MINOR REVISION

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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 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 differen...
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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, et...
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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 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, characteriza...view more

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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 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 microbio...view more

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    • Technical specification
      40 pages
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    • Technical specification
      43 pages
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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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    • Standard
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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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      59 pages
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      62 pages
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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, pa...view more

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This document specifies a procedure for the interpretation of data generated by the preservation
efficacy test or by the microbiological risk assessment, or both, when evaluating the overall
antimicrobial protection of a cosmetic product.
It comprises:
— a preservation efficacy test;
— a procedure for evaluating the overall antimicrobial protection of a cosmetic product that is not
considered low risk, based on a risk assessment described in ISO 29621.
The preservation efficacy test is a ...
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This document 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 document 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, characteriza...view more

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This proposal described a set of HPLC/UV procedures for the identification and quantitative determination in cosmetic products of 22 organic UV filters authorized in the EU: Camphor Benzalkonium Methosulfate (CBM), Homosalate (HS), Benzophenone-3 (BZ3), Phenylbenzimidazole Sulfonic Acid (PBS), Terephthalylidene Dicamphor Sulfonic Acid (TDS), Butyl Methoxydibenzoylmethane (BDM), Octocrylene (OCR), Ethylhexyl Methoxycinnamate (EMC), PEG-25 PABA (P25), Isoamyl p-Methoxycinnamate (IMC), Ethylhexyl T...view more

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This document specifies an analytical method, based on liquid-chromatography (LC) with ultraviolet/visible spectrometry (UV/Vis) detection for the detection and quantitative determination of 22 organic UV filters in use in the EU framework. This method has been validated for emulsion-based cosmetic products, lip-balms, lotions and waters.

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This document describes a screening method for rapid sampling and identifying of diethanolamine
(DEA) in cosmetics and raw materials used in cosmetics by gas chromatography – mass spectroscopy
(GC-MS).
This method is not applicable to the detection and/or quantification of DEA-related ingredients.
When this method is used to analyse unfamiliar sample matrices analysts are advised to confirm the
applicability and flexibility of the techniques in their matrix.
Under the conditions specified ...
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Methods for the quantication of fluoride concentrations in dental products including dentifrice, oral rinse,
fluoride releasing varnishes, and other fluoride containing products. The methods are based on fluoride ionselective
electrode technology for the analysis of fluoride in aqueous samples derived from dental products.

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ISO/TR 18811:2018 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. ISO/TR 18811:2018 does not aim to specify the condit...view more

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ISO 19448:2018 specifies test methods for the quantification of fluoride concentrations in dental products including dentifrices, gels, oral rinses, fluoride releasing varnishes, and other fluoride containing products. The methods are based on fluoride ion-selective electrode technology for the analysis of fluoride in aqueous samples derived from dental products.

