This document defines a global approach for the validation of a quantitative analytical method, based on
the construction and interpretation of an accuracy profile, and specifies its characterization procedure.
This procedure is particularly applicable for internal validation in a cosmetic testing laboratory, but
its scope can be extended to the interpretation of data collected for an interlaboratory study designed
according to the recommendations of the ISO 5725-1. It does not apply to microbiological trials. The
present approach is particularly suited to handle the wide diversity of matrices in cosmetics. This
document only applies to already fully-developed and finalized methods for which selectivity/
specificity have already been studied and the scope of the method to be validated has already been
defined, in terms of matrix types and measurand (for example analyte) concentrations.

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This document provides answers to questions which can arise when calculating indexes and contents
according to ISO 16128-1 and ISO 16128-2.
It clarifies conditions on process, solvents and carbon sources to qualify ingredients regarding the
ISO 16128 series. Detailed examples, explaining how to use the ISO 16128 series are also provided.

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This aim of this standard is to provide a process for the determination of mercury in cosmetics by means of cold vapour atomic adsorption (AAS) after pressure digestion.
The procedure was validated in 2015 by means of a multi laboratory study in combination with cold vapour AAS determination process for mercury with eight laboratories participating. Overall, seven samples representing different matrices (lipstick, tattoo colourant, body lotion, toothpaste, eyeshadow and water make-up) with varying mercury contents between 0,110 mg/kg and 5,84 mg/kg were analysed.

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This International Standard specifies the determination of mercury in cosmetics by integrated mercury analytical systems. The purpose of this standard is :
•   Description of the analytical procedure
•   Validation and characterization of the method by its accuracy profile

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This document specifies a method for the in vivo determination of UVA protection factor (UVAPF) 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 UVA radiation induced by solar ultraviolet rays.

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This document specifies an analytical procedure for direct determination of traces of mercury in finished cosmetic products by thermal decomposition – atomic absorption spectrometry (mercury analyser).
This document aims to provide a procedure of quantification of mercury traces in cosmetic products that consumers can be exposed to in their usage. This method describes the determination of mercury traces in cosmetics by direct solid analysis with no need of prior digestion. Total mercury (both inorganic and organic species) can be quantified either in solid or liquid samples.

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This document specifies a method for determination of mercury in cosmetics by means of cold vapour atomic absorption spectrometry (AAS) with a prior pressure digestion.

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This document specifies a method for the in vivo determination of UVA protection factor (UVAPF) 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 UVA radiation induced by solar ultraviolet rays.

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This document specifies an analytical procedure for direct determination of traces of mercury in finished cosmetic products by thermal decomposition – atomic absorption spectrometry (mercury analyser). This document aims to provide a procedure of quantification of mercury traces in cosmetic products that consumers can be exposed to in their usage. This method describes the determination of mercury traces in cosmetics by direct solid analysis with no need of prior digestion. Total mercury (both inorganic and organic species) can be quantified either in solid or liquid samples.

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This document specifies a method for determination of mercury in cosmetics by means of cold vapour atomic absorption spectrometry (AAS) with a prior pressure digestion.

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This document specifies a procedure for evaluating the water resistance retention percentage, by comparing the sun protection factor (SPF) before water immersion (hereafter referred to as the "static" SPF) and after a fixed period of water immersion (hereafter referred to as the "wet" SPF).

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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.

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This document specifies a procedure of water immersion for the in vivo determination of the water resistance of sunscreen products.
This document is applicable to products intended to be placed in contact with human skin including any component able to absorb, reflect or scatter UV rays and which, in addition, are designed to be less readily removed from the skin by water and/or during water immersion. It is intended to be read in conjunction with ISO 24444.

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This document specifies a procedure of water immersion for the in vivo determination of the water
resistance of sunscreen products.
This document is applicable to products intended to be placed in contact with human skin including
any component able to absorb, reflect or scatter UV rays and which, in addition, are designed to be less
readily removed from the skin by water and/or during water immersion. It is intended to be read in
conjunction with ISO 24444.

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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.

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This document gives guidance for the enumeration and/or detection of microorganisms present in a
cosmetic product that is impregnated or coated onto a substrate (i.e. wipes and masks) where sampling
and microbiological influence of the manufactured product presents particular challenges in terms of
microbiological sampling and testing.
The principle of this document can also be applied to test similar products (e.g. cushion, impregnated
sponge, etc.) or applicators (e.g. brush, puff, sponge, etc.) with modification of the procedure as
appropriate.

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This document specifies a procedure for evaluating the water resistance retention percentage, by
comparing the sun protection factor (SPF) before water immersion (hereafter referred to as the “static”
SPF) and after a fixed period of water immersion (hereafter referred to as the “wet” SPF).

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This document specifies a method for the in vivo determination of UVA protection factor (UVAPF) 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 UVA radiation induced by solar ultraviolet rays.

