Annual teaching event for Dr. Landolfi to Level II Master organized by the University of Bari – Pharmacy University, online thisyear for the Covid-19 pandemic.Annual teaching event for Dr. Landolfi to Level II Master organized by the University of Bari – Pharmacy University, online this year for the Covid-19 pandemic.
Cosmetics in the EU are regulated by Regulation (EC) N° 1223/2009. The Regulation requires that cosmetic products are safe for consumers. Their safety must be carefully assessed by a qualified safety assessor responsible for a unique dossier (Product Information File, PIF) that need to be composed for each individual cosmetic coming on the European market.
Safety assessment of cosmetic products in Europe is based on the safety assessment of theingredients and is exposure-driven. This scientific exercise is usual performed based on data obtained through animal experimentation. Since 11 March 2013, the testing and marketing bans that were introduced via the 7th Amendment of the former Cosmetic Directive 76/768/EC, fully apply. This means that oral No-observable-Adverse-Effect-Levels (NOAELs), obtained through sub-chronic toxicity studies or developmental toxicity studies, are no longer available.
The Safety assessment of cosmetic ingredients is not a standardized procedure but should be performed on case-by-case basis using the available data and to apply the best science-based approach.
Notably, checklist approaches and decisions based on hazard alone are considered inappropriate and not adequate to assess safety.
A systematic stepwise approach must be followed for the safety assessment of cosmetic ingredients and cosmetic products, starting from conservative assumptions and including refined approaches, as required and/or appropriate.
The safety assessments should utilize the most up to date approaches available while taking into account current legal/regulatory requirements.