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This European Standard specifies a HPLC/UV method for the assay of hydroquinone, 3 ethers of hydroquinone and 4 corticosteroids most frequently found in illegally sold skin whitening cosmetic products: clobetasol propionate, betamethasone dipropionate, fluocinonide and fluocinolone acetonide.
This standard also proposes HPLC/UV methods for the identification of 38 corticosteroids may be found in skin whitening products. Indeed, as corticosteroids could be deliberately introduced in skin whiteni...
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This part of ISO 16128 provides guidelines on definitions for natural and organic cosmetic ingredients.
In addition to natural and organic ingredients, other ingredient categories which may be necessary for
natural and organic product development are defined with associated restrictions.
ISO 16128 does not address product communication (e.g. claims and labelling), human safety,
environmental safety and socio-economic considerations (e.g. fair trade), and the characteristics of
packaging mat...
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      13 pages
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This Technical Report introduces most common and typical analytical approaches for screening and
quantification of heavy metals of general interest at both raw material and finished product level. This
Technical Report covers techniques from traditional colourimetric reaction, which can be executed
without expensive instrument to the high-end one, like that of inductively coupled plasma-mass
spectrometry (ICP-MS), which allows detection of elements at μg/kg level. Thus, this Technical Report...
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This document describes approaches to calculate natural, natural origin, organic and organic origin
indexes that apply to the ingredient categories defined in ISO 16128-1. This document also offers a
framework to determine the natural, natural origin, organic and organic origin content of products
based on the ingredient characterization.
Neither ISO 16128-1 nor this document addresses product communication (e.g. claims and labelling),
human safety, environmental safety, socio-economic cons...
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This European Standard specifies a HPLC/UV method for the identification and quantification of hydroquinone, 3 ethers of hydroquinone and 4 corticosteroids most frequently found in illegally sold skin whitening cosmetic products: clobetasol propionate, betamethasone dipropionate, fluocinonide and fluocinolone acetonide.
This standard also gives HPLC/UV methods for the identification of 38 corticosteroids that may be found in skin whitening cosmetic products (see Annex D).
This standard is not ...
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ISO 16128-2:2017 describes approaches to calculate natural, natural origin, organic and organic origin indexes that apply to the ingredient categories defined in ISO 16128‑1. This document also offers a framework to determine the natural, natural origin, organic and organic origin content of products based on the ingredient characterization. Neither ISO 16128‑1 nor this document addresses product communication (e.g. claims and labelling), human safety, environmental safety, socio-economic consid...view more

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      14 pages
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This document specifies requirements for the physical and chemical properties of dentifrices and
provides guidelines for suitable test methods. It also specifies requirements for the marking, labelling
and packaging of dentifrices.
This document applies to dentifrices, including toothpastes, destined to be used by the consumers on a
daily basis with a toothbrush to promote oral hygiene.
Specific qualitative and quantitative requirements for freedom from biological and toxicological
hazards...
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ISO 16212:2017 gives general guidelines for enumeration of yeast and mould present in cosmetics by counting the colonies on selective agar medium after aerobic incubation.
In order to ensure product quality and safety for consumers, it is advisable to perform an appropriate microbiological risk analysis to determine the types of cosmetic products to which ISO 16212:2017 is applicable. Products considered to present a low microbiological risk (see ISO 29621) include those with low water activity...
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ISO/TR 18818:2017 describes a screening method for rapid sampling and identifying of diethanolamine (DEA) in cosmetics and raw materials used in cosmetics by gas chromatography ? mass spectroscopy (GC-MS). This method is not applicable to the detection and/or quantification of DEA-related ingredients. When this method is used to analyse unfamiliar sample matrices analysts are advised to confirm the applicability and flexibility of the techniques in their matrix. Under the conditions specified th...view more

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ISO 11609:2017 specifies requirements for the physical and chemical properties of dentifrices and provides guidelines for suitable test methods. It also specifies requirements for the marking, labelling and packaging of dentifrices.
ISO 11609:2017 applies to dentifrices, including toothpastes, destined to be used by the consumers on a daily basis with a toothbrush to promote oral hygiene.
Specific qualitative and quantitative requirements for freedom from biological and toxicological hazards a...
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ISO 21149:2017 gives general guidelines for enumeration and detection of aerobic mesophilic bacteria present in cosmetics
- by counting the colonies on agar medium after aerobic incubation, or
- by checking the absence of bacterial growth after enrichment.
Because of the large variety of cosmetic products within this field of application, this method may not be appropriate for some products in every detail (e.g. certain water immiscible products). Other methods (e.g. automated) may be substit...
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ISO 21148:2017 gives general instructions for carrying out microbiological examinations of cosmetic products, in order to ensure their quality and safety, in accordance with an appropriate risk analysis (e.g. low water activity, hydro-alcoholic, extreme pH values).
Because of the large variety of products and potential uses within this field of application, these instructions might not be appropriate for some products in every detail (e.g. certain water-immiscible products).

