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Friday, October 19, 2018Dossiers

Annex I to Regulation 1223/2009: the dossier

Dossier Annexe I du Règlement 1223/2009

Annex I to Cosmetics Regulation 1223/2009, which regulates cosmetic products in Europe since 11 July 2013, is a fundamental section of the text. It describes the content of the CPSR, the Cosmetic Product Safety Report, which must be included in the Product Information File (PIF), with many obligations, particularly in terms of the data to be collected. Point by point, this dossier covers the various chapters of Annex I from a practical point of view, in order to understand the safety report properly and avoid the most frequent errors in its constitution.

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Annex I, Part A

It is in fact a collection of information intended to allow the final assessment of the product safety. It requires a long process of collecting validated technical information. It can be carried out internally by the company, or it can be outsourced and entrusted to a consultant or a specialized firm, but does not necessarily have to involve a toxicologist: it is rather a technical-administrative step. Which includes 10 points.

Annex I, Part B

Once all the data has been collected in Part A, they are submitted to the safety assessor. He has then to take into account all the information contained in it, to conclude that the product is safe and to proceed with the wording of Part B, which contains 4 points.

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