The practice of risk assessment and regulation of substances has largely developed as a patchwork of circumstantial additions to a nowadays more or less shared international toolbox. The dominant drivers from the US and Europe have pursued remarkably different approaches in the use of these tools for regulation, i.e., a more risk-based approach in the US and a more precautionary approach in Eur...

Noteworthy, both European agencies most recently have started a discussion toward strategic planning including the tools and ways safety assessments should be done. This represents a major change from their former more receiving and executing roles. It is not clear how much of this change is harmonized and coordinated, e.g., by the Agency Network Scientific Advice54 (ANSA), but they appear rath...

Case presentation: J.A.P.N., male, 7 years old, born at full-term, without gestational complications. He presented significant delay in motor development, started crawling 8 months, but never acquired gait. In addition, he palpebral ptosis since birth. evolved throughout his life with a pattern of distal atrophy the upper and lower limbs, addition to recurrent episodes hospitalizations due rhab...

The REACH Regulation requires information on acute oral toxicity for substances produced or imported in quantities greater than one ton per year. When registering, animal testing should be used as last resort. The standard acute oral toxicity test requires use of animals. Therefore, the European Chemicals Agency examined whether alternative ways exist to generate information on acute oral toxic...

Residual styrene present in polystyrene food packaging may migrate into food at low levels. To assure safe use, safe exposure levels are derived for consumers potentially exposed via food using No/Low Adverse Effect Levels from animal and human studies and assessment factors proposed by European organisations (EFSA, ECHA, ECETOC). Ototoxicity and developmental toxicity in rats and human ototoxi...

The enantioselectivity of epoxide hydrolase from Agrobacterium radiobacter (EchA) was improved using error-prone PCR and DNA shuffling. An agar plate assay was used to screen the mutant libraries for activity. Screening for improved enantioselectivity was subsequently done by spectrophotometric progress curve analysis of the conversion of para-nitrophenyl glycidyl ether (pNPGE). Kinetic resolut...