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16.5.2012 Official
Journal
of
the
European
Union L
128/5
COMMISSION IMPLEMENTING REGULATION (EU) No 414/2012
of 15 May 2012
amending Regulation (EC) No 554/2008 as regards the minimum content and the minimum
recommended dose of an enzyme preparation of 6-phytase as a feed additive in feed for turkeys
for fattening
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(3) The
European
Food
Safety
Authority
concluded
in
its
opinion of 13 November 2011 that the preparation
Having regard to the Treaty on the Functioning of the European
concerned has the potential to improve phosphorus utili
Union,
sation in turkeys for fattening at the requested minimum
dose of 500 FTU/kg ( 3 ) complete feedingstuff.
Having regard to Regulation (EC) No 1831/2003 of the
European Parliament and of the Council of 22 September
(4) The
conditions
provided
for
in
Article
5
of
Regulation
2003 on additives for use in animal nutrition ( 1 ), and in
(EC) No 1831/2003 are satisfied.
particular Article 13(3) thereof,
(5) Regulation
(EC)
No
554/2008
should
therefore
be
Whereas:
amended accordingly.
(1) An enzyme preparation of 6-phytase (EC 3.1.3.26),
(6) The
measures
provided
for
in
this
Regulation
are
in
belonging to the additive category of ‘zootechnical
accordance with the opinion of the Standing
additives’, was authorised for 10 years as a feed
Committee on the Food Chain and Animal Health,
additive for use for chickens for fattening, laying hens,
ducks for fattening, turkeys for fattening and weaned
HAS ADOPTED THIS REGULATION:
piglets by Commission Regulation (EC) No 554/2008 ( 2 ).
Article 1
(2) In
accordance
with
Article
13(3)
of
Regulation
(EC)
No Regulation (EC) No 554/2008 is amended in accordance with
1831/2003, the holder of the authorisation has proposed
the Annex to this Regulation.
changing the terms of authorisation of the preparation
concerned by reducing its minimum content and the
Article 2
minimum recommended dose from 1 000 FTU/kg to
500 FTU/kg complete feedingstuff, as regards use for
This Regulation shall enter into force on the twentieth day
turkeys for fattening. That application was accompanied
following that of its publication in the Official Journal of the
by the relevant supporting data.
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 15 May 2012.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 158, 18.6.2008, p. 14.
( 3 ) EFSA Journal 2012; 10(1):2533.

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L 128/6
ANNEX
The Annex to Regulation (EC) No 554/2008 is replaced by the following:
‘ANNEX
EN
Identifi
Minimum
Maximum

content
content
cation
Species or
End of
number
Name of the holder
category of
Maximum
Other provisions
period of
of the
of authorisation
Additive
Composition, chemical formula, description,
analytical method
animal
age
Units of activity/kg of
authorisation
additive
complete feedingstuff with a
moisture content of 12 %
Category of zootechnical additives. Functional group: digestibility enhancers
4a5 AB
Enzymes 6-phytase
Additive composition
Chickens
— 500
FTU
— 1.
In
the
directions
for
use
of
the
8.7.2018
GmbH
EC 3.1.3.26
for
additive and premixture, indicate
Preparation of 6-phytase EC 3.1.3.26
Off
fattening
the storage temperature, storage life,
produced by Pichia pastoris (DSM 15927)
and stability to pelleting.
icial
having a minimum activity of:
Laying
— 250
FTU
—
2. Recommended dose per kilogram of
Jour
Solid form: 2 500 FTU/g (1 )
hens
complete feedingstuff:
nal
Liquid form: 5 000 FTU/ml
Ducks for
— 250
FTU
—
— chickens for fattening:
of
fattening
500-2 500 FTU,
the
Characterisation of the active substance
Turkeys for
— 500
FTU
—
— laying hens:
European
6-phytase EC 3.1.3.26 produced by
fattening
250-2 000 FTU,
Pichia pastoris (DSM 15927)
— ducks for fattening:
Piglets
— 100
FTU
—
250-2 000 FTU,
Union
(weaned)
Analytical method (2 )
— turkeys for fattening:
Colorimetric method based on reaction
500-2 700 FTU,
of vanadomolybdate on organic
— piglets (weaned):
phosphate produced by reaction on a
100-2 500 FTU.
phytate-containing substrate (sodium
phosphate) at pH 5,5 and 37 °C.
3. For use in compound feed
containing more than 0,25 %
phytin-bound phosphorus.
4. For use in weaned piglets up to
approximately 35 kg.
5. For safety: breathing protection
glasses and gloves shall be used
during handling.
16.5.2012
(1 ) 1 FTU is the amount of enzyme which liberates 1 micromole of inorganic phosphate per minute from sodium phytate at pH 5,5 and 37 °C.
(2 ) Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/crl-feed-additives’

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Document Outline

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