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Scientific Opinion EFSA Journal 20xx; volume(issue):xxxx 1 SCIENTIFIC OPINION 2 Technical Guidance on the assessment of the toxigenic potential of Bacillus 1 3 and related genera used in animal nutrition 4 EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)2,3 5 European Food Safety Authority (EFSA), Parma, Italy 6 ABSTRACT 7 8 9 10 11 KEY WORDS 12 13 14 15 16 1 On request from EFSA, Question No EFSA-Q-2009-00973, adopted on DD Month YYYY. 2 Panel members: Gabriele Aquilina, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Joop de Knecht, Noël Albert Dierick, Mikolaj Antoni Gralak, Jürgen Gropp, Ingrid Halle, Christer Hogstrand, Reinhard Kroker, Lubomir Leng, Secundino Lopez Puente, Anne-Katrine Lundebye Haldorsen, Alberto Mantovani, Giovanna Martelli, Miklós Mézes, Derek Renshaw, Maria Saarela, Kristen Sejrsen and Johannes Westendorf. Correspondence: [email protected] 3 Acknowledgement: The Panel wishes to thank the members of the Working Group on Micro-organisms including Atte von Wright, Per Einar Granum and Christophe Nguyen-thé for the preparation of this opinion. Suggested citation: EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP); Error! Reference source not found.. EFSA Journal 20xx; volume(issue):xxxx. [12 pp.]. doi:10.2903/j.efsa.20NN.NNNN. Available online: www.efsa.europa.eu © European Food Safety Authority, 20xx 1 Technical guidance on Bacillus safety 17 TABLE OF CONTENTS 18 Abstract .................................................................................................................................................... 1 19 Table of contents ...................................................................................................................................... 2 20 Terms of reference ............................................................................................................................... 3 21 1. Introduction ...................................................................................................................................... 4 22 2. Taxonomy ......................................................................................................................................... 4 23 2.1. Current taxonomy and phylogeny of Bacillus and related genera (other than B. cereus 24 group) ............................................................................................................................................... 4 25 2.2. Current taxonomy and phylogeny of the Bacillus cereus group ............................................. 5 26 3. Safety concerns caused by Bacillus species ..................................................................................... 5 27 3.1. Virulence factors found in Bacillus and related genera (other than B. cereus group) ............ 5 28 3.2. Virulence factors of Bacillus cereus responsible for gastro intestinal diseases ...................... 7 29 4. Methods to detect toxigenic potential .............................................................................................. 7 30 4.1. Bacillus and related genera (other than B. cereus group) ....................................................... 8 31 4.2. Bacillus cereus taxonomic group ............................................................................................ 8 32 References ................................................................................................................................................ 8 33 Annex ..................................................................................................................................................... 12 34 35 EFSA Journal 20xx; volume(issue):xxxx 2 Technical guidance on Bacillus safety 36 BACKGROUND AS PROVIDED BY EFSA 37 38 Regulation (EC) No 1831/20034 establishes the rules governing the Community authorisation of 39 additives for use in animal nutrition. Moreover, Article 7(6) of this Regulation provides for the 40 European Food Safety Authority (EFSA) to publish detailed guidance to assist applicants in the 41 preparation and presentations of applications. 42 EFSA has the responsibility to assess the safety of feed additives before an authorisation is granted. A 43 considerable amount of feed additives are composed by micro-organisms. As a tool to simplify and 44 harmonise within EFSA the assessment of micro-organisms used in food and feed, the Scientific 45 Committee published one opinion on the introduction of a Qualified Presumption of Safety (QPS) 46 approach for the assessment of selected micro-organisms (EFSA, 2007). This last opinion has been 47 updated on a yearly basis, and will be continuously updated in the future. The QPS approach is 48 currently used by the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) 49 in the assessment of microbial products subject to a pre-authorisation assessment. 