SIST EN ISO 18861:2022
(Main)Cosmetics - Sun protection test methods - Percentage of water resistance (ISO 18861:2020)
Cosmetics - Sun protection test methods - Percentage of water resistance (ISO 18861:2020)
This document specifies a procedure for evaluating the water resistance retention percentage, by
comparing the sun protection factor (SPF) before water immersion (hereafter referred to as the “static”
SPF) and after a fixed period of water immersion (hereafter referred to as the “wet” SPF).
Kosmetische Mittel - Untersuchungsverfahren für Sonnenschutzmittel - Prozentualer Anteil der Wasserbeständigkeit (ISO 18861:2020)
Dieses Dokument legt ein Verfahren für die Bewertung des Prozentsatzes der bewahrten Wasserbeständigkeit fest, indem die Sonnenschutzfaktoren (SSF) vor dem Eintauchen in Wasser (anschließend als „statischer“ SSF bezeichnet) und nach einer festgelegten Dauer des Eintauchens in Wasser (anschließend als „feuchter“ SSF bezeichnet) miteinander verglichen werden.
Cosmétiques - Méthodes d’essai de protection solaire - Pourcentage de résistance à l’eau (ISO 18861:2020)
Le présent document spécifie un mode opératoire pour évaluer le pourcentage de rémanence à l'eau en comparant le facteur de protection solaire (FPS) avant immersion dans l'eau (appelé ici « FPS statique ») et après une durée fixe d'immersion dans l'eau (appelé ici « FPS humide »).
Kozmetika - Metode za preskušanje zaščite pred soncem - Odstotek vodoodpornosti (ISO 18861:2020)
Ta dokument določa postopek za vrednotenje odstotka ohranjanja vodoodpornosti s primerjavo zaščitnega faktorja (SPF) pred potopitvijo v vodo (v nadaljevanju: »statični« zaščitni faktor) in zaščitnega faktorja po določenem času potopitve v vodo (v nadaljevanju: »mokri« zaščitni faktor).
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 18861:2022
01-julij-2022
Kozmetika - Metode za preskušanje zaščite pred soncem - Odstotek
vodoodpornosti (ISO 18861:2020)
Cosmetics - Sun protection test methods - Percentage of water resistance (ISO
18861:2020)
Kosmetische Mittel - Untersuchungsverfahren für Sonnenschutzmittel - Prozentualer
Anteil der Wasserbeständigkeit (ISO 18861:2020)
Cosmétiques - Méthodes d’essai de protection solaire - Pourcentage de résistance à
l’eau (ISO 18861:2020)
Ta slovenski standard je istoveten z: EN ISO 18861:2021
ICS:
71.100.70 Kozmetika. Toaletni Cosmetics. Toiletries
pripomočki
SIST EN ISO 18861:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 18861:2022
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SIST EN ISO 18861:2022
EN ISO 18861
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2021
EUROPÄISCHE NORM
ICS 71.100.70
English Version
Cosmetics - Sun protection test methods - Percentage of
water resistance (ISO 18861:2020)
Cosmétiques - Méthodes d'essai de protection solaire - Kosmetische Mittel - Untersuchungsverfahren für
Pourcentage de résistance à l'eau (ISO 18861:2020) Sonnenschutzmittel - Prozentualer Anteil der
Wasserbeständigkeit (ISO 18861:2020)
This European Standard was approved by CEN on 5 December 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 18861:2021 E
worldwide for CEN national Members.
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SIST EN ISO 18861:2022
EN ISO 18861:2021 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 18861:2022
EN ISO 18861:2021 (E)
European foreword
The text of ISO 18861:2020 has been prepared by Technical Committee ISO/TC 217 "Cosmetics” of the
International Organization for Standardization (ISO) and has been taken over as EN ISO 18861:2021 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 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.
Any feedback and questions on this document should be directed to the users’ national standards body.
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 18861:2020 has been approved by CEN as EN ISO 18861:2021 without any modification.
3
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SIST EN ISO 18861:2022
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SIST EN ISO 18861:2022
INTERNATIONAL ISO
STANDARD 18861
First edition
2020-09
Cosmetics — Sun protection test
methods — Percentage of water
resistance
Cosmétiques — Méthodes d’essai de protection solaire — Pourcentage
de résistance à l’eau
Reference number
ISO 18861:2020(E)
©
ISO 2020
---------------------- Page: 7 ----------------------
SIST EN ISO 18861:2022
ISO 18861:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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 2020 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 18861:2022
ISO 18861:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Test method . 2
4.1 Outline of the method . 2
4.2 Test subject selection. 2
4.3 Test area . 2
4.4 Product application . 2
4.5 Water immersion procedure . 2
4.6 Reference water resistant sun product . 3
4.7 Determination of the minimum erythemal dose (MED) . 3
4.8 Number of test subjects . 3
4.9 Test chronology . 3
5 Calculations and data handling . 3
5.1 General . 3
5.2 SPF before immersion. 3
5.3 SPF after immersion . 4
5.4 Individual percentage of water resistance . 4
5.5 Mean percentage of water resistance . 4
5.6 Calculation of lower confidence limit on the mean percentage of water resistance . 4
5.7 Acceptance criteria for reference product P2 . 5
6 Test report . 5
Annex A (normative) Simulated swim test device design . 6
Annex B (normative) Test procedure and chronology . 7
Annex C (normative) Standard reference sunscreen .10
Bibliography .11
© ISO 2020 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 18861:2022
ISO 18861:2020(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.
