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22.12.2012 Official
Journal
of
the
European
Union L
356/61
COMMISSION IMPLEMENTING REGULATION (EU) No 1265/2012
of 17 December 2012
amending Implementing Regulation (EU) No 837/2012 as regards the minimum activity of a
preparation of 6-phytase produced by Aspergillus oryzae (DSM 22594) as feed additive for
poultry, weaned piglets, pigs for fattening and sows (holder of authorisation DSM Nutritional
Products)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
expected to introduce hazards to the target species,
consumers, users or the environment not already
Having regard to the Treaty on the Functioning of the European
considered and it is efficacious at the minimum activity
Union,
of 10 000 FYT/g. The Authority does not consider that
there is a need for specific requirements of post-market
Having regard to Regulation (EC) No 1831/2003 of the
monitoring. It also verified the report on the method of
European Parliament and of the Council of 22 September
analysis of the feed additive in feed submitted
2003 on additives for use in animal nutrition ( 1 ), and in
by the Reference Laboratory set up by Regulation (EC)
particular Article 13(3) thereof,
No 1831/2003.
Whereas:
(4) The
conditions
provided
for
in
Article
5
of
Regulation
(EC) No 1831/2003 are satisfied.
(1)
The use of a preparation of 6-phytase (EC 3.1.3.26)
produced by Aspergillus oryzae (DSM 22594), belonging
(5) Implementing
Regulation
(EU)
No
837/2012
should
to the additive category of ‘zootechnical additives’, was
therefore be amended accordingly.
authorised for 10 years as a feed additive for use
on poultry, weaned piglets, pigs for fattening and
(6) The
measures
provided
for
in
this
Regulation
are
in
sows by Commission Implementing Regulation (EU)
accordance with the opinion of the Standing
No 837/2012 ( 2 ).
Committee on the Food Chain and Animal Health,
(2) In
accordance
with
Article
13(3)
of
Regulation
(EC)
No
1831/2003, the holder of the authorisation has proposed
HAS ADOPTED THIS REGULATION:
changing the terms of the authorisation of the prep
aration concerned by adding a new solid formulation
Article 1
with a minimum activity of 10 000 FYT/g. The appli
The Annex to Implementing Regulation (EU) No 837/2012 is
cation was accompanied by the relevant supporting
amended in accordance with the Annex to this Regulation.
data. The Commission forwarded that application to
the European Food Safety Authority (hereinafter ‘the
Article 2
Authority’).
This Regulation shall enter into force on the twentieth day
(3) The
Authority
concluded
in
its
opinion
of
24
May following that of its publication in the Official Journal of the
2012 ( 3 ) that the new enzyme solid formulation is not
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 17 December 2012.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 252, 19.9.2012, p. 7.
( 3 ) EFSA Journal 2012; 10(6):2730.

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L 356/62
ANNEX
The Annex to Implementing Regulation (EU) No 837/2012 is replaced by the following:
‘ANNEX
EN
Minimum
Maximum

content
content
Identification
Species or
number of the Name of the holder
category of
Maximum
Other provisions
End of period of
additive
of authorisation
Additive
Composition, chemical formula, description,
analytical method
animal
age
Units of activity/kg of
authorisation
complete feedingstuff with a
moisture content of 12 %
Category of zootechnical additives. Functional group: digestibility enhancers
4a18 DSM
Nutritional
6-phytase (EC Additive composition
Poultry
— 500
FYT
— 1.
In
the
directions
for
use
of
the
9 October
Products
3.1.3.26)
additive and premixture, indicate
2022
Preparation of 6-phytase (EC 3.1.3.26)
Pigs for
Off
the storage temperature, storage
produced by Aspergillus oryzae
fattening
life, and stability to pelleting.
icial
(DSM 22594) with a minimum activity of:
10 000 FYT (1 )/g in solid form
Piglets
2. Recommended dose per kilogram
Jour
20 000 FYT/g in liquid form
(weaned)
of complete feed for:
nal
Sows 1
000
FYT
— poultry, piglets (weaned) and
Characterisation of the active substance
of
pigs for fattening: 500-
the
6-phytase (EC 3.1.3.26) produced by
4 000 FYT,
European
Aspergillus oryzae (DSM 22594)
— sows: 1 000-4 000 FYT.
Analytical method (2 )
3. For use in feed containing more
than 0,23 % phytin-bound phos
Union
For quantification of 6-phytase in feed:
phorus.
Colorimetric method measuring the
4. For safety: breathing protection,
inorganic phosphate released by the
glasses and gloves shall be used
6-phytase from phytate (ISO 30024:2009)
during handling.
5. For use in weaned piglets up to
35 kg.
(1 ) 1 FYT is the amount of enzyme which liberates 1 μmol of inorganic phosphate from phytate per minute under reaction conditions with a phytate concentration of 5,0 mM 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’
22.12.2012

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Document Outline

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