Commission Regulation (EC) No 163/2008 of 22 February 2008 concerning an authorisation of the preparation Lanthanum carbonate octahydrate (Lantharenol) as a feed additive (Text with EEA relevance)
Date: 2008-02-22
Institutions: European Commission
Subjects: food additive, market approval, pet food, zootechnics

23.2.2008

EN

Official Journal of the European Union

L 50/3

COMMISSION REGULATION (EC) No 163/2008

of 22 February 2008

concerning an authorisation of the preparation Lanthanum carbonate octahydrate (Lantharenol) as a
feed additive

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

the
Having regard to Regulation (EC) No 1831/2003 of
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,

Whereas:

Regulation (EC) No 1831/2003 provides for the author-
isation of additives for use in animal nutrition and for
the grounds and procedures for granting such author-
isation.

It

exclude

authorisation.

risk which would,

further concluded that

for human health relative to incidental exposure to the
additive (2).
that preparation
does not present any other
in
accordance with Article 5(2) of Regulation (EC) No
1831/2003,
Lantharenol has
shown to decrease the phosphorus excretion via urine.
The opinion of
recommend
appropriate measures for user safety.
It considers that
there is a need for specific requirements of post-market
monitoring to recognise any long-term adverse effects in
cats. This opinion also verifies the report on the method
of analysis of the feed additive in feed submitted by the
Community Reference Laboratory set up by Regulation
(EC) No 1831/2003.

the Authority does not

that preparation shows

The assessment of
the
conditions for authorisation, provided for in Article 5
satisfied.
of Regulation (EC) No 1831/2003,
Accordingly,
that preparation should be
the use of
authorised, as specified in the Annex to this Regulation.

that

are

The measures provided for in this Regulation are in
accordance with
Standing
Committee on the Food Chain and Animal Health,

opinion

the

the

of

(5)

(6)

In accordance with Article 7 of Regulation (EC) No
1831/2003, an application was submitted for the author-
isation of the preparation set out in the Annex to this
Regulation. That application was accompanied by the
particulars and documents required under Article 7(3)
of Regulation (EC) No 1831/2003.

HAS ADOPTED THIS REGULATION:

preparation

The application concerns a request for authorisation of
the
octahydrate
(Lantharenol), as a feed additive for cats, to be classified
in the additive category ‘zootechnical additives’.

Lanthanum carbonate

The European Food Safety Authority (the Authority)
concluded in its opinion of 18 September 2007 that
the
octahydrate
(Lantharenol) does not have adverse effect on animal
health or the environment and does not pose concerns

Lanthanum carbonate

preparation

(1) OJ L 268, 18.10.2003, p. 29. Regulation as

amended by
Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005,
p. 8).

Article 1

The preparation specified in the Annex, belonging to the
additive category ‘zootechnical additives’ and to the functional
group ‘other zootechnical additives’, is authorised as an additive
in animal nutrition subject to the conditions laid down in that
Annex.

Article 2

This Regulation shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.

(2) Opinion of

the Scientific Panel on Additives and Products or
Substances used in Animal Feed (FEEDAP) on safety and efficacy
of Lantharenol
(Lanthanum carbonate octahydrate) as a feed
additive for cats according to Regulation (EC) No 1831/2003,
summary. Adopted on 18 September 2007. The EFSA Journal
(2007) 542, 1-15.

(1)

(2)

(3)

(4)

L 50/4

EN

Official Journal of the European Union

23.2.2008

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 22 February 2008.

For the Commission

Markos KYPRIANOU
Member of the Commission

23.2.2008

EN

Official Journal of the European Union

L 50/5

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