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Name of the ingredient
Streptococcus salivarius
Synonym
Streptococcus salivarius M18, BLIS M18™
Definition of the ingredient
Streptococcus salivarius is a bacterium found as part of the normal human oral microflora, predominately colonising the oral cavity (teeth, tongue). They are Gram positive, cocci which grow in chains or pairs, are catalase negative and nonmotile. On blood agar they form non-haemolytic colonies. They form distinctive mucoid colonies when grown on sucrose agar, due to the production of extracellular polysaccharides.
BLIS M18™ is a freeze-dried culture of Streptococcus salivarius M18 (NLT 1 x 1011 CFU/g) in a protective matrix of food-grade Maltodextrin, Trehalose Dihydrate and Lactitol.
S. salivarius M18 has been deposited in the American Type Culture Collection (ATCC) as ATCC BAA 2593. It also has been lodged with the German Collection of Microorganisms and Cell Cultures Deutsche Sammlung von Mikroorganismen und Zellkuturen GmbH) under the accession number DSM 14685. The strain is also patented for the prevention of dental caries (Patent number: US 7,226,590 B2) in the following territories: New Zealand, United States, European Union, Canada, Australia, China, India, Denmark, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland and the United Kingdom.
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Appearance | Visual evaluation | Free flowing off-white powder |
| Odour/taste | Organoleptic evaluation | Proteinaceuous taste |
| Characteristics | ||
| Particle size | Sieve analysis | 90% NMT 500µm |
| Water activity (aw) | USP <1112> | NMT 0.25 |
| Identification | ||
| Microscopic morphology | USP <1113> Gram staining |
Gram reaction: positive Cellular shape: cocci in chains or pairs |
| Macroscopic morphology | Visual examination of growth on Mitis salivarius agar at 37°C in 5% CO2 in air after 24-48 hr |
Colony size: 1-2 mm in diameter Colony shape:
Colony colour: blue Colony texture: mucoid |
| Visual examination of growth on Blood agar [Columbia Agar Base with 5% human blood] at 37°C in 5% CO2 in air after 24-48 hr |
Colony size: NMT 1 mm in diameter Colony shape:
Colony Colour: white Colony Texture: butyrous Haemolysis: None |
|
| Biochemical profile |
USP <1113> biochemical tests and/ or Automated microbial identification test (e.g. API 20 Strep test system) |
Negative for: catalase Positive for: acetoin production, β-glucosidase, α-galactosidase, β-galactosidase leucine aminopeptidase, D-lactose, D-trehalose, inulin, and D-raffinose. |
| Molecular identification of strain | Heng NC (2011)[1] | Matches the sequence for S. salivarius M18 |
| Deferred antagonism, P- typing producer | Tagg and Bannister (1979)[2], Burton (2013)[3] |
Matches the fingerprint for S. salivarius M18 (677) |
| Assay | ||
| Streptococcus salivarius M18 | Viable plate count on CAB K12 agar cultured at 37°C in 5% CO2 in air after 24-48 hr per Ishijama (2012)[4], Burton (2011)[5] modified to enumerate M18 | NLT 1 x 1011 CFU/g |
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Microbiology | ||
| Total aerobic microbial count @ 35˚C | Compendium 5th Edition 2015, Chapter 8 (excluding S. salivarius M18) | NMT 10,000 CFU/g |
| Coliforms | Compendium 5th Edition 2015 chapter 9 modified | Not detected/g |
| E. coli | Compendium 5th Edition 2015 chapter 9 modified | Not detected/g |
| Salmonella | ISO 6579:2002 (E) | Not detected/25g |
| Mesophilic aerobic spore count @ 35°C | Compendium 5th Edition 2015 chapter 23 | NMT 200 CFU/g |
| Coagulase producing Staphylococcus aureus | ISO 6888-3:2003 | Not detected/g |
| Moulds | BP | NMT 50 CFU/g |
| Yeasts | BP | NMT 50 CFU/g |
| Notes | ||
| While ingredient manufacturers are encouraged to include limits for incidental metals and non-metals, it is the product into which those substances are formulated that contains the ingredient, alone or in combination with other ingredients, which must comply with the acceptance criteria set in the United States Pharmacopoeia - National Formulary (USP-NF) general chapter '<2232> Elemental Contaminants in Dietary Supplements'. | ||
Key to abbreviations
BP = British Pharmacopoeia
CFU = Colony forming units
NLT = Not less than
NMT = Not more than
Ph Eur = European Pharmacopoeia
USP = United States Pharmacopoeia
Footnotes
| [1] | Heng NC, (2011). Genome sequence of the bacteriocin-producing oral probiotic Streptococcus salivarius strain M18. J Bacteriol 193(22), 6402-3. |
|---|---|
| [2] | Tagg, J. R. & Bannister, L. V. (1979). "Fingerprinting" B-Haemolytic Streptococci by their Production of and Sensitivity to Bacteriocine-Like inhibitors. The Journal of Medical Microbiology, 12(4), 397-411. |
| [3] | Burton JP, W. P. (2013). Persistence of the oral probiotic Streptococcus salivarius M18 is dose dependent and mega plasmid transfer can augment their bacteriocin production and adhesion characteristics. PLoS One, Jun 13;(8(6)), e65991 |
| [4] | Ishijima SA, H.K. (2012). Effect of Streptococcus salivarius K12 on the in vitro growth of Candida albicans and its protective effect in an oral candidiasis model. Appl Environ Microbiol., 78(7), 2190 – 2199 |
| [5] | Burton JP, C.S. (2011). Evaluation of safety and human tolerance of the oral probiotic Streptococcus salivarius K12: a randomized, placebo-controlled, double-blind study. Food Chem Toxicol., 49(9), 2356-2364 |