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This document provides a method for quantification of trace levels of heavy metals in cosmetic products.
This document refers only to chromium, cobalt, nickel, arsenic, cadmium, antimony and lead. The methodology can apply to other elements, however, it is the responsibility of the analyst to demonstrate that it fits that purpose.

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This document provides a method for quantification of trace levels of heavy metals in cosmetic products.
This document refers only to chromium, cobalt, nickel, arsenic, cadmium, antimony and lead. The
methodology can apply to other elements, however, it is the responsibility of the analyst to demonstrate
that it fits that purpose.

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The proposed standard aims at describing a method to analyze 57 chemically defined suspected allergens (some of them existing under several isomeric forms or as mixtures) in ready to inject fragrance and raw material samples according to the SCCS opinion. (SCCS/1459/11).
This new analytical method uses gas chromatography and mass spectrometry (GC-MS) to detect and to quantify the 57 fragrance substances and their relevant isomers at a concentration higher than 0.0002% (2 mg/kg) in ready to inject fragrance and raw material samples. Making this method available will allow the screening of (complex) ready to inject fragrance and raw material samples to be undertaken for the presence of any of those chemically defined suspected allergens. It will therefore be a basis for the calculation of adequate information to the cosmetics industry in order to provide adequate consumer information. The present analytical method uses GC-MS by combination of two GC columns of different polarity with a dedicated methodology for quantitation.

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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.

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This document specifies the requirements and test methods for external tooth bleaching products. These products are intended for use in the oral cavity, either by professional application (in-office tooth bleaching products) or consumer application (professional or non-professional home use of tooth bleaching products), or both. It also specifies requirements for their packaging, labelling and manufacturer's instructions for use.
This document is not applicable to tooth bleaching products:
—     specified in ISO 11609;
—     intended to change colour perception of natural teeth by mechanical methods (e.g. stain removal) or using restorative approaches, such as veneers or crowns;
—     auxiliary or supplementary materials (e.g. tray materials) and instruments or devices (e.g. lights) that are used in conjunction with the bleaching products.
This document does not specify biological safety aspects of tooth bleaching products.
NOTE     Maximum concentration of a bleaching agent for professional or non-professional use is subject to each country's regulatory body.

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This document provides answers to questions which can arise when calculating indexes and contents according to ISO 16128-1 and ISO 16128-2. It clarifies conditions on process, solvents and carbon sources to qualify ingredients regarding the ISO 16128 series. Detailed examples, explaining how to use the ISO 16128 series are also provided.

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This document classifies denture adhesives used by wearers of removable dentures; it also specifies
requirements, test methods and instructions to be supplied for the use of such products.
This document is applicable to denture adhesives for use by the consumer and excludes the dental lining
materials prescribed or applied by dental professionals.

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This document provides a method for quantification of trace levels of heavy metals in cosmetic products. This document refers only to chromium, cobalt, nickel, arsenic, cadmium, antimony and lead. The methodology can apply to other elements, however, it is the responsibility of the analyst to demonstrate that it fits that purpose.

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This document specifies the requirements and test methods for external tooth bleaching products.
These products are intended for use in the oral cavity, either by professional application (in-office
tooth bleaching products) or consumer application (professional or non-professional home use of
tooth bleaching products), or both. It also specifies requirements for their packaging, labelling and
manufacturer’s instructions for use.
This document is not applicable to tooth bleaching products:
— specified in ISO 11609;
— intended to change colour perception of natural teeth by mechanical methods (e.g. stain removal)
or using restorative approaches, such as veneers or crowns;
— auxiliary or supplementary materials (e.g. tray materials) and instruments or devices (e.g. lights)
that are used in conjunction with the bleaching products.
This document does not specify biological safety aspects of tooth bleaching products.
NOTE Maximum concentration of a bleaching agent for professional or non-professional use is subject to
each country’s regulatory body.

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This document specifies requirements and test methods for total digestible fluoride content and a minimum soluble fluoride release potential in dental varnishes containing fluoride, intended for use in the oral cavity directly on the outer surfaces of teeth and fillings. It also specifies packaging and labelling requirements, including the instructions for use. This document covers fluoride varnishes to be applied by dental health care workers.

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This Technical Reports describes quality designations and indications for algae and directly derived products from algae production required for or by cosmetics producers and industry. It does not apply to Food and Feed sectors.
Note: This TRs does not provide instructions on existing handling of technical requirements in existing legislations

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This document gives an overview of recommendations on product specifications, and other relevant information, for algae and algae products for cosmetics industry.
This document does not apply to food and feed applications.
This document does not provide instructions on handling of technical requirements in existing legislations.

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This document specifies a procedure for evaluating the water resistance retention percentage, by comparing the sun protection factor (SPF) before water immersion (hereafter referred to as the "static" SPF) and after a fixed period of water immersion (hereafter referred to as the "wet" SPF).

