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. This also specifies packaging and labelling requirements, including the instructions for use. This document covers fluoride varnishes to be applied by dental health care workers.
This document does not apply to fast acting topical fluoride products such as fluoride oral rinses.

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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. This also specifies packaging and labelling requirements, including the instructions for use. This document covers fluoride varnishes to be applied by dental health care workers.
This document does not apply to fast acting topical fluoride products such as fluoride oral rinses.

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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. This also specifies packaging and labelling requirements, including the instructions for use. This document covers fluoride varnishes to be applied by dental health care workers. This document does not apply to fast acting topical fluoride products such as fluoride oral rinses.

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This document specifies physical and chemical requirements and test methods for oral rinses. It also specifies requirements on the accompanying information to be given in the manufacturer's instructions for use and on containers as well as the requirements for packaging. Common labelling aspects are specified in order to enhance international understanding and trade.
This document is not applicable to other delivery systems (e.g. mouth sprays, foams, powders). It is not intended to describe regulatory aspects, e.g. methods of prescription.
This document is not applicable to oral rinses available by prescription only.

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This document specifies physical and chemical requirements and test methods for oral rinses. It also specifies requirements on the accompanying information to be given in the manufacturer's instructions for use and on containers as well as the requirements for packaging. Common labelling aspects are specified in order to enhance international understanding and trade.
This document is not applicable to other delivery systems (e.g. mouth sprays, foams, powders). It is not intended to describe regulatory aspects, e.g. methods of prescription.
This document is not applicable to oral rinses available by prescription only.

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This document provides a procedure to characterize the sun protection factor (SPF), UVA protection factor (UVA-PF) and critical wavelength (CW) protection of sunscreen products without requiring biological responses. The test method is applicable for emulsions and single-phase products. The method has not been evaluated for use with powder forms sunscreen products.
This document gives specifications to enable determination of the absolute spectral absorbance characteristics of a sunscreen product on skin to estimate sunburn and UVA protection. 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.

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This document specifies a method for the in vitro determination of sun protection factor (SPF). This method is applicable to sunscreen products in form of an emulsion or alcoholic one-phase formulation, excluding in form of a loose or compressed powder or stick. Specifications are given to enable determination of the spectral absorbance characteristics of SPF protection in a reproducible manner.
Use of this method is strictly for the determination of a static sun protection factor. It is not applicable for the determination of water-resistance properties of a sun protection product.

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This document specifies a method for the in vitro determination of sun protection factor (SPF). This method is applicable to sunscreen products in form of an emulsion or alcoholic one-phase formulation, excluding in form of a loose or compressed powder or stick. Specifications are given to enable determination of the spectral absorbance characteristics of SPF protection in a reproducible manner.
Use of this method is strictly for the determination of a static sun protection factor. It is not applicable for the determination of water-resistance properties of a sun protection product.

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This document provides a procedure to characterize the sun protection factor (SPF), UVA protection factor (UVA-PF) and critical wavelength (CW) protection of sunscreen products without requiring biological responses. The test method is applicable for emulsions and single-phase products. The method has not been evaluated for use with powder forms sunscreen products.
This document gives specifications to enable determination of the absolute spectral absorbance characteristics of a sunscreen product on skin to estimate sunburn and UVA protection. 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.

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This document provides a procedure to characterize the sun protection factor (SPF), UVA protection factor (UVA-PF) and critical wavelength (CW) protection of sunscreen products without requiring biological responses. The test method is applicable for emulsions and single-phase products. The method has not been evaluated for use with powder forms sunscreen products. This document gives specifications to enable determination of the absolute spectral absorbance characteristics of a sunscreen product on skin to estimate sunburn and UVA protection. 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.

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    52 pages
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This document specifies a method for the in vitro determination of sun protection factor (SPF). This method is applicable to sunscreen products in form of an emulsion or alcoholic one-phase formulation, excluding in form of a loose or compressed powder or stick. Specifications are given to enable determination of the spectral absorbance characteristics of SPF protection in a reproducible manner. Use of this method is strictly for the determination of a static sun protection factor. It is not applicable for the determination of water-resistance properties of a sun protection product.

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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 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 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 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 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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  • Draft
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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 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 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 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 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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The present method permits the identification and quantification of the volatile compounds suspected as allergens, which are present in the fragrance compounds and fragrance raw materials used in cosmetic products. The analysis is performed by gas chromatography and mass spectrometry (GC-MS) on matrix samples which are "ready to be injected" and which are compatible with gas chromatography.
The analytes covered by this procedure are based on the contents of Tables 13.1 and 13.2 in the SCCS 1459/11 opinion document (1) and as listed in the legislation proposed by the European Commission. The rationale behind the final choice of procedure analytes is given in the table found in Annex J.
The method was validated at IFRA and CEN level.

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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 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 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 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 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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    69 pages
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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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