“…In addition to scientific disadvantages such as unknown exact composition, seasonal and geographical lot-to-lot variability (Baker, 2016b), and unintended interaction with test substances (Groothuis et al, 2015;Kramer et al, 2009), which can lead to unexpected or undesired outcomes, serious safety concerns for laboratory personnel in terms of endotoxins, mycoplasma and viral contaminants or prion proteins (Dormont, 1999;Wessman and Levings, 1999;Hawkes, 2015), as well as ethical concerns vine fetuses in the last third of their development, if it takes place on EU territory, is thus a procedure under the Directive because the serum is clearly used for scientific purposes and is extracted from a living animal. Therefore, the procedures would need to undergo a project review and authorization by a competent authority.…”