Animal Feed

EFSA Journal 2010;10(7):2787
SCIENTIFIC OPINION
Scientific Opinion on the safety and efficacy of bentonite as a technological

feed additive for all species1
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) 2,3
European Food Safety Authority (EFSA), Parma, Italy
ABSTRACT
Bentonites are colloidal clays composed largely of montmorillonite. They are currently authorised for use as feed
additives (binders, anti-caking agents and coagulants) to a maximum of 20 g/kg feedingstuffs. They are also
authorised for use as food additives. A consortium is seeking the re-authorisation of bentonites as pellet binders
and anti-caking agents and authorisation for a new application for the control of radionuclide contamination.
Chickens and piglets tolerated the addition of bentonite at a concentration of 3 % of diet and dairy cows tolerated
2 % added bentonite. Trout are reported to tolerate at least 2.5 % bentonite in the diet. Since the application is for
all animal species and all bentonites, and as a margin of safety is difficult to establish, the FEEDAP Panel
considers that the presently authorised limit of 2 % of diet should be retained. Addition of bentonites to diets is
incompatible with the use of robenidine and is expected to reduce the effectiveness of other coccidiostats. No
concerns for the safety of consumers of food products derived from animals fed diets containing bentonite were
identified. Bentonites are not skin irritants but may be mildly irritant to the eye. Although skin sensitisation was
not considered, the Panel notes that bentonites are used in cosmetics. The Panel considers it prudent to assume
that all bentonite dusts pose a hazard to those handling the additive. Bentonites are ubiquitous soil components,
and their use in animal production is not expected to adversely affect the environment. Bentonites can increase
pellet durability when added to complete feed at concentrations of between 1 % and 2 %. Since bentonites are
authorised for use, without restriction, as anti-caking agents in food and can be assumed to demonstrate similar
properties when applied to feed materials, no further demonstration of efficacy is considered necessary.
Bentonites added to feed contaminated by radioactive fallout or made available to grazing animals will reduce
levels of radiocaesium in animals and their products.
European Food Safety Authority, 2012
KEY WORDS
Technological additive, anti-caking agent, binder, substances for control of radionuclide contamination,
bentonite, safety, efficacy
1
2
On request from the European Commission, Question No EFSA-Q-2010-01539, adopted on 14 June 2012.
Panel members: Gabriele Aquilina, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Joop de Knecht, Nol
Albert Dierick, Mikolaj Antoni Gralak, Jrgen Gropp, Ingrid Halle, Christer Hogstrand, the late Reinhard Kroker, Lubomir
Leng, Secundino Lpez Puente, Anne-Katrine Lundebye Haldorsen, Alberto Mantovani, Giovanna Martelli, Mikls
Mzes, Derek Renshaw, Maria Saarela, Kristen Sejrsen and Johannes Westendorf. Correspondence:
FEEDAP@efsa.europa.eu
Acknowledgement: The Panel wishes to thank the members of the Working Group on mycotoxin detoxifying agents,
including Isabelle Oswald, for the preparatory work on this scientific opinion.
Suggested citation: EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP); Scientific
Opinion on the safety and efficacy of bentonite as a technological feed additive for all species. EFSA Journal
2010;10(7):2787. [19 pp.] doi:10.2903/j.efsa.2012.2787. Available online: www.efsa.europa.eu/efsajournal
European Food Safety Authority, 2012
Bentonite for all species
SUMMARY
Following a request from the European Commission, the Panel on Additives and Products or
Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety, for
target animals, consumer, users and the environment, and the efficacy of a group of bentonites.
Bentonites are colloidal and plastic clay materials composed largely of montmorillonite (a species of
dioctahedral smectite). The properties of bentonites can vary considerably depending on geological
origin and any post-extraction modification, and their individual characteristics have a marked bearing
on their economic use. Bentonites (E558) are currently authorised for use as feed additives, with the
name Bentonite-montmorillonite, as binders, anti-caking agents and coagulants under the category
technological additives to a maximum of 20 g/kg feedingstuffs. They are also authorised for use as
food additives.
A consortium of companies concerned with the sourcing and supply of bentonites to the feed industry
is now seeking the re-authorisation of bentonite as a technological additive (functional groups: binders
and anti-caking agents) and authorisation for a new application for the control of radionuclide
contamination.
The results of studies submitted by the applicant showed that both chickens and piglets tolerate
bentonite addition at 3 % of diet and dairy cows tolerate bentonite at 2 % of total intake. Although
these studies were carried out using a single sample of bentonite, its composition was typical of most
other bentonites described in this application, and so these results are considered to extend to other
bentonites. Other data from the literature show that trout tolerate bentonite at 2.5 % of diet (the lowest
concentration studied). However, in poultry, 0.5 % bentonite reduces manganese availability in
chickens for fattening. Given that any authorisation will be for bentonites limited only by specification
and that the application is for all animal species, and as a margin of safety is difficult to establish, the
FEEDAP Panel considers that the presently authorised limit of 2 % of diet (20 000 mg/kg complete
feed) should be retained.
The data available suggest that addition of bentonites to diets is incompatible with the use of
robenidine as a coccidiostat. Levels of bentonite higher than 0.5 % are also expected to reduce the
effectiveness of other coccidiostats.
The FEEDAP Panel considers that there is no reason to be concerned for the safety of consumers of
food products derived from animals fed diets containing bentonite.
Bentonites are not skin irritants but may be mildly irritant to the eye. Although skin sensitisation was
not considered, the Panel notes that bentonites are widely used in cosmetics. However, the Panel
considers it prudent to assume that all bentonite dusts pose a hazard to those handling the additive.
Bentonite is ubiquitous in the environment, being a natural component of soil. Therefore, it is not
expected that its use as a feed additive would adversely affect the environment.
Bentonites can increase pellet durability when added to complete feed at concentrations of between
1 % and 2 %. Since bentonites are authorised for use as anti-caking agents in food without restriction
and can be reasonably assumed to demonstrate similar properties when applied to feed or feed
materials which show a tendency to cake, no further demonstration of efficacy is considered
necessary. Bentonites added to feed contaminated by radioactive fallout or made available to grazing
animals will reduce levels of radiocaesium in animals and their products. Since the use of bentonites
for this purpose will be restricted to emergency situations, the FEEDAP Panel does not see a reason to
set a maximum limit.
The Panel recommends that the definition of a bentonite for feed use should specify a minimum
smectite content of 70 % and that restrictions should be placed on the concurrent use of bentonites
with
coccidiostats
and
some
other
medicinal
substances.
EFSA Journal 2012;10(7):2787
TABLE OF CONTENTS
Abstract ....................................................................................................................................................1
Summary ..................................................................................................................................................2
Table of contents ......................................................................................................................................3
Background ..............................................................................................................................................4
Terms of reference....................................................................................................................................4
Assessment ...............................................................................................................................................6
1. Introduction ......................................................................................................................................6
2. Characterisation ................................................................................................................................6
2.1. Characterisation of the product .................................................................................................6
2.1.1.
Mineralogical analysis ......................................................................................................6
2.1.2.
Elemental composition .....................................................................................................8
2.2.
Purity .......................................................................................................................................8
2.3.
Physical properties ..................................................................................................................9
2.4.
Production process ..................................................................................................................9
2.5.
Stability and homogeneity ......................................................................................................9
2.5.1.
Shelf-life ...........................................................................................................................9
2.5.2.
Homogeneity ..................................................................................................................10
2.6.
Conditions of use ..................................................................................................................10
2.7. Evaluation of the analytical methods by the European Union Reference Laboratory (EURL) .10
3. Safety ..............................................................................................................................................10
3.1.
Safety for the target species ..................................................................................................10
3.1.1.
Tolerance studies ............................................................................................................10
3.1.2.
Interactions with other constituents of the diet ...............................................................12
3.1.3.
Conclusions on safety for target species ........................................................................12
3.2.
Safety for the consumer ........................................................................................................12
3.3.
Safety for the user .................................................................................................................13
3.4.
Safety for the environment....................................................................................................13
4. Efficacy...........................................................................................................................................13
4.1.
Efficacy of bentonites as binders ..........................................................................................13
4.2.
Efficacy of bentonites as anti-caking agents .........................................................................14
4.3.
Efficacy of bentonites as substances for control of radionuclide contamination ..................14
4.4.
Conclusions on efficacy ........................................................................................................15
Conclusions and Recommendations .......................................................................................................16
Documentation provided to EFSA .........................................................................................................16
References ..............................................................................................................................................17
Appendix ................................................................................................................................................19
EFSA Journal 2012;10(7):2787
BACKGROUND
Regulation (EC) No 1831/20034 establishes the rules governing the Community authorisation of
additives for use in animal nutrition. In particular, Article 4(1) of that Regulation lays down that any
person seeking authorisation for a feed additive or for a new use of a feed additive shall submit an
application in accordance with Article 7. Article 10(2) of that Regulation also specifies that for
existing products within the meaning of Article 10(1), an application shall be submitted in accordance
with Article 7, at the latest one year before the expiry date of the authorisation given pursuant to
Directive 70/524/EEC for additives with a limited authorisation period.
The European Commission received a request from the company EUBA aisbl5 for reevaluation/authorisation of the product bentonite, to be used as a feed additive for all animal species
(category: technological additive; functional group: binders, anticaking agents and substances for
control of radionucleide contamination) under the conditions mentioned in Table 1.
According to Article 7(1) of Regulation (EC) No 1831/2003, the Commission forwarded the
application to the European Food Safety Authority (EFSA) as an application under Article 10 (reevaluation) and under Article 4(1) (authorisation of a feed additive or new use of a feed additive).
EFSA received directly from the applicant the technical dossier in support of this application.6
According to Article 8 of that Regulation, EFSA, after verifying the particulars and documents
submitted by the applicant, shall undertake an assessment in order to determine whether the feed
additive complies with the conditions laid down in Article 5. The particulars and documents in support
of the application were considered valid by EFSA as of 29 April 2011.
The additive bentonite is authorised as technological additive (E558) as binder, anticaking agent and
coagulant.7
EFSA delivered an opinion on the safety and efficacy of another bentonite when used as substances
for the reduction of the contamination of feed with mycotoxins (EFSA, 2011).
TERMS OF REFERENCE
According to Article 8 of Regulation (EC) No 1831/2003, EFSA shall determine whether the feed
additive complies with the conditions laid down in Article 5. EFSA shall deliver an opinion on the
safety for the target animals, consumer, user and the environment and the efficacy of the product
bentonite, when used under the conditions described in Table 1.
5
6
7
Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use
in animal nutrition. OJ L 268, 18.10.2003, p. 29.
EUBA aisbl, Rue des deux Eglises, 26, B-1000 Brussels, Belgium.
EFSA Dossier reference: FAD-2010-0233.
Commission list of the authorised additives in feedingstuffs published in application of Article 9t (b) of Council Directive
70/524/EEC concerning additives in feedingstuffs (2004/C 50/01). OJ C 50, 25.2.2004, p. 1.
EFSA Journal 2012;10(7):2787
Table 1:
Description and conditions of use of the additive as proposed by the applicant
Additive
Registration number/EC No/No
(if appropriate)
Bentonite
Category(ies) of additive
1. Technological feed additive

