DIN CEN ISO/TS 17919:2014-03

Botulinum neurotoxin-producing clostridia are ubiquitous in the environment. Botulism is a severe neuroparalytic disease resulting from the action of botulinum neurotoxins (BoNTs). Seven different serotypes of BoNTs (type A to G) and a number of subtypes have been identified to date. BoNT type A (BoNT/A), type B (BoNT/B), type E (BoNT/E) and type F (BoNT/F) are mainly responsible for botulism in humans and the genes encoding these toxins are the targets of this Technical Specification. BoNT type A, B, E, and F-producing clostridia exist in four physiologically distinct groups (Group I Clostridium botulinum, Group II C. botulinum, C. baratii, C. butyricum). This Technical Specification specifies a horizontal method for the molecular detection of clostridia carrying botulinum neurotoxin A, B, E, and F genes by a PCR method. This method detects the genes and not the toxins, therefore a positive result does not necessarily mean the presence of these toxins in the sample investigated. This Technical Specification is applicable to products for human consumption, animal feed, and environmental samples. The PCR assays for detection of genetic sequences encoding specific toxin types are described in annexes. This Technical Specification serves for consumer health protection. The committee responsible for this standard is NA 057-01-06-01 AK "Polymerase-Kettenreaktion zum Nachweis von Mikroorganismen" ("Polymerase chain reaction for the detection of microorganisms") at DIN.