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5.3.2011 Official
Journal
of
the
European
Union L
60/3
REGULATIONS
COMMISSION REGULATION (EU) No 221/2011
of 4 March 2011
concerning the authorisation of 6-phytase (EC 3.1.3.26) produced by Aspergillus oryzae DSM 14223
as a feed additive for salmonids (holder of authorisation DSM Nutritional Products Ltd represented
by DSM Nutritional products Sp. Z o.o)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
concluded in its opinion of 10 November 2010 ( 3 ) that,
under the proposed conditions of use, 6-phytase (EC
3.1.3.26) produced by Aspergillus oryzae DSM 14223
Having regard to the Treaty on the Functioning of the European
does not have an adverse effect on animal health,
Union,
human health or the environment, and that its use can
improve the phosphorus utilisation. The Authority does
not consider that there is a need for specific requirements
of post-market monitoring. It also verified the report on
Having regard to Regulation (EC) No 1831/2003 of the
the method of analysis of the feed additive in feed
European Parliament and of the Council of 22 September
submitted by the European Union Reference Laboratory
2003 on additives for use in animal nutrition ( 1 ), and in
for Feed Additives set up by Regulation (EC) No
particular Article 9(2) thereof,
1831/2003.
Whereas:
(6) The
assessment
of
6-phytase
(EC
3.1.3.26)
produced
by
Aspergillus oryzae DSM 14223 shows that the conditions
for authorisation, as provided for in Article 5 of Regu
lation (EC) No 1831/2003, are satisfied. Accordingly, the
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
orisation of additives for use in animal nutrition and
use of this preparation should be authorised as specified
for the grounds and procedures for granting such auth
in the Annex to this Regulation.
orisation.
(7)
In the interest of clarity, the entry on 6-phytase (EC
3.1.3.26) produced by Aspergillus oryzae DSM 14223 in
(2) In
accordance
with
Article
7
of
Regulation
(EC)
No
Regulation (EC) No 521/2005 should be deleted.
1831/2003, an application was submitted for the auth

orisation of the enzyme preparation 6-phytase (EC
3.1.3.26) produced by Aspergillus oryzae DSM 14223.
That application was accompanied by the particulars
(8) The
measures
provided
for
in
this
Regulation
are
in
and documents required pursuant to Article 7(3) of
accordance with the opinion of the Standing
Regulation (EC) No 1831/2003.
Committee on the Food Chain and Animal Health,
(3) The
application
concerns
the
authorisation
of
6-phytase HAS ADOPTED THIS REGULATION:
(EC 3.1.3.26) produced by Aspergillus oryzae DSM 14223
as a feed additive for salmonids, to be classified in the
additive category ‘zootechnical additives’.
Article 1
The preparation specified in the Annex, belonging to the
additive category ‘zootechnical additives’ and to the functional
(4) Its
use
was
also
provisionally
authorised
for
salmonids
by group ‘digestibility enhancers’, is authorised as an additive in
Commission Regulation (EC) No 521/2005 ( 2 ).
animal nutrition, subject to the conditions laid down in that
Annex.
(5) New
data
were
submitted
in
support
of
the
application
for the authorisation of 6-phytase (EC 3.1.3.26) produced
Article 2
by Aspergillus oryzae DSM 14223 for salmonids. The
European Food Safety Authority (‘the Authority’)
In Regulation (EC) No 521/2005, Article 2 and Annex II are
deleted.
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 84, 2.4.2005, p. 3.
( 3 ) The EFSA Journal 2010; 8(12):1915.

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L 60/4
EN
Official Journal of the European Union
5.3.2011
Article 3
This Regulation shall enter into force on the 20th day following 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, 4 March 2011.
For the Commission
The President
José Manuel BARROSO

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5.3.2011 Off
ANNEX
Minimum
Maximum
content
content
Identification
Species or
End of period
number of the
Name of the holder
category of
Maximum age
Other provisions
of
additive
of 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
4a1641(i) DSM Nutritional
6-phytase
Additive composition
Salmonids
— 750
FYT
— 1.
In
the
directions
for
use
25 March
Products Ltd repre (EC 3.1.3.26)
Preparation of 6-phytase produced
of the additive and
2021
sented by DSM
by Aspergillus oryzae DSM 14223
premixture, indicate the
Nutritional products
having a minimum activity of:
storage temperature,
Sp. Z o.o
liquid form: 20 000 FYT (1 )/g
storage life, and stability
to pelleting.
Characterisation of the active substance
2. For use in feed containing
6-phytase produced by Aspergillus
more than 0,23
%
icial
oryzae DSM 14223
phytin-bound phos
phorus.
Jour
Analytical method (2 )
3. For safety: breathing
nal
protection, glasses and
Colorimetric method based on
gloves shall be used
of
reaction of vanadomolybdate on
during handling.
the
inorganic phosphate produced by
action of 6-phytase produced by
European
Aspergillus oryzae DSM 14223 on
a phytate-containing substrate
(sodium phytate) at pH 5,5 and
Union
37 °C,
quantified
against
a
standard curve from inorganic
phosphate.
(1 ) One FYT is the amount of enzyme that releases 1 μmol of inorganic phosphate from sodium phytate per minute under reaction conditions with a phytate concentration of 5,0 mM at pH 5,5 and a temperature of 37 °C during 30
minutes incubation.
(2 ) Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: www.irmm.jrc.be/crl-feed-additives
L
60/5

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