EN ISO 24444:2020/A1:2022

Cosmetics - Sun protection test methods - In vivo determination of the sun protection factor (SPF) - Amendment 1 (ISO 24444:2019/Amd 1:2022)

Kosmetische Mittel - Untersuchungsverfahren für Sonnenschutzmittel - In-vivo-Bestimmung des Sonnenschutzfaktors (SSF) - Änderung 1 (ISO 24444:2019/Amd 1:2022)

No scope available

Cosmétiques - Méthodes d'essai de protection solaire - Détermination in vivo du facteur de protection solaire (FPS) - Amendement 1 (ISO 24444:2019/Amd 1:2022)

Kozmetika - Metode za preskušanje zaščite pred soncem - Določevanje faktorja zaščite pred soncem (SPF) in vivo - Dopolnilo A1 (ISO 24444:2019/Amd 1:2022)

General Information

• Status: Published
• Publication Date: 29-Mar-2022
• Withdrawal Date: 29-Sep-2022
• ICS: 71.100.70 - Cosmetics. Toiletries
• Technical Committee: CEN/TC 392 - Cosmetics
• Drafting Committee: CEN/TC 392 - Cosmetics
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 30-Mar-2022
• Completion Date: 30-Mar-2022
• Ref Project: SIST EN ISO 24444:2020/A1:2022 - Cosmetics - Sun protection test methods - In vivo determination of the sun protection factor (SPF) - Amendment 1 (ISO 24444:2019/Amd 1:2022)

Relations

• Amends: EN ISO 24444:2020 - Cosmetics - Sun protection test methods - In vivo determination of the sun protection factor (SPF) (ISO 24444:2019)
• Effective Date: 23-Dec-2020

Overview

EN ISO 24444:2020/A1:2022 is Amendment 1 to the international test method ISO 24444:2019, endorsed by CEN for use across European national standards bodies. It updates the in vivo procedure for determining the sun protection factor (SPF) of cosmetic sunscreens. The amendment was approved by CEN on 30 January 2022 and published in 2022; national adoption occurred through CEN members.

Key topics and technical requirements

This amendment introduces specific, measurable changes to the existing SPF test method. Key technical points include:

• Beam uniformity (multiple output devices)

  • The average uniformity of all beams shall be ≥ 90%, and no individual port may have uniformity < 85%.

• Reference standard selection for lower SPF claims

  • For SPF claims ≤ 24, any reference standard listed in Annex C may be used for each subject.

• Statistical acceptance criterion for test products

  • The 95% confidence interval (CI) on the mean SPF for the test product must comply with ±17% of the measured mean SPF. This statistical requirement applies only to test products (not to reference sunscreens).
  • The number of subjects is determined to meet this CI requirement (minimum 10 valid results, increased as needed up to 20 valid results).
  • Reference sunscreens must have mean values within their acceptance ranges (Annex C); no additional statistical criterion is required for them.
  • Full statistical procedure described in Annex D.

• Viscosity specification update

  • In C.5.3.3 the viscosity lower limit is changed from 16 000 to 17 000 mPas, giving a test range 17 000–19 000 mPas measured with Brookfield DVIII Ultra, Spindle RV-5 at 10 r/min.

Applications and who uses it

This amendment is essential for:

• Cosmetic manufacturers verifying and substantiating SPF labeling and marketing claims
• Contract and in-house test laboratories performing standardized in vivo SPF determinations
• Regulatory authorities and conformity assessors reviewing product compliance
• R&D and quality assurance teams optimizing sunscreen formulations and test protocols

Using the amended criteria helps ensure consistent, reproducible SPF results across labs and jurisdictions.

Related standards

• EN ISO 24444:2020 (base standard endorsed by CEN)
• ISO 24444:2019/Amd 1:2022 (original ISO amendment text)

Keywords: EN ISO 24444:2020/A1:2022, ISO 24444 amendment, in vivo SPF determination, sun protection test methods, SPF testing, sun protection factor, reference sunscreen, beam uniformity, 95% confidence interval, viscosity specification.

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2022
Kozmetika - Metode za preskušanje zaščite pred soncem - Določevanje faktorja
zaščite pred soncem (SPF) in vivo - Dopolnilo A1 (ISO 24444:2019/Amd 1:2022)
Cosmetics - Sun protection test methods - In vivo determination of the sun protection
factor (SPF) - Amendment 1 (ISO 24444:2019/Amd 1:2022)
Kosmetische Mittel - Untersuchungsverfahren für Sonnenschutzmittel - In-vivo-
Bestimmung des Sonnenschutzfaktors (SSF) - Änderung 1 (ISO 24444:2019/Amd
1:2022)
Cosmétiques - Méthodes d'essai de protection solaire - Détermination in vivo du facteur
de protection solaire (FPS) - Amendement 1 (ISO 24444:2019/Amd 1:2022)
Ta slovenski standard je istoveten z: EN ISO 24444:2020/A1:2022
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 24444:2020/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2022
EUROPÄISCHE NORM
ICS 71.100.70
English Version
Cosmetics - Sun protection test methods - In vivo
determination of the sun protection factor (SPF) -
Amendment 1 (ISO 24444:2019/Amd 1:2022)
Cosmétiques - Méthodes d'essai de protection solaire - Kosmetische Mittel - Untersuchungsverfahren für
Détermination in vivo du facteur de protection solaire Sonnenschutzmittel - In-vivo-Bestimmung des
(FPS) - Amendement 1 (ISO 24444:2019/Amd 1:2022) Sonnenschutzfaktors (SSF) - Änderung 1 (ISO
24444:2019/Amd 1:2022)
This amendment A1 modifies the European Standard EN ISO 24444:2020; it was approved by CEN on 30 January 2022.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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 24444:2020/A1:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 24444:2020/A1:2022) 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 September 2022, and conflicting national standards
shall be withdrawn at the latest by September 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/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 24444:2019/Amd 1:2022 has been approved by CEN as EN ISO 24444:2020/A1:2022
without any modification.
INTERNATIONAL ISO
STANDARD 24444
Second edition
2019-12
AMENDMENT 1
2022-03
Cosmetics — Sun protection test
methods — In vivo determination of
the sun protection factor (SPF)
AMENDMENT 1
C
...