COMMISSION IMPLEMENTING REGUL ATION (EU) 2021/967 
of 16 June 2021
concer ning the renewal of the author isation of manganese chelate of hydro xy analogue of 
methionine as a feed additiv e for all animal species, and repealing Regulation (EU) No 350/2010 
(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 and renewing such author isation.
(2) Mangan ese chelate of hydroxy analogue of methionine was author ised for 10 years as a feed additive for all animal 
species by Commission Regulation (EU) No 350/2010 (2).
(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of 
the author isation of manganese chelate of hydroxy analogue of methionine as feed additive for all animal species in 
the additive catego ry ‘nutr itional additives ’. That application was accompanied by the particulars and documents 
required under Article 14(2) of Regulation (EC) No 1831/2003.
(4) It results from the opinion of the European Food Safe ty Author ity (‘the Auth ority’) of 30 Sept ember 2020 (3)that, 
under the proposed conditions of use, manganese chelate of hydroxy analogue of methionine does not have an 
adverse effect on animal health, consumer safety or the environment. The Author ity also concluded for the additive 
a risk for the user by inhalation and that it is a skin sensitizer . Theref ore, the Commission considers that appropr iate 
prote ctive measures should be take n to prevent adverse effects on human health, in particular as regar ds the users of 
the additive. The proof of the efficacy of the additive, on whic h the initial author isation was based, withstands in a 
renewal procedure. The Author ity 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 manganese chelate of hydroxy analogue of methionine shows that the conditions for 
author isation, as provid ed for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. According ly, the 
author isation of this additive should be renewed.
(6) As a consequence of the renewal of the author isation of manganese chelat e of hydro xy analogue of methionine as 
feed additive, Regulation (EU) No 350/2010 should be repealed.
(7) Since safet y reasons do not require the immediate application of the modifications to the conditions of author isation 
for manganese chelat e of hydroxy analogue of methionine, it is appropr iate to allow a transitional period for 
inter ested parties to prepare themselves to meet the new requirements resulting from the renewal of the 
author isation.
(8) 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 Regulation (EU) No 350/2010 of 23 Apr il 2010 concer ning the author isation of manganese chelat e of hydro xy analogue 
of methionine as a feed additive for all animal species (OJ L 104, 24.4.2010, p. 34).
(3)EFSA Journal 2020;18(11):6281EN Offi cial Jour nal of the European Union 17.6.2021                                                                                                                                         L 214/41  HAS ADOPTED THIS REGUL ATION:
Article 1
The author isation of the additive specifi ed in the Annex, belonging to the additive categor y ‘nutr itional additives ’and to the 
functional group ‘compounds of trace elements ’, is renewed subject to the conditions laid down in that Annex.
Article 2
1. Mangan ese chelat e of hydroxy analogue of methionine and premixtures containing this additive, which are produced 
and labelled before 7 Januar y 2022 in accordance with the rules applicable before 7 July 2021 may continue to be placed 
on the mark et and used until the existing stoc ks are exhaust ed.
2. Feed mater ials and compound feed containing manganese chelate of hydro xy analogue of methionine, whic h are 
produced and labelled before 7 July 2022 in accordance with the rules applicable before 7 July 2021 may continue to be 
placed on the market and used until the existing stoc ks are exhaust ed if they are intended for food-producing animals.
3. Feed mater ials and compound feed containing manganese chelate of hydro xy analogue of methionine, whic h are 
produced and labelled before 7 July 2023 in accordance with the rules applicable before 7 July 2021 may continue to be 
placed on the market and used until the existing stoc ks are exhaust ed if they are intended for non-f ood-producing animals.
Article 3
Regulation (EU) No 350/2010 is repealed.
Article 4
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 June 2021 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 214/42                                                                                                                                         17.6.2021  ANNEX 
Identification 
number of the 
additiveName 
of the 
holder 
of 
autho -
risa-
tionAdditiveComposition, chemical formula, descr iption, 
analytical methodSpecies or 
category of 
animalMaxi -
mum 
ageMini -
mum 
con-
tentMaximum content
Other provisionsEnd of period of 
author isationConten t of element (Mn) in  
mg/kg of complet e feed 
with a moisture conten t of 
12 %
Categor y of nutr itional additiv es. Functional group: compounds of trace elements
3b510 - Mangan ese 
chelate of 
hydroxy 
analogue of 
methionineChar acter isation of the additive :
Mangan ese chelat e of hydroxy analogue 
of methionine containing 14 % 
manganese and 76 % (2-h ydro xy- 
4-methyl thio) butanoic acid.
Maximum cont ent of nick el: 170 ppm.
Solid form.
Analytical method (1):
For the quantification of the hydro xy 
analogue of methionine cont ent in the 
feed additive:
— Titrimetr y, poten tiometr ic titration 
after oxidation reduction reaction;
For the quantif ication of total manganese 
in the feed additive and premixtures:
— Atomic Absor ption Spectrometr y, 
AAS (EN ISO 6869); or
— Inductively Coupled Plasma – 
Atomic Emission Spectrometr y, 
ICP-AES (EN 15510); or
— Inductively Coupled Plasma – 
Atomic Emission Spectrometr y 
after pressure diges tion, ICP-AES 
(EN 15621);All 
species- - Fish: 100 (total)
Other species: 
150 (total)1.The additive shall be incor porat ed 
into feed in the form of a premixture.
2.Mangan ese chelate of hydro xy analo ­
gue of methionine may be placed on 
the mark et and used as an additive 
consisting of a preparation.
3.For users of the additive and premix ­
tures, feed business operat ors shall 
establish operational procedures 
and appropr iate organisational mea ­
sures to address the pote ntial risks by 
inhalation, dermal contact or eyes 
contact, in particular due to the con­
tent of heavy metals including nick el. 
Where risks cannot be reduced to an 
acceptable level by these procedures 
and measures, the additive and pre­
mixtures shall be used with appropr i­
ate personal prot ective equipment.7 July 2031EN Offi cial Jour nal of the European Union 17.6.2021                                                                                                                                         L 214/43  For the quantif ication of total manganese 
in feed mate rials and compo und feed:
— Atomic Absor ption Spectrometr y, 
AAS (Commission Regulation (EC) 
No 152/2009, Annex IV-C); or
— Atomic Absor ption Spectrometr y, 
AAS (EN ISO 6869); or
— Inductively Coupled Plasma – 
Atomic Emission Spectrometr y, 
ICP-AES (EN 15510); or
— Inductively Coupled Plasma – 
Atomic Emission Spectrometr y 
after pressure diges tion, ICP-AES 
(EN 15621).
(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 tsEN Offi cial Jour nal of the European Union L 214/44                                                                                                                                         17.6.2021