The synthesis of drug substances involves the use of reactive chemicals, reagents, solvents, catalysts, and other processing aids. As a result of chemical synthesis or subsequent degradation, impurities reside in all drug substances and associated veterinary medicinal products (VMPs).
EFSA Guidance on the establishment of the residue definition for dietary risk assessment provides directions for determining the metabolites that require hazard identification and characterisation using scientific tools and methods ((Q)SAR), read-across, threshold of toxicological concern (TTC)) and available data in combination, and for developing an appropriate testing strategy for these compounds.
Under Regulation (EC) 1223/2009 all cosmetic ingredients must be demonstrated that they do not pose any health concerns under normal conditions of use.
E-cigarettes are products that can be used for consumption of nicotine-containing vapour via a mouth piece. Solutions of e-cigarettes usually contain a mixture of propylene glycol (PG), which increases flavour, vegetable glycerin, which increases vapour, nicotine (≤ 20 mg/mL), and flavourings.
Have a look at our recent minireview on read-across: this publication provides a brief overview on key developments on the use of read-across, regulatory and scientific expectations, practical hurdles and open challenges.
Great News! EFSA published the evaluation of the existing QSAR models for prediction of genotoxicity of pesticides and their metabolites, and our colleague Mojca Fuart Gatnik is one of the co-authors.
SAVE THE DATE! Join the workshop: "Quality by Design: science and technology for quality and innovation in Food", Parma 27th May.
