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.

It is applicable to SPF and UVA protection, and both in vivo and in vitro methods.

It is intended to complement personal involvement and reasoning in the implementation of ISO 22716.

ISO/TR 24475:2010 covers the quality aspects of the cosmetic product, but does not take into account safety aspects for the personnel, nor does it cover aspects of protection of the environment or those concerning the safety and efficacy of the finished products.

ISO/TR 24475:2010 cannot be used alone and needs as a prerequisite a good knowledge of ISO 22716 which is the reference document.

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.

Le présent document vise à délimiter les cas d'évaporation partielle de l'extrait produit ainsi que des mélanges de solvants évaporés utilisés par la suite, indépendamment des catégories.

Le producteur de l'extrait peut utiliser différentes méthodes (par exemple effectuer des mesurages à l'aide d'instruments, caractériser la volatilité des solvants, s'appuyer sur les valeurs publiées des taux d'évaporation, etc.) afin de déterminer le ou les indices de l'extrait. Quelles que soient la méthode et sa justification, le justificatif et les déterminations employés sont mis à la disposition des parties intéressées, sur demande.

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 this method is reliable for quantification with DEA level at 1 000 mg/kg (0,1 %).

However, samples with lower concentrations (<0,1 %) or otherwise unusual compositions or characteristics can present difficulties (such as, for example, peak tailing) that preclude the direct use of this method.

Le présent document n'est pas destiné à spécifier les conditions, les paramètres ou les critères des essais de stabilité.

Compte tenu de la grande diversité des produits cosmétiques, des conditions de stockage et d'utilisation, il est impossible de définir un moyen unique d'évaluer la stabilité des produits. Par conséquent, il appartient au fabricant de spécifier et de justifier le protocole de stabilité régissant les méthodes d'essai, leurs spécifications et les conditions dans lesquelles les produits seront soumis à essais.

ISO/TR 14735:2013 covers the reduction or elimination of adventitious nitrite sources, reduction or elimination of secondary amino sources, incorporation of inhibitors to N-nitrosamine formation and analytical methodologies for total N-nitroso compounds and specific methods for N-nitrosodiethanolamine (NDELA).