COMMISSION IMPLEMENTING REGUL ATION (EU) 2019/10 
of 3 Januar y 2019 
concer ning the author isation of a preparation of a natural mixture of illite- montmor illonite- 
kaolinite as a feed additiv e for all animal species 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regar d to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 
on additives for use in animal nutr ition (1), and in particular Article 9(2) thereof, 
Whereas: 
(1)  Regulation (EC) No 1831/2003 provi des for the author isation of additives for use in animal nutr ition and for the 
grounds and procedures for granting such author isation. 
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitte d for the author is­
ation of a preparation of a natural mixture of illite-montmor illonite-kaoli nite. That application was accompan ied 
by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. 
(3)  That application concer ns the author isation of a preparation of a natural mixture of illite-montmor illonite- 
kaolinit e as a feed additive for all animal species, to be classif ied in the additive catego ry ‘techn ological additives ’. 
(4)  The European Food Safety Author ity (‘the Auth ority’) concluded in its opinions of 1 December 2015 (2), 5 July 
2017 (3) and 5 July 2018 (4) that, under the proposed conditions of use, the preparation of a natural mixture of 
illite-montmor illonite-kaoli nite does not have an adverse effect on animal health, human health or the 
environment. The Authority also concluded that it is effective as a binder and anticaking agent. The Author ity 
does not consider that there is a need for specifi c requirements of post-market monitori ng. It also verified the 
repor t on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by 
Regulation (EC) No 1831/2003. 
(5)  The assessment of the preparation of a natural mixture of illite-montmor illonite-kaoli nite shows that the 
conditions for author isation, as provi ded for in Article 5 of Regulation (EC) No 1831/2003, are satisfi ed. 
According ly, the use of that preparation should be author ised as specifi ed in the Annex to this Regulation. 
(6)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
The preparation specifi ed in the Annex, belonging to the additive catego ry ‘technological additives ’ and to the functional 
group ‘binders’ and ‘anticaking agents’, is author ised as an additive in animal nutr ition, subject to the conditions laid 
down in the Annex. 
Article 2 
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union. 4.1.2019 L 2/13 Official Jour nal of the European Union EN     
(1)OJ L 268, 18.10.2003, p. 29. 
(2)EFSA Jour nal 2016; 14(1):4342. 
(3)EFSA Jour nal 2017; 15(7):4940. 
(4)EFSA Jour nal 2018; 16(7):5387. This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 3 Januar y 2019. 
For the Commission 
The President 
Jean-Claude JUNCK ER  4.1.2019 L 2/14 Official Jour nal of the European Union EN     ANNEX 
Identifica ­
tion 
number of 
the additive Additive Compo sition, chemical formula, 
descr iption, analytical method Species or categ ory 
of animal Maximum 
age Minimum 
content Maximum 
conten t 
Other provisions End of period 
of author is­
ation mg of additive/kg of 
compl ete feedingstuff with 
a moisture conten t of 12 % 
Technological additiv es: binders 
1g599 Illite-mon ­
tmor illonite - 
kaolinit e Additive composition 
Preparation of a natural mixture 
of illite- montmor illonite-kaoli ­
nite, having a minimum content 
of: 
—  40 % of illite 
—  10 % of montmor illonit e 
—  8 % of kaolinite 
Char acter isation of the active sub­
stance 
Illite: 
CAS number 106958-53-6 
K(Al,Fe)2AlSi3O10(OH)2 · H2O 
Montmor illonite : 
CAS number 1318-93-0 
Nax[(Al2-xMgx)Si4O10) (OH)2] 
Kaoli nite: 
CAS number 1318-74-7 
Al2(OH)4(SiO5) 
Iron (structural) 10 % average 
Free of asbest os 
Analytical method (1) 
Character isation of the feed addi ­
tive: 
—X-ray diffraction (XRD) to­
gether with 
—  X-ray fluorescence (XRF). Chick ens for 
fattening and 
minor poultr y 
species for 
fattening. 
