The Cosmetic's Directive for the dossier system requires that the manufacturer, or the person(s) who ordered the manufacture, or the agent, or the importer, maintain a dossier for each product placed on the market. These product dossiers are to be kept at the address which appears on the label of the product (Art. 7a).

Content of the Dossier

	Article 7a, which consists of numerous parts, specifies that the dossier must include the following
	The qualitative and quantitative composition of the product.
	The physico-chemical and microbiological specifications of the raw materials and the finished product and the purity and microbiological control criteria of the cosmetic product
	The method of manufacture.
	An assessment of the safety for human health of the finished product.
	The name and address of the person or organization who made the safety assessment.
	Existing data on undesirable effects from the use of the product.
	Proof of effect claimed for the cosmetic product.

Creating the Dossier

It is important for all manufacturers of cosmetic products that any and all of the work necessary for inclusion in the E.U. dossier be done by knowledgeable people

Equally important to manufacturers is that they receive, either through internal or external means, the correct and up to date regulatory facts for inclusion in the dossier and for filing other necessary documents

IRSI has conducted and continues to conduct studies, both for safety and efficacy of cosmetic products destined for marketing in the E.U. Also, through key alliances, IRSI is knowledgeable with all aspects of the Cosmetic's Directive. In addition, IRSI can, through these key alliances, provide additional consulting assistance for managing the E.U. Dossier system

Accurate Reporting