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 Wallace & 8 others Metka 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)

Research output: Contribution to journalArticle

2 Citations (Scopus)
3 Downloads (Pure)

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

Fingerprint

food
animal
inorganic compound
matrix
carcinogen
European Commission
commodity
analytical method
risk assessment
blood
screening
effect
method
decision
opinion
inorganic substance
exposure
laboratory
document

Keywords

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

Cite this

Knutsen, H. K., Alexander, J., Barregård, L., Bignami, M., Brüschweiler, B., Ceccatelli, S., ... EFSA Panel on Contaminants in the Food Chain (CONTAM) (2018). 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. EFSA Journal, 16(7), [e05332]. https://doi.org/10.2903/j.efsa.2018.5332

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

In: EFSA Journal, Vol. 16, No. 7, e05332, 07.2018.

Research output: Contribution to journalArticle

Knutsen, HK, Alexander, J, Barregård, L, Bignami, M, Brüschweiler, B, Ceccatelli, S, Cottrill, B, Dinovi, M, Edler, L, Grasl-Kraupp, B, Hogstrand, C, Nebbia, CS, Oswald, IP, Petersen, A, Rose, M, Roudot, A-C, Schwerdtle, T, Vollmer, G, Vleminckx, C, Wallace, H, Filipič, M, Fürst, P, O'Keeffe, M, Penninks, A, Van Leeuwen, R, Baert, K, Hoogenboom, LR & EFSA Panel on Contaminants in the Food Chain (CONTAM) 2018, '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', EFSA Journal, vol. 16, no. 7, e05332. https://doi.org/10.2903/j.efsa.2018.5332
Knutsen, Helle Katrine ; Alexander, Jan ; Barregård, Lars ; Bignami, Margherita ; Brüschweiler, Beat ; Ceccatelli, Sandra ; Cottrill, Bruce ; Dinovi, Michael ; Edler, Lutz ; Grasl-Kraupp, Bettina ; Hogstrand, Christer ; Nebbia, Carlo Stefano ; Oswald, Isabelle P. ; Petersen, Annette ; Rose, Martin ; Roudot, Alain-Claude ; Schwerdtle, Tanja ; Vollmer, Günter ; Vleminckx, Christiane ; Wallace, Heather ; Filipič, Metka ; Fürst, Peter ; O'Keeffe, Michael ; Penninks, André ; Van Leeuwen, Rolaf ; Baert, Katleen ; Hoogenboom, Laurentius (Ron) ; EFSA Panel on Contaminants in the Food Chain (CONTAM). / 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. In: EFSA Journal. 2018 ; Vol. 16, No. 7.
@article{b4c356fc685c495f82444850d855b595,
title = "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",
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.",
keywords = "reference point for action (RPA), toxicological screening value (TSV), decision limit (CCa), non-allowed pharmacologically active substances",
author = "Knutsen, {Helle Katrine} and Jan Alexander and Lars Barreg{\aa}rd and Margherita Bignami and Beat Br{\"u}schweiler and Sandra Ceccatelli and Bruce Cottrill and Michael Dinovi and Lutz Edler and Bettina Grasl-Kraupp and Christer Hogstrand and Nebbia, {Carlo Stefano} and Oswald, {Isabelle P.} and Annette Petersen and Martin Rose and Alain-Claude Roudot and Tanja Schwerdtle and G{\"u}nter Vollmer and Christiane Vleminckx and Heather Wallace and Metka Filipič and Peter F{\"u}rst and Michael O'Keeffe and Andr{\'e} Penninks and {Van Leeuwen}, Rolaf and Katleen Baert and Hoogenboom, {Laurentius (Ron)} and {EFSA Panel on Contaminants in the Food Chain (CONTAM)}",
note = "The CONTAM Panel acknowledges all European competent institutions and other stakeholders that supported the data collection for the Comprehensive European Food Consumption Database. Adopted: 14 June 2018",
year = "2018",
month = "7",
doi = "10.2903/j.efsa.2018.5332",
language = "English",
volume = "16",
journal = "EFSA Journal",
issn = "1831-4732",
publisher = "John Wiley & Sons, Ltd",
number = "7",

}

TY - JOUR

T1 - 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

AU - Knutsen, Helle Katrine

AU - Alexander, Jan

AU - Barregård, Lars

AU - Bignami, Margherita

AU - Brüschweiler, Beat

AU - Ceccatelli, Sandra

AU - Cottrill, Bruce

AU - Dinovi, Michael

AU - Edler, Lutz

AU - Grasl-Kraupp, Bettina

AU - Hogstrand, Christer

AU - Nebbia, Carlo Stefano

AU - Oswald, Isabelle P.

AU - Petersen, Annette

AU - Rose, Martin

AU - Roudot, Alain-Claude

AU - Schwerdtle, Tanja

AU - Vollmer, Günter

AU - Vleminckx, Christiane

AU - Wallace, Heather

AU - Filipič, Metka

AU - Fürst, Peter

AU - O'Keeffe, Michael

AU - Penninks, André

AU - Van Leeuwen, Rolaf

AU - Baert, Katleen

AU - Hoogenboom, Laurentius (Ron)

AU - EFSA Panel on Contaminants in the Food Chain (CONTAM)

N1 - The CONTAM Panel acknowledges all European competent institutions and other stakeholders that supported the data collection for the Comprehensive European Food Consumption Database. Adopted: 14 June 2018

PY - 2018/7

Y1 - 2018/7

N2 - 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.

AB - 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.

KW - reference point for action (RPA)

KW - toxicological screening value (TSV)

KW - decision limit (CCa)

KW - non-allowed pharmacologically active substances

U2 - 10.2903/j.efsa.2018.5332

DO - 10.2903/j.efsa.2018.5332

M3 - Article

VL - 16

JO - EFSA Journal

JF - EFSA Journal

SN - 1831-4732

IS - 7

M1 - e05332

ER -