COMMISSION IMPLEMENTING REGUL ATION (EU) 2023/60 
of 5 Januar y 2023
concer ning the author isation of conjugated linoleic acid (t10, c12)-methylester as a feed additiv e for 
pigs for fattening and dair y cows (holder of 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 an author isation.
(2) The substance conjugat ed linoleic acid (t10, c12)-meth ylester was author ised without a time limit in accordance 
with Council Directive 70/524/EEC (2)as a feed additive for all animal species, and was included in the catego ry 
‘nutr itional additives ’ and functional group ‘vitamins, pro-vitamins and chemically well-defined substances having 
similar effect’. That substance was subsequently entered into the Register of feed additives as an existing product, in 
accordance with Article 10(1), point (b), of Regulation (EC) No 1831/2003.
(3) The inclusion of conjugat ed linoleic acid (t10, c12)-methylest er in the group ‘vitamins, pro-vitamins and chemically 
well-def ined substances having similar effect’ was based on a repor t of 18 March 1994 of the Scientifi c Committ ee 
for Animal Nutr ition on the classificat ion of vitamins in the Annex to Directive 70/524/EEC. This repor t considered 
that this substance had a similar effect to that of a vitamin.
(4) In accordance with Article 10(2) of Regulation (EC) No 1831/2003, in conjunction with Article 7 thereof, an 
application was submitte d on 13 October 2010 for the author isation of conjugat ed linoleic acid (t10, c12)- 
meth ylester as a feed additive for pigs for fattening and dair y cows. The applicant requested the additive to be 
classifie d in the additive categor y ‘nutr itional additives ’ and in the functional group ‘vitamins, pro-vitamins and 
chemically well-def ined substances having similar effect’. The application was accompan ied by the particulars and 
documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(5) The European Food Safety Auth ority (‘the Author ity’) concluded in its opinion of 3 December 2015 (3)that, under 
the proposed conditions of use, conjugat ed linoleic acid (t10, c12)-methylest er used in the nutr ition of pigs for 
fattening and dair y cows does not have adverse effects on animal health, consumer safety or the environment. 
Concer ning pigs for fattening , the Author ity concluded that conjug ated linoleic acid (t10, c12)-meth ylester might 
have a poten tial for an impro vement of the feed to gain ratio. It effectively increases fat firmness due to an increased 
amount of saturated fatty acids in the subcutaneous fat. There is also an increase in intramuscular fat, its degree of 
saturation and in marbling score. Conjugat ed linoleic acid (t10, c12)-meth ylester might also have a potential to 
imp rove the propor tion of lean meat to subcutaneous fat in the carcass. For dair y cows , the Author ity concluded 
that conjugat ed linoleic acid (t10, c12)-methylest er reduces milk fat conte nt and has the poten tial to reduce milk fat 
(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)EFSA Jour nal 2016;14(1):4348.EN Offi cial Jour nal of the European Union 6.1.2023 L 5/19  yield and milk energy output. In a further opinion of 24 Januar y 2019 (4), the Author ity state d that the allocation of 
this additive to the catego ry ‘nutr itional additives ’ did not seem to be justif ied. The Commission, taking into account 
the considerations from the Author ity and the effects of the additive on the zoote chnical performa nce of pigs for 
fattening and dair y cows, has decided to classify this additive under the catego ry ‘zoot echnical additives ’ and under 
the functional group ‘other zootec hnical additives’.
(6) The Author ity concluded that the exposure of users by inhalation of the solid product is likely to be minimal. As 
regards the liquid product, no data on poten tial mist formation were provid ed. A beadlet formulation of the liquid 
product elicited mild but persistent dermal irritation, whereas it was not an eye irritant. The skin sensitisation 
poten tial was masked by the effect of the placebo. Neither the liquid nor the solid product was tested as such for 
skin and eye irritation and skin sensitisation. The Author ity further concluded that the additive was effective. The 
Authority does not consider that there is a need for specifi c requirements of post-market monitori ng. The initial 
method of analysis provided by the applicant was validat ed by the Reference Laboratory set up by Regulation (EC) 
No 1831/2003 and verified by EFSA. Due to the fact that maximum/minimum conte nts are established in the EFSA 
opinion, the first method of analysis was not considered sufficient for the purpose of Regulation (EC) No 1831/2003 
as the method applied only to feed additives but not to premixtures and feedingstuffs and did not quantify the level 
of incor poration of the additive in those premixtures and feedingstuffs. The applicant submitted a second method 
for the quantif ication in premixtures and feedingstuffs that was validate d by the Reference Laboratory .
(7) The assessment of conjugat ed linoleic acid (t10, c12)-methylest er shows that the conditions for author isation, as 
provid ed for in Article 5 of Regulation (EC) No 1831/2003, are satisfi ed. According ly, the use of that substance 
should be author ised. The Commission considers that appropr iate prot ective measures should be taken to prevent 
adverse effects on human health, in particular as regar ds the users of the additive.
