ISO 24443:2021/FDAmd 1
(Amendment)Cosmetics — Determination of sunscreen UVA photoprotection in vitro — Amendment 1
Cosmetics — Determination of sunscreen UVA photoprotection in vitro — Amendment 1
Cosmétiques — Détermination in vitro de la photoprotection des produits de protection solaire aux UVA — Amendement 1
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Standards Content (Sample)
FINAL DRAFT
Amendment
ISO 24443:2021/
FDAM 1
ISO/TC 217
Cosmetics — Determination of
Secretariat: INSO
sunscreen UVA photoprotection in
Voting begins on:
vitro
2025-11-20
AMENDMENT 1
Voting terminates on:
2026-01-15
Cosmétiques — Détermination in vitro de la photoprotection des
produits de protection solaire aux UVA
AMENDEMENT 1
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 SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO 24443:2021/FDAM 1:2025(en) © ISO 2025
FINAL DRAFT
ISO 24443:2021/FDAM 1:2025(en)
Amendment
ISO 24443:2021/
FDAM 1
ISO/TC 217
Cosmetics — Determination of
Secretariat: INSO
sunscreen UVA photoprotection
Voting begins on:
in vitro
AMENDMENT 1
Voting terminates on:
Cosmétiques — Détermination in vitro de la photoprotection des
produits de protection solaire aux UVA
AMENDEMENT 1
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 SUPPOR TING DOCUMENTATION.
© ISO 2025
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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 Reference number
ISO 24443:2021/FDAM 1:2025(en) © ISO 2025
ii
ISO 24443:2021/FDAM 1:2025(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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).
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.
iii
ISO 24443:2021/FDAM 1:2025(en)
Cosmetics — Determination of sunscreen UVA
photoprotection in vitro
AMENDMENT 1
5.6
Add the following text at the end of the subclause:
The product should be stored, in the dark, between (27 ±2) °C and (32 ±2) °C for at least twelve hours
before the start of the test.
The surface of sandblasted plates should be cleaned with a dry, antistatic microfibre cloth.
The plates should be handled carefully by holding them by the edges, avoiding finger contact with the
surface. A reference mark should be made on each plate to ensure the whole measurement process
proceeds in the same order and direction each time. The plates shall be used without additional
treatment on surface (chemical and/or physical). The plates shall be used only once.
5.7
Add a new clause 5.7 “Robot”:
5.7 Robot
5.7.1 General
The robot shall be in accordance with Annex H and shall have:
a) positional repeatability of at least ±0,1 mm in x, y and z axes,
b) degrees of freedom equal to at least 6 rotating joints,
c) a payload of at least 0,5 kg,
d) a vertical force (z axis), measured in the centre of the plate (with the finger tool and finger cot,
without X and y axis movement), of (6,0 ± 0,5) N.
The robotic appliance shall be checked by a suitably qualified expert at regular intervals (at least every
twelve months) to ensure conformance to the mechanical and spreading specifications given in 5.7.3.
The finger tool shall be replaced after every cycle of 400 spreading operations or when damaged (e.g.
cracks, etc.).
5.7.2 Specifications
The robot shall be in accordance with Annex H and shall have:
ISO 24443:2021/FDAM 1:2025(en)
a) positional repeatability of at least ±0,1 mm in x, y and z axes,
b) degrees of freedom equal to at least 6 rotating joints,
c) a payload of at least 0,5 kg,
d) a vertical force (z axis), measured in the centre of the plate (with the finger tool and finger cot, with-
out x and y axis movement), of (6,0 ± 0,5) N.
5.7.3 Monitoring
The robotic appliance shall be checked by a suitably qualified expert at regular intervals (at least every
twelve months) to ensure conformance to the mechanical and spreading specifications given in 5.7.3.
The finger tool shall be replaced after every cycle of 400 spreading operations or when damaged (e.g.
cracks, etc.).
6.4
Reorganise the clause into four subclauses:
6.4 Sample application
6.4.1 Preparation
Before application of the product, the temperatu
...
