Food and Drug Administration (FDA) GRAS Status- July 2011

In July 2011, BLIS Technologies Limited achieved a significant milestone with its oral probiotic called BLIS K12™  by obtaining GRAS status, which now enables this probiotic to be included as an ingredient in food products within the United States.

The US Food and Drug Administration (FDA) requires all ingredients used in food manufacturing to obtain a standard for safety, which is referred to as GRAS (Generally Recognised As Safe). Until July 2011 the Company’s BLIS K12™  probiotic has only been able to be sold as a dietary supplement but now after receiving GRAS status, the company will dramatically expand market opportunities for the company and enable the BLIS K12 ™ probiotic to be marketed and sold to all food manufacturers in the United States.

The programme had taken two years to achieve and follows an FDA-approved process that allows a company to obtain GRAS status by consulting with an independent panel of world leading experts in disciplines such as microbiology and toxicology to determine if the BLIS K12™  probiotic meets the FDA’s stringent criteria for safety.

The BLIS K12™  probiotic is already approved as a food ingredient in both Australia and New Zealand but its GRAS status in the United States effectively launches this novel probiotic ingredient into the global market for food manufacturing.

Is it safe for children?

Lozenges are not safe for children under 3 years of age due to choking hazard. Products in the form of powder are safe for children over 12 months of age.

All humans have Streptococcus salivarius in their oral cavity. Streptococcus salivarius are common in the mouth and make up to 40% of all the bacteria in the normal healthy mouth.  

Is BLIS K12 safe for pregnant women?

BLIS K12 is safe for pregnant women. This is because Streptococcus salivarius is widely present in human beings. Researchers have determined that newborn babies usually receive and become colonised with bacteria from the saliva of their mother within hours of birth. Professor John Tagg and his team of researchers at New Zealand’s University of Otago are currently trialling whether giving expectant women the BLIS K12™ oral probiotic in the last few weeks of pregnancy results in K12 transferring to their baby. The hope is that this will then set up the baby with a beneficial population of Streptococcus salivarius K12 from birth that might stay with them throughout their lives. Breast-feeding infants consume large numbers of S. salivarius, as it is also commonly present in human breast milk.

Safety Facts about the Streptococcus salivarius K12 strain: 

(1) There is considerable scientific information specifically focussed upon the safety of strain K12 which includes two peer reviewed published papers (Burton et al 2006 and Burton et al 2010) and a third paper pending of a large human safety study conducted in the US. There are also a number of scientific publications relating specifically to this strain.

(2) The Food and Agriculture Organisation of the United Nations in 2002 offered a draft document regarding the characterisation of new probiotics for food use in which it is recommended that each strain of a bacterial species should be separately evaluated for its safety. This requirement has been met for the K12 strain.

(3) K12 does not produce any known deleterious metabolic by-products such as D-lactate from lactose fermentation.

(4) The entire S. salivarius K12 genome has been sequenced. Analysis of the sequence has failed to detect any genes associated with pathogenicity or unusual antibiotic resistance.

(5) The antibiotic sensitivities of Streptococus salivarius K12 are similar to those of other naturally-occurring S. salivarius isolates and strain K12 is sensitive to all commonly used clinically relevant antibiotics.

(6) The American Type Culture Collection gives S. salivarius a safety rating of Biosafety level I (the safest).   

(7) Streptococcus salivarius is highly related (99% at 16S rRNA gene level) to Streptococcus thermophilus, a bacterium widely used in the dairy industry. There is also a long history in the literature of Streptococcus salivarius being used in food manufacture. It has been shown by definitive molecular typing that Streptococcus salivarius is a member of the starter cultures used for traditional fermented milks and it is present in traditional raw milk European cheeses.  

(8) Streptococcus salivarius is listed as an ingredient in use in the US before 1994 by the National Nutritional Foods Association (NNFA now NPA) as listed on the FDA website.

(9) More than 50 million doses of Streptococus salivarius K12-containing products have been distributed since 2001 in New Zealand, Australia, Japan, Taiwan and the US with no adverse reactions directly attributable to Streptococus salivarius K12 occurring.   

(10) Streptococcus salivarius K12 is classified as a food in Australia and New Zealand and can be used in food without limitation in these countries. Streptococcus salivarius K12 is also an approved cosmetic ingredient. Streptococcus salivarius K12 ingredient is produced according to ISO 22000 regulations.

(11) Strong science focus.

Is BLIS K12™ Genetically Modified?

BLIS K12™ is not genetically modified