2. Section 1 – Identity, characterization and conditions of use of the additive, methods of control:
2.1 Identity of the additive
2.1.1 Proposed (proprietary) name (s) of the additive:
LACTIC ACID BACILLUS POWDER (Earlier known as Lactobacillus sporogenes)
Functional group and mode of action:
Spores of Bacillus coagulans (Earlier known as Lactobacillus sporogenes)
The metabolic activities of Lactobacilli are responsible for their therapeutic benefits.
Proteins are broken down into easily assimilable components.
Proteins + H2O ----------------------- polypeptides
Polypeptides + H2O ------------------- Amino acids
These activities of lactobacilli in the gastrointestinal tract make proteins ingested by the host easily digestible.
Complex fats are broken-down into easily assimilable components.
Triglycerides (fat) --------------------- fatty acids + Glycerol
Lactobacilli can breakdown cholesterol in serum lipids and assist in the deconjugation of bile salts. Emulsification of dietary fat is an intermediate process in fat absorption. Bile salts together with phospholipids and cholesterol form micelles, which help in the absorption of cholesterol. Lactobacilli deconjugate the bile salts in the intestine to form bile acids and thereby inhibit micelle formation. This leads to decreased absorption of cholesterol. Cholesterol entering the intestine through the enterohepatic circulation is similarly treated. Lactobacilli elaborate the enzyme conjugated bile acid hydrolase (CBH) which hydrolyses bile salts, and hydroxyl steroid dehydrogenase (HSDH) which degrades bile acids and interrupts the enterohepatic circulation of bile acids.
Lactic acid bacteria have the enzymes β-galactosidase, glycolases and lactic dehydrogenase (LDH) which produce lactic acid from lactose. Lactic acid produced is reported to have some physiological benefits such as:
Enhancing the digestibility of milk proteins by precipitating them in fine curd particles
Improving the utilization of calcium, phosphorous, and iron
Stimulating the secretion of gastric juices
Propulsion of stomach contents, and
Serving as a source of energy in the process of respiration
In humans, both isomers i.e., D (-) Levorotatory Lactic acid and L (+) Dextrorotatory Lactic Acid are absorbed from the intestinal tract. Whereas L (+) Lactic Acid is completely and rapidly metabolized in glycogen synthesis, D (-) Lactic Acid is metabolized at a lesser rate and un-metabolised acid is excreted in the urine. The presence of un-metabolised Lactic acid results in metabolic acidosis in infants. L. sporogenes produces only L (+) Lactic acid and the ability of lactobacilli to convert lactose to lactic acid is used in the successful treatment of Lactose intolerance.
2.1.3. Qualitative and quantitative composition:
Bacillus coagulans powder is available in following different strengths.
1000 Million Viable Spores per gram
2000 Million Viable Spores per gram
3000 Million Viable Spores per gram
6000 Million Viable Spores per gram
10,000 Million Viable Spores per gram
12,000 Million Viable Spores per gram
15,000 Million Viable Spores per gram
50,000 Million Viable Spores per gram
100,000 Million Viable Spores per gram
blended with inert material such as Lactose, Maltodextrin, Mannitol, dextrose, talc, starch etc.
2.1.4. Specifications, purity criteria:
Description : A white to grayish powder with characteristic odour and slightly sweet taste.
Identification : Gram positive rods with terminal spores.
Loss on drying : Not more than 5% or 10 % depending on the diluent used.
Lactic Acid producing capacity : Not less than 10 ml of 0.05 M Sodium hydroxide consumed
Viable Spore Count : Not less than specified million viable spores per gram.
Yeast and Mould count : Not more than 100 CFU / g.
Other organisms : Not more than 150 millions per gram
Escherichia coli : Should be absent
Staphylococcus aureus : Should be absent
Salmonella spp. : Should be absent
Pseudomonas aeruginosa : Should be absent