Update: methodological principles and scientific methods to be taken into account when establishing Reference Points for Action (RPAs) for non‐allowed pharmacologically active substances present in food of animal origin

Helle Katrine Knutsen, Jan Alexander, Lars Barregård, Margherita Bignami, Beat Brüschweiler, Sandra Ceccatelli, Bruce Cottrill, Michael Dinovi, Lutz Edler, Bettina Grasl-Kraupp, Christer Hogstrand, Carlo Stefano Nebbia, Isabelle P. Oswald, Annette Petersen, Martin Rose, Alain-Claude Roudot, Tanja Schwerdtle, Günter Vollmer, Christiane Vleminckx, Heather WallaceMetka Filipič, Peter Fürst, Michael O'Keeffe, André Penninks, Rolaf Van Leeuwen, Katleen Baert, Laurentius (Ron) Hoogenboom, EFSA Panel on Contaminants in the Food Chain (CONTAM)

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Abstract

EFSA was asked by the European Commission to update the Scientific Opinion on methodological principles and scientific methods to be taken into account when establishing Reference Points for Action (RPAs) for non‐allowed pharmacologically active substances in food of animal origin. This guidance document presents a simple and pragmatic approach which takes into account both analytical and toxicological considerations. The RPA shall be based on the reasonably achievable lowest residue concentration that can unequivocally be determined by official control laboratories, i.e. the reasonably achievable lowest decision limit (CCα). The aim is to check whether this concentration is low enough to adequately protect the consumers of food commodities that contain that substance. The proposed step‐wise approach applies toxicological screening values (TSVs), based on genotoxic potential, pharmacological activity, as well as other effects of the substance. The highest dietary exposure corresponding to the reasonably achievable lowest CCα for the substance has to be estimated and compared with the TSV. Where equal to or lower than the TSV, the reasonably achievable lowest CCα can be accepted as the RPA. If higher, the sensitivity of the analytical method needs to be improved. In the case where no further analytical improvements are feasible within a short to medium time frame, a substance‐specific risk assessment should be considered. This also applies when the potential adverse effects do not allow use of the decision tree, as for high potency carcinogens, inorganic substances or compounds with allergenic effects or causing blood dyscrasias. The CONTAM Panel concluded that RPAs should be food matrix independent. RPAs cannot be applied to non‐edible matrices, which are also monitored for non‐allowed pharmacologically active substances.
Original languageEnglish
Article numbere05332
Number of pages25
JournalEFSA Journal
Volume16
Issue number7
Early online date24 Jul 2018
DOIs
Publication statusPublished - Jul 2018

Keywords

  • reference point for action (RPA)
  • toxicological screening value (TSV)
  • decision limit (CCa)
  • non-allowed pharmacologically active substances

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