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.