Regulatory affairs: New challenges and new skills needed
In the last two decades, an impressive increase of regulations have been released at a worldwide level but particularly in the western countries and mainly in the European union. All these new pieces of regulations have been accompanied by millions of pages of technical guidelines. In many cases different regulations are connected each other and, therefore, need to be studied and carefully evaluated on the whole. We are obviously referring to the regulations which drive our knowledge regarding the safety of chemical compounds including drugs and cosmetics but also addressed to medical devices and food/feed.
It’ is not possible for limited space in this paper to list all the regulations we are referring to but we can just remember the most important: Reg. EC n. 1907/2006 (called Reach) and the additional Reg. EC n. 1272/2008 (CLP) for the classifications of substances and mixtures. A huge number of regulations on Safety Data Sheet preparation criteria started with the implementation of the Directive EEC 91/155 and lasting (at the moment ) with the EU Reg. 830/2015. New regulations for agrochemi ...