COMMISSION IMPLEMENTING REGUL ATION (EU) 2022/654 
of 20 Apr il 2022
concer ning the author isation of butylated hydro xyanisole as a feed additiv e for cats 
(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 Articles 9(2) and 10(5) 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. In particular , Article 10(2), in conjunction with Article 
10(7) of that Regulation, provid es for specifi c procedures for the re-evaluation of additives author ised pursuant to 
Council Directive 70/524/EEC (2)and Council Directive 82/471/EEC (3).
(2) Butylated hydro xyanisole was author ised without a time limit as a feed additive for all animal species in accordance 
with Council Directive 70/524/EEC. This additive has been subsequently entered in the Registe r of feed additives as 
an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.
(3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an 
application was submitte d for the re-evaluation of butylated hydroxyanisole as a feed additive for all animal species. 
The applicant has later withdrawn the application with regar d to cats, due to the adop tion by EFSA on 12 November 
2019 (4)of a non-f avourable opinion concer ning the safety of the additive for use for cats. The re-evaluation of 
butylated hydroxyanisole result ed in the author isation thereof as a feed additive for all animal species excep t cats, by 
Commission Implementing Regulation (EU) 2020/1399 (5).
(4) Article 10(5) of Regulation (EC) No 1831/2003 requires the adoptio n of a Regulation withdra wing from the mark et 
feed additives for whic h no application in accordance with Article 10(2) and (7) of that Regulation was submitt ed 
before the deadline set in those provisions, or for which an application was submitte d but subsequently withdrawn.
(5) Since the applicant has withdra wn the application with regard to cats, butylate d hydro xyanisole (E 320) should be 
withdra wn from the mark et as a feed additive for cats.
(6) In accordance with Article 7 of Regulation (EC) No 1831/2003, a new application was submitted for the 
author isation of butylated hydroxyanisole as a feed additive for cats, to be classif ied in the catego ry ‘techn ological 
additives ’ and in the functional group ‘antio xidants’. That application was accompanied by the particulars and 
documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(1)OJ L 268, 18.10.2003, p. 29.
(2)Council Directive 70/524/EEC of 23 November 1970 concer ning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).
(3)Council Directive 82/471/EEC of 30 June 1982 concer ning certain products used in animal nutr ition (OJ L 213, 21.7.1982, p. 8).
(4)EFSA Jour nal 2019;17(12):5913.
(5)Commission Implementing Regulation (EU) 2020/1399 of 5 October 2020 concer ning the author isation of butylated hydro xyanisole 
as a feed additive for all animal species excep t cats (OJ L 324, 6.10.2020, p. 29).EN Offi cial Jour nal of the European Union L 119/84 21.4.2022  (7) The European Food Safet y Author ity (‘the Author ity’) concluded in its opinion of 23 June 2021 (6)that, under the 
proposed conditions of use, butylated hydroxyanisole does not have an adverse effect on animal health, consumer 
safety or the environment. It also concluded that the additive should be considered as a skin and eye irritant and a 
poten tial skin 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 also 
concluded that since butylated hydroxyanisole is author ised as an antio xidant for use in food at compar able use 
levels, no studies are required to demonstrate the efficacy of butylated hydroxyanisole as an antio xidant in feed for 
cats. It also verified the repor t on the methods of analysis of the feed additive in feed submitte d by the Reference 
Laboratory set up by Regulation (EC) No 1831/2003.
(8) The assessment of butylated hydroxyanisole 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 butylated hydroxyanisole should be 
author ised as specif ied in the Annex to this Regulation.
(9) As butylated hydro xyanisole as a feed additive for cats is ready to be newly author ised simultaneously to the 
adoptio n of a measure requir ing a withdrawal from the mark et of the additive under the previous conditions of 
author isation in accordance with Article 10(5) of Regulation (EC) No 1831/2003, such withdra wal from the mark et 
should not prevent the effective application of the new author isation. The terms of the new author isation diffe r from 
the previous ones in particular in that they provide for a more specifi c descr iption of the additive and for the related 
methods of analysis, a new identification number of the additive and other provisions relat ed to the directions of use 
and users’ safety for the additive and premixture concer ned.
