Cosmetics - Determination of sunscreen UVA photoprotection in vitro - Amendment 1 (ISO 24443:2021/FDAM 1:2025)

Kosmetische Mittel - In-vitro-Bestimmung des UVA-Schutzes von Sonnenschutzmitteln - Änderung 1 (ISO 24443:2021/FDAM 1:2025)

Cosmétiques - Détermination in vitro de la photoprotection des produits de protection solaire aux UVA - Amendement 1 (ISO 24443:2021/FDAM 1:2025)

Kozmetika - Določanje zaščitnega faktorja UVA in vitro - Dopolnilo A1 (ISO 24443:2021/FDAM 1:2025)

General Information

Status
Not Published
Publication Date
15-Apr-2026
Technical Committee
CEN/TC 392 - Cosmetics
Drafting Committee
CEN/TC 392 - Cosmetics
Current Stage
5020 - Submission to Vote - Formal Approval
Start Date
20-Nov-2025
Completion Date
20-Nov-2025

Relations

Effective Date
25-Dec-2024

Overview

EN ISO 24443:2021/FprA1 is an amendment to ISO 24443:2021 prepared under ISO/TC 217 (Cosmetics) in collaboration with CEN. The document refines the in‑vitro method for determination of sunscreen UVA photoprotection, with specific changes to substrate preparation, temperature control, spreading procedures and plate surface parameters. The amendment is circulated as a draft (ISO 24443:2021/DAM 1:2025) and clarifies operational steps to improve repeatability and laboratory reproducibility.

Key Topics

  • Substrate / plate preparation

    • Use rough‑side uppermost PMMA plates with application area ≥ 16 cm².
    • Products and plates should be handled in the dark; product storage recommended between 27 (±2 °C) and 32 (±2 °C) for at least 12 hours before testing.
    • Sandblasted plate surfaces should be cleaned with a dry, antistatic microfibre cloth and handled by the edges; avoid finger contact and use a reference mark to keep measurement order and direction consistent.
    • Plates are to be used once and without additional surface treatment.
  • Application and spreading

    • Application rates: 1.3 mg/cm² (±1.6%) for moulded plates and 1.2 mg/cm² (±1.5%) for sandblasted plates.
    • Dose accuracy via mass loss of pipette or volumetric measures (positive‑displacement automatic pipette recommended).
    • Deposit as at least twelve small droplets, weighing plates after application for non‑volatile products; deposit and weighing should not exceed 30 s.
    • Spreading is a two‑phase process (circular passes then alternating horizontal/vertical strokes) with defined numbers of passes and timings (~30 s second phase; adapted timings for alcoholic or oil products).
    • If using a fingertip, do not use finger cots; if using an automated mechanical fingertip, follow specific finger‑cot saturation, inspection and replacement steps.
  • Drying and exposure conditions

    • Treated samples should dry 30–60 min in the dark at the same temperature as UV exposure conditions (e.g., 27 °C or 30 °C ±2 °C).
    • Spray products in pressurised containers must be degassed and left 24 h at room temperature before sampling.
  • Plate surface parameters updated

    • The Rdq value for sandblasted PMMA plate is revised to 12,0 ± 2,5.
    • Other surface metrics (Ra, Rv, A1, Ssc, Vvv) are specified in Annex D.

Applications

This amendment is directly relevant to: manufacturers of sunscreens, independent testing laboratories, regulatory bodies assessing UVA photoprotection, and R&D teams validating in‑vitro test methods. The clarified procedures help improve measurement consistency, reduce variability and support robust product claims for UVA protection.

Related Standards

  • ISO 24443:2021 - Cosmetics - Determination of sunscreen UVA photoprotection in vitro.
  • EN ISO 24443:2021/prA1 - CEN parallel document and national adoptions (e.g., SIST EN ISO 24443:2022/oprA1:2025).

For implementation questions or patent declarations, refer to the ISO draft notice and contact your national standards body or the ISO copyright office.

