Agriculture Reference
In-Depth Information
Biogalactosidase BL
(EFSA, 2011d)
Saccharomyces
cerevisiae
Aspergillus
niger
Chickens for
fattening
Alpha-galactosidase
(in
S. cerevisiae
),
beta-glucanase (
A.
niger
)
The standard set of studies
performed for each
enzyme separately (except
for sensitization, which
was tested with glucanase
only). Both enzymes were
mildly irritant to skin and
eyes, and glucanase was
also a mild sensitizer.
Effi cacy demonstrated in
all target animal
categories.
Although the product is
considered as an irritant to
skin and eyes and also a
dermal irritant, it has been
authorized.
Ronozyme RumiStar
(EFSA, 2012)
Bacillus
licheniformis
Dairy cows
Alpha-amylase
The standard set of studies
performed, except for
sensitization tests.
No conclusive evidence
of effi cacy
demonstrated.
In the absence of test data,
the product is considered
as a potential sensitizer.
L
-Valine feed grade
(EFSA, 2008f)
Escherichia coli
All animal
species
Two gene cassettes
from
E. coli
strains
increasing the
capacity of
L
-valine
production and
enabling the use of
variable carbon
sources for
production.
Absence of virulence factors
in the production strain
demonstrated, as well as
absence of the production
strain and recombinant
DNA in the product.
Genotoxicity and 90-day
oral toxicity studies
provided and the skin and
eye irritation, sensitization
and inhalation toxicity
provided.
No actual effi cacy studies
provided.
The safety studies were all
performed with >98% pure
product, although the purity
in the product specifi cation
was given as >95%. The
product was authorized
with a minimum purity
specifi cation of 98%.
L
-Isoleucine
(EFSA, 2010)
Escherichia coli
All animal
species
Absence of virulence factors
in the production strain
demonstrated, as well as
absence of the production
strain and recombinant
DNA in the product. A
short-term study on piglets
with a tenfold overdose
Demonstration of
bioequivalence with
pharmaceutical grade
L
-leucine in piglets.
