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31.10.2013 Official
Journal
of
the
European
Union L
289/33
COMMISSION IMPLEMENTING REGULATION (EU) No 1060/2013
of 29 October 2013
concerning the authorisation of bentonite as a feed additive for all animal species
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
bentonite as substance for reduction of the contami
nation of feed by mycotoxins for all animal species.
Those applications request that additive to be classified
in the additive category ‘technological additives’ and were
Having regard to the Treaty on the Functioning of the European
accompanied by the particulars and documents required
Union,
under Article 7(3) of Regulation (EC) No 1831/2003.
Having regard to Regulation (EC) No 1831/2003 of the
(4) The
European
Food
Safety
Authority
(‘the
Authority’)
European Parliament and of the Council of 22 September
concluded in its opinions of 2 February 2011 ( 4 ),
2003 on additives for use in animal nutrition (
14 June 2011 ( 5 ) and 14 June 2012 ( 6 ) that, under the

1 ), and in
particular Article 9(2) thereof,
proposed conditions of use, bentonite does not have an
adverse effect on animal health, human health or the
environment, and that it has the potential to be effi
cacious as binder and anticaking agent and as
substance for control of radionuclide contamination for
Whereas:
all animal species. It was also recognised that bentonite
has the potential to be efficacious as aflatoxin binder for
dairy cows and that this conclusion can be extended to
all ruminants. The Authority does not consider that there
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
is a need for specific requirements of post-market moni
orisation of additives for use in animal nutrition and
toring. It also verified the report on the method of
for the grounds and procedures for granting such auth
analysis of the feed additive in feed submitted by the
orisation. Article 10 of that Regulation provides for the
Reference Laboratory set up by Regulation (EC) No
re-evaluation of additives authorised pursuant to Council
1831/2003.
Directive 70/524/EEC ( 2 ).
(5) Since
the
provided in vitro studies meet the conditions for
(2) Bentonite
was
authorised
without
a
time
limit
in
the demonstration of the efficacy of the technological
accordance with Directive 70/524/EEC as a feed
additives laid down by Commission Regulation (EC) No
additive belonging to the group of binders, anticaking
429/2008 ( 7 ), in particular under item 4 of Annex II and
agents and coagulants, for use in all animal species, by
under item 1.4 of Annex III thereto, and they were
Commission Directive 82/822/EEC (
recognised able to demonstrate the clear evidence to

3 ). That additive was
subsequently entered in the Register of feed additives as
bind aflatoxin B1 (AfB) and moreover the binding
an existing product, in accordance with Article 10(1)(b)
capacity, restricted to aflatoxin B1, was defined as a char
of Regulation (EC) No 1831/2003.
acteristic of the bentonite, the conclusion on efficacy as a

substance for reduction of the contamination of feed by
mycotoxins can be considered sufficient to be extended
to its use on poultry and pigs.
(3) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No
1831/2003 in conjunction with Article 7 of that Regu
lation, an application was submitted for the re-evaluation
of bentonite as a feed additive for all animal species as
(6) The
assessment
of
bentonite
shows
that
the
conditions
for authorisation, as provided for in Article 5 of Regu
binders and anticaking agents and, in accordance with
lation (EC) No 1831/2003, are satisfied. Accordingly, the
Article 7 of that Regulation, for a new authorisation as
use of that additive should be authorised as specified in
substance for control of radionuclide contamination, for
the Annexes to this Regulation.
all animal species. In addition, in accordance with
Article 7 of Regulation (EC) No 1831/2003, an appli
cation was submitted for a new authorisation of
( 4 ) EFSA Journal 2011; 9(2):2007.
( 5 ) EFSA Journal 2011; 9(6):2276.
( 6 ) EFSA Journal 2012; 10(7):2787.
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 7 ) Commission Regulation (EC) No 429/2008 of 25 April 2008 on
( 2 ) Council Directive 70/524/EEC of 23 November 1970 concerning
detailed rules for the implementation of Regulation (EC) No
additives in feeding-stuffs (OJ L 270, 14.12.1970, p. 1).
1831/2003 of the European Parliament and of the Council as
( 3 ) Forty-first Commission Directive 82/822/EEC of 19 November 1982
regards the preparation and the presentation of applications and
amending the Annexes to Council Directive 70/524/EEC concerning
the assessment and the authorisation of feed additives (OJ L 133,
additives in feedingstuffs (OJ L 347, 7.12.1982, p. 16).
22.5.2008, p. 1).

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L 289/34
EN
Official Journal of the European Union
31.10.2013
(7)
Since safety reasons do not require the immediate appli
mycotoxins’, ‘binders’, ‘anticaking agents’ and ‘substances for
cation of the modifications to the conditions of auth
control of radionuclide contamination’ is authorised as an
orisation of bentonite as binder and anticaking agent, it
additive in animal nutrition, subject to the conditions laid
is appropriate to allow a transitional period for interested
down in those Annexes.
parties to prepare themselves to meet the new
requirements resulting from the authorisation.
Article 2
(8) The
measures
provided
for
in
this
Regulation
are
in The additive specified in Annex II belonging to the functional
accordance with the opinion of the Standing
groups ‘binders’ and ‘anticaking agents’ and feed containing that
Committee on the Food Chain and Animal Health,
additive, which are produced and labelled before 19 November
2015 in accordance with the rules applicable before
19 November 2013 may continue to be placed on the
HAS ADOPTED THIS REGULATION:
market and used until the existing stocks are exhausted.
Article 1
Article 3
Bentonite specified in the Annexes, belonging to the additive
This Regulation shall enter into force on the twentieth day
category ‘technological additives’ and to the functional groups
following that of its publication in the Official Journal of the
‘substances for reduction of the contamination of feed by
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 29 October 2013.
For the Commission
The President
José Manuel BARROSO

