Review of Mycotoxin-Detoxifying Agents Used As Feed Additives: Mode of Action, Efficacy and Feed/Food Safety1
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SCIENTIFIC REPORT submitted to EFSA Review of mycotoxin-detoxifying agents used as feed additives: mode of action, efficacy and feed/food safety1 Prepared by AFSSA (Agence Française de Sécurité Sanitaire des Aliments): Caroline BOUDERGUE, Christine BUREL, Sylviane DRAGACCI, Marie-Christine FAVROT, Jean-Marc FREMY, Claire MASSIMI, Philippe PRIGENT - FRANCE CODA-CERVA (Centre d‟étude et de recherches vétérinaires et agrochimiques): Philippe DEBONGNIE, Luc PUSSEMIER - BELGIUM INRA Clermont-Ferrand (Institut National de la Recherche Agronomique): Hamid BOUDRA, Diego MORGAVI - FRANCE INRA Toulouse (Institut National de la Recherche Agronomique): Isabelle OSWALD - FRANCE IRTA (Institut de Recerca i Tecnologia Agroalimentaries): Anna PEREZ - SPAIN ISPA (Istituto di Scienze delle Produzioni Alimentari): Giuseppina AVANTAGGIATO - ITALY 1 Reference number of the call for proposal: CFP/EFSA/FEEDAP/2009/01 The present document has been produced and adopted by the bodies identified above as author(s). In accordance with Article 36 of Regulation (EC) No 178/2002, this task has been carried out exclusively by the author(s) in the context of a grant agreement between the European Food Safety Authority and the author(s). The present document is published complying with the transparency principle to which the European Food Safety Authority is subject. It may not be considered as an output adopted by EFSA. EFSA reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the authors. 1 Abstract Mycotoxins are small and quite stable molecules which are extremely difficult to remove or eradicate, and which enter the feed chain while keeping their toxic properties. The mycotoxins of major concern as feed contaminants that are potentially removable from feed, are mainly aflatoxins, ochratoxin A, Fusarium toxins (trichothecenes like deoxynivalenol, diacetoxyscirpenol, nivalenol, T2-toxin/HT2-toxin, zearalenone and fumonisins). One of the strategies for reducing the exposure to mycotoxins is to decrease their bioavailability by including various mycotoxin-adsorbing agents in the compound feed, which leads to a reduction of mycotoxin uptake as well as distribution to the blood and target organs. Another strategy is the degradation of mycotoxins into non-toxic metabolites by using biotransforming agents such as bacteria/fungi or enzymes. The specific objectives of the project are to provide a critical and extensive review on mycotoxins detoxifying agents. To this purpose, the consortium performed: The compilation and critical analysis of all published data available in the scientific literature ; The compilation and critical analysis of “grey literature” published worldwide (searches in patents databases) ; The audition of companies involved in the development and manufacture of mycotoxin- detoxifying agents, as well as stakeholders of feed manufacturer‟s; Comparison, validation and synthesis of the reviewed materials. The report made an inventory of agents which may possibly reduce the impact of mycotoxins in feedstuffs by reviewing the literature and by collecting data from feed manufacturer‟s or from information published on the Internet. The present report gives also the mechanism of action of the agents listed, by reviewing in vitro studies and identifies the relevant end-points to be studied when testing the efficacy of mycotoxin- detoxifying agents in in vivo trials. Finally this document points out the benefits and risks associated with the potential uses of these agents and gives recommendations for the assessment of such products as feed additives. Key words Mycotoxin, mycotoxin-detoxifying agents, adsorbing agents, biotransforming agents, poultry, pigs, ruminants, feed. The present document has been produced and adopted by the bodies identified above as author(s). In accordance with Article 36 of Regulation (EC) No 178/2002, this task has been carried out exclusively by the author(s) in the context of a grant agreement between the European Food Safety Authority and the author(s). The present document is published complying with the transparency principle to which the European Food Safety Authority is subject. It may not be considered as an output adopted by EFSA. EFSA reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the authors. 2 Terms of reference This grant was awarded by EFSA to: AFSSA CODA-CERVA INRA Clermont-Ferrand INRA Toulouse IRTA ISPA Grant title: Review of mycotoxin detoxifying agents used as feed additives: mode of action, efficacy and feed/food safety. Grant number: CFP/EFSA/FEEDAP/2009/01. Acknowledgements On behalf of the whole consortium, we would like to thank: - Dr Jorina Geys from the CERVA and professors Larondelle and Schneider from the Catholic University of Louvain (Belgium) for their collaboration to this project; - Gilbert Postollec and Charlotte Valat from AFSSA Ploufragran, for their help and participation during the writing of this report; - Jean-Pierre Jouany from INRA Clermont-Ferrand for his support; - The scientific experts from the Scientific Committee specialized in Animal Feeding from AFSSA, in particular François Grosjean, Michel Etienne, Bernard-Marie Paragon, and Philippe Schmidely. The present document has been produced and adopted by the bodies identified above as author(s). In accordance with Article 36 of Regulation (EC) No 178/2002, this task has been carried out exclusively by the author(s) in the context of a grant agreement between the European Food Safety Authority and the author(s). The present document is published complying with the transparency principle to which the European Food Safety Authority is subject. It may not be considered as an output adopted by EFSA. EFSA reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the authors. 3 Table of Contents Abstract .................................................................................................................................................... 2 Key words ................................................................................................................................................ 2 Terms of reference ................................................................................................................................... 3 Acknowledgements .................................................................................................................................. 3 Glossary .................................................................................................................................................... 6 List of tables ............................................................................................................................................. 8 List of figures ........................................................................................................................................... 8 List of annexes ......................................................................................................................................... 9 1. BACKGROUND AND OBJECTIVES ......................................................................................... 10 1.1. Objectives ............................................................................................................................. 10 1.2. Overview on the mycotoxin hazard and involvement in the feed chain ............................... 10 1.2.1. Assessment .......................................................................................................................... 10 1.2.2. Existing risk management measures ................................................................................... 15 2. DESCRIPTION OF SUBCATEGORIES OF MYCOTOXIN DETOXIFYING AGENTS .......... 19 2.1. Definition of mycotoxin-detoxifying agents subcategories .................................................. 19 2.2. Inventory of agents which may possibly reduce the impact of mycotoxins in feedstuffs: review of the literature ....................................................................................................................... 19 2.2.1. Mycotoxin-adsorbing agents ............................................................................................... 19 2.2.2. Mycotoxin-biotransforming agents ..................................................................................... 22 2.3. Comprehensive list of mycotoxin-detoxifying agents (marketed or on way of development), indications for use and composition: request from companies .......................................................... 33 2.3.1. Request from companies ..................................................................................................... 33 2.3.2. Answers collected from companies ..................................................................................... 33 2.4. Collection of information on mycotoxin-detoxifying agents which has been published on the Internet ......................................................................................................................................... 34 3. MECHANISMS OF ACTION OF MYCOTOXIN-DETOXIFYING AGENTS STUDIED IN VITRO....................................................................................................................................................