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Senyong Dairy CO., Ltd. announced that the U.S. Food and Drug Administration (
FDA
) has issued a non-objection letter to Senyong's proprietary strain of Bifidobacteria
M-16V
for food and infant formula).
grass
certification process is an
FDA
-approved pathway that allows
companies to organize independent teams of scientists to conduct
GRAS
reviews, followed by
GRAS
if an ingredient meets
FDA
safety standards. To ensure greater confidence in its ingredients, Senyong has submitted its security files to
FDA
for review, which has resulted in two no-objection letters.9
, U.S.
FDA
for Senyong Company for Food (
GRAS
Bulletin No.
GRN000453
) and for The short Bifidobacteria
M-16V
safety report for infant formula (
GRAS
bulletin number
GRN000454
) issued a "no objection letter".short Bifidobacteria
M-16V
is Senyong's second flagship probiotic strain, which will be officially launched at the Western Trade Fair in Las Vegas, Nevada,
11
14
,
15
,
November
.2009,
Senyong's first flagship probiotic, long Bifidobacteria
BB536
(
GRAS
bulletin number
GRN000268
), acquired the
GRAS
status, which is one of the best-selling probiotics in Japan.
GRAS
for infant formula ingredients is determined with extreme caution and the safety of this sensitive group is ensured by the latest and most stringent scientific and regulatory standards. Dr
Claire Kruger,
, President,
,
DABT
,
,
. He was
member of the
group of experts involved in the
Bifidobacteria
M-16V
Self-affirmation
GRAS
2012.Kruger
added: "The safety of short Bifidobacteria
M-16V
was confirmed by the Panel of Experts following a comprehensive review of this probiotic, including an assessment of all data in accordance with the safety standards set out in the
/
World Health Organization (
FAO/WHO
) Microbiological Evaluation Guidelines for Probiotics in Food."Short Bifidobacteria
M-16V
and Senyong's signature probiotic long Bifidobacteria
BB536
are naturally present in healthy infants and adults, the latter is one of the world's most studied probiotic strains. The
34
scientific papers on
M-16V
support the use of this probiotic to maintain human health."
M-16V
has been recognized for its safety and effectiveness, particularly in promoting the healthy growth of low-weight newborns, and has been used by low-weight newborns in neonatal intensive care units (
NICU
) at approximately
100,
hospitals in Japan. Because of its effectiveness, doctors in the hospital were unable to stop using it.
Michio Ikeda
, general manager of Senyong International, said in a statement, "We will accelerate our actions to
to document its safety and
and contribute to the health of infants and young children around the world." M-16V
probiotics are characterized by: l
resident bacteria in the human body (which is the main Bifidobacteria species in the
infant intestinal bacterium) l
senyong's unique culture technology to create its high stability l
supported by
34
scientific studies, including clinical studies of low-weight newborn s
l manufactured at
HACCP
(Hazard Analysis and Key Control Points) certified plants in Japan, l
genome sequence analysis, antibiotic resistance studies, toxicology trials and clinical studies have been used in neonatal intensive care units at more than
100
hospitals to confirm its safety