HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 252/14
EN
Official Journal of the European Union
19.9.2012
COMMISSION IMPLEMENTING REGULATION (EU) No 840/2012
of 18 September 2012
concerning the authorisation of 6-phytase (EC 3.1.3.26) produced by Schizosaccharomyces pombe
(ATCC 5233) as a feed additive for all avian species for fattening other than chickens for fattening,
turkeys for fattening and ducks for fattening and all avian species for laying other than laying hens
(holder of authorisation Danisco Animal Nutrition)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(5)
New data were submitted in support of the application
for the authorisation of 6-phytase (EC 3.1.3.26) produced
by Schizosaccharomyces pombe (ATCC 5233) for use as feed
additive to all avian species for fattening other than
Having regard to the Treaty on the Functioning of the European
chickens for fattening, turkeys for fattening and ducks
Union,
for fattening and all avian species for laying other than
laying hens. The European Food Safety Authority (‘the
Authority’) concluded in its opinion of 7 March
2012 ( 4 ) that, under the proposed conditions of use, 6-
Having regard to Regulation (EC) No 1831/2003 of the
phytase (EC 3.1.3.26) produced by Schizosaccharomyces
European Parliament and of the Council of 22 September
pombe (ATCC 5233) does not have an adverse effect
2003 on additives for use in animal nutrition ( 1 ), and in
on animal health, human health or the environment,
particular Article 9(2) thereof,
and that its use can improve the phosphorus utilisation
in all target species. The Authority does not consider that
there is a need for specific requirements of post-market
monitoring. It also verified the report on the method of
Whereas:
analysis of the feed additive in feed submitted by the
Reference Laboratory set up by Regulation (EC) No
1831/2003.
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
orisation of additives for use in animal nutrition and
for the grounds and procedures for granting such auth
(6) The
assessment
of
6-phytase
(EC
3.1.3.26)
produced
by
orisation.
Schizosaccharomyces pombe (ATCC 5233) shows that the
conditions for authorisation, as provided for in Article 5
of Regulation (EC) No 1831/2003, are satisfied. Accord
ingly, the use of this preparation should be authorised as
(2) In
accordance
with
Article
7
of
Regulation
(EC)
No
specified in the Annex to this Regulation.
1831/2003, an application was submitted for the auth
orisation of 6-phytase (EC 3.1.3.26) produced by Schizo
saccharomyces pombe (ATCC 5233). The application was
(7) The
measures
provided
for
in
this
Regulation
are
in
accompanied by the particulars and documents required
accordance with the opinion of the Standing
under Article 7(3) of 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 Schizosaccharomyces pombe
(ATCC 5233) as a feed additive for all avian species for
fattening other than chickens for fattening, turkeys for
fattening and ducks for fattening and all avian species for
Article 1
laying other than laying hens, to be classified in the
The preparation specified in the Annex, belonging to the
additive category ‘zootechnical additives’.
additive category ‘zootechnical additives’ and to the functional
group ‘digestibility enhancers’, is authorised as an additive in
animal nutrition, subject to the conditions laid down in that
Annex.
(4)
The use of preparations of 6-phytase EC 3.1.3.26 was
authorised for 10 years for chickens for fattening, turkeys
for fattening, laying hens, piglets (weaned), ducks for
fattening, pigs for fattening and sows by Commission
Article 2
Regulations (EC) No 785/2007
( 2 ) and (EC) No
379/2009 (
This Regulation shall enter into force on the twentieth day

3 ).
following that of its publication in the Official Journal of the
European Union.
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 175, 5.7.2007, p. 5.
( 3 ) OJ L 116, 9.5.2009, p. 6.
( 4 ) EFSA Journal 2012; 10(3):2619.

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EN
19.9.2012 Official
Journal
of
the
European
Union L
252/15
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 18 September 2012.
For the Commission
The President
José Manuel BARROSO

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L 252/16
ANNEX
Minimum
Maximum
content
content
Identification Name of the
Species or
number of
holder of
Additive
Composition, chemical formula, description, analytical
category of
Maximum
Other provisions
End of period of
the additive
authori
method
age
Units of activity/kg of complete
authorisation
sation
animal
feedingstuff with a moisture
EN
content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers
4a1640 Danisco 6-phytase
Additive composition
All avian
— 250
FTU 1.
In
the
directions
for
use
of
the
9 October 2022
Animal
EC 3.1.3.26
Preparation of 6-phytase (EC 3.1.3.26) produced
species for
additive and premixture, indicate
Nutrition
by Schizosaccharomyces pombe (ATCC 5233) fattening
the storage temperature, storage
(legal
having a minimum activity of:
other than
life, and stability to pelleting.
entity
chickens for
2. For use in compound feed
Danisco
Liquid and solid form: 5 000 FTU (1 )/g
fattening,
containing more than 0,23
%
(UK)
turkeys for
Off
phytin-bound phosphorus.
Limited)
fattening and
icial
Characterisation of the active substance
ducks for
3. Maximum recommended dose:
6-phytase (EC 3.1.3.26) produced by Schizosac
fattening
1 000 FTU/kg of complete feed
Jour
charomyces pombe (ATCC 5233)
ingstuff.
nal
All avian
150 FTU
4. For safety: breathing protection
species for
glasses and gloves shall be used
of
Analytical method (2 )
laying other
during handling.
the
Determination of 6-phytase EC 3.1.3.26 in feed than laying
European
additive: colorimetric method based on the
hens
quantification of inorganic phosphate released
by the enzyme from sodium phytate.
Union
Determination of 6-phytase EC 3.1.3.26 in feed
premixtures and feedingstuff: EN ISO 30024:
colorimetric method based on the quantification
of inorganic phosphate released by the enzyme
from sodium phytate (after dilution with heat-
treated whole grain flour).
(1 ) 1 FTU is the amount of enzyme which liberates 1 micromole of inorganic phosphate per minute from a sodium phytate substrate at pH 5,5 and 37 °C.
(2 ) Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx
19.9.2012

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Document Outline

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