Introduction: The Safety Assessment in a consolidated workflow
The preparation of the PIF, CPSR and Safety Assessment 1 is a key point for the correct application of Reg. 1223/2009. Their realization, however, presents various criticalities deriving from many factors, which have been identified and focused on during a long “on field” experience of the writers. The study of the legislation in its application and of the critical issues identified, have promoted an ambitious project, which has resulted in the creation of an innovative tool, now made available to cosmetic companies by Cosmetica Italia Servizi, developed by the Angel Consulting team with the scientific supervision of the Department of Earth, Environment and Life Sciences (DISTAV) of the University of Genoa.
First of all: What is a Safety Assessment?
From the point of view of a Regulatory Area Manager, the PIFCPSR-Safety Assessment 1 is sometimes the purpose of their life. From the CEO’s perspective, it’s sometimes just a cost.
Each of them would carry out the Safety Assessment in a different way, but none of them is right, and this is why a shared and opened vision is needed.
The purpose from which the Cosmetic Product Safety Report/Safety Assessment was born is quite intuitive: the current legislation is based on self-monitoring, with a post-market survey carried out by the Competent Authorities. Among the obligations, in addition to carrying out controls and of toxicological checks, the Responsible Person must document the study path that led to the decision to place a product on the market. And here is a first answer to the starting question: the Safety Assessment is a decisionmaking tool.