Draft

EN ISO 24443:2022/oprA1:2025

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Frequently Asked Questions

EN ISO 24443:2021/FprA1 is a draft published by the European Committee for Standardization (CEN). Its full title is "Cosmetics - Determination of sunscreen UVA photoprotection in vitro - Amendment 1 (ISO 24443:2021/FDAM 1:2025)". This standard covers: Cosmetics - Determination of sunscreen UVA photoprotection in vitro - Amendment 1 (ISO 24443:2021/FDAM 1:2025)

Cosmetics - Determination of sunscreen UVA photoprotection in vitro - Amendment 1 (ISO 24443:2021/FDAM 1:2025)

EN ISO 24443:2021/FprA1 is classified under the following ICS (International Classification for Standards) categories: 11.100.10 - In vitro diagnostic test systems; 71.100.70 - Cosmetics. Toiletries. The ICS classification helps identify the subject area and facilitates finding related standards.

EN ISO 24443:2021/FprA1 has the following relationships with other standards: It is inter standard links to EN ISO 24443:2021. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN ISO 24443:2021/FprA1 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)


SLOVENSKI STANDARD
SIST EN ISO 24443:2022/oprA1:2025
01-junij-2025
Kozmetika - Določevanje zaščitnega faktorja UVA in vitro - Dopolnilo A1 (ISO
24443:2021/DAM 1:2025)
Cosmetics - Determination of sunscreen UVA photoprotection in vitro - Amendment 1
(ISO 24443:2021/DAM 1:2025)
Kosmetische Mittel - In-vitro-Bestimmung des UVA-Schutzes von Sonnenschutzmitteln -
Änderung 1 (ISO 24443:2021/DAM 1:2025)
Cosmétiques - Détermination in vitro de la photoprotection des produits de protection
solaire aux UVA - Amendement 1 (ISO 24443:2021/DAM 1:2025)
Ta slovenski standard je istoveten z: EN ISO 24443:2021/prA1
ICS:
71.100.70 Kozmetika. Toaletni Cosmetics. Toiletries
pripomočki
SIST EN ISO 24443:2022/oprA1:2025 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

SIST EN ISO 24443:2022/oprA1:2025

SIST EN ISO 24443:2022/oprA1:2025
DRAFT
Amendment
ISO 24443:2021/
DAM 1
ISO/TC 217
Cosmetics — Determination of
Secretariat: INSO
sunscreen UVA photoprotection in
vitro
Voting begins on:
2025-05-05
AMENDMENT 1
Voting terminates on:
2025-07-28
Cosmétiques — Détermination in vitro de la photoprotection UVA
AMENDEMENT 1
ICS: 71.100.70
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
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.
Reference number
ISO 24443:2021/DAM 1:2025(en)
SIST EN ISO 24443:2022/oprA1:2025
DRAFT
ISO 24443:2021/DAM 1:2025(en)
Amendment
ISO 24443:2021/
DAM 1
ISO/TC 217
Cosmetics — Determination of
Secretariat: INSO
sunscreen UVA photoprotection
in vitro
Voting begins on:
AMENDMENT 1
Voting terminates on:
Cosmétiques — Détermination in vitro de la photoprotection UVA
AMENDEMENT 1
ICS: 71.100.70
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO 24443:2021/DAM 1:2025(en)
ii
SIST EN ISO 24443:2022/oprA1:2025
ISO 24443:2021/DAM 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 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 second edition (ISO 24443:2021), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— The temperature range has been clarified and revised,
— The plate use has been revised,
— The mechanical spreading has been clarified,
— The Rdq parameter of the sandblasted PMMA plate has been revised.
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
SIST EN ISO 24443:2022/oprA1:2025

SIST EN ISO 24443:2022/oprA1:2025
ISO 24443:2021/DAM 1:2025(en)
Cosmetics — Determination of sunscreen UVA
photoprotection in vitro
AMENDMENT 1
Page 5, section 5.6
Add the phrase “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.”.
Add the phrase “The surface of sandblasted plates should be cleaned with a dry, antistatic microfibre cloth.”.
Add the phrase “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.”
5.6 Substrate/plate
The substrate/plate is the material to which the test product is to be applied. For this method, PMMA
plates with one rough side of the substrate shall be used and are commercially available. The size of the
substrate should be chosen such that the application area is not less than 16 cm².
The specifications and preparation of this type of plate[17][18] are described in Annex D.
Product should be stored, in the dark, between 27 (±2 °C) and 32
...

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