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Regulatory Affairs

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Cosmetics Dossier

Cosmetics DossierThe cosmetic dossier is not only a simple data collection, but it revises in a critical way all information regarding raw materials, manufacturing processes, product presentation and all aspects leading to the safety assessment of a cosmetic product.

The cosmetic dossier (PIF – Product Information File) is mandatory for any product marketed in the Community territory. Such obligation is provided for also for those products on the market before 11th July 2013.

The authority can access the dossier, also including a report on the product safety, through the responsible person. The dossier does not need to be physically present in the premises of the responsible person, but it has to be made available within 72 hours from the request of the relevant authorities.

Just as the European notification is only one for all Countries belonging to the EU where the product is marketed, so each cosmetic product will be accompanied by a dossier according to the following formula:

One product --> One notification --> One dossier

The cosmetic dossier should be prepared in the language of the country where the product is marketed or in a language understandable by the authorities, usually in English.

The product information file (PIF) can be prepared in paper copy or in electronic format and will have to be updated at each change in formulation or ingredients as well as in order to reflect the regulation evolution or following the occurrence of serious undesirable effects to be registered inside the dossier itself.

According to Annex I of Regulation EC 1223/2009, the safety report will have to include the following information:

Part A
  • Quantitative and qualitative composition of the cosmetic products
  • Physical/chemical characteristics and stability of the cosmetic product
  • Microbiological quality
  • Impurities, residues, information on the packaging material
  • Normal use and use that can be reasonably be expected
  • Exposure to the cosmetic product
  • Exposure to substances
  • Toxicological profile of the substances
  • Undesirable effects and serious undesirable effects
  • Information the cosmetic product
Part B
  • Conclusions of the assessment
  • Warnings and use instructions reported on the label
  • Justification
  • Information on the assessor and approval of Part B
Starting from some basic information:
  • Quantitative formulation
  • Stability studies on the finished product
  • Chemical/Physical studies on the finished product
  • Efficacy studies, if any
  • Description of the manufacturing process
  • Technical sheets of the ingredients used
Di Renzo Regulatory Affairs can prepare the PIF (Product Information File) independently searching for the missing data regarding the different toxicological aspects of each single ingredients used in the formulation.

Each data (either provided or searched) will be used to assess any technical and scientific aspect, producing a final safety assessment of the product.