title: Regulatory risk assessments: Is there a need to reduce uncertainty and enhance robustness?
abstract: A critical evaluation of several recent regulatory risk assessments has been undertaken. These relate to propyl paraben (as a food additive, cosmetic ingredient or pharmaceutical excipient), cobalt (in terms of a safety-based limit for pharmaceuticals) and the cancer Threshold of Toxicological Concern as applied to food contaminants and pharmaceutical impurities. In all cases, a number of concerns can be raised regarding the reliability of the current assessments, some examples being absence of data audits, use of single-dose and/or non-good laboratory practice studies to determine safety metrics, use of a biased data set and questionable methodology and lack of consistency with precedents and regulatory guidance. Drawing on these findings, a set of recommendations is provided to reduce uncertainty and improve the quality and robustness of future regulatory risk assessments.
authors.affiliation: Xiphora Biopharma Consulting, Bristol, UK snodind@xiphora.com.
authors.forename: D J
authors.initials: DJ
authors.lastname: Snodin
mesh_terms: D000818:Animals; D003035:Cobalt / Q000633:toxicity*; D003358:Cosmetics / Q000633:toxicity; D005079:Excipients / Q000633:toxicity; D005503:Food Additives / Q000633:toxicity; D033161:Government Regulation; D006801:Humans; D010226:Parabens / Q000633:toxicity*; D018570:Risk Assessment / Q000331:legislation & jurisprudence*; D035501:Uncertainty
chemical_list: D003358:Cosmetics; D005079:Excipients; D005503:Food Additives; D010226:Parabens; D003035:Cobalt; C006068:propylparaben
keywords: Propyl paraben; cobalt; cosmetics ingredient; food additive; impurity; non-cancer TTC; pharmaceutical excipient; risk assessment