(10) Since there is no safety reason requir ing the immediate withdrawal from the market of butylated hydroxyanisole as a 
feed additive for cats under the previous conditions of author isation, it is appropr iate to allow a limited transitional 
period for inter ested parties, within which existing stoc ks of butylated hydroxyanisole as a feed additive for cats, 
premixtures, feed mat erials and compound feed produced with that additive may be used up, in order to meet the 
new requirements resulting from the author isation.
(11) 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
Author isation
The substance specifi ed in the Annex, belonging to the additive cate gory ‘technological additives ’ and to the functional 
group ‘antio xidants’, is author ised as an additive in animal nutr ition, subject to the conditions laid down in that Annex.
Article 2
Withdra wal from the market
Butylated hydroxyanisole (E 320) shall be withdrawn from the market as a feed additive for cats to the extent that it does 
not meet the conditions laid down in the author isation referred to in Article 1.
(6)EFSA Jour nal 2021;19(7):6714.EN Offi cial Jour nal of the European Union 21.4.2022 L 119/85  Article 3
Transitional measures concer ning the withdrawal from the market
1. Butylated hydroxyanisole as a feed additive for cats and premixtures containing it, whic h are produced and labelled 
before 11 November 2022 in accordance with the rules applicable before 11 May 2022 may continue to be placed on the 
mark et and used until the existing stoc ks are exhaust ed.
2. Com pound feed and feed mater ials intended for cats containing butylated hydroxyanisole, which are produced and 
labelled before 11 May 2023 in accordance with the rules applicable before 11 May 2022 may continue to be placed on 
the mark et and used until the existing stoc ks are exhaust ed.
Article 4
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 States.
Done at Brussels, 20 Apr il 2022 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 119/86 21.4.2022  ANNEX 
Identifica -
tion 
number of 
the additiveAdditiveChemical formula, descr iption, methods of 
analysisSpecies or 
categor y of 
animalMaximum 
ageMinimum 
contentMaximum 
content
Other provisionsEnd of period of 
author isation mg of active substance/kg of 
complet e feedingstuff with a 
moisture conten t of 12 %
Categor y: Technological additiv es. Functional group: antio xidants
1b320 Butylated 
hydroxyanisoleAdditive composition
Butylated hydro xyanisole (BHA)
(≥ 98,5 %)
Waxy Solid formCats - - 150 1.In the directions for use of the 
additive and premixture, the 
stora ge conditions shall be 
indicated .
2.BHA can be used in combination 
with butylate d hydroxytoluene 
(BHT) up to 150 mg of the 
mixture/kg of compl ete feed.
3.For users of the additive and 
premixtures, feed business opera ­
tors shall establish operational 
procedures and organisational 
measures to address poten tial 
risks resulting from its use. Where 
those risks cannot be eliminated 
or reduced to a minimum by such 
procedures and measures, the 
additive and premixtures shall 
be used with personal prot ective 
equipment, including skin, eye 
and breathing protection.11 May 2032
Char acter isation of the active substance
Mixture of:
— 2-tert-butyl-4-hydro xyanisole
— 3-tert-butyl-4-hydro xyanisole (≥ 85 %)
CAS No: 25013-16-5
C11H16O2
Analytical method (1)
For the quantification of BHA in the feed 
additive:
— Gas Chromat ography coupled to Flame 
Ionization Detection (GC-FID) (FCC7 
method)EN Offi cial Jour nal of the European Union 21.4.2022 L 119/87  For the quantifi cation of BHA in premixtures 
and feedingstuffs:
— Reversed Phase High Performance Liquid 
Chromatograph y coupled to UltraViolet- 
Diode-Ar ray Detection (RP-HPLC-UV - 
DAD, 285 nm)
(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 119/88 21.4.2022  