g) Binders - h) Control of radionucleide contamination - i) Anti-caking
agents
E 558
Functional group(s) of additive
Description
Chemical
Purity criteria
formula
(if appropriate)
Not appropriate
Smectite above 50%
Composition, description
Bentonite
Trade name (if appropriate)
Method of analysis
(if appropriate)
X-Ray Diffraction
Not appropriate
Name
of
the
holder
authorisation (if appropriate)
of
EUBA aisbl
Conditions of use
Species or
category of
animal
Maximum Age
all animal
species and
categories
Minimum content
Maximum content
mg or Units of activity or CFU/kg of complete
feedingstuffs (select what applicable)
-
Withdrawal period
(if appropriate)
Not appropriate
Other provisions and additional requirements for the labelling

Specific conditions or restrictions
Not appropriate
for use (if appropriate)
For user safety: breathing protection during handling and safety glasses
Specific conditions or restrictions
and gloves. Store in original closed packaging, in cool, dry place. Avoid
for handling (if appropriate)
dust generation.
Post-market monitoring
Not appropriate (existing feed additive)
(if appropriate)
Specific conditions for use in

complementary feedingstuffs
The E558 feed additive is given continuously during animal rearing.
(if appropriate)
Marker residue
Not appropriate
EFSA Journal 2012;10(7):2787
Maximum Residue Limit (MRL) (if appropriate)

