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19.9.2012 Official
Journal
of
the
European
Union L
252/21
COMMISSION IMPLEMENTING REGULATION (EU) No 842/2012
of 18 September 2012
concerning the authorisation of a preparation of lanthanum carbonate octahydrate as a feed additive
for dogs (holder of authorisation Bayer Animal Health GmbH)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
conditions of use, lanthanum carbonate octahydrate does
not have an adverse effect on the target species ( 3 ). It
Having regard to the Treaty on the Functioning of the European
further concluded that lanthanum carbonate octahydrate
Union,
has the potential to reduce the phosphorus bioavailability
in adult dogs. It could not, however, comment on the
Having regard to Regulation (EC) No 1831/2003 of the
long-term effects. It also verified the report on the
European Parliament and of the Council of 22 September
method of analysis of the feed additive in feed
2003 on additives for use in animal nutrition ( 1 ), and in
submitted by the Reference Laboratory set up by Regu
particular Article 9(2) thereof,
lation (EC) No 1831/2003.
Whereas:
(6) The
assessment
of
lanthanum
carbonate
octahydrate,
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
CAS number 6487-39-4, shows that the conditions for
orisation of additives for use in animal nutrition and
authorisation, as provided for in Article 5 of Regulation
for the grounds and procedures for granting such auth
(EC) No 1831/2003, are satisfied. Accordingly, the use of
orisation.
that preparation should be authorised, as specified in the
Annex to this Regulation. It is appropriate to provide for
(2) In
accordance
with
Article
7
of
Regulation
(EC)
No
post-market monitoring as regards long-term adverse
1831/2003, an application was submitted for the auth
effects.
orisation of the preparation of lanthanum carbonate
octahydrate, CAS number 6487-39-4. That application
(7) The
measures
provided
for
in
this
Regulation
are
in
was accompanied by the particulars and documents
accordance with the opinion of the Standing
required under Article 7(3) of Regulation (EC) No
Committee on the Food Chain and Animal Health,
1831/2003.
HAS ADOPTED THIS REGULATION:
(3) The
application
concerns
the
authorisation
of
the
prep
aration lanthanum carbonate octahydrate CAS number
Article 1
6487-39-4 as a feed additive for dogs, to be classified
in the additive category ‘zootechnical additives’.
The preparation specified in the Annex, belonging to the
additive category ‘zootechnical additives’ and to the functional
(4) The
use
of
that
preparation
was
authorised
for
10
years group ‘other zootechnical additives’, is authorised as an additive
for cats by Commission Regulation (EC) No
in animal nutrition subject to the conditions laid down in that
163/2008 ( 2 ).
Annex.
(5) New
data
were
submitted
in
support
of
the
application
Article 2
for authorisation of lanthanum carbonate octahydrate,
CAS number 6487-39-4, for dogs. The European Food
This Regulation shall enter into force on the twentieth day
Safety Authority (‘the Authority’) concluded in its
following that of its publication in the Official Journal of the
opinion of 6 March 2012 that, under the proposed
European Union.
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
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 50, 23.2.2008, p. 3.
( 3 ) EFSA Journal 2012; 10(3):2618.

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L 252/22
ANNEX
Minimum Maximum
content
content
Identification Name of the
Species or
number of
holder of
Additive
Composition, chemical formula, description, analytical category of Maximum mg/kg of complete
Other provisions
End of period of
the additive
authorisation
method.
animal
age
authorisation
feedingstuff with a
EN
moisture content of

12 %
Category of zootechnical additives. Functional group: other zootechnical additives (decrease in phosphorus excretion via urine)
4d1 Bayer Lanthanum
Additive composition
Dogs
— 1
500 7
500 Post-market
monitoring
on
chronic
adverse 9 October 2022
Animal
carbonate
Preparation of lanthanum carbonate octahy
effects is required.
Health
octahydrate
drate.
GmbH
In the directions for use of the additive:
At least 85
% lanthanum carbonate
octahydrate as active substance
‘— for adult dogs
Off
— recommended dose of inclusion in
icial
moist feed with 20-25 % dry matter
Characterisation of the active substance
content: 340 to 2 100 mg per kg
Jour
Lanthanum carbonate octahydrate
La
— avoid simultaneous use of feeds with

nal
2 (CO 3) 3 8H 2O
CAS number 6487-39-4
high level of phosphorus’
of
the
Analytical method (
European
1 )
Quantification of carbonate in the feed
additive:
Community method (Commission Regulation
Union
(EC) No 152/2009) (2 )
Quantification of lanthanum in the feed
additive and feedingstuff: inductively coupled
plasma atomic emission spectrometry
(ICP-AES).
(1 ) Details of the analytical methods are available at the following address of the Reference Laboratory for Feed Additives: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx
(2 ) OJ L 54, 26.2.2009, p. 1.
19.9.2012

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Document Outline

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