COMMISSION IMPLEMENTING REGUL ATION (EU) 2019/9 
of 3 Januar y 2019 
concer ning the author isation of betaine anh ydrous as a feed additiv e for food-producing animals 
except rabbits 
(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 submitt ed for the author is­
ation of betaine anhydrous. 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 betaine anhydrous as a feed additive for food-producing animals 
to be classified in the additive functional group ‘vitamins, provitamins and chemically well-defined substances 
having a similar effect’. Subsequently , the applicant withdrew the application for rabbits. 
(4)  The European Food Safety Author ity (‘the Author ity’) concluded in its opinion of 12 June 2018 (2) that, under 
the proposed conditions of use, betaine anhydrous does not have adverse effects on animal health, human health 
or the environment. The Author ity concluded that betaine anhydrous has a nutr itional role and is an effective 
source of betaine with a potential to be efficacious in all animal species. 
(5)  The Author ity further noted that the solid form has the poten tial to generate dust ; theref ore, exposure by 
inhalation cannot be excl uded. In addition, the Author ity state d that betaine anhydrous should be considered 
hazardous by inhalation, irritant to skin, eyes and mucous membranes and a skin sensitiser . Consequently , 
appropr iate prot ective measures should be taken with respect to the handling of the solid form of betaine 
anhydrous. 
(6)  The Author ity concluded that the liquid form of betaine anhydrous contains a high propor tion of unknown 
mate rial; theref ore, it is not possible to conclude on its safet y. Consequently , only the solid form should be 
author ised. 
(7)  The Auth ority does not consider that there is a need for specifi c 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 Laborat ory 
set up by Regulation (EC) No 1831/2003. 
(8)  The assessment of betaine anhydrous 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 this additive should be author ised as 
specified in the Annex to this Regulation. 
(9)  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 
Author isation 
The substance specifi ed in the Annex, belonging to the additive categor y ‘nutr itional additives ’ and to the functional 
group ‘vitamins, provi tamins and chemical ly well-defined substances having a similar effect’, is author ised as a feed 
additive in animal nutr ition, subject to the conditions laid down in that Annex. 4.1.2019 L 2/10 Official Jour nal of the European Union EN     
(1)OJ L 268, 18.10.2003, p. 29. 
(2)EFSA Journal 2018;16(7):5335 Article 2 
Entr y into force 
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 State s. 
Done at Brussels, 3 Januar y 2019. 
For the Commission 
The President 
Jean-Claude JUNCK ER  4.1.2019 L 2/11 Official Jour nal of the European Union EN     ANNEX 
Identifica ­
tion 
number of 
the additive Name of 
the holder 
of 
author isa­
tion Additive Compo sition, chemi cal formula, 
descr iption, analytical method Species or 
categ ory of 
animal Maximum 
age Minimum 
content Maximum 
content 
Other provisions End of 
period of 
author isa­
tion mg of active substance/kg 
of complet e feedingstuff 
with a moisture conten t of 
12 % 
Categor y of nutr itional additiv es. Functional group: vita mins, provitamins and chemically well-def ined subst ances having a similar effect 
3a921i AB Vista 
Iber ia S.L. Betaine 
anhydrous 
produced 
from 
genetically 
modified 
sugar beet Additive composition 
Betaine anhydrous 
Char acter isation of the active sub­
stance 
Betaine C5H11NO2 
CAS number: 107-43-7 
Betaine anhydrous, crystalline sol­
id form, produced by extraction 
from genetically modifi ed KM- 
ØØØH71-4 sugar beet. 
Purity criteria: min. 97 % (on an­
hydrous basis) 
Method of Analysis (1) 
For the deter mination of betaine 
anhydrous (expressed as total be­
taine) in the feed additiv e, premix ­
tures, and feedingstuffs. High Per­
formance Liquid Chromat ography 
method with refractive index de­
tector (HPL C-RI). Food-produ ­
cing animals 
excep t rab­
bits — —  1.  Betaine anhydrous may be placed 
on the market and used as an addi ­
tive consisting of a preparation. 
2.In the directions for use of the addi ­
tive and premixtures, the storag e 
and stability to heat treatment shall 
be indicate d. 
3.  On the label of the additive and the 
premixture the following shall be 
indicated ‘Recommended not to ex­
ceed levels of: 2 000 mg of betai ­
ne/kg of compl ete feed (with a 
moisture content of 12 %)’. 
4.For users of the additive and pre­
mixtures, feed business operators 
shall establish operational proce ­
dures and organisational measures 
to address poten tial risks by inhala ­
tion, dermal contact or eyes contact. 
Where those risks cannot be elimin ­
ated or reduced to a minimum by 
such procedures and measures, the 
additive and premixtures shall be 
used with personal prot ective equip ­
ment, including breathing prot ec­
tion, safety glasses and gloves . 4 August 
2028 
(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 2/12 Official Jour nal of the European Union EN