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M/389 - Sunscreen products

Standardisation mandate assigned to CEN concerning methods for testing efficacy of suncreen products

General Information

Organization
CEN - CEN European Committee for Standardization
Status
Confirmed
Resolution Reference
CEN/BT C054/2006
Resolution Date
18-Oct-2006
Type Of Decision
(Dis-)Approval of mandate

Frequently Asked Questions

A European Standardization Mandate is a formal request from the European Commission to the European Standardization Organizations (CEN, CENELEC, and ETSI) to develop European standards (ENs) in support of EU legislation and policies. Mandates are issued under Regulation (EU) No 1025/2012 and help ensure that products and services meet the essential requirements set out in EU directives and regulations.

M/389 is a European Standardization Mandate titled "Standardisation mandate assigned to CEN concerning methods for testing efficacy of suncreen products". Standardisation mandate assigned to CEN concerning methods for testing efficacy of suncreen products There are 10 standards developed under this mandate.

Standards developed in response to a mandate and cited in the Official Journal of the European Union become "harmonized standards". Products manufactured in compliance with harmonized standards benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation, facilitating CE marking and market access across the European Economic Area.

Standardization Organization
ICS
Technical Committee
Directive
50
CEN
EN ISO 24443:2021(Main)
Cosmetics - Determination of sunscreen UVA photoprotection in vitro (ISO 24443:2021, Corrected version 2022-02)
SIST EN ISO 24443:2022

This document specifies an in vitro procedure to characterize the UVA protection of sunscreen products. Specifications are given to enable determination of the spectral absorbance characteristics of UVA protection in a reproducible manner.
In order to determine relevant UVA protection parameters, the method has been created to provide an UV spectral absorbance curve from which a number of calculations and evaluations can be undertaken. These include calculation of the Ultraviolet-A protection factor (UVA-PF) [correlating with in vivo UVA-PF from the persistent pigment darkening (PPD) testing procedure], critical wavelength and UVA absorbance proportionality. These computations are optional and relate to local sunscreen product labelling requirements. This method relies on the use of static in vivo SPF results for scaling the UV absorbance curve.
This document is not applicable to powder products such as pressed powder and loose powder products.

  • Standard
    45 pages
    English language
    e-Library read for
    1 day
SIST
SIST EN ISO 24443:2022(Main)
Cosmetics - Determination of sunscreen UVA photoprotection in vitro (ISO 24443:2021, Corrected version 2022-02)
EN ISO 24443:2021

This document specifies an in vitro procedure to characterize the UVA protection of sunscreen products. Specifications are given to enable determination of the spectral absorbance characteristics of UVA protection in a reproducible manner.
In order to determine relevant UVA protection parameters, the method has been created to provide an UV spectral absorbance curve from which a number of calculations and evaluations can be undertaken. These include calculation of the Ultraviolet-A protection factor (UVA-PF) [correlating with in vivo UVA-PF from the persistent pigment darkening (PPD) testing procedure], critical wavelength and UVA absorbance proportionality. These computations are optional and relate to local sunscreen product labelling requirements. This method relies on the use of static in vivo SPF results for scaling the UV absorbance curve.
This document is not applicable to powder products such as pressed powder and loose powder products.

  • Standard
    45 pages
    English language
    e-Library read for
    1 day
CEN
EN ISO 24444:2020(Main)
Cosmetics - Sun protection test methods - In vivo determination of the sun protection factor (SPF) (ISO 24444:2019)
SIST EN ISO 24444:2020

This document specifies a method for the in vivo determination of the sun protection factor (SPF) of sunscreen products. It is applicable to products that contain any component able to absorb, reflect or scatter ultraviolet (UV) rays and which are intended to be placed in contact with human skin.
This document provides a basis for the evaluation of sunscreen products for the protection of human skin against erythema induced by solar ultraviolet rays.

  • Standard
    69 pages
    English language
    e-Library read for
    1 day
SIST
SIST EN ISO 24444:2020(Main)
Cosmetics - Sun protection test methods - In vivo determination of the sun protection factor (SPF) (ISO 24444:2019)
EN ISO 24444:2020

This document specifies a method for the in vivo determination of the sun protection factor (SPF) of sunscreen products. It is applicable to products that contain any component able to absorb, reflect or scatter ultraviolet (UV) rays and which are intended to be placed in contact with human skin.
This document provides a basis for the evaluation of sunscreen products for the protection of human skin against erythema induced by solar ultraviolet rays.

