During the 30th session of its Matinales de la Cosmétique, Sylvain-Romain Cotte, expert in cosmetic regulation, presented the details of the content of the PIF (Product Information File). Focus on Part B of the report on the safety of the cosmetic product, as required by Annex I of Regulation 1223/2009.
Point 1 : Conclusion of the assessment
This is a paragraph in which the safety assessor undertakes, in view of the elements he has examined, to ensure that there is no a priori risk associated with the use of the product, specifying the normal or reasonably foreseeable conditions of use.
Point 2: Warnings and instructions for use on the label
The safety assessor shall indicate the warnings and instructions for use to be included on the label.
This point may concern all warning elements on the primary and/or secondary packaging of the product (flammability, areas of application, precautions for use, etc.), and may imply a reference to the examination of the BATs.
Point 3 : Reasoning
The safety assessor shall explain the scientific approach that led to his conclusion in Point 1 and his possible reservations in Point 2, based on the information provided in Part A of the Safety Report.
His reasoning can be supported by several points:
• The evaluation and analysis of safety margins
• A specific evaluation for products intended for children under three years of age and those intended exclusively for external intimate hygiene
• The evaluation of possible interactions of substances contained in the …