Species or category of
Target tissue(s) or
animal
food products
Not appropriate
Not appropriate
Maximum content in
tissues
Not appropriate
ASSESSMENT
1.
Introduction
The term bentonite was first applied to a specific highly colloidal clay found near Fort Benton,
Montana, USA. This clay swells to several times its original volume when placed in water and forms
thixotropic gels when small amounts are added to water. Clays resembling bentonite have since been
found in almost all countries in the world and in rocks of a wide variety of ages. Thus, the term
bentonite has been redefined to describe any highly colloidal and plastic clay material composed
largely, but not exclusively, of montmorillonite (a species of dioctahedral smectite) without reference
to a particular origin. The properties of bentonites can vary considerably depending on geological
origin and any post-extraction modification, and their individual characteristics have a marked bearing
on their economic use.
Bentonites are of considerable commercial importance, finding bulk uses in decolourizing oils, in the
bonding of casting sands and in the manufacture of catalysts and oilwell drilling muds. Numerous
more minor applications have also been recorded, including some in food production and animal
nutrition.
Bentonites (E558) are currently authorised for use as feed additives, with the name Bentonitemontmorillonite, as binders, anti-caking agents and coagulants under the category technological
additives to a maximum of 20 g/kg feedingstuffs. They are also authorised for use as food additives
under Directive 95/2/EC,8 with a specification established by Directive 2008/84/EC.9
A consortium of companies (the European Bentonite Producers AssociationEUBA aisbl) concerned
with the sourcing and supply of bentonites to the feed industry is now seeking the re-authorisation of
bentonite as a technological additive (functional groups (g) binders and (i) anti-caking agents) as
foreseen in Regulation (EC) No 1831/2003. A new application, (h) control of radionuclide
contamination, is also proposed.
2.
Characterisation
2.1.
Characterisation of the product
Bentonites are characterised primarily by the content of smectite and secondly by the presence of other
mineral types. X-ray diffraction (XRD) is commonly used to provide a full mineralogical analysis. A
crude estimate of the smectite content alone can also be obtained in samples known to contain
montmorillonite by comparing the extent of adsorption of methylene blue dye with that of a reference
sample of bentonite. Clays can also be characterised by their elemental composition, usually
determined/expressed as the corresponding oxides. Both mineralogical and chemical approaches have
been used to characterise the various bentonite samples available to the consortium.
2.1.1.
Mineralogical analysis
The smectite content and batch-to-batch variation of the bentonite samples are shown in Table 2. The
table includes data from all of the companies except company D, which characterised its product only
by chemical analysis.
European Parliament and Council Directive No 95/2/EC of 20 February 1995 on food additives other than colours and
sweeteners OJ L 61, 18.3.1995, p. 1.
Commission Directive 2008/84/EC of 27 August 2008 laying down specific purity criteria on food additives other than
colours and sweeteners OJ L 253, 20.9.2008, p. 1.
EFSA Journal 2012;10(7):2787
Table 2:
Smectite content of the bentonite samples
Company
A10
B11
C12
E13
F14
G15
H16
Smectite ( %) (mean SD)

70.6 1.1
92.4 2.1
50.5
74.2 2.0
78.2 6.7
83.1 11.2
83.8 2.6
No of batches
6
5
1
6
5
22
5
Method of analysis
X-ray diffraction
X-ray diffraction
X-ray diffraction
X-ray diffraction
Methylene blue
X-ray diffraction
X-ray diffraction
A full mineralogical analysis, based on five batches, of the product from company A showed that the
major minerals present in addition to smectite are plagioclase (9.4 %), K-feldspar (9.8 %) and opal
(4.2 %), which together with other identified minor components account for 99.9 % of the clay. Data
from company B showed that the smectite consists wholly of the single species montmorillonite with
small amounts of other minerals (notably quartz and K-feldspar) accounting for the remainder. The
single sample from company C showed a very different mineral composition, with only half identified
as smectite. The remainder consisted of opal (39.8 %), the zeolite mordenite (6.8 %) and plagioclase
(2.7 %). In the case of company E, quartz (8.9 %), illite (5.2 %) and opal (5 %), together with smectite
and some other identified minerals present in trace amounts, accounted for more than 95 % of the clay.
The samples from the company F were assayed using the methylene blue method, which does not
provide information on minerals other than smectites.
The 22 samples from company G covered a range of materials with different smectite contents ranging
from 63 % to 97 %. In each case, the minerals accounting for the remainder of the dry matter were
identified (in most cases silica and feldspars). The remaining data, from company H, did not differ
greatly from the majority of the other samples, with sepiolite (10 %), quartz (2.0 %) and dolomite
(2 %) being the major minerals found in addition to smectite.
10
Technical dossier/Section II/Annex II_2-1-4.

12
13
14
15
16
11
EFSA Journal 2012;10(7):2787
2.1.2.
Elemental composition
The main chemical elements that characterise the various bentonite samples are silicon dioxide (SiO 2),
magnesium oxide (MgO), aluminium oxide (Al2O3) and sodium oxide (Na2O). These were determined
using X-ray fluorescence (XRF) analysis, wet chemical analysis or atomic absorption spectrometry.
Typical results for the samples available to the consortium are summarised in Table 3. These data
were provided only for samples available to five of the eight consortium members.
Table 3:
Chemical analysis of the main elements found in the bentonite samples. Values are the
mean of three batches, except for companies D and H, which provided data on five
batches
Company
B17
C18
D19
G20
H21
SiO2 ( %)
51.5
72.4
56.7
54.5
54.0
MgO (%)
2.7
2.4
2.6
3.7
26.1
Al2O3 (%)
16.5
13.1
23.8
18.5
4.1
Na2O (%)
3.1
2.4
1.2
2.3
2.2
Method of analysis
X-ray fluorescence
X-ray fluorescence
Not given
Not given
Not given
The mean loss on ignition was 7.6 % (5.69.6 %) based on data from five samples. A sixth sample
gave very low values (<1 %) because samples were pre-dried at 105 C before ignition.
2.2.
Purity
At least three batches of the different products were each analysed for heavy metals (lead, cadmium,
mercury) and arsenic content.22 In the case of the product from company B, zinc, chromium, nickel
and copper were additionally measured. Lead content, based on analysis of nine products, varied
between 4.3 and 27.6 mg/kg. All values are below the maximum of 30 mg/kg specified in the
Undesirable Substances Directive (Directive 2002/32/EC),23 but two samples would have failed to
meet the specification for bentonites for food use. All of the samples were well below the upper limit
for cadmium of 2 mg/kg set by Directive 2002/32/EC. Although arsenic and mercury are not
specifically regulated for these group of additives, Directive 2002/32/EC sets maximum contents for
arsenic in mineral feedingstuffs of 12 mg/kg and 20 mg/kg in magnesium oxide which can be taken as
indicative. The analysed values for arsenic ranged from 1 to 15.5 mg/kg, which would be largely
compliant with these maximum values. However, six out of seven samples analysed would have failed
to meet the much more restrictive value of 2 mg/kg applied to food additive use. Mercury
contamination appears not to be a problem since its level in all samples was below 0.1 mg/kg, the
value accepted for complete feedingstuffs.
Dioxins were measured in at least three batches by each producer (except company D, which assayed
only a single batch) and ranged between 0.02 and 0.33 ng PCDD/F (polychlorinated dibenzo-p-dioxin
and polychlorinated dibenzofuran; WHO toxic equivalent (TEQ))/kg.24 Dioxin and dioxin-like
polychlorinated biphenyls (PCBs) were measured by six producers (at least three batches each) and
levels were found to range between 0.07 and 0.39 ng PCDD/F-PCBs (WHO-TEQ)/kg. All analysed
levels were below the limits set in Directive 2002/32/EC.
17
Technical dossier/Section II/Annex II_2-1-11a.

