Risk Assessment of Bacillus coagulans Used as "Other Substances"
Danica Grahek-Ogden *
Norwegian Scientific Committee for Food Safety (VKM), Norway.
Karl Eckner
Norwegian Scientific Committee for Food Safety (VKM), Norwegian Veterinary Institute (VI), Norway.
Georg Kapperud
Norwegian Scientific Committee for Food Safety (VKM), Norwegian Institute of Public Health (FHI), Norway.
Jørgen Lassen
Norwegian Scientific Committee for Food Safety (VKM), Norway.
Judith Narvhus
Norwegian Scientific Committee for Food Safety (VKM), Norwegian University of Life Sciences (NMBU), Norway.
Truls Nesbakken
Norwegian Scientific Committee for Food Safety (VKM), Norwegian University of Life Sciences (NMBU), Norway.
Lucy Robertson
Norwegian Scientific Committee for Food Safety (VKM), Norwegian University of Life Sciences (NMBU), Norway.
Jan Thomas Rosnes
Norwegian Scientific Committee for Food Safety (VKM), NOFIMA, Norway.
Olaug Taran Skjerdal
Norwegian Scientific Committee for Food Safety (VKM), Norwegian Veterinary Institute (VI), Norway.
Eystein Skjerve
Norwegian Scientific Committee for Food Safety (VKM), Norwegian University of Life Sciences (NMBU), Norway.
Line Vold
Norwegian Scientific Committee for Food Safety (VKM), Norwegian Institute of Public Health (FHI), Norway.
Siamak Yazdankhah
Norwegian Scientific Committee for Food Safety (VKM), Norway.
Yngvild Wasteson
Norwegian Scientific Committee for Food Safety (VKM), Norwegian University of Life Sciences (NMBU), Norway.
*Author to whom correspondence should be addressed.
Abstract
The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the risk of "other substances" in food supplements sold in Norway. These risk assessments will provide NFSA with the scientific basis while regulating the addition of “other substances” to food supplements and other foods.
"Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitamins or minerals that have a nutritional and/or physiological effect. It is added mainly to food supplements, but also to other foods. VKM has not in this series of risk assessments of "other substances" evaluated any claimed beneficial effects from these substances, only possible adverse effects.
The present report is a risk assessment of Bacillus coagulans, and it is based on previous risk assessments and articles retrieved from a literature search.
The risk of B. coagulans was assessed for the general population. However, in previous assessments of “probiotics” published by VKM, concerns have been identified for specific groups. Therefore, the risk was assessed for the age group with immature gastro-intestinal microbiota (age group 0-36 months), population with mature gastro-intestinal microbiota (>3 years) and vulnerable groups independent of age. VKM has also assessed the risk of B. coagulans in food supplements independent of the dose and have assessed exposure in general terms.
Other sources of B. coagulans, such as foods, have not been included in the present risk assessment.
VKM concludes that it is unlikely that B. coagulans causes adverse health effects in the general healthy population with mature gastro-intestinal tract. Acquired resistance genes have been detected in this species and the assessment of susceptibility to antibiotics for each single strain is required.
However, no data on long-term adverse effects on infants and young children were identified. As evidence is accruing that the early microbial composition of the neonatal gut is important for the development of the gut microbiota and the immune system of the growing child, it is not possible to exclude that a daily supply of a single particular bacterial strain over a prolonged period of time to an immature gastro-intestinal tract may have long-term, although still unknown, adverse effects on that development.
Keywords: Adverse health effect, negative health effect, norwegian food safety authority, norwegian scientific committee for food safety, other substances, risk assessment, vkm, Bacillus coagulans, food supplement.