50 One of the genera included in this opinion is Bacillus, which is commonly found in a number of feed 51 additives. The QPS opinion imposes, for Bacillus, the qualification that the absence of food poisoning 52 toxins, surfactant activity or enterotoxic activity. In 2000 the Scientific Committee for Animal 53 Nutrition (SCAN) adopted an opinion on the safety of use of Bacillus species in animal nutrition. 54 Since the adoption of the SCAN opinion on this matter, new scientific data have become available that 55 call for a revision of the taxonomy and toxin production of the Bacillus species. Therefore, the 56 FEEDAP Panel considers it necessary to update this document in order to provide applicants with 57 proportionate and up-to-date guidance on how to conduct the safety assessment of these products. 58 59 TERMS OF REFERENCE 60 The FEEDAP Panel is requested produce a Technical Guidance on the safety of use of Bacillus 61 species in animal nutrition taking into account the opinion from the Scientific Committee for Animal 62 Nutrition (SCAN) on the safety of use of Bacillus species in animal nutrition and any new scientific 63 data available. 64 65 4 OJ L 268, 18.10.2003, p. 29. EFSA Journal 20xx; volume(issue):xxxx 3 Technical guidance on Bacillus safety 66 67 1. INTRODUCTION 68 A number of strains of Bacillus species are used in animal production either directly as microbial feed 69 additives or as the source of other feed additives, notably enzymes. Approximately half of the present 70 production of bulk enzymes derives from strains of this or related genera. Regulation (EC) No 71 1831/2003 requires that all feed additives, including microorganisms, are assessed for safety before 72 being placed on the market. The principal safety concern for consumers and, to a lesser extent 73 livestock, associated with Bacillus (and related genera) is a capacity for toxin production. However, 74 the capacity for toxin production is unevenly distributed over the genus, occurring frequently in some 75 species and more rarely, if at all, in others. For this reason the Scientific Committee on Animal 76 Nutrition (SCAN) recommended that the use of strains of the Bacillus cereus taxonomic group, a 77 group containing many known pathogenic strains, be strongly discouraged, but recognised that strains 78 from other Bacillus species may be considered safe (EC, 2000). The FEEDAP Panel concurs with this 79 general position. 80 The Qualified Presumption of Safety (QPS) approach to the safety assessment of microorganisms 81 adopted by EFSA is considered applicable to most of the commercially relevant Bacillus species. This 82 approach requires the unambiguous identification of the strain being assessed, a demonstration of a 83 lack of antibiotic resistance determinants and, in particular, evidence that the strain lacks a capacity for 84 toxin production. Any other strain of Bacillus or related genera not falling within the scope of the QPS 85 approach would also require an assessment of toxigenic potential. To date, applicants seeking 86 regulatory approval for a novel strain of Bacillus have relied for guidance on how to assess toxigenic 87 potential on the SCAN Opinion on the safety of use of Bacillus species in animal nutrition published 88 in 2000. The SCAN guidance takes as its basis the then existing knowledge on the structure and 89 biogenesis of toxins produced by B. cereus, assuming that toxins found in other Bacillus species 90 would have sufficiently similar properties to be detected by the methods developed for the B. cereus 91 group. Subsequent to the SCAN opinion there have been significant developments both in the 92 knowledge of toxins prevalent in the B. cereus group and, more importantly, in the toxigenic potential 93 of other Bacillus species and their prevalence. These developments are reviewed below. In addition, 94 more refined methods of genetic analysis are now more widely available. 95 In view of the need to update the guidance contained within the original SCAN opinion, the FEEDAP 96 Panel takes the opportunity to adopt the revision as part of the technical guidance provided to 97 applicants seeking authorisation of feed additives. 98 2. Taxonomy 99 100 2.1. Current taxonomy and phylogeny of Bacillus and related genera (other than B. 101 cereus group) 102 Since the first edition of the Bergey’s Manual of Systematic Bacteriology, the structure and content of 103 the genus Bacillus have been substantially modified (Claus and Berkeley, 1986; Ash et al., 1993; 104 Priest, 1993). It was recognised as being very heterogeneous both genetically and phenotypically and 105 Ash et al.,
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