Since the release of the Cosmetics Regulation, which will apply in July 2013, in lieu of the current Directive, and especially due to its Annex I, more than one cosmetic company wonders. The Cosmed associationis to give it a very practical answer, when releasing, in January 2012, an exhaustive Practical Guide (in French only), explaining the needed data and the way to get them.
What is new in the Cosmetics Regulation, when compared to the Directive, is that its Annex I precisely details all the data that shall be written in the Report on Safety of the cosmetic product, a major part of the Product Information File.
This report shall be filled in prior to any placing of a product on the market. It shall comprise much data:
• Quantitative and qualitative composition of the cosmetic product
• Physical/chemical characteristics and stability of the cosmetic product
• Microbiological quality
• Impurities, traces, information about the packaging material
• Normal and reasonably foreseeable use
• Exposure to the cosmetic product
• Exposure to the substances
• Toxicological profile of the substances
• Undesirable effects and serious undesirable effects
• Information on the cosmetic product
A question, a chapter
Everyone of these points is dealt with in a full chapter in this Guide: for every point, the targets are detailed, the data to collect and where to get them from are given. Plus advice and practical tools to avoid pitfalls, ambiguities and even deadlocks, with suggested alternatives.
Written by a 29-strong team of experts (responsible persons, formulators, safety assessors, packaging managers, microbiologists, consultants, test laboratories, lawyers …