Technical dossier/Section II/Annex II_2-1-11b.
19
20
21
22
Technical dossier/Section II/Annexes II_2-1-15 to II_2-1-22.
23
Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal
feed OJ L 140, 30.5.2002, p. 10, last amended OJ L 308, 20, 24.11.2009.
24
18
EFSA Journal 2012;10(7):2787
2.3.
Physical properties
The bulk density of the bentonite samples shows a wide variation (5161 242 kg/m3), as might be
expected given the differences in mineral composition. However, all samples are characterised by a
low particle size, as determined by laser diffraction, and, where measured, a correspondingly high
dusting potential, as measured by the StauberHeubach method (Table 4).25
Table 4:
Bulk density, particle size distribution and dusting potential of the bentonite samples
Bulk density(kg/m3)
Company
A
B
C
929.4 8.6 (n = 10)

1 231 11.2 (n = 10)
535 2 (n = 3)
650 50 (n = 3)
519.6 3.7 (n = 3)
875.2 (n = 5), varying

from 704 to 1 021
863.3 15.3 (n = 3)
751 3 (n = 3)
Particle size distribution

14.6 % < 10 m (n = 3)
55.9 % < 50 m (n = 3)
89.2 % < 100 m (n = 3)
17.9 % < 10 m (n = 3)
65.7 % < 50 m (n = 3)
29.9 % < 10 m (n = 3)
77.0 % < 50 m (n = 3)
95.7 % < 100 m (n = 3)
3.2 % < 10 m (n = 3)
14.8 % < 50 m (n = 3)
100 % < 100 m (n = 3)
31.3 % < 10 m (n = 3)
83.9 % < 50 m (n = 3)
97.8 % < 100 m (n = 3)
17.6 % < 10 m (n = 6)
65.5 % < 50 m (n = 6)
69.6 % < 100 m (n = 6)
14.0 % < 10 m (n = 3)
57.7 % < 50 m (n = 3)
78.2 % < 100 m (n = 3)
68 % < 45 m (n = 3)
Dusting potential
(g/m3)
N/A
N/A
N/A
1.8 (n = 3)
5.8 (n = 3)
N/A
11.4 (n = 1)
(n = 3)
N/A, not available.
2.4.
Production process
The additive is obtained by mining from a variety of locations, including some within the European
Union. Extraction is followed by crushing, drying, grinding and packaging for shipment. Some
applicants use a soda activation process with calcium bentonites, using sodium carbonate to increase
the swelling and adsorption behaviour and to raise pH.
2.5.
Stability and homogeneity
2.5.1.
Shelf-life
Studies demonstrating shelf-life are not required for mineral-based products which are assumed stable.
However, three studies have been provided by two of the producers. Determination of smectite content
(by the methylene blue method) after 3 or 4 years storage showed no variation.26 A further study
showed that the mineral composition measured by X-ray diffraction of three batches of bentonite
remained constant after 6 years storage.27
25

27
26
EFSA Journal 2012;10(7):2787
2.5.2.
Homogeneity
A single sample of bentonite, which included cobalt (100 mg/kg feed) as a micro-tracer, was mixed
with an unspecified feed.28 A total of 15 samples were collected and assayed for the cobalt content.
Using this method, the micro-tracer showed good distribution with a coefficient of variation (CV) of
4.2 %.
The capacity of the other bentonite samples to mix homogeneously was estimated using a statistical
method (Jansen, 1992) that requires data on additive density, dose and mean particle size to calculate
the extent to which the additive will randomly distribute in feed materials.29 This method gives very
low CV values. However, this method has been developed to test the working accuracy of mixing
equipment.
2.6.
Conditions of use
The applicant proposes the use of bentonites with all species or categories of animals without any
maximum content but suggests a recommended use level of 2.5 % without identifying a particular
purpose. It is also proposed to retain the existing prohibition of use with medicinal substances but to
remove the current restriction on the use of bentonite with coccidiostats, which limits concurrent use
to six specified compounds.
2.7.
Evaluation of the analytical methods by the European Union Reference Laboratory

(EURL)
EFSA has verified the EURL report as it relates to the methods used for the control of the active
substance in animal feed. The Executive Summary of the EURL report can be found in the appendix.
3.
Safety
3.1.
Safety for the target species
3.1.1.
Tolerance studies
Dairy cows
A total of 40 dairy cows (mean weight 621 kg) were used in a cross-over study with three periods of
28 days each.30 Periods 1 and 3 were control periods while in period 2 animals received a daily dose of
bentonite (from company H) of 400 g/head per day. Since animals consumed ~20 kg dry matter (DM)
daily this dose is calculated to correspond to an inclusion level of 2 % on a DM basis. Feed intake and
milk production were measured daily and milk composition and blood parameters (insulin, glucose,
cortisol, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and non-esterified fatty
acids) were measured at the end of each period.
No significant effects on milk production were observed, although feed intake was significantly
reduced during the period of bentonite supplementation. Despite this reduction in intake, the fat and
protein content of milk were significantly increased by supplementation. No significant effects on the
measured blood parameters were observed, although there was a tendency towards increased blood
fatty acids during the period of supplementation.
Piglets
A total of 96 weaned piglets (34 weeks old, weighing approximately 6.7 kg) were allocated to four
treatments (six replicates of four piglets per treatment).31 The breed used was a
28

