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6.9.2011 Official
Journal
of
the
European
Union L
229/5
COMMISSION IMPLEMENTING REGULATION (EU) No 886/2011
of 5 September 2011
concerning the authorisation of 6-phytase (EC 3.1.3.26) produced by Trichoderma reesei
(CBS 122001) as a feed additive for sows (holder of authorisation Roal Oy)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
by Trichoderma reesei (CBS 122001) for sows. The
European Food Safety Authority (‘the Authority’)
Having regard to the Treaty on the Functioning of the European
concluded in its opinion of 15 March 2011 ( 4 ) that,
Union,
under the proposed conditions of use, 6-phytase
(EC 3.1.3.26) produced by Trichoderma reesei (CBS
Having regard to Regulation (EC) No 1831/2003 of the
122001) does not have an adverse effect on animal
European Parliament and of the Council of 22 September
health, human health or the environment, and that its
2003 on additives for use in animal nutrition ( 1 ), and in
use can improve the calcium and phosphorus digestibility
particular Article 9(2) thereof,
in sows. The Authority does not consider that there is a
need for specific requirements of post-market moni
Whereas:
toring. It also verified the report on the method of
analysis of the feed additive in feed submitted by the
(1) Regulation
(EC)
No
1831/2003
provides
for
the
authori
Community Reference Laboratory set up by Regulation
sation of additives for use in animal nutrition and for the
(EC) No 1831/2003.
grounds and procedures for granting such authorisation.
(6) The
assessment
of
6-phytase
(EC
3.1.3.26)
produced
by
(2) In
accordance
with
Article
7
of
Regulation
(EC)
Trichoderma reesei (CBS 122001) shows that the
No 1831/2003, an application was submitted for the
conditions for authorisation, as provided for in
authorisation of the enzyme preparation 6-phytase
Article 5 of Regulation (EC) No 1831/2003, are satisfied.
(EC 3.1.3.26) produced by Trichoderma reesei (CBS
Accordingly, the use of this preparation should be auth
122001). The application was accompanied by the
orised as specified in the Annex to this Regulation.
particulars and documents required under Article 7(3)
of Regulation (EC) No 1831/2003.
(7) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
(3) The application concerns the authorisation of
Committee on the Food Chain and Animal Health,
6-phytase (EC 3.1.3.26) produced by Trichoderma reesei
HAS ADOPTED THIS REGULATION:
(CBS 122001) as a feed additive for sows, to be classified
in the additive category ‘zootechnical additives’.
Article 1
(4) The
use
of
that
preparation
was
authorised
for
10
years The preparation specified in the Annex, belonging to the
for poultry for fattening and breeding other than turkeys
additive category ‘zootechnical additives’ and to the functional
for fattening, for poultry for laying and for pigs other
group ‘digestibility enhancers’, is authorised as an additive in
than sows by Commission Regulation (EU)
animal nutrition, subject to the conditions laid down in that
No 277/2010 (
Annex.

2 ), and for turkeys by Commission Regu
lation (EU) No 891/2010 ( 3 ).
Article 2
(5) New
data
were
submitted
in
support
of
the
application This Regulation shall enter into force on the 20th day following
for the authorisation of 6-phytase (EC 3.1.3.26) produced
its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 5 September 2011.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 86, 1.4.2010, p. 13.
( 3 ) OJ L 266, 9.10.2010, p. 4.
( 4 ) EFSA Journal 2011; 9(3):2111.

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L 229/6
ANNEX
Minimum
Maximum
content
content
Identification
Species or
End of period
number of the Name of the holder of
category of
Maximum age
Other provisions
of
additive
authorisation
Additive
Composition, chemical formula,
description, analytical method
animal
Units of activity /kg of complete
authorisation
feedingstuff with a moisture
EN
content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers
4a12 Roal
Oy 6-phytase
EC
3.1.3.26 Additive
composition:
Sows
— 250
PPU
— 1.
In
the
directions
for
use
26 September
Preparation of 6-phytase
of the additive and
2021
(EC 3.1.3.26) produced by
premixture, indicate the
Trichoderma reesei (CBS 122001)
storage temperature,
with a minimum activity of:
storage life, and stability
to pelleting.
40 000 PPU (1 ) /g in solid form
Off
10 000 PPU /g in liquid form
2. Maximum recommended
icial
dose per kilogram of
Characterisation of the active
complete feed for sows:
Jour
substance:
1 000 PPU.
nal
of 6-phytase (EC 3.1.3.26)
of
produced by Trichoderma reesei
3. For use in feed containing
the
(CBS 122001)
more than 0,23 %
phytin- bound
European
phosphorus.
Analytical method (2 ):
Colorimetric method quantifying
4. For safety: breathing
the activity of 6-phytase by
protection, glasses and
Union
measuring released inorganic
gloves shall be used
phosphate from sodium phytate by
during handling.
analysing the colour formed by
reduction of a phosphomolybdate
complex.
(1 ) 1 PPU is the amount of enzyme which liberates 1 μmol of inorganic phosphate from sodium phytate per minute at pH =5,0 and 37 °C.
(2 ) Details of the analytical methods are available at the following address of the Community Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx
6.9.2011

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