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31.10.2013 Off
ANNEX I
Minimum
Maximum
content
content
Identification
Species or
number of the
Additive
Chemical formula, description, methods of
category of
Maximum age
Other provisions
End of period of
mg of active substance/kg of
additive
analysis
animal
authorisation
complete feedingstuff with a
moisture content of 12 %
EN

Category of technological additives. Functional group: substances for reduction of the contamination of feed by mycotoxins: aflatoxin B1
1m558 Bentonite Additive
composition
Ruminants
— 20
000 1.
Indicate
in
the
instructions
for
use:
19 November 2023
Bentonite: ≥ 70 % smectite (dioctahedral Poultry
— ‘The simultaneous oral use with macrolides
montmorillonite)
shall be avoided’;
Pigs
Characterisation of active substance
— for poultry: ‘The simultaneous use with
robenidine shall be avoided’.
Bentonite: ≥ 70 % smectite (dioctahedral
montmorillonite)
2. For poultry: the simultaneous use with cocci
icial
diostats other than robenidine is contraindicated
< 10 % opal and feldspar
Jour
with level of bentonite above 5 000 mg/kg of
complete feed.
nal
< 4 % quartz and calcite
3. The total amount of bentonite must not exceed
of
AfB 1-binding capacity (BC AfB1) above
the permitted maximum level in complete feed
the
90 %
ingstuff of 20 000 mg/kg of complete feeding
European
stuff.
Analytical method (1 )
4. The use of the additive is allowed in feeding
For the determination of bentonite in
stuffs complying with the European Union legis
feed additive: X-ray diffraction (XRD)
Union
lation on undesirable substances in animal feed.
For the determination of BC AfB1 of the
5. For safety: breathing protection, glasses and
additive: adsorption test carried out in a
gloves shall be used during handling.
buffer solution at pH 5,0 with a concen
tration of 4 mg/l for AfB 1 and 0,02 %
(w/v) for the feed additive.
(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
L
289/35

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L 289/36
ANNEX II
Minimum content Maximum
content
Identification
number of
Additive
Chemical formula, description,
Species or category
mg of active substance/kg of complete
Other provisions
End of period of
the additive
methods of analysis
of animal
Maximum age
authorisation
feedingstuff with a moisture content of
12 %
EN
Category of technological additives. Functional group: binders

1m558i Bentonite Additive
composition
All animal
— 20
000 1.
Indicate
in
the
instructions
for
use:
19 November 2023
species
Bentonite: ≥ 50 % smectite
— ‘The simultaneous oral use with
macrolides shall be avoided’;
Characterisation of active substance
— in poultry: ‘The simultaneous use with
robenidine shall be avoided’.
Bentonite: ≥ 50 % smectite
Off
icial
2. For poultry: the simultaneous use with
Analytical method (1 )
coccidiostats other than robenidine is
Jour
contraindicated with level of bentonite
nal
For the determination in feed
above 5 000 mg/kg of complete feed.
additive: X-ray diffraction (XRD)
of
the
3. The total amount of bentonite must not
exceed the permitted maximum level in
European
complete feedingstuff of 20 000 mg/kg of
complete feedingstuff.
Union
4. For safety: breathing protection, glasses and
gloves shall be used during handling.
Category of technological additives. Functional group: anticaking agents
1m558i Bentonite Additive
composition
All animal
— 20
000 1.
Indicate
in
the
instructions
for
use:
19 November 2023
species
Bentonite: ≥ 50 % smectite
— ‘The simultaneous oral use with
macrolides shall be avoided’;
Characterisation of active substance
— in poultry: ‘The simultaneous use with
Bentonite: ≥ 50 % smectite
robenidine shall be avoided’.
Analytical method (1 )
31.10.2013
For the determination in feed
additive: X-ray diffraction (XRD)

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31.10.2013 Off
Minimum content Maximum
content
Identification
number of
Additive
Chemical formula, description,
Species or category
mg of active substance/kg of complete
Other provisions
End of period of
the additive
methods of analysis
of animal
Maximum age
authorisation
feedingstuff with a moisture content of
12 %
2. For poultry: the simultaneous use with
coccidiostats other than robenidine is
EN
contraindicated with level of bentonite

above 5 000 mg/kg of complete feed.
3. The total amount of bentonite must not
exceed the permitted maximum level in
complete feedingstuff of 20 000 mg/kg of
complete feedingstuff.
4. For safety: breathing protection, glasses and
gloves shall be used during handling.
icial
Category of technological additives. Functional group: substances for control of radionuclide contamination (134/137 Cs)
Jour
1m558i Bentonite Additive
composition
All animal
—
— 1.
Indicate
in
the
instructions
for
use: 19 November 2023
nal
species
Bentonite: ≥ 50 % smectite
— ‘The simultaneous oral use with
of
macrolides shall be avoided’;
the
Characterisation of active substance
European
— in poultry: ‘The simultaneous use with
Bentonite: ≥ 50 % smectite
robenidine shall be avoided’.
Analytical method (1 )
2. For poultry: the simultaneous use with
Union
coccidiostats other than robenidine is
For the determination in feed
contraindicated with level of bentonite
additive: X-ray diffraction (XRD)
above 5 000 mg/kg of complete feed.
3. The mixture of different sources of
bentonite must not exceed the permitted
maximum level in complete feedingstuff of
20 000 mg/kg of complete feedingstuff.
4. The additive may be used where feed is
contaminated by radiocaesium to control
it in animals and their products.
5. For safety: breathing protection, glasses and
gloves shall be used during handling.
(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
L
289/37

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