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ISO 18415:2017 gives general guidelines for the detection and identification of specified microorganisms in cosmetic products as well as for the detection and identification of other kinds of aerobic mesophilic non-specified microorganisms in cosmetic products.
Microorganisms considered as specified in this document might differ from country to country according to national practices or regulations. Most of them considered as specified microorganisms include one or more of the following species...
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ISO 16212:2017 gives general guidelines for enumeration of yeast and mould present in cosmetics by counting the colonies on selective agar medium after aerobic incubation. In order to ensure product quality and safety for consumers, it is advisable to perform an appropriate microbiological risk analysis to determine the types of cosmetic products to which ISO 16212:2017 is applicable. Products considered to present a low microbiological risk (see ISO 29621) include those with low water activity ...view more

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      19 pages
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    • Standard
      21 pages
      French language

ISO 21149:2017 gives general guidelines for enumeration and detection of aerobic mesophilic bacteria present in cosmetics - by counting the colonies on agar medium after aerobic incubation, or - by checking the absence of bacterial growth after enrichment. Because of the large variety of cosmetic products within this field of application, this method may not be appropriate for some products in every detail (e.g. certain water immiscible products). Other methods (e.g. automated) may be substitute...view more

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    • Standard
      24 pages
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      24 pages
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ISO 18415:2017 gives general guidelines for the detection and identification of specified microorganisms in cosmetic products as well as for the detection and identification of other kinds of aerobic mesophilic non-specified microorganisms in cosmetic products. Microorganisms considered as specified in this document might differ from country to country according to national practices or regulations. Most of them considered as specified microorganisms include one or more of the following species:...view more

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      19 pages
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      19 pages
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ISO 21148:2017 gives general instructions for carrying out microbiological examinations of cosmetic products, in order to ensure their quality and safety, in accordance with an appropriate risk analysis (e.g. low water activity, hydro-alcoholic, extreme pH values). Because of the large variety of products and potential uses within this field of application, these instructions might not be appropriate for some products in every detail (e.g. certain water-immiscible products).

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      22 pages
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ISO 29621:2017 gives guidance to cosmetic manufacturers and regulatory bodies to help define those finished products that, based on a risk assessment, present a low risk of microbial contamination during production and/or intended use, and therefore, do not require the application of microbiological International Standards for cosmetics.

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ISO 29621:2017 gives guidance to cosmetic manufacturers and regulatory bodies to help define those finished products that, based on a risk assessment, present a low risk of microbial contamination during production and/or intended use, and therefore, do not require the application of microbiological International Standards for cosmetics.

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      12 pages
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This International Standard specifies requirements and test methods for performance criteria for
manual interdental brushes with a round cross-section of the brush head and consisting of a wired
stem with inserted filaments. It also specifies the accompanying information such as manufacturer’s
instructions for use and labelling of the packaging.
Excluded are interdental brushes with a plastic core.
This International Standard is not applicable to powered interdental brushes, manual toothbru...
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This Technical Report gives general guidelines to explain the use of ISO cosmetic microbiological
standards depending on the objective (in-market control, product development, etc.) and the product
to be tested.
This Technical Report can be used to fulfil the requirements of the ISO standard on microbiological
limits (ISO 17516).

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ISO/TR 19838:2016 gives general guidelines to explain the use of ISO cosmetic microbiological standards depending on the objective (in-market control, product development, etc.) and the product to be tested.
ISO/TR 19838:2016 can be used to fulfil the requirements of the ISO standard on microbiological limits (ISO 17516).

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ISO/TR 19838:2016 gives general guidelines to explain the use of ISO cosmetic microbiological standards depending on the objective (in-market control, product development, etc.) and the product to be tested. ISO/TR 19838:2016 can be used to fulfil the requirements of the ISO standard on microbiological limits (ISO 17516).

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      15 pages
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    • Technical report
      15 pages
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ISO 16128-1:2016 provides guidelines on definitions for natural and organic cosmetic ingredients. In addition to natural and organic ingredients, other ingredient categories which may be necessary for natural and organic product development are defined with associated restrictions. ISO 16128 does not address product communication (e.g. claims and labelling), human safety, environmental safety and socio-economic considerations (e.g. fair trade), and the characteristics of packaging materials or r...view more

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    • Standard
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    • Standard
      13 pages
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