SIST EN ISO 16217:2022

Cosmetics - Sun protection test methods - Water immersion procedure for determining water resistance (ISO 16217:2020)

This document specifies a procedure of water immersion for the in vivo determination of the water resistance of sunscreen products.
This document is applicable to products intended to be placed in contact with human skin including any component able to absorb, reflect or scatter UV rays and which, in addition, are designed to be less readily removed from the skin by water and/or during water immersion. It is intended to be read in conjunction with ISO 24444.

Kosmetische Mittel - Untersuchungsverfahren für Sonnnenschutzmittel - Wasserimmersionsverfahren zur Bestimmung der Wasserbeständigkeit (ISO 16217:2020)

Dieses Dokument legt ein Verfahren für das Eintauchen in Wasser für die In-vivo-Bestimmung der Wasserbeständigkeit von Sonnenschutzmitteln fest.
Dieses Dokument ist anwendbar auf Sonnenschutzmittel, einschließlich aller Bestandteile, die UV-Strahlung absorbieren, reflektieren oder streuen können, die dafür vorgesehen sind, mit der menschlichen Haut in Kontakt zu kommen und schwerer durch Wasser und/oder während des Eintauchens in Wasser von der Haut entfernt zu werden. Es ist dafür vorgesehen, in Zusammenhang mit ISO 24444 gelesen zu werden.

Cosmétiques - Méthodes d'essai de protection solaire - Mode opératoire d’immersion dans l’eau pour la détermination de la résistance à l'eau (ISO 16217:2020)

Le présent document spécifie un mode opératoire d'immersion dans l'eau utilisé pour la détermination in vivo de la résistance à l'eau des produits solaires.
Le présent document est applicable aux produits destinés à être mis en contact avec la peau humaine, y compris tout composant pouvant absorber, réfléchir ou diffuser les rayons UV, et qui sont en outre conçus pour être moins faciles à éliminer de la peau sous l'action de l'eau et/ou pendant l'immersion dans l'eau. Il est destiné à être lu conjointement avec l'ISO 24444.

Kozmetika - Metode za preskušanje zaščite pred soncem - Postopek s potopitvijo v vodo za določanje vodoodpornosti (ISO 16217:2020)

Ta dokument določa postopek potopitve v vodo za določevanje vodoodpornosti in vivo sredstev za zaščito kože pred soncem.
Ta dokument se uporablja za izdelke, namenjene nanosu na človeško kožo, vključno s katero koli komponento, ki lahko vpija, odbija ali razprši ultravijolične žarke, in ki so poleg tega zasnovani tako, da jih je težje odstraniti s kože z vodo in/ali med potopitvijo v vodo. Uporabljati ga je treba v povezavi s standardom ISO 24444.

General Information

• Status: Published
• Public Enquiry End Date: 01-Oct-2021
• Publication Date: 15-Jun-2022
• ICS: 71.100.70 - Cosmetics. Toiletries
• Technical Committee: KDS - Cosmetics, chemical disinfectants and surface active agents
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 21-Apr-2022
• Due Date: 26-Jun-2022
• Completion Date: 16-Jun-2022
• Ref Project: EN ISO 16217:2021 - Cosmetics - Sun protection test methods - Water immersion procedure for determining water resistance (ISO 16217:2020)

Overview

EN ISO 16217:2021 - Cosmetics: Sun protection test methods - Water immersion procedure for determining water resistance (ISO 16217:2020) is a CEN-adopted European version of the ISO standard that defines an in vivo water immersion procedure to determine the water resistance of sunscreen products. It applies to topical products and any component intended to absorb, reflect or scatter UV radiation and formulated to resist removal by water. The standard is intended to be read in conjunction with ISO 24444 (in vivo determination of SPF).

Key topics and requirements

• Scope: Specifies an in vivo water immersion challenge inserted into the ISO 24444 SPF test sequence for products designed to be water‑resistant.
• Test sequence: Sunscreen application → dry‑down (per ISO 24444) → water immersion in a simulated swim device → drying → UV exposure and SPF measurement using ISO 24444 procedures.
• Test subjects: Human volunteers enrolled per ISO 24444 criteria; minimum 10 subjects for water resistance studies. Informed written consent specific to water immersion testing is required.
• SPF metrics defined:
  • Individual water resistance SPF (SPFiwr): SPF measured on each subject after immersion.
  • Post‑water immersion SPF: Arithmetic mean of valid individual water resistance SPF values (expressed to one decimal by truncation).
  • Water resistance SPF (SPFwr): Group mean of SPFiwr values.
• Apparatus and annexes: Includes normative annexes covering a simulated swim test device design (Annex A), standardized water requirements (Annex B), a standard reference sunscreen (Annex C), and product positioning on subjects (Annex D).
• Validation and statistics: Clauses address procedural validation, calculation methods, and statistical criteria for reporting water resistance SPF (see Clause 8).

