COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/1371 
of 1 Oct ober 2020 
concer ning the author isation of a preparation of endo-1,4-beta-xy lanase and endo-1,4-beta-gluca nase 
as a feed additiv e for lactating sows (holder of the author isation BASF SE) 
(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 9(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 such author isation. 
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the author isation 
of a preparation of endo-1,4-beta-xylanase and endo-1,4-beta-g lucanase. That application was accompanied by the 
particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. 
(3) The application concer ns the author isation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by 
Aspergillus niger CBS 109.713 and endo-1,4-beta-g lucanase (EC 3.2.1.4) produced by Aspergillus niger DSM 18 404 
as a feed additive for lactating sows to be classifie d in the additive catego ry ‘zootec hnical additives’ and in the 
functional group ‘digestibility enhancers ’. 
(4) The European Food Safety Author ity (‘the Author ity’) concluded in its opinion of 29 Januar y 2020 (2) that, under the 
proposed conditions of use, the preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus niger CBS 
109.713 and endo-1,4-beta-g lucanase (EC 3.2.1.4) produced by Aspergillus niger DSM 18 404 does not have an 
adverse effect on animal health, consumer safety or the environment. It was also concluded that the additive should 
be considered as a potential skin and respirator y 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 Author ity concluded that the additive is efficacious as a zootec hnical additive in improving the 
diges tibility of the diets in lactating sows. The Author ity does not consider that there is a need for specific 
requirements of post-market monitor ing. It also verified the repor t on the method of analysis of the feed additive in 
feed submitted by the Reference Laborator y set up by Regulation (EC) No 1831/2003. 
(5) The assessment of the preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus niger CBS 109.713 
and endo-1,4-beta-g lucanase (EC 3.2.1.4) produced by Aspergillus niger DSM 18 404 shows that the conditions for 
author isation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. According ly, the use of 
that preparation should be author ised as specified in the Annex to this Regulation. 
(6) 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, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
The preparation specified in the Annex, belonging to the additive categor y ‘zoot echnical additives ’ and to the functional 
group ‘diges tibility enhancers’, is author ised as an additive in animal nutr ition, subject to the conditions laid down in that 
Annex. 
(1)OJ L 268, 18.10.2003, p. 29. 
(2)EFSA Jour nal 2020;18(2):6025. EN Offi cial Jour nal of the European Union L 319/8                                                                                                                                           2.10.2020   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, 1 October 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union 2.10.2020                                                                                                                                           L 319/9   ANNEX 
Identi-
fication 
num-
ber of 
the 
addi-
tive Name of the 
holder of 
author isation Additive Composition, chemical formula, descr iption, 
analytical method Species or 
category of 
animal Maximum 
age Minimum 
content Maximum 
content 
Other provisions End of period of 
author isation Units of activity/kg of 
complet e feedingstuff with 
a moisture content of 12 % 
Categor y of zootechnical additiv es. Functional group: digestibility enhancers. 
4a7 BASF SE Endo-1,4-beta- 
xylanase (EC 
3.2.1.8) and 
endo-1,4-beta- 
glucanase (EC 
3.2.1.4) Additive composition 
Preparation of endo-1,4-beta-xylanase (EC 
3.2.1.8) produced by Aspergillus niger CBS 
109.713 and endo-1,4-beta-g lucanase (EC 
3.2.1.4) produced by Aspergillus niger DSM 
18 404 having a minimum activity of 
5 600 TXU (1) and 2 500 TGU (2)/g in solid 
or liquid form Lactating 
sows - 560 TXU 
250 TGU - 1. In the directions for use of 
the additive and premix­
ture, the storag e condi­
tions and stability to heat 
treatment shall be indi­
cated . 22 October 2030 
Char acter isation of activ e substance 
Endo-1,4-beta-xylanase (EC 3.2.1.8) produ­
ced by Aspergillus niger CBS 109.713 and 
endo-1,4-beta- glucanase (EC 3.2.1.4) produ­
ced by Aspergillus niger DSM 18 404 2. For users of the additive 
and premixtures, feed 
business operat ors shall 
establish operational pro­
cedures and organisa­
tional measures to ad­
dress potential risks 
resulting from their use. 
Where those risks cannot 
be eliminate d or reduced 
to a minimum by such 
procedures and measures, 
the additive and premix­
tures shall be used with 
personal prot ective 
equipment, including 
skin, eyes and breathing 
prote ction. Analytical method (3) 
For quantifi cation of endo-1,4-beta-xylanase 
in the feed additive, premixtures and feed 
mater ials and compo und feed: 
Viscosimetr ic method based on decrease of vis­
cosity produced by action of endo-1,4-beta- 
xylanase on the xylan containing substrate 
(wheat arabino xylan) at pH = 3,5 and 55 °C. 
For quantifi cation of endo-1,4-beta-g luca­
nase in the feed additive, premixtures, feed 
mater ials and compo und feed: 
Viscosimetr ic method based on decrease of vis­
cosity produced by action of endo-1,4-beta- 
glucanase on the glucan containing substrate 
(barle y betag lucan) at pH = 3,5 and 40 °C. 
(1) One TXU is defined as the amount of enzyme that liberat es 5 μmol of reducing sugars (xylose equivalents) from wheat arabino xylan per minut e at pH = 3,5 and 55 °C. 
(2) One TGU is defin ed as the amount of enzyme that liberates 1 μmol of reducing sugars (glucose equivalents) from barley betag lucan per minut e at pH = 3,5 and 40 °C. 
(3) 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 L 319/10                                                                                                                                         2.10.2020   