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.
iv © ISO 2020 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 18861:2022
ISO 18861:2020(E)
Introduction
The protection which cosmetic products containing organic or inorganic sunscreens provide against
sunburn is neither absolute nor permanent.
One of the many factors that can have an effect on the level of protection given by these products is
water contact. UV absorbers in the formulation can leach out or be physically removed by the washing
action in the sea or swimming pool.
In order to make the sun products more effective, manufacturers have developed formulations which
are more substantive to the skin during water immersion. These products have been variously labelled
as water resistant or very water resistant.
In order to substantiate these product efficacy claims, a number of methods has been developed and
published: including a method promulgated in the United States of America FDA monograph on OTC
sunscreen drug products (Federal Register/ Vol. 58, No 90). Standard methods have also been published
in Australia/New Zealand (AS/NZS 2640) and in the Republic of South Africa (SABS 1557).
The method for conditions required for water resistance SPF test exists as an International Standard,
i.e. ISO 16217, and requires a sun protection factor to be measured following a defined water immersion
procedure.
This document describes the procedure for water resistant percentage calculation, based on water
immersion procedure described in ISO 16217, which is the ratio between before and after bath SPF.
The SPF measurement procedure is that described by ISO 24444.
All references to the sun protection factor (SPF) test method herein, relate to ISO 24444.
The reader should ensure that the latest version of ISO 24444 sun protection factor (SPF) test method
is followed.
© ISO 2020 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST EN ISO 18861:2022
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SIST EN ISO 18861:2022
INTERNATIONAL STANDARD ISO 18861:2020(E)
Cosmetics — Sun protection test methods — Percentage of
water resistance
1 Scope
This document specifies a procedure for evaluating the water resistance retention percentage, by
comparing the sun protection factor (SPF) before water immersion (hereafter referred to as the “static”
SPF) and after a fixed period of water immersion (hereafter referred to as the “wet” SPF).
2 Normative references
The following document is 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 16217:2020, Cosmetics — Sun protection test methods — Water immersion procedure for determining
water resistance
ISO 24444:2019, 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 http:// www .electropedia .org/
3.1
simulated swim test device
spa, whirlpool or similar device designed for water immersion
[SOURCE: ISO 16217:2020, 3.1]
3.2
standardized water
water for use in the simulated swim test device (3.1)
3.3
static sun protection factor
static SPF
SPF
is
SPF without water
...
SLOVENSKI STANDARD
oSIST prEN ISO 18861:2021
01-september-2021
Kozmetika - Metode za preskušanje zaščite pred soncem - Odstotek
vodoodpornosti (ISO 18861:2020)
Cosmetics - Sun protection test methods - Percentage of water resistance (ISO
18861:2020)
Kosmetische Mittel - Untersuchungsverfahren für Sonnenschutzmittel - Prozentualer
Anteil der Wasserbeständigkeit (ISO 18861:2020)
Cosmétiques - Méthodes d’essai de protection solaire - Pourcentage de résistance à
l’eau (ISO 18861:2020)
Ta slovenski standard je istoveten z: prEN ISO 18861
ICS:
71.100.70 Kozmetika. Toaletni Cosmetics. Toiletries
pripomočki
oSIST prEN ISO 18861:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 18861:2021
---------------------- Page: 2 ----------------------
oSIST prEN ISO 18861:2021
INTERNATIONAL ISO
STANDARD 18861
First edition
2020-09
Cosmetics — Sun protection test
methods — Percentage of water
resistance
Cosmétiques — Méthodes d’essai de protection solaire — Pourcentage
de résistance à l’eau
Reference number
ISO 18861:2020(E)
©
ISO 2020
---------------------- Page: 3 ----------------------
oSIST prEN ISO 18861:2021
ISO 18861:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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 2020 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 18861:2021
ISO 18861:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Test method . 2
4.1 Outline of the method . 2
4.2 Test subject selection. 2
4.3 Test area . 2
4.4 Product application . 2
4.5 Water immersion procedure . 2
4.6 Reference water resistant sun product . 3
4.7 Determination of the minimum erythemal dose (MED) . 3
4.8 Number of test subjects . 3
4.9 Test chronology . 3
5 Calculations and data handling . 3
5.1 General . 3
5.2 SPF before immersion. 3
5.3 SPF after immersion . 4
5.4 Individual percentage of water resistance . 4
5.5 Mean percentage of water resistance . 4
5.6 Calculation of lower confidence limit on the mean percentage of water resistance . 4
5.7 Acceptance criteria for reference product P2 . 5
6 Test report . 5
Annex A (normative) Simulated swim test device design . 6
Annex B (normative) Test procedure and chronology . 7
Annex C (normative) Standard reference sunscreen .10
Bibliography .11
© ISO 2020 – All rights reserved iii
---------------------- Page: 5 ----------------------
oSIST prEN ISO 18861:2021
ISO 18861:2020(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.
