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What Is Included In A Cosmetic Dossier?

The cosmetic dossier isn’t just a simplistic data collection process, but it critically reviews all the data concerning production materials, processes, product presentation and all aspects of a safety assessment of a product.


The information contained in the dossier will be used to assess the detailed product composition, technical product description (including packaging and labeling information), single ingredients (raw materials) data, additives and any related contaminants, product safety assessment (safety report), manufacturing information (GMP), scientific claim support and much more.


The cosmetic dossier also called a Product Information File (PIF) is created after a challenge test is successfully carried out and before the product is launched into the market. The record should be made available to everyone as well as a report on the safety of the product. The product does not necessarily need to have the cosmetic dossier on it, but the manufacturers have to ensure that once the information is requested that it will be made available within 48hours. The file must be complete with all compulsory content available. It should be up to date (documents preferably not older than three years) and in accordance with the latest EU standards (e.g. codes of practices, MSDS format, allergen declarations, etc.).


The product information file (PIF) can be made as a hard copy or as an electronic document and will have to be renewed at each stage to reflect the ever changing regulations or following an occurrence of serious unwanted effects that is registered within the dossier.


Annex I of Regulation EC 1223/2009 states that a cosmetic dossier must include the below information:


Part A


Exposure to substances,


Physical/chemical properties and balance of the cosmetic product,


Regular use and use that can be reasonably be expected,


Toxicological profile of the materials,


Information the cosmetic product,


Impurities, residues, and information on the packaging material,


Exposure to the cosmetic product,


Quantitative and qualitative composition of the cosmetic products,


Undesirable effects and serious undesirable effects,


Microbiological quality,


Part B




Warnings and use instructions reported on the label,


Information on the assessor and approval of Part B,


Conclusions of the assessment,


Starting from some basic information:


Efficacy studies, if any,


Technical sheets of the ingredients used,


Quantitative formulation,


Stability studies on the finished product,


Description of the manufacturing process,


Chemical/Physical studies on the finished product,


In the European Union, only one notification is required for all countries within the union, same is expected where the product is marketed, because each product will be launched with the file. Also, the cosmetic dossier needs to be created in the same language as that of the EU country where the product will be promoted or in the same language that is understood by the regulatory bodies; most times in English.