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24.2.2011 Official
Journal
of
the
European
Union L
49/11
COMMISSION REGULATION (EU) No 171/2011
of 23 February 2011
concerning the authorisation of 6-phytase (EC 3.1.3.26) produced by Aspergillus oryzae DSM 14223
as a feed additive for poultry and for porcine species and amending Regulation (EC) No 255/2005
(holder of authorisation DSM Nutritional Products Ltd represented by DSM Nutritional products
Sp. z o.o)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
pigs for fattening and sows and, in accordance with
Article 7 of that Regulation, for a new use on poultry
species and porcine species, not covered previously,
Having regard to the Treaty on the Functioning of the European
requesting that additive to be classified in the additive
Union,
category ‘zootechnical additives’. That application was
accompanied by the particulars and documents required
under Article 7(3) of Regulation (EC) No 1831/2003.
Having regard to Regulation (EC) No 1831/2003 of the
European Parliament and of the Council of 22 September
2003 on additives for use in animal nutrition ( 1 ), and in
particular Article 9(2) thereof,
(5) New
data
were
submitted
to
support
the
application.
The
European Food Safety Authority (‘the Authority’)
concluded in its opinion of 6 October 2010 ( 5 ) that,
Whereas:
under the proposed conditions of use, 6-phytase (EC
3.1.3.26) produced by Aspergillus oryzae DSM 14223
does not have an adverse effect on animal health,
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
human health or the environment, and that its use can
orisation of additives for use in animal nutrition and
improve the digestibility of phosphorus. The Authority
for the grounds and procedures for granting such auth
does not consider that there is a need for specific
orisation. Article 10 of that Regulation provides for the
requirements of post-market monitoring. It also verified
re-evaluation of additives authorised pursuant to Council
the report on the method of analysis of the feed additive
Directive 70/524/EEC ( 2 ).
in feed submitted by the Community Reference
Laboratory set up by Regulation (EC) No 1831/2003.
(2) 6-phytase
(EC
3.1.3.26)
produced
by Aspergillus oryzae
DSM 14223 was authorised in accordance with
Directive 70/524/EEC as a feed additive without a time
(6) The
assessment
of
6-phytase
(EC
3.1.3.26)
produced
by
limit for chickens for fattening, laying hens, turkeys for
Aspergillus oryzae DSM 14223 shows that the conditions
fattening, piglets, pigs for fattening and sows by
for authorisation, as provided for in Article 5 of Regu
Commission Regulation (EC) No 255/2005 ( 3 ). That
lation (EC) No 1831/2003, are satisfied. Accordingly, the
additive was subsequently entered in the Community
use of this preparation should be authorised as specified
Register of feed additives as an existing product, in
in the Annex to this Regulation.
accordance with Article 10(1)(b) of Regulation (EC) No
1831/2003.
(3) That
feed
additive
was
also
authorised
in
accordance
with (7)
As a consequence of a new authorisation being granted
Regulation (EC) No 1831/2003 for 10 years for ducks by
by this Regulation, the entry for 6-phytase (EC 3.1.3.26)
Commission Regulation (EC) No 1500/2007 of
produced by Aspergillus oryzae DSM 14223 in Regulation
18 December 2007 concerning the authorisation of a
(EC) No 255/2005 should be deleted.
new use of 6-phytase EC 3.1.3.26 (Ronozyme) as a
feed additive ( 4 ).
(8) In
the
interest
of
clarity,
Regulation
(EC)
No
1500/2007
(4) In
accordance
with
Article
10(2)
of
Regulation
(EC)
should be repealed.
No 1831/2003 in conjunction with Article 7 of that
Regulation, an application was submitted for the re-
evaluation of 6-phytase (EC 3.1.3.26) produced by Asper
gillus oryzae DSM 14223 as a feed additive for chickens
for fattening, laying hens, turkeys for fattening, piglets,
(9)
Since the modifications to the conditions of the auth
orisation are not related to safety reasons, it is appro
priate to allow a transitional period for the disposal of
( 1 ) OJ L 268, 18.10.2003, p. 29.
existing stocks of pre-mixtures and compound feed.
( 2 ) OJ L 270, 14.12.1970, p. 1.
( 3 ) OJ L 45, 16.2.2005, p. 3.
( 4 ) OJ L 333, 19.12.2007, p. 54.
( 5 ) EFSA Journal 2010; 8(10):1862.

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L 49/12
EN
Official Journal of the European Union
24.2.2011
(10) The
measures
provided
for
in
this
Regulation
are
in
Article 4
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
Pre-mixtures and compound feed containing 6-phytase (EC
3.1.3.26) produced by Aspergillus oryzae DSM 14223 which
are labelled in accordance with Directive 70/524/EEC and Regu
HAS ADOPTED THIS REGULATION:
lation (EC) No 255/2005 may continue to be placed on the
market and used until the existing stocks are exhausted.
Article 1
The preparation specified in the Annex, belonging to the
additive category ‘zootechnical additives’ and to the functional
Pre-mixtures and compound feed containing 6-phytase (EC
group ‘digestibility enhancers’, is authorised as an additive in
3.1.3.26) produced by Aspergillus oryzae DSM 14223 which
animal nutrition, subject to the conditions laid down in that
are labelled in accordance with Regulations (EC) No
Annex.
1831/2003 and (EC) No 1500/2007 may continue to be
placed on the market and used until the existing stocks are
Article 2
exhausted.
In Annex II to Regulation (EC) No 255/2005, the entry EC
No: 1614(i), additive: 6-phytase EC 3.1.3.26, is deleted.
Article 5
Article 3
This Regulation shall enter into force on the 20th day following
Regulation (EC) No 1500/2007 is repealed.
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, 23 February 2011.
For the Commission
The President
José Manuel BARROSO

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24.2.2011 Off
ANNEX
Minimum
Maximum
content
content
Identification
Species or
number of the Name of the holder of
category of
Maximum age
Other provisions
End of period 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
4a1641(i) DSM Nutritional
6-phytase
Additive composition
Poultry for
— 300
FYT
— 1.
In
the
directions
for
use
16 March 2021
Products Ltd repre
breeding
of the additive and
sented by DSM EC 3.1.3.26
Preparation of 6-phytase produced
and for
premixture, indicate the
Nutritional products
by Aspergillus oryzae DSM 14223
laying
storage temperature,
Sp. Z o.o
having a minimum activity of:
storage life, and stability
to pelleting.
Other
250 FYT
Solid form: 5 000 FYT/g (1 )
poultry
2. For use in feed containing
icial
Liquid form: 20 000 FYT/g
more than 0,23
%
Pigs for
750 FYT
phytin-bound phos
breeding
Jour
Characterisation of the active substance
phorus.
and minor
nal
porcine
6-phytase produced by Aspergillus
3. For safety: breathing
species for
of
oryzae DSM 14223
protection, glasses and
breeding
the
gloves shall be used
European
Analytical method (2 )
during handling.
Other pigs
500 FYT
and minor
Colorimetric method based on porcine
reaction of vanadomolybdate on
species
Union
inorganic phosphate produced by
action of 6-phytase on a phytate-
containing substrate (sodium
phytate) at pH 5,5 and 37 °C,
quantified against a standard
curve from inorganic phosphate.
(1 ) 1 FYT is the amount of enzyme that liberates 1 micromole of inorganic phosphate per minute from sodium phytate at pH 5,5 and a temperature of 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.
L
49/13

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