(8) Since safet y reasons do not require the immediate application of the modifications to the conditions of author isation 
of conjug ated linoleic acid (t10, c12)-meth ylester to the use of that substance in the nutr ition of pigs for fattening 
and dair y cows, it is appropr iate to allow a transitional period for inter ested parties to prepare themselves to meet 
the new requirements resulting from the author isation.
(9) 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 substance specified in the Annex, belonging to the additive catego ry ‘zootec hnical additives’ and to the functional 
group ‘other zootec hnical additives’, is author ised as a feed additive for fattening pigs and dair y cows, in accordance with 
the conditions laid down in that Annex.
Article 2
1. The substance specified in the Annex and premixtures containing that substance, which are intended for pigs for 
fattening and dair y cows and are produced and labelled before 26 July 2023 in accordance with the rules applicable before 
26 Januar y 2023 may continue to be placed on the market and used until the existing stoc ks are exhausted.
(4)EFSA Jour nal 2019;17(3):5614.EN Offi cial Jour nal of the European Union L 5/20 6.1.2023  2. Feed mater ials and compo und feed containing the substance specified in the Annex, whic h are intende d for pigs for 
fattening and dair y cows and are produced and labelled before 26 Januar y 2024 in accordance with the rules applicable 
before 26 Januar y 2023 may continue to be placed on the mark et and used until the existing stoc ks are exhaust ed.
Article 3
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, 5 Januar y 2023 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 6.1.2023 L 5/21  ANNEX 
Identifica -
tion 
number of 
the additiveName of the 
holder of 
author isationAdditiveComposition, chemical formula, descr iption, analytical 
methodSpecies or 
categor y 
of animalMaximum 
ageMinimum 
contentMaximum 
conten t
Other provisionsEnd of period 
of 
author isationmg of active  
substance/kg of 
complet e feed ingstuff 
with a moisture 
content of 12 %
Category of Zootec hnical additives. Functional group: Other zootec hnical additives (impro vement of zootec hnical parameters/perf ormance)
4d895 BASF SE Conjugat ed 
linoleic acid 
(t10, c12)- 
meth ylesterAdditive composition:
Preparation of omega-6-f atty acid as t10,c12- 
octadecadienoic acid (conjugat ed linoleic acid)- 
meth ylester (CLA(t10,c12)-ME).
Liquid formulation:
CLA (t10,c12)-ME ≥ 28 %
CLA (c9,t11)-ME ≥ 28 %
CLA (t10,c12) < 2 %
CLA (c9,t11) < 2 %
Fatty acids of sunf lower oil: 38-42 % free or as 
meth ylester s and less than 1 % as trans trans 
isomers.
Solid formulation:
CLA (t10,c12)-ME: ≥ 9 %
CLA (c9,t11)-ME: ≥ 9 %
CLA (t10,c12): < 1 %
CLA (c9,t11): < 1 %
Fatty acids of sunf lower oil:13-15 % (free or as 
meth ylester s).
Vegetable oils (hydrog enated triglycerides, 
predominantly stearic acid and to a minor extent 
palmitic
acid): 44,5 %.
Colloidal silica: 15 %.
Calcium sulphate : 5 %.Pigs for 
fattening- 400 5 000 1.In the directions for use of the 
additive and premixtures, the 
stora ge conditions and stabi ­
lity to heat treatment shall be 
indicated .
2.For dair y cows, the level of 
CLA (t10,c12)-ME in the daily 
ration shall not exceed 10 
g/head/da y.
3.For users of the additive and 
premixtures, feed business 
operat ors shall establish op­
erational procedures and or­
gani sational measures to ad­
dress pote ntial health risks 
resulting from their use. 
Where those risks cannot be 
eliminated or reduced to a 
minimum by such proce ­
dures and measures, the addi ­
tive and premixtures shall be 
used with personal protect ive 
equipment, including eye and 
skin protection.26.1.2033
Dair y 
cows175 350
- -EN Offi cial Jour nal of the European Union L 5/22 6.1.2023  Char acter isation of the activ e substance:
Conjug ated linoleic acid (t10,c12)-methylest er.
Chemical formula: C19 H34O2
CAS number : 21870-97-3
Analytical method :(1)
— For the deter mination of Omega- 6-fatty acid as 
octadecadienoic acid (trans-10, cis-12- isomer) 
in feed additive: gas Chromat ography coupled 
to Flame Ionization Detector (GC-FID)
—For the quantifi cation of CLA (t10,c12)-meth y­
lester in premixtures and feedingstuffs:
— high performance liquid chromat ography 
coupled to spectrophotom etric detection 
(HPL C-UV)
(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 6.1.2023 L 5/23