COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/2120 
of 16 December 2020 
amending Implementing Regulation (EU) 2016/1964 as regards the author isation of a preparation of 
montmor illonite-illite as feed additiv e for all animal species 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Havi ng regar d to the Treaty on the Functioning of the European Union, 
Havi ng rega rd to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 Sept ember 2003 on 
additives for use in animal nutr ition (1), and in particular Article 13(2) thereof, 
Whereas: 
(1) Regulation (EC) No 1831/2003 provid es for the author isation of additives for use in animal nutr ition and for the 
grounds and procedures for granting or modifying such author isation. 
(2) The use of a preparation of montmor illonite-i llite as a feed additive was author ised for all animal species by 
Commission Implementing Regulation (EU) 2016/1964 (2). 
(3) In accordance with Article 13(1) of Regulation (EC) No 1831/2003, the Commission request ed the European Food 
Safety Author ity (‘the Auth ority’) to issue an opinion on whether the author isation of a preparation of 
montmor illonite-i llite as a feed additive would still meet the conditions laid down in Article 5 of Regulation (EC) 
No 1831/2003, consider ing a modific ation of the terms of that author isation. The modification relates to the 
current author isation for the use of the additive as anticaking agent in compl ementar y feedingstuffs. The request 
was accompanied by the relevant suppor ting data. 
(4) The Author ity concluded in its opinions of 30 Octobe r 2014 (3), 10 Sept ember 2015 (4) and 20 March 2020 (5) that 
the proposed modifi cation to the term s of author isation of the preparation of montmor illonite-i llite does not 
modify the previous conclusions that the additive does not have an adverse effect on animal health, consumer safety 
or the envi ronment. It also concluded that dust generat ed during normal handling of the additive has the poten tial to 
expose the whole of the respirator y tract of users to harmful substances (crystalline silica) for whic h no safe levels of 
exposure have been identif ied and that in the absence of data on the effects on skin and eyes, must be considered as 
irritant to skin and eyes and as a poten tial dermal sensitiser . Theref ore, the Commission considers that appropr iate 
prote ctive measures should be taken to prevent adverse effects on human health, in particular as regar ds the users 
of the additive. The Authority has also concluded that the additive is efficacious as an anti-caking agent. The 
Authority does not consider that there is a need for specific requirements of post-market monitori ng. It also verified 
the repor t on the methods of analysis of the feed additives in feed submitted by the Reference Laboratory set up by 
Regulation (EC) No 1831/2003. 
(5) The assessment of the proposed modifi cation to the author isation shows that the conditions for author isation, as 
provid ed for in Article 5 of Regulation (EC) No 1831/2003, are satisfi ed. 
(6) Implementing Regulation (EU) 2016/1964 should theref ore be amended according ly. 
(7) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed, 
(1)OJ L 268, 18.10.2003, p. 29. 
(2)Commission Implementing Regulation (EU) 2016/1964 of 9 November 2016 concer ning the author isations of a preparation of 
dolomite- magnesite for dair y cows and other ruminants for dair y production, weaned piglets and pigs for fattening and a preparation 
of montmor illonit e-illite for all animal species as feed additives (OJ L 303, 10.11.2016, p. 7). 
(3)EFSA Journal 2014;12(11):3904 
(4)EFSA Journal 2015;13(9):4237 
(5)EFSA Journal 2020;18(5):6095. EN Offi cial Jour nal of the European Union L 426/22                                                                                                                                       17.12.2020   HAS ADOPTED THIS REGUL ATION: 
Article 1 
The Annex to Implementing Regulation (EU) 2016/1964 is amended in accordance with the Annex to this Regulation. 
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. 
This Regulation shall be binding in its entirety and directly applicable in all Member States. 
Done at Brussels, 16 December 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union 17.12.2020                                                                                                                                       L 426/23   ANNEX 
In the Annex to Implementing Regulation (EU) 2016/1964, the entr y concer ning the additive montmor illonit e-illite with the identification number 1g557 is replaced by the follo wing:                                                               
Identif ica-
tion 
number of 
the 
additiv e Additiv e Composition, chemical formula, 
descr iption, analytical method Species or categor y 
of animal Maxi-
mum 
age Minimum 
content Maximum 
content 
Other provisions End of period of 
author isation mg of additiv e/kg of 
complete feedingstuf f 
with a moisture 
content of 12 % 
Categor y of technological additiv es. Functional group: binders 
‘1g557 Montmor illonite-Illit e Additiv e composition 
Preparation of montmor illonite -illite 
mixe d layer clay mineral: phyllosili­
cates ≥ 75 % 
Character isation of activ e sub­
stance 
Phyllosilicates ≥ 75 %: 
≥ 35 % montmor illonite -illite (swel­
lable) 
≥ 30 % illite/muscovit e 
≤ 15 % kaolinit e (non-swellable) 
Quar tz ≤ 20 % 
Iron (structural) 3,6 % (averag e) 
Free of asbest os All animal species - 10 000 20 000 1. The instr uctions for use shall indicate 
the follo wing: 
— “The simultaneous oral use with 
macrolides shall be avoided”, 
— ”In addition, for poultr y, the 
simultaneous use with robenidine 
shall be avoided”. 