  • Standard
    69 pages
    English language
    e-Library read for
    1 day
CEN
EN ISO 24443:2012(Main)
Determination of sunscreen UVA photoprotection in vitro (ISO 24443:2012)
SIST EN ISO 24443:2012

ISO 24443:2012 specifies an in vitro procedure to characterize the UVA protection of sunscreen products. Specifications are given to enable determination of the spectral absorbance characteristics of UVA protection in a reproducible manner.
In order to determine relevant UVA protection parameters, the method has been created to provide a UV spectral absorbance curve from which a number of calculations and evaluations can be undertaken. This method relies on the use of in vivo SPF results for scaling the UV absorbance curve.

  • Standard
    34 pages
    English language
    e-Library read for
    1 day
CEN
EN ISO 24442:2011(Main)
Cosmetics - Sun protection test methods - In vivo determination of sunscreen UVA protection (ISO 24442:2011)
SIST EN ISO 24442:2012

ISO 24442:2011 specifies an in vivo method for assessment of the UVA protection factor (UVAPF) of topical sunscreen products. It is applicable to cosmetics, drugs and other products intended to be topically applied to human skin, including any component able to absorb, reflect or scatter UV rays.
ISO 24442:2011 provides a basis for the evaluation of sunscreen products for the protection of human skin against UVA radiation from solar or other light sources.

  • Standard
    34 pages
    English language
    e-Library read for
    1 day
CEN
EN ISO 24444:2010(Main)
Cosmetics - Sun protection test methods - In vivo determination of the sun protection factor (SPF) (ISO 24444:2010)
SIST EN ISO 24444:2011

ISO 24444:2010 specifies a method for the in vivo determination of the sun protection factor (SPF) of sunscreen products. This International Standard is applicable to products that contain any component able to absorb, reflect or scatter ultraviolet (UV) rays and which are intended to be placed in contact with human skin.
ISO 24444:2010 provides a basis for the evaluation of sunscreen products for the protection of human skin against erythema induced by solar ultraviolet rays.

  • Standard
    53 pages
    English language
    e-Library read for
    1 day
SIST
SIST EN ISO 24442:2012(Main)
Cosmetics - Sun protection test methods - In vivo determination of sunscreen UVA protection (ISO 24442:2011)
EN ISO 24442:2011

ISO 24442:2011 specifies an in vivo method for assessment of the UVA protection factor (UVAPF) of topical sunscreen products. It is applicable to cosmetics, drugs and other products intended to be topically applied to human skin, including any component able to absorb, reflect or scatter UV rays.
ISO 24442:2011 provides a basis for the evaluation of sunscreen products for the protection of human skin against UVA radiation from solar or other light sources.

  • Standard
    34 pages
    English language
    e-Library read for
    1 day
SIST
SIST EN ISO 24443:2012(Main)
Determination of sunscreen UVA photoprotection in vitro (ISO 24443:2012)
EN ISO 24443:2012

ISO 24443:2012 specifies an in vitro procedure to characterize the UVA protection of sunscreen products. Specifications are given to enable determination of the spectral absorbance characteristics of UVA protection in a reproducible manner.
In order to determine relevant UVA protection parameters, the method has been created to provide a UV spectral absorbance curve from which a number of calculations and evaluations can be undertaken. This method relies on the use of in vivo SPF results for scaling the UV absorbance curve.

  • Standard
    34 pages
    English language
    e-Library read for
    1 day
SIST
SIST EN ISO 24444:2011(Main)
Cosmetics - Sun protection test methods - In vivo determination of the sun protection factor (SPF) (ISO 24444:2010)
EN ISO 24444:2010

ISO 24444:2010 specifies a method for the in vivo determination of the sun protection factor (SPF) of sunscreen products. This International Standard is applicable to products that contain any component able to absorb, reflect or scatter ultraviolet (UV) rays and which are intended to be placed in contact with human skin.
ISO 24444:2010 provides a basis for the evaluation of sunscreen products for the protection of human skin against erythema induced by solar ultraviolet rays.

  • Standard
    53 pages
    English language
    e-Library read for
    1 day
50