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1.6.2011 Official
Journal
of
the
European
Union L
146/7
COMMISSION IMPLEMENTING REGULATION (EU) No 532/2011
of 31 May 2011
concerning the authorisation of robenidine hydrochloride as a feed additive for rabbits for breeding
and rabbits for fattening (holder of authorisation Alpharma Belgium BVBA) and amending
Regulations (EC) No 2430/1999 and (EC) No 1800/2004
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Article 5 of Regulation (EC) No 1831/2003, are satisfied.
Accordingly, the use of this preparation should be au
Having regard to the Treaty on the Functioning of the European
thorised as specified in the Annex to this Regulation.
Union,
Having regard to Regulation (EC) No 1831/2003 of the
(6)
As a consequence of a new authorisation being granted
European Parliament and of the Council of 22 September
by this Regulation, the entry in Regulation (EC) No
2003 on additives for use in animal nutrition ( 1 ), and in
2430/1999 concerning robenidine hydrochloride for
particular Article 9(2) thereof,
rabbits for breeding purposes is deleted.
Whereas:
(7) As
a
further
consequence
of
this
new
authorisation,
the
(1) Regulation
(EC)
No
1831/2003
provides
for
the
au
entry for robenidine hydrochloride in the Annex to
thorisation of additives for use in animal nutrition and
Regulation (EC) No 1800/2004 should be amended.
for the grounds and procedures for granting such au
thorisation. Article 10 of that Regulation provides for
the re-evaluation of additives authorised pursuant to
(8)
Since the modifications to the conditions of authorisation
Council Directive 70/524/EEC (
are not related to safety reasons, it is appropriate to allow

2 ).
a transitional period for the disposal of existing stocks of
(2) Robenidine
hydrochloride,
CAS
number
25875-50-7,
pre-mixtures and compound feed containing this prep
was authorised for 10 years in accordance with
aration, as authorised by Regulation (EC) No 2430/1999
Directive 70/524/EEC as a coccidiostat for use on
for use on rabbits for breeding purposes and by Regu
rabbits for breeding by Commission Regulation (EC)
lation (EC) No 1800/2004 for use on rabbits for
No 2430/1999 ( 3 ) and for use on turkeys, chickens for
fattening.
fattening and rabbits for fattening by Commission Regu
lation (EC) No 1800/2004
( 4 ). The additive was
(9) The
measures
provided
for
in
this
Regulation
are
in
subsequently entered in the Register of Feed Additives
accordance with the opinion of the Standing
as an existing product, in accordance with Article 10(1)
Committee on the Food Chain and Animal Health,
of Regulation (EC) No 1831/2003.
(3) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No HAS ADOPTED THIS REGULATION:
1831/2003 in conjunction with Article 7 of that Regu
lation, an application was submitted for the re-evaluation
Article 1
of robenidine hydrochloride as a feed additive for rabbits
for breeding and rabbits for fattening, requesting that
The preparation specified in the Annex I, belonging to the
additive to be classified in the additive category ‘cocci
additive category ‘coccidiostats and histomonostats’ is au
diostats and histomonostats’. That application was
thorised as an additive in animal nutrition subject to the
accompanied by the particulars and documents required
conditions laid down in that Annex.
under Article 7(3) of Regulation (EC) No 1831/2003.
(4) The
European
Food
Safety
Authority
(the
Authority)
Article 2
concluded in its opinion of 7 March 2011 that, under
In Annex I to Regulation (EC) No 2430/1999, the entry under
the proposed conditions of use, robenidine hydrochloride
registration number of additive E 758 concerning robenidine
does not have an adverse effect on animal health, human
hydrochloride for rabbits for breeding purposes is deleted.
health or the environment, and that the additive is
effective in controlling coccidiosis in rabbits for
fattening and for breeding (
Article 3

5 ). It also verified the report
on the method of analysis of the feed additive in feed
The Annex to Regulation (EC) No 1800/2004 is amended in
submitted by the European Union Reference Laboratory
accordance with Annex II to this Regulation.
for Feed Additives set up by Regulation (EC) No
1831/2003.
Article 4
(5) The
assessment
of
robenidine
hydrochloride
shows
that
the conditions for authorisation, as provided for in
Premixtures and compound feed labelled in accordance with
Directive 70/524/EEC and containing robenidine hydrochloride,
as authorised by Regulation (EC) No 2430/1999 for use on
( 1 ) OJ L 268, 18.10.2003, p. 29.
rabbits for breeding purposes and by Regulation (EC) No
( 2 ) OJ L 270, 14.12.1970, p. 1.
1800/2004 for use on rabbits for fattening, may continue to
( 3 ) OJ L 296, 17.11.1999, p. 3.
( 4 ) OJ L 317, 16.10.2004, p. 37.
be placed on the market and used until the existing stocks are
( 5 ) EFSA Journal 2011;9(3):2102.
exhausted.

