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10.7.2013 Official
Journal
of
the
European
Union L
189/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION IMPLEMENTING REGULATION (EU) No 651/2013
of 9 July 2013
concerning the authorisation of clinoptilolite of sedimentary origin as a feed additive for all animal
species and amending Regulation (EC) No 1810/2005
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
application was accompanied by the particulars and
documents required under Article 7(3) of Regulation
(EC) No 1831/2003.
Having regard to the Treaty on the Functioning of the European
Union,
(4) The
European
Food
Safety
Authority
(‘the
Authority’)
Having regard to Regulation (EC) No 1831/2003 of the
concluded in its opinion of 12 December 2012 ( 4 ) that,
European Parliament and of the Council of 22 September
under the proposed conditions of use, clinoptilolite of
2003 on additives for use in animal nutrition (
sedimentary origin does not have an adverse effect on

1 ), and in
particular Article 9(2) thereof,
animal health, the environment or, provided that
adequate measures to protect users are taken, on
human health, and that it has the potential to be effi
Whereas:
cacious as pellet binder and anticaking agent at
10 000 mg/kg of complete feedingstuff. The Authority
does not consider that there is a need for specific
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
requirements of post-market monitoring. It also verified
orisation of additives for use in animal nutrition and
the report on the method of analysis of the feed additive
for the grounds and procedures for granting such auth
in feed submitted by the Reference Laboratory set up by
orisation. Article 10 of that Regulation provides for the
Regulation (EC) No 1831/2003.
re-evaluation of additives authorised pursuant to Council
Directive 70/524/EEC ( 2 ).
(5)
The assessment of clinoptilolite of sedimentary origin
shows that the conditions for authorisation, as
(2) Clinoptilolite
of
sedimentary
origin
was
authorised
provided for in Article 5 of Regulation (EC) No
without a time limit in accordance with Directive
1831/2003, are satisfied. Accordingly, the use of that
70/524/EEC as a feed additive for use on pigs for
additive should be authorised as specified in the Annex
fattening, chickens for fattening, turkeys for fattening,
to this Regulation.
bovines and salmon by Commission Regulation (EC)
No 1810/2005
( 3 ). That additive was subsequently
entered in the Register of feed additives as an existing
(6)
As a new authorisation is granted in accordance with
product, in accordance with Article 10(1) of Regulation
Regulation (EC) No 1831/2003, Regulation (EC) No
(EC) No 1831/2003.
1810/2005 should be amended accordingly.
(3) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No
1831/2003 in conjunction with Article 7 thereof, an
(7)
Since safety reasons do not require the immediate appli
application was submitted for the re-evaluation of clinop
cation of the modifications to the conditions of auth
tilolite of sedimentary origin as a feed additive for pigs
orisation, it is appropriate to allow a transitional period
for fattening, chickens for fattening, turkeys for fattening,
for interested parties to prepare themselves to meet the
bovines and salmon and, in accordance with Article 7 of
new requirements resulting from the authorisation.
that Regulation, for a new use for all other animal
species, requesting that additive to be classified in the
additive category ‘technological additives’. That
(8) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 270, 14.12.1970, p. 1.
( 3 ) OJ L 291, 5.11.2005, p. 5.
( 4 ) EFSA Journal 2013; 11(1):3039.

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L 189/2
EN
Official Journal of the European Union
10.7.2013
HAS ADOPTED THIS REGULATION:
Article 3
Transitional measures
Article 1
The additive specified in Annex and feed containing that
Authorisation
additive, which are produced and labelled before 30 January
Clinoptilolite of sedimentary specified in the Annex, belonging
2014 in accordance with the rules applicable before 30 July
to the additive category ‘technological additives’ and to the
2013 may continue to be placed on the market and used
functional groups ‘binders’ and ‘anticaking agents’, is authorised
until the existing stocks are exhausted.
as an additive in animal nutrition, subject to the conditions laid
down in that Annex.
Article 4
Article 2
Entry into force
Amendments to Regulation (EC) No 1810/2005
This Regulation shall enter into force on the twentieth day
In Annex II of Regulation (EC) No 1810/2005, the entry E 568,
following that of its publication in the Official Journal of the
clinoptilolite of sedimentary origin, is deleted.
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 9 July 2013.
For the Commission
The President
José Manuel BARROSO

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10.7.2013 Off
ANNEX
Minimum
Identification Name of the
Species or
content
Maximum content
number of the
holder of
Additive
Composition, chemical formula, description,
category of
Maximum
Other provisions
End of period of
additive
authorisation
analytical method
animal
age
authorisation
mg/kg of complete feedingstuff
with a moisture content of 12 %
EN

Category of technological additives. Functional group: binders
1g568
— Clinoptilolite
Additive composition
All animal
—
— 10
000 1.
For
safety:
it
is
recommended
to
30 July 2023
of sedimentary
species
use breathing and eyes
origin
Clinoptilolite of sedimentary origin ≥ 80 %
protections and gloves during
(Powder form).
handling.
Characterisation of active substance
2. Total quantity of clinoptilolite
of sedimentary origin from all
Clinoptilolite (hydrated sodium calcium
sources shall not exceed the
aluminosilicate) of sedimentary origin
maximum content of
≥ 80 % and clay minerals ≤ 20 % (free of
10 000 mg.
icial
fibres and quartz).
Jour
CAS Number 12173-10-3
nal
Analytical method (1 )
of
For the determination of clinoptilolite of
the
sedimentary origin in feed additive: X-ray
European
diffraction (XRD).
Category of technological additives. Functional group: anticaking agents
Union
1g568
— Clinoptilolite
Additive composition
All animal
—
— 10
000 1.
For
safety:
it
is
recommended
to
30 July 2023
of sedimentary
species
use breathing and eyes
origin
Clinoptilolite of sedimentary origin ≥ 80 %
protections and gloves during
(Powder form).
handling.
Characterisation of active substance
2. Total quantity of clinoptilolite
of sedimentary origin from all
Clinoptilolite (hydrated sodium calcium
sources shall not exceed the
aluminosilicate) of sedimentary origin
maximum content of
≥ 80 % and clay minerals ≤ 20 % (free of
10 000 mg.
fibres and quartz).
CAS Number 12173-10-3
Analytical method (1 )
For the determination of clinoptilolite of
sedimentary origin in feed additive: X-ray
diffraction (XRD).
L
(1 ) Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx
189/3

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