Information needed to support hazard identification and risk assessment of toxic substances.
1993 Decision support methodologies international workshop. Atlanta GA USA, 1993/10/18.
Today pharmacokinetic data are not routinely required for food safety evaluation.
The new Red Book, the Center's outline of animal testing protocols, does suggest some pharmacokinetic studies, but their use is still limited.
But the situation is changing and the role of pharmacokinetics and physiologically based pharmacokinetic modeling will probably increase for several reasons. (1) The increasing role of quantitative risk assessment and regulations acknowledging and permitting some level of risk.
This places a demand of greater quantitation of risk and emphasizes the need for better measurement of effective dose.
We made need to consider more carefully the possible nonlinear pharmacokinetic effects in high-to-low dose extrapolation. (2) The increasing need to understand more about a chemical's mechanism of action prior to a major corporate commitment.
The increasing cost of mistakes in judgment regarding a chemical's prospects in the commercial and regulatory arena are demanding a better and deeper understanding of possible toxic effects. (3) The increasing desire to expand the use of a successful additive beyond the spectrum of the uses covered in the original approval.
This usually means the request for a higher ADI.
This must be based on more refined toxicity testing and better estimate of effective dose in order to permit the reduction of the SF. (4) The advent of novel foods for which conventional toxicological methods are inappropriate.
Mots-clés Pascal : Aliment, Additif alimentaire, Toxicité, Concentration maximale admissible, Evaluation, Homme, Etats Unis, Amérique du Nord, Amérique, Dose journalière, Food and Drug Administration, Dose sans effet
Mots-clés Pascal anglais : Food, Food additive, Toxicity, Maximum permissible concentration, Evaluation, Human, United States, North America, America, Daily dose, Food and Drug Administration, No observed effect level
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 95-0525926
Code Inist : 002B03H. Création : 01/03/1996.