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L 146/8
EN
Official Journal of the European Union
1.6.2011
Article 5
This Regulation shall enter into force on the 20th day following 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, 31 May 2011.
For the Commission
The President
José Manuel BARROSO

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1.6.2011 Off
ANNEX I
Minimum Maximum
content
content
Maximum Residue
Identification Name of the
Additive
Species or
Limits (MRLs) in
number of
holder of
(Trade
Composition, chemical formula, description, category of Maximum
mg of active
Other provisions
End of period of
the relevant
the additive
authorisation
name)
analytical method
animal
age
substance/kg of
authorisation foodstuffs of animal
EN
complete feedingstuff
origin

with a moisture
content of 12 %
Coccidiostats and histomonostats
5 1 758 Alpharma Robenidi
Additive composition
Rabbits
— 50 66 1.
The
additive
shall
be
incorporated
in 21 June
200 μg/kg wet
Belgium
ne hydro
for
compound feed in the form of a pre-
2021
weight for liver
BVBA
chloride
Robenidine hydrochloride: 66 g/kg
breeding
mixture.
and kidney
66g/kg
Lignosulfonate: 40 g/kg
(Cycostat
2. Robenidine hydrochloride shall not be
100 μg /kg wet
Rabbits
50 66
66G)
Calcium sulphate dihydrate: 894 g/kg
mixed with other coccidiostats.
weight for all
for
other tissues
fattening
icial
Active substance
3. For safety: breathing protection, glasses
and gloves shall be used during
Jour
Robenidine hydrochloride,
handling.
nal
C 15H 13Cl 2N 5 . HCl,
4. A post-market monitoring program on
of
CAS number: 25875-50-7,
the resistance to Eimeria spp. shall be
the
planned and executed by the holder of
1,3-bis [(p-chlorobenzylidene) amino]-
authorisation.
European
guanidine hydrochloride: > 97 %
Related impurities:
5. Use is prohibited at least 5 days before
slaughter.
N,N',N''-Tris[(p-Cl-benzylidene)
Union
amino]guanidine (TRIS): ≤ 0,5 %
Bis-4[4-Cl-benzylidene]hydrazine
(AZIN): ≤ 0,5 %
Analytical methods (1 )
Determination of robenidine hydro
chloride in feed: reverse phase high
performance liquid chromatography
coupled to ultraviolet spectrometry
(HPLC/UV) in accordance with
Method E in Annex IV to Commission
Regulation (EC) No 152/2009 (2 ).
(1 ) Details of the analytical methods are available at the following address of the European Union Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx
(2 ) OJ L 54, 26.2.2009, p. 1.
L
146/9

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L 146/10
ANNEX II
The Annex to Regulation (EC) No 1800/2004 is replaced by the following:
‘ANNEX
EN
Name and the
Minimum
Maximum

Registration registration number
content
content
number of
of the person
Additive
Maximum
Other provisions
End of period of
the additive
responsible for
(Trade name)
Composition, chemical formula, description
Species or
category of animal
age
authorisation
putting additive into
mg of active substance/kg of
circulation
complete feedingstuff
Coccidiostats and other medicinal substances
E 758 Alpharma Robenidine
Additive composition
Chickens for
— 30 36 Use
is
prohibited
at
least
29 October 2014
Belgium BVBA
hydrochloride
fattening
5 days before slaughter.
Off
66 g/kg
Robenidine hydrochloride: 66 g/kg
icial
(Cycostat 66G)
Lignosulfonate: 40 g/kg
Turkeys 30 36 Use
is
prohibited
at
least
29 October 2014’
Calcium sulphate dihydrate: 894 g/kg
5 days before slaughter.
Jour
nal
Active substance
of
Robenidine hydrochloride,
the
C
European

15H 13Cl 2N 5. HCl,
1,3-bis [(p-chlorobenzylidene) amino]-
guanidine hydrochloride CAS number:
25875-50-7,
Union
Related impurities:
N,N',N''-Tris[(p-Cl-
benzylidene)amino]guanidine (TRIS): ≤ 0,5 %
Bis-4[4-Cl-benzylidene]hydrazine (AZIN):
≤ 0,5 %
1.6.2011

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