.2 Number of test subjects
The minimum number of valid UVAPF results shall be 10 and the maximum number of valid UVAPF
i i
results shall be 20. In order to achieve between 10 and 20 valid results, a maximum of five individual
invalid results may be excluded from the calculation of the mean UVAPF. For the test to be considered
valid for the first 10 subjects, the resulting range of the 95 % CI of the mean shall be within ± 17 %.
Consequently the actual number of test subjects used will fall between a minimum of 10 and a maximum
of 25 subjects (i.e. a maximum of 20 valid results plus 5 rejected invalid results).
Results may only be declared invalid and excluded from the calculation of the mean UVAPF according
to 9.5.3 or because of non-compliance with the related protocol.
In order to determine the number of test subjects, the 95 % confidence interval (95 % CI) on the
mean UVAPF shall be taken into account. A minimum of 10 subjects shall be tested. The test shall be
considered valid for the first 10 subjects if the resulting range of the 95 % CI of the mean UVAPF shall be
within ± 17 % of the mean UVAPF. If it is not within ± 17 % of the mean UVAPF, the number of subjects
shall be increased stepwise from the minimum number of 10 until the 95 % CI statistical criterion is
met (up to a maximum of 20 valid results from a maximum of 25 subjects tested). If the statistical
criterion has not been met after 20 valid results from a maximum of 25 subjects, then the test shall be
rejected. For details on statistical definitions, sequential procedure and calculations, refer to Annex D.
6 Apparatus and materials— Source of ultraviolet radiation
6.1 General
The artificial light source used shall comply with the source spect
...
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