The European Dossier: a challenge for the cosmetic chemist?

The cosmetic dossier, as requested by the EU law, is the result of various product elements: formulations, technology, safety and efficacy. The cosmetic dossier should be an harmonic collection of product informations: the quali-quantitative formulations and the raw materials documentation are the starting point. In this matter the suppliers role is fundamental as many informations are needed other than INCI name: blends clarifications, analysis certification with related methods, safety data and relevant toxicological informations. As for the production method, according to GMP, this is the detailed description of the production process, including the intermediate phases and filling and packaging. Furthermore the dossier must enclose the safety evaluation, signed by a qualified responsible. The general toxicological profile of the ingredients, their chemical structure and the exposure level are taken into account. The dossier shall be completed with the proof of the claimed effects, when justified by the type of declaration. This means that terminology for labels and leaflet should be selected and proper efficacy tests shall be performed if relevant.