Applications

• Claim substantiation: Provide robust, standardized evidence for “water‑resistant” or “very water‑resistant” sunscreen claims.
• Product development: Compare formulations and optimize water‑resistant properties during R&D.
• Quality control and regulatory compliance: Support labeling and compliance with national/regional cosmetic regulations and industry best practices.
• Independent test laboratories: Standardizes in vivo protocols to produce reproducible, comparable results across labs.

Who should use this standard

• Cosmetic manufacturers and formulators targeting water‑resistant sunscreen claims
• Contract testing laboratories and clinical testing facilities
• Regulatory affairs and compliance teams verifying labeling claims
• Product development and quality assurance teams assessing SPF performance after water exposure

Related standards

• ISO 24444:2019 - Cosmetics - Sun protection test methods - In vivo determination of the sun protection factor (mandatory companion standard for SPF measurement)

Keywords: EN ISO 16217:2021, ISO 16217:2020, water resistance, sunscreen testing, water immersion procedure, sun protection test methods, SPF, ISO 24444, simulated swim test device.

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2022
Kozmetika - Metode za preskušanje zaščite pred soncem - Postopek s potopitvijo
v vodo za določanje vodoodpornosti (ISO 16217:2020)
Cosmetics - Sun protection test methods - Water immersion procedure for determining
water resistance (ISO 16217:2020)
Kosmetische Mittel - Untersuchungsverfahren für Sonnnenschutzmittel -
Wasserimmersionsverfahren zur Bestimmung der Wasserbeständigkeit (ISO
16217:2020)
Cosmétiques - Méthodes d'essai de protection solaire - Mode opératoire d’immersion
dans l’eau pour la détermination de la résistance à l'eau (ISO 16217:2020)
Ta slovenski standard je istoveten z: EN ISO 16217:2021
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 16217
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2021
EUROPÄISCHE NORM
ICS 71.100.70
English Version
Cosmetics - Sun protection test methods - Water
immersion procedure for determining water resistance
(ISO 16217:2020)
Cosmétiques - Méthodes d'essai de protection solaire - Kosmetische Mittel - Untersuchungsverfahren für
Mode opératoire d'immersion dans l'eau pour la Sonnenschutzmittel - Wasserimmersionsverfahren zur
détermination de la résistance à l'eau (ISO Bestimmung der Wasserbeständigkeit (ISO
16217:2020) 16217:2020)
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 16217:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 16217:2020 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 16217:2021 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 16217:2020 has been approved by CEN as EN ISO 16217:2021 without any modification.

INTERNATIONAL ISO
STANDARD 16217
First edition
2020-05
Cosmetics — Sun protection test
methods — Water immersion
procedure for determining water
resistance
Cosmétiques — Méthodes d'essai de protection solaire — Mode
opératoire d’immersion dans l’eau pour la détermination de la
résistance à l'eau
Reference number
ISO 16217:2020(E)
©
ISO 2020
ISO 16217:2020(E)
© 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: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

ISO 16217:2020(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 2
4.1 Main steps . 2
4.2 General principle . 2
5 Test criteria . 2
5.1 Selection of the test subjects . 2
5.2 Test area . 3
5.3 Product application . 3
6 Water immersion procedure . 3
6.1 Room conditions . 3
6.2 Water quality . 3
6.3 Immersion sequencing cycle . 3
6.4 Positioning of test subjects . 3
6.5 Drying after immersion . 4
6.6 Reversion to ISO 24444 procedure . 4
7 Water quality and condition . 4
8 Procedural validation . 4
8.1 General . 4
8.2 Calculation of the individual water resistance SPF (SPF ). 4
iwr
8.3 Calculation of the water resistance SPF (SPF ) . 5
wr
8.4 Statistical criterion . 5
9 Test report — post-water immersion SPF . 5
Annex A (normative) Simulated swim test device design . 6
Annex B (normative) Standardized water requirements . 7
Annex C (normative) Standard reference sunscreen . 8
Annex D (normative) Product positioning on test subjects . 9
Bibliography .10
ISO 16217:2020(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
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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

INTERNATIONAL STANDARD ISO 16217:2020(E)
Cosmetics — Sun protection test methods — Water
immersion procedure for determining water resistance
1 Scope
This document specifies a procedure of water immersion for the in vivo determination of the water
resistance of sunscreen products.
This document is applicable to products intended to be placed in contact with human skin including
any component able to absorb, reflect or scatter UV rays and which, in addition, are designed to be less
readily removed from the skin by water and/or during water immersion. It is i
...