The purpose of this Guideline is to help the Cosmetic Industry in assessing the safety of the product as well as the Regulators in auditing the data contained in the Product Information File (PIF). This guideline serves to highlight some of the important considerations in the safety assessment of cosmetic product in line with Article 8 d) of the ASEAN Cosmetics Directive1 which requires an “assessment of the safety for human health of the finished product, its ingredients, its chemical structure and its level of exposure”. This safety assessment is to be performed by a qualified professional defined as the “Safety Assessor”.
Main Content
Objective
General Approach
Ingredients
Safety Evaluation of Finished Products
Safety Claims
Responsibility of the Safety Assessor
Raw Material Supplier Responsibilities
Manufacturer Responsibilities
Distributor Responsibilities
Regulatory Responsibilities
References