title: Zero tolerances in food and animal feed -- are there any scientific alternatives? A European point of view on an international controversy.
abstract: A number of zero tolerance provisions are contained in both food and animal feed law, e.g. for chemical substances whose occurrence is not permitted or is directly prohibited in food or animal feed. In the European Union, bans of this kind were introduced to give consumers and animals the greatest possible protection from substances with a possible hazard potential within the intendment of the hazard prevention principles and current precautionary measures. This also applies to substances for which an acceptable daily intake cannot be derived and a maximum residue limit cannot, therefore, be established, e.g. due to missing or inadequate toxicological data. Zero tolerances are also under discussion as trade barriers because their use has triggered numerous legal disputes. This paper draws together the results of an evaluation of alternative risk assessment methods to be used for the risk assessment of substances to which currently only zero tolerances apply. It will demonstrate that, depending on the available toxicological data, a scientifically sound risk assessment may still be possible. In this context, the two concepts - margin of exposure and threshold of toxicological concern - are very promising approaches. Until the scientific and sociopolitical discussions have been completed, it is essential that the principle of zero tolerances be upheld, especially for those substances which may be genotoxic carcinogens. In microbiology, there is no legal room for manoeuvre with regard to food safety criteria established for reasons of consumer health protection on the basis of scientific assessments.
authors.affiliation: Federal Institute for Risk Assessment, Section 55, - Residues of Medicinal Products, Diedersdorfer Weg 1, 12277 Berlin, Germany. bfr@bfr.bund.de
authors.forename: Thomas
authors.initials: T
authors.lastname: Heberer
authors.forename: Monika
authors.initials: M
authors.lastname: Lahrssen-Wiederholt
authors.forename: Helmut
authors.initials: H
authors.lastname: Schafft
authors.forename: Klaus
authors.initials: K
authors.lastname: Abraham
authors.forename: Hildegard
authors.initials: H
authors.lastname: Pzyrembel
authors.forename: Klaus Juergen
authors.initials: KJ
authors.lastname: Henning
authors.forename: Marianna
authors.initials: M
authors.lastname: Schauzu
authors.forename: Juliane
authors.initials: J
authors.lastname: Braeunig
authors.forename: Mario
authors.initials: M
authors.lastname: Goetz
authors.forename: Lars
authors.initials: L
authors.lastname: Niemann
authors.forename: Ursula
authors.initials: U
authors.lastname: Gundert-Remy
authors.forename: Andreas
authors.initials: A
authors.lastname: Luch
authors.forename: Bernd
authors.initials: B
authors.lastname: Appel
authors.forename: Ursula
authors.initials: U
authors.lastname: Banasiak
authors.forename: Gaby Fleur
authors.initials: GF
authors.lastname: Böl
authors.forename: Alfonso
authors.initials: A
authors.lastname: Lampen
authors.forename: Reiner
authors.initials: R
authors.lastname: Wittkowski
authors.forename: Andreas
authors.initials: A
authors.lastname: Hensel
mesh_terms: D000821:Animal Feed; D005062:European Union; D005502:Food; D005503:Food Additives; D005506:Food Contamination; D005516:Food Microbiology; D030841:Food, Genetically Modified; D007881:Legislation, Food; D010573:Pesticide Residues; D030821:Plants, Genetically Modified; D018570:Risk Assessment
chemical_list: D005503:Food Additives; D010573:Pesticide Residues