ISO 24443:2021/DAMFDAmd 1:2025(en)
AMENDMENT 1
ISO/TC 217/WG 7
Secretariat: INSO
Date: 2025-07-1411-06
Cosmetics — Determination of sunscreen UVA photoprotection in
vitro
AMENDMENT 1
Cosmétiques — Détermination in vitro de la photoprotection des produits de protection solaire aux UVA
AMENDEMENT 1
FDIS stage
ISO 24443:2021/Amd1:2025FDAmd 1(en)
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'sISO’s member body in the country of the requester.
ISO Copyright Officecopyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
Email: copyright@iso.org
E-mail: copyright@iso.org
Website: www.iso.orgwww.iso.org
Published in Switzerland.
ii © ISO 2025 – All rights reserved
ii
ISO 24443:2021/DAMFDAmd 1:2025(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents.www.iso.org/patents. ISO shall not be held responsible for identifying any or all such
patent rights.
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.htmlwww.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).
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.
© ISO 2025 – All rights reserved
iii
ISO 24443:2021/DAM 1:2025(en)
Cosmetics — Determination of sunscreen UVA photoprotection in
vitro — Amendment
AMENDMENT 1
5.6
Add the following text at the end of the subclause:
ProductThe product should be stored, in the dark, between (27 (± ±2) °C) and (32 (± ±2) °C) for at least
twelve hours before the start of the test.
The surface of sandblasted plates should be cleaned with a dry, antistatic microfibre cloth.
The plates should be handled carefully by holding them by the edges, avoiding finger contact with the
surface. A reference mark should be made on each plate to ensure the whole measurement process
proceeds in the same order and direction each time. The plates shall be used without additional treatment
on surface (chemical and/or physical). The plates shall be used only once.
5.7
Add a new clause 5.7 “Robot”:
5.7 Robot
5.7.1 General
The robot shall be in accordance with Annex F H and shall have:
a) positional repeatability of at least ±0,1 mm in x, y and z axes,
b) degrees of freedom equal to at least 6 rotating joints,
c) a payload of at least 0,5 kg,
d) a vertical force (z axis), measured in the centre of the plate (with the finger tool and finger cot, without
X and y axis movement), of (6,0 ± ± 0,5) N.
The robotic appliance shall be checked by a suitably qualified expert at regular intervals (at least every
twelve months) to ensure complianceconformance to the mechanical and spreading specifications given
in 5.7.23. The finger tool shall be replaced after every cycle of 400 spreading operations or when damaged
(e.g. cracks, etc.).
5.7.1 2 Specifications
The robot shall be in accordance with Annex F H and shall have:
a) positional repeatability of at least ±0,1 mm in x, y and z axes,
ISO 24443:2021/Amd1:2025(EFDAmd 1(en)
b) degrees of freedom equal to at least 6 rotating joints,
c) a payload of at least 0,5 kg,
d) a vertical force (z axis), measured in the centre of the plate (with the finger tool and finger cot, without
x and y axis movement), of (6,0 ± 0,5) N.
a) positional repeatability of at least ±0,1 mm in x, y and z axes,
b) degrees of freedom equal to at least 6 rotating joints,
c) a payload of at least 0,5 kg,
d) a vertical force (z axis), measured in the centre of the plate (with the finger tool and finger cot,
without x and y axis movement), of (6,0 ± 0,5) N.
5.7.2 3 Monitoring
The robotic appliance shall be checked by a suitably qualified expert at regular intervals (at least every
twelve months) to ensure complianceconformance to the mechanical and spreading specifications given
in 5.7.23. The finger tool shall be replaced after every cycle of 400 spreading operations or when damaged
(e.g. cracks, etc.).
6.4
Reorganise the clause into four subclauses:
6.4 Sample application
6.4.1 Preparation
Before application of the product, the temperature of the surface of the plate should be between (27
(± ±2) °C) and (32 (± ±2) °C) and should be the same during the different steps of the process implying
at least the weighing, the product application, the spreading, the drying and the UV exposure steps.
The sunscreen product is applied to a new untreated roughened PMMA plate (with the roughened side
2 2
uppermost) by mass, at an application rate of 1,3 mg/cm (±1,6 %) for moulded plates and 1,2 mg/cm
(±1,5 %) for sandblasted plates.
To ensure dose accuracy and repeatability, the application area should be not less than 16 cm .
The application dose may be determined by measuring the mass loss of the pipette before and after
application of the product; alternatively, it may be applied based on volumetric measurements with
consideration of th
...
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