30
Supplementary information/Tolerance-study_Bentonite_Ruminant.
31
Supplementary information/Tolerance-study_Bentonite_Piglet.
29
EFSA Journal 2012;10(7):2787
10
(Landrace Duroc) Pietrain cross. The study was divided in two repetitions because of space
limitations. The four groups were a control group fed only the basal diet and three treatment groups
given the basal diet supplemented with bentonite (from company H) at 0.2 %, 0.5 % and 3 % w/w. The
duration of the study was 35 days, by which time the animals had reached a weight of ~ 21 kg. The
animals were individually weighed during and at the end of the study. Feed intake was measured per
pen.
At the end of the experiment, blood was taken from nine piglets in the control group, six in each of the
two intermediate treatment groups and four in the highest dose group. Red and white blood cell
counts, packed cell volume, haemoglobin, mean corpuscular volume, mean corpuscular haemoglobin
and mean corpuscular haemoglobin concentration, serum AST, ALT, alkaline phosphatase (AP) and
gamma-glutamyl transpeptidase (GGT) enzyme activities and total protein, albumin and cholesterol
concentrations were determined. The piglets were then slaughtered and subject to gross pathology.
No significant effects on feed intake or feed conversion were observed. No adverse effects on blood
parameters or gross pathology were seen.
Poultry
A total of 960 male Ross 308 chickens were distributed among 24 pens (40 birds each).32 Six
replicates pens were used for a control group fed a basal diet in pellet form and for each of three
treatment groups in which bentonite (company H) was added to the basal diet at 0.1 %, 0.5 % or 3.0 %.
The duration of treatment was 42 days, during which period birds reached a weight of ~2.5 kg.
Performance was measured and the health of birds monitored. Blood was collected at the end of the
study from two birds per pen in the control group and the highest dose group. Erythrocyte count,
haematocrit, mean corpuscular volume, haemoglobin and mean corpuscular haemoglobin total protein,
cholesterol, AP and ALT were measured. The birds were then sacrificed and subjected to gross
pathology.
There were no significant differences in the performance characteristics of the four groups. Mortality
was approximately 9 % (attributed largely to leg disorders and kidney urates) but did not differ
significantly between groups. No significant differences in blood parameters or gross pathology
between the control and the high-dose groups were observed.
A second study was carried out at the same location, and with essentially the same design.33 Again 960
Ross 308 chickens were allocated to 24 pens of 40 birds each. In this case the four groups were a
untreated control group fed a basal diet, two treatment groups in which the basal diet was
supplemented with 0.3 % or 2.0 % bentonite (from company H) and a third treatment group in which
the diet was supplemented with hydrated sodium calcium aluminosilicate (HSCAS) at 2 % w/w. The
duration of treatment was 38 days and birds reached a final weight of ~2.2 kg. In this study only
performance characteristics were measured.
There were no significant differences in final weight, weight gain or feed intake between the control
and bentonite-treated groups. However, 2 % bentonite had a small but significant negative effect on
feed to gain ratio. Overall mortality was low (<3.0 %).
A negative influence of bentonite on mortality, egg production and feed efficiency in laying hens at
inclusion levels of 1.5 % was observed by Ali et al. (1994). Bentonite has also been found to decrease
egg yolk colour and to have a tendency to lower egg production (at 14 % inclusion), but to increase
shell strength (Vogt, 1992). Ambula et al. (2003) noted no effect on performance of the inclusion
0.25 % or 0.5 % bentonite. Olver et al. (1989) did not observe significant dietary effects with bentonite
at an inclusion rate of 28 %. Bentonite at 1 % and 1.5 % inclusion rate significantly improved egg
production (Bhatti and Sahota, 1998; Tauqir et al., 2000). In another study, egg yield and weight were
32
33
Supplementary information/Tolerance-study_Bentonite_Chicken.
Supplementary information/Tolerance&Performance-study_Bentonite_Chicken.
EFSA Journal 2012;10(7):2787
11
not influenced by bentonite levels ranging from 1.5 % to 3.5 %, but feed efficiency was slightly higher
at the highest inclusion rate (Inal et al., 2000).
Fish
Eya et al. (2008) assessed the effects of bentonites on the performance and body composition of
rainbow trout. During the feeding trial, quadruplicate groups of 15 rainbow trout (mean initial weight
SD, 104.2 0.7 g) were grown in freshwater (salinity, 0 %; temperature:, 1416 16 C) over 90
days. Fish were hand fed twice a day with diets containing 40 % crude protein supplemented with 0 %
(control), 2.5 %, 5.0 % or 10 % bentonite. Alpha-cellulose replaced bentonite in the control diet in
order to keep the diet isonitrogenous and isoenergetic. There was a statistically significant decrease
(P < 0.05) in percentage weight gain, specific growth rate and feed efficiency in fish fed dietary
bentonite at 5 % and 10 % compared with those fish on the control diet.
3.1.2.
Interactions with other constituents of the diet
Bentonite (0.5 %) decreased the anticoccidial effects of low levels of monensin (55 mg/kg) and
salinomycin (22 mg/kg), but not when the coccidiostats were used at the recommended levels (Gray et
al., 1998). Bentonite (2 %) rendered tilmicosin ineffective (Shryock et al., 1994). Robenidine (and
ipronidazole and buquinolate) were found to be incompatible with bentonite and ruled not to be used
in combination by the FDA (1969, 1971, 1972). The Canadian Bureau of Veterinary Drugs (1992)
reported a case of insufficient efficacy of tylosin when fed concurrently with bentonite to bovines.
Desheng et al. (2005), in a 3-week study, monitored bone mineral content in chickens for fattening.
The levels of calcium, phosphorus, copper, iron and zinc in bone were not affected by 0.5 %
montmorillonite, but fluorine, manganese and lead in bone were decreased. The authors concluded that
supplementation of manganese is necessary when chickens are fed diets containing montmorillonite.
3.1.3.
Conclusions on safety for target species
The results of the studies submitted by the applicant showed that both chickens and piglets tolerate
bentonite addition at 3 % of diet and dairy cows tolerate added bentonite at 2 % of total intake.
Although these studies were carried out using a single sample of bentonite, its composition was typical
of most other bentonites described in this application, and so these results are considered to extend to
other bentonites. Other data from literature showed that trout tolerate bentonite at a level of 2.5 % (the
lowest concentration studied). In poultry, 0.5 % bentonite reduced manganese availability in chickens
for fattening.
Given that any authorisation will be for bentonites limited only by specification and that the
application is for all animal species, and as a margin of safety is difficult to establish, the FEEDAP
Panel considers that the presently authorised limit of 2 % of diet (20 000 mg/kg complete feed) should
be retained.
robenidine as a coccidiostat. Levels of bentonite higher than 0.5 % are expected to reduce the
3.2.
Safety for the consumer
Since bentonite is authorised for use as food additive without any restriction, no studies concerning the
safety for the consumer are required for bentonites under application if they meet the purity criteria
described in the Annex of Commission Directive 2008/84/EC.34 Most of the bentonites under
application do not fully fulfil the requirements of a food additive.
34
OJ L 253, 20.9.2008, p. 1.
EFSA Journal 2012;10(7):2787
12
Clays are essentially not absorbed, and carryover to tissues/products is therefore not relevant.
Montmorillonites are not genotoxic based on a series of tests (Prival et al., 1991; Li et al., 2010;
Sharma et al., 2010). A long-term (28-week) toxicity study in rats (Afriyie-Gyawu et al., 2005)
indicates that levels of calcium montmorillonite as high as 2.0 % (w/w) do not result in overt toxicity,
as determined by zootechnical parameters, gross and histological pathology, haematological
parameters or clinical chemistry.
Consequently, the FEEDAP Panel considers that there is no concern in terms of safety for the
consumer of food products from animals fed diets containing the bentonites seeking authorisation.
3.3.
Safety for the user
A series of skin and eye irritancy studies in rabbits were carried out according to the relevant OECD
protocols using four different bentonite samples: two unmodified and two which had been soda or acid
treated.35 None of the samples were irritant to skin, but mild symptoms were observed in eyes, notably
general redness and transient conjunctivitis. Accordingly, all four samples were considered mildly
irritant to the eye. Although skin sensitisation was not considered, the Panel notes that bentonites are
widely used in cosmetics.
No inhalation toxicity study has been performed, despite the high dusting potential of many of the
products and the generally small particle size (1584 % below 50 m and 331 % below 10 m).
Information on the toxicity of bentonite by the inhalation route in humans is limited to case reports
and case series. In most of these, qualitative and quantitative information on exposure is very limited,
and confounding factors, such as exposure to silica and tobacco smoke, are not considered (WHO,
2005). It has been shown that bentonite airborne dust is associated with elevated susceptibility to
pulmonary infections (Hatch et al., 1985). In addition, handling fullers earth (often referred to as a
bentonite) has been associated with pneumoconiosis. It is not established whether these effects on the
lung are a consequence only of the silica present in most bentonites or are a general property of the
bentonite mineral mix. Intratracheal administration of bentonite to rats revealed a high cytotoxic
potential; however, the acute inflammatory response was short-lived and the cell population returned
to normal within few weeks (Sykes et al., 1983; Vallyathan, 1994). These studies did not consider
chronic exposure.
In the absence of data it seems prudent to consider that all bentonite dusts pose a hazard to those
handling the additive.
3.4.
Safety for the environment
4.
Efficacy
4.1.
Efficacy of bentonites as binders
The results of two extensive studies to examine pellet durability are provided.36 Both studies included
typical chicken, pig and beef cattle feeds prepared without bentonite or containing 1 % or 2 %
bentonite (from company F for chicken and beef cattle feeds and from company H for the pig feed). In
the first study, feed ingredients were ground to pass though a 3-mm sieve and 3 % palm oil was added
at the mixer stage. Three 200-kg batches were prepared for each treatment, giving a total nine batches
per feed type. In the second study the feed ingredients were ground to pass through a 5-mm sieve and
6 % soy oil added to the mixer. Two 300-kg batches were then prepared for each treatment, giving six
35
36
Technical dossier/Section III/Annexes 3-3-1 to 3-3-8.

