It is now more than a year and a half since the application of Regulation 1223/2009, but it was only yesterday, at an AEFI conference attended by AEFI cosmetics spokesperson Maria Riera, the pharmacologist from the Department of Experimental Pathology at the Institute of Biomedical Research, Oriol Bulbena, and the director of the Technical Pharmaceutical Office Mercè Camps, that the changes involving updates to the Dossier were discussed for the first time. And the reflections that took place there should mark a turning point in the way in which cosmetics specialists should understand the new Regulation.
For many, until now, the Dossier was a necessary - and mandatory - document to be able to market their cosmetic product. However, as we have progressed in the interpretation of the new Regulation, we have also realised that it is a living document, which must be subject to change and renewal as the circumstances of the product itself require it. And this is a major change to be taken into account for companies in the sector.
When an entity generates the dossier in order to market a cosmetic product, it does so on the basis of the composition of the product at that moment. For commercial reasons or subjective preferences, often after the dossier has been created, changes are made to the product's composition, either in the ingredients, preservatives -especially in the case of parabens, which are being replaced by other preservatives-, or colourings.And that, according to the Regulation, also implies a review of the dossier, so that it is up to date.
In this way, it is necessary to break with the mentality that the dossier is part of the initial procedures prior to the marketing of a cosmetic product, and put it in its place, understanding that it is a living document that should accompany the cosmetic on all its journeys.