Regulatory toxicology: more experts needed

INTRODUCTION
Many years ago, around the mid-1990s, I was discussing with a manager of an important German chemical industry whether he needed more experts to evaluate the dangers and risks of chemical substances.
He, with more experience than me, a young Business Development Manager at the beginning of his career, said “you will see in a few years the demand for experts in the field of risk assessment for human health and environmental impact will increase considerably and there will not be enough resources to devote to this work”. We commented on this issue together! I didn’t believe it much even though already at that time the European regulations and not only were constantly increasing in terms of numbers and depth of requests.

From that time and, particularly, 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. New regulations for agrochemical (Reg. EC. n. 1107/2009) and for biocide products (EC n. 528/2012). New Regulation for Cosmetics Product evaluation (Reg. EC n. 1223/2009) and for Medical Devices (Reg. EU n. 745/2017) and in vitro Diagnostics (EU n. 746/2017) and so on. A revision regarding the Directive on drugs is expected soon.
In the area of food/feed the most important is surely the Novel Food Regulation (EU n. 2283/2015 and its amendments) which regulate the introduction of food considered novel (new) as for some criteria. In the pharma area a number of ICH and or EMA guidances regarding the PDE (Permissible Daily Exposure) assessment for multipurpose plants, OEL (Occupational Exposure Level), genotoxic impurities assessment in active, principle, final products, solvent and for elemental impurities have been delivered. Environmental Risk Assessment (ERA) is covered by the first EMA guidance delivered in 2006 and following documents.
Additionally, at European level, The European Green Deal  along the Chemical Strategy for Sustainability (2030 Vision) to be applied for the next years up to 2050 in the European Union, pushed the need of specific experts including economist to get its targets. The EU GD presents a roadmap for making the EU’s economy sustainable by turning climate and environmental challenges into opportunities across all policy areas and making the transition just and inclusive for all. The European Green Deal aims to boost the efficient use of resources by moving to a clean, circular economy and stop climate change, revert biodiversity loss and cut pollution. It outlines investments needed and financing tools available and explains how to ensure a just and inclusive transition.