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.
iv © ISO 2020 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 18861:2021
ISO 18861:2020(E)
Introduction
The protection which cosmetic products containing organic or inorganic sunscreens provide against
sunburn is neither absolute nor permanent.
One of the many factors that can have an effect on the level of protection given by these products is
water contact. UV absorbers in the formulation can leach out or be physically removed by the washing
action in the sea or swimming pool.
In order to make the sun products more effective, manufacturers have developed formulations which
are more substantive to the skin during water immersion. These products have been variously labelled
as water resistant or very water resistant.
In order to substantiate these product efficacy claims, a number of methods has been developed and
published: including a method promulgated in the United States of America FDA monograph on OTC
sunscreen drug products (Federal Register/ Vol. 58, No 90). Standard methods have also been published
in Australia/New Zealand (AS/NZS 2640) and in the Republic of South Africa (SABS 1557).
The method for conditions required for water resistance SPF test exists as an International Standard,
i.e. ISO 16217, and requires a sun protection factor to be measured following a defined water immersion
procedure.
This document describes the procedure for water resistant percentage calculation, based on water
immersion procedure described in ISO 16217, which is the ratio between before and after bath SPF.
The SPF measurement procedure is that described by ISO 24444.
All references to the sun protection factor (SPF) test method herein, relate to ISO 24444.
The reader should ensure that the latest version of ISO 24444 sun protection factor (SPF) test method
is followed.
© ISO 2020 – All rights reserved v
---------------------- Page: 7 ----------------------
oSIST prEN ISO 18861:2021
---------------------- Page: 8 ----------------------
oSIST prEN ISO 18861:2021
INTERNATIONAL STANDARD ISO 18861:2020(E)
Cosmetics — Sun protection test methods — Percentage of
water resistance
1 Scope
This document specifies a procedure for evaluating the water resistance retention percentage, by
comparing the sun protection factor (SPF) before water immersion (hereafter referred to as the “static”
SPF) and after a fixed period of water immersion (hereafter referred to as the “wet” SPF).
2 Normative references
The following document is 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 16217:2020, Cosmetics — Sun protection test methods — Water immersion procedure for determining
water resistance
ISO 24444:2019, 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 http:// www .electropedia .org/
3.1
simulated swim test device
spa, whirlpool or similar device designed for water immersion
[SOURCE: ISO 16217:2020, 3.1]
3.2
standardized water
water for use in the simulated swim test device (3.1)
3.3
static sun protection factor
static SPF
SPF
is
SPF without water resistance challenge
3.4
SPF before water immersion
arithmetic mean of all valid SPF (3.3) values for the study, expressed to one decimal by truncation
is
© ISO 2020 – All rights reserved 1
---------------------- Page: 9 ----------------------
oSIST prEN ISO 18861:2021
ISO 18861:2020(E)
3.5
individual water resistance sun protection factor
individual water resistance SPF
SPF
iwr
SPF determined after the water immersion step on each subject
3.6
SPF post water immersion
arithmetic mean of all valid SPF (3.5) values for the study, expressed to one decimal by truncation
iwr
4 Test method
4.1 Outline of the method
The principle is to compare the sun protection factor (SPF) for a sunscreen product after a period of
immersion in water with the static SPF without immersion in water.
4.2 Test subject selection
Participants are enrolled for the study in accordance with the criteria described in ISO 24444. At least
10 subjects shall be selected.
[1]
The Declaration of Helsinki is relevant to testing using human subjects. Informed, written (signature)
consent shall be obtained from all test subjects. The consent should include specific consent to
participate in water resistance testing including length of time — temperature of the water — likelihood
of becoming chilled during testing.
4.3 Test area
As per the requirements of ISO 24444, the individual product test sites and the unprotected test site
shall be delineated within the region between the scapula line and the waist. Additionally, the test sites
shall be configured such that they will be fully immersed when the test subject is located comfortably
in the simulated swim test device. Test product application to test sites should be randomized on each
individual subject and over the whole test panel, as described in ISO 24444.
4.4 Product application
The product shall be applied according to the procedure set out in ISO 24444.
4.5 Water immersion procedure
The static SPF (SPF ) is determined in accordance with the ISO 24444.
is
To determine th
...
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