2. For poultr y: the simultaneous oral use 
with coccidiostats other than robeni­
dine is contraindicated with level of 
montmor illonite-i llite abov e 10 000 
mg/kg of compl ete feed. 
3. In the labelling of feed additive and 
premixtures containing it, the follo w­
ing shall be indicated: “The additive, 
montmor illonite-i llite, is rich in (iner t) 
iron”. 
4.For users of the additive and premix­
tures, feed business operat ors shall es­
tablish operational procedures and or­
gani sational measures to address 
poten tial risks resulting from its use. 
Where those risks cannot be elimi­
nated or reduced to a minimum by 30 November 2026’ 
Analytical method (1) 
For the determination in feed addi­
tive: 
— X-ray diffraction (XRD) 
— Inductively coupled plasma 
atomi c emission spectroscop y 
(ICP -AES) EN Offi cial Jour nal of the European Union L 426/24                                                                                                                                       17.12.2020   Identif ica-
tion 
number of 
the 
additiv e Additiv e Composition, chemical formula, 
descr iption, analytical method Species or categor y 
of animal Maxi-
mum 
age Minimum 
content Maximum 
content 
Other provisions End of period of 
author isation mg of additiv e/kg of 
complete feedingstuf f 
with a moisture 
content of 12 % 
such procedures and measures, the ad­
ditive and premixtures shall be used 
with personal protective equipment, 
including breathing protection 
5. total amount of diffe rent sources of 
montmor illonite-i llite in compl ete 
feedingstuff shall not excee ded the 
permitted maximum level of 20 000 
mg/kg of compl ete feedingstuff. 
(1) Details of the analytical methods are avail able at the follo wing address of the Reference Laboratory : https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-repor ts   EN Offi cial Jour nal of the European Union 17.12.2020                                                                                                                                       L 426/25   Identif ica-
tion 
number of 
the 
additiv e Additiv e Composition, chemical formula, 
descr iption, analytical method Species or categor y 
of animal Maxi-
mum 
age Minimum 
content Maximum 
content 
Other provisions End of period of 
author isation mg of additiv e/kg of 
complete feedingstuf f 
with a moisture 
content of 12 % 
Categor y of technological additiv es. Functional group: anti-caking agent 
‘1g557 Montmor illonite-Illit e Additiv e composition 
Preparation of montmor illonite -illite 
mixe d layer clay mineral: phyllosili­
cates ≥ 75 % 
Character isation of activ e sub­
stance 
Phyllosilicates ≥ 75 %: 
≥ 35 % montmor illonite -illite (swel­
lable) 
≥ 30 % illite/muscovit e 
≤ 15 % kaolinit e (non-swellable) 
Quar tz ≤ 20 % 
Iron (structural) 3,6 % (averag e) 
Free of asbest os All animal species - - 20 000 1. The instr uctions for use shall indicate 
the follo wing: 
— “The simultaneous oral use with 
macrolides shall be avoided”, 
— ”In addition, for poultr y, the 
simultaneous use with robenidine 
shall be avoided”. 
2.The additive shall be used at a mini­
mum level of: 
— 10 000 mg/kg when it is used as 
anti-caking agent directly in com­
plementar y feedingstuffs, 
— 20 000 mg/kg when it is used as 
anti-caking agent in compl ete fee­
dingstuffs. 
3. For poultr y: the simultaneous oral use 
with coccidiostats other than robeni­
dine is contraindicated . 
4. In the labelling of feed additive and 
premixtures containing it, the follo w­
ing shall be indicated: “The additive, 
montmor illonite-i llite, is rich in (iner t) 
iron”. 
5.For users of the additive and premix­
tures, feed business operat ors shall es­
tablish operational procedures and or­
gani sational measures to address 30 November 2026’ 
Analytical method (1) 
For the determination in feed addi­
tive: 
— X-ray diffraction (XRD) 
— Inductively coupled plasma 
atomi c emission spectroscop y 
(ICP -AES) EN Offi cial Jour nal of the European Union L 426/26                                                                                                                                       17.12.2020   Identif ica-
tion 
number of 
the 
additiv e Additiv e Composition, chemical formula, 
descr iption, analytical method Species or categor y 
of animal Maxi-
mum 
age Minimum 
content Maximum 
content 
Other provisions End of period of 
author isation mg of additiv e/kg of 
complete feedingstuf f 
with a moisture 
content of 12 % 
poten tial risks resulting from its use. 
Where those risks cannot be elimi­
nated or reduced to a minimum by 
such procedures and measures, the ad­
ditive and premixtures shall be used 
with personal protective equipment, 
including breathing protection 
6. The tota l amount of different sources 
of montmor illonite-illit e in compl ete 
feedingstuff shall not excee ded the 
permitted maximum level of 20 000 
mg/kg of compl ete feedingstuff. 
(1) Details of the analytical methods are avail able at the follo wing address of the Reference Laboratory : https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-repor ts   EN Offi cial Jour nal of the European Union 17.12.2020                                                                                                                                       L 426/27