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This document specifies requirements and test methods for total digestible fluoride content and a
minimum soluble fluoride release potential in dental varnishes containing fluoride, intended for use
in the oral cavity directly on the outer surfaces of teeth and fillings. It also specifies packaging and
labelling requirements, including the instructions for use. This document covers fluoride varnishes to
be applied by dental health care workers.

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This document specifies requirements and test methods for the physical properties of powered
toothbrushes in order to promote the safety of these products for their intended use.
There are different technologies of powered toothbrushes. Common features of those powered
toothbrushes to which this document applies are:
— a battery;
— a motor;
— a mechanical or magnetic drive system;
— a moving brush head with tufted filaments.
Powered toothbrushes can have a moving brush head with different motions (e.g. oscillating-rotating,
side-by-side), frequencies and velocities.
The requirements listed in this document apply to all types of powered toothbrushes. However, there is a
possibility that some requirements are not applicable for all types, for example brush head plate retention
can only be applied if the brush has a head portion that might get detached from the brush shaft.
This document is not applicable to other types of powered oral hygiene devices (such as powered
interdental brushes) or manual toothbrushes.

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This document specifies a procedure for evaluating the water resistance retention percentage, by comparing the sun protection factor (SPF) before water immersion (hereafter referred to as the "static" SPF) and after a fixed period of water immersion (hereafter referred to as the "wet" SPF).

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This document gives guidance for the enumeration and/or detection of microorganisms present in a cosmetic product that is impregnated or coated onto a substrate (i.e. wipes and masks) where sampling and microbiological influence of the manufactured product presents particular challenges in terms of microbiological sampling and testing.
The principle of this document can also be applied to test similar products (e.g. cushion, impregnated sponge, etc.) or applicators (e.g. brush, puff, sponge, etc.) with modification of the procedure as appropriate.

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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.

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This document specifies a procedure of water immersion for the in vivo determination of the water resistance of sunscreen products.
This document is applicable to products intended to be placed in contact with human skin including any component able to absorb, reflect or scatter UV rays and which, in addition, are designed to be less readily removed from the skin by water and/or during water immersion. It is intended to be read in conjunction with ISO 24444.

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This document specifies a method for the simultaneous determination of the total alkali content and the total fatty matter content of soaps (including liquid soaps), excluding compounded products.

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This document specifies a procedure of water immersion for the in vivo determination of the water resistance of sunscreen products. This document is applicable to products intended to be placed in contact with human skin including any component able to absorb, reflect or scatter UV rays and which, in addition, are designed to be less readily removed from the skin by water and/or during water immersion. It is intended to be read in conjunction with ISO 24444.

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This standard specifies a method for the in vivo determination of the sun protectionfactor (SPF) of sunscreen products. It is applicable to products that containany component able to absorb, reflect or scatter ultraviolet (UV) rays and whichare intended to be placed in contact with human skin.This document provides abasis for the evaluation of sunscreen products for the protection of human skinagainst erythema induced by solar ultraviolet rays.

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This standard describes additional information to use with ISO 16128-2 for the special situation of hydrolates. It clarifies the method of determining the organic index in the absence of measurement of the quantity of water introduced.

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This standard describes the industry best practices to address the concentration of extracts which is related to ISO 16128-2:2017, 4.2. Evaporation of solvents to dryness it not addressed in this document. This document aims to delineate the cases when an extract is produced and, afterwards the mixture of evaporated solvents used, regardless of the categories, are partially evaporated. The producer of the extract can utilize different approaches (e.g. measurement by instrumentation, characterization of solvent volatility, published values of evaporation rates, etc.) to determine the index (es) of the extract. Despite the approach and justification, the rational and determinations used is made available to interested parties, when requested.

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This document defines a global approach for the validation of a quantitative analytical method, based on the construction and interpretation of an accuracy profile, and specifies its characterization procedure. This procedure is particularly applicable for internal validation in a cosmetic testing laboratory, but its scope can be extended to the interpretation of data collected for an interlaboratory study designed according to the recommendations of the ISO 5725-1. It does not apply to microbiological trials. The present approach is particularly suited to handle the wide diversity of matrices in cosmetics. This document only applies to already fully-developed and finalized methods for which selectivity/specificity have already been studied and the scope of the method to be validated has already been defined, in terms of matrix types and measurand (for example analyte) concentrations.

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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.

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This Standard gives guidelines for the stability testing of cosmetic products. It reviews readily available bibliographic references that provide a resource for the assessment of the stability of cosmetic products. This review of the available guidelines that assess the stability of cosmetic products can serve as a technical/scientific framework to identify the most suitable methods for the assessment of the stability of cosmetic products. This document does not aim to specify the conditions, parameters or criteria of stability testing. Considering the wide variety of cosmetic products, storage and use conditions, it is not possible to define a single way to assess product stability. Therefore, it is up to the manufacturer to specify and justify the stability protocol to cover test methods, specifications and conditions at which products will be tested.

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