Supplementary information/May 2012/Efficacy_study_E558_Bentonite_Final-report.
EFSA Journal 2012;10(7):2787
13
batches for each feed type. In both studies the feeds were then pelleted at 65 C. Pellet sizes were
3 mm for chicken feed and 4 mm for pig and beef cattle feed.
Pellet durability was estimated using a rotating Pfost box, in which a 500-g sample of the pelleted
feed was subjected to tumbling motion for 10 min. The weight of particles (fines) released and passing
through a 2-mm sieve (chicken feed) or a 2.5-mm sieve (pig and beef cattle feeds) was then measured
and subtracted from the initial weight. This residual weight was expressed as a percentage of the
original weight to give a measure of durability. Five subsamples were measured for each batch of feed.
The durability of pellets produced in the first trial ranged from 92.7 % to 94.5 % and was not
significantly improved by bentonite addition. In the second study, the durability of pellets produced in
the absence of bentonite was considerably reduced as a result of the changed formulation (chicken
feed 86.9 %, pig feed 65.0 % and beef cattle feed 66.0 %). Addition of bentonite to the chicken feed
significantly improved durability, but the extent of improvement was not affected by dose (Table 5).
The same benefit of bentonite addition was seen with the pig and beef cattle feeds, but here the extent
of improvement reflected the dose of bentonite used.
Table 5:
The effect of bentonite addition on pellet durability expressed as percentage dry matter
remaining after testing (study 2)
Feed
Chicken
Pig
Beef cattle
No bentonite
86.9a
65.0a
66.0a
1% bentonite
92.2b
74.4b
73.8b
2 % bentonite
92.9b
78.8c
77.2c
P-value
0.018
0.001
0.002
a, b, cMeans in a row not sharing a common superscript letter are significantly different.
4.2.
Efficacy of bentonites as anti-caking agents
Bentonites currently are authorised for use, without restriction, as anti-caking agents in food. Since it
is reasonable to assume that bentonites would show similar properties when applied to feed or feed
materials that show a tendency to cake, no further demonstration of efficacy is considered necessary.
4.3.
Efficacy of bentonites as substances for control of radionuclide contamination
The reduced adsorption of radionuclides by addition of bentonite in animal feed has been studied since
radioactive fallout was first detected. As early as 1970, Mirna described experiments with guinea pigs
and pigs in which it was demonstrated that administration of bentonite in feed significantly reduced
caesium-137 in muscle and skin (Mirna, 1970).
The Chernobyl reactor disaster in 1986 rekindled interest in this subject and provided some practical
experience of treating grazing animals. The results of subsequent studies, as well as of some earlier
studies, were reviewed by Voigt (1993) and the findings are summarised in Table 6. Voigt concluded
that bentonites were the most effective of the minerals tested for the reduction of radiocaesium in
animal products and that the apparent differences in their effectiveness may relate to the origin and
forms of bentonites used in the experiments.
EFSA Journal 2012;10(7):2787
14
Table 6:
Effect of bentonite on the radiocaesium concentration in farm animals and their products
(modified from Voigt, 1993)
Dose of bentonite
per day
8 %*
10 %
23 g
106 g
5g
36 g
10 %
200 g
300 g
600 g
500 g
100 g
200 g
250 g
500 g
250 g
500 g
250 g
500 g
750 g
100 g
100 g
5%
5%
Animal
Product
Goat
Lamb
Sheep
Sheep
Lamb
Lamb
Dairy cow
Dairy cow
Milk
Meat
Muscle
Dairy cow
Dairy cow
Milk
Meat
Milk
Dairy cow
Milk
Dairy cow
Milk
Pig
Pig
Pig
Chicken
Meat
Muscle
Meat
Meat
Milk
Milk
Reduction factor
5.9
8
1.2
1.7
1.2
1.5
2.514
1.3
2.2
5.0
3.7
4.3
1.4
1.3
2.0
2.0
1.6
3.0
1.8
3.2
3.2
1.9
1.72.1
3.3
1.4
Reference1
Barth et al., 1969
Anderson, 1989
Beresford et al., 1989
Van den Hock, 1980

Piva et al., 1989
Voigt et al., 1989

Giese, 1989
Mitchell et al., 1989

Hove and Erken, 1988
Voigt et al., 1989

Giese, 1989
Anderson et al., 1990
Anderson et al., 1990
* Refers in each case to the percentage of dry matter intake.

1 For references, see Voigt, 1993
A typical study was that of Unsworth and co-workers, who examined the effects on radiocaesium
levels in milk of the inclusion of bentonite in the diets of dairy cows fed naturally contaminated silage
(Unsworth et al., 1989). In untreated controls, radiocaesium in milk reached a plateau after 5 days and
remained at that level for the remainder of the 6-week experiment. In animals consuming a diet
supplemented with 300, 600 or 900 g bentonite per head per day there was a significant reduction, of
approximately 73 %, in radiocaesium (134/137Cs) levels in the milk of animals given the two higher
doses. However, at the highest dose there was evidence of feed refusal and reduced performance.
Relatively little work on the use of minerals as radiocaesium binders has been carried out since the
immediate aftermath of the Chernobyl disaster with the exception of work with reindeer in
Scandinavia. Ahman (1996) reported that 25 g per day of bentonite reduced radiocaesium transfer to
one-third of that in untreated animals. It was acknowledged that higher doses of bentonite could have
provided a further reduction but led to problems associated with increased water requirements. In fact,
dietary supplementation of bentonite in reindeer in Sweden was discontinued a few years post
Chernobyl as it was not considered cost-effective (Ahman, 1999).
Bentonites could prove useful after a contamination event because of their ready availability in large
quantities.
4.4.
Conclusions on efficacy
Bentonites can increase pellet durability when added at concentrations between 1 % and 2 % complete
feed.
EFSA Journal 2012;10(7):2787
15
Since bentonites are authorised for use as anti-caking agents in food without restriction and can be
reasonably assumed to demonstrate similar properties when applied to feed or feed materials which
show a tendency to cake, no further demonstration of efficacy is considered necessary.
Bentonites will reduce radiocaesium in animals exposed to contaminated feed and, consequently, in
products of animal origin. Since the use of bentonites for this purpose will be restricted to emergency
situations the FEEDAP Panel does not see a reason to set a maximum limit.
CONCLUSIONS AND RECOMMENDATIONS

