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M/389 - Sunscreen products

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

Mandate M/389 assigns CEN the task of developing European standards for testing the efficacy of sunscreen products. The mandate focuses on establishing harmonized methods to evaluate the performance and protective qualities of sunscreens. This standardisation work aims to support regulatory compliance, enhance consumer safety, and ensure consistent product quality across the EU market. The mandate's approval, referenced by CEN/BT C054/2006, formalizes the European Commission's request for CEN to create reliable and scientifically sound testing procedures for sunscreen efficacy.

Purpose

This mandate relates to the standardisation of methods for testing the efficacy of sunscreen products. It aims to support the development of harmonised standards that ensure reliable and consistent evaluation of sunscreen performance across the European market.

Standardisation request

The mandate requests the European Committee for Standardisation (CEN) to establish standardized testing methods specifically focused on assessing the effectiveness of sunscreen products. These methods are expected to cover parameters relevant to sun protection, likely including UV protection factors and other performance indicators.

Expected deliverables

  • Development of standardised testing methods for evaluating sunscreen efficacy.
  • Guidelines or protocols that can be used by manufacturers, testing laboratories, and regulatory bodies to assess sunscreen products uniformly.
  • Contributions towards harmonised technical criteria to facilitate market surveillance and consumer protection.

Context

The mandate, referenced as M/389, was issued to ensure the uniformity of sunscreen product testing within the EU. This is critical for consumer safety and regulatory compliance, addressing the need for standardized approaches to measure sun protection performance. The decision concerning the mandate was documented under resolution CEN/BT C054/2006. This standardisation effort supports the broader goal of harmonising product testing to reduce market fragmentation and enhance the quality and reliability of sunscreen products available to consumers.

This mandate covers standardisation work related to methods for testing the efficacy of sunscreen products. It focuses on establishing standardized testing procedures to evaluate the performance and effectiveness of sunscreens in protecting against sun exposure.

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
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

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.