Cattle for 
fattening and 
minor ruminants 
for fattening 
Pigs for fattening 
and weaned 
piglets — 5 000 50 000 1.  In the directions for use of the additive 
and premixtures, the storag e conditions 
and stability to heat treatment shall be 
indicate d. 
2.For users of the additive and premix ­
tures, feed business operators shall es­
tablish operational procedures and or­
ganisational measures to address 
poten tial risks resulting from their use. 
Where those risks cannot be eliminated 
or reduced to a minimum by such pro­
cedures and measures, the additive and 
premixtures shall be used with personal 
prot ective equipment, including breath ­
ing prot ection. 
3.In the labelling of the additive and pre­
mixtures containing it, the following 
shall be indicate d: ‘The additive illite- 
montmor illonite -kaolinite is rich in (in­
ert) iron’ . 
4.The total amount of differ ent uses of il­
lite-montmor illonite-kaolinit e in com ­
plete feedingstuff shall not excee d the 
permitted maximum level for the rel­
evant species or cate gory of animals. 
5.  The instr uctions for use shall indicate 
the follo wing: 
—  ‘The simultaneous oral use with 
macrolides shall be avoided’ . 24 Januar y 
2029 
All other animal 
species and 
catego ries — 5 000 20 000 4.1.2019 L 2/15 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Additive Compo sition, chemical formula, 
descr iption, analytical method Species or categ ory 
of animal Maximum 
age Minimum 
content Maximum 
conten t 
Other provisions End of period 
of author is­
ation mg of additive/kg of 
compl ete feedingstuff with 
a moisture conten t of 12 % 
Technological additiv es: anticaking agents 
1g599 Illite-mon ­
tmor illonite - 
kaolinit e Additive composition 
Preparation of a natural mixture 
of illite- montmor illonite-kaoli ­
nite, having a minimum content 
of: 
—  40 % of illite 
—  10 % of montmor illonit e 
—  8 % of kaolinite 
Char acter isation of the active sub­
stance 
Illite: 
CAS number 106958-53-6 
K(Al,Fe)2AlSi3O10(OH)2 · H2O 
Montmor illonite : 
CAS number 1318-93-0 
Nax[(Al2-xMgx)Si4O10) (OH)2] 
Kaoli nite: 
CAS number 1318-74-7 
Al2(OH)4(SiO5) 
Iron (structural) 10 % average 
Free of asbest os 
Analytical method (1) 
Character isation of the feed addi ­
tive: 
—X-ray diffraction (XRD) to­
gether with 
—  X-ray fluorescence (XRF). Chick ens for 
fattening and 
minor poultr y 
species for 
fattening. 
Cattle for 
fattening and 
minor ruminants 
for fattening 
Pigs for fattening 
and weaned 
piglets — 5 000 50 000 1.  In the directions for use of the additive 
and premixtures, the storag e conditions 
and stability to heat treatment shall be 
indicate d. 
2.For users of the additive and premix ­
tures, feed business operators shall es­
tablish operational procedures and or­
ganisational measures to address 
poten tial risks resulting from their use. 
Where those risks cannot be eliminated 
or reduced to a minimum by such pro­
cedures and measures, the additive and 
premixtures shall be used with personal 
prot ective equipment, including breath ­
ing prot ection. 
3.In the labelling of the additive and pre­
mixtures containing it, the following 
shall be indicate d: ‘The additive illite- 
montmor illonite -kaolinite is rich in (in­
ert) iron’ . 
4.The total amount of differ ent uses of il­
lite-montmor illonite-kaolinit e in com ­
plete feedingstuff shall not excee d the 
permitted maximum level for the rel­
evant species or cate gory of animals. 
5.  The instr uctions for use shall indicate 
the follo wing: 
—  ‘The simultaneous oral use with 
macrolides shall be avoided’ . 24 Januar y 
2029 
All other animal 
species and 
catego ries — 5 000 20 000 
(1)  Details of the analytical methods are available at the following address of the Reference Laborato ry: https://ec.europa.eu/jrc/en/eurl/feed-addi tives/evaluation-repor ts   4.1.2019 L 2/16 Official Jour nal of the European Union EN