CONCLUSIONS
Given that any authorisation will be for bentonites limited only by specification and that the
application is for all animal species, and as a margin of safety is difficult to establish, the FEEDAP
Panel considers that the presently authorised limit of 2 % of diet (20 000 mg/kg complete feed) should
be retained to protect target animal safety.
robenidine as a coccidiostat. Levels of bentonite higher than 0.5 % are expected to reduce the
The FEEDAP Panel considers that there is no concern for the safety of consumers of food products
derived from animals fed diets containing bentonite.
Bentonites are not skin irritants but may be mildly irritant to the eye. Although skin sensitisation was
not considered, the Panel notes that bentonites are widely used in cosmetics. The FEEDAP Panel
considers it prudent to assume that all bentonite dusts pose a hazard to those handling the additive.
Bentonites can increase pellet durability when added to complete feed at concentrations of between
1 % and 2 %. Since bentonites are authorised for use, without restriction, as anti-caking agents in food
and can be reasonably assumed to demonstrate similar properties when applied to feed or feed
materials which show a tendency to cake, no further demonstration of efficacy is considered
necessary. Bentonites added to feed contaminated by radioactive fallout or made available to grazing
animals will reduce levels of radiocaesium in animals and their products. Since the use of bentonites
for this purpose will be restricted to emergency situations, the FEEDAP Panel does not see a reason to
set a maximum limit.
RECOMMENDATIONS
Directive 2008/84/EC sets for bentonites intended for use in food a minimum montmorillonite content
of 80 %. This seems unduly restrictive for feed use. Consequently, the Panel recommends that the
definition of a bentonite for feed use should specify a minimum smectite content of 70 %.
Other provisions should include: If used at levels above 5 000 mg/kg, simultaneous use with
coccidiostats is not allowed (without exceptions).
The interactions between bentonite and other medicinal substances (macrolide antibiotics) in poultry
and bovines would support a warning statement in the labelling of bentonite, e.g. The simultaneous
oral use with certain medicinal substances (e.g. macrolides) should be avoided.
DOCUMENTATION PROVIDED TO EFSA

1.
Bentonite. March 2010. Submitted by EUBA aisbl.
EFSA Journal 2012;10(7):2787
16
2. Bentonite. Supplementary information May 2012. Submitted by EUBA aisbl.

3. Evaluation report of the European Union Reference Laboratory for Feed Additives on the
methods(s) of analysis for bentonite.
4. Comments from Member States received through the ScienceNet.
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Afriyie-Gyawu E, Mackie J, Dash B, Wiles M, Taylor J, Huebner H, Tang L, Guan H, Wang JS and
Phillips T, 2005. Chronic toxicological evaluation of dietary NovaSil clay in SpragueDawley rats.
Food Additives and Contaminants, 22, 259269.
Ahman B, 1996. Effect of bentonite and ammonium-ferric(III)-hexacyanoferrate(II) on uptake and
elimination of radiocaesium in reindeer. Journal of Environmental Radioactivity, 31, 2950.
Ahman B, 1999. Direct monitoring of radiocaesium in live reindeer and reindeer carcasses.
Proceedings of the 12th ordinary meeting of the Nordic Society for Radiation Protection, Skagen,
Denmark, 2327 August, Ris National Laboratory, Roskilde, 159162.
Ali S, Chaudhry MS, Anjum MS, Ali S and Baig MY, 1994. Study on the effect of sodiumbentonite
on the performance of commercial layers. Pakistan Journal of Science, 46, 134136.
Ambula MK, Oduho GW and Tuitoek JK, 2003. Effects of high-tannin sorghum and bentonite on the
performance of laying hens. Tropical Animal Health and Production, 35, 285292.
Bhatti BM and Sahota AW, 1998. Effect of dietary supplementation of sodium bentonite on laying
performance of White Leghorn, Fayoumi and Rhode Island Red breeds of chickens. Pakistan
Veterinary Journal, 18, 168169.
Canadian Bureau of Veterinary Drugs, 1992. Suspected drug adverse reactions reported to the Bureau
of Veterinary Drugs. Canadian Veterinary Journal, 33, 237244.
Desheng Q, Fan L, Yanhu Y and Niya Z, 2005. Adsorption of aflatoxin B1 on montmorillonite.
Poultry Science, 84, 959961.
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), 2011.
Scientific Opinion on the safety and efficacy of bentonite (dioctahedral montmorillonite) as feed
additive for all species. EFSA Journal 9(2):2007. 24 pp.
Eya JC, Parsons A, Haile I and Jagidi P, 2008. Effects of dietary zeolites (bentonite and mordenite) on
the performance juvenile rainbow trout Oncorhynchus mykiss. Australian Journal of Basic and
Applied Sciences, 2, 961967.
FDA (Food Drug Administration), 1969. Food additives. Buquinolate. Federal Register, 34(183),
14733.
FDA (Food Drug Administration), 1971. New animal drugs for use in animal feeds. Ipronidazole.
Washington, DC, USA. Federal Register, 36(195), 12901.
FDA (Food Drug Administration), 1972. New animal drugs for use in animal feeds. Robenidine
hydrochloride. Washington, DC, USA. Federal Register, 37(244), 27621.
Gray SJ, Ward TL, Southern LL and Ingram DR, 1998. Interactive effects of sodium bentonite and
coccidiosis with monensin or salinomycin in chicks. Poultry Science, 77, 600604.
Hatch GE, Boykin E, Graham JA, Lewtas J, Pott F, Loud K and Mumford JL, 1985. Inhalable
particles and pulmonary host defense: in vivo and in vitro effects of ambient air and combustion
particles. Environmental Research, 36, 6780.
Inal F, Gulsen N, Coskun B and Arslan C, 2000. The effects of bentonite on egg performance of
laying hens. Indian Journal of Animal Sciences, 70, 194196.
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17
Jansen HD, 1992. Mischtechnik im Futtermittelbetrieb. Anforderungen an Mischenlage, Arbeits- und

