A cosmetic dossier model? No thanks!
According to the European Regulation, for the marketing of cosmetic products, the relevant responsible person is bound to notify the product into an online portal and prepare a dossier (PIF – Product Information File). What is the PIF of a cosmetic product? It is a dossier needed to demonstrate the safety and efficacy of the cosmetic product through data, calculations, references and studies.
The Regulation provides indications on what should be reported in the PIF. Some European guidelines are also available and can be useful to assess the characteristics of the product. However, there is no standard form to be filled in for the drafting of each product.
Indications and guidance on the PIF preparation can also be found in any research engine. Of course, the best way is to follow the advice given by the European Authorities or the opinion of a competent regulatory consultant. So, if there is plenty of suggestions, actual facsimiles of a cosmetic dossier are lacking, but this is due to the nature of the PIF, as defined by Regulation EC 1223/2009.
What is the PIF?
The PIF is not a simple check list of technical documents or data to be stored such, for instance, starting materials safety sheets, chemical-physical features, or microbiological analyses of the finished product.
The PIF includes a reasoned and scientifically justified report taking into account every aspect of the finished product, such as the manufacturing steps, the material of the container and the type of immediate packaging, toxicology and toxicokinetics information on the ingredients, in relation to the type and method of use of the finished product.
Therefore, each cosmetic product is a special case to be examined in the complexity of its many faces, justifying with a rational and scientific support every single decision taken by the safety assessor.
It is therefore clear that, due to the specificity of the dossier, it is difficult to establish a generic cost for the drafting of a cosmetic PIF. The commitment, in terms of money and resources, that is required much depends on the type of cosmetic product and on the information available about it.
Software are also available. These were developed to generate PIFs based on data uploaded by the user about the product, but the report generated by a software cannot be complete and requires, in any case, an assessment and a report by an expert.
In short, this is the reason why it is difficult, if not impossible, to find a model of cosmetic dossier that can fit a great number of cosmetics, as assessing options that appear to be logic for a product, cannot be valid for another, although belonging to the same cosmetic category.
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