Mischgenauigkeit. Die Mhle+ Mischfuttertechnik, 129, 265270.
Li PR, Wei JC, Chiu YF, Su HL, Peng FC and Lin JJ, 2010. Evaluation on cytotoxicity and
genotoxicity of the exfoliated silicate nanoclay. Applied Materials & Interfaces, 2, 16081613.
Mirna A. 1970. Beeinflussung der radioaktiven Kontamination von Tieren durch Zufutterung von
Tonmineralien. Tierphysiologie, Tierernhrung und Futtermittelkontrolle, 26, 7282.
Olver MD, 1989. Sodium bentonite as a component in layer diets. South Africa British Poultry
Science, 30, 841846.
Prival MJ, Simmon VF and Mortelmans KE, 1991. Bacterial mutagenicity testing of 49 food
ingredients gives very few positive results. Mutation Research, Genetic Toxicology Testing, 260,
321329.
Sharma AK, Schmidt B, Frandsen H, Jacobsen NR, Larsen EH and Binderup ML, 2010. Genotoxicity
of unmodified and organo-modified montmorillonite. Mutation Research, Genetic Toxicology and
Environmental Mutagenesis, 700, 1825.
Shryock TR, Klink PR, Readnour RS and Tonkinson LV, 1994. Effect of bentonite incorporated in a
feed ration with tilmicosin in the prevention of induced Mycoplasma gallisepticum airsacculitis in
broiler chickens. Avian Diseases, 38, 501505.
Sykes SE, Morgan A, Moores SR, Davison W, Beck J and Holmes A, 1983. The advantages and
limitations of an in vivo test system for investigating the cytotoxicity and fibrogenicity of fibrous
dusts. Environmental Health Perspectives, 51, 267273.
Tauqir NA, Chughtai ZI, Farooqi ZA, 2000. Effect of different levels of Himax BS-7 (sodium
bentonite) on the performance of commercial layers. Pakistan Veterinary Journal, 20, 105106.
Unsworth EF, Pearce J, McMurray CH, Moss BW, Gordon FJ and Rice D, 1989. Investigations of the
use of clay minerals and Prussian blue in reducing the transfer of dietary radiocaesium to milk. The
Science of The Total Environment, 85, 339347.
Vallyathan V, 1994. Generation of oxygen radicals by minerals and its correlation to cytotoxicity.
Environmental Health Perspectives, 102(Suppl. 10), 111115.
Vogt H, 1992. The effect of bentonite and kieselguhr in laying hen rations. Landbauforschung
Voelkenrode, 42, 8994.
Voigt, G, 1993. Chemical methods to reduce the radioactive contamination of animals and their
products in agricultural ecosystems. The Science of The Total Environment, 137, 205225.
WHO (World Health Organization), 2005. Environmental Health Criteria 231. Bentonite, kaolin, and
selected clay minerals.
EFSA Journal 2012;10(7):2787
18
APPENDIX
Executive Summary of the Evaluation Report of the European Union Reference Laboratory for
Feed Additives on the Method(s) of Analysis for Bentonite for all animal species/categories37
In the current application authorisation is sought under articles 4(1) and 10(2) for Bentonite under the
technological additives, functional group 2(g) binders, 2(h) substances for control of
radionucleide contamination and 2(i) anti-caking agents, according to the classification system of
Annex I of Regulation (EC) No 1831/2003. Authorisation is sought for the use of the feed additive for
all animal species and categories.
Bentonite is a white to beige, green, blue or brown powder or granulates, containing of a minimum of
50% of dioctahedral smectite (known as montmorillonite). Bentonite is intended to be incorporated in
premixtures, complete or complementary feedingstuffs, with no recommended minimum or maximum
levels.
For the determination of the mineralogical and geological parameters of the Bentonite in the feed
additive, the Applicant submitted several analytical methods, including X-ray Diffraction (XRD),
Methylene-Blue Adsorption, X-Ray Fluorescence (XRF) and Atomic Absorption Spectrometry
(AAS). The EURL recommends for official control the X-ray Diffraction (XRD) method for the
determination of Bentonite in the feed additive.
The Applicant did not provide any experimental method or data for the determination of Bentonite in
premixtures and feedingstuffs. Therefore the EURL cannot evaluate nor recommend any method for
official control to determine Bentonite in premixtures and feedingstuffs.
Further testing or validation of the methods to be performed through the consortium of National
Reference Laboratories as specified by Article 10 (Commission Regulation (EC) No 378/2005) is not
considered necessary.
37
Full report available on the EURL website: http://irmm.jrc.ec.europa.eu/SiteCollectionDocuments/FinRep-FAD-20100233.pdf
EFSA Journal 2012;10(7):2787
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EFSA Journal 2010;10(7):2787

Scientific Opinion on the safety and efficacy of bentonite as a technological

European Food Safety Authority, 2012

Bentonite for all species

Bentonite for all species

EFSA Journal 2012;10(7):2787

Bentonite for all species

EFSA Journal 2012;10(7):2787

Bentonite for all species

Description and conditions of use of the additive as proposed by the applicant

1. Technological feed additive

Functional group(s) of additive

Other provisions and additional requirements for the labelling

Not appropriate (existing feed additive)

Specific conditions for use in

EFSA Journal 2012;10(7):2787

Maximum Residue Limit (MRL) (if appropriate)

Bentonite for all species

Characterisation of the product

EFSA Journal 2012;10(7):2787

Bentonite for all species

Smectite content of the bentonite samples

Smectite ( %) (mean SD)

Technical dossier/Section II/Annex II_2-1-4.

EFSA Journal 2012;10(7):2787

Bentonite for all species

Technical dossier/Section II/Annex II_2-1-11a.

EFSA Journal 2012;10(7):2787

Bentonite for all species

929.4 8.6 (n = 10)

875.2 (n = 5), varying

Particle size distribution

N/A, not available.

Stability and homogeneity

Technical dossier/Section II/Annexes II_2-1-23 to II_2-1-30.

EFSA Journal 2012;10(7):2787

Bentonite for all species

Evaluation of the analytical methods by the European Union Reference Laboratory

Safety for the target species

Technical dossier/Section II/Annex II_2-4-6.

EFSA Journal 2012;10(7):2787

Bentonite for all species

EFSA Journal 2012;10(7):2787

Bentonite for all species

Interactions with other constituents of the diet

Conclusions on safety for target species

Safety for the consumer

EFSA Journal 2012;10(7):2787

Bentonite for all species

Safety for the user

Safety for the environment

Efficacy of bentonites as binders

Technical dossier/Section III/Annexes 3-3-1 to 3-3-8.

EFSA Journal 2012;10(7):2787

Bentonite for all species

Efficacy of bentonites as anti-caking agents

Efficacy of bentonites as substances for control of radionuclide contamination

EFSA Journal 2012;10(7):2787

Bentonite for all species

Van den Hock, 1980

Voigt et al., 1989

Mitchell et al., 1989

Voigt et al., 1989

* Refers in each case to the percentage of dry matter intake.